Recirculating implantable drug delivery system

• US 6,198,966 B1
• Filed: 02/26/1999
• Issued: 03/06/2001
• Est. Priority Date: 02/26/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Hayes, Michael J.
• Application Number:
  US09/258,527
• Time in Patent Office: 739 Days
• Field of Search: 604/19, 604/20, 604/21, 604/30, 604/501, 604/503, 604/508, 604/65-67, 604/82-85, 604/186, 604/246, 604/257, 604/890--89
• US Class Current: 604/20
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• 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
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

A drug delivery system recirculate carrier fluid in closed-loop fashion, thereby requiring only a relatively small amount of carrier fluid for operation. A pump provides continuous flow of carrier fluid to a delivery interface in a recirculating path. A metering device, which may be either passive or active, dispenses drug from a reservoir into the carrier fluid in the recirculating path and maintains a constant concentration of drug at the delivery interface, which may comprise a semipermeable membrane. The recirculating path is preferably in the form of a dual-lumen catheter which provides a supply leg to a delivery interface and a return leg from the drug delivery interface to the pump. Drug concentration sensors may be provided to measure the concentration of drug in the recirculating path or in the human body and to actively adjust the metering device accordingly.

Claims

1. A system for delivering drug therapy to a living body, comprising:

a) a drug reservoir for containing a supply of drug;

b) a recirculating closed loop carrier path including a carrier fluid contained therein, the recirculating carrier path connected to the drug reservoir;

c) a metering device for introducing drug from the drug reservoir into the carrier fluid to substantially maintain a predetermined concentration of drug in the carrier fluid, the metering device operatively connected to the drug reservoir; and

d) a delivery interface located on the recirculating carrier path for permitting controlled passage of the drug from the carrier fluid to the human body.

2. The system of claim 1, wherein the metering device comprises a passive metering device.

3. The system of claim 1, wherein the metering device comprises an active metering device.

4. The system of claim 1, wherein the recirculating carrier path includes a dual-lumen catheter having a supply leg and a return leg, and a pump in fluid communication with the dual-lumen catheter to pump the carrier fluid from the return leg to the supply leg.

5. The system of claim 1, wherein the drug is provided in powder form.

6. The system of claim 1, wherein the metering device further comprises at least one sensor for sensing the concentration of drug in the carrier fluid.

7. The system of claim 1, wherein the metering device further comprises a sensor for sensing the concentration of drug in the living body.

8. The system of claim 1, wherein the delivery interface comprises a semi-permeable membrane adapted to permit migration of drug into the living body while preventing a net migration of the carrier fluid out of the recirculating path.

9. The system of claim 1, wherein the delivery interface comprises an iontophoretic system for creating an electric field to assist in the migration of drug from the recirculating path into the living body.

10. A method of delivering a beneficial agent to a living body, the method comprising the steps of:

a) providing a recirculating closed-loop path of carrier fluid;

b) providing a drug delivery interface in communication with the carrier fluid; and

c) metering drug into the carrier fluid in the recirculating closed-loop path.

11. The method of claim 10, further comprising the step of substantially maintaining a predetermined concentration of drug in the carrier fluid at the delivery interface.

12. The method of claim 10, wherein the step of metering drug further comprises the step of actively metering drug.

13. The method of claim 10, wherein the step of metering drug further comprises the step of passively metering drug.

14. The method of claim 10, wherein the step of metering drug further comprises the step of sensing the concentration of drug in the recirculating path.

15. A system for delivering drug therapy to a living body, comprising:

a) a drug reservoir for containing a supply of drug;

b) a recirculating closed-loop carrier path including a dual-lumen catheter having a supply leg and a return leg and carrier fluid contained therein, the recirculating carrier path connected to the drug reservoir;

c) a metering device operatively connected to the drug reservoir for introducing drug from the drug reservoir into the carrier fluid to substantially maintain a predetermined concentration of drug in the carrier fluid, the metering device including at least one sensor for sensing the concentration of drug in the carrier fluid;

d) a delivery interface located on the recirculating carrier path for permitting controlled passage of the drug from the carrier fluid to the human body, including a semi-permeable membrane adapted to permit migration of drug into the living body while preventing a net migration of the carrier fluid out of the recirculating path; and

e) a pump in fluid communication with the dual-lumen catheter to pump the carrier fluid from the return leg to the supply leg.

16. A method of delivering a beneficial agent to a living body, the method comprising the steps of:

a) providing a recirculating closed-loop path of carrier fluid;

b) providing a drug delivery interface in communication with the carrier fluid; and

c) actively metering drug into the carrier fluid in the recirculating closed-loop path by sensing the concentration of drug in the recirculating path to substantially maintain a predetermined concentration of drug in the carrier fluid at the delivery interface.

17. A method of delivering a beneficial agent to a living body, the method comprising the steps of:

a) providing a recirculating closed-loop path of carrier fluid;

b) providing a drug delivery interface in communication with the carrier fluid; and

c) passively metering drug into the carrier fluid in the recirculating closed-loop path to substantially maintain a predetermined concentration of drug in the carrier fluid at the delivery interface.