Needle-free jet injection drug delivery device

Abstract

A device for delivering a drug includes a housing; at least one nozzle at a portion of the housing; a source of drug in the housing; and an energy source for providing a pressure of up to about 2,000 psi for driving the drug through the at least one nozzle and out of the housing. The drug is delivered to tissue under microjet propulsion. The device is particularly useful for drug delivery applications such as transdermal and ocular by way of example.

Description

FIELD AND BACKGROUND OF THE INVENTION [0001] The present invention relates, in general, to drug delivery and, in particular, to a new and useful device and method for the needle-free delivery of drugs with minimal trauma to tissue and that are suitable for delivering drugs in sensitive areas of the body such as the eye, nasal passageways, mouth and other areas of the body. [0002] Despite the continual advances in medical technology, particularly in the treatment of various diseases such as heart disease, vascular disease, ophthalmic disease, cancer, pain, allergies, orthopedic repair and many other diseases and conditions, there are a significant number of patients for whom conventional surgical and interventional therapies are not feasible or are insufficient to treat the disease or condition. For many patients, medical treatment with drugs and the like is the only feasible treatment available. [0003] There have been many recent advances in drug therapies, particularly with regard ...

AI Technical Summary

Benefits of technology

[0022] The present invention is directed to new and useful devices and methods for the needle-free delivery of drugs with minimal trauma to tissu

Problems solved by technology

Despite the continual advances in medical technology, particularly in the treatment of various diseases such as heart disease, vascular disease, ophthalmic disease, cancer, pain, allergies, orthopedic repair and many other diseases and conditions, there are a significant number of patients for whom conventional surgical and interventional therapies are not feasible or are insufficient to treat the disease or condition.

Although there have been advances in needle-based drug delivery/injection systems, these systems have significant shortcomings and disadvantages.

One such disadvantage is that the use of a needle or other penetrating means to inject the targeted tissue area unavoidably involves making a hole into the target site thereby causing trauma and tissue injury at the local tissue site.

Another disadvantage with this needle penetrating and injection approach is that it is very common for a substantial amount of the injectate to leak back out or exude from the hole created by the needle or penetrating member.

Often, this leaked injectate is released systemically throughout the body or is wasted depriving the patient of the prescribed therapy or dosing amounts of the drug.

This also results in increased treatment costs and requires more injections, time and agent in order to achieve the desired affect.

Furthermore, it is known that needle injections or penetration into the tissue can traumatize or destroy tissue cells and, as a result, increase a patient's risk of post-operative trauma, pain and discomfort at the local site and surrounding area.

This is particularly due to the difficulty in precisely controlling the penetration of the needle during injection.

The more injections or penetrations, the greater the cell destruction and tissue trauma that is likely experienced.

Still another disadvantage of needle-based injections, especially where multiple injections are required, is the inability to carefully track the location of each injection site so as to prevent the accidental delivery of drug to non-diseased tissue or repeat delivery of the drug to the same injection hole.

These types of devices could present a greater risk of releasing the agent systemically.

Additionally, with these types of devices, it is more difficult to assess the actual dosing of the target area that takes place.

Thus, these types of devices have the disadvantages of being less effective, possibly not as safe, and definitely more costly than the commonly known needle injection approaches and technology.

In order to effectively lyse the thrombus, the thrombolytics are typically infused for many hours, even as much as a day or more, increasing the necessary length of hospital stay and the overall cost of the procedure.

In great part, this is due to the size of the injection stream and, thus, the size of the nozzle orifice.

There are several significant limitations with current jet injection technology.

First, injection times associated with these conventional needle-free jet injectors are typically several seconds in length, which puts the patient at risk of laceration if they should move (e.g., flinch) or if the injector should be jarred from the injection site during an injection.

Second, the perceived pain is equivalent to a conventional needle and syringe.

Third, jet injectors are prone to deliver so-called “wet injections” where medicine leaks back out through the site of injection, a result that has given rise to concerns about accuracy of the delivered dose.

This size resulted more from the practical limitations of plastic injection molding for high volume commercial manufacturing than from any effort at optimizing the size for user comfort and minimization or elimination of any “leaking” of the injected medicament.

This trade-off of sub-optimal performance for manufacturability has resulted i

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