Osmotic drug delivery monitoring system and method

• US 6,283,953 B1
• Filed: 12/22/1998
• Issued: 09/04/2001
• Est. Priority Date: 12/31/1997
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Berry, Stephen A., Stewart, Gregory R., Jordan, Scott D., Eckenhoff, James B., Ayer, Rupal
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/217,822
• Time in Patent Office: 987 Days
• Field of Search: 604/20, 604/21, 604/890.1, 604/891.1, 604/892.2, 604/131, 424/422, 424/423, 424/424
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2250/00 Specially adapted for animals
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• 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 5/1424 Manually operated pumps
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion

Abstract

Performance of delivery systems for delivering beneficial agents to an animal are monitored to determine the delivery rate of the beneficial agent and the proper operation of the beneficial agent delivery device. Performance monitoring can be achieved by monitoring the physical configuration of the implanted osmotic delivery device from the exterior of the body to determine the amount of beneficial agent delivered and/or the delivery rate of the beneficial agent. The monitoring of the physical configuration of the implanted osmotic delivery device may be performed in different manners such as by X-ray or fluoroscopic monitoring of the implant structure or magnetic determination of a piston location within the implant. Performance monitoring can also be achieved by use of a performance marker within the beneficial agent to produce a specifically detectable response which can be measured noninvasively in body fluids or by-products.

Claims

1. An osmotic delivery device for delivery of a beneficial agent to an animal comprising:

an implantable reservoir having at least one opening for delivering a beneficial agent contained within an interior of the reservoir to an organ of an animal;

an osmotic engine adapted to cause the release of the beneficial agent contained within the reservoir to the animal; and

means for noninvasively measuring the release of the beneficial agent from the reservoir from outside of tissue in which the delivery device is implanted.

2. The osmotic delivery device of claim 1, wherein the means for noninvasively measuring the release of the beneficial agent from the reservoir includes a first radiopaque marker on a portion of the reservoir and a second radiopaque marker on a movable piston positioned within the reservoir and separating the beneficial agent from the osmotic engine.

3. The osmotic delivery device of claim 2, wherein the implantable reservoir includes at least one passage allowing liquid to pass into the osmotic engine to cause the osmotic engine to swell and move the movable piston within the reservoir.

4. The osmotic delivery device of claim 1, wherein the means for noninvasively measuring the release of the beneficial agent from the reservoir includes a magnetic piston positioned within the implantable reservoir between the osmotic engine and the beneficial agent and a gauge for determining the position of the magnetic piston from an exterior of the animal.

5. The osmotic delivery device of claim 4, wherein the gauge for determining the position of the magnetic piston includes a movable magnetic member.

6. The osmotic delivery device of claim 5, wherein the implantable reservoir includes means for aligning the gauge with the reservoir.

7. The osmotic de livery device of claim 4, wherein the magnetic piston includes magnetic particles in a piston lubricant.

8. The osmotic delivery device of claim 1, wherein the means for noninvasively measuring the release of the beneficial agent from the reservoir includes a marker incorporated in the beneficial agent, the marker providing a detectable response which can be measured noninvasively in body fluids or by-products to monitor release of the beneficial agent.

9. The osmotic delivery device of claim 8, wherein the marker is an azo dye which can be detected in patient fluid samples.

10. The osmotic delivery device of claim 9, wherein the azo dye is visually detected in the fluid samples.

11. The osmotic delivery device of claim 9, wherein the azo dye is detectable in the fluid samples by diagnostic reaction.

12. The osmotic delivery device of claim 8, wherein the marker is a peptide or protein which gives specific reagent responses.

13. The osmotic delivery device of claim 8, wherein the marker is a compound which is vaporized and detectable in expelled breath.

14. The osmotic delivery device of claim 8, wherein the marker is a metabolite of the beneficial agent, the metabolite producing measurable responses.

15. The osmotic delivery device of claim 8, wherein the marker is measurable in tissue by the use of an external light source.

16. A method of monitoring performance of an osmotic drug delivery system comprising:

implanting an osmotic drug delivery device having a movable piston in an animal; and

determining a position of the implanted movable piston within the osmotic drug delivery device from an exterior of the animal.

17. The method of monitoring performance of the osmotic drug delivery system according to claim 16, wherein the position of the movable piston is determined by fluoroscopy.

18. The method of monitoring performance of the osmotic drug delivery system according to claim 16, wherein the position of the movable piston is determined by X-ray.

19. The method of monitoring performance of the osmotic drug delivery system according to claim 16, wherein the position of the movable piston is determined by a magnetic gauge.