Intravesical drug delivery devices

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.

We claim: 
     
         1 . An intravesical medical device for controlled drug delivery, comprising:
 a device body that comprises at least one drug reservoir lumen and at least one air lumen separate from the at least one drug reservoir lumen, the at least one air lumen containing a volume of entrapped air; and   a drug formulation positioned in the at least one drug reservoir lumen, the drug formulation comprising at least one drug,   wherein the at least one air lumen is adjacent to and coextensive with at least a part of the at least one drug reservoir lumen.   
     
     
         2 . The device of  claim 1 , wherein the device body is deformable between a retention shape and a low profile shape for deployment in the bladder of a patient. 
     
     
         3 . The device of  claim 1 , wherein the air lumen comprises a flexible elongated tube. 
     
     
         4 . The device of  claim 3 , wherein the drug reservoir lumen comprises a flexible elongated tube. 
     
     
         5 . The device of  claim 1 , wherein the device body comprises a unitary body comprising the drug reservoir lumen and the air lumen. 
     
     
         6 . The device of  claim 5 , wherein the unitary body further comprises a retention frame lumen, and the device structure further includes a retention frame disposed in the retention frame lumen. 
     
     
         7 . The device of  claim 5 , wherein the unitary body has a wall that is relatively thinner about the drug reservoir lumen and a wall that is relatively thicker about the air lumen. 
     
     
         8 . The device of  claim 5 , wherein the unitary body has a water permeable wall about the drug reservoir lumen and a wall about the air lumen that is coated with a non-water permeable material. 
     
     
         9 . The device of  claim 5 , wherein the unitary body comprises an internal wall that divides the body into at least two compartments that form the at least one drug reservoir lumen and the at least one air lumen. 
     
     
         10 . The device of  claim 1 , wherein the drug formulation comprises a plurality of solid drug tablets disposed in the drug reservoir lumen. 
     
     
         11 . The device of  claim 1 , wherein the air lumen is sealed at one or more ends with an adhesive or with one or more plugs. 
     
     
         12 . The device of  claim 1 , wherein the device body is cylindrically shaped. 
     
     
         13 . The device of  claim 1 , wherein the drug reservoir lumen and the air lumen share at least one wall. 
     
     
         14 . An intravesical medical device for controlled drug delivery, comprising:
 a unitary device body that comprises at least one drug reservoir lumen, a retention frame lumen, and at least one air lumen separate from the at least one drug reservoir lumen, the at least one air lumen containing a volume of entrapped air;   a drug formulation positioned in the at least one drug reservoir lumen, the drug formulation comprising at least one drug; and   a retention frame disposed in the retention frame lumen,   wherein the unitary body comprises an internal wall that divides the body into at least two compartments that form the at least one drug reservoir lumen and the at least one air lumen, the at least one air lumen being adjacent to and coextensive with at least a part of the at least one drug reservoir lumen.   
     
     
         15 . The device of  claim 14 , wherein the device body is deformable between a retention shape and a low profile shape for deployment in the bladder of a patient. 
     
     
         16 . The device of  claim 14 , wherein the drug formulation comprises a plurality of solid drug tablets disposed in the drug reservoir lumen. 
     
     
         17 . The device of  claim 14 , wherein the air lumen is sealed at one or more ends with an adhesive or with one or more plugs. 
     
     
         18 . The device of  claim 14 , wherein the device body is cylindrically shaped. 
     
     
         19 . The device of  claim 14 , wherein the unitary body has a wall that is relatively thinner about the drug reservoir lumen and a wall that is relatively thicker about the air lumen. 
     
     
         20 . The device of  claim 14 , wherein the unitary body has a water permeable wall about the drug reservoir lumen and a wall about the air lumen that is coated with a non-water permeable material. 
     
     
         21 . An intravesical medical device for controlled drug delivery, comprising:
 a unitary device body that comprises at least one drug reservoir lumen, a retention frame lumen, and at least one air lumen separate from the at least one drug reservoir lumen, the at least one air lumen containing a volume of entrapped air;   a drug formulation positioned in the at least one drug reservoir lumen, the drug formulation comprising at least one drug; and   a retention frame disposed in the retention frame lumen,   wherein at least two of the at least one drug reservoir lumen, the retention frame lumen, and the at least one air lumen are adjacent to and coextensive with one another.   
     
     
         22 . The device of  claim 21 , wherein the device body is deformable between a retention shape and a low profile shape for deployment in the bladder of a patient. 
     
     
         23 . The device of  claim 21 , wherein the drug formulation comprises a plurality of solid drug tablets disposed in the drug reservoir lumen. 
     
     
         24 . The device of  claim 21 , wherein the air lumen is sealed at one or more ends with an adhesive or with one or more plugs. 
     
     
         25 . The device of  claim 21 , wherein the device body is cylindrically shaped. 
     
     
         26 . The device of  claim 21 , wherein the unitary body has a wall that is relatively thinner about the drug reservoir lumen and a wall that is relatively thicker about the air lumen. 
     
     
         27 . The device of  claim 21 , wherein the unitary body has a water permeable wall about the drug reservoir lumen and a wall about the air lumen that is coated with a non-water permeable material.