Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-01-29
2001-12-11
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06328714
ABSTRACT:
TECHNICAL FIELD
The invention relates generally to a needleless syringe for use in delivery of particles of a therapeutic agent to a target surface. More particularly, the invention pertains to a reusable needleless syringe system that uses a replaceable cartridge unit having a sealed chamber, a source of particles of a therapeutic agent, and a source of a driving gas contained at super-atmospheric pressure. The invention further pertains to a reusable needleless syringe system that uses a replaceable nozzle assembly.
BACKGROUND
In commonly-owned U.S. Pat. No.
5,630,796 to Bellhouse et al., a non-invasive 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, typically having a rupturable membrane initially closing the passage through the nozzle adjacent to the upstream end of the nozzle. Particles of 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. The supersonic gas flow produced in the nozzle entrains the particles and accelerates them to suitable velocities for transdermal delivery into tissue such as skin or muscle.
SUMMARY OF THE INVENTION
It is a primary object of the invention to provide a reusable needleless syringe device that employs one or more replaceable components. Accordingly, in one aspect of the invention, a replaceable cartridge is provided for use in a needleless syringe. The replaceable cartridge is formed from a housing having a top end and a bottom end, wherein the bottom end has an inlet aperture and an outlet aperture that are side-by-side and in fluid communication with each other by way of an internal gas passageway which extends through the housing. The cartridge further includes a particle container containing a suitable amount of particles for a single therapeutic or diagnostic particle administration. The particle container is arranged within the housing and positioned over the outlet. The cartridge also contains a source of compressed gas, again suitable for powering a single therapeutic or diagnostic particle administration. The source of compressed case is arranged in sealable communication with the inlet, wherein the source includes an exterior portion which extends away from the housing and an interior portion which extends through the inlet and partially into the gas passageway such that a breach can be made to the interior portion in order to release compressed gas from the source and into the gas passageway.
In one configuration of the replaceable cartridge, the internal gas passageway is substantially in the shape of a U. In addition, the replaceable cartridge can accommodate an inserted expansion chamber at the downstream end of the gas passageway, or the housing can molded or otherwise constructed to include an expansion chamber portion within the gas passageway. A filter element can likewise be included within the gas passageway.
In another aspect of the invention, a replaceable nozzle assembly is provided for use in a needleless syringe. The replaceable nozzle assembly includes an elongate particle acceleration nozzle having an upstream end, a downstream end and a gas passageway extending between the upstream and downstream ends. The gas passageway has an upper convergent section, a lower divergent section, and a throat section connecting the convergent and divergent sections. An outwardly projecting, disk-shaped annular flange is provided at the upstream terminus of the nozzle, which flange provides an external shoulder. The nozzle assembly further includes a cylindrical filter element which fits over and substantially surrounds the elongate particle acceleration nozzle. The filter element is separately replaceable from the nozzle. The filter element rests upon the external shoulder provided by the flange. The filter element includes a filter medium which provides a barrier against fine particles which, having insufficient momentum, may rebound from the target surface during or shortly after a particle delivery operation has been carried out.
In a still further aspect of the invention, a reusable needleless syringe device is provided. The reusable needleless syringe contains either or both the replaceable cartridge and the replaceable nozzle assembly of the present invention.
It is an advantage of the invention that a reusable needleless syringe can be provided which allows for multiple particle delivery operations to be carried out. It is a further advantage of the invention that the replaceable cartridges and nozzle assemblies of the present invention can be easily mass produced, packaged, stored, handled and then disposed of, significantly reducing the per-shot cost of operating a needleless syringe device.
These and other objects, aspects, embodiments and advantages of the present invention will readily occur to those of ordinary skill in the art in view of the disclosure herein.
REFERENCES:
patent: 5630796 (1997-05-01), Bellhouse et al.
patent: WO 94/02188 (1994-02-01), None
patent: WO 96/04947 (1996-02-01), None
patent: WO 96/12513 (1996-05-01), None
patent: WO 96/20022 (1996-07-01), None
patent: WO 97/34652 (1997-09-01), None
patent: WO 97/47730 (1997-12-01), None
Bellhouse Emily L.
Patterson Graeme L. J.
Weekes Stuart G.
McCracken Thomas P.
Mendez Manuel
PowderJect Research Limited
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