MXPA06005060A - Implantable radiotherapy/brachytherapy radiation detecting apparatus and methods - Google Patents

Abstract

An interstitial brachytherapy apparatus and method for delivering and monitoring radioactive emissions delivered to tissue surrounding a resected tissue cavity. The brachytherapy device including a catheter body member having a proximal end, a distal end, and an outer spatial volume disposed proximate to the distal end of the body member. A radiation source is disposed in the outer spatial volume and a treatment feedback sensor is provided on the device. In use, the treatment feedback sensor can measure the radiation dose delivered from the radiation source.

Description

METHODS AND APPARATUS RADIATION DETECTOR IMPLANTABLE FOR RADIOTHERAPY / BRAQUIOTERAPIA Field of the Invention The present invention generally relates to apparatus and methods for use in the treatment of tissue proliferative disorders and more particularly, apparatus and methods for the treatment of said disorders by administering radiation with a brachytherapy apparatus that also measures the characteristics of the treatment. BACKGROUND OF THE INVENTION Malignant tumors are often treated by surgical removal 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 the radiation to the target of residual malignant cells after resection, with the goal of sterilizing them, reducing the index of recurrence or delaying the time for recurrence. Radiation therapy can be administered through one of several methods or a combination of methods, including permanent or temporary interstitial brachytherapy and external beam radiation. Brachytherapy refers to radiation therapy administered by a spatially confined source of therapeutic rays inserted into the body at, or near, a tumor or other site of tissue proliferative disorder. For example, brachytherapy can be performed by planting the radiation sources directly into the tissue to be treated. Brachytherapy is most appropriate where 1) the new growth of the malignant tumor occurs locally, within 2 or 3 cm of the original lm of the primary tumor site; 2) Radiation therapy is a proven treatment to control poorly ignored tumor growth; and 3) there is a response relationship to the radiation dose for malignant tumor, but the dose that can be ad- ministered in a manner consistent with conventional external beam radiotherapy is limited by tolerance or normal tissue. In brachytherapy, radiation doses are higher in close proximity to the radiotherapeutic source, providing a high dose to the tumor while spreading into the normal tissues surrounding it. Brachytherapy is useful for the treatment of malignant tumors of the brain and chest, among others. The prior art brachytherapy apparatuses have provided a number of advances in the ad ministration of radiation to the target tissue. For example, in the North American Patent No. 6,41 3,204 awarded to Winkler describes a brachytherapy method and apparatus for the treatment of tissue surrounding a surgically excised tumor with radioactive emissions to kill cancer cells that may be present in the tissue surrounding the tumor. Your mor removed. The radiation is administered in a predetermined dose range defined as being between a minimum prescribed absorbed dose for the administration of therapeutic effects to the tissue which may include cancerous cells and a maximum prescribed absorbed dose above which it may result. necrosis of healthy tissue. The resulting treatment helps prevent overexposure to tissue in and near the brachytherapy apparatus and still administering the prescribed minimum dose at the maximum prescribed distance from the apparatus. Although these advances have improved the treatment of tissue proliferative disorders, there are still some challenges. Currently, the desirable radiation dose is calculated based on the characteristics of the braq uiotherapy applicator (apparatus), the radiation source, and the tissue surrounding the morphology., although the actual dose administered is not tested to ensure that an envelope and / or sub-treatment does not occur. For example, if the radiation source is a radioactive seed placed in the center of an expanded balloon, the calculated dose is based on the central placement of the radiation source. If for some reason the radioactive seed was placed outside the center, the prior art brachytherapy apparatus does not have the means to determine that this dangerous situation has occurred or is occurring. The prior art brachytherapy apparatus also lack the ability to directly sense the tissue surrounding the tumor and determine the effectiveness of the treatment of the tissue proliferative disorder. SUMMARY OF THE INVENTION The present invention provides an apparatus and methods of brachytherapy to administer and monitor radioactive emissions to an internal location of the body. The apparatus includes a catheter body element having a proximal end, a distal end and an outer spatial volume positioned near the distal end of the body member. A radiation source is preferably placed in the outer spatial volume and a feedback sensor of the treatment is placed in the apparatus. In one embodiment, the treatment feedback sensor is a radiation sensor which can detect the radiation emitted by the radiation source. The radiation sensor preferably produces useful data to determine if the radiation dose administered was within the prescribed range. The data may also be preferably used to determine if the desired radiation profile was delivered to the tissues surrounding the tumor. In another aspect of the present invention, the treatment feedback sensor has the ability to detect tissue temperature, oxygenation, pH, concentration of the treatment agent, concentration of cytokines, and other characteristics related to radiation treatment. In one embodiment, the treatment feedback sensor is placed within the catheter body member. Other locations where the sensor may be preferably located include placement in an element of its expandable surface which defines the outer or outer space of the apparatus. In another embodiment, the present invention includes a radiation therapy apparatus for administering and monitoring radioactive emissions to a cavity of an extenuated body. The apparatus includes an element of the catheter body with proximal and distal ends, an element of its expandable surface placed near the distal end of the catheter body, a feedback sensor of the treatment and an external radiation source placed outside the catheter. tissue cavity to deliver radiation to the target tissue that surrounds the tissue cavity. The expandable surface element may be placed within the cavity of the excised tissue and expanded to position the surrounding tissue so that the administration of the radiation beam of the external radiation source is ad ministered and accurately measured by the patient. retro-sensing sensor of the treatment placed inside the tissue cavity. In another embodiment, the present invention includes the method of administration and monitoring of radioactive emissions to an internal location of the body. The method includes inserting a brachytherapy apparatus into the expanded cavity, the brachytherapy apparatus including a catheter body member with proximal and distal ends and an expandable surface element positioned near the distal end of the catheter body member. Preferably a radiation source is placed within the expandable surface element. The method further includes inserting a radiation sensor into the excised cavity and administering a minimum dose of absorbed radiation prescribed to a target tissue., the target tissue being defined between the expandable surface element and a minimum distance away from the expandable surface element. The radiation sensor senses the dose of radiation administered and the sensor data output confirms that the brachytherapy apparatus administers the minimum prescribed dose.

In another embodiment, the present invention includes a brachytherapy apparatus for administering and monitoring radioactive emissions to an internal location of the body. The apparatus includes a catheter body element having a proximal end, a distal end and an outer spatial volume positioned near the distal end of the body member. A radiation source is placed in the outer spatial volume and a feedback sensor of the treatment is provided in the apparatus. The feedback sensor of the treatment can be used to evaluate the treatment of tissue proliferative disorders. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings: Figure 1 illustrates the apparatus of the present invention which includes a sectional view of the external spatial volume that shows the radiation sensors placed on it; Figure 2 illustrates another embodiment of the brachytherapy apparatus of the present invention shown in perspective; Figure 3 illustrates another embodiment of the brachytherapy apparatus of the present invention shown in a full view; Figure 3A illustrates a cross-sectional view of the apparatus illustrated in Figure 3; Figure 4 illustrates another embodiment of the brachytherapy apparatus of the present invention shown in a complete view; and Figure 5 illustrates another embodiment of the brachytherapy apparatus of the present invention shown in a full view. Detailed Description of the Invention The present invention provides interstitial brachytherapy devices that can administer radioactive emissions used to treat tissue proliferative disorders and detect the characteristics of the treatment to monitor the treatment regimen. The apparatuses include a catheter body element with a proximal end, a distal end and an inner lumen. The outer spatial volume is placed near the distal end of the body member having preferably placed a source of radiation therein. A sensor of feedback of the treatment is placed in the device. Brachytherapy devices treat tissue proliferative disorders, such as your cancerous mores, by administering radiation to the target area which contains both cancer cells and healthy tissues. Radiation destroys most radiosensitive cells, that is, cancerous cells, although it is expected that the damage to the healthy salt tissue surrounding them will be minimized. The most effective treatment delivers a dose above the minimum radiation dose needed to destroy the proliferative tissue and below the maximum radiation dose to limit damage to healthy tissues. In addition to administering a radiation dose within the appropriate range, brachytherapy devices can also deliver the radiation in a desired pattern. For example, one may wish to administer radiation in a uniform three-dimensional profile. During use, the desired radiation dose is calculated based on factors, such as the position of the radiation source, the type of radiation used and the characteristics of the tissue and the brachytherapy device. The brachytherapy apparatus is then placed inside the tissue cavity and is ad ministered to the dose. Unfortunately, variations in the brachytherapy apparatus in the surrounding tissue or in the placement of the radiation source which may affect the dose administered. For example, in some cases the source of radiation is charged into the brachytherapy apparatus after the device has been placed inside the tissue cavity, but if the radiation source is incorrectly placed during the process. load, the surrounding tissue may not receive the desired treatment. The present invention overcomes these difficulties by placing a retroalimentation sensor in the brachytherapy apparatus. In a modality, the treatment feedback sensor is a radiation sensor that can monitor the administered dose and ensure that the dose of radiation prescribed to the correct tissue is ad mistered. In addition, the radiation sensor data allows the dose to be modified based on the feedback of an initial fraction of radiotherapy / brachial therapy. In addition to detecting radiation, or as an alternative, the treatment feedback sensor can detect other features related to the treatment of tissue proliferative disorders. For example, the treatment feedback sensor could detect tissue changes caused by radiation treatment including changes in tissue temperature, oxygenation, pH and concentration of cytokines. By monitoring these characteristics, the effectiveness of the treatment can be analyzed. In addition, the radiation treatment can be combined with other complementary treatments, such as heating the tissue and / or administering a treatment agent (for example, a drug of imiotherapy). The treatment feedback sensor can be used to monitor supplementary treatment regimens. For example, the sensors can be used to detect the administration of a treatment agent, for example, the flow of a chemotherapy drug that is being administered to the tissue surrounding the tumor or to detect changes in tissue caused by the supplemental treatment. , for example, changes in tissue temperature. Figure 1 illustrates an embodiment of the brachytherapy apparatus 10 of the present invention that includes a catheter body member 16 having a proximal end 12, a distal end 14 and an interior lumen 18. The outer spatial volume 20 is preferably placed at the distal end of the catheter body element 16. The proximal end of the catheter body 16 preferably includes a handle portion 22 for manipulating the apparatus and a port 24 which opens the interior lumen 18. At least one sensor is placed of the treatment 26 in the apparatus and can be placed within the body member of the catheter 16 as shown in figure 1. Further, a radiation source (not shown) is preferably placed within the outer spatial volume 20. The volume outer space 20 is preferably defined by an expandable surface element 28 which can be used to position the fabric, provide the space between the radiation source and the adjacent tissue and / or supply the content of the materials of the radiation source. In addition, the sensor 26 (or sensors 26) can be placed on the expandable surface element 28 as shown in Figure 2. A person skilled in the art will appreciate that placement of the sensor 26 on the expandable surface element could include placing it on the interior and exterior surface of the element of its expandable surface 28, as well as placing the sensor inside the wall of the expandable surface element 28. In one embodiment, the feedback sensor of the treatment placed on the expandable surface element can perceive radiation ("radiation sensor"). A radiation sensor may be preferable to provide an accurate view of the strength of the radiation as it leaves the apparatus. Other types of sensors can also be placed on the expandable surface element to detect the effect of radiation on the surrounding tissue. The sensor may also have the ability to perceive other features of the treatment of the tissue in contact with the element of its expandable surface. A variety of expandable surface elements can be used with the present invention and in one embodiment, the expandable surface element 28 is a balloon that can be inflated. It should be understood that the term "balloon" is intended to include devices that can be stretched which may be, but do not need to be constructed from an elastic material. Example balloons include a variety of stretchable devices designed for use with surgical catheters. During use, the balloon can be expanded by injecting the inflation material through the catheter body member 6 and into the balloon by means of an inflation port 34 in the catheter body member. In one embodiment, the balloon is constructed of a solid material that is substantially impermeable to the active components of the treatment liquid (e.g., the material of the radiation source), with which it can be filled and is also waterproof to bodily fl uids, for example, blood loss, cerebrospinal fluid and the like. A non-permeable balloon is useful in conjunction with a radioactive treatment fl uid to prevent radioactive material escaping from the treatment apparatus and contamination of the surgical field or tissues of the patient. In another embodiment, the balloon is permeable to a treatment agent and allows the treatment agent to pass out of the apparatus 10 and into the lumen of the body, the body cavity or the anatomic site of the location of the apparatus. The permeable balloon is useful when the treatment agent is a drug such as, for example, a chemotherapeutic drug so that it is effective with the majority of contact with the tissue. US Pat. Nos. 6,537,194 issued to Winkler and 5,931,774 issued to Williams et al., Describe exemplary permeable balloons and treatment substances and are incorporated herein by reference in their entirety. The feedback sensor of the treatment can be used to monitor the passage of the treatment agent out of the permeable balloon. For example, the feedback sensor of treatment 26 could be placed on the balloon to measure the concentration of the treatment agent. An additional sensor could also be placed in or on the apparatus surrounding the tissue 10 to detect the concentration of the treatment agent. By placing the feedback sensor of the treatment in the apparatus, a user can monitor the administration of a treatment material of the apparatus to the surrounding tissue. The sensor could be used to find information on the rate of administration, the amount of administration, the uniformity of administration, and other dosage administration. Such a sensor can be particularly helpful because it can overcome the difficulty in determining the amount of treatment agent that is being administered and where it is being administered. Currently, the rate of administration of the treatment agent is determined indirectly by measuring factors, such as the pressure applied to the fluid and / or the change in the volume of the fluid. The feedback sensors of the treatment of the present invention allow direct measurement of the treatment agent as it leaves the apparatus. A treatment agent can also be administered from the balloon surface to the tissue surrounding it. Application for a North American Patent entitled "Methods and Apparatus for Brachytherapy that Use the Drug", legal file number 1 01 360-63; describes said apparatuses and is incorporated in its entirety in the present description as a reference. A feedback sensor of the treatment can be used to detect the administration of a treatment agent from the surface of the balloon to the surrounding tissue. A sensor placed in a layer of the treatment material placed on the outer surface can preferably perceive the amount of treatment agent that has been administered and / or the amount that remains. The sensors are useful to determine when the treatment agent has been completely administered. When multiple treatment agents are layered on the outer surface of the balloon, the sensor is also useful for sensing which treatment agent is being administered. The sensor could also be used to detect the level of the treatment agent in the adjacent tissue. The invention also contemplates the use of multiple balloons, for example, a double wall structure as illustrated in Figure 3. Said balloon may comprise, for example, an inner balloon 30 containing an interior spatial volume 32 which is being placed inside. of an outer balloon 28 and the outer balloon defines the external spatial volume 20 as the space between the inner wall and the outer wall. Outer spatial volume 20 preferably is in fluid communication with the first inner lumen 18 through the first inflation port 34, while the inner spatial volume 32 is preferably in fluid communication with the second inner lumen 36 by means of the second inflation port 38. The first and second interior lumens 18, 36 are shown by the cross-sectional view of the catheter body element 16 of Figure 3A. A double-walled balloon (or even a balloon of a higher order, eg, triple wall) provides more options for controlling and directing the radiation dosage. For example, a double-walled balloon can provide the space between the radiation source and the adjacent tissue, so that more powerful radiation sources can be used (See, for example, US Pat. Nos. 5,913,813 issued to Williams et al. and 6,413,204 granted to Winkler et al., which are incorporated in their entirety as reference to the present description.While a source of "warmer" radiation allows the administration of a deeper absorbed dose in the targeted tissue and reduces the risk of healthy tissue necrosis, proper separation and placement of the source of radiation is important, therefore, the sensor 26 of the present invention can provide useful feedback to ensure that the walls of the balloons and balloons are correctly configured. source of radiation, in particular, a feedback sensor can be used in treatment that senses radiation for To detect radiation levels and determine if any area is receiving too much or too little radiation. Other sensors could be used to indirectly determine separation and correct placement by monitoring the characteristics, such as the temperature of the tissue. In some applications, the brachytherapy apparatus 10 is designed to produce a dosage profile consistent with the shape of the outer spatial volume. That is, the dose absorbed within the target tissue at the equidistant points of the surface of the outer spatial volume must be substantially uniform in substantially each one of the directions creating three-dimensional isodose profiles substantially similar in shape to the outer spatial volume . In addition, the expandable surface element of the outer spatial volume may be firm enough to force the target tissue into the shape of the expandable surface element. With the tissue formed in this way, the tissue surrounding the tumor receives a dose of radiation. The feedback sensors of the treatment placed in the apparatus of the present invention can be used to confirm that the tri-di mensional isodose profile is generated and that it is delivered to the surrounding tissue. The sensors may be particularly useful where the expanded surface element is used to form the walls of the tissue cavity. Although imaging techniques can confirm the relative position of the tissue cavity and the brachytherapy apparatus, the treatment feedback sensors can provide a real dosing information to ensure that the tissue and the apparatus do not change during the treatment. The procedure. Although the sensors can be placed anywhere on the apparatus, it may be desirable to place the treatment feedback sensors that sense the radiation in the expandable surface element, as shown in Figure 3 to directly test the radiation levels that leave the surface of the apparatus (for example, all radiation sensor readings must be simply equal). In an alternative embodiment, it may be desirable to administer an asymmetric radiation dose to protect the radiation-sensitive tissues. Two possible adaptations for administering an asymmetric dose include the protection of the radiation and / or the placement of the radiation source in an asymmetric configuration, as described in US Pat. No. 6,482. , 142 granted to Win kler et al. , which is incorporated in its entirety as reference to the present description. For example, protection can be achieved when all or a portion of the element of its expandable surface is formed from, or coated with, a radiopaque material. The asymmetric isodose profile can also be created by the relative position of the radiation source or sources between them and towards the outer spatial volume. The administration of an asymmetric dose is an additional challenge because the dose of radiation is focused in one region and protected from another. If the device is placed incorrectly inside the tissue cavity or if the radiation profile has an unexpected shape, the sensitive tissue could be damaged. Therefore, the treatment feedback sensors can help to protect radiation sensitive tissue by confirming correct protection and proper placement of the 1 0 device. Although the sensors may be located anywhere on the device to provide the necessary Dosing information, the sensors placed to the outside or the outside of the apparatus 1 0 can provide valuable data with respect to the amount of radiation reaching the sensitive tissue. In one embodiment, the treatment feedback sensor which senses radiation may be placed in the wall of a tissue cavity in the area in which protection is needed. The radiation source of the present invention preferably includes any radiation source, which can deliver radiation to treat tissue proliferative disorders. Examples of radiation sources include high-dose brachytherapy radiation, medium-dose brachytherapy radiation, low-dose brachytherapy radiation, dose-driven rate brachytherapy radiation, external beam radiation, and combinations thereof. Although the apparatus of the present invention is described with reference to radiation sources placed within the apparatus, possible sources of radiation may include external radiation sources placed outside the apparatus or the patient's body such as IMTR, 3-D conformation, orthovoltage, stereotactic radiation and combinations thereof. In a modality, the apparatus 10 treats tissue proliferative disorders using the expandable surface element to position and / or stabilize the tissue surrounding the tissue cavity and then deliver the radiation from an external source to the tissue cavity. The North American Patent Application entitled "SYSTEMS AND METHODS FOR PLACING TISSUES FOR USE WITH RADIATION THERAPY", legal file number 101360-64, describes said apparatuses and is incorporated in its entirety to the present description as a reference. The feedback sensors of the treatment placed in the apparatus can provide feedback to ensure that the prescribed dose is delivered to the placed tissue. The radiation source can also be placed within the brachytherapy apparatus 10 and even more preferably, it can be placed within the outer spatial volume 20. In particular, the radiation source can be placed within the interior spatial volume 32, within the spatial volume external 20, for example, inside an inner balloon, as shown in Figure 3. The radiation source may include previously determined radionuclides, for example, 1-125, 1-131, Yb-169 and other sources of radiation, such as radionuclides that emit photons, beta particles, gamma radiation and other therapeutic rays including x-ray radiation (for example, man-made radiation sources, such as miniature x-ray generators or linear accelerators). The radioactive material contained within the outer spatial volume can be a liquid made from any solution of radionuclides, for example, a solution of 1-125 or 1-131. The radioactive liquid can also be produced using a paste of a suitable fluid containing small particles of solid radionuclides, such as Au-198, Y-90. In addition, radionuclides can be incorporated into a gel. One skilled in the art will appreciate that various sources of radiation can be used with the brachytherapy apparatus of the present invention. In another embodiment, the radiation source can be a solid spherical radiation emitting material 40 placed within the body element of the catheter 16, as shown in Figure 4. For example, radioactive microspheres of the type achieved in 3M. Company of St. Paul, Minn., Can be used. The radioactive source can be either pre-loaded into the catheter body element at the time of manufacture or loaded into the apparatus after it has been implanted into the space previously occupied by the excised tumor. The solid radiation emitting material 40 can be inserted through the catheter 1 6 into a cable 42, for example, using a rear charger (not shown). Such a solid configuration of the radioactive nucleus offers an advantage because it allows a wider range of radionuclides than if it is imitated in liquids. The solid radionuclides that could be used with the apparatus of the present invention are generally currently obtained as radiation sources of brachytherapy. The feedback sensors of the treatment can provide valuable information regarding the characteristics of the radiation source. For example, a radiation perception sensor may be used to provide data on the location of the material of the radiation source after it is loaded into the apparatus. These data can then be used to calculate the radiation dose and / or to alert users if the material of the radiation source is incorrectly charged. Useful radiation sensors can be placed in any part of the apparatus including the catheter body member 6 and the expandable surface element 28. In one embodiment, the radiation sensor (or sensors) is placed in the body of the catheter body. catheter to detect when the material of the radiation source is correctly placed. For example, as shown in Figure 4, the sensors can be placed at the point on the element of the catheter body where it is desired to place the radiation emitting material 40. When the sensor reaches its maximum radiation reading the The user will know that the radiation emitter material is positioned correctly. The catheter body element 1 6 of the apparatus 1 0 provides means for placing the outer spatial volume 20 within the cavity of the excised tissue and presents a path for the delivery of the material from the radiation source and the inflation material. (if it is used). Although the exemplary catheter body elements illustrated in the figures have a tubular construction, one skilled in the art will appreciate that the catheter body member 16 can have a variety of shapes and sizes. Catheter body elements suitable for use in the present invention may include catheters, which are known in the art. Although the catheter body element 1 6 can be constructed from a variety of materials, in one embodiment, the material of the catheter body element is silicone, preferably a silicone which is at least partially radio-opaque. , thereby facilitating the location of x-rays of the catheter body element 1 6 after insertion of the apparatus 1 0. The catheter body member 1 6 may also include conventional adapters for attachment to a liquid receptacle. of treatment and the balloon, as well as apparatuses, for example, straight angle apparatuses, to take the shape of the body element of the catheter 1 6 to the contours of the patient's body. As shown in Figure 1, the feedback sensors of the treatment 26 can be placed within the body member of the catheter 1 6 to provide information on the treatment of a proliferative tissue disorder that is being administered to the patient. The sensor or sensors may be placed within any interior lumen (eg, first interior lumen 1 8) of the catheter body member 1 6. Alternatively, the sensors 26 could be placed within the element wall. of the catheter body 16 or on the outside of the catheter body element. The multiple sensors 26, which are shown in Figure 1, may be preferable to improve the accuracy and provide a more detailed photograph of the therapy. In one embodiment, a separate radiation sensing sensors 26 can provide data from points along the entire trajectory of the brachytherapy apparatus 10. Preferably, the sensors 26 are placed at intervals of approximately 1 cm.

The feedback sensor of the treatment 26 used with the apparatus of the present invention preferably includes radiation sensors capable of detecting and / or measuring the radiation administered by brachytherapy apparatus or external beam radiotherapy. Example radiation i includes the penetration of emissions, such as gamma rays, x-rays and non-penetrating emissions, such as beta particles (negative and positive), alpha particles, protons and combinations thereof. Preferably, the radiation sensors have the ability to measure radiation in a range of about 1.0 Gy to 400 Gy. An example radiation sensor may include the MOS FET sensor, diode dosimeters, ionization chambers, inert thermumum dosimeters and combinations thereof. The radiation sensor should preferably be small enough to be placed in the brachytherapy device. For example, the sensor can be in a range of approximately 0.01 mm to 3.0 cm in the longest dimension. The preferred sizes for the individual sensors is 1 mm by 1 μm by 3 μm, or smaller in any of these dimensions. In addition to the ability to perceive the radiation, or as an alternative, the treatment feedback sensor 26 can preferentially detect other physical properties, such as temperature, tissue oxygenation, pH, drug concentration, cytokine concentration and / or other tissue properties. The treatment feedback sensor 26 may be placed in the brachytherapy apparatus 10 in a variety of ways by fixing the sensor to the apparatus. By coupling the sensor with the apparatus, the location of the apparatus is known and the sensor and the brachytherapy apparatus can be inserted in a single step. A person skilled in the art will appreciate that the sensor can be attached to the apparatus in a variety of ways, including but not limited to, by adhesion, embedding within the brachytherapy apparatus, molding of the insert, deposition on the surface, ultrasonic welding. ica and cord. In an alternative embodiment, the treatment feedback sensor 26 may be placed non-permanently in the brachytherapy apparatus 1 0. For example, the sensor may be in contact with the apparatus, but not coupled to it. The non-coupling contact allows the sensor 26 to be inserted into a tissue cavity separately from the brachytherapy apparatus 1 0. In one embodiment, the sensor can be inserted into a tissue cavity and then inserted. and expanded the brachytherapy apparatus. The expansion of the brachytherapy apparatus can then hold the sensor in its position during therapy. Alternatively, the sensor 26 may be placed within the apparatus 10 by insertion into the catheter body member 16 before or after insertion of the brachytherapy apparatus into the tissue cavity. In yet another embodiment, an additional sensor may be placed around the exterior of the apparatus 1 0. Figure 5 shows the sensors 26 placed in the tissue 50 that surrounds the cavity of the excised tissue. By placing the sensors outside the apparatus, as well as on the apparatus, the characteristics of the tissue can be determined at a distance from the apparatus. For example, the radiation level is expected to fall as a function of the distance from the radiation source and sensors placed in the area surrounding the tissue can confirm that the radiation falls to the expected level. In addition, sensors placed on the tissue more than the target area of the tissue can be used to confi rm a minimum dose (or no dose) that is ad ministered to healthy tissue. Said sensors may also have the ability to perceive other treatment characteristics, such as temperature and concentration of the treatment agent. In conjunction with the data received from the treatment feedback sensor 26, additional information such as the location of the sensor helps to determine the profile of the radiation dose. Although the sensor 26 can be placed at a previously determined location, the location can also be determined in vivo. For example, the treatment feedback sensor may preferably be visible for a medical processing mode, such as radiotherapy (eg, x-ray, fluoroscopy), computerized tomography, development of resonance imaging. magnetic and ultrasound. In a fashion, the brachytherapy apparatus is inserted into the tissue cavity and then the apparatus and / or sensor is taken in an image to determine the location of the apparatus and the sensor. Other means for determining the position of the apparatus the sensor and / or target tissue include fiducial markers. Fiducial markers may be markers placed on the apparatus and may include anatomical marks on the body, and / or implanted foreign bodies, such as radio-opaque markers or surgical fasteners. The treatment feedback sensor is preferably communicated with an external device that displays the radiation dose on the screen, processes and / or registers it. The communication between the sensor and the external device can be made by means of a direct physical connection (by means of cables or fiber that transmits the signals) or by means of a wireless interface that communicates the signal without the benefit of the wiring. The present invention also includes the method for using the brachytherapy apparatus to treat the target tissue and to sense the radioactive emissions. The interstitial brachytherapy apparatus of the present invention can be used in the treatment of a variety of malignant tumors and is especially useful in the treatment of breast and brain tumors. The treatment feedback sensor 26 can monitor the treatment and help ensure that the prescribed successful treatment of the surrounding tissue. Many breast cancer patients are candidates for breast conservation surgery, also known as lumpectomy, a procedure that is usually done at an early stage, in small tumors. Breast conservation surgery is usually followed by post-operative radiation therapy. Studies report that 80% of breast cancer recurrences after conservation surgery occur near the site of the original tumor, strongly suggesting that a tumor bed "promoted" by local radiation to deliver a strong direct dose They can be effective in killing any remaining cancer and preventing recurrence at the original site. Numerous studies and clinical trials have established the survival equivalence of appropriate patients treated with conservation surgery plus radiation therapy compared with mastectomy. Surgery and radiation therapy are the standard treatments for malignant solid tumors of the brain. The goal of surgery is to remove as much of the tumor as possible without damaging the vital tissue of the brain. The ability to remove the entire malignant tumor is limited by its tendency to infiltrate adjacent to normal tissue. Partial removal reduces the amount of your blood that will be treated by radiation therapy and, under some circumstances, helps relieve symptoms by reducing pressure on the brain. A method according to the present invention for treating these and other malignant tumors begins with the surgical removal of a tumor site to eliminate at least a portion of the cancerous tumor and the creation of a resection cavity. After tumor resection the surgeon places an interstitial brachytherapy apparatus, having an outer spatial volume as described above, into the tissue cavity. The external spatial volume, being preferably defined by an expandable surface element, it is expanded and the prescribed dose of radiotherapy is ad ministered. This treatment may be repeated during the course of the treatment regimen. In one embodiment, the feedback sensors of the treatment placed in the apparatus sense the radiation delivered by the radiation source during the radiation dosing. Radiation sensors can administer data during irradiation (ie, real-time measurement), after each radiotherapy / brachytherapy fraction and / or at the time of completing the full course of radiotherapy / brachytherapy. The data is preferably collected by a computer and can be used to verify the dose of radiation administered. The verification step confirms that the radiation dose is administered to the correct area and / or is within the prescribed limits. A feedback step can also be useful to modify future radiation doses (or fractions) to improve the distributed radiation profile. In particular, the sensor 26 can detect the radioactive emissions and administer the data with respect to the detected radiation levels. In one embodiment, the radiation source emits a first dose of radiation which is detected by the sensor placed in the apparatus. The first dose can be any dose smaller than the full dose prescribed. The data collected from the first dose is then used to evaluate the dosage profile and the dosage intensity and any errors can be set before administering the full dose. In another embodiment, the treatment feedback sensors may be used to evaluate the treatment procedure. The sensors can collect the data used to determine if residual malignant cells are being destroyed and to assess damage to healthy tissues. By perceiving the physical characteristics of the tissue surrounding the tumor, such as, for example, oxygenation, pH, temperature and concentration of cytokines, a user can determine how the dose administered to the tissue surrounding the tumor affected. In some cases, different regions of tissues or different patients may require different doses of radiation. By using the feedback sensors of the treatment to directly sense the tissue surrounding the tumor, the apparatus of the present invention can help ensure effective treatment. In yet another embodiment, the treatment feedback sensor may sense the administration of a supplemental treatment, such as heating the tissue or administering a treatment agent. The sensors placed in the device can be used to monitor the supplementary treatment and determine its effectiveness. One skilled in the art will appreciate that the foregoing is only illustrative of the principles of the present invention and that 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 (57)

1. CLAIMS 1. A brachytherapy apparatus for administering and monitoring radioactive emissions to an internal location of the body, which comprises: an element of the catheter body having a proximal end, a distal end and an outer spatial volume positioned near the distal end of the body. body element; a radiation source placed in the outer spatial volume; and a radiation sensor provided in the apparatus; wherein the radiation sensor measures the radiation delivered from the radiation source. The apparatus as described in claim 1, characterized in that the radiation sensor is placed inside the body element of the catheter. The apparatus as described in claim 2, characterized in that the radiation sensor is placed at the center of the outer spatial volume. 4. The apparatus as described in claim 1, characterized in that the radiation sensor is placed within the outer spatial volume. The apparatus as described in claim 1, characterized in that the outer spatial volume is defined by an expandable surface element and the radiation sensor is coupled with the expandable surface. The apparatus as described in claim 1, characterized in that an additional radiation sensor is placed outside the brachytherapy apparatus. The apparatus as described in claim 1, characterized in that the outer spatial volume is defined by an expandable surface element. 8. The apparatus as described in claim 7, characterized in that the radiation source generates a three-dimensional sodosis profile that is substantially similar in shape to the expandable surface element. The apparatus as described in claim 8, characterized in that the sensor output is used to verify that a three-dimensional isodose profile is substantially similar in shape to the expandable surface element which is delivered to the adjacent tissue. The apparatus as described in claim 8, characterized in that the radiation sensor is coupled with the expandable surface element. The apparatus as described in claim 1, characterized in that the brachytherapy apparatus generates an asymmetric isodose radiation profile. 12. The apparatus as described in claim 1, characterized in that the interior spatial volume is placed within the outer spatial volume. The apparatus as described in claim 12, characterized in that the source of radiation is placed within the interior spatial volume. The apparatus as described in claim 13, characterized in that the interior and exterior spatial volumes are defined by inner and outer balloons. The apparatus as described in claim 14, characterized in that at least one radiation sensor is placed on the inner and outer ball. 16. The apparatus as described in claim 1, characterized in that the source of radiation is a source of solid radiation. The apparatus as described in claim 16, characterized in that the radiation sensor is placed in the catheter body element at a position in the longitudinal direction where it is desired to place the radiation source. 18. The apparatus as described in claim 1, characterized in that the brachytherapy apparatus is an interstitial brachytherapy apparatus. 19. The apparatus as described in claim 1, characterized in that more than one radiation sensor is provided. 20. The apparatus as described in claim 19, characterized in that the radiation sensor is placed in the tissue adjacent to the apparatus. 21. The apparatus as described in claim 19, characterized in that the radiation sensor is placed in the wall of the cavity of the excised tissue. 22. The apparatus as described in claim 1, characterized in that the radiation delivered from the radiation source is altered if the radiation dose is outside the prescribed range. 23. A radiation therapy apparatus for administering and monitoring radioactive emissions to an excised tumor cavity, which comprises: an element of the catheter body having a proximal end, a distal end and an expandable surface element positioned near the end distant from the catheter body element; an external radiation source that can be placed outside the cavity of the excised tissue; and a radiation sensor; wherein the expandable surface element can be placed within the cavity of the excised and expanded tissue to position the surrounding tissue, so that the administration of a radiation beam from the external radiation source is administered and measured exactly by the radiation sensor placed inside the tissue cavity. 24. The apparatus as described in claim 23, characterized in that the radiation sensor is positioned within the catheter body member. 25. The apparatus as described in claim 23, characterized in that the radiation sensor is placed on the expandable surface element. 26. A method for administering and monitoring radioactive emissions to an internal location of the body, which comprises: inserting a brachytherapy device into an excised cavity, including the brachytherapy device, an element of the catheter body with proximal ends. and distant, an element of its expandable surface placed near the distal end of the catheter body member, and a radiation source positioned within the expandable surface element; inserting a radiation sensor into the excised cavity; ad administering a prescribed dose of absorbed radiation for therapeutic effects to a target tissue, the target tissue being defined between the expandable surface element and a minimum distance away from the expandable surface element; and perceive the radiation dose; wherein the output of the sensor confirms that the brachytherapy apparatus administers the prescribed minimum dose. The method as described in claim 26, characterized in that the brachytherapy apparatus provides a controlled dose in an expandable surface element to reduce or prevent necrosis of healthy tissue near the expandable surface. 28. The method as described in claim 26, characterized in that the radiation sensor is placed in the brachytherapy apparatus. 29. The method as described in claim 28, characterized in that the radiation sensor is placed on the expandable surface element. 30. The method as described in claim 28, characterized in that the radiation sensor is positioned within the catheter body member. 31. The method as described in claim 26, characterized in that more than one sensor is used with the apparatus. 32. The method as described in claim 31, characterized in that a sensor is placed on the wall of the excised cavity. 33. The method as described in claim 31, characterized in that a sensor is placed in the tissue adjacent to the apparatus. 34. The method as described in claim 26, characterized in that the data collected from the perception of the radiation dose are used to confirm that the dose of radiation administered is within a prescribed dose range. 35. The method as described in claim 26, characterized in that an alert is sent to a user if the radiation dose is outside the prescribed dose range. 36. The method as described in claim 35, characterized in that the radiation dose is altered if the perceived radiation dose is outside the prescribed dose range. 37. The method as described in claim 26, characterized in that the brachytherapy apparatus administers an asymmetric dose of radiation so that the radiation-sensitive tissue adjacent to the apparatus is protected and a radiation sensor is placed between the apparatus of brachytherapy and tissue sensitive to radiation. 38. A brachytherapy apparatus for administering radioactive emissions to the internal location of the body, which comprises: an element of the catheter body having a proximal end, a distal end and an outer spatial volume positioned near the distal end of the element of the body; a source of radiation placed in the external spatial volume; and a feedback sensor for treatment provided in the apparatus; wherein the feedback sensor treatment can be used to evaluate the treatment of tissue proliferative disorders. 39. The apparatus as described in claim 38, characterized in that the treatment feedback sensor measures the radiation delivered from the radiation source. 40. The apparatus as described in claim 39, characterized in that a further processing feedback sensor is placed outside the brachytherapy apparatus. 41 The apparatus as described in claim 38, characterized in that the feedback sensor of the treatment detects the administration of a supplementary treatment. 42. The apparatus as described in claim 41, characterized in that the feedback sensor of the treatment monitors the administration of a treatment agent to the surrounding tissue. 43. The apparatus as described in claim 38, characterized in that the feedback sensor of the treatment measures one of the selected characteristics of the group consisting of tissue temperature, oxygenation, pH, concentration of the treatment agent. and with cytokine concentration. 44. The apparatus as described in claim 43, characterized in that the outer spatial volume is defined by a permeable balloon and the feedback sensor of the treatment detects a treatment agent which has the ability to permeate through the wall of the permeable ball. 45. The apparatus as described in claim 38, characterized in that the outer spatial volume is defined by an expandable surface element and the feedback sensor of the treatment is coupled with the expandable surface. 46. The apparatus as described in claim 38, characterized in that the feedback sensor of the treatment is placed within an element of the catheter body. 47. A method for administering radioactive emissions to an internal location of the body, which comprises: inserting a brachytherapy device into an excised cavity, including the brachytherapy apparatus, an element of the catheter body with proximal and distant ends. , an expandable surface element positioned near the distal end of the catheter body member and a radiation source positioned within the expandable surface element thereof; inserting a feedback sensor of the treatment into the excised cavity; administering a dose of minimum absorbed radiation prescribed for therapeutic effects to a target tissue, the target tissue being defined between the expandable surface element and a minimum distance outside the expandable surface element; and perceive the adjacent tissue; where the sensor output is used to monitor the effectiveness of the therapeutic radiation dose. 48. The method as described in claim 47, characterized in that the brachytherapy apparatus provides a controlled dose of radiation in the expandable surface element thereof to reduce or prevent necrosis of the healthy tissue near the expandable surface. 49. The method as described in claim 47, characterized in that the treatment feedback sensor is placed in the brachytherapy apparatus. 50. The method as described in claim 47, characterized in that the retroalimentation sensor of the treatment is placed on the expandable surface element. 51 The method as described in claim 47, characterized in that the feedback sensor of the treatment is placed on the wall of the extruded cavity. 52. The method as described in claim 47, characterized in that the treatment feedback sensor is placed in the tissue adjacent to the apparatus. 53. The method as described in claim 47, characterized in that a user is notified if the dose of radiation is outside the dose range! '; prescribed 54. The method as described in claim 53, characterized in that the radiation dose is altered if the perceived radiation dose is outside the prescribed dose range. 55. The method as described in claim 47, characterized in that the feedback sensor of the treatment measures one of the selected characteristics of the group consisting of tissue temperature, oxygenation, pH, concentration of the treatment agent and concentration of cytokines. . 56. The method as described in claim 47, characterized in that the treatment agent is administered to the tissue surrounding the apparatus. 57. The method as described in claim 56, characterized in that the feedback sensor of the treatment monitors the administration of the treatment agent.