Vivo drug development and delivery systems and methods

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The present disclosure generally pertains to in vivo drug development and delivery systems and methods. The systems include a hollow tubular assembly with a chamber for receiving and transmitting an ionizing substrate solution, and a structure to transmit non-radioactive ionizing radiation to the ionizing substrate solution. The resulting free radical drug is transferred directly into a patient treatment site through an applicator. The systems and methods described herein provide simple, inexpensive techniques for in vivo production of an optimal chemotherapeutic drug without the use of radioactive radiation and directly injecting the drug into the patient's tissue with very minimal systemic side-effects.

This application is a continuation-in-part of and claims priority to U.S. patent application Ser. No. 13/917,522, entitled, “Drug Delivery and Treatment Systems and Methods” and filed on Jun. 13, 2013, which is incorporated herein by reference. This application also claims priority to U.S. Provisional Patent Application No. 61/912,110, entitled “In Vivo Drug Development and Treatment Systems and Methods,” and filed on Dec. 5, 2013, which is incorporated herein by reference, and U.S. Provisional Patent Application No. 61/918,515, entitled “In Vivo Drug Development and Treatment Systems and Methods,” and filed on Dec. 19, 2013, which is incorporated herein by reference. U.S. patent application Ser. No. 13/917,522 claims priority to U.S. Patent Provisional Application 61/659,077, entitled “Drug Delivery and Treatment Systems and Methods,” and filed on Jun. 13, 2012, which is incorporated herein by reference.

Cancer is an insidious and complex disease requiring multiple modality options. The three prevailing treatment options include surgery, chemotherapy, and nuclear or radioactive radiation. Surgical procedures, such as debulking, remove a portion of a malignant tumor, but it is often difficult to eliminate all of the diseased tissue such that the tumor returns. Radiotherapy includes irradiation, radiation therapy, or radiation oncology and is defined as the use of ionizing radioactive radiation to treat disease, kill cancer cells, or shrink tumors. Chemotherapy is the use of chemicals to treat disease, which is not limited to cancer. All three procedures have advantages as well as serious systemic consequences. There are many different types of cancers, as well as other diseases, each requiring individual treatment options utilizing a combination of the above-described therapies.

Many cancer patients receive at least one form of radiotherapy during their treatment cycle. Traditionally, radiotherapy is conducted in specialized facilities at a significant cost, sometimes on the order of hundreds of thousands of dollars per patient. Ionizing radiation is produced when a particle, such as a photon, acquires enough energy to remove an electron from an atom or molecule. Ionizing radiation is a biological and environmental hazard. Direct ionizing radiation describes charged particles (electrons, protons, and alpha particles) with sufficient energy to produce ionization by collision. Indirect ionizing radiation generally refers to the use of uncharged particles (neutrons and photons) to liberate particles by direct ionization. Radiotherapy generally involves the use of indirect radiation for the generation of free radicals, such as hydroxyl radicals, which then damage cancerous or diseased cells.

The energy level of an electromagnetic particle is indirectly proportional to its wavelength. For example, gamma rays with wavelengths of 50 fm have an energy level of about 25 MeV; x-rays with 50 pm wavelength yield about 25 keV; ultraviolet light with a wavelength of 100 nm yields about 12 eV; visible light with a wavelength of 550 nm yields about 2 eV; and microwaves with 1 cm wavelength exhibit roughly 120 μeV.

One major obstacle in the treatment of aggressive cancers is the fact that these cancers require chemotherapeutic or radiotherapeutic doses that are harmful or fatal to the patient. Treatment of cancer is systemic, where the cytotoxic drugs or radiation attack both malignant cells and healthy tissues. Selectively targeting the diseased cells is very difficult. In addition, radiation or chemotherapy treatment suppresses the immune system and therefore makes the patient susceptible to a host of other diseases. An additional complication is the fact that the patient's body adapts to the treatment and becomes resistant to further therapy.

Glioblastoma multiforme (GBM) tumors are the most common and aggressive malignant brain tumors in humans and are classified by the World Health Organization (WHO) as Grade IV tumors. Most GBM tumors originate in the deep white matter of the brain and quickly infiltrate other areas of the brain and the body. GBM tumors may grow very large before symptoms become apparent. GBM tumors are one of the most aggressive, resulting in a typical survival rate of less than a year after diagnosis. Treatment of these types of tumors is generally palliative, i.e., focusing on relieving and preventing the suffering of the patient, as there is no cure currently available. Recurrent tumors usually occur within 2 cm of the original tumor post treatment, which generally involves surgery followed by radiation and chemotherapy. GBM tumors are very resistant to chemotherapy. Aggressive radiation or chemotherapy treatment of recurrent tumors is difficult because the health of the patient is compromised and further procedures will shorten survival time. Patients suffering from GBM tumors and other cancers, such as pancreatic cancer, typically have poor prognosis as the available treatment options become too toxic and ineffective for continued treatment.

What is needed in the art, therefore, is a targeted, localized, minimally invasive cancer treatment which is readily available, causes fewer side effects for the patient and can be periodically repeated as needed to prevent the reoccurrence of the cancer.