WO2007145965A2

WO2007145965A2 - Method and apparatus for delivering targeted therapy to a patient

Info

Publication number: WO2007145965A2
Application number: PCT/US2007/013268
Authority: WO
Inventors: Anurag K. Singh
Original assignee: The Government Of The United States Of America, Represented By The Secretary, Department Of Health And Human Services
Priority date: 2006-06-08
Filing date: 2007-06-06
Publication date: 2007-12-21
Also published as: WO2007145965A3

Abstract

An applicator for delivering targeted radiation brachytherapy to a portion of tissue defining a cavity of a patient. The applicator includes a balloon adapted for introduction to the cavity of the patient, wherein the balloon has a deflated state in which the balloon is adapted for insertion into the cavity and an inflated state in which the balloon is enlarged for at least partially filling the cavity of the patient. The balloon moves from the deflated state to the inflated state upon introduction of pressurized fluid to an interior of the balloon. The applicator also includes a conduit in fluid communication with the interior of the balloon for introducing pressurized fluid to the interior of the balloon to move the balloon from the deflated state to the inflated state, and a catheter extending over at least a portion of the balloon for delivering treatment from at least one treatment source to the tissue adjacent the cavity. A movable steering device is also provided to move the balloon with respect to the portion of tissue to be subjected to therapeutic treatment. The radiation source may be a plurality of radiation sources located in a localized area on the balloon.

Description

METHOD AND APPARATUS FOR DELIVERING TARGETED THERAPY TO A

PATIENT

[0001] This application claims the benefit of U.S. Provisional Patent Application No.

60/811,762, filed June 8, 2006, which is herein incorporated by reference.

BACKGROUND OF THE INVENTION

[0002] The present invention relates generally to delivering targeted therapy to a patient, and more specifically to delivering targeted radiation therapy to tissue adjacent a cavity of the patient.

[0003] In radiation brachytherapy, catheters are placed in close proximity to the tissue targeted for radiation. Currently, such proximity is achieved by free-hand placement of brachytherapy catheters over a needle. However, such free-hand placement is challenging and can vary greatly between operators, making it difficult to consistently achieve accurate placement of the catheter. Moreover, a variety of organs are inaccessible for free-hand placement of brachytherapy catheters and therefore are not routinely treated with brachytherapy. Single balloon catheters have been used for brachytherapy to treat breast cancer using a radiation source positioned within the center of the balloon. However, controlling the distribution of radiation to the target tissue as well as achieving a quick fall- off of dose to the non-target tissue can be difficult because of the single dwell position of the radiation source and because of the distance between the source and the target tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus are not limitative of the present invention and wherein:

[0005] FIG. 1 is a perspective view of an applicator of the present invention including a balloon shown in a deflated state; [0006] FIG. 2 is a partially cut-away perspective view of the applicator of FIG. 1 showing the balloon in an inflated state;

[0007] FIG. 3 is a partially cut-away perspective view of a cavity of a patient and an applicator system of the present invention for delivering targeted radiation brachytherapy to tissue adjacent the cavity;

[0008] FIG. 4 is a partially cut-away perspective view of a cavity of a patient and an applicator system of the present invention for delivering targeted thermal therapy to tissue adjacent the cavity,

[0009] FIG. 5 is a partially cut-away perspective view of a cavity of a patient and an applicator system of the present invention for facilitating the delivery of external beam radiation to tissue adjacent the cavity; and

[0010] FIG. 6 is a perspective view of an alternative embodiment of the applicator of the present invention.

[0011] FIG. 7 is a perspective view of another alternative embodiment of the applicator of the present invention.

[0012] FIG. 8 is an end view of a balloon of the applicator of FIG. 7.

[0013] FIG. 9 is a side view of a steering mechanism for the applicator of FIG. 7.

[0014] FIGS. 1OA and 1OB schematically show comparative radiation profiles depending on the size of the localized area encompassed by circle 35 shown in FIG. 8. FIG. 1OA is the profile obtained by a circle 35 having a smaller diameter than in FIG. 1OB.

[0015] Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

[0016] In one aspect, the present invention includes an applicator for delivering therapeutic treatment to a portion of tissue defining a cavity of a patient. The applicator includes a balloon adapted for introduction into the cavity of the patient, the balloon having a deflated state in which the balloon is adapted for insertion into the cavity and an inflated state in which the balloon is enlarged for at least partially filling the cavity of the patient. The applicator also includes at least one treatment source carried by the balloon for delivering treatment to the portion of tissue defining the cavity and a movable viewing device adapted for introduction into the cavity of the patient. The viewing device can be coupled to the balloon so that movement of the viewing device effects movement of the balloon, to thereby enable maneuvering of the balloon and the treatment source with respect to the portion of tissue defining the cavity.

[0017] In another aspect, a method is provided for delivering therapeutic treatment to a portion of tissue defining a cavity of a patient. The method includes introducing into the cavity (1) a deflated balloon carrying at least one treatment source and (2) a movable viewing device coupled to the balloon whereby movement of the viewing device effects movement of the balloon, to thereby enable maneuvering of the balloon and the treatment source within the cavity. The method further includes inflating the balloon within the cavity and moving the viewing device to maneuver the balloon and the treatment source with respect to the portion of the tissue to be subjected to therapeutic treatment.

[0018] In yet another aspect, the present invention is directed to delivering therapeutic treatment to a portion of tissue defining a cavity of a patient. The applicator includes a balloon adapted for introduction into the cavity of the patient, the balloon having a deflated state in which the balloon is adapted for insertion into the cavity and an inflated state in which the balloon is enlarged for at least partially filling the cavity of the patient. In addition, the applicator includes a plurality of treatment sources carried by the balloon for delivering treatment to the portion of tissue defining the cavity, the plurality of treatment sources being located in a localized area of the balloon.

[0019] In still another aspect, another method of delivering therapeutic treatment to a portion of tissue defining a cavity of a patient is provided. The method includes introducing into the cavity a deflated balloon carrying a plurality of treatment sources for delivering treatment to the portion of tissue defining the cavity, the plurality of treatment sources being located in a localized area of the balloon. The method further includes inflating the balloon within the cavity and delivering an effective dosage to the portion of tissue defining the cavity.

[0020] In another aspect, the present invention is directed to an applicator for delivering therapeutic treatment to a portion of tissue defining a cavity of a patient. The applicator includes a first balloon adapted for introduction into the cavity of the patient, the balloon having a deflated state in which the first balloon is adapted for insertion into the cavity and an inflated state in which the first balloon is enlarged for at least partially filling the cavity of the patient. The applicator also includes a second balloon located within the first balloon. The second balloon is adapted for introduction to the cavity of the patient simultaneous with the first balloon. The second balloon has a deflated state in which the second balloon is adapted for insertion into the cavity and an inflated state in which the second balloon is enlarged for at least partially filling the cavity of the patient. At least one treatment source is carried by the second balloon for delivering treatment to tissue adjacent the cavity. In addition, the applicator includes a movable steering device adapted for introduction into the cavity of the patient. The steering device is coupled to the second balloon so that movement of the steering device effects movement of the second balloon, to thereby enable maneuvering of the second balloon and the treatment source with respect to the portion of tissue defining the cavity.

[0021] Other features of the present invention will be in part apparent and in part pointed out hereinafter.

[0022] It should be understood that any one embodiment of the invention might not exhibit all aspects and provide all advantages of the invention.

[0023] Further scope of applicability of the present application will become more apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from the detailed description. [0024] Referring now to the drawings, and more specifically to FIGS. 1 and 2, an applicator is designated in its entirety by the reference numeral 20. The applicator 20 includes a catheter 22 and a body (generally designated by 24) having a first end (generally designated by 26), a second end (generally designated by 28), a conduit 30 extending between the first end and the second end, and a balloon (generally designated by 32).

[0025] The balloon 32 is adapted for introduction to a cavity (designated by 62 in

FIG. 3) of a patient, such as a patient's bladder, esophagus, and/or rectum. More specifically, the balloon 32 has a deflated state (FIG. 1) in which the balloon and the first end 26 of the body 24 are adapted for insertion into the cavity through an entrance to the cavity. Additionally, at least a portion of the conduit 30 may also be adapted for insertion through the entrance and into the cavity. The first end 26 of the body 24, the balloon 32 in its deflated state, and where applicable all or a portion of the conduit 30, are sized and shaped appropriately for insertion into the particular cavity (e.g., bladder) through its entrance. The entrance is preferably natural (e.g., the urethra to the bladder), but may be surgically created. The balloon 32 also has an inflated state (FIG. 2) in which the balloon is enlarged for at least partially filling the cavity. The conduit 30 is in fluid communication with an interior 34 of the balloon 32 for introducing pressurized fluid to the interior of the balloon to move (inflate) the balloon 32 from the deflated state to the inflated state. Pressurized fluid is introduced into the conduit 30 through an opening (generally designated by 36) within the body 24 in fluid communication with the conduit. Although any suitable fluid (e.g., saline) may be introduced into the conduit 30 and the interior 34 of the balloon to move the balloon from the deflated state to the inflated state without departing from the scope of the present invention, in one embodiment air is used to move the balloon from the deflated state to the inflated state.

[0026] As illustrated in FIGS. 1 and 2, the balloon 32 defines the first end 26 of the body 24. However, the balloon 32 may be suitably positioned anywhere along the body 24 such that the balloon is adapted for insertion into the cavity and for movement (inflation) to the inflated state once received within the cavity. Additionally, in the inflated state the balloon 32 may be suitably shaped for the particular cavity. For example, the balloon 32 may be generally spherical in the inflated state when the balloon is intended to at least partially fill a patient's bladder, or may be generally cylindrical in the inflated state when the balloon is intended to at least partially fill a patient's rectum or esophagus. The particular size (e.g., radius) of the balloon 32 in the inflated state may also vary depending upon the particular cavity in which it is intended to be used. Additionally, the balloon 32 may be inflatable to a variety of sizes and/or shapes such that the inflated state of the balloon may comprise a plurality of states each having a different size and/or shape.

[0027J The body 24 may be formed from any suitable material(s), for example rubber and/or plastic. Although different sections of the body 24 may be formed from different materials, in one embodiment the entirety of the body is formed from one material. The portions of the body 24 adapted for introduction to the patient's cavity may be formed from any material suitable for use within the cavity, so that such portions do not damage tissue adjacent the cavity and/or injure/infect the patient. Additionally, in one embodiment at least a portion of the body 24 (e.g., at least a portion of the conduit 30 and/or the balloon 32) is formed from a transparent material to facilitate use of a viewing apparatus (70, FIG. 3) with the applicator 20, as is described in more detail below.

[0028] The catheter 22 extends over at least a portion of the balloon 32 and is adapted for movement with the balloon as the balloon is moved from the deflated state to the inflated state. Although the applicator 20 is described herein and illustrated in FIGS. 1, 2, and 6 as including only one catheter 22, it should be understood that the applicator 20 may include a plurality of catheters as is illustrated in FIGS. 3-5. The size of the entrance to the cavity may influence the maximum number of catheters included with the applicator 20. As Illustrated in FIGS. 1 and 2, in one embodiment the catheter 22 extends through the conduit 30 and along an interior surface 37 of the balloon 32, and is attached to the interior surface for movement with the interior surface when the balloon is moved from the deflated state to the inflated state. The catheter 22 may also be attached to an interior surface 38 of the conduit 30. In an alternative embodiment, the catheter 22 extends along an exterior surface 40 of the conduit 30 and/or an exterior surface 42 of the balloon. In yet another alternative embodiment, the catheter extends within the body 24, and more specifically within a wall 44 of the body defining at least one of the conduit 30 and the balloon 32. As will be described in more detail below, the catheter 22 is adapted to receive a device (not shown in FIGS. 1 and 2) facilitating treatment of the tissue adjacent the patient's cavity. [0029] As illustrated in FIG. 3, the applicator 20 described above may be used to deliver targeted radiation brachytherapy to tissue (generally designated by 60) adjacent a patient's cavity (generally designated by 62). More specifically, an applicator system (generally designated by 64) includes the applicator 20 and a radiation source (generally designated by 66) in the catheter 22. Each catheter 22 may include any number of radiation sources 66. Although other radiation sources may be used without departing from the scope of the present invention (e.g., radioactive ribbons, radioactive pellets), in the exemplary embodiment illustrated in FIG. 3 the radiation source 66 is a radioactive seed 66 attached to a wire 68. The seed may be formed from any suitable radioactive isotope, such as Indium 192, Cesium 137, Iodine 125, and/or Palladium 103. The wire 68 is positioned in the catheter 22 so the seed 66 is generally adjacent the balloon 32. The applicator system 64 may also include a viewing apparatus 70 positioned generally adjacent the balloon 32 for viewing the catheter 22 and the tissue 60 adjacent the cavity 62, as is described below. Although other viewing apparatus may be used without departing from the scope of the present invention, in one embodiment the viewing apparatus 70 is a fiber optic scope (e.g., a 3.4 mm Flexible Fiber Optic Nasopharyngoscope, commercially available from Kelleher Medical, Inc. of Richmond, Va.)

[0030] To deliver targeted radiation brachytherapy to the tissue 60, when the balloon

32 is in the deflated state a portion of the applicator 20 is inserted into the patient's cavity 62 through its entrance 74, such that the balloon and a portion of the catheter 22 are inserted into the cavity. The radiation source 66 is inserted into the catheter 22 so the radiation source is generally adjacent the balloon. For example, in the exemplary embodiment illustrated in FIG. 3, the wire 68 is inserted into the catheter 22 so the radioactive seed 66 is generally adjacent the balloon 32. In one embodiment, the radiation source 66 is inserted into the catheter 22 prior to insertion of the applicator 20 into the cavity 62. In another embodiment, the radiation source 66 is inserted into the catheter 22 after insertion of the applicator 20 into the cavity 62. In yet another embodiment, the radiation source 66 is inserted into the catheter 22 generally simultaneously with insertion of the applicator 20 into the cavity 62. Once the balloon 32 is received within the cavity 62 and the radiation source 66 is positioned in the catheter 22 adjacent the balloon, pressurized fluid is introduced to the conduit 30 and into the interior 34 of the balloon to inflate the balloon and move it from the deflated state to the inflated state. The balloon 32 is inflated (moved) to an inflated state wherein the radiation source 66 is at a predetermined dwell position, and more specifically a predetermined distance from areas 76 of the tissue 60 targeted for brachytherapy and from areas 78 of the tissue not targeted for brachytherapy. By controlling the predetermined dwell position, a dose distribution of radiation delivered into the tissue 60 can be controlled. More specifically, the amount of radiation delivered to the targeted tissue 76 can be more accurately controlled while facilitating a generally quick fall off of the dose to the non- targeted tissue 78.

[0031] Depending on the type and size of the cavity 62 and/or the desired predetermined dwell position(s) of the radiation source(s), the balloon 32 in the inflated state may completely fill the cavity 62 so the exterior surface 42 of the balloon contacts some or all of the tissue 60, or may only partially fill the cavity as illustrated in FIG. 3. Additionally, depending on the type and size of the cavity 62 and/or the desired predetermined dwell position(s), some or all of the tissue 60 may deform to the shape of the balloon 32 in its inflated state, or portions or all of the balloon in its inflated state may deform to the shape of the cavity. The number of catheters 22 included with the applicator 20 may also depend on the type and size of the cavity 62, the desired predetermined dwell position(s), and/or the size of the entrance 74 to the cavity. For example, when a large area of the tissue 60 is targeted for brachytherapy it may be desirable to include the maximum number of catheters 22 the entrance 74 to the cavity allows to obtain as many different dwell positions for the radiation source(s) 66 as possible.

[0032] Additionally, it may be desirable to rotate the balloon 32 to increase the number of dwell positions for the radiation source(s) 66 and thereby further control the dose distribution of radiation delivered into the tissue 60. For example, for large cavities with small entrances, the applicator 20 may include only one catheter 22 so the applicator 20 is more easily and comfortably inserted into the cavity 62, yet the balloon 32 can be rotated to obtain multiple dwell positions for the radiation source(s) in the catheter 22. The viewing apparatus 70 may be used to monitor rotation of the balloon 32 to ensure the radiation source(s) 66 is accurately located at the desired predetermined dwell position(s). Additionally, the viewing apparatus 70 may be used to generally view/monitor/document the tissue 60, including the targeted and non-targeted areas 76, 78, the applicator 20 and its various components, and the brachytherapy procedure being performed on the patient. The viewing apparatus 70 may be positioned anywhere on/in the applicator 20 facilitating its purpose(s). For example, the viewing apparatus 70 may be inserted into a catheter 22 before or after insertion of the applicator 20 and such that the apparatus is positioned in the catheter generally adjacent the balloon 32 for viewing the catheter and the tissue 60.

[0033] As illustrated in FIG. 4, the applicator 20 described above may be used to deliver targeted thermal therapy to tissue (generally designated by 80) adjacent a patient's cavity (generally designated by 82). More specifically, an applicator system 84 includes the applicator 20 and a heat source (generally designated by 86) in the catheter 22. Each catheter 22 may include any number of heat sources 86. Although other heat sources may be used without departing from the scope of the present invention (e.g., radiofrequency antennas, ultrasound applicators), in the exemplary embodiment illustrated in FIG. 4 the heat source 86 is an antenna 86 configured to emit microwaves into the tissue 80 to heat the tissue. Although other types of antennas may be used without departing from the scope of the present invention (e.g., line dipole or multisection antennas), in one embodiment the antenna 86 is a helical antenna. The antenna 86 is positioned in the catheter 22 such that the antenna emits microwaves generally adjacent the balloon 32. Similar to the applicator system described above and illustrated in FIG. 3, the applicator system 84 may also include a viewing apparatus (not shown) positioned generally adjacent the balloon 32 for viewing the catheter 22 and the tissue 80 adjacent the cavity 82.

[0034] To deliver targeted thermal therapy to the tissue 80, when the balloon 32 is in the deflated state a portion of the applicator 20 is inserted into the patient's cavity 82 through its entrance 94, such that the balloon and a portion of the catheter 22 are inserted into the cavity. The heat source 86 is inserted into the catheter 22 so the heat source is generally adjacent the balloon. For example, in the exemplary embodiment illustrated in FIG. 4, the antenna 86 is inserted into the catheter 22 so the antenna emits microwaves generally adjacent the balloon 32. In one embodiment, the heat source 86 is inserted into the catheter 22 prior to insertion of the applicator 20 into the cavity 82. In another embodiment, the heat source 86 is inserted into the catheter 22 after insertion of the applicator 20 into the cavity 82. In yet another embodiment, the heat source 86 is inserted into the catheter 22 generally simultaneous with insertion of the applicator 20 into the cavity 82. Once the balloon 32 is received within the cavity 82 and the heat source 86 is positioned in the catheter 22 adjacent the balloon, pressurized fluid is introduced to the conduit 30 and into the interior 34 of the balloon to inflate the balloon and move it from the deflated state to the inflated state. The balloon 32 is inflated to an inflated state wherein the heat source 86 is at a predetermined dwell position, and more specifically a predetermined distance from areas 96 of the tissue 80 targeted for thermal therapy and from areas 98 of the tissue not targeted for thermal therapy. By controlling the predetermined dwell position, a temperature increase of the targeted tissue 96 and the non-targeted tissue 98 can be controlled.

[0035] Depending on the type and size of the cavity 82 and/or the desired predetermined dwell position(s) of the heat source(s), the balloon 32 in the inflated state may completely fill the cavity 82 such that the exterior surface 42 of the balloon contacts some or all of the tissue 80, or may only partially fill the cavity as illustrated in FIG. 4. Additionally, depending on the type and size of the cavity 82 and/or the desired predetermined dwell position(s), some or all of the tissue 80 may deform to the shape of the balloon 32 in its inflated state, or portions or all of the balloon in its inflated state may deform to the shape of the cavity. The number of catheters 22 included with the applicator 20 may also depend on the type and size of the cavity 82, the desired predetermined dwell position(s), and/or the size of the entrance 94 to the cavity. For example, when a large area of the tissue 80 is targeted for thermal therapy it may be desirable to include the maximum number of catheters 22 the entrance 94 to the cavity allows to obtain as many different dwell positions for the heat source(s) 86 as possible.

[0036] Similar to the applicator system described above and illustrated in FIG. 3, it may be desirable to rotate the balloon 32 to increase the number of dwell positions for the heat source(s) 86. As described above with regard to FIG. 3, a viewing apparatus may be used to monitor rotation of the balloon 32 as well as to generally view/monitor the tissue 80, including the targeted and non-targeted areas 96, 98, as well as applicator 20 and its various components.

[0037] As illustrated in FIG. 5, the applicator 20 described above may be used to facilitate the delivery of external beam radiation and/or external thermal therapy to tissue (generally designated by 100) adjacent the patient's cavity (generally designated by 102). More specifically, an applicator system 104 includes the applicator 20 and a radio opaque marker (generally designated by 106) in the catheter 22. Each catheter 22 may include any number of radio opaque markers 106. Although other radio opaque markers 106 may be used without departing from the scope of the present invention (e.g., cerrobend, steel), in the exemplary embodiment illustrated in FIG. 5 the radio opaque marker 106 is formed from lead. The marker 106 is positioned in the catheter 22 so that the marker is generally adjacent the balloon 32. When an x-ray is taken of the patient's cavity 102, the marker 106 can then be used to mark the location of the balloon 32 to facilitate the delivery of external beam radiation and/or external thermal therapy to a predetermined area of the tissue 100.

[0038] As illustrated in FIG. 6, in an alternative embodiment the applicator 20 includes a body (generally designated by 124) in addition to the body 24. The body 124 has a first end (generally designated by 126), a second end (generally designated by 128), a conduit 130 extending between the first end and the second end, and a balloon (generally designated by 132). Either of the conduit 30 and the conduit 130 may be referred to herein as a first conduit or a second conduit. Additionally, either of the balloon 32 and the balloon 132 may be referred to herein as a first balloon or a second balloon. As with the body 24, the balloon 132 is adapted for introduction to a patient's cavity. More specifically, the balloon 132 has a deflated state (not shown) in which the balloon 132 and the first end 126 of the body 124 are adapted for insertion into the cavity through its entrance. Additionally, at least a portion of the conduit 130 may also be adapted for insertion through the entrance and into the cavity. The first end 126 of the body 124, the balloon 132 in its deflated state, and where applicable all or a portion of the conduit 130, are sized and shaped appropriately for insertion into the particular cavity (e.g., bladder) through its entrance (e.g., urethra). The body 124 is positioned relative to the body 24 so the balloon 132 is adjacent the balloon 32, such that the balloon 132 is adapted for introduction to the patient's cavity generally simultaneously with the balloon 32. In one embodiment, as illustrated in FIG. 6, the body 124 surrounds the body 24 such that the balloon 132 surrounds the balloon 32.

[00391 As illustrated in FIG. 6, the balloon 132 also has an inflated state in which the balloon is enlarged for at least partially filling the cavity. The conduit 130 is in fluid communication with an interior 134 of the balloon 132 for introducing pressurized fluid to the interior of the balloon to move the balloon 132 from the deflated state to the inflated state. Pressurized fluid is introduced into the conduit 130 through an opening (generally designated by 136) within the body 124 in fluid communication with the conduit. Although any suitable fluid (e.g., saline) may be introduced into the conduit 130 and the interior 134 of the balloon to move the balloon from the deflated state to the inflated state without departing from the scope of the present invention, in one embodiment air is used to move the balloon from the deflated state to the inflated state. As illustrated in FIG. 6, the balloon 132 defines the first end 126 of the body 124. However, the balloon 132 may be suitably positioned anywhere along the body 124 such that the balloon 132 is adjacent the balloon 32 and is adapted for insertion into the cavity and movement to the inflated state once received within the cavity. Additionally, as with the balloon 32, in the inflated state the balloon 132 may be suitably shaped for the particular cavity. The particular size (e.g., radius) of the balloon 132 in the inflated state may also vary for the particular cavity. Additionally, the balloon 132 may be inflatable to a variety of sizes and/or shapes such that the inflated state of the balloon may comprise a plurality of states each having a different size and/or shape.

[0040] Similar to the body 24, the body 124 may be formed from any suitable material(s), for example rubber and/or plastic. Although different portions of the body 124 may be formed from different materials, in one embodiment the entirety of the body is formed from one material. The portions of the body 124 adapted for introduction to the patient's cavity may be formed from any material suitable for use within the cavity, so that such portions do not damage tissue adjacent the cavity and/or injure/infect the patient. Additionally, in one embodiment at least a portion of the body 124 (e.g., at least a portion of the conduit 130 and/or the balloon 132) is formed from a transparent material to facilitate use of a viewing apparatus (not shown in FIG. 6) with the applicator 20, as is described in more detail above.

[0041] This alternative embodiment of the applicator 20 facilitates even more control over an accurate predetermined dwell position of the radiation source(s) 66 (FIG. 3) and/or the heat source(s) 86 by using two separate balloons 32, 132 to control the position of catheter 22, and therefore the radiation source(s) and/or the heat source(s), and the position of the tissue adjacent the cavity, respectively. [0042] As illustrated in FIG. 7, in an alternative embodiment the applicator 20 includes a body (generally designated by 224) in addition to the body 24. The body 224 has a first end (generally designated by 226), a second end (generally designated by 228), a conduit 230 extending between the first end and the second end, and a balloon (generally designated by 232). Either of the conduit 30 and the conduit 230 may be referred to herein as a first conduit or a second conduit. Additionally, either of the balloon 32 and the balloon 232 may be referred to herein as a first balloon or a second balloon. As with the body 24, the balloon 232 is adapted for introduction to a patient's cavity. More specifically, the balloon 232 has a deflated state (not shown) in which the balloon 232 and the first end 226 of the body 224 are adapted for insertion into the cavity through its entrance. Additionally, at least a portion of the conduit 230 may also be adapted for insertion through the entrance and into the cavity. The first end 226 of the body 224, the balloon 232 in its deflated state, and where applicable all or a portion of the conduit 230, are sized and shaped appropriately for insertion into the particular cavity (e.g., bladder) through its entrance (e.g., urethra). The body 224 is positioned relative to the body 24 so the balloon 232 is adjacent the balloon 32, such that the balloon 232 is adapted for introduction to the patient's cavity generally simultaneous with the balloon 32. In one embodiment, as illustrated in FIG. 7, the body 224 surrounds the body 24 such that the balloon 232 surrounds the balloon 32.

[0043J As illustrated in FIG. 7, the balloon 232 also has an inflated state in which the balloon is enlarged for at least partially filling the cavity. The conduit 230 is in fluid communication with an interior 234 of the balloon 232 for introducing pressurized fluid to the interior of the balloon to move the balloon 232 from the deflated state to the inflated state. Pressurized fluid is introduced into the conduit 230 through an opening (generally designated by 236) within the body 224 in fluid communication with the conduit. Although any suitable fluid (e.g., saline) may be introduced into the conduit 230 and the interior 234 of the balloon to move the balloon from the deflated state to the inflated state without departing from the scope of the present invention, in one embodiment air is used to move the balloon from the deflated state to the inflated state. As illustrated in FIG. 7, the balloon 232 defines the first end 226 of the body 224. However, the balloon 232 may be suitably positioned anywhere along the body 224 such that the balloon 232 is adjacent the balloon 32 and is adapted for insertion into the cavity and movement to the inflated state once received within the cavity. Additionally, as with the balloon 32, in the inflated state the balloon 232 may be suitably shaped for the particular cavity. The particular size (e.g., radius) of the balloon 232 in the inflated state may also vary for the particular cavity. Additionally, the balloon 232 may be inflatable to a variety of sizes and/or shapes such that the inflated state of the balloon may comprise a plurality of states each having a different size and/or shape.

[0044] Similar to the body 24, the body 224 may be formed from any suitable material(s), for example rubber and/or plastic. Although different portions of the body 224 may be formed from different materials, in one embodiment the entirety of the body is formed from one material. The portions of the body 224 adapted for introduction to the patient's cavity may be formed from any material suitable for use within the cavity, so that such portions do not damage tissue adjacent the cavity and/or injure/infect the patient. Additionally, in one embodiment at least a portion of the body 224 (e.g., at least a portion of the conduit 230 and/or the balloon 232) is formed from a transparent material to facilitate use of a viewing/steering apparatus 300 with the applicator 20, similar to the viewing apparatus 70 above and described in more detail below.

[0045] In this alternative embodiment, which is a variation of the applicator 20 illustrated in FIG. 6, the body 24 includes a plurality of catheters 22 that are arranged such that they converge toward each other at a localized area 35 (FIG. 8) to provide a "boost effect". With this arrangement, a plurality of radiation sources 66 and/or heat sources 86 can be placed in the boost area 35 to provide treatment to a larger surface of the tissue adjacent the cavity. Although eight catheters 22 have been shown, any number of catheters may be provided as appropriate. In addition, depending on the desired boost effect, not all catheters need to have a radiation source or heating source associated therewith.

[0046] The size of the localized area can be varied as desired, depending on the degree of concentration of the radiation as desired. Thus, the diameter of the localized area is typically as little as 1% to 5% of the diameter of the inflated balloon to as much as 10%, 20%, 25% or 50% of the diameter of the inflated balloon.

[0047] As illustrated in FIG. 7, the plurality of catheters 22 can originate from a single catheter 22 that extends along the body 24 and then branches outward into separate catheters adjacent the balloon 32. Alternatively, a plurality of separate catheters 22 may be provided such that they extend along the entire length of body 24. In addition, the catheters 22 can be formed on or provided on the interior surface of the body 24 and balloon 32, on the exterior surface of the body 24 and balloon 32, internal to the body 24 and balloon 32, or any combination of the foregoing. In this manner greater flexibility with the placement of the radiation sources 66 and/or heating sources 86 can be achieved. In addition to a number of radiation sources and/or heating sources, one of the catheters 22 can be configured to receive the viewing/steering device 300 therein.

[0048] Because the localized area 35 is at a fixed location on balloon 32, a viewing/steering device 300 may be used to further move the balloon 32 within balloon 232. The viewing/steering device 300 may be partially dependent on the type of material that is used to form the body 24 and balloon 32. For example, depending on the flexibility of the body 24 and balloon 32, the viewing/steering device 300 may be a fiber optic scope, such as the 3.4 mm Flexible Fiber Optic Nasopharyngoscope described above. Alternatively, a more robust endoscope design may used for less flexible materials, such as, but not limited to, those set forth in U.S. Patent No. 3,610,231, entitled "Endoscope", to Takahasi et al. or U.S. Patent No. 7,044,907, entitled "Steerable Endoscope and Improved Method of Insertion", to Belson. U.S. Patent Nos. 3,610,231 and 7,044,907 are hereby incorporated by reference.

[0049] By way of example, FIG. 9 shows a viewing/steering device 300 similar to those disclosed by Takahasi et al. As illustrated in FIG. 9, the viewing/steering device 300 includes a control housing 310, an elongated flexible tube 320, and a forward end portion 330. The control housing is connected to the proximal end of the flexible tube 320 and includes a gripping mechanism 340. The forward end 330 is connected to the distal end portion of the flexible tube 320. An objective lens system may be provided in a viewing window of the forward end portion 330 so that images are transported by way of an image- transmitting optic system to an ocular viewing means 340. A fiber optic illuminating system extends from the forward end 330 to the control housing 310 to illuminate the tissue being treated. A control mechanism 350 is provided to control the orientation of the forward end 330.

[0050] In this arrangement, the forward end 330, along with the flexible tube 320, may be inserted into one of the catheters 22. Alternatively, one of the catheters 22 may take the form of the flexible tube 320 and thus, the viewing/steering device 300 may be formed integral with the body 24 and balloon 32. By manipulating the control mechanism 350 the forward end 330 along with the balloon 32 can be further manipulated within balloon 232. This configuration provides a further degree of movement over the applicators described in FIGS. 1-6 in that the localized area 35 on balloon 32 can be moved such that the radiation sources 66 and/or heating sources 86 treat a larger surface area of tissue without penetrating too deep beneath the surface.

[0051] The above described applicator 20 can be used to treat cancerous tissue in many different cavities, such as, for example, esophageal cancer, gastric cancer, rectal cancer, colon cancer, breast cancer, either interoperational or perioperational, and sarcomas, either interoperational or perioperational. For example, bladder cancer typically occurs as superficial growth on a surface of the bladder and the cancerous cells do not extend far beneath the surface tissue. While it would be possible to treat the cancerous cells with one of the applicators illustrated in FIGS. 1-6, the resulting treatment may damage too many normal cells beneath the cancerous cells as the applicator 20 is repositioned. However, with the applicator 20 illustrated in FIGS. 7-9, the size of the localized area 35 can be controlled by the placement of the radiation and/or heat source in the catheters 22. By providing a localized area 35, the treatment can be spread over a greater area thereby limiting the damage to normal cells and providing an effective therapeutic dose to the cancerous cells by providing a boost effect as illustrated in FIGS. 1OA and 1OB.

[0052] As illustrated in FIG. 1OA, a smaller localized area 35 creates a boost effect having a small cross-section and high intensity of treatment. As illustrated in FIG. 1OB, a larger localized area 35 creates a boost effect that has a larger cross-section with a lower intensity. The size of the localized area 35 is selected depending on the size of the tissue that needs to be treated and the intensity of the dose desired. It is apparent that the closer the radiation sources 66 and/or heating sources 86 are in the localized area 35, the greater the intensity and focus of the dose.

[0053] In operation, the localized area 35 may be moved by using the viewing/steering mechanism 300 to maneuver the balloon 32 and localized area 32 with respect to the portion of the tissue to be treated. Further orientation of the localized area 35 may be accomplished by rotating the applicator 20 and/or body 24 in a clockwise or counterclockwise direction. In this manner, the amount of treatment provided to the cancerous cells can be controlled and independently verified by the viewing/steering mechanism 300.

[0054] Although only one embodiment of the viewing/steering device 300 has been shown, other viewing/steering devices can be used without departing from the scope of the invention. The viewing/steering device should provide the ability to move the balloon 32 within balloon 232 to assist in the treatment of tissue. Preferably, the viewing/steering device should also provide the ability to inspect the treatment site to verify that the desired region has been treated sufficiently. As an alternative to a single viewing/steering device, the function of the viewing/steering device may be split into two separate devices where one is used to inspect the treatment site while the other is used to move the balloon 32 within balloon 32.

[0055] An exemplary arrangement of separate devices would include an optical system with an objective lens system fixed at a specific location on the balloon 232. The steering mechanism of the endoscope described above could be formed integral to body 24 or inserted into a catheter 22. With a fixed viewing device and a separate steering device, cancerous tissue that is larger than the localized area 35 can be more systematically treated. For example, the fixed optical system can be oriented to observe the cancerous tissue while the separate steering device moves the balloon 32 to move the localized area 35 across the cancerous tissue. In this manner, a clear view of the tissue to be treated is maintained while the localized area 35 is maneuvered with respect to the tissue.

[0056] Although the applicator 20 of FIG. 7 has been shown as used with body 224 and balloon 232, the body 24 and balloon 32 may be used without body 224 and balloon 232.

[0057] Although each of the applicator systems described and illustrated herein are described and illustrated separately, it should be understood that the systems may be used in combination to perform a combination of targeted radiation brachytherapy and/or targeted thermal therapy, and/or to facilitate external beam radiation. For example, an applicator of the present invention may include a catheter having a radiation source therein, a catheter having a heat source therein, and/or a catheter having a radio opaque marker therein. Additionally, an applicator of the present invention may include a catheter having one or more of a radiation source, a heat source, and a radio opaque marker therein. Accordingly, a single applicator of the present invention may be used to simultaneously perform a combination of targeted radiation brachytherapy and/or targeted thermal therapy, and/or to facilitate external beam radiation and/or external thermal therapy.

[0058] As used herein, the term "cavity" includes any cavity of any animal where it is desired to deliver targeted radiation brachytherapy to tissue adjacent the cavity.

[0059] The above-described applicator and applicator systems are cost-effective and reliable for performing targeted radiation brachytherapy and targeted thermal therapy, and for facilitating external beam radiation. More specifically, the applicator and applicator systems of the present invention may facilitate access to previously inaccessible organs and cavities for targeted radiation brachytherapy and targeted thermal therapy such as, for example, the bladder, the rectum, the intestine, the vagina, the uterus, the fallopian tubes, the esophagus, the stomach, the bronchus, nasopharynx, and the nasal cavity. Additionally, the present invention can be rotated to allow an almost unlimited number of potential dwell positions for radiation and/or heat sources, and a viewing apparatus may be used along with the applicator to ensure accurate positioning of the radiation and/or heat sources, as well as generally monitoring the procedure being performed. Furthermore, access to most cavities is no more invasive than placement of a Foley catheter, which may allow for outpatient treatment with minimum or no analgesia.

[0060] Exemplary embodiments of applicator systems are described above in detail.

The systems are not limited to the specific embodiments described herein, but rather, components of each system may be utilized independently and separately from other components described herein. Each applicator system component can also be used in combination with other applicator system components.

[0061] When introducing elements of the present invention or the preferred embodiment(s) thereof, the articles "a", "an", "the" and "said" are intended to mean that there are one or more of the elements. The terms "comprising", "including" and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. [0062] As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

[0063] The invention thus being described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

Claims

WHAT IS CLAIMED:

1. An applicator for delivering therapeutic treatment to a portion of tissue defining a cavity of a patient, the applicator comprising: a balloon adapted for introduction into the cavity of the patient, the balloon having a deflated state in which the balloon is adapted for insertion into the cavity and an inflated state in which the balloon is enlarged for at least partially filling the cavity of the patient; at least one treatment source carried by the balloon for delivering treatment to tissue adjacent the cavity; and a movable steering device adapted for introduction into the cavity of the patient, the steering device being coupled to the balloon so that movement of the steering device effects movement of the balloon, to thereby enable maneuvering of the balloon and the treatment source with respect to the portion of tissue defining the cavity.

2. An applicator as recited in claim 1, wherein the steering device is a viewing device that comprises a fiber optic scope fastened to a surface of the balloon.

3. An applicator as recited in claim 2, wherein: at least a portion of the balloon is formed of transparent material; and the fiber optic scope is disposed within the balloon at a position that permits viewing through the transparent material.

4. An applicator as recited in claim 1, wherein the treatment source comprises a plurality of narrow elements that converge toward a point on a surface of the balloon when the balloon is in an inflated or partially inflated state.

5. An applicator as recited in claim 3, wherein the fiber optic scope is steerable and fastened to the inner surface of the balloon.

6. As applicator as recited in claim 1, wherein the steering device is attached to a housing of a catheter supporting the balloon.

7. A method of delivering therapeutic treatment to a portion of tissue defining a cavity of a patient, the method comprising the steps of: introducing into the cavity (1) a deflated balloon carrying at least one treatment source and (2) a movable viewing device coupled to the balloon whereby movement of the viewing device effects movement of the balloon, to thereby enable maneuvering of the balloon and the treatment source within the cavity; inflating the balloon within the cavity; and moving the viewing device to maneuver the balloon and the treatment source with respect to the portion of tissue to be subjected to therapeutic treatment.

8. The method as recited in claim 7, wherein the viewing device is disposed within the balloon for viewing through the material of the balloon.

9. An applicator for delivering therapeutic treatment to a portion of tissue defining a cavity of a patient, the applicator comprising: a balloon adapted for introduction into the cavity of the patient, the balloon having a deflated state in which the balloon is adapted for insertion into the cavity and an inflated state in which the balloon is enlarged for at least partially filling the cavity of the patient; and a plurality of treatment sources carried by the balloon for delivering treatment to the portion of tissue defining the cavity, the plurality of treatment sources being located in a localized area of the balloon.

10. The applicator according to claim 8, further comprising: a movable steering device adapted for introduction into the cavity of the patient, the steering device being coupled to the balloon so that movement of the steering device effects movement of the balloon, to thereby enable maneuvering of the balloon and the treatment source with respect to the portion of tissue defining the cavity.

11. The applicator according to claim 10, wherein the steering device is a viewing device comprising a fiber optic scope.

12. A method of delivering therapeutic treatment to a portion of tissue defining a cavity of a patient, the method comprising the steps of: introducing into the cavity a deflated balloon carrying a plurality of treatment sources for delivering treatment to the portion of tissue defining the cavity, the plurality of treatment sources being located in a localized area of the balloon; inflating the balloon within the cavity; and delivering an effective dosage to the tissue adjacent the cavity.

13. The method according to claim 12, further comprising: introducing into the cavity a movable viewing device coupled to the balloon whereby movement of the viewing device effects movement of the balloon, to thereby enable maneuvering of the balloon and the plurality of treatment sources within the cavity; and moving the viewing device to maneuver the balloon and the plurality of treatment sources with respect to the portion of tissue to be subjected to therapeutic treatment.

14. The applicator according to claim 1, wherein the at least one treatment source is selected from one of a radiation source and a heat treatment source.

15. The applicator according to claim 9, wherein the plurality of treatment sources is selected from one of radiation sources and heat treatment sources.

16. The method according to claim 7, wherein the at least one treatment source is selected from one of a radiation source and a heat treatment source.

17. The method according to claim 12, wherein the at least one treatment source is selected from one of a radiation source and a heat treatment source.

18. An applicator for delivering therapeutic treatment to a portion of tissue defining a cavity of a patient, the applicator comprising: a first balloon adapted for introduction into the cavity of the patient, the balloon having a deflated state in which the balloon is adapted for insertion into the cavity and an inflated state in which the balloon is enlarged for at least partially filling the cavity of the patient; an second balloon located within the first balloon, the second balloon being adapted for introduction to the cavity of the patient simultaneous with the first balloon, the second balloon having a deflated state in which the second balloon is adapted for insertion into the cavity and an inflated state in which the second balloon is enlarged for at least partially filling the cavity of the patient; at least one treatment source carried by the second balloon for delivering treatment to tissue adjacent the cavity; a movable steering device adapted for introduction into the cavity of the patient, the steering device being coupled to the second balloon so that movement of the steering device effects movement of the second balloon, to thereby enable maneuvering of the second balloon and the treatment source with respect to the portion of tissue defining the cavity.

19. The applicator according to claim 18, wherein the at least one treatment source comprises a plurality of treatment sources being located in a localized area on the second balloon.

20. The applicator according to claim 1, wherein the at least one treatment source is selected from one of a radiation source, a microwave source, and a radiofrequency source.