Combined hyperthermia and dilation catheter

An apparatus for treatment of conditions in which it is desired to simultaneously hyperthermally treat diseased tissue in a patient and dilate a lumen of a patient which is being compressed and obstructed by diseased target tissue and/or surrounding tissue, said apparatus comprising:

• (a) an outer catheter having a distal end, a proximal end having a plurality of ports therein, and a plurality of lumens situated through said outer catheter, said lumens including a lumen adapted for carrying heating means, inlet and outlet lumens respectively adapted for carrying a fluid into and out of at least one of an inflatable dilation balloon and an inflatable fixation balloon, said fluid being for the inflation of said balloons and alternatively also for acting as a coolant;
• and up to one or more separate lumens adapted for performing one or more of the functions of carrying temperature sensing means;
• circulating a coolant fluid through the outer catheter when said fluid for the inflation of said dilation and fixation balloons is not also a coolant;
• carrying catheter guiding means;
• and for drainage of fluid;
• such that there is a corresponding portion of said proximal end of said outer catheter which cooperates with each lumen in said outer catheter;
• (b) an inner catheter member, mounted in said outer catheter, and having a distal end, a proximal end, and a plurality of lumens therethrough;
• (c) heating means, axially mounted at said distal end of said inner catheter, and extending within one of said plurality of lumens in said inner catheter member provided therefor, said heating means being for applying energy to selected diseased target tissue to produce hyperthermal effects therein, thereby causing a therapeutic alteration of cells in said target tissue;
• (d) an inflatable dilation balloon mounted at the distal end of the outer catheter for accomplishing at least one of the functions of enlarging an obstructed lumen in the vicinity of said target tissue by compressing obstructive tissue, and restricting blood flow to at least one of said target tissue and to non-target tissue in the vicinity of said target tissue, in order to reduce the energy absorbing heat sink effect produced by blood-enriched tissue, thereby causing a more complete and more uniform absorption of energy by said target tissue;
• said dilation balloon having a preform diameter, and an oriented diameter greater than said preform diameter, such that the ratio of the oriented diameter to the preform diameter is from about 4.0 to about 7.0;
• said dilation balloon also having a preform length, such that the ratio of the oriented length to the preform length is from about 1.5 to about 3.0;
• said dilation balloon being fabricated from a material which imparts sufficient hoop strength and burst pressure to the balloon to enable it to perform its intended function, while being bio-compatible and having sufficient softness and pliability to prevent damage to non-target tissue with which it comes into contact;
• (e) an inflatable fixation balloon mounted within the distal end of said outer catheter adjacent to said dilation balloon, a distance along the length of said outer catheter in a direction toward the proximal end of said outer catheter;
• said fixation balloon having a preform diameter, and an oriented diameter greater than said preform diameter, such that the ratio of the oriented diameter to the preform diameter is from about 4.0 to about 7.0;
• said fixation balloon also having a preform length and an oriented length greater than said preform length, such that the ratio of the oriented length to the preform length is from about 1.5 to about 3.0;
• said fixation balloon being fabricated from a material which imparts sufficient hoop strength and burst pressure to the balloon to enable it to perform its intended function, while being bio-compatible and having sufficient softness and pliability to prevent damage to tissue with which it comes into contact;
• (f) temperature sensing means disposed in a manner selected from the group consisting of:
• being carried in a lumen in said outer catheter;
• and
• mounted on said dilation balloon, said temperature sensing means further including a temperature signal transmitting lead attached at one end thereof to said temperature sensing means, and at an opposite end thereof to means for indicating temperature readings measured by said temperature sensing means;
• and
• (g) at least one fluid for inflating said dilation balloon and said fixation balloon, said at least one fluid for inflating said dilation balloon and said fixation balloon being carried into said dilation balloon and said fixation balloon through at least one inlet lumen in said outer catheter and out of said dilation balloon and said fixation balloon through at least one outlet lumen in said outer catheter.

An apparatus for treatment of conditions in which it is desired to simultaneously hyperthermally treat diseased target tissue in a patient and dilate a lumen of a patient which is being compressed and obstructed by diseased target tissue and/or surrounding tissue, said apparatus having an overall proximal end and an overall distal end, with said apparatus comprising:

• (a) an outer catheter having a distal end, a proximal end having a plurality of ports therein, and a plurality of lumens situated through said outer catheter, said lumens including a lumen adapted for carrying heating means, lumens adapted for carrying a fluid into and out of at least one of an inflatable dilation balloon and an inflatable fixation balloon, said fluid being for the inflation of said balloons and alternatively also for acting as a coolant;
• and up to one or more separate lumens adapted for performing one or more of the functions of carrying temperature sensing means;
• circulating a coolant fluid through the outer catheter when said fluid for the inflation of said dilation and fixation balloons is not also a coolant;
• carrying catheter guiding means;
• and for drainage of fluid;
• such that there is a corresponding port in said proximal end of said outer catheter which cooperates with each lumen in said outer catheter, and further such that said outer catheter is fabricated in a plurality of interconnectable subsections, including at least a first subsection and a last subsection, and up to a plurality of intermediate subsections, with each subsection having a proximal end and a distal end, such that said proximal end of said first subsection is situated at said overall proximal end of said apparatus, said distal end of said last subsection is situated at said overall distal end of said apparatus;
• and said proximal end of any of said plurality of intermediate subsections is in communication with said distal end of another one of said subsections to which it is immediately adjoining, beginning with said distal end of said first subsection;
• and said distal end of any of said plurality of intermediate subsections is in communication with said proximal end of another one of said subsections to which it is immediately adjoining, ending with said proximal end of said last subsection;
• and further such that when there are no intermediate subsections, said distal end of said first subsection is in communication with said proximal end of said last subsection;
• with said subsections being configured such that while the internal path of lumens through any subsection may be the same as or different from the internal path of lumens through other subsections with which it is in communication, each said subsection is fabricated to have a configuration of lumens at its said proximal end and its said distal end which is identical to the configuration of lumens at the proximal end and the distal end of each other subsection, so that each subsection is interchangeable with and interconnectable to one another;
• (b) heating means, axially mounted within the distal end of the outer catheter in the lumen provided therefor, for applying energy to selected diseased target tissue to produce hyperthermal effects therein, thereby causing a therapeutic alteration of cells in said target tissue;
• (c) an inflatable dilation balloon mounted at the distal end of the outer catheter for accomplishing at least one of the functions of enlarging an obstructed lumen in the vicinity of said target tissue by compressing obstructive tissue, and restricting blood flow to at least one of said target tissue and to non-target tissue in the vicinity of said target tissue, in order to reduce the energy absorbing heat sink effect produced by blood-enriched tissue, thereby causing a more complete and more uniform absorption of energy by said target tissue;
• said dilation balloon having a preform diameter, and an oriented diameter greater than said preform diameter, such that the ratio of the oriented diameter to the preform diameter is from about 4.0 to about 7.0;
• said dilation balloon also having a preform length and an oriented length greater than said preform length, such that the ratio of the oriented length to the preform length is from about 1.5 to about 3.0;
• said dilation balloon being fabricated from a material which imparts sufficient hoop strength and burst pressure to the balloon to enable it to perform its intended function, while being bio-compatible and having sufficient softness and pliability to prevent damage to non-target tissue with which it comes into contact;
• (d) an inflatable fixation balloon mounted within the distal end of said outer catheter adjacent to said dilation balloon, a distance along the length of said outer catheter in a direction toward the proximal end of said outer catheter;
• said fixation balloon having a preform diameter, and an oriented diameter greater than said preform diameter, such that the ratio of the oriented diameter to the preform diameter is from about 4.0 to about 7.0;
• said fixation balloon also having a preform length and an oriented length greater than said preform length, such that the ratio of the oriented length to the preform length is from about 1.5 to about 3.0;
• said fixation balloon being fabricated from a material which imparts sufficient hoop strength and burst pressure to the balloon to enable it to perform its intended function, while being bio-compatible and having sufficient softness and pliability to prevent damage to tissue with which it comes into contact;
• (e) temperature sensing means disposed in a manner selected from the group consisting of:
• being carried in a lumen in said outer catheter;
• and mounted on said dilation balloon
• said temperature sensing means further including a temperature signal transmitting lead attached at one end thereof to said temperature sensing means, and at an opposite and thereof to means for indicating temperature readings measured by said temperature sensing means;
• and
• (f) at least one fluid for inflating said dilation balloon and said fixation balloon, said at least one fluid for inflating said dilation balloon and said fixation balloon being carried into said dilation balloon and said fixation balloon through at least one inlet lumen in said outer catheter and out of said dilation balloon and said fixation balloon through at least one outlet lumen in said outer catheter, such that said at least one inlet lumen of said outer catheter and said at least one outlet lumen of said outer catheter each constitute at least one of said plurality of lumens situated through said outer catheter.