Contrast media for using in medical and diagnostic procedures and methods of using the same

Abstract

The present invention relates to contrast media having a low concentration of contrast agent (active ingredient) and/or low Hounsfield value for use in medical or diagnostic procedures, or for therapeutic use. In one alternative embodiment, the contrast media are comprised of a contrast agent, alone or in combination with a stabilizing agent or osmotic agent. The present invention is directed to a contrast media having a Hounsfield value less than 250. In another embodiment, the contrast media comprises a contrast agent, such as a less than 2% w/v barium-based compound. In another embodiment, the present invention also relates to formulations and methods for distending and imaging an anatomic segment of an individual.

1 . A contrast media for use in imaging an individual's anatomic segment comprising: a contrast agent comprising an iodine-based compound and an osmotic agent; said contrast media having a Hounsfield value from about −500 to about 250. 
   
   
       2 . The contrast media of  claim 1 , wherein the Hounsfield value is about 1 to about 200. 
   
   
       3 . The contrast media of  claim 1 , wherein the Hounsfield value is about 5 to about 45. 
   
   
       4 . The contrast media of  claim 1 , wherein the Hounsfield value is about 15 to about 35. 
   
   
       5 . The contrast media of  claim 1 , wherein the Hounsfield value is about 20 to abut 30. 
   
   
       6 . The contrast media of  claim 1 , wherein the concentration of the contrast agent is less than 2% by weight. 
   
   
       7 . The contrast media of  claim 1 , wherein the concentration of the contrast agent is from about 0.01% to about 0.8% w/v. 
   
   
       8 . The contrast media of  claim 1 , wherein the concentration of the contrast agent is from about 0.01% to about 0.5% w/v. 
   
   
       9 . The contrast media of  claim 1 , wherein the concentration of the contrast agent is from about 0.1% to about 0.5% w/v. 
   
   
       10 . The contrast media of  claim 1 , wherein the concentration of the contrast agent is from about 0.01% to about 0.2% w/v. 
   
   
       11 - 14 . (canceled) 
   
   
       15 . The contrast media of  claim 1 , further comprising a stabilizing agent. 
   
   
       16 . (canceled) 
   
   
       17 . The contrast media of  claim 1 , further comprising about 0.005% to about 40% of a stabilizing agent. 
   
   
       18 . The contrast media of  claim 1 , further comprising about 0.05% to about 10% xanthan gum. 
   
   
       19 . The contrast media of  claim 1 , further comprising about 0.005% to about 60% of an osmotic agent. 
   
   
       20 . The contrast media of  claim 19 , wherein the osmotic agent comprises a sugar-based compound. 
   
   
       21 . The contrast media of  claim 20 , wherein the sugar-based compound comprises a monosaccharide, disaccharide or polysaccharide. 
   
   
       22 . The contrast media of  claim 21 , wherein the polysaccharide comprises sorbitol. 
   
   
       23 . A contrast media for use in imaging an individual's anatomic segment comprising less than 2 w/v % of an iodine-based compound; about 0.01,% to about 30% of a stabilizing agent and about 0.05% to about 60% of an osmotic agent. 
   
   
       24 . The contrast media of  claim 23 , wherein the stabilizing agent comprises xanthan gum and the osmotic agent is selected from sorbitol, mannitol, or xylitol. 
   
   
       25 . The contrast media of  claim 23 , comprising about 0.001% to about 0.5% of the iodine-based compound; about 0.05% to about 1% xanthan gum and about 0.05% to about 5% of sorbitol, mannitol, or xylitol. 
   
   
       26 . The contrast media of  claim 23 , wherein the contrast media is provided in an aqueous suspension. 
   
   
       27 . The contrast media of  claim 23 , comprising about 0.05% to about 15% of a stabilizing agent. 
   
   
       28 . (canceled) 
   
   
       29 . The contrast media of  claim 23 , comprising about 1% to about 25% of an osmotic agent. 
   
   
       30 - 31 . (canceled) 
   
   
       32 . The contrast media of claim  31 , wherein the contrast media comprises about 0.05% to about 5% of sorbitol. 
   
   
       33 . The contrast media of  claim 23 , comprising about 0.001% to about 5% of the iodine-based compound; about 0.01% to about 5% xanthan gum and about 1% to about 15% sorbitol. 
   
   
       34 . A method of performing a diagnostic procedure comprising: (a) administering a contrast media to an individual; said contrast media comprising an iodine-based contrast agent, said contrast media having a Hounsfield value from about −500 to about 250; and (b) performing the medical or diagnostic procedure on the individual during or after administering the contrast media to the individual. 
   
   
       35 . The method of  claim 34 , where the contrast media has a Hounsfield value from about −500 to about 100. 
   
   
       36 . The method of  claim 34 , wherein the Hounsfield value is about 1 to about 200. 
   
   
       37 . The method of  claim 34 , wherein the Hounsfield value is about 5 to about 45. 
   
   
       38 . The method of  claim 34 , wherein the Hounsfield value is about 15 to about 35. 
   
   
       39 . The method of  claim 34 , wherein the Hounsfield value is about 20 to abut 30. 
   
   
       40 . The method of  claim 34 , wherein the concentration of the contrast agent is less than 2% by weight. 
   
   
       41 . The method of  claim 34 , wherein the concentration of the contrast agent is from about 0.01% to about 0.8% w/v. 
   
   
       42 . The method of  claim 34 , wherein the concentration of the contrast agent is from about 0.01% to about 0.5% w/v. 
   
   
       43 . The method of  claim 34 , wherein the concentration of the contrast agent is from about 0.1% to about 0.5% w/v. 
   
   
       44 . The method of  claim 34 , wherein the concentration of the contrast agent is from about 0.01% to about 0.2% w/v. 
   
   
       45 . A method of imaging an anatomic segment of an individual comprising the steps of: (a) administering a contrast media comprising an iodine-based contrast agent; said contrast media having a Hounsfield value from about −500 to about 250; (b) conducting an imaging procedure to obtain the image of the individual's anatomic segment during or after administering the contrast media to the individual; and (c) generating the image of the anatomic segment. 
   
   
       46 . The method of  claim 45 , wherein at least a portion of the gastrointestinal tract is imaged. 
   
   
       47 . The method of  claim 45 , wherein the small intestine is imaged. 
   
   
       48 . The method of  claim 45 , wherein the colon is imaged. 
   
   
       49 . The method of  claim 45 , wherein the pancreas is imaged. 
   
   
       50 . The method of  claim 45 , wherein the duodenum is imaged. 
   
   
       51 . The method of  claim 45 , wherein the cecum is imaged. 
   
   
       52 . The method of  claim 45 , wherein the bowel is imaged. 
   
   
       53 . The method of  claim 45 , wherein the large intestine is imaged. 
   
   
       54 . The method of  claim 45 , wherein the jejunum is imaged. 
   
   
       55 . The method of  claim 45 , wherein the ileum is imaged. 
   
   
       56 . The method of  claim 45 , wherein the appendix is imaged. 
   
   
       57 . The method of  claim 45 , wherein the pancreas is imaged. 
   
   
       58 . The method of  claim 45 , wherein the duodenum is imaged. 
   
   
       59 . The method of  claim 45 , wherein the sigmoid is imaged. 
   
   
       60 . The method of  claim 45 , wherein the rectum is imaged. 
   
   
       61 . The method of  claim 45 , wherein the stomach is imaged. 
   
   
       62 . A method of diagnosing a disease in an individual comprising: (a) administering to said individual a contrast media comprising an iodine-based contrast agent; said contrast media having a Hounsfield value from about −500 to about 250; (2) conducting an imaging procedure to obtain the image of an individual's anatomic segment; (3) generating the image of the anatomic segment; and (4) evaluating the images to diagnose the presence of the disease. 
   
   
       63 . The method of  claim 62 , wherein said disease is selected from the group consisting of ulcerations, lesions and tumors. 
   
   
       64 . The method of  claim 62 , wherein said disease is cancer. 
   
   
       65 . The method of  claim 62 , wherein said disease is inflammatory bowel disease, Crohn's Disease, ulcerative colitis or irritable bowel syndrome. 
   
   
       66 . The method of  claim 62 , wherein said disease is a disease of the pancreas, spleen, liver or gall bladder. 
   
   
       67 . The method of  claim 62 , wherein said disease is a disease of the lymph nodes. 
   
   
       68 . The method of  claim 62 , wherein said disease is a disease of the vascular system. 
   
   
       69 . A method of delineating the lumen of an anatomic segment of an individual for a medical or diagnostic procedure, said method comprising the steps of: (a) providing a contrast media comprising an iodine-based compound into the lumen of the individual's anatomic segment to facilitate delineation of the anatomic segment; said contrast media having a Houndsfield value from −500 to about 250. 
   
   
       70 . A method of distending an anatomic segment of an individual for a medical or diagnostic procedure comprising the steps of: (a) providing a contrast media comprising an iodine-based compound into the lumen of the individual's anatomic segment to facilitate distention of the anatomic segment; said contrast media having a Houndsfield value from about −500 to about 250. 
   
   
       71 . The method of  claim 69 , wherein said anatomic segment is the gastrointestinal tract. 
   
   
       72 . The method of  claim 69 , wherein said anatomic segment is the small intestine. 
   
   
       73 . The method of  claim 69 , wherein said anatomic segment is the large intestine. 
   
   
       74 . The method of  claim 69 , wherein said anatomic segment is the colon. 
   
   
       75 . The method of  claim 69 , wherein said anatomic segment is the bowel. 
   
   
       76 . The method of  claim 69 , wherein, said contrast media has a Hounsfield value from about −500 to about 100. 
   
   
       77 . The method of  claim 69 , wherein the Hounsfield value is about 1 to about 200. 
   
   
       78 . The method of  claim 69 , wherein the Hounsfield value is about 5 to about 45. 
   
   
       79 . The method of  claim 69 , wherein the Hounsfield value is about 15 to about 35. 
   
   
       80 . The method of  claim 69 , wherein the Hounsfield value is about 20 to abut 30. 
   
   
       81 . The method of  claim 69 , wherein the concentration of the contrast agent is less than 2% by weight. 
   
   
       82 . The method of  claim 69 , wherein the concentration of the contrast agent is from about 0.01% to about 0.8% w/v. 
   
   
       83 . The method of  claim 69 , wherein the concentration of the contrast agent is from about 0.01% to about 0.5% w/v. 
   
   
       84 . The method of  claim 69 , wherein the concentration of the contrast agent is from about 0.1% to about 0.5% w/v. 
   
   
       85 . The method of  claim 69 , wherein the concentration of the contrast agent is from about 0.01% to about 0.2% w/v. 
   
   
       86 . The contrast media of  claim 20 , wherein the sugar-based compound is selected from sorbitol, mannitol, or xylitol. 
   
   
       87 . The method of  claim 70 , wherein said anatomic segment is the gastrointestinal tract. 
   
   
       88 . The method of  claim 70 , wherein said anatomic segment is the small intestine. 
   
   
       89 . The method of  claim 70 , wherein said anatomic segment is the large intestine. 
   
   
       90 . The method of  claim 70 , wherein said anatomic segment is the colon. 
   
   
       91 . The method of  claim 70 , wherein said anatomic segment is the bowel. 
   
   
       92 . The method of  claim 70 , wherein, said contrast media has a Hounsfield value from about −500 to about 100. 
   
   
       93 . The method of  claim 70 , wherein the Hounsfield value is about 1 to about 200. 
   
   
       94 . The method of  claim 70 , wherein the Hounsfield value is about 5 to about 45. 
   
   
       95 . The method of  claim 70 , wherein the Hounsfield value is about 15 to about 35. 
   
   
       96 . The method of  claim 70 , wherein the Hounsfield value is about 20 to abut 30. 
   
   
       97 . The method of  claim 70 , wherein the concentration of the contrast agent is less than 2% by weight. 
   
   
       98 . The method of  claim 70 , wherein the concentration of the contrast agent is from about 0.01% to about 0.8% w/v. 
   
   
       99 . The method of  claim 70 , wherein the concentration of the contrast agent is from about 0.01% to about 0.5% w/v. 
   
   
       100 . The method of  claim 70 , wherein the concentration of the contrast agent is from about 0.1% to about 0.5% w/v. 
   
   
       101 . The method of  claim 70 , wherein the concentration of the contrast agent is from about 0.01% to about 0.2% w/v.