WO2000057799A1

WO2000057799A1 - Blade insertion apparatus for keratomes

Info

Publication number: WO2000057799A1
Application number: PCT/US2000/007705
Authority: WO
Inventors: Randall M. Meador; Michael L. Kliewer; Stan L. Smith
Original assignee: Lasersight Technologies, Inc.
Priority date: 1999-03-26
Filing date: 2000-03-23
Publication date: 2000-10-05
Also published as: WO2000057799A9; AU3770100A

Abstract

An apparatus (10), and technique for inserting a blade (26) into a keratome includes a blade holder (24), and a blade (26) having a cutting edge (30), the blade (26) being coupled with the blade holder (24) thereby defining a blade holder assembly (12). A housing assembly (12) is provided. The blade holder assembly (22) is disposed in the housing assembly (12) for movement with respect to the housing assembly (12). The housing assembly (12) is constructed, and arranged to protect the cutting edge (30) of the blade (24), and to receive a keratome. An ejector (44) is constructed, and arranged to move the blade holder assembly (22) in the housing assembly (12), and into a keratome (37) when a keratome (37) is received by the housing assembly (12). Thereafter, the injector (44) moves the keratome (37) from the housing assembly (12).

Description

BLADE INSERTION APPARATUS FOR KERATOMES

This application is based on and claims priority from U S Provisional Application 60/1 26,332, filed on March 26, 1999, and U S Provisional Application 60/126,693, filed March 29, 1999

Field of the Invention

The present invention relates generally to a device used for inserting a blade into a keratome while protecting the blade edge and preventing contamination of the sterile blade

Background of the Invention

Keratomes are used primarily in LASIK corrective eye procedures to generate a flap in the cornea After the flap is generated, laser refractive surgery is performed on the cornea to correct for eyesight conditions such as myopia, hyperopia, and astigmatism Typically, a stainless steel surgical blade is used as the cutting surface in the keratome and the sterile blade is disposed of after the procedure is completed

The blade edge is very sharp and the sharpness and integrity of the edge of the blade determines the cutting quality Currently, the state of the art is to use forceps or tweezers to manually pick up the bare blade and place the bare blade into the keratome However, handling of the bare blade in such a manner may compromise the integrity of the blade and/or may greatly increase the chance of contamination of the blade

Accordingly, there is a need to provide an apparatus and technique for inserting a blade into a keratome which protects the integrity of the blade edge and eliminates the possibility of contamination of the sterile blade SUMMARY OF THE INVENTION

An object of the invention is to fulfill the need referred to above In accordance with the principles of the present invention, this objective is achieved by providing an apparatus for inserting a blade into a keratome The apparatus includes a blade holder and a blade having a cutting edge The blade is coupled with the blade holder thereby defining a blade holder assembly A housing assembly is provided and the blade holder assembly is disposed in the housing assembly for movement with respect to the housing assembly The housing assembly is constructed and arranged to protect the cutting edge of the blade and to receive a keratome An ejector is constructed and arranged to move the blade holder assembly in the housing assembly and into a keratome when a keratome is received by the housing assembly Thereafter, the ejector may move the keratome from the housing assembly

In accordance with another aspect of the invention, a method of loading a blade into a keratome is provided The method includes providing a housing assembly carrying a blade holder assembly for movement within the housing assembly, the blade holder assembly includes a blade having a cutting edge, the blade is disposed in the housing assembly so that the cutting edge does not contact any part of the housing assembly, coupling a keratome to the housing assembly so that an interior of the keratome is disposed to receive the blade holder assembly, moving the blade holder assembly in the housing assembly and into the keratome, and removing the keratome from the housing assembly

Other objects, features and characteristics of the present invention, as well as the methods of operation and the functions of the related elements of the structure, the combination of parts and economics of manufacture will become more apparent upon consideration of the following detailed description and appended claims with reference to the accompanying drawings, all of which form a part of this specification

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described in greater detail herein below with reference to the drawings wherein:

FIG. 1 is a perspective view of a blade insertion apparatus provided in accordance with the principles of the present invention, shown in position to receive a keratome,

FIG. 2 is a perspective view of the blade insertion apparatus of FIG. 1 , shown in an unassembled condition,

FIG. 3 is a plan view of a conventional blade for use in the blade insertion apparatus of FIG. 1 ,

FIG. 4 is a plan view of a blade holder assembly of the blade insertion apparatus of FIG. 1 ,

FIG. 5 is a side view of the blade holder assembly of the blade insertion apparatus of FIG. 1 ;

FIG. 6 is a perspective view of the housing assembly of the blade insertion apparatus of FIG 1 ,

FIG. 7 is a view of the housing assembly as seen from the direction of arrow A in FIG. 6, and

FIG. 8 is a perspective view of an ejector of the blade insertion apparatus of FIG. 1 .

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

Special care must be taken to insert a blade into a keratome for performing LASIK corrective eye procedures. The blade is a sterile instrument that cannot be contaminated with handling prior to or during the procedures. Thus, with reference to FIG. 1 , an apparatus for inserting a blade into a keratome in accordance with the principles of the present invention is shown generally indicated at 10. The apparatus 10 includes a housing assembly, generally indicated at 12, having an upper housing 14 and a lower housing 16 (FIG. 2). The lower housing 16 has a plurality of pins 18 extending upwardly from an upper surface 19 thereof which mate with apertures 20 defined in the upper housing 14 to join the lower housing 16 to the upper housing 14. It can be appreciated that the pins 18 can be provided on the upper housing 14 with the apertures 20 being defined in the lower housing

16.

With reference to FIG. 7, the lower surface 21 of the upper housing 14 is constructed and arranged to receive a blade holder assembly, generally indicated at 22. It can be appreciated that the upper surface 19 of the lower housing 16 can be constructed and arranged to receive a blade holder assembly 22. As shown in FIG. 4, the blade holder assembly 22 includes a blade holder 24 coupled to a blade 26 for cutting corneal tissue. A suitable blade 26 is an

UltraEdge™ keratome blade commercially available from LaserSight Technologies, Inc in Winter Park, Florida. As shown in FIG 3, the blade 26 is generally rectangular member having a cutting edge 30 and a central cut-out 32 The blade holder 24 includes a protruding portion 34 (FIG 6) which is received in the cut-out 32 thus coupling the blade holder 24 to the blade 26.

As best shown in FIG 5, the upper and lower housings 14 and 16, respectively, have surface features which cooperate to define a keratome receiving recess 36 in an end of the housing assembly 12 The keratome receiving recess 36 is constructed and arranged to receive a conventional keratome 37, the function of which will be explained below. In addition, the upper and lower housings have surface features which cooperated to define a first channel 38 and a second channel 40. The first channel 38 (FIG. 6) extends from edge 39 of the housing assembly 12 to the keratome receiving recess 36.

The first channel 38 is disposed to receive the cutting edge 30 of the blade 26 so that the cutting edge 30 is never contacted by any portion of the housing assembly 12 Thus, the first channel 38 ensures that the integrity of the cutting edge 30 of the blade 26 is not compromised when the blade holder assembly 22 (and thus the blade 26) is moved from the housing assembly 12 and into the keratome 37, as will be explained more fully below.

Referring to FIG. 6, the blade holder 24 includes a portion 42 which extends upwardly from the blade 26 Portion 42 is received in the second channel 40 of the housing assembly 12 so as to be contacted within the second channel 40 as will be explained more fully below. The second channel 40 extends from edge 39 to the keratome receiving recess 36 and defines a guide for guiding the blade holder assembly 22 from the housing assembly 12 into the keratome 37. The upper and lower housings of the housing assembly 12 are preferably molded from plastic material, particularly LEXAN® to promote sliding of the blade holder 24 in the second channel 40. In addition, the blade holder 24 is preferably molded from plastic material, particularly "PEEK" to promote sliding of the blade holder 24 in the second channel 40.

The apparatus 10 includes an ejector 44 having an elongated portion 45 sized to be inserted into the second channel 40. The tip of the elongated portion 45 has a blade holder engaging surface 46. Surface 46 is constructed and arranged to move the blade holder assembly 22 into the keratome 37 when the keratome 37 is disposed in the keratome receiving recess 36. The ejector 44 also has a keratome engaging surface 48 disposed inwardly from the tip of the ejector 44. The keratome engaging surface 48 is constructed and arranged to move the keratome 37, with the blade holder assembly 22 therein, from the housing assembly 12. A handle 47 is coupled to the elongated portion for manually manipulating the ejector 44.

To assemble the apparatus 10, first the blade holder assembly 22 is placed on the lower surface 21 of the upper housing 14. The upper housing 14 is then coupled to the lower housing via the pin- aperture connections as described above. Once assembled, the portion 42 of the blade holder 24 is disposed in the second channel 40 and the cutting edge 30 of the blade 26 is disposed in the first channel 38 and is thus protected. The housing assembly 12 with the blade holder assembly 22 therein, and the ejector 44 are sterilized and packaged.

To use the apparatus 10, the package is opened in a sterile environment. The keratome 37 is inserted into the keratome receiving recess 36 and is located therein via location pads 50 of the lower housing 16. The keratome 37 may be, e.g., the UltraShaper™ cutting head A991 1 1 commercially available from LaserSight Technologies, Inc The keratome 37 has an opening 51 to receive the blade holder assembly 22 therein The ejector 44 is inserted into the second channel 40 at edge 39 of and into the assembled housing 12 until the blade holder engaging surface 46 contacts portion 42 of the blade holder assembly 22 The ejector 44 is pushed farther into the second channel 40 which pushes the blade holder assembly 22 into the opening 51 in the keratome 37 The length engaging surface 46 is such that the blade holder assembly 22 is centered in the keratome 37 Still further insertion of the ejector 44 into the second channel 40 causes the keratome engaging surface 48 of the ejector 44 to engage the keratome 37 to eject the keratome 37, with the blade holder assembly 22 therein, from the housing assembly 12 Thus, the blade 26 is protected from contamination and the cutting edge 30 of the blade 26 protected from being compromised The empty housing assembly 12 and the ejector 44 can then be discarded

Thus, the apparatus of the invention inserts a blade into a keratome using an apparatus in a manner which protects the integrity of the blade edge, eliminates the possibility of contamination of the sterile blade, properly loads the blade into its correct position within the keratome, and ejects the keratome from the apparatus when the blade is properly loaded in the keratome

The foregoing preferred embodiments have been shown and described for the purposes of illustrating the structural and functional principles of the present invention, as well as illustrating the methods of employing the preferred embodiments and are subject to change without departing from such principles Therefore, this invention includes all modifications encompassed within the spirit of the following claims

Claims

What is claimed is

1 An apparatus for inserting a blade into a keratome, the apparatus comprising a blade holder, a blade having a cutting edge, said blade being coupled with said blade holder thereby defining a blade holder assembly, and a housing assembly, said blade holder assembly being disposed in said housing assembly for movement with respect to said housing assembly, said housing assembly being constructed and arranged to protect said cutting edge of said blade and to receive a keratome

2 The apparatus according to claim 1 , further comprising an ejector constructed and arranged to move said blade holder assembly in said housing assembly and into a keratome when a keratome is received by said housing assembly, and thereafter to move the keratome from said housing assembly

3 The apparatus according to claim 2, wherein said housing assembly includes a keratome receiving recess

4 The apparatus according to claim 3, wherein said housing assembly includes a channel communicating with said keratome receiving recess and disposed to receive said cutting edge of said blade so that said cutting edge is not contacted by any portion of said housing assembly as said blade holder assembly is moved

5 The apparatus according to claim 3, wherein said housing assembly includes a channel communicating with said keratome receiving recess and receiving at least a portion of said blade holder assembly so that said blade holder assembly may move in said second channel towards to said keratome receiving recess

6 The apparatus according to claim 1 , wherein said blade includes a cut-out therein and said blade holder includes a protruding portion engaged with said cut-out to couple said blade holder to said blade

7 The apparatus according to claim 5, wherein said portion of said blade holder assembly extends upwardly from said blade so as to be contacted within said second channel

8 The apparatus according to claim 1 , wherein said housing assembly is composed of plastic

9 The apparatus according to claim 3, wherein said housing assembly comprises an upper housing coupled to a lower housing with said blade holder assembly disposed between said upper and lower housings

10 The apparatus according to claim 9, wherein one of said upper and lower housings includes pins and the other of said upper and lower housings includes recesses receiving said pins to coupled said upper and lower housings

1 1 The apparatus according to claim 9, wherein said upper and lower housings cooperate to define a keratome receiving recess

12 The apparatus according to claim 1 1 , wherein said upper and lower housings cooperate to define a channel communicating with said keratome receiving recess and disposed to receive said cutting edge of said blade so that said cutting edge is not contacted by any portion of said housings as said blade holder assembly is moved

13. The apparatus according to claim 1 1 , wherein said upper and lower housings cooperate to define a channel communicating with said keratome receiving recess and receiving at least a portion of said blade holder assembly so that said blade holder assembly may move in said second channel towards to said keratome receiving recess.

14. The apparatus according to claim 5, wherein said ejector has a blade holder contacting surface at a tip thereof to contact said portion of said blade holder assembly and a keratome engaging surface disposed inwardly from said tip to engage a keratome.

15. The apparatus according to claim 14, wherein a portion of said ejector is sized to be inserted into said channel to contact said portion of said blade holder assembly.

16. The apparatus according to claim 1 , in combination with a keratome received by said housing assembly.

17. The apparatus according to claim 16, wherein said housing assembly includes a keratome receiving recess which receives said keratome therein.

18. A method of loading a blade into a keratome, the method including: providing a housing assembly carrying a blade holder assembly for movement within said housing assembly, said blade holder assembly including a blade having a cutting edge; coupling a keratome to said housing assembly; moving said blade holder assembly into said keratome; and removing said keratome from said housing assembly.

19. The method according to claim 18, wherein said blade is disposed in said housing assembly so that said cutting edge does not contact any part of said housing assembly.

20. The method according to claim 18, wherein an interior of said keratome is disposed to receive said blade holder assembly.

21 . The method according to claim 18, wherein an ejector is provided which is operatively associated with said housing assembly, said ejector initially contacting said blade holder assembly to move said blade holder assembly into said keratome and thereafter, said ejector contacting said keratome to remove the keratome from said housing assembly.

22. The method according to claim 21 , wherein said ejector centers the blade holder assembly in the keratome.

23. The method according to claim 21 , wherein said housing assembly has a first channel receiving said cutting edge and a second channel receiving at least a portion of said blade holder assembly, the method including inserting said ejector into said second channel to first contact said portion of said blade holder assembly to move the blade holder assembly in said housing assembly and into the keratome and further inserting said ejector into said second channel until said ejector contacts said keratome to remove the keratome from said housing assembly.

24. An apparatus for inserting a blade into a keratome, the apparatus comprising: cutting means for cutting corneal tissue, said cutting means having a cutting edge; and housing means for housing said cutting means for movement with respect to said housing means, said housing means being constructed and arranged to protect said cutting edge of cutting means and to receive a keratome

25. The apparatus according to claim 24, further comprising means for moving said cutting means in said housing means and into a keratome when a keratome is received by said housing means, and thereafter to move the keratome from said housing means.

26. The apparatus according to claim 24, in combination with a keratome received by said housing means.