Method and apparatus for the fail-safe termination of in vivo drug delivery from an implantable drug delivery system

Patent metadata

Field	Value
Publication number	US-10953154-B2
Application number	US-201615769401-A
Country	US
Kind code	B2
Filing date	Oct 19, 2016
Priority date	Oct 19, 2015
Publication date	Mar 23, 2021
Grant date	Mar 23, 2021

Abstract

A method for the fail-safe termination of in vivo drug delivery from an implantable drug delivery system, the method comprising: providing an implantable drug delivery system comprising: a housing having a reservoir for containing a drug, and a port for dispensing the drug to a patient; and an emergency deactivation unit disposed between the reservoir and the port, the emergency deactivation unit comprising a composite structure comprising a biocompatible ferromagnetic mesh open to fluid flow and a hydrophobic meltable material, the hydrophobic meltable material comprising at least one hole therein for enabling a fluid to pass through the hydrophobic meltable material; implanting the implantable drug delivery system within a patient; enabling the drug to flow from the reservoir, through the at least one hole in the hydrophobic meltable material and out the port; and when drug flow is to be terminated, applying a magnetic field to the composite structure, such that a current is induced in the ferromagnetic mesh which heats the ferromagnetic mesh and melts the hydrophobic meltable material, thereby closing the at least one hole in the hydrophobic meltable material and blocking drug delivery to the patient.

First claim

What is claimed is:

1. A method for a fail-safe termination of in vivo drug delivery from an implantable drug delivery system, the method comprising:
providing an implantable drug delivery system comprising:
a housing having a reservoir for containing a drug, and a port for dispensing the drug to a patient; and
an emergency deactivation unit disposed between the reservoir and the port, the emergency deactivation unit comprising a composite structure comprising a biocompatible ferromagnetic mesh open to fluid flow and a hydrophobic meltable material, the hydrophobic meltable material comprising at least one hole therein for enabling a fluid to pass through the hydrophobic meltable material;

implanting the implantable drug delivery system within a patient;
enabling the drug to flow from the reservoir, through the at least one hole in the hydrophobic meltable material and out the port; and
when drug flow is to be terminated, applying a magnetic field to the composite structure, such that a current is induced in the ferromagnetic mesh which heats the ferromagnetic mesh and melts the hydrophobic meltable material, thereby closing the at least one hole in the hydrophobic meltable material and blocking drug delivery to the patient.

2. A method according to claim 1 wherein the ferromagnetic mesh comprises stainless steel.

3. A method according to claim 1 wherein the ferromagnetic mesh has a size of approximately 10×10 mm, a thickness of approximately 150 μm, and openings having a diameter of approximately 300 μm.

4. A method according to claim 1 wherein the hydrophobic meltable material comprises polycaprolactone (PCL).

5. A method according to claim 1 wherein the hydrophobic meltable material is solid at physiological temperature and melts at approximately 5 degrees above physiological temperature.

6. A method according to claim 1 wherein the ferromagnetic mesh is sandwiched within the hydrophobic meltable material.

7. Apparatus for a fail-safe termination of in vivo drug delivery from an implantable drug delivery system, the apparatus comprising:
an implantable drug delivery system comprising:
a housing having a reservoir for containing a drug, and a port for dispensing the drug to a patient; and
an emergency deactivation unit disposed between the reservoir and the port, the emergency deactivation unit comprising a composite structure comprising a biocompatible ferromagnetic mesh open to fluid flow and a hydrophobic meltable material, the hydrophobic meltable material comprising at least one hole therein for enabling a fluid to pass through the hydrophobic meltable material;
wherein, when an appropriate magnetic field is applied to the composite structure, a current is induced in the ferromagnetic mesh which heats the ferromagnetic mesh and melts the hydrophobic meltable material, thereby closing the at least one hole in the hydrophobic meltable material and blocking drug delivery to the patient.

8. Apparatus according to claim 7 wherein the ferromagnetic mesh comprises stainless steel.

9. Apparatus according to claim 7 wherein the ferromagnetic mesh has a size of approximately 10×10 mm, a thickness of approximately 150 μm, and openings having a diameter of approximately 300 μm.

10. Apparatus according to claim 7 wherein the hydrophobic meltable material comprises polycaprolactone (PCL).

11. Apparatus according to claim 7 wherein the hydrophobic meltable material is solid at physiological temperature and melts at approximately 5 degrees above physiological temperature.

12. Apparatus according to claim 7 wherein the ferromagnetic mesh is sandwiched within the hydrophobic meltable material.

13. A method for a fail-safe termination of fluid flow through a fluid pathway, the method comprising:
providing an emergency deactivation unit comprising a composite structure comprising a biocompatible ferromagnetic mesh open to fluid flow and a hydrophobic meltable material, the hydrophobic meltable material comprising at least one hole therein for enabling a fluid to pass through the hydrophobic meltable material;
positioning the emergency deactivation unit within a fluid pathway;
enabling fluid to flow from one side of the emergency deactivation unit, through the at least one hole in the hydrophobic meltable material, to the other side of the emergency deactivation unit; and
when fluid flow is to be terminated, applying a magnetic field to the composite structure, such that a current is induced in the ferromagnetic mesh which heats the ferromagnetic mesh and melts the hydrophobic meltable material, thereby closing the at least one hole in the hydrophobic meltable material and blocking fluid flow through the emergency deactivation unit.

14. A method according to claim 13 wherein the ferromagnetic mesh comprises stainless steel.

15. A method according to claim 13 wherein the ferromagnetic mesh has a size of approximately 10×10 mm, a thickness of approximately 150 μm, and openings having a diameter of approximately 300 μm.

16. A method according to claim 13 wherein the hydrophobic meltable material comprises polycaprolactone (PCL).

17. A method according to claim 13 wherein the hydrophobic meltable material is solid at physiological temperature and melts at approximately 5 degrees above physiological temperature.

18. A method according to claim 13 wherein the ferromagnetic mesh is sandwiched within the hydrophobic meltable material.

19. Apparatus for a fail-safe termination of fluid flow through a fluid pathway, the apparatus comprising:
an emergency deactivation unit comprising a composite structure comprising a biocompatible ferromagnetic mesh open to fluid flow and a hydrophobic meltable material, the hydrophobic meltable material comprising at least one hole therein for enabling a fluid to pass through the hydrophobic meltable material;
wherein, when an appropriate magnetic field is applied to the composite structure, a current is induced in the ferromagnetic mesh which heats the ferromagnetic mesh and melts the hydrophobic meltable material, thereby closing the at least one hole in the hydrophobic meltable material and blocking fluid flow through the emergency deactivation unit.

20. Apparatus according to claim 19 wherein the ferromagnetic mesh comprises stainless steel.

21. Apparatus according to claim 19 wherein the ferromagnetic mesh has a size of approximately 10×10 mm, a thickness of approximately 150 μm, and openings having a diameter of approximately 300 μm.

22. Apparatus according to claim 19 wherein the hydrophobic meltable material comprises polycaprolactone (PCL).

23. Apparatus according to claim 19 wherein the hydrophobic meltable material is solid at physiological temperature and melts at approximately 5 degrees above physiological temperature.

24. Apparatus according to claim 19 wherein the ferromagnetic mesh is sandwiched within the hydrophobic meltable material.

25. A method for a fail-safe termination of in vivo drug delivery from an implantable drug delivery system, the method comprising:
providing an implantable drug delivery system comprising:
a housing having a reservoir for containing a drug, and a port for dispensing the drug to a patient; and
an emergency deactivation unit disposed between the reservoir and the port, the emergency deactivation unit comprising:
a barrier element comprising hydrophobic material having a solid state at physiological temperature and a flowable

Assignees

• Methodist Hospital

Inventors

• Farina Marco
• Hood Robert Lyle
• Grattoni Alessandro

Classifications

• F16K99/003 Primary

  Valves for single use only · CPC title

• F16K13/10

  by means of liquid or granular medium · CPC title

• F16K2099/0088

  Implanted devices · CPC title

• F16K99/0044

  using thermo-electric means · CPC title

• A61M5/14

  Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor · CPC title