Balloon expandable temporary radioisotope stent system

A system for creating a temporary stent within a vessel of a human body, the system comprising:

• a flexible guide wire;
• a rapid exchange balloon angioplasty catheter having distal and proximal sections, and being adapted for dilatation of an arterial stenosis, the balloon angioplasty catheter having an inner shaft and an outer shaft each having distal and proximal ends both shafts being located at the distal section of the balloon angioplasty catheter, and an inflatable balloon that connects the inner shaft to the outer shaft, the balloon angioplasty catheter having a lumen for the guide wire which exits from the distal end of the inner shaft with a lumen entry that is situated just proximal to the proximal end of the outer shaft, the balloon angioplasty catheter also having a proximal section that remains outside the body;
• and,
• a stent assembly coaxially mounted onto the balloon angioplasty catheter and having a proximal section and a distal section at which distal section is located a temporary stent whose distal end is fixedly attached near the distal end of the inner shaft of the balloon angioplasty catheter, the temporary stent's proximal end being fixedly attached to the distal end of an elongated pusher tube, the pusher tube having a guide wire entry slit situated near its distal end, and the pusher tube being adapted to cooperate with the proximal section of the balloon angioplasty catheter to cause the temporary stent to be deployed radially outward or to be retracted so that the temporary stent reforms around the balloon of the balloon angioplasty catheter for removal of the system from the vessel.

A method for treatment of an arterial stenosis comprising the following steps:

• a) placing a temporary stent system formed from a stent assembly and a balloon angioplasty catheter into an artery of a human body, the stent assembly and the balloon angioplasty catheter each having a distal section and a proximal section, the balloon angioplasty catheter having an inflatable balloon located at its distal section and having a proximal section that is situated outside of the human body, the stent assembly having a temporary stent located at its distal section and an elongated pusher tube fixedly attached to the temporary stent and extending in a proximal direction, the pusher tube having a proximal section that extends outside the human body and includes a means for locking the proximal tube's proximal section to the proximal section of the balloon angioplasty catheter,
• b) expanding an inflatable balloon that is at the distal end of the balloon angioplasty catheter and within the temporary stent so as to push the stent radially outward against a stenosis,
• c) simultaneously applying a forward force at the proximal section of the stent assembly and a backward pull at the proximal section of the balloon angioplasty catheter,
• d) engaging the locking means on the stent assembly's proximal section to frictionally attach the stent assembly to the balloon angioplasty catheter,
• e) deflating the balloon,
• f) positionally maintaining said temporary stent in fixed position to expose an arterial wall in contact with the stent to be irradiated from a radioisotope source located on the stent,
• g) disengaging the locking means on the stent assembly's proximal section,
• h) simultaneously applying a backward force on the proximal section of the stent assembly while applying a forward force on the proximal section of the balloon angioplasty catheter, and
• i removing the temporary stent from the human body.