Abstract: A brachytherapy apparatus is composed of a tubular needle with forwardly protruding cutting edges at its tip, a holder supporting the needle and a driver for electromechanically causing the needle to undergo a continuous or oscillatory rotary motion around its axis and/or a reciprocating linear motion in the longitudinal direction such that its front opening at its tip can reliably reach a specified position inside a patient's tissue without being deflected or bowing when it encounters an obstruction such as a calcification or a small bone. Such motions may be provided by a piezoelectric hammer and a piezoelectric tamper. After the needle is thus correctly positioned, a brachytherapy device such as a radioactive seed or a reflector may be pushed through and out of the needle by means of a pusher as the needle is retracted to leave a track inside the tissue. A quickly hardening liquid may be thereafter injected through the needle to immobilize the deposited brachytherapy device.

Abstract: The present invention relates to an apparatus and method for administering a radioactive tracer dye and an inhibitor compound into a breast duct of the breast and imaging the breast for breast lesions. The radioactive tracer dye may be Tc-99m sestamibi and the inhibitor compound may inhibit a P-glycoprotein pump in tumor cells. When the inhibitor compound inhibits the P-glycoprotein pump in tumor cells, the radioactive tracer dye may effectively accumulate in tumor cells and improve the sensitivity of nuclear imaging of breast lesions.

Abstract: A transfer device usable in a system for intraluminal treatment of a selected site in a body of a patient in which the transfer device comprises an integral pump for pressurizing and circulating fluid through a fluid path defined by the transfer device and associated catheter. A removable fluid cartridge is provided including a reservoir from which fluid is drawn by the pump and into which fluid is returned after being circulated through the fluid path. The pump may be a peristaltic pump and the fluid cartridge may include an elongated fluid pick-up having an inlet through which fluid is introduced into the transfer device. The fluid pick-up is sized in length so that the inlet is always submerged in the fluid regardless of the orientation of the transfer device.

Abstract: A medical device includes a cavity communicable with a body to deliver or to receive a fluid, and a radiation source configured to expose a portion of the cavity to radiation.

Abstract: A positioning system for an x-ray catheter or other endoluminal device includes retractable needles or suction means to position the x-ray catheter at the desired site.

Abstract: The invention relates to a device and method for inserting a needle in an animal body for effecting radiation therapy in said body, comprising a template for positioning the needles to be inserted, needle drive means for drive a needle through said template towards a desired location in the body, and real-time imaging means for creating and presenting an image of the desired location and the position of said needle during the insertion of said needle. Due to the fact that the bevelled tip of a hollow needle cause the needle to diverge away from the “line of insertion or movement” and away from the actual desired position in the animal body adversely affecting the dosimetry quality of the implanted seeds a more accurate insertion of the needle is required. According to the invention the device is provided with adjusting means for adjusting a movement of said needle towards said desired location during insertion.

Abstract: Disclosed are novel radioactive compositions which are particularly suited for treating solid mass tumors via catheter delivery.

Abstract: A system for brachytherapy is provided. The system includes an implantation device having a spacer and a socket at opposing ends of the spacer. The device further includes a seed securely positioned within the socket. A plurality of spacers and seeds may be joined into an assembly. The device may be deployed at an implantation site by use of a delivery mechanism, such as needle. The presence of the spacers minimizes movement of the seeds subsequent to deployment, so as not to alter dose distribution for subsequent irradiation.

Abstract: The present invention provides improved devices, methods, and kits for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides controlled radiosensitizer delivery in combination with ionizing radiation to selected locations within a patient's vasculature to reduce and/or inhibit restenosis and hyperplasia rates with increased efficacy. In one embodiment, the combination radiation and radiosensitizer delivery catheter for inhibiting hyperplasia comprises a catheter body having a proximal end and distal end, an ionizing radiation source coupleable to the catheter body for applying a radiation dose to a body lumen, and means coupleable to the catheter body or the radiation source for releasing a radiosensitizer to the body lumen.

Abstract: A manifold system allows for the movement of a radioactive fluid from a container to a treatment balloon or other device, and the withdrawal of the radioactive fluid from the treatment device. The system allows for the convenient movement of the fluid, with minimal radiation exposure for those using the system. The manifold system is particularly useful in the use of radiation to prevent restenosis of arteries.

Abstract: To accomplish isolation and removal of a substance from a vasculature, a catheter is employed to occlude a vessel of the vasculature. The substance is thus isolated in the vasculature and can be removed. In this way, the substance is removed before entering other parts of the circulatory system. This method is applicable to removal of contrast from the coronary sinus shortly after injection of the coronary arteries with the contrast. The method substantially minimizes or avoids renal dysfunction caused by angiographic procedures in which contrast must be injected. Such angiographic procedures are often performed during intervention procedures. This method substantially prevents circulation of the contrast to the kidneys where it could otherwise cause renal dysfunction or failure. The apparatus for implementation of the method is also disclosed.

Abstract: The disclosure details a novel method of use of the radioactive isotope Xenon-133 (Xe-133) in the radiotherapy of cancer. Xe-133 gas is infused directly into the core of the tumor and diffuses as microbubbles of gas toward the tumor boundaries where it is eventually taken up into patent capillaries and excreted by the lungs. During its infusion and diffusion throughout the tumor the Xe-133 exposes the cancerous tissue to very high fluxes of beta rays which penetrate tissue at about one millimeter increments. This limited penetration is very distructive to tissue while the Xe-133 gas is contained within the tumor. However, when the Xe-133 reaches the surface of the tumor, normal capillary blood flow carries it away and thereby minimizes exposure to normal tissues. Xenon-133 represents the only radioactive gas isotope which is suitable to practice the invention.

Abstract: Locally deposited polymer depots are used as a vehicle for the immobilization and local delivery of a radionuclide or radiopharmaceutical. Radionuclides are incorporated in their elemental forms, as inorganic compounds, or are attached to a larger molecule or incorporated into the polymer, by physical or chemical methods. Ancillary structure may be employed to control the rate of release. Standard radionuclides which have been used for local radiotherapy may be used, such as radionuclides of iodine, iridium, radium, cesium, yttrium or other elements.

Abstract: The invention encompasses methods and apparatus for pumping fluid from one location to another through the repetitive expansion and collapse of bubbles generated as a result of the absorption of repetitive pulses of radiation in a fluid. This pumping phenomenon can be used to aid removal of a total or partial occlusion in a body passage by emulsifying the occlusion with acoustic shock and pressure waves or by causing mechanically disrupting the occlusive material.

Abstract: Disclosed are methods for treating AVMs in a mammal by use of a radiation composition.

Abstract: There is provided a device and a method for irradiating vascular tissues. The device generally includes a transfer device having a first chamber and a second chamber and a piston slidably disposed between the chambers. A ballon catheter is provided for positioning witin the vascular system and is connected to the transfer device such that an inflation lumen of the balloon catheter is in fluid communication with the second chamber. A proximal end of the balloon catheter is affixed to a mounting block which is configured to receive the transfer device. An inflation device is provided to force fluid into the first chamber such that the piston is driven to force a radioactive fluid contained in the second chamber into the balloon.

Abstract: An apparatus for treating a body structure with radiation and a method for using the same. The apparatus comprising a concentrator for receiving a solution comprising a radioactive material and for increasing the concentration of the radioactive material in solution; a calibrator operatively associated with the concentrator for measuring a level of radiation associated with the radioactive material; and a delivery unit for transferring the solution directly from the apparatus to a balloon catheter.

Abstract: A method and system are provided for eroding or ablating a shaped volume of an eye's corneal tissue in accordance with the treatment of a specified eye condition. To determine the laser beam shot pattern, a plurality of laser beam shots of uniform intensity are first selected to form a uniform shot pattern of uniform shot density. The laser beam shots applied in accordance with the uniform shot pattern of uniform shot density would be capable of eroding a volume of the corneal tissue of uniform height. The volume of uniform height is approximately equivalent to that of the shaped volume. The laser beam shots are applied to the corneal tissue in a spatially distributed pattern spread over an area approximately equivalent to the surface area of the shaped volume to be eroded. The spatially distributed pattern extends the uniform shot pattern in fixed angles from a reference position on the shaped volume representative of the shaped volume's axis of symmetry.

Abstract: This invention is a transfer device and catheter assembly for the delivery of treatment elements to a selected location within the intraluminal passageways of a patient as part of an intraluminal radiation system. The transfer device includes a gate member that permits the treatment elements to leave the transfer device only if the catheter is attached thereto. A pressure indicator provides a visual indication of the fluid pressure within the transfer device, and a pressure relief valve provides for a release of the fluid if the pressure exceeds a predetermined pressure. Transfer device also includes a treatment element detection system, low power indicator, a counter system, and an electromagnetic locking mechanism to prevent the opening or closing of the gate member when less than all of the treatment elements are in the transfer device.

Abstract: Locally deposited polymer depots are used as a vehicle for the immobilization and local delivery of a radionuclide or radiopharmaceutical. Radionuclides are incorporated in their elemental forms, as inorganic compounds, or are attached to a larger molecule or incorporated into the polymer, by physical or chemical methods. Ancillary structure may be employed to control the rate of release. Standard radionuclides which have been used for local radiotherapy may be used, such as radionuclides of iodine, iridium, radium, cesium, yttrium or other elements.

Abstract: Disclosed are methods for the endovascular formation of a radioactive stent using a radioactive composition. These compositions are delivered to one or more vascular sites in a mammal as a fluid composition which solidifies in vivo to form a solid, coherent radioactive mass, preferably in the form or a stent. The solidified mass stents the vascular site thereby delivering the radioactivity attendant with the composition resulting in inhibition of restenosis.

Abstract: An enhanced visibility composition for implantation from a remote source, so that the composition can be readily observed under fluoroscopy or other imaging techniques. The compositions include a biocompatible matrix, such as a hard tissue implant material for example, and radiopaque particles mixed in the matrix. The radiopaque particles have a particle size between about 120&mgr; and 2200&mgr;, more preferably about 350&mgr; and 2200&mgr;, even more preferably between about 450&mgr; and 1600&mgr;, and most preferably between about 570&mgr;0 and 1150&mgr;. Preferably the hard tissue implant and the radiopaque particles are formed or prepared in a slurry. Optionally, the enhanced visibility composition may further include additional radiopaque particles or contrast particles mixed in with the composition, which have a particle size between about 120&mgr; and 350&mgr;, preferably between about 120&mgr; and 250&mgr;.

Abstract: An apparatus and a method to treat a disease process in a luminal structure. A dual-balloon catheter for treating a disease process in a luminal structure of a patient comprises an inner balloon, an outer balloon substantially concentric with and substantially surrounding the inner balloon, an inner balloon fluid delivery lumen in fluid connection with the inner balloon, and an outer balloon fluid delivery lumen in fluid connection with the outer balloon.

Abstract: Disclosed are novel radioactive compositions which are particularly suited for treating solid mass tumors via catheter delivery.

Abstract: Disclosed are methods for treating solid mass prostate tumors in a male mammal by use of a radiation composition.

Abstract: An implantable cancer therapy device includes adjacent segments of a radioactive therapeutic and an adjunctive therapeutic. The segments of radioactive therapeutic and adjunctive therapeutic can be alternatively disposed in a predetermined spatial array. The implantation can be permanent or temporary. The device can be a substantially cylindrical filament or plurality of spaced radioactive seed overlaid with an adjunctive therapeutic. The device can also be a monofilament comprising an adjunctive therapeutic, the monofilament having spaced depressions for indicating length and facilitating cutting.

Abstract: A radiation delivery catheter with inflatable chambers which provide a layer of radiation of minimum effective dose possible to be delivered as close as possible to the origin of disease within a blood vessel. The device can be centered within the true lumen of a vessel to provide even dispersion of the radiation agent to the outer wall of the vessel. The catheter comprises two central self centering balloons, one thin radiation agent inflatable chamber, and one radiation spread cloaking inflatable chamber with high strength properties resistant to rupture.

Abstract: A catheter apparatus filled with a radiation carrier material such as an inert radioactive gas for the treatment of restenosis after angioplasty, and malignancies. The inflated catheter includes a plurality of discrete chambers for transporting the radioactive carrier material, and a plurality of discrete chambers enabling substantial blood flow through the artery during treatment with the prescribed radiation. The inflated catheter may also comprise one unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall of the lumen attenuates transmission dose to the blood circulating through the hollow inner lumen of the catheter device. The system also creates increased by-product radiation, from the impact of beta particles and gamma protons traveling toward the lumen wall.

Abstract: An implantable seed for simultaneous delivery of thermal and radioactive radiation to target tissue comprises a tube or rod of a ferromagnetic alloy which, when subjected to an oscillating magnetic field will heat up, the alloy also being coated or otherwise treated with a radioactive isotope which gives off X-ray radiation during the decay thereof.

Abstract: Disclosed are novel radioactive compositions which are particularly suited for treating solid mass tumors via catheter delivery.

Abstract: An implantable seed for simultaneous delivery of thermal and radioactive radiation to target tissue comprises a tube or rod of a ferromagnetic alloy which, when subjected to an oscillating magnetic field will heat up, the alloy also being coated or otherwise treated with a radioactive isotope which gives off X-ray radiation during the decay thereof.

Abstract: There is provided a device and a method for irradiating vascular tissues. The device generally includes a transfer device having a first chamber and a second chamber and a piston slidably disposed between the chambers. A balloon catheter is provided for positioning within the vascular system and is connected to the transfer device such that an inflation lumen of the balloon catheter is in fluid communication with the second chamber. A proximal end of the balloon catheter is affixed to a mounting block which is configured to receive the transfer device. An inflation device is provided to force fluid into the first chamber such that the piston is driven to force a radioactive fluid contained in the second chamber into the balloon.

Abstract: A multi-diameter hypodermic needle, including a thin walled tubing with at least two sections having different internal diameters, is used to inject a X-ray contrast fluid in a rapid manner such that a subsequent image of the injected area evinces enhanced contrast characteristics.

Abstract: Locally deposited polymer depots are used as a vehicle for the immobilization and local delivery of a radionuclide or radiopharmaceutical. Radionuclides are incorporated in their elemental forms, as inorganic compounds, or are attached to a larger molecule or incorporated into the polymer, by physical or chemical methods. Ancillary structure may be employed to control the rate of release. Standard radionuclides which have been used for local radiotherapy may be used, such as radionuclides of iodine, iridium, radium, cesium, yttrium or other elements.

Abstract: A process for surgically correcting presbyopia includes anesthetizing a patient and marking a portion of an eye of the patient which is to be ablated. At least a portion of the cornea is resected to expose the corneal stroma. An annular portion of the corneal stroma is then ablated using radiation from a laser beam. After ablation, the cornea is repositioned onto the eye. The cornea may be resected such that a portion of the cornea remains intact, and is folded back to expose the corneal stroma. Alternatively, a complete disk of the cornea may be removed from the eyes to thereby expose the corneal stroma. After exposure but before ablating, the corneal stroma should be dried to prevent uneven ablation which may occur if fluids are present on the stroma. The laser beam may be directed in a circular fashion until an annular ablation is formed, or a mask may be provided over a central area of the corneal stroma. To prevent edema, the ablated portion should be cleaned by brushing and irrigating.

Abstract: A sheath for a syringe barrel, includes a main body in which a radiation shielding device for holding a syringe filled with pharmaceutical liquid therein is fitted, a male luer provided at a front end of the main body and designed to set a disposable needle, and a transfixing needle extending backward from inside of the male luer to penetrate a rubber plug at an opening at a front end of a syringe held in the main body.

Abstract: The subject invention provides a method of detecting gene transfer to and expression in a target tissue of a host subject comprising: (a) administering to the host subject a transfer vector containing a marker gene not naturally present in the host and nontoxic to the host, wherein the transfer vector transfects cells of the target tissue, under conditions such that the marker gene is expressed in transfected cells of the target tissue, thereby generating a marker gene product; (b) administering to the host subject a labelled marker substrate which is not metabolized by non-transfected cells, under conditions such that the marker substrate is metabolized by the marker gene product of step (a) to produce a labelled marker metabolite which is substantially retained in the transfected cells throughout a time-period sufficient for imaging the labelled marker metabolite; and (c) imaging the labelled marker metabolite, thereby detecting gene transfer to and expression in the target tissue.

Abstract: A disposable single-use kit for administering a precise dose of radioactive tracer to a subject with an accuracy of at least 99.9% by weight. The kit comprises a syringe, pre-filled with a known quantity of a radioactive tracer as injectate. The back of a small-bore needle is affixed to the syringe front. The front of a removable plastic needle cover incorporates airtight means for creating and maintaining an airlock in the needle front, thereby to prevent any contact between the tracer and the cover and so preclude any loss of tracer upon removal of the cover from the needle. A valve normally seals the syringe back, the valve including actuatable means for enabling a fluid flow into the syringe back, both for pre-filling of the syringe with injectate and for flushing of the injectate from the syringe into the subject.

Abstract: The automatic injection device comprises two syringes, one for injecting a measured quantity of radionuclide and a second for injecting a saline solution for flushing the intravenous tubing through which the radionuclide has been delivered. Each of these syringes is driven by a motor which compresses the plunger of the syringe causing it to inject its contents. The motors receive an activation signal from a computer controller which initiates the injection sequence upon receipt of a trigger signal which is provided either by a separate seizure detection computer, by activation by the patient who recognizes an aura indicative of an imminent seizure, or by activation by medical personnel observing the patient. The computer implements a delay cycle to permit verification of the trigger to avoid initiating the injection sequence in the event of false alarms.

Abstract: A method of treating solid tumor cancer in a living being by prolonging the time a therapeutically effective agent remains in the tumor. The method comprises the steps of selecting particles of an aggregated protein and injecting them interstitially into the tumor. The therapeutically effective agent colloidal radioactive phosphorous is injected into the tumor either after the injection of the proteinaceous particles, or simultaneously.

Abstract: The present invention provides radiation synovectomy compositions for treating inflamed synovium containing a radionuclide complex bound to a substantially insoluble particle as the radiolabelled synovectomy agent in a sufficient amount of provide satisfactory synovectomy of the inflamed synovium together with a pharmaceutically acceptable vehicle, the radionuclide being a beta emitter that will substantially ablate the inflamed synovium, but not significantly damage underlying articular cartilage, the radionuclide complex being substantially kinetically stable, and if said radionuclide or radionuclide complex leaks from said joint it will be excreted from the body, the agent having a particle size such that there is essentially little or no leakage of the radionuclide complex from the joint after administration.

Abstract: The present invention relates to radiopharmaceutical products used in the treatment of thyroid diseases. In particular, the present invention relates to sodium iodide .sup.131 I capsules which have increased stability and lower volatility.The objects of the present invention are achieved by providing a .sup.131 I capsule having a matrix material and antioxidant additive combination which provides for increased stability and reduced volatility of the capsule.

Abstract: A method or the treatment and diagnosis of tumors is disclosed. This method comprises the administration of an effective amount of a radiohalogenated pyrimidine nucleoside to the tumor affected site.

Abstract: Radioactive compositions containing a calcific matrix and methods for using the compositions for therapeutic radiation treatment including rheumatoid arthritis are disclosed.

Abstract: A holding device for a syringe while filling the syringe with radioactive liquid allows the syringe to be held such that a user is not exposed to radioactive rays. The holder generally comprises first and second rigid elongate members joined by a hinge. The first member distal end terminates in a finger flange bracket for receiving and retaining a syringe finger flange. The second member distal end terminates in a thumb flange bracket for receiving and retaining a syringe plunger thumb flange. An adjustable metering device restricts the angle through which the arms can move. In an exemplary embodiment, the finger flange and thumb flange brackets are removable.

Abstract: A composition comprises an antigen-specific antibody or antigen-binding fragment thereof labeled with Iodine-124 at a site other than, and which does not significantly interfere with, the antibody-antigen binding site. An in vivo method of radiotherapy directed to an antigenic site comprises administering to a subject in need of the therapy an amount of the antigen-specific composition described above effective to attain a reduction of the size of a tumor associated with the antigen. An in vivo method for detecting and localizing an antigenic site in a subject in need of such detection comprises administering to the subject an amount of the antigen-specific composition of the invention effective to localize the antigen-antibody binding site and scanning the subject's body with a positron-emitter detector to attain the localization of the site.

Abstract: A method for the treatment and diagnosis of tumors is disclosed. This method comprises the direct administration of an effective anti-tumor amount of a radiohalogenated pyrimidine nucleoside such as .sup.123 IUdR or .sup.125 IUdR to the affected site.

Abstract: The parenteral use of adenosine, functional adenosine receptor agonists which include 1-methyl-2-phenylethyladenosine, 5-ethyl carboxamide adenosine, cyclopentyl adenosine and 2-chloro adenosine; metabolic precursors or by-products of adenosine which include adenine and inosine; and phosphorylated derivatives of adenosine including adenosine monophosphate, adenosine diphosphate and adenosine triphosphate in conjunction with various invasive and noninvasive diagnostic techniques to detect the presence or assess the severity of vascular disease is a novel application (indication) for these compounds and forms the basis of this patent application.

Abstract: An aggregate suspension containing holmium-166 hydroxide and a carrier (such as a particulate ferric hydroxide) is injected into a patient's anesthetized joint (such as a knee joint or hip joint) for the treatment of inflamed synovial tissues such as present in arthritis, especially rheumatoid arthritis. The aggregate suspension is in a range of particle sizes from 1 to 40 microns. The holmium-166-containing suspension treats the synovial tissues, whereby radiation synovectomy takes place.

Abstract: Radiolabeled colloid compositions and a method for the preparation of radionuclide-colloid compositions useful in the treatment of rheumatoid arthritis are disclosed. A radionuclide selected from the group consisting of Sm-135, Ho-166, In-155m, Y-90, Gd-159 La-140, Lu-177, or Yb-175 is sorbed to a previously prepared iron-hydroxide colloid. The radiolabeled colloid compositions are comprised of spherical aggregations containing greater than 50% of the radioactive metal in iron-hydroxide particles. The method produces stable radionuclide iron-hydroxide compositions which are useful in therapeutic procedures such as radiation synovectomy.