Brachytherapy devices and methods for therapeutic radiation procedures

Abstract

Radiation therapy or brachytherapy devices, systems and methods are in general catheter form and include at least one balloon that assists in placement of radio therapeutic members at desired treatment locations within an existing body cavity or at a site that was formed under a patient's skin for treatment purposes. One or more detectors, such as microdiodes, are present on the device, and a hyperthermia tube or the like is also included that delivers hyperthermia treatment for the target treatment site or sites. Data collected by the detector allows the medical professional to monitor radiation treatment and, when desired, interaction between hyperthermia treatment and radiation delivery by the radiation treatment member.

1 . A therapeutic catheter, comprising:
 a catheter body that is configured to not deform under pressure encountered during passage from an insertion location to a target location within a radiation treatment subject for radiation therapy at the target location, the catheter body having an outside surface;   one or more radio therapeutic sources having prescribed radioactivity, wherein the radio therapeutic source is a liquid source of radiation;   a therapeutic balloon associated with the catheter body, said therapeutic balloon having a proximal end portion and a distal end portion, said therapeutic balloon being configured to receive one or more of the radio therapeutic sources, said therapeutic balloon and catheter body configured to have sufficient axial strength and radial extendibility to position the radio therapeutic member for radiation therapy when the balloon is inflated;   an inflation tube which permits inflation and deflation of said therapeutic balloon while the therapeutic catheter is within a radiation treatment subject;   at least one detector that collects data on radiation at a treatment location of the therapeutic catheter;   a hyperthermia component that delivers hyperthermia treatment that interacts with radiation delivery by the radiation treatment member; and   the data collected by the detector is processed for monitoring interaction between the radiation treatment member and the hyperthermia component.   
     
     
         2 . The therapeutic catheter in accordance with  claim 1 , wherein said detector is on the therapeutic balloon. 
     
     
         3 . The therapeutic catheter in accordance with  claim 2 , wherein said detector is secured to the therapeutic balloon. 
     
     
         4 . The therapeutic catheter in accordance with  claim 1 , further including a securement member affixed to the catheter, and the securement member secures the therapeutic catheter to the radiation treatment subject. 
     
     
         5 . The therapeutic catheter in accordance with  claim 4 , wherein the securement member is a template positioned near said proximal end portion of the therapeutic balloon, said template having a plurality of holes therethrough, said catheter body being located through one of said holes in the template, another of said holes of said template receiving and thereby directing at least one said radio therapeutic member into the receiving member of the therapeutic balloon. 
     
     
         6 . The therapeutic catheter in accordance with  claim 5 , further including suture holes in said template to suture the therapeutic catheter to tissue surrounding the insertion location which is an orifice of an existing body cavity of the radiation treatment subject and into which the therapeutic catheter is inserted to provide securement. 
     
     
         7 . The therapeutic catheter in accordance with  claim 5 , wherein said securement member includes at least one anchoring catheter for insertion into a body orifice near the insertion location, said anchoring catheter having an inflatable anchoring balloon. 
     
     
         8 . The therapeutic catheter in accordance with  claim 1 , wherein the catheter body and the therapeutic balloon include respective distal ends, and said distal end of the catheter body extends distally of said distal end of the therapeutic balloon, further including a passageway longitudinally through the catheter body from its said distal end to its proximal end, said passageway being large enough to accommodate excrement or other body fluid flow therethrough during a radiation therapy procedure. 
     
     
         9 . The therapeutic catheter in accordance with  claim 1 , wherein the therapeutic balloon is secured to a portion of the outside surface of the catheter body, and a receiving member secures at least one of the radio therapeutic sources to the therapeutic balloon. 
     
     
         10 . The therapeutic catheter in accordance with  claim 1 , wherein said therapeutic balloon provides manipulation of the target location within the radiation treatment subject by expansive engagement between the therapeutic balloon and the target location upon inflation of the therapeutic balloon. 
     
     
         11 . The therapeutic catheter in accordance with  claim 1 , wherein the liquid source of radiation is present within the therapeutic balloon. 
     
     
         12 . A therapeutic catheter, comprising:
 a catheter body that is sized, shaped and adapted to not deform under pressure encountered during passage from an insertion location to a target location within a radiation treatment subject for radiation therapy at the target location, the catheter body having an outside surface;   a therapeutic balloon associated with the catheter body, said therapeutic balloon having a collapsed condition and an expanded condition;   a fluid or solution of radio therapeutic material having prescribed radioactivity within the interior of said therapeutic balloon, which radio therapeutic material moves generally to the target location for radiation therapy with the balloon;   at least one detector that collects data on radiation at a treatment location of the therapeutic catheter;   a hyperthermia component that delivers hyperthermia treatment that interacts with radiation delivery by the radiation treatment member; and   the data collected by the detector is processed for monitoring interaction between the radiation treatment member and the hyperthermia component.   
     
     
         13 . The therapeutic catheter in accordance with  claim 12 , wherein the hyperthermia component is of the energy type selected from the group consisting of thermal, microwave, ultrasonic, radiant and combinations thereof, which energy is applied without or with radiation, and whether simultaneously, pre-irradiation or post-irradiation. 
     
     
         14 . A bifurcated therapeutic radiation catheter, comprising:
 a therapeutic catheter body that is sufficiently axially rigid to permit insertion through long, narrow body cavities, said catheter body having a proximal end portion and a distal end portion;   a therapeutic balloon secured to the proximal end portion of the catheter body, said therapeutic balloon is bifurcated into two sections, each section having a separate distal end portion, each section being configured such that when inflated each said section engages internal tissue of a hypopharynx, nasopharynx, superglottic or subglottic region and such that one said section enters one pyriform fossa and another said section enters another said pyriform fossa;   a passageway that extends from the proximal end portion of the catheter body to the bifurcated balloon, said passageway communicating with each said section of the therapeutic balloon to inflate or deflate each section of said therapeutic balloon;   each said bifurcated balloon section includes at least one radio therapeutic member that moves with the respective balloon section when the respective balloon section expands into engagement with said internal tissue;   at least one detector that collects data on radiation at a treatment location of the therapeutic catheter;   a hyperthermia component that delivers hyperthermia treatment that interacts with radiation delivery by the radiation treatment member; and   the data collected by the detector is processed for monitoring interaction between the radiation treatment member and the hyperthermia component.   
     
     
         15 . The bifurcated therapeutic catheter in accordance with  claim 14 , wherein said therapeutic catheter includes an anchoring balloon at said distal end portion of the catheter body. 
     
     
         16 . The bifurcated therapeutic catheter in accordance with  claim 14 , wherein at least one said passageway is provided for each of the bifurcated sections and is configured to inflate or deflate each bifurcated section independently. 
     
     
         17 . A therapeutic radiation treatment procedure comprising:
 selecting a therapeutic catheter including a catheter body, a therapeutic balloon secured to the catheter body, a passageway which permits passage of inflation fluid into and out from said balloon, a detector generally at a treatment location, and a hyperthermia component that delivers hyperthermia treatment;   inserting the therapeutic catheter through an insertion location of a living patient until a desired length of the therapeutic balloon is inserted into the body cavity to provide a desired catheter penetration depth to a target location;   loading, before, during or after said inserting, at least one radio therapeutic source into place in engagement with the therapeutic balloon, said radio therapeutic source containing a prescribed radioactivity;   inflating the therapeutic balloon thus inserted until the therapeutic balloon engages internal tissue of the body cavity and thereby moving said radio therapeutic member into position for radiation treatment;   delivering hyperthermia treatment to the treatment location; and   collecting data from the detector, the data including radiation level and location and effects of the hyperthermia treatment.   
     
     
         18 . The therapeutic procedure in accordance with  claim 17 , further including securing the catheter to a portion of the patient after said inserting step has commenced. 
     
     
         19 . The therapeutic procedure in accordance with  claim 17 , wherein said selecting includes selecting a therapeutic catheter having an anchoring balloon, and wherein said securing includes positioning the anchoring balloon within a body opening and thereafter inflating the anchoring balloon and securing the anchoring balloon within this body opening. 
     
     
         20 . The therapeutic procedure in accordance with  claim 17 , further including passing fluids between the body cavity and a location exterior of the therapeutic catheter, said passing being through the catheter body. 
     
     
         21 . The therapeutic procedure in accordance with  claim 17 , further including delivering companion treatment regimens to the treatment location, the regimens being selected from the group consisting of chemotherapy fluids, chemotherapy microspheres, analgesic fluids, analgesic microspheres and combinations thereof. 
     
     
         22 . The therapeutic procedure in accordance with  claim 17 , wherein said selecting includes selecting a therapeutic catheter that is bifurcated into sections, and inserting each bifurcated section into a separate location of the living patient.