Sub-mucosal agent delivery apparatus,system and method

Abstract

An agent delivery apparatus for administering a pharmacological agent formulation to a sub-mucosal compartment of a body organ, comprising injector means having an internal formulation chamber that is adapted to receive and contain the pharmacological agent formulation therein and an elongated agent delivery member having a first end that is in communication with the internal formulation chamber and a delivery nozzle end, the injector means including force generating means that is adapted to generate sufficient force to expel the pharmacological agent formulation from the injector means and into and through the agent delivery member, and out of the delivery nozzle end of the elongated agent delivery member with a delivery pressure in the range of approximately 50-1000 psi.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 342,162, filed Apr. 8, 2010.FIELD OF THE INVENTION[0002]This invention relates generally to trans-mucosal agent delivery as a means of treating various conditions affecting mucosa and sub-mucosa of an organ, such as the eye, nose, mouth, throat, trachea, esophagus, stomach, urethra, bladder and vagina. More particularly, the invention relates to improved means for performing mucosa and sub-mucosal agent delivery with the benefits of improved safety for the patient and increased efficiency for the practitioner.BACKGROUND OF THE INVENTION[0003]As is well known in the art, delivery of pharmacological agents (or drugs) to a specific organ or tissue can be achieved through systemic or local administration. In systemic administration, the agent is introduced into the systemic, or general, circulation by ingestion, injection, inhalation and trans-dermal or trans-mucosal a...

AI Technical Summary

Benefits of technology

The invention is an apparatus for delivering a pharmacological agent to the submucosal compartment of a body organ. It includes an injector with a force generating means to expel the agent from the injector and through the delivery member and nozzle. The delivery member can be fixed or flexible, and it has a hood to position it on the organ and a microneedle limiter to control the penetration depth. The injector can contain multiple pharmacological agent formulations for delivery. The method involves positioning the delivery apparatus and activating it to expel the agent into the submucosal compartment of the body organ. The technical effects are a more targeted delivery of pharmacological agents to the desired location and improved absorption through the mucosal layer.

Problems solved by technology

A disadvantage, however, is that the agent must be administered at relatively high doses in order to reach the target area in sufficient quantity.

Moreover, the agent is delivered to the entire body, which can include sites where the agent can cause significant side effects.

This is especially true for chemotherapeutic agents that tend to present significant systemic toxicity, and steroids, which present significant long-term systemic side effects.

Another significant disadvantage of systemic administration is that transfer of many pharmacological agents from the blood to certain tissues. such as the brain or an eye, is very inefficient.

Because of the complex nature of the eye, it is susceptible to a large number of abnormalities (and / or diseases).

Treatments of the abnormalities and diseases have, in general, been limited to topical administration of agents or preparations.

A disadvantage of this mode of administration is that not all eye tissues are accessible by this route of delivery.

A further disadvantage of this mode of administration is that it is mostly applicable to small molecular weight pharmacological agents.

Indeed, large molecular weight agents, such as antibodies, are known to diffuse poorly across the cornea or the sclera.

Further, even when jet injection devices are employed to administer pharmacological agents or medication inside the eye, there are several drawbacks and disadvantages associated therewith.

A significant disadvantage is that the conventional jet injection devices do not include a transfer mechanism that is adapted to provide safe, accurate, consistent and rapid delivery of pharmacological agents into the eye; particularly, a sub-mucosal compartment in the eye.

Further significant disadvantages are (i) the conventional jet injection transfer mechanism typically include a rigid, substantially linear delivery member, which in many instances restricts access into a sub-mucosal compartment, and (ii) the jet injection devices do not include any means of ensuring perpendicular placement of the surface of an organ, e.g., eye, which is an important factor to achieve effective agent delivery to an organ's mucosa.

Sub-mucosal injection using a conventional needle is also painful and each injection requires several steps to prepare the eye and safely perform the injection.

The time required to perform injections can thus disrupt office schedules, resulting in unexpected prolongation of patient waiting times.

There are, however, similarly several drawbacks and disadvantages associated with this mode of administration.

By way of example, it is well known in the art that topical application of pharmacological agents on the mucosa is, in many instance, not very effective since the agent has a limited efficacy period, i.e. will generally not last for a long period of time.

Slow release pharmacological agents, such as nano-particles, microspheres and liposome, similarly have a limited efficacy period.

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