Polymeric-matrix brachytherapy sources

Abstract

Therapeutic sources for use in the practice of brachytherapy comprise a radioactive composite that includes (a) a polymeric matrix and (b) a radioactive powder, e.g. Pd-103 or I-125, consisting essentially of very fine radioactive particles that are randomly and essentially uniformly dispersed within the polymeric matrix. The composite may be in the shape of one or more solid cylindrical rods surrounded by a non-radioactive sleeve. Alternatively it may be a hollow rod, suture, film, sheet, or microspheroidal particles.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10 / 614,696, filed Jul. 7, 2003, which is a continuation of U.S. patent application Ser. No. 08 / 563,087, filed Nov. 27, 1995, issued Jul. 8, 2003, as U.S. Pat. No. 6,589,502; the entire disclosures of both are incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention relates to therapeutic radiology. More particularly, the present invention is directed to radioactive materials contained in polymers for use in therapeutic applications known as brachytherapy, to structures fabricated of those materials, and to methods of manufacture and use of these fabricated structures. BACKGROUND OF THE INVENTION [0003] The local treatment of tissue by exposure to radiation-emitting material is now well established. Such treatment targets the tissue adjacent to the source while keeping the radiation effects on neighboring healthy tissue to a minimum. A majo...

AI Technical Summary

Benefits of technology

[0028] Heretofore, brachytherapy sources intended for permanent interstitial implantation have included a metallic capsule to contain the radioactive material. A significant drawback of these metallic capsules is their nonuniform absorption of the emitted radiation, which causes a reduced radiation dose in certain directions. By eliminating the need for metallic capsules, the present invention overcomes the limitations inherent in their use, thereby allowing the full benefits of therapeutic irradiation from an implanted brachytherapy source.

[0063] Restenosis is the process whereby an artery which has been opened by a technique such as balloon angioplasty, experiences a subsequent reduction in its open cross section, due to cell proliferation or plaque formation. Benign and relatively inexpensive techniques, such as balloon angioplasty, fail in approximately 40% of cases due to restenosis, thereby forcing physicians to perform more expensive, and more dangerous, procedures such as coronary artery heart bypass surgery. The present invention provides a radiation source capable of delivering a dose of radiation to an arterial wall which is intended to reduce the likelihood of restenosis, thereby reducing the number of patients who will ultimately require the more expensive and more dangerous procedures. The therapeutic source for this application is preferably a solid rod, manufactured to have a preselected degree of flexibility, or a hollow tube. Such a source must be flexible enough when associated with a catheter to be maneuverable into the treatment site.

Problems solved by technology

Such high energy radiation not only subjects the patient's healthy tissue to more radiation than is desired, but in addition exposes medical personnel as well as other persons coming into contact with the patient, to significant doses of potentially harmful radiation.

Therefore, encapsulating an isotope permits the use of isotopes that would otherwise dissolve in the body and / or present potential toxic consequences to the patient.

Imaging technology is available which is capable of accurately locating the desired position for a seed, but holding the seed in the desired position has proven more difficult.

However, due to the motion of the soft tissue surrounding the seed, vis-vis the rigid capsule of the seed, to use a longer seed would pose too great a likelihood of puncturing a surrounding organ or vessel.

One major drawback to using this device is that it has a tendency to become lodged in the implanting needle due to the effects of moisture on the suture material.

Furthermore, this device does not include the ideal source, i.e., a continuous linear source, but rather relies on a series of separated, discrete sources in a line.

While this product offers a means of attachment, it suffers from representing a series of separated discrete sources rather than a more desirable continuous line source.

Furthermore, a major drawback for metal-encapsulated seeds is that the encapsulating metal absorbs a significant fraction of the radiation emitted by the contained radioisotope, for example about 14% of the iodine-125 X-rays and 40% of the palladium-103 X-rays are absorbed in the encapsulating metal in the current commercial seeds.

As a consequence, to obtain the desired radiation dose rate on the exterior of the seed, additional expensive isotope activity must be added to overcome the losses in the encapsulating metal.

Also because it is necessary to seal the ends of the capsules, the effective thickness of the metal is not the same in all directions resulting in a radiation field around the seed which is not uniform, a fact that complicates treatment planning and raises the possibility of the existence of areas within the treatment volume in which the radiation dose is below that required to kill all tumor cells present.

Thus the current practice of brachytherapy based on the use of discrete encapsulated sources is limited by: 1) the need to associate groups of discrete seeds together by some means so that they can be placed into tissue in a predetermined array and held in that array throughout the therapeutic life of the sources, 2) the need for complex treatment planning that takes into account the discrete nature of the seeds and the shape of the radiation field around each seed with the assumption the field shape around each seed is the same, 3) the need to add excess expensive isotope to compensate for the radiation absorption in the encapsulating metal, and 4) the creation of a nonuniform radiation field around the source because the effective thickness of the encapsulating metal is not the same in all directions.

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