IMPLANTABLE DRUG-DELIVERY DEVICES, AND APPARATUS AND METHODS FOR REFILLING THE DEVICES

• US 20090192493A1
• Filed: 01/02/2009
• Published: 07/30/2009
• Est. Priority Date: 01/03/2008
• Status: Abandoned Application

• Current Assignee: University of Southern California
• Original Assignee: University of Southern California
• Inventors: Saati, Saloomeh, Meng, Ellis, Humayun, Mark, Lo, Ronalee, Li, Po-Ying
• Application Number:
  US12/348,178
• Publication Number:
  US 20090192493A1
• Time in Patent Office: Days
• US Class Current: 604/513
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2005/14284 with needle insertion means
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

In various embodiments, a needle is employed in refilling drug-delivery devices.

Claims

1. A needle for refilling an implantable drug-delivery device having a needle entry port that comprises a throat for receiving the needle therethrough, the needle comprising:

a hollow shaft terminating in a tip;

a fluid exit port along the shaft proximate to the tip; and

means for limiting an extent of entry of the needle into the entry port.

2. The needle of claim 1, wherein the limitation means comprises a stop on the shaft.

3. The needle of claim 2, wherein the stop is a ring surrounding and fixedly mounted to the shaft, the ring having an outer diameter exceeding a width of the throat.

4. The needle of claim 2, wherein the stop is spherically-shaped, cylindrically-shaped, rectangularly-shaped, or pyramidally-shaped.

5. The needle of claim 1, wherein the limitation means is constructed of a biocompatible material.

6. The needle of claim 1, wherein the limitation means is constructed of at least one of a metal, a plastic, or a composite material.

7. The needle of claim 1, wherein the limitation means is constructed of a material selected from the group consisting of PDMS, polyimide, polypropylene, PEEK, polycarbonate, an acetyl film, polyoxymethylene plastic, gold, stainless steel, nickel, and chrome.

8. The needle of claim 1, wherein the tip is conically-shaped.

9. The needle of claim 1, wherein the fluid exit port is positioned intermediate to the tip and the limitation means.

10. An implantable drug-delivery device, comprising:

a drug reservoir;

a needle entry port comprising a throat for receiving a refill needle therethrough; and

a vestibule into which the throat opens, the vestibule (i) being wider than the throat, (ii) comprising a stop on a wall opposite the throat for halting progress of a needle into the vestibule through the throat, and (iii) being in fluid communication with the drug reservoir.

11. The implantable drug-delivery device of claim 10, wherein the stop is sized so as to halt the progress of a needle comprising an exit port at a point at which the exit port is in fluid communication with the vestibule.

12. The implantable drug-delivery device of claim 10, wherein a top surface of the stop is cup-shaped.

13. The implantable drug-delivery device of claim 10, wherein the stop is constructed of a biocompatible material.

14. The implantable drug-delivery device of claim 10, wherein the stop is constructed of at least one of a metal, a plastic, or a composite material.

15. The implantable drug-delivery device of claim 10, wherein the stop is constructed of a material selected from the group consisting of PDMS, polyimide, polypropylene, PEEK, polycarbonate, an acetyl film, polyoxymethylene plastic, gold, stainless steel, nickel, and chrome.

16. The implantable drug-delivery device of claim 10 further comprising a check valve located between the vestibule and the drug reservoir.

17. The implantable drug-delivery device of claim 10, wherein the needle entry port further comprises a self-sealing material.

18. An implantable drug-delivery device, comprising:

a drug reservoir;

a needle entry port comprising a throat for receiving a refill needle therethrough, the throat opening into a vestibule that is in fluid communication with the drug reservoir; and

a visualization ring surrounding the needle entry port, the visualization ring being visible through ocular tissue so as to visually indicate a position of the needle entry port.

19. The implantable drug-delivery device of claim 18, wherein the visualization ring is constructed of a biocompatible material.

20. The implantable drug-delivery device of claim 18, wherein the visualization ring is constructed of a material that withstands penetration by the refill needle.

21. The implantable drug-delivery device of claim 18, wherein the visualization ring is visible through a patient'"'"'s conjunctiva.

22. The implantable drug-delivery device of claim 18, wherein the visualization ring comprises a fluorescent pigment.

23. The implantable drug-delivery device of claim 22, wherein the fluorescent pigment is selected from the group consisting of a luminescent aerogel, a nanoparticle, a phthalocyanine pigment, fluorescein isothiocyanate, rhodamine, coumarin, cyanine, an Alexa Fluor, a DyLight Fluor, a quantum dot, a green fluorescent protein, and a luciferin.

24. The implantable drug-delivery device of claim 18, wherein the visualization ring comprises a light emitting diode.

25. The implantable drug-delivery device of claim 18 further comprising a light emitting diode and optical fiber for conducting light from the light emitting diode to and around the visualization ring.

26. The implantable drug-delivery device of claim 18, wherein the visualization ring comprises a material that enhances surface echogenicity and acoustic shadowing.

27. The implantable drug-delivery device of claim 18 further comprising electronics to move or vibrate the visualization ring.

28. The implantable drug-delivery device of claim 18, wherein the visualization ring comprises a magnetic material.

29. A method for refilling a drug-delivery device implanted within a patient, comprising:

inserting, into a needle entry port of the drug-delivery device, a distal tip of a needle that comprises a hollow shaft and a stop on the shaft;

advancing the needle into the needle entry port until the stop limits further entry of the needle into the entry port; and

delivering drug through the hollow shaft of the needle, out a fluid exit port positioned along the shaft of the needle proximate the tip, and into the drug-delivery device.

30. The method of claim 29, wherein the stop is a ring surrounding the shaft of the needle, the ring having an outer diameter exceeding a width of the entry port.

31. The method of claim 29 further comprising locating, prior to inserting the distal tip of the needle into the needle entry port, a visualization ring visually indicating the position of the needle entry port.

32. The method of claim 31, wherein the visualization ring surrounds the needle entry port and is visible through the patient'"'"'s conjunctiva.

33. A method for refilling a drug-delivery device implanted within a patient, comprising:

inserting, into a needle entry port of the drug-delivery device, a distal tip of a needle;

advancing the needle through the needle entry port into a vestibule of the drug-delivery device until a stop positioned on a wall of the vestibule opposite the needle entry port halts further entry of the needle; and

delivering drug through a hollow shaft of the needle, out a fluid exit port positioned along the shaft of the needle proximate the tip, and into the vestibule.

34. The method of claim 33, wherein the stop halts further entry of the needle at a point at which the exit port of the needle is in fluid communication with the vestibule.

35. The method of claim 33 further comprising locating, prior to inserting the distal tip of the needle into the needle entry port, a visualization ring visually indicating the position of the needle entry port.

36. The method of claim 35, wherein the visualization ring surrounds the needle entry port and is visible through the patient'"'"'s conjunctiva.