Patent Application
20070173680
The inventions relate generally to systems and methods for treating tissue, and in particular, the treatment of proliferative tissue, such as malignant tumors, using radiotherapy and hyperthermic therapy.
It is known to treat proliferative tissue, such as cancerous tumors, using a surgical resection procedure. In a typical resection procedure, as much of the malignant tissue as possible is surgically cut from the patient's body, thereby creating an interstitial cavity. To prevent the infiltration of tumor cells, thereby limiting the therapeutic effect of the resection, it is typically common practice to supplement the resection procedure by targeting the tissue margin surrounding the interstitial cavity with radiation, with the goal of reducing its size or stabilizing it. Radiation therapy can be administered using one or more of a variety of techniques, including external-beam radiation, stereotactic radiosurgery, and brachytherapy. It is the latter that is pertinent to the claimed invention.
Brachytherapy can be performed by placing radiation sources (e.g., radioactive seeds) directly into the tissue to be treated, and when used in conjunction with surgical resection, within the interstitial cavity. To achieve the minimum prescribed dosage of radioactivity within the targeted tissue region, high activity radiation seeds are often used, resulting in the necrosis of healthy tissue, along with the malignant tissue. In order to facilitate a more uniform radiation exposure, thereby allowing the dosage of the radioactive seeds to be more tailored to the size of the interstitial cavity, it is known to expand a balloon around the radioactive source, so that the tissue margin is radially spaced about the radioactive source in a uniform manner. U.S. Pat. No. 6,413,204, which is fully and expressly incorporated herein by reference, describes such an apparatus.
Although the use of a balloon to facilitate the uniform application of radiation into the tissue margin surrounding an interstitial cavity is generally beneficial, certain regions of the tissue margin may not always conform to the balloon, thereby creating spaces or air gaps between the tissue margin and balloon, and resulting in a somewhat non-uniform application of radiation into the tissue margin.
Recently, it has been discovered that the use of hyperthermia (HT) therapy can be used as an adjunct to standard radiation therapy, such as brachytherapy, to increase the efficacy of the treatment. Hyperthermia can be defined as the treatment of disease by raising body temperature. When treating cancer, hyperthermia involves the use of heating devices (e.g., microwave applicators, ultrasound, low energy radio frequency conduction probes, or a sophisticated thermometry system of micro-thermocouples placed externally) in the natural cavities of the body, or in the case of surgical resection, interstially, to make cancerous tumors more operable, radiosensitive, or susceptible to cancer therapy measures. Hyperthermia can be applied prior to, during, and/or subsequent to the radiation therapy.
According to a study published in the May 1, 2005 edition of the Journal of Clinical Oncology, patients with post-mastectomy chest wall recurrence of breast cancer who were given HT therapy experienced complete response (total disappearance of the tumor) at a rate nearly three times higher than those patients who received radiation treatment alone. The use of adjuvant HT therapy also demonstrated a significant improvement in tumor control, among patients with recurrent melanoma as well as head and neck and other tumors when compared to stand-alone radiation therapy. It is thought that when combined with radiation therapy, HT therapy creates a mechanism that interferes with the cellular repair of radiation-induced DNA damage.
While it has been proven that the application of HT therapy facilitates the efficacy of standard radiation therapy, such as brachytherapy, separate tissue heating devices are needed, thereby complicating and generally increasing procedure time.
There thus remains a need to provide an integrated apparatus and method capable of applying brachytherapy/HT therapy to the tissue margin surrounding an interstitial cavity, while ensuring that the tissue margin uniformly surrounds the radiation source used during brachytherapy, thereby ensuring the uniform application of radiation to the tissue margin.
In accordance with a first aspect of the present inventions, a method of treating a tissue margin surrounding an interstitial cavity is provided. The interstitial cavity may be created by resecting tissue, e.g., malignant tissue, from the patient's body to create the interstitial cavity. The interstitial cavity may assume any shape, but in a typical method, the interstitial cavity is spherically shaped.
The method comprises introducing a probe having an expandable hyperthermic body within the interstitial cavity, expanding the hyperthermic body within the interstitial cavity into contact with the tissue margin, heating the tissue margin with the hyperthermic body, and conveying therapeutic x-ray radiation from the hyperthermic body into the tissue margin. The x-ray radiation may originate from a location anywhere in or on the hyperthermic body, but in one method, the x-ray radiation originates from a location within an interior region of the hyperthermic body, e.g., at a location radially centered within the hyperthermic body. The tissue margin may be heated with the hyperthermic body prior to, or while, applying the therapeutic radiation from the hyperthermic body into the tissue margin. In any event, the same device that is used to apply x-ray radiation to the tissue margin is also conveniently used to heat the tissue margin, thereby increasing the therapeutic effect of the radiation therapy.
In an optional method, heating of the tissue margin with the hypothermic body ablates the tissue margin. By way of non-limiting example, ablation of the tissue margin conforms the interstitial cavity to the shape of the expanded hypothermic body, which removes air gaps between the hyperthermic body and the tissue margin, thereby providing for a more uniform application of the therapeutic radiation. In this case, ablation of the tissue margin is performed prior to the application of therapeutic radiation. The tissue margin may also be ablated by the hyperthermic body subsequent to applying the therapeutic radiation, e.g., to necrose any remaining malignant tissue.
In accordance with a second aspect of the present inventions, a therapeutic probe for treating tissue within a patient's body is provided. The therapeutic probe comprises an elongate shaft, a radioactive source configured for being located at a distal end of the shaft, and an expandable hyperthermic body carried by a distal end of the elongate shaft and surrounding the distally located radioactive source. The hyperthermic body is configured for radially conveying heat and radiation from the radioactive source into the tissue.
In one embodiment, the hyperthermic body is configured to conform with an interstitial cavity. For example, the hyperthermic body may be self-expandable. In this case, the hyperthermic body may comprises a foam electrode body, and the elongate shaft may comprise at least one fluid lumen in communication with the foam electrode body. The hyperthermic body, when expanded, may assume any suitable shape, but in one embodiment, is spherically-shaped. In an optional embodiment, the hyperthermic body is configured for radially conveying ablation energy into the tissue. Ablation of the tissue may be advantageous for the same reasons discussed above.
The radioactive source may be configured for being located anywhere in or on the hyperthermic body, but in one embodiment, is configured for being located within a radial center of the hyperthermic body. In another embodiment, the therapeutic probe comprises an elongated element carrying the radioactive source, and the elongated shaft comprises a delivery lumen configured for receiving the elongated element. The therapeutic probe may comprise an electrical connector carried by a proximal end of the elongated shaft, wherein the hyperthermic body comprises an electrode electrically coupled to the electrical connector.
In accordance with a third aspect of the present inventions, a system for treating tissue within a patient's body is provided. The system comprises the therapeutic probe described above, and a source of thermal energy coupled to the hyperthermic body.
Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
The drawings illustrate the design and utility of preferred embodiment(s) of the invention, in which similar elements are referred to by common reference numerals. In order to better appreciate the advantages and objects of the invention, reference should be made to the accompanying drawings that illustrate the preferred embodiment(s). The drawings, however, depict the embodiment(s) of the invention, and should not be taken as limiting its scope. With this caveat, the embodiment(s) of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Referring generally to
As will be further appreciated below, ablation energy can be conveyed from the treatment probe 12 in order to pre-condition the tissue margin, and in particular, to elevate the temperature within the tissue margin, as well as to physically mold or fix the interstitial cavity into a desired and uniform shape. The same treatment probe 12 can then be operated to emit X-ray radiation into the tissue margin in a uniform manner, thereby necrosing most, if not all, of the malignant tissue within the tissue margin. The elevated temperature of the tissue margin resulting from the previous ablation step increases the therapeutic effect of the X-ray radiation treatment. During the X-ray radiation delivery, the treatment probe 12 can also be operated to maintain the elevated temperature of the tissue margin, thereby ensuring that the combined radiation/HT therapy is continued. Lastly, the treatment probe 12 can be operated to further ablate the tissue margin, thereby ensuring that all of the malignant tissue within the tissue margin is necrosed, as well as to further continue the combined effect of the radiation/HT therapy.
Referring further to
The probe shaft 18 may be rigid, semi-rigid, or flexible depending upon the designed means for introducing the probe 12 into the interstitial cavity, and may be composed of any suitable biocompatible material. As best shown in
The handle assembly 28 includes a handle sleeve 38 shaped in a manner that facilitates grasping by a physician or medical technician. The handle sleeve 38 is preferably composed of a durable and rigid material, such as medical grade plastic, and is ergonomically molded to allow a physician to more easily manipulate the treatment probe 12. The handle assembly 28 further includes a fluid infusion port 40 in fluid communication with the ablation body 26 via the fluid delivery lumens 32 carried by the probe shaft 18, and an electrical connector 42 electrically coupled to the ablation body 26 via the RF wire 36 carried by the probe shaft 18. The infusion port 40 is configured for mating with the proximal end of a fluid conduit 44 connected to the fluid source 16. The electrical connector 42 is configured for mating with the proximal end of a RF cable 46 connected to the RF generator 14. Alternatively, the RF cable 46 may be hardwired within the handle sleeve 38. Lastly, the handle assembly 28 includes a locking member 48 configured for mating with the radioactive mechanism 24, as will be described in further detail below.
The radioactive mechanism 24 includes an elongated shaft 50 having a proximal end 52 and a distal end 54, a radioactive source 56 carried by the distal end 54 of the elongated shaft 50, and a locking member 58 carried by the proximal end 52 of the elongated shaft 50. The elongated shaft 50 may be composed of any rigid or semi-rigid material, such as stainless steel, that provides the shaft 50 with the column strength sufficient to introduce the radioactive source 56 through the delivery lumen 30 of the probe shaft 18. The radioactive source 56 can be composed of any suitable solid X-ray radiation emitting material, such as Palladium-103 or Iodine-125. To ensure that only the tissue surrounding the ablation body 26 is exposed to X-ray radiation, a radiation shielding (not shown) can be applied to the exterior surface of the probe shaft 18, e.g., by coating, proximal to the ablation body 26.
The shaft 50 of the radioactive mechanism 24 is dimensioned and configured, such that radioactive source 56 is situated in the radial center and axial center of the ablation body 26 when the radioactive mechanism 24 is completely located within the delivery lumen 30 of the probe shaft 18. To ensure that the radioactive mechanism 24 does not extend past the desired axial location, the probe shaft 18 includes a stopper 60 (shown best in
The expandable ablation body 26 surrounds the radioactive source 56 when the radioactive mechanism 24 is completely located within the delivery lumen 30 of the probe shaft 18, and is constructed in a manner that allows it to both expand and convey ablation energy, and in particular, RF energy. In the illustrated embodiment, the ablation body 26 comprises an internal electrode 62 (shown best in
The internal electrode 62 can be composed of any electrically conductive material, such as gold, platinum, etc., and can be formed onto the probe shaft 18 using any suitable manner, such as coating, sputtering, etc., or by forming the internal electrode 62 as a discrete element that can then be mounted to the probe shaft 18 using, e.g., an interference fit. The internal electrode 62 is suitably coupled to the RF wire 36 extending through the RF wire lumen 34 of the probe shaft 18, so that the electrical connector 42 located on the handle assembly 28 is in electrical communication with the internal electrode 62. To provide exterior access to the RF wire 36 from the internal electrode 62, the distal end of the RF wire 36 can extend through an access port (not shown) transversely formed through the wall of the probe shaft 18.
The outer electrode body 64 can be composed of any material that allows it to radially convey ablation energy from the internal electrode 62 outward into any surrounding tissue, while also allowing the passage of radiation from the radioactive source 56 into the surrounding tissue. In the illustrated embodiment, the outer electrode body 64 is composed of a foam material. Suitable materials that can be used to construct the outer electrode body 64 include open-cell foam (such as polyethylene foam, polyurethane foam, polyvinylchloride foam) and medical-grade sponges. Further details regarding exemplary constructions of foam electrode bodies are disclosed in U.S. patent application Ser. No. 11/xxx,xxx (Attorney Docket No. 28-7045232001), entitled “Compressible/Expandable Hydrophilic Ablation Electrode”, which is fully and expressly incorporated herein by reference.
It can be appreciated that the foam outer electrode body 64 is self-expandable. That is, the outer electrode body 64 will expand in the absence of a compressive force. An outer sheath 66 (shown in
The outer electrode body 64 is in fluid communication with the fluid delivery lumens 32 extending the probe shaft 18, so that the infusion port 40 located on the handle assembly 28 is in fluid communication with outer electrode body 64. To provide exterior access to fluid delivery lumens 32, access ports (not shown) are transversely formed through the wall of the probe shaft 18. Thus, it can be appreciated that when the outer electrode body 64 is saturated with an electrically conductive fluid, such as saline, an electrical path is formed through the outer electrode body 64, so that electrical energy in the form of RF energy can be transmitted from the internal electrode, through the outer electrode body 64, into any tissue surrounding the ablation body 26.
It should be appreciated that the ablation body 26 may have constructions other than that illustrated in
Referring back to
RF current is preferably delivered from the RF generator 14 to the ablation body 26 in a monopolar fashion, which means that current will pass from the ablation body 26, which is configured to concentrate the energy flux in order to have an injurious effect on the adjacent tissue, and a dispersive electrode (not shown), which is located remotely from the ablation body 26, and has a sufficiently large area (typically 130 cm2 for an adult), so that the current density is low and non-injurious to surrounding tissue. In the illustrated embodiment, the dispersive electrode may be attached externally to the patient, e.g., using a contact pad placed on the patient's flank.
The electrically conductive fluid source 16 may take the form of any device capable of introducing an electrically conductive fluid into the infusion port 40 under a positive pressure. For example, the fluid source 16 may take the form of a syringe or an automated pump assembly.
Having described the structure of the tissue treatment system 10, its operation in treating target tissue will now be described. The target tissue may be located anywhere in the body where radiation/hyperthermic exposure may be beneficial. Most commonly, the treatment region will be located within an organ of the body, such as the liver, kidney, pancreas, breast, prostrate (not accessed via the urethra), and the like. The tissue treatment system 10 particularly lends itself well to the treatment of a tissue margin surrounding an interstitial cavity resulting from the removal of a volume of malignant tissue. The volume of the interstitial cavity will ultimately depend on the size of the tumor or other tissue resected from the patient's body, typically being in the range of 1 cm3 to 150 cm3, and often from 2 cm3 to 35 cm3.
The shape of the interstitial cavity will typically be spherical to match the spherical profile of the radiation energy used to treat the tissue margin, thereby minimizing the volume of healthy tissue that is necrosed. The treatment region may be identified using conventional imaging techniques capable of elucidating a target tissue, e.g., tumor tissue, such as ultrasonic scanning, magnetic resonance imaging (MRI), computer-assisted tomography (CAT), fluoroscopy, nuclear scanning (using radiolabeled tumor-specific probes), and the like. Preferred is the use of high resolution ultrasound of the tumor or other lesion being treated, either intraoperatively or externally.
Referring now to
After the treatment region TR has been resected to create the interstitial cavity IC, the probe 12 is introduced through the tissue T in a standard manner, so that the ablation body 26 (not shown) is located within the interstitial cavity IC (
Next, the fluid source 16 is coupled to the infusion port 40 located on the handle assembly 28 (shown in
Next, the radiation mechanism 24 is inserted within the delivery lumen 30 of the treatment probe 12 until the distal end of the radiation mechanism 24 abuts the stopper 60 at the end of the delivery lumen 30 (shown in
Next, the RF generator 14 is again operated to necrose any tissue in the tissue margin TM that has not been necrosed by the radiation therapy, thereby expanding the ablation region A (
Although particular embodiments of the present invention have been shown and described, it should be understood that the above discussion is not intended to limit the present invention to these embodiments. It will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present invention. Thus, the present invention is intended to cover alternatives, modifications, and equivalents that may fall within the spirit and scope of the present invention as defined by the claims.
