초록 ▼

A method and apparatus for delivering therapeutic or diagnostic agents as a low pressure high velocity spray into tissue. According to the particular desired spray characteristics, the spray may be generated via the combined use of pressure atomization and electrostatic spray charging, or via the co

A method and apparatus for delivering therapeutic or diagnostic agents as a low pressure high velocity spray into tissue. According to the particular desired spray characteristics, the spray may be generated via the combined use of pressure atomization and electrostatic spray charging, or via the combined use of pressure atomization and electrostatic atomization. Particle velocity, spray flow-rate, and spray dispersion are further controlled via electrostatic means.

대표청구항 ▼

1. A method of injecting a fluid agent into tissue, which comprises: delivering said fluid agent to a capillary in fluid communication with a nozzle, said nozzle having a converging section, a throat region downstream of said converging section, and a diverging section downstream of said throat regi

1. A method of injecting a fluid agent into tissue, which comprises: delivering said fluid agent to a capillary in fluid communication with a nozzle, said nozzle having a converging section, a throat region downstream of said converging section, and a diverging section downstream of said throat region, with said capillary fluid communication comprising fluid communication with said nozzle converging section;pressurizing said delivered fluid agent to a level effective for pressure atomizing said pressurized fluid agent into fluid particles as said pressurized fluid agent passes through said nozzle, and for two phase flow in said delivered fluid agent to occur at said throat region;applying a high voltage potential between a first electrode disposed adjacent to said fluid agent passing through said nozzle converging section, and a second electrode disposed downstream of said first electrode and electrically isolated from said first electrode to create a non-uniform electric field that electrostatically spray charges said fluid agent;and directing said charged particles towards said tissue resulting in said charged particles impinging and penetrating said tissue. 2. The method according to claim 1, wherein: said electrostatic spray charging results from said non-uniform electric field causing electrostatic atomization of said fluid agent. 3. The method according to claim 1, further comprising: affecting the movement of said charged particles prior to impingement on said tissue, by passing said charged particles through a downstream electric potential field created by one or more focusing electrodes disposed downstream of said throat region, wherein said movement is selected from the list consisting of accelerating, decelerating, focusing, dispersing, and combination of the foregoing. 4. The method according to claim 3, wherein: said downstream focusing electrodes alternate in polarity. 5. The method according to claim 3, wherein: said downstream electric potential field varies with time, with said time dependent downstream field parameters selected from the list consisting of magnitude, polarity, and combination of the foregoing. 6. The method according to claim 1, wherein: said fluid agent is derived from two or more components;and further comprising mixing said components to form said fluid agent prior to said pressurizing step. 7. The method according to claim 6 wherein: said mixing step is selected from the list consisting of:a) delivering said components to a mixing tank where said mixing to form said fluid agent occurs, andb) delivering said components to said capillary where said mixing to form said fluid agent occurs. 8. The method according to claim 1, wherein: said fluid agent is derived from two or more components;at least one of said components is in the dry state with each said dry state component(s) contained in a dry state component vial(s), and at least one of the other components is in the fluid state with each said fluid state component(s) contained in a fluid state component vial(s);and further comprising: transferring said fluid state component(s) to said dry state component vial(s),and mixing said dry state component(s) and said fluid state component(s) to form said fluid agent. 9. The method according to claim 1, wherein: said fluid agent is derived from two or more components;at least one of said components is in the dry state with each said dry state component(s) contained in a dry state component vial(s), and at least one of the other components is in the fluid state with each said fluid state component(s) contained in a fluid state component vial(s);and further comprising: i) drawing said fluid state component(s) into said capillary,ii) transferring said fluid state component(s) from said capillary to said dry state component vial(s), andiii) mixing said dry state component(s) and said fluid state component(s) to form said fluid agent. 10. The method according to claim 1, wherein: said fluid agent is an agent selected from the list consisting of therapeutic agents, diagnostic agents, and combination of the foregoing. 11. The method according to claim 1, further comprising: varying the cross-sectional area of said throat region to vary particle size and velocity. 12. The method according to claim 1, wherein: said fluid agent pressurizing produces nozzle upstream pressure effective to achieve supersonic flow in said particles exiting said nozzle. 13. The method according to claim 1, further comprising: controlling particle tissue penetration by varying one or more parameters selected from the list consisting of: a) the distance between said first and second electrodes,b) the diameter of said second electrode, wherein said second electrode is in the shape of a ring, andc) the potential difference between said first and second electrodes. 14. The method according to claim 1, wherein: said second electrode is a ring electrode comprised of two electrically isolated semicircles, with said second electrode disposed to be in contact with said tissue; andfurther comprising passing a brief burst of alternating current across said semicircles just prior to injection resulting in electro-anesthesia to the injection area. 15. The method according to claim 1, wherein: said second electrode is a ring electrode comprised of two electrically isolated semicircles;and further comprising modifying the shape of the plume of the particles exiting said nozzle by:maintaining one semicircle at ground, and maintaining the other semicircle and said first electrode at potentials opposite in sign from each other. 16. An apparatus for injecting a fluid agent into tissue, comprising: a nozzle having a converging section, a throat region downstream of said converging section, and a diverging section downstream of said throat region;a capillary in fluid communication with said converging section;a pressurizing region containing an amount of said fluid agent, wherein said pressurizing region is selected from the list consisting of: a) said nozzle's converging section, and b) said capillary;apparatus to pressurize said fluid agent in said pressurizing region to a level effective for pressure atomizing said pressurized fluid agent into fluid particles as said pressurized fluid agent passes through said nozzle, and for two phase flow in said fluid agent to occur at said throat region, wherein said pressurizing apparatus is selected from the group consisting of a) a piston in contact with said fluid agent and exerting force on said fluid agent, andb) one or more pumps in fluid communication with said pressurizing region;a first electrode disposed adjacent to said fluid agent passing through said nozzle converging section;a second electrode disposed downstream of said first electrode and electrically isolated from said first electrode;said first and second electrodes having a non-uniform electric field created between them, wherein said non-uniform electric field electrostatically spray charges said fluid particles; andwherein said fluid particles have velocities sufficient to impinge and penetrate said tissue, with said velocities resulting from said pressure atomization and the acceleration of the particles from the electrostatic charges on the particles. 17. The apparatus according to claim 16, wherein: said electrostatic spray charging results from said non-uniform electric field causing electrostatic atomization of said fluid agent. 18. The apparatus according to claim 16, further comprising: one or more focusing electrodes disposed downstream of said throat region;said downstream focusing electrode(s) having a downstream electric potential field through which said charged particles pass, thereby affecting the movement of said charged particles prior to impingement on said tissue, wherein said movement is selected from the list consisting of accelerating, decelerating, focusing, dispersing, and combination of the foregoing. 19. The apparatus according to claim 18, wherein: said downstream focusing electrodes alternate in polarity. 20. The apparatus according to claim 18 wherein: said downstream electric potential field varies with time, with said time dependent downstream field parameters selected from the list consisting of magnitude, polarity, and combination of the foregoing. 21. The apparatus according to claim 16, wherein: said fluid agent is derived from two or more components;and further comprising: a reservoir to hold each fluid agent component,and a mixing tank (where mixing of said fluid agent components occur to form said fluid agent) in fluid communication with each said reservoir, and with said capillary. 22. The apparatus according to claim 16, wherein: said fluid agent is derived from two or more components;at least one of said components is in the dry state, and at least one of the other components is in the fluid state:and further comprising: i) a dry state component vial to contain each dry state component,ii) a fluid state component vial to contain each fluid state component; andwherein each fluid state component vial is in fluid communication with the dry state component vial to which the fluid component is desired to be added, allowing mixing of said dry state component and fluid state component to form said fluid agent. 23. The apparatus according to claim 16, wherein: said fluid agent is derived from two or more components;at least one of said components is in the dry state, and at least one of the other components is in the fluid state;and further comprising: i) a dry state component vial to contain each dry state component,ii) a fluid state component vial to contain each fluid state component; andwherein each fluid state component vial is in fluid communication with said capillary, and said capillary is in fluid communication with each said dry state component vial;wherein said fluid communication between said capillary and said fluid state component vial(s) enables said fluid state component(s) to be drawn into said capillary;wherein said fluid communication between said capillary and said dry state component vial(s) enables said fluid state component(s) to be transferred to said dry state component vial(s),and wherein mixing of said fluid state component(s) and dry state component(s) in said dry state component vial(s) occur to form said fluid agent. 24. The apparatus according to claim 16 wherein: said fluid agent is derived from two or more components;and further comprising: a reservoir to hold each fluid agent component, with each reservoir being in fluid communication with said capillary;and wherein mixing of said fluid agent components in said capillary occurs to form said fluid agent. 25. The apparatus according to claim 16, wherein: said fluid agent is an agent selected from the list consisting of therapeutic, diagnostic agents, and combination of the foregoing. 26. The apparatus according to claim 16, further comprising: one or more nozzle throat area flow control elements selected from the group consisting of: a) a valve disposed in said nozzle throat region, andb) a metering rod disposed in and coaxial with said nozzle, said rod having an end (“throat end”) proximal to said nozzle throat region, wherein varying the distance between the metering rod throat end and said nozzle throat region serves to vary the cross-sectional area of said nozzle throat. 27. The apparatus according to claim 16, wherein: said pressurizing apparatus produces nozzle upstream pressure effective to achieve supersonic flow in said particles exiting said nozzle. 28. The apparatus according to claim 16, wherein: particle tissue penetration is controlled by varying one or more parameters selected from the list consisting of: a) the distance between said first and second electrodes,b) the diameter of said second electrode, wherein said second electrode is in the shape of a ring,c) the potential difference between said first and second electrodes, andd) any combination of the foregoing. 29. The apparatus according to claim 16, wherein: said second electrode is a ring electrode comprised of two electrically isolated semicircles, with said second electrode disposed to be in contact with said tissue; andfurther comprising means for passing a brief burst of alternating current across said semicircles just prior to injection resulting in electro-anesthesia to the injection area. 30. The apparatus according to claim 16, wherein: said second electrode is a ring electrode comprised of two electrically isolated semicircles;one semicircle is at ground potential;the other semicircle and said first electrode are at potentials opposite in sign from each other, resulting in modifying the shape of the plume of the particles exiting said nozzle.