Systems and methods for subretinal delivery of therapeutic agents

• US 10,010,447 B2
• Filed: 12/18/2013
• Issued: 07/03/2018
• Est. Priority Date: 12/18/2013
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Novartis Ag
• Inventors: Kashani, Pooria S., Papac, Michael
• Primary Examiner(s): Gilbert, Andrew
• Assistant Examiner(s): FREHE, WILLIAM R
• Application Number:
  US14/132,859
• Publication Number:
  US 20150164687A1
• Time in Patent Office: 1,658 Days
• Field of Search: 604 22
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 5/178 Syringes
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

Abstract

A retinal treatment system for delivering therapeutic agents to a target location with a retina is disclosed herein. The retinal treatment system includes a console having a control system and a handheld device coupled to the control system. The handheld device includes an inner tube disposed within an outer tube and being axially moveable within the outer tube. The inner tube has a perforating tip that is configured to perforate an inner limiting membrane of the retina. The handheld device further includes a chamber coupled to a proximal end of the inner tube that is configured to receive a fluid containing therapeutic agents injectable from the perforating tip. The control system of the retinal treatment system permits a user to maintain a position of the handheld device relative to the retina and activate an injection of a portion of the fluid through the inner tube into the retina.

Claims

1. A retinal treatment device for delivering therapeutic agents to a target location within a retina, the retinal treatment device comprising:

an outer tube having a lumen and having a distal end and a proximal end, the outer tube being sized to penetrate an eye to conduct retinal surgeries;

a flexible tip sealingly coupled to the distal end of the outer tube, the flexible tip being configured to flexibly conform to a retinal surface when abutted against the retinal surface;

an inner tube disposed within the lumen of the outer tube, the inner tube having a proximal end and a distal end, the distal end extending into the flexible tip, the inner tube being configured to extend from the flexible tip and penetrate through a portion of the retina into a subretinal space;

at least one sealant channel in the flexible tip separate from the inner tube;

a sealing gel configured to form a seal between the retinal treatment device and the retina to prevent reflux of therapeutic agents when the sealing gel is ejected from the flexible tip; and

a chamber coupled to the proximal end of the inner tube, the chamber configured to receive a fluid containing therapeutic agents injectable through the inner tube into the subretinal space.

2. The retinal treatment device of claim 1, wherein the inner tube is configured to move relative to the outer tube and the flexible tip when a perforating tip of the inner tube is inserted into the retina.

3. The retinal treatment device of claim 1, further comprising a force moderation structure that moderates a force applied by a perforating tip of the inner tube.

4. The retinal treatment device of claim 3, wherein the force moderation structure is a spring.

5. The retinal treatment device of claim 4, wherein the spring is configured to prevent an applied force from exceeding a force required to perforate a retinal pigment epithelium layer of the eye.

6. The retinal treatment device of claim 1, wherein the inner tube is coupled to a drive mechanism that drives a perforating tip of the inner tube into the retina.

7. The retinal treatment device of claim 6, wherein the drive mechanism is a pneumatic or electric drive mechanism or a slider drive mechanism disposed on a hand-held controller.

8. The retinal treatment device of claim 1, wherein the first chamber defines a volume containing the therapeutic agent that is further defined by a plunger, the plunger being actuatable to inject a portion of the therapeutic agent from the volume through the inner tube into the subretinal space.

9. The retinal treatment device of claim 8, wherein the plunger is configured to be actuated electronically, pneumatically, or mechanically.

10. The retinal treatment device of claim 8, wherein the plunger is actuated by manual control or by computer control.

11. The retinal treatment device of claim 1, wherein the inner tube extends through a central channel of the flexible tip, the flexible tip comprising at least two sealant channels permitting the sealing gel to be ejected from the flexible tip.

12. The retinal treatment device of claim 11, wherein a volume of the sealing gel is disposed in a space between the inner tube and the outer tube.

13. The retinal treatment device of claim 1, wherein the inner tube comprises a chemically-treated interior surface.

14. The retinal treatment device of claim 1, wherein a distal portion of the inner tube comprises a curved section that curves when extended beyond the flexible tip to inject fluid horizontally into the subretinal space.

15. The retinal treatment device of claim 1, wherein the chamber is configured to receive a cartridge containing a pre-determined volume of fluid containing therapeutic agents.

16. The retinal treatment device of claim 1, further comprising a solution injected through the inner tube to form a bleb in the subretinal space prior to injecting the fluid containing therapeutic agents from the chamber.

17. A retinal treatment system for delivering therapeutic agents to a target location with a retina, the retinal treatment system comprising:

a console having a control system;

a handheld device coupled to the control system by a communication line, the handheld device comprising;

an inner tube disposed within an outer tube and being axially moveable within the outer tube, the inner tube having a perforating tip at a distal end thereof configured to perforate an inner limiting membrane of the retina;

a force moderation structure coupled to the perforating tip that moderates a force applied by the perforating tip of the inner tube, wherein the force moderation structure is configured to prevent an applied force from exceeding a force required to perforate a retinal pigment epithelium layer of the eye; and

a chamber coupled to a proximal end of the inner tube, the chamber configured to receive a fluid containing therapeutic agents injectable from the perforating tip; and

wherein the control system permits a user to maintain a position of the handheld device relative to the retina and activate an injection of a portion of the fluid through the inner tube into the retina.

18. The retinal treatment system of claim 17, wherein the control system comprises a footswitch having a pedal, a position of the pedal communicating a desired injection parameter to the console over a communication link between the control system and the footswitch.

19. The retinal treatment system of claim 18, wherein the desired injection parameter is a flow rate-, a pressure, or a sheer stress.

20. The retinal treatment system of claim 18, wherein an activation of the footswitch causes a predetermined volume of the fluid to be injected into the retina.

21. The retinal treatment system of claim 20, wherein the predetermined volume is set using an interface provided by the console.

22. The retinal treatment system of claim 17, further comprising an optical coherence tomography (OCT) system for measuring a thickness of the retina.