Contact Probe for the Delivery of Laser Energy

• US 20100076419A1
• Filed: 10/30/2008
• Published: 03/25/2010
• Est. Priority Date: 10/30/2007
• Status: Active Grant

• Current Assignee: Iridex Corporation, National University Hospital Pte Limited (Temasek Holdings Pte Ltd. (Investment Management))
• Original Assignee: National University Hospital (Government of Singapore), Iridex Corporation
• Inventors: Chew, Paul T.K., Dorin, Giorgio, Buzawa, David M.
• Granted Patent: US 8,945,103 B2
• Time in Patent Office: Days
• US Class Current: 606/6
• CPC Class Codes: A61F 2009/00868 Ciliary muscles or trabecular meshwork
• CPC Class Codes: A61F 2009/00891 Glaucoma
• 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 9/00821 for coagulation
• CPC Class Codes: A61F 9/009 Auxiliary devices making contact with the eyeball and coupling in laser light, e.g. goniolenses apparatus for eye examination A61B3/0008

Abstract

Systems, devices, and methods for treating a glaucomatous eye are provided. An amount of pulsed laser energy is delivered to the pars plana of the eye by a hand-holdable device which comprises a hand-holdable elongate member and a contact member disposed on an end of the elongate member. A contact surface of the contact member is placed in direct contact with the eye so that a reference edge of the contact member aligns with the limbus and a treatment axis defined by the elongate member is angularly offset from the optical axis of the eye. The amount of pulsed laser energy delivered is insufficient to effect therapeutic photocoagulation but is sufficient to increase uveoscleral outflow so as to maintain a reduction from pre-laser treatment intraocular pressure. Amounts of pulsed laser energy will be transmitted to a circumferential series of tissue regions of the eye.

Claims

1. A laser treatment method for an eye, the eye having a pars plana posterior to a pars plicata and a pre-laser treatment intraocular pressure, the method comprising:

delivering an amount of pulsed laser energy to the pars plana of the eye, wherein the amount is insufficient to effect therapeutic photocoagulation and is sufficient to maintain a reduction from the pre-laser treatment intraocular pressure.

2. The method of claim 1, wherein the amount is sufficient to maintain the reduction from the pre-laser treatment intraocular pressure more than 5 months after the pulsed laser energy is delivered.

3. The method of claim 1 wherein the amount is sufficient to increase uveoscleral outflow so as to maintain the reduction from the pre-treatment intraocular pressure.

4. The method of claim 1, and further comprising:

positioning a laser delivery tip of a probe in contact with an outer surface of the eye and delivering the amount of pulsed laser energy from the positioned probe;

so that the pulsed laser energy is oriented toward a first pars plana region; and

such that permanent thermal damage to the pars plicata is avoided.

5. The method of claim 4, the eye having an optical axis, wherein positioning the tip of the probe in contact with the surface of the eye comprises orienting the probe so that the pulsed laser energy is angularly offset from the optical axis.

6. The method of claim 5, wherein the probe defines a treatment axis along which the pulsed laser energy is delivered, and wherein positioning the contact surface of the probe in contact with the surface of the eye comprises positioning the probe so that the treatment axis is generally perpendicular with the surface of the eye.

7. The method of claim 4, wherein positioning the tip of the probe in contact with the surface of the eye comprises positioning a reference structure of a contact surface of the probe in alignment with a reference feature of the eye, the laser delivery tip being disposed along the contact surface so that the pulsed laser energy is delivered posteriorly to a limbus of the eye by over 2 mm.

8. The method of claim 7, wherein the first pars plana region is posterior to the limbus by over 3 mm.

9. The method of claim 7 wherein the reference feature of the eye comprises the limbus, and wherein the reference structure of the contact surface comprises an edge separated from the laser delivery tip by over 2 mm, wherein the edge extends between opposed lateral placement sides of the contact surface, and wherein the pulsed laser energy is delivered to the first pars plana region while the probe is held at a fixed position against the eye, and further comprising incrementally moving the probe laterally, with reference to the sides of the contact surface, along the limbus so as to sequentially treat a plurality of circumferentially offset regions of the pars plana, the offset regions defining angular widths about the ocular axis of from 5 to 20 degrees.

10. The method of claim 4 wherein the pulsed laser energy is delivered to the first pars plana region of the eye for at least about 1 second.

11. The method of claim 1 wherein the pulsed laser energy comprises pulsed infrared laser energy and total laser energy directed to the pars plana is less than 75 J.

12. The method of claim 1 wherein the pulsed laser energy is delivered from a plurality of fixed probe locations, wherein the pulsed laser energy has a wavelength of 810 nm, wherein each pulse has an energy of less than 1 mJ, and wherein total laser energy directed to the pars plana is less than 40 J.

13. The method of claim 12 wherein the pulsed laser energy has a wavelength of 810 nm.

14. The method of claim 1, wherein the pulsed laser energy has a duty cycle of about 50% or less.

15. The method of claim 14, wherein the pulsed laser energy has a duty cycle of about 20% or less.

16. The method of claim 1, wherein a first portion of the pulsed laser energy is directed to a first arc about the optical axis of the eye.

17. The method of claim 16 wherein the first arc is disposed on a superior region of the eye.

18. The method of claim 16 further comprising directing a second portion of the pulsed laser beam toward a second arc about the optical axis of the eye spaced away from the first arc, the second arc being disposed along an inferior region of the eye.

19. The method of claim 1 wherein positioning the tip of the probe in contact with the surface of the eye comprises sliding the tip of the probe in alignment with the pars plana during delivery of the pulsed laser energy.

20. The method of claim 1 wherein the amount of energy is delivered without direct posterior eye pain alleviating agent delivery, and without excessive pain.

21. A method of reducing excessive intraocular pressure in an eye, the method comprising:

transmitting a pulsed laser beam to an annular pattern of tissue regions of an eye by;

positioning a tip of a probe in contact with the surface of the eye in a position at least 3 mm posterior of the limbus;

directing the pulsed laser beam from the positioned tip of the probe from the position toward an associated tissue region of the eye such that associated tissue region is treated and the coagulation within the eye is inhibited;

re-positioning the tip of the probe in contact with the surface of the eye in another position disposed at least 3 mm posterior of the limbus and circumferentially offset from the treated region about an optical axis of the eye and again directing the pulsed laser beam from the probe to an associated tissue region until the circumferential series of tissue regions have been treated;

the pulsed laser beam being delivered while the probe is maintained at each of the positions toward the associated tissue regions of the eye such that an aggregate amount of the pulsed laser beam delivered to the tissue regions alleviates the excessive intraocular more than five months after the tissue regions have been treated.

22. A method for treating an eye by reducing intraocular pressure, the method comprising:

positioning a tip of a probe in contact with the surface of the eye so that the tip of the probe is posterior the limbus of the eye by a desired distance;

moving the tip of the probe across the surface of the eye while the tip of the probe is maintained at the desired distance posterior the limbus of the eye; and

delivering pulsed laser energy toward a region of the eye posterior to the limbus while the tip of the probe is slid across the eye and maintained in contact with the surface of the eye.

23. A hand-holdable device for delivering optical energy to treat an eye, the device comprising:

a hand-holdable elongate member defining a treatment axis and adapted to receive an optical fiber for delivering optical energy along the treatment axis; and

a contact member disposed on an end of the elongate member, the contact member comprising a reference element and defining a contact surface,

wherein when the contact surface is placed in direct contact with the eye and the reference element is aligned with a reference feature of the eye, the contact surface conforms with a region of the surface of the eye and the treatment axis forms a predetermined, non-zero angle with the optical axis of the eye.

24. The device of claim 23 wherein when the contact surface is placed in direct contact with the eye and the reference element is aligned with a reference feature of the eye, the treatment axis is perpendicular to the surface of the eye.

25. The device of claim 23 wherein the contact surface conforms to the shape of the sclera of the eye at the limbus of the eye when the contact surface is placed in direct contact with the eye and the reference element is aligned with the reference feature of the eye.

26. The device of claim 23 further comprising an optical energy source coupled to the elongate member, wherein the delivered optical energy comprises light energy from one or more light emitting diodes of the optical energy source.

27. The device of claim 23 further comprising an optical energy source coupled to the elongate member, wherein the delivered optical energy comprises light energy from one or more lasers of the optical energy source.

28. The device of claim 27 wherein the delivered optical energy is pulsed.

29. The device of claim 28 wherein the delivered pulsed optical energy has a duty cycle of about 50% or less.

30. The device of claim 29 wherein the delivered pulsed optical energy has a duty cycle of about 20% or less.

31. The device of claim 23 wherein the hand-holdable device is adapted to deliver optical energy to a region of the eye posterior to the limbus when the contact surface is placed in direct contact with the eye and the reference element is aligned with a reference feature of the eye, the region of the eye posterior to the limbus being selected from the group consisting of the pars plana of the eye, the pars plana-pars plicata junction of the eye, and the posterior portion of the pars plicata of the eye.

32. The device of claim 23 wherein the contact surface of the contact member defines a protruding optical energy delivery tip disposed along the treatment axis.

33. The device of claim 23 wherein the reference feature comprises a reference edge shaped to conform with the limbus of the eye.

34. The device of claim 23 wherein an optical energy output aperture is spaced away from the reference edge by at least about 3 mm to facilitate optical irradiation over at least one of the pars plana of the eye, the pars plana-pars plicata junction, and the posterior portion of the pars plicata of the eye.

35. The device of claim 23 wherein the contact surface comprises a first side relief and a second side relief opposite the first side relief, the first side relief and the second side relief being adjacent the reference element of the contact surface with a width of the contact surface therebetween, wherein the width of the contact surface is sized to contact a treatment region of the eye along a plurality of circumferentially adjacent treatment regions forming an arc centered about the optical axis of the eye with the circumferentially adjacent treatment regions spaced apart from each other by from 5°

degrees to 30°

degrees.

36. The device of claim 35 wherein circumferentially adjacent treatment regions are spaced apart from each other by about 10°

degrees.

37. A device for delivering optical energy to treat an eye, the eye having a pars plana, the device comprising:

a handpiece;

a contact member disposed on an end of the handpiece, the contact member comprising a target tissue reference element and a treatment site spacing reference element and defining a contact surface; and

a laser delivery tip adapted to couple with an optical energy source;

the laser delivery tip positioned relative to the target tissue reference element such that, when the contact surface is placed in direct contact with an outer surface of the eye with the target tissue reference element aligned with a reference feature of the eye and optical energy is delivered from the laser delivery tip the optical energy is directed toward the pars plana at an associated treatment site; and

the laser delivery tip positioned relative to the treatment site spacing reference element such that a circumferential series of treatment sites are defined when the contact surface is repeatedly placed in direct contact with an outer surface of the eye with the target tissue reference element aligned with a reference feature of the eye and the treatment site spacing reference element aligned with a feature of a prior treatment; and

delivery of an amount of pulsed laser energy from the circumferential series of treatment sites to the pars plana that is insufficient to effect therapeutic photocoagulation can be sufficient to maintain a reduction from the pre-laser treatment intraocular pressure.

38. The handpiece of claim 37, wherein the amount is sufficient to increase uveoscleral outflow.

39. A handpiece adapted to direct and deliver optical energy in a predetermined direction defined as its optical axis, and suitable for delivery of optical energy to a patient'"'"'s eye, the eye having a shaped sclera, a cornea, a limbus, and an optical axis, the handpiece incorporating pieces, portions or features that aid in the repeatable application of the handpiece with respect to certain reference features of the patient'"'"'s eye that may be either permanent or temporary, such placement aid provided with respect to treatment angle/direction of optical output axis, with treatment axis essentially not parallel to the optical axis of the patient'"'"'s eye;

and one or more of the following parameters;

locational position, indentation pressure or depth spacing between discrete treatment sites.

40. The device described in claim 39 where the method of delivery of optical energy from its source to its treatment target includes one or more optical fibers.

41. The device described in claim 39 where the source of optical energy delivered is intended to be one or more lasers.

42. The device described in claim 39 where the source of optical energy delivered is intended to be one or more light emitting diodes (LEDs).

43. The device described in claim 39 where the treatment angle/direction is essentially normal (perpendicular) to the reference surface.

44. The device described in claim 43 where the reference surface is the sclera.

45. The device described in claim 43 where the reference surface is the cornea.

46. The device described in claim 39 where the feature facilitating placement with respect to a reference surface is one or more curves or facets approximating a portion of a sphere.

47. The device described in claim 46 where the feature facilitating placement with respect to a reference surface is one or more curves or facets approximating a portion of a concave sphere.

48. The device described in claim 39 where the locational reference is at least partly derived from the limbus (ocular region of intersection and transition between the corneal and scleral curves).

49. The device described in claim 39 where the specific dimensional reference from the limbus is 0 to 4 mm, and may be in a direction anterior or posterior to the limbus.

50. The device described in claim 39 where the reference for indentation depth or pressure is at least partly derived from the scleral surface.

51. The device described in claim 39 where the indentation depth measured from the reference surface in its natural position is between 0 and 1.5 mm.

52. The device described in claim 39 where the reference for indentation depth or pressure is at least partly derived from the corneal surface.

53. The device described in claim 39 where the reference for spacing between adjacent treatment sites is at least partly derived from one or more previous treatment sites.

54. The device described in claim 53 where the spacing between adjacent treatment sites is such so as to permit 1 to 6 application sites per clock-hour (5 to 30 degree angular spacing, or 12 to 72 sites per full treatment circumference).