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Claims for Patent: 4,550,022

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Claims for Patent: 4,550,022

Title: Tissue irrigating solution
Abstract:A tissue irrigating solution useful for irrigating animal tissue, such as ocular tissue and neuro tissue, during surgery, contains sodium, potassium, magnesium, calcium, chloride, and bicarbonate ions as well as dextrose and glutathione in proportions consistant with the osmotic stability and continued metabolism of the tissue cells. The irrigating solution is prepared by mixing a first basic solution which provides the bicarbonate and a second acidic solution which provides the calcium, magnesium, dextrose and glutathione. The first and second solutions may be stored as stable, sterile solutions for extended periods of time and mixed within 24 hours of use.
Inventor(s): Garabedian; Michael E. (Arlington, TX), Roehrs; Robert E. (Fort Worth, TX)
Assignee: Alcon Laboratories, Inc. (Fort Worth, TX)
Application Number:06/582,564
Patent Claims: 1. A two-part tissue irrigating product comprising:

a stable, sterile prepackaged basic solution containing bicarbonate ions,

a stable, sterile prepackaged acidic solution containing dextrose, glutathione, calcium ions and magnesium ions,

at least one of said solutions containing sodium ions, at least one of said solutions containing potassium ions and at least one of said solutions containing chloride ions,

said acidic and basic solutions when mixed together forming the irrigating solution for irrigating body tissues during surgery, the irrigating solution containing between about 130 and about 180 mM/l sodium ions, between about 3 and about 10 mM/l potassium ions, between about 1 and about 5mM/l calcium ions, between about 0.5 and about 4 mM/l magnesium ions, between about 10 and about 50 mM/l bicarbonate ions, between about 2 and about 10 mM/l dextrose, and between about 0.03 and about 0.5 mM/l oxidized glutathione or the equivalent amount of reduced glutathione, and said irrigating solution having a pH of between about 6.8 and about 8.0 and an osmolality of between 250 and about 350 mOsm/kg.

2. A system according to claim 1 wherein said basic solution also contains phosphate ions in sufficient quantity that the phosphate ion concentration in said tissue irrigating solution is between about 1 and about 5 mM/l.

3. A two-part tissue irrigating product comprising:

a stable, sterile prepackaged basic solution containing bicarbonate ions, sodium ions and potassium ions,

a stable, sterile prepackaged acidic solution containing calcium ions, magnesium ions, dextrose, and glutathione,

and at least one of said solutions containing chloride ions,

said acidic and basic solutions when mixed together forming the irrigating solution for irrigating body tissues during surgery, the irrigating solution containing between about 130 and about 180 mM/l sodium ions, between about 3 and about 10 mM/l potassium ions, between about 1 and about 5 mM/l calcium ions, between about 0.5 and about 4 mM/l magnesium ions, between about 10 and about 50 mM/l bicarbonate ions, between about 2 and about 10 mM/l dextrose, and between about 0.03 and about 0.5 mM/l oxidized glutathione or the equivalent amount of reduced glutathione, and said irrigating solution having a pH of between about 6.8 and about 8.0 and an osmolality of between 250 and about 350 mOsm/kg.

4. An irrigating product according to claim 1 wherein said sodium ions are contained in said basic solution.

5. An irrigating product according to claim 1 wherein said potassium ions are contained in said basic solution.

6. An irrigating product according to claim 3 having an osmolality of between about 290 and about 320 mOsm/kg.

7. An irrigating product according to claim 3 having a pH of between about 7.2 and about 7.8.

8. An irrigating product according to claim 3 wherein said basic solution also contains phosphate ions in sufficient quantity that the phosphate ion concentration in said tissue irrigating solution is between about 1 and about 5 mM/l.

9. An irrigating product according to claim 8 wherein the pH of said basic solution is between about 7.2 and about 7.8, and the pH of said acidic solution is below about 5.

10. An irrigating product according to claim 8 wherein the volume ratio of said basic solution to said acidic solution is between about 10:1 and about 40:1.

11. An irrigating product according to claim 8 wherein said basic solution contains sodium chloride, potassium chloride, dibasic sodium phosphate, and sodium bicarbonate, and said acidic solution contains calcium chloride, magnesium chloride, dextrose, and oxidized glutathione.

12. An irrigating product according to claim 11 wherein the pH of said basic solution is between about 7.2 and about 7.8.

13. An irrigating product according to claim 11 wherein the pH of said acidic solution is below about 5.

14. An irrigating product according to claim 11 wherein the volume ratio of said basic solution to said acidic solution is between about 10:1 and about 40:1.

15. An article of manufacture containing a two-part tissue irrigating product comprising:

(a) a package containing a stable, sterile basic solution containing bicarbonate ions, sodium ions and potassium ions, said package containing the solution under vacuum;

(b) a vial containing a stable, sterile acidic solution containing calcium ions, magnesium ions, dextrose, and glutathione, said vial being closed with a rubber stopper;

(c) a sterile double-ended needle;

and at least one of said solutions containing chloride ions,

said acidic and basic solutions being mixed together by aseptically inserting one end of the double-ended needle into the package containing the basic solution, and the other end into the vial containing the acidic solution, and transferring the acidic solution into the basic solution by the vacuum under which the basic solution is maintained,

said acidic and basic solutions when mixed together forming the irrigating solution for irrigating body tissues during surgery, the irrigating solution containing between about 103 and about 108 mM/l sodium ions, between about 3 and about 10 mM/l potassium ions, between about 1 and bout 5 mM/l calcium ions, between about 0.5 and about 4 mM/l magnesium ions, between about 10 and about 50 mM/l bicarbonate ions, between about 2 and about 10 mM/l dextrose, and between about 0.03 and about 0.5 mM/l oxidized glutathione or the equivalent amount of reduced glutathione, and said irrigating solution having a pH of between about 6.8 and about 8.0 and an osmolality of between 250 and about 350 mOsm/kg.

16. An article of manufacture according to claim 15 wherein said basic solution also contains phosphate ions in sufficient quantity that the phosphate ion concentation in said tissue irrigating solution is between about 1 and about 5 mM/l.
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