US 2026/0166288 A1 · Drug Delivery Device with Intravesical Tolerability

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.

Claims19

Dependent claims

An intravesical drug delivery system comprising:

a silicone body which comprises a drug reservoir lumen and a retention frame lumen, wherein the drug reservoir lumen includes a first sealed end and an opposed second sealed end, and a release aperture;
a plurality of mini-tablets disposed in the drug reservoir lumen, wherein at least some of the mini-tablets comprise at least 75% by weight of a drug which comprises gemcitabine or a salt form thereof, with the remainder of the weight of the at least some of the mini-tablets being one or more excipients;
and
a retention frame disposed in the retention frame lumen, wherein the retention frame comprises a nitinol wire,
wherein the drug delivery system is deformable between a deployment shape for passage of the drug delivery system through a patient's urethra, and a retention shape having dimensions that provide intravesical mobility of the drug delivery system and that are configured to prevent voiding of the system through the urethra, and
wherein the drug delivery system has dimensions, buoyancy, or both, that are configured to preclude the drug delivery system from entering ureter orifices of the patient.

3 more elements

Dependencies are inferred from the claim text.

Drug Delivery Device with Intravesical Tolerability

Life of this patent

Drug Delivery Device with Intravesical Tolerability

Life of this patent

Abstract

Claims19