Delivery system and method of use for the eye

• US 8,540,659 B2
• Filed: 01/07/2008
• Issued: 09/24/2013
• Est. Priority Date: 05/19/2000
• Status: Expired due to Term

• Current Assignee: Ivantis Inc.
• Original Assignee: Michael S. Berlin
• Inventors: Berlin, Michael S.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US11/970,488
• Publication Number:
  US 20080108934A1
• Time in Patent Office: 2,087 Days
• Field of Search: 604 8- 10, 604/27, 604/294, 604/264, 604/284, 604/523, 606107-109, 606/151, 606/167, 600/398, 623/1.1, 623/4.1, 623/11.1, 623/1.35
• US Class Current: 604/8
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00066 intensity
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00321 Head or parts thereof
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/2255 Optical elements at the distal end of probe tips
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/15 Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
• CPC Class Codes: A61F 2009/00844 : Feedback systems
• CPC Class Codes: A61F 2009/00868 : Ciliary muscles or trabecular meshwork
• CPC Class Codes: A61F 2009/00891 : Glaucoma
• CPC Class Codes: A61F 9/00 : Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand caps with means for protecting the eyes A42B1/018; visors for helmets A42B3/22; retractors A61B17/02; manipulators specially adapted for use in surgery A61B34/70; appliances to aid invalids to move about A61H3/00; exercisers for the eyes A61H5/00; eye baths A61H35/02; sunglasses or goggles having the same features as spectacles G02C
• 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 9/008 : using laser
• CPC Class Codes: A61F 9/00802 : for photoablation

Abstract

A method and delivery system are disclosed for creating an aqueous flow pathway in the trabecular meshwork, juxtacanalicular trabecular meshwork and Schlemm'"'"'s canal of an eye for reducing elevated intraocular pressure. Pulsed laser radiation is delivered from the distal end of a fiber-optic probe sufficient to cause photoablation of selected portions of the trabecular meshwork, the juxtacanalicular trabecular meshwork and an inner wall of Schlemm'"'"'s canal in the target site. The fiber-optic probe may be advanced so as to create an aperture in the inner wall of Schlemm'"'"'s canal in which fluid from the anterior chamber of the eye flows. The method and delivery system may further be used on any tissue types in the body.

Claims

1. A method of providing an artificial passageway for fluid to flow from the anterior chamber of an eye through the trabecular meshwork, the juxtacanulicular trabecular meshwork and the inner wall of Schlemm'"'"'s canal, comprising:

inserting an intraocular implant from the anterior chamber of the eye through the trabecular meshwork, the juxtacanulicular trabecular meshwork and the inner wall of Schlemm'"'"'s canal without substantially impinging the outer wall of Schlemm'"'"'s canal, the intraocular implant having a fluid passageway there through, a distal end and a proximal end, the distal end being positioned adjacent the inner wall of Schlemm'"'"'s canal and spaced from the outer wall of Schlemm'"'"'s canal, and the proximal end being positioned at the anterior chamber of the eye so as to enable the fluid to flow from the anterior chamber of the eye into Schlemm'"'"'s canal; and

securing the intraocular implant in place so that it does not ordinarily impinge the outer wall of Schlemm'"'"'s canal, thereby avoiding trauma to the outer wall of Schlemm'"'"'s canal and reducing the likelihood of stimulating an inflammatory cascade and subsequent scar tissue.

2. The method of claim 1, wherein the inner diameter of the fluid passageway is between 10 and 200 microns.

3. The method of claim 1, further comprising forming an opening for inserting the implant in one or more of the trabecular meshwork, the juxtacanulicular trabecular meshwork, and the inner wall of Schlemm'"'"'s canal by photoablation.

4. The method of claim 3, wherein photoablation is accomplished by delivering optical energy to the location at which the opening is to be formed with a fiber optic probe.

5. The method of claim 4, wherein the optical energy is generated by an ultraviolet emitting laser.

6. The method of claim 4, wherein the optical energy is generated by an excimer laser.

7. The method of claim 1, further comprising forming an opening for inserting the implant in one or more of the trabecular meshwork, the juxtacanulicular trabecular meshwork, and the inner wall of Schlemm'"'"'s canal by application of a cutting cannula.

8. The method of claim 1, further comprising inserting the intraocular implant into the anterior chamber of the eye through a corneal incision.

9. The method of claim 1, further comprising inserting the intraocular implant into the anterior chamber of the eye through a self-sealing incision in the eye.

10. The method of claim 1, wherein, when the implant is positioned in the eye the proximal end of the implant engages the trabecular meshwork and the distal end of the implant engages the inner wall of Schlemm'"'"'s canal.

11. The method of claim 1, further comprising providing an inserter device that is configured to carry the intraocular implant.

12. The method of claim 11, wherein positioning the intraocular implant comprises advancing the intraocular implant relative to the inserter device.

13. The method of claim 12, wherein the distal end of the implant includes a foldable leg, and further comprising unfolding the foldable leg to abut the inner wall of Schlemm'"'"'s canal.

14. The method of claim 12, wherein at least one relatively thin, hook-like, retention member is attached to the proximal end of the implant, and further comprising causing the retention member to engage the trabecular meshwork to hold the implant in place.

15. An intraocular implant, comprising:

a body, having a proximal end, a middle portion, a distal end, and a fluid passageway there through;

the proximal end being sized and shaped to terminate proximal to the juxtacanulicular trabecular meshwork;

the middle portion being sized and shaped to provide a fluid flow path from the anterior chamber of the eye through the trabecular meshwork, the juxtacanulicular trabecular meshwork, and the inner wall of Schlemm'"'"'s canal of the eye when inserted there through and secured in place; and

a fastening member for securing the implant in place so as not to impinge the outer wall of Schlemm'"'"'s canal, thereby avoiding trauma to the outer wall of Schlemm'"'"'s canal and reducing the likelihood of stimulating an inflammatory cascade and subsequent scar tissue.

16. The implant of claim 15, wherein the distal end of the implant includes a foldable leg adapted to be unfolded so as to abut the inner wall of Schlemm'"'"'s canal.

17. The implant of claim 15, wherein at least one relatively thin, hook-like, retention member is attached to the proximal end of the implant to engage the trabecular meshwork to hold the implant in place.

18. The implant of claim 15, wherein the distal end outer cross-sectional dimension is between substantially 10 and 100 microns greater than the middle portion outer cross-sectional dimension.

19. The implant of claim 15, wherein the implant comprises at least one of stainless steel, thermoplastic, polymethylmethacrylate, nylon, and polypropylene.

20. The implant of claim 15, wherein the fastening member comprises a flange attached to the middle portion to engage tissue proximal to the inner wall of Schlemm'"'"'s canal to hold the implant in place.

21. The implant of claim 15, wherein the fastening member comprises an expandable member adapted to engage a wall of the natural aqueous outflow space when the implant is positioned in the eye.

22. The implant of claim 15, wherein the wall thickness of the middle portion is thin relative to the diameter of the middle portion.

23. The implant of claim 15, wherein the fastening member comprises flanges disposed at the distal end and the proximal end whose outside diameters are greater than the outside diameter of the middle portion so as to retain the implant in the passageway once inserted.