Device for delivering biological agents

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S506000, C604S060000

Reexamination Certificate

active

06258070

ABSTRACT:

BACKGROUND OF THE INVENTION
Much effort has been expended in recent years to find an effective and superior way of administering drugs to patients' bodies. Products such as the transdermal patch and once-a-day orally administered pills that more precisely deliver drugs have been developed. Such products are a boon to patients for they boost the effectiveness of the drugs and limit side effects by precisely controlling how quickly drugs are released in the body; by keeping drugs at a constant level and by delivering them exactly where needed.
One such development is the injection or implantation of drugs in the form of in microscopic particles or pellets at a disease site. The drugs are encapsulated in polymers or fatty compounds, such as liposomes which permit slow release of the encapsulated drug over time thereby potentially lowering the drugs toxicity.
In addition, there are times when it is desirable to deliver a biological agent that is in a non-conventional form to a disease site such as a drug in a loose particulate form, or a quantity of cells, cell clusters or cellular extracts in a biocompatible solution. A particulate biological agent can be in a granular, powdered, or microsphere form. The problem with biological agents in these forms is that they are difficult to properly deliver to a diseased tissue site.
SUMMARY OF THE INVENTION
The present invention provides a novel device with a distal end insertable into the tissue or a body cavity of a patient for delivering both particulate and liquid biological agents in a quick, predictable, safe and easy manner without damaging the biological agent. This is important in the delivery of cells or microspheres. The biological agent delivery device includes a cannula having a longitudinally extending wall and a distal end with a notch opening formed in the wall near the distal end. A flexible membrane disposed within the cannula notch opening has a support/delivery surface for supporting a quantity of a biological agent. Temperature controlled fluid is disposed within the wall of the cannula to laterally displace the support surface of the flexible membrane to deliver the biological agent to the desired tissue site.
In preferred embodiments, the temperature controlled fluid can be a liquid or a gas. The fluid is cooled or heated in order to cool or heat tissue surrounding the delivery site. Cooling the tissue surrounding the delivery site constricts blood vessels within the tissue and slows the rate at which the biological agent passes into the bloodstream. Heating the tissue surrounding the delivery site widens the blood vessels and increases the rate at which the biological agent passes into the bloodstream. The present invention biological agent delivery device further includes an outer tube mounted concentric with the cannula. The cannula is capable of sliding within the outer tube to retract or extend the cannula relative to the outer tube for enclosing the cannula notch within the outer tube for insertion into tissue or exposing the cannula notch beyond the outer tube to allow delivery of the biological agent after insertion into tissue. The flexible membrane is preferably a tubular member having a closed terminal end which extends within the cannula, with the support surface of the flexible membrane being located near the closed terminal end and positioned within the cannula notch. When the flexible membrane is in a non-displaced state, the support surface is indented into the flexible membrane to form a pouch. This pouch can optionally be preformed.
In still another preferred embodiment, the present invention biological agent delivery device is a flexible catheter with fiber optics being optionally provided within the cannula for delivering radiation to a desired tissue or body cavity site. A lens associated with the fiber optics enables viewing of regions external to the cannula.


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