Intravascular radiotherapy employing a liquid-suspended source

Claim 1

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said target area comprising a wall of the blood vessel, said elongate member further including a longitudinal hole therethrough defining a fluid passage; fluid expansible means connected to said elongate member in fluid communication with said passage for containing a fluid having a radioactive material therein; and means for introducing said fluid into said fluid passage to expand the fluid expansible means toward said wall, the radioactive material in said fluid being substantially uniformly dispersed in said fluid expansible means such that the wall of the blood vessel is substantially uniformly exposed to radiation from said radioactive material for a given treatment time.

Claim 2

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said target area comprising a wall of the blood vessel, said elongate member further including a longitudinal hole therethrough defining a fluid passage; fluid expansible means connected to said elongate member in fluid communication with said passage for containing a fluid having a radioactive material therein; and means for introducing said fluid into said fluid passage to expand the fluid expansible means toward said wall, the radioactive material in said fluid being substantially uniformly dispersed in said fluid expansible means such that the wall of the blood vessel is substantially uniformly exposed to radiation from said radioactive material for a given treatment time.

Claim 10

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising an inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; and means for detecting pressure in said treatment balloon inflation lumen.

Claim 11

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising an inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; and means for detecting pressure in said treatment balloon inflation lumen.

Claim 12

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising a first inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; and a containment balloon, said containment balloon comprising a second inflatable balloon having an interior chamber, said containment balloon being sealed to the distal end of said elongate member with said interior chamber of said containment balloon surrounding said treatment balloon.

Claim 13

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising a first inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; and a containment balloon, said containment balloon comprising a second inflatable balloon having an interior chamber, said containment balloon being sealed to the distal end of said elongate member with said interior chamber of said containment balloon surrounding said treatment balloon.

Claim 16

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising an inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; and an inert expansion balloon, said inert expansion balloon comprising an expandable balloon having an interior chamber, said inert expansion balloon being sealed to the distal end of said elongate member and contained within the interior chamber of said treatment balloon.

Claim 17

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising an inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; and an inert expansion balloon, said inert expansion balloon comprising an expandable balloon having an interior chamber, said inert expansion balloon being sealed to the distal end of said elongate member and contained within the interior chamber of said treatment balloon.

Claim 19

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising; a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising an inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; first and second blocking balloons, each balloon having an interior chamber, said first blocking balloon being sealed to the distal end of said elongate member distal of said treatment balloon, said second blocking balloon being sealed to the distal end of said elongate member proximal of said treatment balloon, said elongate member further including a blocking balloon inflation lumen, said blocking balloon inflation lumen comprising a longitudinal hole through said elongate member, the interior chambers of said first and second blocking balloons being in fluid communication with said blocking balloon inflation lumen; and means for introducing a liquid into said blocking balloon inflation lumen to fill the interior chambers of said first and second blocking balloons.

Claim 20

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising; a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a treatment balloon, said treatment balloon comprising an inflatable balloon having an interior chamber, said treatment balloon being sealed to the distal end of said elongate member with the interior chamber of said treatment balloon in fluid communication with said treatment balloon inflation lumen; means for introducing a fluid containing a radioactive material into said treatment balloon inflation lumen to fill the interior chamber of said treatment balloon for exposure of said target area to said radioactive material for a predetermined period of time; first and second blocking balloons, each balloon having an interior chamber, said first blocking balloon being sealed to the distal end of said elongate member distal of said treatment balloon, said second blocking balloon being sealed to the distal end of said elongate member proximal of said treatment balloon, said elongate member further including a blocking balloon inflation lumen, said blocking balloon inflation lumen comprising a longitudinal hole through said elongate member, the interior chambers of said first and second blocking balloons being in fluid communication with said blocking balloon inflation lumen; and means for introducing a liquid into said blocking balloon inflation lumen to fill the interior chambers of said first and second blocking balloons.

Claim 21

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end and an outer surface, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a sleeve-shaped treatment balloon, said sleeve-shaped balloon comprising an expandable, substantially cylindrical hollow sleeve having a substantially cylindrical inner wall and a substantially cylindrical outer wall defining a chamber therebetween, the inner wall of said sleeve-shaped balloon being attached to the outer surface of the distal end of said elongate member along a longitudinal line of contact with the chamber in fluid communication with said treatment balloon inflation lumen, at least a portion of said inner wall overlapping said outer wall in an unexpanded condition of said balloon; means for expanding said sleeve against an interior wall of said blood vessel; and means for introducing a fluid containing a radioactive material into said inflation lumen to fill the chamber of said sleeve for substantially uniform exposure of said target area to said radioactive material for a predetermined period of time.

Claim 22

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end and an outer surface, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said elongate member further including a longitudinal hole therethrough defining a treatment balloon inflation lumen; a sleeve-shaped treatment balloon, said sleeve-shaped balloon comprising an expandable, substantially cylindrical hollow sleeve having a substantially cylindrical inner wall and a substantially cylindrical outer wall defining a chamber therebetween, the inner wall of said sleeve-shaped balloon being attached to the outer surface of the distal end of said elongate member along a longitudinal line of contact with the chamber in fluid communication with said treatment balloon inflation lumen, at least a portion of said inner wall overlapping said outer wall in an unexpanded condition of said balloon; means for expanding said sleeve against an interior wall of said blood vessel; and means for introducing a fluid containing a radioactive material into said inflation lumen to fill the chamber of said sleeve for substantially uniform exposure of said target area to said radioactive material for a predetermined period of time.

Claim 23

A method of preventing stenosis and restenosis of a selected portion of a blood vessel in a patient comprising: selecting a catheter comprising an elongate member having a proximal and a distal end, and including a treatment balloon, said treatment balloon comprising an inflatable balloon attached to the distal end of said catheter, said catheter being sized and of sufficient flexibility for introduction into the selected portion of the blood vessel; advancing the catheter along a cardiovascular lumen or the patient until said treatment balloon is disposed in the selected portion of the blood vessel adjacent a wall of said blood vessel; inflating said treatment balloon with a liquid containing radioactive material; maintaining said treatment balloon inflated with said liquid, the radioactive material in said liquid being substantially uniformly dispersed in said treatment balloon such that the wall of the blood vessel is substantially uniformly exposed to radiation from said radioactive material for a predetermined period of time; withdrawing the liquid from said treatment balloon to allow said treatment balloon to collapse; and withdrawing said catheter from the patient.

Claim 24

A method of preventing stenosis and restenosis of a selected portion of a blood vessel in a patient comprising: selecting a catheter comprising an elongate member having a proximal and a distal end, and including a treatment balloon, said treatment balloon comprising an inflatable balloon attached to the distal end of said catheter, said catheter being sized and of sufficient flexibility for introduction into the selected portion of the blood vessel; advancing the catheter along a cardiovascular lumen or the patient until said treatment balloon is disposed in the selected portion of the blood vessel adjacent a wall of said blood vessel; inflating said treatment balloon with a liquid containing radioactive material; maintaining said treatment balloon inflated with said liquid, the radioactive material in said liquid being substantially uniformly dispersed in said treatment balloon such that the wall of the blood vessel is substantially uniformly exposed to radiation from said radioactive material for a predetermined period of time; withdrawing the liquid from said treatment balloon to allow said treatment balloon to collapse; and withdrawing said catheter from the patient.

Claim 26

A method of preventing stenosis and restenosis of a selected portion of a blood vessel in a patient comprising: selecting a catheter comprising an elongate member having a proximal and a distal end, and including a treatment balloon, said treatment balloon comprising an inflatable balloon attached to the distal end of said catheter, said catheter further including a containment balloon disposed about said treatment balloon, said catheter being sized and of sufficient flexibility for introduction into the selected portion of the blood vessel; advancing the catheter along a cardiovascular lumen of the patient until said treatment and containment balloons are disposed in the selected portion of the blood vessel; inflating said containment balloon with a radio-opaque contrast medium to verify integrity of said containment balloon prior to inflating said treatment balloon; inflating said treatment balloon with a liquid containing radioactive material; maintaining said treatment balloon inflated with said liquid for a predetermined period of time; withdrawing the liquid from said treatment balloon to allow said treatment balloon to collapse; and withdrawing said catheter from the patient.

Claim 27

A method of preventing stenosis and restenosis of a selected portion of a blood vessel in a patient comprising: selecting a catheter comprising an elongate member having a proximal and a distal end, and including a treatment balloon, said treatment balloon comprising an inflatable balloon attached to the distal end of said catheter, said catheter further including a containment balloon disposed about said treatment balloon, said catheter being sized and of sufficient flexibility for introduction into the selected portion of the blood vessel; advancing the catheter along a cardiovascular lumen of the patient until said treatment and containment balloons are disposed in the selected portion of the blood vessel; inflating said containment balloon with a radio-opaque contrast medium to verify integrity of said containment balloon prior to inflating said treatment balloon; inflating said treatment balloon with a liquid containing radioactive material; maintaining said treatment balloon inflated with said liquid for a predetermined period of time; withdrawing the liquid from said treatment balloon to allow said treatment balloon to collapse; and withdrawing said catheter from the patient.

Claim 29

An apparatus for localized radiotherapy of a body lumen, such as a coronary artery, comprising: an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility to be introducible into a patient's body through a body lumen until the distal end is disposed at a target area within the body lumen, said elongate member further including a longitudinal passage therethrough; a fluid expansible means connected to said elongate member in fluid communication with said passage for containing a fluid having a radioactive material therein; and means for introducing said fluid into said passage to expand said fluid expansible means toward an interior wall of said body lumen, the radioactive material in said fluid being substantially uniformly dispersed in said fluid expansible means such that the wall of the lumen is substantially uniformly exposed to radiation for a predetermined period of time.

Claim 30

An apparatus for localized radiotherapy of a body lumen, such as a coronary artery, comprising: an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility to be introducible into a patient's body through a body lumen until the distal end is disposed at a target area within the body lumen, said elongate member further including a longitudinal passage therethrough; a fluid expansible means connected to said elongate member in fluid communication with said passage for containing a fluid having a radioactive material therein; and means for introducing said fluid into said passage to expand said fluid expansible means toward an interior wall of said body lumen, the radioactive material in said fluid being substantially uniformly dispersed in said fluid expansible means such that the wall of the lumen is substantially uniformly exposed to radiation for a predetermined period of time.

Claim 32

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said target area comprising a wall of the blood vessel, said elongate member further including a longitudinal hole therethrough defining a fluid passage; an inflatable balloon connected to said elongate member and having an interior chamber in fluid communication with said fluid passage; injector means connected to said elongate member for introducing a fluid through said fluid passage and into the interior chamber of the balloon under pressure; and a fluid in said interior chamber under pressure from said injector means so as to expand said balloon toward the wall of the blood vessel, a radioactive material substantially uniformly dispersed in said fluid such that the wall of the blood vessel is substantially uniformly exposed to radiation from said radioactive material for a given treatment time.

Claim 33

An apparatus for localized intravascular radiotherapy of a blood vessel, such as a coronary artery, comprising: a catheter, said catheter comprising an elongate member having a proximal and a distal end, said elongate member being sized and of sufficient flexibility for introduction into a patient's body through a cardiovascular lumen until the distal end is disposed at a target area within the blood vessel, said target area comprising a wall of the blood vessel, said elongate member further including a longitudinal hole therethrough defining a fluid passage; an inflatable balloon connected to said elongate member and having an interior chamber in fluid communication with said fluid passage; injector means connected to said elongate member for introducing a fluid through said fluid passage and into the interior chamber of the balloon under pressure; and a fluid in said interior chamber under pressure from said injector means so as to expand said balloon toward the wall of the blood vessel, a radioactive material substantially uniformly dispersed in said fluid such that the wall of the blood vessel is substantially uniformly exposed to radiation from said radioactive material for a given treatment time.

Claim 34

A method of localized radiotherapy of a selected portion of a body lumen in a patient comprising: providing an elongate member having a proximal and a distal end, and a fluid expansible means attached to the distal end of said elongate member, said elongate member being sized and of sufficient flexibility for introduction into the selected portion of the body lumen; advancing the elongate member along the body lumen of the patient until said fluid expansible means is disposed in the selected portion of the body lumen adjacent a wall thereof; expanding the fluid expansible means with a fluid containing a radioactive material such that the radioactive material is substantially uniformly dispersed in the fluid expansible means; maintaining said fluid in a non-ionizing environment in said fluid expansible means for a predetermined treatment time; withdrawing said fluid from said fluid expansible means to allow said fluid expansible means to contract; and withdrawing said elongate member from the patient.

Claim 35

A method of localized radiotherapy of a selected portion of a body lumen in a patient comprising: providing an elongate member having a proximal and a distal end, and a fluid expansible means attached to the distal end of said elongate member, said elongate member being sized and of sufficient flexibility for introduction into the selected portion of the body lumen; advancing the elongate member along the body lumen of the patient until said fluid expansible means is disposed in the selected portion of the body lumen adjacent a wall thereof; expanding the fluid expansible means with a fluid containing a radioactive material such that the radioactive material is substantially uniformly dispersed in the fluid expansible means; maintaining said fluid in a non-ionizing environment in said fluid expansible means for a predetermined treatment time; withdrawing said fluid from said fluid expansible means to allow said fluid expansible means to contract; and withdrawing said elongate member from the patient.