IMPLANTABLE DRUG DELIVERY SYSTEM HAVING PERIODIC DRUG DELIVERY REGIMEN TO AVOID GRANULOMAS

• US 20100152713A1
• Filed: 09/08/2009
• Published: 06/17/2010
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: FLO, LLC
• Original Assignee: Flowonix Medical, Inc.
• Inventors: Adler, Steven C., Burke, Paul
• Granted Patent: US 9,180,282 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

An implantable drug delivery system including: a biocompatible or bio-inert housing containing a drug infusion pump, a drug chamber from which a liquid drug is dispensed when the pump applies a force to the drug chamber, and an internal controller actuating the pump; a delivery catheter extending from the housing to one or more drug delivery treatment sites in a target tissue, wherein the catheter includes a lumen having an inlet to receive a drug pumped from the drug chamber and an outlet are positioned at the target tissue, wherein the drug flows through the outlet to the target tissue, and wherein the internal controller stores and executes an automatic periodic flow regimen which commands the pump and drug chamber to periodically dispense an intermittent bolus or pulse of the liquid drug, wherein the periodic flow regimen provides a prophylactic treatment for granuloma.

Claims

1. An implantable drug delivery system comprising:

a biocompatible or bio-inert housing containing a drug infusion pump, a drug chamber from which a liquid drug is dispensed when the pump applies a force to the drug chamber, and an internal controller actuating the pump;

a delivery catheter extending from the housing to one or more drug delivery treatment sites in a target tissue, wherein the catheter includes a lumen having an inlet to receive a drug pumped from the drug chamber and an outlet are positioned at the target tissue, wherein the drug flows through the outlet to the target tissue, and

wherein the internal controller stores and executes an automatic periodic flow regimen which commands the pump and drug chamber to periodically dispense an intermittent bolus or pulse of the liquid drug, wherein the periodic flow regimen provides a prophylactic treatment for granuloma.

2. The implantable drug delivery system of claim 1 wherein the treatment site is the spinal canal and the drug chamber contains a morphine based drug formulation.

3. The implantable drug delivery system of claim 1 wherein the flow regimen includes a drug delivery cycle having a first period of no drug infusion and a second period of drug delivery by the bolus or the pulse, wherein the first period is at least five times longer than the second period and no more than twenty times longer than the second period.

4. A method for automatically dispensing a drug from an implantable drug delivery system having a biocompatible or bio-inert housing containing a drug infusion pump, a drug chamber, and an internal controller actuating the pump, and a delivery catheter, the method comprising:

programming a drug delivery regime for automatic drug infusion into the controller, wherein the drug delivery regime includes a periodic drug dispensing schedule to provide a prophylactic treatment to avoid granulomas proximate to the target tissue;

positioning the delivery catheter to a target tissue in a mammalian patient;

executing by the controller the drug delivery regime to periodically actuate the drug infusion pump to periodically discharge a bolus or pulse of a liquid containing the drug from the drug chamber and into the delivery catheter, and

periodically and automatically delivering the bolus or pulse of the liquid containing the drug to the target tissue.

5. The method of claim 4 wherein the treatment site is the spinal canal and the drug chamber contains a morphine based drug formulation.

6. The method of claim 4 wherein the drug delivery regime regimen includes a drug delivery cycle having a first period of no drug infusion and a second period of drug delivery by the bolus or the pulse of the liquid, wherein the first period is at least five times longer than the second period and no more than twenty times longer than the second period.