Use of injectable biomaterials for the repair and augmentation of the anal sphincters

DETAILED DESCRIPTION OF THE INVENTION The invention is a method for repairing structurally defective or inadequately functioning muscles of the anal sphincters by perianally administering an effective amount of an injectable biomaterial(s), with and without wound healing agents, into the defect or structural deformity.
The invention further comprises a method for improving the competency of incompetent anal sphincters by administering injectable biomaterials into the anal sinuses between the blood vessels.
Improvement of the sphincter's competence will improve fecal and flatus continence and increase the anorectal squeeze pressure, resulting in improved control.
The term "incompetent," as used herein, refers to sphincter muscles that are inadequately functioning or nonfunctioning due to the deterioration of the sphincter muscles or due to a structural deformity caused by anatomic disruption of the sphincter mechanism.
The term "improving the competency," as used herein, means augmenting the existing sphincter muscle to improve the patient's baseline continence level.
Improved competence would result in increased resting squeeze pressure, maximal squeeze pressure, and threshold volume as can be measured by standard manometric tests.
An alternative method for measuring improved competence is by a change in clinical grading from major incontinence to minor incontinence to continence.
Major incontinence occurs when there is deficient control or lack of control of stool of normal consistency.
Minor incontinence is a disorder in which there is partial soiling or occasional incontinence of flatus or of loose or watery stools.
Continence is when there is no soiling or occasional incontinence to flatus or loose or watery stools.
The term "effective amount" as used herein, means the quantity of biomaterial needed to repair anal sphincter muscle or to achieve improved competence as measured by standard manometry or the quantity of wound healing agents needed to achieve improved healing.
The effective amount of biomaterial administered may vary depending on the patient's own ability to absorb or break down the biomaterial, the consistency and concentration of the material, and the site and condition being treated