Rotary device and method for removing ophthalmic lens

• US 6,117,149 A
• Filed: 02/11/1999
• Issued: 09/12/2000
• Est. Priority Date: 11/30/1992
• Status: Expired due to Term

• Current Assignee: Neomedix Corp.
• Original Assignee: Optex Ophthalmologics, Inc.
• Inventors: Mirhashemi, Soheila, Mittelstein, Michael, Sorensen, John T.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US09/248,421
• Time in Patent Office: 579 Days
• Field of Search: 606/107, 606/166, 606/170, 128/898
• US Class Current: 606/166
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• 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

Abstract

A system and method for reducing and removing and ophthalmic lens of a mammalian eye. The system includes a rotary lens-reducing probe device of either straight or curved configuration, the probe device comprising a tubular outer sheath through which a rotatable drive shaft extends. A rotating lens-reducing head member is positioned on the distal end of the drive shaft. The head member is configured and constructed to draw a flow of fluid and lens matter into contact therewith, thereby facilitating complete reduction of the entire lens without requiring significant axial (i.e., longitudinal) movement of the probe within the lens capsule. The distal portion of the tubular sheath is preferably configured to shield a portion of the lens-reducing head, during operation, to avoid inadvertent damage to lens capsule. Also, the distal portion of the sheath may be aimed or positioned to direct the flow of fluid and lens matter created by the rotating head in a preferred flow path within the lens capsule. The device may incorporate infusion and/or aspiration for infusing and/or withdrawing fluid and/or debris into/from the eye.

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 elongate tubular sheath having a lumen;

ii) a rotatable drive shaft extending longitudinally through said elongate tubular sheath, said drive shaft having a distal end;

iii) a rotatable lens-reducing head positioned on the distal end of said drive shaft, wherein said rotatable lens-reducing head incorporates an impeller which is configured to draw a flow of fluid toward said lens-reducing head;

iv) said tubular sheath being configured and positioned, during operation of the device, such that a distal portion of the sheath will shield a portion of the lens-reducing head while allowing the remainder of the head to contact and reduce lens matter.

2. The device of claim 1 further in combination with a drive motor connectable to said drive shaft, to rotatably drive said drive shaft and said lens-reducing head.

3. The device of claim 1 wherein said distal portion of said tubular sheath comprises:

a first side which extends beyond the distal end of the rotatable lens-reducing head during operation thereby shielding a first side of said lens-reducing head;

a second side which terminates short of the distal end of the lens-reducing head during operation thereof; and

a transverse frontal surface which extends from the distal end of the first side of said sheath to the distal end of the second side of said sheath.

4. The device of claim 3 wherein said transverse frontal surface is curved.

5. The device of claim 4 wherein said transverse frontal surface is straight.

6. The device of claim 3 wherein said distal portion of said sheath comprises:

a tube having a closed distal end which substantially surrounds said lens-reducing head during operation thereof, and which has at least one aperture formed near the closed distal end of said tube to permit said lens-reducing head to contact and reduce lens material through said aperture.

7. The device of claim 1 wherein the distal portion of said tubular sheath is further configured and positioned to shield one side of the lens-reducing head while another side of the lens-reducing head remains unshielded, and such that most of said flow of fluid is exhausted away from said lens-reducing head in the general direction of the side which remains unshielded.

8. The device of claim 1 wherein said device includes means for changing the relative positioning of the lens-reducing head and the tubular sheath between:

a nonoperative position wherein the lens-reducing head is positioned within the tubular sheath; and

,

an operative position wherein a portion of the lens-reducing head is shielded by a portion of the sheath and the remainder of the lens-reducing head is sufficiently unshielded by the sheath and allowed to contact and reduce lens matter.

9. The device of claim 8 wherein said means for changing the relative positioning of the lens-reducing head and the tubular sheath comprises:

apparatus for longitudinally moving the tubular sheath back and forth while the rotatable drive shaft and lens-reducing head remain longitudinally stationary.

10. The device of claim 8 wherein said means for changing the relative positioning of the lens-reducing head and the tubular sheath comprises:

apparatus for longitudinally moving the rotatable drive shaft and lens reducing head back and forth while the tubular sheath remains longitudinally stationary.

11. The device of claim 1 wherein said tubular sheath is rotatable so as to permit the operator to adjust the rotational orientation of the tubular sheath, after the device has been inserted into the lens capsule.

12. The device of claim 1 further comprising:

a fluid flow passageway extending longitudinally through said probe for infusing fluid into the lens capsule.

13. The device of claim 12 wherein said rotatable drive shaft extends through a non-rotatable tubular sleeve having an outer surface and an inner surface defining a lumen, and wherein said tubular sleeve is disposed longitudinally within the lumen of said tubular sheath, and wherein said fluid flow passageway comprises a space which exists between the inner surface of said tubular sleeve and said rotatable drive shaft.

14. The device of claim 13 further comprising:

a helical bearing member having a multiplicity of spaced-apart helical convolutions, said bearing member being disposed within the fluid flow passageway provided between the inner surface of said tubular sleeve and the outer surface of said rotatable shaft so as to rotatably hold said shaft in an axially centered position within said sleeve; and

,

whereby, a helical fluid flow passageway is created by the disposition of said helical bearing member within said fluid flow space.

15. The device of claim 14 wherein said helical bearing member is configured such that rotation of said shaft will pump fluid in the distal direction through said helical fluid flow passageway.

16. The device of claim 14 wherein said helical bearing member is divided into a plurality of oppositely wound segments, said oppositely wound segments to deter any pumping effect created by rotation of said drive shaft.

17. The device of claim 13 further comprising a second fluid flow passageway between the outer surface of said sleeve and the inner surface of said tubular sheath.

18. The device of claim 17 wherein at least one fluid/debris inlet aperture is formed in said tubular sheath near the distal end thereof to facilitate suctioning of fluid and debris through said second fluid flow passageway.

19. The device of claim 13 further comprising:

a bulkhead positioned transversely within the tubular sheath, near the distal end thereof;

a central aperture extending longitudinally through said bulkhead;

the lumen of said tubular sleeve being aligned with said aperture such that said rotatable drive shaft which extends through said tubular sleeve also extends through said central aperture, said drive shaft being smaller in diameter than said aperture such that a space exists to allow fluid infused through said fluid flow passageway to flow around said drive shaft, through said central aperture, and out of the distal end of the tubular sheath.

20. The device of claim 19 wherein:

the distal end of the tubular sleeve is in abutment with and supported by said bulkhead to hold the distal end of the sleeve in position within the surrounding tubular sheath with the lumen of said sleeve in axial alignment with said aperture.

21. The device of claim 13 further comprising:

a bulkhead positioned transversely within the lumen of said tubular sheath, near the distal end thereof;

a central aperture extending longitudinally though said bulkhead;

a tubular extension member interposed between the distal end of said drive shaft and said lens-reducing head, said tubular extension member extending longitudinally through the central aperture of said bulkhead and having a lumen, said tubular extension member being rotatable concurrently with rotation of said drive shaft and said lens-reducing head, said tubular extension member having at least one fluid inlet aperture located proximal to said bulkhead and in communication with said first fluid flow space, and at least one fluid outlet aperture located distal to said bulkhead;

said device being thereby operable such that fluid may be infused in the distal direction through the first fluid flow space and through the lumen of said tubular extension member, such that said fluid will flow out of the outlet aperture of said tubular extension member and into a mammalian eye in which said device is inserted.

22. The device of claim 21 wherein said tubular extension member has an outer bearing surface which rides in contact with said central aperture of said bulkhead as said tubular extension member rotates in conjunction with said drive shaft and said lens reducing head.

23. The device of claim 12 further in combination with:

a source of irrigation fluid connected to said fluid flow passageway to facilitate infusion of irrigation fluid through said fluid passageway.

24. The device of claim 1 further comprising:

a fluid flow passageway extending longitudinally through said probe for aspirating fluid and debris from the lens capsule.

25. The device of claim 24 further in combination with:

a source of negative pressure connected to said fluid passageway to aspirate fluid and debris through said fluid passageway.

26. The device of claim 1 wherein said elongate probe is of straight configuration.

27. The device of claim 1 wherein said elongate probe is of curved configuration.

28. The device of claim 1 wherein one of said tubular sheath and said rotatable drive shaft are longitudinally moveable relative to the other to alternately position the rotatable lens-reducing head relative to the tubular sheath in:

a first position wherein the lens-reducing head is positioned within the tubular sheath; and

,

a second position wherein at least a portion of the lens-reducing head is sufficiently exposed to contact and reduce lens matter during operation of said device.

29. The device of claim 28 wherein a non-rotating tubular sleeve is mounted about said drive shaft and held in fixed or longitudinal relation to said drive shaft and lens-reducing head, said tubular sleeve extending longitudinally within the lumen of said tubular sheath.

30. The device of claim 29 wherein said elongate probe is of curved configuration and wherein:

said rotatable drive shaft is sufficiently pliable to rotate while in said curved configuration; and

,

one of said tubular sheath and said tubular sleeve are formed of rigid material shaped in said curved configuration and the other thereof is formed of material which is sufficiently pliable to conform to said curved configuration as the device is transitioned between said first and second positions.

31. The device of claim 30 wherein said tubular sheath is pliable and said tubular sleeve is rigid.

32. The device of claim 30 wherein said tubular sheath is rigid and tubular sleeve is pliable.

33. A method for reducing an ophthalmic lens within the lens capsule within a mammalian eye, said method comprising the steps of:

a) providing a lens-reducing device which comprises;

i) a tubular sheath having a distal end;

ii) an elongate drive shaft extending longitudinally through said tubular sheath and having a distal end;

iii) a rotating lens-reducing head positioned on the distal end of said drive shaft, the lens-reducing head having an impeller; and

iv) said sheath being configured and positioned, during operation of said device, such that the distal end of the sheath will shield one side of the lens-reducing head, while allowing an unshielded portion of the lens-reducing head to remain sufficiently unshielded to contact and reduce lens matter within the lens capsule;

b) inserting said device into the eye such that the distal end of the sheath is positioned at a non-centered location within the lens capsule;

c) positioning the sheath to cause the shielded side of the lens-reducing head to be located adjacent a selected portion of the lens capsule;

d) rotationally driving the drive shaft and lens-reducing head to effect reduction of the ophthalmic lens, the impeller on the lens-reducing head configured to draw fluid axially toward the distal end.

34. The method of claim 33 wherein step b) further comprises:

inserting the probe at an angle relative to a longitudinal axis of the eye, with the distal end of the probe being located in said non-centered position within the lens capsule.

35. The method of claim 33 wherein step c) further comprises:

positioning said sheath such that the flow of fluid exhausted from the rotating head will be caused to flow around the periphery of the lens capsule.

36. The method of claim 35 wherein the sheath of the device is rotatable, and wherein said positioning of said sheath comprises:

rotating said sheath to cause the distal end of the sheath to become situated such that the unshielded portion of the sheath is directed toward the center of the lens capsule.

37. The method of claim 33 wherein step c) comprises:

rotating said sheath such that the flow of fluid created by rotation of the lens-reducing head will;

i) initially spin the lens in a flat plane within the lens capsule to facilitate initial reduction of a peripheral portion of the lens; and

ii) thereafter cause the remainder of the lens to tumble within the lens capsule to cause repeated contact of the lens with the lens-reducing head, thereby facilitating complete reduction of the remaining portion of the lens.

38. The method of claim 33 further comprising the step of:

infusing a fluid into the lens capsule.

39. The method of claim 33 further comprising the step of:

aspirating fluid and debris from the lens capsule.

40. The method of claim 33 further comprising the step of:

concomitantly infusing fluid into the lens capsule and aspirating fluid and debris from the lens capsule.

41. The method of claim 33 wherein:

the device provided in step a) incorporates means for alternately positioning the lens-reducing head, relative to the sheath, in;

i) a first position whereby the entire lens-reducing head is located within and shielded by the sheath; and

ii) a second position wherein one side of the lens-reducing head is shielded by the distal tip portion of the sheath and a remaining portion of the lens-reducing head is unshielded and capable of contacting and reducing lens matter within the lens capsule; and

wherein the method further comprises the steps of;

initially causing the lens-reducing head to be located in said first position during insertion of the probe into the lens capsule; and

subsequently causing the lens-reducing head to become positioned in said second position to facilitate reduction of the ophthalmic lens within the lens capsule.

42. The method of claim 41 wherein, prior to insertion of the device in step b, of the method, said method comprises the additional step of:

causing said lens-reducing head to be in said first position relative to said sheath to facilitate insertion of the device into the eye; and

,

prior to the performance of step d, said method comprises the additional step of;

causing said lens-reducing head to be moved to said second position, relative to said sheath, to facilitate reduction of the ophthalmic lens.

43. The method of claim 42 wherein the step of "causing the lens-reducing head to be placed in said first position relative to the sheath" is accomplished by longitudinally advancing the sheath in the distal direction.

44. The method of claim 42 wherein the step of "causing the lens-reducing head to be located in said second position relative to said sheath" is accomplished by longitudinally retracting said sheath in the proximal direction.

45. 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 elongate tubular sheath having a distal portion comprising;

a first side which extends beyond the distal end of the rotatable lens-reducing head during operation;

a second side which terminates short of the distal end of the lens-reducing head during operation thereof;

a transverse frontal surface which extends from the distal end of the first side of said sheath to the distal end of the second side of said sheath; and

a tube having a closed distal end which substantially surrounds said lens-reducing head during operation thereof, and which has at least one aperture formed near the closed distal end of said tube to permit said lens-reducing head to contact and reduce lens material through said aperture;

ii) a rotatable drive shaft extending longitudinally through said elongate tubular sheath, said drive shaft having a distal end; and

iii) a rotatable lens-reducing head positioned on the distal end of said drive shaft;

iv) said tubular sheath being configured and positioned, during operation of the device, such the first side of the sheath will shield a first side of the lens-reducing head while the second side of the sheath allows a second side of the head to contact and reduce lens matter.

46. 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 elongate tubular sheath;

ii) a rotatable drive shaft extending longitudinally through said elongate tubular sheath, said drive shaft having a distal end;

iii) a rotatable lens-reducing head positioned on the distal end of said drive shaft; and

iv) means for changing the relative positioning of the lens-reducing head and the tubular sheath between;

a nonoperative position wherein the lens-reducing head is positioned within the tubular sheath; and

,

an operative position wherein a portion of the lens-reducing head is shielded by a portion of the sheath and the remainder of the lens-reducing head is sufficiently unshielded by the sheath and allowed to contact and reduce lens matter;

v) said tubular sheath being configured and positioned, during operation of the device, such that a distal portion of the sheath will shield a portion of the lens-reducing head while allowing the remainder of the head to contact and reduce lens matter.

47. The device of claim 46 wherein said means for changing the relative positioning of the lens-reducing head and the tubular sheath comprises:

apparatus for longitudinally moving the tubular sheath back and forth while the rotatable drive shaft and lens-reducing head remain longitudinally stationary.

48. The device of claim 46 wherein said means for changing the relative positioning of the lens-reducing head and the tubular sheath comprises:

apparatus for longitudinally moving the rotatable drive shaft and lens reducing head back and forth while the tubular sheath remains longitudinally stationary.

49. 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 elongate tubular sheath;

ii) a rotatable drive shaft extending longitudinally through said elongate tubular sheath, said drive shaft having a distal end; and

iii) a rotatable lens-reducing head positioned on the distal end of said drive shaft;

iv) said tubular sheath being configured and positioned, during operation of the device, such that a distal portion of the sheath will shield a portion of the lens-reducing head while allowing the remainder of the head to contact and reduce lens matter, and wherein said tubular sheath is rotatable so as to permit the operator to adjust the rotational orientation of the tubular sheath, after the device has been inserted into the lens capsule.

50. 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 elongate tubular sheath having a lumen;

ii) a rotatable drive shaft extending longitudinally through said elongate tubular sheath, said drive shaft having a distal end;

iii) a rotatable lens-reducing head positioned on the distal end of said drive shaft;

iv) a fluid flow passageway extending longitudinally through said probe for infusing fluid into the lens capsule; and

v) a non-rotatable tubular sleeve having an outer surface and an inner surface defining a lumen, said tubular sleeve being disposed longitudinally within the lumen of said tubular sheath, said rotatable drive shaft extending through said non-rotatable tubular sleeve, and wherein said fluid flow passageway comprises a space which exists between the inner surface of said tubular sleeve and said rotatable drive shaft;

vi) said tubular sheath being configured and positioned, during operation of the device, such that a distal portion of the sheath will shield a portion of the lens-reducing head while allowing the remainder of the head to contact and reduce lens matter.

51. The device of claim 50 further comprising a second fluid flow passageway between the outer surface of said sleeve and the inner surface of said tubular sheath.

52. The device of claim 51 wherein at least one fluid/debris inlet aperture is formed in said tubular sheath near the distal end thereof to facilitate suctioning of fluid and debris through said second fluid flow passageway.

53. The device of claim 50 further comprising:

a bulkhead positioned transversely within the tubular sheath, near the distal end thereof;

a central aperture extending longitudinally through said bulkhead;

the lumen of said tubular sleeve being aligned with said aperture such that said rotatable drive shaft which extends through said tubular sleeve also extends through said central aperture, said drive shaft being smaller in diameter than said aperture such that a space exists to allow fluid infused through said fluid flow passageway to flow around said drive shaft, through said central aperture, and out of the distal end of the tubular sheath.

54. The device of claim 53 wherein:

the distal end of the tubular sleeve is in abutment with and supported by said bulkhead to hold the distal end of the sleeve in position within the surrounding tubular sheath with the lumen of said sleeve in axial alignment with said aperture.

55. The device of claim 50 further comprising:

a helical bearing member having a multiplicity of spaced-apart helical convolutions, said bearing member being disposed within the fluid flow passageway provided between the inner surface of said tubular sleeve and the outer surface of said rotatable shaft so as to rotatably hold said shaft in an axially centered position within said sleeve; and

,

whereby, a helical fluid flow passageway is created by the disposition of said helical bearing member within said fluid flow space.

56. The device of claim 55 wherein said helical bearing member is configured such that rotation of said shaft will pump fluid in the distal direction through said helical fluid flow passageway.

57. The device of claim 55 wherein said helical bearing member is divided into a plurality of oppositely wound segments, said oppositely wound segments to deter any pumping effect created by rotation of said drive shaft.

58. The device of claim 50 further comprising:

a bulkhead positioned transversely within the lumen of said tubular sheath, near the distal end thereof;

a central aperture extending longitudinally through said bulkhead; and

a tubular extension member interposed between the distal end of said drive shaft and said lens-reducing head, said tubular extension member extending longitudinally through the central aperture of said bulkhead and having a lumen, said tubular extension member being rotatable concurrently with rotation of said drive shaft and said lens-reducing head, said tubular extension member having at least one fluid inlet aperture located proximal to said bulkhead and in communication with said first fluid flow space, and at least one fluid outlet aperture located distal to said bulkhead;

said device being thereby operable such that fluid may be infused in the distal direction through the first fluid flow space and through the lumen of said tubular extension member, such that said fluid will flow out of the outlet aperture of said tubular extension member and into a mammalian eye in which said device is inserted.

59. The device of claim 55 wherein said tubular extension member has an outer bearing surface which rides in contact with said central aperture of said bulkhead as said tubular extension member rotates in conjunction with said drive shaft and said lens reducing head.

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

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

i) an elongate tubular sheath;

ii) a rotatable drive shaft extending longitudinally through said elongate tubular sheath, said drive shaft having a distal end; and

iii) a rotatable lens-reducing head positioned on the distal end of said drive shaft;

iv) said tubular sheath being configured and positioned, during operation of the device, such that a distal portion of the sheath will shield a portion of the lens-reducing head while allowing the remainder of the head to contact and reduce lens matter.

61. The device of claim 60 wherein said rotatable lens-reducing head incorporates an impeller which is configured to draw a flow of fluid toward said lens-reducing head, and wherein the distal portion of said tubular sheath is further configured and positioned to shield one side of the lens-reducing head while another side of the lens-reducing head remains unshielded, and such that most of said flow of fluid is exhausted away from said lens-reducing head in the general direction of the side which remains unshielded.

62. 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 elongate tubular sheath having a lumen;

ii) a rotatable drive shaft extending longitudinally through said elongate tubular sheath, said drive shaft having a distal end; and

iii) a rotatable lens-reducing head positioned on the distal end of said drive shaft;

iv) said tubular sheath being configured and positioned, during operation of the device, such that a distal portion of the sheath will shield a portion of the lens-reducing head while allowing the remainder of the head to contact and reduce lens matter;

v) wherein one of said tubular sheath and said rotatable drive shaft are longitudinally moveable relative to the other to alternately position the rotatable lens-reducing head relative to the tubular sheath in;

a first position wherein the lens-reducing head is positioned within the tubular sheath; and

,

a second position wherein at least a portion of the lens-reducing head is sufficiently exposed to contact and reduce lens matter during operation of said device.

63. The device of claim 62 wherein a non-rotating tubular sleeve is mounted about said drive shaft and held in fixed or longitudinal relation to said drive shaft and lens-reducing head, said tubular sleeve extending longitudinally within the lumen of said tubular sheath.

64. The device of claim 63 wherein said elongate probe is of curved configuration and wherein:

said rotatable drive shaft is sufficiently pliable to rotate while in said curved configuration; and

,

one of said tubular sheath and said tubular sleeve are formed of rigid material shaped in said curved configuration and the other thereof is formed of material which is sufficiently pliable to conform to said curved configuration as the device is transitioned between said first and second positions.

65. The device of claim 64 wherein said tubular sheath is pliable and said tubular sleeve is rigid.

66. The device of claim 64 wherein said tubular sheath is rigid and tubular sleeve is pliable.