Method and apparatus for sensing position between layers of an eye

• US 10,322,028 B2
• Filed: 09/01/2015
• Issued: 06/18/2019
• Est. Priority Date: 09/11/2014
• Status: Active Grant

• Current Assignee: Gyroscope Therapeutics Limited
• Original Assignee: Orbit Biomedical Limited (Gyroscope Therapeutics Limited)
• Inventors: Price, Daniel W., Oberkircher, Brendan J., Sokhanvar, Saeed, Yasevac, Daniel J., Bruehwiler, Michel, Soffer, Leah R., Johnson, Gregory W., Dannaher, William D., Troller, Stefan, Schnell, Urban, Roulet, Jean Christophe, Saurer, Alain, Keane, Michael F.
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/842,035
• Publication Number:
  US 20160074212A1
• Time in Patent Office: 1,386 Days
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 3/0041 characterised by display arrangements
• CPC Class Codes: A61B 3/102 for optical coherence tomography [OCT]
• CPC Class Codes: A61B 3/12 for looking at the eye fundus, e.g. ophthalmoscopes A61B3/13 takes precedence
• CPC Class Codes: A61B 90/20 Surgical microscopes characterised by non-optical aspects
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• 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: G02B 3/0087 with index gradient

Abstract

An apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, an actuation assembly, and a detection/visualization system. 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. The cannula may be inserted through a sclerotomy incision and advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer. The detection/visualization system is operable to detect or visualize penetration of the choroid of a patient'"'"'s eye and provide feedback to the operator and/or automatic control of the apparatus based on penetration of the choroid.

Claims

1. A system for delivering therapeutic agent to an eye, wherein the system comprises:

(a) a surgical instrument, wherein the surgical instrument comprises;

(i) a body,

(ii) 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,

(iii) a hollow needle having a sharp distal tip, wherein the needle is slidable relative to the cannula, and

(iv) an actuation assembly, wherein 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; and

(b) an interferometer system comprising;

(i) a light source,

(ii) an optical fiber in communication with the light source, and

(iii) an optical probe coupled with a distal end of the optical fiber, wherein the optical probe is coupled with a distal portion of the hollow needle such that a central axis of the optical probe is laterally offset from a central axis of the distal portion of the hollow needle, wherein the optical probe is operable to slide concurrently with the hollow needle within the cannula,

wherein the optical probe is configured to project light onto tissue and receive light reflected back from the tissue such that the interferometer system is operable to provide data indicating a position of the distal tip of the hollow needle within a patient'"'"'s eye.

2. The system of claim 1, wherein the optical probe comprises a gradient-index (GRIN) lens.

3. The system of claim 1, wherein the exit axis is oriented obliquely relative to the longitudinal axis of the cannula.

4. The system of claim 1, wherein the interferometer system comprises a spectrometer.

5. The system of claim 1, wherein the interferometer system is operable to provide an operator with an optical coherence tomography (OCT) scan that depicts sub-surface layers of the eye, wherein the system further comprises a display operable to depict the OCT scan of the interferometer.

6. The system of claim 1, wherein the interferometer system comprises a dispersive white-light interferometer (D-WLI).

7. The system of claim 1, wherein the interferometer system comprises a display operable to depict a choroid and a retina of a patient'"'"'s eye.

8. The system of claim 1, wherein the optical probe of the interferometer system is coupled with the distal portion of the hollow needle via an adhesive layer.

9. The system of claim 1, wherein the interferometer system is operable to provide visual, audible, and/or tactile feedback to an operator in response to the hollow needle piercing the choroid.

10. The system of claim 1, wherein the interferometer system comprises a position tracking system.

11. The system of claim 1, wherein the optical probe is positioned proximally relative to the distal tip of the needle.

12. The system of claim 1, wherein the optical probe is oriented substantially parallel to the needle.

13. The system of claim 1, wherein the optical probe is coupled to an exterior side surface of the hollow needle.

14. A system for delivering therapeutic agent to an eye, wherein the system comprises:

(a) a surgical instrument, wherein the surgical instrument comprises;

(i) a body,

(ii) 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,

(iii) a hollow needle having a sharp distal tip, wherein the needle is translatable relative to the cannula,

(iv) a light-emitting fiber optic cable, wherein the fiber optic cable is operable to emit light into the patient'"'"'s eye through a retina thereof, and

(v) an actuation assembly, wherein 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;

(b) a microscope positionable adjacent to a cornea of the patient'"'"'s eye, wherein the microscope is operable to receive light emitted from the fiber optic cable as the light exits the patient'"'"'s eye through a pupil thereof; and

(c) an image sensor operatively connected with the microscope, wherein the image sensor is operable to detect that the light received by the microscope exceeds a threshold light intensity associated with the distal tip of the needle reaching a subretinal space in the patient'"'"'s eye.

15. The system of claim 14, wherein the fiber optic cable is coupled with a distal portion of the hollow needle such that the fiber optic cable is operable to slide concurrently with the hollow needle within the cannula.

16. The system of claim 14, wherein in response to the image sensor detecting that the received light exceeds the threshold light intensity, the system is operable to at least one of:

(a) provide an indication to a user, or

(b) cease translation of the needle relative to the cannula.

17. The system of claim 14, wherein the actuation assembly comprises a servo motor, wherein the servo motor is operable to drive translation of the needle relative to the cannula, wherein the actuation assembly further comprises a servo controller in communication with the image sensor, wherein the servo controller is operable to control the servo motor to cease translation of the needle in response to detection by the image sensor that the received light exceeds the threshold light intensity.

18. The system of claim 14, wherein the microscope comprises:

(i) a beam splitter, and

(ii) a view port,

wherein the microscope is configured to receive light emitted from the fiber optic cable through the patient'"'"'s eye, wherein the beam splitter is operable to separate the received light into a first light beam viewable by a user through the view port, and a second light beam directed to the image sensor,

wherein the image sensor is operable to detect that the second light beam exceeds the threshold light intensity associated with the distal tip of the needle reaching a subretinal space in the patient'"'"'s eye.

19. A system for delivering therapeutic agent to an eye, wherein the system comprises:

(a) a surgical instrument, wherein the surgical instrument comprises;

(i) a body,

(ii) 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,

(iii) a hollow needle having a sharp distal tip, wherein the needle is slidable relative to the cannula, and

(iv) an actuation assembly, wherein 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; and

(b) a detection or visualization system having;

(i) an optical fiber, and

(ii) an optical probe at a distal end of the optical fiber, wherein the optical probe is configured to project light onto tissue and receive light reflected back from the tissue,

wherein the optical fiber and the optical probe are fixedly disposed along an exterior side surface of a distal portion of the needle and are operable to slide concurrently with the needle within the cannula, wherein the detection or visualization system is operable to detect or visualize penetration of the choroid of the patient'"'"'s eye.

20. The system of claim 19, wherein the optical fiber and the optical probe are fixed relative to the exterior side surface of the needle with an adhesive element.