Injector apparatus and method for drug delivery

• US 9,861,521 B2
• Filed: 05/15/2015
• Issued: 01/09/2018
• 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, Jr., Eugene, 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): Price, Nathan R
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US14/713,505
• Publication Number:
  US 20150250647A1
• Time in Patent Office: 970 Days
• 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 system comprising:

an injection lumen configured to provide a pathway for injecting a therapeutic agent into the ocular implant using positive pressure applied through the injection lumen;

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

a receiver chamber fluidly coupled to the outlet lumen, the receiver chamber configured to receive fluid that exits the ocular implant via the outlet lumen;

wherein injection of the therapeutic agent into the ocular implant via the injection lumen upon application of the positive pressure displaces the first amount of pre-existing fluid in the ocular implant into the receiver chamber via the outlet lumen.

2. A system as in claim 1, further comprising a needle that defines the injection lumen.

3. A system as in claim 2, wherein an opening near the end of the needle permits fluid to pass from the injection lumen into the ocular implant.

4. A system as in claim 2, further comprising a sheath positioned at least partially around an outer surface of the needle such that the sheath and the needle are concentric so as to form the outlet lumen between an inner surface of the sheath and the outer surface of the needle.

5. A system as in claim 4, wherein the sheath forms at least one opening through which fluid can pass from the implant into the outlet lumen.

6. A system as in claim 5, wherein the opening is between a distal-most end of the sheath and an outer surface of the needle.

7. A system as in claim 4, wherein the opening near the end of the needle is distal of an opening into the outlet lumen.

8. A system as in claim 4, wherein a distal tip of the sheath tapers such that at least a portion of the distal tip of the sheath contacts an outer surface of the needle.

9. A system as in claim 4, wherein at least a portion of a distal tip of the sheath is spaced from an outer surface of the needle.

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

11. A system as in claim 1, further comprising a source chamber fluidly coupled to the injection lumen, the source chamber providing a source of therapeutic agent for injecting into the ocular implant via the injection lumen.

12. A system as in claim 11, wherein the source chamber is removably attached to the injection lumen.

13. A system as in claim 11, wherein the source chamber is loaded with a therapeutic agent.

14. A system as in claim 11, wherein the source chamber is part of a syringe that attaches to the injection lumen.

15. A 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.

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

17. A system as in claim 1, wherein the injection lumen and outlet lumen are sized to insert through a resealable septum of the ocular implant in a resealable manner.

18. A system as in claim 17, wherein the injection lumen is a lumen of a needle that is 33 gauge.

19. A system as in claim 18, wherein the outlet lumen is a lumen of a sheath that is 30 gauge.

20. A system as in claim 7, wherein the first amount of pre-existing fluid is displaced from the ocular implant and mixing with the therapeutic agent injected via the injection lumen is substantially inhibited.