Pulmonary artery banding device

Abstract

Pulmonary artery banding device ( 1 ) includes an inflating banding ring ( 2 ), to be installed around the patient's pulmonary artery (PA), an extending tube ( 3 ), and an insufflating button ( 4 ), the extending tube ( 3 ) connecting insufflating button ( 4 ) to the banding inflating ring, the banding ring being configured as a C-shape hydraulic sleeve forming a support for an inflating balloon, whose external wall ( 2 a ) is formed by a thin rigid silicon layer, and whose inside wall ( 2 b ) is formed by a thin flexible silicon layer, at the apart ends of the banding ring two brims being disposed ( 2 c ) to facilitate the size banding adjustment according with the pulmonary artery calibre (PA). The banding ring are provided with holes ( 2 e ) for passage of sutures fixating the ring on the pulmonary artery of the patient; the insufflating button being configured as a cylindrical reservoir and being provided with holes ( 4 a ) for sutures.

1 . Improvements introduced in an pulmonary artery banding device, device ( 1 ) constituted by an inflating banding ring ( 2 ), to be installed around the patient pulmonary artery (PA), by an extending tube ( 3 ), and by an insufflating button ( 4 ), implanted subcutaneary in the patient's thorax; said extending tube ( 3 ) connecting insufflating button ( 4 ) to the banding inflating ring ( 2 ), keeping everybody linked to each other, characterized by the fact of the said banding ring ( 2 ) configured by a hydraulic sleeve in the shape of “C,” forming a support for an inflating balloon, whose external wall ( 2   a ) is formed by a thin rigid silicon layer, or similar, that prevents the ring radial distention from within inside to outside (centrifugal distention), and whose inside wall ( 2   b ) is formed by a thin flexible silicon layer, or similar, that allows the outside ring radial distention from within outside to inside (centripetal distention), at the apart ends of the said banding ring ( 2 ), two brims are disposed ( 2   c ) to facilitate the size banding adjustment according with the pulmonary artery caliber (PA); said banding ring ( 2 ) is still provided of an appropriate number of holes or loops with holes ( 2   e ), along all extension of his non apart borders, placed equidistant and spaced to each other, for fixation points (sutures) passage of the said ring in the pulmonary artery patient's; the extending tube ( 3 ), also of silicon, or similar, provides the communication between the banding ring ( 2 ) and the insufflating button ( 4 ), with the purpose to transmit an appropriate liquid injected in the button for the banding ring sleeve; the insufflating button ( 4 ) is configured by a cylindrical reservoir made in auto-stamped silicon, or similar, whose base presents a preferable porcelain metallic plate, to limit the introduction injection liquid needle point; said button ( 4 ) is provided of a multiplicity of holes ( 4   a ) disposed close to outlying border, to passed the fixation points (sutures) of said button ( 4 ) in the patient's thoracic wall, allowing the banding ring ( 2 ) insufflation or “unsufflation” by percutaneous path.  
   
   
       2 . An improvement in an ADJUSTABLE BANDING SYSTEM ( 1 ), adapted to restrict blood flow through the small pulmonary arteries of neonates, comprising: 
 an inflating banding ring ( 2 ), to be implanted around the neonate PA branches, a connecting tubing ( 3 ), and    a self-sealing inflating reservoir ( 4 ), implantable in the patient's subcutaneous thorax, all parts of the Banding System being of or covered by medical grade silicone and produced with radiopaque material to be visualized on a chest roentgenogram, in order to provide information regarding the position of the implanted device,    said banding ring ( 2 ) being configured as a “C” shape hydraulic cuff, with an outer wall ( 2   a ) formed by a thin non-distensible silicone layer, or similar, that prevents centrifugal distention of the hydraulic cuff, further including some small flanges to attach the banding ring to the PA adventitia with sutures to keep said banding ring from migrating distally,    the inner portion ( 2   b ) of said banding ring being formed by a thin flexible and distensible silicone balloon, or similar, that allows inward distension as it is inflated, the “C” shaped banding ring ending in two apart ends ( 2   c ) for adequate sizing of the band according to neonate's PA size,    the twist-resistant and non-distensible flexible connecting tube ( 3 ) providing communication between the banding ring ( 2 ) and the inflating reservoir ( 4 ), with the purpose of taking the fluid injected percutaneously in the inflation reservoir to the banding ring, thus varying the PA diameter according to the volume of injected fluid, the inflating reservoir ( 4 ) being configured by a ceramic cylindrical sink, with a self-sealing silicone diaphragm at the top and a lateral aperture connected hermetically to the tube,    a 3 mm thick silicone base having four small holes ( 4   a ) around the rim to enable suturing to subcutaneous tissue,    wherein the banding ring constriction is adjustable by injecting    or removing fluid percutaneously from the inflation reservoir.