WO2017191549A1 - Dispositif destiné au traitement du prolapsus de la valve mitrale - Google Patents

Dispositif destiné au traitement du prolapsus de la valve mitrale Download PDF

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Publication number
WO2017191549A1
WO2017191549A1 PCT/IB2017/052530 IB2017052530W WO2017191549A1 WO 2017191549 A1 WO2017191549 A1 WO 2017191549A1 IB 2017052530 W IB2017052530 W IB 2017052530W WO 2017191549 A1 WO2017191549 A1 WO 2017191549A1
Authority
WO
WIPO (PCT)
Prior art keywords
mitral valve
openwork
left atrium
millimetres
size
Prior art date
Application number
PCT/IB2017/052530
Other languages
English (en)
Inventor
David Peter Shaw
Original Assignee
LAINCHBURY, John George
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 LAINCHBURY, John George filed Critical LAINCHBURY, John George
Publication of WO2017191549A1 publication Critical patent/WO2017191549A1/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
    • A61F2/2442—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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0071—Three-dimensional shapes spherical

Definitions

  • the present invention relates to a device for the treatment of mitral valve prolapse.
  • the mitral valve in a human being is a bicuspid valve located between the left atrium and left ventricle of the heart.
  • the mitral valve is designed to allow blood flow from the left atrium into the left ventricle when the ventricular pressure is lower than the atrial pressure, and to close to prevent backflow from the ventricle into the atrium when the ventricle contracts and thus increases the blood pressure in the ventricle. Any damage to the mitral valve can allow blood to regurgitate i.e. to flow back into the left atrium when the left ventricle contracts. This significantly decreases the efficiency of the heart.
  • each half of the mitral valve consists of a leaflet formed of flexible material which is anchored by cords (the chordae tendineae) located at several points around its perimeter, to the controlling papillary muscles in the left ventricle.
  • each half of the mitral valve may diagrammatically be visualised as a parachute 10, with the leaflet as the parachute canopy 11 , the cords as the parachute lines 12, and a parachute load as the papillary muscles 13.
  • Figure 2 illustrates diagrammatically the manner in which the mitral valve seals:- the two leaflets (shown as parachute canopies 11) are expanded by the increased blood pressure in the left ventricle so that the leaflets are pushed into the lower part of the left atrium and contact each other to form a seal. In this position, the cords 12 are taut.
  • a flail leaflet where the leaflet can move out of its correct position because it is not properly anchored, and thus fail to form an effective seal.
  • a flail leaflet is shown diagrammatically in figure 3 as leaflet portion 11 a with a broken cord 12a attached.
  • a number of techniques have been developed for the repair of a damaged mitral valve: e.g. the entire valve can be replaced with an artificial valve;
  • the broken or stretched cord can be replaced with an artificial cord or with a chordal transplant
  • the flail portion of the leaflet can be tethered to another leaflet.
  • a transcatheter technique which uses a mitral valve clip to tether the flail section to an adjacent leaflet.
  • this technique is suitable only for some valve failures and it also requires a high level of skill and is time-consuming.
  • An object of the present invention is the provision of a device which will allow effective treatment of a mitral valve prolapse without invasive surgery and which is comparatively simple to position correctly.
  • the present invention provides a device for the treatment of mitral valve prolapse, said device comprising an openwork body capable of being collapsed sufficiently to permit transcatheter delivery and of being expanded when in position in the left atrium; the size and shape of said device being such that a surface of the expanded openwork body supports a mitral valve in the closed position; wherein said openwork body provides a series of apertures such that blood can flow through said body in use.
  • openwork refers to open cage work, or lattice, i.e. a plurality of elongated members interconnected to form a structure with a plurality of apertures.
  • the apertures are sufficiently small to adequately support the mitral valve in the closed position, but are sufficiently large to avoid the risk of occlusion when in situ.
  • the apertures need not be uniform in size or spacing, but typically each side of an aperture would be in the size range 6 millimetres - 14 millimetres, preferably in the size range 6 millimetres - 10 millimetres.
  • the openwork body may be any of a wide variety of regular or irregular shapes:- the sole requirements are that the body is of an openwork material, that it is capable of being collapsed and then expanded, and that it provides one or more surfaces which, when the body is correctly positioned in the left atrium, are capable of re-establishing the closure plane of the mitral valve.
  • the surface of the expanded body is a convex surface and forms part of the surface of the sphere.
  • the surface need not be a curved surface and, if curved, need not be a regularly curved surface.
  • Suitable shapes are a sphere, an ovoid, and a truncated cube.
  • a scan e.g. CT scan or ultrasound scan
  • a device in accordance with the present invention would then be sized and shaped to provide a good fit.
  • the present invention further provides a method for the treatment of mitral valve prolapse which includes the steps of:
  • the device inserting the device by means of a selected blood vessel into the left atrium; expanding the device so as to occupy a major portion of the left atrium, such that a surface of the device provides an openwork surface or surfaces lying over the mitral valve, so as to support the mitral valve in the closed position.
  • the device could be made of a variety of suitable biologically compatible materials such as nitinol (nickel/titanium alloy) or titanium; biologically compatible plastics materials also could be used.
  • the device may be constructed such that the elongated members forming the device can be slid between a collapsed and an expanded condition and/or the device may be made of a shape metal (memory metal) such as a nickel titanium alloy, (e.g. Nitinol) in the same manner as self expandable metallic stents.
  • a shape metal such as a nickel titanium alloy, (e.g. Nitinol) in the same manner as self expandable metallic stents.
  • Figure 1 is a diagrammatic representation of part of a mitral valve
  • Figure 2 is a diagrammatic representation of a mitral valve when closed
  • Figure 3 is a diagrammatic representation of a damaged mitral valve
  • Figure 4 is a section through a human heart showing the left atrium and the left ventricle;
  • Figure 5 is a section through a human heart showing the left atrium and the left ventricle, with a device according to the present invention positioned in the left atrium;
  • Figures 6 and 7 are diagrammatic views of two other possible shapes of devices. Best Mode for Carrying out the Invention
  • a human heart 15 including the left ventricle 16 and a left atrium 17.
  • a mitral valve 18 is formed from a pair of leaflets 19, 20 which are supported by two sets of spaced cords 21 , 22 which extend between the respective leaflets 19, 20 and the corresponding papillary muscles 23, 24.
  • a device 25 in accordance with the present invention is inserted in the left atrium, as shown in Figure 5.
  • the device 25 occupies a substantial proportion of the left atrium - this automatically positions the device 25 correctly, and ensures that the device cannot move away from the mitral valve 18.
  • part of the surface of the device 25 overlies and supports the leaflets 19, 20 of the mitral valve 18 when the valve is in the closed position; this prevents a flail leaflet from moving out of position and ensures a satisfactory closure of the valve 18.
  • the device 25 is an openwork sphere made of a biologically compatible material as discussed above.
  • the device 25 need not be a true sphere (see above), but it must provide a surface or surfaces against which the leaflets of the mitral valve 18 can close.
  • the apertures 26 of the device 25 need not be a specific size or shape, nor do they need to be regularly spaced. However, it is important that the apertures 26 are sufficiently small that when the device 25 is in position, it provides adequate support to the leaflets i.e. that it re-establishes the closure plane of the mitral valve. In addition, it is important that the apertures 26 are sufficiently large that they do not encourage occlusion when in position, because it is essential that blood can flow freely through the device 25, and thus through the left atrium. It is believed that apertures having sides in the size range 6 millimetres - 14 millimetres will be suitable in practice.
  • Figures 6 and 7 show two other possible shapes for the device:- Figure 6 shows an ovoid shape, Figure 7 shows a truncated cube shape. For clarity, Figure 7 shows the truncated cube as a solid, rather than openwork, but the device is of course openwork.
  • the shape and size of the left atrium varies considerably from one person to another, and the best practice would be to carry out a scan, (e.g. CT scan or ultrasound scan) of the patient to establish the size and shape of the left atrium as accurately as possible, and then either custom make the device to the required size and shape or select the best fit from a range of pre-made devices.
  • a scan e.g. CT scan or ultrasound scan
  • the device 25 is positioned by collapsing the device so that it is suitable for transcatheter insertion, and then inserting the catheter plus device 25 through the femoral vein, into the right atrium and then through the septum into the left atrium.
  • the insertion can be guided in known manner using x-ray and/or ultrasound scanning; accurate scanning will enable the device to be turned to a specified orientation before expanding the device to the position shown in Figure 5.
  • the device 25 can be designed such that it will operate satisfactorily in any orientation.
  • the above described device and insertion method offers a significantly less invasive solution to the problem of mitral valve failure.
  • the insertion method requires a lower skill level than either invasive surgery or the use of a mitral valve clip. The device can be removed if necessary.

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)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif destiné au traitement du prolapsus de la valve mitrale, ledit dispositif comprenant un corps ajouré apte à être suffisamment replié pour permettre une administration par transcathéter et à être déployé lorsqu'il est en position dans l'oreillette gauche ; la taille et la forme dudit dispositif étant telles qu'une surface du corps ajouré déployé soutient une valve mitrale en position fermée ; ledit corps ajouré formant une série d'ouvertures de sorte que le sang puisse s'écouler dans ledit corps lors de son utilisation.
PCT/IB2017/052530 2016-05-05 2017-05-02 Dispositif destiné au traitement du prolapsus de la valve mitrale WO2017191549A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662331999P 2016-05-05 2016-05-05
US62/331,999 2016-05-05

Publications (1)

Publication Number Publication Date
WO2017191549A1 true WO2017191549A1 (fr) 2017-11-09

Family

ID=60202817

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2017/052530 WO2017191549A1 (fr) 2016-05-05 2017-05-02 Dispositif destiné au traitement du prolapsus de la valve mitrale

Country Status (1)

Country Link
WO (1) WO2017191549A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003028558A2 (fr) * 2001-10-01 2003-04-10 Ample Medical Corporation Procede et dispositifs destines aux traitements de valvule cardiaque
WO2005007036A1 (fr) * 2003-07-18 2005-01-27 Brivant Research & Development Limited Dispositif de correction de l'inversion des feuillets d'une valvule cardiaque
US20060058871A1 (en) * 2004-09-14 2006-03-16 Edwards Lifesciences, Ag Device and method for treatment of heart valve regurgitation
WO2007025028A1 (fr) * 2005-08-25 2007-03-01 The Cleveland Clinic Foundation Valve atrioventriculaire percutanee et procede d'utilisation
US20070270943A1 (en) * 2006-05-18 2007-11-22 Jan Otto Solem Device and method for improving heart valve function

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003028558A2 (fr) * 2001-10-01 2003-04-10 Ample Medical Corporation Procede et dispositifs destines aux traitements de valvule cardiaque
WO2005007036A1 (fr) * 2003-07-18 2005-01-27 Brivant Research & Development Limited Dispositif de correction de l'inversion des feuillets d'une valvule cardiaque
US20060058871A1 (en) * 2004-09-14 2006-03-16 Edwards Lifesciences, Ag Device and method for treatment of heart valve regurgitation
WO2007025028A1 (fr) * 2005-08-25 2007-03-01 The Cleveland Clinic Foundation Valve atrioventriculaire percutanee et procede d'utilisation
US20070270943A1 (en) * 2006-05-18 2007-11-22 Jan Otto Solem Device and method for improving heart valve function

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