WO2018050202A1 - Implant cardiaque - Google Patents

Implant cardiaque Download PDF

Info

Publication number
WO2018050202A1
WO2018050202A1 PCT/EP2016/001564 EP2016001564W WO2018050202A1 WO 2018050202 A1 WO2018050202 A1 WO 2018050202A1 EP 2016001564 W EP2016001564 W EP 2016001564W WO 2018050202 A1 WO2018050202 A1 WO 2018050202A1
Authority
WO
WIPO (PCT)
Prior art keywords
attachment element
tubular
sheath
heart
tubular attachment
Prior art date
Application number
PCT/EP2016/001564
Other languages
English (en)
Inventor
Thomas Gerhardt
Raz Bar-On
Stefan Menzl
Leah KIDNEY
Niklas Maximilian NATHE
Youssef Biadillah
Merle ALLERDIßEN
Original Assignee
Coramaze Technologies 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 Coramaze Technologies Gmbh filed Critical Coramaze Technologies Gmbh
Priority to PCT/EP2016/001564 priority Critical patent/WO2018050202A1/fr
Publication of WO2018050202A1 publication Critical patent/WO2018050202A1/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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • such implants are positioned in such a way that a closure element of the implant is situated in the valve annulus and closes a remaining gap of the closed valve leaflets.
  • the closure element is connected to an anchoring element being configured to fix the closure element within the heart in the desired position i.e. in the valve annulus preferably to be contacted by the closing valve leaflets.
  • anchoring element punctured into the myocardium of the ventricle for fixation of the closure element.
  • modern implants provide a less invasive fixation just by contacting the interior wall of the atrium and/or the ventricle with the outer surface areas of an anchoring element formed of an expanded cage that is connected to the closure element.
  • Anchoring elements particularly the ones formed as a cage may be attached to the closure element on the atrial and/or ventricular side, most preferred only on the atrial side of the closure element.
  • Such cage and closure element typically is in a collapsed state for feeding the entire implant through a catheter into the heart where it is expanded after release from the catheter for fixation purposes.
  • the sheath is formed of a hose having tapered end areas / necks, accordingly the end areas of the hose have in the expanded state a smaller cross section / diameter compared to the part of the hose in between.
  • the end areas are attached to the tubular attachment element by sealingly contacting they inner surface of the hose to the exterior surface of the tubular attachment element.
  • the tapered end areas of the sheath or balloon formed by it do not contribute to the surface area of the expanded closure element to which the leaflets of a heart valve, preferably the mitral valve may coapt.
  • any direction mentioned in this application text is to be understood in relation to the implant correctly implanted in the heart, preferably if the closure element is positioned in the valve annulus, preferably of the mitral valve. Accordingly, an upper part of the implant is positioned in the atrium and a lower part is positioned in the ventricle.
  • the axial length of the hose having such a turn on at least one of the ends is shorter compared to a hose having no such turn at an end, particularly without reducing the axial length of the inflated balloon that comes into contact with the leaflets. Consequently, in the construction of the invention the distance between the two areas on the exterior surface of the attachment element to which the two
  • respective end areas of the hose are attached may be reduced in comparison to the know state of the art and as a result the overall length is shortened.
  • the surface area being turned outside in is a part of a Z- fold surrounding the tubular attachment area and being formed by the end of the hose being axially displaced towards the opposite end, particularly in the Z-folded state the inner surface of the tapered neck being sealingly attached to the exterior surface of the attachment element.
  • the surface area being turned outside in forms an inverted neck of the hose, in this inverted state the former exterior surface of the hose being sealingly attached to the exterior surface of the tubular attachment element.
  • This embodiment provides the possibility to even more reduce the overall length of the implant.
  • the coverage may be formed as a tapered hose, the end of the hose having the bigger cross section being attached to a not turned exterior surface area of the sheath and the end of the hose having the smaller cross section being attached to the exterior surface of the tubular attachment element or to a tapered not turned surface part of the sheath, preferably that itself is attached to the exterior surface of the tubular attachment element.
  • the tubular attachment element comprises a first axially extending lower tubular part being covered or at least coverable by the sheath and a second axially extending upper tubular part, preferably being external to the sheath, the upper tubular part extending between the first lower tubular part and the upper (atrial) end of the tubular attachment element.
  • the lower and the upper tubular flexible parts may be axially spaced by means of a rigid tubular part of the tubular attachment element, preferably the rigid part being formed of the original non-cut tube.
  • at least the tubular attachment and preferably the tubular attachment element and the strips of the anchoring cage may be formed of a unitary single tube.
  • Figure 1 A illustrates a first embodiment of the invention in comparison to the known construction (dashed lines), having a first anchoring cage
  • Figure 1 B illustrates an improvement of Figure 1 A by covering the
  • the cage C formed of all strips 4,5,6,7 and branches 4a,4b, 5a, 5b and 6, 6b comprises several strips, preferably the respective last but one strips 6 being formed of merged branches 5a, 5b that have a curved section CS being convex to a non-shown heart wall and concave towards the proximal part PP.
  • a respective curved section CS preferably has a tangent T perpendicular to the central axis A of the tubular element 1. Accordingly, each such curved section CS comprises a part being bent back from the distal part towards the proximal part PP of the cage.
  • Each such curved section CS of a strip 6 may form a first part of an S-shaped configuration wherein the second part of this S-shaped configuration is formed at least in part of the last branches 6a, 6b into which the strip 6 is split along the extension.
  • Each one of the last branches 6a, 6b is accordingly bent towards the distal part again and also has a non-shown tangent perpendicular to the axis A.
  • the part of the cage C opposite to the tubular element 1 has a concave part CP surrounding the central axis A and being depressed towards the inner volume of the cage C and preferably concave towards the heart wall. Consequently, the connected ends 7 or the free ends 7 of consecutively discussed embodiments will be free of contact to the heart wall.
  • This shown construction may also apply to all embodiments of Figures 1 ,2,3.
  • Figure 1 B illustrates an improvement of the embodiment shown in figure 1A.
  • FIG 1 B the coverage 2e is shown with a small distance to the sheath 2. This is just for better visibility. In the real construction the coverage 2e is connected to the sheath 2 and / or attachment element 1.
  • FIG 2 shows an embodiment of the closure element wherein the lower end area 2a of the sheath 2 is not just turned outside in but totally inverted, i.e. turned by 180 degrees. Accordingly, here the former exterior surface of the not inverted area is in the inverted state facing the exterior surface of the attachment element 1 and sealingly attached to it. It can also be seen by comparison with the dashed lines showing the state of the art that the overall length may be even more reduced.

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

La présente invention concerne un implant cardiaque, étant particulièrement conçu pour réduire ou éliminer une insuffisance de valvule cardiaque après implantation dans le cœur, comprenant un élément de fermeture pouvant être positionné à l'intérieur de l'anneau de valvule cardiaque, étant particulièrement conçu pour fermer ou au moins pour réduire un espace restant entre les feuillets de valvule de fermeture, l'élément de fermeture comprenant un élément de fixation tubulaire (1) et une gaine (2) entourant au moins partiellement l'élément de fixation tubulaire, la gaine étant formée d'un tuyau présentant deux zones d'extrémité opposées, particulièrement deux zones d'extrémité formant col effilé opposées, la gaine étant fixée à l'élément de fixation tubulaire dans les zones d'extrémité respectives pour fournir une lumière gonflable entre la gaine et l'élément de fixation et un élément d'ancrage (C) étant fixé à l'élément de fermeture, particulièrement à son élément de fixation tubulaire, afin de fixer l'implant dans le cœur, préférablement pour la fixation non effractive par contact de surface entre la surface extérieure de l'élément d'ancrage et une surface intérieure d'une lumière du cœur, préférablement l'atrium, au moins l'une des zones d'extrémité du tuyau comprenant une surface étant tournée vers l'extérieur et étant entourée de la gaine elle-même.
PCT/EP2016/001564 2016-09-16 2016-09-16 Implant cardiaque WO2018050202A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2016/001564 WO2018050202A1 (fr) 2016-09-16 2016-09-16 Implant cardiaque

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2016/001564 WO2018050202A1 (fr) 2016-09-16 2016-09-16 Implant cardiaque

Publications (1)

Publication Number Publication Date
WO2018050202A1 true WO2018050202A1 (fr) 2018-03-22

Family

ID=57113240

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2016/001564 WO2018050202A1 (fr) 2016-09-16 2016-09-16 Implant cardiaque

Country Status (1)

Country Link
WO (1) WO2018050202A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021067043A1 (fr) * 2019-09-30 2021-04-08 Edwards Lifesciences Corporation Dispositifs d'étanchéité de valvule cardiaque et dispositifs de pose correspondants
WO2022074655A1 (fr) * 2020-10-09 2022-04-14 Coramaze Technologies Ltd. Dispositif de traitement d'insuffisance valvulaire

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060058871A1 (en) * 2004-09-14 2006-03-16 Edwards Lifesciences, Ag Device and method for treatment of heart valve regurgitation
US20070293943A1 (en) * 2006-06-15 2007-12-20 Mednua Limited Medical device suitable for use in treatment of a valve
US20110224784A1 (en) * 2004-12-15 2011-09-15 Mednua Limited Medical device suitable for use in treatment of a valve
US20140277404A1 (en) * 2013-03-15 2014-09-18 Cardiosolutions, Inc. Trans-apical implant systems, implants and methods
US20150073547A1 (en) * 2005-10-26 2015-03-12 Cardiosolutions, Inc. Balloon mitral spacer

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060058871A1 (en) * 2004-09-14 2006-03-16 Edwards Lifesciences, Ag Device and method for treatment of heart valve regurgitation
US20110224784A1 (en) * 2004-12-15 2011-09-15 Mednua Limited Medical device suitable for use in treatment of a valve
US20150073547A1 (en) * 2005-10-26 2015-03-12 Cardiosolutions, Inc. Balloon mitral spacer
US20070293943A1 (en) * 2006-06-15 2007-12-20 Mednua Limited Medical device suitable for use in treatment of a valve
US20140277404A1 (en) * 2013-03-15 2014-09-18 Cardiosolutions, Inc. Trans-apical implant systems, implants and methods

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021067043A1 (fr) * 2019-09-30 2021-04-08 Edwards Lifesciences Corporation Dispositifs d'étanchéité de valvule cardiaque et dispositifs de pose correspondants
WO2022074655A1 (fr) * 2020-10-09 2022-04-14 Coramaze Technologies Ltd. Dispositif de traitement d'insuffisance valvulaire

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