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Implantable Drug Delivery Device and Methods of Treating Male Genitourinary and Surrounding Tissues

a drug delivery and implantable technology, applied in the field of medical devices, can solve the problems of not being popular or widespread in the treatment of most urologists, reducing the quantity of drugs to reach the desired site, and relatively high failure rate of systemic antibiotic administration

Inactive Publication Date: 2010-01-07
MASSACHUSETTS INST OF TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025]In one embodiment, an implantable drug delivery device is provided that includes a resorbable, elastic device body having at least one elongated sidewall, at least one drug reservoir defined therein, and at least one drug formulation in the drug reservoir. The device body may include a hydrophobic elastomeric polyester which degrades in vivo by surface erosion. The device body preferably provides controlled release of the drug in vivo. In a preferred embodiment, the implantable drug delivery device is dimensioned and has an elasticity suitable for deployment of the drug delivery device via urethral catheter or transrectal injection into and retention in a seminal vesicle, prostate, ejaculatory duct, or vas deferens in a patient. In one embodiment, the hydrophobic elastomeric polyester comprises or consists of a poly(glycerol-sebacic acid). In a preferred embodiment, the device body includes at least one aperture and provides controlled release of the drug in vivo by osmotic pressure.

Problems solved by technology

These systemic methods may produce undesirable side effects and may result in the metabolization of the drug by physiological processes, ultimately reducing the quantity of drug to reach the desired site.
Some have advocated direct injection of antibiotics to the prostate gland due to the relatively high failure rate of systemic antibiotic administration.
While local prostate antibiotic injection has shown reasonable efficacy in clinical trials, it has not yet become a popular or widespread therapy in use among most urologists.

Method used

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  • Implantable Drug Delivery Device and Methods of Treating Male Genitourinary and Surrounding Tissues
  • Implantable Drug Delivery Device and Methods of Treating Male Genitourinary and Surrounding Tissues
  • Implantable Drug Delivery Device and Methods of Treating Male Genitourinary and Surrounding Tissues

Examples

Experimental program
Comparison scheme
Effect test

example 1

Making a Drug Delivery Device

[0097]A prototype PGS module for in vitro development was constructed and tested for drug release kinetics with ciprofloxacin, a fluoroquinolone commonly prescribed for chronic prostatitis and other UTIs. The prototype module 900 is shown in FIG. 9. The prototype module 900 was rectangular in shape with an internal cylindrical core for housing a 300 μm diameter drug rod 902 and contained a single 100 μm release orifice 904. Modules were formed through melting of PGS pre-polymer within a wire-strung aluminum mold followed by a polymerization reaction under heat and vacuum for 48 hours. The PGS casting remained within the mold as a laser microablation process drilled orifices at select locations on the top surface of the casting, which projected down to the embedded 300 μm diameter longitudinal wires.

[0098]Wires were pulled out of the mold through the sides and the PGS casting was removed from the mold and cut into rectangular modules measuring 10 mm×1.5 m...

example 2

In vitro Release Kinetics of the Drug Delivery Device

[0100]For in vitro measurement of release kinetics, prototype PGS devices loaded with ciprofloxacin were made as described in Example 1, were mounted on the inside of a glass vial, and were immersed in 2 mL de-ionized water. Time point measurements of ciprofloxacin-HCl (CIP) concentration in the surrounding media were taken roughly every 12 hours over an 8-10 day period using a quantitative HPLC-UV detection method developed for CIP.

[0101]FIG. 10 illustrates the results of a representative CIP release experiment for two PGS modules having a 100 μm orifice and a control module without an orifice. The payload for each module is noted in μg. An induction time was observed before the onset of zero-order controlled release kinetics during which time water permeated into the devices and began to dissolve some of the drug payload. The two modules having 100 μm orifices were observed to release CIP at nearly the same rate after induction ...

example 3

Delivery of Lidocaine to the Vesicular Gland of Rabbit

[0111]A pilot in vivo experiment was conducted with a non-resorbable silicone device implanted in the vesicular gland of a rabbit (2.7 kg, New Zealand White, male). The drug used was lidocaine and total loading was 2 mg. This experiment was designed to simulate the situation when the device is implanted in a location other than the bladder, such as the seminal vesicle for men. The non-resorbable device for a rabbit experiment is shown in FIG. 13, and lidocaine plasma concentration over the time is shown in FIG. 14.

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Abstract

A method is provided for local controlled delivery of a drug to the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of a patient in need of treatment. In one embodiment, the method includes implanting a resorbable drug delivery device within the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of the patient. The drug delivery device may include an elastic device body housing at least one drug reservoir which contains at least one drug. In a preferred embodiment, the method further includes releasing the drug from the device in a controlled manner to, typically directly to, the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. application Ser. No. 11 / 463,956, filed Aug. 11, 2006, which claims benefit of U.S. Provisional Application No. 60 / 726,490, filed Oct. 12, 2005, and U.S. Provisional Application No. 60 / 707,676, filed Aug. 11, 2005, each of which is incorporated herein by reference. This application also claims benefit of U.S. Provisional Application No. 61 / 087,687, filed Aug. 9, 2008, which is incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]This invention is generally in the field of medical devices, and more particularly relates to implantable drug delivery devices for controlled release of drug locally to a tissue site.[0003]The efficacy of many drugs is directly related to the way in which they are administered. Various systemic methods of drug delivery include oral, intravenous, intramuscular, and transdermal. These systemic methods may produce undesirable side effects and may result ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61P43/00
CPCA61K9/0034A61L29/06A61M31/002A61L2300/00A61L31/16A61L31/14A61L31/06A61L29/14A61L29/16C08L83/04C08L67/00A61P43/00A61K9/0004A61L2300/21
Inventor TOBIAS, IRENE SOPHIELEE, HEEJINCIMA, MICHAEL J.DIMITRAKOV, JORDAN
Owner MASSACHUSETTS INST OF TECH
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