Methods and Devices for Implantation of Intraocular Pressure Sensors

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.

1 . (canceled) 
     
     
         2 . 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 chamber of the eye by advancing the IOP sensor into the eye chamber to directly measure the IOP of the eye chamber, wherein the IOP sensor is defined along a distal portion of the IOP sensor device, wherein the IOP sensor device resides in a support structure and the IOP sensor device and support structure are disposed, at least partly, in a distal portion of an injector device;   anchoring the IOP sensor within the chamber of the eye by engaging one or more anchoring members of the support structure with a sclera of the eye, wherein the one or more anchoring members are disposed on a proximal portion of the support structure; and   releasing the IOP sensor device from the injector device with the IOP sensor disposed within the chamber of the eye while the one or more anchoring members remain engaged against the sclera so as to stabilize a position of the IOP sensor within the chamber for long-term IOP monitoring.   
     
     
         3 . The method of  claim 2 , wherein the support structure is shaped so that a sensing diaphragm of the IOP sensor is exposed while the sclera is engaged by the one or more anchoring members. 
     
     
         4 . The method of  claim 3 , wherein the support structure is formed of a monolithic material comprising any of: silicon, titanium and a shape memory alloy. 
     
     
         5 . The method of  claim 2 , wherein each of the one or more anchoring members are integrally formed with the support structure. 
     
     
         6 . The method of  claim 2 , wherein anchoring comprises engaging an outer surface of the sclera with a first anchoring member and engaging an inside surface of the sclera with a second anchoring member. 
     
     
         7 . The method of  claim 6 , wherein the first and second anchoring members are of substantially the same construction but spaced apart so as to accommodate the sclera in between. 
     
     
         8 . The method of  claim 2 , wherein the one or more anchoring members are laterally deployable. 
     
     
         9 . The method of  claim 2 , wherein the one or more anchoring members are not laterally deployable. 
     
     
         10 . The method of  claim 9 , wherein the one or more anchoring members are defined as ridges that are extended laterally outward from the support structure. 
     
     
         11 . The method of  claim 2 , further comprising:
 at least partly penetrating the sclera with a surgical tool or a distal portion of the injector before advancing the IOP sensor through the penetrated sclera.   
     
     
         12 . The method of  claim 11 , wherein the sclera is penetrated, at least partly, at the pars plana region so that the IOP sensor is advanced into the vitreous body. 
     
     
         13 . The method of  claim 11 , wherein advancing the IOP sensor comprises at least partly penetrating the sclera with the surgical tool before positioning the injector on the eye and advancing the injector device through the penetrated sclera. 
     
     
         14 . The method of  claim 11 , wherein the IOP sensor device has a delivery profile suitable for passage through a penetration made by the surgical tool or a needle of size gauge  19  or higher. 
     
     
         15 . The method of  claim 2 , wherein the IOP sensor device comprises a stacked device that includes a MEMS sensor layer, a CMOS wafer comprising a digitizing ASIC, and a thin-film energy storage wafer. 
     
     
         16 . The method of  claim 2 , wherein the IOP sensor includes a MEMs device formed by a wafer process, wherein the IOP sensor device is advanced along an insertion axis in-plane with the MEMs device. 
     
     
         17 . The method of  claim 2 , further comprising:
 explanting the IOP sensor device from the eye by engaging, with an extraction tool, an extraction feature on a proximal portion of the support structure.   
     
     
         18 . The method of  claim 17 , wherein explanting further comprises moving the extraction tool after engaging the extraction feature, thereby disengaging the one or more anchoring features from engagement with the sclera to allow proximal retraction of the IOP sensor from the eye. 
     
     
         19 . A method of implanting a sensor device, the method comprising:
 advancing an implantable sensor device with an injector positioned along an insertion axis into a body tissue or body space within a patient, the sensor device including a sensor formed, at least in part, by a wafer process, wherein the sensor is defined along a distal portion of the sensor device, wherein the sensor device is disposed within a support structure having one or more anchoring members on a proximal portion thereof, wherein the one or more anchoring member comprises a first and second anchoring member that are spaced apart; and   positioning the first and second anchoring members of the device so as to engage a proximal surface and distal surface of a tissue wall of the patient adjacent the tissue or body space being monitored by the implantable sensor, wherein the first and second anchoring member are integral parts of the support structure.   
     
     
         20 . The method of  claim 19 , the method comprising:
 penetrating, at least partly, into the body tissue or body space to be monitored with a surgical tool that is separate from the injector device.   
     
     
         21 . The method of  claim 19 , wherein the sensor is a MEMS device that includes a pressure sensor having a sensing diaphragm for directly measuring pressure in the tissue or body space and a separate reference sensor disposed adjacent the pressure 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 by the sensor.