DEVICES AND METHODS FOR OCULAR SURGERY

• US 20190183681A1
• Filed: 12/14/2018
• Published: 06/20/2019
• Est. Priority Date: 12/14/2017
• Status: Active Grant

• Current Assignee: Carl Zeiss Meditec Cataract Technology Inc. (Carl-Zeiss-Stiftung)
• Original Assignee: Iantech, Inc. (Carl-Zeiss-Stiftung)
• Inventors: Schaller, Michael P., Bentley, Peter, Clauson, Luke W., Guguchkova, Maria Tsontcheva, Newell, Matthew, Larson, Adam
• Granted Patent: US 10,932,951 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2009/0087 Lens
• CPC Class Codes: A61F 2009/00889 Capsulotomy
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• CPC Class Codes: A61F 9/00745 using mechanical vibrations, e.g. ultrasonic
• CPC Class Codes: A61F 9/00754 for cutting or perforating the anterior lens capsule, e.g. capsulotomes
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61F 9/008 using laser
• 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

Abstract

A surgical device for cutting a lens within a capsular bag of an eye. Related methods, systems, and devices are also provided.

Claims

1. A surgical device for cutting a lens within a capsular bag of an eye, the device comprising:

a shaft extending from a housing along a longitudinal axis of the device, the shaft having a lumen and a distal end;

a cutting element movable through the lumen of the shaft, the cutting element comprising;

a first sectioning element; and

a second sectioning element,

wherein each of the first and second sectioning elements has a first end, a second end, and a distal loop formed between the first and second ends; and

an actuator operatively coupled to the cutting element,

wherein the cutting element is configured to transition from a first, retracted configuration towards a second, expanded configuration upon a first activation of the actuator, and

wherein, when in the second, expanded configuration, the distal loop of each of the first and second sectioning element defines an enlarged open area located outside the distal end of the shaft, the enlarged open area having a first leg advanced distally relative to the distal end of the shaft and a second leg positioned proximally to the distal end of the shaft.

2. The device of claim 1, wherein, when the cutting element is in the second, expanded configuration, the distal loops defining the enlarged open areas of each of the first and second sectioning elements are aligned generally within a plane parallel to one another.

3. The device of claim 2, wherein a second activation of the actuator or a second, different actuator causes the distal loop defining the enlarged open area of one of the first and second sectioning elements to move angularly relative to the plane transitioning the cutting element into a third, splayed configuration.

4. The device of claim 2, wherein a second activation of the actuator or a second, different actuator causes the distal loop defining the enlarged open area of both of the first and second sectioning elements to move angularly away from one another transitioning the cutting element into a third, splayed configuration.

5. The device of claim 1, further comprising an intermediate sectioning element positioned between the first and second sectioning elements, wherein the intermediate sectioning element has a first end, a second end, and a distal loop formed between the first and second ends.

6. The device of claim 5, wherein, when the cutting element is in the second, expanded configuration, the distal loop of the intermediate sectioning element defines an enlarged open area located outside the distal end of the shaft, the enlarged open area of the intermediate sectioning element having a first leg advanced distally relative to the distal end of the shaft and a second leg positioned proximally to the distal end of the shaft.

7. The device of claim 6, wherein, when the cutting element is in the second, expanded configuration, the distal loops defining the enlarged open areas of each of the first, second, and intermediate sectioning elements are aligned generally within a plane parallel to one another.

8. The device of claim 7, wherein a second activation of the actuator or a second, different actuator causes the distal loops defining the enlarged open areas of both the first and second sectioning elements to move angularly away from the intermediate sectioning element transitioning the cutting element into a third, splayed configuration.

9. The device of claim 8, wherein the first and second sectioning elements move between about 15 degrees to about 45 degrees relative to the plane, the plane being a substantially vertical plane.

10. The device of claim 1, wherein the first ends and the second ends of each of the first and second sectioning elements are movable relative to the shaft.

11. The device of claim 10, wherein the first ends are axially movable along the longitudinal axis of the device, and wherein the second ends are angularly movable relative to the longitudinal axis of the device.

12. The device of claim 1, wherein the first ends of each of the first and second sectioning elements are movable relative to the longitudinal axis of the device and the second ends of each of the first and second sectioning elements are fixed relative to the longitudinal axis of the device.

13. The device of claim 12, wherein the first ends are axially movable along the longitudinal axis of the device and angularly movable relative to the longitudinal axis of the device.

14. The device of claim 1, wherein the actuator is a slider movable along the longitudinal axis of the housing.

15. The device of claim 14, further comprising a sled positioned within the housing and coupled to move with the slider relative to the housing, the sled having a first loop carrier coupled to the first sectioning element and a second loop carrier coupled to the second sectioning element.

16. The device of claim 15, wherein movement of the slider a first distance in a distal direction relative to the housing translates the sled distally causing the distal loops of the first and second sectioning elements to define the enlarged open areas and transition the cutting element towards the second, expanded configuration.

17. The device of claim 16, wherein movement of the slider a second distance in the distal direction beyond the first distance causes the distal loops defining the enlarged open areas of the first and second sectioning elements to move angularly away from one another transitioning the cutting element into a third, splayed configuration.

18. The device of claim 16, wherein the first loop carrier is configured to rotate around a first axis of rotation in a first direction and the second loop carrier is configured to rotate around a second axis of rotation in a second direction opposite the first direction.

19. The device of claim 18, wherein rotation of the first loop carrier around the first axis of rotation causes the distal loop of the first sectioning element to splay in the first direction and rotation of the second loop carrier around the second axis of rotation causes the distal loop of the second sectioning element to splay in the second opposite direction.

20. The device of claim 19, wherein movement of the slider a second distance in the distal direction beyond the first distance rotates the first and second loop carriers around their axes of rotation transitioning the cutting element towards a third, splayed configuration.

21. The device of claim 16, further comprising a wedge positioned within a distal end region of the housing.

22. The device of claim 21, wherein movement of the slider a second distance in the distal direction beyond the first distance urges the first and second loop carriers against the wedge causing the first loop carrier to rotate around a first axis of rotation in a first direction and causing the second loop carrier to rotate around a second axis of rotation in a second, opposite direction resulting in the distal loops defining the enlarged open areas of the first and second sectioning elements to splay apart.

23. The device of claim 21, wherein the wedge is movable in a proximal direction upon actuation of a second, different actuator.

24. The device of claim 23, wherein movement of the wedge in a proximal direction urges the wedge against the first and second loop carriers causing the first loop carrier to rotate around a first axis of rotation in a first direction and causing the second loop carrier to rotate around a second axis of rotation in a second, opposite direction resulting in the distal loops defining the enlarged open areas of the first and second sectioning elements to splay apart.

25. The device of claim 23, wherein the wedge is movable in a proximal direction to cause splay of the first and second loop carriers independent of a relative location of the sled along the longitudinal axis of the device.

26. The device of claim 1, wherein, when the cutting element is in the second, enlarged configuration, the distal loops defining the enlarged open areas of the first and second sectioning element are generally oval in shape and have a maximum width of about 4.0 mm to about 20 mm, and a maximum height of about 1.0 mm to about 15 mm.

27. The device of claim 21, wherein the distal loops defining the enlarged open areas of the first and second sectioning elements are configured to splay angularly away from each other transitioning the cutting element into the third, splayed configuration independent of a size of the enlarged open areas.

28. The device of claim 27, wherein the size of the enlarged open areas of the first and second sectioning elements prior to splay is selectable.

29. The device of claim 28, further comprising an adjustor configured to change a relative distance between the wedge and the sled.

30. The device of claim 29, wherein a shorter relative distance achieves a smaller open area of the first and second sectioning elements in the second, expanded configuration prior to splay, and wherein a longer relative distance achieves a larger open area of the first and second sectioning elements prior to splay.

31. A surgical device for cutting a lens within a capsular bag of an eye, the device comprising:

a shaft extending from a housing along a longitudinal axis of the device, the shaft having a lumen and a distal end;

a cutting element movable through the lumen of the shaft, the cutting element comprising at least a first sectioning element having a first end, a second end, and a distal loop formed between the first and second ends;

a slider operatively coupled to the cutting element and movable along the longitudinal axis of the housing; and

a stroke counting mechanism coupled to the slider and contained within the housing,

wherein the cutting element is configured to transition from a first, retracted configuration towards a second, expanded configuration upon distal extension of the slider, and

wherein, when in the second, expanded configuration, the distal loop of the at least a first sectioning element defines an enlarged open area located outside the distal end of the shaft, the enlarged open area having a first leg advanced distally relative to the distal end of the shaft and a second leg positioned proximally to the distal end of the shaft, and

wherein the stroke counting mechanism is configured to track distal extensions and/or proximal extensions of the slider.

32. The device of claim 31, wherein the stroke counting mechanism is configured to cause a lock-out event that prevents distal extension of the slider after the lock-out event.

33. The device of claim 32, wherein the stroke counting mechanism comprises:

a cylindrical counting barrel having a plurality of ramp blocks;

a hard stop; and

a pair of slider ramps shaped and arranged to engage with the plurality of ramp blocks on the counting barrel causing the counting barrel to rotate around the longitudinal axis of the device.

34. The device of claim 33, wherein each distal extension of the slider turns the cylindrical counting barrel a fraction of a full revolution around the longitudinal axis of the device.

35. The device of claim 34, wherein the cylindrical counting barrel is configured to turn up to about 24 fractions before the lock-out event occurs.

36. The device of claim 35, wherein the lock-out event prevents distal extension of the slider and allows proximal retraction of the slider.

37. The device of claim 36, wherein the slider is configured to extend about 3 to about 30 strokes in a distal direction before the lock-out event occurs and the slider is locked in a rearward position.

38. The device of claim 33, further comprising a lock-out warning feature.

39. The device of claim 38, wherein the lock-out warning feature comprises a lock-out warning window extending through the housing providing a visible indication of a position of the counting barrel within the housing relative to the hard stop of the stroke counting mechanism.

40. The device of claim 39, wherein the counting barrel is axially movable within the housing and has an outer surface having a color that contrasts with a color of the housing.

41. The device of claim 40, wherein, when the counting barrel is positioned near the lock-out warning window, the color of the counting barrel is visible through the lock-out warning window providing an indication of the distal extensions of the slider available before the lock-out event occurs.

42. The device of claim 39, wherein the counting barrel has a series of markings on an outer surface and is fixed relative to the lock-out warning window.

43. The device of claim 42, wherein the series of markings indicates a number of distal extensions performed by the slider.

44. The device of claim 39, wherein the slider further comprises a shutter window, wherein when the slider is moved toward a distal end region of the housing, the shutter window of the slider and the lock-out warning window of the housing align revealing the series of markings on the barrel, and wherein when the slider is moved proximally away from the distal end region of the housing, the shutter window of the slider and the lock-out warning window of the housing do not align and the series of markings on the barrel are not visible.