Patent Application
20150011856
1. Field of the Disclosure
This invention relates generally to the field of medical devices. More specifically, the invention relates to a method and device using impedance for the detection of fluid (e.g., blood) bleeding such as pericardial effusion, retroperitoneal effusion, etc.
2. Background Information
Radiofrequency ablation (RF ablation) or other invasive cardiac procedures which involve operation within the cardiac chambers, coronary arteries or the heart's venous anatomy have saved many lives. These procedures often involve percutaneous access into the cardiac chambers or epicardial arterial or venous vessels. Catheter, pacing lead, sheath, or other types of device manipulations frequently are performed as key parts of these procedures. Example of this include balloon angioplasty or stent placement. Often, catheter access to the femoral artery is needed to enable access to the heart of elsewhere in the body.
A rare but potentially dangerous complication of these and similar procedures is inadvertent perforation of a cardiac chamber or an epicardial vessel. Retroperitoneal bleeding, arteriovenous fistula, pseudoaneurysms, and hematoma formation is also possible at the site of the insertion of the catheter into the femoral or other artery or vein. Perforations of a cardiac chamber or an epicardial vessel may lead to accumulation of blood (or other fluids) in the pericardial space or sac. This condition is referred to pericardial effusion. Cardiac tamponade is the patho-physiologic state wherein accumulation of blood or other fluid in the pericardial space or sac leads to impaired filling of the heart and a secondary decrease in cardiac output and consequential hemodynamic derangement. It is not unusual in clinical procedures for the onset of perforation to be heralded by the onset of hemodynamic derangements such as drop in blood pressure. In such cases it is frequently only at that time that the presence of a perforation is recognized. Much time may have elapsed between the creation of a perforation and the subsequent accumulation of enough blood or fluid to create a hemodynamically-significant pericardial effusion or tamponade. Of critical clinical significance is that early detection of such perforation may allow the operator to implement interventions (for example discontinuation of peri-operative anticoagulation) that would mitigate the untoward consequences of pericardial effusion.
Retroperitoneal bleeding, arteriovenous fistulae, or hematomas may lead to hemotoma formation, pain, blood loss, shock, or death. Its detection is frequently only noted after hypotension or other symptoms are noted. There may be no other signs associated with bleeding. As in the case of a pericardial effusion prompt recognition offers the opportunity for potentially lifesaving intervention. Another frequent complication of such procedures involves development of blood clots (“thrombosis”) within the body of the sheath. These clots may travel (“embolize”) via the circulation and lead to necrosis or ischemia of tissue subserved by these blood vessels.
It follows that a method and device which could more rapidly detect the presence of pericardial or retroperitoneal bleeding, aretriovenous fistula, or hematoma, prior to the onset of symptoms, is highly desirable. Rapid detection of such bleeding or fluid accumulation can lead to more timely management—such as aborting the procedure or reversal of the patient's anticoagulation response during such cardiac procedures.
In accordance with at least one embodiment, a method is disclosed to detect internal bleeding complications. The method includes determining, by an impedance assessment unit, a bioimpedance value at each of a plurality of frequencies. The method further includes normalizing, by the impedance assessment unit, each bioimpedance value at each frequency to a calibration bioimpedance value at that same frequency to produce a set of normalized bioimpedance values at the plurality of frequencies. The method also includes computing a bleed indication value based on the set of normalized bioimpedance values; and generating an alarm indicative of a bleed complication based on a comparison of the bleed indication value to a threshold.
Another embodiment includes a bleed detection apparatus that includes a signal generator to generate an input electrical signal to be provided to an electrode coupled to human tissue. The apparatus may also include a processor coupled to the signal generator to cause the electrical signal to be provided to the electrode to and to receive a response signal from the electrode and to compute a bioimpedance based on the input electrical signal and the response signal. The processor is to:
In the following discussion and in the claims, the term “fluid” is defined to include blood and other types of body fluids or gases that may bleed or leak from a vessel or organ. All references to an impedance measurement being made encompasses any of the variations described herein as performed by the combination of the impedance assessment unit and an external apparatus.
In accordance with preferred embodiments of the invention, a system and method are disclosed herein that involves real-time assessment of resistance or impedance to an electrical signal (current or voltage). Accumulation of sufficient fluid or blood in such areas as the pericardial space leads to changes in both the direct current (DC) resistance and/or the complex impedance to alternating current (AC) current flow. A change in either the resistance or the complex impedance signals fluid accumulation in the space through which the electrical current travels. Embodiments of the invention also use conduction time between two vectors as another variable which may be analyzed. Various embodiments are described herein for measuring impedance to detect fluid bleeding. Impedance may be computed by injecting a known current (DC or AC) and measuring the resulting voltage, or imposing a known voltage across the electrodes and measuring the resulting current. The ratio of voltage to current determines impedance.
In accordance with one such embodiment,
Impedance between pairs of electrodes within the sheath can also be measured to assess the presence of such phenomenona as clots within the sheath. In this embodiment, the system can be based on using only one pair of electrodes such that the injected current and the detected voltage are from one pair of electrodes, or on multiple pairs of electrodes such that the injected current and the detected voltage are two separate pairs of electrodes. For example, one pair of electrodes is used to inject current and another pair of electrodes is used to measure the resulting voltage to thereby assess impedance, or vice versa (a known voltage is imposed on pair of electrodes and current is measured). Although two different pairs of electrodes are used, an electrode may be common to both pairs. Other configurations utilizing multiple electrodes are also feasible embodiments.
The sheath 12 may be coupled to a hub 15 which may incorporate a hemostasis valve 21 from which a side arm 4 may extend that allows the sheath to be used to administer fluids and or drugs. A valve 16 is provided on the opposing end of the side arm 14. The introducer 10 also includes a dilator 28 that is insertable into the hollow sheath 12. The dilator and sheath function to permit a catheter to be inserted into the blood vessel. Independently from the preceding features, the sheath 12 may also include other features to facilitate simple “peel-away” removal without disturbing a catheter having been passed the lumen of the sheath 12. Referring still to
In
In
In some embodiments, the electrode 20 is located on the sheath so that the electrode will be inside the blood vessel once the sheath is inserted into the vessel. In other embodiments, the electrode may be provided on the sheath at the proximal end outside the blood vessel (and perhaps even outside the person's body). In such embodiments, the electrode 20 preferably is provided on the inner surface of the sheath (similar to that shown in
The current source 36 or logic 38 measures the voltage across the electrodes 20, 30 resulting from the current, and computes the ratio of the voltage to current to compute impedance. The impedance is altered in the presence of bleeding and thus can be correlated to bleeding such as retroperitoneal bleeding. The presence of the bleeding may also be referred to as an internal bleeding complication (IBC). The device may also calculate the conduction time between the electrodes. Bleeding will also alter the conduction time between tissues. Alternatively, rather than a current source, a voltage source can be used to impose a specified voltage on the electrodes 20, 30 and the resulting current level is measured to compute impedance.
The logic 38 may comprise an IBC algorithm to detect an IBC that may occur during the introduction of the catheter into the blood vessel 29. The algorithm may be represented by two main segments—a calibration segment and a measurement or monitoring segment. The IBC algorithm, or simply the algorithm, may be used by the logic 38 to detect the IBC based on the measured impedance data and to set an alarm upon detecting the IBC event. The algorithm may begin processing the impedance data at insertion of the sheath into the person and it may continue to process until the sheath is removed so that there is continuous monitoring of the person.
The calibration segment of the algorithm may be implemented by the logic 38 during the first few seconds, as much as 20 seconds, after the sheath is inserted into the person and the impedance measuring apparatus 35 is enabled. The calibration segment may establish a baseline impedance value and function for the person for each of the plurality of frequencies, which may then be used by the monitoring segment to determine if any bleeding has occurred. The algorithm's calibration segment may first take a couple of impedance measurements at each of the plurality of frequencies then take their average to establish a baseline impedance value. This baseline impedance value may then be used to normalize all subsequent impedance measurements.
After the baseline impedance value has been established, the logic 38 may begin to generate a time dependent line of the impedance measurements by adding the absolute value of the impedance change from measurement to measurement. The line shows that the impedance of the person drifts, and this drift may be due to polarization of the human tissue and inherent noise of the system. The impedance measuring apparatus 35 may implement a low now filter to filter out some of the noise, but the noise may continue to affect the drift in the measurement. As the logic 38 continues to generate the line from the impedance measurements (again, this is done for each of the plurality of frequencies), the algorithm may fit the line with a representative function. The fit may be used later by the monitoring segment of the algorithm.
Lastly, the algorithm may calculate a distribution and a standard deviation for the baseline impedance across the plurality of the frequencies. The distribution may show the spread in the impedance measurements across the plurality of frequencies and the standard deviation may be used by the algorithm to establish a threshold for the impedance measurements. The threshold may be used by the logic to determine when to turn on an alarm alerting the physician of a potential IBC event. The threshold may be set at a multiple of the standard deviation of the distribution of the baseline impedance values, for example, three standard deviations may be the threshold.
The calibration segment of the algorithm may be processed by the logic 38 and may be completed in only a few seconds of being enabled. In presence of an IBC event, the calibration segment may be completed before any bleeding has had time to grow to a level that may be detected by the logic 38.
The logic 38, after completing the calibration segment, may transition into the monitoring segment of the algorithm. The monitoring segment may continue to process and analyze subsequent impedance measurements and compare them to the baseline distribution to determine the presence of an IBC. At each of the subsequent impedance measurements after the calibration segment has finished the algorithm may first normalize the impedance value for each of the plurality of frequencies by the baseline impedance value for the corresponding frequency. The normalized impedance values for each of the plurality of frequencies may then be reduced by the fit line established during calibration. A distribution, average and standard deviation for the resulting values may then be computed. The distribution and/or the standard deviation may then be compared to (e.g., subtracted from) the threshold to determine whether or not an IBC event has occurred. For example, if the distribution of the subsequent impedance values has changed by more than three standard deviations away from the baseline distribution, then the logic 38 may set off an alarm. On the other hand, if the distributions are within the threshold of one another, then the logic 38 continues to run the algorithm.
The comparison of the distribution may also include computing the average impedance across the plurality of frequencies for each subsequent impedance measurement then comparing that average to the threshold, which may be three times the baseline standard deviation. If the impedance value for any of the plurality of frequencies changes more than the three standard deviation threshold, then the logic 38 sounds the alarm. The comparison of each frequency to the threshold separately may be calculated since differences in impedance changes at the various frequencies being different due to variations in the person's tissue. Some frequencies may be more sensitive to the bleeding therefore detecting it sooner.
The monitoring segment of the IBC algorithm may be performed on impedance measurements on virtually any time scale, but may have a lower limit determined by the logic 38. The monitoring analysis steps of the algorithm may be set by the attending physician to be performed every second, 5 seconds, 10 seconds, minute. Alternatively, the frequency of the analysis may be dynamically altered during operation so to perform the analysis more or less often. The frequency at which the monitoring segment of the algorithm is run may be selected through an interface of the impedance measuring apparatus 35. The selection mechanism may be a knob selecting a time interval, or a soft input that allows a user to set a time interval by entering a number of seconds, or a series of switches associated with a different time either in seconds or minutes.
The non-sheath electrodes 30 may be located at any of a variety of locations. The illustrative embodiment of
In accordance with at least some embodiments, the sheath 12 may comprise two or more electrodes 20. Another pair of electrodes may be attached to the patient's skin (e.g. back, abdomen) as noted above. One pair comprising one of the sheath electrodes and one of the skin electrodes is used to inject current and the other pair of electrodes (i.e., the other sheath electrode and skin electrode) is used to measure the resulting voltage for the impedance computation.
In another embodiment, the sheath 12 may include four electrodes as shown in
In some embodiments, each possible pair of electrodes is used to send/receive current with the remaining electrodes used to measure voltage for an impedance computation.
In some embodiments, each possible pair of electrodes is used to send/receive current with the remaining electrodes used to measure voltage for an impedance calculation. The system may cycle through each such electrode pair combination.
In yet other embodiments, the sheath may not have any electrodes. Instead, multiple electrodes (e.g., 5 or more) are placed on the patient's abdomen near the tip of electrode-less sheath. As before, each possible electrode combination is cycled through the process of sending the current, conducting the current, measuring the voltage, and computing the impedance.
At 110, the impedance measuring apparatus 35 determines if the impedance is indicative of bleeding. In some embodiments, the logic 38 of the impedance (or conduction time) measuring apparatus 35 compares the computed impedance to a predetermined threshold, derived threshold based on baseline measurements at the onset of the procedure, otherwise defined acceptable range. The logic 38 determines that bleeding has occurred if the computed impedance or conduction time is outside of the acceptable range for the threshold as previously defined. If bleeding has been detected, the logic 38 may alert a user via an audible and/or visual indicator.
In some embodiments, the impedance measuring apparatus 35 injects a known current and measures the resulting voltage to determine impedance. In other embodiments, the impedance measuring apparatus 35 applies a known voltage to the electrodes and measures the resulting current to determine impedance.
It may be desirable to leave the sheath 12 in place in the person's blood vessel following the completion of the medical procedure (e.g., RF ablation) for which the sheath was used in the first place. It is possible that bleeding (e.g., retroperitoneal bleeding) will begin after the completion of the medical procedure. With the sheath 12 still in place, impedance measurements can be made via the impedance measuring apparatus 35 to detect post-medical procedure completion onset of bleeding. A user of the impedance measuring apparatus can activate a control (e.g., press a button) on the impedance measuring apparatus to activate an impedance/bleed monitoring.
Besides retroperitoneal bleeding, arteriovenous fistulae, or hematomas, other types of internal bleeding may occur as well. For example, during a catheterization procedure of a patient's heart or surrounding blood vessel(s), bleeding can occur into the pericardial space. In accordance with various embodiments, a catheter includes one or more electrodes, at least one of which is used to make impedance measurements as described above to detect bleeding such as pericardial effusion. In another embodiment of this invention the tip of the catheter or electrode may be located on any guide wire used during coronary intervention (a wire over which a coronary stent or angioplasty apparatus may be advanced is always utilized during such procedures). In this embodiment, the guide wire is or contains an electrode. In such a situation the impedance between the tip of the wire and any second electrode as described elsewhere (such as a skin patch electrode) can be utilized. In another embodiment a distal and proximal electrode (relative to the location of coronary blockage which is to be angioplastied or stented) within the same wire may be used to assess progression of clot formation or perforation and effusion.
Electrodes 172 are provided on a catheter 170 and electrically coupled to the signal generator 154. One or more additional electrodes 174 may also be provided and coupled to signal generator 154. Under control of the processor 152 (via execution of application 159), the signal generator 154 selects one pair of electrodes 172, 174, applies a known current using a plurality of frequencies, as discussed above, to one of the electrodes in the selected pair and receives the current via the electrode. The detector 153 determines the resulting voltage across a selected pair of electrodes, which may be the same pair or a different pair of electrodes from that pair used to apply the voltage, and provides the voltage measurement to the processor 152. The detector 153 may comprise an analog-to-digital converter to convert the voltage measurement to digital form for the processor. Both the current and voltage values are provided to the processor which then computes the impedance (ratio of voltage to current), or conduction time and compares the computed impedance or conduction time to a corresponding threshold to determine if bleeding has occurred. A pair of electrodes can be selected coupling two of the electrodes 172, 174 to the signal generator (via a switching device). The signal generator can select two electrodes from among electrodes 172 on the catheter, two electrodes from among electrodes 174, or one electrode each from electrode sets 172 and 174.
If two electrodes 172 are selected on the catheter 170, the impedance measuring apparatus 150 can detect a blood clot within the catheter by measuring the impedance between the two catheter electrodes. The same is true with respect to the embodiment of
The catheter 170 can be inserted into any of a variety of veins or arteries. In one embodiment, the catheter 170 is inserted into the femoral artery (for detection, for example, of retroperitoneal effusion), the heart or coronary vasculature such as the coronary sinus (for detection of pericardial effusion), or other blood vessels or anatomic structures. The coronary sinus is an epicardial vein through which venous drainage of coronary circulation occurs. It is on the inferior surface of the left atrium. More distally this structure turns into the great cardiac vein or any of its other tributaries.
The electrodes 174 may be located at any of variety of sites. An electrode 174, for example, may be located on the person's esophagus, on the person's skin, or on the person's heart. Moreover, impedance can be measured for detecting bleeding between, for example, the coronary sinus and skin, coronary sinus and esophagus, skin and skin (e.g., patient's front and back), heart and coronary sinus, heart and esophagus, two sites on the same catheter, two sites on the same sheath, two sites on the same vein and femoral artery to skin.
As explained herein, more than two electrodes can be used for measuring impedance. Impedance can be measured between any pair of electrodes and such an impedance measurement represents a vector. For example, in a three-electrode system (first, second, and third electrodes), there are three possible impedance vectors including the impedance between the first and second electrodes, the impedance between the first and third electrodes, and the impedance between the second and third electrodes. The number of vectors increases disproportionately with increasing numbers of electrodes. The physical location of the various electrodes may be useful to detect bleeding in different locations. For example, bleeding may occur between the first and second electrodes, but the fluid (e.g., blood) may not be present between the second and third electrodes. Thus, in this example, the impedance vector associated with the first and second electrodes may be indicative of the bleed, but not so the impedance vector associated with the second and third electrodes or possibly the first and third electrodes. Moreover, more than two electrodes provides an enhanced ability to detect bleeding in different locations than might be possible in a two-electrode only system.
In some embodiments, the computed impedance may be resistance while in other embodiments, the computed impedance is complex having both amplitude and phase components. In other embodiments the computed variable is conduction velocity. Further, the impedance measuring apparatus 150 (or impedance measuring apparatus 35 in
The calibration software 162 may implement the calibration segment of the IBC algorithm discussed above in conjunction with logic 38. The calibration software 162 may use the impedance values calculated by the processor 152 to establish the baseline impedance values, the baseline impedance distribution and standard deviation along with the fit line. The distribution and standard deviation may be used to determine a impedance threshold for detecting an IBC event. The establishment and calculation of all the calibration values may be performed using several of the first measurements before a bleeding, if one had occurred, may be severe enough to be detectable.
The application 159 may contain the monitoring segment of the IBC algorithm discussed above in relation to the logic 38 of
The calibration mode begins at 202. A pair of electrodes is selected at 204 and at 206 and 208, an impedance measurement is taken and the computed impedance is recorded (e.g., stored in storage 158) (as amplitude and/or phase values). Preferably, the impedance measurement for a selected pair of electrodes is taken over the course of several breaths by the patient. The impedance computed for the selected impedance vector will vary during a respiratory cycle. By taking the impedance measurement over the course of several breaths (e.g., 10 seconds), the impedance measuring apparatus can account for the normal variations in impedance. The threshold (amplitude or phase) may be computed as an average during the recording period or may be set as the peak value detected (or a value slightly higher (e.g., 5% higher) than the peak). At 210, the impedance measuring apparatus determines whether there is an additional impedance vector for which a threshold is to be determined. If there is, control loops back to step 204 at which such an electrode pair is selected. If not more electrode pairs are to be selected, than the calibration mode stops at 212. This calibration process may take several minutes. The same calibration variables may be measured for conduction velocities.
Once the calibration process is completed, the medical procedure (which might result in bleeding or clot formation) can begin. Any bleeding will be detected a change in impedance above deviating from an impedance threshold (e.g., an increase above the threshold or decrease below the threshold).
The impedance measuring techniques described herein to detect bleeding are also usable to detect a hemothorax. In this application, electrode locations would include the anterior chest and posterior chest walls, the esophagus at the level near the heart, the trachea, as well as numerous intravascular and intra-cardiac and intra-coronary locations. The electrodes may be on catheters or wires.
With regards to conduction velocity, the logic (e.g., that contained in the measuring devices described herein) assesses the conduction time between the onset of the electrical impulse in the first (transmitting) electrode and second (receiving) electrode. These electrodes are identical to the electrodes described in embodiments of this invention. The electrical output is in the same range with regards to frequency and amplitude. The measured variable, however, is the difference (delta) in time (usually milliseconds) between onset of stimulus (electrical output) in the transmitting electrode and sensing of that impulse (electrical sensing) in the receiving electrode. Conduction velocity is heterogeneous with variations in tissue characteristic. As fluid develops, the conduction velocity between the transmitting and receiving electrode will also change. This will be noted as a deviation from a baseline values (similar to the impedance values/thresholds described herein). An alert will then be issued. The various embodiments of apparatus and methods described above can also be used to measure conduction velocity and use conduction velocity to determine thickening of the heart and the presence of fluid bleeding.
In accordance with some embodiments, the sheath 12 includes a wireless transceiver that is able to wireless transmit impedance values or impedance-related values to an external apparatus rather than via a wired connection as shown in
As will be explained below, the impedance assessment unit 248 connects to the electrodes via conductors 17 and is used during an impedance measurement. The impedance assessment unit may include a power source. In one embodiment, the impedance assessment unit sets a predetermined current or voltage for one pair of electrodes and measures the resulting voltage or current from another electrode pair. The impedance assessment unit may also include a wireless transmitter to transmit the measured voltage/current to the external apparatus which in turn computes impedance based on the received, measured voltage/current and a prior knowledge of the predetermined current/voltage set by the impedance assessment unit 248 using the algorithm discussed in association with logic 38 of
The power source 249 may comprise a battery (disposable or rechargeable), a charged capacitor, a wireless power receiver, or other sources of electrical power. The power source 249 provides electrical power to the controller 250, wireless transceiver 252, storage 254 and source unit 256.
The controller 250 executes software 260 provided on storage 254. The controller 250, upon executing software 260, provides the impedance assessment unit 248 with some or all of the functionality described herein. The storage 254 may comprise volatile storage (e.g., random access memory), non-volatile storage (e.g., flash storage, read only memory, etc.), or combinations of both volatile and non-volatile storage. Data 262 consumed or produced by the software can also be stored on storage 254. For example, measured current or voltage values, computed impedance values, etc. can be stored on storage 254 pending wireless transmission through the wireless transceiver 252 to an external apparatus.
The wireless transceiver may be implemented in accordance with any suitable wireless protocol such as BLUETOOTH, WiFi, etc. The transceiver may be capable of transmitting only, or may be capable of transmitting and receiving. The controller 250 causes the wireless transceiver to transmit values indicative of impedance (current, voltage) or impedance values themselves. The transceiver 252 may be a bi-directional device to permit outgoing transmissions of data, as well as receive incoming commands from an external apparatus. For example, an external apparatus may send a command to the controller 250 via the wireless transceiver 252 to command the impedance assessment unit 248 to initiate a process by which impedance is determined, or to transmit previously stored data (e.g., current, voltage, and/or impedance).
The source unit 256 receives power from the power source 249 and generates a current or voltage under control by the controller 250. The source unit 256 may generate a predetermined current or voltage, and is broadly referred to as a source unit to indicate either or both possibilities. The source unit 256 is connected to a pair of electrodes (electrodes 20a and 20d in the example of
The measurement unit 258 measures the resulting voltage or current. That is, if the source unit 256 injects a predetermined current into the patient, the measurement unit 258 measures the resulting voltage. If the source unit 256 imposes a predetermined voltage across electrodes 20a,d, the measurement unit 258 measures the resulting current. In either case, the measurement unit 258 provides the measured electrical parameter to the controller 250.
The controller 250 thus knows the magnitude of the predetermined current or voltage generated by the source unit 256 and the magnitude of the measured voltage or current from the measurement unit 258. As such, the controller 250 can compute impedance, and do so as the ratio of voltage to current and transmit the computed impedance to the external apparatus. However, as noted above, the controller 250 may not compute impedance and instead transmit the measured electrical parameter (voltage or current) to the external apparatus for the external apparatus to compute impedance. The external apparatus may or may not know what predetermined current or voltage was set by the source unit 256. If the external apparatus does know the magnitude of the source unit's current/voltage, that value need not be (but of course can be) transmitted to the external apparatus. If the external apparatus is not aware of the source unit's current/voltage magnitude, the controller 250 preferably transmits both the measured voltage/current from the measurement unit 258 and the source unit's predetermined current/voltage.
The external apparatus 235 may also comprise a means of receiving inputs from a user (not shown) so the user may configure the impedance assessment unit 248 to perform monitoring events at predetermined times or, alternatively, to set a desired time frame, i.e., every 5 seconds, for the IBC algorithm to perform monitoring analysis. For example, the input may be a knob used to select one of several periods (e.g., 1 second, 5 seconds, 10 seconds, 1 minute, etc.) or the input device may be a computer drop down menu with the same time frames. Alternatively, the external apparatus 235 may contain a manual trigger so that the analysis is performed whenever the trigger is activated. Further, the input may allow a user to enter a specific time for performing the analysis, e.g., every 10 minutes.
Regardless of whether the impedance assessment unit 248 computes impedance or transmits the necessary data for the external apparatus to compute the impedance, the computed impedance may be resistance based on DC current/voltage. In other embodiments, AC current/voltage is used and complex impedance is computed as a magnitude and a phase. AC currents/voltages have an associated frequency and impedance measurements can be made at any one or more of multiple different frequencies. All references to an impedance measurement being made encompass any of the variations described herein as performed by the combination of the impedance assessment unit and an external apparatus.
Impedance measurements made at certain frequencies may provide more useful information than at other frequencies. At certain frequencies, it may be difficult to detect a bleed, where as other frequencies, bleed detection is easier. Further, the particular frequenc(ies) useful to detect a bleed may vary from patient to patient. Accordingly, a calibration is performed at the beginning of a procedure using a sheath as described above. The calibration may include the calibration segment of the IBC algorithm discussed above in relation to the logic 38 of FIG. 6. The calibration may entail performing multiple impedance measurements at various frequencies. In some implementations, the range of acceptable frequencies is from 1000 Hz to 500 KHz, although a different frequency range may be acceptable as well. Within the frequency range multiple discrete frequencies are chosen to make the impedance measurement. For example, 10 KHz may be chosen as well as 1000 Hz, and 100 KHz.
The source unit 256 may be capable of injecting an AC current (or generating an AC voltage) at various frequencies as commanded by the controller 250. The controller 250 preferably is configured (e.g., by way of software 260) to initiate multiple impedance measurements at various frequencies during the calibration process. Each measured electrical parameter (e.g., voltage) may be stored in data 262 in storage 254 and mapped to the frequency of the source signal (e.g., current) that caused the measured voltage to occur. Thus, multiple AC voltages (or current) may be stored in storage 254, one voltage (or current) corresponding to each AC current (or voltage) frequency. The measured parameters may be kept in storage 254 and/or wirelessly transmitted to the external apparatus 235.
The calibration process may be initiated in any suitable manner. For example, a wireless command to initiate the calibration process may be transmitted from the external apparatus 235 to the impedance assessment unit 248. Alternatively, impedance assessment unit 248 may have a user input control (e.g., a button, switch, etc.) that a user can activate to initiate the calibration process. Further still and in the case in which the power source is a battery, an electrically insulative strip may prevent at least one of the battery's contacts from connecting the to the rest of the impedance assessment unit 248 circuitry. Removal of the strip may cause the controller 250 to initialize and start the calibration process.
Then, at predetermined time periods (e.g., once per minute) after calibration, the controller 250 initiates additional impedance measurements to be made. The controller 250 may implement the monitoring segment of the IBC algorithm discussed above and that may be located in the software 260 of the storage 254 if the external apparatus 235 does not implement the IBC algorithm. At the expiration of each such time period, the controller 250 may also cause multiple impedance measurements to be initiated at the same frequencies used during the calibration process. After computing the impedance values at the various frequencies (whether the impedance assessment unit or the external apparatus makes the computation as explained above), a comparison is made between each such impedance value and a previously computed threshold based on the impedance distribution of the baseline calibration values. A determination is made as to whether the difference, as an absolute value, between the impedance value and the previously computed impedance value (e.g., calibration impedance value) is greater than a predetermined threshold, e.g., greater than three times the baseline standard deviation. An impedance difference greater than the threshold is an indicator of a bleed. Another way to make the comparison is compute a ratio of the current impedance value to the previously computed impedance value and then compare the ratio to a predetermined range. A ratio being outside the range is an indicator of a bleed. Bleeds may be easier to detect at certain frequencies rather than others for certain patients and thus the probability is higher that an actual bleed will be detected if multiple frequencies are used.
The process of taking impedance measurements and comparing to a previous impedance value (e.g., calibration impedance values) is repeated at the expiration of each subsequent time period. Additionally or alternatively, the impedance assessment unit 248 may be triggered manually to initiate an impedance measurement. The user can activate the user control noted above, if such a user control is provided, or the external apparatus 235 may wirelessly transmit a command to cause the controller 250 to initiate a new impedance measurement.
Referring again to
At 400, the method includes determining a bioimpedance value at each of a plurality of frequencies during the calibration phase. The frequencies may include any frequencies and any number of frequencies. In one example, the frequencies used to make the bioimpedance measurements include 5 KHz, 10 KHz, 50 KHz, 100 KHz, and 500 KHz. For purposes of illustration, five bioimpedance measurements are assumed and are designated as Z1, Z2, Z3, Z4, and Z5. The bioimpedance measurements Z1-Z5 taken during calibration are referred to herein as calibration bioimpedance values. The bioimpedance values measured during calibration may be normalized to themselves, that is, Z1/Z1, Z2/Z2, and so on. The normalized calibration bioimpedance values are referred to as “calibration ratios.”
After calibration and periodically during the catheterization process, the method includes again making the bioimpedance measurements at the same frequencies. For purpose of illustration, the five such impedance values measured after calibration are referred to as ZA, ZB, ZC, ZD, and ZE. At 402, the method includes normalizing each bioimpedance value ZA-ZB at each frequency to a calibration bioimpedance value at that same frequency to produce a set of normalized bioimpedance values at the plurality of frequencies. In one example, the calibration bioimpedance value used to normalize each of the bioimpedance values ZA-ZE is the calibration bioimpedance values Z1-Z5 measured during calibration. More specifically, each bioimpedance value ZA-ZE is divided by itself (ZA/Z1, ZB/Z2, ZC/Z3, ZD/Z4, and ZE/Z5). If no bleed complication condition exists, then these ratios ought to be approximately 1. If a bleed condition exists following calibration, one or more of the ratios will diverge from 1.
The method includes determining whether the newly computed bioimpedance values over the various frequencies are significantly the same or different from the calibration bioimpedance values. The newly computed bioimpedance values being significantly different from the calibration bioimpedance values may indicate the occurrence of a bleed complication condition. The newly computed bioimpedance values not being significantly different from the calibration bioimpedance values may indicate that a bleed complication condition has not occurred.
At 404, the method includes computing a bleed indication value based on the set of normalized bioimpedance values. In one example, computing the bleed indication value includes computing, at each frequency, the absolute value of a difference between a calibration ratio (normalized calibration bioimpedance value) at that frequency and the subsequent normalized bioimpedance value at the same frequency. For example, the equation below illustrates this calculation for one frequency:
|Z1/Z1−ZA/Z1|
The bleed indication value further may be computed based on the sum of the absolute value computed above and the calibration ratio (normalized calibration bioimpedance value), and then averaging these values across all frequencies. The equation below illustrates an example of the aforementioned computation for one such frequency and is referred to as a bioimpedance rend value:
Z1/Z1+|Z1/Z1−ZA/Z1|
This calculation is performed as well for all frequencies and then the results are averaged to compute the bleed indication value.
The method may further include performing a statistical test on the set of normalized bioimpedance values acquired during calibration compared to the normalized bioimpedance values acquired subsequently. One example of such a test is the T-Test which produces a p-value (i.e., a confidence value). Inputs to the T-Test algorithm may include the average of the normalized calibration bioimpedance values, the average of the subsequently acquired normalized bioimpedance values (after calibration), and the number of elements being averaged (5 in the example above). A p-value less than 0.05 indicates that a difference in the averages is statistically significant, and a p-value greater than 0.05 indicates a lack of statistical significance of a difference in the averages.
The method includes (at 406) generating an alarm indicative of a bleed complication based on a comparison of the bleed indication value to a threshold. In one example, the threshold may be 1.4 and thus the average for the non-calibration normalized bioimpedance values being greater than 1.4 may indicate the occurrence of a bleed complication condition. This operation may also include the use of the p-value. For example, a bleed complication condition may be determined if both of the following conditions are true:
Further still, the apparatus may generate an alarm based on the above two conditions being true for at least two consecutive sets of bioimpedance values measured during the catheterization procedure.
While the embodiments of the invention have been shown and described, modifications thereof can be made by one skilled in the art without departing from the spirit and teachings of the invention. The embodiments described and the examples provided herein are exemplary only, and are not intended to be limiting. Many variations and modifications of the invention disclosed herein are possible and are within the scope of the invention. Accordingly, the scope of protection is not limited by the description set out above, but is only limited by the claims which follow, that scope including all equivalents of the subject matter of the claims.
A bleed detection apparatus such as that shown herein may be used to perform the method of
The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.
This application claims priority to and incorporates by reference U.S. Provisional Appln. No. 61/842,763 filed Jul. 3, 2013 and titled “Introducer-Based Bleed Detection Technique.”
| Number | Date | Country | |
|---|---|---|---|
| 61842763 | Jul 2013 | US |
