Methods and devices for implantation of intraocular pressure sensors

• US 10,213,107 B2
• Filed: 07/01/2015
• Issued: 02/26/2019
• Est. Priority Date: 07/01/2014
• Status: Active Grant

• Current Assignee: Injectsense, Inc.
• Original Assignee: Injectsense, Inc.
• Inventors: Cao, Ariel, Malaret, Enrique
• Primary Examiner(s): Cerioni, Daniel
• Assistant Examiner(s): Kolderman, Nicholas E
• Application Number:
  US14/789,491
• Publication Number:
  US 20160000325A1
• Time in Patent Office: 1,336 Days
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 3/16 for measuring intraocular pressure, e.g. tonometers
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/6821 Eye
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Methods and devices for implanting an intra-ocular pressure sensor within an eye of a patient are provided herein. Methods include penetrating a conjunctiva and sclera with a distal tip of a fluid-filled syringe and positioning the pressure sensor within a vitreous body of the eye by injecting the sensor device through the distal tip. The sensor device may be stabilized by one or more anchoring members engaged with the sclera so that the pressure sensor of the sensor device remains within the vitreous body. Methods further include advancing a sensor device having a distal penetrating tip through at least a portion of the sclera to position the sensor within the vitreous body and extracting of the sensor devices described herein by proximally retracting the sensor device using an extraction feature of the sensor device.

Claims

1. A method for implanting an intraocular pressure (IOP) sensor device in an eye of a patient, said method comprising:

positioning an IOP sensor of the IOP sensor device within a vitreous body of the eye by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour, wherein the IOP sensor device resides in a support structure, wherein the IOP sensor is injected by a fluid-filled syringe;

anchoring the IOP sensor within the vitreous body of the eye with one or more anchoring members of the support structure, the one or more anchoring members being integral parts of the support structure; and

releasing the IOP sensor from the fluid-filled syringe by pushing the IOP sensor through a distal tip thereof by displacing a fluid within the syringe, wherein displacing the fluid from the syringe comprises retracting the distal tip from the syringe so as to stabilize a position of the IOP sensor within the vitreous body during release from the syringe.

2. The method of claim 1, wherein a sensing diaphragm of the IOP sensor is disposed entirely within the vitreous body for direct measurement of the IOP of the vitreous humour.

3. The method of claim 1, further comprising:

correlating a sensitivity of the IOP measurement of the vitreous humour to an IOP of the aqueous humour in an anterior chamber of the eye.

4. The method of claim 1, further comprising:

penetrating partly through a sclera of the eye with an instrument; and

advancing the IOP sensor into the partly penetrated sclera so as to complete penetration of the sclera with a distal tip of the IOP sensor.

5. The method of claim 1, further comprising:

penetrating a distal tip of an injector or syringe through a conjunctiva and a sclera of the eye and into the vitreous body, wherein the IOP sensor is injected through the distal tip of the injector or syringe.

6. The method of claim 5 wherein positioning the IOP sensor comprises distally advancing the distal tip of the injector or syringe until a distal facing surface of the injector or syringe abuts against the conjunctiva.

7. The method of claim 5, wherein the distal tip comprises a needle having a gauge of 19 or higher, wherein the IOP sensor comprises a portion of a sensor device having a maximum thickness of about 600 microns or less to facilitate injection through the needle along an insertion axis in-plane with the sensor device.

8. The method of claim 5 further comprising:

releasing the IOP sensor from the injector or syringe.

9. The method of claim 5, further comprising:

positioning the injector or syringe within an ora serrata region of the eye prior to penetrating the distal tip of the injector or syringe so as to avoid any optic structures of a retina of the eye.

10. The method of claim 9, further comprising:

injecting a fluid into the conjunctiva prior to penetrating the distal tip of the injector or syringe, thereby creating at least a ballooned portion of the conjunctiva in the ora serrata region.

11. The method of claim 10, wherein the fluid comprises an anesthetic such that injecting the fluid into the conjunctiva reduces sensitivity in the eye of the patient prior to penetrating the sclera with the distal tip of the injector or syringe.

12. The method of claim 10, wherein penetrating comprises inserting the distal tip of the injector or syringe through the conjunctiva at the at least ballooned portion, and wherein anchoring comprises deploying the one or more anchoring members along the sclera and covering a proximal end of the device with the conjunctiva after implantation.

13. The method of claim 12, further comprising orienting the distal tip of the injector or syringe substantially perpendicular to the sclera after insertion into the conjunctiva at the at least ballooned portion to facilitate penetration of the sclera and avoid any optic structures of a retina of the eye.

14. The method of claim 7, wherein the IOP sensor includes a MEMs device formed by a wafer process, wherein the sensor device is injected along an insertion axis in-plane with the MEMs device.

15. The method of claim 14, further comprising:

anchoring the IOP sensor within the vitreous body by deploying the one or more anchoring members against the sclera.

16. The method of claim 15, wherein the one or more anchoring members are resiliently biased to extend laterally outward relative to the insertion axis and are constrained within the distal tip toward the insertion axis such that releasing the IOP sensor from the injector or syringe deploys the one or more anchoring members.

17. The method of claim 15, wherein the one or more anchoring members are deployed proximally of the sclera along the insertion axis so as to inhibit movement of the IOP sensor further into the vitreous body by engaging the one or more deployed anchoring members substantially flush with the sclera.

18. The method of claim 15, wherein the one or more anchoring members comprise at least a first and second anchoring member such that anchoring comprises deploying the first anchoring member along the sclera outside of the vitreous body and deploying the second anchoring member along the sclera inside the vitreous body so as to inhibit axial movement of the IOP sensor along the insertion axis after implantation.

19. The method of claim 1, wherein the sensor is injected transverse to a pars plana region in between the ora serrata and limbus of the eye.

20. The method of claim 1, wherein the support structure is an outer casing or housing that extends only partly about the IOP sensor device such that at least a portion of the sensor is exposed.

21. The method of claim 1, wherein positioning comprises advancing a penetrating tip of the support structure through a sclera into the vitreous body, and anchoring comprises engaging the sclera with the one or more anchoring members disposed at a proximal end of the support structure so as to maintain a position of the IOP sensor within the vitreous body.

22. A method for implanting an intraocular pressure (IOP) sensor device in an eye of a patient, said method comprising:

positioning an IOP sensor of the IOP sensor device within a vitreous body of the eye by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour, wherein the IOP sensor device resides in a support structure, wherein the IOP sensor is injected by a fluid-filled syringe;

anchoring the IOP sensor within the vitreous body of the eye with one or more anchoring members of the support structure, the one or more anchoring members being integral parts of the support structure; and

releasing the IOP sensor from the fluid-filled syringe by pushing the IOP sensor through a distal tip thereof by displacing a fluid within the syringe, wherein releasing the IOP sensor comprises retracting the distal tip into a body of the injector or syringe while a distal facing surface of the injector or syringe is abutted against the conjunctiva.

23. The method of claim 22, wherein releasing the IOP sensor comprises maintaining a position of the IOP sensor within the vitreous body using a pusher member during retraction of the distal tip into the body of the injector or syringe.

24. A method for implanting an intraocular pressure (IOP) sensor device in an eye of a patient, said method comprising:

positioning an IOP sensor of the IOP sensor device within a vitreous body of the eye by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour, wherein the IOP sensor device resides in a support structure, wherein the IOP sensor includes a MEMs device formed by a wafer process, wherein the sensor device is injected along an insertion axis in-plane with the MEMs device;

anchoring the IOP sensor within the vitreous body of the eye with one or more anchoring members of the support structure, the one or more anchoring members being integral parts of the support structure;

penetrating a distal tip of an injector or syringe through a conjunctiva and a sclera of the eye and into the vitreous body, wherein the IOP sensor is injected through the distal tip of the injector or syringe, wherein the distal tip comprises a needle having a gauge of 19 or higher, wherein the IOP sensor comprises a portion of a sensor device having a maximum thickness of about 600 microns or less to facilitate injection through the needle along an insertion axis in-plane with the sensor device; and

anchoring the IOP sensor within the vitreous body by deploying the one or more anchoring members against the sclera, wherein the one or more anchoring members and the IOP sensor are defined portions of a MEMs device formed by a wafer process, the one or more anchoring members being proximal of the IOP sensor along the insertion axis such that the IOP sensor resides within the vitreous body while the one or more anchoring members are deployed proximally of the sclera along the insertion axis.

25. The method of claim 24, wherein anchoring comprises engaging the sclera by the one or more anchoring members that are resiliently deflectable in a direction in-plane with a wafer in which the one or more anchoring members are formed.

26. A method for implanting an intraocular pressure (IOP) sensor in an eye of a patient, the method comprising:

positioning an IOP sensor within a vitreous body of the eye by injecting the IOP sensor into the vitreous body to measure the IOP within a vitreous humour of the eye;

penetrating a distal tip of an injector or syringe through a conjunctiva and a sclera of the eye and into the vitreous body, wherein the IOP sensor is injected through the distal tip of the injector or syringe, wherein the distal tip comprises a needle having a gauge of 19 or higher and the IOP sensor comprises a portion of a sensor device having a maximum thickness of about 600 microns or less to facilitate injection through the needle along an insertion axis in-plane with the sensor device, the IOP sensor including a MEMs device formed by a wafer process, wherein the sensor device is injected along an insertion axis in-plane with the MEMs device;

anchoring the IOP sensor within the vitreous body by deploying one or more anchoring members against the sclera, wherein the one or more anchoring members comprise at least a first and second anchoring member such that anchoring comprises deploying the first anchoring member along the sclera outside of the vitreous body and deploying the second anchoring member along the sclera inside the vitreous body so as to inhibit axial movement of the IOP sensor along the insertion axis after implantation; and

extracting the IOP sensor by attaching an extraction tool to an extraction feature of the IOP sensor disposed outside the vitreous body, wherein extracting comprises pulling the extraction feature until an anchoring force provided by the at least second anchoring member is overcome.

27. A method for implanting an intraocular pressure (IOP) sensor device in an eye of a patient, said method comprising:

positioning an IOP sensor of the IOP sensor device within a vitreous body of the eye by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour, wherein the IOP sensor device resides in a support structure, wherein the IOP sensor includes a separate reference sensor disposed adjacent the IOP sensor configured for detecting second order effects associated with stress in the sensor device to allow cancellation of the second order effects from the pressure measurement obtained from the IOP sensor; and

anchoring the IOP sensor within the vitreous body of the eye with one or more anchoring members of the support structure, the one or more anchoring members being integral parts of the support structure.

28. The method of claim 27, further comprising:

embedding data, with the implanted IOP sensor device, within the IOP measurement relating to the second order effects detected by the reference sensor.

29. A method for implanting an intraocular pressure (IOP) sensor in an eye of a patient, the method comprising:

positioning an IOP sensor within a vitreous body of the eye by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour, wherein the IOP sensor includes a reference sensor disposed adjacent the IOP sensor configured for detecting one or more second order effects so as to allow cancellation of the second order effects from the pressure measurement obtained from the IOP sensor, wherein the IOP sensor and the reference sensor are of a substantially similar construction having a cavity, except the cavity of the IOP sensor is under vacuum such that the sensing diaphragm is sensitive to changes of pressure such that a signal from the IOP sensor corresponds to changes in pressure and the corresponding cavity of the reference sensor is filled such that a signal obtained from the reference sensor corresponds to the second order effects; and

cancelling the second order effects associated with the IOP measurement obtained from the IOP sensor using the signal from the reference sensor.

30. A method of anchoring an implant, the method comprising:

inserting an implantable device through a distal tip of an injector or syringe along an insertion axis into a body tissue or body space within a patient, the device being formed, at least in part, by a wafer process; and

deploying one or more anchoring members of the device so as to extend laterally outward from the insertion axis to inhibit movement of the implanted device within the body tissue or body space, wherein the one more anchoring members comprise a portion of a wafer of the device defined so as to be resiliently deflectable in a direction in-plane with the wafer.