Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-06-23
2004-02-03
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S070000, C604S140000
Reexamination Certificate
active
06685669
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to a needleless syringe for use in delivery of particles comprising a therapeutic agent to a target surface. More particularly, the invention is drawn to a needleless syringe system configured for delivery of particles comprising a therapeutic agent from a first surface of a diaphragm using a force imparted upon a second surface of the diaphragm by a gas flow.
BACKGROUND OF THE INVENTION
In commonly owned U.S. Pat. No. 5,630,796, a noninvasive delivery system is described that entails the use of a needleless syringe. The syringe is used for transdermal delivery of powdered therapeutic compounds and compositions to skin, muscle, blood or lymph. The syringe can also be used in conjunction with surgery to deliver therapeutics to organ surfaces, solid tumors and/or to surgical cavities (e.g., tumor beds or cavities after tumor resection).
The needleless syringe is constructed as an elongate tubular nozzle, having a rupturable membrane initially closing the passage through the nozzle adjacent to the upstream end of the nozzle. Particles comprising a powdered therapeutic agent are located adjacent to the membrane. The therapeutic agent is delivered using an energizing means which applies a gaseous pressure to the upstream side of the membrane that is sufficient to burst the membrane, thereby producing a supersonic gas flow through the nozzle in which the particles are entrained.
As explained in U.S. Pat. No. 5,630,796, the particles comprising the therapeutic agent may be carrier particles coated, for example, with genetic material, or may be powdered therapeutic agents for all kinds of therapeutic use. With respect to delivery of powdered therapeutic agents per se, e.g., agents delivered without the aid of a carrier particle, general delivery parameters include a particle size preferably in the range of about 10-40 &mgr;m, a particle density preferably in the range of about 0.5-2.0 g/cm
3
, and an initial velocity preferably in the range of about 200-2500 m/sec with a momentum density preferably in the range of 4-7 kg/sec/m.
SUMMARY OF THE INVENTION
In one embodiment of the invention, a needleless syringe is provided. The needleless syringe is capable of accelerating particles comprising a therapeutic agent across skin or mucosal tissue of a vertebrate subject. The syringe comprises, in operative combination, a body having a lumen extending therethrough. The lumen has an upstream terminus and a downstream terminus, and the upstream terminus of the lumen is interfaced with an energizing means such as a volume of a pressurized driving gas. The syringe further includes a diaphragm arranged adjacent to the downstream terminus of the lumen, wherein the diaphragm has an internal surface facing the lumen and an external surface facing outwardly from the syringe. The diaphragm is moveable between an initial position in which a concavity is provided on the external surface of the diaphragm, and a dynamic position in which the external surface of the diaphragm is substantially convex.
In certain aspects of the invention, the diaphragm is an eversible dome-shaped membrane that is comprised of a flexible polymeric material. In other aspects, the diaphragm is a bistable membrane that is moveable between an initial, inverted position and a dynamic, everted position. Particles comprising a therapeutic agent are generally housed within the concavity provided by the external surface of the diaphragm when in its initial position. The body of the needleless syringe can be configured as an elongate tubular structure with the diaphragm arranged over the downstream terminus of a lumen extending along the major axis of the tubular structure, or over an opening adjacent to the downstream terminus, which opening faces in a direction substantially perpendicular to the major axis of the tubular structure.
In another embodiment, a dome-shaped diaphragm for use with a needleless syringe is provided. The diaphragm has a concavity that sealably contains particles comprising a therapeutic agent.
In yet a further embodiment of the invention, a method for transdermal delivery of particles comprising a therapeutic agent is provided. The method entails providing a needleless syringe according to the invention, wherein the syringe has a diaphragm with a concave surface and a convex surface, and particles comprising the therapeutic agent are disposed on the concave surface of the diaphragm. A gaseous shock wave is released in a direction toward the convex surface of the diaphragm, wherein the shock wave provides sufficient motive force to impel the diaphragm to an everted position, thereby dislodging the particles from the diaphragm and accelerating them toward a target surface.
In certain aspects of the invention, the particles are accelerated toward the target surface in a direction substantially collinear with the direction of travel of the gaseous shock wave. In other aspects of the invention, the particles are accelerated toward the target surface in a direction transverse to the direction of travel of the gaseous shock wave.
These and other embodiments of the present invention will readily occur to those of ordinary skill in the art in view of the disclosure herein.
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Bell John
Bellhouse Brian John
Foley & Lardner
Mendez Manuel
PowderJect Research Limited
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