Abstract: The present invention provides a system and method of applying low dose, localized radiotherapy which is effective to reduce or eliminate the formation of post-operative scar tissue at surgical sites, such as an epidural site after spinal surgery. In an exemplary embodiment, a device is implantable before closing a surgical site as a barrier, the device being designed to deliver a desired therapeutic amount of energy to particular tissue. The device can be a barrier layer, seed containment unit, radiospike, or catheter. The energy may be provided by the material of the device itself, or may be provided by an external source, such as by circulating radioactive fluid through the device itself. Various embodiments include additional components of the device which deliver drug or chemical agents to targeted tissue and/or shield components to prevent dosage to non-targeted tissue.

Abstract: A catheter assembly for use in radiation therapy of a patient by insertion into a vessel, passageway or cavity to deliver radioactive material to a treatment site within the patient. The distal end of the catheter assembly (10) includes a noncompliant inner balloon (18) therearound that is inflatable with a non-radioactive fluid (such as CO2 or saline or contrast medium), and an outer balloon (16) therearound that is inflated with radioactive fluid (such as radiogas like xenon-133 ) and is noncompliant to conform the vessel wall to the balloon's shape at the treatment site for optimal distribution of dose. The inner balloon allows reduction in volume of the amount of radioactive fluid necessary to achieve a desired dose. The inner and outer balloons (112,108) may be affixed to inner and outer catheters (104,102), respectively.

Abstract: The directional-ionizing energy emitting implant is for attachment either to natural tissue or a prosthetic device, and delivers a prescribed dosage of energy to targeted tissue. The insert device includes an energy-source material within the insert device that delivers the prescribed dosage of energy to the targeted tissue, while minimizing exposure of nontargeted tissue. The targeted tissue has a known energy-response profile and is adjacent to the targeted tissue. The energy-source material in combination with the prosthetic device defines an actual energy-delivery distribution field. The energy-delivery distribution field has a configuration similar to the known energy-responsive profile of the targeted tissue. The prescribed dosage of energy is applied from energy-source material within the insert device and directed to the targeted tissue.

Abstract: The directional-ionizing energy emitting implant is for attachment either to natural tissue or a prosthetic device, and delivers a prescribed dosage of energy to targeted tissue. The insert device includes an energy-source material within the insert device that delivers the prescribed dosage of energy to the targeted tissue, while minimizing exposure of nontargeted tissue. The targeted tissue has a known energy-response profile and is adjacent to the targeted tissue. The energy-source material in combination with the prosthetic device defines an actual energy-delivery distribution field. The energy-delivery distribution field has a configuration similar to the known energy-responsive profile of the targeted tissue. The prescribed dosage of energy is applied from energy-source material within the insert device and directed to the targeted tissue.

Abstract: The present invention provides a system and method of applying low dose, localized radiotherapy which is effective to reduce or eliminate the formation of post-operative scar tissue at surgical sites, such as an epidural site after spinal surgery. In an exemplary embodiment, a device is implantable before closing a surgical site as a barrier, the device being designed to deliver a desired therapeutic amount of energy to particular tissue. The device can be a barrier layer, seed containment unit, radiospike, or catheter. The energy may be provided by the material of the device itself, or may be provided by an external source, such as by circulating radioactive fluid through the device itself. Various embodiments include additional components of the device which deliver drug or chemical agents to targeted tissue and/or shield components to prevent dosage to non-targeted tissue.

Abstract: A catheter assembly for use in radiation therapy of a patient by insertion into a vessel, passageway or cavity to deliver radioactive material to a treatment site within the patient. The distal end of the catheter assembly (10) includes a noncompliant inner balloon (18) therearound that is inflatable with a non-radioactive fluid (such as CO2 or saline or contrast medium), and an outer balloon (16) therearound that is inflated with radioactive fluid (such as radiogas like xenon-133) and is noncompliant to conform the vessel wall to the balloon's shape at the treatment site for optimal distribution of dose. The inner balloon allows reduction in volume of the amount of radioactive fluid necessary to achieve a desired dose. The inner and outer balloons (112,108) may be affixed to inner and outer catheters (104,102), respectively.

Abstract: A catheter apparatus and radiation dosimetry unit indicator for delivery of a prescribed radiation dose to a patient. A radiotherapy source vial (700) includes a fluid container (701) of radioactive fluid with a seal (702,731) disposed about the container. Seal (702,731) is moveable with respect to container (701) to change the contained volume therein. A radioactive fluid transport site (703) is in communication with the contained volume and with an exterior (726) of the container (701), and may include a septum (707) or a valve (711). An engagement mechanism (704) is connectable to an external control mechanism (706) whereby the contained volume in the radioactive fluid container can be decreased and increased by actuation of the external control mechanism.

Abstract: A balloon catheter assembly (10) including a balloon section (14), a radiofluid port (40), and a magnetizing section. The magnetizing section generates a magnetic field that enhances the energy of the electrons (Beta particles) from radiofluid within the balloon section to increase the depth dose. The magnetizing section may comprise a solenoid arrangement (70) wherein wires (72,74) within catheter wall (20) having coils (76) surrounding the catheter within the balloon section (14) are connected to a controlled source (86,88) of milliamperage or microamperage, and generate a magnetic field within balloon section (14). Permanently magnetized distal end portions (116,138) of the catheter (112) or guide wire (118) or both, within balloon section (114), may be used to generate the magnetic field, or may be used in conjunction with a solenoid arrangement.

Abstract: A catheter apparatus (20) and radiation dosimetry unit indicator (21) for delivery of a prescribed radiation dose to a patient. The catheter is filled with a radiation carrier material such as an inert radioactive gas (12) for the treatment of, for example, restenosis after angioplasty, and malignancies. The inflated catheter includes a plurality of discrete chambers such as balloon sections (22, 24, 26) for transporting the radioactive carrier material, and a plurality of discrete chambers (32, 34, 36) enabling substantial blood flow through the artery during treatment with the prescribed radiation. The inflated catheter can also comprise a one-unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall (25) of the inflation lumen attenuates transmission dose to the blood circulating through the hollow inner lumen of the catheter device.

Abstract: A catheter apparatus and radiation dosimetry unit indicator for delivery of a prescribed radiation dose to a patient. The catheter is filled with a radiation carrier material such as an inert radioactive gas for the treatment of, for example, 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 can also comprise a one-unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall of the inflation 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: A catheter apparatus (20) and radiation dosimetry unit indicator (21) for delivery of a prescribed radiation dose to a patient. The catheter is filled with a radiation carrier material such as an inert radioactive gas (12) for the treatment of, for example, restenosis after angioplasty, and malignancies. The inflated catheter includes a plurality of discrete chambers such as balloon sections (22, 24, 26) for transporting the radioactive carrier material, and a plurality of discrete chambers (32, 34, 36) enabling substantial blood flow through the artery during treatment with the prescribed radiation. The inflated catheter can also comprise a one-unit balloon. A specific metal coating enhances the radiation dose delivered to the target. The wall (25) of the inflation lumen attenuates transmission dose to the blood circulating through the hollow inner lumen of the catheter device.

Abstract: An implant system and a method for delivering a dosage of radiation to targeted tissue. The system comprises a prosthetic device that functionally replaces or is additive to a body structure or joint, and a radio source material. The radio source material is positioned either on or within the prosthetic device. The actual radiation delivery distribution field has a similar configuration to the profile of the targeted tissue. The implant system is particularly useful for inhibiting heterotopic ossification.

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: A system, apparatus, and method for administering radiation internal to a patient involving a catheter, having disposed therewithin a radiation carrier material such as an inert radioactive gas, like xenon, for the treatment of restenosis after angioplasty, and malignancies. When the catheter apparatus is inflated, it may include 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.