MXPA06005062A - Brachytherapy apparatus and method for treating a target tissue through an external surface of the tissue - Google Patents

Abstract

A brachytherapy device is provided for treating a target tissue through an external surface area of the target tissue. The device includes an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough. A fluid retaining member is mated to the distal portion of the insertion member and has a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a cavity formed therein in fluid communication with the at least one lumen in the insertion member. A plurality of anchor members can be distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated.

Description

7 ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), - befare the expiration of the time litnit for amending the European (AT, BE, BG, CH, CY, CZ, DE , DK, EE, ES, Fl, claims and to be republished in the event of receipt of FR, GB, GR, HU, IE, IS, IT, LU, MC, NL, PL, PT, RO, SE, amendments YES , SK, TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). For two-letter codes and other abbreviations, refer to the "Guid¬ Published: ance Notes on Codes andAbbreviations "appearing at the begin- BRAQUIOTERAPY APPARATUS AND METHOD FOR TREATING AN OBJECTIVE TISSUE THROUGH A SURFACE EXTERNAL TO THE TISSUE Field of the Invention The present invention relates generally to an apparatus and method for use in the treatment of tissue prollferative disorders, and more particularly, to an apparatus and method for the treatment of said disorders in the body by the application of radiation to a surface of a fabric. Background of the Invention Malignant tumors are frequently treated by surgical resection of the tumor to remove as much of the tumor as possible. However, the infiltration of tumor cells into the normal tissue surrounding the tumor may limit the therapeutic value of surgical resection because infiltration may be difficult or impossible to treat surgically. Radiation therapy may be used to supplement surgical resection by sending it to the target of the residual margin of the tumor after resection, with the goal of reducing or stabilizing the tumor. Radiation therapy can be administered through one of several methods or a combination of methods that include external beam radiation, stereotactic radiosurgery and permanent or temporary interstitial brachytherapy, the term "brachytherapy" as used in the present description, refers to a therapy administered by a spatially confined radiation source inserted into the body at or near a tumor or other site of a tissue proliferative disorder. Due to the proximity of the radiation source, brachytherapy offers the advantage of administering a more localized dose to the region of the target tissue. For example, brachytherapy is performed by implanting radiation sources directly into the tissue to be treated. The brachytherapy is the most appropriate where 1) occurs locally in new growth of the malignant tumor, within 2 or 3 cm of the original limit of the site of the primary tumor; 2) Radiation is a proven treatment to control the growth of a malignant tumor; and 3) there is a response relationship to the radiation dose for the malignant tumor, but the dose that can be administered safely with conventional external beam radiotherapy is limited by the tolerance of normal tissue. In brachytherapy, the radiation dose is the highest in close proximity to the radotherapeutic source, providing a high dose to the tumor while protecting the surrounding normal tissue. An example of a brachytherapy apparatus is described in U.S. Patent No. 5,030,195 issued to Nardl, entitled "Radioactive Seed Patch for Prophylactic Therapy." Nardi discloses a method and apparatus for treating tissue surrounding a tumor surgically excised with radioactive emissions to kill any cancer cells that may be present in the tissue surrounding the excised tumor. In order to implement radioactive emissions, Nardi provides a low-energy radioactive seed patch that can not be absorbed made from a plastic mesh that has iodine-125 seeds bound in it. The patch is put in place at the time of surgery after tumor resection and remains there indefinitely. Although the apparatus described in the Nardi patent provides some advantages, the patch is limited to the use of permanently implanted radioactive seeds, which in some applications may be less effective than other sources of radiation. In addition, Nardi does not describe methods for designing radiation dosing to avoid complete dosing in sensitive tissue or to reduce the amount of radiation that escapes within the body. Accordingly, there is still a need for an apparatus that can be used to effectively deliver radiation from a solid and / or liquid radioactive source to the target tissue within the human body.

SUMMARY OF THE INVENTION The present invention generally provides a brachytherap apparatus for the treatment of a target tissue surrounding a surgical removal site. In one embodiment the apparatus includes an insertion element having a proximal portion, a distal portion and at least one lumen extending therethrough. A fluid retention element is coupled to the distal portion of the insert and has a first surface that is formed to take the form of a predetermined external surface area of a tissue to be treated and at least one cavity formed therein in fluid communication with said at least one lumen in the Insertion element. A plurality of anchor elements may be distributed around the periphery of the first surface to anchor the first surface to an external surface area of a fabric to be treated. During use, the brachytherapy apparatus is adapted to receive a radiation source through at least one lumen within a cavity in the fluid retention element to deliver radiation to the tissue to be treated. Preferably, the liquid retention element is formed to provide a uniform radiation dosage throughout the first surface when the liquid retention element is filled with a radioactive liquid. The fluid retention element may also include a second its surface opposite the first surface, and a peripheral wall extending between the first and second surfaces to define the cavity therein. The peripheral wall preferably has a substantially uniform depth. In an exemplary embodiment, the liquid retention element can be substantially dummy or oval. In another embodiment, the liquid retention element can move between a closed position in which the liquid retention element is positioned adjacent to the insertion element and an open position in which the liquid retention element it extends outward from the insertion element. Preferably, the fluid retention element is an expandable balloon element that is inflated in the open and deflated position in the closed position. The expandable balloon element may have a predetermined shape in the open position so that, when inflated, the expandable balloon member is effective to cover a predetermined tissue area. Although the previously determined shape may vary, in an exemplary embodiment, the previously determined shape of the expandable balloon element is substantially disc-shaped or oval-shaped. In another embodiment, the liquid retention element can be formed from a shape memory material and can have a three-dimensional shape in the open position and a substantially folded shape in the closed position. Again, the liquid retention element preferably has substantially the shape of a disk or an oval shape in the open position. In other aspects of the present invention, there is provided a brachytherapy apparatus having an elongate catheter element with a proximal portion, a distal portion and at least u that extends therethrough. A balloon element is positioned around the distal portion of the elongate catheter element and has a cavity formed therein and is in fluid communication with at least one lumen in the elongate catheter. The balloon element includes a first tissue contacting surface formed to take the form of a predetermined external surface area of a tissue to be treated. The apparatus also includes a radiation source in the form of a liquid placed inside the balloon cavity. The catheter element may be coupled with the balloon element in any position in the balloon. Sample sites for the connection of the catheter element and the balloon element include the treatment surface of the balloon, a surface opposite the treatment surface and the periphery of the balloon element. In yet another embodiment of the present invention, there is provided a method for treating tissue surrounding a surgical extraction site. The Incl method takes the step of providing at least one brachytherapy apparatus for administering radioactive em ions. The apparatus preferably includes a catheter element having proximal and distal ends and at least one line extending therethrough and at least one fluid retention element positioned near the distal end of the element. of catheter. The liquid retention element includes a cavity formed therein in communication with at least one lumen in the catheter element and first its surface formed to take the form of a predetermined external surface area of a catheter. tissue that is going to be treated. The method further includes the steps of intra-operatively placing said at least one brachytherapy apparatus on an external surface of a tissue to be treated, and introducing a controlled dose of a radiation source through said at least one lumen. in the catheter to the liquid retention element for treating the tissue. Preferably, the radiation source is placed inside the brachytherapy apparatus after placement of the apparatus on a tissue surface and is removed from the apparatus prior to removal of the apparatus. The method can include the step of adhering the liquid retention element to a predetermined external surface area of a tissue to be treated. BRIEF DESCRIPTION OF THE DRAWINGS The above features, objects and advantages of the present invention may be appreciated by those skilled in the art from the following detailed description of a preferred embodiment, especially when considered in conjunction with the accompanying drawings. in which: Fig. 1 is an illustration of a perspective view of a modality of a brachytherapy apparatus according to the present invention; Figure 2 is a side view illustration of the distal portion of the apparatus shown in Figure 1; Figure 3 is an illustration of another embodiment of the brachytherapy apparatus of the present invention shown in a perspective view; Figure 4A is an illustration of another embodiment of the brachytherapy apparatus containing multiple cavities; Figure 4B is an illustration of another embodiment of the brachytherapy apparatus containing last cavities; Fig. 5A is an illustration of a patient's lung having a lesion removed surgically from it; Figure 5B is an illustration of the lung illustrated in Figure 5A having the excised lesion closed by suture; and Figure 5C is an illustration of the lung shown in Figure 5B having a brachytherapy apparatus adhered thereto in accordance with the present invention. Detailed Description of the Invention The present invention generally provides a radiotherapy apparatus, and preferably a brachytherapy apparatus for delivering radiation to tissue and / or bone. Although the system can be used for a variety of purposes, the system is preferably used to treat tissues near the excised tumor site, and more particularly, to treat an outer surface of the tissue surrounding the closed site of tumor resection, by example, in the lungs of a patient. Figures 1 and 2 illustrate one embodiment of a brachytherapy apparatus 10 which generally includes an insertion element, for example, a catheter element 12 having a proximal portion 12a, a distal portion 12b and at least one lumen 12c that it extends through it. An expandable surface element, illustrated as the liquid retention element 20, can be coupled to the distal portion 12b of the catheter element 12 and includes a cavity 21 formed therein in fluid communication with said at least one lumen 12c in the catheter element 12. During use, the liquid retention element 20 is placed in an external surface area of a tissue to be treated and the cavity 21 is effective to receive a radiation source, generally either in the liquid or solid form, to deliver radiation to the tissue to be treated. The catheter element 12 may have a variety of configurations, but is preferably a flexible or semi-flexible elongate element having a proximal portion 12a, a distal portion 12b and at least one lumen 12c formed therein extending through the next and distant portions 12a, 12b. The lumen 12c may terminate at or near a distant port 14 formed in the distal portion 12b of the catheter 12. As shown in FIG. 1, the proximal end 12a of the catheter 12 preferably includes a percutaneous port 23 to provide access to the catheter 12. liquid retention element 20 once the device 10 is implanted in a patient. Although only one interior lumen 12c is illustrated in Figure 2, one skilled in the art will readily appreciate that the catheter element 12 may have one or more internal lumens or that other means known in the art for administering fluids and / or may be used. air to the liquid retention element 20.

The liquid retention element 20 can have a variety of configurations, shapes and sizes. However, the fluid retention element preferably includes a cavity 21 formed therein in fluid communication with said at least one lumen 12c formed in the catheter element 12. In one embodiment, the retention element of The liquids 20 are configured and adapted to receive a liquid radiation source. In addition, at least one outer surface of the liquid retention element 20 is preferably a tissue contacting surface which is adapted to be placed on or optionally take the form of an externally determined surface area of a predetermined surface area. tissue that is going to be treated. In addition, one skilled in the art will appreciate that the fluid retention element can include any number of cavities formed therein, and one or more of its surfaces can be adapted to be placed on its outer tissue surface that will be treated. As shown in Figure 2, the liquid retention element 20 includes a first tissue contacting surface 24, a second opposing surface 22 and a peripheral side wall 26 extending therebetween. The first and second surfaces 2422 may each have virtually any size, but preferably, the first surface thereof 24 has the size which is sufficient to cover a predetermined external surface area of a tissue to be treated. The shape of the first and second surfaces 24, 22 may also vary, but the first surface 24 must be adapted to be placed on an external surface of the fabric. In one example modality, the first surface 24 is substantially flat, but preferably flexible or semi-flexible to allow the surface 24 to take the shape of the surface of the fabric. The second surface 22 may also vary in shape and size, but preferably has a shape and size substantially the same as that of the first surface 22 to provide a radiation dose a iforme wherein a liquid radioisotope within the liquid retaining member 20 provides the radiation dose. In one embodiment, the radiation dosage can be achieved by providing a peripheral side wall 26 having a substantially constant width w extending between the first and second surfaces 24, 22. The uniform width w of the wall side 26 facilitates the uniform distribution of the radioactive liquid from the liquid retention element 20, thereby providing a uniform dosage of radiation with the exception of the effects of the edge on the entire surface 24 when the liquid retention element is filled with the radioactive liquid.

Although the embodiment of FIGS. 1 and 2 illustrates a liquid retention element having substantially the shape of disk 20, which is advantageous because it can provide a substantially uniform radiation dosage, one skilled in the art will appreciate that the element Liquid retention 20 can have a variety of configurations. By way of example and not limitation, the first and second opposing surfaces of the liquid retention element can be square, oval, rectangular, etc. In a preferred embodiment, the first surface is oval in shape. The inventors have discovered that an oval shape can provide complete coverage of a target tissue region while being easier to manipulate than other forms, in particular, during surgery for the treatment of lung tumors. In addition, although the size of the liquid retention element 20 can be previously determined, the size can be selected during the treatment by inflating the liquid retention element to a desired level. In certain embodiments of the present invention, the surface area of the first surface may have from about 4 cm2 to 100 cm2. The liquid retention element 20 also preferably includes at least one anchoring element 28a to 28d formed therein and coupled thereto for damaging the liquid retention element 20 to the surface of the fabric. The anchoring elements of the 28a to 28d can be formed on or coupled to any portion of the lug retainer 20 and can have a variety of configurations. Preferably, each or both of the anchor elements of the 28a to d is placed around a periphery of the first surface 22. In the illustrated mode, said configuration results in the anchor elements 28 from a to d which are placed. around the peripheral wall 26 of, or adjacent to the first surface 24. A variety of anchor elements 28 can be used from a to d, including, for example, eyelets, hooks, adhesives and combinations thereof. Figure 2 illustrates the anchor elements 28 from a to d in the form of eyelets. During use, each anchor element 28 from a to d may be sutured or otherwise adhered to the surface of the tissue to securely impute the liquid retention element 20 within the patient. In the embodiment illustrated in Figures 1 and 2, a catheter 12 is adhered to the fluid retention element 20 on the second surface 22 and possibly also on the first surface 24. In a further embodiment, illustrated in Figure 3, the catheter 12 is adhered to the liquid retaining element 20 in one portion and preferably in two opposite portions of the side wall 26. By adhering the catheter 12 along the side wall 26, the geometry of the preferred apparatus 10 is obtained. for the insertion of the apparatus for a desired treatment area in certain treatment procedures. For example, the geometry of the embodiment illustrated in Figure 3 may be preferred for use in the treatment of lung tumors wherein the apparatus 10 must be moved laterally beyond the patient's ribs. Although in the embodiment illustrated in Figure 3 the catheter 12 is centrally connected to the liquid retention element 20, one skilled in the art will recognize that other configurations are possible. The liquid retention element 20 may also include a variety of other features not shown or described in the present disclosure. In another embodiment, the liquid retention element 20 can be adapted to protect the radiation sensitive tissue. By way of non-limiting example, all or a portion of the second surface 22 and / or the peripheral wall 26 can be formed from or coated with a radio-opaque material that is effective to protect the tissue surrounding the treatment site. . In an example mode, the complete liquid retention element 20, except the tissue contacting surface 24, is radio-opaque. The coating (not shown) can be strategically placed to protect the radiation sensitive tissue and / or to provide an asymmetric isodose curve as described in US Patent No. 6,482,142, issued November 19, 2002 and entitled "Apparatus and Asymmetric Radiation Dosing Method "which is incorporated herein by reference. Suitable radio opaque materials for coating include, for example, barium, tungsten, bismuth, tantalum and tin. As an alternative to the coating portions of the liquid retention element 20, an absorbent or radiation blocking protection (not shown) can be placed in and around particular areas of the liquid retention element 20 to produce an isodose curve desired. One skilled in the art will appreciate that other configurations may be employed to achieve the desired isodose curves and / or protect radiation sensitive tissue. In yet another embodiment, the liquid retention element can be adapted to provide a space between the radiation source and the tissue. By way of non-limiting example, as shown in Figures 4A and 4B, the liquid retention element 20 'can include a divider placed therein to separate the lower cavity in a first and second cavities 21a', 21b '. Each cavity 21a ', 21b' is preferably in communication with a port 14a ', 14b' to allow a radiation source to be delivered to the first cavity 21a 'and the liquid or air to be administered to the second cavity 21b'. During use, the second cavity 21b 'is effective to separate the radiation source at a distance from the tissue surface. By providing a uniform separation between the radiation source (in the illustrated embodiment, a liquid radiation source, such as lotrex that is available from Proxima Therapeutics, Inc., of Alpharetta, Georgia) would be preferred, a uniform prescribed dose of radiation can penetrate into the target tissue while minimizing the opportunity for healthy tissue necrosis in contact with or near the liquid retention element 20 'as described in US Patent No. 6,413,204 issued to Winkler et al, which is incorporated in its entirety to the present description as a reference. One skilled in the art will appreciate that a variety of techniques can be used to provide separation between the radiation source and the tissue. By way of non-limiting example, the liquid retention element 20 'may include a second balloon element placed around the liquid retention element to provide the space, as described in US Patent No. 6,413,204. In addition to providing the space, a second interior cavity can be used to deliver a therapeutic agent to the target tissue. For example, at least a portion of the retaining element 20 can be defined by a porous material, and can be used to deliver a therapeutic agent from the cavity 21b 'to the adjacent tissue. In one embodiment, the tissue contacting surface 24 is defined by a porous membrane through which a therapeutic agent can be administered. U.S. Patent No. 6,083,148 to Williams describes exemplary brachytherapy methods and apparatus utilizing the porous walls of the balloon, which is incorporated herein by reference in its entirety. The therapeutic agent is preferably a medically useful agent, for example, a chemotherapeutic agent, an anti-neoplastic agent, an anti-angiogenesis agent, an immuno-regulator, a hormonal agent (including agonists and antagonists), an immunotherapeutic agent, an antibiotic, or a combination thereof. Other therapeutic agents and useful porous materials are described in US Pat. No. 6, 200,257 granted to Winkler, which is incorporated in its entirety to the present description as a reference. During use, the liquid retention element 20 can preferably be moved between a closed unexpanded shape, and an expanded open shape in which the liquid retention element 20 has a predetermined shape, as shown in FIGS. , 2 and 3. When placed in the expanded position, the previously determined shape is preferably adapted to cover an external surface area of a target tissue to be dosed with the radiation. The movement of the liquid retention element 20 between the open and closed positions can be achieved by a variety of techniques. Although the liquid retention element 20 is preferably inflated using a liquid, air or a source of radiation, movement can optionally be achieved by using a drive element (not shown), such as a cable, pulley assembly, lever or a similar apparatus, effective to move the liquid retention element to one of the open or closed positions. A person skilled in the art will readily appreciate that a variety of different actuation elements can be used to position the liquid retention element 20 within the patient adjacent to the extraction site, to move the liquid retention element 20 between the open and closed positions. closed. In an exemplary embodiment, the liquid retention element 20 is an expandable balloon element having a predetermined shape in the expanded position. It should be understood that the term "balloon" is intended to include apparatus that can be stretched, which may be, but is not necessarily constructed of, an elastic material. In an alternative embodiment, the liquid retention element 20 can be formed of a shape memory material, in which the liquid retention element 20 has a three-dimensional shape in the open position and a substantially substantial shape. bent in the closed position. Without intending any limitation, the liquid retention element 20 may be formed from a wall of polymeric film, which may comprise a biocompatible radiation-resistant polymer. Suitable polymers include, for example, silicas, polyurethanes, polyethylene, polypropylene, polyester and PVC. Still further, the liquid retention element 20 can be formed in accordance with the balloon and / or expandable surface elements thereof described in US Patent No. 6,41 3,204, which is incorporated in its entirety to the present description. as reference. The present invention also provides a method for treating a target tissue through an external surface area of the target tissue. FIGS. 5A to 5C illustrate one embodiment of a method for using a brachytherapy apparatus to treat a tumor of the lung removed by the application of a brachytherapy apparatus to an external surface of the tumor. In Figure 5A, the cancerous tissue has been excised from the lung creating an excised cavity or "wedge" 50. After the wedge-shaped resection, the cavity 50 is closed sutured or stapled, as shown in Figure 5B, which illustrates the sutures 52. The brachytherapy apparatus according to the present invention can be placed intra-operatively within the patient's body and the liquid retention element can be placed on an external surface of the lung close to the sutured resection site 52 (an externally determined surface area). If the liquid retention element 20 is introduced in a closed configuration, the liquid retention element 20 can be inflated or otherwise moved to the open position, at which point it is preferably adhered to the tissue using one or more anchor elements. 28 from a to d. Inflation can be achieved with air or other liquids, such as saline or a radiation-absorbing liquid, such as a contrast medium used in angiography, or alternatively, the radioactive liquid may be pre-loaded into the liquid-retaining element prior to anchoring the liquid-retaining element to the liquid. tissue. However, preferably the radioactive liquid is introduced into the liquid retention element 20 after it is anchored to the tissue surface. The radioactive source remains in the liquid retention element 20 until the prescribed dose of radiotherapy is administered, or the radioactive source can be inserted for prescribed amounts of time on a daily scheduled basis or otherwise until the dosage has been achieved. prescribed The radioactive source is then recovered and the catheter is removed. The application of radiotherapy using a radioactive source may also be performed in accordance with many descriptions and examples provided in US Patent No. 6,413,204, issued July 2, 2002, and entitled "Apparatus and Method of Interstitial Brachytherapy for the Treatment of Disorders. Proliferative Fabrics ", which has been incorporated into the present description as reference above. The radiation treatment may end at the time of the removal of the brachytherapy device, or the brachytherapy may be supplemented by additional doses of radiation supplied externally. By way of non-limiting example, the radioactive material can be a liquid made from any solution of radionuclide (s), for example, a solution of 1-125 or 1-131 or a radioactive liquid that can be produced using a paste of particles small ones containing a suitable liquid of solid radionuclides, such as Au-198, Y-90. In addition, radionuclides can be incorporated into a gel. A radioactive material useful in the present invention is the sterile single-use lotrex ™, a sodium 3- (125l) iodo-4-hydroxybenzenesulfonate (1251-HBS) containing a non-pyrogenic solution for single use, which is available from Proxima Therapeutics, Inc., of Alpharetta, Georgia. In addition, the radiation source employed in the brachytherapy apparatus and the method of the present invention may be a source of solid radiation or other non-liquid form, such as an x-ray emitter. Again, by way of non-limiting example, a solid radiation source for use with the present invention could include radioactive microspheres of the type available from 3M Company of St. Paul, Minnesota. This radioactive source can be either pre-loaded inside the catheter at the time of its manufacture or loaded into the device after it has been implanted. The solid radiation emitting material can be inserted through the catheter 12 into a cable, for example, using a back charger (not shown). This configuration of the solid radioactive core offers the advantage that it allows a wider range of radionuclides than if it is limited to liquids. Said radionuclides that could be used with the administration apparatus of the present invention are generally present as sources of brachytherapy radiation. In this embodiment, the solid spherical radiation source is surrounded by a liquid retention element 20, defining a spatial volume between the radiation source and the liquid retention element that can be occupied by the radioactive radiation absorbing material, such as air, water or a contrast material. In a further embodiment, the radiation source, instead of comprising a single solid sphere, may comprise a plurality of radiation emitting particles 44 strategically placed within the liquid retention element 20 so as to radiate in all directions, or more particularly towards the target tissue through the contact surface of the fabric 24 with a substantially equal intensity. This plurality of radiation emitting particles can be mounted at the distal end of a plurality of wires that are routed through the catheter body 12 and exit a plurality of ports formed through the wall of the catheter port. This adaptation allows the exact placement of the individual radiation sources to generate a desired resulting profile. One skilled in the art will appreciate that the above description is only illustrative of the principles of the present invention, and those skilled in the art can make various modifications without departing from the scope and spirit of the present invention. All references cited herein are expressly incorporated by reference in their entirety.

Claims (52)

1. CLAIMS 1.- A brachytherapy apparatus for the treatment of a target tissue through an external surface area of the target tissue, which comprises: an insertion element having a proximal portion, a distant portion and at least one lumen that extends through it; and a liquid retention element coupled to the distal portion of the insert that has a first surface that is formed to take the form of a predetermined external surface area of a tissue to be treated and a cavity formed in the same in fluid communication with said at least one lumen of the insertion element. wherein the brachytherapy apparatus is adapted to receive a radiation source through at least one lumen within the cavity of the liquid retention element to deliver radiation to the tissue to be treated.
2. 2. The apparatus as described in claim 1, characterized in that the liquid retention element includes a plurality of anchor elements distributed around the periphery of the first surface to anchor the first surface to an external surface area. of a fabric that is going to be treated.
3. 3. The apparatus as described in claim 2, characterized in that the plurality of anchor elements are selected from the group consisting of eyelets, a hook, an adhesive and a combination thereof.
4. 4. The apparatus as described in claim 1, characterized in that the liquid retention element is formed to provide a uniform radiation dose throughout the first surface when the liquid retention element is filled with a radioactive liquid. .
5. 5. The apparatus as described in claim 1, characterized in that the source of radiation received through at least one lumen is a source of solid radiation.
6. 6. The apparatus as described in claim 1, characterized in that the source of radiation received through at least one lumen is in the form of a gas.
7. 7. The apparatus as described in claim 4, which further comprises a source of radiation in the form of a liquid and wherein the liquid retention element is effective to removably receive the source of radiation.
8. 8. - The apparatus as described in claim 1, characterized in that the first surface is substantially planar.
9. 9. The apparatus as described in claim 1, characterized in that the liquid retention element includes a second surface opposite the first surface and a peripheral wall extending between the first and second surfaces to define a cavity in the same.
10. 10. The apparatus as described in claim 9, characterized in that the peripheral wall has a substantially uniform depth.
11. 11. The apparatus as described in claim 9, characterized in that the liquid retention element has substantially the disc shape.
12. 12. The apparatus as described in claim 9, characterized in that at least a portion of at least one of the second peripheral wall surfaces are radiopaque to protect the non-target tissue from radiation.
13. 13. The apparatus as described in claim 1, characterized in that the liquid retention element can move between a closed position in which the liquid retention element is placed adjacent to the insertion element, and the position open in which the liquid retention element extends outwardly of the insertion element.
14. 14. The apparatus as described in claim 13, characterized in that the liquid retention element is an expandable balloon element that is inflated in the open and deflated position in the closed position.
15. 15. The apparatus as described in claim 14, characterized in that the expandable balloon element has a previously determined shape in the open position so that, when inflated, the expandable balloon element is effective to cover a predetermined tissue area.
16. 16. The apparatus as described in claim 15, characterized in that the predetermined shape of the expandable balloon element is substantially a disk shape.
17. 17. The apparatus as described in claim 13, characterized in that the liquid retention element is formed of a shape memory material and wherein the liquid retention element has a three-dimensional shape in the open position and a shape substantially bent in the closed position.
18. 18. The apparatus as described in claim 17, characterized in that the liquid retention element has substantially the disc shape in the open position.
19. 19. The apparatus as described in claim 1, characterized in that the insertion element is a flexible catheter.
20. 20. The apparatus as described in claim 1, characterized in that the tissue to be treated is a lung.
21. 21. A liquid retention element apparatus comprising: an elongated catheter element having a proximal portion, a distal portion and at least one lumen extending therethrough; a balloon element positioned around the distal portion of the elongate catheter element and having a cavity formed therein and which is in fluid communication with at least one lumen in the elongate catheter, the balloon element having a first surface of contacting the formed tissue to take the form of a predetermined external surface area of the tissue to be treated; and a source of radiation in the form of a liquid placed within the balloon cavity.
22. 22. The apparatus as described in claim 21, characterized in that the balloon element includes a plurality of anchor elements distributed around a periphery of the first surface to anchor the first surface to an external surface area of an tissue that is going to be treated.
23. 23. The apparatus as described in claim 22, characterized in that the plurality of anchor elements are selected from the group consisting of eyelets, a hook, an adhesive and a combination thereof.
24. 24. The apparatus as described in claim 21, characterized in that the balloon element is formed to provide a uniform radiation dosage throughout the first surface.
25. 25. The apparatus as described in claim 21, characterized in that the first surface is substantially planar.
26. 26. The apparatus as described in claim 21, characterized in that the balloon element includes a second surface opposite the first surface and a peripheral wall extending between the first and second surfaces to define a cavity therein. .
27. 27. The apparatus as described in claim 26, characterized in that the peripheral wall has a substantially uniform depth.
28. 28. The apparatus as described in claim 26, characterized in that the balloon element has substantially the disc shape.
29. 29. The apparatus as described in claim 26, characterized in that at least a portion of at least the first surface and the peripheral wall are radio-opaque to protect the non-target tissue from radiation.
30. 30. The apparatus as described in claim 21, characterized in that the balloon element can move between a deflated closed position in which the liquid retention element is placed adjacent to the insertion element, and the open position inflated in which the liquid retention element extends outwardly from the insertion element.
31. 31. The apparatus as described in claim 30, characterized in that the expandable balloon element has a previously determined shape in the open position so that when inflated, the expandable balloon element is effective to cover an area of the balloon. previously determined tissue.
32. 32. The apparatus as described in claim 31, characterized in that the predetermined shape of the expandable balloon element is generally substantially of a disc shape.
33. 33. The apparatus as described in claim 21, characterized in that the insertion element is a flexible catheter.
34. 34.- A brachytherapy apparatus for the treatment of a target tissue through an external surface area of the target tissue, which comprises: an item of function having a proximal portion, a distant portion and at least one lumen that extends through it; and a balloon element coupled to the distal portion of the insert and having a first surface formed to take the form of an area of its predetermined external surface of a tissue to be treated, and a first and second cavities formed therein, each cavity in fluid communication with at least one lumen in the operating element; wherein the brachytherapy apparatus is adapted to receive a radiation source through a lumen within at least one of the first and second cavities of the fluid retention element to deliver radiation to the tissue to be treaty.
35. 35.- The apparatus as described in claim 34, characterized in that the first cavity is placed between the second cavity and the tissue to be treated.
36. 36.- The apparatus as described in claim 35, characterized in that the first cavity is effective to separate a radiation source placed in the second cavity at a distance from the surface of the tissue.
37. 37. The apparatus as described in claim 35, characterized in that the first cavity is adapted to receive and administer a therapeutic agent to the tissue to be treated.
38. 38. The apparatus as described in claim 37, characterized in that the first surface is formed of a porous material for administering a therapeutic agent.
39. 39. The apparatus as described in claim 37, characterized in that the therapeutic agent is selected from the group consisting of a chemotherapy agent, an anti-neoplastic agent, an anti-angiogenesis agent, an agent in a regulator, a hormonal agent, a non-therapeutic agent, an antibiotic and combinations thereof.
40. 40. - A method for treating a target tissue through an external surface area of the target tissue which comprises: providing at least one brachytherapy apparatus for administering radioactive emissions, having the apparatus: an element of catheters that have a proximal end and a distal end and at least one lumen that extends through it; at least one liquid retention member positioned near the distal end of the catheter element, the retention member providing a cavity formed therein in com- munication with at least one lumen in the member. of catheter and a first surface formed to take the form of an area of its previously determined external surface of a tissue to be treated; placing intra-operatively said at least one brachytherapy apparatus on an outer surface of the tissue of a tissue to be treated; introducing a controlled dose of a radiation source through at least one lumen of the catheter to the fluid retention element for treating the tissue.
41. 41. The method as described in claim 40, characterized in that the source of radiation is placed inside the brachytherapy apparatus after placing the apparatus on a tissue surface.
42. 42. The method as described in claim 40, which further comprises the steps of removing the radiation source from the apparatus and removing the apparatus.
43. 43. The method as described in claim 40, which further comprises the step of ad wounding the fluid retention element to an area of its previously determined external surface of a tissue that is to be treaty.
44. 44. The method as described in claim 43, characterized in that the liquid retention element is adhered to a predetermined external surface area of a tissue to be treated using a clamping apparatus selected from the group. of staples, sutures, fasteners, bolts, nails, screws and combinations thereof.
45. 45. The method as described in claim 40, characterized in that the liquid retention element is effective to removably receive the source of radiation and where the radiation source is in a liquid form.
46. 46.- The method as described in claim 40, characterized in that the liquid retention element can be moved from a closed position in which the liquid retention element is placed adjacent to the catheter element and a position open in which the liquid retention element extends outwardly from the catheter element.
47. 47. The method as described in claim 46, characterized in that the liquid retention element is an expandable balloon element that is inflated in the open and deflated position in the closed position.
48. 48. The method as described in claim 47, characterized in that the expandable balloon element has a predetermined shape in the open position so that, when inflated, the balloon element is effective to cover a balloon. area of its external surface previously determined of a tissue that is going to be treated.
49. 49. The method as described in claim 48, characterized in that the predetermined shape of the balloon element is substantially a disk shape.
50. 50.- The method as described in claim 40, characterized in that the liquid retention element is formed of a shape memory material and wherein the liquid retention element has a three dimensional shape in the position open and a shape substantially bent in the closed position.
51. 51. The method as described in claim 50, characterized in that the liquid retaining element substantially has a disc shape in the open position.
52. 52. The method as described in claim 40, characterized in that the liquid retention element has a size adapted to receive a predetermined amount of a liquid radiation source.