Treatment of ocular disease
The invention relates to a novel apparatus for the treatment of ocular disease, particularly glaucoma. The apparatus consists of a locating device to locate Schlemm's Canal within the anterior portion of the eye and a surgical tool to access the canal for treatment. The apparatus allows for guided, minimally invasive surgical access to Schlemm's Canal to enable surgical procedures to be performed on the canal and trabecular meshwork to reduce intraocular pressure. The apparatus may also deliver devices or substances to Schlemm's Canal in the treatment of glaucoma.
1. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the locating device comprises an ultrasound imaging transducer; and
wherein the tissue contacting surface of the locating device is curved to approximate a curve of the exterior surface on an anterior of the patient's eye.
2. The apparatus of claim 1 , further comprising an image processing system and a display device for displaying an ultrasound image of the eye produced by the ultrasound imaging transducer of the locating device, the ultrasound image of the eye providing a visual indication of when Schlemm's Canal is located in the imaging plane of the locating device distal to the tissue contacting surface of the locating device.
3. The apparatus of claim 1 , wherein the ultrasound imaging transducer operates at an ultrasound frequency of at least 10 MHz.
4. The apparatus of claim 1 , wherein the ultrasound imaging transducer operates at an ultrasound frequency of at least 40 MHz.
5. The apparatus of claim 1 , further comprising means to introduce an ultrasound contrast agent into the patient's aqueous humor.
6. The apparatus of claim 1 , wherein the locating device further comprises an audible or visible signal to indicate when Schlemm's Canal is located in the imaging plane of the locating device distal to the tissue contacting surface of the locating device.
7. The apparatus of claim 1 , wherein the locating device further comprises a raised ridge around a periphery of the tissue contacting surface.
8. The apparatus of claim 1 , wherein the microsurgical device comprises a microcannula.
9. The apparatus of claim 8 , wherein the microcannula incorporates a cutting tip to penetrate a sclera of the eye.
10. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the microsurgical device comprises a microcannula; and
wherein a distal portion of the microcannula is curved with a radius of approximately 12-14 mm to accommodate a curvature of Schlemm's Canal.
11. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the microsurgical device comprises a microcannula; and
wherein the microcannula has an outer diameter of less than 200 microns.
12. The apparatus of claim 11 , wherein the locating device comprises an ultrasound imaging transducer.
13. The apparatus of claim 12 , wherein the tissue contacting surface of the locating means is curved to approximate a curve of the exterior surface on an anterior of the patient's eye.
14. The apparatus of claim 12 , wherein the tissue contacting surface of the locating device is curved to approximate a curve of the exterior surface on an anterior of the patient's eye.
15. The apparatus of claim 14 , wherein the locating device comprises an optical detector.
16. The apparatus of claim 15 , further comprising an image processing system and a display device for displaying an optical image of the eye produced by the optical detector of the locating device, the optical image of the eye providing a visual indication of when Schlemm's Canal is located in the imaging plane of the locating device distal to the tissue contacting surface of the locating device.
17. The apparatus of claim 15 , wherein the locating device further comprises an audible or visible signal to indicate when Schlemm's Canal is located in the imaging plane of the locating device distal to the tissue contacting surface of the locating device.
18. The apparatus of claim 15 , further comprising means to introduce to a fluorescent tracer into the patient's aqueous humor.
19. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the microsurgical device comprises a microcannula; and
an inflatable dilating balloon mounted on a distal end of the microcannula.
20. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device comprising a microcannula;
a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device; and
a device having an inflatable dilating balloon mounted on a distal end of the device, wherein the distal end of the device is configured for insertion through the microcannula.
21. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm'Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device; and
an implant configured for implantation by the microsurgical device into Schlemm's Canal to maintain flow of aqueous humor.
22. The apparatus of claim 21 , wherein the implant comprises a stent.
23. The apparatus of claim 22 , wherein the stent comprises a biodegradable material.
24. The apparatus of claim 21 , wherein the implant comprises microparticles.
25. The apparatus of claim 24 , wherein the microparticles comprise a biodegradable material.
26. The apparatus of claim 21 , wherein the implant comprises microspheres.
27. The apparatus of claim 26 , wherein the microspheres comprise a biodegradable material.
28. The apparatus of claim 21 , wherein the implant comprises a drug releasing material.
29. The apparatus of claim 28 , wherein the drug releasing material contains a drug effective in the treatment of glaucoma.
30. The apparatus of claim 21 , wherein the microsurgical device comprises a microcannula slidably positioned within a guide sleeve.
31. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the locating device comprises an optical detector; and
wherein the optical detector comprises a high intensity white light illumination source.
32. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the locating device comprises an optical detector; and
wherein the optical detector comprises an optically coherent illumination source.
33. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the locating device comprises an optical detector; and
wherein the optical detector comprises a fiber optic device.
34. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the locating device comprises an optical detector; and
wherein the optical detector utilizes detection via visible wavelengths of light.
35. An apparatus for treating ocular disease in a patient, the apparatus comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device;
wherein the locating device comprises an optical detector; and
wherein the optical detector utilizes detection via infrared wavelengths.
36. An apparatus for treating ocular disease in a patient, comprising:
a handle, the handle having a longitudinal axis;
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device being coupled to the handle such that the tissue contacting surface is approximately perpendicular to the longitudinal axis of the handle, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately perpendicular to the longitudinal axis of the handle of the apparatus;
wherein the tissue contacting surface of the locating device is curved to approximate a curve of the exterior surface on an anterior of the patient's eye.
37. The apparatus of claim 36 , wherein the locating device comprises an ultrasound imaging transducer.
38. The apparatus of claim 37 , further comprising an image processing system and a display device for displaying an ultrasound image of the eye produced by the ultrasound imaging transducer of the locating device, the ultrasound image of the eye providing a visual indication of when Schlemm's Canal is located in the imaging plane of the locating device distal to the tissue contacting surface of the locating device.
39. The apparatus of claim 37 , wherein the ultrasound imaging transducer operates at an ultrasound frequency of at least 10 MHz.
40. The apparatus of claim 37 , wherein the ultrasound imaging transducer operates at an ultrasound frequency of at least 40 MHz.
41. The apparatus of claim 37 , further comprising means to introduce an ultrasound contrast agent into the patient's aqueous humor.
42. The apparatus of claim 37 , wherein the locating device further comprises an audible or visible signal to indicate when Schlemm's Canal is located in the imaging plane of the locating device distal to the tissue contacting surface of the locating device.
43. The apparatus of claim 36 , wherein the locating device further comprises a raised ridge around a periphery of the tissue contacting surface.
44. The apparatus of claim 36 , wherein the microsurgical device comprises a microcannula.
45. The apparatus of claim 44 , wherein the microcannula incorporates a cutting tip to penetrate a sclera of the eye.
46. An apparatus for treating ocular disease in a patient, comprising:
a handle, the handle having a longitudinal axis;
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device being coupled to the handle such that the tissue contacting surface is approximately perpendicular to the longitudinal axis of the handle, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately perpendicular to the longitudinal axis of the handle of the apparatus;
wherein the microsurgical device comprises a microcannula; and
wherein a distal portion of the microcannula is curved with a radius of approximately 12-14 mm to accommodate a curvature of Schlemm's Canal.
47. An apparatus for treating ocular disease in a patient, comprising:
a handle, the handle having a longitudinal axis;
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device being coupled to the handle such that the tissue contacting surface is approximately perpendicular to the longitudinal axis of the handle, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately perpendicular to the longitudinal axis of the handle of the apparatus;
wherein the microsurgical device comprises a microcannula; and
wherein the microcannula has an outer diameter of less than 200 microns.
48. An apparatus for treating ocular disease in a patient, comprising:
a handle, the handle having a longitudinal axis;
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device being coupled to the handle such that the tissue contacting surface is approximately perpendicular to the longitudinal axis of the handle, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device comprising a microcannula;
a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately perpendicular to the longitudinal axis of the handle of the apparatus; and
an inflatable dilating balloon mounted on a distal end of the microcannula.
49. An apparatus for treating ocular disease in a patient, comprising:
a handle, the handle having a longitudinal axis;
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device being coupled to the handle such that the tissue contacting surface is approximately perpendicular to the longitudinal axis of the handle, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device comprising a microcannula;
a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately perpendicular to the longitudinal axis of the handle of the apparatus; and
a device having an inflatable dilating balloon mounted on a distal end of the device, wherein the distal end of the device is configured for insertion through the microcannula.
50. An apparatus for treating ocular disease in a patient, comprising:
a handle, the handle having a longitudinal axis;
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device being coupled to the handle such that the tissue contacting surface is approximately perpendicular to the longitudinal axis of the handle, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye and for indicating when Schlemm's Canal is located in a imaging plane that extends distally from the tissue contacting surface of the locating device;
a microsurgical device;
a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device being configured to access Schlemm's Canal within the imaging plane of the locating device and to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately perpendicular to the longitudinal axis of the handle of the apparatus; and
an implant configured for implantation by the microsurgical device into Schlemm's Canal to maintain flow of aqueous humor.
51. The apparatus of claim 50 , wherein the implant comprises a stent.
52. The apparatus of claim 51 , wherein the stent comprises a biodegradable material.
53. The apparatus of claim 50 , wherein the implant comprises microparticles.
54. The apparatus of claim 53 , wherein the microparticles comprise a biodegradable material.
55. The apparatus of claim 50 , wherein the implant comprises microspheres.
56. The apparatus of claim 55 , wherein the microspheres comprise a biodegradable material.
57. The apparatus of claim 50 , wherein the implant comprises a drug releasing material.
58. The apparatus of claim 57 , wherein the drug releasing material contains a drug effective in the treatment of glaucoma.
59. An apparatus for treating ocular disease in a patient, comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device having a cantilever beam that extends axially with respect to the tissue contacting surface of the locating device, a guiding sleeve coupled to the cantilever beam, an angle adjustment mechanism for adjusting an angle of the guiding sleeve with respect to the tissue contacting surface of the locating device and a mechanism for advancing the microsurgical device through the guiding sleeve and into Schlemm's Canal within the patient's eye
wherein the microsurgical device comprises a microcannula slidably positioned within the guide sleeve; and
wherein the mechanism for advancing the microsurgical device through the guiding sleeve and into Schlemm's Canal within the patient's eye comprises a thumbwheel configured to engage a lead screw connected to the microcannula.
60. The apparatus of claim 59 , wherein the surgical access device is configured to deliver the microsurgical device into Schlemm's Canal along a path spaced apart distally from the tissue contacting surface of the locating device and approximately parallel to the tissue contacting surface of the locating device.
61. The apparatus of claim 59 , further comprising a handle having a longitudinal axis, wherein the tissue contacting surface is approximately perpendicular to the longitudinal axis of the handle, and wherein the surgical access device is configured to deliver the microsurgical device into Schlemm's Canal along a path approximately perpendicular to the longitudinal axis of the handle.
62. The apparatus of claim 59 , wherein the locating device comprises an ultrasound imaging transducer, and wherein the apparatus further comprises an image processing system and a display device for displaying an ultrasound image of the eye produced by the ultrasound imaging transducer of the locating device, the ultrasound image of the eye providing a visual indication of when Schlemm's Canal is located in the imaging plane of the locating device distal to the tissue contacting surface of the locating device.
63. An apparatus for treating ocular disease in a patient, comprising:
a locating device, the locating device having a tissue contacting surface configured for contacting an exterior surface of the patient's eye, the locating device adapted for non-invasively locating Schlemm's Canal within the patient's eye;
a microsurgical device;
and a surgical access device physically coupled to the locating device for guiding the microsurgical device in relation to the locating device, the surgical access device having a cantilever beam that extends axially with respect to the tissue contacting surface of the locating device, a guiding sleeve coupled to the cantilever beam, an angle adjustment mechanism for adjusting an angle of the guiding sleeve with respect to the tissue contacting surface of the locating device and a mechanism for advancing the microsurgical device through the guiding sleeve and into Schlemm's Canal within the patient's eye;
wherein the microsurgical device comprises a microcannula slidably positioned within the guide sleeve and an inflatable dilating balloon mounted on a distal end of the microcannula.
64. The apparatus of claim 63 , wherein the mechanism for advancing the microsurgical device through the guiding sleeve and into Schlemm's Canal within the patient's eye comprises a thumbwheel configured to engage a lead screw connected to the microcannula.