US4865836A — Brominated perfluorocarbon emulsions for internal…

Claim 1

Independent Claim 154 words

A process for preparing a brominated perfluorocarbon emulsion capable of carrying oxygen to animal tissues having size stability characteristics for an extended period of time and resistant to attack by animal organisms in animal body fluids, comprising the steps of: a. dispersing purified phospholipid emulsifier in a buffered aqueous solution containing an osmotic agent, and a biocompatible amount of a compound selected from the group consisting of sterols, tocopherols and combinations thereof; b. gradually mixing into said dispersed emulsifier and solution from about 55% to about 125% weight per volume of brominated perfluorocarbon; and, c. directing said mixture through a emulsification apparatus having fluid velocities of at least 1500 feet per second under such high shear conditions as to form a stable, heat-sterilizable emulsion, wherein the amount of emulsifier in said emulsion is an effective amount and the amount of osmotic agent and the buffer are effective to approximate physiological biocompatible osmolarity and pH.

Claim 2

Dependent Claim 154 words

A process for preparing a brominated perfluorocarbon emulsion capable of carrying oxygen to animal tissues having size stability characteristics for an extended period of time and resistant to attack by animal organisms in animal body fluids, comprising the steps of: a. dispersing purified phospholipid emulsifier in a buffered aqueous solution containing an osmotic agent, and a biocompatible amount of a compound selected from the group consisting of sterols, tocopherols and combinations thereof; b. gradually mixing into said dispersed emulsifier and solution from about 55% to about 125% weight per volume of brominated perfluorocarbon; and, c. directing said mixture through a emulsification apparatus having fluid velocities of at least 1500 feet per second under such high shear conditions as to form a stable, heat-sterilizable emulsion, wherein the amount of emulsifier in said emulsion is an effective amount and the amount of osmotic agent and the buffer are effective to approximate physiological biocompatible osmolarity and pH.

Claim 3

Dependent Claim 103 words

A process for preparing a brominated perfluorocarbon emulsion capable of carrying oxygen to animal tissues having size stability characteristics for an extended period of time, comprising the steps of: a. dispersing purified emulsifier in a buffered aqueous solution of an osmotic agent; b. mixing from about 55% to 125% weight per volume of brominated perfluorocarbon into said dispersion of emulsifier and solution; and, c. passing the resulting mixture through an emulsifying apparatus generating such high shear conditions as to form a stable, heat-sterilizable emulsion, wherein the amounts of buffer and osmotic agent in said emulsion are effective to approximate physiological pH and osmolarity.

Claim 4

Dependent Claim 103 words

A process for preparing a brominated perfluorocarbon emulsion capable of carrying oxygen to animal tissues having size stability characteristics for an extended period of time, comprising the steps of: a. dispersing purified emulsifier in a buffered aqueous solution of an osmotic agent; b. mixing from about 55% to 125% weight per volume of brominated perfluorocarbon into said dispersion of emulsifier and solution; and, c. passing the resulting mixture through an emulsifying apparatus generating such high shear conditions as to form a stable, heat-sterilizable emulsion, wherein the amounts of buffer and osmotic agent in said emulsion are effective to approximate physiological pH and osmolarity.

Claim 5

Dependent Claim 50 words

The process of claim 2, wherein said passing step further comprises passing the resulting mixture through said emulsifying apparatus a plurality of times in a plurality of flows in separate flow paths and redirecting said plurality of flows into each other at least 4,000 pounds per square inch of pressure.

Claim 6

Dependent Claim 23 words

The process of claim 2 wherein in said passing step, said mixture is flowing at velocities in excess of 1500 feet per second.

Claim 7

Dependent Claim 104 words

A process for preparing a fluorocarbon emulsion capable of carrying oxygen to animal tissues, said emulsion having substantial particle size stability characteristics for an extended period of time and through heat sterilization, comprising the steps of: a. mixing an effective amount of an emulsifier in an aqueous phase; b. mixing of from about 55% to 125% weight per volume of a non-toxic fluorocarbon into said mixture of emulsifier and aqueous phase; and c. passing the fluorocarbon-containing mixture through a mechanical emulsifying apparatus having a flow path, in which said mixture is subjected to sufficiently high shear rates to form a stable, heat sterilizable emulsion.

Claim 8

Dependent Claim 104 words

A process for preparing a fluorocarbon emulsion capable of carrying oxygen to animal tissues, said emulsion having substantial particle size stability characteristics for an extended period of time and through heat sterilization, comprising the steps of: a. mixing an effective amount of an emulsifier in an aqueous phase; b. mixing of from about 55% to 125% weight per volume of a non-toxic fluorocarbon into said mixture of emulsifier and aqueous phase; and c. passing the fluorocarbon-containing mixture through a mechanical emulsifying apparatus having a flow path, in which said mixture is subjected to sufficiently high shear rates to form a stable, heat sterilizable emulsion.

Claim 9

Dependent Claim 11 words

The process of claim 5 wherein said passing step is repeated.

Claim 10

Dependent Claim 15 words

The process of claim 6 wherein said passing step is repeated at least four times.

Claim 11

Dependent Claim 21 words

The process of claim 5 wherein in said passing step, said flow is maintained at approximately 1500 feet per second velocity.

Claim 12

Dependent Claim 100 words

A process for preparing a fluorocarbon emulsion having particle size stability characteristics for an extended period of time, comprising the steps of: a. mixing an effective amount of emulsifier and from about 55% weight per volume to 125% weight per volume of a biocompatible fluorocarbon into an aqueous phase to form a mixture; and, b. placing said mixture in an emulsification apparatus and pressurizing said mixture at a pressure of at least 4000 pounds per square inch to force said mixture through at least one high shear emulsification flow path at a velocity of at least 1500 feet per second.

Claim 13

Dependent Claim 100 words

A process for preparing a fluorocarbon emulsion having particle size stability characteristics for an extended period of time, comprising the steps of: a. mixing an effective amount of emulsifier and from about 55% weight per volume to 125% weight per volume of a biocompatible fluorocarbon into an aqueous phase to form a mixture; and, b. placing said mixture in an emulsification apparatus and pressurizing said mixture at a pressure of at least 4000 pounds per square inch to force said mixture through at least one high shear emulsification flow path at a velocity of at least 1500 feet per second.

Claim 14

Dependent Claim 34 words

The process of claim 9 wherein in said pressurizing step, said mixture is forced into a plurality of flow paths which direct the mixture flows to impinge against each other in an impingement cavity.

Claim 15

Dependent Claim 26 words

The process of claim 9 wherein said mixing step, the fluorocarbon is mixed into said aqueous phase after said emulsifier is mixed into said aqueous phase.

Claim 16

Dependent Claim 21 words

The process of claim 11 wherein said fluorocarbon is mixed into said aqueous phase in said at least one flow path.

Claim 17

Dependent Claim 19 words

The process of claim 11 wherein in said mixing step, a buffering agent is mixed into said aqueous phase.

Claim 18

Dependent Claim 19 words

The process of claim 11 wherein in said mixing step, an osmotic agent is mixed into said aqueous phase.

Claim 19

Dependent Claim 12 words

The process of claim 9 wherein said fluorocarbon is a brominated fluorocarbon.

Claim 20

Dependent Claim 26 words

The process of claim 5, wherein said fluorocarbon-containing mixture is subjected to a pressure of at least 4000 pounds per square inch in said emulsifying apparatus.

Claim 21

Dependent Claim 25 words

The process of claim 5, wherein said fluorocarbon-containing mixture is subjected to flow rates of at least 1500 feet per second in said emulsifying apparatus.

Claim 22

Dependent Claim 93 words

A process for preparing a fluorocarbon emulsion capable of carrying oxygen to animal tissues, said emulsion having substantial particle size stability characteristics for an extended period of time though heat sterilization, comprising the steps of: combining an aqueous phase with an effective amount of an emulsifier and from about 50% to about 125% weight per volume of a fluorocarbon to form a mixture; and passing the fluorocarbon-containing mixture through a mechanical emulsification apparatus in which said mixture is subjected to sufficiently high flow rates and pressures to form a stable, heat sterilizable emulsion.

Claim 23

Dependent Claim 93 words

A process for preparing a fluorocarbon emulsion capable of carrying oxygen to animal tissues, said emulsion having substantial particle size stability characteristics for an extended period of time though heat sterilization, comprising the steps of: combining an aqueous phase with an effective amount of an emulsifier and from about 50% to about 125% weight per volume of a fluorocarbon to form a mixture; and passing the fluorocarbon-containing mixture through a mechanical emulsification apparatus in which said mixture is subjected to sufficiently high flow rates and pressures to form a stable, heat sterilizable emulsion.

Claim 24

Dependent Claim 10 words

The process of claim 18, wherein said fluorocarbon is brominated.

Claim 25

Dependent Claim 25 words

The process of claim 18, wherein said mixture is subjected to a pressure of at least 4000 pounds per square inch in said emulsifying apparatus.

Claim 26

Dependent Claim 20 words

The process of claim 18, wherein said mixture is subjected to flow rates of at least 1500 feet per second.

Claim 27

Dependent Claim 21 words

The process of claim 18, wherein said mixture contains from about 80% to about 125% weight per volume of said fluorocarbon.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1992-09-11	1993-03-13	1993-09-12	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1996-09-11	1997-03-13	1997-09-12	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2000-09-11	2001-03-13	2001-09-12	$7700.00	Window Closed / Lapsed

Brominated perfluorocarbon emulsions for internal animal use for contrast enhancement and oxygen transport

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