Apparatus and method to form entry bleb for subretinal delivery of therapeutic agent

• US 10,646,374 B2
• Filed: 05/31/2017
• Issued: 05/12/2020
• Est. Priority Date: 06/17/2016
• Status: Active Grant

• Current Assignee: Gyroscope Therapeutics Limited (Novartis Ag)
• Original Assignee: Orbit Biomedical Limited (Novartis Ag)
• Inventors: Price, Daniel W., Oberkircher, Brendan J., Prenger, Daniel J., King, Geoffrey, Meyer, Thomas E., Ko, Benjamin L.
• Primary Examiner(s): Lee, Brandy S
• Assistant Examiner(s): Trinh, Hong-Van N
• Application Number:
  US15/609,386
• Publication Number:
  US 20170360607A1
• Time in Patent Office: 1,077 Days
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• 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 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06

Abstract

An apparatus includes an injector, a first fluid conduit, a second fluid line, and a control module. The injector includes a body, a flexible cannula, a flexible needle, and a sensor. The needle is configured to translate relative to the cannula. The sensor is operable to detect a position of the needle relative to the cannula. The first and second fluid lines are coupled with the needle. The control module is in communication with the sensor, with the first fluid conduit, and with the second fluid conduit. The control module is configured to provide delivery of a first fluid through the first conduit to the needle based on a signal from the sensor. The control module is further configured to provide delivery of a second fluid through the second conduit to the needle.

Claims

1. An apparatus, comprising:

(a) an injector, wherein the injector comprises;

(i) a body,

(ii) a flexible cannula extending distally from the body,

(iii) a flexible needle, wherein the flexible needle is configured to translate relative to the flexible cannula, and

(iv) a sensor, wherein the sensor is operable to detect a position of the flexible needle relative to the flexible cannula;

(b) a first fluid conduit coupled with the flexible needle;

(c) a second fluid conduit coupled with the flexible needle; and

(d) a control module, wherein the control module is in communication with the sensor, wherein the control module is in communication with the first fluid conduit, wherein the control module is in communication with the second fluid conduit,

wherein the control module is configured to provide automated delivery of a first fluid through the first fluid conduit to the flexible needle in response to distal movement of the flexible needle as sensed by the sensor,

wherein the control module is further configured to provide delivery of a second fluid through the second fluid conduit to the flexible needle.

2. The apparatus of claim 1, wherein the sensor comprises a linear potentiometer.

3. The apparatus of claim 1, further comprising a needle actuator, wherein the needle actuator is operable to drive the flexible needle longitudinally relative to the flexible cannula, wherein the sensor is coupled with the needle actuator.

4. The apparatus of claim 1, wherein the first fluid conduit and the second fluid conduit form a tube set extending between the injector and the control module.

5. The apparatus of claim 1, wherein the flexible cannula is sized and configured to fit through a sclerotomy formed in a patient'"'"'s eye.

6. The apparatus of claim 1, wherein the injector further comprises:

(i) an injector subassembly, wherein the body, the flexible cannula, and the flexible needle are part of the injector subassembly, and

(ii) an injector driver subassembly, wherein the injector driver subassembly comprises a needle driver.

7. The apparatus of claim 6, wherein the sensor is contained in the injector driver subassembly.

8. The apparatus of claim 1, wherein the injector further comprises:

(i) a needle driver contained within the body, and

(ii) a first user input feature extending from the body, wherein the first user input feature is operable to actuate the needle driver to thereby translate the flexible needle relative to the flexible cannula.

9. The apparatus of claim 8, wherein the first user input feature comprises a rotary knob rotatably coupled with the body.

10. The apparatus of claim 8, wherein the injector further comprises a second user input feature, wherein the control module is further configured to provide delivery of the second fluid through the second fluid conduit to the flexible needle in response to actuation of the second user input feature.

11. The apparatus of claim 10, wherein the second user input feature comprises a button.

12. The apparatus of claim 10, wherein the control module is further configured to provide automated delivery of the second fluid through the second fluid conduit to the flexible needle in response to actuation of the second user input feature.

13. The apparatus of claim 1, wherein the first fluid comprises a combination of a liquid and a gas.

14. The apparatus of claim 13, wherein the control module is configured to provide delivery of the liquid, followed by delivery of the gas, based on a signal from the sensor.

15. The apparatus of claim 13, wherein the control module is configured to provide delivery of the liquid, followed by alternating pulses of the gas and the liquid, based on a signal from the sensor.

16. The apparatus of claim 1, wherein the control module is configured to provide delivery of the first fluid through the first fluid conduit to the flexible needle based on a signal from the sensor indicating that the flexible needle is moving distally relative to the flexible cannula.

17. An apparatus, comprising:

(a) an injector, wherein the injector comprises;

(i) a body,

(ii) a flexible cannula extending distally from the body,

(iii) a flexible needle, wherein the flexible needle is configured to translate relative to the flexible cannula, and

(iv) a sensor, wherein the sensor is operable to detect a position of the flexible needle relative to the flexible cannula; and

(b) a control module, wherein the control module is in communication with the sensor,

wherein the control module is configured to provide automated delivery of a combination of a first liquid and a gas through a first conduit to the flexible needle in response to distal movement of the flexible needle as sensed by the sensor,

wherein the control module is further configured to provide delivery of a second fluid through a second conduit to the flexible needle after delivering the combination of the first liquid and the gas to the flexible needle.

18. The apparatus of claim 17, further comprising a user input feature, wherein the control module is further configured to provide, in response to actuation of the user input feature, automated delivery of the second fluid through the second fluid conduit to the flexible needle after delivering the combination of the first liquid and the gas to the flexible needle.

19. An apparatus, comprising:

(a) an injector, wherein the injector comprises;

(i) a body,

(ii) a flexible cannula extending distally from the body,

(iii) a flexible needle, wherein the flexible needle is configured to translate relative to the flexible cannula, and

(iv) a sensor, wherein the sensor is operable to detect a position of the flexible needle relative to the flexible cannula;

(b) a first fluid conduit coupled with the flexible needle;

(c) a second fluid conduit coupled with the flexible needle; and

(d) a control module, wherein the control module is in communication with the sensor, wherein the control module is in communication with the first fluid conduit, wherein the control module is in communication with the second fluid conduit,

wherein the control module is configured to provide delivery of a first fluid through the first fluid conduit to the flexible needle based on a signal from the sensor,

wherein the control module is further configured to provide delivery of a second fluid through the second fluid conduit to the flexible needle

wherein the control module is configured to provide at least one of an audible tone, illumination of a light, or generation of tactile feedback to indicate to an operator when the flexible needle is in a fully proximal position or a fully distal position.