WO2008071817A1 - Active annuloplasty system for the progressive treatment of valvular insufficiencies and other cardiovascular pathologies - Google Patents
Active annuloplasty system for the progressive treatment of valvular insufficiencies and other cardiovascular pathologies Download PDFInfo
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- WO2008071817A1 WO2008071817A1 PCT/ES2007/000719 ES2007000719W WO2008071817A1 WO 2008071817 A1 WO2008071817 A1 WO 2008071817A1 ES 2007000719 W ES2007000719 W ES 2007000719W WO 2008071817 A1 WO2008071817 A1 WO 2008071817A1
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- ring
- shape memory
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- heating
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Classifications
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- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
- A61F2210/0023—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
-
- 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
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
Definitions
- the invention falls within the technical sector of implantable medical devices related to cardiac pathologies. More specifically in relation to the problems of valvular insufficiencies and other valvulopathies, which can be corrected by annuloplasty devices.
- Valve insufficiencies are alterations of the heart valves produced by an incomplete closure of the same.
- the use depends on the severity of the problem) of complete valve prostheses or annuloplasty systems, which recompose the shape of the valve ring, stands out.
- annuloplasty rings to solve the specific problem of mitral regurgitation is detailed below, the treatment of other valvulopathies being similar.
- the mitral valve consists of two components that are responsible for channeling blood from the atrium to the left ventricle.
- the so-called mitral valve complex which is composed of the mitral ring, the mitral valve leaflets and the commissures that join both leaflets.
- this valve has the so-called "tensioner” complex, which in turn consists of the tendon cords, which continue with the papillary muscles anchored in the left ventricle.
- the failure of any of these components translates into functional alterations of the mitral apparatus, such as the mitral insufficiency explained below, and hemodynamic repercussions.
- Mitral regurgitation is defined as systolic regurgitation of blood from the ventricle to the left atrium due to incompetence in the closure of the mitral valve. It can be produced by three main mechanisms: 1) a primary mitral valve disease; 2) an anatomical or functional alteration of the papillary cords and muscles, and 3) a disorder in the proper functioning of the left atrium and ventricle.
- Valve reconstruction is currently the treatment of choice for mitral regurgitation whenever possible. With the help of preoperative transesophageal echocardiography, the situation and extent of the lesions can be located, which allows the surgeon to assess the possibilities of valve repair and develop a precise plan of the necessary surgical maneuvers.
- the objective of this surgery is not only limited to eliminating mitral regurgitation, but also in many cases to reconstruct the geometry of the entire mitral valve apparatus, in order to ensure the durability of the repair.
- This surgical restitution towards a normal geometry consists of: a) increase or reduction of abnormal veils; b) replacement of broken or thinned tendon cords using "Goretex" type sutures, and c) annuloplasty.
- Annuloplasty consists in the introduction of a jugular device, which is placed in the coronary sinus and which, after application of traction, retraction or heat, decreases its perimeter, achieving the reduction of the mitral ring.
- This invention focuses on an active device for annuloplasty, whose progressive action can be activated and controlled remotely.
- Patents such as -> Lashinski EPl 646332 propose remote action, but without specifying a specific method for mechanical actuation. They propose solutions based on motors and screw-type devices, which have not resulted in commercial devices. Nor have publications been found regarding previous clinical trials related to developmental stages. Others propose solutions for mechanical actuation in Dase to inflatable devices, such as those used in other medical devices such as balloon stents, but which cannot be carried out without resorting to a new surgical intervention.
- the proposed invention arises, which stands out for the way to produce the reduction of the device section (in stages and progressive), for its reversibility to achieve an optimal adjustment, for the use of materials with temperature-shape memory of activation superior to that of the human body, by the heating methods to activate the "shape memory effect", by its manufacturing process (even custom-made) and by electronically controlled remote activation.
- the present invention relates to an active annuloplasty system for the progressive treatment of valvular insufficiencies and other cardiovascular pathologies, comprising:
- Said internal electronics consists of at least one or several small-sized batteries, an antenna to receive the signals from the external control device and a microcontroller, which allows the interpretation of the control signals and enables the passage of current through the (s) resistance (s) or the conductive wire to be heated to activate the polymer and produce its phase and geometry change.
- the ring can be made with any type of shape memory polymer, but the activation temperature must be higher than that of the human body (4
- the activation temperature can be adjusted (with slight variations in the composition of the chosen material) and close to that of the human body, so that with adequate insulation, avoid contact with tissues and associated damage.
- Said activation temperature can be adjusted (with slight variations in the composition of the chosen material) and close to that of the human body, so that with adequate insulation, avoid contact with tissues and associated damage.
- the ring can be made of any type of metal alloy with shape memory or any type of polymer with memory memory, but the activation temperature must be higher than that of the human body, as in the previous case.
- Reversibility can be achieved in any of the rings thanks to the inclusion of different sections of active material (metallic or polymeric) with shape memory; some with a transient form greater than the permanent one and others with a transient form less than the permanent one.
- the activation of the first sectors leads to a decrease in diameter and the activation of the second sectors leads to an increase in diameter.
- a tubular element of biocompatible material intended for coating the active ring (s); optionally with inner tabs at one of its ends and outer at the other, whose mission is to act as an interlocking device (in the case of not wanting reversibility). Likewise, it acts as a thermal insulator, protecting the mucous membranes from unwanted heating and preventing the deterioration of the actuator rings and associated electronic components.
- An external electronic control element which can be a mobile phone, a PDA or any portable or fixed electronic device, for sending control signals to the internal electronics that govern the activation of the heating resistors. Activation is thus allowed in the consultation of the cardiologist or prescriber, as well as domiciliary under proper supervision.
- Information between the implanted device and the electronic external control element is carried out by means of wireless technologies.
- step by step or progressive action is intended to:
- the reversibility of the system is intended to:> Avoid excessive closure of the annuloplasty ring and the harmful effects that this could entail.
- an active ring based on the use of electroactive polymers can be used.
- Said ring has a distribution of linear elements made of electroactive polymer, which respond to electrical stimuli with contractions or dilations. When the stimulus ceases, the contraction ceases, however, the help of an interlocking element allows the annuloplasty system to preserve the reduction in diameter.
- the use of several electroactive elements, connected to the internal control electronics that activate them according to the orders sent from the external electronic control element, allows step-by-step and / or progressive action.
- biocompatible coatings deposited with the help of PVD (physical vapor deposition), CVD (chemical vapor deposition), molecular beam epitaxy or any other type of technology that allows thin layers of material to be deposited can be used. from 1 nm to 100 ⁇ m thick.
- the shape of the implantable device can be customized to the dimensions of the different valve rings of the patient; through the use of preoperative technologies, (for example, CT scan, CT scan, echocardiography transesophageal, transthoracic echocardiography, and other internal inspection technologies), in combination with computer-aided design and manufacturing technologies (CAD - CAM).
- preoperative technologies for example, CT scan, CT scan, echocardiography transesophageal, transthoracic echocardiography, and other internal inspection technologies
- CAD - CAM computer-aided design and manufacturing technologies
- the external dimensions of the implantable device are similar to those of existing commercial products that normally have a rigid metal ring inside (quasi-annular shape adapted to the geometry of the different valve rings of the human being, with 28 mm to 32 rom of maximum diametral dimension). Said rigid ring is replaced in this invention by the actuator rings with shape memory and the need for control electronics, properly distributed, does not influence the final dimensions decisively.
- the most bulky components are external and can be connected to the power grid, which also allows mitigating the consumption limitations of the active implant.
- the system object of this invention can be used, for the treatment of various cardiovascular pathologies, in addition to valvular pathologies such as mitral insufficiency, aortic insufficiency, tricuspid insufficiency, and any other type of pathologies corrected by annuloplasty.
- Figure 1 Schematic representation of the main elements of the invention. 1.- Active annuloplasty ring with control electronics.
- Figure 2. Active ring for actuation of the annuloplasty device.
- 5. Polymeric material with shape memory.
- 6. Internal resistance for heating.
- the CAD design (3 D geometry with the help of computer-aided design programs) of the active rings based on shape memory polymers is carried out. Once the CAD design is completed, the first prototypes are obtained by stereolithography, a technology explained below.
- the process begins with the elevator located at a distance from the surface of the liquid equal to the thickness of the first section to be processed.
- the laser traces the surface of the section and its contour, following the data from the CAD file with the geometry of the piece.
- the monomers in liquid state, when subjected to ultraviolet radiation polymerize remaining in solid state. Once this section has solidified, the elevator lowers its position to reach the height of the next layer. The operation is repeated until the final physical piece is obtained in epoxy resin.
- silicone molds are manufactured using said prototypes obtained by stereolithography as models. It is proposed to obtain, under vacuum casting in said molds, prototypes with the final dimension using polymer with shape memory (generally a mixture of two resins that give rise to the material with shape memory) involves casting.
- polymer with shape memory generally a mixture of two resins that give rise to the material with shape memory
- the ring For heating by resistances or wire, the ring is formed with the desired final dimension (the one necessary to eliminate valvular insufficiency, between about 27 mm and 30 mm of maximum diametral dimension in the case of mitral insufficiency) and with the resistances already placed .
- the ring is then heated homogeneously to a temperature higher than the transition temperature (about 5 0 C above the transition temperature, located between 41 0 C and 43 0 C) and forced to adapt the expanded transient shape (used for this, tooling in the shape of a cone trunk), allowing it to cool to room temperature.
- the process is called "shape memory training.”
- the process is as follows. First, the ring is molded with the desired final dimension (the one necessary to eliminate mitral regurgitation once implanted). Said first austenitic phase is cooled to room temperature preserving the shape but changing to martensitic structure. He is then forced to adapt the form expanded transient (can be used for this purpose in the form of a cone trunk). The resistance or the heating wire connected to the battery is then placed for feeding.
- Said rings in an expanded transient form will return to their original or permanent dimensions (those obtained by vacuum casting in silicone molds or by molding), by postoperative heating and consequently exceeding the activation temperatures.
- Reversibility can be achieved in the rings thanks to the inclusion of different sections of active material (metallic or polymeric) with shape memory; some with a transient form greater than the permanent one and others with a transient form less than the permanent one.
- active material metallic or polymeric
- the battery and the electronics are connected to control the heating of the resistors.
- the passage of current (intensity of 50 to 300 mA) for each resistance (values between 1 ⁇ and 10 ⁇ ) produces a local increase in temperature, which properly controlled leads to the change of phase of the material and its consequent decrease in dimension.
- the associated control electronics allows to act on the resistances independently, at different times and carry out the desired progressive or "step by step” action.
- the actuator ring is manufactured, it is covered with the polymer in a tubular form (which has a side groove for this purpose) and acts as a protective and interlocking device (optional in the case of not wanting reversibility), thanks to the inner and outer tabs that it has at its ends.
- the drug releaser can be manufactured with the help of CAD-CAM technologies such as active rings and be included adjacent to the tubular element, pending textile coating.
- biocompatible fabric or polymer similar to those used in existing products, with suitable holes to facilitate implantation of the device.
- CVD or PVD coating processes can be used, in their low temperature modalities (thus avoiding altering the properties of shape memory materials), to achieve additional layers of biocompatible material between 1 nm and 100 ⁇ m thick.
- the shape of the implantable device can be customized to the dimensions of the patient's valve rings; through the use of preoperative internal inspection technologies, in combination with computer-aided design and manufacturing technologies (CAD - CAM). Once the CAD files have been obtained tailored to the patient, the process would be similar to that described.
- CAD - CAM computer-aided design and manufacturing technologies
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- 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
The invention relates to a teleoperated active annuloplasty system which can be used for the controlled, progressive, reversible and postoperative treatment of mitral insufficiency and other cardiovascular pathologies that can be corrected with the use of annuloplasty rings. The invention is based on the use of a shape-memory actuator ring which can be heated using external devices in order to activate the shape-memory effect which produces the geometric change intended to reduce mitral insufficiency. The prosthesis includes control electronics which receive external commands and act accordingly. The inventive means enable reversible, progressive step-by-step actuation, thereby providing a more controlled method generating less haemodynamic instability and intended for the treatment of various valve diseases.
Description
Título.- Title.-
"Sistema de anuloplastia activo para el tratamiento progresivo de patologías cardiovasculares""Active annuloplasty system for the progressive treatment of cardiovascular pathologies"
Sector técnico.-Technical Sector.-
La invención se encuadra en el sector técnico de dispositivos médicos implantables relacionados con patologías cardiacas. Más concretamente en el relativo a los problemas de insuficiencias valvulares y otras valvulopatías, corregibles mediante dispositivos de anuloplastia.The invention falls within the technical sector of implantable medical devices related to cardiac pathologies. More specifically in relation to the problems of valvular insufficiencies and other valvulopathies, which can be corrected by annuloplasty devices.
Estado de la Técnica.-State of the Art.-
Las insuficiencias valvulares son alteraciones de las válvulas cardiacas producidas por un cierre incompleto de las mismas. Entre los distintos tratamientos, destaca el empleo (en función de la severidad del problema) de prótesis valvulares completas o sistemas de anuloplastia, que recomponen la forma del anillo valvular.Valve insufficiencies are alterations of the heart valves produced by an incomplete closure of the same. Among the different treatments, the use (depending on the severity of the problem) of complete valve prostheses or annuloplasty systems, which recompose the shape of the valve ring, stands out.
Se detalla a continuación la aplicación de anillos de anuloplastia para resolver el problema concreto de la insuficiencia mitral, siendo el tratamiento de otras valvulopatías similar.The application of annuloplasty rings to solve the specific problem of mitral regurgitation is detailed below, the treatment of other valvulopathies being similar.
La válvula mitral consta de dos componentes que se encargan de canalizar la sangre desde la aurícula al ventrículo izquierdo. En primer lugar, el llamado complejo valvular mitral, que está compuesto por el anillo mitral, las valvas de la válvula mitral y las comisuras que unen ambas valvas. Además del propio complejo valvular mitral, esta válvula tiene el llamado complejo "tensor", que a su vez consta de las cuerdas tendinosas, que se continúan con los músculos papilares anclados en el ventrículo izquierdo. El fracaso de cualquiera de estos componentes se traduce en alteraciones funcionales del aparato mitral, como la insuficiencia mitral explicada a continuación, y repercusiones hemodinámicas.
Se define la insuficiencia mitral como la regurgitación sistólica de sangre desde el ventrículo a la aurícula izquierda debida a la incompetencia en el cierre de la válvula mitral. Puede producirse por tres mecanismos principales: 1) una enfermedad primaria de la válvula mitral; 2) una alteración anatómica o funcional de las cuerdas y músculos papilares, y 3) un trastorno en el correcto funcionamiento de la aurícula y el ventrículo izquierdos.The mitral valve consists of two components that are responsible for channeling blood from the atrium to the left ventricle. First, the so-called mitral valve complex, which is composed of the mitral ring, the mitral valve leaflets and the commissures that join both leaflets. In addition to the mitral valve complex itself, this valve has the so-called "tensioner" complex, which in turn consists of the tendon cords, which continue with the papillary muscles anchored in the left ventricle. The failure of any of these components translates into functional alterations of the mitral apparatus, such as the mitral insufficiency explained below, and hemodynamic repercussions. Mitral regurgitation is defined as systolic regurgitation of blood from the ventricle to the left atrium due to incompetence in the closure of the mitral valve. It can be produced by three main mechanisms: 1) a primary mitral valve disease; 2) an anatomical or functional alteration of the papillary cords and muscles, and 3) a disorder in the proper functioning of the left atrium and ventricle.
La reconstrucción valvular es actualmente el tratamiento de elección de la insuficiencia mitral siempre que sea posible. Con ayuda de la ecocardiografϊa transesofágica preoperatoria se pueden localizar la situación y extensión de las lesiones, lo que permite al cirujano valorar las posibilidades de reparación valvular y desarrollar un plan preciso de las maniobras quirúrgicas necesarias. Hoy en día, el objetivo de esta cirugía no se limita solamente a eliminar la insuficiencia mitral, sino también en muchos casos a reconstruir la geometría de todo el aparato valvular mitral, con objeto de asegurar la durabilidad de la reparación. Esta restitución quirúrgica hacia una geometría normal consiste en: a) aumento o reducción de los velos anormales; b) recambio de cuerdas tendinosas rotas o adelgazadas empleando suturas tipo "Goretex", y c) anuloplastia.Valve reconstruction is currently the treatment of choice for mitral regurgitation whenever possible. With the help of preoperative transesophageal echocardiography, the situation and extent of the lesions can be located, which allows the surgeon to assess the possibilities of valve repair and develop a precise plan of the necessary surgical maneuvers. Today, the objective of this surgery is not only limited to eliminating mitral regurgitation, but also in many cases to reconstruct the geometry of the entire mitral valve apparatus, in order to ensure the durability of the repair. This surgical restitution towards a normal geometry consists of: a) increase or reduction of abnormal veils; b) replacement of broken or thinned tendon cords using "Goretex" type sutures, and c) annuloplasty.
La anuloplastia consiste en la introducción de un dispositivo por vía yugular, que se coloca en el seno coronario y que tras aplicación de tracción, retracción o calor disminuye su perímetro, logrando la reducción del anillo mitral. Esta invención se centra en un dispositivo activo para anuloplastia, cuya progresiva actuación pueda ser activada y controlada a distancia. Los dispositivos comerciales existentes y las deseables mejoras, que dan lugar a la invención, se explican a continuación.Annuloplasty consists in the introduction of a jugular device, which is placed in the coronary sinus and which, after application of traction, retraction or heat, decreases its perimeter, achieving the reduction of the mitral ring. This invention focuses on an active device for annuloplasty, whose progressive action can be activated and controlled remotely. Existing commercial devices and desirable improvements, which give rise to the invention, are explained below.
La descripción hecha por Carpentier de un anillo protésico rígido que permitiera una reducción selectiva de todo el anillo mitral abrió el campo de la reparación mitral moderna. Desde entonces, se han desarrollado una serie de prótesis, que básicamente pueden ser clasificadas como rígidas o flexibles y totales o parciales. Las prótesis rígidas y monoplanares han sido desplazadas debido a los numerosos trabajos experimentales y clínicos que han demostrado que el perímetro del anillo mitral cambia de tamaño y forma continuamente durante el ciclo cardíaco.
El reciente hallazgo de que estos cambios se producen de forma tridimensional con un anillo en forma de paraboloide hiperbólico ha dado origen a nuevas prótesis tridimensionales rígidas. Sin embargo estos diseños ignoran también los cambios continuos de esta estructura. Duran propone la sustitución de dispositivos más convencionales (como los de Cosgrove - Edwards y Carpentier - Edwards), por otros desarrollos flexibles o semirrígidos que reproduzcan la forma tridimensional, como el comercializado por Medtronic Inc..Carpentier's description of a rigid prosthetic ring that allowed a selective reduction of the entire mitral ring opened the field of modern mitral repair. Since then, a series of prostheses have been developed, which can basically be classified as rigid or flexible and total or partial. Rigid and monoplanar prostheses have been displaced due to the numerous experimental and clinical works that have shown that the perimeter of the mitral ring changes size and shape continuously during the cardiac cycle. The recent finding that these changes occur three-dimensionally with a hyperbolic paraboloid-shaped ring has given rise to new rigid three-dimensional prostheses. However, these designs also ignore the continuous changes of this structure. Duran proposes the replacement of more conventional devices (such as Cosgrove - Edwards and Carpentier - Edwards), with other flexible or semi-rigid developments that reproduce the three-dimensional form, such as that marketed by Medtronic Inc ..
Todas las prótesis han estado basadas en la observación de que la dilatación patológica del anillo mitral no es homogénea, sino que se limita fundamentalmente al segmento posterior. El segmento anterior del anillo, al ser fibroso, se consideraba inextensible. Este principio se utilizó no sólo como método para la selección del tamaño de prótesis adecuado, sino también para el diseño de prótesis parciales que solamente reducen y sostienen el anillo posterior. Estos tipos de anuloplastia reducen el tiempo quirúrgico y permiten conservar los cambios fisiológicos que ocurren en el área intertrigonal. Recientemente se ha demostrado con sonomicrometría en un modelo ovino que la distancia intertrigonal cambia en un 12% durante el ciclo cardíaco. Este hallazgo, que cuestiona el principio de la inmovilidad del annulus normal, ha sido confirmado recientemente por un estudio necrópsico en controles y en enfermos con cardiopatía isquémica y miocardiopatía dilatada, que mostró una dilatación del área intertrigonal de hasta el 40%.All prostheses have been based on the observation that the pathological dilation of the mitral ring is not homogeneous, but is limited mainly to the posterior segment. The anterior segment of the ring, being fibrous, was considered inextensible. This principle was used not only as a method for the selection of the appropriate prosthesis size, but also for the design of partial prostheses that only reduce and support the posterior ring. These types of annuloplasty reduce surgical time and allow the physiological changes that occur in the intertrigonal area to be preserved. Recently it has been demonstrated with sonomicrometry in an sheep model that the intertrigonal distance changes by 12% during the cardiac cycle. This finding, which questions the principle of normal annulus immobility, has recently been confirmed by a necropsy study in controls and in patients with ischemic heart disease and dilated cardiomyopathy, which showed an intertrigonal area dilation of up to 40%.
Todos estos datos permiten concluir que la prótesis mitral ideal debe: a) prevenir la dilatación del área intertrigonal; b) reducir la dilatación, y c) restaurar su forma en silla de paraboloide hiperbólico. En principio solamente un anillo flexible y completo cumple con todas estas características.All these data allow us to conclude that the ideal mitral prosthesis should: a) prevent dilation of the intertrigonal area; b) reduce dilation, and c) restore its hyperbolic paraboloid chair shape. In principle, only a flexible and complete ring meets all these characteristics.
En lo referente a dispositivos comerciales empleados habitualmente para el tratamiento de valvulopatías destacan:
• Banda "Cosgrove - Edwards" para tratamienxo αe la regurgitación mitrai. Modelo rígido 4600 / 4625. Patentes previas -» US2001010018, US5350420, WO9101697, US5041130.Regarding commercial devices commonly used for the treatment of valvulopathies, the following stand out: • Band "Cosgrove - Edwards" for treatment and mitigation regurgitation. Rigid model 4600 / 4625. Previous patents - »US2001010018, US5350420, WO9101697, US5041130.
• El propio Cosgrove ha patentado diversos métodos de apoyo al implante de sus anillos -> US2005027352.• Cosgrove itself has patented various methods to support the implant of its rings -> US2005027352.
• Banda y anillo "Carpentier - Edwards" para tratamiento de la regurgitación mitrai. Modelo rígido Classic 4400 / 4425 y modelo rígido Classic 4450 / 4475. Patentes previas -> CA2539459 (2005-04-21), US2005131533, WO0062715.• Band and ring "Carpentier - Edwards" for mitrai regurgitation treatment. Classic 4400/4425 rigid model and Classic 4450/4475 rigid model. Previous patents -> CA2539459 (2005-04-21), US2005131533, WO0062715.
• Anillo elástico "Duran" para tratamiento de la regurgitación mitrai. Patentes previas a la comercialización -> WO2004000172, US5258021.• Elastic ring "Duran" for mitrai regurgitation treatment. Patents prior to marketing -> WO2004000172, US5258021.
Todos ellos han sido fruto de patentes y siguen empleándose casi indistintamente, pese a las ventajas de los anillos elásticos expuestas anteriormente. Una vez implantados conservan su geometría y es durante la propia operación, cuando producen la reducción de sección necesaria para mitigar la regurgitación. Esto supone una solicitación adicional al corazón, que puede dar lugar a complicaciones postoperatorias.All of them have been the result of patents and are still used almost interchangeably, despite the advantages of the elastic rings set out above. Once implanted they retain their geometry and it is during the operation itself, when they produce the necessary section reduction to mitigate regurgitation. This implies an additional request to the heart, which can lead to postoperative complications.
Dichos dispositivos comerciales, tampoco permiten modificación geométrica postoperatoria en caso de error de cálculo de la sección final más adecuada, salvo con una nueva intervención quirúrgica.These commercial devices also do not allow postoperative geometric modification in case of calculation error of the most appropriate final section, except with a new surgical intervention.
Sería deseable colocar un anillo con la misma forma que el propio anillo mitrai del paciente y una vez éste se haya recuperado de la operación, accionar dicho anillo de forma progresiva, reversible y a distancia. Se pretende así no perder una situación de equilibrio, no sobrecargar en exceso al corazón del paciente y optimizar el ajuste final, reduciendo al máximo el problema.It would be desirable to place a ring in the same way as the patient's own mitrai ring and once the patient has recovered from the operation, actuate said ring progressively, reversibly and remotely. It is thus intended not to lose an equilibrium situation, not to excessively overload the patient's heart and optimize the final adjustment, minimizing the problem.
Patentes como la de -> Lashinski EPl 646332, proponen actuación a distancia, pero sin concretar un método específico para el accionamiento mecánico. Proponen soluciones en base a motores y dispositivos tipo tornillo-sinfín, que no han dado lugar a dispositivos comerciales. Tampoco se han encontrado publicaciones referentes a ensayos clínicos previos relacionados con etapas de desarrollo.
Otras proponen soluciones para el accionamiento mecánico en Dase a dispositivos hinchables, como las empleadas en otros dispositivos médicos tipo stents con balón, pero que no se pueden llevar a cabo sin recurrir a una nueva intervención quirúrgica.Patents such as -> Lashinski EPl 646332, propose remote action, but without specifying a specific method for mechanical actuation. They propose solutions based on motors and screw-type devices, which have not resulted in commercial devices. Nor have publications been found regarding previous clinical trials related to developmental stages. Others propose solutions for mechanical actuation in Dase to inflatable devices, such as those used in other medical devices such as balloon stents, but which cannot be carried out without resorting to a new surgical intervention.
Por otro lado el empleo de materiales con memoria de forma, como solución al accionamiento mecánico (pero sin actuación a distancia) para conseguir la reducción de sección buscada, ha sido también objeto de patente -> Casanova US2006100697. Se propone el empleo de polímeros o aleaciones con memoria de forma, cuya temperatura de activación (cuya superación lleva al cambio geométrico) se sitúa entre los 250C y los 350C. Dichos materiales son similares a los utilizados en otros productos implantables como stents autoexpandibles. De esta manera, durante la propia operación y simplemente por contacto con el cuerpo humano, se activa la reducción de sección. Esto no permite la actuación por etapas, progresiva y postoperatoria, una vez el paciente esté recuperado, objeto de la invención presentada.On the other hand the use of materials with shape memory, as a solution to the mechanical drive (but without remote action) to achieve the desired section reduction, has also been the subject of a patent -> Casanova US2006100697. The use of polymers or alloys with shape memory is proposed, whose activation temperature (whose overcoming leads to geometric change) is between 25 0 C and 35 0 C. These materials are similar to those used in other implantable products such as self-expanding stents. In this way, during the operation itself and simply by contact with the human body, section reduction is activated. This does not allow the progressive and postoperative stage action, once the patient is recovered, object of the presented invention.
La combinación de actuación a distancia postoperatoria con un accionamiento mecánico controlable, resultaría muy adecuada para mejorar el tratamiento de valvulopatías.The combination of postoperative distance action with a controllable mechanical drive would be very suitable to improve the treatment of valvulopathies.
En base a dichos objetivos surge la invención propuesta, que destaca por la forma de producir la reducción de sección del dispositivo (por etapas y progresiva), por su reversibilidad para conseguir un ajuste óptimo, por el empleo de materiales con memoria de forma con temperatura de activación superior a la del cuerpo humano, por los métodos de calentamiento para activar el "efecto memoria de forma", por su proceso de fabricación (incluso a medida) y por la activación a distancia controlada electrónicamente.Based on these objectives, the proposed invention arises, which stands out for the way to produce the reduction of the device section (in stages and progressive), for its reversibility to achieve an optimal adjustment, for the use of materials with temperature-shape memory of activation superior to that of the human body, by the heating methods to activate the "shape memory effect", by its manufacturing process (even custom-made) and by electronically controlled remote activation.
Además la inclusión de un liberador de fármacos, el textil biocompatible y la posibilidad de realizar recubrimientos biocompatibles adicionales, ayudan a solucionar problemas de rechazo tras el implante. Todo ello da lugar a un dispositivo de dimensiones similares a los ya existentes comercialmente. Se explica en detalle en el apartado siguiente.
Descripción detallada de la invención. -In addition, the inclusion of a drug releaser, biocompatible textile and the possibility of additional biocompatible coatings help solve rejection problems after implantation. All this gives rise to a device of similar dimensions to those already existing commercially. It is explained in detail in the following section. Detailed description of the invention. -
La presente invención se refiere a un sistema de anuloplastia activo para el tratamiento progresivo de insuficiencias valvulares y otras patologías cardiovasculares, que comprende:The present invention relates to an active annuloplasty system for the progressive treatment of valvular insufficiencies and other cardiovascular pathologies, comprising:
• Un elemento anular de geometría variable con activación a distancia, para actuación postoperatoria, reversible, "paso a paso" y/o progresiva, en base al empleo individual o combinado de los siguientes anillos con electrónica de control: o Anillo polimérico con memoria de forma y temperatura de activación superior a la del cuerpo humano con resistencias distribuidas internamente, para el calentamiento y consiguiente desencadenamiento del "efecto memoria de forma" que lleva a la disminución (o aumento) de diámetro buscada. Dispone también de sistema de alimentación y electrónica de control teleoperada, que permite la activación secuencial o simultánea de las resistencias, para calentar distintas zonas del anillo y conseguir una actuación "paso a paso" o progresiva. Dicha electrónica interna consta al menos de una o varias pilas de tamaño reducido, una antena para recibir las señales del dispositivo de mando extemo y un microcontrolador, que permita la interpretación de las señales de mando y habilite el paso de corriente por la(s) resistencia(s) o el hilo conductor a calentar para activar el polímero y producir su cambio de fase y geometría. El anillo puede estar fabricado con cualquier tipo de polímero con memoria de forma, pero la temperatura de activación debe ser superior a la del cuerpo humano (de 4• An annular element of variable geometry with remote activation, for postoperative, reversible, "step by step" and / or progressive action, based on the individual or combined use of the following rings with control electronics: o Polymeric ring with memory of activation form and temperature higher than that of the human body with internally distributed resistances, for heating and consequent triggering of the "shape memory effect" that leads to the decrease (or increase) in diameter sought. It also has a power supply system and teleoperated control electronics, which allows the sequential or simultaneous activation of the resistors, to heat different areas of the ring and achieve a "step by step" or progressive action. Said internal electronics consists of at least one or several small-sized batteries, an antenna to receive the signals from the external control device and a microcontroller, which allows the interpretation of the control signals and enables the passage of current through the (s) resistance (s) or the conductive wire to be heated to activate the polymer and produce its phase and geometry change. The ring can be made with any type of shape memory polymer, but the activation temperature must be higher than that of the human body (4
0C a 6 0C). Esto posibilita la actuación postoperatoria mediante el adecuado calentamiento. Dicha temperatura de activación puede ajustarse (con leves variaciones de composición del material elegido) y acercarse a la del cuerpo humano, de tal manera que con un aislamiento adecuado, evite el contacto con tejidos y daños asociados. o Anillo metálico con memoria de forma y temperatura de activación superior a la del cuerpo humano con resistencias distribuidas en contacto con el anillo, para el calentamiento y consiguiente desencadenamiento del "efecto memoria de forma". Dispone también de sistema de alimentación y electrónica de control teleoperada, similar a la descrita para el anillo polimérico. El anillo puede estar fabricado con cualquier tipo de aleación metálica con memoria de forma o
cualquier tipo de polímero con memoria de íbrma, pero la temperatura de activación debe ser superior a la del cuerpo humano, como en el caso anterior. 0 C to 6 0 C). This enables postoperative action through adequate heating. Said activation temperature can be adjusted (with slight variations in the composition of the chosen material) and close to that of the human body, so that with adequate insulation, avoid contact with tissues and associated damage. o Metal ring with shape memory and activation temperature higher than that of the human body with resistances distributed in contact with the ring, for heating and consequent triggering of the "shape memory effect". It also has a power supply system and teleoperated control electronics, similar to that described for the polymer ring. The ring can be made of any type of metal alloy with shape memory or any type of polymer with memory memory, but the activation temperature must be higher than that of the human body, as in the previous case.
La reversibilidad se puede conseguir en cualquiera de los anillos gracias a la inclusión de distintos tramos de material activo (metálico o polimérico) con memoria de forma; unos con forma transitoria mayor que la permanente y otros con forma transitoria menor que la permanente. De esta manera, la activación de los primeros sectores lleva a la disminución de diámetro y la activación de los segundos sectores lleva al aumento de diámetro. • Un elemento tubular de material biocompatible, destinado al recubrimiento del (de los) anillo(s) activo(s); opcionalmente con pestañas interiores en uno de sus extremos y exteriores en el otro, cuya misión es actuar como dispositivo de enclavamiento (en el caso de no desear reversibilidad). Así mismo actúa como aislante térmico protegiendo a las mucosas de calentamientos no deseados y evitando el deterioro de los anillos actuadores y de los componentes electrónicos asociados.Reversibility can be achieved in any of the rings thanks to the inclusion of different sections of active material (metallic or polymeric) with shape memory; some with a transient form greater than the permanent one and others with a transient form less than the permanent one. In this way, the activation of the first sectors leads to a decrease in diameter and the activation of the second sectors leads to an increase in diameter. • A tubular element of biocompatible material, intended for coating the active ring (s); optionally with inner tabs at one of its ends and outer at the other, whose mission is to act as an interlocking device (in the case of not wanting reversibility). Likewise, it acts as a thermal insulator, protecting the mucous membranes from unwanted heating and preventing the deterioration of the actuator rings and associated electronic components.
• Depósito liberador de fármacos polimérico con memoria de forma y activación similar a la descrita para cualquiera de los dos anillos actuadores, destinado al suministro de agentes antimicrobianos o antibióticos, que permitan el tratamiento postoperatorio de patologías como endocarditis bacteriana y otras infecciones.• Polymeric drug-releasing depot with shape and activation memory similar to that described for any of the two actuator rings, intended for the supply of antimicrobial agents or antibiotics, which allow the postoperative treatment of pathologies such as bacterial endocarditis and other infections.
Puede disponer de resistencia o hilo de calentamiento propio, actuado convenientemente, en función de las señales recibidas por el elemento electrónico externo de control y de la interpretación que de dichas señales realice el microcontrolador. • Recubrimiento externo fabricado con cualquier tipo de textil o polímero biocompatible, con agujeros distribuidos de forma que ayuden implantar y coser el dispositivo de anuloplastia a la pared valvular.It can have its own heating element or resistance, acted conveniently, depending on the signals received by the external electronic control element and the interpretation that the microcontroller makes of said signals. • External coating made of any type of biocompatible textile or polymer, with holes distributed in a way that helps implant and sew the annuloplasty device to the valve wall.
• Un elemento electrónico externo de control, que puede ser un teléfono móvil, una PDA o cualquier dispositivo electrónico portátil o fijo, para el envío de señales de mando a la electrónica interna que gobierna la activación de las resistencias de calentamiento. Se permite así la activación tanto en la consulta del cardiólogo o prescriptor, como domiciliaria bajo la supervisión adecuada. La comunicación de
o• An external electronic control element, which can be a mobile phone, a PDA or any portable or fixed electronic device, for sending control signals to the internal electronics that govern the activation of the heating resistors. Activation is thus allowed in the consultation of the cardiologist or prescriber, as well as domiciliary under proper supervision. The communication of or
información entre el dispositivo implantado y el elemento electrónico de control externo se realiza por medio de tecnologías inalámbricas.Information between the implanted device and the electronic external control element is carried out by means of wireless technologies.
La actuación paso a paso o progresiva está destinada a:The step by step or progressive action is intended to:
> Evitar la pérdida de una situación de equilibrio hemodinámico en el paciente.> Avoid losing a hemodynamic equilibrium situation in the patient.
> No sobrecargar en exceso al corazón del paciente durante el implante de la prótesis.> Do not overload the patient's heart during implant implantation.
La reversibilidad del sistema está destinada a: > Evitar el cierre excesivo del anillo de anuloplastia y los nocivos efectos que ello podría conllevar.The reversibility of the system is intended to:> Avoid excessive closure of the annuloplasty ring and the harmful effects that this could entail.
> Permitir un ajuste más exacto de la dimensión final del dispositivo, consiguiendo una máxima mejora de la insuficiencia valvular.> Allow a more exact adjustment of the final dimension of the device, achieving a maximum improvement of valve insufficiency.
Como alternativa al empleo de un anillo con memoria de forma, se puede emplear un anillo activo basado en el empleo de polímeros electroactivos. Dicho anillo dispone de una distribución de elementos lineales fabricados con polimérico electroactivo, que responden a estímulos eléctricos con contracciones o dilataciones. Al cesar el estímulo la contracción cesa, sin embargo la ayuda de un elemento de enclavamiento permite al sistema de anuloplastia conservar la reducción de diámetro. El empleo de varios elementos electroactivos, conectados a la electrónica de control interna que los activa según las órdenes enviadas desde el elemento electrónico externo de control, permite la actuación paso a paso y/o progresiva.As an alternative to the use of a shape memory ring, an active ring based on the use of electroactive polymers can be used. Said ring has a distribution of linear elements made of electroactive polymer, which respond to electrical stimuli with contractions or dilations. When the stimulus ceases, the contraction ceases, however, the help of an interlocking element allows the annuloplasty system to preserve the reduction in diameter. The use of several electroactive elements, connected to the internal control electronics that activate them according to the orders sent from the external electronic control element, allows step-by-step and / or progressive action.
Para las distintas alternativas se pueden emplear recubrimientos biocompatibles adicionales depositados con ayuda de tecnologías PVD (deposición física de vapor), CVD (deposición química de vapor), epitaxia de haces moleculares o cualquier otro tipo de tecnología que permita depositar capas delgadas de material que tengan desde 1 nm hasta 100 μm de espesor.For the different alternatives, additional biocompatible coatings deposited with the help of PVD (physical vapor deposition), CVD (chemical vapor deposition), molecular beam epitaxy or any other type of technology that allows thin layers of material to be deposited can be used. from 1 nm to 100 μm thick.
La forma del dispositivo implantable puede personalizarse a las dimensiones de los distintos anillos valvulares del paciente; mediante el empleo de tecnologías preoperatorias, (por ejemplo tomografía axial computerizada TAC, ecocardiografía
transesofágica, ecocardiografía transtorácica, y otras tecnologías de inspección interna), en combinación con tecnologías de diseño y fabricación asistidas por computador (CAD - CAM).The shape of the implantable device can be customized to the dimensions of the different valve rings of the patient; through the use of preoperative technologies, (for example, CT scan, CT scan, echocardiography transesophageal, transthoracic echocardiography, and other internal inspection technologies), in combination with computer-aided design and manufacturing technologies (CAD - CAM).
Las dimensiones externas del dispositivo implantable son similares a las de productos comerciales existentes que disponen normalmente de un anillo metálico rígido en su interior (forma cuasi-anular adaptada a la geometría de los distintos anillos valvulares del ser humano, con 28 mm a 32 rom de dimensión diametral máxima). Dicho anillo rígido es sustituido en esta invención, por los anillos actuadores con memoria de forma y la necesidad de electrónica de control, distribuida de forma adecuada, no influye de manera determinante en las dimensiones finales. Los componentes más voluminosos son externos y pueden conectarse a la red eléctrica, lo que permite también mitigar las limitaciones de consumo del implante activo.The external dimensions of the implantable device are similar to those of existing commercial products that normally have a rigid metal ring inside (quasi-annular shape adapted to the geometry of the different valve rings of the human being, with 28 mm to 32 rom of maximum diametral dimension). Said rigid ring is replaced in this invention by the actuator rings with shape memory and the need for control electronics, properly distributed, does not influence the final dimensions decisively. The most bulky components are external and can be connected to the power grid, which also allows mitigating the consumption limitations of the active implant.
Así mismo, mediante modificaciones adecuadas de la geometría externa (siempre con posibilidad de adaptarlas para cada paciente), puede emplearse el sistema objeto de esta invención, para el tratamiento de diversas patologías cardiovasculares, además de las patologías valvulares como insuficiencia mitral, insuficiencia aórtica, insuficiencia tricúspide, y cualquier otro tipo de patologías corregidas mediante anuloplastia.Likewise, by means of appropriate modifications of the external geometry (always with the possibility of adapting them for each patient), the system object of this invention can be used, for the treatment of various cardiovascular pathologies, in addition to valvular pathologies such as mitral insufficiency, aortic insufficiency, tricuspid insufficiency, and any other type of pathologies corrected by annuloplasty.
Se detalla la invención en los siguientes apartados mediante un modo de realización de la misma y con ayuda de figuras.
The invention is detailed in the following sections by means of an embodiment thereof and with the help of figures.
Breve descripción de los dibujos.-Brief description of the drawings.-
Figura 1.- Representación esquemática de los principales elementos de la invención. 1.- Anillo de anuloplástia activo con electrónica de control.Figure 1.- Schematic representation of the main elements of the invention. 1.- Active annuloplasty ring with control electronics.
2.- Electrónica de control asociada al anillo de anuloplástia activo. 3.- Elemento electrónico de control externo. 4.- Dispositivo liberador de fármaco.2.- Control electronics associated with the active annuloplasty ring. 3.- External control electronic element. 4.- Drug releasing device.
Figura 2.- Anillo activo para accionamiento del dispositivo de anuloplástia. Polímero (o aleación) con memoria de forma con resistencias internas (o adyacentes en el caso de emplear aleación con memoria de forma) para calentamiento. 5.- Material polimérico con memoria de forma. 6.- Resistencias internas para calentamiento.Figure 2.- Active ring for actuation of the annuloplasty device. Polymer (or alloy) with shape memory with internal resistances (or adjacent in the case of using shape memory alloy) for heating. 5.- Polymeric material with shape memory. 6.- Internal resistance for heating.
Figura 3.- Sección longitudinal de la prótesis con las distintas capas:Figure 3.- Longitudinal section of the prosthesis with the different layers:
7.- Capa Interna.- Anillo(s) actuador(es) con la electrónica asociada. 8.- Capa Intermedia.- Elemento polimérico tubular para protección de los tejidos adyacentes y enclavamiento opcional. 9.- Capa Externa.- Textil o polímero biocompatible.7.- Internal Layer.- Ring (s) actuator (s) with associated electronics. 8.- Intermediate layer.- Tubular polymeric element for protection of adjacent tissues and optional interlocking. 9.- External layer.- Textile or biocompatible polymer.
Exposición de al menos un modo de realización de la invención.-Exposure of at least one embodiment of the invention.-
La presente invención se ilustra adicionalmente mediante el siguiente modo de realización, que no pretende ser limitativo de su alcance.The present invention is further illustrated by the following embodiment, which is not intended to be limiting of its scope.
En primer lugar se realiza el diseño CAD (geometría en 3 D con ayuda de programas de diseño asistido por ordenador) de los anillos activos basados en polímeros con memoria de forma. Una vez realizado el diseño CAD se obtienen los primeros prototipos por estereolitografía, tecnología que se explica a continuación.First of all, the CAD design (3 D geometry with the help of computer-aided design programs) of the active rings based on shape memory polymers is carried out. Once the CAD design is completed, the first prototypes are obtained by stereolithography, a technology explained below.
Los sistemas de prototipado rápido surgen inicialmente en 1987 con el proceso de "Estereolitografía" de la empresa estadounidense 3D Systems, y en la actualidad es la
tecnología más extendida. Se basa en la posibilidad de activar la reacción de polimerización de una resina epoxi en estado líquido mediante la proyección de un haz láser, de potencia y frecuencia adecuadas al tipo de resina. El proceso comienza con el elevador situado a una distancia de la superficie del líquido igual al grosor de la primera sección a procesar. El láser traza la superficie de la sección y su contorno, siguiendo los datos provenientes del archivo CAD con la geometría de la pieza. Los monómeros en estado líquido, al ser sometidos a radiación ultravioleta polimerizan quedando en estado sólido. Una vez solidificada esta sección, el elevador baja su posición para situarse a la altura de la siguiente capa. Se repite la operación hasta conseguir la pieza física final en resina epoxi.Rapid prototyping systems initially emerged in 1987 with the "Stereolithography" process of the American company 3D Systems, and is currently the more widespread technology It is based on the possibility of activating the polymerization reaction of an epoxy resin in a liquid state by projecting a laser beam, of adequate power and frequency to the type of resin. The process begins with the elevator located at a distance from the surface of the liquid equal to the thickness of the first section to be processed. The laser traces the surface of the section and its contour, following the data from the CAD file with the geometry of the piece. The monomers in liquid state, when subjected to ultraviolet radiation polymerize remaining in solid state. Once this section has solidified, the elevator lowers its position to reach the height of the next layer. The operation is repeated until the final physical piece is obtained in epoxy resin.
Posteriormente, se fabrican moldes de silicona usando dichos prototipos obtenidos por estereolitografía como modelos. Se propone obtener, por colada bajo vacío en dichos moldes, los prototipos con la dimensión final empleando polímero con memoria de forma (generalmente implica la colada una mezcla de dos resinas que dan lugar al material con memoria de forma).Subsequently, silicone molds are manufactured using said prototypes obtained by stereolithography as models. It is proposed to obtain, under vacuum casting in said molds, prototypes with the final dimension using polymer with shape memory (generally a mixture of two resins that give rise to the material with shape memory) involves casting.
Para el calentamiento por resistencias o hilo, se conforma el anillo con la dimensión final deseada (la necesaria para eliminar la insuficiencia valvular, entre unos 27 mm y 30 mm de dimensión diametral máxima para el caso de insuficiencia mitral) y con las resistencias ya colocadas.For heating by resistances or wire, the ring is formed with the desired final dimension (the one necessary to eliminate valvular insufficiency, between about 27 mm and 30 mm of maximum diametral dimension in the case of mitral insufficiency) and with the resistances already placed .
A continuación se calienta homogéneamente el anillo a temperatura superior a la de transición (unos 50C por encima de la temperatura de transición, situada entre 41 0C y 43 0C) y se le obliga a adaptar la forma transitoria expandida (se emplea para ello utillaje en forma de tronco de cono), dejándolo enfriar hasta temperatura ambiente. El proceso se denomina "entrenamiento de la memoria de forma".The ring is then heated homogeneously to a temperature higher than the transition temperature (about 5 0 C above the transition temperature, located between 41 0 C and 43 0 C) and forced to adapt the expanded transient shape (used for this, tooling in the shape of a cone trunk), allowing it to cool to room temperature. The process is called "shape memory training."
En el caso de emplear un anillo activo de aleación con memoria de forma, el proceso es el siguiente. En primer lugar se moldea el anillo con la dimensión final deseada (la necesaria para eliminar la insuficiencia mitral una vez implantado). Dicha primera fase austenítica se enfría a temperatura ambiente conservando la forma pero cambiando a estructura martensítica maclada. A continuación se le obliga a adaptar la forma
transitoria expandida (se puede emplear para ello utillaje en forma de tronco de cono). Se coloca posteriormente la resistencia o el hilo calentador conectado a la batería para su alimentación.In the case of using an active alloy ring with shape memory, the process is as follows. First, the ring is molded with the desired final dimension (the one necessary to eliminate mitral regurgitation once implanted). Said first austenitic phase is cooled to room temperature preserving the shape but changing to martensitic structure. He is then forced to adapt the form expanded transient (can be used for this purpose in the form of a cone trunk). The resistance or the heating wire connected to the battery is then placed for feeding.
Dichos anillos en forma transitoria expandida, retornarán a sus dimensiones originales o permanentes, (las obtenidas por colada bajo vacío en moldes de silicona o por moldeo), mediante el calentamiento postoperatorio y consiguiente superación de las temperaturas de activación.Said rings in an expanded transient form, will return to their original or permanent dimensions (those obtained by vacuum casting in silicone molds or by molding), by postoperative heating and consequently exceeding the activation temperatures.
La reversibilidad se puede conseguir en los anillos gracias a la inclusión de distintos tramos de material activo (metálico o polimérico) con memoria de forma; unos con forma transitoria mayor que la permanente y otros con forma transitoria menor que la permanente. De esta manera, la activación de los primeros sectores lleva a la disminución de diámetro y la activación de los segundos sectores lleva al aumento de diámetro.Reversibility can be achieved in the rings thanks to the inclusion of different sections of active material (metallic or polymeric) with shape memory; some with a transient form greater than the permanent one and others with a transient form less than the permanent one. In this way, the activation of the first sectors leads to a decrease in diameter and the activation of the second sectors leads to an increase in diameter.
Una vez obtenidos los anillos, se conectan la batería y la electrónica que permiten controlar el calentamiento de las resistencias. El paso de corriente (intensidad de 50 a 300 mA) por cada resistencia (valores entre 1 Ω y 10 Ω) produce un aumento local de temperatura, que controlado adecuadamente lleva al cambio de fase del material y a su consiguiente disminución de dimensión. La electrónica de control asociada, permite actuar sobre las resistencias de forma independiente, en distintos momentos y llevar a cabo la actuación progresiva o "paso a paso" deseada.Once the rings are obtained, the battery and the electronics are connected to control the heating of the resistors. The passage of current (intensity of 50 to 300 mA) for each resistance (values between 1 Ω and 10 Ω) produces a local increase in temperature, which properly controlled leads to the change of phase of the material and its consequent decrease in dimension. The associated control electronics, allows to act on the resistances independently, at different times and carry out the desired progressive or "step by step" action.
Una vez fabricado el anillo actuador, se procede a su recubrimiento con el polímero en forma tubular (que dispone de ranura lateral a tal efecto) y que actúa como dispositivo protector y de enclavamiento (opcional en el caso de no desear reversibilidad), gracias a las pestañas interiores y exteriores de que dispone en sus extremos. El liberador de fármaco puede fabricarse con ayuda de tecnologías CAD - CAM como los anillos activos e incluirse adyacente al elemento tubular, a la espera del recubrimiento textil.Once the actuator ring is manufactured, it is covered with the polymer in a tubular form (which has a side groove for this purpose) and acts as a protective and interlocking device (optional in the case of not wanting reversibility), thanks to the inner and outer tabs that it has at its ends. The drug releaser can be manufactured with the help of CAD-CAM technologies such as active rings and be included adjacent to the tubular element, pending textile coating.
Por último se recubre de tejido o polímero biocompatibles, similares a los empleados en los productos ya existentes, con agujeros adecuados a facilitar el implante del
dispositivo. Se pueden emplear procesos de recubrimiento CVD o PVD, en sus modalidades de baja temperatura, (evitando así alterar las propiedades de los materiales con memoria de forma), para conseguir capas adicionales de material biocompatible entre 1 nm y 100 μm de espesor.Finally, it is covered with biocompatible fabric or polymer, similar to those used in existing products, with suitable holes to facilitate implantation of the device. CVD or PVD coating processes can be used, in their low temperature modalities (thus avoiding altering the properties of shape memory materials), to achieve additional layers of biocompatible material between 1 nm and 100 μm thick.
La forma del dispositivo implantable puede personalizarse a las dimensiones de los anillos valvulares del paciente; mediante el empleo de tecnologías preoperatorios de inspección interna, en combinación con tecnologías de diseño y fabricación asistidas por computador (CAD - CAM). Una vez obtenidos los archivos CAD a medida del paciente, el proceso sería similar al expuesto.
The shape of the implantable device can be customized to the dimensions of the patient's valve rings; through the use of preoperative internal inspection technologies, in combination with computer-aided design and manufacturing technologies (CAD - CAM). Once the CAD files have been obtained tailored to the patient, the process would be similar to that described.
Claims
1.- Sistema de anuloplastia activo para el tratamiento progresivo de insuficiencias valvulares y otras patologías cardiovasculares, que comprende los siguientes elementos que posibilitan el tratamiento postoperatorio, a distancia, progresivo y reversible:1.- Active annuloplasty system for the progressive treatment of valvular insufficiencies and other cardiovascular pathologies, which includes the following elements that enable postoperative, remote, progressive and reversible treatment:
• un elemento anular de geometría variable con activación a distancia, para actuación postoperatoria, reversible, "paso a paso" y/o progresiva en base al empleo individual o combinado de: o un anillo polimérico con memoria de forma y temperatura de activación superior a la del cuerpo humano con hilo calefactor y/o resistencias distribuidas internamente, para el calentamiento y consiguiente desencadenamiento del efecto "memoria de forma" que lleva a la disminución (o aumento) de diámetro buscada, y que dispone también de sistema de alimentación y electrónica de control teleoperada, que permiten la activación secuencial o simultánea del hilo calefactor y/o de las resistencias, que calientan las distintas zonas del anillo y consiguen una actuación "paso a paso" o progresiva, y/o o un anillo metálico con memoria de forma y temperatura de activación superior a la del cuerpo humano con resistencias distribuidas en contacto con el anillo, para el calentamiento y consiguiente desencadenamiento del "efecto memoria de forma", y que dispone también de sistema de alimentación y electrónica de control teleoperada, similar a la descrita para el anillo polimérico anterior,• a variable geometry annular element with remote activation, for postoperative, reversible, "step-by-step" and / or progressive action based on the individual or combined use of: o a polymeric ring with shape memory and activation temperature greater than that of the human body with heating wire and / or internally distributed resistors, for heating and consequent triggering of the "shape memory" effect that leads to the decrease (or increase) in diameter sought, and which also has a power and electronic system teleoperated control, which allows the sequential or simultaneous activation of the heating wire and / or the resistors, which heat the different areas of the ring and achieve a "step by step" or progressive action, and / or a metal ring with shape memory and activation temperature higher than that of the human body with resistances distributed in contact with the ring, for heating and consequent triggering of the "shape memory effect", and which also has a power supply system and teleoperated control electronics, similar to that described for the previous polymeric ring,
garantizando la reversibilidad en cualquiera de los anillos mediante la inclusión de distintos tramos de material activo (metálico o polimérico) con memoria de forma , unos con forma transitoria mayor que la permanente y otros con forma transitoria menor que la permanente,guaranteeing the reversibility in any of the rings by including different sections of active material (metallic or polymeric) with shape memory, some with a transient shape greater than the permanent one and others with a transient shape less than the permanent one,
• acompañados cada uno de ellos o ambos combinados por un elemento electrónico externo de control, que puede ser cualquier dispositivo electrónico portátil o fijo, para el envío de señales de mando a la electrónica interna que gobierna la activación de las resistencias de calentamiento o el hilo de calentamiento. • accompanied by each or both of them combined by an external electronic control element, which can be any portable or fixed electronic device, for sending control signals to the internal electronics that govern the activation of the heating resistors or the wire of heating.
2.- Sistema según reivindicación 1, en el que la comunicación de información entre el dispositivo implantado y el elemento electrónico externo de control se realiza por medio de tecnologías inalámbricas.2. System according to claim 1, wherein the communication of information between the implanted device and the external electronic control element is carried out by means of wireless technologies.
3.- Sistema según reivindicaciones 1 y 2, que dispone de un elemento tubular de material biocompatible, destinado al recubrimiento del (de los) anillo(s) activo(s); con pestañas interiores en uno de sus extremos y exteriores en el otro, cuya misión es actuar como dispositivo de protección y enclavamiento.3. System according to claims 1 and 2, which has a tubular element of biocompatible material, intended for coating the active ring (s); with inner tabs at one of its ends and outer at the other, whose mission is to act as a protection and interlocking device.
4.- Sistema según reivindicaciones 1 a 3, que dispone de un depósito liberador de fármacos polimérico con memoria de forma y activación similar a la descrita para el anillo actuador, destinado al suministro de agentes antimicrobianos o antibióticos.4. System according to claims 1 to 3, which has a polymeric drug releasing tank with memory of shape and activation similar to that described for the actuator ring, intended for the supply of antimicrobial agents or antibiotics.
5.- Sistema según reivindicaciones 1 a 4, que dispone de un recubrimiento externo de textil biocompatible con agujeros distribuidos de forma que ayuden implantar y coser el dispositivo de anuloplastia a la pared valvular.5. System according to claims 1 to 4, which has an outer covering of biocompatible textile with holes distributed so as to help implant and sew the annuloplasty device to the valve wall.
6.- Sistema según reivindicaciones 1 a 5, en el que el (los) anillo(s) activo(s), puede(n) ser sustituido(s) por un anillo constituido por una distribución longitudinal de elementos lineales de polímero electroactivo, conectados a la electrónica de control para su accionamiento. 6. System according to claims 1 to 5, wherein the active ring (s), can be replaced by a ring consisting of a longitudinal distribution of linear elements of electroactive polymer, connected to the control electronics for operation.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES200603149A ES2277794B2 (en) | 2006-12-13 | 2006-12-13 | ACTIVE ANULOPLASTIC SYSTEM FOR THE PROGRESSIVE TREATMENT OF VALVULAR INSUFFICIENCIES AND OTHER CARDIOVASCULAR PATHOLOGIES. |
| ESP200603149 | 2006-12-13 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2008071817A1 true WO2008071817A1 (en) | 2008-06-19 |
| WO2008071817B1 WO2008071817B1 (en) | 2008-07-31 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/ES2007/000719 WO2008071817A1 (en) | 2006-12-13 | 2007-12-12 | Active annuloplasty system for the progressive treatment of valvular insufficiencies and other cardiovascular pathologies |
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| Country | Link |
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| ES (1) | ES2277794B2 (en) |
| WO (1) | WO2008071817A1 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| ES2277794A1 (en) | 2007-07-16 |
| ES2277794B2 (en) | 2008-05-16 |
| WO2008071817B1 (en) | 2008-07-31 |
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