Implantable drug delivery device with bladder retention feature

Patent metadata

Field	Value
Publication number	US-9457176-B2
Application number	US-201113267469-A
Country	US
Kind code	B2
Filing date	Oct 6, 2011
Priority date	Oct 6, 2010
Publication date	Oct 4, 2016
Grant date	Oct 4, 2016

Abstract

Implantable devices and methods for controlled drug delivery are provided. The device includes a device structure deformable between a retention shape and a low profile shape for deployment in the bladder of a patient and has a drug reservoir lumen in which a drug formulation is housed. The device also includes a buoyancy retention portion, which includes a volume of entrapped air or a gas-generating or effervescent powder which will generate a volume of entrapped air following contact with urine in the bladder. The buoyancy retention portion may include a water permeable and/or biodegradable wall, which can release the entrapped air following drug release, to cause the device to sink into the bladder neck to facilitate device expulsion without the need for a device retrieval medical procedure.

First claim

We claim:

1. An implantable medical device for controlled drug delivery, comprising:
a device structure which comprises a device body having at least one drug reservoir lumen, the device structure being deformable between a coiled retention shape and a low profile shape for deployment in the bladder of a patient;
a drug formulation positioned in the at least one drug reservoir lumen, the drug formulation comprising at least one drug; and
at least one buoyancy retention portion, which comprises at least one retention air element comprising a volume of entrapped air, the retention air element being wholly disposed within the at least one drug reservoir lumen and adjacent at least a portion of the drug formulation,
wherein the buoyancy retention portion comprises a water permeable or biodegradable wall, which at least in part defines a space containing the volume of entrapped air,
wherein the buoyancy retention portion is configured to release the entrapped air at a selected time following implantation of the device.

2. The device of claim 1 , wherein the at least one retention air element is in the form of a hollow capsule or a closed-cell foam, the capsule or the cells of the foam containing the entrapped air.

3. The device of claim 1 , wherein the drug formulation comprises a plurality of solid drug tablets disposed in the drug reservoir lumen.

4. The device of claim 1 , wherein the drug comprises lidocaine.

5. The device of claim 1 , wherein
the buoyancy retention portion comprises the biodegradable wall, which degrades or erodes in vivo.

6. The device of claim 1 , wherein
the buoyancy retention portion comprises the water permeable wall, which is coated by a non-water-permeable coating that erodes or degrades in vivo.

7. The device of claim 1 , wherein the at least one buoyancy retention portion is configured to release the entrapped air following release of at least a portion of the drug in vivo.

8. The device of claim 1 , wherein the volume of entrapped air is sufficient to retain the device in the bladder during urination.

9. The device of claim 1 , wherein the device body is a tube having a diameter of 5 mm or less in the coiled retention shape and in the low-profile shape.

10. An implantable medical device for controlled drug delivery, comprising:
a device structure which comprises a device body having at least one drug reservoir lumen, the device structure being deformable between a coiled retention shape and a low-profile shape for deployment in the bladder of a patient;
a drug formulation positioned in the drug reservoir lumen, the drug formulation comprising at least one drug; and
at least one buoyancy retention portion, which comprises a gas-generating or effervescent powder disposed wholly within the at least one drug reservoir lumen, such that the gas-generating or effervescent powder and the drug formulation are disposed within a continuous volume of the drug reservoir lumen.

11. The device of claim 10 , wherein the at least one buoyancy retention portion is expandable from a collapsed or compressed deployment form to an inflated form filled with gas produced from the gas-generating or effervescent powder.

12. The device of claim 10 , wherein the at least one buoyancy retention portion comprises a water-permeable wall.

13. The device of claim 10 , wherein the gas-generating or effervescent powder comprises:
an organic acid or its acidic salt, and
an alkali metal bicarbonate or carbonate.

14. The device of claim 10 , wherein the gas-generating or effervescent powder comprises citric acid, malic acid, tartaric acid, adipic acid, fumaric acid, succinic acid, ascorbic acid, maleic acid, alginic acid, sodium dihydrogen phosphate, disodium hydrogen phosphate, or a combination thereof.

15. The device of claim 10 , wherein the gas-generating or effervescent powder comprises sodium bicarbonate, potassium bicarbonate, calcium carbonate, sodium carbonate, potassium carbonate, or a combination thereof.

16. The device of claim 10 , wherein the drug formulation comprises a plurality of solid drug tablets disposed in the drug reservoir lumen.

17. The device of claim 10 , wherein the drug comprises lidocaine.

18. The device of claim 10 , wherein the at least one buoyancy retention portion comprises a wall formed from a material that degrades or erodes in vivo.

19. The device of claim 10 , wherein the at least one buoyancy retention portion comprises a wall formed of a water permeable material, which is coated by a non-water-permeable coating that erodes or degrades in vivo.

20. The device of claim 10 , wherein the gas-generating or effervescent powder is configured to generate an entrapped gas sufficient to facilitate flotation of the device in the bladder upon deployment.

21. The device of claim 10 , wherein the device body is a tube having a constant diameter in the coiled retention shape and in the low-profile shape.

22. The device of claim 21 , wherein the diameter is 5 mm or less.

23. The device of claim 10 , wherein the gas-generating or effervescent powder is configured to generate an entrapped gas and the at least one buoyancy retention portion is configured to release the entrapped gas following release of at least a portion of the drug in vivo.

24. The device of claim 10 , wherein the gas-generating or effervescent powder is configured to generate an entrapped gas and the at least one buoyancy retention portion is configured to release the entrapped gas at a select time following implantation of the device.

25. The device of claim 10 , wherein the gas-generating or effervescent powder is configured to generate an entrapped gas sufficient to retain the device in the bladder during urination.

26. An intravesical drug delivery device, comprising:
an elongated device body having a first end, an opposed second end, and a drug reservoir lumen in the body between the first and second ends, the drug reservoir lumen having a first end and an opposed second end;
a drug formulation positioned in the drug reservoir lumen; and
at least one buoyancy retention element comprising a gas entrapped by a wall, wherein the wall entrapping the gas further defines the drug reservoir lumen and contains the drug formulation,
wherein the device body is configured to be elastically deformable between a coiled retention shape and a low profile shape for deployment in the bladder of a patient,
wherein the at least one buoyancy retention element is configured to release the entrapped gas at a select time following implantation of the device.

27. The device of claim 26 , wherein the at least one buoyancy retention element comprises a hollow capsule or a closed-cell foam.

28. The device of claim 26 , wherein the wall of the at least one buoyancy retention element comprises a water-permeable wall that is degradable or erodible in vivo.

29. The device of claim 26 , wherein the apparent diameter of the device body is 5 mm or less.

30. The device of claim 26 , wherein the entrapped gas is sufficient to facilitate flotation of the device in the bladder upon deployment.

31. The device of claim 26 , wherein the at least one buoyancy retention element is configured to release the entrapped gas following release of at least a portion of the drug.

32. The device of claim 26 , wherein the ent

Assignees

• Lee Heejin
• Duc Hong Linh Ho
• Taris Biomedical Llc

Inventors

• Lee Heejin
• Duc Hong Linh Ho

Classifications

• A61K9/20

  Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)} · CPC title

• A61K9/0034

  Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants · CPC title

• A61L31/10

  Macromolecular materials · CPC title

• A61K31/167

  having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title