Fluid exchange apparatus and methods

• US 9,883,968 B2
• Filed: 09/13/2012
• Issued: 02/06/2018
• 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): Stigell, Theodore
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US13/615,229
• Publication Number:
  US 20130165860A1
• Time in Patent Office: 1,972 Days
• Field of Search: 604 43- 44, 604117, 604 614
• 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. 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 connector configured to reversibly couple to a syringe;

a needle fixedly coupled to the connector and having a wall defining an injection lumen configured for injecting a therapeutic agent into the ocular implant through an opening from the injection lumen, the therapeutic agent having a first fluid density;

a sheath fixedly positioned over the needle, the sheath having a wall defining an outlet lumen between an inner diameter of the wall of the sheath and an outer diameter of the wall of the needle, the wall of the sheath having a wall thickness and at least one opening extending through the wall thickness into the outlet lumen, the outlet lumen providing a pathway through which pre-existing liquid in the ocular implant exits the ocular implant as therapeutic agent is injected into the ocular implant through the needle, the pre-existing liquid having a second fluid density; and

a receiver chamber fixedly coupled to the sheath and fluidly coupled to the outlet lumen of the sheath, the receiver chamber configured to receive the pre-existing liquid that exits the ocular implant via the at least one opening extending through the wall thickness of the sheath,

wherein the injection lumen is in a fixed position relative to the outlet lumen such that the opening from the injection lumen is positioned distal to a distal end of the sheath, and

wherein injection of the therapeutic agent into the ocular implant upon application of positive pressure by the syringe via the injection lumen displaces, with at least partial separation from the injected therapeutic agent, the pre-existing liquid in the ocular implant into the receiver chamber via the at least one opening of the sheath.

2. A system as in claim 1, 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.

3. A system as in claim 2, 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.

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

5. A system as in claim 1, wherein the receiver chamber is removable from the injection system.

6. A system as in claim 1, wherein the receiver chamber is removable from the injection system and contains a sample of the displaced pre-existing liquid from the ocular implant, and further comprising a sample container sized and shaped to receive the receiver chamber, the sample container being sized and shaped for placement into a centrifuge.

7. A system as in claim 1, wherein the wall includes a plurality of openings extending through the wall thickness, the plurality of openings positioned circumferentially about the sheath.

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

9. A system as in claim 8, wherein the at least one opening of the sheath is positioned distal to the receiver chamber and is separated distally from the stop by a distance from about 0.25 to about 2 mm.

10. A system as in claim 9, wherein the at least one opening of the sheath is a plurality of openings extending through the wall thickness that are located at a plurality of circumferential locations around a longitudinal axis of the sheath.

11. A system as in claim 9, wherein the at least one opening of the sheath is a plurality of openings extending through the wall thickness that are located at a plurality of axial locations along a longitudinal axis of the sheath.

12. A system as in claim 1, wherein the receiver chamber comprises a penetrable barrier configured to be penetrated by a needle in order to draw a sample from the receiver chamber.

13. A system as in claim 1, wherein the second fluid density is less than the first fluid density.

14. A system 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.

15. A system 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.

16. A system 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 system.

17. A system as in claim 16, wherein therapeutic agent flows from the syringe through the at least one opening from the injection lumen when the connector is reversibly coupled to the syringe.

18. A system 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.

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

20. A system as in claim 18, wherein the syringe is pre-filled with the predetermined amount of the therapeutic fluid.