Implantable drug delivery system having periodic drug delivery regimen to avoid granulomas

• US 9,180,282 B2
• Filed: 09/08/2009
• Issued: 11/10/2015
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: FLO, LLC
• Original Assignee: Flowonix Medical, Inc.
• Inventors: Adler, Steven C., Burke, Paul
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/555,257
• Publication Number:
  US 20100152713A1
• Time in Patent Office: 2,254 Days
• Field of Search: 604/890.1, 604/891.1, 604/506, 604/500, 604/892.1, 604/66, 607/3
• US Class Current: 1/1
• 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 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, the periodic flow regimen including a drug delivery cycle having at least 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, wherein the periodic flow regimen provides a prophylactic treatment for granuloma, wherein the one or more drug delivery treatment sites is the spinal canal and the drug chamber contains a morphine based drug formulation, the implantable drug delivery system further comprising;

a memory; and

a processor coupled to the memory and configured with processor-executable commands to perform operations comprising;

receiving a drug dosage input value corresponding to a total quantity of the drug to be dispensed over a treatment period, wherein the treatment period is longer than the period of the drug delivery cycle; and

based on the received drug dosage input value, determining values corresponding to the first period of no drug infusion and the second period of drug delivery in the drug delivery cycle so as to provide the total quantity of the drug being dispensed over the treatment period as specified by the received drug dosage input value, wherein the value corresponding to the period of no drug infusion is determined based on a timing of a dissipation of the therapeutic effect resulting from the delivery by a bolus or pulse of the drug and a time period of no drug infusion needed to avoid granulomas proximate to the target tissue.

2. The implantable drug delivery system of claim 1 wherein the flow regimen includes a drug delivery cycle having at least 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.

5. The implantable drug delivery system of claim 1, wherein the first period of no drug infusion in the drug delivery cycle is greater than 3.5 hours.

6. The implantable drug delivery system of claim 1, wherein the second period of drug delivery in the drug delivery cycle is between 1 minute and 24 minutes.

3. 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:

receiving, at a controller, a drug dosage input value corresponding to a total quantity of the drug to be dispensed over a treatment period, wherein the treatment period is longer than a period of a drug delivery cycle;

based on the received drug dosage input value, determining values corresponding to a first period of no drug infusion and a second period of drug delivery in the drug delivery cycle so as to provide the total quantity of the drug being dispensed over the treatment period as specified by the received drug dosage input value, wherein the value corresponding to the period of no drug infusion is determined based on a timing of a dissipation of the therapeutic effect resulting from the delivery by a bolus or pulse of the drug and a time period of no drug infusion needed to avoid granulomas proximate to the target tissue;

programming a drug delivery regime for automatic drug infusion into the internal controller, wherein the drug delivery regime includes a periodic drug dispensing schedule comprising the drug delivery cycle having at least the first period of no drug infusion and the second period of drug delivery by a bolus or pulse of the liquid, wherein the first period is at least five times longer than the second period, to provide a prophylactic treatment to avoid granulomas proximate to a target tissue;

positioning the delivery catheter to one or more drug delivery treatment sites in a target tissue in a mammalian patient, wherein the one or more drug delivery treatment sites is the spinal canal and the drug chamber contains a morphine based drug formulation;

executing by the internal 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.

4. The method of claim 3 wherein the drug delivery regime regimen includes a drug delivery cycle having at least 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.

7. The method of claim 3, wherein the first period of no drug infusion in the drug delivery cycle is greater than 3.5 hours.

8. The method of claim 3, wherein the second period of drug delivery in the drug delivery cycle is between 1 minute and 24 minutes.