Method and apparatus for reprofiling or smoothing the anterior or stromal cornea by scraping

• US 5,591,185 A
• Filed: 11/28/1994
• Issued: 01/07/1997
• Est. Priority Date: 12/14/1989
• Status: Expired due to Fees

• Current Assignee: Corneal Conturing Development, L.L.C.
• Original Assignee: Corneal Conturing Development, L.L.C.
• Inventors: Nadalsky, Michael, Gibson, David R., Nordquist, Robert E., Kilmer, Lauren G.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/345,245
• Time in Patent Office: 771 Days
• Field of Search: 606/166, 606/161, 606/5, 606/180
• US Class Current: 606/166
• CPC Class Codes: A61F 9/013 Instruments for compensation of ocular refraction A61F9/008 takes precedence; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
• CPC Class Codes: Y10S 977/904 for medical, immunological, body treatment, or diagnosis

Abstract

A method for reprofiling or otherwise smoothing and enhancing the anterior or stromal cornea by scraping. The method is useful as a primary technique for reprofiling the stromal portion of the cornea following a lamellar keratectomy or as a secondary technique for use in combination with other corneal refractive procedure to dislocate debris and smooth and enhance a worked area of the cornea.

Claims

1. A method of reprofiling a cornea, which comprises:

(a) performing a lamellar keratectomy to obtain a corneal lamella and reveal a stromal bed;

(b) scraping said stromal bed with a sharpened, substantially planar knife-edge blade to obtain a desired curvature, said knife-edge blade being oriented substantially perpendicular relative to said stromal bed; and

(c) replacing said corneal lamella upon said stromal bed.

2. A method of reprofiling a cornea, which comprises:

(a) performing a lamellar keratectomy to obtain a corneal lamella and reveal a stromal bed;

(b) rotating or oscillating a scraping tool upon said stromal bed to modify the contour of said stromal bed and obtain a desired curvature, said scraping tool having at least one sharpened, substantially planar knife-edge scraper blade for placement substantially perpendicular relative to said stromal bed; and

(c) replacing said corneal lamella upon said stromal bed.

3. A method of reprofiling a cornea, which comprises:

(a) performing a lamellar keratectomy to obtain a corneal lamella and reveal a stromal bed;

(b) reshaping said stromal bed by laser photoablation to obtain a modified stromal bed of a desired curvature;

(c) smoothing the surface of said modified stromal bed by rotating or oscillating a scraping tool upon said surface; and

(d) replacing said corneal lamella upon said stromal bed.

4. A method of reprofiling a cornea, which comprises:

(a) resetting a portion of said cornea in a manner such that said resected portion remains hinged to said cornea at one point;

(b) folding said resected portion up and away from said cornea to reveal a stromal bed;

(c) reshaping said stromal bed by laser photoablation to obtain a modified stromal bed of a desired curvature;

(d) smoothing the surface of said modified stromal bed by rotating or oscillating a scraping tool upon said surface; and

(e) folding said resected portion back over said modified stromal bed.

5. A method of smoothing an anterior or exposed stromal corneal surface that has been corrugated, rippled, roughened or hardened due to the performance of a corneal refractive procedure, which comprises rotating or oscillating a scraping tool upon said corrugated, rippled, roughened or hardened surface until said surface is smoothed, said scraping tool having at least one sharpened, substantially planar knife-edge scraper blade for placement substantially perpendicular relative to said surface.

6. A method of dislocating debris from an anterior or exposed stromal corneal surface that has been corrugated, rippled, roughened or hardened due to the performance of a corneal refractive procedure, which comprises the steps of rotating or oscillating a scraping tool upon said debris-containing surface until said debris is dislodged, said scraping tool having at least one sharpened, substantially planar knife-edge scraper blade for placement substantially perpendicular relative to said surface.

7. A method of reprofiling a cornea, which comprises:

(a) resecting a portion of said cornea in a manner such that said resected portion remains hinged to said cornea at one point;

(b) folding said resected portion up and away from said cornea to reveal a stromal bed;

(c) performing a corneal refractive procedure to obtain a modified stromal bed of a desired curvature;

(d) smoothing the surface of said modified stromal bed by rotating or oscillating a scraping tool upon said surface; and

(e) folding said resected portion back over said modified stromal bed.

8. A method of enhancing the optical zone of a cornea, which comprises the steps of performing a corneal refractive procedure as a primary technique for reprofiling said cornea followed by performing a distinct secondary technique, said secondary technique comprising rotating or oscillating a scraping tool upon the surface of said cornea, said scraping tool having at least one sharpened, substantially planar knife-edge scraper blade for placement substantially perpendicular relative to said surface.

9. An improved method of reprofiling a cornea wherein a corneal refractive procedure is performed upon an anterior or exposed stromal corneal surface as a primary technique to alter the refractive characteristics of said cornea, said procedure producing a worked area upon said cornea, the improvement comprising performing a distinct secondary technique to smooth and enhance said worked area, said secondary technique comprising rotating or oscillating a scraping tool upon said worked area of said cornea, said scraping tool having at least one sharpened, substantially planar knife-edge scraper blade for placement substantially perpendicular relative to said worked area.

10. An apparatus for reprofiling the anterior or stromal corneal portion of an eye of animals (including humans), said eye having a visual axis, to change the corneal radius and thus correct refractive errors, to finish or fine tune the cornea following a refractive correction procedure, or to otherwise smooth or enhance the cornea following a refractive correction procedure, comprising:

a transparent, resilient vacuum ring for attachment to said cornea coaxially to said visual axis;

an adapter for attachment to said vacuum ring, said adapter having conduits for vacuum communication with said vacuum ring;

a rotatable sleeve having a central bore axially extending therethrough for threadable engagement with said adapter, said rotatable sleeve having a lower end for making sealed contact with said cornea;

means to provide an independently controllable vacuum to said vacuum ring and to the interior of said sleeve;

a micrometer assembly, said micrometer assembly having a lower piece for coaxial engagement with said central bore of said sleeve and a micrometer nut for affecting incremental vertical movement of said assembly coaxially relative to a visual axis of said cornea;

said lower piece and said micrometer nut having a central bore axially extending therethrough; and

a scraping tool having a cylindrical body with a central bore, said body adapted to be received within said central bores of said lower piece of said micrometer assembly and said micrometer nut, said scraping tool having, at its upper end, an enlarged grip which rests upon said micrometer nut, and at least one sharpened knife edge substantially planar blade at its bottom end for scraping said anterior or stromal corneal portion.

11. The apparatus of claim 10, wherein said lower piece of said micrometer assembly is threadably connected with said central bore of said sleeve.

12. The apparatus of claim 10, wherein said lower piece of said micrometer assembly is integrally joined to said sleeve such that said lower piece and said sleeve are one piece.

13. The apparatus according to claim 10, further comprising a means for viewing said cornea during reprofiling, said means being insertable into said central bore of said scraping tool.

14. The apparatus according to claim 13, wherein said means for viewing comprises a magnifying stem for use in conjunction with a surgical microscope.

15. The apparatus according to claim 13, wherein said means for viewing comprises an optical viewer having an elongated sleeve insertable into said central bore of said scrapping tool, a lens, a video camera, and means to connect said camera to a video monitor.

16. The apparatus according to claim 15, further comprising a hand held support for retaining said micrometer assembly and means affixed to said hand held support to provide a controllable light source adjacent said vacuum ring and sleeve assembly.

17. The apparatus of claim 15, further comprising means for duplicating manual-like motion to impart to said scraping tool a rotating or oscillating motion about a vertical axis that is substantially coaxial with said visual axis.

18. A method of reprofiling the anterior or stromal corneal portion of an eye of animals (including humans), said eye having a visual axis, to change the corneal radius and thus correct refractive errors, to finish or fine tune the cornea following a refractive correction procedure, or to otherwise smooth or enhance the cornea following a refractive correction procedure, comprising the steps of:

positioning a vacuum ring upon the cornea and coaxial to a visual axis of said cornea;

positioning an adapter upon said vacuum ring, said adapter having conduits for vacuum communication with said vacuum ring;

threadably engaging a rotatable sleeve having a central bore axially extending therethrough with said adapter, said rotatable sleeve having a lower end for making sealed contact with said cornea;

supplying a first vacuum to said ring, and a second vacuum to an interior of said sleeve;

positioning a micrometer assembly upon said sleeve, said micrometer assembly having a lower piece for coaxial engagement with said central bore of said sleeve and a micrometer nut for affecting incremental vertical movement of said assembly coaxially relative to a visual axis of said cornea, said lower piece and said micrometer nut having a central bore axially extending therethrough;

positioning, upon said micrometer nut and within said central bores of said lower piece and said micrometer assembly, a corneal scraping tool having a sharpened knife edge substantially planar blade such that said knife edge is perpendicular to said visual axis of said cornea; and

turning said scraping tool to scrape said anterior or stromal corneal portion to obtain a desired change in curvature.

19. The method of claim 18, wherein said lower piece of said micrometer assembly is threadably connected with said central bore of said sleeve.

20. The method of claim 18, wherein said lower piece of said micrometer assembly is integrally joined to said sleeve such that said lower piece and said sleeve are fixedly joined together.

21. The method according to claim 18, further comprising a means for viewing said cornea during reprofiling, said means being insertable into said central bore of said scraping tool.

22. The method according to claim 21, wherein said means for viewing comprises a magnifying stem for use in conjunction with a surgical microscope.

23. The method according to claim 21, wherein said means for viewing comprises an optical viewer having an elongated sleeve insertable into said central bore of said scraping tool, a lens, a video camera, and means to connect said camera to a video monitor.

24. The method according to claim 23, further comprising a hand held support for retaining said micrometer assembly and means affixed to said hand held support to provide a controllable light source adjacent said vacuum ring and sleeve assembly.

25. The method of claim 18, further comprising means for duplicating manual-like motion to impart to said scraping tool a rotating or oscillating motion about a vertical axis that is substantially coaxial with said visual axis.