Patent Grant
9700250
Embodiments of the present disclosure generally relate to blood glucose and more particularly to methods and devices that utilize antenna resonance principles to detect changes in the transmembrane electrolyte balance due to glucose induced fluid shift.
Congestive heart failure (CHF) is emerging as a major public health concern, representing a significant cause of hospitalization for individuals aged 65 years and older. Two of the most prominent risk factors for heart failure are hypertension (high blood pressure) and diabetes. Not only do people with diabetes tend to have a cluster of risk factors for heart diseases, including hypertension, obesity, insulin resistance, and abnormal blood lipid levels, but diabetes itself is also an independent risk factor for the condition. People with diabetes are more likely to develop heart disease than the general population.
For people with diabetes, there is growing evidence that controlling blood glucose levels is very important in preventing heart disease. According to the American Diabetes Association, self-monitoring of blood glucose (SMBG) has a positive impact on the outcome of therapy and helps to achieve specific glycemic goals. However, the inconvenience, expense, pain, and complexity involved in invasive measurement methods commercially available lead to underutilization, mainly in people with type II diabetes.
Today, certain noninvasive (NI) methods have been proposed for determining blood glucose levels. The convention NI methods fall into two categories. The first category of methods is based on the measurement of glucose using one or more of the intrinsic molecular properties of glucose, such as the near-infrared or mid-infrared absorption coefficient, optical rotation, Raman shifts, and photo-acoustic absorption, as well as others. The second category of methods measures the effects of glucose on the physical properties of blood and tissue. The second category of methods is based on an assumption that glucose is a dominant (highly fluctuating) blood analyte and, as such, contributes significantly to the change in the relevant physical parameters of the tissue. Hence, measurement of such parameters can lead indirectly to evaluation of the blood glucose (BG) level. The measured parameters are evaluated relatively to calibration, performed through correlation of the NI signal to a reference BG value. Therefore, the relative change of glucose in blood or interstitial fluid (ISF) plays the major role, as other blood analytes, which are less fluctuating, are fully or at least partially eliminated through calibration.
However, conventional methods for measuring blood glucose experience certain limitations. For example, non-invasive methods may require a blood sample to be taken before testing and/or may be available only when the patient visits a doctor's office. For example, at least some conventional methods use external devices that have sensors attached to the skin. The skin sensors present the potential for variations in the sensor-skin interface, changes in microcirculation, and metabolic rate etc. Those variables cause some challenges in measurement accuracy and sophisticated calibration is required for achieving required accuracy. Further, conventional methods may require the patient to take certain actions to perform the test at various times throughout the day.
A need remains for a blood glucose monitoring device and method that are accurate, painless, and easy-to-operate in order to encourage more frequent testing, leading to tighter glucose control and a delaying/decreasing of long-term complications and the associated health care costs.
In accordance with one embodiment, a blood glucose sensing device is provided that comprises a house having an exterior surface and that defines an interior space. The housing is configures to be located within a cardiovascular pathway of a patient. A resonant antenna is located within the interior space defined by the housing. The resonant antenna comprises an inductive reactance and a capacitive reactance. The inductive and capacitive reactance have values that define a blood glucose sensitive resonant frequency such that a resonant frequency of the resonant antenna varies in response to changes in blood glucose levels within the blood in the cardiovascular pathway surrounding the housing.
Optionally, the device comprises a microprocessor that is configured to process signals received from the resonant antenna to generate data representative of the blood glucose level. The microprocessor may process the signals from the resonant antenna to determine the resonant frequency of the resonant antenna; and based on the resonant frequency, determine the blood glucose level. The device may comprise an implantable medical device (IMD) coupled to a proximal end of a lead, the IMD including the microprocessor, the lead having a distal end configured to be implanted within a heart of the patient. The resonant antenna may be located within the IMD.
Optionally, the device further comprises a battery circuit further comprising an excitation circuit electrically coupled to receive power from the battery circuit. The excitation circuit is further configured to excite the resonant antenna by generating an excitation signal. The resonant antenna is configured to be excited by an excitation signal from an external source. A microcontroller is configured to build a map of the relations between resonant frequencies, permittivities and glucose levels.
Optionally, the device may comprise a microcontroller configured to collect measurements indicative of the resonant frequency of the resonant antenna and calculate data indicative of a glucose level of the blood based on the measurements indicative of the resonant frequency. The microcontroller may be further configured to repeat the collecting and calculating operation during at least first and second test intervals and to determine whether the glucose levels change between the first and second test intervals.
In accordance with an embodiment herein, a method is provided that comprises implanting a blood glucose sensing device within a cardiovascular pathway of a patient, the sensing device includes a resonant antenna that has a blood glucose sensitive resonant frequency that varies in response to changes in blood glucose levels of the blood. The method generates an excitation signal to excite the resonant antenna. The method collects measurements indicative of the resonant frequency of the resonant antenna and calculates data indicative of a glucose level of the blood based on the measurements indicative of the resonant frequency.
Optionally, the generating, collecting and calculating operations are repeated during at least first and second test intervals, the method further comprising determining whether the glucose level changes between the first and second test intervals. Optionally the method calculates a permittivity of the blood based on the measurements and identifying a change in the glucose level based on a change in the permittivity of the blood over time. The calculating operation includes comparing the change in the permittivity to the threshold, and the identifying operation identifies that the glucose level has changed when the change in permittivity exceeds the threshold. Optionally, the method determines the resonant frequency based on the measurements and determining a permittivity of the blood proximate to the resonant antenna based on the resonant frequency.
Optionally, the generating operation includes generating the excitation signal from an external source outside of the patient. The generating operation includes generating the excitation signal from an implantable device within the patient. Optionally, the method may comprise an implantable device which may include the blood glucose sensing device.
The description that follows sets forth one or more illustrative embodiments. It will be apparent that the teachings herein may be embodied in a wide variety of forms, some of which may appear to be quite different from those of the disclosed embodiments. Consequently, the specific structural and functional details disclosed herein are merely representative and do not limit the scope of the disclosure. For example, based on the teachings herein one skilled in the art should appreciate that the various structural and functional details disclosed herein may be incorporated in an embodiment independently of any other structural or functional details. Thus, an apparatus may be implemented or a method practiced using any number of the structural or functional details set forth in any disclosed embodiment(s). Also, an apparatus may be implemented or a method practiced using other structural or functional details in addition to or other than the structural or functional details set forth in any disclosed embodiment(s).
In accordance with embodiments herein, methods and devices utilize the interaction between blood cellular membrane potential and antenna resonance principles to detect changes in glucose levels. Blood exhibits a certain electrolyte balance that is based in part on cellular membrane potential. When glucose levels change, the transmembrane electrolyte balance is disrupted due to a glucose-induced fluid shift. The fluid shift causes changes in the cell membrane potential. Variations of the metabolically active enantiomer D-glucose affect the permittivity and conductivity of the cellular membranes. Hence, glucose-induced water and ion transport across the cellular membrane leads to changes in the electrical properties of the cellular and consequently extracellular compartments.
By way of example, a blood glucose sensing device may be incorporated into various structures that are located within the cardiovascular system. For example, cardiac rhythm management (CRM) devices (e.g., pacers, implantable cardioverter defibrillators, cardiac rhythm management devices or leadless pacers) are positioned within the blood flow system. The glucose device may be implemented within a CMEMS circuit which represent a micro-electromechanical system (MEMS) merged with a complementary metal oxide semiconductor (CMOS) circuit The glucose sensing device may be implanted within various chambers of the heart (e.g. RV, RA and LV or RA) which enable the elimination of several variables associated with external devices. Measuring glucose concentration by a sensor on a lead or CMEMs or leadless pacer (LP) provides continuous, highly accurate glucose monitoring.
Embodiments herein provide methods and devices that utilize resonant antenna based glucose sensors in a pacing lead, a CRM device, a CMEMS sensor or LP that would detect glucose concentration in the blood surrounding the lead or the sensor. Embodiments herein provide non-invasive glucose monitoring for better management of heart failure co-morbidities therefore reducing hospitalization and health care costs.
The device 102 comprises a glucose sensitive resonant antenna 111 that includes capacitive reactance and inductive reactance. The device 102 includes circuitry to detect changes in a resonant frequency of the resonant antenna 111 and based thereon generate data indicative of glucose levels. For example, an integrated circuit 120 (having one or more processors), one or more associated electrical conductors 122, and a battery circuit 124 (comprising a battery) may be coupled to the resonant antenna 111 for detecting the operating frequency of the resonant antenna(s), identifying permittivity calculating glucose levels, identifying pressure levels, and/or for exciting the resonant antenna(s). The integrated circuit 120, the electrical conductors 122, and the battery circuit 124 are located within the interior space 110 of the housing 106.
Optionally, the sensing device 102 may also include a resonant antenna sensitive to changes in blood pressure. For example, a pressure sensitive resonant antenna maybe included similar to the pressure sensitive resonant antennas described in Patent Application Publication US 2014/010627, the complete subject matter of which is expressly incorporated herein by reference in its entirety.
Optionally, the device 102 may include components for sensing cardiac signals and/or stimulating (e.g., pacing) cardiac tissue. For example, the device may operate in one or more of the following modes: VDD, DDD, VVIR, CRT, or some other suitable mode. These components may include, for example, an electrode 126 (e.g., a helical electrode), an electrode 128 (e.g., a ring electrode), one or more additional electrodes (represented by electrode 130), and other circuitry. This other circuitry may include, for example, corresponding functionality of the integrated circuit 120, one or more of the electrical conductors 122, and the battery circuit 124.
The graph 12 corresponds to a changing glucose level and illustrates the relation between various resonant frequencies of a resonant antenna and a corresponding amount of permittivity exhibited by surrounding blood. By way of example, the permittivity—SRF graph 12 illustrates that, for a given resonant antenna, when the permittivity within the blood is relatively high (e.g. 65) the resonant antenna exhibits a low SRF (e.g. near approximately 1 GHz). When the glucose concentration changes, this reduces blood permittivity, and thus the resonant antenna exhibits a higher SRF (e.g., the SRF is approximately 8 GHz, when the blood exhibits a permittivity of approximately 50). As additional examples, the graph 12 shows that a blood pool having a corresponding glucose concentration and a permittivity of 55 will cause the resonant antenna to exhibit an SRF of about 6 GHz. When the permittivity is 45, the resonant antenna will exhibit an SRF of approximately 10 GHz. The graph 12 may vary based on the particular resonant antenna. The graph 12 represents one example of how the SRF varies for a particular resonant antenna relative to the amount of glucose in the blood pool.
The model 10 may be determined for individual patients, for each resonant antenna, for types of resonant antennas and the like. As explained herein, once the model 10 is determined, changes in the glucose concentration may be determined by monitoring changes in SRF, such as relative to baseline SRF characteristics. Embodiments herein maintain a permittivity glucose relation between various permittivity levels and glucose levels and P-SPF model 10. The permittivity-glucose (PG) relation and P-SPF model 10 may be predetermined through laboratory work, while calibration can be done periodically through operation or at other times. One or more PG relations and P-SPF models 10 may be stored in a data store in an LIMD, sensor device, external device, network system, locally or remotely. The PG relation and P-SRF model 10 are used to determine glucose levels.
The resonant antenna 206 comprises a capacitive reactance and an inductive reactance, the values of which are selected to cause the resonant antenna 206 to resonate at a select reference frequency when in the presence of blood having a corresponding reference or select glucose level. In this case, the resonant antenna 206 is excited (e.g., induced with a signal that causes the resonant antenna 206 to resonate) by an externally generated radiofrequency (RF) signal 214. As one example, the RF signal 214 maybe generated by an external antenna that may be help against the patient or provided within another common structure used by the patient. For example, the antenna may be provided under a bed, within a pillow, within a chair back, automobile seat back, handheld and the like. The antenna is connected to an external device such as a bedside monitor, a portable computer, smart phone, smart watch and the like. Upon excitation, an oscillating signal 216 (represented, for convenience, by a dashed line) at the resonant frequency is established in the resonant antenna 206.
The capacitance and inductance reactance values are set to define a blood glucose sensitive resonant frequency such that a resonant frequency of the resonant antenna 206 varies in response to changes in blood glucose levels within the blood in the cardiovascular pathway surrounding the housing. A change in the blood glucose level will result in a change in a permittivity characteristic (and/or other electrical characteristic) of the blood. The change in permittivity, in turn, causes a change in the resonant frequency of the resonant antenna 206. Thus, a change in glucose level will correspond to a change in the frequency of the oscillating signal 216.
The circuit 218 collects measurements indicative of the resonant frequency. For example, the oscillating signal 216 is detected by the circuit 218 (e.g., a high impedance sense amplifier, a low impedance current sensing circuit, or some other suitable circuit) and provided to the signal processing circuit 220. The signal processing circuit 220 processes the measurements of the received signal to determine at least one frequency of the signal. The signal processing circuit 220 utilizes the frequency to calculate data representative of the glucose level of the blood surrounding the device 202.
The signal processing circuit 220 may then store this data in the memory circuit 222 for subsequent use. For example, as discussed below, the device 202 may periodically collect data over a period of time, and send the stored data to an external device at some later point in time. As another example, one or more operating parameters (e.g., pacing parameters) of the device 202 may be adjusted based on the glucose data. To facilitate receiving the oscillating signal 216, the signal processing circuit 220 and/or the circuit 218 may comprise one or more of: a sensing circuit, an amplifier, a filter, a switching circuit, or other suitable circuits. These circuits may perform one or more of: detecting, filtering, or amplifying the oscillating signal 216.
As represented by corresponding lines in
The signal processing circuit 220 is also electrically coupled to each electrode 228 and 230 (e.g., via the circuit 224) for sensing cardiac activity and/or stimulating cardiac tissue. Thus, in some cases, the electrodes 228 and 230 are used for stimulating cardiac tissue. In some cases, one or more of the electrodes 228 and 230 may be used for sensing cardiac activity (e.g., for near-field sensing and/or far-field sensing). For example, the electrodes 228 and 230 may correspond to the electrodes 126 and 128 of
The sensing/pacing circuit 224 is electrically coupled to the electrodes 228 and 230 to receive electrical signals indicative of cardiac activity and/or to output cardiac stimulation signals (e.g., pacing pulses). To facilitate interfacing with these components, the sensing/pacing circuit 224 may comprise one or more of: a sensing circuit, an amplifier, a filter, a signal generator, a signal driver, a switching circuit, or other suitable circuits. Thus, the sensing/pacing circuit 224 may filter, amplify, and detect signals received from the electrodes 228 and 230. In addition, the sensing/pacing circuit 224 may generate, filter, and amplify signals sent to the electrodes 228 and 230.
The signal processing circuit 220 may process cardiac signals received via the sensing/pacing circuit 224 to identify cardiac events. For example, a microprocessor of the signal processing circuit 220 may be configured to acquire intra-cardiac electrogram data (and/or other cardiac related signal data) and identify P waves, R waves, T waves and other cardiac events of interest. Based on analysis of these cardiac events, the processing circuit may selectively generate stimulation signals (e.g., pacing pulses) to be delivered to cardiac tissue via one or more electrodes. The signal processing circuit 220 also may control stimulation operations by controlling the signals generated by the sensing/pacing circuit 224. For example, a microprocessor of the signal processing circuit 220 may be configured to trigger the generation of pacing signals, specify pacing signal characteristics (e.g., energy level and duration), and inhibit pacing signals.
It should be appreciated that the signal processing circuit 220 may take various forms in different embodiments. For example, in some implementations, a single circuit (e.g., a microprocessor) may be employed to handle processing for both glucose sensing and cardiac operations. In other implementations, however, different circuits may be employed to provide the processing for these different operations.
Furthermore, in some embodiments, the resonant frequency of the resonant antenna may be determined by an external device. In such a case, the leadless glucose sensing device 202 need not employ the circuit 218 or the capability of generating data representative of cardiac glucose. Rather, based on the resonant frequency determination made by the external device, the external device will determine the blood glucose level.
Embodiments herein calculate a self-resonant frequency of the resonant antennas and calculate corresponding blood permittivity, glucose levels and pressure in various manners. As one example, a template may be constructed that maps various SRF to permittivity levels, where the map or template includes multiple graphs plotting functional relations between permittivity and SRF, each graph associated with a corresponding glucose level. Next, methods are described in connection with
At 234, the system transmits a reference excitation signal. The excitation signal may be generated by an external RF transmitter source, such as an antenna located near the patient. Optionally, the excitation signal may be generated by an implanted transmitter source, such as within an IMD, a leadless pacemaker or other implanted device. The reference excitation signal may be generated by the same implanted device (e.g., IMD or LP) that includes the glucose sensing device. Optionally, the resonant antenna may be used to generate the reference excitation signal, such as when the resonant antenna is driven by an oscillator. The reference excitation signal may be maintained at a constant amplitude and frequency through a select test period of time. Alternatively, the amplitude and/or frequency of the reference excitation signal may be varied within a select range during individual transmit intervals over the select test period of time.
At 236, the resonant antenna is monitored to collect measurements related to one or more characteristics indicative of the resonant behavior of the resonant antenna. For example, the measurements may represent impedance, voltage and/or current measurements across input terminals of the resonant antenna. When the resonant antenna is implemented within an IMD or LP, a processor or microcontroller therein may collect the impedance, voltage and/or current measurements across the resonant antenna. Additionally or alternatively, the measurements may be collected by an external device that measures impedance, voltage and/or current measurements across terminals of a separate transmit or receive antenna external to the patient. The measurements may correspond to an amount of reflection experienced as a transmit antenna and/or the amount of reflection experienced at the resonant antenna.
The operations at 234 and 236 may be performed once when using an excitation pulse with multiple frequency components or may be repeated in an iterative manner in connection with multiple reference signals transmitted at various select frequencies to obtain a collection of measurements indicative of the resonant behavior of the resonant antenna at the select frequencies.
At 238, the method determines the resonant frequency of the resonant antenna based on the measurements collected at 236. The resonant frequency is determined from the measurements utilizing various methods. At 238, the method saves the measurements (collected at 236), the resonant frequency (determined at 238) and, optionally, the parameters defining the reference signals (transmitted at 234).
At 240, the method determines the permittivity of the blood pool that is surrounding or located proximate to the resonant antenna. The permittivity may be determined based on the resonant frequency determined at 238. More than one permittivity level may be determined at 240 based upon corresponding different resonant frequencies, measurements and reference signals collected at 234-238. The permittivity value or values determined at 240 are stored for the present measurement session along with the additional information determined at 234-238.
At 242, the method measures the glucose level of the blood pool proximate to the resonant antenna utilizing a secondary measurement device. The glucose level may be measures in various manners, such as by measuring the glucose level directly from a blood sample or other test method. For example, the glucose level may be determined through fluid chemical analysis, breath chemical analysis, infrared spectroscopy, optical coherence tomography, thermal spectroscopy, ocular spectroscopy, fluorescence or impedance spectroscopy. Alternatively, conventional ultrasound, electromagnetic or thermal techniques may be utilized to measure the blood glucose level. At 242, the glucose level is saved in connection with the information generated and saved during the operations at 232-240.
At 244, the method determines whether to repeat the process. For example, the operations at 232-242 may be repeated at different times of day, and/or while a patient is experiencing different levels of physical or other types of stress. The operations at 232-244 may be repeated before and after meals, as well as based on other criteria that may affect a patient's blood glucose level. When it is determined to repeat the process, flow returns to 234. Otherwise, the process ends. Optionally, the operations at 232-244 may be repeated at the time of device implant or during checkups, where the patient's blood glucose is temporarily changed while in the hospital or clinic. Optionally, the operations 232-244 may be performed in a test lab when the device is manufactured before implant.
Each time the operations at 234-242 are repeated, the saved information is updated based on a present measurement/data collection session and stored, to create a map defining patterns between SRF, permittivity and glucose levels for the patient. By way of example only, a map may be recorded that includes all or a portion of the data points illustrated in
At 256, the resonant antenna is monitored to collect measurements related to one or more characteristics concerning the resonant behavior of the resonant antenna. As noted herein, the measurements may represent impedance, voltage and/or current measurements across the input terminals of the resonant antenna. When the resonant antenna is implemented within an IMD or LP, a processor or microcontroller therein may collect the impedance, voltage and/or current measurement across the resonant antenna. Additionally or alternatively, the measurements may be collected by an external device that measures impedance, voltage and/or current measurements across terminals of a separate transmit or receive antenna.
The operations at 254 and 256 may be performed once with a multi-frequency excitation signal or may be repeated in an iterative manner in connection with multiple base excitation signals transmitted at various select frequencies to obtain a collection of measurements indicative of the resonant behavior of the resonant antenna at various frequencies.
At 258, the method determines the resonant frequency of the resonant antenna based on the measurements collected at 256. The resonant frequency may be determined from the measurements utilizing various methods.
At 260, the method determines the permittivity of the blood pool that is surrounding or located proximate to the resonant antenna. The permittivity may be determined based on the resonant frequency determined at 238, as well as based on the known constant properties of the capacitive circuit and inductive circuit within the resonant antenna. By way of example, the measurements may be compared to one or more previously stored P-SPF models and PG relations associated with the current patient or a collection of patients (such as generated in connection with
At 262, the method compares the current blood permittivity with previously recorded permittivity level or levels to identify an amount and nature of change in the blood permittivity.
At 264, the method determines whether the change in permittivity exceeds a threshold, also referred to as a common glucose level threshold. The threshold corresponds to an amount of change in permittivity that may be experienced without representing a change in blood glucose level. It is recognized that blood permittivity may change for other reasons within certain limits, other than due to glucose level changes. The threshold at 264 is set to differentiate between permittivity changes due to blood glucose and other reasons. When the permittivity change exceeds the threshold, flow moves to 266. Otherwise, flow returns to 254.
At 266, the method identifies a new glucose level associated with the current permittivity value. For example, the new glucose level may be determined based on one or more templates or other information prerecorded in connection with the present patient, and/or in connection with a control group of patients.
Thereafter, the process of
In this embodiment, the resonant antenna 306 is excited by an internal excitation circuit 314 instead of by external excitation signals. The excitation circuit 314 generates a signal (e.g., a single pulse, a set of pulses, or a periodic pulse signal) that serves to excite the resonant antenna 306 and, if applicable, maintain oscillations in the resonant antenna 306. To this end, the excitation circuit 314 may include an oscillator 332 that generates an excitation signal or some other suitable excitation signal generator circuit.
In some implementations, the signal processing circuit 320 (or some other suitable circuit of the device 302) includes a processor that, among other things, controls the operation of the excitation circuit 314. For example, upon receipt of a suitable command from an external device (e.g., an external monitoring device) at the signal processing circuit 320, the excitation circuit 314 may be controlled to commence excitation of the resonant antenna 306. Alternatively, the signal processing circuit 320 may be configured to initiate excitation at certain times (e.g., periodically). Concurrent with either of the above operations, the processor of the signal processing circuit 320 may commence processing of the received oscillating signal 316 and generating data representative of the glucose level in the surrounding blood.
A leadless glucose sensing device may communicate with external devices in different ways in different embodiments.
The device 402 includes a resonant antenna 408, a signal processing circuit 410 (having one or more processors), a memory circuit 412, and a battery circuit 414 that are electrically coupled with one another, if applicable. Several other circuits that would be included in the device 402 are not shown to reduce the complexity of
The device 402 also includes a telemetry circuit 424 and associated antenna 426 for communicating with the external device 406 via RF signals 428. For example, the external device 406 may communicate with the device 402 to initiate glucose sensing operations, to upload data generated by the glucose sensing operations, to control cardiac-related operations, and so on. Of note, the external device 406 may employ a smaller antenna (not shown) than the antenna 416 since less RF energy may be required to communicate with the device 402 than is required to excite the resonant antenna 408 due to the use of lower frequency RF signals for this communication.
By way of example, the external excitation device 404, and/or device 406, may represent a personal health care, a home health care, or a bedside monitor. The device 404 may be joined to a remote medical network. The decide 404 may transmit raw data, as well as test results to the medical network. The antenna 416 may be located under or proximate to a patient's bed, in a pillow, in a chair back, in an automobile seat (bottom or back rest) and the like.
The configuration of
The resonant antenna 650 may be located at various positions on the header 672 such as proximate the mating end 655, the termination end 653 or elsewhere.
The resonant antenna 650 includes various segments that are stamped and formed with one another. A base segment 652 is configured to mount to a support structure within the header 672. The base segment 652 is joined with a vertical wall segment 654 that extends upward (or outward) from the support structure. An upper platform segment 656 is joined to the vertical wall and is oriented to extend along a connector region where pins on the lead are received in the termination reception area 657 in the header 672. A stub segment 658 projects laterally outward from the platform segment 656, and a lateral leg segment 660 extends downward from the platform 656. A foot segment 662 is joined to the outer end of the lateral leg segment 660. The segments 652-662 collectively define the antenna 650 to have a select capacitive reactance and select inductive reactance, thereby turning the antenna 650 to a select resonant frequency when in the presence of blood having a known permittivity. It is recognized that the shapes and dimensions of the segments 652-662 may be varied based on the available space within the header 672, as well as based on the resonant properties that are desired.
Optionally, the resonant antenna may be constructed similar to a Bluetooth antenna, but modified to have a higher resonant frequency (e.g., higher than 2.45 GHz). The resonant antennas described herein are examples of various designs that afford a substantial amount of (e.g., maximum) interaction with the surrounding blood. To afford a substantial amount of interaction with surrounding blood, the antenna may be designed as an electrical antenna (instead of as a magnetic antenna). For example, the resonant antenna may be constructed as a microstrip antenna, patch antenna, hybrid antenna and the like. For example, the hybrid antenna may be a planar inverted F-antenna, inverted L-antenna and the like.
A distal section of the leadless intra-cardiac medical device 702 comprises a helix electrode 704 that is actively affixed to an inner wall of the RV. The helix electrode 704 in combination with a ring electrode 706 may be used for near-field sensing of RV events. In addition, bipolar electrodes 708 and 710 at a proximal section of the leadless intra-cardiac medical device 702 may be employed for far-field sensing of RA events and/or other cardiac events. Here, the electrodes 708 and 710 may be optimized for such far-field sensing based on, for example, one or more of: placement of the electrodes 708 and 710 at a proximal section of the leadless intra-cardiac medical device 702, increased spacing between the electrodes 708 and 710, or increased sizing of the electrodes 708 and 710.
In accordance with embodiments herein, one or more of the leads 820, 824 and 830 may include one or more resonant antenna having a resonant frequency sensitive to permittivity of the surrounding blood pool. Optionally, the header 872 of the IMD 870 may include one or more resonant antenna having a resonant frequency sensitive to permittivity of the proximate blood pool.
To sense atrial cardiac signals and to provide right atrial chamber stimulation therapy, the IMD 870 is coupled to an implantable right atrial lead 820 having at least an atrial tip electrode 822, which typically is implanted in the patient's right atrial appendage. The IMD 870 may be a pacing device, a pacing apparatus, a cardiac rhythm management device, an implantable cardiac stimulation device, an implantable cardioverter/defibrillator (ICD) and/or a cardiac resynchronization therapy (CRT) device.
To sense left atrial and ventricular cardiac signals and to provide left chamber pacing therapy, the IMD 870 is coupled to an LV lead 824. The LV lead 824 may receive atrial and ventricular cardiac signals and deliver left ventricular pacing therapy using a left ventricular (LV) tip electrode 826, and intermediate LV electrodes 823, 825 and 829. Left atrial pacing therapy uses, for example, first and second left atrial (LA) electrodes 827 and 828. The LV and LA electrodes 823-829 may represent sensing sites, where cardiac signals are sensed, and/or may represent pacing and/or shock therapy sites. A right ventricular lead 830 includes an RV tip electrode 832, an RV ring electrode 834, an RV coil electrode 836, and a superior vena cava (SVC) coil electrode 838 (also known as a RA coil electrode). The right ventricular lead 830 is capable of sensing cardiac signals, and delivering stimulation in the form of pacing and shock therapy to the SVC and/or right ventricle.
In various embodiments, the device 900 may be adapted to treat both fast and slow arrhythmias with stimulation therapy, including cardioversion, defibrillation, and pacing stimulation. While a particular multi-chamber device is shown, it is to be appreciated and understood that this is done for illustration purposes. Thus, the techniques and methods described below can be implemented in connection with any suitably configured or configurable device. Accordingly, one of skill in the art could readily duplicate, eliminate, or disable the appropriate circuitry in any desired combination to provide a device capable of treating the appropriate chamber(s) with, for example, cardioversion, defibrillation, and pacing stimulation. A housing 905 for the device 900 is often referred to as the “can”, “case” or “case electrode”, and may be programmably selected to act as the return electrode for all “unipolar” modes. The housing 905 may further be used as a return electrode alone or in combination with one or more coil electrodes (not shown) for shocking purposes. As discussed herein, the housing 905 may be constructed of a biocompatible material (e.g., titanium) to facilitate implant within a patient.
The device 900 further includes a plurality of terminals that connect the internal circuitry of the device 900 to electrodes 901, 902, 912, and 914 of the device 900. Here, the name of the electrodes to which each terminal is connected is shown next to that terminal. The device 900 may be configured to include various other terminals depending on the requirements of a given application. Thus, it should be appreciated that other terminals (and associated circuitry) may be employed in other embodiments.
To achieve right atrial sensing and pacing, a right atrial tip terminal (A.sub.R TIP) is adapted for connection to a right atrial tip electrode 902. A right atrial ring terminal (A.sub.R RING) may also be included and adapted for connection to a right atrial ring electrode 901. To achieve right ventricular sensing and pacing, a right ventricular tip terminal (V.sub.R TIP) and a right ventricular ring terminal (V.sub.R RING) are adapted for connection to a right ventricular tip electrode 912 and a right ventricular ring electrode 914, respectively.
At the core of the device 900 is a programmable microcontroller 920 that controls the various modes of stimulation therapy. As is well known in the art, microcontroller 920 typically includes a microprocessor, or equivalent control circuitry, designed specifically for controlling the delivery of stimulation therapy, and may further include memory such as RAM, ROM and flash memory, logic and timing circuitry, state machine circuitry, and I/O circuitry. Typically, microcontroller 920 includes the ability to process or monitor input signals (data or information) as controlled by a program code stored in a designated block of memory. The type of microcontroller is not critical to the described implementations. Rather, any suitable microcontroller 920 may be used that carries out the functions described herein. The use of microprocessor-based control circuits for performing timing and data analysis functions are well known in the art.
Representative types of control circuitry that may be used in connection with the described embodiments can include the microprocessor-based control system of U.S. Pat. No. 4,940,052 (Mann et al.), the state-machine of U.S. Pat. No. 4,712,555 (Thornander et al.) and U.S. Pat. No. 4,944,298 (Sholder), all of which are incorporated by reference herein. For a more detailed description of the various timing intervals that may be used within the device and their inter-relationship, see U.S. Pat. No. 4,788,980 (Mann et al.), also incorporated herein by reference.
Microcontroller 920 further includes timing control circuitry 932 to control the timing of the stimulation pulses (e.g., pacing rate, atrioventricular (AV) delay, inter-atrial conduction (A-A) delay, or inter-ventricular conduction (V-V) delay, etc.) or other operations, as well as to keep track of the timing of refractory periods, blanking intervals, noise detection windows, evoked response windows, alert intervals, marker channel timing, etc., as known in the art.
Microcontroller 920 further includes an arrhythmia detector 934. The arrhythmia detector 934 may be utilized by the device 900 for determining desirable times to administer various therapies. The arrhythmia detector 934 may be implemented, for example, in hardware as part of the microcontroller 920, or as software/firmware instructions programmed into the device 900 and executed on the microcontroller 920 during certain modes of operation.
Microcontroller 920 may include a morphology discrimination module 936, a capture detection module 937 and an auto sensing module 938. These modules are optionally used to implement various exemplary recognition algorithms or methods. The aforementioned components may be implemented, for example, in hardware as part of the microcontroller 920, or as software/firmware instructions programmed into the device 900 and executed on the microcontroller 920 during certain modes of operation.
The electrode configuration switch 926 includes a plurality of switches for connecting the desired terminals (e.g., that are connected to electrodes, coils, sensors, etc.) to the appropriate I/O circuits, thereby providing complete terminal and, hence, electrode programmability. Accordingly, switch 926, in response to a control signal 942 from the microcontroller 920, may be used to determine the polarity of the stimulation pulses (e.g., unipolar, bipolar, combipolar, etc.) by selectively closing the appropriate combination of switches (not shown) as is known in the art.
Atrial sensing circuits (ATR. SENSE) 944 and ventricular sensing circuits (VTR. SENSE) 946 may also be selectively coupled to the right atrial electrodes and the right ventricular electrodes through the switch 926 for detecting the presence of cardiac activity in each of the four chambers of the heart. Accordingly, the atrial and ventricular sensing circuits 944 and 946 may include dedicated sense amplifiers, multiplexed amplifiers, or shared amplifiers. Switch 926 determines the “sensing polarity” of the cardiac signal by selectively closing the appropriate switches, as is also known in the art. In this way, the clinician may program the sensing polarity independent of the stimulation polarity. The sensing circuits (e.g., circuits 944 and 946) are optionally capable of obtaining information indicative of tissue capture.
Each sensing circuit 944 and 946 preferably employs one or more low power, precision amplifiers with programmable gain, automatic gain control, bandpass filtering, a threshold detection circuit, or some combination of these components, to selectively sense the cardiac signal of interest. The automatic gain control enables the device 900 to deal effectively with the difficult problem of sensing the low amplitude signal characteristics of atrial or ventricular fibrillation.
The outputs of the atrial and ventricular sensing circuits 944 and 946 are connected to the microcontroller 920, which, in turn, is able to trigger or inhibit the atrial and ventricular pulse generators 922 and 924, respectively, in a demand fashion in response to the absence or presence of cardiac activity in the appropriate chambers of the heart. Furthermore, as described herein, the microcontroller 920 is also capable of analyzing information output from the sensing circuits 944 and 946, a data acquisition system 952, or both. This information may be used to determine or detect whether and to what degree tissue capture has occurred and to program a pulse, or pulses, in response to such determinations. The sensing circuits 944 and 946, in turn, receive control signals over signal lines 948 and 950, respectively, from the microcontroller 920 for purposes of controlling the gain, threshold, polarization charge removal circuitry (not shown), and the timing of any blocking circuitry (not shown) coupled to the inputs of the sensing circuits 944 and 946 as is known in the art.
For arrhythmia detection, the device 900 utilizes the atrial and ventricular sensing circuits 944 and 946 to sense cardiac signals to determine whether a rhythm is physiologic or pathologic. It should be appreciated that other components may be used to detect arrhythmia depending on the system objectives. In reference to arrhythmias, as used herein, “sensing” is reserved for the noting of an electrical signal or obtaining data (information), and “detection” is the processing (analysis) of these sensed signals and noting the presence of an arrhythmia.
Timing intervals between sensed events (e.g., P-waves, R-waves, and depolarization signals associated with fibrillation) may be classified by the arrhythmia detector 934 of the microcontroller 920 by comparing them to a predefined rate zone limit (e.g., bradycardia, normal, low rate VT, high rate VT, and fibrillation rate zones) and various other characteristics (e.g., sudden onset, stability, physiologic sensors, and morphology, etc.) in order to determine the type of remedial therapy that is needed (e.g., bradycardia pacing, anti-tachycardia pacing, cardioversion shocks or defibrillation shocks, collectively referred to as “tiered therapy”). Similar rules may be applied to the atrial channel to determine if there is an atrial tachyarrhythmia or atrial fibrillation with appropriate classification and intervention.
Cardiac signals or other signals may be applied to inputs of an analog-to-digital (A/D) data acquisition system 952. The data acquisition system 952 is configured (e.g., via signal line 956) to acquire intra-cardiac electrogram (“IEGM”) signals or other signals, convert the raw analog data into a digital signal, and store the digital signals for later processing, for telemetric transmission to an external device 954, or both. For example, the data acquisition system 952 may be coupled to the right atrial electrodes and the right ventricular electrodes through the switch 926 to sample cardiac signals across any pair of desired electrodes.
The data acquisition system 952 also may be coupled to receive signals from other input devices. For example, the data acquisition system 952 may sample signals from a physiologic sensor 970 or other components shown in
The microcontroller 920 is further coupled to a memory 960 by a suitable data/address bus 962, wherein the programmable operating parameters used by the microcontroller 920 are stored and modified, as required, in order to customize the operation of the device 900 to suit the needs of a particular patient. Such operating parameters define, for example, pacing pulse amplitude, pulse duration, electrode polarity, rate, sensitivity, automatic features, arrhythmia detection criteria, and the amplitude, waveshape and vector of each shocking pulse to be delivered to the patient's heart H within each respective tier of therapy. One feature of the described embodiments is the ability to sense and store a relatively large amount of data (e.g., from the data acquisition system 952), which data may then be used for subsequent analysis to guide the programming of the device 900.
Advantageously, the operating parameters of the implantable device 900 may be non-invasively programmed into the memory 960 through a telemetry circuit 964 in telemetric communication via communication link 966 with the external device 954, such as a programmer, transtelephonic transceiver, a diagnostic system analyzer or some other device. The microcontroller 920 activates the telemetry circuit 964 with a control signal (e.g., via bus 968). The telemetry circuit 964 advantageously allows intra-cardiac electrograms and status information relating to the operation of the device 900 (as contained in the microcontroller 920 or memory 960) to be sent to the external device 954 through an established communication link 966.
The device 900 includes one or more physiologic sensors 970. At least one sensor 970 comprises a glucose sensor as taught herein. In some embodiments, the device 900 may include a “rate-responsive” sensor that may provide, for example, information to aid in adjustment of pacing stimulation rate according to the exercise state of the patient. One or more physiologic sensors 970 (e.g., a glucose sensor) may be used to detect changes in cardiac output, changes in the physiological condition of the heart, or diurnal changes in activity (e.g., detecting sleep and wake states). Accordingly, the microcontroller 920 may respond to this sensing by adjusting the various pacing parameters (such as rate, A-V Delay, V-V Delay, etc.) at which the atrial and ventricular pulse generators 922 and 924 generate stimulation pulses.
While shown as being included within the device 900, it is to be understood that a physiologic sensor 970 may also be external to the device 900, yet still be implanted within or carried by the patient. Examples of physiologic sensors that may be implemented in conjunction with the device 900 include sensors that sense respiration rate, pH of blood, ventricular gradient, oxygen saturation, blood glucose and so forth. Another sensor that may be used is one that detects activity variance, wherein an activity sensor is monitored diurnally to detect the low variance in the measurement corresponding to the sleep state. For a more detailed description of an activity variance sensor, the reader is directed to U.S. Pat. No. 5,476,483 (Bornzin et al.), which patent is hereby incorporated by reference.
The one or more physiologic sensors 970 may optionally include one or more of components to help detect movement (via, e.g., a position sensor or an accelerometer) and minute ventilation (via an MV sensor) in the patient. Signals generated by the position sensor and MV sensor may be passed to the microcontroller 920 for analysis in determining whether to adjust the pacing rate, etc. The microcontroller 920 may thus monitor the signals for indications of the patient's position and activity status, such as whether the patient is climbing up stairs or descending down stairs or whether the patient is sitting up after lying down.
The device 900 additionally includes a battery 976 that provides operating power to all of the circuits shown in
The device 900 can further include magnet detection circuitry (not shown), coupled to the microcontroller 920, to detect when a magnet is placed over the device 900. A magnet may be used by a clinician to perform various test functions of the device 900 and to signal the microcontroller 920 that the external device 954 is in place to receive data from or transmit data to the microcontroller 920 through the telemetry circuit 964.
The device 900 further includes an impedance measuring circuit 978 that is enabled by the microcontroller 920 via a control signal 980. The known uses for an impedance measuring circuit 978 include, but are not limited to, electrode impedance surveillance during the acute and chronic phases for proper performance, electrode positioning or dislodgement; detecting operable electrodes and automatically switching to an operable pair if dislodgement occurs; measuring respiration or minute ventilation; measuring thoracic impedance for determining shock thresholds; detecting when the device 900 has been implanted; measuring stroke volume; and detecting the opening of heart valves, etc. The impedance measuring circuit 978 is advantageously coupled to the switch 926 so that any desired electrode may be used.
In the case where the device 900 is intended to operate as an implantable cardioverter/defibrillator (ICD) device, it detects the occurrence of an arrhythmia, and automatically applies an appropriate therapy to the heart aimed at terminating the detected arrhythmia. To this end, the microcontroller 920 may include a shocking circuit (not shown). The shocking circuit generates shocking pulses of low (e.g., up to 0.5 J), moderate (e.g., 0.5 J to 10 J), or high energy (e.g., 11 J to 40 J), as controlled by the microcontroller 920. Such shocking pulses may be applied to the patient's heart H through, for example, two or more shocking electrodes (not shown).
Cardioversion level shocks are generally considered to be of low to moderate energy level (so as to minimize pain felt by the patient), be synchronized with an R-wave, pertain to the treatment of tachycardia, or some combination of the above. Defibrillation shocks are generally of moderate to high energy level (i.e., corresponding to thresholds in the range of 5 J to 40 J), delivered asynchronously (since R-waves may be too disorganized), and pertaining to the treatment of fibrillation. Accordingly, the microcontroller 920 is capable of controlling the synchronous or asynchronous delivery of the shocking pulses.
The device 900 thus illustrates several components that may provide the implantable intra-cardiac medical device functionality described above. For example, the microcontroller 920 may control and perform the operations of
As represented by block 1004, in embodiments where the leadless intra-cardiac medical device comprises an active resonant antenna, the device may trigger an excitation circuit to excite the resonant antenna. As discussed herein, this trigger may be based on receipt of a message or signal, based on a glucose sensing schedule (e.g., periodic sensing) implemented at the device, or based on some other factor(s).
As represented by block 1006, the leadless intra-cardiac medical device processes signal produced by the excited resonant antenna to determine at least one frequency of the signals. For example, the device may monitor the frequency of the signals over a period of time to determine how the frequency varies over that period of time.
As represented by block 1008, the leadless intra-cardiac medical device generates data representative of the glucose level based on the at least one frequency determined at block 1006. For example, the device may generate data indicative of how the measured cardiac glucose varies over a designated period of time.
As represented by block 1010, the leadless intra-cardiac medical device transmits the data generated at block 1008 to an external device (e.g., an external monitoring device) via RF signaling. For example, the leadless intra-cardiac medical device may send this information on-demand (e.g., in response to a message), according to a schedule (e.g., periodically), or in some other suitable manner.
In the illustrated example, the implanted device 1102 is a leadless intra-cardiac medical device including a resonant antenna glucose sensor (not shown) in accordance with the teachings herein. For example, the implanted device 1102 may be a pacemaker, an implantable cardioverter defibrillator, or some other similar device. It should be appreciated, however, that the implanted device 1102 may take other forms.
The external device 1104 also may take various forms. For example, the external device 1104 may be a base station, a programmer, a home safety monitor, a personal monitor, a follow-up monitor, a wearable monitor, or some other type of device that is configured to communicate with the implanted device 1102. The communication link 1106 may be used to transfer information between the devices 1102 and 1104 in conjunction with various applications such as remote home-monitoring, clinical visits, data acquisition, remote follow-up, and portable or wearable patient monitoring/control systems. For example, when information needs to be transferred between the devices 1102 and 1104, the patient P moves into a position that is relatively close to the external device 1104, or vice versa.
The external device 1104 may send information it receives from an implanted device to another device (e.g., that may provide a more convenient means for a physician to review the information). For example, the external device 1104 may send the information to a web server (not shown). In this way, the physician may remotely access the information (e.g., by accessing a website). The physician may then review the information uploaded from the implantable device to determine whether medical intervention is warranted.
It should be appreciated that various modifications may be incorporated into the disclosed embodiments based on the teachings herein. For example, the structure and functionality taught herein may be incorporated into types of devices other than the specific types of devices described above. In addition, glucose sensors for a leadless intra-cardiac medical device may be implemented in different ways in different embodiments based on the teachings herein. Different types of structural members and mechanical support structures may be employed in conjunction with a leadless intra-cardiac medical device as taught herein. Also, various algorithms or techniques may be employed to monitor glucose in various cardiac chambers (e.g., RA, RV, LA, and LV chambers) in accordance with the teachings herein. In some aspects, an apparatus or any component of an apparatus may be configured to provide functionality as taught herein by, for example, manufacturing (e.g., fabricating) the apparatus or component so that it will provide the functionality, by programming the apparatus or component so that it will provide the functionality, or through the use of some other suitable means.
In some embodiments, code including instructions (e.g., software, firmware, middleware, etc.) may be executed on one or more processing devices to implement one or more of the described functions or components. The code and associated components (e.g., data structures and other components used by the code or used to execute the code) may be stored in an appropriate data memory that is readable by a processing device (e.g., commonly referred to as a computer-readable medium).
Moreover, some of the operations described herein may be performed by a device that is located externally with respect to the body of the patient. For example, an implanted device may send raw data or processed data to an external device that then performs the necessary processing.
The signals discussed herein may take various forms. For example, in some embodiments a signal may comprise electrical signals transmitted over a wire, light pulses transmitted through an optical medium such as an optical fiber or air, or RF waves transmitted through a medium such as air, and so on. In addition, a plurality of signals may be collectively referred to as a signal herein. The signals discussed above also may take the form of data. For example, in some embodiments an application program may send a signal to another application program. Such a signal may be stored in a data memory.
Moreover, the recited order of the blocks in the processes disclosed herein is simply an example of a suitable approach. Thus, operations associated with such blocks may be rearranged while remaining within the scope of the present disclosure. Similarly, the accompanying method claims present operations in a sample order, and are not necessarily limited to the specific order presented.
Also, it should be understood that any reference to elements herein using a designation such as “first,” “second,” and so forth does not generally limit the quantity or order of those elements. Rather, these designations may be used herein as a convenient method of distinguishing between two or more different elements or instances of an element. Thus, a reference to first and second elements does not mean that only two elements may be employed there or that the first element must precede the second element in some manner. Also, unless stated otherwise a set of elements may comprise one or more elements. In addition, terminology of the form “at least one of A, B, or C” or “one or more of A, B, or C” or “at least one of the group consisting of A, B, and C” used in the description or the claims means “A or B or C or any combination of these elements.” For example, this terminology may include A, or B, or C, or A and B, or A and C, or A and B and C, or 2A, or 2B, or 2C, and so on.
As used herein, the term “determining” encompasses a wide variety of actions. For example, “determining” may include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining, and the like. Also, “determining” may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Also, “determining” may include resolving, selecting, choosing, establishing, and the like.
While certain embodiments have been described above in detail and shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative of and not restrictive of the teachings herein. In particular, it should be recognized that the teachings herein apply to a wide variety of apparatuses and methods. It will thus be recognized that various modifications may be made to the illustrated embodiments or other embodiments, without departing from the broad scope thereof. In view of the above, it will be understood that the teachings herein are intended to cover any changes, adaptations or modifications that are within the scope of the disclosure.
The (module/controller) may include any processor-based or microprocessor-based system including systems using microcontrollers, reduced instruction set computers (RISC), application specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), logic circuits, and any other circuit or processor capable of executing the functions described herein. Additionally or alternatively, the (module/controller) represent circuit modules that may be implemented as hardware with associated instructions (for example, software stored on a tangible and non-transitory computer readable storage medium, such as a computer hard drive, ROM, RAM, or the like) that perform the operations described herein. The above examples are exemplary only, and are thus not intended to limit in any way the definition and/or meaning of the term “controller.” The (module/controller) may execute a set of instructions that are stored in one or more storage elements, in order to process data. The storage elements may also store data or other information as desired or needed. The storage element may be in the form of an information source or a physical memory element within the (module/controller) The set of instructions may include various commands that instruct the (module/controller) to perform specific operations such as the methods and processes of the various embodiments of the subject matter described herein. The set of instructions may be in the form of a software program. The software may be in various forms such as system software or application software. Further, the software may be in the form of a collection of separate programs or modules, a program module within a larger program or a portion of a program module. The software also may include modular programming in the form of object-oriented programming. The processing of input data by the processing machine may be in response to user commands, or in response to results of previous processing, or in response to a request made by another processing machine.
It is to be understood that the subject matter described herein is not limited in its application to the details of construction and the arrangement of components set forth in the description herein or illustrated in the drawings hereof. The subject matter described herein is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. While the dimensions, types of materials and coatings described herein are intended to define the parameters of the invention, they are by no means limiting and are exemplary embodiments. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. Further, the limitations of the following claims are not written in means—plus-function format and are not intended to be interpreted based on 35 U.S.C. §112(f), unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure.
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