WO2012065856A2 - Valve cardiaque biologique à endoprothèse - Google Patents

Valve cardiaque biologique à endoprothèse Download PDF

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Publication number
WO2012065856A2
WO2012065856A2 PCT/EP2011/069371 EP2011069371W WO2012065856A2 WO 2012065856 A2 WO2012065856 A2 WO 2012065856A2 EP 2011069371 W EP2011069371 W EP 2011069371W WO 2012065856 A2 WO2012065856 A2 WO 2012065856A2
Authority
WO
WIPO (PCT)
Prior art keywords
heart valve
diameter
fastening ring
axial end
frame
Prior art date
Application number
PCT/EP2011/069371
Other languages
German (de)
English (en)
Other versions
WO2012065856A3 (fr
Inventor
Hans-Hinrich Sievers
Meinhard Aits
Norbert W. Guldner
Michael Scharfschwerdt
Kathrin Rosenbohm
Sandra Schneider
Original Assignee
Hans-Hinrich Sievers
Meinhard Aits
Guldner Norbert W
Michael Scharfschwerdt
Kathrin Rosenbohm
Sandra Schneider
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 Hans-Hinrich Sievers, Meinhard Aits, Guldner Norbert W, Michael Scharfschwerdt, Kathrin Rosenbohm, Sandra Schneider filed Critical Hans-Hinrich Sievers
Publication of WO2012065856A2 publication Critical patent/WO2012065856A2/fr
Publication of WO2012065856A3 publication Critical patent/WO2012065856A3/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
    • A61F2/2412—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
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the invention relates to a gestated biological heart valve.
  • biological heart valves which have a valve frame, for example made of wire, which forms a stent. At this frame the flap sails or pocket flaps are attached from biological material. At an axial end, d. H. At one end in the direction of flow through the heart valve, a fastening ring is formed on the flap frame, which serves for fastening the heart valve in a blood vessel, in particular for suturing the heart valve in the aortic root.
  • the stented biological heart valve according to the invention is in particular a replacement for the aortic valve, d. H. intended and trained for use in the human aorta.
  • the heart valve according to the invention is intended to replace the natural heart valve, d. H. the natural heart valve is removed before insertion of the heart valve according to the invention.
  • the biological heart valve according to the invention comprises a valve frame, on which the flap flaps or valve leaflets are fastened in particular of biological material.
  • a fastening ring is formed or attached to the flap frame, which serves for securing the heart valve in a blood vessel, in particular the aorta.
  • the fastening ring is designed in particular as a sewing ring made of a material which can be sewn to the tissue of the blood vessel or the aorta. In particular, it is a textile material which is suitable for sewing.
  • this attachment or sewing ring always has a diameter which is greater than the outer diameter of the valve frame.
  • the flap frame is made variable in its diameter or in the cross-sectional area defined by it.
  • the flap frame according to the invention is designed such that the diameter or the cross section in the radial direction so ver- can be changed that the diameter or the spanned cross-sectional area of the valve frame after insertion of the heart valve into the blood vessel is expandable relative to the mounting ring.
  • the stretched by the flap frame cross-sectional area after the extension may be greater than the clamped by the mounting ring cross-sectional area.
  • the flap frame can be designed so that, starting from its initial diameter, it is first reduced in diameter, then inserted into the blood vessel and subsequently expanded again to the starting diameter.
  • the diameter of the flap frame can then be expanded, in which case a larger flow cross-section is made possible in the functional state.
  • a flow cross section can be achieved which essentially corresponds to the cross section of the natural heart valve to be replaced or even larger than the natural flow cross section.
  • the flap frame is at least at its the mounting ring facing axial end variable in diameter. This is the area where the flap flaps are attached at their lowest point. This is the area of the valve frame with the largest diameter.
  • the valve leaflets or pocket flaps contact the coaptation surface and thus form the closure or, if they fold outward, the flow passage of the heart valve.
  • the flap frame is designed in such a way that, after insertion into the aorta, it can be expanded or expanded in its diameter or cross section into the sinus aortae.
  • the valve frame is designed such that it can partially expand into the sinus aortae. Ie. in particular, the arches of the valve frame expand into the sinus aortae, while the area of the commissures does not substantially expand.
  • a stretched from the flap frame cross-sectional shape is achieved, which is given essentially by the natural cross-sectional shape, taking into account the extensions in the sinus aortae.
  • the radial extent increases at least in individual peripheral portions with no exact circular shape must be given.
  • the existing in the sinus aortae space for receiving the valve frame can be used and the pocket flaps can be arranged similar to the natural valves and thus obtained essentially the natural flow cross-section.
  • the change of the diameter or the change of the cross-sectional area in the radial direction is achieved by an elastic deformation of the flap frame.
  • the flap frame is preferably elastically deformable such that it shrinks for insertion in its outer diameter or outer cross section and expands after insertion by elastic restoring forces in its diameter. Ie.
  • the flap frame is compressed radially inwardly, whereby elastic return forces are generated in the material of the Klappenge- steep.
  • suitable holding means the flap frame can be kept in this compressed state. After insertion, the holding means can be released, whereby the flap frame then expands due to the elastic restoring forces back to its original shape.
  • the flap frame is preferably made at least partially of a spring material and / or a material with shape memory properties, preferably, the flap frame is formed of a metallic material having such material properties.
  • At least one releasable retaining means is provided which holds the flap frame in its lesser diameter state.
  • the holding means is designed so that it can be solved after insertion of the heart valve, but preferably completely removed, so that the valve frame then widens in the state of larger diameter and remains in this state.
  • the flap frame is preferably designed so that it automatically holds the shape of larger diameter in its rest or initial position and must be held by external force in the state with a smaller diameter.
  • the flap frame has a maximum diameter which is equal to or greater than the outer diameter of the fastening ring.
  • the pocket flaps or valve leaflets arranged on the flap frame do not essentially reduce the flow cross-section, since the pocket flaps can be arranged so that they essentially completely release the cross-section defined by the fastening ring in the opened state.
  • the flap frame has, at its axial end facing the fastening ring, a maximum diameter which ensures an inner diameter which is equal to or greater than the outer diameter of the heart valve at the axially opposite end.
  • This embodiment ensures that the flow cross-section in the region of the flap frame and the pocket flaps is limited only by the cross-section bounded by the opened pocket flaps on the opening side of the pocket flaps.
  • the flap frame is designed or dimensioned such that it has a maximum flow cross-section which is equal to or greater than the flow cross-section of the natural heart valve to be replaced.
  • a maximum flow cross-section which is equal to or greater than the flow cross-section of the natural heart valve to be replaced.
  • differently dimensioned artificial heart valves can be provided which can replace differently sized natural heart valves, wherein the maximum flow cross section is equal to or greater than the flow cross section of the natural heart valve to be replaced in each case in these heart valves according to the invention.
  • variable diameter of the flap frame further preferably has a minimum diameter which is less than or equal to the outer diameter of the fastening ring is.
  • the insertion of the heart valves is favored, since the maximum outer diameter, which is taken into account during insertion, corresponds to the outer diameter of the fastening ring.
  • the minimum diameter of the valve frame is smaller than the outer diameter of the fastening ring, the trouble-free sewing of the fastening ring on the tissue of the blood vessel is ensured.
  • the flap frame is attached to a first axial end of the fastening ring, wherein the fastening ring has a fastening region adjacent to the opposite second axial end of the fastening ring and spaced from the first and the second axial end of the fastening ring between these axial ends a kink region is formed which allows the folding over of the fastening ring when widening the diameter of the flap frame in such a way that a region of the fastening ring adjoining the first axial end of the fastening ring comes to lie above the fastening area.
  • This embodiment is particularly suitable for sewing the fastening ring in the aorta.
  • the fastening ring is preferably formed in this embodiment as a sewing ring, for example of a textile material.
  • the attachment area which adjoins the axial end of the attachment ring, which faces away from the flap frame, is sewn, ie, in this area, the threads and nodes are placed.
  • the fastening ring is provided with at least one peripheral portion having two fastening areas or adjacent areas which are intended to act on one another in the axial direction.
  • This arrangement of two seam areas or Nahfringe is preferably provided in the commissures and serves to provide better Beschesf Trentskon.
  • a two Nahf range from the axial end of the Befesf Trentsringes beabsfandet between the arches of the Klappengesfells, ie be located in the field of commissures.
  • This Nahf Society may arc-shaped or undulating between the sheets so that the Nahf Quarry so away from the axial end of the Befesf concernssringes that the Schei- telpunkf this second Nahf Anlagenes between the sheets has its furthest distance from the Befesfistsringes.
  • Such a trained Nahf Championship has the idea that the sutures of the patient's anafomia can be better approximated during attachment.
  • the seaming region of the binding ring adjacent the axial end serves for attachment in the area of the arches and in the areas between the arches, in the event that the arcuate course of the second seam area can not be matched with the anafomia of the patient ,
  • the invention will now be described by way of example with reference to the accompanying drawings. In these shows: a schematic view of the valve frame,
  • Fig. 4 shows a detail of the valve frame with attached
  • FIG. 5 shows schematically the flap frame with mounting ring in the inserted state into the aorta
  • FIG. 6 is an overall view of a heart valve according to the invention.
  • Fig. 7 is an overall view of a heart valve according to the invention according to FIG. 6 with an alternative embodiment of the fastening ring.
  • the flap frame 2 is formed in the example shown here from wire with resilient properties.
  • the flap frame 2 is formed of three sheets 4, which are respectively provided for holding a pocket flap 5 (see Figs. 6 and 7).
  • the fastening ring adjoins.
  • the legs of the sheets 4 are connected to each other by means of oppositely curved connecting sheets 6, wherein the radius of the connecting sheets 6 is significantly smaller than the radius of the sheets 4.
  • the flap frame can be elastically compressed in the radial direction R, whereby the diameter decreases relative to the longitudinal axis X.
  • the longitudinal axis X is the axis along which the flow direction passes through the heart valve. In the diameter reduction shown in FIG.
  • the sheets 4 are pressed radially inward, resulting in a deformation both in the sheets 4 and in particular in the connecting sheets 6, which is resilient and reversible.
  • the diameter or cross section at a first axial end 8 to which the fastening ring 10 is fastened to the flap frame 2 is reduced.
  • sufficient space is created during insertion into the aorta in this area to be able to sew the fastening ring, which is designed as a sewing ring, with the tissue of the aorta.
  • a retaining means not shown in detail here which holds the flap frame 2 in the state shown in Fig. 2a and Fig.
  • the flap frame 2 relaxes due to the elastic restoring forces in the radial direction R and in Diameter extended, as shown in Figs. 3a and 3b.
  • the sheets 4 move radially outwards, so that the diameter is widened, in particular in the region of the first axial end 8 which adjoins the fastening ring 10.
  • the arches 4 can move into the sinus aortae, as shown in FIG. 5.
  • the flap flap holding structure of the flap frame 2 can be moved out of the flow cross-section substantially, so that the flow cross-section through the heart valve is not substantially smaller than the diameter of the fastening ring 10 and the flow cross-section with respect to the natural heart valve is not substantially reduced ,
  • the fastening ring 10 which is a sewing ring, essentially consists of a sleeve whose first axial end de 12 is connected to the first axial end 8 of the valve frame.
  • an annular bend line or a kink region 16 along which the mounting ring 10 can fold down such that the annular first axial end comes to rest on the annular second axial end 14, wherein the axial ends 12th and 14 radially outward and the kink portion 16 is radially inward.
  • This state is achieved when the flap frame 2 is brought into the extended diameter state, which is shown in Fig. 3a, as it pulls the flap frame 2 at its first axial end 8, the first axial end 12 of the fastening ring 10 radially outward.
  • the fastening ring 10 is made of a textile material, for example, so that it is suitable for sewing with the vessel wall of the aorta.
  • the sewing takes place in a fastening region 18 of the fastening ring 10, which is located between the second axial end 14 and the bending region 16.
  • the stitching is performed when the flap frame 2 is in its reduced diameter position as shown in Figs. 2a and 2b.
  • the first axial end 12 of the fastening ring 10 lies radially further inward than the second axial end 14, so that the fastening region 18 is freely accessible and the fastening ring 10 can be sutured by means of threads 20 to the annulus 22 of the aorta.
  • the knots 24 are formed on the attachment portion 18.
  • the sheets 4 are pressed radially outwards and thus the first axial end 12 of the fastening ring 10 is pulled radially outwards so that the portion of the fastening ring between the bending region 16 and the first axial end 12 covers the attachment region 18.
  • the knots 24 are covered and protected between the two sections of the fastening ring 10.
  • the cage 2 moves into the sinus aortae 26, so that they are accommodated in this enlarged section of the aorta and do not reduce the transverse diameter of the suture relative to the annulus 22. In this way, essentially the natural Sfrömungsquerschnitf can be maintained.
  • the fastening region 18 of the fastening ring 10 forms in both embodiments, ie both in the embodiment according to FIG. 6 and in the embodiment according to FIG. 7, a first sewing ring or seam region.
  • a second seam region 28 is formed in each case in the region of the commissures 27.
  • This second seam region 28 extends in the axial direction between the sheets 4 in the region of the commissures in the area of the commissures, so that the greatest distance in the region of the vertex of the seam region 28 lies between the sheets 4 in the region of the commissure 27 is.
  • This more curved or more wavy course of the second seam region 28 has the advantage that when inserting the heart valve in this area, the seam can follow the natural anatomy of the patient.
  • the sewing takes place in the region of the fastening region 18 of the fastening ring 10, so that overall a more wave-shaped seam course can be achieved.
  • the attachment or the attachment can also be made in the area of the commissures 27 Sewing the heart valve in the attachment region 18 of the fastening ring 10 done, which then no or only a less wavy course of the seam is achieved.
  • the second seam region 28 is formed above the fastening ring in the region of the commissure 27.
  • a corresponding arcuate tab 29 adjacent to the axial end 12 of the mounting ring 10 and wegersharen from this.
  • the second seam region 28 is formed on a tab 30, which extends directly from the bending region 16 of the sewing ring 10. In this embodiment, a direct transition of the seam or fastening region 18 into the seam region 28 at the edge of the flap 30 is achieved.

Landscapes

  • 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

L'invention concerne une valve cardiaque biologique à endoprothèse pour le remplacement d'une valve cardiaque naturelle, comportant un support de valve, des valves semi-lunaires fixées sur celui-ci, de même qu'une bague de fixation réalisée à une extrémité axiale du support de valve pour la fixation de la valve cardiaque dans un vaisseau sanguin. Dans ce cadre, le support de valve peut être de diamètre variable au moins au niveau de son extrémité axiale tournée vers la bague de fixation, de sorte que le diamètre du support de valve peut être élargi par rapport à la bague de fixation après l'installation de la valve cardiaque dans le vaisseau sanguin.
PCT/EP2011/069371 2010-11-17 2011-11-03 Valve cardiaque biologique à endoprothèse WO2012065856A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE201010051632 DE102010051632B4 (de) 2010-11-17 2010-11-17 Gestentete biologische Herzklappe
DE102010051632.5 2010-11-17

Publications (2)

Publication Number Publication Date
WO2012065856A2 true WO2012065856A2 (fr) 2012-05-24
WO2012065856A3 WO2012065856A3 (fr) 2012-09-20

Family

ID=44906141

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2011/069371 WO2012065856A2 (fr) 2010-11-17 2011-11-03 Valve cardiaque biologique à endoprothèse

Country Status (2)

Country Link
DE (1) DE102010051632B4 (fr)
WO (1) WO2012065856A2 (fr)

Families Citing this family (17)

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Publication number Priority date Publication date Assignee Title
US8579964B2 (en) 2010-05-05 2013-11-12 Neovasc Inc. Transcatheter mitral valve prosthesis
US9554897B2 (en) 2011-04-28 2017-01-31 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US9308087B2 (en) 2011-04-28 2016-04-12 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US9345573B2 (en) 2012-05-30 2016-05-24 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US9572665B2 (en) 2013-04-04 2017-02-21 Neovasc Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
DE102014223522A1 (de) 2014-11-18 2016-05-19 Hans-Hinrich Sievers Biologische Herzklappenprothese
DE102015206099A1 (de) 2015-04-02 2016-10-06 Hans-Hinrich Sievers Herzklappenprothese
DE102015206098B4 (de) 2015-04-02 2018-09-27 Hans-Hinrich Sievers Implantationshilfe für eine biologische Herzklappenprothese sowie Herzklappenprothesensystem
DE102015206097A1 (de) * 2015-04-02 2016-10-06 Hans-Hinrich Sievers Herzklappenprothese
CN108882981B (zh) 2016-01-29 2021-08-10 内奥瓦斯克迪亚拉公司 用于防止流出阻塞的假体瓣膜
AU2017361296B2 (en) 2016-11-21 2022-09-29 Neovasc Tiara Inc. Methods and systems for rapid retraction of a transcatheter heart valve delivery system
CN111263622A (zh) 2017-08-25 2020-06-09 内奥瓦斯克迪亚拉公司 顺序展开的经导管二尖瓣假体
CA3118599A1 (fr) 2018-11-08 2020-05-14 Neovasc Tiara Inc. Deploiement ventriculaire d'une prothese de valvule mitrale transcatheter
AU2020256195B2 (en) 2019-04-01 2022-10-13 Neovasc Tiara Inc. Controllably deployable prosthetic valve
US11491006B2 (en) 2019-04-10 2022-11-08 Neovasc Tiara Inc. Prosthetic valve with natural blood flow
US11779742B2 (en) 2019-05-20 2023-10-10 Neovasc Tiara Inc. Introducer with hemostasis mechanism
US11311376B2 (en) 2019-06-20 2022-04-26 Neovase Tiara Inc. Low profile prosthetic mitral valve

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GB9312666D0 (en) * 1993-06-18 1993-08-04 Vesely Ivan Bioprostetic heart valve
US7189258B2 (en) * 2002-01-02 2007-03-13 Medtronic, Inc. Heart valve system
US8840663B2 (en) * 2003-12-23 2014-09-23 Sadra Medical, Inc. Repositionable heart valve method
WO2007054015A1 (fr) * 2005-11-09 2007-05-18 Ning Wen Endoprothese de type valvule cardiaque artificielle, et procede de tissage correspondant
US8398704B2 (en) * 2008-02-26 2013-03-19 Jenavalve Technology, Inc. Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
EP2419050B2 (fr) * 2009-04-15 2023-10-18 Edwards Lifesciences CardiAQ LLC Implant vasculaire et système d'introduction

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Title
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Also Published As

Publication number Publication date
DE102010051632A1 (de) 2012-05-24
WO2012065856A3 (fr) 2012-09-20
DE102010051632B4 (de) 2013-09-12

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