Thermal balloon angioplasty
First Claim
1. A method for carrying out balloon catheter angioplasty within a coronary artery having a stenosis comprising the steps of:
- positioning the balloon or the catheter within the stenosis of the artery,increasing the temperature of the stenosis and artery surrounding the balloon prior to the inflation of the balloon to an inflation extent sufficient to cause outward expansion for a clinically appropriate time period and to a temperature level sufficient to cause a change in the stenosis and surrounding artery from a relatively solid state into a softer and more moldable state and thereafter increasing the inflation of the balloon so that outward expansion occurs within the stenosis and artery in said softer and more moldable state to thus reduce the tendency to fracture during expansion,reducing the temperature of the stenosis and surrounding artery while maintaining the expansion by balloon inflation for a clinically appropriate time period and to a temperature level sufficient to re-establish the relatively solid state thereof so as to increase the tendency to maintain the stenosis and artery in the expanded condition; and
then deflating the balloon and thereafter withdrawing the catheter.
1 Assignment
0 Petitions
Accused Products
Abstract
A method for remodeling a body lumen, such as a coronary artery, having a stenosis to expand the stenosis comprising the steps of increasing the temperature of the body lumen and stenosis at the region of the stenosis for a time period and to a temperature level sufficient to cause a change in the stenosis and body lumen region from a relatively solid state into a softer and more moldable state and thereafter expanding the stenosis and the body lumen region while in the softer and more moldable state to thus reduce the tendency to fracture during expansion, and reducing the temperature of the stenosis and body lumen region while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state thereof so as to increase the tendency to maintain the stenosis and body lumen region in the expanded condition. An improved heat applying balloon catheter is provided including passages for displacing the heated balloon inflating liquid with a cooling liquid to carry out the method.
-
Citations
20 Claims
-
1. A method for carrying out balloon catheter angioplasty within a coronary artery having a stenosis comprising the steps of:
-
positioning the balloon or the catheter within the stenosis of the artery, increasing the temperature of the stenosis and artery surrounding the balloon prior to the inflation of the balloon to an inflation extent sufficient to cause outward expansion for a clinically appropriate time period and to a temperature level sufficient to cause a change in the stenosis and surrounding artery from a relatively solid state into a softer and more moldable state and thereafter increasing the inflation of the balloon so that outward expansion occurs within the stenosis and artery in said softer and more moldable state to thus reduce the tendency to fracture during expansion, reducing the temperature of the stenosis and surrounding artery while maintaining the expansion by balloon inflation for a clinically appropriate time period and to a temperature level sufficient to re-establish the relatively solid state thereof so as to increase the tendency to maintain the stenosis and artery in the expanded condition; and then deflating the balloon and thereafter withdrawing the catheter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
-
-
10. A method for remodeling a body lumen having a stenosis, to expand the stenosis comprising the steps of:
-
increasing the temperature of the body lumen and stenosis at the region of the stenosis for a time period and to a temperature level sufficient to cause a change in the stenosis and body lumen region from a relatively solid state into a softer and more moldable state and thereafter expanding the stenosis and the body lumen region while in said softer and more moldable state to thus reduce the tendency to fracture during expansion, and reducing the temperature of the stenosis and body lumen region while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state thereof so as to increase the tendency to maintain the stenosis and body lumen region in the expanded condition. - View Dependent Claims (11, 12, 13)
-
-
14. An angioplasty apparatus for remodeling a body lumen having a stenosis to expand the stenosis comprising
a catheter comprising an elongated body of flexible material having a distal end portion, an expandable balloon having an interior surrounding said catheter at the distal end portion thereof, said catheter body having an inlet passage extending longitudinally therethrough from an inlet position therein to an outlet position at said distal end portion and an outlet passage extending longitudinally therethrough from an inlet portion at said distal end portions to an outlet position, said inlet passage having an outlet opening at said outlet position communicating with the interior of said balloon through which liquid under pressure in said inlet passage can enter the interior of said balloon, said outlet passage having an inlet opening at said inlet position communicating with the interior of said balloon through which liquid under pressure within said balloon can pass from the balloon into the outlet passage, heating means at the distal end portion of said catheter operable when connected with a source of electrical energy to heat liquid within the interior of said balloon, wire means extending within the flexible material of said catheter for selectively connecting a remote source of electrical energy with said heating means, and means operatively connected with the catheter at the inlet and outlet positions of said inlet and outlet passages for (1) introducing a balloon inflating and heating liquid within said inlet passage with an initial pressure sufficient to establish a liquid pressure within said balloon sufficient to inflate the same into contact with an area of stenosis within a body lumen region within which the distal end portion of said catheter is engaged while said wire means connects the electrical energy source to said heating means to operate the same to heat the liquid under pressure within the balloon to a predetermined temperature sufficient to conduct sufficient heat to the body lumen region to change the tissue in the arterial region and stenosis from a relatively solid state into a softer and more moldable state so that while therein an increase in the liquid pressure within the balloon increases the inflation of the balloon and expands the area of stenosis within the body lumen region within a first predetermined time (2) following the expiration of the first predetermined time displacing the balloon inflation and heating liquid within said inlet passage and the interior of said balloon outward through said outlet passage with a cooling liquid while maintaining an inflating pressure within the interior of said balloon for a second predetermined time sufficient to change the tissue in the body lumen region and stenosis into a relatively solid state to thereby enhance the formation of a smooth inner wall in the body lumen region and (3) following the expiration of the second predetermined time relieving the pressure of the liquid within the interior of the balloon sufficient to deflate the same for removal from the body lumen region.
-
20. Apparatus for remodeling a body lumen having a stenosis to expand the stenosis comprising:
-
a catheter, means connected with said catheter for (1) increasing the temperature of the body lumen and stenosis at the region of the stenosis for a time period and to a temperature level sufficient to cause a change in the stenosis and body lumen region from a relatively solid state into a softer and more moldable state and (2) thereafter expanding the stenosis and the body lumen region while in said softer and more moldable state to thus reduce the tendency to fracture during expansion, and means connected with said catheter for reducing the temperature of the stenosis and body lumen region while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state thereof so as to increase the tendency to maintain the stenosis and body lumen region in the expanded condition.
-
Specification