IP Library › Granted Patent US 12,326,492
Granted Patent B2
US 12,326,492 · App. 16/205,654 · Granted Jun 10, 2025

Systems and methods of detecting interstitial cystitis

Inventors: Jonathan Kaufman (Pittsburgh, PA); Michael B. Chancellor (Pittsburgh, PA)
Assignee: LIPELLA PHARMACEUTICALS, INC.
G01R33/5601A61B5/0044A61B5/055A61K49/0004A61K49/103A61K49/105A61K49/1827
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Quick Facts
Patent No.
US 12,326,492
App. No.
16/205,654
Granted
Jun 10, 2025
Kind
B2
Abstract

The invention provides systems and methods for providing a diagnostic examination to a patient, including, but not limited to a determination of the permeability of a patients' body cavity.

Claims (53)

1. A method for measuring permeability of a body cavity in a patient comprising:

administering a composition comprising a T1-reducing contrast agent and a T2-reducing contrast agent directly into or onto the body cavity of the patient;

imaging the body cavity in the patient, the body cavity comprising a lumen and a luminal surface, the lumen having the T1-reducing contrast agent and the T2-reducing contrast agent; and

determining diffusion of the T1-reducing contrast agent from the lumen of the body cavity across the luminal surface of the body cavity,

wherein diffusion of the T1-reducing contrast agent across the luminal surface of the body cavity is indicative of permeability of the body cavity associated with pathologic breakdown of one or more layers of the body cavity,

wherein the T2-reducing contrast agent is retained within the lumen, and

wherein the body cavity is urinary bladder or ureters.

2. The method of claim 1 , wherein the composition further comprises an aqueous solvent.

3. The method of claim 1 , wherein imaging the patient comprises imaging via magnetic resonance imaging.

4. The method of claim 1 , wherein imaging the patient is performed within about 10 minutes of administration of the composition.

5. The method of claim 1 , wherein the T1-reducing contrast agent comprises a gadolinium compound.

6. The method of claim 5 , wherein the gadolinium compound is selected from the group consisting of gadopentetate dimeglumine (Gd-DTPA), gadoterate meglumine, gadoversetamide, gadoteridol, gadodiamide, gadobenate dimeglumine, gadobutrol, gadoxetate disodium, gadofosveset trisodium, and combinations thereof.

7. The method of claim 5 , wherein the gadolinium compound is encapsulated in liposomes.

8. The method of claim 1 , wherein the T2-reducing contrast agent comprises an iron oxide.

9. The method of claim 1 , wherein the iron oxide is selected from the group consisting of iron (II) oxide, iron (III) oxide, ferumoxytol, iron nickel oxide nanopowder, iron oxide (II,III) magnetic nanoparticles, iron-nickel alloy nanopowder, magnetic iron oxide nanoparticles, carbon coated iron nanopowder, and combinations thereof.

10. The method of claim 8 , wherein the iron oxide is encapsulated in liposomes.

11. The method of claim 1 , wherein the body cavity in the patient is the urinary bladder.

12. The method of claim 11 , wherein the patient is suspected of having interstitial cystitis, bladder pain syndrome, or a combination thereof.

13. The method of claim 11 , wherein administration of the composition is achieved by instillation into the lumen of the urinary bladder.

14. A method for measuring permeability of a body cavity in a patient comprising:

imaging the body cavity in the patient after administering a composition comprising a T1-reducing contrast agent and a T2-reducing contrast agent directly into or onto the body cavity of the patient, the body cavity comprising a lumen and a luminal surface, the lumen having the T1-reducing contrast agent and the T2-reducing contrast agent; and

determining diffusion of the T1-reducing contrast agent from the lumen of the body cavity across the luminal surface of the body cavity,

wherein diffusion of the T1-reducing contrast agent across the luminal surface of the body cavity is indicative of permeability of the body cavity associated with pathologic breakdown of one or more layers of the body cavity,

wherein the T2-reducing contrast agent is retained within the lumen, and

wherein the body cavity in the patient is urinary bladder or ureters.

15. The method of claim 14 , wherein the composition further comprises an aqueous solvent.

16. The method of claim 14 , wherein imaging the patient comprises imaging via magnetic resonance imaging.

17. The method of claim 14 , wherein imaging the patient is performed within about 10 minutes of administration of the composition.

18. The method of claim 14 , wherein the T1-reducing contrast agent comprises a gadolinium compound.

19. The method of claim 18 , wherein the gadolinium compound is selected from the group consisting of gadopentetate dimeglumine (Gd-DTPA), gadoterate meglumine, gadoversetamide, gadoteridol, gadodiamide, gadobenate dimeglumine, gadobutrol, gadoxetate disodium, gadofosveset trisodium, and combinations thereof.

20. The method of claim 19 , wherein the gadolinium compound is encapsulated in liposomes.

21. The method of claim 14 , wherein the T2-reducing contrast agent comprises an iron oxide.

22. The method of claim 21 , wherein the iron oxide is selected from the group consisting of iron (II) oxide, iron (III) oxide, ferumoxytol, iron nickel oxide nanopowder, iron oxide (II,III) magnetic nanoparticles, iron-nickel alloy nanopowder, magnetic iron oxide nanoparticles, carbon coated iron nanopowder, and combinations thereof.

23. The method of claim 21 , wherein the iron oxide is encapsulated in liposomes.

24. The method of claim 14 , wherein the body cavity in the patient is the urinary bladder.

25. The method of claim 24 , wherein the patient is suspected of having interstitial cystitis, bladder pain syndrome, or a combination thereof.

26. The method of claim 25 , wherein administration of the composition is achieved by injection, instillation, catheterization, infusion, or a combination thereof into the lumen of the urinary bladder.

27. The method of claim 1 , wherein the composition comprises a concentration of the T2-reducing contrast agent configured to completely mask a contrast effect of the T1-reducing contrast agent in the composition.

28. The method of claim 14 , wherein the composition comprises a concentration of the T2-reducing contrast agent configured to completely mask a contrast effect of the T1-reducing contrast agent in the composition.

29. The method of claim 1 , wherein the T2-reducing contrast agent has an average particle diameter from about 3.5 microns to about 80 microns,

wherein the luminal surface is impermeable to the T2-reducing contrast agent such that the T2-reducing contrast agent is retained within the lumen.

30. The method of claim 29 , wherein the T1-reducing contrast agent has an average particle diameter less than the average particle diameter of the T2-reducing contrast agent.

31. The method of claim 14 , wherein the T2-reducing contrast agent has an average particle diameter from about 3.5 microns to about 80 microns,

wherein the luminal surface is impermeable to the T2-reducing contrast agent such that the T2-reducing contrast agent is retained within the lumen.

32. The method of claim 31 , wherein the T1-reducing contrast agent has an average particle diameter less than the average particle diameter of the T2-reducing contrast agent.

33. The method of claim 1 , wherein administration of the composition is achieved by instillation.

34. The method of claim 1 , wherein the composition is administered through a natural opening to the body cavity.

35. The method of claim 1 , wherein the composition is administered orally.

36. The method of claim 14 , wherein administration of the composition is achieved by instillation.

37. The method of claim 14 , wherein the composition is administered through a natural opening to the body cavity.

38. The method of claim 14 , wherein the composition is administered orally.

39. The method of claim 1 , wherein the body cavity in the patient is the ureters.

40. The method of claim 14 , wherein the body cavity in the patient is the ureters.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2026
From: LIPELLA PHARMACEUTICALS INC.
To: XRAIY LLC
Reel/Frame 075199/0666 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 26, 2019
From: KAUFMAN, JONATHAN
To: LIPELLA PHARMACEUTICALS, INC.
Reel/Frame 050169/0766 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 26, 2019
From: CHANCELLOR, MICHAEL B.
To: LIPELLA PHARMACEUTICALS, INC.
Reel/Frame 050169/0897 →
Continuity (6)
Continuation 14862923 · Sep 23, 2015
Continuation In Part 14678638 · Apr 3, 2015
Continuation In Part PCTUS2015024309 · Apr 3, 2015
Provisional Application 62062339 · Oct 10, 2014
Provisional Application 61974964 · Apr 3, 2014
Related Publication 20190094323A1 · Mar 28, 2019
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