WO2019011391A1 - Implant cardiaque - Google Patents

Implant cardiaque Download PDF

Info

Publication number
WO2019011391A1
WO2019011391A1 PCT/EP2017/000806 EP2017000806W WO2019011391A1 WO 2019011391 A1 WO2019011391 A1 WO 2019011391A1 EP 2017000806 W EP2017000806 W EP 2017000806W WO 2019011391 A1 WO2019011391 A1 WO 2019011391A1
Authority
WO
WIPO (PCT)
Prior art keywords
heart
foam
closure element
leaflets
closure
Prior art date
Application number
PCT/EP2017/000806
Other languages
English (en)
Inventor
Thomas Gerhardt
Leah KIDNEY
Stefan Daniel Menzl
Youssef Biadillah
Laura FIGULLA
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/EP2017/000806 priority Critical patent/WO2019011391A1/fr
Publication of WO2019011391A1 publication Critical patent/WO2019011391A1/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
    • A61F2250/0014—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
    • A61F2250/0023—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 porosity
    • A61F2250/0024—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 porosity made from both porous and non-porous parts, e.g. adjacent parts
    • 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
    • A61F2250/003—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 adsorbability or resorbability, i.e. in adsorption or resorption time

Definitions

  • the invention relates to a heart implant, particularly a heart implant being configured to reduce or eliminate a heart valve insufficiency after implantation into the heart.
  • such implants are positioned in such a way that a closure element of the implant is situated in the valve annulus (for example mitral or tricuspid valve) and closes a remaining gap of the closed valve leaflets.
  • the closure element is connected to at least one anchoring element, for example an anchoring cage, 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.
  • the closure element may be formed by an inflatable sheath / membrane that is positioned, preferably coaxially positioned around a central column element, preferably a tubular central column element and fixed to this element at the respective ends of the sheath / membrane to get a fluid tight space around the central column element.
  • a fluid tight sheath may be inflated with a fluid.
  • the areas of attaching the sheath to the central column element also define the upper and lower end of the closure element.
  • Such kind of closure element may cause problems due to leakage of the sheath, resulting in a partial loss of its functionality.
  • the closure element may be also formed of a sheath/membrane being supported by an expanded part of a central column element, preferably tubular central column element.
  • the expanded part may form a scaffold structure, preferably a meshed scaffold structure that supports the sheath from the inside.
  • the sheath also here prevents blood from passing through the valve in a closed leaflet state and may also be fluid tight. In such a kind of closure element the coapting leaflets may get harmed by the very rigid scaffold structure under the sheath.
  • the sheath of such a closure element is not necessarily fluid tight from the beginning of the implantation.
  • the sheath may have pores for allowing blood to enter the inner space of the closure element but may not allow clotted blood to escape from the inner space of the closure element.
  • the blood may get clotted more and more with time and may close the sheath and thus form the closure element accordingly.
  • the clotted blood inside the closure element forms a rigid body underlying the sheath that may cause problems to the coapting leaflets.
  • the closure element is a plug that is configured to be positioned within the valve annulus of a valve that is to be treated. This plug will close or at least reduce a remaining gap between the closing leaflets of the valve.
  • Such cage typically is crimped into a collapsed state for insertion of the entire implant through a catheter into the heart where it is expanded after release from the catheter for fixation purposes.
  • the invention preferably relates to such implants having an expandable, particularly mesh-like anchoring cage formed of preferably interconnected strips for anchoring purposes,
  • An anchoring cage may also be formed without meshes, particularly just by several side-by-side-lying strips having no interconnections.
  • the invention in general also relates to non-meshed cages and any other suitable anchoring element(s) attached to the closure element for fixation purposes, particularly for atraumatic fixation purposes.
  • an anchoring element is an anchor configured to fix the implant in the heart, preferably by surface contact only, i.e. without puncturing the myocard.
  • the central column element preferably a tubular column element or tube has a lower end and an upper end and is split into several strips at least at the upper end, the strips forming an expandable cage as mentioned, particularly for fixing the heart implant to the atrium of the heart by surface contact between an exterior surface of the expandable cage (the several strips) and an interior atrium surface.
  • the mentioned positions “lower” and “upper” or directions mentioned in this disclosure are to be understood in the intended position of the implant if it is correctly implanted in the heart.
  • the atrium is positioned above the ventricle and accordingly the lower end of the closure element faces the ventricle, particularly is positioned in the ventricle and the upper end faces the atrium, particularly is positioned in the atrium if correctly implanted.
  • a middle part of the closure element between the upper and lower end is passing through the annulus of the valve that is to be treated, preferably the mitral or tricuspid valve.
  • the central column element particularly the tubular central column element preferably the so formed scaffold structure and the strips of an anchoring cage may originate from one single tube by cutting the tubular wall several times, preferably in an axial direction the mentioned strips all start their extension from an annular upper end area of the central column element / scaffold structure and preferably are equally spaced along the circumference of this end.
  • Such a cage may also be formed of strips starting their extension at the lower end of the central column element.
  • An anchoring element, particularly cage-like element is preferably formed by splitting and merging strips thus forming a half mesh between the points of splitting and merging. This embodiment is also preferred for the invention described in this disclosure.
  • An anchoring cage having several meshes is formed that way for solely fixing the heart implant to the atrium and/or ventricle of the heart by surface contact between the exterior cage surface and the interior surface of the respective heart lumen (atrium or ventricle).
  • the invention relates to an implant having a single anchoring cage only on the atrial side of the closure element.
  • a cage being formed of several expanded strips originating from a cut tube by radial expansion provides the advantage that the strips may generate a radial force being essentially perpendicular to the axis of extension of the (tubular) attachment element to keep the anchoring cage in place after implantation and expansion.
  • the anchoring cage is sufficiently compliant in radial direction in order to adapt its shape to the atrium.
  • the closure elements of the state of the art it is an object of the invention to improve the closure elements of existing heart implants and to provide an inventive implant that provides a harmless surface of the closure element for the coapting leaflets.
  • the improvement shall provide a mechanical isolation between the leaflets and any rigid structure in the closure element, like central columns or expanded scaffold structures.
  • the implant and method of treatment may be also applied to animals, particularly mammalian animals.
  • a heart implant comprising a closure element being configured to be positioned within the heart valve annulus, particularly being configured to close or at least to reduce a remaining gap between closing valve leaflets, and an anchoring element being attached to the closure element for fixing the implant in the heart, preferably for atraumatic fixing by surface contact between the exterior surface of the anchoring element and an interior surface of a heart lumen, preferably the atrium, most preferred the left atrium
  • the closure element comprises at least one foam element, particularly at least in or below the areas of the closure element being configured to be contacted by coapting leaflets.
  • a foam element in the closure element particularly at least in those areas that get contacted by the leaflets, preferably at least in the mid area of the closure element in regards to its axial extension.
  • the axial mid area of a closure element is typically positioned in the valve annulus to get in contact with the leaflets.
  • the foam element may form the top surface of the closure element and is contacted by the leaflets directly or that the foam element is positioned underneath the surface area of the closure element, particularly a sheath or membrane that gets in contact with the leaflets. In this latter embodiment the foam element will be indirectly contacted by the leaflets.
  • the foam element is positioned in or at the closure element between the leaflets and any kind or internal rigid structure, like a scaffold structure or a big agglomeration of clotted blood.
  • the foam element is configured to be at least partially compressed if directly or indirectly contacted by the leaflets. "At least partially” shall preferably mean that the compression will take place at least in the surface area of a foam element being near the leaflets.
  • any force exerted by the leaflets to the contacted surface of the closure element or vice versa is at least partially absorbed by the integral resilience of a foam element.
  • the mentioned at least one foam- element may comprise internal pores / cells that are open to the surroundings and may get filled with a fluid, particularly with blood.
  • Open to the surrounding shall preferably mean that the pores / cells are accessible and may get filled with blood from the outside of the closure element or form the inside of the closure element, particularly if the internal volume of the closure element is filled with blood or can be filled with blood.
  • the pores / cells of the at least one foam element may be closed and accordingly may not get filled by any fluid from the outside, but may by filled with a fluid in the cells / pores, preferably a gas.
  • a fluid in the cells / pores preferably a gas.
  • Such kind of construction may be even more resilient than the afore-mentioned embodiment.
  • the invention may also provide that the foam element comprises closed cells / pores and open cells / pores simultaneously, particularly a mixture of those different cells being uniformly distributed.
  • the open cells / pores may be filled with blood after implantation as mentioned before and the closed cells / pores may remain as they are.
  • the ratio of open cells/ pores and closed cells /pores may be different for different applications or patients and accordingly by selecting different ratios from a stock of different implants a desired overall resilience of the closure element may be achieved.
  • the foam element may be configured to be self-expanding to a predetermined shape, thus providing the entire closure element with the desired shape.
  • the foam element may suck in blood into its pores /cells when it is expanding.
  • the foam element may be used for triggering the expansion process of the closure element, for example by opening an inlet port for blood in the closure element.
  • the foam element is compressed and comprises open cells and maybe also closed cells. The cells tend to expand but expansion is prevented unless the inflow of blood into the cells / pores is allowed, for example by opening an inlet port.
  • Such an inlet port may be positioned in the end of the closure element, particularly the end of a tubular column element in the closure element facing the ventricle.
  • the closure element is completely consisting of a foam element, that is connected to the anchoring element.
  • the foam element may be fused or differently connected to the anchoring element.
  • the foam element may have circular cross section (regarded perpendicular to its axial extension) in a mid section and may be tapered at its upper and lower end respectively.
  • the closure element comprises a central column element, particularly a slotted tube or meshed scaffold, the central column element being at least partially surrounded, preferably entirely surrounded by the at least one foam element.
  • a central column element may be split into several strips at its upper end facing the atrium for forming the anchoring element by means of such strips. Those strips may extend upwards and towards the top of the atrium and bent back by at least 180 degree towards the closure element. The bent back part of the strips is preferably surrounding the part of the strips that extend upwards.
  • the foam element may be positioned between the central column element and a sheath, particularly an inflatable membrane, surrounding the central column element. It may be provided that inflation may comprise the filling of the internal volume of the sheath and
  • the foam element may be positioned on the outer surface of a sheath, particularly an inflatable membrane, surrounding the central column element.
  • the internal volume of the closure element surrounded by the sheath may be filled with a fluid for inflation purposes. Blood may be used for such fluid.
  • the sheath may also be supported by a scaffold structure on the inside surface of the sheath.
  • the scaffold structure may be formed of an expanded tube, as it is known from stent structures.
  • the outer foam elements will preferably form the surfaces that are contacted by coapting leaflets.
  • the foam element is circumferentially distributed around the closure element by 360 degrees. In fact it would be sufficient to provide foam pads at those positions of the outer surface of the closure element that get in contact with the leaflets.
  • the closure element may comprise a number of foam elements, being formed as foam pads in or below the areas of the closure element being
  • coapting leaflets particularly a number of foam pads corresponding to the number of leaflets, particularly 2 to 3 pads.
  • Such a respective foam pad may extend between the inner surface of a sheath configured to be contacted by leaflets, particularly of an inflatable membrane, and the outer surface of a central column element, that is surrounded by the sheath in the circumferential direction.
  • a respective foam pad may also be attached to the outer surface of a sheath surrounding a central column element.
  • the foam element may be formed of a first foamed material that is covered by a non-porous surface element, particularly a membrane, being formed of a second material being different to the first material.
  • the foam element may also be formed of a first foamed material and comprises a non-porous surface being formed of the same first material.
  • a method of treating a heart valve insufficiency may be performed by implanting an implant into the heart, the implant comprising a closure element that is positioned within the heart valve annulus and being configured to close or at least to reduce a remaining gap between closing valve leaflets and comprising an anchoring element being attached to the closure element, the implant being fixed in the heart with the anchoring element, preferably by surface contact between the exterior surface of the anchoring element and an interior surface of a heart lumen, preferably the atrium, wherein forces exerted to the closure element by the coapting leaflets are absorbed by at least one foam element comprised in the closure element and being compressed by the coapting leaflets.
  • closure element and the anchoring element may be realized in general as mentioned before in the introductory section.
  • Figure 1 shows an implant of the invention having a closure element and an anchoring element, the closure element being entirely formed of a foam element allowing rotation
  • Figure 2 shows a closure element of a similar implant having a separate
  • Figure 3 shows the closure element of an implant comprising a central column element surrounded by a foam element
  • Figure 4 shows the closure element having an expanded scaffold structure surrounded by a foam element
  • Figure 5 shows the closure element having a central column element and foam elements on the inner side of a surrounding sheath
  • Figure 6 shows the closure element having a central column element and foam elements on the external surface of the sheath
  • Figure 1 shows a schematic view of an implant according to the invention having a lower closure element 1 and an upper anchoring element 2 formed of several strips 2a.
  • the closure element 1 is configured to be positioned in the valve annulus, for example of the mitral valve. It is preferably the mid section 1 a that is surrounded by the valve annulus if the correct position is achieved and contacted by the valve leaflets.
  • the lower end 1 b of the closure element 1 is in this case positioned in the ventricle and the upper end 1c is positioned in the atrium of the heart.
  • the several strips 2a of the anchoring element 2 emerge near and around the central axis A from the upper end 1c of the closure element 1 towards the top of the atrium and are bent back by at least 180 degrees towards the ventricle.
  • the far ends 2b of these strips 2a surround the strip parts 2c that emerge from the closure element 1.
  • the closure element 1 is in this embodiment formed entirely of a foam element 3 having pores 3a that are open or closed.
  • the foam element 3 acts like a sponge capable of sucking in blood if the closure element 1 comes into contact with blood and expands.
  • the expanded foam element (particularly a sponge) defines the shape of the closure element after expansion.
  • the closure element has a circular cross section, is extending along the central axis A and has a tapered shape at both ends 1 b / 1 c.
  • the surface 4, that comes into contact with the leaflets is formed by the material of the foam element and accordingly is a part of the foam element.
  • This surface may be smooth without pores but it is also possible that this surface comprises partial pores, i.e. small recesses.
  • theses pores and recesses on the surface will get filled with blood that clots in the pores, thus creating a lot of distinct clots being connected by the foam material, namely the foam membranes between pores.
  • FIG. 1 shows only the closure element 1 of a different embodiment.
  • the construction of the anchoring element 2 is the same as in Figure 1. In the upper part of the closure element 1 some emerging strips 2c of the anchoring element 2 are shown.
  • the foam element 3 is covered by a separate sheath 4 preferably made of a material different from the material of the foam element.
  • Figure 3 depicts another embodiment in which the closure element 1 comprises a central column element 5 surrounded by the foam element 3. Also in this case the foam element 3 may be covered by a separate sheath 4 or may have a smooth surface 4 made of its own material.
  • the central column element 5 is aligned coaxial to the central axis A of the implant and may pass trough the entire length of the closure element.
  • the central column element may be formed of a slotted tube to provide flexibility to the column element.
  • the slots 5a are perpendicular to the axis A.
  • the several strips 2a of the anchoring element are merging into the central column element 5 with their lower ends 2c.
  • These strips and the column element may be formed of the same original tube, preferably by laser cutting.
  • Figure 4 shows an embodiment of a closure element 1 having a central column element 5 that is expanded and forms meshes 5b. Such a construction is similar to a stent and provides a scaffold structure.
  • the expanded column element 5 is surrounded by a foam element 3 and the foam element is preferably surrounded by a sheath 4 or forms its own smooth surface.
  • the expanded column element 5 of the closure element 1 and the strips 2a of the anchoring element 2 may be formed of the same original tubular element, preferably by laser cutting.
  • the embodiment of Figure 5 has a closure element similar to Figure 3.
  • the central column element 5 is surrounded by the sheath 4 that gets contacted by the coapting leaflets.
  • On the inner side of the sheath 4 several foam pads 3 may be positioned having an angular spacing.
  • the number of foam pads is preferably equal to the number of leaflets in the valve.
  • the foam pads may by free of contact to the central column 5 (right upper picture) or may extend between the sheath 4 and the central column element, contacting both (right lower picture)
  • Figure 6 is similar to figure 5 but the foam pad is positioned on the external surface of the sheath 4.
  • the implants partially shown in Figures 2 to 6 may all have the same anchoring element as shown in Figure 1.
  • inventive closure elements may have anchoring elements being different to the one shown in Figure 1. Any kind of suitable but not shown anchoring element may be used in combination with a closure element of an implant according to the invention.

Abstract

La présente invention concerne un implant cardiaque, configuré en particulier pour réduire ou éliminer une insuffisance valvulaire après implantation dans le cœur, comprenant un élément de fermeture (1) conçu pour être positionné dans l'anneau de valve cardiaque, configuré en particulier pour fermer ou au moins pour réduire un espacement résiduel entre des feuillets de valve se fermant, un élément d'ancrage (2) étant fixé à l'élément de fermeture (1) pour fixer l'implant dans le cœur, l'élément d'ancrage (1) étant de préférence configuré pour être fixé de manière atraumatique par contact de surface entre la surface extérieure de l'élément d'ancrage (2) et une surface intérieure d'une lumière cardiaque, de préférence l'atrium, l'élément de fermeture (1) comprenant au moins un élément en mousse (3), notamment au moins dans les zones de l'élément de fermeture (1) avec lesquelles les feuillets coaptants doivent venir en contact, ou au-dessous de celles-ci. L'invention concerne en outre une méthode de traitement de l'insuffisance valvulaire.
PCT/EP2017/000806 2017-07-10 2017-07-10 Implant cardiaque WO2019011391A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2017/000806 WO2019011391A1 (fr) 2017-07-10 2017-07-10 Implant cardiaque

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2017/000806 WO2019011391A1 (fr) 2017-07-10 2017-07-10 Implant cardiaque

Publications (1)

Publication Number Publication Date
WO2019011391A1 true WO2019011391A1 (fr) 2019-01-17

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ID=59506226

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2017/000806 WO2019011391A1 (fr) 2017-07-10 2017-07-10 Implant cardiaque

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WO (1) WO2019011391A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008141322A1 (fr) * 2007-05-14 2008-11-20 Cardiosolutions, Inc. Espaceur mitral à ballonnet
US20130338763A1 (en) * 2012-05-16 2013-12-19 Edwards Lifesciences Corporation Devices and methods for reducing cardiac valve regurgitation
US20160228246A1 (en) * 2015-02-10 2016-08-11 Edwards Lifesciences Corporation Offset cardiac leaflet coaptation element
CA2984977A1 (fr) * 2015-05-12 2016-11-17 Universitat Duisburg-Essen Dispositif implantable pour ameliorer ou supprimer une insuffisance valvulaire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008141322A1 (fr) * 2007-05-14 2008-11-20 Cardiosolutions, Inc. Espaceur mitral à ballonnet
US20130338763A1 (en) * 2012-05-16 2013-12-19 Edwards Lifesciences Corporation Devices and methods for reducing cardiac valve regurgitation
US20160228246A1 (en) * 2015-02-10 2016-08-11 Edwards Lifesciences Corporation Offset cardiac leaflet coaptation element
CA2984977A1 (fr) * 2015-05-12 2016-11-17 Universitat Duisburg-Essen Dispositif implantable pour ameliorer ou supprimer une insuffisance valvulaire

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