Methods and articles for delivering viable cells into solid tissue

Abstract

Embodiments provide swallowable devices, preparations and methods for delivering viable cells (VC) into the GI tract including GI wall tissue or other tissue site. Particular embodiments provide a swallowable device such as a capsule for delivering VC into an intestinal wall or other site. The VC can be contained within a tissue-penetrating shell disposed in the capsule that protects the VC as they pass through the GI tract until they are inserted into GI tract tissue or other location. The shell desirably has shape, size and material consistency to be contained in a swallowable capsule, delivered from the capsule into solid tissue by the application of force on the shell and biodegrade within the solid tissue to release the VC into the tissue. Within the shell or other structure the VC can be maintained in a viability-sustaining gel that preserves the viability of the VC for selected time periods.

1 . (canceled) 
     
     
         2 . A method for producing a therapeutic effect in a patient, the method comprising:
 swallowing an enclosure containing a tissue penetrating article which contains a mass of viable cells, wherein the article passes through the gastrointestinal tract with the article intact and the cells remaining viable;   releasing the article from the enclosure in response to a condition in the gastrointestinal tract; and   propelling the article to penetrate into gastrointestinal tissue and releasing the cells or substances produced by the cells to produce the therapeutic effect in the patient.   
     
     
         3 . The method of  claim 2 , wherein the therapeutic effect is glucose regulation. 
     
     
         4 . The method of  claim 2 , wherein the therapeutic effect is a production of insulin within the patient's body. 
     
     
         5 . The method of  claim 2 , wherein the therapeutic effect is a production of an incretin within the patient's body. 
     
     
         6 . The method of  claim 2 , wherein the therapeutic effect is a production of gastrin within the patient's body. 
     
     
         7 . The method of  claim 2 , wherein the therapeutic effect is an effect on the patient's immune system. 
     
     
         8 . The method of  claim 7 , wherein the therapeutic effect is a suppression of the patient's immune system. 
     
     
         9 . The method of  claim 2 , wherein the therapeutic effect is reseeding of a mucosa of the patient's small intestine, large intestine or stomach. 
     
     
         10 . The method of  claim 2 , wherein the gastro-intestinal tissue is stomach wall tissue, intestinal wall tissue, small intestine wall tissue or peritoneal wall tissue. 
     
     
         11 . The method of  claim 2 , wherein the condition is a pH or a pH in the small intestine. 
     
     
         12 . The method of  claim 2 , wherein propelling the article comprises applying a propulsive force by means of the expansion of an expandable member. 
     
     
         13 . The method of  claim 12 , wherein the expandable member is expanded by a chemical reaction triggered in response to a pH in the small intestine or other location in the intestinal tract. 
     
     
         14 . The method of  claim 1 , wherein the cells are in a suspended reanimatable state prior to being ingested by the patient. 
     
     
         15 . The method of  claim 14 , wherein the cells are reanimated after ingestion of the enclosure by conditions in the intestinal tissue including at least one of temperature, blood supply or oxygen supply. 
     
     
         16 . The method of  claim 14 , wherein the cells are frozen prior to being swallowed by the patient. 
     
     
         17 . The method of  claim 2 , wherein the cells are protected from conditions of the gastrointestinal tract by a barrier provided by the article. 
     
     
         18 . The method of  claim 17 , wherein the barrier remains intact while the article passes through the gastrointestinal tract and biodegrades within the intestinal tissue. 
     
     
         19 . The method of  claim 18 , wherein the barrier comprises a biodegradable polymer. 
     
     
         20 . The method of  claim 17 , wherein the barrier comprises a wall having fenestrations. 
     
     
         22 . The method of  claim 20 , wherein the fenestrations are configured to allow the passage of fluids and molecules but to contain the cells and gel, at least a portion of the shell including fenestrations having a slower rate of biodegradation relative to the rest of the shell. 
     
     
         23 . The method of claim  21 , wherein at least a portion of the cells remain in the article and produce a therapeutic compound which diffuses out of the fenestrations. 
     
     
         24 . The method of  claim 2 , wherein the cells are present in a viability-sustaining gel. 
     
     
         25 . The method of claim  54 , wherein the viability-sustaining gel is at least partially saturated with one of oxygen, nitrogen or other inert gas to preserve the viability of the cells. 
     
     
         26 . The method of  claim 2 , wherein the viable cells are therapeutic cells, entero-endocrine cells, gastric enteroendocrine cells, or intestinal enteroendocrine cells. 
     
     
         27 . The method of  claim 26 , wherein the viable cells are selected from a group consisting of pancreatic B-cells, L-cells, K-cells, G-cells, I-cells, immune cells, stem cells, mesenchymal stem cells, and hematopoietic stem cells. 
     
     
         29 . The method of  claim 2 , wherein once delivered into intestinal tissue, the cells produce a therapeutic compound released within the body. 
     
     
         30 . The method of  claim 29 , wherein the therapeutic compound comprises a glucose regulating compound, insulin, an incretin, or Gastrin. 
     
     
         31 . The method of  claim 29 , wherein at least a portion of the cells remain in the article while producing the therapeutic compound. 
     
     
         32 . A method for producing a therapeutic effect in a patient, the method comprising:
 swallowing an enclosure containing a tissue penetrating article which contains a mass of viable cells, wherein the article passes through the gastrointestinal tract with the cells remaining viable;   releasing the article from the enclosure in response to a condition in the gastro-intestinal tract; and   propelling the article to penetrate into gastro-intestinal tissue and releasing the cells or substances produced by the cells to produce the therapeutic effect in the patient.