CORNEAL EPITHELIAL POCKET FORMATION SYSTEMS, COMPONENTS AND METHODS

• US 20070239184A1
• Filed: 03/29/2007
• Published: 10/11/2007
• Est. Priority Date: 04/10/2006
• Status: Active Grant

• Current Assignee: Forsight Labs, LLC
• Original Assignee: Forsight Labs, LLC
• Inventors: Wolf, Daniel, Gaeckle, Markus, Maas, Helmut, Riehl, Tanja
• Granted Patent: US 7,883,520 B2
• Time in Patent Office: Days
• US Class Current: 606/166
• CPC Class Codes: A61F 9/0133 Knives or scalpels specially adapted therefor

Abstract

Corneal epithelial pocket formation systems include a cutting head and a blade coupled to the cutting head. The blade is coupled to the cutting head at an orientation that is effective in maintaining a viable separated pocket defining portion of corneal epithelium of an eye of a patient during formation of a corneal epithelial pocket of the eye. The blade includes a cutting edge surface at its distal end. The cutting edge surface is effective in separating the corneal epithelium from the underlying Bowman'"'"'s membrane of the eye without leaving residual corneal epithelial cells in contact with Bowman'"'"'s membrane that may result in corneal epithelial cell growth between a corneal implant located in the corneal epithelial pocket and the underlying Bowman'"'"'s membrane. Versions of the present systems include spring loaded blade holders, which may be removable from the cutting head. Versions also can include applanators. Packages containing spring loaded blade holders and blades, and disposable blades useful with the present systems are also described. The components, including disposable components, can be used to produce the present systems, and the present systems and components can be used in methods of enhancing or correcting a patient'"'"'s vision.

Claims

1. A corneal epithelial pocket formation system, comprising:

a cutting head; and

a blade coupled to the cutting head at an orientation effective in maintaining a viable separated pocket defining portion of corneal epithelium of an eye of a patient during formation of a corneal epithelial pocket of the eye, the blade comprising a cutting edge surface at the distal end of the blade effective in separating the corneal epithelium from an area of the underlying Bowman'"'"'s membrane of the eye substantially without leaving residual corneal epithelial cells in contact with Bowman'"'"'s membrane in the area that may result in corneal epithelial cell growth between a corneal implant located in the corneal epithelial pocket and the underlying Bowman'"'"'s membrane.

2. The system of claim 1, wherein the blade is oriented at an angle of about 0°

from a straight line extending along a longitudinal guidance path of the blade.

3. The system of claim 1, wherein the cutting edge surface is effective in separating the corneal epithelium from the underlying Bowman'"'"'s membrane without leaving any visually identifiable corneal epithelial cells adjacent to the underlying Bowman'"'"'s membrane.

4. The system of claim 1, wherein the blade has a maximum width substantially equal to the length of the cutting edge surface.

5. The system of claim 1, wherein the blade has a maximum width at the distal end of the blade and a second width at a more proximal location that is less than the maximum width.

6. The system of claim 1, wherein the blade is configured to be transversely oscillated, and has a distal portion that has a width effective in forming a corneal epithelial pocket comprising first and second lateral epithelial pocket edges at Bowman'"'"'s membrane during transverse oscillation of the blade, and an adjacent proximal portion that has a proximal portion width effective in preventing contact of the proximal portion with the first or second lateral epithelial pocket edges during transverse oscillation of the blade.

7. The system of claim 1, wherein the blade is configured to be transversely oscillated, and the cutting head comprises an applanator effective in forming an applanation area having a minimum width that is greater than a maximum transverse dimension of the distal end of the blade during transverse oscillation of the blade.

8. The system of claim 1, wherein the cutting head comprises an applanator provided at a distance of at least about 190 micrometers from the cutting edge surface of the blade.

9. The system of claim 1, further comprising a removable blade holder in contact with the blade and removable from the cutting head.

10. The system of claim 9, wherein the blade holder is a spring loaded blade holder.

11. The system of claim 9, wherein the blade holder is formed from a resilient material providing a biasing force effective in controlling movement of the blade during formation of a corneal epithelial pocket.

12. The system of claim 9, wherein the blade holder, when engaged with the cutting head, is actuated by a motor to cause oscillation of the blade.

13. The system of claim 1, further comprising a suction ring that comprises a cornea contacting portion and a spaced apart cutting head guidance portion, and the blade cutting edge surface is located between the cornea contacting portion and the cutting head guidance portion during formation of the corneal epithelial pocket.

14. The system of claim 1, wherein the cutting edge surface has a cross-sectional radius in a range from about 300 nanometers to about 800 nanometers.

15. A corneal epithelial pocket formation system, comprising:

a suction ring comprising a cornea contacting portion and a spaced apart cutting head guidance portion;

a cutting head in contact with the cutting head guidance portion of the suction ring, the cutting head comprising an applanator configured to provide an applanation area on a cornea of an eye during a corneal epithelial pocket forming procedure, a spring loaded blade holder, and a blade extending from the spring loaded blade holder at an angle of about 0°

from a straight line extending along a longitudinal guidance path of the blade, the blade having a distal end portion that comprises a cutting edge surface defining a maximum width of the blade, and a proximal end portion defining a width less than the distal end portion; and

a housing comprising a motor configured to provide movement of the blade, the movement including transverse oscillating movement of the blade which causes the cutting edge surface to oscillate, the movement is effective to form an epithelial pocket having a maximum transverse dimension less than a minimum transverse dimension of the applanation area provided by the applanator.

16. A method for producing a corneal epithelial pocket formation system, comprising:

providing a corneal epithelial pocket forming blade retained by a spring loaded blade holder, the blade comprising a cutting edge surface at the distal end of the blade effective in separating a portion of corneal epithelium of an eye of a patient from the underlying Bowman'"'"'s membrane of the eye during formation of a corneal epithelial pocket, substantially without leaving residual corneal epithelial cells in contact with Bowman'"'"'s membrane that may result in corneal epithelial cell growth between a corneal implant located in the corneal epithelial pocket and the underlying Bowman'"'"'s membrane; and

engaging the blade holder with a cutting head of a motorized device so that the blade is provided at an orientation effective in maintaining a viable separated pocket defining portion of corneal epithelium of an eye of a patient during formation of a corneal epithelial pocket of the eye.

17. A method for enhancing vision of a patient, comprising:

forming a corneal epithelial pocket in an eye of a patient using a corneal epithelial pocket formation system, comprising;

a cutting head; and

a blade coupled to the cutting head at an orientation effective in maintaining a viable separated pocket defining portion of corneal epithelium of an eye of a patient during formation of a corneal epithelial pocket of the eye, the blade comprising a cutting edge surface at the distal end of the blade effective in separating the corneal epithelium from an area of the underlying Bowman'"'"'s membrane of the eye substantially without leaving residual corneal epithelial cells in contact with Bowman'"'"'s membrane in the area that may result in corneal epithelial cell growth between a corneal implant located in the corneal epithelial pocket and the underlying Bowman'"'"'s membrane.

18. The method of claim 17, further comprising inserting a corneal implant into the corneal epithelial pocket.

19. A package, comprising:

a corneal epithelial pocket forming blade; and

a spring loaded blade holder removably engageable with a cutting head of a motorized device, the blade holder being structured to retain the corneal epithelial pocket forming blade at an orientation effective in maintaining a viable separated pocket defining a portion of corneal epithelium of an eye of a patient during formation of a corneal epithelial pocket of the eye when the blade holder is engaged with the cutting head.

20. The package of claim 19, wherein the blade and blade holder are sterilized.

21. A blade for a corneal epithelial pocket formation system, comprising:

a distal end portion and an adjacent proximal portion; and

a cutting edge surface located at a distal end of the blade effective in separating a portion of corneal epithelium of an eye of a patient from an underlying Bowman'"'"'s membrane of the eye during formation of a corneal epithelial pocket, substantially without leaving residual corneal epithelial cells in contact with the Bowman'"'"'s membrane that may result in corneal epithelial cell growth between a corneal implant located in the corneal epithelial pocket and the underlying Bowman'"'"'s membrane, wherein the adjacent proximal portion is located in the corneal epithelial pocket during formation thereof and has a width less than the width of the distal end portion.