WO2020098849A1 - Nouvelle prothèse valvulaire biologique comprenant un anneau de suture - Google Patents

Nouvelle prothèse valvulaire biologique comprenant un anneau de suture Download PDF

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Publication number
WO2020098849A1
WO2020098849A1 PCT/DE2019/000284 DE2019000284W WO2020098849A1 WO 2020098849 A1 WO2020098849 A1 WO 2020098849A1 DE 2019000284 W DE2019000284 W DE 2019000284W WO 2020098849 A1 WO2020098849 A1 WO 2020098849A1
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WO
WIPO (PCT)
Prior art keywords
valve
prosthesis
biological
frame
stent
Prior art date
Application number
PCT/DE2019/000284
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German (de)
English (en)
Inventor
Moneera Bobaky
Khiralddin Kalla
Omar Kalaa
Nerouz Boubaki
Original Assignee
Moneera Bobaky
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Moneera Bobaky filed Critical Moneera Bobaky
Priority to EP19812904.1A priority Critical patent/EP3880126A1/fr
Publication of WO2020098849A1 publication Critical patent/WO2020098849A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415—Manufacturing methods

Definitions

  • This invention relates to bioprosthetic heart valves that combine the advantages of a low gradient across the valve, the hyperelastic valve stent, the high coaptation zone, and absolute compatibility with the Secoderen catheter-assisted percutaneous implantation (valve in valve).
  • the invention relates to biological heart valves which are suitable for surgical implantation or mini-incision.
  • biological heart valves are available as replacements for the heart valve, which include a valve frame made of wire, for example, which forms a stent.
  • the flap sails or pocket flaps, which are made of biological material, are attached to this frame.
  • Biological tissue heart valves have evolved into a number of specialized designs to meet patients' continued need for a biological valve prosthesis that is free of structural defects and can prolong adult life.
  • a biological valve prosthesis continues to be sought which fulfills the following goals: (1) low tensions on the coaptation surface of the sails in the closed position; (2) hemodynamic efficiency through maximum flexible stent design without deterioration of the coaptation; (3) hemodynamic efficiency through minimal flow gradients through the valve prosthesis; (4) Compatibility with a possible later catheter-supported valve implantation of a new prosthesis in an old prosthesis.
  • the basic valve level of an artificial flap is the level that is at maximum there is persistent contact with the patient's heart tissue after implantation. So if the valve has a base ring, it is in the basic valve plane; (2) the over-the-level biological prosthesis is a biological valve with a base ring constructed at the lower axial end of the valve prosthesis, i.e. at the axial end of the prosthesis opposite to the direction of flow through the valve prosthesis; (3) the biological prosthesis of the sub-plane type is a biological valve with a base ring constructed at the upper axial end of the valve frame of the prosthesis, i.e.
  • the presented invention is a biological heart valve prosthesis which is provided with a fastening ring (1) which is attached to the upper axial end of the valve frame of the prosthesis, that is to say at the axial end in the flow direction through the valve prosthesis on the valve frame (2).
  • the fastening ring (1) is used to fasten the valve prosthesis to the heart tissue and in particular to sew the valve prosthesis onto the heart tissue.
  • This valve is suitable for open surgical implantation or mini incision.
  • the presented invention is a biological heart valve prosthesis with valve pockets that are constructed under the plane of the control ring opposite to the direction of flow through the valve prosthesis, e.g. in the mitral position of the atrial side.
  • the present invention is an under-the-plane (under the attachment and suture ring) biological heart valve prosthesis, is a biological heart valve with a base ring constructed at the upper axial end of the prosthesis valve frame, i.e. at the axial end of the prosthesis in the direction of flow through the valve prosthesis, this biological Heart valve prosthesis are constructed from chemically fixed biological pericardium. These valve prostheses have three valve leaflets that are fixed in one position to ensure that the sails open under minimal forward blood flow pressures and close under minimal reflux pressure.
  • valve leaflets can be used using both a single pericardial patch (FIG. 38, FIG. 59, FIG. 60, FIG. 40, FIG. 43, FIG. 45) and three separate pericardial patches (FIG. 37, FIG. 39) , FIG. 40, FIG. 43, FIG. 45).
  • this pericardial patch is cut and sewn as necessary to construct three valve pockets that are attached to the frame of the valve or directly to the stent using sutures.
  • the previous patented or existing biological prostheses which are suitable for open surgical implantation, are provided with a fastening ring which is fastened to the lower axial end of the valve prosthesis, i.e. at the axial end opposite to the direction of flow through the valve prosthesis on the valve frame.
  • the fastening ring is used to fasten the valve prosthesis to the heart tissue and in particular to sew the valve prosthesis onto the heart tissue.
  • the previous patented and existing biological prostheses, which are suitable for open surgery implantation are all of the type of the biological valve prosthesis above the level and cause the valve channel phenomenon.
  • the presented invention is a biological heart valve prosthesis, which is suitable for open surgical implantation or for mini incision, according to the above classification, of the type of the biological prosthesis under the plane, whereby the valve channel phenomenon is minimized.
  • the first embodiment (Fig. 1, 3, 6) of the valve prosthesis presented has minimal valve-channel phenomenon because the blood flowing through the valve not only through the longitudinal axis of the valve but also through the three openings (4th ) occurs in the flap frame (2) (Fig. 44, Fig. 62).
  • the biological heart valve prosthesis presented in particular the first embodiment (FIGS. 1, 3, 6), does not produce a channel in the opening phase and thus no additional pressure gradients through the valve.
  • the biological valve prostheses are useful as a replacement for the heart valves.
  • another preferred for the replacement of a defective aortic valve, another for the replacement of a defective mitral valve all embodiments of the presented biological valve prosthesis of the invention are according to the above classification of the type of biological prosthesis below the level therefore includes a suture ring (1) and an atypical one Flap frame (2).
  • the first embodiment (Fig. 1, 3, 5, 6, 57) having three side openings (4) in the framework of the valve prosthesis (2) and three valve leaflets with normal height
  • the second embodiment (Fig. 8, 3, 5, 10, 57) shows three lateral openings (4) in the frame (2) of the valve prosthesis and three raised valve leaflets (3)
  • the third embodiment (Fig. 13, Fig. 14, Fig. 5, Fig. 57) with a reduced cylindrical frame (2) without side openings and with normal height of the flap sail
  • the fourth embodiment (Fig. 13, 12, 5, 57) with a reduced cylindrical frame (2) without side openings and with raised flap sail (3).
  • the seam ring (1) is attached to the upper end of the atypical valve frame (2), that is to say at the axial end of the prosthesis in the flow direction through the valve prosthesis on the valve frame (2).
  • Such a low cylindrical shape (Fig. 13, 14) of the frame is able to reduce the pressure gradient of the flow through the valve prosthesis, since only a low valve-channel phenomenon can occur.
  • Such a non-cylindrical shape (Fig. 1, 3, 6) of the frame (with three openings in the valve frame) is able to minimize the pressure gradient of the flow through the valve prosthesis since a valve-channel phenomenon cannot occur because the blood flowing through the valve not only enters the valve frame (2) through the longitudinal axis of the valve but also through the three openings (4) (Fig. 44, Fig. 62).
  • the present invention presents a bioprosthetic heart valve comprising an elastic stent (14) made of an elastic spring metal.
  • the stent is preferably surrounded by an outer pericardium layer and provided with two specific bands (13, 16) to prevent excessive expansion.
  • the elastic stent is preferably constructed with non-linear spring characteristics (clever spring characteristics through fused microlaminate structure) for symmetrical expansion and contraction movements.
  • non-linear spring characteristics curvature through fused microlaminate structure
  • Such a fused micro-laminated structure of the metal stent is able to reduce tensions in the commissure (5) and coaptation zones without leading to a valve prolapse, since the geometric changes in the transverse plane of the valve are bound.
  • the elastic stent (14) of the presented biological flap prosthesis extends on the sewing ring (2) and on the frame of the flap (2), which ensures maximum structural strength and maximum support of the flap sail (3).
  • the stent is preferably covered with a chemically fixed pericardium layer (9) which extends on the sewing ring and on the frame of the valve and is fastened to the stent and to the valve flap with suture material (19, 6, 7, 11, 15).
  • a chemically fixed pericardium layer (9) which extends on the sewing ring and on the frame of the valve and is fastened to the stent and to the valve flap with suture material (19, 6, 7, 11, 15).
  • the suture ring (1) and the frame (2) are constructed using a core stent covered with a pericardial layer. This uniform structure serves as an attachment point for both valve leaflets (3) and the commissures (5) of the valve prosthesis.
  • the Paradox-Bernoulli phenomenon (Fig. 46); In fact, it is a known physical phenomenon, but it has never been used in the medical field. This is a special position of the Venturi tube (Fig. 61). In this case (in the case of the paradoxical Bernoulli phenomenon) the narrow tube extends within the wide tube and the gradient remains as in the Venturi tube, i.e. when the flow flows through the narrow tube towards the wide tube, the pressure in the following wide tube becomes higher than in the previous narrow tube. When the narrow tube that extends into the wide tube is flexible, it is pushed in and narrowed.
  • This paradox-Bernoulli phenomenon occurs in all existing biological valves because it creates a channel that extends in the aorta, thereby pushing the valve leaflets inward and constricting them.
  • the presented valve prosthesis according to the invention does not create a channel in the aortic root and is not pressed inwards and is not constricted.
  • valve prosthesis according to the invention is compatible with a valve catheter-protected valve implantation (valve in valve), since no left ventricular outflow stenosis and no cardiovascular hypoperfusion can occur.
  • the presented valve prosthesis according to the invention represents an ideal replacement for the mitral valve in patients with relatively small left ventricles and defective mitral valve, since this valve converts part of the atrial volume into a ventricular volume (FIGS. 44, 62), since this valve prosthesis is implanted in the atrium , which maintains the relaxation function of the heart.
  • the presented valve prosthesis of the present invention provides a maximally flexible stent that maintains the contraction of the heart base after mitral valve replacement, thereby improving heart performance after implantation.
  • Valve prosthesis enables maximum coaptation, which minimizes the backflow through the valve prosthesis and the tension on the valve leaflets and on the commissure.
  • valve prosthesis according to the invention presented is an ideal replacement for HOCM patients who need a mitral valve replacement, since this does not cause a SAM phenomenon since it is implanted in the left atrium (FIG. 44, 62).
  • FIG. 1 is a top side three-dimensional perspective view of the first preferred embodiment based on the present invention.
  • FIG. 2 is an enlarged view of a detail from FIG. 1 through the drawn square.
  • 3 is a bottom side three-dimensional perspective view of the first and second preferred embodiments based on the present invention.
  • FIG. 4 is an enlarged view of a detail from FIG. 3 through the drawn square.
  • FIG. 5 is a top three-dimensional perspective view of the first, second, third, or fourth preferred embodiments based on the present invention.
  • FIGS. 6 is a side perspective view of the first embodiment in FIGS. 1 and 3, but from a certain side view.
  • FIG. 7 is an enlarged view of a detail from FIG. 6 through the drawn square.
  • FIG. 8 is a top side three-dimensional perspective view of the second preferred embodiment based on the present invention.
  • FIG. 9 is an enlarged view of a detail from FIG. 8 through the drawn square.
  • FIG. 10 is a side perspective view of the second embodiment in FIG. 8 but from a certain side perspective.
  • FIG. 11 is an enlarged view of a detail from FIG. 10 through the drawn square.
  • Fig. 12 is a side perspective view of the fourth embodiment but from a certain side perspective.
  • FIG. 13 is a bottom side three-dimensional perspective view of the third or fourth preferred embodiments based on the present invention.
  • FIG. 14 is a side perspective view of the third embodiment but from a certain side perspective.
  • Fig. 15 is an upper side three-dimensional perspective view of the first embodiment in Fig. 1 after removal of the outer textile layer (10).
  • FIG. 16 is an enlarged view of a detail from FIG. 15 through the drawn square.
  • Fig. 17 is a bottom side three-dimensional perspective view of the first or second preferred embodiment based on the present invention after removing the outer fabric layer (10).
  • FIG. 18 is an enlarged view of a detail from FIG. 17 through the drawn square.
  • Fig. 19 is a side perspective view of the first embodiment in Fig. 1 but from a certain side view based on the present invention after removal of the outer textile layer (10).
  • FIG. 20 is an enlarged view of a detail from FIG. 19 through the drawn square.
  • Fig. 21 is an upper side three-dimensional perspective view of the first embodiment in Fig. 1 after removal of the outer textile layer (10) and removal of the stent-covering pericardium layer (9).
  • FIG. 22 is an enlarged view of a detail from FIG. 21 through the drawn square.
  • FIG. 23 is a bottom side three-dimensional perspective view of the first and second preferred embodiments based on the present invention after removing the outer fabric layer (10) and removing the stent-covering pericardium layer (9).
  • FIG. 24 is an enlarged view of a detail from FIG. 23 through the drawn square.
  • 25 is a bottom side three-dimensional perspective view of the first preferred embodiment based on the present invention after removing the outer fabric layer (10), removing the stent-covering pericardial layer (9) and removing two valve leaflets.
  • FIG. 26 is an enlarged view of a detail from FIG. 25 through the drawn square.
  • Fig. 27 is an upper side three-dimensional perspective view of the first embodiment in Fig. 1 after removal of the outer textile layer (10), removal of the stent-covering pericardial layer (9) and removal of two valve leaflets.
  • FIG. 28 is an enlarged view of a detail from FIG. 27 through the drawn square.
  • Fig. 29 is a top side three-dimensional perspective view of the first embodiment in Fig. 1 after removal of the outer fabric layer (10), removal of the stent-covering pericardial layer (9), removal of two valve leaflets and removal of the specific band (13), however from another particular point of view compared to FIG. 27.
  • FIG. 30 is an enlarged view of a detail from FIG. 29 through the drawn circle.
  • Fig. 41 is a repetition of Fig. 29 when the second preferred form of elastic stent shown in Fig. 55 of the first embodiment is used.
  • FIG. 42 is an enlarged view of a detail from FIG. 41 through the drawn circle.
  • Fig. 31 is similar to Fig. 27, but from a different point of view compared to Fig. 27.
  • FIG. 32 is an enlarged view of a detail from FIG. 31 through the drawn circle.
  • Fig. 33 is a top side three-dimensional perspective view of the first embodiment in Fig. 1 after partial removal of the outer fabric layer (10), partial removal of the stent-covering pericardial layer (9), removal of two valve leaflets and partial removal of the specific band (13), however from another particular point of view compared to FIG. 27.
  • Fig. 34 is an enlarged view of a portion of Fig. 33 through the drawn circle.
  • Fig. 35 is a perspective three-dimensional sectional view of the first embodiment through the planes I and II in Fig. 5.
  • 36 is an enlarged view of a detail from FIG. 35 through the drawn rectangle.
  • 38, 59, 60 and 40 show how the three valve leaflets are constructed using a single pericardial patch.
  • Figures 37, 39 and 40 show how the three valve leaflets are constructed using three separate pericardial patches. In both cases, this pericardial patch is cut and sewn as necessary to construct three valve pockets.
  • 38, 59, 60, 40, 43 and 45 show, in sequence, how the three flap pockets (3) are constructed using a single pericardial patch and then attached to the stent (14) and how the stent is surrounded by an outer pericardial layer.
  • 44, 44 and 62 show how the presented valve is implanted in the left atrium and how the blood flowing through the valve not only through the longitudinal axis of the valve but also through the three openings (4) in the The flap frame (2) enters.
  • Fig. 46 is a schematic drawing showing the Paradox-Bernoulli phenomenon.
  • Fig. 47 is a schematic drawing showing the valve channel phenomenon.
  • Fig. (48, 49, 50, 51) show how the elastic stent can be constructed in different spring segment shapes.
  • Fig. 52 shows the shape of a possible stent of the first embodiment of the invention when the stent is made of a strong polymer.
  • FIG. 54 is an enlarged view of a detail from FIG. 53 through the drawn circle. 55 shows the second preferred form of the elastic stent of the first presented embodiment of the invention.
  • FIG. 56 is an enlarged view of a detail from FIG. 55 through the drawn circle.
  • Fig. 63 shows the preferred shape of the elastic stent of the second proposed embodiment of the invention.
  • Fig. 64 is an enlarged view of a portion of Fig. 63 through the drawn circle.
  • 57 is a top perspective view of the first, second, third or fourth preferred embodiment based on the present invention.
  • FIG. 58 is an enlarged view of a detail from FIG. 57 through the drawn circle.
  • Fig. 61 is a schematic diagram showing a venturi experiment.
  • Fig. 64 is an enlarged view of a portion of Fig. 63 through the drawn circle.
  • (2) is the flap frame.
  • (3) are the three flap sails.
  • (4) are the three side openings in the frame of the valve prosthesis.
  • (5) are three commissures of the cap prosthesis.
  • Suture material (19, 6, 7, 11, 15) is suture material.
  • (8) sid three strips that protrude laterally inwards from the stent arch (17) of the second embodiment (Fig. 63, Fig. 64).
  • (8) are also the three ledges which protrude laterally inwards from the stent arch (17) of the second form of the stent of the first embodiment (FIG. 41, FIG. 42, FIG. 55, FIG. 56).
  • the present invention is a biological valve prosthesis of the type below the plane (under the fastening and suture ring), is a biological valve with a base ring (suture ring) (1), which is constructed at the upper axial end of the valve frame (2) of the prosthesis, that is, the suture ring was constructed at the axial end of the prosthesis in the direction of flow through the valve prosthesis on the valve frame of the prosthesis.
  • This biological Heart valve prosthesis are constructed from chemically fixed biological pericardium.
  • the presented biological heart valve prosthesis is provided with a fastening ring (1) which is attached to the upper axial end of the valve frame (2) of the prosthesis, that is to say at the axial end in the flow direction through the valve prosthesis on the valve frame (2).
  • the fastening ring (1) is used to fasten the valve prosthesis to the heart tissue and in particular to sew the valve prosthesis onto the heart tissue.
  • This valve is suitable for open surgical implantation or mini incision.
  • These valve prostheses have three flap sails (3) (valve leaflet).
  • the three valve leaflets can be used using both a single pericardial patch (FIG. 38, FIG. 59, FIG. 60, FIG. 40, FIG. 43, FIG. 45) and three separate pericardial patches (FIG. 37, FIG. 39) , FIG. 40, FIG. 43, FIG. 45).
  • this pericardial patch is cut and sewn as necessary to construct three valve pockets that attach to the frame of the valve or directly to the stent using sutures (19, 6, 7, 11, 15) will.
  • the valve prosthesis which is suitable for open surgical implantation or for a mini incision, is of the type of the biological prosthesis below the plane, that is, the suture ring is constructed at the axial end of the prosthesis in the flow direction through the valve prosthesis on the valve frame of the prosthesis, whereby various embodiments of the presented biological valve prosthesis of the invention have been presented, each of which has a different type of application.
  • the biological valve prostheses are useful as a replacement for the heart valve.
  • the first embodiment Figs. 1, 3, 5, 6, 57
  • Fig. 1 the first embodiment having three side openings (4) within the valve prosthesis (2)
  • three normal height valve leaflets second embodiment Fig.
  • the stent (14) extends on the suture ring (1) and the frame (2) of the valve.
  • the stent is preferably covered with a chemically fixed pericardium layer (9) which extends on the suture ring (1) and on the frame (2) of the valve and with suture material (7, 6, 11, 15, 19) on the stent and is attached to the flap sail.
  • the suture ring and frame are constructed using a core stent (14) covered with a pericardial layer (9).
  • This uniform structure serves as an attachment point for both valve leaflets (3) by means of a seam (6) and the commissures (5) by means of a seam (15).
  • the seam ring (1) and the frame (2) of the flap can be covered from the outside with a textile layer (10).
  • the flap sails (3) which are constructed as three flap pockets, are fixed to the lower axial end of the flap frame and thus also to its covering pericardium layer by means of suture material (19) (Fig. 36).
  • Each flap sail which is constructed as a flap pocket, is provided with a transition (12) which extends to the stent and is fixed there with special suture material (6).
  • the stent is provided with two specific bands (13, 16) which are attached to the stent and valve leaflets with sutures (6, 19) to prevent excessive expansion.
  • the bioprosthetic heart valve comprises a stent (14). wherein the stent can be constructed in different spring segment shapes (for example FIGS. 55, 53, 48, 49, 50, 51).
  • the stent can be made of a strong polymer, which means that bands (13, 6) are no longer required (FIG. 52).
  • the stent can consist of a combination of wires and polymer (for example, Figures 50, 51).
  • the seam ring (1) is at the upper end of the atypical flap frame (2), which is designed in a low cylindrical shape (Fig.
  • the biological valve prosthesis has three commissures (5), which are attached to the frame (2) as well as to the stent (14) at certain fixation points (18) or on three strips (8) that protrude laterally inwards from the stent arch ( 17) protrude, are fixed with seams (15).

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Bioprothèse implantable chirurgicalement du type avec anneau de suture (Fig. 62 et 44), qui est une valve biologique comprenant un anneau de base (anneau de suture), qui est construit sur l'extrémité axiale supérieure du cadre de valve de la prothèse, c'est-à-dire à l'extrémité axiale de la prothèse dans le sens de l'écoulement à travers la prothèse valvulaire. Lorsque cette valve est, par exemple, implantée dans la position mitrale, l'élément de valve maximal se trouve dans l'oreillette, c'est-à-dire (1). aucun élément de valve dans le ventricule, (2). aucun phénomène SAM, (3). aucune sténose du LVOT, (4). aucune extrasystole par le contact d'un élément de valve avec le ventricule gauche, (5). Compatibilité maximale avec une implantation de valve par cathétérisme ultérieure possible d'une nouvelle prothèse dans une ancienne prothèse, (6). efficacité hémodynamique par anneau de suture à flexibilité maximale sans dégradation de la coaptation, étant donné qu'un deuxième anneau soutient la coaptation (7). efficacité hémodynamique par gradient d'écoulement minimal à travers la prothèse valvulaire, étant donné que dans le premier mode de réalisation (Fig 1, 3, 5, 6, 57, 62 et 44) le sang coule dans la prothèse valvulaire par trois ouvertures latérales. Cette valve est adaptée pour une implantation chirurgicale ouverte ou une mini-incisure. Autrement dit, la présente invention concerne une prothèse de valve cardiaque biologique comprenant des poches de valve, qui sont construites en dessous du plan de l'anneau de fixation dans la direction opposée à celle de l'écoulement à travers de la prothèse valvulaire, c'est-à-dire, p. ex., dans la position mitrale du côté de l'oreillette.
PCT/DE2019/000284 2018-11-13 2019-10-21 Nouvelle prothèse valvulaire biologique comprenant un anneau de suture WO2020098849A1 (fr)

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DE102018009061.3A DE102018009061A1 (de) 2018-11-13 2018-11-13 Neue biologische Klappenprothese des Typs unter dem Nahtring
DE102018009061.3 2018-11-13

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DE102014223522A1 (de) * 2014-11-18 2016-05-19 Hans-Hinrich Sievers Biologische Herzklappenprothese
DE102015206097A1 (de) * 2015-04-02 2016-10-06 Hans-Hinrich Sievers Herzklappenprothese

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US6312464B1 (en) * 1999-04-28 2001-11-06 NAVIA JOSé L. Method of implanting a stentless cardiac valve prosthesis
US7914569B2 (en) * 2005-05-13 2011-03-29 Medtronics Corevalve Llc Heart valve prosthesis and methods of manufacture and use
GR1007028B (el) * 2009-11-11 2010-10-22 Ευσταθιος-Ανδρεας Αγαθος Υποστηρικτης βιοπροσθετικων βαλβιδων με διαγλωχινικο συνδεσμο σχηματος καρδιας

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Publication number Priority date Publication date Assignee Title
US20100331972A1 (en) * 2009-06-26 2010-12-30 Edwards Lifesciences Corporation Unitary Quick Connect Prosthetic Heart Valve and Deployment System and Methods
DE102014223522A1 (de) * 2014-11-18 2016-05-19 Hans-Hinrich Sievers Biologische Herzklappenprothese
DE102015206097A1 (de) * 2015-04-02 2016-10-06 Hans-Hinrich Sievers Herzklappenprothese

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EP3880126A1 (fr) 2021-09-22

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