Glaucoma treatment device

• US 9,789,000 B2
• Filed: 05/07/2015
• Issued: 10/17/2017
• Est. Priority Date: 01/17/2006
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Novartis Ag
• Inventors: de Juan, Jr., Eugene, Boyd, Stephen, Deem, Mark E., Gifford, III, Hanson S., Rosenman, Dan
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US14/706,893
• Publication Number:
  US 20150238360A1
• Time in Patent Office: 894 Days
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/142 Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• 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 9/007 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: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61F 9/0133 Knives or scalpels specially adapted therefor
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2202/04 Liquids
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Claims

1. A method of treating an eye comprising:

introducing an elongated applier of a delivery instrument through a cornea of the eye and into an anterior chamber of the eye, wherein the elongated applier comprises a proximal opening, a distal opening, and an internal lumen that forms a fluid pathway and wherein at least a distal portion of the elongated applier is flexible to deflect against a tissue of the eye, and wherein an ocular implant is removably coupled to the elongated applier as the elongated applier is introduced through the cornea, the delivery instrument defining a longitudinal axis and comprising;

(a) a hand-held component;

(b) the elongated applier operatively coupled to the hand-held component, the elongated applier comprising a proximal region aligned with the longitudinal axis and a distal region, the distal region being curved away from the longitudinal axis during introduction of the ocular implant into the anterior chamber; and

(c) a deployment structure having a proximal end coupled to the hand-held component and a distal end positioned around the elongated applier proximal of the ocular implant when the ocular implant is removably attached to the delivery instrument;

dissecting at least a portion of the ciliary body from the sclera proximate a scleral spur to form a dissected tissue plane between the ciliary body and the sclera;

advancing a distal region of the elongated applier toward the suprachoroidal space through the dissected tissue plane;

injecting a fluid through the lumen of the elongated applier and out of the distal opening of the elongated applier, wherein the fluid is supplied via the proximal opening of the elongated applier that is fluidly connected to the fluid pathway of the elongated applier; and

actuating the delivery instrument to move the elongated applier of the delivery instrument in a proximal direction out of the ocular implant while the ocular implant remains fixed relative to a portion of the delivery instrument so to release the elongated applier from the ocular implant, wherein the distal region of the elongated applier withdraws into the deployment structure and conforms to the longitudinal axis of the delivery instrument as the distal region withdraws into the deployment structure.

2. A method as in claim 1, wherein a distal portion of the elongated applier is non-linear.

3. A method as in claim 1, wherein the non-linear portion of the elongated applier is curved.

4. A method as in claim 1, wherein injecting the fluid through the lumen of the elongated applier and out of the distal opening of the elongated applier hydro dissects tissue surrounding the dissected tissue plane.

5. A method as in claim 4, wherein injecting the fluid through the lumen of the elongated applier and out of the distal opening of the elongated applier hydro dissects between the choroid and the sclera.

6. A method as in claim 4, wherein injecting the fluid through the lumen of the elongated applier and out of the distal opening of the elongated applier forms a lake region between the choroid and the sclera in the suprachoroidal space.

7. A method as in claim 6, wherein the lake reduces an intraocular pressure of the eye by increasing outflow of aqueous humor from the interior chamber.

8. A method as in claim 6, wherein the lake delivers at least one therapeutic agent over a period of time.

9. A method as in claim 1, wherein the injected fluid is a viscoelastic substance.

10. A method as in claim 1, wherein the injected fluid includes at least one drug.

11. A method as in claim 1, wherein the injected fluid includes at least one dye configured to assist in visualizing the fluid during or after injection.

12. A method as in claim 1, wherein the ocular implant is placed in the suprachoroidal space near the injected fluid.

13. A method as in claim 1, wherein the elongated applier is a guidewire that extends through a lumen of the ocular implant.

14. A method as in claim 13, wherein the guidewire includes a distal region that curves away from a longitudinal axis of a proximal region of the guidewire.

15. A method as in claim 13, wherein the guidewire includes a distal tip that forms a distalmost portion of the guidewire, and wherein the distal tip is configured to bluntly dissect eye tissue.

16. A method as in claim 1, wherein the delivery instrument includes a proximal component configured for manipulation by a user to direct a distal region of the elongate applier to the suprachoroidal space.

17. A method as in claim 16, wherein the proximal component of the delivery instrument includes at least a portion of the fluid pathway.