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EP-4360592-B1 - A CARDIAC AORTO-MITRAL PROSTHESIS FOR THE HUMAN HEART

EP4360592B1EP 4360592 B1EP4360592 B1EP 4360592B1EP-4360592-B1

Inventors

  • Andrasi, Terezia

Dates

Publication Date
20260513
Application Date
20221025

Claims (15)

  1. A cardiac aorto-mitral prosthesis (1) for the human heart (20), consisting of a pericardial patch, forming a template of the aorto-mitral curtain (25), comprising • two leaflets (2,3) separated by a mental partition (4) that is a central line and separates the cardiac aorto-mitral prosthesis (1) into a first leaflet (2) and a second leaflet (3) for a placement of the cardiac aorto-mitral prosthesis between the aortic valve and the mitral valve during a surgical operation to the human heart, and • one first leaflet (2) having a first leaflet recess (5) which serves for the inclusion of the aortic valve annulus (23a), and the other second leaflet (3) having a second leaflet recess (6) which serves for the inclusion of the mitral valve annulus (21a), characterized in that • the cardiac aorto-mitral prosthesis (1) has over both leaflets (2,3) one larger recess (7) for the support to the tricuspid valve annulus (22a), and • on the opposite side of the larger recess (7) over both leaflets (2,3) an outer edge (8) which forms a support to the frame of the inner layer of the atrio-ventricular junction of the human heart (20).
  2. The cardiac aorto-mitral prosthesis (1) according to claim 1, characterized in that the mental partition (4) is marked by a visible line or by a folding.
  3. The cardiac aorto-mitral prosthesis (1) according to claim 2, characterized in that markings are present on the aorto-mitral prosthesis (1) that mark the positions of the commissures of the aortic valve or of the mitral valve (21).
  4. The cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 3, characterized in that another third leaflet (17) is attached to the prosthesis (1) along the mental partition (4) for a covering of the aortic wall (27a) of the aorta (27).
  5. The cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 4, characterized in that another fourth leaflet (18) is attached to the prosthesis along the mental partition (4) for a covering of the left atrial roof.
  6. The cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 5, characterized in that the cardiac aorto-mitral prosthesis (1) has a first leaflet extension (11) that extends the ending (9) of the right aortic annular part that includes the aortic valve (23) and supports the tricuspid valve annulus (22a).
  7. The cardiac aorto-mitral prosthesis (1) according to claim 6, characterized in that the first leaflet extension (11) is marked by a folding (11a) or by a visible line in separation from an ending (9) of the first leaflet (2) that includes the aortic valve (23) and supports the tricuspid valve annulus (22a).
  8. The cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 7, characterized in that the cardiac aorto-mitral prosthesis (1) has a recess extension (19) over the recess ending (19a) of the second leaflet (3) in separation from the unextended cardiac aorto-mitral prosthesis (1) of the pericardial patch of the cardiac aorto-mitral prosthesis (1) over the anterior cusp of the mitral valve annulus (21a).
  9. The cardiac aorto-mitral prosthesis (1) according to claim 8, characterized in that the recess extension (19) is marked by a visible line over the recess ending (19a) in separation from the unextended cardiac aorto-mitral prosthesis (1).
  10. The cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 9, characterized in that an artificial mitral valve prosthesis (30) is attached to the cardiac aorto-mitral prosthesis (1).
  11. The cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 10, characterized in that an artificial aortic valve prosthesis (26) is attached to the cardiac aorto-mitral prosthesis (1).
  12. The cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 11, characterized in that the cardiac aorto-mitral prosthesis (1) is made of a pericardial patch that is made from bovine pericardium or Dacron-fabric or Teflon fabric.
  13. A process for the production of a cardiac aorto-mitral prosthesis (1) according to one of claims 1 to 12, wherein a pericardial patch is taken and cut into two leaflets (2,3) separated by a mental partition (4) of the cardiac aorto-mitral prosthesis (1) that is a central line and that separates the cardiac aorto-mitral prosthesis (1) into the first leaflet (2) and second leaflet (3) as two annular parts (2,3) between the aortic valve annulus (23a) and the mitral valve annulus (21a) of the human heart, and • into one first leaflet (2) a first leaflet recess (5) is cut which serves for the inclusion of the aortic valve annulus (23a), and • into the other second leaflet (3) a second leaflet recess (6) is cut which serves for the inclusion of the mitral valve annulus (21a), characterized in that • into the prosthesis (1) one larger recess (7) is cut over both leaflets (2,3) for the support of the tricuspid valve annulus (22a), and • into the opposite side of the larger recess (7) an outer edge (8) is cut which forms a support to the frame of the inner layer of the atrio-ventricular junction of the human heart (20).
  14. The process for the production of a cardiac aorto-mitral prosthesis (1) according to claim 13, characterized in that a further third leaflet (17) is attached to the cardiac aorto-mitral prosthesis (1) for a covering of the aortic wall (27a) of the aorta (27) or a further fourth leaflet (18) as a further leaflet for a covering of the left atrial roof or a third (17) and a fourth leaflet (18) as further leaflets is or are attached to the cardiac aorto-mitral prosthesis (1).
  15. The process for the production of a cardiac aorto-mitral prosthesis (1) according to claim 13 or claim 14, characterized in that a recess extension (19) is left in the second leaflet recess (6) of the pericardial patch over the mitral valve annulus (21a) in the cutting of the second leaflet recess (6) for the mitral valve annulus (21a).

Description

The invention is directed to a cardiac aorto-mitral prosthesis for the human heart that replaces the cardiac aorto-mitral curtain during surgical operations to the human heart, as defined by claim 1. The prosthesis is capable to anatomically replace the cardiac aorto-mitral curtain which may be affected during a replacement of the mitral valve or of the aortic valve. The cardiac aorto-mitral prosthesis offers a shaping that matches the anatomic shape of the intervalvular fibrous body including the 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 the operation time and simplifying the surgical procedure. The cardiac aorto-mitral improves the recovery perspectives and the physical wellness of the patient after the surgical operation. The invention is also directed to a process for the production of the cardiac aorto-mitral prosthesis, as defined by claim 13. Surgical operations to the human heart are nowadays frequently carried out for the anatomic replacement of the mitral valve, the aortic valve or both the mitral valve and the aortic valve. Such a replacement of the aortic valve or the mitral valve is often caused by a valve endocarditis. Between the aortic valve annulus and the mitral valve annulus, an intervalvular fibrous body is anatomically situated which is part of the central fibrous body of the human heart. During operations for the replacement of the aortic valve or the mitral valve, the tissue of the intervalvular fibrous body of the human heart between the aortic valve annulus and the mitral valve annulus must be replaced frequently. The reasons for such a replacement may be for instance a damage of the intervalvular fibrous body by an infective endocarditis or a degenerative calcification. The intervalvular fibrous body in the human heart in the specific position between the aortic valve annulus and the mitral valve annulus is also known in the art as the cardiac aorto-mitral curtain. The replacement of the intervalvular fibrous body is known in the state of the art. The reconstructive technique that is currently most widely used for a replacement of the intervalvular fibrous body during an aortic and mitral valve replacement was described and pioneered by T. E. David et al. (T. E. David et al., J. Thorac. Cardiovasc. Surg., "Aortic and mitral valve replacement with reconstruction of the intervalvular fibrous body", volume 114 (5), pages 766-771, 1997). This method uses a single pericardial patch to reconstruct the intervalvular fibrous body by an artificial cardiac aorto-mitral curtain. After excising the aortic valve and the mitral valve, the diseased intervalvular fibrous body is removed and a properly tailored patch of Dacron-fabric or bovine pericardium is sutured to the lateral and medial fibrous trigones and the aortic root, reestablishing the annuli of the aortic and mitral valve. Then, the aortic valve and the mitral valve are replaced. This method reconstructs the cardiac aorto-mitral curtain for a replacement of the intervalvular fibrous body, but does not replace the anatomically right and left fibrous trigons of the human heart. The right fibrous trigon and left fibrous trigon of the heart are therefore often left insufficiently attended during an aortic valve or a mitral valve replacement. The replacement of the intervalvular fibrous body in the surgery of the human heart is often called in the state of the art the "Commando"-operation. The risks of the method as described by T. E. David et al. have been studied. Davierwala et al. (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, pages 146-152, 2014) further examined the risks that are involved with such a replacement of the intervalvular fibrous body during an infective endocarditis. Statistic data for the chances of success and for the mortality rates of the operation for the replacement of the intervalvular fibrous body were established. The same method as with T. E. David et al. was applied. A single pericardial patch was used to reconstruct the intervalvular fibrous body. This pericardial patch was an elliptical pericardial patch to which the anterior annular circumference of the mitral valve prosthesis and the non-coronary circumference of the aortic valve prosthesis were sutured. It was concluded that the reconstruction of the intervalvular fibrous body is an operation with a certain risk, but is the only option to cure a damage of the intervalvular fibrous body by infective endocarditis. This disease without treatment culminates into a 100 %-mortality. Petterson et al. (Petterson et al., Multimed Man Cardiothorac Surg., "Reconstruction of fibrous skeleton: technique, pitfalls and results", 2014, DOI:10.1093/mmcts/mmu004) describ