Device and method for glaucoma management and treatment

• US 8,926,510 B2
• Filed: 04/27/2012
• Issued: 01/06/2015
• Est. Priority Date: 04/27/2011
• Status: Active Grant

• Current Assignee: iSTAR Medical SA
• Original Assignee: iSTAR Medical SA
• Inventors: Marshall, Andrew J., Maginness, Max G., Alvarez, Michel
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US13/457,882
• Publication Number:
  US 20120302861A1
• Time in Patent Office: 984 Days
• Field of Search: 600398-406, 600/561, 600/587
• US Class Current: 600/398
• CPC Class Codes: A61B 3/16 for measuring intraocular pressure, e.g. tonometers
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Described herein is a device for glaucoma treatment and monitoring that comprises a combination of an intraocular pressure (IOP) sensor and a glaucoma drainage device. The device comprises an IOP sensor and an inductive antenna mounted within a porous biocompatible material that forms the drainage path. The IOP sensor is mounted in a footplate portion of the device and is mountable in the anterior chamber of an eye. The footplate portion is connected to a body portion that houses the spiral antenna by a neck portion which retains the footplate portion in a suitable position within the anterior chamber. Due to its size, the footplate portion housing the IOP sensor can readily be inserted into the anterior chamber with the body portion housing the spiral antenna located outside of the anterior chamber in a sub-scleral space to disperse the aqueous humour.

Claims

1. An integrated intraocular device comprising:

an intraocular pressure sensor element;

an antenna element; and

an aqueous humour drainage element, wherein, the drainage element consists of a porous biocompatible material, wherein the porous biocompatible material substantially encases the intraocular pressure sensor element and the antenna element, and wherein the porous biocompatible material comprises substantially spherical interconnected open pores having a mean pore diameter between 20 μ

m and 40 μ

m and is configured to provide isotropic flow paths for draining aqueous humour into tissue.

2. The integrated intraocular device according to claim 1, wherein the drainage element comprises a body portion housing the antenna element and a footplate portion housing the intraocular pressure sensor element.

3. The integrated intraocular device according to claim 2, wherein the body portion and the footplate portion are connected to one another by a smaller section neck portion for retaining the drainage element within the eye.

4. The integrated intraocular device according to claim 2, wherein the body portion has a periphery and is substantially circular and the antenna element comprises a circular spiral located within the circular body portion.

5. The integrated intraocular device according to claim 4, wherein the antenna element is substantially arranged around the periphery of the body portion.

6. The integrated intraocular device according to claim 2, wherein the body portion is substantially rectangular and the antenna element comprises a rectangular spiral located within the rectangular body portion.

7. The integrated intraocular device according to claim 2, wherein the antenna element and the intraocular pressure sensor element are connected by leads that pass between the body portion and the footplate portion.

8. The integrated intraocular device according to claim 7, further comprising at least one protective layer located between the intraocular pressure sensor element, the antenna element, the leads and the porous biocompatible material, the porous biocompatible material encasing each protective layer.

9. The integrated intraocular device according to claim 8, wherein a single protective layer is formed around the intraocular pressure sensor element, the antenna element and the leads, the single protective layer having an opening near the intraocular pressure sensor element to allow pressure of the aqueous humour to be measured through the porous biocompatible material.

10. The integrated intraocular device according to claim 1, wherein the porous biocompatible material comprises a natural polymer.

11. The integrated intraocular device according to claim 1, wherein the porous biocompatible material comprises a synthetic polymer.

12. The integrated intraocular device according to claim 11, wherein the synthetic polymer comprises silicone rubber.

13. The integrated intraocular device according to claim 1, wherein porous biocompatible material has a mean thickness of between 100 μ

m and 1000 μ

m.

14. The integrated intraocular device according to claim 13, wherein the mean thickness of the porous biocompatible material is between 100 μ

m and 500 μ

m.

15. The integrated intraocular device according to claim 14, wherein the mean thickness of the porous biocompatible material is between 200 μ

m and 500 μ

m.

16. The integrated intraocular device according to claim 1, wherein the mean pore diameter is between 25 μ

m and 30 μ

m.

17. The integrated intraocular device according to claim 1, wherein the substantially spherical open pores have pore interconnections having a width of between 15% and 40% of the mean pore diameter.

18. The integrated intraocular device according to claim 1, wherein the porous biocompatible material comprises an irregular outer surface having a topography comprising a plurality of peaks and valleys, each peak having a height of between about 100 μ

m and about 2000 μ

m and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured.

19. The integrated intraocular device according to claim 18, wherein the porous biocompatible material has a mean thickness of between 100 μ

m and 1000 μ

m, and wherein the irregular outer surface has surface variations of between 100 μ

m and 300 μ

m from the mean thickness of the porous biocompatible material.

20. The integrated intraocular device according to claim 1, wherein the porous biocompatible material provides a drain for aqueous humour flow with a resistance not exceeding 1 mmHg pressure drop for a flow of 1 μ

l/min.

21. The integrated intraocular device according to claim 1, wherein the antenna element comprises an inductive antenna element.

22. The integrated intraocular device according to claim 21, wherein the antenna element is passive.

23. The integrated intraocular device according to claim 1, wherein the intraocular pressure sensor element is passive.

24. The integrated intraocular device according to claim 1, further comprising an intraocular pressure sensor processing system, the intraocular pressure sensor element forming a part of the intraocular pressure sensor processing system.

25. The integrated intraocular device according to claim 24, wherein the intraocular pressure sensor processing system comprises a decoder for decoding signals received by the antenna element and a detector for obtaining power signals from the signals received by the antenna element.

26. The integrated intraocular device according to claim 25, wherein the intraocular pressure sensor processing system further comprises an energy storage module for storing energy relating to the power signals derived from the received signals.

27. The integrated intraocular device according to claim 24, wherein the intraocular pressure sensor processing system comprises an encoder for encoding signals to be transmitted by the antenna element.

28. An intraocular pressure monitoring system comprising:

an interrogation and processing system;

an integrated intraocular device, the intraocular device being arranged to communicate wirelessly with the interrogation and processing system, wherein the integrated intraocular device comprising;

an intraocular pressure sensor element;

an antenna element; and

an aqueous humour drainage element, and wherein, the drainage element consists of a porous biocompatible material, wherein the porous biocompatible material substantially encases the intraocular pressure sensor element and the antenna element, and wherein the porous biocompatible material comprises substantially spherical interconnected open pores having a mean pore diameter between 20 μ

m and 40 μ

m and is configured to provide isotropic flow paths for draining aqueous humour into tissue.

29. The intraocular pressure monitoring system according to claim 28, wherein the interrogation and processing system comprises a transceiver element for transmitting activation signals to the integrated intraocular device and for receiving signals corresponding to intraocular pressure measurements taken by the integrated intraocular device when activated.

30. The intraocular pressure monitoring system according to claim 29, wherein the interrogation and processing system comprises a communications module for transmitting data relating to the intraocular pressure measurements to a remote location.

31. The intraocular pressure monitoring system according to claim 28, wherein the interrogation and processing system is mounted in at least one of a pair of eye glasses, a wand, a pillowcase, and a sheet.

32. A method of monitoring intraocular pressure, the method comprising the steps of:

(a) implanting an integrated intraocular device including;

(i) an intraocular pressure sensor element;

(ii) an antenna element; and

(iii) an aqueous humour drainage element, wherein the drainage element consists of a porous biocompatible material, wherein the porous biocompatible material substantially encases the intraocular pressure sensor element and the antenna element, and wherein the porous biocompatible material comprises substantially spherical interconnected open pores having a mean pore diameter between 20 μ

m and 40 μ

m and is configured to provide isotropic flow paths for draining aqueous humour into tissue; and

(b) determining intraocular pressure measurements using the intraocular pressure sensor element within the integrated intraocular device;

wherein, step (a) comprises implanting the portion of the device having the intraocular pressure sensor element within the anterior chamber of the eye.

33. The method of monitoring intraocular pressure according to claim 32, wherein the drainage element comprises a body portion housing the antenna element and a footplate portion housing the intraocular pressure sensor element, and the body portion and the footplate portion are connected to one another by a smaller section neck portion for retaining the drainage element within the eye, and wherein step (a) comprises making a limbal incision in the eye;

positioning the footplate portion within the anterior chamber of the eye, the neck portion being located in the limbal incision; and

positioning the body portion within the exterior layers of the eye.

34. A method of monitoring intraocular pressure according to claim 33, wherein step (a) further comprises positioning the body portion between the choroid and the sclera of the eye.

35. A method of monitoring intraocular pressure according to claim 32, wherein step b) comprises using an extracorporeal device to interface with the intraocular pressure sensor element to obtain an output of the intraocular pressure measurements.