Method and apparatus for subretinal administration of therapeutic agent

• US 10,226,379 B2
• Filed: 02/11/2015
• Issued: 03/12/2019
• Est. Priority Date: 02/12/2014
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson), Gyroscope Therapeutics Limited (Novartis Ag)
• Original Assignee: Orbit Biomedical Limited (Novartis Ag)
• Inventors: Oberkircher, Brendan J., Price, Daniel W., Keane, Michael F., Sokhanvar, Saeed, Yasevac, Daniel J., Bruehwiler, Michel G., Soffer, Leah R., Khan, Isaac J., Ko, Benjamin L., Riemann, Christopher D., Grubbs, Nathan D.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Watts, Tezita
• Application Number:
  US14/619,256
• Publication Number:
  US 20150223977A1
• Time in Patent Office: 1,490 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 2005/1585 Needle inserters
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An apparatus for delivering therapeutic agent to an eye includes a body, a cannula, a hollow needle, and an actuation assembly. The cannula extends distally from the body and is sized and configured to be insertable between a choroid and a sclera of a patient'"'"'s eye. The actuation assembly is operable to actuate the needle relative to the cannula to thereby drive a distal portion of the needle along an exit axis that is obliquely oriented relative to the longitudinal axis of the cannula. The cannula may be inserted through a sclerotomy incision to position a distal end of the cannula at a posterior region of the eye, between the choroid and sclera. The needle may be advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer, adjacent to the area of geographic atrophy.

Claims

1. An apparatus for delivering therapeutic agent to an eye, wherein the apparatus comprises:

(a) a body;

(b) a cannula extending distally from the body, wherein the cannula is sized and configured to be insertable between a choroid and a sclera of a patient'"'"'s eye, wherein the cannula defines a longitudinal axis;

(c) a hollow needle, wherein the hollow needle is slidable relative to the cannula; and

(d) an actuation assembly, wherein the actuation assembly is operable to actuate the hollow needle relative to the cannula, wherein the actuation assembly comprises;

(i) a knob, and

(ii) a coupling element that operatively couples the knob with the hollow needle, wherein the coupling element is slidably engaged with the knob and is configured to translate axially relative to the knob,

wherein the knob is rotatable relative to the body to drive movement of the coupling element relative to the body and thereby drive actuation of the hollow needle relative to the cannula.

2. The apparatus of claim 1, wherein the actuation assembly includes an actuation member that is movable relative to the body to actuate the hollow needle.

3. The apparatus of claim 2, wherein the actuation member is translatable relative to the body to actuate the hollow needle.

4. The apparatus of claim 2, wherein the actuation member is rotatable relative to the body to actuate the hollow needle.

5. The apparatus of claim 4, wherein the actuation assembly includes a threaded member that is associated with the actuation member, wherein the threaded member is configured to engage a threaded bore in the body to actuate the hollow needle when the actuation member is rotated relative to the body.

6. The apparatus of claim 1, wherein the needle includes a sharp distal tip.

7. The apparatus of claim 6, wherein the sharp distal tip of the hollow needle comprises a first bevel, a second bevel, and a third bevel, wherein the first bevel, second bevel, and third bevel are each oriented obliquely relative to each other.

8. The apparatus of claim 1, wherein the cannula includes a blunt distal end.

9. The apparatus of claim 1, wherein the cannula includes a beveled distal end, wherein the beveled distal end has a bevel angle, wherein the bevel angle is between approximately 10°

and approximately 30°

.

10. The apparatus of claim 1, wherein the cannula defines a plurality of lumens extending longitudinally through the length of the cannula, wherein at least one lumen of the plurality of lumens is configured to slidably receive the hollow needle.

11. The apparatus of claim 1, wherein the cannula has a bending stiffness between 0.7×

10<sup>−

6</sup> Nm² and 11.1×

10<sup>−

6</sup> Nm².

12. The apparatus of claim 1, wherein the cannula has a bending stiffness between 2.0×

10<sup>−

6</sup> Nm² to 6.0×

10<sup>−

6</sup> Nm².

13. The apparatus of claim 1, further comprising a valve assembly, wherein the valve assembly is operable to provide fluid communication between a fluid source and the needle, wherein the valve assembly is configured to translate with the hollow needle relative to the body.

14. The apparatus of claim 1, wherein an exterior of the knob includes a channel, wherein the coupling element is slidably engaged with the channel.

15. The apparatus of claim 1, further comprising a fluid flow path supply tube that extends distally from a proximal end of the body to a distal end of the body, wherein the fluid flow path supply tube communicates with the hollow needle and is configured to direct fluid to the hollow needle from a fluid source.

16. The apparatus of claim 1, wherein the actuation assembly further comprises an actuation member coupled with the hollow needle and configured to translate axially relative to the body, wherein the coupling element is configured to drive axial translation of the actuation member to thereby actuate the hollow needle relative to the cannula in response to rotation of the knob relative to the body.

17. The apparatus of claim 1, wherein the cannula includes a distal opening defining an exit axis along which a distal portion of the hollow needle is configured to extend, wherein the exit axis is obliquely oriented relative to the longitudinal axis of the cannula.

18. An apparatus for delivering therapeutic agent to an eye, wherein the apparatus comprises:

(a) a body defining a longitudinal axis;

(b) a cannula extending distally from the body, wherein the cannula is sized and configured to be insertable between a choroid and a sclera of a patient'"'"'s eye;

(c) a hollow needle, wherein the hollow needle is slidable relative to the cannula; and

(d) an actuation assembly, wherein the actuation assembly is operable to actuate the hollow needle relative to the cannula, wherein the actuation assembly comprises;

(i) a knob, wherein the knob is rotatable relative to the body,

(ii) an actuation member operatively coupled with the hollow needle, wherein the actuation member is translatable with the hollow needle relative to the body,

(iii) a channel, wherein the channel extends in a plane parallel to the longitudinal axis, and

(iv) a protrusion slidably engaged with the channel, wherein the protrusion extends transversely to the longitudinal axis and is operatively coupled with the actuation member and with the knob,

wherein the protrusion is configured to translate axially through the channel in response to rotation of the knob relative to the body to thereby drive translation of the actuation member relative to the body and actuation of the needle relative to the cannula.