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-11813432-B2
Application number	US-202117209919-A
Country	US
Kind code	B2
Filing date	Mar 23, 2021
Priority date	Oct 19, 2015
Publication date	Nov 14, 2023
Grant date	Nov 14, 2023

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 fail-safe termination of fluid flow through a fluid pathway, the method comprising:
providing an emergency deactivation unit including a barrier element comprising a hydrophobic material having a solid state at physiological temperature and a flowable state above physiological temperature, the barrier element comprising an opening extending therethrough for allowing fluid to pass through the barrier element, and the barrier element comprising a heating element positioned to increase a temperature of the barrier element when activated;
positioning the emergency deactivation unit within the fluid pathway;
enabling fluid to flow from one side of the barrier element, through the opening in the barrier element, to the other side of the barrier element; and
when fluid flow is to be terminated, increasing the temperature of the barrier element, causing the hydrophobic material of the barrier element to flow, whereby to close the opening in the barrier element and block fluid flow through the emergency deactivation unit.

2. The method according to claim 1 , wherein increasing the temperature of the barrier element comprises applying energy to the barrier element from outside of the emergency deactivation unit.

3. The method according to claim 1 , wherein increasing the temperature of the barrier element comprises applying a magnetic field to the barrier element.

4. The method according to claim 1 , wherein the heating element is activated when exposed to a magnetic field.

5. The method according to claim 1 , wherein the heating element is activated when external energy is applied thereto.

6. Apparatus for fail-safe termination of fluid flow through a fluid pathway, the apparatus comprising:
an emergency deactivation unit including a barrier element comprising a hydrophobic material having a solid state at physiological temperature and a flowable state above physiological temperature, the barrier element comprising an opening extending therethrough for allowing fluid to pass through the barrier element from a first side thereof to a second side thereof, and the barrier element comprising a heating element positioned to increase a temperature of the barrier element when activated;
wherein appropriately increasing the temperature of the barrier element causes the hydrophobic material of the barrier element to flow, whereby to close the opening in the barrier element and block fluid flow through the emergency deactivation unit.

7. The apparatus according to claim 6 , wherein appropriately increasing the temperature of the barrier element comprises applying a magnetic field to the barrier element.

8. The apparatus according to claim 6 , wherein the heating element is activated via a magnetic field.

9. The apparatus according to claim 6 , comprising a cover proximate the emergency deactivation unit and defining a hole therethrough for allowing fluid to pass through the cover, wherein a space is defined between the cover and the emergency deactivation unit to separate the emergency deactivation unit from a physiological environment.

10. The apparatus according to claim 6 , wherein the barrier element is biocompatible.

11. A method for manufacturing apparatus for fail-safe termination of fluid flow through a fluid pathway, the method comprising:
providing a substrate comprising a first hydrophobic material having a solid state at physiological temperature and a flowable state above physiological temperature;
positioning a heating element on the substrate;
positioning, atop the substrate and the heating element, a cover comprising a second hydrophobic material having a solid state at physiological temperature and a flowable state above physiological temperature; and
adhering the cover to the substrate and forming an opening through the cover and the substrate adjacent to the heating element, such that the opening through the substrate is closable in response to activation of the heating element.

12. The method according to claim 11 , wherein the first hydrophobic material and the second hydrophobic material both comprise polycaprolactone.

13. The method according to claim 11 , wherein the heating element comprises a magnetic heating element adapted to increase in temperature when exposed to a magnetic field.

14. The method according to claim 13 , wherein the magnetic heating element comprises a ferromagnetic mesh.

15. The method according to claim 11 , wherein the opening is defined through the cover and the substrate to allow fluid to flow therethrough before activation of the heating element.

16. The method according to claim 11 , wherein the heating element comprises a mesh aligned with and extending across the opening through the substrate.

17. The method according to claim 11 , wherein the heating element is biocompatible.

Assignees

• Methodist Hospital

Inventors

• Farina Marco
• Hood Robert Lyle
• Grattoni Alessandro

Classifications

• A61M5/16881 Primary

  Regulating valves (on-off valves, e.g. clamps A61M39/28) · CPC title

• A61K9/0009

  involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis · CPC title

• A61K9/0024

  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 title

• A61K47/02

  Inorganic compounds · CPC title

• A61K47/34

  Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) · CPC title