The present invention generally relates to pressure monitoring devices and particularly to pressure monitoring devices for monitoring pressure within a biological system.
Intraocular pressure (TOP) monitoring is essential in study and cure of diseases such as glaucoma. Increased and decreased IOP both are potentially harmful to a patient's eyesight. In many cases the damage caused is irreversible. Hence it is important to monitor the IOP continuously and accurately in patient with a diseased eye. So far there have been devices which attempt to measure the IOP based on applied pressure and deformation of the eyeball. However these devices are bulky, and are not capable of continuous monitoring.
Therefore, there is a need for a system for monitoring of the IOP in a patient's eye with a minimally invasive device which is light weight, portable, and capable of providing continuous measurements and communicating the measurement to an external monitoring device.
According to one aspect of the current teachings a pressure monitoring system is disclosed. The pressure monitoring system includes a stimulation/response circuit configured to transmit a first signal during a stimulation mode, and receive a second signal during a response mode in response to the first signal, and a pressure monitoring apparatus configured to receive the first signal during the stimulation mode and transmit the second signal during the response mode, wherein the pressure monitoring apparatus includes a capacitive pressure sensor assembly providing a variable capacitance in response to variable pressure being applied to the capacitive pressure sensor assembly, an insertion needle assembly having an insertion opening, the insertion needle assembly being coupled to the capacitive pressure sensor assembly, wherein fluid pressure at the insertion opening is fluidly communicated with the capacitive pressure sensor assembly thereby affecting capacitance of the capacitive pressure sensor assembly, and a coil assembly having an inductance, the coil assembly being coupled to the capacitive pressure sensor assembly, wherein the coil assembly and the capacitive pressure sensor assembly form a tank circuit with a variable resonant frequency, and wherein the coil assembly receives the first signal and transmits the second signal a time difference later.
According to another aspect of the current teachings a pressure monitoring apparatus is disclosed. The pressure monitoring apparatus includes a capacitive pressure sensor assembly providing a variable capacitance in response to variable pressure being applied to the capacitive pressure sensor assembly, an insertion needle assembly having an insertion opening, the insertion needle assembly being coupled to the capacitive pressure sensor assembly, wherein fluid pressure at the insertion opening is fluidly communicated with the capacitive pressure sensor assembly thereby affecting capacitance of the capacitive pressure sensor assembly, and a coil assembly having an inductance, the coil assembly being coupled to the capacitive pressure sensor assembly.
According to yet another aspect of the current teachings a method for monitoring intraocular pressure is disclosed. The method includes implanting a pressure monitoring apparatus in a subject's eye, the pressure monitoring apparatus having a variable capacitance in response to intraocular pressure, and an inductance forming a tank circuit, fluidly coupling intraocular fluid with the pressure monitoring apparatus, transmitting a first signal during a stimulation mode, receiving the first signal by the tank circuit during the stimulation mode, energizing the tank circuit in response to receiving the first signal, and transmitting a second signal by the tank circuit a period of time after receiving the first signal.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and described in the following written specification. It is understood that no limitation to the scope of the invention is thereby intended. It is further understood that the present invention includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles of the invention as would normally occur to one of ordinary skill in the art to which this invention pertains.
A system for using a capacitive pressure sensor for monitoring intraocular pressure (TOP) changes is disclosed. This type of sensor provides advantages of high sensitivity and low power consumption. In addition, zero DC power consumption and convenient inductor-capacitor (L-C) tank wireless readout circuitry make capacitive pressure sensors more favorable for this type of application.
I/O device 12, a processing circuit 14 and a memory 16. The I/O device 12 may include an input/output user interface, graphical user interface, keyboards, pointing devices, remote and/or local communication links, displays, and other devices that allow externally generated information to be provided to the TOP measuring system 10, and also allow internal information of the IOP measuring system 10 to be communicated externally.
The processing circuit 14 may suitably be a general purpose computer processing circuit such as a microprocessor and its associated circuitry. Alternatively, the processing circuit may be a dedicated instrumentation equipment specifically designed to operate the TOP measuring system 10. The processing circuit 14 is operable to carry out operations related to measuring the IOP pressure. The processing circuit 14 is connected to the I/O circuit 12 for receiving information from the I/O circuit 12 and for providing information to the I/O circuit 12.
The memory 16 stores program instructions 18 that are executed by the processing circuit 14 and/or any other components as appropriate. The memory 16 is also configured to store data from the IOP measurements as well as other data related to the IOP measuring system 10. The memory 16 may include read-only memory (ROM), as well as electrically erasable programmable ROM, random access memory and other forms of memory known by a person of ordinary skill in the art. The memory 16 is connected to the processing circuit 14 to provide information to the processing circuit 14 as well as receive information from the processing circuit 14.
The IOP measuring system 10 further includes a stimulation/response circuit 300 connected to the processing circuit 14. The sensor stimulation/response circuit 300 provides a stimulus for an intraocular pressure monitoring apparatus (IPMA) 100 and measures the effects of the stimulus. The stimulus may be controlled by the processing circuit 14 and where the measured value is communicated to the processing circuit 14. The IPMA 100 includes the capacitive pressure sensor assembly 150 as well as a coil assembly 200, described in greater detail below.
Referring to
Referring to
Cu, Al and any conductive materials. Each of the two terminals 202 and 204 is connected to a wire 208 that is wrapped in the shape of a coil. The coil-shaped wire 208 is made form a conductive material such as Ti/Au, Cr/Au, Ti/Pt, Cr/Pt, Cu, Al and other conductive materials. The coil-shaped wire 208 is part of an L-C tank circuit, described further below, wherein the coil-shaped wire 208 provide the majority of the inductance. The wire 208 is encased with a bio-compatible and inert material layer 210 such as glass, parylene, polyimide, Polydimethylsiloxane (PDMS), acrylic, Cyclobutene (BCB), or other polymers. The layer 210 seals the wire 208 such that when the IPMA 100 is implanted into the eye, ocular fluids do not cause shorting of the wires between each rotation of the wire in the coil-shaped wire 208. Such a shorting can adversely affect the inductance.
Referring to
The capacitor is part of the L-C tank circuit, discussed above. The capacitance of the capacitor is affected by the position of the top flexible membrane 160. In response to the flexure of the top flexible membrane 160, lump capacitance of the capacitor increases based on the following formula:
wherein C is the capacitance,
εr is the dielectric constant (also known as the relative static permittivity),
ε0 is the electric constant,
S is the surface area of the overlapped portions of the top flexible membrane 160 and the bottom plate 162, and
d is the distance between the top flexible membrane 160 and the bottom plate 162. The quantity
εr is dependent on the material chosen for the dielectric. The capacitance C has an inverse relationship with the distance between the top flexible membrane 160 and the bottom plate 162. Therefore, as the distance d decreases the capacitance C increases. Increase in the capacitance C affects the resonant frequency of the tank circuit according to the following formula:
wherein f is the resonant frequency of the tank circuit,
L is the inductance, and
C is the capacitance. In the IPMA 100, the inductance L is configured to be substantially constant as defined by the coil assembly 200, while the capacitance C is configured to vary in response to application of IOP. As the IOP increases, the distance between the top flexible membrane 160 and the bottom plate 162 decreases, which causes the capacitance C to increase, which in turn causes the resonant frequency f to decrease.
Referring to
Referring to
In operation, the transmitted signal (i.e., the first signal) that is picked up by the coil assembly 200 energizes the LC tank circuit. Depending on the frequency of the transmitted signal and how close that frequency is to the resonant frequency of the LC tank circuit (discussed above), a short amount of time later, the tank circuit begins to retransmit the second signal. The time lag between the two signals (i.e., the original transmitted signal by the coil 302 and the retransmitted signal by the tank circuit) define the phase difference between these signals. At resonant frequency magnitude of the retransmitted signal approaches the magnitude of the transmitted signal. However, due to losses in the tank circuit, mainly electrical resistance of the coil assembly 200 and contact resistance between the terminals 202 and 204 of the coil assembly 200 and the terminals 152 and 154 of the capacitive pressure sensor assembly 150, the retransmitted signal has an attenuated magnitude as compared to the transmitted signal even at the resonant frequency.
The authors of the present disclosure envision the stimulation/response circuit 300 to be mountable on a pair of glasses that can be worn by a human subject which can wirelessly (or with a wired channel) communicate with the processing circuit 14. The stimulation/response circuit 300 can be mounted on the glasses near the eye for monitoring IOP.
According to one embodiment, upon implantation, the needle 172 penetrates the sclera and then can be in contact with the vitreous chamber which contains the vitreous humor. Referring to
The authors of the present disclosure have also shown by experiments on cadaver eyes that pressure values based on measurements at the posterior part of the eye correlate well with pressure values at the anterior part of the eye making IPMA 100 relatively location independent.
Most other intra-ocular sensor technologies are designed to be totally implanted within the eye and/or to perform measurement at the anterior chamber of the eye. However with the IPMA 100, partial insertion of the sensor makes the sensor minimally invasive, easy to implant, and generates minimal irritation for the subject.
Once implanted, the insertion needle assembly 170 established fluid communication between the capacitive pressure sensor assembly 150 and the ocular fluid. Accordingly, IOP in the anterior chamber of the eye applies pressure to the top flexible membrane 160 of the capacitive pressure sensor assembly 150 causing the top flexible membrane 160 to flex inwardly toward the bottom plate 162. As discussed above. the flexure of the deformable membrane increases the capacitance of the capacitive pressure sensor assembly 150.
The stimulation/response circuit 300, provides the stimulation signal with a sweeping frequency near the expected resonant frequency of the tank circuit of the capacitive pressure sensor assembly 150 during the stimulation mode. The tank circuit is thereby energized by electromagnetically coupling the external field generated by the coil 302 (see
Referring to
f=−0.0149P+63.763,
wherein f is frequency of the resonant frequency of the tank circuit, and
P is the pressure applied to the top flexible membrane 160. This relationship agrees with the analysis discussed above. As the pressure increases, the top flexible membrane 160 deforms, causing the capacitance of the tank circuit to increase, which causes the resonant frequency of the tank circuit to decrease.
Referring to
In reference to
Referring to
In operation, a clinician/researcher prepares the desired implantation site in a subject's eye. The clinician/researcher loads an IPMA 100 into the actuation end 410 and positions the insertion tool 400 over the desired site. Once positioned, the clinician/researcher presses the actuation knob so that the plunger 408 comes in contact with IPMA 100 and causes forward motion of the IPMA 100 into the subject's eye. Upon release of the actuation knob 404, the knob 404 under the biasing force of the biasing member 406 returns to the non-actuated position (depicted in
Different packaging and fabrication methods have been developed to fabricate and assemble an IPMA 100 which are described below. Process flows for these packaging methods, starting with a pressure sensor with backside silicon, is shown in
Referring to
Referring to
Referring to
Referring to
The coil assembly can be fabricated using a standard flex circuit fabrication process. Usage of a flexible material for the coil reduces the irritation for the patient and allows easy placement underneath the orbital fat. The flexible material also allows a larger area for the coil which in turn increases inductance. Higher inductance reduces the resonant frequency of the LC tank thus lowering the signal loss passing through the body. Hence coil inductance and capacitance of the IPMA 100 can be designed such that these components would not require the stimulation/response circuit 300 to be excessively close to the IPMA 100. Therefore, the components of the stimulation/response circuit 300 can be positioned a comfortable distance away from the subject in order to measure the IOP. The coil assembly 200 can be bonded to the capacitive pressure sensor assembly 150 terminals 152 and 154 using flip-chip bonding techniques.
Those skilled in the art will recognize that numerous modifications can be made to the specific implementations described above. Therefore, the following claims are not to be limited to the specific embodiments illustrated and described above. The claims, as originally presented and as they may be amended, encompass variations, alternatives, modifications, improvements, equivalents, and substantial equivalents of the embodiments and teachings disclosed herein, including those that are presently unforeseen or unappreciated, and that, for example, may arise from applicants/patentees and others.
This application claims the benefit of a U.S. Provisional Application Ser. No. 61/321,494 the entire content of which is incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2011/031437 | 4/6/2011 | WO | 00 | 10/8/2012 |
Number | Date | Country | |
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61321494 | Apr 2010 | US |