Article and method for focused delivery of therapeutic and/or diagnostic materials

This Application claims benefit of and priority to Provisional Application No. 61/017,815, filed Dec. 31, 2007 and U.S. patent application Ser. No. 11/578,695, filed Oct. 17, 2006, both of which are hereby incorporated by reference in their entirety.

The present disclosure is generally directed to an article and method for delivering therapeutic and/or diagnostic materials and more particularly to an article and method for focused delivery of pharmaceuticals or other therapeutic materials and/or diagnostic materials to humans and other living organisms.

Many diseases, such as cancer, are often pernicious and very aggressive. Treatment is often complicated by the fact that some of the most effective treatment methods can have a deleterious impact on surrounding healthy tissue and cells. As a result, more recent efforts have moved toward therapies which attempt to target only unhealthy cells and thereby minimize the impact on healthy cells.

Hyperthermia is one such approach to cancer therapy. Hyperthermia associated with radiotherapy or chemotherapy is a method for cancer treatment, although the molecular mechanisms of this process are not well understood. Hyperthermia exhibits various anti-tumor effects, including damage of tumor vasculature.

Cancer cells are more sensitive to higher body temperatures than are normal cells. Hyperthermia destroys cancer cells by raising the tumor temperature to a “high fever” range, similar to the way the body uses fever naturally when combating other forms of disease. Because the body\'s means of dissipating heat is through cooling from blood circulation, sluggish or irregular blood flow leaves cancerous tumor cells vulnerable to destruction at elevated temperatures that are safe for surrounding healthy tissues with normal, efficient blood cooling systems.

Although not wishing to be bound by theory, scientists attribute the destruction of cancer cells at hyperthermic temperatures to damage in the plasma membrane, the cytoskeleton and the cell nucleus. Cancer cells are vulnerable to hyperthermia therapy particularly due to their high acidity caused by the inability to properly expel waste created by anaerobic metabolism. Hyperthermia attacks acidic cells, disrupting the stability of cellular proteins and killing them.

Radiofrequency (RF) hyperthermia is a non-ionizing form of radiation therapy that can substantially improve results from cancer treatment. For chemotherapy drugs that depend on blood transport for delivery, hyperthermia used in combination with chemotherapy (thermo-chemotherapy) enhances blood flow in tumor tissues, increasing the uptake of chemotherapy drugs in tumor membranes. Hyperthermia also induces disassembly of the cytoskeleton, which enlarges the tumor pores for easier drug entry. Once delivered, hyperthermic temperatures can be used as a drug activator, accelerating chemical reactions through heat and drawing essential oxygen molecules to tumor tissue for chemical reaction with the drug. This technology can be designed to optimize those factors that are antagonistic to neoplastic growth.

Several therapies are associated with non-ionizing RF hyperthermic therapy. One is RF ablation where direct radio-stimulation of cancerous tissues creates a local intense heat enough to kill neoplastic cells. Another RF approach is to direct RF at nanoparticle targets localized in the tumor site. These nanospheres are affixed with antibodies to focus the delivery of the nanoparticle to the tumor site that then becomes the target of RF stimulation to directly deliver heat to the local tissue. Still another approach is to combine the separate actions of chemotherapeutic agents with tissue hyperthermia.

In an embodiment of the present disclosure, a microfiber extrudate includes a bio-compatible polymer matrix forming a body of the microfiber extrudate, an exogenously excitable material arranged within the body, and an active load arranged within the body.

In another embodiment of the present disclosure, a discrete exogenously excitable domain includes an exogenously excitable material. The exogenously excitable material is configured to be excited by an exogenous stimulus. The exogenously excitable domain is arranged for positioning in a microfiber extrudate. The microfiber extrudate includes a bio-compatible polymer matrix forming a body of the microfiber extrudate, the exogenously excitable material in a discrete domain within the body.

In another embodiment of the present disclosure, a discrete active load domain includes a therapeutic material. The therapeutic material is configured to be released into a living organism. The active load domain is arranged for positioning in a microfiber extrudate. The microfiber extrudate includes a bio-compatible polymer matrix forming a body of the microfiber extrudate, with the active load arranged as a discrete domain within the body.

In another embodiment of the present disclosure, a microfiber extrudate delivery process includes medically identifying a region for treatment by the active load, administering a microfiber extrudate, and applying the exogenous stimulus to the region for treatment, thereby releasing an active load into the region for treatment. In the embodiment, the microfiber extrudate includes a bio-compatible polymer matrix forming a body of the microfiber extrudate, an exogenously excitable material arranged within the body, and the active load arranged within the body.

In another embodiment of the present disclosure, a microfiber extrudate includes a bio-compatible polymer matrix forming a body of the microfiber extrudate, an exogenously excitable material arranged within the body, and an active load arranged within the body. In the embodiment, the bio-compatible polymer matrix includes a polymer selected from the group consisting of poly(FAD-SA), poly(CCP-SA), poly(FA-SA), poly(EAD-SA), poly glycolide, poly lactic acid, copolymers thereof, and combinations thereof. The exogenously excitable material configured to be excited by an exogenous stimulus is selected from the group of stimuli consisting of radiofrequency excitation, microwave excitation, terahertz excitation, mid infrared excitation, near infrared excitation, visible excitation, ultraviolet excitation, x-irradiation excitation, magnetic excitation, electron beam irradiation excitation, and combinations thereof. The active load has therapeutic properties.

Exemplary embodiments may be used for selectively attacking cancer cells by administering a microfiber extrudate having an exogenously excitable material that may be excited to selectively attack cancer cells while leaving healthy cells intact.

An advantage of the present disclosure includes selectively delivering a therapeutic material, which may, for example, be used for selective attack of cancer cells.

Another advantage of the present disclosure includes selectively delivering a diagnostic material, which may, for example, be used for identifying cancer cells.

Yet another advantage of the present disclosure includes the ability to combine two components that would otherwise impose compositional difficulties into the same structure.