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

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.

1 . A method for local delivery of a drug to the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of a patient in need of treatment, comprising:
 implanting a resorbable drug delivery device within the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of the patient, wherein the drug delivery device comprises an elastic device body housing at least one drug reservoir which contains at least one drug; and   permitting the drug to be released from the device in a controlled manner to the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens.   
   
   
       2 . The method of  claim 1 , wherein the step of implanting the resorbable drug delivery device comprises placement of a catheter and in the urethra followed by cystoscopic deployment of the drug delivery device through the catheter. 
   
   
       3 . The method of  claim 1 , wherein the step of implanting the resorbable drug delivery device comprises transrectal injection. 
   
   
       4 . The method of  claim 1 , wherein the step of implanting the drug delivery device further comprises imaging and positioning of the drug delivery device by transrectal ultrasonography. 
   
   
       5 . The method of  claim 1 , wherein the patient presents with chronic prostatitis, vesiculitis, post-prostatectomy complications, or a cancer involving the prostate gland, bladder, or rectum. 
   
   
       6 . The method of  claim 1 , wherein the device body comprises an elastomeric poly(glycerol-sebacic acid). 
   
   
       7 . The method of  claim 1 , wherein the release of the drug in vivo is osmotically driven for at least a portion of the drug released. 
   
   
       8 . The method of  claim 1 , wherein following release of substantially all of the drug, the device body degrades by surface erosion into biocompatible monomers. 
   
   
       9 . A method for local delivery of a drug to a genitourinary tissue site of a patient in need of treatment, comprising:
 implanting a resorbable drug delivery device within a genitourinary site of the patient, wherein the drug delivery device comprises an elastic device body housing at least one drug reservoir which contains at least one drug; and   permitting the drug to be released from the device in a controlled manner to the genitourinary site,   wherein the step of implantation comprises insertion of the device through a bore of a hollow needle or cannula.   
   
   
       10 . A method for local delivery of a drug to a genitourinary site of a patient in need of treatment, comprising:
 implanting a resorbable drug delivery device within a non-lumenal genitourinary tissue site of the patient, wherein the drug delivery device comprises an elastic device body housing at least one drug reservoir which contains at least one drug; and   permitting the drug to be released from the device in a controlled manner to the genitourinary tissue site.   
   
   
       11 . An implantable medical device comprising:
 a resorbable, elastic device body having at least one elongated sidewall and at least one payload reservoir defined therein; and   a payload stored in the payload reservoir,   wherein the device body provides controlled release of the payload in vivo and   wherein the implantable medical device is dimensioned and has an elasticity suitable for deployment of the medical device via urethral catheter or transrectal injection into and retention in a genitourinary site in a patient.   
   
   
       12 . The device of  claim 1 , wherein the device is dimensioned and has an elasticity suitable for deployment into and retention in a seminal vesicle, ejaculatory duct, prostate, or vas deferens in a patient. 
   
   
       13 . The device of  claim 11 , wherein the resorbable, elastic device body comprises an elastomeric polymer. 
   
   
       14 . The device of  claim 13 , wherein the elastomeric polymer is a hydrophobic elastomeric polyester. 
   
   
       15 . The device of  claim 14 , wherein the hydrophobic elastomeric polyester is a poly(glycerol-sebacic acid). 
   
   
       16 . The device of  claim 13 , wherein the elastomeric polymer comprises a poly(caprolactone), a polyanhydride, an amino alcohol-based poly(ester amide), or a poly(octane-diol citrate). 
   
   
       17 . The device of  claim 11 , wherein the device body provides controlled release of the payload in vivo by osmotic pressure, diffusion, surface erosion, or a combination thereof. 
   
   
       18 . The device of  claim 11 , wherein the device body comprises one or more apertures. 
   
   
       19 . The device of  claim 18 , wherein the sidewalls are selectively permeable to water and impermeable to the payload. 
   
   
       20 . The device of  claim 19 , wherein release of the payload from the device in vivo is osmotically driven. 
   
   
       21 . The device of  claim 20 , wherein the diameter of each of the one or more apertures is between about 20 and about 300 μm. 
   
   
       22 . The device of  claim 18 , further comprising a degradable membrane in register with at least one of the one or more apertures, wherein degradation of the membrane in vivo occurs more quickly than degradation of the device body in vivo. 
   
   
       23 . The device of  claim 11 , wherein release of the payload from the device in vivo occurs by diffusion through one or more apertures in the device body, the sidewall of the device body, or a combination thereof. 
   
   
       24 . The device of  claim 11 , wherein release of the payload from the device in vivo occurs by surface erosion of the device body, wherein the device body comprises a matrix material having at least one drug. 
   
   
       25 . The device of  claim 11 , wherein the payload comprises at least one drug. 
   
   
       26 . The device of  claim 25 , wherein the drug comprises an antibiotic agent, an immunosuppressant, an anti-inflammatory agent, a chemotherapeutic agent, a local anesthetic, or a combination thereof. 
   
   
       27 . The device of  claim 25 , wherein the drug in the payload reservoir is in a solid or semi-solid form. 
   
   
       28 . The device of  claim 11 , wherein the device is sized and shaped to fit into a 14 to 18 gauge transrectal needle. 
   
   
       29 . The device of  claim 11 , wherein the device is sized and shaped to fit into a 16 to 18 French urethral catheter. 
   
   
       30 . The device of  claim 11 , wherein the device is configured to be passed through a catheter and is capable of being urged through the catheter by a stylet. 
   
   
       31 . The device of  claim 11 , wherein the device body has an outer diameter between about 0.6 mm and about 3 mm. 
   
   
       32 . The device of  claim 11 , wherein the device body has a length between about 1 cm and about 7 cm. 
   
   
       33 . The device of  claim 11 , wherein the sidewalls have a thickness between about 100 μm and about 600 μm. 
   
   
       34 . The device of  claim 11 , wherein the device body comprises two or more discrete payload reservoirs, which are defined by the sidewalls and at least one partition. 
   
   
       35 . An implantable drug delivery device comprising:
 a resorbable, elastic device body having at least one elongated sidewall and at least one drug reservoir defined therein, wherein the device body comprises a hydrophobic elastomeric polyester which degrades in vivo by surface erosion; and   at least one drug formulation in the drug reservoir, wherein the device body provides controlled release of the drug in vivo,   wherein 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.   
   
   
       36 . The device of  claim 35 , wherein the hydrophobic elastomeric polyester is a poly(glycerol-sebacic acid). 
   
   
       37 . The device of  claim 35 , wherein the device body comprises at least one aperture and provides controlled release of the drug in vivo by osmotic pressure. 
   
   
       38 . An osmotic pump device comprising:
 a housing made of a bioresorbable elastomer and having at least one aperture; and   a drug contained in the housing,   wherein the pump device is configured to dispense the drug in vivo, driven by osmotic pressure, through the at least one aperture.   
   
   
       39 . The osmotic pump device of  claim 38 , wherein the bioresorbable elastomer comprises a poly(glycerol-sebacic acid). 
   
   
       40 . The osmotic pump device of  claim 38 , which is dimensioned and has an elasticity suitable for deployment into and retention in a seminal vesicle, prostate, ejaculatory duct, or vas deferens in a patient. 
   
   
       41 . A method of making an implantable drug delivery device comprising:
 providing a pre-polymer for forming a biocompatible, resorbable elastomer;   extruding or molding the pre-polymer into a device body having an elongated shape which comprises a first end, an opposed second end, at least one sidewall between the first and second ends and a hollow bore defined by the at least one sidewall;   polymerizing the pre-polymer to produce a cross-linked elastomeric polymer;   loading a drug formulation into the hollow bore; and   closing off the hollow bore at positions to contain the drug formulation therein to form an implantable drug delivery device, which is dimensioned and has an elasticity suitable for deployment of the drug delivery device via urethral catheterization or transrectal injection into and retention in a genitourinary site in a patient.