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Details for Patent: 4,863,716

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Details for Patent: 4,863,716

Title: Determination of fallopian tubal patency by magnetic resonance imaging
Abstract:This invention is a method for obtaining improved NMR images of the uterine cavity and fallopian tubes comprising imjecting a physiologically acceptable solution of a chelate of a parmagnetic material into the uterus under sufficient pressure to cause the solution to pass through the fallopian tubes and obtaining an enhanced NMR image of the tissue surrounding the fallopian tubes. The chelates and the injection solutions thereof do not include carbohydrate groups or other compounds which might support growth of Staphylococcus aureus or other pathological miroorganisms in the peritoneal cavity. Kits including contrast medium and non-metallic uterine balloon catheters suitable for use with NMRI procedures are also included within the scope of this invention.
Inventor(s): Quay; Steven C. (Los Altos Hills, CA), Rocklage; Scott M. (Saratoga, CA)
Assignee: Salutar, Inc. (Sunnyvale, CA)
Filing Date:Jun 04, 1987
Application Number:07/058,180
Claims:1. A method for determining fallopian tubal patency comprising injecting a physiologically acceptable liquid contrast medium containing a resolution enhancing concentration of a compatible paramagnetic metal ion complexed with a chelating agent, into a fallopian tubal duct and exposing the fallopian tubal duct to an NMR measuring step to which the contrast medium is responsive, thereby imaging the fallopian tubal duct, wherein the chelating agent is a dipyridoxyl phosphate compound of Formula I: ##STR12## wherein R is hydrogen or ##STR13## R.sub.1 is hydrogen or ##STR14## and one of R and R.sub.1 is other than hydrogen; R.sub.3 is alkylene having from 1 to 8 carbons, 1,2-cycloalkylene having from 5 to 8 carbons, or 1,2-arylene having from 6 to 10 carbons, or

R.sub.4 is hydrogen, hydroxymethyl, alkyl having from 1 to 6 carbons or ##STR15## R.sub.5 and R.sub.6 are each, individually, hydroxy, alkoxy having from 1 to 18 carbons, hydroxy-substituted alkoxy havig from 1 to 18 carbons, amino having from 1 to 18 carbons;

the phosphate group mono and diesters of the compounds thereof with monohydric and polyhydric alcohols having from 1 to 18 carbons, or alkylamino alcohols, each having from 1 to 18 carbons, and the salts thereof.

2. The method of claim 1 wherein R is ##STR16## and R.sub.1 is ##STR17##

3. The method of claim 2 wherein R.sub.5 and R.sub.6 are each, individually, hydroxy, alkoxy having from 1 to 8 carbons, amino having from 1 to 8 carbons.

4. The method of claim 3 wherein R.sub.5 and R.sub.6 are hydroxy or a salt thereof.

5. The method of claim 4 wherein the chelating agent is

N,N'-(dipyridoxyl-5-phosphate)alkylendiamine-N,N'-diacetic acid or

N,N'-(dipyridoxyl-5-phosphate)-1,2-cycloalkylenediamine-N,N'-diacetic acid.

6. The method of claim 5 wherein the paramagnetic metal ion is Fe(III), Mn(II) or Gd(III) and the chelating agent is N,N'-(dipyridoxyl-5-phosphate)ethylenediamine-N,N'-diacetic acid.

7. The method of claim 5, wherein the paramagnetic metal ion is Fe(III), Mn(II) or Gd(III) and the chelating agent is N,N'-(dipyridoxyl-5-phosphate)trans-1,2-cyclohexylenediamine-N,N'-diacetic acid.

8. A method for determining fallopian tubal patency comprising injecting a physiologically acceptable liquid contrast medium containing a resolution enhancing concentration of a compatible paramagnetic metal ion complexed with a chelating agent, into a fallopian tubal duct and exposing the fallopian tubal duct to an NMR measuring step to which the contrast medium is responsive, thereby imaging the fallopian tubal duct, wherein the chelating agent is a dipyridoxyl phosphate compound of Formula II ##STR18## wherein R.sub.7 is hydroxy, alkoxy having from 1 to 18 carbons, hydroxy-substituted alkoxy having from 1 to 18 carbons, amino having from 1 to 18 carbons;

R.sub.8 is hydrogen or ##STR19## R.sub.9 is hydroxy, alkoxy having from 1 to 18 carbons, amino having from 1 to 18 carbons; and

R.sub.10 is alkylene having from 1 to 8 carbons, 1,2-cycloalkylene having from 5 to 8 carbons, or 1,2-arylene having from 6 to 10 carbons; and

the pharmaceutically acceptable water-soluble salts thereof.

9. The method of claim 8 wherein the paramagnetic metal ion is Fe(III), Mn(II) or Gd(III) and the chelating agent is N,N'-(dipyridoxyl)alkylenediamine-N,N'-diacetic acid or N,N'-(dipyridoxyl)-1,2-cycloalkylenediamine-N,N'-diacetic acid.

10. The method of claim 9 wherein the paramagnetic metal ion is Mn(II), Fe(III) or Gd(III) and the chelating agent is N,N'-(dipyridoxyl)ethylenediamine-N,N'-diacetic acid.
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