Corneal implant introducer and method of use

• US 6,050,999 A
• Filed: 12/18/1997
• Issued: 04/18/2000
• Est. Priority Date: 12/18/1997
• Status: Expired due to Fees

• Current Assignee: Addition Technology, Inc. (AJL Ophthalmic SA)
• Original Assignee: KeraVision, Inc.
• Inventors: Scholl, John A., Silvestrini, Thomas A., Paraschac, Joseph F.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US08/993,594
• Time in Patent Office: 852 Days
• Field of Search: 606/107, 606/1, 606/205, 623/4, 623/6, 604/62, 221/4, 219/236
• US Class Current: 606/107
• CPC Class Codes: A61F 2/148 Implantation instruments specially adapted therefor
• 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 623/906 Corneal

Abstract

A device for introducing a corneal implant into a cornea of a human eye. The device includes a body, a member coupled thereto, and a guide portion. The body has a distal end and a proximal end. The guide portion is disposed at the distal end of the body and forms a channel. The guide portion is configured for laterally supporting the implant when positioned in the channel and the member is arranged to axially support the implant when positioned in the channel.

Claims

1. A device for introducing a corneal implant into a cornea of a human eye in an implanted configuration, the device comprising a body, a member coupled thereto, a guide portion, said guide portion being sized for receiving the corneal implant in its said implanted configuration, said body having a distal end and a proximal end, the guide portion being disposed at the distal end of the body and forming a channel, the guide portion being configured for laterally supporting the implant when positioned in the channel and the member being arranged to axially support the implant when positioned in the channel, and a slide extending distally from the guide portion and adapted for insertion into the eye, the slide being configured to expose a portion of the implant when positioned on the slide.

2. A device as set forth in claim 1 wherein the member comprises a drive member movable in a distal direction to urge the implant through at least a portion of the channel.

3. A device as set forth in claim 1 wherein the body comprises an elongated tubular member configured for receiving at least one implant with a longitudinal axis of the implant extending generally parallel to a central longitudinal axis of the device.

4. A device as set forth in claim 3 wherein the drive member comprises a plunger axially slidable within the tubular member.

5. A device as set forth in claim 3 further comprising a retaining member extending from a distal end of the tubular member for retaining the implant within the device.

6. A device as set forth in claim 5 wherein the retaining member comprises a ring extending over the distal end of the tubular member.

7. A device as set forth in claim 6 wherein a distal end of the ring is tapered.

8. A device as set forth in claim 6 wherein the ring is made from a flexible, resilient material.

10. A device as set forth in claim 1 further comprising a slide extending from the distal end of the body and adapted for insertion into an incision formed in the cornea of the eye.

11. A device as set forth in claim 10 wherein the slide is curved in a forward direction away from a central longitudinal axis of the device, the slide being positioned on the body such that the implant is located rearward of the slide as it exits the body.

12. A device as set forth in claim 10 wherein the slide is threadably connected to the body for removal and replacement of the slide.

13. A device as set forth in claim 10 wherein the body comprises a first locking element and the slide comprises a second locking element engageable with the first locking element for securely connecting the slide to the body.

9. A device for introducing a corneal implant into a cornea of a human eye in an implanted configuration, the device comprising a body, a member coupled thereto, and a guide portion, said guide portion being sized for receiving the corneal implant in its said implanted configuration, said body having a distal end and a proximal end, the guide portion being disposed at the distal end of the body and forming a channel, the guide portion being configured for laterally supporting the implant when positioned in the channel and the member being arranged to axially support the implant when positioned in the channel, the distal end of the ring being normally biased to a closed position to prevent the implant from being inadvertently dispensed from the device, the distal end of the ring being expansible to an open position to allow the implant to pass through an opening in the distal end of the ring.

14. A device for introducing a corneal implant into a cornea of a human eye, the device comprising a body, a guide portion, and a cartridge for storing and retaining a plurality of implants, the cartridge comprising a piston and a lever, the lever being movable between a closed position for retaining the implants within the cartridge, and an open position for releasing one implant from the cartridge, said body having a distal end and a proximal end, the guide portion being disposed at the distal end of the body, the guide portion being configured for laterally supporting the implant and the piston being arranged to axially support the implant when positioned on the guide.

15. A device as set forth in claim 14 wherein the lever is biased to its closed position, the piston being operable upon movement in a distal direction to pivotally move the lever from its closed position to its open position.

16. A device for introducing a corneal implant into a cornea of a human eye, the device comprising a body, a member coupled thereto, and a guide portion, said body having a distal end and a proximal end, the guide portion being disposed at the distal end of the body and forming a channel, the guide portion being configured for laterally supporting the implant when positioned in the channel and comprising a pair of fingers configured for grasping the implant therebetween, the fingers being movable between an open position for loading and releasing the implant into and from the device, and a closed position for holding the implant, each finger having a longitudinal groove formed therein, the grooves defining the channel when the fingers are in the closed position, and the member being arranged to axially support the implant when positioned in the channel.

17. A device as set forth in claim 16 wherein the channel has a generally hexagonal cross-sectional shape.

18. A device as set forth in claim 16 wherein the member comprises a piston operable to move the implant through the channel as the piston moves in a distal direction.

20. A device as set forth in claim 16 wherein the member comprises a stop connected to one of the fingers for limiting longitudinal movement of the implant relative to the channel and preventing movement of the implant in a distal direction away from the eye during introduction of the implant into the eye, the channel having a cross-sectional shape generally corresponding to the cross-sectional shape of the implant.

19. A device for introducing a corneal implant into a cornea of a human eye in an implanted configuration, the device comprising a body, a member coupled thereto, and a guide portion, said guide portion being sized for receiving the corneal implant in its said implanted configuration, said body having a distal end and a proximal end, the guide portion being disposed at the distal end of the body and forming a channel, the guide portion being configured for laterally supporting the implant when positioned in the channel and the member being arranged to axially support the implant when positioned in the channel, the guide portion comprising a pair of fingers configured for grasping the implant therebetween, the fingers being movable between an open position for loading and releasing the implant into and from the device, and a closed position for holding the implant, the fingers defining the channel when in the closed position, the body comprising a pair of generally parallel arms, the fingers extending from the arms, and further comprising a cam longitudinally slidable between the arms and operable to spread the arms to move the fingers to their open position.

21. A device for introducing a corneal implant into the cornea of a human eye in an implanted configuration, the device comprising a body having a distal end and a proximal end, a guide portion disposed at the distal end of the body and forming a channel, a corneal implant laterally supported within the channel in its said implanted configuration, a member coupled to said body such that it can provide axial support to the implant, and a slide extending distally from the guide portion and adapted for insertion into the eye, the slide being configured to expose a portion of the implant when positioned on the slide.

22. A device as set forth in claim 21 wherein the member comprises a piston slidably coupled to the body.

23. A device as set forth in claim 21 wherein the member comprises a flange fixedly coupled to the body for providing the axial support to the implant.

24. A method for introducing a corneal implant into a cornea of a mammalian eye in an implanted configuration comprising the steps of:

making an incision in the eye;

providing a corneal implant in a holder in its said implanted configuration;

placing the implant directly adjacent to the eye without inserting the holder into the eye;

axially forcing the implant into an incision formed in the cornea of the eye while the corneal implant remains in its said implanted configuration and the holder remains adjacent to the eye without insertion of the holder into the eye.

25. A method as set forth in claim 24 further comprising creating a stromal delamination to receive the implant.

28. A method as set forth in claim 24 wherein the step of providing a corneal implant in a holder comprises moving a piston in a proximal direction to move fingers of the holder away from one another to load the implant into the holder.

29. A method as set forth in claim 24 wherein the step of axially forcing the implant into the incision comprises moving a piston of the holder to force the implant into the incision.

26. A method for introducing a corneal implant into a cornea of a mammalian eye comprising the steps of:

providing a corneal implant in a holder;

placing the implant in the holder and sterilizing the holder after placing the implant into the holder; and

axially forcing the implant into an incision formed in the cornea of the eye.

27. A method as set forth in claim 26 wherein placing the implant into the holder comprises placing a plurality of implants into a cartridge and inserting the cartridge into the holder.

30. A device for introducing a corneal implant into a cornea of a human eye, the device comprising a body, a member coupled thereto, a guide portion, and a slide extending from the distal end of the body and adapted for insertion into an incision formed in the cornea of the eye, at least a portion of the slide being generally planar, said body having a distal end and a proximal end, the guide portion being disposed at the distal end of the body and forming a channel, the guide portion being configured for laterally supporting the implant when positioned in the channel and the member being arranged to axially support the implant when positioned in the channel.