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WO2004008998A1 - Valvule cardiaque prothetique mecanique presentant une cinematique d'occlusion amelioree - Google Patents

Valvule cardiaque prothetique mecanique presentant une cinematique d'occlusion amelioree Download PDF

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Publication number
WO2004008998A1
WO2004008998A1 PCT/EP2003/007769 EP0307769W WO2004008998A1 WO 2004008998 A1 WO2004008998 A1 WO 2004008998A1 EP 0307769 W EP0307769 W EP 0307769W WO 2004008998 A1 WO2004008998 A1 WO 2004008998A1
Authority
WO
WIPO (PCT)
Prior art keywords
leaflet
winglets
heart valve
valve
plane
Prior art date
Application number
PCT/EP2003/007769
Other languages
English (en)
Inventor
Anselm Steegers
Bernd Holder
Original Assignee
Lsmedcap Gmbh
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 Lsmedcap Gmbh filed Critical Lsmedcap Gmbh
Priority to AU2003260311A priority Critical patent/AU2003260311A1/en
Publication of WO2004008998A1 publication Critical patent/WO2004008998A1/fr

Links

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
    • A61F2/2403—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 pivoting rigid closure members

Definitions

  • the present invention relates to heart valve prostheses.
  • An object of the present invention is to overcome the above cited problems by providing a heart valve prosthesis according to claim 1.
  • the valve according to the invention makes possible a physiologic kinematics of the occluders by leading the blood flow around the occluders in a way that results in flow forces, which cause an opening (resp. closing) moment during the entire phase of movement of the occluders.
  • the invented design results in several more hemodynamic advantages of the heart valve prostheses.
  • the valve according to the invention the achieved flow of bileaflet valves becomes substantially more laminar, more even and essentially free of disturbances.
  • the flow does not show any more regions of separation as known for prior art designed valves within the wake of the leaflets. Thereby this results in a substantially less degree of blood damage with the known problems of thromboembolic and hemolytic risks.
  • the design according to the present invention results in superior energetic efficacy (i.e. pressure drop, closure volume loss) and excellent leaflet kinematics. Leaflets are significantly less fluttering.
  • trailing edge of the leaflets now can be designed in the ideal orientation parallel to the main flow direction. This leads in a further improved hemodynamic, reduction of wake and flow separation areas, early reattachment to the aortic wall, decreased peripheral vortex street.
  • a parallel orientation of the trailing edge up to now could only be achieved by a special hinge design to force leaflet rotation by a translatory movement which potentially causes an increased risk of thromboembolic events as known from the Medtronic Parallel valve (see literature).
  • the presented valve characteristics makes free design of the hinges possible.
  • the invented valve allows the design of a further increased opening area which is strongly related to the pressure drop and the valve efficacy.
  • leaflets are designed in a way that the peripheral ends of the trailing edge comprise so called “winglets” ( Figures No. 5 and 6), i.e. the peripheral ends of the leaflets have curvatures which for the leaflets in opened position are located within a plane perpendicular to the main flow direction.
  • valves of the prior art have leaflets which are essentially flat or leaflets which are curved or cambered in a plane parallel to the main flow direction or which are substantially evenly curved within the plane perpendicular to the main flow direction.
  • the latter leaflet curvatures of the prior art which might be located in a plane perpendicular to the main flow direction show a grade of curvature which is essentially constant over the length of the trailing edge.
  • the novel geometry involves a curvature where the grade of curvature is increased in a region nearby the tip of the trailing edge to built so called "winglets".
  • winglets a curvature where the grade of curvature is increased in a region nearby the tip of the trailing edge to built so called "winglets”.
  • the invention is not limited to a specific winglet shape or to a specific orientation of the winglets. It is also not limited to a specific number of winglets or to a specific location where the winglets should be fixed to the leaflet.
  • the present invention limited to aortic valve replacements.
  • FIG. 1 Prior art valve.
  • Fig. 2 Native aortic valve principle
  • Fig. 3 Prior art physiological working valve draft.
  • Fig. 4 Working principles.
  • Fig. 5 Perspective view of a bileaflet valve equipped with the novel occluders according to the present invention
  • Fig. 6 Perspective view of a leaflet equipped with the novel winglets according to the present invention.
  • Fig. 7 Leaflet curvature.
  • Fig. 8 Leaflet cambering Fig. 9. Leaflet curvature.
  • FIG. 1 A drawing of the prior art valve is given in Figure No. 1 (100).
  • the valve comprises of a valve ring (120) defined by the leading edge where the blood enters the valve body (121) and the trailing edge (122), where the blood emerges from the valve.
  • the valve body carries two leaflet occluders (130) being adapted to rotate between an open and an closed position by means of suitable hinge mechanisms (110).
  • Leaflet occluders are defined by a leading edge (131 ) and a trailing edge (132) according to the blood flow direction (101). Due to the design principle, the leaflet occluders are to move in a way that the trailing edge closes at the ring, while the leading edges defines the central diameter of the valve.
  • FIG. 2 depicts the native aortic valve. Comprising of the aortic root (210) and three leaflets (221, 222, 223). Blood flows from the ventricular side (201) towards the aortic side (202). The leaflets move according to the given direction (231, 232, 233) as seen from the aortic side.
  • Figure No. 3 shows a draft of a valve according to the physiological kinematics principle.
  • the leaflets (321, 322) defined by a leading edge (331, 332) and a trailing edge (341, 342) according to the main flow direction (301) are received by the ring (310) in a way that the trailing edges (341 , 342) move from the center towards the lateral ring area.
  • FIG. 4 makes the difference between physiological and anti-physiological principle clear: figure No. 4a gives the prior art anti-physiological kinematics while Figure No. 4b depicts the physiological working principle. Blood direction is defined by (410) and (420). Opening movement is given by (411) and (421). Leaflet rotation center is given at (415) and (425), respectively.
  • the valve ring (510) is defined by a leading edge (511) and a trailing edge (512) according to the main flow direction (501).
  • the ring carries two leaflet occluders (521 and 522) which are defined by a leading edge (531 and 532) and a trailing edge (541 and 542).
  • Leaflets are received by hinge mechanisms (551 and 552).
  • the leaflets are equipped with winglets (561 and 562)
  • leaflet body (611) is defined by the leading edge (621) and a trailing edge (631) according to the main flow direction (601).
  • the leaflet is symmetrically equipped with winglets (651 and 661).
  • FIG. 7a Another embodiment is given in Figure No. 7a as seen from the valve outflow side, where the leaflet body (711) with its skeleton line (721) is flat regarding the cross section in the plane substantially orthogonal io the main flow direction (701).
  • Winglets (751 and 761) might be adapted as seen from the drawing.
  • a curved leaflet body might be advantageous as given in Figure No. 7b.
  • Leaflet body (712) might be curved in the main valve area as illustrated by the skeleton line (722) regarding the cross section in the plane substantially orthogonal to the main flow direction (702).
  • the winglets might be adapted as shown (752 and 762).
  • FIG. 7a Another embodiment of the valve leaflets is given in Figure No.
  • Figure 8a gives a leaflet (811) defined by leading edge (821) and trailing edge (831) which is cambered (871) in a plane substantially parallel to the main flow direction (801) but equipped with winglets (851 and 861).
  • Figure 8b gives the flat leaflet body in the same view.
  • the valve body (812) defined by leading edge (822) and trailing edge (832) is equipped with winglets (852 and 862). Whereas the skeleton lines are substantially not curved (881 and 882)
  • FIG. 9 A further embodiment which might be advantageous is given in Figure No. 9.
  • the leaflet body (911) defined by leading edge (921) and trailing edge (931) is curved in a plane substantially parallel to the main flow direction (901).
  • the curvature is defined by the leaflets body skeleton line (981) The orientation of that curvature might be towards the valve center (901) ), see Figure 9a or vice versa (902) ), see Figure 9b.
  • the winglets of this leaflet embodiment might be integrated as shown (951 and 961) or (952 and 962), respectively.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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

L'invention concerne une prothèse de valvule cardiaque mécanique améliorée, et plus particulièrement une valvule prothétique fonctionnant conformément à la cinématique physiologique, c'est-à-dire que les valves de ces valvules s'ouvrent par le centre de la même manière que les valvules naturelles. Les organes d'occlusion (521, 522) du modèle de valvule décrit sont équipés d' « ailettes » (561, 562), ce qui veut dire que les angles périphériques des bords (541, 542) arrières de valves présentent une courbure distincte située, lorsque les valves se trouvent en position ouverte, dans un plan perpendiculaire à l'axe principal (direction d'écoulement ) de la valvule.
PCT/EP2003/007769 2002-07-19 2003-07-17 Valvule cardiaque prothetique mecanique presentant une cinematique d'occlusion amelioree WO2004008998A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003260311A AU2003260311A1 (en) 2002-07-19 2003-07-17 Mechanical heart valve prosthesis with improved occluding kinematics

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH0200404 2002-07-19
CHPCT/CH02/00404 2002-07-19

Publications (1)

Publication Number Publication Date
WO2004008998A1 true WO2004008998A1 (fr) 2004-01-29

Family

ID=30450013

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2003/007769 WO2004008998A1 (fr) 2002-07-19 2003-07-17 Valvule cardiaque prothetique mecanique presentant une cinematique d'occlusion amelioree

Country Status (2)

Country Link
AU (1) AU2003260311A1 (fr)
WO (1) WO2004008998A1 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4078268A (en) 1975-04-24 1978-03-14 St. Jude Medical, Inc. Heart valve prosthesis
US4363142A (en) 1979-10-12 1982-12-14 Mitral Medical, Inc. Prosthetic heart valve
US4676789A (en) 1985-05-16 1987-06-30 Sorensen H Rahbek Heart valve
EP0283413A1 (fr) 1987-03-20 1988-09-21 Jean Colon Valve à au moins un volet basculant par rapport à des pivots élastiques
US4808180A (en) 1987-04-29 1989-02-28 Medtronic, Inc. Prosthetic heart valve
US5116367A (en) * 1989-08-11 1992-05-26 Ned H. C. Hwang Prosthetic heart valve
WO1992021305A1 (fr) * 1991-06-06 1992-12-10 Medtronic, Inc. Prothese de valvule cardiaque a deux valves a courbure composite
US5405381A (en) 1990-08-09 1995-04-11 Olin; Christian Hinged heart valve prosthesis
US5554186A (en) * 1994-12-22 1996-09-10 Baxter International Inc. Bileaflet mechanical heart valve having cropped slot pivot configuration and method for preventing blood stagnation therein
US5814099A (en) 1996-08-12 1998-09-29 Bicer; Demetrio Central opening curved bileaflet heart valve prosthesis

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4078268A (en) 1975-04-24 1978-03-14 St. Jude Medical, Inc. Heart valve prosthesis
US4363142A (en) 1979-10-12 1982-12-14 Mitral Medical, Inc. Prosthetic heart valve
US4676789A (en) 1985-05-16 1987-06-30 Sorensen H Rahbek Heart valve
EP0283413A1 (fr) 1987-03-20 1988-09-21 Jean Colon Valve à au moins un volet basculant par rapport à des pivots élastiques
US4808180A (en) 1987-04-29 1989-02-28 Medtronic, Inc. Prosthetic heart valve
US5116367A (en) * 1989-08-11 1992-05-26 Ned H. C. Hwang Prosthetic heart valve
US5405381A (en) 1990-08-09 1995-04-11 Olin; Christian Hinged heart valve prosthesis
WO1992021305A1 (fr) * 1991-06-06 1992-12-10 Medtronic, Inc. Prothese de valvule cardiaque a deux valves a courbure composite
US5554186A (en) * 1994-12-22 1996-09-10 Baxter International Inc. Bileaflet mechanical heart valve having cropped slot pivot configuration and method for preventing blood stagnation therein
US5814099A (en) 1996-08-12 1998-09-29 Bicer; Demetrio Central opening curved bileaflet heart valve prosthesis

Also Published As

Publication number Publication date
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