INTESTINAL TISSUE ENHANCED WITH THERAPEUTIC SALTS

Abstract

The present invention is product and method for treating wounds, or enhancing wound healing, by contacting the wound with biomaterial or tissue that has been treated with a boron and copper composition.

Claims

1. A method of treating biomaterial comprising contacting the biomaterial with a treatment composition comprising a source of boron ions and a source of copper ions.

2. The method of claim 1 wherein the source of boron ions comprises up to about 80% of the composition.

3. The method of claim 1 wherein the source of copper ions comprises up to about 5% of the composition.

4. The method of claim 1 wherein the treatment composition further comprises one or more of the following ingredients: a source of calcium; a source of potassium; a source a magnesium; a source of sodium; a source of phosphorus; ionic forms or any of the above; oxide forms of any of the above; a source of strontium; a source of zinc; a source of iron; ionic forms of strontium, zinc, or iron; oxide forms of strontium, zinc, or iron; and any of the ingredients listed above alone or in any combination.

5. The method of claim 1 wherein the treatment composition comprises a boron oxide and a copper oxide; and further comprises at least one of an oxide of calcium, potassium, magnesium, sodium, or phosphorus.

6. The method of claim 1 wherein the treatment composition is an electrolyte composition.

7. The method of claim 1 wherein the biomaterial is selected from the group consisting of an ECM-containing material; submucosa tissues; renal capsule membrane; amnion; dura matter; pericardium; serosa; and peritoneum or basement membrane.

8. The method of claim 1 wherein the biomaterial is intestinal submucosa.

9. The method of claim 8 wherein the biomaterial is small intestine submucosa.

10. The method of claim 1 wherein the biomaterial is derived from an animal or human source.

11. The method of claim 1 wherein the biomaterial is contacted with an antimicrobial composition prior to contact with the treatment composition.

12. A product comprising an animal or human tissue treated with a treatment composition comprising a source of boron ions and a source of copper ions.

13. The product of claim 12 further comprising an animal or human tissue further treated with a treatment composition comprising a source of calcium; a source of potassium; a source a magnesium; a source of sodium; a source of phosphorus; ionic forms or any of the above; oxide forms of any of the above; a source of strontium; a source of zinc; a source of iron; ionic forms of strontium, zinc, or iron; oxide forms of strontium, zinc, or iron; and any of the ingredients listed above alone or in any combination.

14. The product of claim 12 further comprising a tissue contacted with an antimicrobial composition prior to contact with the treatment composition.

15. (canceled)

16. The use of a product in the treatment of a wound, said product being produced by treating a biomaterial with a treatment composition comprising a source of boron ions and a source of copper ions.

17. (canceled)

Description

EXAMPLES

Example 1

[0067] Porcine small intestine is harvested by dissecting the entire small intestine tract fresh from an appropriate animal, preferably infection-free, preferably in the 150-200 Lb. range. The small intestine will measure approximately 20 feet in length. The jejunum of the intestine is identified and dissected away from the duodenum and ileum. While the duodenum and ileum may be processed in accordance to the teaching of this invention the jejunum is preferred. The jejunum is longitudinally dissected, and the mucosal lining is removed by mechanical scraping, such as with a razor blade. Care is taken not to cut the submucosa. Secondarily the serosal surface is cleaned and separated away. The jejunal submucosa is then washed by immersing in isotonic saline. A minimum of three washes are recommended. Washes are conducted at room temperature with stirring. Each wash will be approximately 15 minutes in length.

[0068] Once cleaned the washed tissue is ready to be treated with an antibiotic solution. One particularly useful antibiotic solution consists of: 1000 gms. Saline; 1.0 gm. Penicillin sodium salt; 0.0105 gm. Amphotericin B; 0.10 gm. Streptomycin sulfate.

[0069] The cleaned tissue is placed into the antibiotic solution at room temperature. Stirring is recommended and the tissue is processed in this manner for a minimum of 17 hours.

Preparation of a Treatment Solution

[0070] A salt solution is prepared using a stock salt solution of Avalon Medical's commercially available RediHeal wound treatment. RediHeal is a borate base bioceramic consisting of oxides of various salts including:

TABLE-US-00001 Compound Percent B.sub.20.sub.3 51.6 CaO 20.0 K.sub.20 12.0 MgO 5.0 Na.sub.20 6.0 P.sub.20.sub.5 4.0 CuO 0.40 (or 0.0) Sr 0.0 (or 0.1) ZnO 1.0 Fe.sub.20.sub.3 0.0 (or 0.1)

[0071] In some formulations, copper is included (CuO, 0.40 above), and the mixture does not contain Sr (0.0) or Fe.sub.2O.sub.3 (0.0). In other formulations, copper is not used (0.0), and both Sr (0.1) and Fe.sub.2O.sub.3 (0.1) are included.

[0072] A 10% w/w solution of electrolyte solution may be prepared by adding 100 gr. RediHeal into distilled water (900 gms.) and mixing approximately 8 hours. The resulting solution is cloudy white and is filtered to separate the particulate.

[0073] SIS which has been cleaned and subjected to washing in an antibiotic solution in accordance to the described method is subsequently washed in a 0.9% saline solution a total of three times. Each wash is conducted for 15 minutes.

[0074] The washed SIS tissue is immersed into the salt solution. With stirring, the SIS becomes infused with the salt solution. One useful ratio of SIS tissue to salt solution is: 13 gms. (tamped) SIS/900 mL. electrolyte solution.

[0075] After stirring for a period of time, e.g., 1-45 minutes, the SIS is removed from the solution and placed onto a pin frame and the tissue is mildly stretched. The tissue/pin frame combination is frozen to 40 F. Alternately the tissue can be frozen using dry ice.

[0076] The tissue/pin frame is subsequently placed into a lyophilizer and the tissue is dried for a period of 2-12 hours or until such time that the tissue is dry. At this time the tissue appears white in color and is rigid in nature.

[0077] Subsequently the tissue is removed from the lyophilizer, trimmed to size, placed into an appropriate container and processed for sterilization. The tissue may be sterilized using any suitable or known technique or process, including but not limited to ETO or electron beam radiation.

Example 2. Powder/Ground SIS

[0078] A further useful embodiment of SIS relates to the need for the granularized or powder form of the tissue.

[0079] Tissue harvested from an appropriate source is cleaned as previously described. In order to form a powder form of the SIS material the following steps are conducted:

[0080] Cleaned, wet, processed tissue is macerated using a knife, razor, scissor etc. until pieces are small enough to be placed into a laboratory mill such as a Wiley mill.

[0081] Prior to milling the small pieces are frozen w/dry ice, or nitrogen.

[0082] The frozen pieces in tandem with the dry ice are forced thru and past the cutting edges of the mill. The resulting pieces will shear until they can drop through the screen size of the mill. The powder containing a quantity of dry ice is placed into a pan which can be then re-frozen and then further processed for lyophilization. The tissue is processed until a white, granular appearance is obvious.

Subsequently the powdered tissue is packaged for sterilization via e-beam or ETG. Sterile tissue processed to form powder is useful in the treatment of wounds in which a sheet for of SIS/salt is not conducive to use.

[0083] While the invention has been described in some detail by way of illustration and example, it should be understood that the invention is susceptible to various modifications and alternative forms, and is not restricted to the specific embodiments set forth in the Examples. It should be understood that these specific embodiments are not intended to limit the invention but, on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.