Cardiac aorto-mitral prosthesis for human heart

Abstract

To provide a cardiac aorto-mitral prosthesis for a human heart that replaces a cardiac aorto-mitral curtain during a surgical operation to the human heart.SOLUTION: A cardiac aorto-mitral prosthesis enables anatomically replacing a cardiac aorto-mitral curtain which may be affected during replacement of a mitral valve or an aortic valve. The cardiac aorto-mitral prosthesis offers a shaping that matches the anatomic shape of an intervalvular fibrous body including left and right fibrous trigons between the mitral valve and the aortic valve. The cardiac aorto-mitral prosthesis can be implanted quickly during a surgical operation, thereby shortening an operation time and simplifying a surgical procedure. The cardiac aorto-mitral prosthesis improves the recovery perspective and physical wellness of a patient after the surgical operation. The present invention is also directed to a process for production of the cardiac aorto-mitral prosthesis.SELECTED DRAWING: Figure 22

Description

[Technical Field]

[0001] The present invention relates to an aortic-mitral valve prosthesis for a human heart that replaces the aortic-mitral valve curtain during a surgical procedure on the human heart. The prosthesis is capable of anatomically replacing the aortic-mitral valve curtain that may be affected during mitral or aortic valve replacement. The aortic-mitral valve prosthesis provides a shape that conforms to the anatomical shape of the intervalvular fibrous body, including the left and right fibrous trigones between the mitral and aortic valves. The aortic-mitral valve prosthesis can be implanted quickly during surgery, thereby shortening the surgical time and simplifying the surgical procedure. The aortic-mitral valve prosthesis improves the recovery and physical health of patients after surgery. The present invention also relates to a process for manufacturing the aortic-mitral valve prosthesis. [Background technology]

[0002] Surgeries on the human heart today are often performed for anatomical replacement of the mitral valve, aortic valve, or both the mitral and aortic valves. Such aortic or mitral valve replacements are often performed due to valvular endocarditis. The intervalvular fibrous tissue, part of the central fibrous tissue of the human heart, is anatomically located between the aortic and mitral annulus. During surgery for aortic or mitral valve replacement, the tissue of the intervalvular fibrous tissue of the human heart between the aortic and mitral annulus must frequently be replaced. The reason for such replacement may be, for example, damage to the intervalvular fibrous tissue due to infective endocarditis or degenerative calcification. The intervalvular fibrous tissue in the human heart at the specific location between the aortic and mitral annulus is also known in the art as the cardiac aortic-mitral valve curtain.

[0003] Intervalvular fibrous body replacement is known in the state of the art. The currently most widely used reconstruction technique for intervalvular fibrous body replacement during aortic and mitral valve replacement was described and developed by TEDavid et al. (TEDavid et al., J. Thorac. Cardiovasc. Surg., "Aortic and Mitral Valve Replacement with Reconstruction of the Intervalvular Fibrous Body," Volume 114(5), pp. 766-771, 1997). This method uses a single pericardial patch to reconstruct the intervalvular fibrous body with an artificial cardiac aortic-mitral valve curtain. After opening the aortic and mitral valves, the diseased intervalvular fibrous body is removed, and appropriately tailored patches of Dacron or bovine pericardium are sutured to the lateral and central fibrous trigone and the aortic root, reestablishing the aortic and mitral valve annulus. The aortic and mitral valves are then replaced. This method reconstructs the cardiac aortic-mitral valve curtain for replacement of the intervalvular fibrous body, but does not replace the anatomical right and left fibrous trigones of the human heart. Therefore, the right and left fibrous trigones of the heart are often left inadequately cared for during aortic or mitral valve replacement.

[0004] Replacement of intervalvular fibrous bodies in human cardiac surgery is often referred to in the state of the art as the "Commando" procedure.

[0005] The risks of the method described by TEDavid et al. have been investigated. Davierwala et al. (Davierwala et al., "Double valve replacement and reconstruction of the intervalvular fibrous body in patients with active infective endocarditis," European Journal of Cardio-Thoracic Surgery, Volume 45, Issue 1, pp. 146-152, 2014) further investigated the risks associated with such replacement of the intervalvular fibrous body during infective endocarditis. Statistical data on the likelihood of success and mortality rates for surgery to replace the intervalvular fibrous body have been established. The same method as TEDavid et al. has been applied. A single pericardial patch is used to reconstruct the intervalvular fibrous body. This patch is an elliptical patch, to which the anterior annular periphery of the mitral valve prosthesis and the noncoronary periphery of the aortic valve prosthesis are sutured. It was concluded that reconstruction of the intervalvular fibrous membrane, although a surgical procedure with certain risks, is the only option for repairing damage to the intervalvular fibrous membrane caused by infective endocarditis. If this disease is left untreated, the mortality rate approaches 100%.

[0006] Petterson et al. (Petterson et al., Multimed Man Cardiothorac Surg., "Reconstruction of fibrous skeleton: technique, pitfalls and results", 2014, DOI: 10.1093 / mmcts / mmu004) describe the reconstruction of torn or disrupted intervalvular fibrous bodies during aortic and mitral valve replacement. The importance of mitral valve sizing and the use of an allograft for the aortic valve is described. The same method as TE David et al. is applied. An elliptical pericardial patch is used to reconstruct the intervalvular fibrous bodies. The problem of replacement of the right and left fibrous trigones of the human heart is not mentioned and remains under-cared for.

[0007] (Basel Ramlavi et al., Operative Techniques in Thoracic and Cardiovascular Surgery, "Endocarditis with Involvement of the Aorto-Mitral Curtain," Volume 16, No. 3, October 25, 2019, XP028392709, ISSN: 1522-2942, DOI: 10.1053 / J.OPTECHSTCVS.2011.09.004, retrieved on October 25, 2011, pp. 242-249) describe a surgical treatment of aortic and mitral endocarditis in a human heart involving the aorto-mitral curtain. The document provides a descriptive illustration of the human cardiac anatomy around the aorto-mitral valve complex and describes the removal of an infected aortic valve, revealing disruption of the aorto-mitral curtain below the aortic annulus. This disruption is described as a defect typically involving infected or devitalized tissue in the aortic-mitral valve curtain below the aortic annulus, which is then surgically removed and repaired with a pericardial patch. The document does not show or describe any defects in tissue involving or exposing the trigone of the human heart.

[0008] However, some procedures for replacing the intervalvular fibrous body require replacement of the entire intervalvular fibrous body, located between the aortic and mitral annulus, including the entire left and right trigones. In particular, larger areas of the intervalvular fibrous body must be replaced when the infection spreads to the aortic or mitral valve annulus or both. Even when surgical resection of the fibrous trigones is performed, the proposed replacement is inadequate because the pericardial patch does not conform to the shape of the entire aortic-mitral valve curtain, including the trigones. Removal of the trigones without replacement places strain on the surgical sutures, and the success rate of the surgery decreases depending on how much trigonal tissue is lost. As a result, suture rupture and uncontrollable, life-threatening bleeding can occur during surgery, with significant late complications related to massive bleeding, further infection, and the development of interventricular or interatrial shunts and aneurysms.

[0009] In many cases, the right fibrous trigone, located between the tricuspid, aortic, and mitral annulus, is affected by tears and tension. To solve this problem, an additional quadrangular pericardial patch can be used to replace the portion of the right fibrous trigone located between the additional right coronary artery or noncoronary artery commissure of the aortic valve and an additional segment of the aortic annulus up to the septal segment of the tricuspid annulus. While this procedure can reduce tension on the right-sided sutures of the pericardial patch replacing the aortic-mitral valve curtain, the difficult-to-access left trigone remains unattended, potentially resulting in postoperative suture rupture and bleeding. Importantly, the left trigone remains unattended in all known surgical procedures to date, and its anatomical location, inferior to and close to the origin of the left main coronary artery, represents the most challenging location for surgical access. As a result, tension on the aortic-mitral valve curtain increases, which can lead to tension within the aortic-mitral valve curtain, subsequent rupture of the aortic-mitral valve curtain, and other complications. Typically, in this defect, tension is imposed on the sutures of the pericardial patch, thereby reducing the lifespan of the pericardial patch for the aortic-mitral valve curtain. These defects can occur during surgery or can result in multiple cumulative problems after surgery.

[0010] Several options are available that can reduce tension in the cardiac aortic-mitral valve curtain. The extension of the left atrial roof incision to a left-right atrial transseptal incision, required during valve replacement surgery, and the replacement of the incision with a pericardial patch results in the conversion of the left atrial roof pericardial patch to a transseptal atrial pericardial patch. This approach can reduce tension and subsequent rupture of the aortic-mitral valve curtain. However, the techniques required for this approach increase the complexity and duration of the surgery, thus creating additional risks for the patient.

[0011] The tension on the pericardial patch sutures of the aortic-mitral valve curtain can also be reduced by adding elastic biological or semi-elastic prosthetic material along the aortic annulus. Such tension reduction has been achieved in the state of the art when aortic valve replacement is performed with aortic root replacement and ascending aorta replacement with aortic prostheses. Aortic valve replacement, aortic root replacement, and ascending aorta replacement with aortic prostheses have been reported by Bentall (Bentall H., DeBono A., "A technique for complete replacement of the ascending aorta," Thorax, volume 23, pp. 338-339, 1968). In a preferred embodiment, an entirely biologic homograft may be used for this technique, as described by Quintana (Quintana et al., Ann. Cardiothorac. Surg., "Infective aortic valve endocarditis with root abscess formation: a mitral sparing root-Commando operation," volume 8(6), pp. 711-712, 2019, doi:10.21037 / acs.2019.06.09). These strategies can reduce tension on the pericardial patch sutures of the aortic-mitral valve curtain.

[0012] Stress on the pericardial patch sutures can also be reduced by implanting the aortic valve prosthesis high in the ascending aorta, far above the anatomical aortic annulus. The aortic-mitral valve curtain prosthesis used in this case only needs to support the mitral valve and is less susceptible to stress and tearing. This technique was disclosed by Cabrol et al. (Cabrol et al., J. Thorac. Cardiovasc. Surg., "Complete replacement of the ascending aorta with reimplantation of the coronary arteries: a new surgical approach," volume 81, pp. 309-315, 1981). For this procedure, a tubular prosthesis made of Dacron material is used. However, this technique alters the anatomy of the aortic valve, which is often undesirable for the patient's overall physical health. Furthermore, this approach increases the complexity and duration of the surgical procedure, thus creating additional risks for the patient.

[0013] The techniques listed above can partially alleviate the problems of sutures and tension in the pericardial patch replacing the aortic-mitral valve curtain. However, these techniques increase the complexity and duration of cardiac surgery. Furthermore, the above-mentioned techniques aim to reduce the technical drawbacks of existing procedures for replacing the aortic-mitral valve curtain. All of the described procedures replace only the central portion of the intervalvular fibrous body. These procedures do not aim to perform an anatomical reconstruction of the entire aortic-mitral valve curtain. The intervalvular fibrous body, including the right and left trigones, remains unattended. [Prior art documents] [Non-patent literature]

[0014] [Non-Patent Document 1] TE David et al., J. Thorac. Cardiovasc. Surg., "Aortic and mitral valve replacement with reconstruction of the intervalvular fibrous body", volume 114(5), pp. 766-771, 1997 [Non-patent document 2] Davierwala et al., European Journal of Cardio-Thoracic Surgery “Double valve replacement and reconstruction of the intervalvular fibrous body in patients with active infective endocarditis”, volume 45, issue 1, pp. 146-152, 2014 [Non-patent document 3] Petterson et al., Multimed Man Cardiothorac Surg., “Reconstruction of fibrous skeleton: technique, pitfalls and results”, 2014, DOI:10.1093 / mmcts / mmu004 [Non-patent document 4] Basel Ramlavi et al., Operative Techniques in Thoracic and Cardiovascular Surgery, “Endocarditis with Involvement of the Aorto-Mitral Curtain,” Volume 16, No. 3, October. 25, 2019, XP028392709, ISSN:1522-2942, DOI:10.1053 / J.OPTECHSTCVS.2011.09.004, retrieved on October 25, 2011, pp. 242-249 [Non-patent document 5] Bentall (Bentall H., DeBono A., "A technique for complete replacement of the ascending aorta", Thorax, volume 23, pp. 338-339, 1968) [Non-patent document 6] Quintana et al. (Quintana et al., Ann.Cardiothorac.Surg., "Infective aortic valve endocarditis with root abscess formation: a mitral sparing root-Commando operation", volume 8(6), 711~712, 2019 pages, doi:10.21037 / acs.2019.06.09) [Non-Patent Document 7] Cabrol et al. (Cabrol et al., J. Thorac Cardiovasc. Surg., "Complete replacement of the ascending aorta with reimplantation of the coronary arteries: new surgical approach", volume 81, pp. 309-315, 1981) [Non-patent document 8] S.Manouguian, PGKirchhoff, Ann.Thorac Surg. "Patch enlargement of the aortic and the mitral valve rings with aortic-mitral double-valve replacement", volume 30(4), pp. 396-399, 1980 Summary of the Invention

[0015] Therefore, means are sought to reduce the surgical risk in patients requiring replacement of the aortic-mitral valve curtain during surgery on the mitral or aortic valve of the human heart. Further, means are sought to provide a pericardial patch that reduces the risk of strain and rupture of the human heart during and after surgery involving replacement of the intervalvular fibrous body.

[0016] Those skilled in the art have an objective to provide a means for the replacement of the intervalvular fibrous body with the aortic-mitral valve curtain during surgery on the human heart, while reducing the risk of strain and tearing of the replaced aortic-mitral valve curtain, as well as reducing the surgical risk to the patient.

[0017] The present patent application solves this object by a pericardial patch that serves as an aortic-mitral valve prosthesis that replaces the intervalvular fibrous body with the aortic-mitral valve curtain of a human heart having a shape that matches the anatomical shape of the intervalvular fibrous body, including the left and right fibrous trigones.

[0018] This aortic-mitral valve prosthesis, which replaces the aortic-mitral valve curtain of the human heart in its anatomical shape, significantly eliminates the risk of strain and rupture, reduces surgical complexity, shortens surgical time, improves surgical outcomes, and prevents complications. Furthermore, the optimized positioning of the replaced or repaired aortic and mitral valves and the annular support of the implanted prosthetic valves improve postoperative cardiac function and significantly increase the chances of successful surgical repair.

[0019] During surgery, the present invention can be implanted through both a transaortic left atrial roof surgical approach or a transaortic transseptal approach, with a surgical incision in the left atrial roof leading to the right atrial roof.

[0020] The aortic-mitral cardiac prosthesis is also easy to manufacture, which makes the prosthesis versatile for the surgeon.

[0021] The present patent application describes a cardiac aortic-mitral valve prosthesis for the human heart, consisting of a pericardial patch forming a template for the aortic-mitral valve curtain, a central line, the central line comprising two leaflets separated by a mental partition separating a cardiac aortic-mitral valve prosthesis into a first leaflet and a second leaflet for placement of the cardiac aortic-mitral valve prosthesis between the aortic valve and the mitral valve during a surgical procedure on a human heart; one first leaflet having a first leaflet recess that serves to contain the aortic annulus and the other second leaflet having a second leaflet recess that serves to contain the mitral annulus; The aortic-mitral cardiac prosthesis has one larger recess on both leaflets to support the tricuspid annulus; The present invention primarily claims a cardiac aortic-mitral valve prosthesis, in which on both leaflets, opposite the larger recess, there is an outer edge that forms a support for the inner lining framework of the atrioventricular junction of the human heart.

[0022] Depending on the surgical problem and the placement of the aorto-mitral valve prosthesis, the aorto-mitral valve prosthesis allows for anatomical restoration of the aorto-mitral angle between the mitral and aortic valves. This strategy also reduces the risk of left ventricular outflow tract obstruction. The first and second leaflets of the aorto-mitral valve prosthesis ensure complete anatomical replacement of the intervalvular fibrous body, including the left and right fibrous trigones.

[0023] In an important embodiment of the present invention, the mental divider, which separates the aortic-mitral valve prosthesis into a first leaflet and a second leaflet between the aortic and mitral valves of a human heart, is marked with a visible line. The visible line marks the contact line of the aortic-mitral valve prosthesis between the attachment points of the left coronary artery and the aortic root to the wall of the non-coronary sinus and the attachment point of the left atrial roof to the aortic-mitral valve curtain. This measure saves time during surgery on the human heart, which is often crucial. In one embodiment, the visible line is marked on the pericardial patch with a physiologically inert color. Physiologically inert colors are known to those skilled in the art. The mental divider is usually located centrally between the first and second leaflets. The mental divider is the central line that separates the prosthesis into two tubular portions between the aortic and mitral valves of a human heart.

[0024] In another embodiment, the mental divider is marked with a crease instead of a color. The crease eliminates the use of color, which is useful when color is inappropriate when an immunological reaction is expected. This may apply, for example, to patients prone to immunological reactions or when physiologically inert colors are unavailable for marking. Marking with sutures is also feasible.

[0025] In yet another embodiment of the present invention, the aortic-mitral valve prosthesis has markings present thereon that mark the location of at least one commissure of the aortic valve or mitral valve. These markings mark the location of the commissures within the prosthetic valve that will be implanted into a human heart during surgery, which aids in the alignment of the prosthetic valve. The commissures that can be aligned by the markings include, for example, the left coronary artery commissure, the left non-coronary artery commissure, the right coronary artery commissure, or the right non-coronary artery commissure, or a combination of these commissures of the aortic valve. The commissure may also be the right commissure, the left commissure, or the center of the anterior annulus or a combination of these commissures of the mitral valve. The markings allow the surgeon to quickly and appropriately align the aortic-mitral valve prosthesis with the markings on the pericardial patch during surgery, corresponding to the anatomical locations of the commissures within the human heart. This further saves time and improves the functional outcome of surgical reconstruction.

[0026] In a further important embodiment, the pericardial patch serving as the aortic-mitral valve prosthesis may be extended by another additional third leaflet attached to the aortic-mitral valve prosthesis along the mental partition and serving to replace or expand either the wall of the aortic root or the wall of the ascending aorta. The third leaflet is typically attached by sutures. This additional third leaflet then provides a three-leaflet aortic-mitral valve prosthesis.

[0027] Replacement or enlargement of either the aortic wall, aortic root, or ascending aorta during surgical procedures on the human heart is known in the state of the art. Replacement or enlargement is usually accomplished with a single pericardial patch without the addition of an additional pericardial patch, and is also known as "Manouguian" reconstruction or enlargement (S. Manouguian, PG Kirchhoff, Ann. Thorac Surg. "Patch enlargement of the aortic and the mitral valve rings with aortic-mitral double-valve replacement," Volume 30(4), pp. 396-399, 1980). The aortic-mitral valve curtain of the present invention can be easily supplemented with "Manouguian" reconstruction or enlargement by attaching a third leaflet to the aortic-mitral valve prosthesis along the mental partition.

[0028] The use of an additional third leaflet is indicated when damage to the heart extends to the wall of the aortic root or the wall of the ascending aorta, or when aortic root enlargement is required. The additional third leaflet consists of a pericardial patch. This eliminates the need for a separate repair of the aortic wall with a pericardial patch, thereby saving time during surgery and reducing the risk of misplacement of the aortic-mitral curtain and the wall of the aortic root or ascending aorta. When the Bentall procedure described above is used to replace the aortic valve, root, and wall, the third leaflet can also be used to reconstruct and close the left atrial roof incision, respectively.

[0029] In a further important embodiment, the pericardial patch serving as the aortic-mitral valve prosthesis may be expanded by a fourth leaflet, also attached to the aortic-mitral valve prosthesis along the mental partition. When a fourth leaflet is present, the third leaflet is used to expand the aortic valve annulus and root, and the fourth leaflet is used to replace or close the left atrial roof at the location of the atriotomy. The fourth leaflet is typically attached by sutures. This fourth leaflet then provides a four-leaflet aortic-mitral valve prosthesis. The fourth leaflet is typically used to close or expand the left atrial roof at the location of the surgical incision. Like the third leaflet, the fourth leaflet is made of a pericardial patch. The use of aorto-mitral valve prostheses with a fourth leaflet is indicated when a surgical incision into the left atrial roof is implemented to expose and perform surgery on the mitral or aortic valve, and when replacement of the aorto-mitral valve curtain is required, which is often the case when damage to the heart extends deep into the intervalvular fibrous body and mitral annulus.

[0030] The fourth leaflet eliminates the need for separate repair of the left atrial roof with a separate pericardial patch, saving time during surgery and reducing the risk of misplacement of the left atrial roof pericardial patch relative to the aortic-mitral valve curtain. Insertion of a four-leaflet aortic-mitral valve prosthesis replaces the anatomic aortic-mitral valve curtain, displacing the wall of the ascending aorta or aortic root and closing or expanding the left atrial roof at the location of the surgical incision. The 360° mobility of the four leaflets relative to each other and the mobility of the anterior mitral annulus relative to the left coronary or noncoronary aortic annulus completes the reestablishment of the native anatomic and individual aortic-mitral valve angle. This further optimizes left ventricular function by reducing tension on surgical sutures, maintaining aortic and mitral annular deflection independently, and preventing left ventricular outflow obstruction. Furthermore, the 360° mobility of the four leaflets relative to each other and the mobility of the anterior mitral annulus relative to the left coronary or non-coronary aortic annulus stabilizes the excursions of the aortic and mitral annulus during the cardiac cycle.

[0031] An additional fourth leaflet, attached to the aortic-mitral valve prosthesis along the mental partition to close or expand the left atrial roof, may also be used to cover the wall of the ascending aorta instead of the third leaflet, resulting in a three-leaflet aortic-mitral valve prosthesis. The use of this pericardial patch, which has only a fourth leaflet as an additional leaflet to the first and second leaflets of the aortic-mitral valve prosthesis, is particularly indicated when the procedure described by Bentall et al. involves replacement of the entire aortic root with the ascending aorta and replacement of the aortic-mitral valve curtain with an aortic-mitral valve prosthesis. In these cases, replacement of the left atrial roof is often necessary. The procedure described by Bentall et al., which uses an aortic-mitral valve prosthesis, can also be applied to an embodiment such as that described by Quintana, which uses an aortic homograft.

[0032] For the aortic-mitral valve curtain embodiments having a third leaflet and an additional fourth leaflet, the different shapes of the third leaflet and the additional fourth leaflet allow differentiation between the aortic and left atrial portions of the aortic-mitral valve curtain, thus enabling correct positioning and implantation of the aortic-mitral valve prosthesis during surgery. The different shapes of the triangular embodiment with three leaflets and the square embodiment with four leaflets allow differentiation between the left atrial and aortic portions of the aortic-mitral valve prosthesis, thus enabling correct positioning and rapid implantation of the aortic-mitral valve prosthesis during surgery.

[0033] In a further embodiment of the present invention, a cardiac aortic-mitral valve prosthesis includes an aortic valve and a first leaflet extension extending the end of the right aortic annulus supporting the tricuspid annulus. The use of the first leaflet extension is indicated when damage to the heart extends beyond the right fibrous trigonal segment and into the entire intervalvular fibrous body and the right annular portion of the aortic valve and the tricuspid annulus. This type of damage frequently occurs when inflammation of the aortic annulus extends through the central fibrous body into the aortic annulus and the tricuspid annulus.

[0034] The use of a pericardial patch as a cardiac aortic-mitral valve prosthesis with a first leaflet extension replaces the entire central fibrous body, including the right aortic valve annulus and the tricuspid valve annulus, avoiding the need for a separate pericardial patch to replace the right aortic valve annulus and support the tricuspid valve annulus. This prevents the misplacement of a separate pericardial patch for the replacement of the right aortic valve annulus, including the aortic valve and supporting the tricuspid valve annulus. This saves time during surgical procedures on human hearts and achieves complete replacement of the entire central fibrous body of the heart. Furthermore, anatomical replacement of the aortic-mitral valve angle is achieved, allowing physiological deviation, restoring the function of the aortic and mitral valve annulus, and reducing the risk of left ventricular outflow obstruction. Furthermore, the aortic-mitral valve prosthesis having the first leaflet extension facilitates correct positioning of the aortic valve relative to the mitral valve, as well as facilitating insertion of the aortic-mitral valve prosthesis and reducing the risk of suture tear and bleeding after surgery.

[0035] In this embodiment with the first leaflet extension, a third leaflet or a fourth leaflet, or both the third and fourth leaflets, can be attached to the aortic-mitral cardiac prosthesis. By attaching the third or fourth leaflet to the aortic-mitral cardiac prosthesis, mechanical stability of both the aortic and tricuspid annulus is achieved throughout the cardiac cycle.

[0036] The first leaflet extension may be marked with a crease or visible line separating it from the end of the first leaflet that includes the aortic valve and supports the tricuspid annulus. The marking or crease allows the extension to properly replace the portion of the central fibrous body located between the aortic and tricuspid annulus and also support the tricuspid annulus during surgery, further minimizing the risk of distortion and tearing. The first leaflet extension can be quickly cut and molded to the desired shape to fit and replace the removed portion of tissue if damage to the aortic annulus is found not to have progressed or to have progressed less than expected during surgery.

[0037] In a further embodiment of the present invention, the aortic-mitral valve prosthesis has a recess extension beyond the recess end of the second leaflet, separating the pericardial patch of the aortic-mitral valve prosthesis over the anterior leaflet of the mitral valve annulus from the unextended aortic-mitral valve prosthesis. This recess extension allows for the replacement of progressive damage to the anterior mitral valve annulus while preserving the natural mitral valve coaptation and preserving the entire posterior leaflet of the mitral valve. This progressive damage may be, for example, inflammation, such as endocarditis, of the aortic-mitral valve curtain, including the anterior leaflet of the mitral valve. This approach allows for the storage of the patch with the recess extension, which can be modified by minor incisions to the pericardial patch without the recess extension, if, after access to the human heart and surgical exposure of the mitral valve, damage to the mitral valve annulus is found to be somewhat extensive, requiring mitral valve replacement. This embodiment may also be indicated in clinical cases of significant left atrial enlargement, in which a fourth leaflet of the prosthesis is not necessary and a reduction in the left atrial roof can be performed instead.

[0038] Aortic-mitral valve curtain replacement associated with aortic valve reconstruction has been described in the state of the art by Quintana et al. (Quintana et al., Ann. Cardiothorac. Surg., "Infective aortic valve endocarditis with root abscess formation: a mitral sparing root-Commando operation," Volume 8(6), pp. 711-712, 2019, doi:10.21037 / acs.2019.06.09). A single oval pericardial patch was used to reconstruct the left atrial roof and the noncoronary sinus and wall of the aortic root. This method is also called the "hemi-Commando" procedure. Extension of the pericardial patch to the aortic annulus creates a so-called "hemi-conduit." This procedure has also been suggested for mitral valve replacement. For aortic annulus replacement, the same method was applied as the original method for replacement of the aortic-mitral valve curtain as described by TEDavid et al. However, Quintana et al. did not reconstruct the aortic-mitral valve curtain, and the Quintana method did not extend to the intervalvular fibrous body, including the left and right fibrous trigones, as in the invention described herein. Mitral annulus replacement was not described.

[0039] In one embodiment of the aortic-mitral valve prosthesis with a recess extension, the recess extension is marked with a visible line extending beyond the recess end, separating it from the non-extended aortic-mitral valve prosthesis. The extension may be cut away by the surgeon during surgery to form a standard aortic-mitral valve prosthesis without the recess extension. The marking allows the extension to be quickly cut away and shaped as desired to replace the removed portion of tissue during surgery if damage to the mitral valve annulus is found not to have progressed or to have progressed less than expected. Similar to the marking on the first leaflet extension, the marking can be applied by a physiologically inert color or crease.

[0040] In a further embodiment of the present invention, a prosthetic mitral valve is attached to an aortic-mitral prosthesis. This approach provides an aortic-mitral prosthesis equipped with an attached prosthetic mitral valve. This attachment is typically performed by suturing. By attaching the prosthetic mitral valve to the aortic-mitral prosthesis, the prosthetic mitral valve can be inserted directly into a human heart for mitral valve replacement when the native mitral valve is damaged and must be replaced. Attaching the mitral valve annulus to the aortic-mitral prosthesis saves time during surgery, making the procedure simpler and more precise for the replacement of the aortic-mitral curtain and mitral valve. The additional attachment of a prosthetic aortic valve to replace the native aortic valve, although less frequently performed, is also within the scope of the present invention.

[0041] The first and second leaflets may be provided with markings for the left and right non-coronary artery commissures and the center of the anterior mitral leaflet of the mitral valve prosthesis, which aids in the alignment of the mitral valve prosthesis during surgery, thereby saving time and improving surgical precision.

[0042] Dual replacement of the mitral and aortic valves by replacing the aortic-mitral valve curtain with markings on the first and second leaflets is highly advantageous. Correctly orienting the prosthetic mitral valve prosthesis after aortic-mitral valve curtain removal is often difficult because the positioning of the mitral valve prosthesis depends on the orientation of the aortic valve. The orientation of the aortic valve further depends on the positioning of the coronary artery origins and cannot be changed. The implantation of the mitral valve prosthesis is usually performed before the implantation of the aortic valve prosthesis, which results in the mitral valve prosthesis having no reference point for positioning the mitral valve commissures for implantation. Marking the left and right noncoronary artery commissures on the first and second leaflets and the center of the anterior mitral leaflet of the mitral valve prosthesis allows for perfect orientation and flawless anatomical positioning of the mitral valve prosthesis and subsequent aortic valve prosthesis. Perfect orientation and flawless anatomical positioning of the mitral and aortic valve prostheses restores optimal function of the left ventricular outflow tract.

[0043] Aortic-mitral valve prostheses are typically made from bovine pericardial patches, such as the Model 4700 (10 cm x 15 cm) manufactured by Edwards Lifesciences, Irvine, California. However, any other suitable pericardial patch for surgical procedures may be used with the aortic-mitral valve prosthesis of the present invention. The pericardial patch may be any other bovine pericardial patch manufactured for surgical implantation or Dacron® fabric. Bovine pericardial patch is a standard material for vascular biological patches, allowing for easy fabrication of the pericardial patch required for aortic-mitral valve prostheses. Dacron® is a polyester graft often used in surgical procedures. Both bovine pericardium and Dacron® materials are well known to those skilled in the art and are readily available commercially. Teflon fabric is also suitable for the pericardial patch of aortic-mitral valve prostheses.

[0044] The present patent application also relates to a process for manufacturing the above-described cardiac aortic-mitral valve prosthesis, comprising: The pericardial patch is obtained and cut into two leaflets separated by the mental partition of the aortic-mitral valve prosthesis; a first leaflet recess is cut into one of the first leaflets to serve to contain the aortic valve annulus; a second leaflet recess is cut into the other second leaflet to serve to contain the mitral valve annulus; and one larger recess cut into the prosthesis on both leaflets to support the tricuspid annulus; Opposite the larger recess, an outer edge is cut that forms a support for the inner layer of the atrioventricular junction of the human heart.

[0045] For the manufacturing process of the aortic-mitral valve prosthesis, a pericardial patch of any size is cut to fit the shape of the aortic-mitral valve prosthesis. The manufacturing process of the aortic-mitral valve curtain may be performed, for example, with medical scissors or a scalpel. The manufacturing process of the aortic-mitral valve prosthesis may be performed before or during a surgical procedure. The process may also be performed on an industrial scale.

[0046] The process for manufacturing cardiac aortic-mitral valve prostheses allows for the easy narrowing and shortening of bileaflet aortic-mitral valve prostheses during human cardiac surgery, resulting in a perfect fit to the size and shape of the portion of the central fibrous body that is removed and requires replacement during cardiac surgery. This anatomical reconstruction reduces the risk of bleeding and rupture.

[0047] The size of an aortic-mitral valve prosthesis is determined by the maximum size of the aortic valve prosthesis and the maximum size of the mitral valve prosthesis. The aortic valve prosthesis has a maximum diameter of 29 mm, and the mitral valve prosthesis has a maximum diameter of 33 mm. The size of the aortic-mitral valve prosthesis can be adjusted during surgery by shrinking the pericardial patch to the dimensions of the missing area of ​​the aortic-mitral valve curtain. Size adjustment can be performed before or during surgery, but pre-surgical adjustment is preferred to ensure sufficient accuracy. The prosthesis can be manufactured to fit multiple different valve sizes before surgery. For example, one sample can conform to a 21 mm aortic valve size and a 25 mm mitral valve size, another sample can conform to a 23 mm aortic valve size and a 27 mm mitral valve size, another sample can conform to a 25 mm aortic valve size and a 29 mm mitral valve size, and a final sample can conform to a 27 mm aortic valve size and a 31 mm mitral valve size.

[0048] The prepared cardiac aortic-mitral valve prosthesis may be stored like a standard pericardial patch. During surgery, the aortic-mitral valve prosthesis can be easily thinned with scissors to fit the size and shape of the excised portion of the human heart intervalvular fibrous tissue.

[0049] In one embodiment of the present invention, an additional third leaflet is attached to the aortic-mitral valve prosthesis to cover the aortic wall. By attaching the additional third leaflet, an aortic-mitral valve prosthesis can be provided that can replace the walls of the aortic root and ascending aorta corresponding to the left coronary sinus and the non-coronary sinus of the aortic root. By attaching the third leaflet to the aortic-mitral valve prosthesis, an aortic-mitral valve prosthesis with three leaflets is provided. The additional third leaflet is preferably attached along the mental partition. This three-leaflet pericardial patch then forms a triangular aortic-mitral valve prosthesis. Attachment is preferably performed by suturing. The third leaflet can be adjusted to fit the missing portion of the aortic root and wall that needs to be replaced.

[0050] In a further embodiment of the present invention, an additional fourth leaflet is attached to the aortic-mitral valve prosthesis as an additional leaflet for covering the left atrial roof. Attaching the additional fourth leaflet provides an aortic-mitral valve prosthesis that can cover or expand the left atrial roof at the location of the atriotomy. Attaching the fourth leaflet to the aortic-mitral valve prosthesis provides an aortic-mitral valve prosthesis with four leaflets. The additional fourth leaflet is preferably attached along the mental partition. This four-leaflet pericardial patch is then a quadrangular aortic-mitral valve prosthesis. Attachment is preferably performed by suturing. The fourth leaflet may also be attached to the aortic-mitral valve prosthesis as another leaflet instead of the third leaflet. In this latter case, a three-leaflet pericardial patch including the fourth leaflet is also provided. The fourth leaflet can be tailored to fit the shape and orientation of the left atrial surgical incision for surgical reconstruction of the left atrial roof.

[0051] Resizing of the third and fourth leaflets may be accomplished with, for example, scissors or a scalpel.

[0052] The aortic-mitral valve prosthesis may also be manufactured by leaving a recess extension in the second leaflet recess of the pericardial patch over the mitral valve annulus when cutting the second leaflet recess for the mitral valve annulus. The recess extension in the pericardial patch of the aortic-mitral valve prosthesis over the mitral valve annulus can replace the base of the annulus, including the mitral valve, or the base of the anterior leaflet of the mitral valve during surgery. This recess extension can replace damage progressing to the mitral valve annulus, possibly involving the anterior leaflet. This progressing damage may be, for example, inflammation. The recess extension can be cut off by the surgeon during surgery when damage in the mitral valve annulus requires mitral valve replacement.

[0053] An aortic-mitral valve prosthesis can also be manufactured by integrating a mitral valve prosthesis into an aortic-mitral valve prosthesis, thus providing an aortic-mitral valve curtain prosthesis with an attached mitral valve prosthesis. The attached mitral valve prosthesis is preferably an artificial valve such as a mechanical valve or a biological valve. The aortic-mitral valve curtain prosthesis with an attached mitral valve prosthesis can be directly inserted into a human heart for mitral valve replacement when the native mitral valve is damaged and must be replaced along with the aortic-mitral valve curtain replacement. The aortic-mitral valve curtain prosthesis with an attached aortic valve prosthesis can be directly inserted into a human heart for aortic valve replacement when the native aortic valve is damaged and must be replaced along with the aortic-mitral valve curtain replacement.

[0054] The aortic-mitral valve prosthesis of the present invention may preferably be used in surgical procedures on the human heart, however, it is also contemplated that the aortic-mitral valve prosthesis may also be used in animal hearts having comparable anatomy.

[0055] The present invention has the advantage of providing a cardiac aortic-mitral valve prosthesis with a pericardial patch that reduces surgical risk for the patient and reduces the risk of strain and tearing of the aortic-mitral valve curtain and intervalvular fibrous membrane. Furthermore, the pericardial patch can be more easily and properly positioned during surgery, thereby reducing the surgical risk for the surgeon. The described cardiac aortic-mitral valve prosthesis, which further reduces surgical risk, can save time. Additional surgical procedures are eliminated, which is beneficial to the health and well-being of the patient. Finally, the cardiac aortic-mitral valve prosthesis can be easily manufactured, thereby making the prosthesis more versatile for the surgeon.

[0056] The present invention is further illustrated by the drawings at 56. The drawings are merely illustrative of examples and embodiments of the present invention and are not intended to limit the scope of the invention. The cardiac aortic-mitral valve prosthesis is a pericardial patch that replaces the intervalvular fibrous body of the heart. [Brief explanation of the drawings]

[0057] [Figure 1] FIG. 1 is a top view showing an aortic-mitral cardiac valve prosthesis according to the claimed invention having a first leaflet and a second leaflet separated by a mental partition. [Figure 2] FIG. 1 is a top view showing an aortic-mitral cardiac valve prosthesis according to the claimed invention having two leaflets separated by a longitudinal mental partition rotated 180°. [Figure 3] FIG. 1 is a top view of a third leaflet as the state of the art for aortic wall and aortic root replacement. [Figure 4] FIG. 1 is a top view of a combined third leaflet for aortic wall and aortic root replacement and a state-of-the-art fourth leaflet for left atrial roof replacement. [Figure 5]FIG. 1 is a top view of the combined third and fourth leaflets rotated 180° according to the state of the art. [Figure 6] 1 shows an aortic-mitral cardiac valve prosthesis according to the claimed invention having a recess extension in the second leaflet recess that can be used to replace the mitral valve annulus. [Figure 7] FIG. 1 is a bottom view of a two-leaflet aortic-mitral cardiac valve prosthesis according to the claimed invention with a recessed extension in the second leaflet and a longitudinal mental partition rotated 180°. [Figure 8] 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention in an embodiment having four leaflets. FIG. [Figure 9] FIG. 1 is a bottom view of an aortic-mitral cardiac valve prosthesis according to the claimed invention in an embodiment having four leaflets. [Figure 10] FIG. 1 is a top view of an aortic-mitral cardiac prosthesis according to the claimed invention having a second leaflet with a recessed extension for mitral valve reconstruction and a fourth leaflet for replacing the left atrial roof. [Figure 11] FIG. 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention rotated 180° and having second and fourth leaflets with recessed extensions for mitral valve reconstruction. [Figure 12] FIG. 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention having a second leaflet without a recess extension and a fourth leaflet for replacing the left atrial roof and a longitudinal mental partition. [Figure 13] FIG. 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention, rotated 180°, having a second leaflet without a recess extension and a fourth leaflet for replacing the left atrial roof and a longitudinal mental partition. [Figure 14]FIG. 1 is a top view showing an aortic-mitral cardiac valve prosthesis according to the claimed invention with the second leaflet in the background and the fourth leaflet in the foreground. [Figure 15] 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention, with a recessed extension in the foreground, to which a third leaflet is attached. FIG. [Figure 16] FIG. 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention, with the second leaflet in the background and the third and fourth leaflets in the foreground. [Figure 17] FIG. 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention, with the second leaflet in the background and the third and fourth leaflets in the foreground. [Figure 18] FIG. 1 is a cross-sectional view of a human heart according to the state of the art, just above the atrioventricular valves, as seen after removing the left and right atria, with anatomy to demonstrate the anatomical location of the left and right fibrous trigone and the localization of the intervalvular fibrous bodies of the heart with the anatomical relationship of the aortic, mitral and tricuspid valves. [Figure 19] FIG. 1 is a cross-sectional view of a human heart, just above the atrioventricular valves, as seen after removal of the left and right atria, in which a cardiac aortic-mitral valve prosthesis according to the claimed invention has been inserted for replacement of the intervalvular fibrous body. [Figure 20] FIG. 1 is a top view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention with four leaflets and an attached artificial mechanical aortic valve prosthesis during a surgical procedure. [Figure 21] 1 is a top view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention with four leaflets and an attached artificial mechanical mitral valve prosthesis during a surgical procedure. FIG. [Figure 22]1 shows a human heart during aortic valve replacement with the third leaflet of a cardiac aortic-mitral valve prosthesis according to the claimed invention for expansion of the aortic wall during surgery while the patient remains on the right side. [Figure 23] 1 shows a human heart in which the aortic valve has been replaced by an artificial biological aortic valve prosthesis with a replaced aortic-mitral valve curtain using an aortic-mitral valve prosthesis according to the claimed invention during a surgical procedure while the patient remains on the right side. [Figure 24] FIG. 1 is a top view showing a human heart in which the aortic valve has been replaced by an aortic-mitral cardiac valve prosthesis according to the claimed invention and an aortic root homograft having a third leaflet covering the aortic wall and a fourth leaflet replacing the left atrial roof with the native anatomic left trigone and the native anatomic right trigone. [Figure 25] FIG. 1 shows a lateral radiographic view of a human heart with a visible prosthetic biological mitral valve and a visible prosthetic biological aortic valve according to the state of the art with a re-established aorto-mitral angle α. [Figure 26] FIG. 1 is a lateral radiographic view of a human heart with a prosthetic mechanical mitral valve and a prosthetic mechanical aortic valve according to the state of the art with a re-established aorto-mitral angle between the valves and an aortic-mitral curtain. [Figure 27] FIG. 1 is a side view showing an aortic-mitral cardiac valve prosthesis according to the claimed invention with an attached third leaflet and an attached fourth leaflet for implantation. [Figure 28] FIG. 1 is a side view of a cardiac aortic-mitral valve prosthesis according to the claimed invention with an attached third leaflet and an attached fourth leaflet of the cardiac aortic-mitral valve prosthesis, with the four leaflets being held between the fingers. [Figure 29]FIG. 1 is a side view of an aortic-mitral valve prosthesis according to the claimed invention with an attached third leaflet and an attached fourth leaflet and extension angle β of the aortic-mitral valve prosthesis, with the four leaflets held between the fingers. [Figure 30] FIG. 1 is a top view showing the incision into the aorta and aortic root of a human heart implanted with a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets and a biological mitral valve prosthesis, as viewed during surgery. [Figure 31] FIG. 1 is a lateral view of the aorta of a human heart during replacement of the aortic wall with a third leaflet according to the state of the art while the patient remains on his right side. [Figure 32] FIG. 1 is an enlarged view of the aorta of a human heart during replacement of the aortic wall and aortic root with a Dacron® patch according to the state of the art in the shape of the third leaflet of an aortic-mitral valve prosthesis while the patient is resting on the right side. [Figure 33] FIG. 1 is a top view of an aortic-mitral cardiac prosthesis according to the claimed invention with an attached prosthetic biological mitral valve. [Figure 34] 1 is a top view of an aortic-mitral cardiac prosthesis according to the claimed invention with an attached prosthetic mechanical mitral valve. FIG. [Figure 35] FIG. 1 is a bottom view of an aortic-mitral cardiac valve prosthesis according to the claimed invention having four leaflets and an attached artificial mechanical mitral valve prosthesis. [Figure 36] FIG. 1 is a bottom view of an aortic-mitral cardiac valve prosthesis according to the claimed invention having four leaflets and an attached artificial biological mitral valve prosthesis. [Figure 37] FIG. 1 is a top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention, with the prosthetic biological mitral valve and attached prosthetic biological aortic valve correctly positioned. [Figure 38]FIG. 1 is a top view of a cardiac aortic-mitral valve prosthesis according to the claimed invention with an attached prosthetic mechanical mitral valve and an attached prosthetic mechanical aortic valve correctly positioned. [Figure 39] FIG. 1 is a phantom top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention having a recess extension of the second leaflet recess for replacing the base of the anterior leaflet of a native mitral valve with an artificial biological aortic valve prosthesis. [Figure 40] FIG. 1 shows a cardiac aortic-mitral valve prosthesis according to the claimed invention having a recess extension of the second leaflet recess for replacing the base of the anterior leaflet of the native mitral valve with an artificial mechanical aortic valve prosthesis. [Figure 41] FIG. 1 is a top view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention, which is composed of two leaflets for the manufacturing process, and a third leaflet for covering the aortic wall and a fourth leaflet for replacing the left atrial roof, which are separated therefrom, in combination. [Figure 42] 1 is a top view of a two-leaflet aortic-mitral cardiac valve prosthesis according to the claimed invention, with a combined third and fourth leaflet in the process of manufacture. FIG. [Figure 43] FIG. 1 is a bottom view of a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets in process of manufacture, with an interrupted suture positioned in the center of the aortic-mitral valve curtain, the first leaflet separating from the second leaflet in the foreground, and the third leaflet separating from the fourth leaflet in the background. [Figure 44] FIG. 1 is a top view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention in the process of being manufactured, with a continuous suture placed in the center of the aortic-mitral valve curtain, the third leaflet separating from the fourth leaflet in the foreground, and the first leaflet separating from the second leaflet in the background. [Figure 45] FIG. 1 is a top view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets, with the fourth leaflet in the foreground and the third leaflet in the background, and an attached artificial biological mitral valve prosthesis attached to the second leaflet. [Figure 46] FIG. 1 is a virtual bottom view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets, with the first and second leaflets in the foreground and the third leaflet in the background, and an attached artificial biological mitral valve prosthesis attached to the second leaflet. [Figure 47] FIG. 1 is a phantom top view of an aortic-mitral cardiac valve prosthesis according to the claimed invention having four leaflets, with an attached third leaflet and an attached fourth leaflet held between forceps, and a prosthetic biological aortic valve attached to the first leaflet and a prosthetic biological mitral valve attached to the second leaflet. [Figure 48] FIG. 1 is a side view of an aortic-mitral cardiac prosthesis according to the claimed invention having four leaflets, including a third leaflet and a fourth leaflet, and a prosthetic biological aortic valve attached to the first leaflet and a prosthetic biological mitral valve attached to the second leaflet. [Figure 49] FIG. 1 is a virtual bottom view showing the final prototype of the cardiac aortic-mitral valve prosthesis according to the claimed invention, having four leaflets, a prosthetic biological aortic valve attached to the first leaflet and a prosthetic biological mitral valve attached to the second leaflet. [Figure 50] FIG. 1 is a top view of a four-leaflet aortic-mitral cardiac prosthesis according to the claimed invention, in which a prosthetic mechanical aortic valve is attached to the first leaflet and a prosthetic mechanical mitral valve is attached to the second leaflet. [Figure 51]FIG. 1 is a side view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets, a prosthetic mechanical aortic valve attached to the first leaflet and a prosthetic mechanical mitral valve attached to the second leaflet. [Figure 52] FIG. 1 is a virtual bottom view showing a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets, a prosthetic mechanical aortic valve attached to the first leaflet and a prosthetic mechanical mitral valve attached to the second leaflet. [Figure 53] FIG. 1 is a top view of a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets after implantation, as viewed from outside the heart during sternotomy towards the aortic root while remaining on the right side of the patient, when the third leaflet has not yet been sutured to the aortic wall and after the left atrial roof has been closed by the fourth leaflet. [Figure 54] FIG. 1 is a top view of a cardiac aortic-mitral valve prosthesis according to the claimed invention having four leaflets, looking towards the aortic root from outside the heart during sternotomy while remaining on the patient's right side, after the aortic valve prosthesis with the second leaflet has been implanted into the aortic-mitral curtain, when the third leaflet has not yet been sutured to the aortic wall and after the left atrial roof has been closed by the fourth leaflet. [Figure 55] FIG. 1 shows a cardiac aortic-mitral valve prosthesis according to the claimed invention, as seen from inside the left ventricle looking towards the aortic-mitral valve curtain, with four leaflets and a prosthetic biological mitral valve prosthesis in the foreground and a prosthetic biological aortic valve prosthesis in the background attached to the first and second leaflets of the cardiac aortic-mitral valve prosthesis, both implanted after surgical implantation. [Figure 56]FIG. 1 shows a cardiac aortic-mitral valve prosthesis according to the claimed invention, as seen from inside the left ventricular outflow tract when looking towards the aortic-mitral valve curtain, with four leaflets, as well as a prosthetic biological mitral valve prosthesis and a prosthetic biological aortic valve prosthesis both attached to the cardiac aortic-mitral valve prosthesis after surgical implantation. DETAILED DESCRIPTION OF THE INVENTION

[0058] Figure 1 shows a cardiac aortic-mitral valve prosthesis (1) in a top view, with two leaflets (2, 3), the first leaflet (2) and the second leaflet (3), separated by a central line and a mental divider (4) that separates the prosthesis (1) into two annular sections (2, 3) between the aortic and mitral valve annulus of a human heart. The first leaflet (2) has a first leaflet recess (5) that serves to contain the aortic valve annulus, while the second leaflet (3) has a second leaflet recess (6) that serves to contain the mitral valve annulus. The mental divider (4) can be marked on the cardiac aortic-mitral valve prosthesis (1), for example, with a physiologically inert marker or a simple crease. The prosthesis (1) has one larger recess (7) on both leaflets (2, 3) for support of the aortic-mitral valve prosthesis (1) against the tricuspid annulus, and an outer edge (8) on the opposite side of the prosthesis (1) on both leaflets (2, 3) that forms support for the inner layer of the atrioventricular junction of the human heart. The aortic-mitral valve prosthesis (1) has two ends (9, 10) on the first leaflet (2). On one end (9), the aortic-mitral valve prosthesis (1) has a first leaflet extension (11) that extends the end (9) to replace the missing annulus of the commissure between the aortic and right coronary cusps of the aortic valve. The first leaflet extension (11) can be adjusted as needed during surgery. The first leaflet extension (11) may have an end (11a) marked by a crease or visible line separating it from the end (9). This aids in aligning the aortic-mitral valve prosthesis (1) during surgery. The aortic-mitral valve prosthesis (1) similarly has ends (12, 13) on the second leaflet (3). These ends (12, 13) are extended by second leaflet extensions (14, 15). The second leaflet extensions (14, 15) are separated from the ends by end markings (14a, 15a).These terminal markings (14a, 15a) aid in the alignment of the second leaflet extensions (14, 15) relative to the anterior and posterior commissures of the mitral valve during surgery. The terminal markings (14a, 15a) can be applied to the cardiac aortic-mitral valve prosthesis (1), for example, by physiologically inert markers, sutures, or simple creases.

[0059] Figure 2 shows a bottom view of an aortic-mitral valve prosthesis (1) composed of two leaflets (2, 3). The device (1) is the same as in the previous figure, but rotated 180°. A mental divider (4) separates the two leaflets (2, 3). A longitudinal mental divider (16) separates the first leaflet (2) and the second leaflet (3) into two halves. The longitudinal mental divider (16) marks the connection from the commissure between the left coronary and non-coronary leaflets of the aortic valve to the center point of the anterior leaflet of the mitral valve. This further aids in the alignment of the aortic-mitral valve prosthesis (1) during surgery. The longitudinal mental divider (16) can also be combined with the mental divider (4). The drawing further shows the first leaflet (2), the second leaflet (3), the termini (9, 10, 12, 13), the first leaflet recess (5) that serves to contain the aortic annulus, the second leaflet recess (6) that serves to contain the mitral annulus, one larger recess (7) for supporting the tricuspid annulus, and the outer edge (8) for supporting the lining of the atrioventricular junction of the human heart.

[0060] 3 shows a third leaflet (17) that can be attached to a cardiac aortic-mitral valve prosthesis (1) along the mental partition (4) for augmentation or replacement of the aortic root and aortic wall. Attachment of the third leaflet (17) to the mental partition (4) of the prosthesis (1) is performed along a straight cut (17a) in the third leaflet pericardial patch (17b).

[0061] Figure 4 shows the third leaflet (17) with the fourth leaflet (18) attached. The fourth leaflet (18) with the fourth leaflet pericardial patch (18a) is attached to the straight cut (17a) of the third leaflet (17). The straight cut (17a) is then attached to the mental compartment (4) of the aortic-mitral cardiac prosthesis (1) by sutures. The fourth leaflet (18) serves to enlarge or close the left atrial roof at the location of the atriotomy.

[0062] Figure 5 shows the third leaflet (17) with the fourth leaflet attached. The pericardial patch is the same as in Figure 4 but rotated 180 degrees. The third leaflet patch area (17b) is used to expand or close the aortic root and aortic wall, while the fourth leaflet patch area (18a) serves to replace or close the left atrial roof at the location of the atriotomy. The fourth leaflet pericardial patch (18a) is attached along the straight cut (17a) in the third leaflet (3). On the other side of the straight cut (17a) between the third leaflet (17) and the fourth leaflet (18), the mental partition (4) between the first leaflet (2) and the second leaflet (3) is located.

[0063] FIG. 6 shows a cardiac aortic-mitral valve prosthesis (1) having a recess extension (19) extending beyond the recess end (19a) that marks the anterior mitral valve annulus. The recess end (19a) without the extension (19) forms a recess (6) that serves to encompass the mitral valve annulus. This recess extension (19) can be used during surgery to replace damage to the anterior mitral valve annulus while preserving natural mitral valve coaptation. The recess extension (19) can be adjusted to its exact size by shrinking it slightly before surgery when the human heart is opened and the extent of damage to the anterior leaflet of the mitral valve is visible. Shrinkage can be achieved, for example, with surgical scissors. The recess extension (19) then replaces the damaged portion of the mitral valve and the mitral valve annulus by suturing the recess extension boundary (19b) of the recess extension (19) to the remaining portion of the anterior mitral valve annulus. Therefore, the recessed extension (19) saves time during surgery and allows for the reconstruction of the mitral valve without unnecessary replacement. The cardiac aortic-mitral valve prosthesis (1) with the recessed extension (19) is also called a "semi-conduit."

[0064] Figure 7 shows a cardiac aortic-mitral valve prosthesis (1) rotated 180° relative to the previous drawing, with a recess extension (19) of the recess terminal (19a) serving to contain the mitral valve annulus. The cardiac aortic-mitral valve prosthesis (1) shows the terminals (9, 10, 12, 13), the recess (5) serving to contain the aortic valve annulus, the recess (6) serving to contain the mitral valve annulus, one larger recess (7) for supporting the tricuspid valve annulus, and the outer edge (8) that forms a support for the inner framework of the atrioventricular junction of the human heart. The mental partition (4) and longitudinal mental partition (16) are visible. The mental partition (4) separates the first leaflet (2) from the second leaflet (3), and the longitudinal central partition (16) separates one half of the first leaflet (2) from the other half of the second leaflet (3). The longitudinal mental divider (16) also aligns the aortic-mitral prosthesis (1) and assists the surgeon in properly aligning the aortic-mitral prosthesis (1). An extension (19) can be seen at the recessed end (19a) that can be used to replace a portion of the mitral valve and helps to encompass the mitral annulus.

[0065] Figure 8 shows a cardiac aortic-mitral valve prosthesis (1) with a third leaflet pericardial patch (17b) for replacing or expanding the aortic root wall and aortic wall, and a fourth leaflet pericardial patch (18a) for reconstructing or closing the left atrial roof in the foreground, while the first leaflet (2) and second leaflet (3) are in the background. The ends (9, 10) of the first leaflet (2) and the ends (12, 13) of the second leaflet (3) are visible. The third leaflet (17) and fourth leaflet (18) are sutured to each other over a straight cut (17a) in the third leaflet pericardial patch (17b). The line of the straight cut (17a) coincides with the mental partition (4) separating the first leaflet (2) and the second leaflet (3). The aortic-mitral valve prosthesis (1) with the third leaflet pericardial patch (17b) and the fourth leaflet pericardial patch (18a) allows the wall of the aorta and aortic root to be covered, and the left atrial roof can be reconstructed by replacing the aortic-mitral valve curtain with the first leaflet (2) and the second leaflet (3). Sutures in a straight cut (17a) across the mental partition (4) fuse all four leaflets in the centerline of the aortic-mitral valve prosthesis (1).

[0066] Figure 9 shows a cardiac aortic-mitral valve prosthesis (1) with the first leaflet (2) and second leaflet (3) in the foreground and the third leaflet pericardial patch (17b) and fourth leaflet pericardial patch (18a) in the background. The second leaflet (3) has a recessed extension (19). The recessed extension allows replacement of damaged portions of the mitral valve and damage progressing to the anterior mitral annulus. The mental partition (4) between the first leaflet (2) and second leaflet (3) is also shown in the foreground. On the other side of the mental partition (4), the third leaflet (17) and fourth leaflet (18) are attached to the first leaflet (2) and second leaflet (3) by sutures along the straight cuts (17a).

[0067] Figure 10 shows the second leaflet (3) with a recessed extension (19) attached to it. Also shown is the mental divider (4) separating the second leaflet (3) from the first leaflet (2), as well as the straight cut (17a) sutured to the mental divider (4), and the fourth leaflet pericardial patch (18a). The second leaflet (3) also has a longitudinal mental divider (16) that aligns with the commissures of the anterior aortic valve leaflet of the mitral valve, thereby providing guidance to the surgeon. This saves time and improves precision during the surgical procedure.

[0068] 11 shows the second leaflet (3) with an attached fourth leaflet (18) having a fourth leaflet pericardial patch (18a) rotated 180° relative to the previous figure. In this embodiment, the first leaflet (2) and second leaflet (3) serve the purposes described for the first leaflet (2) and second leaflet (3), and the fourth leaflet (18) serves the purposes described for the fourth leaflet (18).

[0069] Figure 12 shows the second leaflet (3) with the fourth leaflet (18) attached, which has a fourth leaflet pericardial patch (18a). The mental partition (4) separating the first leaflet (2) from the second leaflet (3), the straight cut (17a) sutured to the mental partition (4), and the additional longitudinal mental partition (16) are visible. The recess extension (19) at the end of the recess (19a) that served to contain the mitral valve annulus was present but has been completely cut away along the end of the recess (19a). Cutting the recess extension (19) is performed when the mitral valve annulus of a human heart is in a normal state after opening the heart, and thus no replacement of the mitral valve or part of the mitral valve annulus is required.

[0070] Figure 13 shows the second leaflet (3) with the attached fourth leaflet (18) as a two-leaflet aortic-mitral prosthesis rotated 180° relative to the previous figure. The recess extension (19) of the recess end (19a) was present but was cut away along the recess end (19a) for surgical procedures, as the mitral valve was shown to be in a normal state.

[0071] Figure 14 shows a fourth leaflet (18) serving to replace the left atrial roof by a fourth leaflet pericardial patch (18a) and a fourth leaflet straight cut (18b) of the fourth leaflet pericardial patch (18a). The fourth leaflet (18) is attached to the second leaflet (3) and the first leaflet (2), which is not visible here. Attachment is achieved by the fourth leaflet straight cut (18b) of the fourth leaflet (18) and a suture along the mental partition (4) between the first leaflet (2) and the second leaflet (3). The ends (12, 13) of the second leaflet (3) are visible.

[0072] Figure 15 shows a third leaflet pericardial patch (17a) attached to the second leaflet (3). The first leaflet (2) is not visible here. Attachment is performed along the mental partition (4) between the first leaflet (2) and the second leaflet (3) and a straight cut (17b) in the third pericardial patch (17). The second leaflet (3) has a recessed extension (19) that partially replaces the anterior leaflet of the mitral valve, helping to achieve valve reconstruction and avoid mitral valve replacement.

[0073] Figure 16 shows a third leaflet pericardial patch (17b) with an attached fourth leaflet pericardial patch (18a) in the foreground. The first leaflet (2) and second leaflet (3) are also attached to the combined third leaflet (17) and fourth leaflet (18). The ends (12, 13) of the second leaflet (3) are visible in the background. The first leaflet (2) is not visible here. This embodiment is indicated when aortic wall replacement with the third leaflet (17) or left atrial roof replacement with the fourth leaflet (18) is being performed, as described above.

[0074] Figure 17 shows, in the foreground, a third leaflet pericardial patch (17b) and a fourth leaflet pericardial patch (18a). A second leaflet (3) is attached along a straight cut (17a) in the other side of the third leaflet pericardial patch (17b). The ends (12, 13) of the second leaflet (3) are visible. The first leaflet (2) is not visible here. This embodiment is indicated when aortic wall replacement with the third leaflet (17) is performed, as described above.

[0075] Figure 18 shows a depiction of a human heart (20) with anatomical features relevant to the use of the present invention. The drawing shows the mitral valve (21), tricuspid valve (22), aortic valve (23), and pulmonary valve (24). Between the mitral valve (21) and the aortic valve (23) is located the aortic-mitral valve curtain (25). Within the aortic-mitral valve curtain (25) are located the left trigone (25a) and the right trigone (25b). The aortic-mitral valve curtain (25) may be damaged, for example, by inflammation following bacterial invasion. It is also possible that the aortic-mitral valve curtain (25) may show damage during another cardiac procedure, such as a valve replacement procedure. In this case, replacement of the aortic-mitral valve curtain (25) must be performed. The cardiac aortic-mitral valve prosthesis (1) of the present patent application is capable of replacing the aortic-mitral valve curtain (25) during surgery on the human heart without the long and risky procedure of a pericardial patch. The mitral valve (21) and tricuspid valve (22) are surrounded by the mitral annulus (21 a) and tricuspid annulus (22 a).

[0076] Figure 19 shows the position of the aortic-mitral valve prosthesis (1) of the present invention for replacement of the intervalvular fibrous body. The aortic-mitral valve prosthesis (1), which is a pericardial patch, replaces the entire aortic-mitral valve curtain (25), including the left fibrous trigone (25a), the right fibrous trigone (25b), and the central portion (25c) of the aortic-mitral valve prosthesis (1). Within the aortic-mitral valve prosthesis (1), the ends (12, 13) of the first and second leaflets (3) of the aortic-mitral valve prosthesis (1) are visible. Due to the shape of the aortic-mitral valve prosthesis (1), replacement can be performed quickly and without risk. The aortic-mitral valve prosthesis (1) is preferably prepared from the pericardial patch prior to surgery.

[0077] Figure 20 shows an aortic-mitral valve prosthesis (1) of the present invention having four leaflets (2, 3, 17, 18) during implantation. The first and second leaflets (2) and (3) have been sewn to a human heart (20). The first and second leaflets (2) and (3) are not visible. The third and fourth leaflets (17) and (18) have been attached to the aortic-mitral valve prosthesis (1). The third and fourth leaflet pericardial patches (17b and 18a) are visible. The artificial mechanical aortic valve prosthesis (26a) has been attached to the aortic-mitral valve prosthesis (1). The third leaflet pericardial patch (17b) is visible, replacing the aortic wall (27a) and covering the ascending aorta (27). A fourth leaflet pericardial patch (18a) for enlargement of the left atrial roof (28) can also be seen. A cardiac aortic-mitral valve prosthesis (1) with an artificial mechanical aortic valve prosthesis (26a) is inserted into a human heart (20) through an aortic wall incision (27b). A third leaflet pericardial patch (17b) is brought close to the aorta (27) to replace the aortic wall (27a) and its aortic wall incision (27b). The third leaflet pericardial patch (17b) is lifted by forceps (29a). The aortic wall (27a) is lifted outward from the surrounding tissue (27c) by another forceps (29b).

[0078] Figure 21 shows the aortic-mitral valve prosthesis (1) with the third leaflet (17) and fourth leaflet (18) being implanted. The third leaflet pericardial patch (17b) and fourth leaflet pericardial patch (18a) are visible. After the first leaflet (2) and second leaflet (3) of the aortic-mitral valve prosthesis (1) are sewn together, the left atrial roof (28) is replaced with the fourth leaflet pericardial patch (18a). The fourth leaflet sewn to the left atrial roof (28) is visible. The third leaflet pericardial patch (17b) is being prepared to close the aortic wall (27a). The aortic-mitral valve prosthesis (1) is inserted along with the artificial mechanical mitral valve prosthesis (30a). The artificial mechanical mitral valve prosthesis (30a) is visible through the aortic valve annulus (23a). The artificial aortic valve prosthesis (26) (not visible) is prepared for insertion. Sutures (31) to the aortic valve annulus (23a) are prepared for the artificial aortic valve prosthesis (26). The left coronary artery ostium (32a) and right coronary artery ostium (32b) are visible in the wall of the aortic root (23b) during the surgical procedure.

[0079] Figure 22 shows a human heart (20) with the natural left trigone (25a) and the natural right trigone (25b) during replacement of the central portion of the aortic-mitral valve curtain (25c) being prepared for closure by a cardiac aortic-mitral valve prosthesis (1). A prosthetic aortic valve prosthesis (26), not visible here, is positioned through the aortic wall incision (27b) for replacement during the surgical procedure on the aortic valve (21) and the aortic-mitral valve curtain (25). The aortic wall (27a) is held outward from the aortic valve (21) by forceps (29a). Additional instruments (33) used during the surgical procedure are also shown.

[0080] Figure 23 shows a human heart (20) with an aortic wall incision (27b). The third leaflet pericardial patch (17b) of the aortic-mitral valve prosthesis (1) is visible, being prepared for replacement of the aortic wall (27a) during surgery. The fourth leaflet pericardial patch (18a) of the aortic-mitral valve prosthesis (1) is visible, closing the left atrial roof (28). Replacement of the aortic-mitral valve curtain (25) with the aortic-mitral valve prosthesis (1) is not visible here. Additional instruments (33) used during surgery are also shown. The native aortic valve (23) is also visible.

[0081] Figure 24 shows a human heart (20) with the left trigone (25a) and right trigone (25b) for replacement of the intervalvular fibrous body between the aortic annulus (23a) and the mitral annulus (21a) with an aortic-mitral valve prosthesis (1). A fourth leaflet pericardial patch (18a) replaces the left atrial roof (28). An aortic conduit prosthesis with a valve (34) for replacing the ascending aorta (27), as described by Bentall et al., is sutured to the aortic-mitral valve prosthesis (1). The aortic conduit prosthesis with a valve (34) for the ascending aorta (27), the aortic-mitral valve prosthesis (1), and the fourth leaflet (18) are lifted with forceps (29a). The aortic root (23b) and aortic wall (27a) are shown. Additional instruments (33) used during the surgical procedure are also shown.

[0082] Figure 25 shows an X-ray of a human heart (20) with an artificial mechanical aortic valve prosthesis (26a) and an artificial mechanical mitral valve prosthesis (30a). Between the artificial valves (30a, 34a), the aorto-mitral angle α (35) can be seen in lateral view. The aorto-mitral valve prosthesis (1) of the present invention perfectly adapts to the aorto-mitral angle α (35) due to its flexibility.

[0083] Figure 26 shows in more detail an X-ray of a human heart (20) within the body. The visible prosthetic biological aortic valve prosthesis (30a) and the visible prosthetic biological mitral valve prosthesis (34a) are visible. The intervalvular fibrous body of the aortic-mitral curtain (25) is located within the aortomitral angle (35). The aortic wall (27a) and the left atrial roof (28) are visible.

[0084] Figure 27 shows a cardiac aortic-mitral valve prosthesis (1) having four leaflets. A third leaflet pericardial patch (17b) and a fourth leaflet pericardial patch (18a) are attached to the first leaflet (2) and the second leaflet (3). The cardiac aortic-mitral valve prosthesis (1) is shown as being used for implantation as a cardiac aortic-mitral valve prosthesis (1). The first leaflet (2) and the second leaflet (3) are attached to each other at the mental partition (4) between the first leaflet (2) and the second leaflet (3). The first leaflet (2) and the second leaflet (3) form the cardiac aortic-mitral valve prosthesis (1). The terminal ends (9, 10) of the first leaflet (2) and the terminal ends (12, 13) of the second leaflet (3) are visible. A third leaflet (17) in the form of a third leaflet pericardial patch (17b) and a fourth leaflet (18) in the form of a fourth leaflet pericardial patch (18a) are attached to the cardiac aortic-mitral valve prosthesis (1). Between the first leaflet (2) and the second leaflet (3), an extension angle β (35a) opens, which is positioned into the aorto-mitral angle α (35) during surgery. During replacement according to the present invention, the first leaflet (2) and the second leaflet (3) are positioned into the aorto-mitral angle α (35) between the mitral valve (21) and the aortic valve (23) of the human heart (20) and between the mitral valve (21) with the intervalvular fibrous body and the aortic valve (23).

[0085] Figure 28 shows a cardiac aortic-mitral valve prosthesis (1) with a first leaflet (2) and a second leaflet (3), an attached third leaflet pericardial patch (17b), and an attached fourth leaflet pericardial patch (18a) between two fingers (36). The cardiac aortic-mitral valve prosthesis (1) is held between two fingers (36) at the fourth leaflet pericardial patch (18a). The termini (12, 13) of the second leaflet (3) and the first leaflet extension (11) are visible. The first leaflet (2) and second leaflet (3) serve to replace the intervalvular fibrous body.

[0086] Figure 29 shows a cardiac aortic-mitral valve prosthesis (1) with a first leaflet (2) and a second leaflet (3), an attached third leaflet pericardial patch (17b) and an attached fourth leaflet pericardial patch (18a) between two fingers (36), and an opening extension angle β (35a) between the first leaflet (2) and the second leaflet (3). The extension angle β (35a) can correspond to the aortomitral angle α (35) between the mitral valve (21) and the aortic valve (23) due to the elasticity of the cardiac aortic-mitral valve prosthesis (1).

[0087] Figure 30 shows the aortic wall incision (27b) into the aortic root (23b) and aortic wall (27a) of the aorta (27) of a human heart (20) with an implanted cardiac aortic-mitral valve prosthesis (1) after implantation of the first leaflet (2) and second leaflet (3) is complete. The aorta is closed with clamps (38). An artificial biological mitral valve prosthesis (30b) is positioned in the human heart (20) and sutured. The incision in the left atrial roof (28) is closed by suturing the fourth leaflet (18) with the fourth leaflet suture (18c) to the left atrial roof (28). The third leaflet pericardial patch (17b) for replacing the aortic wall (27a) is partially sutured with the third leaflet suture (17c) and prepared to replace the aortic wall (27a). The aorta (27) is opened through the aortic wall incision (27b), revealing the left ventricular outflow tract (37) after removal of the native aortic valve (23). In this assembled configuration, the aortic wall (27a) is completely closed by the third leaflet pericardial patch (17b) of the aortic-mitral valve prosthesis (1), after which the surgical procedure is complete. The clamps (38) holding and blocking the ascending aorta (27) are visible.

[0088] Figure 31 shows an aortic wall incision (27b) in the aortic wall (27a) during implantation of a four-leaflet aortic-mitral cardiac prosthesis (1). After the first and second leaflets (2) and (3) have been sewn together, a prosthetic mitral valve prosthesis (30a) is positioned and sewn. The aortic wall incision (27b) is closed by suturing a fourth leaflet pericardial patch (18) to the aortic wall incision (27b). To replace the aortic wall (27a), the third leaflet (17b) is prepared for suturing, and the prosthetic mitral valve prosthesis (30a) is positioned within the aortic valve annulus (23a) for replacement. The fourth leaflet pericardial patch (18a) is shown being prepared to replace the left atrial roof (28).

[0089] Figure 32 shows the ascending aorta (27) of a human heart (20) during the final step of implanting the cardiac aortic-mitral valve prosthesis (1) in the aortic wall (27a). The aortic wall incision (27b) into the aortic wall (27a) is closed by the third leaflet (17) with the third leaflet pericardial patch (17b). The third leaflet (17) is attached to the cardiac aortic-mitral valve prosthesis (1), which is not visible here.

[0090] Figure 33 shows an aortic-mitral valve prosthesis (1) as depicted in Figure 1, with an attached prosthetic biological mitral valve prosthesis (30a). In this embodiment, the aortic-mitral valve prosthesis (1) can be used for replacement of the intervalvular fibrous body by replacing the native mitral valve (21). The mental partition length (4a) of the mental partition (4) of the aortic-mitral valve prosthesis (1) is 26 mm to 34 mm, depending on the size of the prosthetic biological mitral valve prosthesis (30b) and the second leaflet recess (6). The size and dimensions of the aortic-mitral valve prosthesis (1) can be adapted during surgery, for example, by cutting, depending on the individual anatomical characteristics of each patient. The position of the longitudinal mental divider (16) can be used to align the aortic-mitral valve prosthesis (1) during surgery relative to the anterior and posterior commissures of the prosthetic biological mitral valve prosthesis (30a). After attachment of the prosthetic biological mitral valve prosthesis (30a) to the aortic-mitral valve prosthesis (1), the distance (16a) from the second leaflet recess (6) to the mental line (4) is 1 mm in an exemplary embodiment. The mental divider end markings (14a, 15b) on the second leaflet extensions (14, 15) can be used to align the aortic-mitral valve prosthesis (1) relative to the valve sutures (39) of the prosthetic biological mitral valve prosthesis (30b) to the aortic-mitral valve prosthesis (1) during surgery.

[0091] Figure 34 shows an aortic-mitral cardiac prosthesis (1) as described in Figure 1, with a prosthetic mechanical mitral valve prosthesis (30a) attached. This embodiment is identical to the embodiment described in Figure 33, except that the prosthetic biological mitral valve (30b) is the prosthetic mechanical mitral valve (30a).

[0092] Figure 35 shows a bottom view of an aortic-mitral valve prosthesis (1) with four leaflets and an attached prosthetic biological mitral valve prosthesis (30b). The mental partition length (4a) of the aortic-mitral valve curtain (4) is 26 mm to 34 mm, depending on the size of the prosthetic mitral valve prosthesis (30). The size and dimensions of the aortic-mitral valve prosthesis (1) can be adapted during surgery, for example, by cutting, to suit the individual anatomical characteristics of each patient. After attachment of the prosthetic biological mitral valve prosthesis (30b) to the aortic-mitral valve prosthesis (1), the distance (16a) from the second leaflet recess (6) to the mental line (4) is 1 mm in a typical embodiment. The end markings (14a, 15b) on the second leaflet extensions (14, 15) can be used to align the aortic-mitral valve prosthesis (1) with respect to the suturing of the mitral valve (21) to the aortic-mitral valve prosthesis (1) during surgery. The third leaflet (17) and fourth leaflet (18) are visible in the background. The mental divider (4) is the suture line for attachment of the third leaflet pericardial patch (17b) and fourth leaflet pericardial patch (18a).

[0093] Figure 36 shows a cardiac aortic-mitral valve prosthesis (1) with four leaflets and an attached mechanical prosthetic mitral valve prosthesis (34b). This embodiment is identical to the embodiment described in Figure 35, except that a mechanical prosthetic mitral valve prosthesis (30a) is used instead of the prosthetic biological mitral valve prosthesis (30b). Because a prosthetic mechanical mitral valve prosthesis (30a) is used in this embodiment, the longitudinal mental partition (16) can be omitted. The third leaflet 17 (18) and the fourth leaflet are visible in the background.

[0094] Figure 37 shows a cardiac aortic-mitral valve prosthesis (1) with an attached prosthetic biological mitral valve prosthesis (30b) and an attached prosthetic biological aortic valve prosthesis (26b). In this embodiment, the aortic-mitral valve curtain (25) with a left trigon (25a) and a right trigon (25b) can be replaced by the cardiac aortic-mitral valve prosthesis (1) with the prosthetic biological mitral valve prosthesis (30b) and the prosthetic biological aortic valve prosthesis (26b) for replacing the native mitral valve (21) and the native aortic valve prosthesis (23). A longitudinal mental partition (16) is visible within the cardiac aortic-mitral valve prosthesis (1). The longitudinal mental partition (16) can be used to properly align the commissures of the prosthetic biological mitral valve prosthesis (30b) and the prosthetic biological aortic valve prosthesis (26b). Terminal markings (11a, 14a, 15a) are applied to the cardiac aortic-mitral valve prosthesis (1). The terminal markings (11a, 14a, 15a) correspond to the commissures of the prosthetic biological mitral valve prosthesis (30b) and the prosthetic biological aortic valve prosthesis (26b). One of the commissures of the prosthetic biological mitral valve prosthesis (30b) is positioned to correspond to the center of the second leaflet recess (6), and one of the terminal markings (11a) is positioned within the prosthetic biological aortic valve prosthesis (26b) to correspond to the commissure between the left and right coronary cusps, the commissure between the right and non-coronary cusps, and the lowest point of the left coronary commissure of the native aortic valve (23) below the left coronary ostium (32a). The longitudinal mental divider (16) can be used to properly align one of the commissures of the artificial biological mitral valve prosthesis (30b) and the artificial biological aortic valve prosthesis (26b), aiding in proper placement of the artificial valve with the cardiac aortic-mitral valve prosthesis (1).

[0095] Figure 38 shows a cardiac aortic-mitral valve prosthesis (1) with an attached prosthetic mechanical mitral valve prosthesis (30a) and an attached prosthetic mechanical aortic valve prosthesis (26a). Unlike the case of a biological prosthesis, the commissures of the prosthetic mechanical aortic valve prosthesis (30a) do not correspond to the commissure between the left and right coronary cusps, the commissure between the right and non-coronary cusps, or the lowest point of the left coronary commissure of the native aortic valve (23). The center of one of the cusps of the prosthetic mechanical aortic valve prosthesis (26a) corresponds to the lowest point of the left coronary commissure below the left coronary ostium (32a). The commissures of the prosthetic mechanical mitral valve prosthesis (30b) may be positioned equidistant from the end markings (14a, 15a) of the second leaflet (3). At this time, the center of the valve leaflets of the artificial mechanical mitral valve prosthesis (1) corresponds to the center of the anterior mitral annulus (21a). This relationship re-establishes the native thermodynamic properties of the mitral and aortic valves in the left ventricular outflow tract (37) and is therefore crucial for patient recovery.

[0096] Figure 39 shows a cardiac aortic-mitral valve prosthesis (1) with an attached artificial biological aortic valve prosthesis (26b) and a recess extension (19). The surgical procedure performed with this embodiment is also called a "hemi-Commando" procedure. During the surgical procedure, the recess end (19a) of the recess extension (19) replaces the annular portion of the anterior leaflet (21b) of the mitral valve (21) and is sutured with a continuous suture to the remaining tissue of the anterior leaflet (21b) of the native mitral valve (21). Thus, the anterior leaflet (21b) of the mitral valve annulus (21a) is reconstructed, and the portion of the mitral valve (21) damaged by inflammation within the recess extension border (19b) of the recess extension (19) can be removed. In a typical embodiment, the distance (16a) from the second leaflet recess (6) to the mental line (4) of the aortic-mitral valve curtain prosthesis (1) is 1 mm after replacement of the aortic-mitral valve curtain prosthesis (1). The posterior leaflet (21c) of the native mitral valve (21), which was not damaged by inflammation, can be reinforced by the annuloplasty band (21d). Thus, the mitral valve (21) is reconstructed, preserving the native coaptation line of the mitral valve leaflets and the native subvalvular tissue. The commissures of the artificial biological aortic valve prosthesis (30) are positioned below the left coronary ostium (32a), corresponding to the lowest point of the left coronary commissure and the terminal marking (11a) on the first leaflet (2). In this embodiment, the aortic-mitral cardiac prosthesis (1) may also be provided with a third leaflet (17) or a fourth leaflet (18) or a third leaflet (17) and a fourth leaflet (18) on the other side of the mental partition (4).

[0097] Figure 40 shows a cardiac aortic-mitral hemiprosthesis (1) with an attached prosthetic mechanical aortic valve prosthesis (26a) and a recess extension (19). The drawing shows the same embodiment as Figure 39, but with an attached prosthetic mechanical aortic valve prosthesis (26a) instead of an attached prosthetic biological aortic valve prosthesis (30). The end marking (11a) of the first leaflet does not correspond to the commissure between the left and right coronary cusps, the commissure between the right and non-coronary cusps, or the lowest point of the left coronary commissure of the prosthetic mechanical aortic valve prosthesis (26a). However, the center of one of the cusps of the prosthetic mechanical aortic valve prosthesis (26a) corresponds to one of the ends (10) of the first leaflet (2), and thus to the lowest point of the left coronary commissure below the left coronary ostium (32a). Thus, proper placement of the artificial mechanical aortic valve prosthesis (26a) is possible. In this embodiment, the cardiac aortic-mitral valve prosthesis (1) can also be provided with a third leaflet (17) or a fourth leaflet (18) or both a third leaflet (17) and a fourth leaflet (18) on the other side of the mental partition (4).

[0098] Figure 41 shows the process of constructing a four-leaflet aortic-mitral valve prosthesis (1) from a pericardial patch. The aortic-mitral valve prosthesis (1) with a first leaflet (2) and a second leaflet (3) is shaped to the desired configuration. Then, markings on the mental partition (4) and longitudinal mental partition (16) are applied at the discretion of the user. In this embodiment, the aortic-mitral valve prosthesis (1) has a mental partition (4) and a longitudinal mental partition (16) between the first leaflet (2) and the second leaflet (3). The combined third leaflet (17) and fourth leaflet (18) are then shaped to the desired configuration and attached to the aortic-mitral valve prosthesis (1) with the first leaflet (2) and the second leaflet (3). In the most useful embodiment, the attachment of the third leaflet (17) or the fourth leaflet (18) or the third leaflet (17) and the fourth leaflet (18) is performed on the other side of the mental divider (4).

[0099] Figure 42 shows the next step in the construction of a four-leaflet aortic-mitral valve prosthesis (1) from a pericardial patch. The first and second leaflets (2) and (3) of the aortic-mitral valve prosthesis (1) are sutured above the mental partition of the new aortic-mitral valve curtain (4) by means of a third leaflet suture (17c) to the third leaflet pericardial patch (17b) and a fourth leaflet suture (18c) to the fourth leaflet pericardial patch (18a). In this way, a four-leaflet aortic-mitral valve prosthesis (1) is constructed. The third leaflet (17) is shown with the third leaflet pericardial patch (17b), and the fourth leaflet (18) is shown with the fourth leaflet pericardial patch (18a). The ends (10, 11) of the first leaflet (2) and the ends (14, 15) of the second leaflet (3) can be seen in the background. In the figure, the cardiac aortic-mitral valve prosthesis (1) is being lifted by two forceps (29a, 29b) for the surgical procedure.

[0100] Figure 43 shows a cardiac aortic-mitral valve prosthesis (1) having four leaflets as seen from below. The third leaflet suture (17c) of the third leaflet (17) to the first leaflet (2) and second leaflet (3) can be seen. The first leaflet (2) and second leaflet (3) with the third leaflet (17) for covering the aortic wall (32) attached to the mental partition (4) of the cardiac aortic-mitral valve prosthesis (1) can be seen along with the third leaflet suture (17c). The cardiac aortic-mitral valve prosthesis (1) is being lifted with tweezers (29a). The third leaflet (17) is attached to the aortic-mitral valve prosthesis (1) along the mental partition (4) between the first leaflet (2) and the second leaflet (3) by the third leaflet sutures (17c). In this embodiment, there is a longitudinal mental partition (16) that is partially covered by the third leaflet sutures (17c). The longitudinal mental partition (16) may be formed, for example, by a crease or marking. The aortic-mitral valve prosthesis (1) is lifted over the third leaflet (17) with tweezers (29a).

[0101] Figure 44 shows an aortic-mitral valve prosthesis (1) having a first leaflet (2), a second leaflet (3), a third leaflet (17), and a fourth leaflet (18). The third leaflet (17) and the fourth leaflet (18) are attached to each other along the mental partition (4) between the first leaflet (2) and the second leaflet (3) by third leaflet sutures (17c). The aortic-mitral valve prosthesis (1) shown here is ready for use in a surgical procedure to replace the intervalvular fibrous body within the aortic-mitral valve curtain with the first leaflet (2) and the second leaflet (3), the aortic wall (32) with the third leaflet (17), and the left atrial roof with the fourth leaflet (18).

[0102] Figure 45 shows an aortic-mitral cardiac valve prosthesis (1) with an attached prosthetic biological mitral valve prosthesis (30b) and third and fourth leaflets (17 and 18). The prosthetic biological mitral valve prosthesis (30b) is sutured over the annular recess (5) with valve sutures (39). The third leaflet (17), intended to replace the wall of the aorta (32), is visible in the background, and the fourth leaflet (18), intended to replace the left atrial roof (28), is visible in the foreground. The aortic-mitral cardiac valve prosthesis (1) is being lifted by forceps (29a) on the third and fourth leaflets (17 and 18). The prosthetic biological mitral valve prosthesis (30b) is stabilized by a valve support frame structure (40) to aid in implantation during surgery and is removed during surgery. The artificial biological mitral valve prosthesis (30b) is used to replace the native mitral valve (21), with the replacement of the aortic-mitral curtain (25) by the aortic-mitral valve prosthesis (1), the aortic wall (29a) by the third leaflet (17), and the left atrial roof (28) by the fourth leaflet (18). The aortic-mitral valve prosthesis (1) is lifted by forceps (29a) on the third leaflet (17) and the fourth leaflet (18).

[0103] Figure 46 shows an aortic-mitral valve prosthesis (1) with an attached biological mitral valve prosthesis (30b), the first leaflet (2) in the foreground, and the attached third leaflet (17) in the background. The third leaflet (17) is visible in the background. The mental partition (4) and longitudinal mental partition (16) are marked. Marking the mental partitions (4, 16) on the attached biological mitral valve prosthesis (30b) and the aortic-mitral valve prosthesis (1) allows for rapid implantation and adequate positioning of all commissures of the biological mitral valve prosthesis (30b) relative to the aortic-mitral valve curtain (25), thus shortening the surgical procedure and improving the functional outcome. The aortic-mitral valve prosthesis (1) in the figure is being lifted with tweezers (29a).

[0104] Figure 47 shows a cardiac aortic-mitral valve prosthesis (1) with an attached prosthetic biological mitral valve prosthesis (30b), an attached prosthetic biological aortic valve prosthesis (26b), an attached third leaflet (17), and an attached fourth leaflet (18) in the foreground. In this embodiment of the cardiac aortic-mitral valve prosthesis (1), the aortic-mitral valve curtain (25) is replaced by the cardiac aortic-mitral valve prosthesis (1), thereby replacing the native mitral valve (21) and the native aortic valve (23). This embodiment is typically indicated when the native mitral valve (21) and the native aortic valve (23) have been damaged, for example, by inflammation. The prosthetic biological mitral valve prosthesis (30b) and the prosthetic biological aortic valve prosthesis (26b) are attached to the aortic-mitral valve prosthesis (1) by valve sutures (39). Also shown is the valve support framework (40) of the prosthetic biological mitral valve prosthesis (30b), which aids in implantation and is removed during the surgical procedure. In the figure, the aortic-mitral valve prosthesis (1) is being lifted by forceps (29a) on the third leaflet (17) and the fourth leaflet (18).

[0105] Figure 48 shows a cardiac aortic-mitral valve prosthesis (1) with an attached biological mitral valve prosthesis (30b), an attached biological aortic valve prosthesis (26b), an attached third leaflet (17), and an attached fourth leaflet (18). This embodiment of the cardiac aortic-mitral valve prosthesis (1) can replace the aortic-mitral valve curtain (25), a damaged mitral valve, a damaged aortic valve, the aortic wall (27a) of the aorta (27), and the left atrial roof (28).

[0106] Figure 49 shows a cardiac aortic-mitral valve prosthesis (1) having a first leaflet (2) and a second leaflet (3). The first leaflet (2) is attached to a prosthetic mitral valve prosthesis (30). The second leaflet (3) is attached to a prosthetic aortic valve prosthesis (26). The mental partition (4) and longitudinal mental partition (16) are shown. In this embodiment, the distance (16b) between the first leaflet recess (5) and the mental partition is 1 mm. The distance (16a) between the mental partition and the second leaflet recess (6) is 1 mm. Therefore, the distance between the first leaflet recess (5) and the second leaflet recess (6) is 2 mm. The attached artificial mitral valve prosthesis (30) and attached aortic cardiac valve prosthesis (26) allow for rapid implantation and adequate positioning of both valves (26, 30) relative to the aortic-mitral valve curtain (25), thus shortening the surgical procedure and improving the functional outcome of the procedure.

[0107] Figure 50 shows a cardiac aortic-mitral valve prosthesis (1) with four leaflets: an attached prosthetic mechanical mitral valve prosthesis (30a), an attached prosthetic mechanical aortic valve prosthesis (26a), and an attached third leaflet (17) and fourth leaflet (18). The attached prosthetic mechanical mitral valve prosthesis (30a) and attached prosthetic mechanical aortic valve prosthesis (26a) allow for rapid implantation and adequate positioning of both valves (26a, 30b) relative to the aortic-mitral valve curtain (25), thus shortening the surgical procedure and improving the functional outcome of the surgery. The cardiac aortic-mitral valve prosthesis (1) is being lifted by forceps (29a) on the third leaflet (17) and fourth leaflet (18).

[0108] Figure 51 shows from another perspective the cardiac aortic-mitral valve prosthesis (1) with four leaflets, an attached prosthetic mechanical mitral valve prosthesis (30a), an attached prosthetic mechanical aortic valve prosthesis (26a), an attached third leaflet (17) and an attached fourth leaflet (18).

[0109] Figure 52 shows a cardiac aortic-mitral valve prosthesis (1) with an attached prosthetic mechanical mitral valve prosthesis (30a), an attached prosthetic mechanical aortic valve prosthesis (26a), and an attached third leaflet (17) and fourth leaflet (18). The attached third leaflet (17) and fourth leaflet (18) are visible in the background and are sutured to the mental partition (4) on the other side. The longitudinal mental partition (16) is also visible. The prosthetic mechanical mitral valve prosthesis (30a) and the prosthetic mechanical aortic valve prosthesis (26a) are attached to the cardiac aortic-mitral valve prosthesis (1) by sutures. The prosthetic mechanical aortic valve prosthesis (26a) is attached to the first leaflet recess (5), and the prosthetic mechanical mitral valve prosthesis (30a) is attached to the second leaflet recess (6).

[0110] Figure 53 shows the cardiac aortic-mitral valve prosthesis (1) implanted into the heart (20) during surgery, remaining on the patient's right side and viewed through the aortic wall incision (27b) toward the native aortic valve (23) and aortic-mitral valve curtain (25). The third leaflet (17), the fourth leaflet (18), and the artificial biological aortic valve prosthesis (26b) are attached to the cardiac aortic-mitral valve prosthesis (1). The third leaflet (17) replaces and closes the aortic wall incision (27b) in the aortic wall (27a) with sutures. The third leaflet sutures (17c) are visible, suturing the third leaflet pericardial patch (17b) and the fourth leaflet pericardial patch (18a) together. The fourth leaflet pericardial patch (18a) and the aortic root (23b) are also visible. The artificial biological aortic valve prosthesis (26b) is positioned in the second leaflet recess (6) of the second leaflet (3) and is sutured to the aortic valve annulus (23a) after removal of the valve support framework (40).

[0111] Figure 54 shows the final steps in implanting a four-leaflet aortic-mitral valve prosthesis (1) before closing the aortic wall incision (27b) in the aortic wall (27a) and completing the surgical procedure. The valve support framework (40) of the prosthetic biological aortic valve prosthesis (26b) has been removed, and the prosthetic biological aortic valve prosthesis (26b) is sutured to the aortic valve annulus (23a) with valve sutures (39). The third leaflet (17) replaces and closes the aortic wall incision (27b) with a direct third leaflet-to-aortic wall suture (17d). The left atrial roof (28) is closed with the fourth leaflet pericardial patch (18) of the aortic-mitral valve prosthesis (1) with sutures (18c).

[0112] Figure 55 shows a four-leaflet aortic-mitral valve prosthesis (1) as seen after opening the left ventricle at the end of a surgical procedure on a human heart (20) in an in vitro experiment. The aortic-mitral valve prosthesis (1) is provided with a prosthetic biological aortic valve prosthesis (26b), a prosthetic biological mitral valve prosthesis (30b), and a third leaflet (17). The left fibrous trigone (25a), right fibrous trigone (25b), and intervalvular fibrous bodies are replaced by the first leaflet (2) and second leaflet (3) of the aortic-mitral valve prosthesis (1). The mental partition (4) and the suture line (17c) between the third leaflet (17) and the fourth leaflet (18) fit within the aortomitral angle α (35), which is only partially visible in this view. The center of the anterior leaflet of the native aortic valve (23) is aligned with the prosthetic biological mitral valve prosthesis (30b) by the end marking (14a) of the second leaflet (3). The commissure between the non-coronary cusp and the right coronary cusp of the prosthetic biological aortic valve prosthesis (26b) is fitted by the prosthetic biological mitral valve prosthesis (30b) below the mitral annulus (21a) within the aorto-mitral angle α (35), located at the end of the coaptation line of the aortic valve cusps. The aorto-mitral angle α (35) is not visible in this view.

[0113] Figure 56 shows a cardiac aortic-mitral valve prosthesis (1) with two leaflets and an attached artificial biological aortic valve prosthesis (26b). The cardiac aortic-mitral valve prosthesis (1) has been implanted and is shown in an in vitro experiment after opening the left ventricle at the end of the surgical procedure. The cardiac aortic-mitral valve prosthesis (1) has been rotated up and down so that it faces the aortomitral angle α (35). After rotating the aortic-mitral valve prosthesis (1) up and down, the first leaflet (2) and second leaflet (3) of the aortic-mitral valve prosthesis (1) are exposed, revealing the first leaflet terminal end (10) and second leaflet terminal end (14) for replacing the left fibrous trigone (25a) of the human heart (20), and the first leaflet extension portion (11) and second leaflet terminal end (15) for replacing the right fibrous trigone (25b) of the human heart (20). The mental partition (4) between the first leaflet (2) and second leaflet (3) is shown. The mental partition fits within the aortic-mitral angle (35). The center of the anterior leaflet of the native aortic valve (23) can be seen along the central portion (25c) of the aortic-mitral valve prosthesis (1). The position of the prosthetic biological aortic valve prosthesis (26b) can be aligned along the longitudinal mental partition (16). The commissure between the non-coronary cusp and the right coronary cusp of the prosthetic biological aortic valve prosthesis (26b) is fitted within the aorto-mitral angle (35) below the mitral annulus (21a) to which the prosthetic biological mitral valve prosthesis (30b) is sutured (39). This embodiment demonstrates the ability of the present invention to displace the fibrous trigones (25a, 25b), reduce tension on the valve sutures (39), re-establish the native anatomic aorto-mitral angle (35), and enable optimal positioning of the cardiac aorto-mitral valve prosthesis (1). [Explanation of symbols]

[0114] 1. Aortic-mitral cardiac prosthesis 2. First leaflet 3 Second leaflet 4 Mental divider 5 First leaflet recess 6 Second leaflet recess 7 Larger recess 8 Outer Edge 9 First leaflet end 10 First leaflet end 11 First leaflet extension 11a End Marking 12 End of second leaflet 13 End of second leaflet 14 Second leaflet end 14a End marking 15 Second leaflet end 15a End Marking 16 Longitudinal mental divider 17 Third Leaflet 17a Third leaflet straight cut 17b Third leaflet pericardial patch 17c Third leaflet suture 17d Direct third leaflet-aortic wall suture 18 Fourth Leaflet 18a Fourth Leaflet Pericardial Patch 18b Fourth leaflet straight cut 18c Fourth leaflet suture 19 Recess extension 19a Recessed end 19b Recess extension boundary 20 Human Heart 21 Mitral valve 21a Mitral annulus 21b Anterior leaflet of native mitral valve 21c Posterior leaflet of native mitral valve 21d Annular band 22 Tricuspid valve 22a Tricuspid annulus 23 Aortic valve 23a Aortic annulus 23b Aortic root 24 Pulmonary valve 25 Aortic-Mitral Curtain 25a left triangle 25b Right triangle 25c Central portion of the aortic-mitral valve curtain 26 Artificial aortic valve prosthesis 26a Artificial mechanical aortic valve prosthesis 26b Artificial biological aortic valve prosthesis 27 Ascending aorta 27a aortic wall 27b Aortic wall incision 27c Tissues around the aorta 28 Left atrial roof 29a Tweezers 29b Another pair of tweezers 30 Artificial Mitral Valve Prosthesis 30a Artificial mechanical mitral valve prosthesis 30b Artificial biological mitral valve prosthesis 31 Circular suture 32a Left coronary ostium 32b Right coronary ostium 33 Surgical instruments 34 Valved aortic conduit prosthesis 35a Aortomitral angle α 35b Extension angle β 36 fingers 37 Left ventricular outflow tract 38 Forceps 39 Valve suture 40 Valve support frame structure

Claims

1. A cardiac aortic-mitral valve prosthesis (1) for a human heart (20) comprising a pericardial patch forming a template for the aortic-mitral valve curtain (25), a central line, comprising two leaflets (2, 3) separated by a mental partition (4) separating the cardiac aortic-mitral valve prosthesis (1) into a first leaflet (2) and a second leaflet (3) for placement of the cardiac aortic-mitral valve prosthesis between the aortic valve and the mitral valve during a surgical procedure on the human heart; an aortic-mitral cardiac valve prosthesis (1) in which one of said first leaflets (2) has a first leaflet recess (5) serving to contain the aortic valve annulus (23a) and the other of said second leaflets (3) has a second leaflet recess (6) serving to contain the mitral valve annulus (21a), the aortic-mitral cardiac prosthesis (1) has one larger recess (7) on both leaflets (2, 3) for supporting the tricuspid annulus (22a), an aortic-mitral cardiac prosthesis (1), characterized in that on both leaflets (2, 3) there is, opposite the larger recess (7), an outer edge (8) which forms a support for the framework of the inner layer of the atrioventricular junction of the human heart (20).

2. 2. Aortic-mitral cardiac prosthesis (1) according to claim 1, characterized in that the mental partition (4) is marked by a visible line or crease.

3. 3. The aortic-mitral cardiac prosthesis (1) according to claim 2, characterized in that markings are present on the aortic-mitral prosthesis (1) that mark the positions of the commissures of the aortic valve or the mitral valve (21).

4. 4. The aortic-mitral cardiac prosthesis (1) according to any one of claims 1 to 3, characterized in that a further third leaflet (17) is attached to the prosthesis (1) along the mental partition (4) to cover the aortic wall (27a) of the aorta (27).

5. 5. The aortic-mitral cardiac prosthesis (1) according to any one of claims 1 to 4, characterized in that a further fourth leaflet (18) is attached to the prosthesis along the mental partition (4) to cover the left atrial roof.

6. 6. The aortic-mitral cardiac valve prosthesis (1) according to any one of claims 1 to 5, characterized in that the aortic-mitral cardiac valve prosthesis has a first leaflet extension (11) extending the end (9) of the right aortic annulus portion that includes the aortic valve (23) and supports the tricuspid annulus (22a).

7. 7. The aortic-mitral cardiac prosthesis (1) according to claim 6, characterized in that the first leaflet extension (11) is marked by a fold (11a) or a visible line separating it from the end (9) of the first leaflet (2) that contains the aortic valve (23) and supports the tricuspid annulus (22a).

8. 8. The aortic-mitral valve prosthesis (1) according to any one of claims 1 to 7, characterized in that the aortic-mitral valve prosthesis (1) has a recess extension (19) beyond the recess end (19a) of the second leaflet (3), separating the pericardial patch of the aortic-mitral valve prosthesis (1) above the anterior leaflet of the mitral valve annulus (21a) from the unextended aortic-mitral valve prosthesis (1).

9. 9. The cardiac aortic-mitral valve prosthesis (1) according to claim 8, characterized in that the recess extension (19) is marked by a visible line beyond the recess end (19a) separating it from the non-extended cardiac aortic-mitral valve prosthesis (1).

10. Aortic-mitral cardiac prosthesis (1) according to any one of claims 1 to 9, characterized in that an artificial mitral valve prosthesis (30) is attached to the aortic-mitral cardiac prosthesis (1).

11. Aortic-mitral cardiac prosthesis (1) according to any one of claims 1 to 10, characterized in that an artificial aortic valve prosthesis (26) is attached to the aortic-mitral cardiac prosthesis (1).

12. 12. The cardiac aortic-mitral valve prosthesis (1) according to any one of claims 1 to 11, characterized in that the cardiac aortic-mitral valve prosthesis (1) is made from bovine pericardium or a pericardial patch made from Dacron or Teflon fabric.

13. 13. A method for manufacturing a cardiac aortic-mitral valve prosthesis (1) according to any one of claims 1 to 12, comprising obtaining a pericardial patch and cutting it into two leaflets (2, 3) separated by a mental partition (4) of the cardiac aortic-mitral valve prosthesis (1), the mental partition (4) being a central line separating the cardiac aortic-mitral valve prosthesis (1) into a first leaflet (2) and a second leaflet (3) as two annular portions (2, 3) between the aortic valve annulus (23a) and the mitral valve annulus (21a) of a human heart; a first leaflet recess (5) is cut in one of the first leaflets (2) that serves to contain said aortic valve annulus (23a); a second leaflet recess (6) is cut into the other second leaflet (3), which serves to contain said mitral valve annulus (21 a), one larger recess (7) is cut into the prosthesis (1) on both leaflets (2, 3) to support the tricuspid annulus (22a); - A method characterized in that, opposite said larger recess (7), an outer edge (8) is cut which forms a support for the framework of the medial layer of the atrioventricular junction of said human heart (20).

14. 14. A method for manufacturing a cardiac aortic-mitral valve prosthesis (1) according to claim 13, characterized in that an additional third leaflet (17) is attached to the cardiac aortic-mitral valve prosthesis (1) to cover the aortic wall (27a) of the aorta (27), or an additional fourth leaflet (18) as an additional leaflet to cover the left atrial roof, or a third leaflet (17) and a fourth leaflet (18) as additional leaflets are attached to the cardiac aortic-mitral valve prosthesis (1).

15. 15. The method for manufacturing a cardiac aortic-mitral valve prosthesis (1) according to claim 13 or 14, characterized in that in cutting the second leaflet recess (6) for the mitral valve annulus (21 a), a recess extension (19) is left in the second leaflet recess (6) of the pericardial patch above the mitral valve annulus (21 a).

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