Sub-retinal tangential needle catheter guide and introducer

• US 9,925,088 B2
• Filed: 06/01/2015
• Issued: 03/27/2018
• Est. Priority Date: 06/06/2014
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson), Gyroscope Therapeutics Limited (Novartis Ag)
• Original Assignee: Janssen Biotech, Inc. (Johnson & Johnson)
• Inventors: Clem, Michael F., Ko, Benjamin L., Roth, Robert H., Abbott, Daniel J., Meyer, Thomas E., Gordon, Paul D.
• Primary Examiner(s): Schmidt, Emily
• Application Number:
  US14/726,977
• Publication Number:
  US 20150351959A1
• Time in Patent Office: 1,030 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: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 includes a body, a needle, a catheter, and an actuator assembly. The needle extends distally from the body. The needle has an inner wall defining a needle lumen. The needle lumen is in fluid communication with a fluid port of the body. The catheter is slidably disposed in the needle lumen. The catheter has a catheter lumen. The first actuator assembly is configured to translate the catheter within and relative to the needle. The apparatus may also include an actuator assembly that is configured to rotate the needle relative to the body. The apparatus may be used to first deliver a leading bleb of fluid to the subretinal space in a patient'"'"'s eye via the needle. The apparatus may then be used to deliver a therapeutic agent to the subretinal space in the patient'"'"'s eye via the catheter.

Claims

1. An apparatus comprising:

(a) a body, wherein the body comprises;

(i) a body distal end,

(ii) a body proximal end, and

(iii) a fluid port;

(b) a needle, wherein the needle projects distally from the body distal end, wherein the needle comprises;

(i) a needle distal end,

(ii) a needle proximal end, and

(iii) an inner wall defining a needle lumen, wherein the needle lumen is in fluid communication with the fluid port;

(c) a catheter, wherein the catheter is slidably disposed in the needle lumen, wherein the catheter comprises;

(i) a catheter distal end,

(ii) a catheter proximal end, and

(iii) a catheter lumen; and

(d) a first actuator assembly, wherein the first actuator assembly is configured to translate the catheter within and relative to the needle, wherein the first actuator assembly includes a translatable member slidably disposed within an interior portion of the body, wherein the translatable member is configured to slidably translate along a longitudinal axis of the body between proximal and distal positions, wherein the translatable member is rotationally fixed relative to the body,

wherein the catheter extends proximally through the translatable member and a proximal end surface of the body, wherein the catheter is coupled to the translatable member and is configured to translate with the translatable member relative to the body and the needle in response to operation of the first actuator assembly.

2. The apparatus of claim 1, wherein the fluid port is located in an intermediate region of the body between the body distal end and the body proximal end.

3. The apparatus of claim 2, wherein the body defines a chamber, wherein the fluid port terminates at the chamber, wherein the needle proximal end terminates at the chamber, wherein the catheter passes through the chamber.

4. The apparatus of claim 1, wherein the needle lumen and catheter are sized to define a gap between the inner wall of the needle and an outer surface of the catheter, wherein the gap is configured to provide a pathway for fluid communication from the fluid port to the needle distal end.

5. The apparatus of claim 1, wherein the needle has a preformed bend.

6. The apparatus of claim 1, wherein the catheter is flexible.

7. The apparatus of claim 1, wherein the first actuator assembly comprises a control wheel rotatably supported by the body, wherein the first actuator assembly is operable to translate the catheter longitudinally within and relative to the needle in response to rotation of the control wheel relative to the body.

8. The apparatus of claim 7, wherein the body defines a longitudinal axis, wherein the control wheel is rotatable relative to the body about an axis that is perpendicular to the longitudinal axis of the body.

9. The apparatus of claim 7, wherein the first actuator assembly comprises:

(i) a pinion coupled with the control wheel, wherein the pinion is configured to rotate in response to rotation of the control wheel, and

(ii) a rack coupled with the catheter, wherein the rack is engaged with the pinion such that the rack is configured to translate in response to rotation of the pinion.

10. The apparatus of claim 1, wherein the first actuator assembly comprises a plunger slidably disposed within the body, wherein the plunger is secured to the catheter such that the catheter is configured to translate relative to the body in response to translation of the plunger relative to the body.

11. The apparatus of claim 1, wherein the needle is configured to rotate relative to the body.

12. The apparatus of claim 11, further comprising a second actuator assembly, wherein the second actuator assembly is operable to rotate the needle relative to the body.

13. The apparatus of claim 12, wherein the second actuator assembly comprises a rotatable member, wherein the rotatable member is rotatable relative to the body, wherein the needle is configured to rotate relative to the body in response to rotation of the rotatable member relative to the body.

14. The apparatus of claim 13, wherein the rotatable member is configured to form a Tuohy-Borst valve.

15. The apparatus of claim 1, further comprising a guidance device, wherein the guidance device comprises:

(i) a base configured to engage a patient'"'"'s eye, and

(ii) at least one guide passageway configured to receive and guide the needle relative to the patient'"'"'s eye.

16. The apparatus of claim 15, wherein the guidance device further comprises a lens engagement feature configured to removably couple with a viewing lens.

17. The apparatus of claim 1, wherein one of the body or the translatable member includes a longitudinal slot and the other of the body or the translatable member includes a projection slidably received within the longitudinal slot, wherein the projection and the longitudinal slot are configured to cooperate to guide translation of the translatable member relative to the body.

18. An apparatus comprising:

(a) a body, wherein the body comprises;

(i) a body distal end, and

(ii) a body proximal end;

(b) a needle, wherein the needle projects distally from the body distal end, wherein the needle comprises;

(i) a needle distal end,

(ii) a needle proximal end, and

(iii) a needle lumen;

(c) a catheter, wherein the catheter is slidably disposed in the needle lumen, wherein the catheter comprises;

(i) a catheter distal end,

(ii) a catheter proximal end, and

(iii) a catheter lumen;

(d) an actuator assembly, wherein the actuator assembly includes a movable member arranged within and rotationally fixed relative to the body, wherein the movable member is coupled to the catheter, wherein the actuator assembly is configured to actuate the movable member to thereby translate the catheter within and relative to the needle; and

(e) a fluid port coupled to the body and arranged between the body distal end and the movable member,

wherein the body defines a fluid chamber in fluid communication with the fluid port and the needle lumen, wherein the fluid chamber is configured to direct fluid from the fluid port to the needle lumen, wherein the catheter extends through the fluid chamber.

19. The apparatus of claim 18, wherein the body further includes an interior cavity spaced proximally from the fluid chamber, wherein the movable member is slidably disposed within the interior cavity.