Fluid exchange apparatus and methods

• US 10,653,554 B2
• Filed: 01/22/2018
• Issued: 05/19/2020
• Est. Priority Date: 09/16/2011
• Status: Active Grant

• Current Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Original Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Inventors: Doud, Darren, Campbell, Randolph E., Erickson, Signe, Macfarlane, K. Angela, Barrett, Mike, Skieller, Christina, Batten, David, Stine, Greg, de Juan, Jr., Eugene, Sutton, Douglas, Farinas, Kathleen Cogan
• Primary Examiner(s): Schmidt, Emily L
• Application Number:
  US15/877,146
• Publication Number:
  US 20180243130A1
• Time in Patent Office: 848 Days
• 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 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2039/0081 Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
• CPC Class Codes: A61M 2039/009 Means for limiting access to the septum, e.g. shields, grids
• 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 2039/0294 having a specific shape matching the shape of a tool to be inserted therein, e.g. for easy introduction, for sealing purposes, guide
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 2205/6054 Magnetic 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

An injector apparatus comprises an elongate structure having one or more openings positionable near a penetrable barrier of an implantable device so as to receive fluid of the implantable device. The apparatus comprises a needle and a sheath extending over at least a portion of the needle. The elongate structure may comprise a distal tip to penetrate tissue and the penetrable barrier, and a distal opening near the tip to release therapeutic fluid into the implantable chamber. In many embodiments the distal tip, the distal opening, and the plurality of openings are separated from a stop that engages a tissue of the patient and limit penetration depth such that the distal opening and the plurality of openings are located along an axis of the implantable device to increase an efficiency of the exchange.

Claims

1. An exchange device to inject a therapeutic agent into an ocular implant that is at least partially implanted in an eye, the exchange device comprising:

a connector configured to reversibly couple to a syringe;

a needle having a proximal end region fixedly coupled to the connector, the needle defining an injection lumen configured for injecting a therapeutic agent into the ocular implant through a distal opening of the needle;

a receiver container coupled to the connector; and

an outer sheath coupled to a distal end region of the receiver container, the outer sheath comprising;

a wall defining an outlet lumen between an inner diameter of the wall and an outer diameter of the needle, the outlet lumen in fluid communication with the receiver container;

a distal tip; and

a plurality of openings extending through the wall of the outer sheath into the outlet lumen,

wherein the receiver container is fixedly coupled to the connector such that the outer sheath is positioned around at least a portion of the needle and the distal opening of the needle is positioned distal to the distal tip of the outer sheath, and

wherein application of positive pressure through the injection lumen by the syringe during injection of the therapeutic agent into the ocular implant displaces, with at least partial separation from the injected therapeutic agent, pre-existing liquid in the ocular implant into the receiver container via the outlet lumen.

2. A device as in claim 1, wherein the distal tip of the outer sheath tapers such that at least a portion of the distal tip of the sheath contacts an outer surface of the needle.

3. A device as in claim 1, wherein at least a portion of the distal tip of the outer sheath is spaced from an outer surface of the needle.

4. A device as in claim 1, wherein the receiver container is removable from the connector.

5. A device as in claim 1, wherein the plurality of openings are positioned circumferentially about the outer sheath.

6. A device as in claim 1, further comprising a stop coupled to the distal end region of the receiver container such that the needle and the sheath extend through the stop, the stop having a surface configured to engage a tissue of the patient.

7. A device as in claim 6, wherein the plurality of openings of the sheath are positioned distal to the receiver container and are separated distally from the stop by a distance from about 0.25 mm to about 2 mm.

8. A device as in claim 7, wherein the plurality of openings are located at a plurality of circumferential locations around a longitudinal axis of the sheath.

9. A device as in claim 7, wherein the plurality of openings of the sheath are located at a plurality of axial locations along a longitudinal axis of the sheath.

10. A device as in claim 1, wherein the distal tip of the sheath tapers at an angle of no more than about 20 degrees to a longitudinal axis of the sheath.

11. A device as in claim 1, wherein the receiver container comprises a penetrable barrier configured to be penetrated in order to draw a sample from the receiver container.

12. A device as in claim 1, wherein the therapeutic agent has a first fluid density and the pre-existing liquid has a second fluid density that is less than the first fluid density.

13. A device as in claim 1, wherein the therapeutic agent has a first fluid viscosity and the pre-existing liquid in the ocular implant has a second fluid viscosity that is less than the first fluid viscosity.

14. A device as in claim 1, wherein the connector comprises a Luer connector, a pressure fit connector, a non-standard connector, or a lock and key mechanism.

15. A device as in claim 1, wherein the connector comprises a lock and the syringe comprises a key configured to unlock the lock of the connector forming a lock and key mechanism to limit access to the device.

16. A device as in claim 1, wherein the therapeutic agent flows from the syringe through the injection lumen when the connector is reversibly coupled to the syringe and positive pressure is applied by the syringe.

17. A device as in claim 1, wherein a predetermined amount of the therapeutic fluid injected into the ocular implant corresponds to no more than about twice a volume of the ocular implant.

18. A device as in claim 17, wherein the volume of the ocular implant is no more than about 100 uL.

19. A device as in claim 17, wherein the syringe is pre-filled with the predetermined amount of the therapeutic fluid.

20. A device as in claim 1, wherein the needle is 33 gauge and a pressure generated within the needle during injection is no greater than about 85 psi.