Ocular implantation device

• US 9,849,027 B2
• Filed: 11/07/2008
• Issued: 12/26/2017
• Est. Priority Date: 11/08/2007
• Status: Active Grant

• Current Assignee: Alimera Sciences, Inc.
• Original Assignee: Alimera Sciences, Inc.
• Inventors: Highley, Brian, Beeson, Morgan, Jackson, Randy, Wayman, Christopher Edward, Shetler, Lance, Cutino, Antonio, Wright, Michael Thomas
• Primary Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US12/266,699
• Publication Number:
  US 20090281520A1
• Time in Patent Office: 3,336 Days
• Field of Search: 604506, 604521, 604 60, 604 64, 604 57, 604234
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

An ocular implantation device comprises a housing having a longitudinal axis, a needle configured to receive an implant, and a plunger and a rod operatively coupled together. The plunger and the rod are disposed in the housing and are collectively, translationally moveable along the longitudinal axis of the housing. The rod is configured to be receivable within at least a portion of the needle to enable the rod to move the implant therethrough. An actuator is operatively engaged with the plunger such that movement of the actuator in a direction aligned with the longitudinal axis of the housing results in the translational movement of the plunger and the rod along the longitudinal axis of the housing in order to deliver the implant through the needle to a target site. An alternative embodiment of an ocular implantation device uses a retractable needle to deliver an implant.

Claims

1. An ocular implantation device comprising:

(a) a housing having a longitudinal axis;

(b) a needle extending from said housing, wherein a lumen of said needle is configured to receive an implant;

(c) a plunger longitudinally disposed within said housing and a longitudinally extending rod operatively coupled thereto, wherein said plunger and said rod are collectively, translationally moveable along the longitudinal axis of said housing, and wherein said rod is configured to be receivable within at least a portion of the lumen;

(d) a continuous track disposed within the housing for aiding in controlling and facilitating delivery of the implant, the continuous track having a proximal section and a distal section divided by a protrusion;

(e) an actuator positioned partially within said housing, the actuator comprising flanges engaged with the continuous track;

(f) a spring operatively interconnected between said actuator and said plunger;

(g) a window disposed in said housing for visually determining a status of the implant; and

(h) a needle stop disposed at a distal end of the housing and axially aligned with the rod, said needle positioned within said needle stop;

(i) wherein said actuator is operatively engaged with said plunger and with said continuous track,

wherein movement of said actuator in a direction aligned with the longitudinal axis of said housing results in the translational movement of said plunger and said rod along the longitudinal axis of said housing,

wherein when said actuator is in a first position in the proximal section of the continuous track, said actuator is in abutting relation with said protrusion and said continuous track guides movement of said actuator in a direction normal to the longitudinal axis of said housing prior to the movement of said actuator in the direction aligned with the longitudinal axis of said housing resulting in the translational movement of said plunger and said rod along the longitudinal axis of said housing, and

wherein when said actuator is in a second position in the distal section of the continuous track, said continuous track guides the movement of said actuator in the direction aligned with the longitudinal axis of said housing for further translational movement of said plunger and said rod, and

wherein said protrusion and said continuous track are configured in such a way that the actuator can travel along the continuous track proximal and distal of said protrusion.

2. The ocular implantation device of claim 1, wherein said spring is a flat spring.

3. The ocular implantation device of claim 1, wherein said implant comprises a bioactive agent.

4. The ocular implantation device of claim 3, wherein the bioactive agent is fluocinolone acetonide.

5. The ocular implantation device of claim 1, further comprising retention means for preventing inadvertent delivery or displacement of the implant.

6. The ocular implantation device of claim 5, wherein the retention means is a core dam.

7. The ocular implantation device of claim 1, wherein said window comprises a magnifying lens.

8. A method of delivering an implant to an eye comprising:

(a) providing the device of claim 1 with said implant preloaded therein;

(b) inserting said needle of said device into said eye; and

(c) applying a force to said actuator of said device in order to deliver said implant to said eye.

9. The method of claim 8, further comprising using said window disposed in said housing of said device to determine the status of said implant.

10. A kit for delivering a tube shaped implant to an eye, comprising the device of claim 1 preloaded with the tube shaped implant including a drug core contained therein with permeable coatings applied to each end of a tube of the tube shaped implant.

11. A kit for delivering a tube shaped implant to an eye, comprising the device of claim 1 preloaded with the tube shaped implant including a drug core contained therein with a permeable coating at one end of a tube of the tube shaped implant and an impermeable member at another end of the tube of the tube shaped implant.

12. A method of delivering an implant to an eye comprising:

(a) providing said device of claim 1 with said implant preloaded therein;

(b) inserting said needle of said device into said eye; and

(c) applying a force to said actuator of said device in order to retract said needle of said device thereby delivering said implant to said eye.

13. The ocular implantation device of claim 1, wherein the needle is retractable.

14. An ocular implantation device comprising:

(a) a housing having a longitudinal axis;

(b) a needle extending longitudinally from said housing, said needle having a lumen extending therethrough, said lumen configured to receive an implant;

(c) a plunger longitudinally positioned within said housing and having a rod extending therefrom, wherein said plunger and said rod are translationally moveable along the longitudinal axis of said housing from an initial position, wherein said rod is receivable within at least a portion of said lumen;

(d) a guide shaft fixedly positioned within and supported by said housing in communication with said needle, said guide shaft cooperatively receiving said plunger and said rod upon the translational movement thereof;

(e) a guide tube positioned concentrically within at least a portion of the guide shaft, where said rod is dimensioned to fit concentrically within the guide tube;

(f) a needle stop disposed at a distal end of the housing and axially aligned with the rod, said needle positioned within said needle stop; and

(g) an actuator communicatively linked to said plunger, said actuator longitudinally moveable from a first position relative to said housing upon application to said actuator of a force aligned with the longitudinal axis of said housing,

wherein the movement of said actuator in a direction aligned with the longitudinal axis of said housing corresponds with the translational movement of said plunger from said initial position along the longitudinal axis of said housing; and

wherein said actuator is capable of movement in a direction normal to the longitudinal axis of said housing that does not result in the translational movement of said plunger and said rod.

15. The ocular implantation device of claim 14, further comprising a window disposed in said housing for visually determining a status of the implant.