Implantable devices and methods for measuring intraocular, subconjunctival or subdermal pressure and/or analyte concentration

• US 9,474,487 B2
• Filed: 07/18/2011
• Issued: 10/25/2016
• Est. Priority Date: 01/09/2003
• Status: Active Grant

• Current Assignee: BCC Enterprise
• Original Assignee: BCC Enterprise
• Inventors: Chuck, Roy S., Baerveldt, George, Chou, Jim-Son
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US13/185,277
• Publication Number:
  US 20120041552A1
• Time in Patent Office: 1,926 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 3/16 for measuring intraocular pressure, e.g. tonometers
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/16 Intraocular lenses
• CPC Class Codes: A61F 2002/1681 having supporting structure for lens, e.g. haptics

Abstract

Methods, apparatus and systems for measuring pressure and/or for quantitative or qualitative measurement of analytes within the eye or elsewhere in the body. Optical pressure sensors and/or optical analyte sensors are implanted in the body and light is cast from an extracorporeal light source, though the cornea, conjunctiva or dermis, and onto a reflective element located within each pressure sensor or analyte sensor. The position or configuration of each sensor'"'"'s reflective element varies with pressure or analyte concentration. Thus, the reflectance spectra of light reflected by the sensors'"'"' reflective elements will vary with changes in pressure or changes in analyte concentration. A spectrometer or other suitable instrument is used to process and analyze the reflectance spectra of the reflected light, thereby obtaining an indication of pressure or analyte concentration adjacent to the sensor(s). The wavelength of the interrogating beam of light may vary to control out potential interference or inaccuracies in the system.

Claims

1. A method of determining intraocular pressure in a human or veterinary patient, said method comprising the steps of:

(A) implanting within the eye an optical pressure sensor that comprises a Fabry-Perot interferometer having two parallel optical reflecting surfaces with an optical reflecting cavity therebetween, wherein one of the optical reflecting surfaces comprises a pressure-sensitive diaphragm that is in contact with intraocular fluid such that the pressure-sensitive diaphragm moves relative to changes in the intraocular pressure of the eye thereby causing the depth of the optical reflecting cavity to vary relative to changes in the intraocular pressure;

(B) positioning a receiver/processor, which comprises an optical spectrum analyzer, at a location in front of the eye;

(C) using a light source to cast emitted light at a plurality of wavelengths through the intact cornea of the eye such that the emitted light enters the optical reflecting cavity and reflected light then reflects from the optical reflecting cavity and travels, free of any waveguide, outwardly through the intact cornea and to the receiver/processor positioned in front of the eye; and

,

(D) using the optical spectrum analyzer to ratiometrically measure reflectance spectra of the reflected light at said plurality of wavelengths and to obtain, on the basis of said ratiometric measurement, an indication of current intraocular pressure.

2. A method according to claim 1 wherein Step (A) comprises implanting the optical pressure sensor such that it is positioned substantially within the anterior chamber of the eye.

3. A method according to claim 1 wherein Step (A) comprises implanting the optical pressure sensor such that it is positioned substantially within the posterior chamber of the eye.

4. A method according to claim 1 wherein the native ophthalmic lens has been removed from the eye leaving at least a portion of the lens capsule intact and wherein Step (A) comprises implanting the optical pressure sensor such that it is positioned substantially′

within at least a remaining portion of the lens capsule.

5. A method according to claim 1 wherein the optical pressure sensor is attached to a support that is configured to hold the optical pressure sensor at a substantially fixed position within the eye, and wherein Step (A) comprises implanting the optical pressure sensor and the support such that the optical pressure sensor is thereby held in a substantially fixed position within the eye.

6. A method according to claim 5 wherein Step (A) comprises implanting the optical pressure sensor and the support such that the optical pressure sensor is held in a substantially fixed position within the anterior chamber of the eye.

7. A method according to claim 5 wherein Step (A) comprises implanting the optical pressure sensor and the support such that the optical pressure sensor is held in a substantially fixed position within the posterior chamber of the eye.

8. A method according to claim 5 wherein the support comprises a lens that is adapted to perform a vision correcting function when implanted in the eye and wherein Step (A) comprises implanting the optical pressure sensor and the support in the eye such that i) the optical pressure sensor senses intraocular pressure and ii) the lens at least partially corrects the patient'"'"'s vision.

9. A method according to claim 5 wherein the support comprises a shunt that is designed to drain aqueous humor in a manner that lowers intraocular pressure of the eye and wherein Step (A) comprises implanting the optical pressure sensor and the support in the eye such that i) that the optical pressure sensor senses intraocular pressure and ii) the shunt drains aqueous humor in a manner that lowers intraocular pressure.

10. A method according to claim 4 wherein the optical pressure sensor is embedded in or attached to a prosthetic lens, said prosthetic lens being implantable within at least a remaining portion of the lens capsule in place of the previously removed native lens.

11. A method according to claim 1 wherein Step (A) comprises positioning the optical pressure sensor in the eye such that, when light is passed from the light source in Step (C), the light will pass through the cornea of the eye and will strike and be reflected by the optical reflecting element cavity.

12. A method according to claim 1 further comprising the steps of:

(E) implanting in the eye a optical analyte sensor having an optical reflecting element that varies in relation to the concentration or presence of at least one analyte;

(F) using a light source to cast light into the eye such that the g will strike and be reflected by the optical reflecting element of the analyte sensor; and

,

(G) using a receiver/processor to receive light which has reflected from the optical reflecting element of the analyte sensor and Co process such reflected light so as to obtain a qualitative or quantitative determination of at least one analyte.

13. A method according to claim 12 wherein the optical pressure sensor and the analyte sensor are attached to a common support that holds both the optical pressure sensor and the analyte sensor at substantially fixed positions within the eye and wherein Steps (A) and (E) are performed concurrently by implanting the optical pressure sensor, analyte sensor and accompanying support within the eye.

14. A method according Co claim 12 wherein different light sources are used in Steps C and F.

15. A method according to claim 12 wherein the same light source is used in Steps C and F.

16. A method according to claim 15 wherein the wavelength of light emitted from the light source is variable and wherein a first wavelength is used in Step (C) and a second wavelength is used in Step (F).

17. A method according to claim 12 wherein different receiver/processors are used in Steps (D) and (G).

18. A method according to claim 12 wherein the same receiver/processor is used in Steps (D) and (G).

19. A method according to claim 18 wherein at least one setting on the receiver/processor is variable and wherein at least one first setting of the receiver/processor is used in Step (D) and at least one second setting of the receiver/processor is used in Step (G).

20. A method according to claim 12 wherein the analyte sensor is adapted to measure or to detect glucose and wherein Step (G) comprises obtaining a qualitative or quantitative determination of glucose.

21. A method according to claim 1 wherein the plurality of wavelengths comprise 820 nm, 850 nm and 880 nm.