Method and system for laser thermokeratoplasty of the cornea

• US 5,437,658 A
• Filed: 10/07/1992
• Issued: 08/01/1995
• Est. Priority Date: 10/07/1992
• Status: Expired due to Term

• Current Assignee: Summit Technologies LLC (Summit Global Group, LLC)
• Original Assignee: Summit Technologies LLC (Summit Global Group, LLC)
• Inventors: Muller, David F., Sacharoff, Alex C.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Harris, Sonya C.
• Application Number:
  US07/957,702
• Time in Patent Office: 1,028 Days
• Field of Search: 606/4, 606/5, 606/6, 606/16, 606/17, 128/898
• US Class Current: 606/5
• CPC Class Codes: A61F 2009/00844 Feedback systems
• CPC Class Codes: A61F 2009/00853 Laser thermal keratoplasty or radial keratotomy
• CPC Class Codes: A61F 2009/00872 Cornea
• CPC Class Codes: A61F 9/00821 for coagulation

Abstract

The invention is a system and method for modifying the corneal curvature by irradiating the cornea to deliver thermal energy to the stroma. The system includes multiple irradiation ports for introducing electromagnetic radiation of a wavelength suitable for absorption in the stroma; positioning means, such as a hemi-spherical dome with several tracks for positioning the irradiation ports, respectively, at locations of a preselected geometric pattern relative to the pretreated cornea, the geometric pattern being selected to correspond to a desired modified shape of the cornea; transmission means adapted to deliver controlled amounts of the radiation from a radiation source to each of the irradiation ports; and the irradiation ports, positioned at the locations of the geometric pattern, constructed to introduce the radiation to treatment volumes of the stroma in a cooperative manner to induce desired shrinkage of the collagenous stromal tissue and cause change in the corneal curvature. Each treatment volume, formed by a radiation pattern emanating from one irradiation port or by intersection of radiation patterns emanating from multiple irradiation ports, is created in a controllable manner to have a desired volume and energy profile. The transmission means that includes fiber optic waveguides are connected to distribution means for dispensing controlled amounts of the radiation to each of the fiber optic waveguides. The system also includes inspection means for observing and evaluating the shrinkage of collagenous tissue.

Claims

1. A thermokeratoplasty system for modifying corneal curvature of a cornea by localized thermal shrinkage of collagenous stromal tissue, said system comprising:

means for inducing localized thermal shrinkage of the collagenous stromal tissue using electromagnetic radiation of a wavelength suitable for absorption in the stroma, said mean including a radiation-distributing device that introduces the electromagnetic radiation to a multiplicity of locations on the surface of the cornea according to a predetermined pattern selected to correspond to a desired modification of said cornea, and

a positioning structure that positions said radiation-distributing device in close, fixed relationship to the cornea and introduces said radiation via said locations to treatment volumes in the stroma below the surface of the cornea to induce localized shrinkage of the collagenous stromal tissue to cause change in the corneal curvature.

2. The system of claim 1 wherein said radiation-distributing device delivers energy to each of said locations at an energy level substantially below the energy necessary for shrinkage of said collagenous stromal tissue and causes energy entering said locations to intersect to form said treatment volumes in the stroma in which the energy level is sufficient to induce shrinkage of the collagenous stromal tissue.

3. The system of claim 1 wherein said means includes a radiation source and said radiation-distributing device further comprises a radiation transmission system for receiving radiation from said source, the radiation reaching the cornea being emitted from a set of irradiation ports positioned corresponding to said locations.

5. The system of claim 4 or 3 wherein said positioning structure positions said irradiation ports according to a selectable geometric pattern relative to said cornea to create a specific distribution of treatment volumes in each of which said desired shrinkage can occur.

6. The system of claim 5 wherein each of said treatment volumes is formed by a radiation pattern emanating from one irradiation port.

7. The system of claim 5 wherein at least two of said ports are cooperatively arranged to cause said desired shrinkage to occur in a treatment volume formed by intersection of radiation patterns emanating from aid irradiation ports, energy of a single radiation pattern being substantially below the energy level necessary for shrinkage of said collagenous stromal tissue, said intersection of radiation patterns forming a treatment volume having sufficient energy to induce shrinkage of said collagenous stromal tissue.

8. The system of claim 7 wherein an adjustable device is provided to vary the spatial relationship of said ports to vary the conditions of intersection of the emitted radiation forming said treatment volumes.

9. The system of claim 5, wherein said positioning structure enables movement of said irradiation ports to selected different locations to change said preselected geometric pattern.

10. The system of claim 5 wherein said positioning structure is attachable to the surface of the cornea in a desired relationship to accurately position said irradiation ports with respect to said cornea.

11. The system of claim 10 further comprising prophylactic means placed between said surface of the cornea and said positioning structure.

12. The system of claim 11 wherein said prophylactic means comprise optical interface matching means for coupling said radiation form said irradiation ports to the cornea without substantial loss.

13. The system of claim 10 wherein said positioning structure includes an eye fixation means for holding said positioning structure at a selected location on said surface of the cornea while preventing movement of the eye.

14. The system of claim 13 wherein said eye fixation means comprises a thornton ring attached to said surface of the cornea by relatively small protrusions.

15. The system of claim 5 wherein said irradiation port includes focusing means for focusing said radiation within the stromal tissue.

16. The system of claim 15 wherein said focusing means and locations of said ports define each said treatment volume and the energy profile of delivered radiation to said treatment volume.

17. The system of claim 15 wherein said focusing means focus said radiation to a desired depth within the stromal tissue.

18. The system of claim 15 wherein said focusing means comprise a focusing lens.

19. The system of claim 15 wherein said focussing means comprise a convergent fiberoptic wave guide.

20. The system of claim 15 wherein said focusing means comprises a self-focusing fiber optic wave guide.

27. The system of claim 5 wherein said irradiation ports comprise optical interface matching means for coupling the radiation to the cornea without substantial radiation loss.

28. The system of claim 27 wherein said optical interface matching means includes a fluid medium.

29. The system of claim 4 or 3 wherein said positioning structure comprises:

a rigid hemi-spherically shaped member positionable upon the surface of said cornea in a desired relationship to the shape of the cornea,

at least two tracks located in said rigid member at spaced apart positions, each track retaining at least one said irradiation port within said rigid member and enabling movement of said irradiation port to selected different locations within said tracks, and

a holding member that holds said irradiation ports at said selected different locations within said tracks, said holding member enabling said ports to reside in locations according to said preselected geometric pattern.

30. The system of claim 29 wherein said positioning structure further comprises a ring shaped member having small protrusions constructed to be affixed to said surface of the cornea, said ring shaped member being connectable to said rigid hemi-spherically shaped member and being adapted to maintain said irradiation ports at said selected different locations within said tracks.

31. The system of claim 30 wherein said positioning structure further comprises a membrane located between said surface of the cornea and said ring shaped member, said membrane transmitting radiation to said cornea from said irradiation ports.

35. The system of claim 4, 1 or 32 further comprising computer control system that governs distribution of said radiation from said source to each irradiation port in accordance with locations of irradiation ports and said desired modification of the cornea.

40. The system of claim 4, 1 or 32 further comprises an inspection system that observes and evaluates said shrinkage of the collagenous stromal tissue while said radiation is introduced to the stroma.

41. The system of claim 4, 1 or 32 further comprises an inspection system that observes and evaluates said shrinkage of the collagenous stromal tissue after said radiation is introduced to the stroma.

42. The system of claim 40 wherein said inspection means comprise a biomicroscope and a slit lamp.

4. A system for modifying curvature of a cornea by irradiating the cornea with electromagnetic radiation of a wavelength suitable for absorption in stromal tissue, said system comprising:

a radiation source, optically coupled to a transmission system, that emits electromagnetic radiation of a wavelength suitable to induce localized thermal shrinkage of the collagenous stromal tissue of the cornea,

said transmission system transmits controlled amounts of said radiation from said source,

said transmission system having multiple irradiation ports for introduction of the electromagnetic radiation to the stroma,

a positioning structure that positions said irradiation ports respectively at preselected relationships to the cornea, said relationships being selected to correspond to a desired modification of the cornea, and

said irradiation ports, positioned at said preselected relationships direct the radiation to respective treatment volumes in the stroma in a cooperative manner to induce localized shrinkage of the collagenous stromal tissue to cause change in the corneal curvature.

21. The system of claim 4 wherein said transmission system comprises a set of fiber optic wave guides each corresponding to a respective irradiation port, said irradiation ports being positioned according to a selectable geometric pattern relative to said cornea to create a specific distribution of treatment volumes, each said wave guide transmitting the radiation from said source to its respective irradiation port.

22. The system of claim 21 wherein each said irradiation port is positioned at a selected location according to said preselected geometric pattern relative to the cornea and adapted to introduce a radiation pattern that forms said treatment volume.

23. The system of claim 21 wherein said irradiation ports are positioned at locations according to said preselected geometric pattern relative to the cornea, said irradiation ports introducing radiation patterns that form said treatment volume at their intersection, energy of a single radiation pattern being substantially below the energy level necessary for shrinkage of the collagenous stromal tissue, said treatment volume created by said intersection of at least two of said radiation patterns having energy sufficient to induce shrinkage of the collagenous stromal tissue.

24. The system of claim 22 further comprising a distribution system, said distribution system distributing desired amounts of energy from said radiation source in a predetermined sequence to each of said fiber optic waveguides.

25. The system of claim 23 further comprising a distribution system, said distribution system distributing simultaneously desired amounts of said radiation from said radiation source to all of said fiber optic waveguides.

26. The system of claim 22 further comprising a distribution system, said distribution system distributing desired amounts of said radiation from said source simultaneously to all of said fiber optic waveguides.

32. A thermokeratoplasty system for modifying curvature of a cornea by irradiating the cornea to deliver thermal energy to collagenous stromal tissue, said system comprising:

a radiation source that emits electromagnetic radiation of a wavelength suitable to induce localized thermal shrinkage of the collagenous stromal tissue of the cornea,

a radiation-distributing device that introduces Controlled amounts of said electromagnetic radiation from said source to a multiplicity of irradiation ports located on locations on the surface of the cornea,

a rigid hemi-spherically shaped member positionable upon the surface of the cornea in a desired relationship to the cornea,

at least two tracks located in said rigid member at spaced apart positions, each track retaining at least one said irradiation port within said rigid member and enabling movement of said irradiation port to a selected location on a preselected geometric pattern, said preselected geometric pattern being selected to correspond to a desired modified shape of said cornea, a holding member that holds said irradiation ports at said selected locations within said tracks according to said preselected geometric pattern,

a ring shaped member having small protrusions affixable to the surface of the cornea, said ring shaped member being connectable to said rigid spherically shaped member to maintain said irradiation ports at said locations, and

said irradiation ports, positioned at said selected locations, that introduce said radiation to be absorbed in selected treatment volumes of the stroma to induce shrinkage of the collagenous stromal tissue and cause change in the corneal curvature to said desired modified shape.

33. The system of claim 32 wherein said ring shaped member is connectable to said rigid hemi-spherically shaped member using a vacuum created between said ring shaped member and said rigid hemi-spherically shaped member.

34. The system of claim 33 wherein said ring shaped member is connectable to said rigid hemi-spherically shaped member in a manner that enables relative rotational movement of the two members.

36. The system of claim 32 wherein said treatment volumes introduced into said stroma via said ports comprise a conical shape.

37. The system of claim 32 wherein said treatment volumes of the stroma are formed by intersection of at least two radiation patterns emanating from said irradiation ports.

38. The system of claim 4 or 32 wherein said wavelength is in the range of about 1.4 μ

m to 3.2 μ

m.

39. The system of claim 32 further comprising a membrane located between the corneal surface of the cornea and said irradiation ports, said membrane transmits light to the cornea from said irradiation port.

43. A method of modifying the corneal curvature by irradiating the cornea to deliver thermal energy to the stroma comprising:

(a) providing a radiation source for emitting electromagnetic radiation of a wavelength suitable to induce localized shrinkage of the collagenous stromal tissue of the cornea,

(b) providing a radiation-distributing device for receiving and distribute said radiation to a set of irradiation ports corresponding to locations for delivering radiation to the stroma,

(c) positioning said irradiation ports respectively according to a preselected geometric pattern relative to said cornea, said pattern being selected to correspond to a desired modification of the cornea,

(d) generating electromagnetic radiation of a wavelength suitable for absorption in the stroma.

(e) transmitting controlled amounts of said radiation from said source to at least one of said irradiation ports, and

(f) introducing to the cornea, at said irradiation ports, said radiation for absorption in treatment volumes of the stroma in a cooperative manner to induce desired thermal shrinkage of the collagenous stromal tissue and to cause change in the corneal curvature.

44. The method of claim 43 wherein said irradiation ports are positioned according to a preselected geometric pattern relative to the shape of the cornea to create a specific distribution of treatment volumes.

45. The method of claim 44 wherein said step of introducing said radiation is performed to form said treatment volume by a radiation pattern emanating from one irradiation port.

46. The method of claim 44 wherein said step of introducing said radiation is performed to form said treatment volume by intersection of radiation patterns emanating from at least two irradiation ports, whereby the energy of a single radiation pattern being substantially below the energy level necessary for shrinkage of the collagenous stromal tissue, said intersecting radiation patterns forming a treatment volume having sufficient energy to induce shrinkage of the collagenous stromal tissue.

47. The method of claim 46 wherein said locations of said irradiation ports are varied in a controllable manner to vary the conditions of intersection of said radiation patterns.

48. The method of claim 44, 45 or 46 further comprising:

(a) moving said irradiation ports to different locations according to a preselected geometric pattern,

(b) transmitting controlled amounts of said radiation from said source to each of said irradiation ports, and

(c) introducing to the cornea, at said irradiation ports, treatment volumes of said radiation for absorption in the stroma to induce shrinkage of the collagenous stromal tissue and to cause change in the corneal curvature to a desired modified shape.

49. The method of claim 48 wherein said step of moving said irradiation ports is performed continually along a path while simultaneously introducing said radiation to the stromal tissue in order to form said treatment volumes, said path being chosen in correlation with said preselected geometric pattern.

50. The method of claim 44 or 45 wherein said step of transmitting said controlled amounts of radiation is performed sequentially to said multiple irradiation ports.

51. The method of claim 46 wherein said step of transmitting said controlled amounts of radiation is performed simultaneously to a set of said irradiation ports constructed to introduced intersection radiation patterns forming said treatment volumes.

52. The method of claim 44, 45 or 46 wherein said step of transmitting said controlled amounts of radiation is performed simultaneously to all said multiple irradiation ports.

53. The method of claim 44, 45 or 46 wherein said step of introducing to the cornea said radiation comprises focussing said radiation to form said treatment volume, said treatment volume extending to a depth of less than about 450 μ

m in the cornea.

54. The method of claim 44, 45 or 46 further comprising a step of inspecting said treatment volumes in the stroma.

55. The method of claim 54 wherein said step of inspecting said treatment volumes in the stroma is performed after causing said shrinkage of the collagenous stromal tissue.

56. The method of claim 54 wherein said step of inspecting said treatment volumes of the stroma is performed while introducing said radiation for absorption in the stroma.