Instruments for use in performing gel injection adjustable keratoplasty

• US 5,607,437 A
• Filed: 09/01/1994
• Issued: 03/04/1997
• Est. Priority Date: 07/12/1990
• Status: Expired due to Term

• Current Assignee: Miami University
• Original Assignee: University of Miami
• Inventors: Lee, William G., Parel, Jean-Marie A., Simon, Gabriel
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/299,423
• Time in Patent Office: 915 Days
• Field of Search: 606/107, 606/166, 606/181, 606/172, 40/618, 40/621, 40/622
• US Class Current: 606/166
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2/147 Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/0133 Knives or scalpels specially adapted therefor
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C08G 65/30 Post-polymerisation treatment, e.g. recovery, purification, drying
• CPC Class Codes: C08G 65/32 Polymers modified by chemical after-treatment
• CPC Class Codes: C08J 2371/02 Polyalkylene oxides
• CPC Class Codes: C08J 3/075 Macromolecular gels
• CPC Class Codes: C08J 3/28 Treatment by wave energy or particle radiation
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

The present invention provides a surgical technique and instrument kit that allows for subtle modification of the corneal curvature by interlamellar injection of a synthetic gel at the corneal periphery while sparing the optical zone. The gel viscosity, volume and disposition within the surgical annular track as well as the diameter of the track, width, depth, and location are all parameters in the refractive change obtained. Following ultrasonic pachymetry performed centrally and at a selected wound entrance located about 2.5 to 3.5 mm from the apex, a one millimeter or so wide, about 75-85% corneal thickness depth radial incision is performed with a micrometric diamond knife adjusted to about 86% corneal thickness. Inserted through the partial-depth incision, a corkscrew-like dissector or helicoidal spatula forms a 360° annular track centered about the apex. A transparent gel is manually injected through the incision, filling the annular channel. Using a surgical keratometer mounted to an operation microscope, the final corneal power is adjusted by massaging and removing the gel as necessary during the primary procedure or subsequent procedures, as the GIAK technique is reversible.

Claims

1. A guiding device for facilitating the insertion of a delaminating device into an incision in the cornea for separating the lamellae of the cornea during a procedure for altering the radius of curvature of the cornea of an eye, said device comprising:

a first section consisting of a flat planar surface of uniform thickness for insertion into an incision in a cornea for guiding the end of a delaminating device between the lamellae of the cornea at a selected depth, and

a second section, coupled to said guide section, for contacting the surface of the cornea to limit the depth of travel of said first section into the incision, wherein said first and second sections are coplanar, and wherein said first section extends curvillinearly from said second section.

2. The device as in claim 1, having a thickness of less than 300 microns.

3. The device as in claim 2, wherein its thickness measures between approximately 80 microns and approximately 100 microns.

4. The device as in claim 1, whereby said device is composed of stainless steel.

5. The device as in claim 1, having a rigidity greater than approximately 5×

10⁶ newtons/meter².

6. The device as in claim 1, whereby said device is composed of plastic.

7. The device as in claim 1, wherein said first and second sections are substantially perpendicular to each other.

8. The device as in claim 1, wherein the length of said first section ranges between 1 millimeter and 6 millimeters.

9. The device as in claim 1, whereby said second section contains portions for contacting the surface of cornea extending further than both outer edges of said first section.

10. A guide for facilitating the insertion of a curved delaminating device into an incision in the cornea for forming an annular channel between lamellae in the cornea at a desired depth spaced radially from the central region of the cornea during a procedure for altering the radius of curvature of the cornea of an eye, said guide comprising:

a first section consisting of a flat planar surface of uniform thickness for insertion into an incision in the cornea for guiding a curved delaminating device between lamellae at a desired depth within the incision; and

a second section consisting of a flat planar surface of the same uniform thickness as said first section, coupled to and co-planar with said first section, for contacting the surface of the cornea to limit the depth of penetration of said first section into the incision in the cornea, wherein said first section extends curvillinearly from said second section at the same radius of curvature as the curved delaminating device.

11. The guide as in claim 10, having a uniform thickness of less than 300 microns.

12. The guide in claim 11, wherein its thickness measures between approximately 80 microns and 100 microns.

13. The guide as in claim 10, wherein the width of said first section is less than the thickness of the delaminating device.

14. The guide as in claim 10, having a rigidity greater than 5×

10⁶ newtons/meter².

15. The guide as in claim 10, wherein said device is composed of plastic.