Systems, apparatus, and methods for administering a substance

Abstract

Apparatus, kits, and methods for administering a substance are presented. A device for administering a substance includes an elongated body having a proximal end and a distal end, the elongated body defining an internal chamber extending between the proximal end and the distal end to direct the substance to the distal end, the distal end to connect with a tip, the tip to be at least partially inserted into an orifice of a body lumen of a subject, the tip having a shape configured to reduce leakage of the substance from the orifice upon the at least partial insertion. The tip includes an opening to pass the substance from the internal chamber into the body lumen; and a transducer to emit an ultrasound wave from the tip into the body lumen, thereby administering the substance to tissue in the body lumen.

1 . A method for administering a substance contained in a fluid to gastro-intestinal tissue of a subject, the method comprising:
 inserting, via an anus of the subject, a tip of a device into a rectum of the subject;   delivering, via an opening in the tip, the fluid into the rectum; and   applying, via the device, an ultrasound wave to the fluid in the rectum of the subject, such that the substance in the fluid is administered to the gastro-intestinal tissue of the subject.   
     
     
         2 . The method of  claim 1 , wherein the substance is selected from an aminosalicylate, a monoclonal antibody, a chemotherapeutic, a vaccine, and nucleic acids. 
     
     
         3 . The method of  claim 2 , wherein the substance includes an aminosalicylate, and wherein the aminosalicylate is mesalamine. 
     
     
         4 . The method of  claim 1 , wherein the substance includes insulin. 
     
     
         5 . The method of  claim 1 , wherein the substance includes hydrocortisone. 
     
     
         6 . The method of  claim 1 , wherein the ultrasound wave is at a frequency from about 20 kHz to about 60 kHz. 
     
     
         7 . The method of  claim 1 , the applying comprising treating or mitigating symptoms associated with inflammatory bowel disease in the subject. 
     
     
         8 . The method of  claim 7 , the applying comprising treating or mitigating symptoms associated with ulcerative colitis in the subject. 
     
     
         9 . The method of  claim 8 , wherein the substance includes mesalamine. 
     
     
         10 . The method of  claim 1 , the applying comprising treating or mitigating symptoms associated with proctitis in the subject. 
     
     
         11 . The method of  claim 1 , the applying comprising treating or mitigating symptoms associated with irritable bowel syndrome in the subject. 
     
     
         12 . The method of  claim 1 , further comprising, prior to the inserting, covering the tip of the device with a cover, including aligning a perforation of the cover with the opening of the device. 
     
     
         13 . The method of  claim 1 , wherein the subject is a mammal. 
     
     
         14 . The method of  claim 1 , further comprising delivering the fluid in the rectum for up to about 30 seconds. 
     
     
         15 . The method of  claim 1 , the applying the ultrasound wave including applying the ultrasound wave with a duty cycle of about 50%. 
     
     
         16 . The method of  claim 15 , the applying the ultrasound wave including applying the ultrasound wave at an intensity from about 2 W/cm 2  to about 13.4 W/cm 2 . 
     
     
         17 . The method of  claim 1 , wherein the tip is configured to form a fluid tight seal with the anus of the subject. 
     
     
         18 . A method for administering an aminosalicylate contained in a fluid to rectal tissue of a subject in need thereof, the method comprising:
 inserting, via the anus of the subject, at least a portion of a tip of a device into the rectum of the subject, the device including a concave region at least partly disposed in the anus of the subject and a delivery region disposed within the rectum of the subject during use, such that the concave region and the delivery region form a fluid-tight seal with the anus of the subject;   passing, via an opening in the delivery region of the device disposed in the rectum of the subject during use, about 10 ml to about 60 ml of the fluid into the rectum for up to 30 seconds; and   applying, via the device, an ultrasound wave to the fluid in the rectum of the subject to administer the substance in the fluid to the rectal tissue of the subject, such that an average temperature increase of the rectal tissue is less than about 2° C.   
     
     
         19 . The method of  claim 18 , the applying the ultrasound wave including applying the ultrasound wave with a duty cycle of about 50% and at an intensity from about 2 W/cm 2  to about 13.4 W/cm 2 . 
     
     
         20 . The method of  claim 18 , the applying the ultrasound wave including applying the ultrasound wave for an ultrasound exposure duration of at most one minute. 
     
     
         21 . The method of  claim 18 , wherein the aminosalicylate is mesalamine, the administering comprising treating or mitigating symptoms associated with ulcerative colitis in the subject in need thereof.