Bladder drug eluting device
View Patent ↗A drug delivery system that can be deployed from a catheter and retained within the bladder for delivery of treatment drug solutions over a period of time. The delivery system includes an inflatable or expandable delivery element that can be collapsed within the catheter tip for navigation into the bladder before being inflated or expanded within the bladder. The inflated or expanded delivery element can engage the bladder walls or sized to be too large to be passed from the bladder such that the delivery element is retained within the bladder after inflation or expansion to administer a treatment drug solution over an extended period of time.
1. A drug delivery device for treating bladder disorders, comprising:
a first catheter having a lumen defined between a proximal end and a distal tip comprising an inner tip space; and
a delivery element having a first non-expanded state and a second expanded state,
wherein the delivery element is fully contained within the inner tip space of the lumen as the distal tip is navigated into a bladder;
wherein the delivery element transitions to the second expanded state when the delivery element is advanced out of the lumen such that the delivery element contacts an internal bladder wall to deliver a treatment drug from the delivery element to the bladder; and
wherein the delivery element is separable from the first catheter after the delivery element transitions to the second expanded state.
2. The drug delivery device of claim 1 , wherein the delivery element comprises a flexible ring, wherein the flexible ring assumes a folded state in the first non-expanded state and assumes a ring shape when in the expanded state.
3. The drug delivery device of claim 2 , wherein the flexible ring comprises a drug eluting flexible ring such that the treatment drug is delivered to the bladder through contact of the drug eluting flexible ring with the internal bladder wall.
4. The drug delivery device of claim 2 , wherein the flexible ring allows passage of urine through a center portion of the ring such that the flexible ring can remain in the expanded state within the bladder without impacting bladder function.
5. The drug delivery device of claim 1 , wherein the delivery element comprises a first inflation balloon, and wherein the first inflation balloon assumes an uninflated state in the first non-expanded state and assumes an inflated state in the second expanded state.
6. The drug delivery device of claim 5 , wherein an exterior balloon wall is in contact with the internal bladder wall when the inflation balloon is in the second expanded state.
7. The drug delivery device of claim 6 , wherein the inflation balloon is inflated with an inflation fluid to assume the second expanded state.
8. The drug delivery device of claim 7 , wherein the inflation fluid comprises the treatment drug.
9. The drug delivery device of claim 5 , wherein the first inflation balloon comprises a semi-permeable membrane.
10. The drug delivery device of claim 5 , wherein the first inflation balloon comprises a plurality of orifices formed in a balloon wall.
11. The drug delivery device of claim 10 , wherein a pressurized inflation fluid is forced through the plurality of orifices, the pressurized inflation fluid including the treatment drug.
12. The drug delivery device of claim 1 , wherein the treatment drug is introduced into the delivery element with a jet injection system.
13. A method for delivering a bladder treatment drug, comprising:
providing a first catheter having a lumen defined between a proximal end and a distal tip comprising an inner tip space, the first catheter including a delivery element within the inner tip space of the lumen;
advancing the delivery element out of the lumen and expanding the delivery element so that the delivery element assumes an expanded disposition within a bladder, wherein the delivery element is in contact with an internal bladder wall;
separating the delivery element from the first catheter within the bladder;
removing the first catheter from the bladder; and
delivering a bladder treatment drug to the internal bladder wall through continuing contact of the delivery element with the internal bladder wall.
14. The method of claim 13 , wherein the delivery element comprises a foldable ring.
15. The method of claim 14 , further comprising:
allowing urine to pass through a center portion of the foldable ring such that urinary function is maintained following removal of the first catheter.
16. The method of claim 15 , further comprising:
eluting the treatment drug from the flexible ring to the internal bladder wall through continued contact of the flexible ring with the internal bladder wall following removal of the first catheter.
17. The method of claim 13 , wherein the delivery element comprises a first inflation balloon, and where the method further comprises:
inflating the first inflation balloon with an inflation fluid such that the first inflation balloon is in contact with the internal bladder wall.
18. The method of claim 17 , wherein the inflation fluid comprises the bladder treatment drug and wherein the expansion of the delivery element and delivery of the bladder treatment drug comprises:
pressurizing the inflation fluid such that the inflation fluid is directed through a plurality of orifices in a wall of the first inflation balloon such that the bladder treatment drug is delivered to the internal bladder wall.
19. The method of claim 13 , further comprising:
injecting the bladder treatment drug into the delivery element with a jet injection system.