Delivery system and method of use for the eye

• US 20020013572A1
• Filed: 05/21/2001
• Published: 01/31/2002
• Est. Priority Date: 05/19/2000
• Status: Active Grant

• Current Assignee: Michael S. Berlin
• Original Assignee: Michael S. Berlin
• Inventors: Berlin, Michael S.
• Application Number:
  US09/860,842
• Publication Number:
  US 20020013572A1
• Time in Patent Office: Days
• US Class Current: 606/4
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00066 intensity
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00321 Head or parts thereof
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/2255 Optical elements at the distal end of probe tips
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/15 Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
• CPC Class Codes: A61F 2009/00844 : Feedback systems
• CPC Class Codes: A61F 2009/00868 : Ciliary muscles or trabecular meshwork
• CPC Class Codes: A61F 2009/00891 : Glaucoma
• CPC Class Codes: A61F 9/00 : Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand caps with means for protecting the eyes A42B1/018; visors for helmets A42B3/22; retractors A61B17/02; manipulators specially adapted for use in surgery A61B34/70; appliances to aid invalids to move about A61H3/00; exercisers for the eyes A61H5/00; eye baths A61H35/02; sunglasses or goggles having the same features as spectacles G02C
• 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 9/00802 : for photoablation

Abstract

A method and delivery system are disclosed for creating an aqueous flow pathway in the trabecular meshwork, juxtacanalicular trabecular meshwork and Schlemm'"'"'s canal of an eye for reducing elevated intraocular pressure. Pulsed laser radiation is delivered from the distal end of a fiber-optic probe sufficient to cause photoablation of selected portions of the trabecular meshwork, the juxtacanalicular trabecular meshwork and an inner wall of Schlemm'"'"'s canal in the target site. The fiber-optic probe may be advanced so as to create an aperture in the inner wall of Schlemm'"'"'s canal in which fluid from the anterior chamber of the eye flows. The method and delivery system may further be used on any tissue types in the body.

Claims

1. A method for reducing intraocular pressure in an eye, said eye comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork and a Schlemni'"'"'s canal, said method comprising the steps of:

identifying target tissues comprising said trabecular meshwork, said juxtacanalicular trabecular meshwork and said Schlemm'"'"'s canal;

analyzing obstructions located in target tissues;

stabilizing an anterior chamber of said eye;

inserting a probe into said anterior chamber of said eye;

positioning a distal end of said probe within an operable limit of said target tissues;

delivering laser energy from said probe sufficient to cause photoablation of portions of at least one of said trabecular meshwork, said juxtacanalicular trabecular meshwork and an inner wall of said Schlemm'"'"'s canal.

2. A method for reducing intraocular pressure in an eye, said eye comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork and a Schlemm'"'"'s canal, said method comprising the steps of:

identifying target tissues comprising said trabecular meshwork, said juxtacanalicular trabecular meshwork and said Schlemm'"'"'s canal;

analyzing obstructions located in said target tissues;

stabilizing an anterior chamber of said eye;

inserting a probe into said anterior chamber of said eye;

positioning a distal end of said probe within an operable limit of said target tissues;

compressing a portion of said target tissues;

delivering laser energy from said probe sufficient to cause photoablation of portions of at least one of said trabecular meshwork, said juxtacanalicular trabecular meshwork and an inner wall of said Schlemm'"'"'s canal.

3. The method of claim 2 wherein said portion of said target tissues compressed is at least a portion of said trabecular meshwork.

4. The method of claim 2 wherein said portion of said target tissues compressed is at least a portion of said Schlemm'"'"'s canal.

5. The method of claim 2 wherein said step of compressing includes providing a viscoelastic fluid into said eye.

6. The method of claim 2 wherein said distal end of said probe compresses said target tissues.

59. The method of claim 5 wherein said viscoelastic fluid has a molecular size that is great than a pore size of said target tissues.

60. The method of claim 5 wherein said viscoelastic fluid has a molecular size that is great than a pore size of said trabecular meshwork.

61. The method of claim 2 wherein said step of compressing comprises providing a combination of a viscoelastic fluid and at least one of an anti-inflammatory agent, antiangiogenic agent, anti-fibroblast agent and a marker substance.

7. A method for reducing intraocular pressure in an eye, said eye comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork and a Schlemm'"'"'s canal, said method comprising the steps of:

advancing a probe into said eye to a position that is one of in contact with a target site and adjacent to said target site, said target site comprising said trabecular meshwork, said juxtacanalicular trabecular meshwork and said Schlemm'"'"'s canal;

delivering energy from said probe sufficient to cause photoablation of portions of at least a portion of each of said juxtacanalicular trabecular meshwork and an inner wall of said Schlemm'"'"'s canal.

8. The method of claim 7, further comprising:

advancing said probe through said trabecular meshwork.

9. The method of claim 8, further comprising:

further advancing said probe through said juxtacanalicuclar trabecular meshwork.

10. The method of claim 9, further comprising:

further advancing said probe though said inner wall of Schlemm'"'"'s canal.

11. The method of claim 7, further comprising the step of delivering a fluid into said Schlemm'"'"'s canal via said probe.

12. The method of claim 7 wherein a xenon chloride excimer laser is used for delivering energy from said probe.

13. The method of claim 12 wherein said excimer laser has a wavelength of 308 nm.

14. The method of claim 7 wherein a solid state 2.94 micron Er:

YAG laser is used for delivering energy from said probe.

15. The method of claim 7 wherein a laser operating at ultraviolet wavelengths in a range from 100 to 400 microns is used for delivering energy from said probe.

16. The method of claim 7 wherein a laser operating at infrared wavelengths ranging from 2.5 to 6.5 microns is used for delivering energy from said probe.

53. The method of claim 7 further comprising:

creating an opening into said Schlemm'"'"'s canal; and

expanding said Schlemm'"'"'s canal.

54. The method of claim 53 further comprising providing a barrier for isolating an outer wall of said Schlemm'"'"'s canal.

55. The method of claim 53 wherein said step of expanding is achieved by one of supplying a viscoelastic material into said Schlemm'"'"'s canal and inserting a stent into said Schlernm'"'"'s canal.

17. A method of controlling an interior anatomy of an eye, said eye comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork and a Schlemm'"'"'s canal, said method comprising the steps of:

creating an opening in said eye;

filling an anterior chamber of said eye with a viscoelastic material through said opening;

sensing an interior pressure within said eye; and

adjusting said interior pressure to compress or decompress at least one of said trabecular meshwork, said juxtacanalicular trabecular meshwork and said Schlemm'"'"'s canal.

18. A method of reducing intraocular pressure in an eye, said eye comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork and a Schlemm'"'"'s canal, said method comprising the steps of

creating a pathway through said trabecular meshwork and an inner wall of said Schlemm'"'"'s canal;

and

inserting an implant device in said pathway, said implant device extending from said inner wall of Schlemm'"'"'s canal to one of an anterior chamber of said eye and into said trabecular meshwork.

19. The method of claim 18, wherein said implant device includes a tubular section extending between a distal section and a proximal section, said distal section engaging said inner wall of Schlemm'"'"'s canal, and said proximal section engaging said trabecular meshwork.

20. An apparatus for providing laser energy to target tissues of an eye, said target tissues comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork and a Schlemm'"'"'s canal, said apparatus comprising:

a laser unit for generating laser energy; and

a laser probe for transmitting laser energy to said target tissues for photoablating a portion of said juxtacanalicular trabecular meshwork and an inner wall of said Schlemrn'"'"'s canal.

21. An intraocular laser probe for manipulating or removing tissue, comprising:

a tubular sleeve having a distal end and a proximal end for coupling to a laser energy unit;

an optical core being disposed within the tubular sleeve, the optical core having a distal tip for transmitting laser energy for causing photoablation of target tissues; and

a sensing device for sensing at least one parameter in said eye.

32. An intraocular laser probe as claimed in claim 21 wherein said at least one parameter is one of temperature and pressure.

56. An intraocular laser probe as claimed in claim 21 wherein said sensing device is located at a distal end of said probe.

57. An intraocular laser probe as claimed in claim 21 wherein said sensing device is located along said tubular sleeve.

22. A device for use in reducing intraocular pressure of an eye, said device to be implanted into said eye, comprising:

a tubular portion having a distal end including a first engaging member for attached to an interior surface of a first structure located in said eye and having a proximal end including a plurality of second engaging members for attaching to a second structure located in said eye

wherein said first structure is an inner wall of said Schlemm'"'"'s canal and said second structure is said trabecular meshwork.

23. An intraocular laser probe for manipulating or removing tissue, comprising:

a tubular sleeve having a distal end and a proximal end for coupling to a laser light unit for providing laser light sufficient to cause photoablation of tissue, the tubular sleeve having a central axis extending between the distal end and the proximal end, the distal end of the tubular sleeve being inclined with respect to the central axis; and

an optical core being disposed within the tubular sleeve for transmitting the laser light, the optical core having a distal tip at the distal end of the tubular sleeve, the distal tip having a predetermined shape for controlling a spot size of the laser light on the target tissue.

24. The laser probe of claim 23, wherein the predetermined shape is normal with respect to the center axis.

25. The laser probe of claim 23, wherein the predetermined shape is convex with respect to the center axis.

26. The laser probe of claim 23, wherein the predetermined curved shape is concaved with respect to the center axis.

27. An intraocular laser probe for manipulating or removing tissue, comprising:

a tubular sleeve having a distal end and a proximal end for coupling to a laser light unit for providing laser light sufficient to cause photoablation of a target tissue, the tubular sleeve having a central axis extending between the distal end and the proximal end, the distal end of the tubular sleeve being inclined with respect to the central axis; and

an optical core being disposed within the tubular sleeve for transmitting the laser light, the optical core having a distal tip at the distal end of the tubular sleeve, the distal tip having an inclined shape with respect to the center axis for controlling a spot size of the laser light on the target tissue; and

an optical control device for adjusting the spot size of the laser light, the optical control device being abutted and adapted to mate with the inclined shape of the distal tip.

28. The laser probe of claim 27, wherein the optical control device is a microprism.

29. The laser probe of claim 27, wherein said optical control device is a microlens.

30. The laser probe of claim 27, wherein said optical control device is a spacer.

31. The laser probe of claim 27, wherein the inclined shape of the distal tip of said optical core is aligned with the inclined shape of the distal end of the tubular sleeve.

33. An apparatus for providing photoablative laser energy to target tissues of an eye, said apparatus comprising:

a probe containing a fiber-optic element,

a handset, coupled to said probe, for controlling operation of said probe;

a servo device coupled to said handset for controlling pressure in said eye;

a laser unit coupled to said handset for supplying photoablative laser energy to said eye through said fiber-optic element;

a first controller coupled to said handset for supplying at least one of aqueous fluids and viscoelastic materials to said probe for delivery to said eye; and

a second controller coupled to said handset for removing waste evacuated through said probe.

34. The apparatus of claim 33, further comprising a motion controller for automating movement of said probe.

35. The apparatus of claim 33, wherein said laser unit comprises a xenon chloride excimer laser.

36. The apparatus of claim 35, wherein said excimer laser has a wavelength of 308 nm.

37. The apparatus of claim 33, wherein said laser unit comprises a solid state 2.94 micron Er:

YAG laser.

38. The apparatus of claim 33, wherein said laser unit comprises a laser operating at ultraviolet wavelengths in a range from 100 to 400 microns.

39. The apparatus of claim 33, wherein said laser unit comprises a laser operating at infrared wavelengths from 2.5 to 6.5 microns.

40. The apparatus of claim 33 further comprising temperature measurement circuitry for sensing temperature at an near said target tissues.

41. The apparatus of claim 40 wherein said temperature measurement circuitry comprises a thermocouple device located at a distal end of said probe and conductors extending through said probe from said thermocouple device to a temperature control device.

42. The apparatus of claim 33 further comprising tissue sensing circuitry for determining when said probe is in contact with said target tissues.

43. The apparatus of claim 42 wherein said tissue sensing circuitry comprises a microswitch located at a distal end of said probe.

44. The apparatus of claim 33 further comprising tissue sensing circuitry for determining when said probe is adjacent to said target tissues.

45. The apparatus of claim 44 wherein said tissue sensing circuitry comprises a pair of microelectrodes located at a distal end of said probe.

46. The apparatus of claim 33 wherein said tissue sensing circuitry controls activation of said laser unit.

47. The apparatus of claim 33 further comprising motion control circuitry for controlling said probe into and through said target tissues.

48. The apparatus of claim 47 wherein said a portion of a distal end of said probe is shaped as a blunt surface.

49. The apparatus of claim 33 wherein said probe includes a device for viewing target tissues.

50. The apparatus of claim 33 wherein said probe includes a heat extraction system for extracting heat during photoablation.

51. The apparatus of claim 50 wherein said heat extraction system comprises a heat sink.

72. The apparatus of claim 50 wherein said heat extraction system comprises a thermal electric device coupled to said probe.

73. The apparatus of claim 50 wherein said heat extraction system comprises a Venturi orifice mounted in said probe.

52. A method of controlling a laser delivery system for photoablating target tissues of an eye with photoablative laser radiation having a fluence and a repetition rate, said method comprising the steps of:

monitoring a sensed temperature adjacent to said target tissues during photoablation;

comparing said sensed temperature to a predetermined temperature;

in response to said step of comparing, if said sensed temperature is greater than said predetermined temperature, adjusting said repetition rate of said laser radiation.

58. An intraocular laser probe for manipulating or removing tissue, comprising:

a tubular sleeve having a distal end and a proximal end for coupling to a laser energy unit;

an optical core being disposed within the tubular sleeve, the optical core having a distal tip for transmitting laser energy for causing photoablation of target tissues;

means for reflecting light pulses from said tissue;

means for generating a signal based on said light pulses wherein said signal comprises data describing a position of said probe in relation to said tissue.

62. A method for photoablating tissue in a body comprising:

advancing a probe said body to a position that is one of in contact with a target site and adjacent to said target site;

delivering energy from said probe sufficient to cause photoablation of portions said tissue;

sensing with said probe at least one of temperature and pressure.

63. The method of claim 62 wherein a xenon chloride excimer laser is used for delivering energy from said probe.

64. The method of claim 63 wherein said excimer laser has a wavelength of 308 nm.

65. The method of claim 62 wherein a solid state 2.94 micron Er:

YAG laser is used for delivering energy from said probe.

66. The method of claim 62 wherein a laser operating at ultraviolet wavelengths in a rage from 100 to 400 microns is used for delivering energy from said probe.

67. The method of claim 62 wherein a laser operating at infrared wavelengths ranging from 2.5 to 6.5 microns is used for delivering energy from said probe.

68. An apparatus for providing photoablative laser energy to target tissues comprising:

a probe having an optical core for transmission of photoablative laser energy;

a handset coupled to said probe;

a sensing device for sensing at least one of pressure, temperature and physical contact of said prove with said target tissues.

69. The apparatus of claim 68 further comprising a laser energy coupled to said probe.

70. A method for reducing intraocular pressure in an eye, said eye comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork, a Schwalbe'"'"'s line and a Schlemm'"'"'s canal, said method comprising the steps of:

identifying target tissues comprising said trabecular meshwork, said juxtacanalicular trabecular meshwork and said Schlemm'"'"'s canal;

stabilizing an anterior chamber of said eye;

selecting a fiber tip for use on a probe, said fiber tip having a unique energy distribution;

inserting said probe into said anterior chamber of said eye;

identifying said Schwalbe'"'"'s line;

positioning said probe at said Schwalbe'"'"'s line;

delivering laser energy from said probe sufficient to cause photoablation said target tissues.

71. A method for reducing intraocular pressure in an eye, said eye comprising a trabecular meshwork, a juxtacanalicular trabecular meshwork, and a Schlemm'"'"'s canal, said method comprising the steps of:

identifying target tissues comprising said trabecular meshwork, said juxtacanalicular trabecular meshwork and said Schlemm'"'"'s canal;

stabilizing an anterior chamber of said eye;

selecting a fiber tip for use on a probe, said fiber tip having a unique energy distribution;

inserting said probe into said anterior chamber of said eye;

identifying an anatomical landmark in said eye;

positioning said probe at said anatomical landmark;

delivering laser energy from said probe sufficient to cause photoablation of said target tissues.