Injector apparatus and method for drug delivery

• US 10,265,215 B2
• Filed: 12/13/2017
• Issued: 04/23/2019
• 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:
  US15/840,965
• Publication Number:
  US 20180161202A1
• Time in Patent Office: 496 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 device for injecting a therapeutic agent into an ocular implant, the implant being at least partially implanted in an eye, the implant further providing at least a first resistance to outflow of therapeutic agent into the eye, the device comprising:

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

an outlet lumen configured to provide a pathway through which a pre-existing fluid in the ocular implant exits the ocular implant; and

a receiving chamber fluidly coupled to the outlet lumen, the receiving chamber configured to receive the pre-existing fluid that exits the ocular implant via the outlet lumen,

wherein the receiving chamber provides a first fluid outflow resistance lower than the first resistance to outflow, and a second fluid outflow resistance greater than the first resistance to outflow;

wherein injection of therapeutic agent into the ocular implant via the injection lumen causes the pre-existing fluid to exit the ocular implant into the receiving chamber via the outlet lumen and a second pre-existing fluid to displace from the receiving chamber; and

further wherein, upon displacement from the receiving chamber of substantially all of the second pre-existing fluid, the second fluid outflow resistance provided by the receiving chamber causes a portion of the therapeutic agent to pass from the implant into the patient'"'"'s eye upon injection of an additional amount of the therapeutic agent into the ocular implant.

2. The device of claim 1, wherein the implant is expandable in the eye from a first, collapsed configuration to a second, enlarged configuration.

3. The device of claim 1, wherein a first porous structure operatively coupled to the receiving chamber provides the first fluid outflow resistance and the second fluid outflow resistance.

4. The device of claim 3, wherein the first porous structure operatively coupled to the receiving chamber has the first fluid outflow resistance to gas outflow and the second fluid outflow resistance to liquid outflow.

5. The device of claim 3, wherein the implant comprises a second porous structure that provides the first resistance to outflow.

6. The device of claim 5, wherein the first fluid outflow resistance of the first porous structure of the receiving chamber is less than the first resistance provided by the second porous structure of the implant, and the second fluid outflow resistance of the first porous structure of the receiving chamber is greater than the first resistance provided by the second portion structure of the implant.

7. The device of claim 1, wherein the second pre-existing fluid is a gas.

8. The device of claim 7, wherein the gas is air.

9. The device of claim 7, wherein the gas is air under vacuum.

10. The device of claim 1, wherein the second pre-existing fluid is displaced from the receiving chamber via a vent.

11. The device of claim 1, wherein the second pre-existing fluid is displaced from the receiving chamber via a valve.

12. The device of claim 1, wherein the injection lumen and outlet lumen are concentrically positioned relative to one another.

13. The device of claim 12, wherein the outlet lumen surrounds the injection lumen along at least a portion of a length of the injection lumen.

14. The device of claim 1, wherein the 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.

15. The device of claim 1, further comprising a hub configured to removably receive a syringe that is configured to fluidly couple to the injection lumen.

16. The device of claim 1, further comprising a needle that defines the injection lumen.

17. The device of claim 16, further comprising a sheath at least partially over the needle so as to form the outlet lumen between an inner surface of the sheath and an outer surface of the needle.

18. The device of claim 17, 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.

19. The device of claim 17, wherein the sheath forms a first opening through which the pre-existing fluid exits the ocular implant into the outlet lumen.

20. The device of claim 19, wherein the first opening is located between a distal-most end of the sheath and an outer surface of the needle.

21. The device of claim 20, wherein a second opening is located at an end of the needle permitting the therapeutic agent to pass from the injection lumen into the ocular implant.

22. The device of claim 21, wherein the second opening is located distal to the first opening.

23. The device of claim 21, wherein the first opening and the second opening are in a fixed position relative to one another.