Injector apparatus and method for drug delivery

• US 9,033,911 B2
• Filed: 08/05/2011
• Issued: 05/19/2015
• Est. Priority Date: 08/05/2010
• Status: Active Grant

• Current Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Original Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Inventors: de Juan, Eugene Jr., Alster, Yair, Farinas, Kathleen Cogan, MacFarlane, K. Angela, Reich, Cary J., Campbell, Randolph E., Doud, Darren, Erickson, Signe, Barrett, Mike, Batten, David, Skieller, Christina, Stine, Greg
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US13/814,461
• Publication Number:
  US 20130324918A1
• Time in Patent Office: 1,383 Days
• Field of Search: 604/27, 604/36, 604/38, 604 43- 44, 604/264, 604/272, 606/107
• US Class Current: 604/36
• CPC Class Codes: A61F 9/00 Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand caps with means for protecting the eyes A42B1/018; visors for helmets A42B3/22; retractors A61B17/02; manipulators specially adapted for use in surgery A61B34/70; appliances to aid invalids to move about A61H3/00; exercisers for the eyes A61H5/00; eye baths A61H35/02; sunglasses or goggles having the same features as spectacles G02C
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• 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 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/31 Details
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

Methods and apparatus provide a therapeutic fluid to devices implanted in the body, for example to containers of devices implanted in the eye of a patient. The methods and apparatus may comprise an injector to increase an amount of therapeutic agent injected into the device implanted in the eye, or a structure to receive the therapeutic fluid within the device implanted in the eye, or combinations thereof. The device implanted in the eye may comprise a reservoir chamber having a fluid with a density different than the therapeutic fluid, and the apparatus can be adapted to at least partially separate the implanted device fluid from therapeutic fluid within the reservoir chamber to increase and amount of therapeutic fluid placed in the reservoir chamber.

Claims

1. A system for injecting a therapeutic agent into an ocular implant, the ocular implant being at least partially implanted in an eye, the system comprising:

a needle defining an internal injection lumen configured to provide a pathway for injecting a therapeutic agent into the ocular implant;

an outlet lumen configured to provide a pathway through which pre-existing fluid in the ocular implant exits the ocular implant as therapeutic agent is injected into the ocular implant through the injection lumen; and

a receiver chamber having a channel fluidly coupled to the outlet lumen and to a first porous structure having a first resistance to flow, the receiver chamber configured to receive the pre-existing fluid that exits the ocular implant via the outlet lumen;

wherein application of a positive pressure into the injection lumen simultaneously injects an amount of the therapeutic agent into the ocular implant via the injection lumen and displaces an amount of pre-existing fluid from the ocular implant into the receiver chamber via the outlet lumen.

2. The system as in claim 1, wherein the outlet lumen and the injection lumen are concentrically positioned relative to one another.

3. The system as in claim 1, further comprising a source chamber configured to be removably attached to the injection lumen.

4. The system as in claim 3, wherein the source chamber is loaded with the therapeutic agent for injecting into the ocular implant via the injection lumen.

5. The system as in claim 3, wherein the source chamber is part of a syringe that attaches to the injection lumen.

6. The system as in claim 1, further comprising a hub configured to removably receive a syringe that is configured to fluidly couple to the injection lumen.

7. The system as in claim 1, further comprising a stop, configured to limit a depth of insertion of the injection lumen into the ocular implant.

8. The system as in claim 1, wherein the outlet lumen surrounds the injection lumen along at least a portion of a length of the injection lumen.

9. The system as in claim 1, wherein the receiver chamber is configured to store in a manner suitable for analysis the amount of pre-existing fluid displaced from the ocular implant.

10. The system as in claim 1, wherein the amount of pre-existing fluid comprises components of the vitreous humor of the eye and a remaining portion of therapeutic agent previously placed in the ocular implant.

11. The system as in claim 1, further comprising the ocular implant, wherein the ocular implant comprises a second porous structure configured to release the therapeutic agent from the ocular implant, the second porous structure having a second resistance to flow.

12. The system as in claim 11, wherein the first resistance to flow of the first porous structure is proportional to or greater than the second resistance to flow of the second porous structure such that a second amount of pre-existing fluid in the ocular implant exits the ocular implant through the second porous structure as the therapeutic agent is injected into the ocular implant through the injection lumen to provide a bolus injection of the pre-existing fluid into the eye.

13. The system as in claim 11, wherein the first resistance to flow is less than the second resistance to flow so as to at least partially separate the amount of pre-existing fluid from the amount of therapeutic agent being injected.

14. The system as in claim 1, wherein the system is configured to inject the therapeutic fluid at a flow rate that inhibits mixing of the amount of the therapeutic fluid with the amount of the pre-existing fluid.

15. The system as in claim 1, wherein the internal injection lumen has a first opening out from the injection lumen and the outlet lumen has a second opening into the outlet lumen, wherein the injection lumen is longer than the outlet lumen such that the first opening from the injection lumen is located distal to the second opening into the outlet lumen.

16. The system as in claim 15, wherein the receiver chamber comprises a container to receive the amount of pre-existing fluid from the ocular implant received through the outlet lumen and wherein the container comprises a vent to pass air displaced from the container and wherein the vent is fluidly coupled to the second opening so as to define a flow path extending from the second opening to the vent and wherein the flow path comprises a resistance to flow so as to encourage at least partial separation between the amount of therapeutic fluid from the amount of pre-existing fluid.