Multifunctional nanoparticles hold great promise for drug/gene delivery and simultaneous diagnostics and therapeutics ("theragnostics") including use of core materials that provide in vivo imaging and opportunities for externally modulated therapeutic interventions. Multilayered nanoparticles can act as nanomedical systems with on-board molecular programming done through the chemistry of highly specialized layers to accomplish complex and potentially decision-making tasks. The targeting process itself is a multi-step process consisting of initial cell recognition through cell surface receptors, cell entry through the membrane in a manner to prevent undesired alterations of the nanomedical system, re-targeting to the appropriate sub-region of the cell where the therapeutic package can be localized, and potentially control of that therapeutic process through feedback systems using molecular biosensors. This paper describes a bionanoengineering design process in which sophisticated nanomedical platform systems can be designed for diagnosis and treatment of disease. The feasibility of most of these subsystems has been demonstrated, but the full integration of these interacting sub-components remains a challenge for the field. Specific examples of sub-components developed for specific applications are described.
Multifunctional nanoparticles hold great promise for drug/gene delivery. Multilayered nanoparticles can act as nanomedical systems with on-board "molecular programming" to accomplish complex multi-step tasks. For example, the targeting process has only begun when the nanosystem has found the correct diseased cell of interest. Then it must pass the cell membrane and avoid enzymatic destruction within the endosomes of the cell. Since the nanosystem is only about one millionth the volume of a human cell, for it to have therapeutic efficacy with its contained package, it must deliver that drug or gene to the appropriate site within the living cell. The successive delayering of these nanosystems in a controlled fashion allows the system to accomplish operations that would be difficult or impossible to do with even complex single molecules. In addition, portions of the nanosystem may be protected from premature degradation or mistargeting to non-diseased cells. All of these problems remain major obstacles to successful drug delivery with a minimum of deleterious side effects to the patient. This paper describes some of the many components involved in the design of a general platform technology for nanomedical systems. The feasibility of most of these components has been demonstrated by our group and others. But the integration of these interacting sub-components remains a challenge. We highlight four components of this process as examples. Each subcomponent has its own sublevels of complexity. But good nanomedical systems have to be designed/engineered as a full nanomedical system, recognizing the need for the other components.
Because of the current health care environment, involved parties are requesting the assessment of patient safety and efficacy following a lower extremity operation. Many foreign countries have registries to assess postoperative patient safety. A similar system does not exist in the United States. The purpose of this study was to create a registry to assess the safety and efficacy of lower extremity implants and procedures. The EVEREST Lower Extremity Registry is an Internet-based database designed to collect clinical outcomes and survivorship data of total ankle implants, hardware implants, and soft-tissue procedures. All data are collected remotely on a secure Web site. Data are collected at defined intervals according to implant or procedure. The investigators consent patients preoperatively using a central Institutional Review Board and are encouraged to enroll consecutive patients. Routine patient reports allow sites constant feedback regarding their patients versus the entire registry population. Patient engagement begins with providing a personalized implant card and is followed with the appropriate scheduling prompts based on interval due dates. Currently, there are 15 sites contributing data to the registry. There are 47, 79, and 27 patients enrolled in the total ankle, ankle hardware, and soft-tissue registries, respectively. Longest term follow-up collected is 12 months. Early outcomes suggest that many surgeons are willing to assimilate a registry system into their practice. This registry supports the critical need for data collection in lower extremity medicine.
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