Electrical muscle stimulation to treat fecal incontinence and/or pelvic prolapse

A method for treating fecal incontinence in a body of a mammal having a rectum formed of a rectal wall extending to an anus, wherein the normal rectal wall includes an anal sphincter muscle comprising an internal anal sphincter surrounding the anus and an external anal sphincter surrounding the internal anal sphincter, and the pelvic floor comprises a levator ani supporting the rectum and subcutaneous pelvic floor muscle fibers, the method comprising:

• implanting at least a first stimulation electrode in operative relation with a first one of the internal anal sphincter, the external anal sphincter, the levator ani, and the pelvic floor muscle fibers;
• implanting at least a second stimulation electrode in operative relation with a second one different than the first one of the internal anal sphincter, the external anal sphincter, the levator ani, and the pelvic floor muscle fibers;
• coupling the first and second stimulation electrodes to a control unit;
• implanting the control unit in the body;
• and
• operating the control unit to selectively generate electrical stimulation and to apply the electrical stimulation through the first and second stimulation electrodes to the respective first and second one of the internal anal sphincter, the external anal sphincter, the levator ani, and the pelvic floor muscle fibers to effect selective muscle contraction about the anus.

A method for treating fecal incontinence in a body of a mammal having a rectum formed of a rectal wall extending to an anus, wherein the normal rectal wall includes an anal sphincter muscle comprising an internal anal sphincter surrounding the anus and an external anal sphincter surrounding the internal anal sphincter and the pelvic floor comprises a levator ani supporting the rectum and subcutaneous pelvic floor muscle fibers, the method comprising:

• providing a medical electrical lead having a lead body extending from a proximal lead connector to a distal lead end comprising at least one distal stimulation electrode and a porous mesh adapted to provide fixation within the body;
• forming a tissue pathway extending between from at least one skin incision and in relation to one of the internal anal sphincter, the external anal sphincter, the levator ani, and subcutaneous pelvic floor muscle fibers;
• passing the mesh and stimulation electrode through the tissue pathway disposing the stimulation electrode and mesh in operative relation with the respective one of the internal anal sphincter, the external anal sphincter, the levator ani and subcutaneous pelvic floor muscle fibers;
• coupling the lead connector to a control unit;
• implanting the control unit within the body;
• and
• operating the control unit to selectively generate electrical stimulation and to apply the electrical stimulation through the stimulation electrode to the respective one of the internal anal sphincter, the external anal sphincter, the levator ani, and the subcutaneous pelvic floor muscle fibers.

A method for treating fecal incontinence in a body of a mammal having a rectum formed of a rectal wall extending to an anus, wherein the normal rectal wall includes an anal sphincter muscle comprising an internal anal sphincter surrounding the anus and an external anal sphincter surrounding the internal anal sphincter and the pelvic floor comprises a levator ani supporting the rectum and subcutaneous pelvic floor muscle fibers, the method comprising:

• providing a medical electrical lead having a lead body extending from a proximal lead connector to a distal lead end comprising at least one distal stimulation electrode;
• supporting the stimulation electrode on a pressure-applying cuff of an artificial anal sphincter in a location adapted to be disposed toward the anal sphincter;
• implanting the pressure-applying cuff around the anal sphincter with the stimulation electrode disposed toward the anal sphincter;
• selectively generating electrical stimulation and applying the electrical stimulation through the stimulation electrode to one or more of the internal anal sphincter, the external anal sphincter and the levator ani;
• and
• operating the artificial anal sphincter to selectively apply mechanical pressure through the pressure-applying cuff to the anal sphincter.

A device for treating fecal incontinence in a body of a mammal having a rectum formed of a rectal wall extending to an anus, wherein the normal rectal wall includes an anal sphincter muscle comprising an internal anal sphincter surrounding the anus and an external anal sphincter surrounding the internal anal sphincter, and the pelvic floor comprises a levator ani supporting the rectum and subcutaneous pelvic floor muscle fibers, the device comprising:

• a device body comprising an elongated fecal sling extending between first and second device ends and including a central support portion adapted to be positioned in supportive relation to one or more of the internal anal sphincter surrounding the anus, the external anal sphincter surrounding the internal anal sphincter, and the pelvic floor;
• a medical electrical lead having a lead body extending from a proximal lead connector to a distal lead end comprising at least one distal stimulation electrode supported by the central support portion;
• and
• self-fixating tissue anchors coupled to the first and second ends, the first and second ends each having a shape that facilitates insertion into tissue to tension the device body and that resists withdrawal from the penetrated tissue.