Injection apparatus and method of using same

• US 6,299,603 B1
• Filed: 08/02/1999
• Issued: 10/09/2001
• Est. Priority Date: 08/03/1998
• Status: Expired due to Term

• Current Assignee: Sun Pharma Global Fze (Sun Pharmaceutical Industries Limited)
• Original Assignee: Insite Vision Incorporated (Daiichi Sankyo Company Limited)
• Inventors: Bowman, Lyle M., Clark, Leslie A., Pfeiffer, James F., Hecker, Karl I.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/366,703
• Time in Patent Office: 799 Days
• Field of Search: 604/116, 604/117, 604/164, 604/174, 604/177, 604/180, 604/48, 604/264, 604/272, 604/274, 604/506-510, 604/289, 606/166
• US Class Current: 604/181
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

The present invention relates to an apparatus and method for using the apparatus for injecting an agent into a tissue, particularly into thin tissues such as the sclera of the eye. The invention provides an apparatus and method for effectively imbedding a needle into a tissue at a predetermined penetration approach angle and penetration distance thereby reducing the risk of penetrating the full thickness of the tissue. The invention includes a support element and a needle guide platform disposed on the support element with an external support surface and a channel extending therethrough and terminating in an aperture at the support surface. A needle disposed in the channel is axially movable along an axis of injection through the channel. The needle is movable from a first retracted position to an extended position corresponding to the penetration distance, along the axis of injection. The axis of injection forms a penetration approach angle of up to about 60° with a tangent of the support surface at a point of intersection of the axis of injection with the projection of the support surface across the aperture.

Claims

1. A method for injecting an agent into scleral tissue, the tissue having a first surface and a second surface defining a tissue thickness, said method comprising:

disposing a needle in an injection apparatus, the apparatus including a support element, a needle guide platform disposed on said support element and having an external support surface configured substantially similar to the natural curvature of the intact sclera, the support surface being configured to substantially conform to the geometry of one of the first and second surface of the tissue, and a channel therethrough, the needle movable along an axis of injection through the channel, the needle having a first end and a second end and including a sidewall defining an outlet in the needle and an inlet disposed in the needle, the inlet being in fluid flow communication with the outlet;

placing the needle in fluid flow communication with a medicament reservoir;

positioning the injection apparatus adjacent a tissue surface;

advancing the needle outwardly through the channel;

imbedding the needle into the scleral tissue at a penetration distance of greater than about the tissue thickness and such that the outlet is adjacent to, and oriented in a direction substantially facing, one of the first and second surfaces of the tissue; and

transferring the agent into the tissue.

2. A method according to claim 1, wherein the needle is imbedded into the target tissue at a penetration distance of greater than about the target tissue thickness.

3. A method according to claim 2, wherein even if the needle were extended, it could not intersect the second target tissue surface.

4. A method according to claim 2, wherein the needle is imbedded into the target tissue at a penetration distance of about 1.5 mm to about 4 mm.

5. A method according to claim 2, wherein the needle is imbedded into the target tissue at a penetration distance of about 2 mm to about 3 mm.

6. A method according to claim 1, wherein in the transferring step, the agent is transferred at a rate of about 1 to about 10 microliters/second.

7. A method according to claim 6, wherein in the transferring step, the agent is transferred at a rate of about 1 to about 4 microliters/second.

8. A method according to claim 7, wherein in the transferring step, the agent is transferred at a rate of about 4 microliters/second.