Directional-ionizing energy emitting implant

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. The prescribed energy dosage is determined by using known characteristics of the energy-source material, and by the placement of the energy-source material relative to the targeted tissue. The implant system reduces any occurrence of heterotopic ossification caused by the implant, inhibits growth or migration of benign or malignant living cells, and minimizes or even eliminates infectious processes or delayed keloid or scar formation induced from surgical placement of a functional prosthesis or fixation device, in tissue within or about the device due to its targeted therapeutic energy emission effects.

Description

FIELD OF USE [0001] The present invention relates to an implanted apparatus having an insert device that is additive to or the replacement for an anatomic body structure or joint for the purpose of delivering a prescribed dosage of energy to targeted tissue to inhibit growth or migration of benign or malignant living cells and to minimize or even eliminate infectious or inflammatory processes, scarring, and fibrosis in tissue within or about the device due to its targeted energy effects. BACKGROUND OF THE INVENTION [0002] Total or partial prosthetic replacements are now common orthopedic surgical procedures. As the age of the general population increases, the number of such replacements is also increasing. Common symptoms generally can be caused by progressive degenerative osteoarthritis, prior localized trauma, previous local surgical procedures within the region, ankylosing spondylitis, and idiopathic skeletal hyperostosis. [0003] A common delayed complication following such repla...

AI Technical Summary

Benefits of technology

[0014] External beam irradiation establishes therapeutic effectiveness. The directional-ionizing energy emitting implant device of the present invention is for attachment either to natural tissue or a prosthetic device, and delivers a prescribed dosage of energy to targeted tissue. The implant device includes an energy-source material that delivers the prescribed dosage of energy to the targeted tissue, while minimizing exposure of nontargeted tissue. The targeted tissue has a known 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 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. The prescribed energy dosage is determined by using known characteristics of the energy-source material, and by the placement of the energy-source material relative to the targeted tissue. The implant system reduces the occurrence of heterotopic ossification caused by the implant, inhibits growth or migration of benign or malignant living cells, and minimizes or even eliminates infectious processes or delayed keloid or scar formation induced from surgical placement of a functional prosthesis or fixation device, in tissue within or about the device due to its targeted radiation effects.

[0015] The present invention is a directional-ionizing energy emitting implant device 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 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 to minimize or even eliminate infectious or inflammatory processes or delayed keloid or scar formation induced from surgical placement of a functional prosthesis or fixation device in tissue within or about the device due to its targeted radiation effects.

[0016] When such therapy is delivered within a narrow period of time, the prophylactic use of external beam radiation therapy demonstrates an effective reduction of the incidence and severity of heterotopic ossification. A limited, relatively low-dose of focal ionizing radiation to the specific target tissue, when administered predominantly in the first several hours to two days after surgery has proven beneficial clinical results with virtually no short or long term side effects.

[0019] The directional-ionizing energy emitting implant device and method of the present invention offer numerous medical, safety and economic advantages over conventional radiotherapy. The structure of this system dramatically improves the delivery of the radiation to the targeted tissue as compared with the non-targeted tissue, inherently accommodating for individual patient differences in morphology. Improved radiation efficacy is achieved by delivering a continuous dose rate of radiation and by utilizing known characteristics of various radio nuclides; such as half-life, specific activity, specific concentration, and type of energy decay.

[0020] The artificially implanted apparatus is functionally replacing or is additive to a normal anatomic body structure or joint. The apparatus is implanted, imbedded, or contained in a housing for strategically localized solid, liquid, gel-like, gaseous, or other intermediate phase radio-emitting substance or capable of inducing ionizing radiation, phosphorescence, luminescence, or fluorescence; whereby a precalibrated general or specific total dose, dose rate, or depth dose is delivered to adjacent target tissue to inhibit growth, migration, or differentiation of benign or malignant living cells; to inhibit heterotopic ossification; and to minimize infectious or inflammatory processes or minimize delayed scar or keloid formation in such tissue.

[0021] Since the radiation only travels a short distance within the patient's soft tissue and essentially only through the targeted area, there is minimal radiation risk to medical personnel and healthy tissue within the patient. Such radiation may begin its effective delivery immediately at the time of the procedure or is activated in delay post-operatively and over the immediate critical time frame for heterotopic ossification formation and / or minimize infectious, inflammatory, or scarring processes in such tissue. The radio nuclide dosage eventually decays to a non-radioactive state thereby enabling healing and without functional impairment to the prosthesis or fixation devices. The patient is discharged after recovery and receives the equivalent radiation benefit of several fractionated external beam treatments without the time, inconvenience, discomfort, and expense of conventional radiotherapy, while minimizing exposure to nontargeted tissue. Also, the system and method of the present invention promote more routine use of prophylactic radiation to prevent heterotopic ossification and minimize infectious, inflammatory, or scarring processes in such tissue by enabling potential broader physician access, flexible treatment judgments, and less patient pain and inconvenience.

Problems solved by technology

This complication results from excessive migration, replication, or differentiation of local primitive mesenchymal cells which are stimulated by the surgical trauma.

These osteoblastic cells then produce osteoid which is eventually transformed into calcified deposits or bone tissue, but in undesirable locations.

Heterotopic ossification causes varying degrees of debilitating pain, functional or mobile impairment, and increases the likelihood of repeat procedures after a period of time from several months to a few years.

External beam radiation therapy is often not prescribed because of the time required for set-up and treatment, the availability of single fraction treatments and variations in prescribed dose, patient discomfort and side effects, the need to irradiate tissue outside the target field, and economic considerations.

In addition, many patients are not considered for radiation treatment until late in the recovery process, which further limits treatment options.

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