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US4558032A
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Synthetic whole blood substitute and a method of making the same
Assignee: Quixote Corp
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Filing: 1983-06-29
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Granted: 1985-12-10
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Expires: 2003-06-29
Abstract
Abstract A composition of matter which comprises a synthetic whole blood useful as a substitute for whole natural blood and a method of making the same are disclosed. The method of manufacture yields a composition of matter comprised of a two phase coacervate system. The claimed system successfully duplicates the two phase heterogeneous physico-chemical system of naturally occurring whole blood. Also disclosed is a phase of the claimed method of manufacture which produces a composition of matter, useful as a substitute for hematocrit. Also disclosed is an embodiment employing a hemoglobin component which is preferably selected from stroma free hemoglobin, synthetic liposomes containing stroma free hemoglobin, microencapsulated stroma free hemoglobin, or emulsified droplets of coacervate containing stroma free hemoglobin. It is preferred that the microencapsulated stroma free hemoglobin when employed ranges in size from 0.1 to 10 microns. Among the main ingredients of the blood substitute composition are gelatin or modified fluid gelatin and acacia.
Inventors
- 👤 Charles S. Ecanow
- 👤 Bernard Ecanow
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 17:35
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0026; G; G03; G03C; G03C1/00; G03C1/005; G03C1/04; G03C1/047; G03C2001/0471
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
128 words
A method of preparing a synthetic whole blood substitute which comprises the steps of: (a) mixing thoroughly 5 to 15% weight to volume of a gelatin selected from modified fluid gelatin or gelatin powder with 5 to 15% weight to volume of acacia which has been dispersed in sterile water; (b) storing the solution undisturbed at a temperature of from about 4° to 10° C. for 12 to 72 hours to produce a two phase coacervate system comprising an aqueous coacervate phase and a bulk water phase; (c) adjusting the pH of said system within the range of whole human blood by the addition of an alkaline substance; and (d) adding such amount of a salt to said system as will make it isotonic with whole human blood.
Claim 2
Independent Claim
128 words
A method of preparing a synthetic whole blood substitute which comprises the steps of: (a) mixing thoroughly 5 to 15% weight to volume of a gelatin selected from modified fluid gelatin or gelatin powder with 5 to 15% weight to volume of acacia which has been dispersed in sterile water; (b) storing the solution undisturbed at a temperature of from about 4° to 10° C. for 12 to 72 hours to produce a two phase coacervate system comprising an aqueous coacervate phase and a bulk water phase; (c) adjusting the pH of said system within the range of whole human blood by the addition of an alkaline substance; and (d) adding such amount of a salt to said system as will make it isotonic with whole human blood.
Claim 3
Dependent Claim
49 words
The method of claim 1 including the additional steps of: adding hydrochloric acid dropwise to the solution at ambient temperature to enhance formation of the two phase coacervate system, adjusting the pH of said system with NaOH, and adding NaCl to render said system isotonic with whole human blood.
Claim 4
Dependent Claim
21 words
A composition of matter useful as a substitute for whole blood which is prepared according to the method of claim 1.
Claim 5
Dependent Claim
27 words
The method of claim 1 comprising the additional step of separating the two phase coacervate system into its aqueous coacervate phase and its equilibrium bulk water phase.
Claim 6
Dependent Claim
35 words
A composition of matter consisting of the coacervate phase of a two phase coacervate system prepared according to the method of claim 4 which is useful as a semi-prepared synthetic substitute for naturally occurring hematocrit.
Claim 7
Dependent Claim
65 words
The method of claim 4 which comprises the additional step of adding a hemoglobin component selected from stroma free hemoglobin, synthetic liposomes containing stroma free hemoglobin, or microencapsulated stroma free hemoglobin, or emulsified droplets made with the coacervate phase and containing stroma free hemoglobin, to the said coacervate phase, so that the final product contains 1 to 20% weight to volume of said hemoglobin component.
Claim 8
Dependent Claim
35 words
The method of claim 1 which comprises the additional step of adding such amount of a sterol as will result in a 1% weight to volume of a sterol in the two phase coacervate system.
Claim 9
Dependent Claim
27 words
The method of claim 7 wherein the sterol is selected from a group consisting of cholesterol, ergosterol, 7-dehydrocholesterol, α sitosterol, β sitosterol, γ-sitosterol, campesterol and mixtures thereof.
Claim 10
Dependent Claim
10 words
The method of claim 8 wherein the sterol is cholesterol.
Claim 11
Dependent Claim
22 words
The method of claim 9 which comprises the additional step of adding calcium chloride powder to a concentration of 5 mg %.
Claim 12
Dependent Claim
21 words
The method of claim 10 which comprises the additional step of adding potassium chloride to a concentration of 3 mg %.
Claim 13
Dependent Claim
30 words
The method of claim 11 which comprises the additional step of titrating said coacervate system to pH in the range of about 7.3 to 7.5, by adding an alkaline substance.
Claim 14
Dependent Claim
28 words
The method of claim 1, including the step of emulsifying the two phase coacervate system to produce droplets ranging in size from about 0.1 to about 10 microns.
Claim 15
Dependent Claim
20 words
The method of claim 1 which comprises the additional step of adding another component selected from enzymes, proteins, or drugs.
Claim 16
Dependent Claim
82 words
A synthetic whole blood substitute comprising an aqueous solution of about 5 to 15% weight to volume acacia, about 5 to 15% weight to volume of a gelatin selected from modified fluid gelatin or gelatin powder; an alkaline substance sufficient to adjust the pH to that of whole human blood; and an amount of a salt sufficient to render the solution isotonic with whole human blood; said components forming a coacervate system having a coacervate phase and an equilibrium bulk water phase.
Claim 17
Dependent Claim
82 words
A synthetic whole blood substitute comprising an aqueous solution of about 5 to 15% weight to volume acacia, about 5 to 15% weight to volume of a gelatin selected from modified fluid gelatin or gelatin powder; an alkaline substance sufficient to adjust the pH to that of whole human blood; and an amount of a salt sufficient to render the solution isotonic with whole human blood; said components forming a coacervate system having a coacervate phase and an equilibrium bulk water phase.
Claim 18
Dependent Claim
51 words
The synthetic whole blood substitute according to claim 15, including a sterol, CaCl 2 , KCl, enzymes, proteins, drugs, a hemoglobin component selected from stroma free hemoglobin, synthetic liposomes containing stroma free hemoglobin, microencapsulated hemoglobin, or emulsified droplets made with the coacervate phase and containing stroma free hemoglobin, or mixtures thereof.
Claim 19
Dependent Claim
22 words
The coacervate phase of the synthetic whole blood substitute of claim 15, said coacervate phase comprising a semi-prepared synthetic substitute for hematocrit.
Claim 20
Dependent Claim
27 words
The synthetic whole blood substitute of claim 16, wherein the sterol is selected from cholesterol, ergosterol, 7-dehydrocholesterol, α sitosterol, β sitosterol, γ sitosterol, campesterol, or mixtures thereof.
Claim 21
Dependent Claim
23 words
The synthetic whole blood substitute of claim 15, in the form of an emulsion having droplets from 0.1 to 10 microns in size.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-12-09 | 1989-06-10 | 1989-12-10 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-12-09 | 1993-06-10 | 1993-12-10 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-12-09 | 1997-06-10 | 1997-12-10 | $7700.00 | Window Closed / Lapsed |