What is claimed is:
1. A collagenous biomaterial medical device, comprising:
a) a submucosa tissue;
b) the submucosa having an endotoxin level less than 12 endotoxin units per gram per gram of submucosa; and
c) the submucosa having an absorbency level of greater than 1.01 grams of water per gram of submucosa.
2. The collagenous biomaterial of claim 1 wherein the submucosa has an absorbency level of greater than 2.0 grams of water per gram of submucosa.
3. The collagenous biomaterial of claim 1 wherein the submucosa has an absorbency level of greater than 3.0 grams of water per gram of submucosa.
4. The collagenous biomaterial of claim 1 wherein the submucosa has an absorbency level of greater than 3.1 grams of water per gram of submucosa.
5. The collagenous biomaterial of claim 1 wherein the submucosa has an absorbency level of greater than 5.3 grams of water per gram of submucosa.
6. The collagenous biomaterial of claim 1 wherein the submucosa has an absorbency level approximately in the range of 3.0 to 5.4 grams of water per gram of submucosa.
7. The collagenous biomaterial of claim 6 wherein a radiopaque marker is disposed on the submucosa.
8. The collagenous biomaterial of claim 1 wherein the submucosa has a density of greater than 0.01 grams per cubic centimeter.
9. The collagenous biomaterial of claim 1 wherein the submucosa has a density less than 0.65 grams per cubic centimeter.
10. The collagenous biomaterial of claim 1 wherein the submucosa has a density greater than 0.10 grams per cubic centimeter and less than 0.65 grams per cubic centimeter.
11. The collagenous biomaterial of claim 1 wherein the submucosa has a density greater than 0.15 grams per cubic centimeter and less than 0.65 grams per cubic centimeter.
12. The collagenous biomaterial of claim 1 wherein the submucosa has a density greater than 0.16 and less than 0.65 grams per cubic centimeter.
13. The collagenous biomaterial of claim 1 wherein the submucosa has a density greater than 0.20 and less than 0.65 grams per cubic centimeter.
14. The collagenous biomaterial of claim 1 wherein the submucosa has a density between 0.10 and 0.40 grams per cubic centimeter.
15. The collagenous biomaterial of claim 1 wherein the submucosa has a density between 0.10 and 0.30 grams per cubic centimeter.
16. The collagenous biomaterial of claim 15 wherein a radiopaque marker is disposed on the submucosa.
17. The collagenous biomaterial of claim 1 further comprising a package containing the biomaterial.
18. The collagenous biomaterial of claim 17 wherein the package further comprises at least one of a gas permeable, sealed, hermetically sealed, sterile, UV protected, and a plurality of pouches.
19. The collagenous biomaterial of claim 17 wherein the package comprises a double pouched, gas permeable, and UV protected package.
20. A collagenous biomaterial medical device, comprising a submucosa of a warm blooded vertebrate, the submucosa having an endotoxin level less than 12 endotoxin units per gram of submucosa, the submucosa further having an absorbency level of greater than 1.01 grams of water per gram of submucosa, the collagenous biomaterial further made by the process comprising the steps of:
sterilizing a source of submucosal tissue;
delaminating the source of submucosal tissue to expose the submucosa;
freezing the submucosa; and
drying the submucosa under vacuum pressure.
21. The collagenous biomaterial of claim 20, wherein the step of delaminating includes the step of comminuting the exposed submucosa.
22. The collagenous biomaterial of claim 20 further including the step of packaging the biomaterial in at least one of a gas permeable, sealed, hermetically sealed, sterile, UV protected, and a plurality of pouches.
23. The collagenous biomaterial of claim 22 further including the step of packaging the biomaterial in a package comprising a gas permeable, sterile, UV protected package.
24. The collagenous biomaterial of claim 23 further including the step of packaging the biomaterial in a package comprising a plurality of pouches.
25. A collagenous biomaterial medical device, comprising:
a) a submucosa tissue
b) the submucosa having an endotoxin level less than 12 endotoxin units per gram of submucosa;
c) the submucosa having an absorbency level of greater than 1.01 grams of water per gram of submucosa;
d) the submucosa having a density greater than 0.10 grams per cubic centimeter and less than 0.65 grams per cubic centimeter; and
e) a package containing the submucosa.
26. The collagenous biomaterial of claim 25, wherein a pharmacologic agent and a radiopaque marker are disposed on the submucosa.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A method for the disinfection of beef comprising the steps of:
preparing a concentrated aqueous solution of a chlorine dioxide liberating compound having a concentration of from about 0.2% to about 25% by weight of the chlorine dioxide liberating compound and having an amount of an acid sufficient to adjust the pH to from about 1.0 to about 5.0;
diluting the concentrated aqueous solution to provide a dilute, acidified solution having a concentration of from about 0.00017% to about 0.17% by weight of the chlorine dioxide liberating compound; and
contacting the dilute, acidified solution with beef to disinfect the beef.
2. The method of claim 1 wherein the chlorine dioxide liberating compound is selected from the group consisting of metal chlorites.
3. The method of claim 2 wherein the concentrated aqueous solution of metal chlorite has a concentration of from about 0.5% to about 4.0% by weight of metal chlorite.
4. The method of claim 2 wherein the chlorine dioxide liberating compound is selected from the group consisting of alkali metal chlorites.
5. The method of claim 2 wherein the chlorine dioxide liberating compound is selected from the group consisting of sodium chlorite and potassium chlorite.
6. The method of claim 2 wherein the chlorine dioxide liberating compound is sodium chlorite.
7. The method of claim 1 wherein the acid is selected from the group consisting of strong acids and weak organic acids.
8. The method of claim 1 wherein the acid is selected from the group consisting of all GRAS acids.
9. The method of claim 1 wherein the acid is citric acid.
10. The method of claim 1 wherein sufficient acid is added to the concentrated aqueous solution to adjust the pH to from about 2.5 to about 2.9.
11. The method of claim 1, wherein the beef is a comminuted beef product.
12. The method of claim 1, wherein the beef is a formed beef product.
13. A method for the disinfection of poultry comprising the steps of:
preparing a concentrated aqueous solution of a chlorine dioxide liberating compound having a concentration of from about 0.2% to about 25% by weight of the chlorine dioxide liberating compound and having an amount of an acid sufficient to adjust the pH to from about 1.0 to about 5.0;
diluting the concentrated aqueous solution to provide a dilute, acidified solution having a concentration of from about 0.00017% to about 0.17% by weight of the chlorine dioxide liberating compound; and
contacting the dilute, acidified solution with poultry to disinfect the poultry.
14. The method of claim 1 wherein the chlorine dioxide liberating compound is selected from the group consisting of metal chlorites.
15. The method of claim 14 wherein the concentrated aqueous solution of metal chlorite has a concentration of from about 0.5% to about 4.0% by weight of metal chlorite.
16. The method of claim 14 wherein the chlorine dioxide liberating compound is selected from the group consisting of alkali metal chlorites.
17. The method of claim 14 wherein the chlorine dioxide liberating compound is selected from the group consisting of sodium chlorite and potassium chlorite.
18. The method of claim 14 wherein the chlorine dioxide liberating compound is sodium chlorite.
19. The method of claim 13 wherein the acid is selected from the group consisting of strong acids and weak organic acids.
20. The method of claim 13 wherein the acid is selected from the group consisting of all GRAS acids.
21. The method of claim 13 wherein the acid is citric acid.
22. The method of claim 13 wherein sufficient acid is added to the concentrated aqueous solution to adjust the pH to from about 2.5 to about 2.9.
23. The method of claim 13, wherein the poultry is a comminuted poultry product.
24. The method of claim 13, wherein the poultry is a formed poultry product.
25. A method for the disinfection of pork comprising the steps of:
preparing a concentrated aqueous solution of a chlorine dioxide liberating compound having a concentration of from about 0.2% to about 25% by weight of the chlorine dioxide liberating compound and having an amount of an acid sufficient to adjust the pH to from about 1.0 to about 5.0;
diluting the concentrated aqueous solution to provide a dilute, acidified solution having a concentration of from about 0.00017% to about 0.17% by weight of the chlorine dioxide liberating compound; and
contacting the dilute, acidified solution with pork to disinfect the pork.
26. The method of claim 25 wherein the chlorine dioxide liberating compound is selected from the group consisting of metal chlorites.
27. The method of claim 26 wherein the concentrated aqueous solution of metal chlorite has a concentration of from about 0.5% to about 4.0% by weight of metal chlorite.
28. The method of claim 26 wherein the chlorine dioxide liberating compound is selected from the group consisting of alkali metal chlorites.
29. The method of claim 26 wherein the chlorine dioxide liberating compound is selected from the group consisting of sodium chlorite and potassium chlorite.
30. The method of claim 26 wherein the chlorine dioxide liberating compound is sodium chlorite.
31. The method of claim 25 wherein the acid is selected from the group consisting of strong acids and weak organic acids.
32. The method of claim 25 wherein the acid is selected from the group consisting of all GRAS acids.
33. The method of claim 25 wherein the acid is citric acid.
34. The method of claim 25 wherein sufficient acid is added to the concentrated aqueous solution to adjust the pH to from about 2.5 to about 2.9.
35. The method of claim 25, wherein the pork is a comminuted pork product.
36. The method of claim 25, wherein the pork is a formed pork product.