Methods and devices for implantation of intraocular pressure sensors
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Publication Number
US-10213107-B2
Publication Date
2019-02-26
Expiration Date
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.
Core Innovation
An intraocular pressure (IOP) sensor device is implanted by positioning an IOP sensor within a vitreous body of an eye by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour. The IOP sensor device resides in a support structure, and the IOP sensor is injected by a fluid-filled syringe. After injection, the IOP sensor is anchored within the vitreous body with one or more anchoring members that are integral parts of the support structure.
The sensor is released from the fluid-filled syringe by pushing the IOP sensor through a distal tip thereof by displacing a fluid within the syringe. Releasing the IOP sensor includes retracting the distal tip from the syringe to stabilize a position of the IOP sensor within the vitreous body during release, and in another configuration includes 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. This places and maintains the sensing element within the vitreous body during release from the injector.
Anchoring is achieved by deploying one or more anchoring members against the sclera, including deploying anchoring member portions along the sclera outside and inside of the vitreous body to inhibit axial movement along the insertion axis after implantation. Extraction is performed by attaching an extraction tool to an extraction feature disposed outside the vitreous body, where extracting comprises pulling the extraction feature until an anchoring force provided by an anchoring member is overcome. In addition, the sensor device may include a MEMs device formed by a wafer process, with an injection axis in-plane with the MEMs device, and resiliently deflectable anchoring member portions defined as part of the wafer.
In some configurations, the IOP sensor includes a separate reference sensor disposed adjacent the IOP sensor for detecting second order effects associated with stress in the sensor device to allow cancellation of the second order effects from the pressure measurement. The IOP sensor and the reference sensor are of substantially similar construction having a cavity, except the cavity of the IOP sensor is under vacuum to make the sensing diaphragm sensitive to changes of pressure, while the corresponding cavity of the reference sensor is filled so that a reference signal corresponds to the second order effects. The second order effects associated with the IOP measurement are cancelled using the reference sensor signal.
Claims Coverage
The document includes six independent claims. The inventive features across these claims relate to injecting and releasing an IOP sensor into the vitreous body, integral support-structure anchoring to inhibit movement, needle- and sensor-thickness-enabled insertion with MEMs/wafer integration, multi-stage anchoring deployed on and within the sclera and extraction overcoming anchoring force, cancellation of second order stress-related effects using an adjacent reference sensor, and a general wafer-processed implant anchoring method with in-plane resilient deflectability.
Injecting an IOP sensor into the vitreous body with fluid-filled syringe release stabilized by distal tip retraction
Positioning an IOP sensor within a vitreous body by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour using a fluid-filled syringe, anchoring the IOP sensor with one or more integral anchoring members of a support structure, and releasing the IOP sensor from the fluid-filled syringe by pushing the IOP sensor through a distal tip by displacing fluid, wherein displacing comprises retracting the distal tip to stabilize the position during release.
Releasing by distal tip retraction with abutment against conjunctiva
Positioning the IOP sensor within the vitreous body by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour using a fluid-filled syringe, anchoring the IOP sensor with one or more integral anchoring members of a support structure, and releasing the IOP sensor by pushing it through a distal tip while releasing comprises retracting the distal tip into a body of the injector or syringe with a distal facing surface abutted against the conjunctiva.
MEMs wafer-processed IOP sensor injected along an insertion axis with needle gauge and sensor thickness enabling conjunctiva/sclera penetration and proximal scleral anchoring
Positioning an IOP sensor within a vitreous body by injecting along an insertion axis in-plane with a MEMs device formed by a wafer process, anchoring the IOP sensor with integral anchoring members of the support structure, penetrating a distal tip of an injector or syringe through conjunctiva and sclera into the vitreous body with a needle gauge of 19 or higher and the IOP sensor having a maximum thickness of about 600 microns or less to facilitate injection, and anchoring by deploying the anchoring members against the sclera with anchoring members proximal of the IOP sensor along the insertion axis.
Multiple anchoring members deployed on and inside sclera to inhibit axial movement with extraction overcoming anchoring force
Positioning an IOP sensor within a vitreous body by injecting the IOP sensor to measure the IOP within a vitreous humour, penetrating a distal tip through conjunctiva and sclera into the vitreous body with a needle gauge of 19 or higher and the IOP sensor having a maximum thickness of about 600 microns or less to facilitate injection along an insertion axis in-plane with a MEMs device formed by a wafer process, anchoring by deploying at least a first and second anchoring member such that anchoring comprises deploying the first anchoring member along sclera outside the vitreous body and deploying the second anchoring member along sclera inside the vitreous body to inhibit axial movement along the insertion axis, and extracting by attaching an extraction tool to an extraction feature disposed outside the vitreous body where extracting comprises pulling the extraction feature until an anchoring force provided by the at least second anchoring member is overcome.
Cancelling second order effects using an adjacent reference sensor with differentiated cavity conditions
Positioning an IOP sensor within a vitreous body by injecting the IOP sensor into the vitreous body to measure the IOP of a vitreous humour, where the IOP sensor device resides in a support structure and 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 with one or more integral anchoring members of the support structure.
Wafer-processed implant anchoring with laterally outward in-plane resiliently deflectable anchoring members
Inserting an implantable device through a distal tip of an injector or syringe along an insertion axis into a body tissue or body space, where the device is formed at least in part by a wafer process, and deploying one or more anchoring members so as to extend laterally outward from the insertion axis to inhibit movement of the implanted device, wherein the anchoring members comprise a portion of a wafer defined to be resiliently deflectable in a direction in-plane with the wafer.
Across the independent claims, the core scope covers injecting an IOP sensor into the vitreous body via a fluid-filled syringe, stabilizing and releasing the sensor during distal tip retraction, anchoring the sensor with integral anchoring members deployed against the sclera to inhibit movement, including axial inhibition and movement inhibition by laterally outward wafer-defined resilient deflection, and extracting via an external tool overcoming an anchoring force. Additional claim scope includes MEMs wafer-processed sensor and anchoring geometry aligned with an insertion axis and needle gauge/thickness constraints, and cancelling second order stress-related effects using an adjacent reference sensor with differentiated cavity conditions to generate a cancellation signal.
Stated Advantages
Inhibiting axial movement of the IOP sensor along the insertion axis after implantation.
Inhibiting movement of the implanted device within body tissue or body space.
Allowing cancellation of second order effects from the pressure measurement.
Documented Applications
Implanting an intraocular pressure (IOP) sensor device in an eye of a patient.
Anchoring an implantable device inserted through a distal tip of an injector or syringe into a body tissue or body space within a patient.
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