Front-end loader for prosthetic occluders and methods thereof
The invention pertains to a system, and related methods, for the percutaneous transluminal delivery and retrieval of a prosthetic occluder through a front-end loader. The prosthetic occluder may be, for example, an intracardiac occluder for a patent foramen ovale. The system includes, in one embodiment, a front-end loader having a beveled distal end. In another embodiment, the system includes a front-end loader having a chamfered rim at the beveled distal end.
1. A percutaneous transluminal system for an intracardiac device having a front-end loader and an introducer sheath having a hub disposed therein, wherein:
said front-end loader comprises:
a proximal portion comprising a proximal end, a distal end, and an expanded lumen positioned therebetween, said expanded lumen having a conical shape and a constantly tapering diameter from said proximal end of said proximal portion to said distal end of said proximal portion; and
a distal portion, comprising a tube comprising a proximal end, a distal end, a lumen extending therethrough, said lumen of said distal portion being co-extensive with said expanded lumen of said proximal portion;
wherein said distal end of said distal portion comprises means for reducing air introduction into a patients' cardiovascular system when said percutaneous transluminal system is in use during delivery of said intracardiac device from said lumen of said distal portion,
wherein the means for reducing air introduction includes a beveled edge at said distal end of said distal portion, said beveled edge including a tip and a base, said base disposed proximally of said tip and said edge defining up to a 75 degree angle,
wherein said beveled edge is chamfered around its entire perimeter, said chamfer defining an opening through said distal end of said distal portion, the chamfer comprising an outer rim and an inner rim and having a width therebetween, said inner rim positioned proximal to said outer rim, and wherein said width between said outer rim and said inner rim is substantially the same or varies about the entire perimeter; and,
said hub within the introducer sheath comprises:
a lumen and a gland disposed therein, wherein the gland is an elastomeric polymer defined by opposing proximal portions extending substantially horizontally from the inner wall of the lumen and distal portions extending from the inner wall of the lumen, wherein one such distal portion defines a slope corresponding to the beveled edge; and wherein further the beveled edge of the distal portion of the loader is sized to be insertable through said opposing proximal portions and said opposing distal portions of the gland, so both the proximal and distal portions of the gland remain engaged and sealed to the distal portion of the loader after the beveled edge passes therethrough;
and wherein further the introducer sheath and the hub have corresponding threaded engagements to secure one to the other.
2. The front-end loader of claim 1 , wherein said means for reducing air introduction receives said intracardiac device to withdraw said intracardiac device from the patient's body.
3. The front-end loader of claim 1 , wherein said intracardiac device comprises an intracardiac occluder.
4. The front-end loader of claim 3 , wherein said intracardiac occluder comprises an occluder for treating an atrial septal defect.
5. The front-end loader of claim 3 , wherein said intracardiac occluder comprises an occluder for treating a ventricular septal defect.
6. The front-end loader of claim 3 , wherein said intracardiac occluder comprises an occluder for treating patent ductus arteriosus.
7. The front-end loader of claim 3 , wherein said intracardiac occluder comprises an occluder for treating patent foramen ovale.