WO2007141361A1 - Prothèse annulaire réglable à distance utilisée dans la réparation des valves mitrale et tricuspide - Google Patents

Prothèse annulaire réglable à distance utilisée dans la réparation des valves mitrale et tricuspide Download PDF

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Publication number
WO2007141361A1
WO2007141361A1 PCT/ES2007/070103 ES2007070103W WO2007141361A1 WO 2007141361 A1 WO2007141361 A1 WO 2007141361A1 ES 2007070103 W ES2007070103 W ES 2007070103W WO 2007141361 A1 WO2007141361 A1 WO 2007141361A1
Authority
WO
WIPO (PCT)
Prior art keywords
ring
rigid
mitral
semi
valve repair
Prior art date
Application number
PCT/ES2007/070103
Other languages
English (en)
Spanish (es)
Inventor
Ignacio RADA MARTÍNEZ
Original Assignee
Rada Martinez Ignacio
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 Rada Martinez Ignacio filed Critical Rada Martinez Ignacio
Publication of WO2007141361A1 publication Critical patent/WO2007141361A1/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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • 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
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable

Definitions

  • the present invention relates to a tele-adjustable prosthetic ring for the repair of the inlet heart valves, that is to say a ring of those that are inserted at the level of the orifices of the heart valves in order to correct the incompetence thereof and in this way try to guarantee the maintenance of a physiological hemodynamic state, avoiding the problems derived from an alteration of the closure of these valves that ultimately leads to heart failure.
  • the object of the invention is to achieve better functional performance of the ring from the point of view of maintaining valvular competence, allowing its modification from the outside once the surgery is performed, its progressive adjustment being possible, avoiding situations of heart failure postoperative and managing to eliminate to a large extent - if not completely - valvular insufficiency, problems that are often associated with the use of conventional rings of fixed size.
  • the insufficiency or defect of closure of the mitral and tricuspid valves is a pathology that presents an increasing frequency in the population, whose evolution implies a deterioration of the function of the heart with the establishment of the heart failure syndrome, thus representing a pathology with long or short term adverse prognosis - depending on the cause that motivates it - and with high prevalence in the population.
  • the surgical treatment of this pathology basically offers two alternatives: the replacement of the valve with a complete prosthesis that mimics the valve function or its repair. This last treatment is preferable given its greater degree of preservation of the valvular apparatus and lower morbidity and mortality associated with the intervention, achieving a more physiological correction of the valvular defect.
  • These rings are generally covered with silicone and elastic material, biocompatible, usually polyester, which allows their insertion, by suture, at the level of the hole or natural ring of the native cardiac, mitral or tricuspid valve, thus achieving a cerclage of the same, since in general the closing defect they present is due to an insufficient coaptation of the valvular veils, frequently produced by dilatation of the native ring.
  • the insufficiency of the inlet heart valves can be described as acute (of rapid establishment) or chronic (of slow and progressive establishment). Most of the cases that undergo repair are due to chronic type insufficiency, that is to say that it has occurred slowly, generally over the course of years, becoming severe. During this slow evolution, the heart finds a path (pathological) of less resistance to eject the blood through the insufficient valve, which, by not closing properly, allows that blood to escape through it with each cardiac contraction. That volume of blood ejected pathologically by the insufficient valve returns to the heart during the next cycle assuming a volumetric overload that gradually dilates the ventricles until it causes them to fail.
  • the dilatation of the ventricles causes the natural rings of the valves to dilate and therefore increases the difficulty of closing or coaptation of the valvular veils, thus generating a vicious circle with increasing valvular insufficiency.
  • the rings intended for valve repairs that currently exist on the market are made of rigid or semi-rigid materials, and have a fixed size. As mentioned, a cardiac surgery procedure with opening of the chest and cardiac chambers is required for insertion. It is of crucial importance the choice of the size of the ring to be inserted, which today can only be made at the time of surgery and depending on certain measures of the patients' anatomy. The fact that there is a wide variety of rings on the market for mitral and tricuspid valve repair indicates in some way the existence of a complex problem, still not well resolved.
  • the tele-adjustable ring for valve repair that the invention proposes could satisfactorily solve a large part of the above-mentioned problem, in each and every one of the aspects mentioned.
  • said ring based on the basic structuring of conventional rings that currently exist on the market, that is, devices made of rigid or semi-rigid biocompatible materials, of fixed size, adapted to the valve anatomy that the patient presents at the time of surgery, focuses the characteristics on the innovative fact that incorporates a mechanism capable of allowing a modification "a posteriori" and from the outside of the body, the shape and size of the ring, once the valve repair surgery.
  • the ring proposed by the invention is basically composed of three elements:
  • Element 1 made of rigid, cylindrical and hollow biocompatible material (titanium or similar), of tubular structure, whose internal section is divided in two subsections throughout it to allow sliding through each of the mentioned subsections of element 2 described below, thus serving as a guide to that element.
  • Element 2 of biocompatible material (elgiloy, nitinol or similar) semi-rigid, with each of its ends inserted in each of the subsections of element 1, delimiting along with it, the area of the ring, and thus mimicking the native valvular anatomy . The ends of this element that are inserted into the element 1, reach the central portion thereof, where the element 3 mentioned below is located.
  • Element 3 constituted by a device that incorporates a source of energy capable of translating orders received from an external unit in the sense of progressively and in a controlled way sliding the ends of element 2 into element 1 in order to close the valve hole, in such a way that each end can slide independently within its corresponding subsection of element 1, or both together, controlling at all times the magnitude of the order sent through an opening, closing and fixing system.
  • the reverse order could also be executed, removing or sliding out the ends of the 2 element if necessary to increase the area of the ring and therefore the valve hole.
  • Element 1 in the case of mitral valve repair, must be inserted into the intertrigonal zone, which constitutes the stiffer portion - less deformable - of the fibrous skeleton of the native valve ring.
  • Element 2 must cover the rest of the annular perimeter.
  • the entire prosthetic ring proposed by the invention incorporates a silicone coating and a biocompatible elastic material, such as polyester, which allows insertion by suture to the native valve ring, constituted from the point anatomically, by the fibrous skeleton of the heart.
  • a biocompatible elastic material such as polyester
  • the ring model presented as an invention being able to be regulated from the outside once the surgery is performed, it allows to adjust properly and controlled, gradually reducing its perimeter and therefore the area of the valvular orifice, by introducing the semi-rigid element in the rigid, achieving adequate coaptation of the veils Valves and thus correcting valvular insufficiency in a progressive manner, similar to how it originated, allowing an adaptation of the heart (ventricles) also progressive and physiological to the repair of the valvular closure defect.
  • This aspect is especially interesting when it comes to the mitral valve, where day-to-day progress is made in the anatomical diagnosis of valvular dysfunction through Doppler echocardiography, trying to discern which portion of the valve is responsible for the insufficiency or incompetence of the same to act more specifically on it and thus provide a more appropriate and effective treatment.
  • This ring model could be valid to treat different types of valvular insufficiency and can be implanted in all degrees of dilation of the native ring without having to choose rings of different sizes and morphologies depending on the cause of the valvular defect.
  • Figure 1 shows in a plan view of the prosthetic ring according to the invention
  • Figure 2 shows in a sectional view of the prosthetic ring according to the invention
  • figure 3 shows in an elevation view the prosthetic ring according to the invention
  • figure 4 shows in a perspective view of the prosthetic ring according to the invention
  • figure 5 shows a perspective view of a remote control according to the invention.
  • the ring object of the invention is constituted by a rigid non-deformable element 1 in which each of the two ends of the element are inserted.
  • semi-rigid 2 to which it serves as a guide both elements being composed of biocompatible material, similar to that used in current rings for use, both elements forming a morphology that mimics the native valvular anatomy.
  • a device is incorporated in the central part of the rigid element 1
  • the element 1 is formed from a rigid metal structure 1-2, cylindrical and hollow of titanium or the like, externally coated with biocompatible materials such as polyester 1-1, silicone 1-2 or the like.
  • the tubular structure whose inner section is divided into two subsections 3-1, 3-2 along its entire length to allow sliding through each of the mentioned subsections of element 2 described below, thus serving of guidance to that element 2.
  • Element 2 is formed from a rigid metal structure 2-1, cylindrical coated externally with biocompatible materials such as polyester 2-3, silicone 2-2 or the like.
  • biocompatible materials such as polyester 2-3, silicone 2-2 or the like.

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 annulaire réglable à distance utilisée dans la réparation des valves mitrale et tricuspide. Ladite prothèse est formée d'un anneau fait d'un matériau biocompatible composé de 3 éléments: un élément tubulaire (1) fait d'un matériau rigide, un autre élément (2) fait d'un matériau semi-rigide (2) glissant par une quelconque de ses extrémités ou les deux de manière simultanée à l'intérieur du premier, et un autre élément constitué d'un dispositif pourvu d'une source d'énergie (4) pouvant recevoir et traduire des ordres à partir d'une unité externe concernant le glissement de manière contrôlée de l'élément semi-rigide de l'anneau dans l'élément tubulaire rigide, au moyen d'un système d'ouverture, de fermeture et de fixation, permettant ainsi, une fois réalisée la chirurgie, de réduire ou d'augmenter sa longueur périmétrique et, par conséquent, sa zone transversale.
PCT/ES2007/070103 2006-06-02 2007-05-30 Prothèse annulaire réglable à distance utilisée dans la réparation des valves mitrale et tricuspide WO2007141361A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP200601481 2006-06-02
ES200601481A ES2310092B1 (es) 2006-06-02 2006-06-02 Anillo protesico teleajustable para reparacion valvular mitral y tricuspide.

Publications (1)

Publication Number Publication Date
WO2007141361A1 true WO2007141361A1 (fr) 2007-12-13

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2007/070103 WO2007141361A1 (fr) 2006-06-02 2007-05-30 Prothèse annulaire réglable à distance utilisée dans la réparation des valves mitrale et tricuspide

Country Status (2)

Country Link
ES (1) ES2310092B1 (fr)
WO (1) WO2007141361A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10111750B2 (en) 2013-12-16 2018-10-30 Jeko Metodiev Madjarov Method and apparatus for therapy of aortic valve
KR101563172B1 (ko) * 2014-05-20 2015-10-27 (주) 타우피엔유메디칼 승모판막 서클라지 시술용 조직보호기구

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3080867A (en) * 1958-05-22 1963-03-12 Eichinger Maximilian Clamping device
US4489446A (en) * 1982-07-14 1984-12-25 Reed Charles C Heart valve prosthesis
US4882813A (en) * 1987-11-18 1989-11-28 Shinagawa Shoko Co., Ltd. Banding clip
WO1999004730A1 (fr) * 1997-07-22 1999-02-04 Baxter International Inc. Anneau pour annuloplastie pouvant etre agrandi
US6183512B1 (en) * 1999-04-16 2001-02-06 Edwards Lifesciences Corporation Flexible annuloplasty system
WO2005055883A1 (fr) * 2003-12-04 2005-06-23 The Brigham And Women's Hospital, Inc. Anneaux d'annuloplastie pour valvule aortique
WO2006012068A2 (fr) * 2004-06-29 2006-02-02 Micardia Corporation Conducteur thermique pour implant cardiaque reglable

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0897705A1 (fr) * 1997-07-25 1999-02-24 The Procter & Gamble Company Articles absorbants comprenant une couche perméable au gaz avec matériau expansible au contact des liquides

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3080867A (en) * 1958-05-22 1963-03-12 Eichinger Maximilian Clamping device
US4489446A (en) * 1982-07-14 1984-12-25 Reed Charles C Heart valve prosthesis
US4882813A (en) * 1987-11-18 1989-11-28 Shinagawa Shoko Co., Ltd. Banding clip
WO1999004730A1 (fr) * 1997-07-22 1999-02-04 Baxter International Inc. Anneau pour annuloplastie pouvant etre agrandi
US6183512B1 (en) * 1999-04-16 2001-02-06 Edwards Lifesciences Corporation Flexible annuloplasty system
WO2005055883A1 (fr) * 2003-12-04 2005-06-23 The Brigham And Women's Hospital, Inc. Anneaux d'annuloplastie pour valvule aortique
WO2006012068A2 (fr) * 2004-06-29 2006-02-02 Micardia Corporation Conducteur thermique pour implant cardiaque reglable

Also Published As

Publication number Publication date
ES2310092A1 (es) 2008-12-16
ES2310092B1 (es) 2009-09-30

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