Device agnostic imaging based cardiovascular haptic system

Abstract

Methods and apparatuses for agnostic haptic feedback computing systems are provided. The system includes a cardiac device, incorporated with a plurality of dissimilar sensors configured to sense one or more input signals based on clinical characteristics of a patient and generate one or more output signals. A processor and haptic graphical user interface is configured to receive and process the one or more output signals and performs haptic transduction based on the one or more output signals. The haptic transduction generates one or more haptic feedback signals and provides sensations to a wearable haptic system and in a preferred embodiment utilizes imaging data alone, in lieu of conventional catheter based sensors, as input to the haptic system.

Description

Attorney Docket: 95983-432709DEVICE AGNOSTIC IMAGING BASED CARDIOVASCULAR HAPTIC SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Application No. 63 / 833.388, filed November 22, 2024, which is expressly incorporated by reference herein.BACKGROUND

[0002] The embodiments described herein relate generally to a tactile I force (haptic) feedback system that is capable of acquiring static, quasistatic, and dynamic physiological I biophysical data from varying sensors and generating real time simulations of signals produced by moving bodily tissues. More particularly, embodiments of the haptic system can be used to provide real time information during a multitude of minimally invasive procedures that employ an inserted instrument such as a cardiac catheter, endoscope, or orthopedic hardware in which the haptic system is device agnostic and is capable of acquiring and storing data from different instructions during actual procedures and played back for data review, education, or for programming simulators.

[0003] Visual and auditory attentional resources quickly saturate during repetitive tasks including prolonged medical procedures including challenging cardiovascular interventions, such as ablation of complex cardiac arrhythmia (ventricular tachycardia, ectopic atrial tachycardia, atrial fibrillation) and catheter-based valve repair. The same holds true for sense of touch; attentional resources fatigue when repetitive afferent signals lead to saturation of post-synaptic receptors in both the peripheral and central nervous systems. Medical catheters, instruments, and sheaths are generally tubular shaped and of a sufficiently small diameter to be inserted into a patient's body through a small incision, puncture or a natural opening. Such catheters can be used to deploy inner catheters, cardiac leads, and electrodes, deliver contrast (e.g., radiopaque dye) or ablative energy and perform diagnostic or therapeutic procedures. Examples include a cardiovascular interventional system for ablation of tissue / cardiac arrhythmia, valve repair I replacement, pacemaker lead extraction, colonoscopy, laparoscopic, orthopedic or thoracoscopic procedures. Unfortunately, as conventionally designed catheters and tools course through a patient's tissues the operator loses his or her ability to appreciate the forces restricting motion secondary to attenuation and frictional effects due to the intervening tissue and compliant natureAttorney Docket: 95983-432709 of the inserted catheters. There remains an unmet need for a haptic system that can input, process, and output tactile and force feedback to an operator from dissimilar sensors that can be used during the time course of a single procedure.

[0004] For example, ablation of cardiac tissue for treatment of arrhythmias such as atrial fibrillation requires different procedures for the same intervention all of which can be performed with equipment supplied by multiple vendors; transeptal puncture to access the left atrium, catheters for ablation of cardiac arrhythmia, deployment of prosthetic valves or left atrial appendage occlusion devices. These interventions require the appropriate degree of tissue: catheter contact to ensure procedural success without risk of damaging or perforating neighboring tissues or perforation of the heart.

[0005] While current state of the art technology can display localization data (e.g., fluoroscopy, electroanatomic mapping), values of force and pressure, changes in tissue impedance and measured tissue voltage (electrogram amplitude I signal), there is an unmet need for sense of touch. In order for haptic feedback to be present during specific phases of the same procedure sensed signals will need to communicate static, quasistatic, and time varying events. This can include time of transeptal puncture (a static single impulse biophysical signal), time varying changes in atrial pressure, tissue: catheter contact force during ablation (e.g., quasistatic measurements of tissue impedance (Boston Scientific)); differentials in measured voltage I electric current; contact force sensing from one or more fiberoptic sensors (Tacticath), contact force sensing from strain gauges or other mechanical sensors of force (Biosense Webster); tissue temperature; reflected light (Luxcath).

[0006] Unfortunately, no currently available technology is capable of haptic feedback with a unified, device agnostic system capable of functioning seamlessly with dissimilar technologies and of significant importance able to prevent saturation of peripheral and central nervous system attentional resources of a clinician or user. In one embodiment described herein, inexpensive, down-sized actuators are geometrically arranged and strategically activated to simulate amplitude and frequency characteristics of sensed physiological signals.Attorney Docket: 95983-432709SUMMARY

[0007] The present disclosure includes one or more of the features recited in the appended claims and / or the following features which, alone or in any combination, may comprise patentable subject matter.

[0008] In various embodiments, the haptic system prevents central and peripheral neurological desensitization while providing users with mechanical, physiological, physical, and anatomical information in a haptic format complementing visual and / or audio displays. In embodiments, the haptic system can be used to provide real time information during a multitude of minimally invasive procedures that employ an inserted instrument such as a cardiac catheter, endoscope, or orthopedic hardware. In embodiments, the haptic system is capable of storing the acquired data as well as the haptic output for future playback in order to teach clinicians in training. Signals acquired can be from varying vendors (device agnostic) and stored during actual procedures and played back for data review, education, or for programming simulators.

[0009] In one embodiment, the haptic system can be used for entertainment purposes. By way of example, laypersons can playback specific cases (of themselves, family members, or fabricated) as to better understand medical procedures and the challenges these procedures pose.

[0010] In various embodiments, the haptic system can recognize dissimilar signal formats near instantaneously, perform A / D conversion and digital signal processing, identify which signals are most accurate and specific for the data set of interest, and generate haptic output with minimal latency. Tactile and force feedback systems incorporated into the design of medical instruments and catheters can reduce complication rates, expedite procedures, and optimize results. Various embodiments are constructed to input differing signals sensed by varying types of mechanical and / or physiologic sensors and process diverse signals with a unified computing system capable of recognizing static, quasistatic, and dynamic data (e.g., time varying waveforms of pressure or force, quasistatic electrical indices of measured impedance, differentials in tissue voltage or current, time varying measurements of temperature, static indices of tissue damage), correcting for inaccuracies due to alterations in signal quality or changes in the sensing environment (e.g., from changes in temperature due to infusion of saline from an ablation catheter) and performing minimal latency transduction of such data as output in a haptic format to a user.

[0011] In various embodiments, the haptic output is processed and designed to activate varying peripheral and central neuroanatomical sites in order to prevent fatigue of tactile and forceAttorney Docket: 95983-432709 sensing attentional resources. These sites including kinesthetic, proprioceptive, temperature, tactile, and pressure receptors in the fingers, hand, and wrist. The haptic feedback is generated by combinations of haptic actuators including but not limited to deformable piezoactuators, linear or rotary motors, smart materials, haptic speakers, voice coils, linear resonant actuator, disc piezoactuator, leveraged piezoactuator, electroactive polymer, stacked and non- stacked piezoceramic actuators, microscale and small scale hydraulic actuators and the like.

[0012] In some embodiments, the haptic system monitors an operator’s handling of inserted instrumentation (e.g., via a haptic sensory glove or other wearable) and calculates haptic to motor response times for quality assurance, educational purposes, and to detect potentially deleterious actions as to alert an operator to modify his or her procedural approach or autonomously terminate the actual procedure. In some embodiments, the haptic sensory wearable / glove is reciprocating and can both sense an operator’s actions, provide haptic feedback and acquire data for future analysis, interpretation, educations, quality assurance as well as for optimization of future iteration haptic systems as described in more detail below.

[0013] Various embodiments are focused on cardiovascular applications, but case examples and descriptions of such embodiments may be exemplary and not limited in scope or spirit to any specific intervention.

[0014] Additional features, which alone or in combination with any other feature(s), such as those listed above and those listed in the claims, may comprise patentable subject matter and will become apparent to those skilled in the art upon consideration of the following detailed description of various embodiments exemplifying the best mode of carrying out the embodiments as presently perceived.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The detailed description particularly refers to the accompanying figures in which:

[0016] Figures 1A-E depict examples of acquired input signals (static, quasistatic, dynamic) to the haptic system:

[0017] Figure 1A illustrates a static signal indicative of tissue necrosis.

[0018] Figure IB illustrates a quasistatic signal indicative of tissue impedance demonstrating tissue damage (steam pop) during ablation.Attorney Docket: 95983-432709

[0019] Figure 1 C illustrates a quasistatic signal of contact sensing magnitude derived from differentials in current, impedance, or voltage between one or more electrodes.

[0020] Figure ID illustrates a quasistatic signal indicative of tissue temperature.

[0021] Figure IE illustrates a quasistatic and dynamic signal of tissue impedance demonstrating pulsatile impedance along the mitral annulus and tissue damage (steam pop) during ablation of the posterior wall (P). respectively.

[0022] Figures 2A-C illustrate examples of dynamic signals:

[0023] Figure 2A illustrates a dynamic signal representative of time varying intracardiac pressure (P).

[0024] Figure 2B illustrates a dynamic signal representative of time varying tissue; catheter contact force (CF).

[0025] Figure 2C illustrates a dynamic signal representative of time varying cardiac tissue motion or blood flow (Q) with sensed signals from a left atrial appendage during atrial fibrillation juxtaposed to left upper pulmonary vein.

[0026] Figures 3A-C illustrate an input of time varying signals (FIG. 3A) (epicardial pressure) into a device agnostic computing system (FIG. 3B) and an output of haptic signals to haptic interface (FIG. 3C).

[0027] Figures 4A-C illustrate a device agnostic multimodal haptic interface for demonstrating deformable haptic surface(s) / shell(s) for communication of tissue deformation and biophysical signals.

[0028] Figure 5 illustrates a haptic system for pulsed field ablation system for atrial fibrillation and sensing of tissue necrosis.

[0029] Figure 6 illustrates varying haptic waveforms I transients used to prevent deficits in haptic attentional resources.

[0030] Figure 7 illustrates a voltage variable input data.

[0031] Figures 8A-D illustrate variable haptic signal generation.

[0032] Figures 9A-B are conceptual simplified block diagrams of a reciprocating haptic sensory wearable(s) incorporated sensors that detect actions of the operator and the temporal and / or spatial relationship to biophysical / physiologic events.

[0033] Figure 10 depicts gating of static and quasistatic signals proportionate to cardiac cycle in a patient with atrial fibrillation.Attorney Docket: 95983-432709

[0034] Figure 11 demonstrates gating of sensed signals to generate haptic effect based on a cardiac cycle using step function with discrete, rather than gradual, increases in haptic effect (e.g., haptic force) based on magnitude of sensed signal (e.g., degree of contact sensing, CS) and no haptic effect below a specific threshold (e.g. contact sensing signal value = 3).

[0035] Figure 12 depicts Figure 11 with programmable haptic gain that can be adjusted after the case begins.

[0036] Figure 13 depicts that during ablation (RFA), temperature data implementation has a curvi linear relationship between temperature and degree of haptic effect.

[0037] Figure 14 depicts Figure 13 with haptic effect during RFA application based on electrogram I voltage properties.

[0038] Figure 15 demonstrates multi-modal haptic effects related to temperature, EGM, contact sensing and relationship of these signals to haptic effect magnitude.

[0039] Figure 16 depicts Figure 15 with layered haptic effect.

[0040] Figure 17 illustrates a haptic speaker (Sp) that generates a haptic force effect encased in a cylindrical tube.

[0041] Figure 18 illustrates a wearable deformable haptic actuator (DHA) with integrated haptic feedback system.

[0042] Figures 19A-B illustrate the haptic force effect of a haptic speaker can be delivered at the same cycle length / frequency of the cardiac cycle or a multiple proportionate to the cardiac cycle.

[0043] Figures 20A-G depict various exemplary geometric arrangements of small dimension haptic actuators that provide a surrogate amplitude scale proportionate to sensed physiological / biophysical signals.

[0044] Figure 21 illustrates a graphical user haptic interface (GUHI) I programmer where input static (Si), quasistatic (Qi), and dynamic (Di) signals are processed and output as static (So), quasistatic (Qo), and dynamic (Do) signals to the wearable haptic construct and also transduced at the level of the GUHI to provide the user with haptic, visual, and acoustic feedback.

[0045] Figure 22 is a flowchart depicting methods for acquiring imaging data (e.g., fluoroscopy, electroanatomic mapping, ultrasound), physiologic signals from catheters (e.g., blood pressure, blood flow, tissue contact, CF) and biophysical signals (e.g., catheter crossing tissue planes including transeptal puncture, index of tissue necrosis, temperature) and implementingAttorney Docket: 95983-432709 convoluted neural networks to analyze the data and cross reference various conventional modalities (ground truth comparators) with non-sensor based imaging modalities (e.g., fluoroscopy, intracardiac echo) to teach the haptic operating system to utilize imaging data to generate haptic effects in lieu of signals normally acquired by intra-cardiac, catheter based sensors.

[0046] While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the examples to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the examples.DETAILED DESCRIPTION

[0047] While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

[0048] It is important for sensed physiological and biophysical information to be accurately represented and processed in a timely fashion as to minimize latency between time of signal origin and haptic presentation. A multitude of sensed signals can be analyzed and cross correlated to confirm acquisition and proper interpretation of biophysical, physical, anatomical, physiologic data sets in real time. Those experienced in the art understand that variations in impedance, localized cardiac electrogram properties (amplitude, morphology, etc.), and assessments of tissue temperature may be erroneous.

[0049] In various embodiments, the haptic system thus utilizes algorithms to detect and correct inaccurate data sets prior to transduction of tactile and / or force information to an operator. By way of example, whether it be analyses of voltage or current magnitude, frequency, phase, signals in the time or frequency domain, direct or calculated impedance; impedance slope, phase, magnitude; admittance, phase differences in measured voltage and current, the haptic system is capable of inputting data, processing, deriving and conveying such data in both a visual and hapticAttorney Docket: 95983-432709 format. Such data can include salient information about the magnitude of applied catheter force, the amplitude of energy being delivered, tissue temperature, and markers of acute or chronic tissue injury. Such algorithms can, for example, utilize reference electrodes and compare real time acquired data to those sensed by contact electrodes to confirm accuracy. Predictor algorithms can analyze the acquired signals and compare them to historical controls I data sets. If erroneous data is identified by any means (e.g., a catheter has stable contact with tissue but saline irrigation used to cool tissue during ablation modifies impedance data) the system can pause haptic feedback or make modifications and corrections to the haptic feedback utilizing the appropriate signal for haptic processing and transduction.

[0050] By way of example, electroanatomic information about catheter electrode location relative to tissue of interest (i.e., in three dimensions) can demonstrate no change in location and comparable motion patterns of the catheter relative to contractile cardiac tissue and serve to confirm that tissue contact has not changed. Likewise, the magnitude, slope, phase, and other properties of intracardiac electrogram signals, impedance, etc. remain stable and confirm stable tissue contact force and thus prevent a change in the quantity or quality of haptic feedback that would occur should the system depend on only one erroneous variable that may otherwise indicate, for example, instability of contact sensing electrodes. Thus, there is need to confirm catheter stability during all aspects of the procedure and is not compromised and affected by the cardiorespiratory cycle, operator or patient movement. In various embodiments, one or more signals can be analyzed to cross-correlate and confirm the accuracy of sensed signals that are to be processed for transduction of haptic feedback. Any correction to how the acquired signals is analyzed prior to haptic transduction are completed with minimal latency and, if possible, adjustments made continuously rather than at discrete time frames (e.g., every 50 milliseconds).

[0051] In various embodiments, temperature based techniques can be used in place of or in addition to non-temperature-based methods (e.g., nature and intensity of voltage signals, differential voltage properties / amplitudes between differing electrode combinations) for determining physical and physiologic properties such as tissue necrosis and tissue catheter contact (force). For example, analysis of thermocouple trends from different catheter locations can provide information representative of tissue contact, thermal injury and the like at different time frames of a given procedure (e.g., during catheter manipulation vs during delivery of ablation energy, when a catheter is located in one specific position / orientation). A precipitous drop in measured tissueAttorney Docket: 95983-432709 temperature can occur as a result of loss of tissue contact rather than tissue cooling naturally or from delivery of cryoablation energy. Change in temperature over time (dT / dt), can be used to differentiate between different physical conditions. If multiple indices are analyzed to determine the accuracy of any acquired data, certain indices can be weighted higher as being more specific and sensitive than others.

[0052] In various embodiments, a default correction system is programmed, or an operator can modify the algorithms (e.g., how different signals are weighted) based on personal preferences or expected physiologic / anatomic conditions (e.g., patient with prior ablation may have more regions of tissue necrosis that affect baseline impedance and an alternate sensing index may be selected). If the operator is using an ablation catheter that has high resolution electrograms from tip electrodes separated by material with high thermal diffusivity or other particular properties, he or she can rely more heavily on the impedance or electrogram data acquired to determine, for example, when an ablation is completed rather than tissue temperature.

[0053] In various embodiments, the delivery of a haptic signal specific for communicating that the target degree of tissue necrosis has occurred is based on sensing of the most reliable signal(s). The system has a correction algorithm that quantifies a variety of relevant signals in real time including catheter tissue contact force, tissue temperature or analysis of tissue necrosis and cross correlates data as to confirm accurate representation of biophysical and physiologic information (e.g., based on the nature or relative amplitude of measured electrogram signals in different locations about an inserted catheter). The correction algorithm can analyze differing signals as described above as well as features of the same signal (e.g., voltage waveform) for confirmation that acquired data is accurate before transduction of sense signals as haptic feedback. As a simple example, impedance trends may not be accurate during application of radiofrequency energy for determination of tissue contact and one or more of contact force sensing, tissue temperature trends, and / or electrogram voltage characteristics are input for data processing and delivery of haptic feedback rather than impedance data.

[0054] In various embodiments, differing characteristics of a single variable can also be analyzed as to determine accuracy of the variable as input for processing and delivery of haptic feedback. Electrogram voltage amplitude (i.e. voltage peak) 702, pulse width (PW) 704, as well as frequency characteristics can be analyzed and processed in processor 708 as depicted in Figure 7. By way of example, the same voltage waveform is analyzed, and the pulse width of the signalAttorney Docket: 95983-432709 is used to derive part or whole of the contact voltage sensing index / signal (CVS) at 712 rather than peak voltage amplitude as a single variable. A combination of pulse width 704 and amplitude 702 can be used, and in one embodiment, the integral of the voltage waveform 706 between two or more electrodes (example) over one or more discrete time frames is the input variable. High amplitude voltage (e.g., 3 mV) with a brief pulse width (e.g., 0.5 mV) suggests inadequate tissue contact, while both high amplitude voltage (2 mV) and longer pulse width (e.g.. 0.5 mV) is an indicator of adequate tissue contact and specificity can be greater than measurements of tissue impedance, temperature or other variables. Frequency spectra or other features of the voltage signal (e.g., electrogram morphology) can be analyzed as well.

[0055] In various embodiments, the same signal can also be used to determine tissue contact as well as degree of tissue necrosis. By way of example, after delivery of ablation energy, relative voltage amplitude between two or more electrogram signals can be analyzed to determine if adequate tissue necrosis has occurred. This relative voltage amplitude can be used as a single variable or in another embodiment weighted amongst multiple variables such as tissue impedance, temperature trends / characteristics at one or more locations, reflected light characteristics and the like. The system can evaluate relative changes in one or more variables from reference values rather than absolute values in order to determine if tissue is viable, diseased (e.g., infarcted or partially ablated), or necrotic tissue. In another embodiment, both the degree of tissue contact and determination of adequate tissue necrosis are transduced as different haptic signals that can be readily differentiated by the operator (e.g., tactile and force feedback, respectively). By way of example, a tactile signal is palpable and proportionate to the degree of tissue contact and a force signal is proportionate to the degree of tissue necrosis.

[0056] In various embodiments, this layered haptic display will prevent saturation of haptic attentional resources. The haptic display in one embodiment is a non-rigid haptic interface such as a piezoactuator having a thickness of less than 5 mm and surface area under 2 cm that can conform and wrap about a catheter handle or be worn on the hand, wrist, finger(s) or other body part of the operator. The haptic interface can be composed of material that incorporates one or more haptic actuators that can be re-utilized including but not limited to piezoactuators and is in no way limited to one type of haptic actuator or materials for fitting the haptic interface upon the user’ s body. The material used to contain the haptic actuators can be disposable and haptic actuators can be sterilized, hermetically sealed, and used multiple times. The haptic display is non-slip andAttorney Docket: 95983-432709 composed of material or fabric that limits heat build-up, sweat, and material creep and in some embodiments contains elastic and / or cellophane type stripping in one or more locations as found in certain surgical masks and respirators and other wearables as to ensure a stable fit and seal from external liquids, blood, bodily secretions of the user and patient. The material can provide haptic effects and / or be solely for support / fitting purposes and not an active component. As depicted in Figure 18 it can extend distally to the fingers with multiple finger holes and above the elbow composed of one or more finger I thumb holes as to be worn about the proximal aspect of one or more fingers / thumb and not encumber the user’s dexterity or control over medical instrumentation and provide a comfortable fit with the digits having some or no material about their surfaces. EFA 1- 6 in this embodiment are not necessarily composed of haptic actuators but in one embodiment are used to stabilize the position of the haptic wearable and can be located in anatomic positions anywhere from the digits to most proximal aspects of a user’s extremity. EFA 6 in one embodiment is positioned just proximal to the elbow and the haptic wearable display has material properties to provide enough tension to secure the wearable along an extremity in a comfortable manner without affecting a user’ s dexterity. The haptic display is designed to prevent the material from creeping, moving, sliding and ensures a fixed position about the user’s skin surface. One or more haptic actuators that provide the same haptic effects can be located in different locations, juxtaposed or separated from the “same actuators” and the haptic system programmed to shift haptic effects from one “same actuator” to another as to reduce fatigue of attentional resources that use sense of touch that can occur from delivering palpable sensations to the same location repeatedly over prolonged time frames.

[0057] In some embodiments, in order for effective ablation of tissue to be accomplished catheter tip orientation should be optimal. In an alternate embodiment described herein, there is haptic representation of catheter tip orientation based on one or more variables (e.g., electroanatomic mapping data, relative temperature / impedance / voltage amplitude of proximal and distal electrode pairs). This haptic data can be presented as a distinct haptic signal that can be differentiated from other haptic signals. By way of example, circumferential deformation of a piezoactuator or other haptic signal is uniform when catheter tip orientation is optimal (perpendicular to the tissue plane) or has a proportionate gradient in degree of deformation (e.g., 0-90 degrees) when orientation is oblique so the operator can modify the position in real time based on sense of touch.Attorney Docket: 95983-432709

[0058] Referring to Figures 1 A-E, one or more sensed signals are acquired and input into the haptic computing system. Referring to Figure 1A, static signal tissue necrosis indicator level (TN) 102 can be derived by one or more sensed signals including tissue temperature, reflected light, reflected ultrasound, electrical impedance, voltage, current, changes in measurements from devices capable of electroporation of tissue (e.g., pulsed field ablation) over a period cycle 104 (such as pulsed filed ablation (PFA) time and / or during a procedure). Once a threshold value is reached, the system delivers a haptic signal that is proportionate to the degree of tissue necrosis. The haptic signal can be a single or series of tactile and / or force feedback indicators including but not limited to; actuator vibration that implements psychophysical haptic rendering techniques to simulate tissue temperature, deformation of a haptic actuator on the hand, finger or other anatomic site, generation of force feedback (e.g., linear actuator), tactile feedback. In some embodiments, the haptic system processes static signals and generates a haptic signal at a prespecified cycle length independent or dependent and proportionate to the cardiac or respiratory cycle or other time varying haptic output as described in more detail below and seen in Figure 10 (e.g., can implement amplitude or frequency modulation to convey certain features of the sensed signal such as the degree of decrease or increase in temperature, indicator of tissue injury).

[0059] Similarly, quasistatic signals (FIGS. IB - IE) are acquired and input into the haptic computing system that outputs one or more haptic signals to a user. By way of example, the haptic system can process the quasistatic signal and generate a haptic signal at a pre-specified cycle length independent or dependent and proportionate to the cardiac or respiratory cycle (Figure 10). This enables a signal that is not time varying to be processed and generate a time varying haptic signal that has both biophysical (e.g., impedance) and physiologic properties (e.g.. simulates cardiac cycle) and is generated by a single haptic actuator (e.g., linear or rotary motor that generates force feedback with periodicity). In order for force feedback to be rendered palpable as force or pressure, the haptic system operates in an optimal fashion with a cycle dependent haptic feedback mechanism that can be gated and proportionate to heart rate. In an alternate embodiment, the haptic actuator provides a non-cyclical feedback to the operator including deformation at a proportionate amount of displacement (e.g., piezoactuator).

[0060] Referring to Figure IB, quasistatic signal of tissue impedance (Z) 106, demonstrating tissue damage (seam pop) during ablation, can be acquired. In embodiments, referring to Figure 1C, quasistatic signal of contact sensing signal (SC) 108, derived fromAttorney Docket: 95983-432709 differentials in current, impedance or voltage between one or more electrodes, can be acquired. In embodiments, referring to Figure ID, quasistatic signal indicative of tissue temperature (temp) 110, can be acquired. Some sensed signals can be both quasistatic and dynamic as is demonstrated in Figure IE where a dynamic, time-varying signal of tissue impedance (Z) 112 is noted while the catheter is in contact with contractile tissue (e.g., mitral annulus, left ventricle, left atrial appendage) and then static when in contact with another anatomic sites (e.g., atrial tissue, pulmonary vein). In embodiments, Figure IE illustrates dynamic and quasistatic signals of tissue impedance demonstrating pulsatile impedance along the mitral annulus and tissue damage (steam pop) during ablation of the posterior wall (P), respectively.

[0061] In various embodiments, the haptic system can employ both a time varying force feedback to the operator and static haptic feedback such as displacement or utilize a time varying force feedback that is gated 1:1 or other ratio (e.g., 2:1, 3: 1) relative to the cardiac cycle (or other cycle lengths) as depicted in Figure 10. In this embodiment, the electrocardiogram (ECG) tracing is input into the haptic system and triggers the haptic force feedback coincident with each electrical depolarization (e.g., surface R wave, IEGM signal) which will be described in more detail below.

[0062] Referring to Figures 2A-C, in various embodiments three different physiologic signals are acquired during a complex intervention for ablation of the pulmonary veins and obliteration of the left atrial appendage (e.g., Watchman). These procedures are performed in order to protect a patient from cardioembolic stroke and requires multiple independent steps each of which enable acquisition of time varying signals from different anatomic sites; transeptal puncture, radiofrequency ablation about the pulmonary veins, deployment of Watchman device in the left atrial appendage. Transeptal puncture (required for gaining access to the left atrium) utilizes a catheter with end hole manometry that measures left atrial pressure (time varying). Referring to Figure 2 A, the left atrial pressure signal 200 is input into the computing system, which processes and outputs the haptic signal driving the actuator, which generates force feedback to the operator with a 1 : 1 ratio to the cardiac cycle. The dynamic signal of Figure 2A is representative of time varying intracardiac pressure (P) 202. Next, as illustrated in Figure 2B, ablation about the pulmonary veins is performed using radiofrequency energy and the computing system inputs contact force (i.e. catheter contact force (CF)) 206 as the time varying signal 204 and again processes and outputs the haptic signal driving the actuator generating force feedback to the operator with a 1:1 ratio to the cardiac cycle. Finally, the operator deploys the Watchman deviceAttorney Docket: 95983-432709 in the left atrial appendage (LAA) and blood flow sensors (e.g., Doppler flow wires) or tissue motion sensors detect that the device is opposed to the LAA confirming accurate placement; the haptic system inputs blood flow I tissue motion (Q) 210 as the time varying signal 208, as illustrated in Figure 2C, and again processes and outputs the haptic signal driving the actuator generating force feedback to the operator with a 1 : 1 ratio, but at a higher frequency as the sensed signal is over 200 cycles per second due to a fibrillating LAA. This signal has a time varying periodicity, variable amplitude signals and is palpably distinct from other time varying signals (T).

[0063] In various embodiments, the same computing system, illustrated in Figures 3A-C, can receive varying input signals 300, as illustrated in Figures 1A-E and other signals as described herein, process them accordingly 302 by a device agnostic computing system (FIG. 3B), for example, and output the haptic response 304 (FIG. 3C). In Figures 3A-C, epicardial pressure is the input signal during access to the epicardial space for ablation of ventricular tachycardia.

[0064] Referring to Figures 4A-C, FIGS. 4A-C depict a piezoactuator (400 in FIG. 4A) based haptic feedback system that provides deformation information to the operator. In embodiments, Figure 4A depicts a device agnostic multimodal haptic interface (e.g., piezoactuator for hand, finger, catheter handle, etc.) demonstrating deformable haptic surface(s) / shell(s) for communication of tissue deformation and biophysical signals (transeptal puncture = Pu) and pressure data (left atrial pressure = LAP). The piezoactuator based feedback system comprising a shell parameter 402, a shell internal border 404 and a catheter handle 406. This deformation can be implemented to convey static information to the operator. By way of example, the tactile feedback 420 is representative of the degree of tissue deformation and proportionate to the pressure head (P) 422 from a catheter opposed to the interatrial septum during transeptal puncture (FIG. 4B). In this example, the intracardiac pressure signal 430 acquired by a catheter with end hole manometry (FIG. 4C) can be used to provide tactile information to the operator as the catheter is manipulated within the left atrium and opposed to the septum with different amounts of applied force and degree of septal deformation (PZ(I)). This is distinct to the time varying pressure waveform acquired when the catheter is free floating in the left atrium (LAP) after puncture (Pu) of the septum (FIG. 4C).

[0065] Figure 5 illustrates pulsed field ablation (PFA) about the pulmonary veins 504 as is known by those experienced in the art. The degree of tissue necrosis (TN) is measured, in which the PFA system 500 for atrial fibrillation generates a tissue necrosis index (TNI) 502 and conveyedAttorney Docket: 95983-432709 to the operator in a haptic format. This can be accomplished with haptic rendering techniques to simulate temperature (e.g., psychophysical haptic rendering) by imparting a high frequency vibration tactile signal where the change in frequency leads the user to sense an increase in heat (due to an increase in high frequency haptic feedback). The extent of tissue necrosis can be measured by assessment of intracardiac electrical properties (e.g., electrogram amplitude, impedance changes), tissue temperature trends / data, or means for tissue characterization (e.g., properties of reflected ultrasound or light). The same haptic computing system can input varying signals and output the appropriate haptic response(s).

[0066] During lengthy cardiac interventions, visual, auditory, and sense of touch attentional resources become saturated. In order to mitigate the saturation or fatigue of post- synaptic receptors in both the peripheral and central nervous systems the haptic system varies the type of haptic feedback signal generated by modifying the haptic intensity and sharpness for each haptic effect over time (Figure 6) using a variable haptic signal generator (FIG. 8C) that accepts input signals 802 (FIG. 8A) at Figure 8B, processes data 804 at Figure 8C and outputs haptic feedback 806 at Figure 8D. By way of example, referring to Figure 6, the action of a given actuator (e.g., haptic speaker, linear motor) is modified to displace over time with rounded 602, sharp 604, or crisp / precise 606 movement such that the degree of displacement, acceleration, deceleration of the element varies providing a distinct haptic sensation with essentially the same information relevant to the measured physiologic or biophysical signal that is sensed (e.g., tissue displacement over time during transeptal puncture, change in contact degree over time).

[0067] In an alternate embodiment, internally or externally deployed sensors (e.g., accelerometers, piezosensors, gyroscopic sensors, located in or on the haptic interface) sense timing of an operator’s simple and complex handle / hand / finger motion and catheter manipulations relative to fiducial events (e.g., transeptal puncture, time between change in sensed signal representative of effective ablation (e.g.. change in impedance, differential voltage, other sensing indicator of tissue necrosis, fluctuation in catheter: tissue contact force)) and time of application or removal of applied ablation energy (e.g., delivery of PFA, cryo or thermal energy, radiofrequency energy) or time of change in catheter position or other salient events. Timing intervals are stored and available for review and comparison to previous haptic motor reaction times from the operator and other interventionalists. The reciprocating haptic sensory glove I rings / wristband incorporates sensors (e.g., accelerometer, gyroscopic sensor, piezosensors) that detectAttorney Docket: 95983-432709 actions of the operator and relationship to biophysical / physiologic events and therapies being delivered as depicted in Figures 9A-B (e.g., delivery of RFA energy, transeptal puncture). In a preferred embodiment, the data from multiple interventionalists and procedures are input from a multitude of device agnostic haptic computing systems and machine learning, deep learning, neural networks, artificial intelligence algorithms are applied to periodically analyze the collective stored data including but not limited to haptic motor reaction times, procedural efficacy, complications, procedural times, diagnostic and therapeutic data, as well as patient clinical variables, operator experience level, and operator chosen equipment as to optimize the system’s overall functionality and identify ideal settings, procedural approaches, types of equipment, haptic actuators, hardware and software configurations for the design and programming of default and programmable setting options for specific users that include a spectrum between novice and highly experienced operators.

[0068] In a preferred embodiment, the haptic operating system is trained to utilize imaging data to track movement of inserted devices and derive displacement and acceleration indices for transduction into haptic signals representative of anatomic location, tissue contact sensing, and catheter: tissue contact force, by making cross comparisons of data acquired from conventional catheter-based sensors, including but not limited to force sensors, electro anatomic mapping (EAM) systems, used during electrophysiology procedures and imaging modalities used for both electrophysiology interventions and during structural heart procedures where no catheter based sensor data is utilized. This training implements CNN based models to capture and track the trajectory of hierarchal features on inserted equipment including but not limited to electrodes, struts on a valvular apparatus, or any other radiopaque or sonographic feature..

[0069] In another embodiment, the system serves as a Haptic Cardiovascular Brain Interface and can time stamp temporal relationships between one or more clinician’s central and peripheral nervous system’s sensing and associated motor responses relative to sensed / measured biophysical and physiologic cardiovascular signals while performing diagnostic and therapeutic interventions on the heart and surrounding anatomic structures and implements sensors for determining peripheral nerve recruitment and relevant motor responses using one or more non- invasive sensors incorporated into the design of a reciprocating wearable haptic device that interfaces with a central nervous system recording device, sensors located on the skin of a user, sensors associated with medical instrument, sensors integrated within a wearable haptic device, orAttorney Docket: 95983-432709 part of a catheter, catheter handle, or robotic system being controlled by the user to complete a diagnostic or therapeutic task on a patient’s cardiovascular system.

[0070] Referring to Figure 9A, one or more sensory inputs as described herein, for example tissue temperature 902, voltage waveform data 904 (such as voltage pulse width 904A, voltage amplitude 904B and / or voltage integral 904C) and / or impedance data 906 can be collected. Prior to haptic transduction 912, the haptic system can utilize algorithms, as described herein, to detect and correct inaccurate data sets. If erroneous data is identified by any means (e.g., a catheter has stable contact with tissue but saline irrigation used to cool tissue during ablation modifies impedance data) the system can pause haptic feedback or make modifications and corrections to the haptic feedback utilizing the appropriate signal for haptic processing and transduction. Once corrected, if necessary, the haptic system can then be processed and designed to activate varying peripheral and central neuroanatomical sites, as haptic output 914, in order to prevent fatigue of tactile and force sensing attentional resources. These sites including kinesthetic 920, proprioceptive 922, temperature (not shown), tactile 926, force 928 and those within haptic sensing wearables 930 (for example, pressure receptors in the fingers, hand, and wrist). The haptic feedback is generated by combinations of haptic actuators including but not limited to deformable piezoactuators, linear or rotary motors, smart materials, haptic speakers and the like.

[0071] Figure 9B represents a conceptual simplified block diagram of a reciprocating haptic sensory wearable(s) (such as glove(s) / ring(s) / wristband(s) / etc., that incorporate sensors that sense / detect actions / signals of the operator and the relationship to biophysical / physiologic events (e.g., delivery of radiofrequency ablation (RFA energy, transeptal puncture). Haptic wearable sensors 940 sense a variety of signals, as described herein that are transmitted to and processed via an RFA generator 942 and a catheter handle / system 944 or an alternate processor (not depicted). Following processing and transduction among the RFA generator 942 and the catheter handle / system 944, processed signals can be facilitated to the operator’s hand(s) / wrist(s) / finger(s) / etc. 950, which one or more haptic effects can be delivered. Sensing and processing of the agnostic haptic system controlled by a timer / counter 946. In embodiments, sensed actions / signals can be stored in data storage 948 for future playback / use. In some embodiments, there is gating 1000 of static and quasistatic signals at a 1:1 ratio with a measured signal such as electrical depolarization or as a multiple (e.g., 2:1) of the measured signals as programmed by a multiplier as depicted in Figure 10 that adjusts the frequency of the haptic signal.Attorney Docket: 95983-432709The adjustment can be or not be (i.e., independent of) a function the contacting sensing signal(s) over time. By way of example, the haptic effect frequency (HEf) 1010 can be a product of heart rate (HR) 1002 and haptic multiplier (fx) 1004 and / or based on the ECG trigger and fx. For example, the HEf cycle is set at 180 for fx = 3 for the initial interface with an HR 1002 measured at 60. Thus, if there is a change in a patient’s heart rate, this will become palpable along with any change in haptic effect that is representative of a physiologic / biophysical signal other than heart rate enabling simultaneous palpation of heart rate and other physiologic signal. The higher frequency haptic effect improves a user’s haptic motor reaction time. In embodiments, gating of static and quasistatic signals can be proportionate to cardiac cycle(s) in patients with atrial fibrillation or averaged and set at a fixed frequency. Thus, by way of example, the measured heart rate is multiplied by a programmable number e.g., 1, 2, 3.... as to modify the generated frequency of the haptic effect but can also represent one or more properties of the measured signal.

[0072] Haptic feedback can be programmed to be linearly proportionate to the amplitude or magnitude of the sensed signal / index or as depicted in Figure 11, or as a step function, so that there are discrete incremental increases in magnitude of haptic feedback (e.g., force of linear motor, degree of deformation of haptic surface) that can be more readily interpretable by the operator rather than gradual proportionate increments or decrements. In various embodiments, no haptic effect can be programmed in certain situations even when there is an input signal (e.g., contact force < 10 gm) and haptic gain adjusted to help the operator better differentiate if an adjustment in applied catheter force is needed when there is inadequate tissue contact. This cutoff (and lower and upper limits) can be modified based on the nature of the tissue instrumented (e.g., posterior wall of the left atrium). Figure 12 depicts Figure 11 but with programmable haptic gain that can be adjusted once initiated (i.e., a haptic algorithm with step function and adjustable gain) wherein there is no haptic effect during no contact sensing signal or when contact force sensed is below a specific threshold. 3, at 1202 and a reached maximum haptic amplitude during contact sensing signal 1204. At 1204, an abrupt increase in generated haptic signal alerts the operator that excessive contact force is being applied and there is risk of tissue puncture / damage and / or the system can use a superimposed haptic effect as well.

[0073] Programmability can be more sophisticated, and the operator can modify the input signal for haptic processing as depicted in Figure 13 where an impedance based contact sensing signal is substituted for a tissue temperature index during application of radiofrequency energy orAttorney Docket: 95983-432709 a layered haptic effect is provided that can include additional data related to other sensed signals. Referring to Figure 13, during ablation (e.g., RFA), contact sensing signal may not solely be used as input to the haptic system. Temperature data can be implemented with a curvilinear relationship between temperature and degree of haptic effect. The haptic effect can be the same as when RFA is not applied, or modified in type of haptic effect, quality I quantity, and / or location of haptic effect (e.g. different anatomic location such as first 2 digits vs last 2 digits). In embodiments, palpate thermal amplitude 1302 can be implemented (on or off) during RFA 1306. In embodiments, palpable intermediate amplitude contact sensing haptic effect 1304 can also be present. In embodiments, no contact sensing haptic effect can be present during RFA 1306 or an effect generated so the user can palpate thermal amplitude.

[0074] Other such sensed signals can include EGM properties as illustrated in Figure 14 and 15. Figure 14 depicts Figure 13 with haptic effect during RFA 1406 application based on electrogram I voltage properties and having an inverse relationship with contact sensing signal data. In this example, electrogram voltage at distal electrodes are analyzed to assess the degree of tissue necrosis (index of ablation success) rather than tissue contact (which would have a directly proportionate relationship to peak electrogram voltage). A layered haptic effect can be implemented (triggered on or off), for example, at 1402 providing an EGM haptic effect during RFA 1406. In embodiments, intermediate haptic amplitude 1404 can also be present.

[0075] Figure 15 demonstrates multi-modal haptic effects related to temperature, EGM, contact sensing and relationship of these signals to haptic effect magnitude. Data communication of haptic effects can be in the form of musical score for qualitative and quantitative description of frequency, amplitude, information in format of a novel “haptic language.” In embodiments, palpate EGM 1402 and / or thermal amplitude 1302 can be implemented (on or off) during RFA 1506. In embodiments, palpable intermediate amplitude contact sensing effect 1504 can also be present. In embodiments, no contact sensing haptic effect can be present during RFA 1306.

[0076] Figure 16 illustrates the composite of using the multiplier and layered haptic effects based on multiple input signals. Figure 16 depicts Figure 15 with layered haptic effect such that temperature is manifested using psychophysical haptic rendering techniques (e.g., vibratory effect to simulate temperature) along with contact sensing index and electrogram data. In embodiments, palpate EGM and / or thermal amplitude 1602 can be implemented (on or off) during RFA 1606. InAttorney Docket: 95983-432709 embodiments, palpable intermediate amplitude contact sensing effect 1604 can also be present. In embodiments, no contact sensing haptic effect can be present during RFA 1606.

[0077] Figure 17 represents and embodiment of a haptic speaker unit 1700, which illustrates a haptic speaker (Sp) that generates a haptic force effect (e.g., contact sensing) encased in a cylindrical tube that has piezoelectric material (Pz) and deforms to generate a haptic tactile effect (e.g.. tissue deformation, temperature, tissue necrosis). The haptic tube can be worn by the operator or incorporated into a catheter handle. In embodiments, the haptic signal is transmitted by a haptic speaker (Sp) voice coil 1702 that generates feedback below the frequency for audible signals and is enclosed in a shallow cylindrical unit that can be worn on the wrist, hand, or other body part, within the haptic speaker unit 1700. Optimally, the haptic speaker unit comprising circumference 1704, which is less than 1 cm in circumference (for example, 0.23 cm), and of length 1706 serves to generate force feedback to the operator. In embodiments, the length 1706 of the haptic speaker unit can be less than 1 cm (for example, 0.5 cm). In an alternate embodiment, the outer surface of the speaker unit is a deformable semi-rigid haptic actuator (e.g., Young ‘s modulus between 0.01 and 0.1 GPa) such as a piezoelectric surface (Pz) 1708 that deforms and provides tactile feedback to the operator and the unit as a whole generates both force and tactile information. The haptic force effect of the speaker can be delivered at the same cycle length I frequency of the cardiac cycle, a percentage of frequency with or without interpolated haptic signals, or a multiple proportionate to the cardiac cycle as depicted in Figures 19a and 19b where haptic effects b and C are interpolated between A and D. For example, haptic frequency rate (HFr) of 180 / 3 Hz, equals three times the heart rate of 60 (HR = 60) based on the programming of a haptic multiplier.

[0078] In yet another embodiment, a wearable deformable haptic actuator (DHA) is a cohesive stretchable polymeric support with electrically conductive elastomeric properties. By way of example and depicted in Figure 18, the DHA blends an elastic fibrous web (EFA) intertwined with piezoactuator filaments with yams of about 500 to 2000 denier uniformly spaced at about 10-30 yams per 0.5 cm width and having Young’s elastic modulus such that there is less than moderate compression and comparable to human tissue such as tendon, skin, ligament (e.g., between 1.0 and 2.0 GPa) with comparable viscoelastic mechanical behavior and force-strain curves. As depicted in Figure 18 EFAs 1-3 are shaped as to conform to the base of one or more fingers (digital) and about the distal aspect of the hand or wrist (palmar or dorsal) at EFA4 and allAttorney Docket: 95983-432709 provide tactile signals. This DHA can be fit with a subsonic (< 20 Hz) haptic speaker (Sp) 1704 that provides force feedback and also can be fit with inaudible high frequency (> 20 Hz) haptic speakers (not shown) that employ psychophysical haptic rendering in one or more locations and provide sensory feedback such as temperature sensations as well as conductive haptic effects to a user’s joints, bones, connective tissues. This complements the delivery of piezoactuator based haptic feedback in other locations providing a blended haptic feedback wearable device.

[0079] In various embodiments, the haptic system and DHA are capable of transducing signals from multiple sensors manufactured by a variety of vendors including impedance-based data (e.g., Boston Scientific, Medtronic), mechanical force sensors (e.g., Biosense Webster), fiberoptic force sensors (e.g., Abbott), temperature indices (e.g., Medtronic), and indices of tissue necrosis based on one or more signals including but not limited to reflected light, ultrasound, intracardiac electrogram signal analysis, impedance, temperature information. The location of the haptic actuators and type of haptic feedback can be in anatomic regions that have myelinated mechanoreceptive afferents such as rapidly adapting type I (Meissner), or rapidly adapting type 2 (Pacinian) receptors rather than slowly adapting type I (Merkel), slowly adapting type 2 (Ruffini) or unmyelinated (e.g., C-tactile) afferents which have slower response times and catered to the type of receptors being innervated. This will optimize operator haptic to motor response times. Stimulated anatomic regions can also include sensory receptors in muscle (e.g., muscle spindles, Golgi tendon organs) that are sensitive to velocity and stretch (e.g., for communication of force information) and joint spaces (e.g., proprioceptive sensors).

[0080] In some embodiments, differing sensory cutaneous branches of the median nerve that innervate the hand, wrist, arm (e.g., palmar digital cutaneous branches, palmar cutaneous branches that arise in the forearm and extend to the hand innervating lateral, medial aspects of the palm and digits) are stimulated by different haptic elements optimizing the operator’s ability to differentiate varying physiologic and biophysical signals based on anatomic location of haptic feedback in addition to the type of haptic feedback. The anatomic location that is provided with haptic feedback can be programmed to vary from time to time (e.g., temperature sensation moves from first and second digits to third and fourth digits) reducing the likelihood of fatigue of haptic attentional resources. The DHA can be disposable or washable, sterilizable and reusable.

[0081] Figure 19 illustrates the haptic force effect of a haptic speaker can be delivered at the same cycle length / frequency of the cardiac cycle or a multiple proportionate to the cardiacAttorney Docket: 95983-432709 cycle. Tn some embodiments, a programmable multiplier fx 1904 (for example, 1 -5) can adjust the frequency of the haptic effect as a function of contacting sensing signal (CS) over time, as depicted by 1920. For example, the haptic effect frequency (HEf) 1910 can be a product of heart rate (HR) 1902 and haptic multiplier (fx) 1904 and / or based on the ECG trigger and fx. For example, the cycle HFr can be set at 180 or 3Hz for initial interface with an HR 1902 set to 60 and a multiplier fx set to 3. all of which can be implemented into haptic algorithm 1912, as illustrated in Figure 19a.

[0082] A number of haptic actuators can be positioned within a haptic display enabling a user to sense a dynamic range amplitude haptic effect proportionate to the magnitude of sensed signals (e.g., pressure, force) that would otherwise not be appreciated with a single haptic actuator. The single haptic actuator in these embodiments is small and low cost (e.g., linear vibrator I accelerometer), yet has a limited dynamic amplitude range due to fixed or limited displacement, acceleration, vibration force, etc. Thus, the system can operate within the size and costs constraints required to fit a wearable haptic interface with such actuators and also be able to convey amplitude information using an array of inexpensive, simple, small dimension elements. To circumvent the limitations of small sized actuators the haptic display I computing system uses a greater number of actuators and applies palpable sensations over a larger surface area. The number of activated actuators is proportionate to the amplitude of the sensed signal as each individual actuator may not be able to generate a dynamic range of haptic amplitudes.

[0083] By way of example, referring to Figure 20a, haptic actuator 1 (Hal) is circular with a diameter between 0.2 and 2 cm and thickness between 0.1-0.5 cm and can deliver a palpable sensation (e.g., vibrotactile effect) but has either a fixed or narrow range of haptic amplitudes unable to be differentiated by the user. For example, each of a set of actuators can generate varying frequency (e.g., 0.5 Hz to 500 kHz) haptic effects if not variable amplitude. Any type, size, shape, or thickness actuator as known by those experienced in the art is within the scope and spirit of the embodiments described herein are by way of example. Figure 20 b-e depicts exemplary geometric arrangements of small dimension haptic actuators that in congregate provide a surrogate amplitude scale proportionate to sensed physiological / biophysical signals. In Figure 20a a single vibrotactile actuator, Hal, delivers a fixed or relatively fixed amplitude haptic effect. This haptic effect can have variable frequency information but has limited or no amplitude dynamic range. In Figure 20b, there are multiple actuators depicted in a linear and semi-circular array. In this example, 5Attorney Docket: 95983-432709 actuators are positioned radially along a circumferential direction (circles with no fill) about a user’s body part such as a wrist, arm, hand, finger or along one axis (solid fills) that in one embodiment is parallel to the axis of the forearm. The central actuator is depicted with a gradient fill as it can function as part of the circumferential or linear array. In different embodiments both or one of the circumferential or linear arrays can be implemented. In order to convey a higher magnitude haptic effect proportionate to a given sensed signal (e.g., pressure, contact force, temperature, index of tissue necrosis, etc.) the number of actuators are incrementally activated with one actuator representing the lowest amplitude sensed signal and an increasing number of actuators representing higher amplitudes. For example, one active actuator represents too low a catheter: tissue contact force, < or = 10 gm, and 5 active actuators indicate a high amplitude (e.g., > 50 gm) while 2-4 actuators represent intermediate amplitudes that can be more optimal for tissue ablation. Varying frequency haptic effects can also be implemented to convey changes in the sensed amplitudes such that higher frequencies correlate with higher amplitudes (Figure 20c). In one embodiment, as an increased number of haptic actuators are active there is a serial increase in frequency of vibrotactile information for all or each sequential one-dimensional actuator as illustrated in Figure 20c. Thus, actuator 1 can have a vibrotactile frequency of 1 Hz, actuator 2 has a frequency of 10 Hz, actuator 3 100 Hz, actuator 4, 1 kHz, and actuator 5 10 kHz. The relative increase in actuator frequency can be linear, curvilinear, logarithmic, or otherwise and when considered together with the number of activated actuators accurately informs the user of changes in the amplitude of a given sensed signal.

[0084] Referring to Figure 20d 10 actuators are oriented in a triangular pattern where an increasing haptic effect is represented by a greater number of actuators delivering haptic effects over a larger surface area (e.g., on the forearm). The maximum haptic effect can represent an alert condition such as excessive contact force or tissue necrosis, one haptic actuator representing too low of a force and intermediate numbers represent a graduated amplitude scale. In another embodiment, each actuator can have a dynamic, albeit limited, magnitude range of haptic effect so that an incremental amplitude of any given sensed events causes a more powerful haptic effect (e.g., linear displacement, force), activation of a greater number of actuators, and a higher frequency haptic effect for any number of haptic actuators.

[0085] The distance between each actuator, orientation, and actuator features can vary in any of the embodiments and are optimized for haptic feedback. For example, in Figure 20d,Attorney Docket: 95983-432709 distance a and b can be between 0.25 and 0.75 cm. Sequential actuators can be separated by increasing or decreasing distances apart but have the same separation in the provided figures. In one aspect, the separation distance and haptic effects (frequency, amplitude, acceleration, contact surface area, qualitative characteristics, stimulation vector) optimize the user’s haptic spatial acuity and ability to distinguish each actuators effect. The anatomic positioning of any given haptic array is likewise optimized to best simulate sensed physiological signals.

[0086] In an alternate embodiment, the array of actuators provides anatomically relevant haptic data confirming tissue contact, tissue catheter: contact force, and / or contact uniformity from an array of intracardiac electrodes used to assess therapeutic systems designed for ablation of cardiac arrhythmia (e.g., pulsed field ablation (PFA)) or as to ensure uniform implantation of a cardiac device (e.g., left atrial appendage occlusion device, prosthetic valve implant).

[0087] PFA is a non-thermal energy that holds promise to ablate cardiac arrhythmia without incidental damage to surrounding structures (esophagus, phrenic nerve, vasculature). PFA ablation systems can have complex electrical waveforms and variable parameters, but all deliver short duration (seconds) high current, low density energy that causes irreversible electroporation and tissue necrosis disconnecting electrical tissue conductivity and blocking arrhythmic substrates. PFA systems have different constructs and can have electrodes positioned in any number of configurations including a circular fashion, ribbon shape, or spherical array. Some can contain a uniform lattice of electrodes for energy delivery as well as for sensing impedance and temperature data (e.g., Affera Inc.). Bipolar electrograms and impedance data acquired between the electrode(s) and a centrally located indifferent electrode measure indices of catheter tissue proximity / contact and local tissue response to energy delivery (e.g., based on impedance change, temperature response).

[0088] While PFA was initially designed to enable tissue ablation without requiring tissue contact, data has emerged that contact is important for effective ablation as it is with thermal and radiofrequency systems. In another aspect described herein, haptic feedback generated by an array of actuators will enable palpation of tissue contact based on data acquired from multiple electrodes simultaneously (e.g., impedance, electrogram, temperature) so that PFA catheter position can be optimized prior to energy delivery by enabling sense of touch confirmation of electrode location as well as identification of effective tissue necrosis (e.g., by using one or more of the same indices for determining tissue contact). Figure 20e illustrates a circular array of haptic actuators that canAttorney Docket: 95983-432709 be positioned about an extremity (wrist, forearm, finger). Each of 8 actuators is representative of a single electrode and can be arranged about one or 2 extremities (Figure 20f). In another embodiment described herein, the geometric arrangement has layers arranged in radial fashion with circular, square, diamond or other shape configuration haptic elements in form of a bullseye wherein activation of the more radially distant actuators indicates a higher amplitude sensed signal. Referring to Figure 20g the central haptic actuator (light hashed) is representative of too low of a force (or low intra-cardiac pressure, inadequate tissue necrosis), the second diamond configuration of 4 actuators (vertical lines) indicates optimal force (or normal intra-cardiac pressure, adequate tissue necrosis) and the outer circular 8 actuators (solid circles) too high of a signal. Different characteristic haptic effects can be manifest by each level of actuator and any number of configurations can be implemented for the haptic interface including but not limited to those that mimic the geometry of catheter-based electrodes (e.g., ribbon, spherical configuration) and are all within the scope and spirit of the invention.

[0089] In another embodiment, user programmability is through a graphical user haptic interface (GUHI) that outputs haptic feedback signals and in one embodiment incorporates capacitive or other haptic touchscreens with palpable effects, for example, at Hl, H2, H3 and H4. In this mode, the haptic touchscreens enable a user to Program and Palpate where the palpated signals are representative of input biophysical and physiologic signals and / or transduced output signals. An operator can modify haptic effect amplitude and frequency to their preference as long a proportionality to the sensed signals is maintained. In regard to amplitude, a virtual knob or slider can be adjusted accordingly such that the distance touched and / or the manual force applied to the appropriate screen icon proportionately adjusts haptic amplitude or audio output. In real life cases such adjustment is not possible once an interventional case has begun as to not lead to misrepresentation of specific signals such as contact force / sensing. In regard to frequency, the haptic touch screen serves to adjust the frequency of the haptic signal whether it be control over psychophysical haptic rendering, an admittance haptic display, or other feature including but not limited to transposing signal frequency to a multiple of the sensed signal in either an audio or haptic format. By way of example, the transposed frequency can render palpable cardiac cycle dependent signals (e.g., beat to beat contact force), quasistatic or static signals (contact sensing index derived from impedance, intracardiac voltage from one or more electrodes) to be 2-5 timesAttorney Docket: 95983-432709 the actual heart rate, or at a lower frequency than the sensed data (e.g., high frequency intracardiac electrogram signals).

[0090] Referring to Figure 21 , graphical user haptic interface (GUHI) / programmer inputs static (Si), quasistatic (Qi), and dynamic (Di), for signal processing and outputs static (So), quasistatic (Qo), and dynamic (Do) signals for transduction at wearable haptic actuators using haptic effects that are not necessarily in the same static, quasistatic or dynamic state as the input signals. Transduction of the input signals into haptic effects can likewise occur at the level of the GUHI / programmer and be palpable at one or more locations including but not limited to Hl, H2, H3, H4 and outputs acoustic signals via audio at speakers A-E. The input and I or output signals are transposed in frequency to be pleasant to the operator and also visible as musical score I notation while preserving amplitude and frequency information. The acoustic output provides the user with a surround sound experience with acoustic directionality relative to the sensed input signals. By way of example, center speaker C would correspond to the most proximal sensed signal closest to the body exterior I operator (e.g., during time of transeptal puncture for palpation of puncture and then left atrial pressure). D and E would reflect most distal input signals (e.g., intracardiac electrograms (IEGM) from within the left and right sided upper pulmonary veins). Speakers A and B can be representative of lEGMs from the left and right sided lower pulmonary veins). The audio output is transposed to have a desirable acoustic signal of similar amplitude and frequency that can be based on user preferences. Once transeptal puncture is completed audio output from C would cease and once an ablation is completed in all four pulmonary veins, there would no longer be IEGM based audio output from speakers A, B, D, and E. Similarly, the haptic wearable would simultaneously provide palpable sensations with the same temporal and geometric spatial features.

[0091] In one embodiment, the GUHI / programmer has displays, DI, D2, ... Dn, of relevant information including fluoroscopic images, electroanatomic mapping data, intra-cardiac electrograms (IEGM), contact force display, and a haptic conductive trackpad that transmits audio in a palpable format from speaker C. Input and output touchpads for programming and a conventional keyboard is present (Keys) that can also provide tactile feedback if so desired. Ideally, the GUHI / programmer is covered with a sterile impermeable covering that does not impede palpation of haptic or acoustic effects and is at least in part a heads up display, transparent enough as to not limit a user’s line of vision.Attorney Docket: 95983-432709

[0092] Referring to Figure 22, The American Board of Thoracic Surgery (ABTS) estimates that 450,000 cardiac procedures will be performed by 2035 due to progressive aging of the US population and the associated prevalence of cardiovascular diseases. Concurrent to the steady decline of practicing physicians, the ABTS projects that the procedural volume per operator will more than double in the next decade. The US healthcare system is unable to provide the necessary manpower to meet demand, particularly in rural and low resource settings, especially as over 10 years are needed to train qualified electrophysiologists (EPs) interventional cardiologists (ICs). In addition, international surveys show that <50% of cardiologists participate in training programmes, even if randozimed trials confirm their benefit on performance. With cardiac procedures transitioning from open-chest surgeries to catheter-based interventions, intracardiac echocardiography (ICE) and / or radiofrequency (RF) transseptal needles have helped reduce procedure times and improve outcomes but are used in a minority of EP cases outside of US to contain costs. ICE and RF add a significant economic burden (up to $3,500 / procedure) and require operators to constantly and altematingly view multiple screens while performing complex maneuvers, limiting motor reaction time, saturating visual attentional resources, and increasing the likelihood of procedural errors. A technology that provides both virtual reality training and realtime augmented reality solutions is needed. The disclosed embodiments provide operators with a palpable appreciation of intracardiac anatomy, implanted device positioning, and physiologic signals and will shorten learning curves and expedite training. When applied to clinical practice this will reduce need for additional costly modalities and provide multisensory feedback if used concomitantly. This is especially important for new professionals in rural, low resource communities, but also needed to improve performance of more skilled operators as technologic approaches in electrophysiology and structural heart interventions continuously evolve.

[0093] Haptic feedback improves attention, cognition, and performance; however, cardiac catheters currently available on the EP procedures provide a visual display of CF magnitude and direction but require visualization of multiple screens (e.g., fluoroscopy, mapping data). Force, pressure, and catheter tissue contact would be best appreciated naturally, using sense of touch and multi-sensory feedback. The disclosed embodiments include systems able to render haptic information during cardiovascular interventions in the absence of simultaneous visual feedback or prior physician training. The disclosed embodiments include wearable technology that uses haptic feedback to provide sense of touch during cardiovascular interventions. The disclosedAttorney Docket: 95983-432709 embodiments include wearable technology that is disposable, low cost, shortens physician training times, improves performance, procedural efficiency and patient outcomes with a device agnostic solution that can seamlessly interface with EP and structural heart catheter systems.

[0094] The disclosed embodiments provide beat-to-beat contact sensing and CF feedback in an animal model and enable palpation of blood flow, intra-cardiac pressure, and sensations of a catheter crossing intra- and extra-cardiac tissue planes using stored physiological signals. The disclosed embodiments enable users to appreciate the presence and variation in CF during ablation, intra-cardiac pressure during transseptal puncture, and electrode contact uniformity during pulsed- field ablation. The disclosed embodiments provide a commercially- viable, ergonomic, and deviceagnostic system for academic and community healthcare centers to streamline training of both new and experienced cardiologists. As intra-cardiac anatomy may be complex and highly variable, it is often defined prior to interventions (e.g., CT scans, electroanatomic mapping data, angiography, etc.). The disclosed embodiments include a virtual reality training tool I simulation interface preprocedure for planning and rehearsal purposes. Portable simulator designs also provide both visual and haptic feedback that replicate actual work flows during both structural heart (e.g., valve repair I replacement, left atrial appendage occlusion), and EP procedures (e.g., arrhythmia ablation).

[0095] The disclosed embodiments include a wearable glove / sleeve design with haptic actuators, drivers, and controllers that acquire imaging data (e.g., fluoroscopy, electroanatomic mapping, ultrasound), physiologic signals from catheters (e.g., blood pressure, blood flow, tissue contact, CF) and biophysical signals (e.g., catheter crossing tissue planes including transeptal puncture, index of tissue necrosis, temperature). A platform is interfaced in the animal and EP lab with catheters that provide physiological and biophysical data (e.g., CF) and the system implements algorithms to transduce acquired imaging data into distinct haptic effects qualitatively and quantitatively in real-time. Convoluted Neural Networks (CNN) are used to localize relevant markers on inserted or implanted devices from imaging data and extract hierarchical features for localization purposes (e.g., catheter tips, electrodes, prosthetic valves). CNN is paired with an object detection network and optical flow tracking algorithm. This data is input to a GPU and Haptic Operating System that derives an acceleration index to complement localization data with haptic force feedback using a 3-D multi- actuator wearable glove / sleeve (see Figure). In addition to rendering physiologic signals and anatomic boundaries palpable, the haptic “display” indicatesAttorney Docket: 95983-432709 the presence of absence of catheter / device tissue contact, simulate magnitidue of applied force, and provide a palpable metric of catheter stability.

[0096] Performance of the system is evaluated using real-time indices collected during prior cardiac interventions and simultaneously stored visual display data from actual cases. Motor reaction time, presence / absence of haptic feedback, time delay between stimulus and reaction to the haptic feedback will be evaluated in both novice and experienced operators. Diagnostic data sets are collected on subjects previously scheduled for procedures (existing IRB approved protocol) and input and process the composite data / signals to transduce tangible, haptic sensations palpable by EPs and ICs wearing the haptic feedback device. A Ground Truth Comparator is used to compare data from electroanatomic mapping and other indices readily available during cardiac ablation procedures to metrics derived from fluoroscopic I imaging data acquired during structural heart procedures using the CNN model’s tagging tools.

[0097] Embodiments of the invention can be described with reference to the following numbered examples:

[0098] Example 1 - A device agnostic haptic computing system that can acquire, process, and perform haptic transduction of biophysical and physiological data input from one or more of a static, quasistatic, and dynamic signal generated by dissimilar sensors sensing from within or exterior to one or more of an animal’s moving bodily structure(s) and; generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and / or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and I or modifying the frequency response, amplitude, and qualitative haptic effect of one or more actuators.

[0099] Example 2 - where said bodily structure of example 1 is one or more of an internal organ, musculoskeletal system, neurologic tissue, blood, subcutaneous, or cutaneous tissue.

[0100] Example 3 - where said internal organ of example 1 is cardiac, pulmonic, or gastrointestinal organ.

[0101] Example 4 - where said static signal of example 1 relates to the position, orientation, deformation of a bodily tissue, temperature, rendering of texture, or biophysical signal.

[0102] Example 5 - where said quasistatic signal of example 1 is one or more characteristic measurement(s) of one or more of impedance, resistance, capacitance, voltage, current, capacitance representative of the status of bodily tissue subjected to an external force and degreeAttorney Docket: 95983-432709 of contact of one or more sensors sensing from within or exterior to one or more of an animal’s moving bodily structure(s).

[0103] Example 6 - where said external force of example 5 is one or more of applied pressure, sensed pressure from within specific organ system, contact force between non biological matter and bodily tissue, cold or hot thermal energy, electric, magnetic, or electromagnetic energy.

[0104] Example 7 - where said dynamic force of example 1 is time varying and proportionate to the cardiac cycle.

[0105] Example 8 - Acquisition, DSP and haptic transduction of biophysical and physiological events that are one or more of a static, quasistatic, and dynamic signal generated by one or more electrode assemblies, a controller, one or more digital signal processors, a programmable computing system, and haptic interface that transduces acquired signals and generates a real time or previously recorded force and tactile feedback to a clinician performing a procedure on a bodily organ, a clinician in training observing a procedure on a bodily organ, or to a non-clinician generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and I or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the amplitude, frequency response and qualitative haptic effect of one or more actuators.

[0106] Example 9 - The real time force and tactile feedback of Example 8 where said real time rendering or simulation includes one or more of haptic feedback, visual feedback, auditory feedback.

[0107] Example 10 - Acquisition, DSP and haptic transduction of biophysical and physiological events that are one or more of a static, quasistatic, and dynamic signal generated by one or more electrode assemblies, a controller, one or more digital signal processors, a programmable computing system, and haptic interface that transduces acquired signals and generates a real time or previously recorded force and tactile feedback to a participant participating in a simulation of a procedure on a bodily organ generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and I or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the amplitude, frequency response and qualitative haptic effect of one or more actuators.Attorney Docket: 95983-432709

[0108] Example 1 1 - The real time force and tactile feedback of Example 10 where said real time rendering or simulation includes one or more of haptic feedback, visual feedback, auditory feedback.

[0109] Example 12 - The quasistatic signal of example 5 where said quasistatic signal is derived from differential amplitude between one or more measurements of impedance, resistance, capacitance, voltage, current, temperature, index of tissue injury, electromagnetic signal.

[0110] Example 13 - The device agnostic haptic computing system of example 1 that outputs haptic signals to a non-rigid haptic interface having a thickness of less than 5 mm and surface area under 2 cm that can be incorporated along the circumference of an existing catheter handle, or worn by the operator.

[0111] Example 14 - The device agnostic haptic computing system of example 1 where said signal is a function of degree of cardiac tissue necrosis about the pulmonary veins and left atrium caused by electroporation by an internally located catheter or externally applied pulse field ablation system.

[0112] Example 15 -A device agnostic haptic computing system where haptic presentation is altered in real time based on a default programming change that modifies the characteristics of haptic signal based on duration of use as to prevent fatigue of attentional resources from repetitive afferent signals that lead to saturation of cutaneous or other sensory receptors and I or uptake of neurotransmitters in the peripheral and / or central nervous systems with haptic effects generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and / or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the amplitude, frequency response and qualitative haptic effect of one or more actuators.

[0113] Example 16 - The device agnostic haptic computing system of example 1 where haptic presentation is altered in real time based on a default programming change that layers varying haptic signals related to one or more sensed biophysical or physiological signals to the operator as to prevent fatigue of attentional resources from repetitive afferent signals that lead to saturation of cutaneous receptors and / or uptake of neurotransmitters in the peripheral and / or central nervous systems.

[0114] Example 17 - The device agnostic haptic computing system of example 1 where haptic presentation is modified in real time based on sensing algorithms in the haptic device (e.g.,Attorney Docket: 95983-432709 detection of increases in an operator’s haptic motor reaction time) that modify the characteristics of haptic signals based on duration of use as to prevent fatigue of additional resources from repetitive afferent signals that lead to saturation of cutaneous or other sensory receptors and affect uptake of neurotransmitters in the peripheral and I or central nervous systems.

[0115] Example 18 - Internally or externally deployed sensors including but not limited to accelerometers, piezosensors) located in or on the haptic interface sense timing of an operator’s simple and complex handle / hand / finger motion and catheter manipulations relative to fiducial events (e.g., transeptal puncture, time between change in sensed signal representative of effective ablation, change in impedance, differential voltage, other sensing indicator of tissue necrosis, fluctuation in catheter: tissue contact force) and time of removal of applied ablation energy (e.g., delivery of PFA, cryo or thermal energy, radiofrequency energy), deployment of intra-cardiac devices (e.g., left atrial appendage occlusion, valve repair systems, valve replacement systems). Timing intervals and motor response times are stored and available for review and comparison to previous haptic motor reaction times from the operator and other interventionalists with haptic effects generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and / or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the amplitude, frequency response and qualitative haptic effect of one or more actuators.

[0116] Example 19 - The device agnostic haptic computing system of example 1 that can acquire, process, and perform haptic transduction of biophysical and physiological data input from one or more of a static, quasistatic, and dynamic signal generated by dissimilar sensors, identify the most accurate signals for signal processing, generate one or more layered haptic effects to an operator, and allow programming of haptic effects based on an operator’s preferences.

[0117] Example 20 - The device agnostic haptic computing system of example 19 where said programming includes one or more of haptic signal amplitude, haptic signal frequency and haptic signal quality.

[0118] Example 21 - the device agnostic system of example 19 where said layered haptic effects are generated in part or whole by a haptic speaker or voice coil enclosed within a deformable piezoactuator cylinder that can be wearable or attached to a catheter handle, deformable piezoactuators, linear or rotary motors, smart materials, linear resonant actuators, discAttorney Docket: 95983-432709 piezoactuators, leveraged piezoactuators, electroactive polymers, stacked and non-stacked piezoceramic actuators, microscale and small scale hydraulic actuators.

[0119] Example 22 - where said haptic agnostic device of example 21 implements actuators whose haptic effects are generated at a multiple frequency relative to the sensed signal and is proportionate to the cardiac cycle.

[0120] Example 23 - the haptic agnostic system of example 16 where said haptic signals are processed and generated in locations as to optimize somatosensory recognition of biophysical and physiologic events.

[0121] Example 24 - the haptic agnostic system of example 1 implementing a reciprocating haptic sensory glove I rings I wristband / sleeve / apparatus that incorporates sensors (e.g., accelerometer, gyroscopic sensor, piezoelectric sensors) that detect actions of the operator and relationship to biophysical / physiologic events and timing of therapies being delivered and can store the data for future analysis and incorporates a polymeric material blend capable of sensing operator’s actions and delivering haptic feedback where said polymeric blend incorporates material with a Young’s elastic modulus comparable to human connective tissue.

[0122] Example 25 - the haptic agnostic system of example 24 where in the polymeric piezoelectric wearable is gently tugged from a haptic subsonic speaker I voice coil construct such that the haptic effect is conductive and directed to the one or more joints in the hand, arm and wrist.

[0123] Example 26 - A method for optimizing the functionality of the device agnostic haptic computing system by using machine learning, deep learning, artificial intelligence analysis of the collective stored data and haptic motor reaction time data of example 18.

[0124] Example 27 - A method for optimizing the functionality of the device agnostic haptic computing system by using machine learning, deep learning, artificial intelligence analysis of the collective stored data and haptic motor reaction time data of example 24.

[0125] Example 28 - The device agnostic haptic computing system of example 1 where said one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and I or force feedback proportionate in amplitude to sensed signal amplitude are likewise positioned about a graphical user haptic interface programmer along with visual displays with corresponding surround sound audio output that provides directionality, spatial, and temporal information to the user along with programmability.Attorney Docket: 95983-432709

[0126] Embodiments of the invention can also be described with reference to the following numbered clauses:

[0127] 1. An agnostic haptic feedback computing system comprising: a cardiac device and one or more dissimilar sensors incorporated with the cardiac device, a plurality of dissimilar sensors configured to sense one or more input signals based on clinical characteristics of a patient, wherein the plurality of dissimilar sensors generate one or more output signals based on the sensed input signals; a processor configured to receive and process the one or more input signals and performs haptic transduction based on the one or more input signals, wherein haptic transduction generates one or more haptic feedback output signals that stimulates one or more neuroanatomical sites of an operator of the cardiac device: and a wearable haptic display that fits along one or more anatomic sites of a user’s extremity, extends from aspects of the fingers and hand to more proximal location about the arm, and is structured, programmed, and designed as to prevent slippage, user fatigue to repeated haptic sensations, limit exposure to body fluids, and is re-usable and / or disposable, providing the user with unencumbered and full dexterous control of the extremity, arm, hand, and digits with haptic effects generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and / or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the amplitude, frequency response and qualitative haptic effect of one or more actuators, wherein the one or more sensed input signals are sensed and stored in real time during use of the cardiac device where said data was acquired from multiple interventionalists and procedures derived from a multitude of device agnostic haptic computing systems and applying one or more of machine learning, deep learning, neural networks, artificial intelligence algorithms to periodically analyze the collective stored data including but not limited to haptic motor reaction times, procedural efficacy, complications, procedural times, diagnostic and therapeutic data, as well as patient clinical variables, operator experience level, and operator chosen equipment as to optimize the system’s overall functionality and recommend ideal settings, procedural approaches, types of equipment, haptic actuators, hardware and software configurations for the programming of default and programmable setting options for specific users.Attorney Docket: 95983-432709

[0128] 2. The agnostic haptic feedback computing system of clause 1 , wherein the agnostic haptic feedback computing system is associated with a reciprocating wearable, wherein the reciprocating wearable is configured to interact with the one or more neuroanatomical sites so as to obtain measurements from a user’s actions and stimulate the one or more neuroanatomical sties.

[0129] 3. The agnostic haptic feedback computing system of clause 2, wherein the one or more neuroanatomical sites comprise one or more peripheral and central neuroanatomical sites; and wherein the reciprocating wearable provides haptic effects to at least one of kinesthetic, proprioceptive, temperature, tactile, and pressure receptors of an operator, physician in training and / or observer.

[0130] 4. The agnostic haptic feedback computing system of clause 2, wherein the reciprocating wearable includes one or more of a glove, a ring, a wristband, and a sleeve.

[0131] 5. The agnostic haptic feedback computing system of clause 1, wherein the haptic feedback effect incorporates a polymeric material with a Young’s elastic modulus approximating human connective tissue.

[0132] 6. The agnostic haptic feedback computing system of either clause 1 or 5, wherein the processor is configured to analyze the one or more input signals and detect inaccurate signals prior to haptic transduction and / or the one or more haptic feedback signals being transmitted.

[0133] 7. The agnostic haptic feedback computing system of any of clauses 1, 5 or 6, wherein the input signals based on the clinical characteristic of the patient comprise one or more of a static signal, a quasistatic signal, and a dynamic signal and the nature of the generated haptic signal is one or more of static, quasistatic, dynamic signal, wherein the nature of the sensed and generated signals can be the same or different.

[0134] 8. The agnostic haptic feedback system computing system of clause 7, wherein the input signals based on the clinical characteristic of the patient are sensed from one or more dynamic input signals of tissue motion, blood flow catheter: tissue contact force, catheter tip orientation, position and catheter stability.

[0135] 9. The agnostic haptic feedback computing system of clause 7, wherein the one or more static signals relate to a position, an orientation, a deformation of a bodily tissue, a temperature, a rendering of texture, or a biophysical signal of the patient.Attorney Docket: 95983-432709

[0136] 10. The agnostic haptic feedback computing system of clause 7, wherein the one or more quasistatic signals relate to one or more characteristic measurement(s) of the patient based on at least one of an impedance, a resistance, a capacitance, a voltage, reflected light, ultrasound, or a current representative of a status of bodily tissue subjected to an external force and a degree of contact of one or more sensors sensing from within or exterior to the patient.

[0137] 11. The agnostic haptic feedback computing system of clause 1, wherein the input signals based on the clinical characteristic of the patient relate to one or more characteristic measurement(s) of the patient, including one or more characteristic measurement(s) based on a measurable index of tissue necrosis.

[0138] 12. The agnostic haptic feedback computing system of either clause 1 or 11, wherein the cardiac device comprises one or more of a left atrial appendage occlusion device, a valvular repair / replacement hardware, an ablation system, a diagnostic cardiac system and a therapeutic cardiac system.

[0139] 13. The agnostic haptic feedback computing system of any of clauses 1. 11 or12, wherein the one or more input signals are selected from a set consisting of: anatomic signals, biophysical signals, or physiological signals.

[0140] 14. The agnostic haptic feedback computing system of any of clauses 1, 11, 12 or 13, wherein the one or more haptic actuators comprise at least one of a haptic speaker, voice coil, deformable piezoactuators, linear or rotary motors, smart material, linear resonant actuator, disc piezoactuator, leveraged piezoactuator, electroactive polymer, stacked and non-stacked piezoceramic actuator, microscale and small scale hydraulic actuator.

[0141] 15. The agnostic haptic feedback computing system of any of clauses 1, 11, 12,13 or 14, wherein the haptic system is configured to store the one or more sensed input signals and the haptic feedback output to be used with respect to future haptic effect delivery.

[0142] 16. The agnostic haptic feedback computing system of any of clauses 1, 11, 12,13, 14 or 15, wherein the one or more sensed input signals are sensed and stored in real time during use of the cardiac device.

[0143] 17. A method for agnostic haptic feedback delivery comprising: sensing, by a plurality of dissimilar sensors, one or more input signals based on clinical characteristics of a patient, wherein the plurality of dissimilar sensors are associated with a cardiac device utilized with the patient;Attorney Docket: 95983-432709 performing haptic transduction to generate one or more haptic feedback signals based on the one or more input signals; transmitting the one or more haptic feedback signals with a reciprocating wearable; designating one or more neuroanatomical sites on a user, in contact with the reciprocating wearable; and sensing and storing the one or more sensed input signals in real time during use of the cardiac device where said data was acquired from multiple interventionalists and procedures derived from a multitude of device agnostic haptic computing systems and applying one or more of machine learning, deep learning, neural networks, artificial intelligence algorithms to periodically analyze the collective stored data including but not limited to haptic motor reaction times, procedural efficacy, complications, procedural times, diagnostic and therapeutic data, as well as patient clinical variables, operator experience level, and operator chosen equipment as to optimize the system’s overall functionality and recommend ideal settings, procedural approaches, types of equipment, haptic actuators, hardware and software configurations for the programming of default and programmable setting options for specific users, where said haptic feedback signals are generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and / or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the frequency response and qualitative haptic effect of one or more actuators.

[0144] 18. The method for agnostic haptic feedback delivery of clause 17, further comprising: analyzing the sensed one or more input signals; detecting inaccurate signals prior to haptic transduction and / or the one or more haptic feedback signals being transmitted: and correcting the detected inaccurate signals.

[0145] 19. The method for agnostic haptic feedback delivery of clause 17, further comprising storing the one or more sensed input signals and the haptic feedback output enabling future haptic effect delivery.

[0146] 20. The agnostic haptic feedback computing system of clause 17 where said computing system utilizes one or more of machine learning, deep learning, neural networks, artificial intelligence algorithms to analyze diagnostic data including one or more ofAttorney Docket: 95983-432709 electroanatomical mapping, intracardiac electrograms, impedance data, voltage signals, indices of contact and contact force between a catheter and biological tissue, temperature, and ultrasound; compare analyzed diagnostic data with the real time fluoroscopic location of inserted catheters, catheter electrodes, and anatomic location of cardiac devices / implants; train the agnostic haptic feedback system to utilize a single imaging modality including but not limited to fluoroscopy or ultrasound, to provide a palpable metric of catheter: tissue contact, contact force, and catheter stability without dependency on electroanatomical mapping, intracardiac electrograms, impedance data, voltage signals, conventional indices of contact and contact force between a catheter and biological tissue, temperature, and ultrasound.

[0147] 21. The agnostic haptic feedback computing system of clause 20 where said fluoroscopic localization is applied to electrophysiology and structural heart procedures including but not limited to pulse field ablation; thermal ablation, LAAO implants, cardiac rhythm management device implants, catheter valve repair and replacement.

[0148] 22. The agnostic haptic feedback computing system of clause 21 where said machine learning, deep learning, neural networks, artificial intelligence algorithms analyze fluoroscopic localization and data acquired by reference electrodes to confirm accuracy prior to programming computing system settings that drive haptic actuators.

[0149] 23. The agnostic haptic feedback computing system of clause 22 where predictor algorithms are utilized to analyze and optimize the accuracy of haptic feedback prior to delivering haptic feedback in less than 50 millisecond time frames.

[0150] 24. The method for performing haptic transduction of clause 17 where said haptic system is trained during cardiac procedures where catheter based sensors and imaging are utilized simultaneously, including but not limited to fluoroscopy, electroanatomic mapping, ultrasound, and physiologic signals from catheters including but not limited to pressure, blood flow, tissue contact. CF, and biophysical signals and implements convoluted neural networks to analyze the visual data and cross reference conventional, non-imaging modalities as ground truth comparators, to teach the haptic operating system how to utilize imaging data including but not limited to fluoroscopy and ultrasound alone to generate haptic effects in lieu of signals normally acquired by intra-cardiac, catheter-based sensors

[0151] 25. The convoluted neural network of clause 24, where CNN based object detection and segmentation methods are implemented along with methods for tracking hierarchalAttorney Docket: 95983-432709 features on inserted catheters or cardiac implants visualized with conventional imaging modalities to detect variable scale objects and regions of interest, derive location, displacement, acceleration indices used to generate haptic feedback to a user.

[0152] The ordering of steps in the various processes, data flows, and flowcharts presented are for illustration purposes and do not necessarily reflect the order that various steps must be performed. The steps may be rearranged in different orders in different embodiments to reflect the needs, desires and preferences of the entity implementing the systems. Furthermore, many steps may be performed simultaneously with other steps in some embodiments.

[0153] Also, techniques, systems, subsystems and methods described and illustrated in the various embodiments as discrete or separate may be combined or integrated with other systems, modules, techniques, or methods without departing from the scope of the present disclosure. Other items shown or discussed as directly coupled or communicating with each other may be coupled through some interface or device, such that the items may no longer be considered directly coupled to each other but may still be indirectly coupled and in communication, whether electrically, mechanically, or otherwise with one another. Other examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the spirit and scope disclosed. The following numbered entries represent a non-exhaustive collection of exemplary embodiments of the instantly disclosed subject matter.

[0154] It should be understood that only selected embodiments have been shown and described and that all possible alternatives, modifications, aspects, combinations, principles, variations, and equivalents that come within the spirit of the disclosure as defined herein or by any of the following claims are desired to be protected. While embodiments of the disclosure have been illustrated and described in detail in the drawings and foregoing description, the same are to be considered as illustrative and not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Additional alternatives, modifications and variations can be apparent to those skilled in the art. Also, while multiple inventive aspects and principles have been presented, they need not be utilized in combination, and many combinations of aspects and principles are possible in light of the various embodiments provided above.

[0155] Any theory, mechanism of operation proof, or finding stated herein is meant to further enhance understanding of principles of the present disclosure and is not intended to make the present disclosure in any way dependent upon such theory, mechanism of operation, illustrativeAttorney Docket: 95983-432709 embodiment, proof, or finding. It should be understood that while the use of the word preferable, preferably or preferred in the description above indicates that the feature so described can be more desirable, it nonetheless cannot be necessary and embodiments lacking the same can be contemplated as within the scope of the disclosure, that scope being defined by the claims that follow.

[0156] When terms of degree such as “generally,” “substantially,” and “about” are used herein in connection with a numerical value or a qualitative term susceptible to a numerical measurement, it is contemplated that an amount that is plus or minus 10 percent, and possibly up to plus or minus 20 percent, of the numerical value, is covered by such language, unless specifically noted otherwise, to at least account for manufacturing tolerances. Otherwise, a suitable definition for “generally,” “substantially,” and “about” is largely, but not necessarily wholly, the term specified.

[0157] In reading the claims it is intended that when words such as “a,” “an,” “at least one.” “at least a portion” are used there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. When the language “at least a portion” and / or “a portion” is used, the item can include a portion and / or the entire item unless specifically stated to the contrary. It should be understood that only selected embodiments have been shown and described and that all possible alternatives, modifications, aspects, combinations, principles, variations, and equivalents that come within the spirit of the disclosure as defined herein or by any of the following claims are desired to be protected. While embodiments of the disclosure have been illustrated and described in detail in the drawings and foregoing description, the same are to be considered as illustrative and not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Additional alternatives, modifications and variations can be apparent to those skilled in the art. Also, while multiple inventive aspects and principles have been presented, they need not be utilized in combination, and many combinations of aspects and principles are possible in light of the various embodiments provided above.

Claims

Attorney Docket: 95983-432709CLAIMS:

1. An agnostic haptic feedback computing system comprising: a cardiac device and one or more dissimilar sensors incorporated with the cardiac device, a plurality of dissimilar sensors configured to sense one or more input signals based on clinical characteristics of a patient, wherein the plurality of dissimilar sensors generate one or more output signals based on the sensed input signals; a processor configured to receive and process the one or more input signals and performs haptic transduction based on the one or more input signals, wherein haptic transduction generates one or more haptic feedback output signals that stimulates one or more neuroanatomical sites of an operator of the cardiac device; and a wearable haptic display that fits along one or more anatomic sites of a user’s extremity, extends from aspects of the fingers and hand to more proximal location about the arm, and is structured, programmed, and designed as to prevent slippage, user fatigue to repeated haptic sensations, limit exposure to body fluids, and is re-usable and / or disposable, providing the user with unencumbered and full dexterous control of the extremity, arm, hand, and digits with haptic effects generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and / or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the amplitude, frequency response and qualitative haptic effect of one or more actuators, wherein the one or more sensed input signals are sensed and stored in real time during use of the cardiac device where said data was acquired from multiple interventionalists and procedures derived from a multitude of device agnostic haptic computing systems and applying one or more of machine learning, deep learning, neural networks, artificial intelligence algorithms to periodically analyze the collective stored data including but not limited to haptic motor reaction times, procedural efficacy, complications, procedural times, diagnostic and therapeutic data, as well as patient clinical variables, operator experience level, and operator chosen equipment as to optimize the system’s overall functionality and recommend ideal settings, procedural approaches, types of equipment, haptic actuators, hardware and software configurations for the programming of default and programmable setting options for specific users.Attorney Docket: 95983-4327092. The agnostic haptic feedback computing system of claim 1 , wherein the agnostic haptic feedback computing system is associated with a reciprocating wearable, wherein the reciprocating wearable is configured to interact with the one or more neuroanatomical sites so as to obtain measurements from a user’s actions and stimulate the one or more neuroanatomical sties.

3. The agnostic haptic feedback computing system of claim 2, wherein the one or more neuroanatomical sites comprise one or more peripheral and central neuroanatomical sites; and wherein the reciprocating wearable provides haptic effects to at least one of kinesthetic, proprioceptive, temperature, tactile, and pressure receptors of an operator, physician in training and / or observer.

4. The agnostic haptic feedback computing system of claim 2, wherein the reciprocating wearable includes one or more of a glove, a ring, a wristband, and a sleeve.

5. The agnostic haptic feedback computing system of claim 1, wherein the haptic feedback effect incorporates a polymeric material with a Young’s elastic modulus approximating human connective tissue.

6. The agnostic haptic feedback computing system of either claim 1 or 5, wherein the processor is configured to analyze the one or more input signals and detect inaccurate signals prior to haptic transduction and / or the one or more haptic feedback signals being transmitted.

7. The agnostic haptic feedback computing system of any of claims 1, 5 or 6, wherein the input signals based on the clinical characteristic of the patient comprise one or more of a static signal, a quasistatic signal, and a dynamic signal and the nature of the generated haptic signal is one or more of static, quasistatic, dynamic signal, wherein the nature of the sensed and generated signals can be the same or different.

8. The agnostic haptic feedback system computing system of claim 7. wherein the input signals based on the clinical characteristic of the patient are sensed from one or more dynamicAttorney Docket: 95983-432709 input signals of tissue motion, blood flow catheter: tissue contact force, catheter tip orientation, position and catheter stability.

9. The agnostic haptic feedback computing system of claim 7, wherein the one or more static signals relate to a position, an orientation, a deformation of a bodily tissue, a temperature, a rendering of texture, or a biophysical signal of the patient.

10. The agnostic haptic feedback computing system of claim 7, wherein the one or more quasistatic signals relate to one or more characteristic measurement(s) of the patient based on at least one of an impedance, a resistance, a capacitance, a voltage, reflected light, ultrasound, or a current representative of a status of bodily tissue subjected to an external force and a degree of contact of one or more sensors sensing from within or exterior to the patient.

11. The agnostic haptic feedback computing system of claim 1, wherein the input signals based on the clinical characteristic of the patient relate to one or more characteristic measurement(s) of the patient, including one or more characteristic measurement(s) based on a measurable index of tissue necrosis.

12. The agnostic haptic feedback computing system of either claim 1 or 11, wherein the cardiac device comprises one or more of a left atrial appendage occlusion device, a valvular repair / replacement hardware, an ablation system, a diagnostic cardiac system and a therapeutic cardiac system.

13. The agnostic haptic feedback computing system of any of claims 1, 11 or 12, wherein the one or more input signals are selected from a set consisting of: anatomic signals, biophysical signals, or physiological signals.

14. The agnostic haptic feedback computing system of any of claims 1, 11, 12 or 13, wherein the one or more haptic actuators comprise at least one of a haptic speaker, voice coil, deformable piezoactuators, linear or rotary motors, smart material, linear resonant actuator, discAttorney Docket: 95983-432709 piezoactuator, leveraged piezoactuator, electroactive polymer, stacked and non-stacked piezoceramic actuator, microscale and small scale hydraulic actuator.

15. The agnostic haptic feedback computing system of any of claims 1, 11, 12, 13 or 14, wherein the haptic system is configured to store the one or more sensed input signals and the haptic feedback output to be used with respect to future haptic effect delivery.

16. The agnostic haptic feedback computing system of any of claims 1, 11, 12, 13, 14 or 15, wherein the one or more sensed input signals are sensed and stored in real time during use of the cardiac device.

17. A method for agnostic haptic feedback delivery comprising: sensing, by a plurality of dissimilar sensors, one or more input signals based on clinical characteristics of a patient, wherein the plurality of dissimilar sensors are associated with a cardiac device utilized with the patient; performing haptic transduction to generate one or more haptic feedback signals based on the one or more input signals; transmitting the one or more haptic feedback signals with a reciprocating wearable; designating one or more neuroanatomical sites on a user, in contact with the reciprocating wearable; and sensing and storing the one or more sensed input signals in real time during use of the cardiac device where said data was acquired from multiple interventionalists and procedures derived from a multitude of device agnostic haptic computing systems and applying one or more of machine learning, deep learning, neural networks, artificial intelligence algorithms to periodically analyze the collective stored data including but not limited to haptic motor reaction times, procedural efficacy, complications, procedural times, diagnostic and therapeutic data, as well as patient clinical variables, operator experience level, and operator chosen equipment as to optimize the system’s overall functionality and recommend ideal settings, procedural approaches, types of equipment, haptic actuators, hardware and software configurations for the programming of default and programmable setting options for specific users.Attorney Docket: 95983-432709 where said haptic feedback signals are generated by one or more haptic actuators positioned in varying geometric arrangements as to provide tactile and / or force feedback proportionate in amplitude to sensed signal amplitude by activating an increasing number of actuators and / or modifying the frequency response and qualitative haptic effect of one or more actuators.

18. The method for agnostic haptic feedback delivery of claim 17, further comprising: analyzing the sensed one or more input signals; detecting inaccurate signals prior to haptic transduction and / or the one or more haptic feedback signals being transmitted; and correcting the detected inaccurate signals.

19. The method for agnostic haptic feedback delivery of claim 17, further comprising: storing the one or more sensed input signals and the haptic feedback output enabling future haptic effect delivery.

20. The agnostic haptic feedback computing system of claim 17 where said computing system utilizes one or more of machine learning, deep learning, neural networks, artificial intelligence algorithms to analyze diagnostic data including one or more of electroanatomical mapping, intracardiac electrograms, impedance data, voltage signals, indices of contact and contact force between a catheter and biological tissue, temperature, and ultrasound; compare analyzed diagnostic data with the real time fluoroscopic location of inserted catheters, catheter electrodes, and anatomic location of cardiac devices I implants; train the agnostic haptic feedback system to utilize a single imaging modality including but not limited to fluoroscopy or ultrasound, to provide a palpable metric of catheter: tissue contact, contact force, and catheter stability without dependency on electroanatomical mapping, intracardiac electrograms, impedance data, voltage signals, conventional indices of contact and contact force between a catheter and biological tissue, temperature, and ultrasound.

21. The agnostic haptic feedback computing system of claim 20 where said fluoroscopic localization is applied to electrophysiology and structural heart procedures includingAttorney Docket: 95983-432709 but not limited to pulse field ablation; thermal ablation, LAAO implants, cardiac rhythm management device implants, catheter valve repair and replacement.

22. The agnostic haptic feedback computing system of claim 21 where said machine learning, deep learning, neural networks, artificial intelligence algorithms analyze fluoroscopic localization and data acquired by reference electrodes to confirm accuracy prior to programming computing system settings that drive haptic actuators.

23. The agnostic haptic feedback computing system of claim 22 where predictor algorithms are utilized to analyze and optimize the accuracy of haptic feedback prior to delivering haptic feedback in less than 50 millisecond time frames.

24. The method for performing haptic transduction of claim 17 where said haptic system is trained during cardiac procedures where catheter based sensors and imaging are utilized simultaneously, including but not limited to fluoroscopy, electroanatomic mapping, ultrasound, and physiologic signals from catheters including but not limited to pressure, blood flow, tissue contact, CF, and biophysical signals and implements convoluted neural networks to analyze the visual data and cross reference conventional, non-imaging modalities as ground truth comparators, to teach the haptic operating system how to utilize imaging data including but not limited to fluoroscopy and ultrasound alone to generate haptic effects in lieu of signals normally acquired by intra-cardiac, catheter-based sensors25. The convoluted neural network of claim 24, where CNN based object detection and segmentation methods are implemented along with methods for tracking hierarchal features on inserted catheters or cardiac implants visualized with conventional imaging modalities to detect variable scale objects and regions of interest, derive location, displacement, acceleration indices used to generate haptic feedback to a user.

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