Sub-mucosal agent delivery method for the eye

• US 8,574,217 B2
• Filed: 02/10/2011
• Issued: 11/05/2013
• Est. Priority Date: 04/08/2010
• Status: Active Grant

• Current Assignee: KMG Pharma, LLC
• Original Assignee: KMG Pharma, LLC
• Inventors: Peyman, Gholam A.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/931,846
• Publication Number:
  US 20110251578A1
• Time in Patent Office: 999 Days
• Field of Search: 604300-302, 604/116, 604/506, 604/521, 604 68- 72, 128/200.14
• US Class Current: 604/521
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

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.

Claims

1. A method for administering a pharmacological agent formulation to a sub-mucosal compartment of an organ, comprising the steps of (i) providing an agent delivery apparatus containing the pharmacological agent formulation in an internal formulation chamber, said agent delivery apparatus including a needleless delivery member, said delivery member including a deformable positioning hood that is adapted to substantially conform to the surface of an organ and position said delivery member on said organ when in an engagement position thereon, needleless injector means that is in communication with said internal formulation chamber, and force generating means that is adapted to generate sufficient force to expel the pharmacological agent formulation from said agent delivery apparatus and into an organ, (ii) positioning said agent delivery apparatus on a surface of a first organ, and (iii) activating said agent delivery apparatus, whereby the pharmacological agent formulation is expelled from said agent delivery apparatus by said force generating means and delivered to the surface of said first organ with a delivery pressure in the range of approximately 100-1000 psi and, whereby a first volume of the pharmacological agent formulation is administered to a sub-mucosal compartment of said first organ, wherein said first organ comprises the eye.

2. The method of claim 1, wherein said first volume of the pharmacological agent formulation administered to said sub-mucosal compartment of said first organ is in the range of approximately 0.025-1 ml.

3. The method of claim 1, wherein said delivery member includes suction means that provides an eye engagement force and seals said delivery member to said first organ when said delivery member is in said engagement position.