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  Directional-ionizing energy emitting implantUSPTO Application #: 20060106273Title: 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. (end of abstract) Agent: Taylor & Aust, P.C. - Avilla, IN, US Inventor: Marc G. Apple USPTO Applicaton #: 20060106273 - Class: 600003000 (USPTO) Related Patent Categories: Surgery, Radioactive Substance Applied To Body For Therapy, Radioactive Substance Placed Within Body (e.g., Inhaled, Implanted, Injected, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20060106273. Brief Patent Description - Full Patent Description - Patent Application Claims
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 replacements is the development of heterotopic ossification within or about the adjacent soft tissue and the prosthesis between the adjoining bone tissue. This complication results from excessive migration, replication, or differentiation of local primitive mesenchymal cells which are stimulated by the surgical trauma. These cells undergo subsequent metabolic and cytologic metamorphosis to become more specialized osteoblastic cells. These osteoblastic cells then produce osteoid which is eventually transformed into calcified deposits or bone tissue, but in undesirable locations. [0004] 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. Between 30 and 35 percent of all untreated patients undergoing total hip prosthesis develop some degree of functional impairment or progressive discomfort, often from heterotopic ossification. [0005] It has been shown in our U.S. Pat. No. 6,120,540 that a radio prosthesis comprising a prosthetic device and a radio source material that is part of the prosthesis device has utility, for example, in a total hip replacement. The radio prosthesis is precalibrated to deliver for dosage, dose rate, and depth dose to adjacent target tissue to inhibit growth. Such radiation begins its effective delivery immediately at the time of the procedure and over the immediate critical time frame for heterotopic ossification formation. Since the radiation only travels a short distance to the targeted area, there is minimal exposure of radiation to medical personnel and healthy tissue within the patient. The dosage eventually decays to a non-radioactive state thereby enabling healing without functional impairment to the prosthesis. No separate removal procedure is required. The patient is discharged upon recovery and receives the equivalent radiation benefit of several fractionated external beam treatments without the time, inconvenience, discomfort, and expense of conventional radio therapy. [0006] External beam irradiation has established therapeutic effectiveness. When such therapy is delivered within a narrow period of time, the prophylactic use of external beam radiation therapy has been shown to effectively reduce 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 side effects. [0007] Other relevant art includes the following: [0008] U.S. Pat. No. 5,681,289 (Wilcox et at) is a system for dispensing a liquid chemical agent, such as an antibiotic, anesthetic, growth factor, hormone, anti-neoplastic agent into a site of a surgical procedure. The system includes at least one bladder with an internal cavity that connects to an open tube through which the liquid chemical agent is passed, under pressure, into the bladder. The bladder is shaped to fit between a prepared bone section and a prosthesis. The bladder is connected by a tube to a reservoir and pump. [0009] U.S. Pat. No. 4,936,823 (Colvin et al) is an implant capsule for insertion into a body canal of a patient to apply radiation treatment to a selected portion of the body canal. The transendoscopic implant capsule is transported through the body canal to apply a therapeutic radiation to a tumor within the patient. The implant capsule is remotely implanted and retrieved with a fiber optic bronchoscope. [0010] U.S. Pat. No. 5,833,593 (Liprie) is a flexible wire for providing a radioactive source to maneuver through a tortuous narrow passage to a treatment site within the patient. The source wire includes an elongated flexible housing tube with a treatment end modified to receive a radioactive core. [0011] While U.S. Pat. No. 5,728,136 (Thal) discloses a spike member for insertion into a bone mass, we are unaware of any such device being used to delivery energy treatment to targeted tissue. 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. [0012] What is needed is a process and structure for providing the radiation dose originating from an internal site to the targeted tissue, whereby the emission profile more closely matches the profile of the targeted tissue; a process and a structure that can be readily adapted for any surgical bone tissue replacement or additive procedures; a process and a structure that is easy to administer, safe for the patient, effectively reducing side effects caused by such surgical procedures; and, a process and struct6ure for eliminating the need for separate post-operative treatment while dramatically (a) reducing any occurrence of heterotopic ossification, and (b) minimizing infectious processes in tissue within or about the device and excessive, restriction fibroid and scarring at the incision or closure site due to its targeted radiation effects. SUMMARY OF THE INVENTION [0013] The needs set forth above are addressed by the directional-ionizing energy emitting implant system and process of the present invention. While the implant system of the present invention is discussed herein in relationship to the delivery of radiation to targeted tissue, one having ordinary skill in the art will readily appreciate the application of the principles of the present invention to other forms of ionizing energy delivery, including but not limited to luminescent energy, hyperthermic energy, and photo-light energy emission forms. [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. [0017] Additional indications for the use of localized, relatively modest, cumulative radiation doses of approximately 600 cGY to 3500 cGy, have demonstrated clinical success in providing some bacteriocidal, bacteriostatic, and sterilizing benefits for living tissue. In addition, similar dose applications inhibit keloid excess scar formation. Such keloid formation at the skin or sub-dermal tissue within or about a surgical scar or injury can cause significant restriction of motion, dys-mobility, pain, or decreased aesthetic appearance. [0018] Ionizing-type radiation exposure is also routinely used in various ways to sterilize and leukocytic reduce blood products from infectious and immunoreactive agents in dose ranges of 1500 to 2500 cGy or more, depending upon the method of fractionation and dose rate and type of energy administration. [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. [0022] While the directional-ionizing energy emitting implant system of the present invention is discussed herein in relationship to hip-joint, it is to be appreciated by one having ordinary skill in the art that this technology is also applicable to total or partial joint replacement, and injury or fracture fixation, such as a total or partial hip, knee, shoulder, or elbow prosthesis. For purposes of discussion herein, unless the context suggests otherwise, a hip replacement is used for purpose of illustration only. The radiation delivery system of the present invention induces the emission of specific radio nuclides enabling the anatomic configuration of the implant, the controlled placement position of one or more radio nuclides, and the selection of the type or composition of the radio source material to deliver a confined and targeted tissue deposition of ionizing radiation to a pre-calibrated dose rate, depth dose, and total delivered dose of prescribed radiation. [0023] For a more complete understanding of the directional-ionizing energy-emitting implant of the present invention, reference is made to the following detailed description and accompanying drawings in which the presently preferred embodiments of the present invention are shown by way of example. As the invention may be embodied in many forms without departing from spirit of essential characteristics thereof, it is expressly understood that the drawings are for purposes of illustration and description only, and are not intended as a definition of the limits of the invention. Throughout the description, like reference numbers refer to the same component throughout the several views. BRIEF DESCRIPTION OF THE DRAWINGS Continue reading... Full patent description for Directional-ionizing energy emitting implant Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Directional-ionizing energy emitting implant patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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