Septal defect occluder

#The present invention generally relates to devices for occluding septal defects or shunts in the heart or the vascular system, and particularly provides a low profile septal defect conforming device reversibly deliverable via catheter to a septal defect site.

#The term “septal defect” generally refers to a perforation or other type hole (i.e., a defect) which passes through a thin wall of muscle or other tissue (i.e., a septum) which divides or separates “areas” within the body. Such defects can occur, either congenitally or by acquisition, between chambers of the heart (i.e., atrium or ventricle) or the great vessels (interatrial and interventricular septal defects or patent ductus arteriosus and aortico-pulmonary window respectively), causing shunting of blood through the opening.

#In the case of the atrium, the presence of a significantly large septal defect can allow blood to shunt across the defect from the left atrium to the right atrium and hence on to the left ventricle, aorta and brain. If the defect is not closed, the risk of stroke is increased.

#FIG. 1 is a side elevational view of the septal defect occluder of the present invention deployed in a septal defect;

#FIG. 2 is an end view of an occluder panel of the septal defect occluder of the present invention, particularly illustrating a center fabric attachment point;

#FIG. 3 is an end view of the frame members of the device of the subject invention having two pairs of opposing inward eyelets;

#As shown generally in FIG. 1, a septal defect closure device 20 of the invention may be attached to the septum S (e.g., an atrial septum) to effectively conform to and block the defect, without protruding into atrial cavities and the like. As described in detail below, once the closure device 20 is in place, it becomes anchored to the septum and prevents the flow of blood through the atrial septum to the adjoining chambers of the heart. This will permit the heart to operate normally.

#Referring now to FIGS. 1 and 2, the extremely low profile closure device includes first and second occluder panels 30, 60. Each panel 30, 60 is generally round (e.g., circular, oval, elliptical etc.) so as to facilitate positioning, and minimizes chances of erosion and puncture. Each panel 30, 60 generally comprises a fabric support structure 32, 62 and fabric 33 suspended from a perimeter 34, 64 of the fabric support structures 32, 62. The occluder panels 30, 60 are conjoined at a plurality of discrete points, located or positioned within the bounds of each of the fabric support structures 32, 62 (i.e., within an area bounded by each perimeter 34, 64 of the support structures 32, 62), as well as on the fabric 33 (which will be further explained with reference to FIGS. 2, 7 and 8). A defect conforming region 80 for the occluder 20 is thereby formed. The nature (i.e., structure, relationships there between and function) of the defect conforming region will be detailed herein below, particularly with reference to FIGS. 1, 2 and 9-14. At this point it may be said that the region 80 expandingly conforms to substantially completely and thoroughly satisfy the perimeter of the defect geometry. This stabilizes panels 30, 60 so that complete coverage of the defect from either direction is achieved. The defect is thereby occluded without distortion of the defect.

#The fabric support structures 32, 62 of the occluder are generally flexible and elastically deformable, and include perimeter and traversing segments 36, 38. Resilient fabric 33 (FIG. 4) is suspended or otherwise affixed to the perimeter segments 36 of the fabric support structures 32, 62. As particularly shown in FIG. 2, the perimeter segments 36 of the fabric support structures 32, 62 extend substantially around the periphery 35 of the fabric 33. The fabric 33 may be formed of a thin, flexible material which can be folded and pulled taut without being damaged. Elastic polymeric materials such as, for example, polyester knit, nylon, polypropylene, polytetrafluoroethylene (e.g., Teflon®), and expanded polytetrafluoroethylene (e.g., GoreTex®), as well as natural fabrics such as silk, are acceptable.