Patent Grant
10022054
Some embodiments relate generally to implanted wireless sensors and sensor systems measuring one or more biomedical parameters for monitoring cardiac health.
Cardiac operations are increasingly commonplace, and usually necessary, given the critical contribution cardiac health makes to a person's well being and survival. It is also recognized, however, that the invasive nature of cardiac procedures, whether they involve implantation of a cardiac device such as a pacemaker or valve repair, has the potential to produce post-surgery stress responses. For example, arrhythmias following cardiothoracic surgery are thought to result from direct mechanical irritation of the pericardium or myocardium, and due to increased sympathetic and hormonal activity. In another example, the use of cardiopulmonary bypass is considered to be linked to systemic inflammatory responses.
Some known approaches to monitoring cardiac health after surgery use implanted cardiac sensors. Wired sensors, however, require passage of wires through cutaneous layers, thereby risking physical injury and infection. Wireless sensors are hence more desirable for such biological operation. Implantation of sensors, however, is an invasive procedure by itself, which elevates and contributes to the risk faced by the patient. There is hence a need for sensors and sensor systems that reduce or otherwise minimize the additional risk associated with sensor-based monitoring of cardiac health after surgery and/or after implantation of a cardiac device.
In some embodiments, a cardiac monitoring system includes multiple sensors configured for implantation in a cardiovascular system of a user. Each sensor includes a sensing unit configured to be disposed in sensory communication with a location in the cardiovascular system for measuring a biological parameter in the location. The sensing unit is also configured to generate a sensory signal associated with the biological parameter. Each sensor also includes a wireless transceiver configured to receive the sensory signal from the sensing unit. The wireless transceiver is further configured to wirelessly transmit the sensory signal to an external processing device disposed outside a body of the user. The external processing device monitors, based on the sensory signal received from at least two sensors from the plurality of sensors, cardiac health associated with at least one of an implanted device or a surgery.
Sensors, cardiac monitoring systems, and methods of cardiac monitoring are disclosed herein. In some embodiments, a cardiac monitoring system includes multiple sensors that can be implanted in one or more locations in the cardiovascular system including, without limitation, a wall of at least one heart chamber of a user, a wall of an artery (e.g. the pulmonary artery), a wall of a vein, and/or the like. Similarly stated, one or more sensors can be implanted in any number of heart chambers. Each sensor can include a sensing unit in sensory communication with the heart chamber in which the sensing unit is implanted. The sensing unit can measure a biological parameter in the heart chamber. The sensing unit generates a sensory signal associated with the biological parameter, such as, for example, an electrical and/or magnetic signal in response to the biological parameter (e.g., pressure) sensed in the heart chamber. Each sensor can also include a wireless transceiver that can receive the sensory signal from the sensing unit and can wirelessly transmit the sensory signal to an external processing device. The external processing device can be disposed outside the body of the user, such that the wireless sensory signal is transmitted through the body of the user.
The external processing device can employ the wirelessly received sensory signal to monitor cardiac health. For example, the sensor can be a pressure sensor implanted in the left atrium of the user, and the external processing device can monitor the sensed pressure to determine whether the mitral valve formed between the left atrium and the left ventricle is functioning properly. Further, in some embodiments, the external processing device can monitor cardiac health based on multiple sensors (i.e., at least two sensors). For example, the sensors can be placed on either side of a repaired mitral valve, and the external processing device can monitor post-repair valve operation via the sensors. Further, the external processing device can monitor an implanted device based on the signal from the sensor(s). For example, the external processing device can be programmed to determine if an implanted left ventricular assist device (LVAD) is functioning properly based on pressure data obtained from two sensors, one implanted in the left atrium (LA) and the other implanted in either the right ventricle (RV), the left ventricle (LV) or the right atrium (RA). In this manner, the external processing device is capable of using the sensor data to monitor cardiac health due to an implanted device and/or a surgery.
In some embodiments, the implanted sensors do not directly communicate their sensory signals to other sensors. Similarly stated, even though the implanted sensors can be mechanically, electrically or functionally linked, the sensory signals are not directly exchanged. In some embodiments, at least one implanted sensor directly communicates a sensory signal to at least one other sensor. It is also possible that the implanted sensors do not directly communicate their sensory signals to the implanted device, which can be otherwise linked to one or more sensors. The implanted device can be in communication with one or more sensors and/or with the external processing device. In some embodiments, at least part of the function of the external processing device can be integrated into the implantable device.
In some embodiments, the wireless transceiver and the sensing unit are coupled, combined and/or bonded together to form a sensing assembly, which can further include a housing. The sensing assembly can be provided in various shapes and configurations, including, but not limited to, cylindrical, flat, and multipart sensing assemblies. Each different sensing assembly design provides different structural characteristics, and hence it is possible to choose a sensing assembly design for implantation based on the nature of the implantation site. For example, a cylindrical sensing assembly can be preferably employed when the wall of the implantation site is relatively thick, while a multipart sensing assembly can be employed when the implantation site provides spatial constraints and cannot accommodate all sensor components. The term ‘implantation site’ as used herein with respect to a sensor, a sensing device, and/or an implanted device generally means the site where the sensor, sensing device, and/or the implanted device, respectively is intended to be implanted.
It is understood that the shape of the sensing assembly and/or the housing of the sensing assembly can be used to characterize the sensor as well. Similarly stated, a cylindrical sensor would have a cylindrical sensing assembly, a flat sensor would have a flat sensing assembly, a multipart sensor would have a multipart sensing assembly, and so on.
In some embodiments, micro electromechanical systems (MEMS) technology can be used to form and/or manufacture the sensing unit and/or the sensing assembly including, for example, bulk micromachining, surface micromachining, dissolved wafer process, high aspect ratio micromachining, nanotechnology, and/or the like.
The anchoring mechanism can be a hollow cylindrical anchor holding the sensor components and/or the housing containing the sensing assembly, and can have a length that is selected based on the nature of the implantation site (e.g. a known wall thickness of the implantation site). The cylindrical anchor can include, for example, a button portion that is broader than the diameter of the implantation site of the sensor. In this manner, the cylindrical anchor can serve as a ‘plug’ that also seals the implantation site. For example, if the implantation site was created during surgery (e.g., the implantation site is a surgical site necessary for the surgery) and needs to be sealed after surgery, the cylindrical sensor can perform a sealing function as well by virtue of its design.
The term ‘surgical site’ as used herein with respect to an implanted device generally means a site that was used during the implantation of the implanted device, but does not hold the implanted device. Stated similarly, for an implanted device, the surgical site is different from the implantation site (described above) of the implanted device. For example, a cavity, aperture or hole defined during implantation of the implanted device can be considered a surgical site. The term ‘surgical site’ as used herein with respect to a surgery, means any site (e.g., portion of the body) used for the purposes of performing the surgery. In some embodiments, the surgical site(s) can serve as implantation site(s) for the sensors described herein. In some embodiments, the sensor can pass through a surgical sites for implantation in a different site. For example, a cavity, aperture or hole defined during a surgery can be considered a surgical site.
In some embodiments, relatively flat sensing assemblies can be used when a low profile of the sensor is desirable. A sensing assembly can be generally characterized as ‘flat’ when its dimension along the depth of the implantation site is smaller than its dimension along a surface of the implantation site. For example, a cylindrical sensing assembly that has a thickness smaller than its width can be characterized as a flat sensing assembly, since it has a low depth of implantation.
In some embodiments, multipart sensing assemblies can separate the sensing unit and the wireless transceiver into two or more subassemblies. A first subassembly, for example, can be a sensing subassembly that includes at least the sensing unit, while one or more of the other components are disposed in a non-sensing subassembly. For example, the sensing subassembly can include the sensing unit and can optionally include processing electronics, while the non-sensing subassembly can include relatively bulkier components such as an induction coil of the wireless transceiver, electronics, and/or power components. In some embodiments, the sensing subassembly provides a smaller footprint and/or is smaller relative to the non-sensing subassembly, in terms of surface area, a dimension, shape, and/or volume. In some embodiments, the sensing subassembly can be implanted in a heart chamber, while the non-sensing assembly can be disposed elsewhere, for example, in another organ, a natural cavity of the patient's body, another portion of the patient's body, or outside the patient's body. The subassemblies can be tethered together electrically, mechanically, and/or by any other suitable means.
While discussed above for pressure, any suitable biological parameter, and/or any number of parameters, can be sensed by each sensing unit including, for example, blood pressure, temperature, blood pH, conductivity, one or more dielectric constants, chemical concentration, a gas content (e.g. oxygen), a metabolite (e.g. glucose), and/or the like.
In some embodiments, the sensing unit can be designed as a capacitive sensing unit. Similarly stated, the sensing unit can operate on the general principle that variation in distances between two electrodes, such as under the influence of a biological parameter, translates to a change in capacitance, where a measure of the change in capacitance is associated with a measure of the biological parameter affecting the change. In some embodiments, at least one electrode is rigidly attached to a substrate, while the other electrode is flexibly attached to the substrate. Flexible attachment permits limited movement of the flexible electrode, and hence results in variation in capacitance as described above.
In some embodiments, one or more of the implanted sensors receives power from an external power source and/or device for operation. Hence, the externally-powered implanted sensor(s) need not include a power source, and alternatively can have a power storage device (e.g. a rechargeable battery, a capacitor, and/or the like) that stores the received power. In some embodiments, the external processing device can provide the external source of power. Similarly stated, the external processing device and the external power source can be collocated. In some embodiments, the wireless transceiver of the sensor can have a single coil for both sensory and power telecommunication. In other embodiments, the wireless transceiver can include a first coil for sensory telecommunication and a second coil for power telecommunication. In some embodiments, the power and/or sensory signals are transmitted by the wireless transceivers via wireless telemetry.
The external processing device can include a readout unit for interfacing the external processing device, such as a display, a Universal Serial Bus (USB) port, a printer, a speaker, and/or any other suitable presentation device. The readout unit can also include signal conditioning, control and/or analysis circuitry and software, can be a stand alone unit or can be connected to a personal computer (PC) or other computer controlled device. The external processing device can monitor the implanted sensors, power the implanted sensors, and/or control the operation of the implanted sensors. The external processing device can additionally or alternatively wirelessly monitor the implanted device, and/or wirelessly control the implanted device.
The implanted device can be any device implanted in the heart, such as a ventricular assist device (VAD) or a replacement valve. Further, in embodiments where the external processing device monitors cardiac health associated with a surgery, any suitable surgery is envisioned, including, for example, a coronary artery bypass graft (CABG), a valve repair, a transcatheter aortic valve operation, a catheter-based operation, a minimally invasive surgery and/or the like.
In some embodiments, a method includes measuring a first biological parameter at a first sensor implanted in a wall of a first chamber of a heart of a user, and generating a first sensory signal associated with the first biological parameter. The method also includes wirelessly transmitting, by the first sensor, the first sensory signal to an external processing device located outside the body of the user. The method also includes measuring a second biological parameter at a second sensor implanted in a wall of a second chamber of the heart, and generating a second sensory signal associated with the second biological parameter. The first and second biological parameters can be suitably selected. In some embodiments, the first and second biological parameters are the same parameter. In other embodiments, the first and second biological parameters are different parameters. The method further includes wirelessly transmitting, by the second sensor, the second sensory signal to the external processing device. The method additionally includes monitoring, based on at least one of the first sensory signal or the second sensory signal, cardiac health associated with at least one of an implanted device or a surgery. Similarly stated, the method provides for cardiac monitoring of a biological parameter after surgery and/or an implanted device via at least two sensors implanted in the heart.
In some embodiments, sensory signals are not communicated between the sensors and/or between the sensors and the implanted device. In other embodiments, sensory signals can be transmitted between the sensors and/or the sensors and an implanted device.
The sensing assemblies of the sensors can be independently designed as cylindrical, flat, and/or multipart assembly, and can be further suitably selected depending on the implantation site, as described above. The sensing unit of at least one of the first and second sensor can be capacitive, and can include a flexible electrode attached to a substrate. In some embodiments, at least one of the first sensor or the second sensor includes additional component(s) such as, for example, a battery, a capacitor, a super capacitor, and/or any other suitable power storage device.
The method can further include monitoring, at the external processing device, sensing information (first and/or second sensory signal), the implanted device, and/or cardiac health. For example, the external processing device can be operable to receive, transmit, and/or otherwise manipulate data associated with any of these monitored features. For example, the external processing device can monitor, charge, and/or control any of the sensors, and can further monitor, charge, and/or control the implanted cardiac device.
The method can also include implanting additional sensors, such as a third sensor, in the heart of the patient. In some embodiments, the method includes placing at least one sensor via a placement catheter. In some embodiments, the sensors are implanted during the same procedure employed for implanting the cardiac device, and/or during a surgery. This can reduce the risk of additional surgical exposure to the patient. When the surgery and/or device implantation results in a surgical site or ‘hole’ in the heart of the patient, at least one of the sensors can be implanted in the surgical site or hole. In this manner, the surgical site is substantially sealed and an additional implantation site for at least one sensor is not required. Further, when the sensor is placed in the surgical site, the sensor can be suitably selected (e.g. as having a cylindrical, flat, or multipart sensing assembly) based on the nature of the surgical site, as described above.
In some embodiments, the sensor is configured to achieve occlusion by a sealing fit and retention of the sensor in its implantation site. In other words, the sensor, or any portion thereof, can be sized, formed of a material, coated, covered, or otherwise treated to increase frictional contact between the surface or surfaces contacting the sensor, and the sensor. The sensor or portions thereof can, for example, be textured, by hatching the surfaces of the sensor. In another example, the sensor can be partly or coated with a slip resistant and biocompatible coating, such as, for example, a viscous gel. In some embodiments, the frictional contact can be increased by the use of a compliant covering. The compliant covering may deform upon pressure contact with the implantation site, which increases the surface area of interaction between the compliant covering and the implantation site, which in turn increases friction. An additional or alternative approach to increasing friction is the use of adhesive materials, and/or coverings. In other embodiments, and as described in further detail herein, any other suitable anchoring method and/or device can be used, such as, for example, sutures, mesh, and/or the like.
In some embodiments, a method includes implanting in a patient a circulatory assist device, such as a VAD or a replacement valve. The method also includes implanting, in a wall of a first chamber of a heart of the patient, a first sensing device in sensory communication with the first chamber of the heart. The first sensing device is operable to measure a first biological parameter in the first chamber of the heart relevant to a performance of the circulatory assist device. The first sensing device is also operable to wirelessly transmit a first signal representative of the first biological parameter to an external processing device disposed outside a body of the patient. The method also includes implanting, in a wall of a second chamber of the heart of the patient, a second sensing device in sensory communication with the second chamber of the heart. The first and second sensing devices can be, for example, pressure sensors. The second sensing device is operable to measure a second biological parameter in the second chamber of the heart relative to the performance of the circulatory assist device. The first and second biological parameters can be the same or different. The second sensing device is also operable to wirelessly transmit a second signal representative of the second biological parameter to the external processing device. The method further includes placing the external processing device into operative wireless communication with each of the first sensing device and the second sensing device. In some embodiments, the external processing device can monitor operation of the circulatory assist device based on the first signal and the second signal.
In some embodiments, the first and/or second sensing device(s) is/are implanted during implantation of a circulatory assist device, thereby avoiding additional risk and trauma to the patient caused by additional surgical procedures. In some embodiments, the method includes implanting the first sensing device in a surgical site (e.g., aperture and/or hole) formed during implantation of the circulatory assist device such that there is no need for a separate implantation site for the first sensing device. The sensing devices can be charged, monitored, and/or controlled by the external processing device, which can also charge, monitor, and/or control the circulatory assist device.
A sensor 10 according to an embodiment is schematically illustrated in
The sensing unit 12 is configured to be disposed, when the sensor 10 is implanted in a wall of a heart chamber, to be in sensory communication with the heart chamber for measuring a biological parameter in the heart chamber, and is further configured to generate a sensory signal associated with the biological parameter. In some embodiments, the biological parameter can be, for example, blood pressure, temperature, blood pH, conductivity, a dielectric constant, a chemical concentration, a gas content (e.g. oxygen), a metabolite (e.g. glucose), and/or the like. In some embodiments, the sensing unit 12 can be configured to measure more than a single biological parameter.
In some embodiments, the cardiovascular system can include, without limitation, a heart chamber that can include, for example, the left atrium (LA), the right atrium (RA), the left ventricle (LV), the right ventricle (RV), the left atrium appendage (LAA), the right atrium appendage (RAA), or veins, or arteries such as a pulmonary artery (PA) and/or the like. In some embodiments, the wall of the heart chambers can include, for example, a wall of the LA, a wall of the RA, a wall of the LV, a wall of the RV, an interatrial septum, an interventricular septum, an atrioventricular septum and/or the like. In some embodiments, the sensing unit 12 can be configured to measure more than one biological parameter, and can be further configured to generate a separate sensory signal for each measured biological parameter.
In some embodiments, the sensing unit 12 is a capacitive sensing unit having two electrodes and based on the general concept that when a small deformable membrane forms or contains one electrode of a capacitor and moves towards or away from the other electrode in response to pressure, a variation in capacitance is observed. In some embodiments, the capacitive sensing unit consists of one flexible electrode and one stationary electrode. In some embodiments, the stationary electrode can be formed, for example, on a substrate, and the flexible electrode can be attached to the same substrate or a separate substrate, such that there is a gap between the two electrodes. The flexible electrode can be configured to move in response to the biological parameter, for example, blood pressure in a heart chamber. Movement of the flexible electrode changes the gap between the two electrodes and thus the capacitance, which can be used to calculate pressure changes. In some embodiments, at least one of the substrates forms the electrode. Similarly stated, the substrate and the electrode can be integrally formed. The electrodes of the sensing unit 12 can be physically and/or communicatively coupled to other components of the sensor 10 using suitable mechanical and/or electrical means, including, but not limited to, signal traces, wires, and/or the like.
Still referring to the substrates of the sensing unit 12, in some embodiments, the substrates on which the electrodes are formed or fabricated can be either rigid, partly rigid and partly flexible (rigiflex substrates), or flexible. Rigid components of substrates can be composed of any suitable material, such as, for example, glass, silicon, ceramics, carbides, alloys, metals, hard polymers, and Teflon and/or the like: Flexible components of substrates can be composed of any suitable material, such as, for example, polymers, parylene, silicone, and/or any biocompatible flexible material. In some embodiments, at least one of the substrates is a rigiflex substrate, and the rigid and flexible components can be made from dissimilar materials. In some embodiments, the material of the substrates increases frictional contact (i.e., by increasing the frictional coefficient) between the substrate and the implantation site.
Still referring to the sensor 10 of
The wireless transceiver 14 is further configured to wirelessly transmit the received sensory signal. In some embodiments, the wireless transceiver 14 transmits the sensory signal without modification. In other embodiments, the wireless transceiver 14 processes the sensory signal prior to transmission by, for example, amplification, rectification, frequency conversion, modulation, format conversion (e.g., binary to hexadecimal), data manipulation (e.g., adding an identification of the sensor 10 to the received sensory signal), and/or the like.
In some embodiments, the wireless transceiver 14 employs one or more modulation schemes for transmitting the sensory signal data. The modulation scheme(s) can be, for example, amplitude modulation, frequency modulation, frequency shift keying, phase shift keying, spread spectrum techniques, and/or the like. In some embodiments, the modulation scheme is selected as a function of the intended use of the sensor 10, the depth of implantation of the sensor, the location of implantation of the sensor, and/or the like.
In some embodiments, the wireless transceiver 14 is also operable to receive a power signal for powering the sensor 10. In some embodiments, the wireless transceiver 14 includes an inductor coil and a core. In some embodiments, the core includes a ferrite composition. In other embodiments, the core is an air core. In some embodiments, the sensor 10 includes a power storage device (not shown), and the wireless transceiver 14 is coupled to the power storage device for storing the power received from the wireless transceiver. In some embodiments, the power storage device can include, for example, a rechargeable battery, a capacitor, a super capacitor, and/or any other suitable power storage device.
Still referring to the wireless transceiver 14, in some embodiments, an inductor coil of the wireless transceiver 14 is made by deposition of a conductive coil on a substrate. In some embodiments, the deposition process includes one or more of electroplating, sputtering, evaporation, screen printing, and/or the like. In some embodiments, the conductive coil is made from one or more highly conductive metals such as silver, copper, gold, and combinations thereof. In some embodiments, the substrate of the induction coil can be rigid, flexible, or partly rigid and partly flexible. In some embodiments, the inductor coil is of a shorter length compared to its width and is hence relatively flat (e.g., coin shaped). In some embodiments, the length of the inductor coil is the same as or larger than its width, such that the inductor coil is thicker and takes on a three-dimensional profile such as, for example, a cylinder.
In some embodiments, the wireless transceiver 14 transmits the sensory signal, receives the power signal, and/or otherwise communicates with other devices based on magnetic telemetry, i.e., via magnetic coupling. In some embodiments, magnetic coupling occurs via an externally applied RF magnetic field. In some embodiments, a single induction coil of the wireless transceiver 14 performs the dual task of transmitting the sensory signal and receiving the power signal. In other embodiments, the wireless transceiver 14 includes two induction coils, where a first induction coil transmits the sensory signal and a second induction coil receives the power signal. In some embodiments, the wireless transceiver 14 is operable to rectify the incoming power waveform to define a direct current.
Referring now to the anchoring mechanism 18 illustrated in
Any suitable biocompatible material can be used for constructing the anchoring mechanism 18, including, for example, nitinol, teflon, parylene, Polyether ether ketone (PEEK), suitable polymers, metals, ceramics, and/or the like.
Referring again to the sensor 10 in
In some embodiments, a biocompatible coating covers part or all of the sensor 10. In some embodiments, the biocompatible coating does not cover the portion of the sensing unit 12 that interacts with the biological environment (e.g. a flexible electrode, as discussed above). Such a biocompatible coating can be, for example, a silicone, a hydrogel, parylene, a polymer, a nitride, a oxide, a nitric oxide generating material, a carbide, a silicide, titanium, and/or the like. In some embodiments, the biocompatible coating increases friction between the sensor 10 and the implantation site.
In some embodiments, additional components can be formed as part of sensor 10, such as, for example, a power storage device (e.g. a battery, capacitor, and/or the like), getters, and/or the like. Suitable materials for getters includes, for example, evaporable getters, nanogetters, titanium films, zirconium films, iron films, and/or the like.
Referring now to
The subscript ‘n’ is used to indicate that one or more sensors are part of the system 20. In some embodiments, for example, n is one. In other embodiments, n can be any other suitable number, for example, two, three, four, or five. In still other embodiments, n can be greater than five.
The external processing device 22 of system 20 is configured to receive sensory signals from the sensors 10a-10n, and based on the sensory signals received from at least one or more sensors (e.g. two sensors, in some embodiments), monitor cardiac health associated with the implanted device 24 and/or a surgical procedure. In some embodiments, the device 22 also controls the sensors 10a-10n (e.g., instruct the sensors 10a-10n to measure a biological parameter at a given rate, request the sensors 10a-10n to measure a biological parameter on-demand, provide power to the sensors 10a-10n, change the biological parameter measured by the sensor, etc.).
In some embodiments, the device 22 wirelessly powers the sensors 10a-10n. In some embodiments, communication of data and/or power between the device 22 and sensors 10a-10n is based on RF magnetic telemetry. In some embodiments, the device 22 is operable when brought within a suitable range and/or operative proximity of the sensors 10a-10n. The device 22, for example, can establish magnetic and/or inductive coupling with the sensors 10a-10n via an RF magnetic field. In some embodiments, the device 22 transmits a substantially continuous level of RF power to sensors 10a-10n. In other embodiments, for example, the device 22 pulses the magnetic RF power to the sensors 10a-10n, to allow temporary power storage by the sensor in, for example, a power storage device (not shown).
When the magnetic field is large enough to induce sufficient voltage in the wireless transceiver 14 of a particular sensor 10, the sensor can be considered ‘active’ to transmit sensory signals to the device 22, and/or to respond to control signals from the device 22. In some embodiments, the device 22 receives sensory signals from the sensors 10a-10n at any suitable interval of time that is preprogrammed and/or otherwise communicated to the sensors. The received sensory signals can be instantaneous or time-delayed. In some embodiments, device 20 receives, or otherwise programs the sensors 10a-10n to transmit the sensory signals during power transmission by device 22, or before/after power transmission by device 22. In some embodiments, the device 22 has at least two modes of operation: a data logging measurement mode with relatively lower rates of sensory signals being received (e.g. about 1 Hz), and a real-time dynamic measurement mode with relatively higher rates of sensor signals being received (e.g. about 100-500 Hz, and all values in-between). In some embodiments, the sensory signals are transmitted using the 13.56 MHz industrial, scientific and medical (ISM) radio band as currently defined by the International Telecommunication Unions (ITU). In other embodiments, the sensory signals are transmitted at any other suitable frequency, as specified by the prevailing regulatory authority and/or standard.
In some embodiments, the external processing device 22 includes an antenna (not shown) and/or a readout unit (not shown). In some embodiments, the readout unit of device 22 includes an analog RF front end, a receiver and/or demodulator, a digital processor, and/or a programmable user interface. Such components of the readout unit can be used by the external processing device 22 to receive signals from and/or transmit signals to the sensors 10a-10n and/or the implanted device 24.
In some embodiments, the external processing device 22 is disposed within a body of a user but outside a heart of the user. In other embodiments, the external processing device 22 is disposed outside the body of the user. A location of the external processing device 22 can be selected based on a size of the external processing device 22, a functionality of the external processing device 22, a parameter to be monitored, and/or the like.
Now referring to the entirety of the system 20 in
Referring to the implanted device 24 of
In some embodiments, the system 20 is a closed loop control system for the implanted device 24. Similarly stated, the implanted device 24 affects the biological parameter(s) monitored by the external processing device 22 via the sensors 10a-10n, and the processing device 22 can use this monitored information to control the implanted device 24. For example, based on one or more values of biological parameters received from the sensors 10a-10n, the external processing device 22 can send a signal to the implanted device 24 to change an operation of the implanted device 24 (e.g., a pump speed, an amount of a drug delivered, an interval of an electric pulse, etc.). In other embodiments, based on one or more values of biological parameters received from the sensors 10a-10n, a user's medication can be tailored, exercises for the user can be tailored and/or a user can make life style changes. In some embodiments, the system 20 is a substantially continuous and near real-time adjustment system, in which the external processing device 22 can send signals to the implanted device 24 without any programmed or built-in delay. In some embodiments, the system 20 is an intermittent adjustment system, in which the external processing device 22 can send signals to the implanted device 24 on a periodic basis that may be determined in any suitable manner (e.g., preprogrammed, based on signals received from the sensors 10a-10n, and/or the like). In some embodiments, the system 20 provides a manual adjustment system, in which the external processing device 22 receives manual commands (e.g., from a physician) to send signals to the implanted device 24.
In some embodiments, the system 20 is operable to perform, for example, remote (e.g. home) monitoring of patients, telephony-based monitoring of patients, web-based monitoring of patients, closed-loop drug delivery to treat the associated diseases or related conditions when the implanted device 24 is configurable for drug delivery, warning systems for critical worsening of the associated diseases (e.g., hydrocephalus or pulmonary edema) or related conditions, portable or ambulatory monitoring or diagnostic systems, battery-operation capability, data storage, reporting global positioning coordinates for emergency applications, and/or communication with other medical devices including but not limited to shunts, pacemakers, defibrillators including implantable cardioverter defibrillators, implantable drug delivery systems, non-implantable drug delivery systems, and wireless medical management systems.
Now describing the various components of
As described above, in use, the cylindrical sensing assembly 36 can be implanted in one or more sites within a body of a patient. For example, the cylindrical sensing assembly 36 can be implanted in a wall of a heart of a patient after combining the cylindrical sensing assembly with an anchoring mechanism. As described above, after implantation, the inductor coil 34 can be used to send signals to and/or receive signals from (e.g., power signals and/or data signals) an external processing device, such as, for example, external processing device 22 shown and described with respect to
The components of the flat sensing assembly 46 include an induction coil 44 as a wireless transceiver, and additional electronics 48 (e.g., an amplifier, a rectifier, an ASIC, etc.). While shown as having a single induction coil 44, in other embodiments, the flat sensing assembly 46 can include more than a single induction coil or other antennas. The substrate 43a can also include, in a cavity 45, additional components such as, for example, a battery, a power storage device, and/or getters.
In some embodiments, the flat sensing assembly 46 can be manufactured by, for example, inserting and attaching the components to the rigid substrate 43a, followed by attaching the flexible substrate 43b to the rigid substrate. In some embodiments, this attachment not only results in realizing the capacitive sensing capability of the assembly 40, but also provides a hermetic seal that protects the various components from the biological environment. Similarly stated, the substrates 43a, 43b can combine to form a protective housing 47 for the flat sensing assembly 46. In some embodiments, the attachment method for the substrates 43a, 43b depends on the materials of the substrates to ensure that the attachment method does not damage the internal components. For example, if the rigid substrate 43a is made of glass and the flexible substrate 43b is made from silicon, permissible methods can include, for example, fusion bonding, anodic bonding, glass frit bonding, thermal bonding, thermal compression bonding, eutectic bonding, solder bonding, laser bonding, plasma-enhanced and/or low temperature variations of the aforementioned bonding methods, and/or the like.
In some embodiments, electronics 53 (e.g., an ASIC, a rectifier, an amplifier, one or more diodes, etc.) are included as part of the sensing assembly 51a in close proximity with sensing unit 52, and are configurable to convert the sensing unit's high impedance output to a low impedance output for ease of transfer to the non-sensing assembly for wireless transmission. In some embodiments, the electronics 53 and the sensing unit 52 are fabricated on the same substrate, fabricated separately but attached to the same substrate, or the sensing unit 52 includes a substrate and the electronics 53 are mounted directly on the sensing unit's substrate. In some embodiments (not shown), the electronics 53 are included as part of the non-sensing assembly 51b and are configurable for receiving, processing, and/or transmitting the signal received from the sensing assembly 51a.
In some embodiments, the tether 51c is an electrical and/or a mechanical connection. In some embodiments, the tether 51c is a flexible connection, a rigid connection, or a combination of flexible and rigid connections. In some embodiments, at least one of the subassemblies 51a, 51b and the tether 51c is coated, potted, or otherwise covered with a biocompatible coating, for purposes of, for example, increasing frictional contact of each component with its respective implantation or placement site.
As described above, in use, the multipart sensing assembly 56 can be implanted in one or more sites within a body of a patient. For example, sensing subassembly 51a can be implanted within a heart of a patient and the non-sensing subassembly 51b can be implanted within another portion of the body of the patient (e.g., a cavity). After implantation, sensing unit 52 can sense a value of a biological parameter. The value can be sent to the non-sensing subassembly 51b via the electronics 53 and the tether 51c. The inductive coil 54 can then send signal a signal associated with the value of the biological parameter to an external processing device, such as, for example, external processing device 22 shown and described with respect to
In some embodiments, placement of a sensing unit/wireless transceiver or a sensing assembly (e.g. the cylindrical assembly 36 of
In some embodiments, after a cardiac device is implanted and/or after a sugary is completed, a delivery sheath or catheter used in the process can be subsequently used for parachuting an implantable sensor into its implantation site (for example in the heart wall) and then tightening pre-loaded sutures (or bands or other similar attachment methods) in order to fix and/or retain the sensor in its proper place. In some embodiments, the implantation site of the sensor is a surgical site. Such a method allows the sensor to be in close proximity to the surgical site.
A variety of methods can be used to deliver the sensor and place it in its implantation site. In some embodiments, such a method can include using a standard delivery sheath or catheter and introducing the sensor through a short feeder in order to place the sensor inside the site. In some embodiments, a specially designed sheath can be used at the beginning of the main operation in order to allow easier delivery and closure of the site after the main operation is completed. In some embodiments, another sheath of smaller caliber is placed coaxially inside the original delivery sheath and the smaller sheath is used for delivery and placement of the sensor. In some embodiments, the device delivery and implantation of the sensor can be compatible with the main operation in a way that adding the sensor as a complimentary task results in minimum or no added risk, (the risk of the main operation is higher), and a minimal amount of additional time.
In some embodiments, and as best illustrated in
In some embodiments, step 1104 results in the formation of a surgical site on the patient. In some embodiments, the surgical site includes an aperture to be closed for recovery, and at least one or steps 1108, 1112 results in one of the sensors 10a, 10b being selected for implantation in the surgical site during step 1104. As such, at least one of the sensors 10a, 10b can be used to occlude the aperture.
At 1116, the external processing device 22 is placed in wireless communication with the sensing devices 10a, 10b. In some embodiments, the external processing device employs the received sensory signals from the sensing devices 10a, 10b to monitor, power, and/or control the medical device 24. In some embodiments, at least part of the function of the external processing device 22 is performed by and/or integrated into the implanted device 24. In some embodiments, the external processing device 22 and the implanted device 24 may be a single device. In some embodiments, the external processing device is integrally formed with another implanted device (not shown) different from the implanted device 24.
In some embodiments, implantable wireless sensors are used as companion devices to cardiac operations. The implantation of the wireless sensors can be a secondary procedure during a cardiac operation. Adding the implant as a complimentary task results in minimum or no added risk since the risk of the main cardiac operation is higher, and a minimum amount of additional time is required to implant the sensors. Using implantable sensors as a companion to a cardiac operation can be useful in cases where a minimally invasive system is needed for monitoring cardiac parameters, such as cardiac pressures, after the cardiac operation. A cardiac monitoring system using such pressure sensors can provide physicians with a substantially real-time, substantially continuous, fast, safe, effective, and highly accurate tool for cardiac monitoring applications. In some embodiments, the pressure sensors can also be part of or attached to another implanted system, including, for example, pacemakers, LVADs, RVADs, BiVADs, ICDs, and/or the like.
In some cardiac operations, an incision or a surgical site (e.g., an aperture) is made in a portion of the heart in order to allow either a delivery sheath, a catheter, or other instrument to enter the heart. After the operation, when the sheath or catheter or instrument is retrieved, the surgical site needs to be closed. Instead of using traditional methods (for example suturing the site), the proposed implantable wireless sensor can be placed, for example, inside the surgical site and used to both close the surgical site and to provide sensing capabilities, for monitoring, for example, cardiac pressures. In another example, the surgical site can be used as a pass-though for access to an implantation site for the sensor to which access might have been otherwise challenging. After the sensor is installed, the surgical site may be closed by any suitable means, for example, by implanting another sensor in the surgical site as described above. Similarly stated, the surgical site defined during the surgery serves as an implantation site for a sensor and/or as a pass-through for a sensor. In embodiments where the implantable sensor is used to close the site after a cardiac surgery, an intraoperative epicardial echocardiography or another suitable procedure can be used for wall thicknesses assessment at the proposed implantation sites to determine the required length of the implantable sensor.
In some embodiments, the wireless sensor is an integrated part of another medical device, for example attached to a pacemaker, VAD, valve or shunt. Based on the specific device, the wireless sensor can be attached and anchored to a part of the device such that it is in contact with the blood or other physiological environment to be monitored. For such devices, the attachment method of the sensor (with or without an anchoring mechanism) to the device can depend on the device and/or application.
While shown and described with respect to
In some embodiments of the various components described herein (e.g. the sensing unit 12, the wireless transceiver 14, the external processing device 22, the implanted device 24, linking elements such as the connector 33, and all combinations, subsystems thereof can include a computing environment 1300 (see
In some embodiments, the processor 1310 can be a general purpose processor, a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and/or the like. In some embodiments, the memory 1320 can be, for example, a random access memory (RAM), a memory buffer, a hard drive, a database, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM) and/or the like.
The computing environment 1300 can be operable to execute computer code to perform the disclosed functionality. Examples of computer code include, but are not limited to, micro-code or micro-instructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter. For example, embodiments can be implemented using Java, C++, or other programming languages (e.g., object-oriented programming languages) and development tools. Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code. Such computer code can also be referred to as a computer program and some embodiments can be in the form of a computer program.
Some embodiments described herein relate to a computer storage product with a non-transitory computer-readable medium (also can be referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include transitory propagating signals per se (e.g., a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable). The media and computer code (also can be referred to as code) may be those designed and constructed for the specific purpose or purposes. Examples of non-transitory computer-readable media include, but are not limited to: magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as Application-Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM) devices. Other embodiments described herein relate to a computer program product, which can include, for example, the instructions and/or computer code discussed herein.
While various embodiments have been described above, it should be understood that they have been presented by way of example only, not limitation, and various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components and/or features of the different embodiments described.
The various embodiments described herein should not to be construed as limiting this disclosure in scope or spirit. It is to be understood that no limitation to the scope of the disclosure is intended thereby. It is to be further understood that resort can be had to various other embodiments, modifications, and equivalents thereof which can suggest themselves to those skilled in the art without departing from the spirit of the present disclosure and/or scope of the appended claims.
Those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific embodiments described specifically herein. Such equivalents are intended to be encompassed in the scope of the following claims.
This non-provisional utility application claims priority to and the benefit of U.S. provisional application Ser. No. 61/494,536, filed on Jun. 8, 2011 entitled “Implantable Wireless Sensors as Companion Devices to Cardiac Operations”, the disclosure of which is incorporated by reference herein in its entirety.
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