Twin Star TDS located in Lexington, KY is a wholly owned subsidiary of Twin Star Medical with an exclusive license to Twin Star Medical infusion systems technology for therapeutic delivery.


Drug Delivery

Local infusion directly to tissue is a growing modality for treatment of infection, pain management and chemotherapeutic or other agents.

Twin Star’s proprietary microporous hollow fiber catheter technology provides great potential improvement in consistently and uniformly delivering therapeutics to tissue.

Catheter system concepts include possible use in short term delivery, or longer term indwelling catheter placement for chemotherapy or pain medications over defined treatment regimens.

This drug delivery technology could potentially be used in three broad classes of clinical conditions. Any combination of these three conditions may occur:

      • Impaired Microcirculation – Conditions such as
         ischemia, infection, trauma, or osteoradionecrosis,
         where the microcirculation is disrupted and thus the
         delivery of blood–borne agents is impaired.

      • Systemic Toxicity – Conditions when limitations
         on systemic dose, duration, or repetition are
         necessary because of systemic toxicity of agents
         such as antibiotics or antimetabolites.

      • Impermeable, Large, and/or Insoluble Agents
         Conditions in which large, poorly diffusible
         molecules (immunoglobulins, growth factors,
         enzymes, and genetic vectors) must be delivered
         to the interstitium.

Caution: Investigational device. Limited by U.S. federal law to investigational use.
Patents issued and pending.




Drug infusion in gel medium

Central Nervous System Drug Delivery

Millions of Americans are afflicted by neurogenerative and malignant diseases affecting the central nervous system (CNS). For many of these diseases, such as Parkinson’s, Alzheimer’s and high grade primary brain tumors, there is currently no curative therapy. Even when effective therapeutic agents are identified, delivery into the CNS at therapeutic concentrations and sufficient distribution is presently difficult to reach clinical efficiency.

Many drugs of larger molecular size andweight are unable to pass the blood–brain barrier. Overcoming the drug–delivery obstacles to the CNS is a critical step in attaining better clinical outcomes.

Direct infusion of drugs into the brain parenchyma using convection–enhanced delivery (CED) results in the treatment of large areas of brain tissue. CED relies on bulk flow to establish a pressure gradient over time, resulting in continuous convective flow and widespread distribution of the drug to the affected areas of the brain.

One limitation of conventional CED treatment involves the backflow of infusate along the catheter body at increased infusion rates.

Another limitation relates to uneven distribution of infusate in tumor or injured tissue as opposed to normal brain tissue. The variability of normal brain tissues and the targeted areas of treatment creates challenges for getting the drug directly to the site.

Porous catheters are designed to improve the distribution of drugs administered directly into the central nervous system and other soft tissues. Porous catheters significantly increase the surface area where the drug or fluid is delivered, at much lower pressures.

Porous catheters can reduce the risk for backflow, while creating overall higher flow rates.




   
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