Methods, apparatus and system for removal of lenses from mammalian eyes

• US 6,506,176 B1
• Filed: 02/16/2000
• Issued: 01/14/2003
• Est. Priority Date: 02/17/1999
• Status: Expired due to Term

• Current Assignee: Neomedix Corp.
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Muri, John I., Sorensen, John T., Ripley, John A., Etherington, Roger F., Mirhashemi, Soheila, Mittelstein, Michael, Gerg, James B.
• Primary Examiner(s): JACYNA, J CASIMER
• Application Number:
  US09/505,098
• Time in Patent Office: 1,063 Days
• Field of Search: 604/22, 606/107, 606/170, 606/180
• US Class Current: 604/22
• CPC Class Codes: A61F 9/00763 with rotating or reciprocating cutting elements, e.g. concentric cutting needles atherectomy cutting instruments A61B17/3207; endoscopic cutting instruments A61B17/320016
• 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 system for removing the lens from an eye of a mammal, including a lens-removal device having a probe for penetrating the lens capsule. The probe includes a sheath that shields a rotating impeller at all times, with the impeller being pneumatically actuated to advance to a lens removal position within the sheath. The impeller is pneumatically rotated using a turbine mechanism within a handle for the probe. Irrigation and aspiration are provided to facilitate removal of the lens tissue. The turbine is driven with pulsed air to prevent stiction. A purge/protection cap helps remove air bubbles from the system prior to use and protects the delicate impeller during transport. An operating system is also provided with a foot pedal actuator.

Claims

1. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising:

an elongate probe insertable into the lens capsule, said probe comprising;

i. an outer tubular sheath comprising a hollow bore extending therethrough and defining a longitudinal axis;

ii. an impeller shaft disposed in said outer tubular sheath, said impeller shaft having an impeller disposed at a distal end thereof, wherein an axis of rotation of said impeller is generally coincident with said longitudinal axis; and

iii. said outer tubular sheath being configured and positioned, during operation of said device, such that a distal portion of said sheath will shield a portion of said impeller while allowing a remainder of said impeller to contact and reduce the lens;

a handpiece having an interior space, a front end, and a back end, wherein an interior portion of said elongate probe extends through said handpiece front end and into said handpiece interior space;

a drive assembly disposed in the interior space of said handpiece;

said drive assembly being functionally connected to a proximal portion of said impeller shaft such that said impeller shaft rotates upon operation of said drive assembly, wherein said drive assembly receives non-rotational energy and transmits rotational energy;

a translation apparatus for longitudinally moving said drive assembly, said translation apparatus being at least partially disposed in said handpiece interior space; and

wherein said translation apparatus comprises an inflatable bladder disposed between said handpiece back end and said drive assembly.

2. The device of claim 1 herein said device includes structure to cause the drive assembly to retract to a position proximate the back end of said handpiece when said bladder is not inflated.

3. The device of claim 2 wherein said structure comprises at least one spring to bias the drive assembly to the retracted position.

4. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising:

an elongate probe insertable into the lens capsule, said probe comprising;

i. an outer tubular sheath comprising a hollow bore extending therethrough and defining a longitudinal axis;

ii. an impeller shaft disposed in said outer tubular sheath, said impeller shaft having an impeller disposed at a distal end thereof, wherein an axis of rotation of said impeller is generally coincident with said longitudinal axis; and

iii. said outer tubular sheath being configured and positioned, during operation of said device, such that a distal portion of said sheath will shield a portion of said impeller while allowing a remainder of said impeller to contact and reduce the lens;

an irrigation channel comprising an outlet in fluidic communication with a proximal opening in said sheath;

an aspiration channel comprising an inlet in fluidic communication with a proximal opening in said impeller shaft; and

an irrigation tube within and rotationally fixed with respect to said tubular sheath, and a bearing disposed between said impeller shaft and said irrigation tube.

5. The device of claim 4 wherein:

said bearing substantially seals an annular space defined by said irrigation tube and said impeller shaft; and

a sheath aperture extending through a wall of said sheath and located near said bearing.

6. The device of claim 5 further comprising an impeller shaft aperture extending through an impeller shaft wall and being located proximate to said sheath aperture.

7. The device of claim 6 wherein said impeller shaft is adapted to advance within said sheath from a retracted position, to the operative position wherein a distal portion of said sheath will shield a portion of said impeller, and wherein said impeller shaft aperture is generally aligned with said sheath aperture when said impeller is in the retracted position.

8. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising:

an elongate probe insertable into the lens capsule, said probe comprising;

i. an outer tubular sheath comprising a hollow bore extending therethrough and defining a longitudinal axis;

ii. an impeller shaft disposed in said outer tubular sheath, said impeller shaft having an impeller disposed at a distal end thereof, wherein an axis of rotation of said impeller is generally coincident with said longitudinal axis; and

iii. said outer tubular sheath being configured and positioned, during operation of said device, such that a distal portion of said sheath will shield a portion of said impeller while allowing a remainder of said impeller to contact and reduce the lens; and

a strainer disposed in said impeller shaft proximate to said impeller shaft distal end.

9. The device of claim 8 wherein:

said impeller shaft comprises a wall; and

said strainer is comprised of a plurality of tabs that radially extend inwardly from said impeller shaft wall to form said strainer.

10. The device of claim 9 wherein the plurality of tabs comprise three symmetrically positioned tabs that extend generally in a radial plane from three generally flat portions of said impeller shaft.

11. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising:

an elongate probe insertable into the lens capsule and defining a longitudinal axis, said probe comprising an impeller shaft at least partially disposed in a sheath, said impeller shaft having an impeller disposed at a distal end thereof, wherein an axis of rotation of said impeller shaft is generally coincident with said longitudinal axis;

a handpiece having an interior space into which a proximal portion of said elongate probe extends;

a drive assembly disposed in said handpiece interior space, said drive assembly being functionally connected to a proximal portion of said impeller shaft such that said impeller shaft rotates upon operation of said drive assembly, wherein said drive assembly received non-rotational energy and transmits rotational energy;

wherein a direct drive connection transfers rotational energy from said drive assembly to said impeller shaft; and

wherein said translation apparatus comprises an inflatable bladder disposed between said handpiece back end and said drive assembly.

12. The device of claim 11 wherein said device includes structure to cause the drive assembly to retract to a position proximate the back end of said handpiece when said bladder is not inflated.

13. The device of claim 12 wherein said structure comprises at least one spring to bias the drive assembly to the retracted position.

14. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising:

an elongate probe insertable into the lens capsule and defining a longitudinal axis, said probe comprising an impeller shaft having a lens-reducing head disposed at a distal end thereof, wherein an axis of rotation of said impeller shaft is generally coincident with said longitudinal axis;

a handpiece having an interior space, a front end, and a back end, wherein a proximal portion of said elongate probe extends through said handpiece front end;

a pneumatic drive assembly disposed in said handpiece interior space, said pneumatic drive assembly comprising a turbine, wherein a direct drive connection transfers rotational energy from said turbine to said impeller shaft;

wherein the turbine comprises a star wheel coupled to rotate with the impeller shaft, and the pneumatic drive assembly includes an injector opening onto the star wheel to direct a flow of gas thereto; and

wherein the injector has a progressively decreasing cross-section in a direction toward the star wheel such that gas passing therethrough will accelerate toward the star wheel.

15. The device of claim 14 wherein the impeller shaft is hollow and adapted to aspirate fluid from the lens capsule, the device further including a fluid block surrounding the impeller shaft and preventing mixing of the aspiration fluid and the gas used to turn the star wheel.

16. The device of claim 15 wherein the fluid block comprises a plurality of fluid bearing blocks.

17. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising:

an elongate probe insertable into the lens capsule and defining a longitudinal axis, said probe comprising an impeller shaft having a lens-reducing head disposed at a distal end thereof, wherein an axis of rotation of said impeller shaft is generally coincident with said longitudinal axis;

a handpiece having an interior space, a front end, and a back end, wherein a proximal portion of said elongate probe extends through said handpiece front end;

a pneumatic drive assembly disposed in said handpiece interior space, said pneumatic drive assembly comprising a turbine, wherein a direct drive connection transfers rotational energy from said turbine to said impeller shaft; and

further comprising a translation apparatus for longitudinally moving said drive assembly, said translation apparatus being at least partially disposed in said handpiece interior space

wherein said translation apparatus comprises an inflatable bladder disposed between said handpiece back end and said drive assembly.

18. The device of claim 17 wherein said device includes at least one spring to bias the drive assembly to retract to a position proximate the back end of said handpiece when said bladder is not inflated.

19. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising:

an elongate probe insertable into the lens capsule and defining a longitudinal axis, said probe comprising an impeller shaft having a lens-reducing head disposed at a distal end thereof, wherein an axis of rotation of said impeller shaft is generally coincident with said longitudinal axis;

a handpiece having an interior space, a front end, and a back end, wherein a proximal portion of said elongate probe extends through said handpiece front end;

a drive assembly disposed in said handpiece interior space functionally connected to a proximal portion of said impeller shaft such that said impeller shaft rotates upon operation of said drive assembly;

a translation apparatus at least partially disposed in said handpiece interior space and connected to longitudinally displace said drive assembly; and

wherein said translation apparatus comprises an inflatable bladder disposed between such handpiece back end and said drive assembly.

20. The device of claim 19 wherein said device includes structure to cause the drive assembly to retract to a position proximate the back end of said handpiece when said bladder is not inflated.

21. The device of claim 20 wherein said structure comprises at least one spring to bias the drive assembly to the retracted position.

22. The device of claim 19 wherein said wherein said bladder comprises:

a cylindrical wall;

a sealed distal end of said bladder cylindrical wall that is adjacent to a proximal end of said drive assembly, wherein said cylindrical wall and said sealed distal end define a bladder interior; and

an open proximal end of said bladder, with a radial inwardly extending lip that is sealed against said handpiece back end.

23. The device of claim 22 further including a port extending through said handpiece back end and adapted for connecting a compressed gas source to said bladder interior to inflate said bladder.

24. The device of claim 19 wherein the impeller shaft is hollow and adapted to aspirate fluid from the lends capsule, the device further including a fluid block surrounding the impeller shaft and preventing mixing of the aspiration fluid and the gas used to inflate said bladder.

25. A device for reducing an ophthalmic lens within the lens capsule of a mammalian eye, said device comprising

an elongate probe insertable into the lens capsule, said probe comprising:

i. an outer tubular sheath having a hollow bore extending therethrough;

ii. a hollow impeller shaft having a lumen and disposed in said outer tubular sheath, said impeller shaft having an impeller disposed at a distal end thereof;

iii. an irrigation tube positioned within and rotationally fixed with respect to the tubular sheath; and

iv. a bearing disposed between said impeller shaft and said irrigation tube;

a handpiece having an interior space into which a proximal portion of said elongate probe extends;

a drive assembly for rotating the impeller shaft;

an irrigation channel disposed in said handpiece interior space, said irrigation channel being in fluid communication with an annular space formed in said elongate probe between said irrigation tube and said impeller shaft; and

an aspiration channel disposed in said handpiece interior space, said aspiration channel being in fluid communication with the lumen of said impeller shaft.

26. The device of claim 25 wherein the drive assembly is disposed in said handpiece interior space and is connected to a proximal portion of said impeller shaft such that said impeller shaft rotates upon operation of said drive assembly;

and

a translation apparatus at least partially disposed in said handpiece interior space and connected to longitudinally displace said drive assembly.

27. The device of claim 26 wherein said drive assembly is pneumatic and comprises a turbine, wherein a direct drive connection transfers rotational energy from said turbine to said impeller shaft.

28. The device of claim 26 wherein said translation apparatus comprises an inflatable bladder disposed between said handpiece back end and said drive assembly.

29. The device of claim 28 wherein said device includes a spring to bias the drive assembly to retract to a position proximate the back end of said handpiece when said bladder is not inflated.

30. The device of claim 26 wherein said irrigation channel includes a tube projecting from said handpiece back end and connected to translate with said drive assembly, the tube being connectable to a fluid supply tube.

31. The device of claim 30 further including a fitting on the tube that fits within a stepped recess in the handpiece back end, and a spring between the fitting and stepped recess to bias the fitting in a proximal direction.

32. The device of claim 26 wherein said aspiration channel includes a tube projecting from said handpiece back end and connected to translate with said drive assembly, the tube being connectable to a source of negative pressure.

33. The device of claim 32 further including a fitting on the tube that fits within a stepped recess in the handpiece back end, and a spring between the fitting and stepped recess to bias the fitting in a proximal direction.

34. A medical device comprising:

an elongate probe insertable into a body and defining a longitudinal axis, said probe comprising a hollow impeller shaft defining a lumen and having a tool disposed at a distal end of said shaft, wherein an axis of rotation of said tool is generally coincident with said longitudinal axis;

a handpiece having an interior space and a front end, wherein a proximal portion of said elongate probe extends through said front end and into said handpiece interior space;

a drive assembly disposed in said handpiece interior space, said drive assembly being connected to a proximal portion of said impeller shaft such that said impeller shaft rotates upon operation of said drive assembly;

an irrigation channel disposed in said handpiece interior space, said irrigation channel being in fluid communication with an irrigation conduit formed in said elongate probe;

an aspiration channel disposed in said handpiece interior space, and aspiration channel being in fluid communication with the lumen of said impeller shaft; and

a fluid block about the impeller shaft between said drive assembly and said handpiece front end, the fluid block providing a barrier between the irrigation channel and aspiration channel.

35. The device of claim 34, further comprising a translation apparatus for longitudinally moving said drive assembly, said translation apparatus being at least partially disposed in said handpiece interior space.

36. The device of claim 35, wherein said translation apparatus comprises an inflatable bladder disposed between a back end of said handpiece and said drive assembly.

37. The device of claim 36 further including a port extending through said handpiece back end and adapted for connecting a compressed gas source to said bladder interior to inflate said bladder.

38. The device of claim 37 wherein the fluid block also provides a barrier ft between both the irrigation channel and aspiration channel, and the compressed gas port.

39. The device of claim 34 wherein said elongate probe further comprises a tubular sheath comprising a mouth having an apex that extends beyond a distal end of said tool during operation thereby shielding a first side of said tool, wherein the mouth is angled so that a portion of said tool extends beyond a plane defined by the mouth, thus allowing the tool.

40. The device of claim 39 further comprising a translation apparatus for longitudinally moving said drive assembly, said translation apparatus being at least partially disposed in said handpiece interior space, wherein a proximal end of said tubular sheath is fixedly attached to the handpiece such that during longitudinal translation of said drive assembly, said sheath and said handpiece remain static relative to said drive assembly and said hollow shaft.

41. The device of claim 40, further comprising an irrigation tube within said tubular sheath that translates with said hollow shaft but is rotationally fixed with respect to the tubular sheath, and a bearing disposed between said hollow shaft and said irrigation tube.

42. The device of claim 34 wherein said tool comprises one or more blades, each of said blades comprising first and second portions, wherein said blade first portion extends approximately radially from said hollow shaft distal end and said blade second portion extends axially and distally from an outward edge of said blade first portion.

43. The device of claim 42, wherein said tool is formed integrally with said hollow shaft.