Intradermal injection system for injecting DNA-based injectables into humans

• US 6,752,780 B2
• Filed: 11/19/2001
• Issued: 06/22/2004
• Est. Priority Date: 08/20/1999
• Status: Expired due to Term

• Current Assignee: Bioject Incorporated
• Original Assignee: Bioject Incorporated
• Inventors: Miller, Robert A., Bonicatto, James M., Stout, Richard R.
• Primary Examiner(s): Thanh, Loan H.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/001,856
• Publication Number:
  US 20020087117A1
• Time in Patent Office: 946 Days
• Field of Search: 604/68-72, 604/140-143, 604/187, 604/131
• US Class Current: 604/68
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

A system for injecting DNA-based medications into humans is provided by the present invention. The system includes a needle-free injector with an injection orifice of approximately 0.004 inches for supplying DNA-based medication at an initial pressure of from 3900 to 4300 psi, and then immediately declining to a level of about 2800 to 3800 psi, and then immediately cutting off pressure to terminate the injection. The injector includes an annular adapter for spacing the injection orifice from the skin of the patient. The adapter includes an abutment against which the injector is disposed so that the orifice is spaced approximately 0.76-1.0 inch from the skin of the patient, the adapter having an inner diameter at the distal end of approximately 0.50-0.70 inches.

Claims

1. A system for injecting a liquid medication under a pressure intradermally into humans, comprising:

a needle-free injector with an injection orifice of approximately 0.004 inches defined therein for supplying the liquid medication, the injector including a removable, annular, intradermal adapter for spacing the injection orifice from the skin of the patient, the adapter including an abutment against which the injector is disposed so that the orifice is spaced at a fixed distance of approximately 0.76-1.0 inch from the skin of the patient, the adapter having an inner diameter of approximately 0.50-0.70 inches at the distal end which is positionable adjacent the skin wherein the intradermal adapter is generally cylindrical and the distal end of the adapter terminates in a flange extending radially outwardly from the adapter.

2. The system of claim 1 wherein the outer diameter of the flange is at least about 0.20 inches greater than the inner diameter of the adapter.

3. A method for performing intradermal injection of liquid injectables into humans, comprising:

fitting, adjacent an orifice of a needle-free injector, a proximal end of a substantially cylindrical intradermal adapter having a proximal and distal end and an internal abutment against which the injector is disposed to provide a fixed spacing of from approximately 0.76 to 1.0 inches from the orifice to the distal end of the adapter, the distal end having an inner diameter of from 0.50 to 0.70 inches;

selecting a needle-free injector having an injection orifice of from 0.004 to 0.005 inches;

holding the distal end of the intradermal adapter against the skin of the patient; and

using the needle-free injector to inject a liquid injectable in a volume of 0.3 ml or less into the intradermal region at an initial peak pressure of from 3900 to 4300 psi, and then permitting the injection pressure to decay to a level of about 2300 to 3800 psi, after which time the pressure is abruptly cut off, terminating the injection.

4. A method for performing intradermal injection of liquid injectables into humans, comprising:

fitting, adjacent an injection orifice of a needle-free injector, a proximal end of a substantially cylindrical intradermal adapter having a proximal and distal end and an internal abutment against which the injector is disposed to provide a fixed spacing of from approximately 0.76 to 1.0 inches from the injection orifice to the distal end of the adapter, the distal end having an inner diameter of from 0.50 to 0.70 inches;

selecting the needle-free injector having the injection orifice of from 0.004 to 0.005 inches;

holding the distal end of the intradermal adapter against the skin of the patient; and

using the needle-free injector to inject a liquid injectable in a volume of 0.3 ml or less into the intradermal region at an initial peak pressure of from 3900 to 4300 psi, and then permitting the injection pressure to decay to a level of about 2300 to 3800 psi, after which time the pressure is abruptly cut off, terminating the injection;

wherein, following a single quick drop and rebound in pressure following the initial peak pressure, there is no more than plus or minus 100 psi variation from the pressure curve of the injection.