Method and apparatus to identify and treat neovascular membranes in the eye

• US 5,279,298 A
• Filed: 11/20/1992
• Issued: 01/18/1994
• Est. Priority Date: 11/20/1992
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Flower, Robert W.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US07/979,691
• Time in Patent Office: 424 Days
• Field of Search: 128/633-634, 128/637, 128/664-667, 128/653.4, 128/654, 128/745, 606/2, 606/3, 606/4, 356/39-41, 351/206, 351/213-214, 351/205, 351/212, 351/211, 351/221, 607/89
• US Class Current: 600/321
• CPC Class Codes: A61B 3/1241 specially adapted for observation of ocular blood flow, e.g. by fluorescein angiography
• CPC Class Codes: A61F 2009/00863 Retina
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61F 9/00821 for coagulation

Abstract

The method and apparatus of the invention allow a neovascular membrane in the ocular vasculature of the fundus of the eye to be identified and treated while minimizing damage to the sensory retina. First a bolus of fluorescent dye is injected and allowed to circulate through the ocular vasculature. When the fundus is diffusely irradiated with laser energy, dye present in the vasculature fluoresces. A neovascular membrane is identified when a particular area of fluorescence differs from the fluorescence of the surrounding normal vasculature. To treat the neovascular membrane, a second laser is focused on the site of the membrane and a second bolus of fluorescent dye is injected. When the presence of the second injection of dye is detected, energy from the focused laser is applied to damage or destroy the neovascular membrane.

Claims

1. A process for locating and treating an abnormality in the ocular vasculature of the fundus of the eye of a living body, said process comprising:

a. injecting a first bolus of a fluorescent dye composition into the circulatory system of the living body;

b. allowing the first bolus to circulate through the body and through the ocular vasculature of the fundus;

c. detecting the presence of the first bolus of dye in the ocular vasculature by diffusely irradiating the fundus of the eye with light energy from a first laser thus causing dye present in the vasculature to fluoresce;

d. detecting the presence and location of the abnormality in the vasculature by examining the fluorescence in the vasculature and identifying at least one location (B) wherein the fluorescence differs from the fluorescence of the surrounding normal vasculature;

e. focusing light energy from a second laser on the location (B) of the detected abnormality;

f. injecting a second bolus of a second fluorescent dye composition into the circulatory system;

g. detecting the presence of the second bolus of dye in the ocular vasculature; and

h. applying light energy from a second laser to treat the detected abnormality.

2. A process according to claim 1, wherein steps c. and d. occur simultaneously and further wherein step c. includes:

detecting the precise instant the first bolus enters the fundus; and

measuring a time thereafter (Δ

t) of maximum fluorescence at the location (B).

3. A process according to claim 2, wherein step g. includes detecting the precise instant the second bolus enters the fundus by diffusely irradiating the fundus of the eye with light energy from the first laser thus causing dye present in the vasculature to fluoresce.

4. A process according to claim 3, wherein step h. is performed at the time (Δ

t).

5. A process according to claim 3, wherein step d. includes:

acquiring successive images of the fundus with the passage of time;

recording each image; and

analyzing each image to identify at least one location (B) wherein the fluorescence differs from the fluorescence of the surrounding normal fundus.

6. A process according to claim 5, wherein in step g., the precise instant the second bolus of dye enters the fundus is detected at a location (A).

7. A process according to claim 5, wherein in step c, the light energy from the first laser is pulsed and further wherein the acquiring of successive images is shuttered and coordinated with the pulsed laser so that the images are acquired only during the laser pulse.

8. A process according to claim 2, wherein detecting the precise instant the first bolus enters the fundus includes:

acquiring successive images of the fundus with the passage of time;

recording each image; and

analyzing each image to identify an exact location (A) at which the dye first enters the fundus.

9. A process according to claim 8, wherein in step c, the light energy from the first laser is pulsed and further wherein the acquiring of successive images is shuttered and coordinated with the pulsed laser so that the images are acquired only during the laser pulse.

10. A process according to claim 1, wherein the first and second lasers are independently focused on the fundus through and by a fundus camera.

11. A process according to claim 10, wherein the second laser is focused on the abnormality by:

positioning a transparent support in a light path of the fundus camera and in a plane conjugate with the plane of the fundus camera, said support being provided with an opening holding a first end of a fiber optic connected at an opposite end to the second laser;

diffusely irradiating the fundus of the eye through the transparent support with the first laser so that the first end of the fiber optic appears as a darkened spot on the fundus; and

moving the transparent support and thus moving the darkened spot to be positioned on the abnormality.

12. A process according to claim 1 including pulsing the light energy from the first laser in step c.

13. A process according to claim 1, wherein the first and second lasers are diode lasers having a wavelength of about 805 nm, said first laser operating at an intensity in the range of 35 mW-170 mW/cm² of retina, said second laser operating at an intensity in the range of 50 mW-200 mW in a 50 μ

diameter spot on the retina, and the first and second fluorescent dye compositions are indocyanine dye compositions.

14. A process according to claim 13, wherein the second fluorescent dye composition also comprises rose bengal dye.

15. A process according to claim 13, wherein the first fluorescent dye composition also comprises sodium fluorescein.

16. A process according to claim 1, wherein the relationship between the first laser and the first fluorescent dye composition and the relationship between the second laser and the second fluorescent dye composition are such that the wavelength of the laser is maximally absorbed by the respective dye composition.

17. A process according to claim 1, wherein the fundus is diffusely irradiated with light energy from the first laser prior to step c. and further wherein the intensity of the light energy is increased instantaneously when the presence of the first fluorescent dye compositions first detected in the fundus.

18. A process for locating and treating an abnormality in the ocular vasculature of the fundus of the eye of a living body, said process comprising:

a. continuously irradiating the fundus of the eye with low level laser irradiation in the range of 35 mW per cm² of retina;

b. injecting a first bolus of a fluorescent dye composition into the circulatory system of a living body;

c. allowing the first bolus to circulate through the body and through the ocular vasculature;

d. detecting the precise instant the presence of the first bolus of dye enters the ocular vasculature by detecting the first appearance of fluorescence in the fundus;

e. operating the laser in a pulsed mode and at a high level of laser irradiation greater than 35 mW per cm² of retina but less than 170 mW per cm² ;

f. acquiring successive images of the fundus with the passage of time as the dye moves through the fundus, using shuttered means for acquiring, while coordinating the laser pulse with the means for acquiring so that the images are acquired only during the laser pulse;

g. continuously irradiating the fundus as in step a;

h. detecting the presence and location of the abnormality in the vasculature by examining the fluorescence in the images and identifying at least one location (B) wherein the fluorescence differs from the fluorescence of the surrounding normal vasculature;

i. focusing light energy from a second laser on the location (B) of the detected abnormality;

j. injecting a second bolus of a second fluorescent dye composition into the circulatory system;

k. detecting the presence of the second bolus of dye in the ocular vasculature; and

l. applying light energy from a second laser to treat the detected abnormality.

19. An apparatus for locating and treating an abnormality in the ocular vasculature of the fundus of the eye of a patient comprising:

a fundus camera focused on the fundus of the eye of a patient;

a first laser which diffusely irradiates the fundus and excites a first fluorescent dye composition in the ocular vasculature of the fundus, said dye composition provided by an intravenous injection of a first bolus to the patient;

means for acquiring images of the fundus, said means for acquiring connected to the fundus camera;

means for recording and analyzing the images to detect and locate the abnormality, said means for recording and analyzing connected to the image acquiring means; and

a second laser focusing on the detected abnormality and applying treatment to the abnormality by exciting a second fluorescent dye composition present in the abnormality, said second dye composition provided by an intravenous injection of a second bolus to the patient;

wherein said first and second lasers are independently focused on the fundus by and fired through the fundus camera.

20. An apparatus according to claim 19, wherein the fundus camera also comprises means to focus the second laser on the abnormality, said means comprising a moveable transparent support provided with an opening holding a first end of a fiber optic connected at an opposite end to the second laser, said transparent support located in a light path within the fundus camera and also located in a plane conjugate with the plane of the fundus.

21. An apparatus according to claim 19, wherein the first and second lasers are diode lasers having a wavelength in the range of 805 nm and the first and second fluorescent dye compositions contain indocyanine green dye.

22. An apparatus according to claim 19, wherein the relationship between the first laser and the first fluorescent dye composition and the relationship between the second laser and the second fluorescent dye composition are such that the wavelength of the laser is maximally absorbed by the respective dye composition.

23. An apparatus according to claim 19, wherein the first laser is able to operate in the continuous mode and in the pulsed mode.

24. An apparatus according to claim 23, wherein the means for acquiring images is shuttered and able to coordinate with the laser operating in the pulsed mode so that images are acquired only during a laser pulse.

25. An apparatus according to claim 19, wherein the first and second lasers are diode lasers having a wavelength in the range of 805 nm and the first fluorescent dye composition is indocyanine green dye and the second fluorescent dye composition is indocyanine green dye and rose bengal dye.

26. An apparatus according to claim 19, wherein the first and second lasers are diode lasers having a wavelength in the range of 805 nm and the first fluorescent dye composition is indocyanine green dye and sodium fluorescein dye and the second fluorescent dye composition is indocyanine green dye.