Apparatus and method for delivery of micro and submicro quantities of materials

• US 6,159,188 A
• Filed: 11/02/1998
• Issued: 12/12/2000
• Est. Priority Date: 01/14/1998
• Status: Expired due to Fees

• Current Assignee: Robert A. Laibovitz, Robert L. Rogers
• Original Assignee: Robert A. Laibovitz, Robert L. Rogers
• Inventors: Rogers, Robert L., Laibovitz, Robert A.
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US09/184,842
• Time in Patent Office: 771 Days
• Field of Search: 604/19, 604/23, 604/24, 604/28, 604/38, 604/289, 604/290, 604/310, 604/311, 222/333, 222/340, 222/360, 222/390, 222/387, 222/494
• US Class Current: 604/294
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00

Abstract

A process and apparatus (invention) permitting the distribution of micro or submicro liter or gram (exceptionally small) quantities of liquids and powders, (hereafter materials) in patterns and quantities that are especially well-suited for ophthalmologic patient self-application of drugs to his own eye(s) with substantially no overdose. The invention is thus also highly beneficial in those many topical drug applications where overdoses should be avoided. This is particularly applicable for the eye, where overdoses can have many deleterious medical consequences. Use of the invention permits exceptionally small doses of ophthalmologic drugs. Moreover, it also permits the repeatability of the quantity size of the materials chosen for delivery. In the case of drugs, particularly opthomologic drugs, this means that the invention permits the repeated multiple distribution of the same chosen drug/carrier quantity resulting in a uniform repeatable dosage. Variation of dose from one application to another is very unacceptable. The preferred apparatus of the invention employs a venturi configuration inventively modified which uses gas under pressure to pump exceptionally small quantities of material from a reservoir for delivery. In especially preferred embodiments of the invention, said reservoir is pressurized by at least a quantity of gas at somewhat above atmospheric. prior to the removal of any material by pumping.

Claims

1. A process for consistently delivering units of essentially repeatably uniform and equal quantities of material in a preselected amount of from 1 nanogram to 1000 micrograms of powder or from 1 nanoliter to 100 microliters of liquid or a combination of both powder and liquid to a location of choice, which comprises in combination the steps of:

a) selecting the quantity of material to be delivered in units of essentially equal quantities of material in any preselected amount of from 1 nanogram to 1000 micrograms of powder or from 1 nanoliter to 100 microliters of liquid or a combination of both powder and liquid;

b) providing a conduit having a back end, a middle portion and a front end;

c) providing a reservoir for said material containing an amount of at least the said quantity of material selected and being operatively connected to said middle portion;

d) providing at said front end a source of a repeatable, measured amount of gas under from 1 to 1000 pounds per square inch pressure above atmospheric, wherein said gas being selected in a quantity having a relationship with said material quantity expressed as from about 0.003 to 300 parts of gas per every part of liquid by weight and 0.1 to 20,000 parts by weight for powder;

e) providing an exit orifice for said back end;

f) releasing said pressurized gas in a measured repeatable amount so as to be conveyed through said conduit and to exit through said orifice;

g) reducing the pressure of said gas as it passes through said middle portion sufficiently to cause said unit quantity of material to exit said reservoir and be entrained by and mix with said gas in both the middle portion and back end of said conduit;

h) expelling said entrained mixture of gas and material through said orifices; and

i) conveying said entrained mixture to said location.

2. The process of claim 1, wherein said combination includes the step of pressurizing said liquid reservoir with the pressurized gas from said source prior to or instantaneous with removing liquid material from said reservoir and the pressure head in said source is from 1 to 1000 pounds per inch above atmospheric.

3. The process of claim 2, wherein said material reservoir is at a pressure of 0.1 to 20 pounds per square inch.

4. The process of claim 3, wherein said material reservoir is at a pressure of from just above zero to 500 pounds per square inch.

5. The process of claim 4, wherein said amount of gas is newly pressured before each of said releases.

6. The process of claim 1, wherein two or more reservoirs are employed.

7. The process of claim 1, wherein said gas is selected from the group consisting of air, carbon dioxide, helium, inert gases and inorganic gases.

8. The process of claim 1, wherein said liquid is drug.

9. The process of claim 1, wherein said powder is a drug.

10. The process of claim 8, wherein said drug is an ophthalmologic drug.

11. The process of claim 9, wherein said drug is an ophthalmologic drug.

12. The process of claim 1, wherein the pressure of said gas is from 7.5 to 1000 pounds per square inch above ambient.

13. A process for consistently delivering units of essentially repeatably uniform and equal quantities of material in a preselected submicro to micro amount of from 1 nanogram to 300 micrograms of powder or from 1 nanoliter to less than 30 microliters of liquid in droplet form or a combination of both powder and liquid to a location of choice, which comprises in combination the steps of:

a) selecting the quantity of material to be delivered in units of essentially equal quantities of material in any preselected amount of from 1 nanogram to 300 micrograms of powder or from 1 nanoliter to less than 30 microliters of liquid droplet form or a combination of both powder and liquid;

b) providing a conduit having a back end, a middle portion and a front end;

c) providing a reservoir for said material containing an amount of at least the said quantity of material selected and being operatively connected to said middle portion;

d) providing at said front end a source of a repeatable, measured amount of gas under from 1 to 1000 pounds per square inch pressure above atmospheric in a quantity having a relationship with said material quantity expressed as from about 0.01 to 100 parts by weight of gas per every part of liquid or 0.2 to 10,000 parts by weight for powder;

e) pressurized said reservoir with at least a pressure exceeding zero pounds per square inch above atmospheric and up to 500 pounds per square inch prior to or essentially simultaneously with removing material from said reservoir;

f) providing an exit orifice for said back end;

g) releasing said pressurized gas in a predetermined quantity so as to be conveyed through said conduit and to exit through said orifice;

h) reducing the pressure of said gas as it passes through said middle portion sufficiently to cause said unit quantity of material to exit said reservoir and be entrained by and mix with said gas in both the middle portion and back end of said conduit;

i) expelling said entrained mixture of gas and material through said orifices; and

j) conveying said entrained mixture to said location.

14. The process of claim 13, wherein said liquid is an ophthalmologic drug.

15. The process of claim 13, wherein said powder is an ophthalmologic drug.

16. The process of claim 13, wherein the mixture exiting said orifice is at higher pressure than ambient.

17. An apparatus for delivering selected quantities of certain materials to a targeted location, which comprises in combination the elements of:

a) a container means having operatively associated therewith;

i) rigid-walled, gas reservoir means;

ii) gas conduit means within said container for repeatedly conveying approximately the same predetermined quantity of a chosen unit of said gas under a selected predetermined pressure;

iii) means for introducing gas under pressure from said gas reservoir means to said gas conduit means within said container means; and

iv) a liquid or powder reservoir means;

b) control means for maintaining aid gas pressure initially at between 1 to 1000 pounds per square inch above ambient;

c) means for removing,

i) from one nanoliter to 100 microliters of liquid material from said reservoir means, or

ii) from one nanogram to 1000 micrograms of powder material from said reservoir means;

d) means for providing from 0.01 to 100 parts of gas for every part of liquid material entrained by such gas such parts being by weight and 0.2 to 10,000 parts of gas for every part of powder such parts being by weight;

e) means for mixing said quantity of removed material with said predetermined quantity of gas to result in a mixture of said gas and said material;

g) means for forceably expelling said mixture from said container and means for propelling a major portion of said removed material at least one inch.

18. The apparatus according to claim 17, wherein said combination includes means for providing gas from said gas reservoir means to said liquid reservoir prior to or simultaneously with any said removal and a pressure ranging from above zero to 1000 pounds per square inch of pressure above ambient in said material reservoir means.

19. The apparatus according to claim 17, wherein said material reservoir is located inside said container.

20. The apparatus according to claim 17, wherein said gas reservoir is located inside said container.

21. The apparatus according of claim 17, wherein said material is a liquid or powder.

22. The apparatus according to claim 17, wherein said reservoir is initially operatively connected by means of pressure connecting means to the initial pressure head from said gas reservoir and conduit blocking means are provided to close said operative connection prior to the expelling of said mixture from said container.

23. The apparatus according to claim 22, wherein air within said air reservoir is compressed by a piston and said conduit blocking means is said piston.

24. The apparatus according to claim 17, wherein gas is contained in a flexible container within said reservoir.

25. The apparatus according to claim 17, wherein said liquid or powder reservoir means are accompanied with at least one other liquid or powder reservoir means.

26. The apparatus according to claim 17, wherein said means for removing liquid or powder material is a metering wheel.

27. The apparatus according to claim 17, wherein said gas reservoir is a syringe.

28. An apparatus for delivering selected quantities of liquid to a targeted location, which comprises in combination the elements of:

a) a rigid essentially closed container containing;

i) gas reservoir means for holding a predetermined quantity of gas under a predetermined pressure of from 1 to 1000 pounds per square inch above ambient located within said container;

ii) pressure release means for releasing said gas pressure located within said container;

iii) fluid reservoir means for holding a fluid to be delivered;

b) first gas conduit means having a cross-sectional diameter of from 50 to 125 mils operatively connected conveying gas from said gas reservoir;

c) second conduit means having a cross-sectional diameter of from 8 to 50 mils for connecting said liquid reservoir with said first gas conduit means;

d) pump means for conveying liquid from said reservoir means to said first conduit means;

e) mixing means for mixing 1 to 30 microliters of liquid form said reservoir with said gas in said first conduit means to form a mixture of said entrained liquid and said gas;

f) exit conduit means having an orifice means for conveying said mixture at least one inch to said location, the diameter of said exit conduit is from 8 to 50 mils.

29. The apparatus according to claim 28, wherein said container is from 3 inch to 10 inch in height and from 1 inch to 4 inch in diameter.