Claims for Patent: 8,679,094

Summary for Patent: 8,679,094

Title:	Implantable device with intravesical tolerability and methods of treatment
Abstract:	Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1 N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.
Inventor(s):	Michael J. Cima, Heejin Lee
Assignee:	Taris Biomedical LLC
Application Number:	US12/972,364
Patent Claims:	1. A medical device which is wholly deployable within the bladder of a human patient and well tolerated by the patient, comprising: an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that are configured to prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that are configured to exclude the medical device from entering the orifices of the ureters, wherein the elastic body houses a drug formulation which is in the form of a plurality of tablets which comprise at least one drug. 2. The device of claim 1, wherein the elastic body exerts a maximum acting force less than 1 N when compressed to a shape with a maximum dimension in any dimension of 3 cm. 3. The device of claim 1, wherein the elastic body exerts a maximum acting force less than 1 N when compressed to a shape with a maximum dimension in any dimension of 1.5 cm. 4. The device of claim 1, wherein the device in the retention shape and uncompressed has a maximum dimension in any direction that is less than 10 cm. 5. The device of claim 1, wherein the device in the retention shape and uncompressed has a maximum dimension in any direction that is from less than 5 cm. 6. The device of claim 1, wherein the device in the retention shape is dimensioned to exclude the device from fitting through an opening having the shape of an isosceles triangle having two sides 2.8 cm long and one side 3.3 cm long. 7. The device of claim 1, wherein the elastic body is elastically deformable to take a low-profile shape having an outer diameter in one direction that is less than about 4 mm. 8. The device of claim 1, wherein the device in a dry state has a density less than 1.5 g/mL. 9. The device of claim 1, wherein the device in a dry state has a density from 0.5 g/mL to 1.3 g/mL. 10. The device of claim 1, wherein the drug formulation has a mass of 275 mg or less. 11. The device of claim 1, wherein the device is configured to release solubilized drug in vivo by osmotic pressure. 12. The device of claim 1, wherein the device is configured to release solubilized drug in vivo by diffusion. 13. The device of claim 1, wherein the elastic body comprises a water permeable elastomeric material. 14. The device of claim 1, wherein the elastic body comprises silicone, poly(urethane), or a combination thereof. 15. The device of claim 1, wherein the at least one drug comprises an anesthetic agent or an analgesic agent. 16. The device of claim 1, wherein the at least one drug comprises lidocaine. 17. The device of claim 1, wherein the at least one drug comprises oxybutynin. 18. The device of claim 1, wherein the at least one drug comprises gemcitabine. 19. The device of claim 1, wherein the at least one drug comprises trospium. 20. The device of claim 1, wherein the tablets have circular flat end faces and a cylindrical side wall. 21. The device of claim 20, wherein the tablets have an aspect ratio of height:width that is greater than 1:1. 22. The device of claim 1, wherein the retention shape has two sub-circles, each having its own smaller arches and sharing a common larger arch. 23. A drug delivery device which is deployable within the bladder of a human patient and well tolerated by the patient, comprising: an elastic body housing a solid drug formulation, wherein the device is deformable between a deployment shape for passage of the device through the urethra and a retention shape for preventing voiding of the device through the urethra, the retention shape having a maximum dimension in any dimension of 6 cm or less when in an uncompressed state and wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 3 cm, wherein the solid drug formulation is in the form of one or more solid drug units having circular flat end faces and a cylindrical side wall. 24. The drug delivery device of claim 23, wherein the solid drug unit has an aspect ratio of height:width that is greater than 1:1. 25. A drug delivery device which is deployable within the bladder of a human patient and well tolerated by the patient, comprising: an elastic body housing a solid drug formulation, wherein the device is deformable between a deployment shape for passage of the device through the urethra and a retention shape for preventing voiding of the device through the urethra, the retention shape having a maximum dimension in any dimension of 6 cm or less when in an uncompressed state and wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 3 cm, wherein the solid drug formulation is in the form of one or more solid drug units, and wherein the retention shape has two sub-circles, each having its own smaller arches and sharing a common larger arch.