The present invention generally relates to a minimally-invasive, hand-held surgical interface that provides real time haptic feedback of tissue mechanics and intra-cardiac fluid dynamics. More particularly, embodiments of the present invention relate to a surgical haptic handle and system useful to provide the operator haptic feedback in therapy interventions involving a balloon tip catheter.
As conventionally designed cardiac catheters course through the tissues and vasculature of a patient the operator looses his or her ability to appreciate the forces restricting catheter motion, tissue properties, anatomic information and clinically important physiological signals due to the attenuation and frictional effects of intervening tissues and the compliant nature of the inserted catheters. Physiologically relevant properties of biological tissue, vascular structures and blood flow are unable to be appreciated qualitatively or measured quantitatively during percutaneous cardiac procedures.
In response to limitations of current technologies, the present inventor Dr. Stuart O. Schecter has designed specific sensor constructs, catheters/conductors and handles. These designs are capable of providing an operator with real time tactile feedback, force feedback, an operating system, and a haptic display/interface that provides physiological information, guides percutaneous cardiovascular procedures, lowers complications rates, improves outcomes, and reduces procedural times. Examples of prior works of Dr. Schecter, in the area of haptics include: U.S. Pat. No. 7,963,925, entitled “Method and Apparatus for Defining the Effect of Atrial Arrhythmias on Cardiac Performance And Directing Therapy Using a Plurality of Intrinsically and Extrinsically Derived Signals,” which discloses a catheter with a sensor and handle arrangement that provides real-time, proportional haptic feedback; U.S. Pat. Pub. No. 2012-0265076 A1, entitled “Microfabricated Cardiac Sensor with Tactile Feedback and Method and Apparatus for Calibrating the Same Using a Plurality of Signals”; U.S. Pat. Pub. No. 2012-0265083 A1, entitled “Cardiovascular Haptic Handle System”; and others.
Wallace D, et al has developed a robotic catheter manipulator that includes at least one force sensor for measuring the force applied to the working catheter by a ditherer during operation (See U.S. Pat. Pub. Nos. 20070233044 and 20070197939). Force measurements are estimated and displayed to the physician via a monitor or display. Such a design is found in ablation catheters manufactured by Hansen Medical Inc., Mountainview, Calif. Though an alarm signal can notify the operator that too high a force is applied via an audio, video or haptic signal, there is no tactile appreciation or simulation of tissue mechanics/motion or blood flow present at the distal portion of the catheter.
Companies such as Intuitive, manufacturer of the DaVinci robot, (See U.S. Pat. No. 8,004,229, Software center and highly configurable robotic systems for surgery and other uses) and Hansen Medical (See U.S. Pat. No. 7,974,681, Robotic catheter system) implement haptic feedback systems that provide notification signals and vibrotactile sensations as an alert when too much force is applied or to direct a user controlling robotic and telesurgical operative systems but are not applicable to bedside catheter based diagnostic and therapeutic procedures. These systems also do not provide the operator with tangible sensations that are physiologically relevant.
While these patents and applications provide new and novel systems and methods for minimally invasive, hand-held surgical interfaces with haptic feedback, it would be desirable to provide improvements that specifically enhance catheter balloon therapy interventions and the catheter therapy delivery components used in such procedures (e.g. U.S. Pat. No. 6,780,183).
Embodiments of the present invention are directed to a catheter handle which functions as a hand held haptic interface including at least a balloon shaped portion for feedback and control of an interventional balloon tipped catheter. The handle may be described as an optimally configured volumetric haptic display that provides real time feedback of tissue mechanics and intra-cardiac fluid dynamics and blood flow in connection with a balloon tip catheter. The handle presents this feedback to the operator as if he or she is the actual anatomic tissue being instrumented. The technologies described herein serve to provide an operator with a haptic display that uses sensors to acquire physiologically relevant data and relay such data in analog and/or digital form, in real time, to a hand held volumetric haptic display that incorporates actuators/components that are preferably the same or similar at both the distally located end-effector and proximally located catheter handle used at the patient bedside. The data can be used to guide procedures and provide clinically relevant diagnostic information.
Embodiments of the invention include a haptic handle system for balloon-tipped catheter interventions that provides real-time haptic feedback in the form of tangible sensations to an operator. The system includes a catheter assembly including a catheter including an elongate body having a proximal end and a distal tip and an end effector, including an interventional balloon having a plurality of sensors, located proximate the distal tip of the catheter. The system further includes a haptic handle coupled to the proximal end of the catheter, where the haptic handle including a balloon-shaped haptic interface that exhibits geometric characteristics reflecting an anatomy of the interventional balloon and provides tangible sensations representative of tissues surrounding the interventional balloon. The haptic handle system further includes a control unit operably connected to the catheter assembly that acquires data from the plurality of sensors and directs actuation of the haptic interface.
Other embodiments of the invention include a haptic handle for balloon-tipped catheter interventions that provides real-time haptic feedback in the form of tangible sensations to an operator holding the handle. The haptic handle including an expandable balloon-shaped haptic interface that exhibits geometric characteristics reflecting an anatomy of a corresponding inflated balloon of a balloon-tipped catheter and sensations representative of the properties of tissue surrounding the corresponding inflated balloon. The expandable balloon-shaped haptic interface includes a plurality of actuators.
Other embodiments of the invention include a haptic handle system for balloon-tipped catheter interventions that provide real-time haptic feedback in the form of tangible sensations to an operator, including a catheter assembly and a bimanual haptic handle. The catheter assembly comprising: a catheter with an elongate body having a proximal end and a distal tip; and an interventional balloon located proximate the distal tip of the catheter. In this haptic handle system, the bimanual haptic handle is coupled to the proximal end of the catheter and includes a haptic interface that exhibits geometric characteristics reflecting an anatomy of the interventional balloon and provides tangible sensations representative of tissues surrounding the interventional balloon. The bimanual haptic handle including means to impart haptic feedback to both hands of the operator where the haptic feedback is imparted to a first more distally located section for one hand and a second more proximally located section for another hand.
Further embodiments of the invention include methods of operation for a haptic handle system. Methods include providing a haptic handle for balloon-tipped catheter interventions, including an expandable balloon-shaped haptic interface with a plurality of actuators. Methods include reproducing geometric characteristic reflecting an anatomy of a corresponding inflated balloon of a balloon-tipped catheter and sensations representative of the properties of tissue surrounding the corresponding inflated balloon with the expandable balloon-shaped haptic interface in real-time.
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
The invention may be embodied in other specific forms without departing from the essential attributes thereof. The illustrated embodiments should be considered in all respects as illustrative and not restrictive.
The inventor has recognized limitations, deficiencies, needs and general characteristics of past medical surgical equipment and procedures across a variety of areas to develop the current haptic handle concepts. Some of these areas are discussed in the following:
Catheters
Medical catheters 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, electrodes, deliver contrast (e.g. radiopaque dye) or ablative energy in form of electromagnetic energy (e.g. current, radiofrequency energy, light), thermal energy (e.g. cryoablation) and are flexible as described by Brock et al in U.S. Pat. No. 7,931,586 and others.
Catheters for performing coronary/peripheral angiography and vascular interventions are also well understood by those experienced in the art. Catheters have been designed for engaging the coronary sinus and positioning pacing leads about the left ventricle for cardiac resynchronization therapy that is often difficult and time-consuming requiring large amounts of radiation exposure. These catheters can also dissect vessels and intracardiac structures leading to cardiovascular collapse. Unfortunately, the operator cannot appreciate the forces along the distal portion of these catheters and mainly relies on radiographic images during catheter manipulation (e.g. fluoroscopy). These images are two-dimensional and necessitate exposure to radiation. Tactile feedback systems incorporated into the design of these catheters would reduce complication rates, expedite procedures and minimize radiation exposure to the operator and patient alike.
Catheters at highest risk for causing complications include those used for atrial fibrillation ablation. Ablation of atrial fibrillation can be accomplished by delivering thermal energy to cardiac tissue, radiofrequency energy, laser energy and cold via cryoablation. Balloon tip catheters are used for cryoablation and involve expanding a balloon at the distal tip of the inserted catheter within the pulmonary venous os. Complications that can occur as a result of ablating tissue about the pulmonary veins include pulmonary venous stenosis, recurrent atrial fibrillation secondary to incomplete ablation, cardiac perforation/tamponade, diaphragm paralysis and stroke. The latter complication occurs from thromboembolism where a blot clot within the heart embolizes to the brain. The left atrial appendage (LAA) is usually where clots lodge and catheter manipulation or ablation within the LAA increases the likelihood of stroke. The LAA is proximate to the left upper pulmonary vein and catheters can be situated mistakenly in the LAA rather than the pulmonary vein. The pulmonary vein and LAA have characteristic tissue motion and blood flow properties that can be differentiated with tactile feedback as described in more detail below.
Recent studies have found cryoablation to be significantly more effective than medication, and patients generally experience less pain than with radiofrequency ablation. Using cold, rather than heat, to disable damaged tissue reduces the chances of impacting healthy heart tissue and surrounding structures. To perform cryoablation, a doctor inserts the balloon catheter into a blood vessel, usually in the upper leg, and then threads it though the body until it reaches the heart. This narrow tube has an inflatable balloon on one end that engages the pulmonary vein. Using advanced imaging techniques, the doctor is able to guide the catheter to the heart but imaging does not provide three dimensional confirmation of anatomic location or provide the operator with feedback about catheter tissue contact or tangible sensations characteristic of anatomic location and cardiac function.
The specific application of a tactile feedback system to such catheter designs will enable the operator to palpate tangible sensations due to blood flow and tissue mechanics thereby improving procedural success and reducing complications. Though the technologies discussed in this disclosure focus on the application of this technology for pulmonary vein ablation using cryoablation techniques, they can be applied to a variety of procedures using balloon tipped catheters within the heart and vasculature (e.g. engaging the coronary arteries and stent deployment, coronary sinus, and performing peripheral vascular interventions).
Handles
Conventional handles at the proximal end of an inserted catheter allow the operator to manipulate inserted catheters. Handles are used for positioning pacemaker leads, catheters, or intravascular delivery/extraction systems, integrated into ablation catheter systems and the like.
Sensors
Miniaturized sensors such as piezoelectric sensors or accelerometers are under development and hold promise to acquire intra-cardiac data representative of myocardial wall motion. Accelerometers can be placed along the body of the catheter and distally about electrodes or implanted leads positioned to be juxtaposed to cardiac ventricular wall locations, such as the left ventricle free wall, right ventricle free wall, and the anterior/septal/lateral wall or other intra-cardiac (e.g. endovascular) and extra-cardiac surfaces (e.g. epicardial). The accelerometers produce signals in response to the motion of the ventricular wall locations that relate to mechanical tissue characteristics during the cardiac cycle. An example of how this technology can be applied to programming of timing intervals within an implanted CRM device can be found in U.S. Pat. No. 7,127,289 by Yinghong Yu, which is hereby incorporated by reference herein.
Aeby and Leo invented tri-axial force sensors that use optical fibers to generate variable intensities of light as a function of deformation See U.S. Pat. Pub. No. 20080009750, which is hereby incorporated by reference herein. This system provides the operator with measurements of contact forces at the catheter's distal end but does not provide tactile feedback simulating cardiac mechanics.
Advances in nanotechnology have enabled fabrication of discrete carbon nanotube based nano-scale force sensors with specific spatial orientations using electron beam lithography (Stampfer, C.; Jungen, A.; Hierold, C. Sensors, 2004. Proceedings of IEEE. Volume, Issue, 24-27 Oct. 2004 Page(s): 1056-1059 vol. 2). Singh et al. (Nanotechnology 2007 18 475501) demonstrate the design and calibration of an individual carbon nanotube (CNT) based mechanical force sensor for measuring cell wall compliance using a micromanipulator inside a scanning electron microscope. These micromachined piezoelectric sensors can calculate the bending modulus of individual multi-walled carbon nanotubes. Ezhilvalavan S, et al. fabricated freestanding lead zirconate titanate force sensors as a parallel plate capacitor structure in various shapes and dimensions (J. Phys 2006.: Conf. Ser. 34 979-984). Kim, Jong-ho developed piezoelectric force sensors (See U.S. Pat. Pub. No. 20050262676) that detect contact pressure along vertical and horizontal axes using oxide metal films and in U.S. Pat. Pub. No. 20060059997. U.S. Pat. Pub. Nos. 20050262676 and 20060059997 are hereby incorporated by reference herein. Kim, Jong-Ho et al also designed a wiring structure for a tri-axial piezo-resistive force sensor placed in multiple directions to sense a contact force with respect to X and Y axes in parallel with a substrate and the Z axis perpendicular to the substrate. MEMS based sensors can also be utilized. Wireless piezoelectric sensors using resonant radiofrequency cavities convert mechanical properties of attached structures into electrical signal changes (Chuang J eta 1. Embeddable wireless strain sensor based on resonant RF cavities. Rev. Sci. Instrum., vol 76, no. 9, p 094703, 2005). These sensors can be used to acquire signals at and about the end-effector of inserted cardiac instrumentation. Wireless displacement sensors based on reverse design of microwave and millimeter-wave antenna arrays have recently developed for structural monitoring purposes (Rizzoli V, et al. A New Wireless Displacement Sensor Based on Reverse Design of Microwave and Millimeter-Wave antenna Array. IEEE Sensors Journal, Vol. 9, No. 11, November 2009. p 1557).
Haptics
Currently available haptic displays include but are not limited to programmable keyboards, augmented mice, trackballs, joysticks, multi-dimensional point and probe-based interactions, exoskeletons, vibro-tactor arrays, gloves, magnetic levitation, and isometric devices (Burdea, G C. Force and Touch Feedback for Virtual Reality. New York: Wiley Interscience, 1996).
Simplified tactile virtual reality interface devices are known by those experienced in the art and have been used in game controllers. These interface devices are becoming more complex as to better simulate sensations such as hitting a tennis racket. See the Handheld computer interface with Haptic Feedback of U.S. Pat. Pub. No. 20110121953 to Grant et al, which is hereby incorporated by reference herein. Haptic technology has been used to simulate medical procedures, for example, for teaching purposes. See U.S. Pat. Nos. 5,389,865 and 5,769,640 to Jacobus et al., which are each hereby incorporated by reference herein.
Cryoablation Systems
During cryoablation for treatment of atrial fibrillation a balloon is positioned at the ostium of the pulmonary vein, and extreme cold energy flows through the catheter to destroy this small amount of tissue and restore normal sinus rhythm. Examples of balloon based catheters include the Arctic Front® Cardiac CryoAblation system (Medtronic CryoCath LP) and the Cardiofocus Endoscopic Ablation System.
The Artic Front CryoAblation system is engineered with a balloon-within-a-balloon design. Liquid nitrous oxide is passed within the inner balloon. A constant vacuum is applied between the balloons to prevent any leakage of refrigerant should the inner balloon be defective. The cryoballoon is available in 23 mm and 28 mm sizes in order to accommodate varying pulmonary vein anatomy. The balloon is advanced over a 0.035 inch wire via the 12 Fr FlexCath® unidirectional steerable sheath. The balloon itself has 45 degrees of bidirectional movement. Any tissue in contact with the balloon freezes with tissue temperatures reaching below minus 50° C. as the liquid nitrous oxide expands to gas. The freeze renders the tissue electrically inert. As a result, the pulmonary veins become electrically isolated when balloon cryothermal ablation is applied to the antrum of the pulmonary veins. This system allows monitoring of pulmonary vein electrical activity so the operator can better identify when complete electrical isolation of the pulmonary vein has been achieved, though recurrent atrial arrhythmia remains frequent with currently available technology. The latter is accomplished with the Achieve Mapping Catheter which has a 15-20 mm mapping diameter and 8 electrodes and is delivered through the CryoBalloon during ablation procedures.
The Cardiofocus Endoscopic Ablation System includes a disposable, 12F, multi-lumen catheter which has an inflatable balloon at its distal end made of a compliant material and is specially shaped to provide wide areas of contact within the pulmonary vein ostium. The balloon size is dynamic as a function of the pressure used to provide inflation. It can span from 20 mm to over 30 mm in diameter. An Arc Generator laser delivery fiber, included with the catheter, provides the conduit to deliver a 30-degree arc of laser energy. The Arc Generator is advanced through the central lumen of the Balloon Catheter for energy delivery. The fluid within the balloon is used to cool the arc generator and passes through the central lumen of the catheter. Separate lumens are available for balloon inflation/deflation, endoscope access and illumination. The system is delivered through a 12 French deflectable sheath introducer that performs transeptal puncture and accesses each of the four pulmonary veins and has a 500 micron, re-usable endoscope for visualization during positioning of the catheter and balloon.
Benefit of Haptic Feedback
Central nervous system processing of tactile stimuli and reaction times to tactile information are faster than to visual stimuli and the presence of haptic feedback improves attention, cognition and performance. The Multiple Resource Theory of attention explains that people have separate pools of attentional resources for the different sensory modalities and that tactile displays are particularly advantageous in situations where auditory and visual channels are heavily loaded, providing faster reaction times than visual feedback alone, especially for alerting operators to unexpected, high priority events and as a redundant cue to visual alerts. With haptic feedback, the operator will not need to visualize another display in addition to focusing on radiographic images, intracardiac electrical data, hemodynamic monitoring, and 3D navigational images. See United States Army Research Laboratory: A Review and Meta Analysis of Vibrotactile and Visual Information Displays, September 2009.
No conventionally available ablation catheters provide the operator with real time reproduction of tissue motion or blood flow. It is recognized that the ability to appreciate intra-cardiac tissue mechanics, blood flow and other physiologically relevant properties will improve procedural success, reduce procedural times, and limit risk of complications such as pulmonary venous stenosis and cardiac perforation. Embodiments of the present invention include a hand held volumetric haptic display that reproduces the physical events occurring at the catheter's distal aspect (e.g. proximate to or about the balloon tip) for the operator at the handle or proximal end of the catheter. The system acquires real time diagnostic information about the vasculature (e.g. pulmonary venous anatomy, coronary artery properties), tissue mechanics, the surrounding structures (e.g. LAA), and the fluid dynamics of intracardiac and intravascular blood flow. In one embodiment, the system is used in conjunction with a catheter based system with one or more expandable balloons at its distal end used for treatment of obstructive vascular lesions or the delivery of therapeutic energy or medications, as described in detail below.
Pulmonary Vein and Pulmonary Venous Blood Flow
Though embodiments of this invention are primarily described in the context of ablation procedures for the treatment of atrial arrhythmias (e.g., pulmonary vein isolation), they are in no way limited in scope and spirit and are applicable to intravascular and intracardiac procedures, transcutaneous aortic valve replacement, valvuloplasty, mitral valvular repair/replacement, coronary and endovascular angioplasty/stent deployment, etc.
The four pulmonary veins are large blood vessels that carry blood from the lungs to the left atrium. They carry oxygenated blood to the heart prior to delivery of the oxygenated blood to the body's tissues. Equipment designed to perform procedures for curing atrial fibrillation aim to ablate the electrical pathways between the pulmonary vein and left atrium. Ablation procedures for atrial fibrillation are being performed with increasing frequency with patients often having two or more repeat procedures. One of the most serious complications is the development of pulmonary vein stenosis. The presentation of pulmonary vein stenosis varies widely. The majority of patients are symptomatic although specific referral bias patterns can affect this. Symptoms may include dyspnea or hemoptysis or may be consistent with bronchitis. Progression of stenosis is unpredictable and may be rapid, (Pulmonary Vein Stenosis Complicating Ablation for Atrial Fibrillation: Clinical Spectrum and Interventional Considerations. David R. Holmes, JrJ Am Coll Cardiol Intv, 2009; 2:267-276) with dramatic increases in pulmonary venous inflow resulting (Tabata, T. et al. J Am Coll Cardiol, 2003; 41:1243-1250).
Pulmonary vein narrowing demonstrated on cardiac MRI has been found to occur in 24-38% of patients having undergone just one AF ablation procedure (Pulmonary Vein Anatomy in Patients Undergoing Catheter Ablation of Atrial Fibrillation: Lessons Learned by Use of Magnetic Resonance Imaging. Kato R et al. Circulation. 2003; 107: 2004-2010 and Incidence and Predictors of Pulmonary Vein Stenosis Following Catheter Ablation of Atrial Fibrillation using the Anatomic Pulmnoary Vein Ablation Approach: Results from Paired Magnetic Resonance Imaging. Dong J et al. J Cardiovasc Electrophysiol 2005, Vol 16, pp. 845-852). Progression of pulmonary vein stenosis can occur over time (Dill T et al. Circulation 2003; 107, 845-850) and can lead to chronic pulmonary conditions, persistent cough, hemoptysis, pleural effusions, congestive heart failure and pulmonary hypertension. Pulmonary vein ostium shape and orientation has been shown to be predictive of occlusion in patients with drug-refractory paroxysmal atrial fibrillation undergoing cryoballoon ablation (“CBA”); (Sorgente, A. et al. Europace (2011) 13 (2): 205-212). CBA techniques may suffer from an inability to create an adequate seal within varying atrial/pulmonary venous geometric anatomy and incomplete ablation. Phrenic Nerve Palsy resulting from inappropriate cryoballoon to PV diameter leading to undersized balloons being positioned too deeply within the PV (Chun KR et al. J Cardiovasc Electrophysiol. 2009; 20(11)1203-1210), while oversizing the balloon results in distortion of the PV orifice and shorter distances between the cryoballoon and phrenic nerve with resulting impingement (Sarabanda A V et al. JACC 2005; 46(10):1902-1912).
The frequency of pulmonary vein stenosis is expected to increase in patients undergoing more than one ablation procedure. Serial evaluation of the pulmonary veins and atrial mechanical function is possible with haptic based monitoring. Pulmonary venous stenosis results in increases in blood flow velocity and turbulence (Pulmonary venous flow by doppler echocardiography: revisited 12 years later. Tomotsugu T et al. J Am Coll Cardiol, 2003; 41:1243-1250, Robbins I M, Colvin E V, Doyle T P, et al. Pulmonary vein stenosis after catheter ablation of atrial fibrillation. Circulation. 1998; 98:1769-1775). This can be appreciated qualitatively and quantitatively with the haptic technology described herein as is discussed in more detail below. This technology will also enable the clinician to derive information about intracardiac anatomy (e.g. based on the shape of an inflated cryoballoon) which can be appreciated tactually and characterized by an operator holding the haptic handle, as described in more detail below.
Atrial Mechanics
Though ablation of atrial fibrillation is aimed at improving clinical symptoms, and in theory, improving cardiac function and atrial mechanical characteristics, data is emerging that scarring after ablation can affect LA transport and systolic function and lead to progressive dyspnea even in the absence of pulmonary vein stenosis. This Stiff Left Atrial Syndrome, characterized by pulmonary hypertension, has recently found to be more often diagnosed in post-ablation patients despite persistent sinus rhythm (Gibson D N et al. Stiff left atrial syndrome after catheter ablation for atrial fibrillation: Clinical characterization, prevalence and predictors. Heart Rhythm, Vol 8, No. 9, 2011). The authors diagnosed this syndrome of diastolic LA dysfunction based on invasive hemodynamic measurements using right heart catheterization (echocardiographic techniques were non-diagnostic). Regional mechanical abnormalities have also been noted along the roof of LA based on CT imaging in four dimensions in a separate study (Tsao H M et al. J Cardiovasc Electrophysiol 2010; 21: 270-277). In a recently published study stroke risk was found to be associated with ablation of atrial fibrillation after radiofrequency and cryoablation MAZE procedures. Patients at highest risk were found to have impairments in atrial mechanical function and increased atrial dimensions (Buber J. et al. J Am Coll Cardiol, 2011; 58:1614-1621). Of note, patients with impairments in atrial mechanical function, despite being in normal sinus rhythm, had a five fold increase in thromboembolic stroke at mean follow-up of two years (n=150).
The ability to measure and qualitatively appreciate left atrial mechanical function and pulmonary venous inflow before, during and after ablation procedures with the technologies described herein will provide the operator with a means for identifying physiologic indices that herald the development of pulmonary venous stenosis and Stiff Left Atrial Syndrome. A means for digitizing and storing acquired data during ablation procedures will enable objective assessment of acquired data, especially for patients undergoing multiple ablation procedures who are at higher risk for such complications. As more patients are expected to undergo repeat procedures and the total number of patients suffering from complications due to ablative techniques increase, there will be an increased need to identify sub-clinical findings that preempt clinically significant consequences.
Sensor Design
In order to accurately acquire the most relevant physiologic data during balloon cryoablation, embodiments of the present invention include sensor systems that utilize nanotechnology (e.g. circumferentially positioned nanosensors). In one embodiment, more than one sensor type (e.g. force sensors) and multiple sensors are used to gather real time physiologic information such as the contact force between the balloon and tissue (e.g. endothelium at the pulmonary venous os, intravascular tissue during angioplasty procedures), deformation of the balloon, tissue motion and blood flow (e.g. identifying pulmonary venous stenosis, intra-coronary stenosis) for representation in the haptic display.
Embodiments of the present invention are not limited in sensor design and other types of sensors including but not limited to electromagnetic systems (e.g. fiberoptics), conventional piezoelectric materials, miniaturized strain gauges, electrically based sensing systems (e.g., resistive, impedance, current, voltage, admittance, etc.), and shape-memory-alloys can be used to gather information about tissue mechanics and multiple actuator types used to provide haptic feedback. Nor is its application limited in scope and spirit as it applies to other interventional procedures (angioplasty, stent deployment, endovascular procedures etc.) where haptic feedback will provide the operator with a tactile appreciation of physiological and anatomic properties from a novel vantage point. Embodiments of the present invention enable the operator to feel what it would be like to be the anatomic tissue being treated in situ, in real time.
Referring to
Each of multiple sensors or sensor strips 22 are deployed in specific regions of one or more segments or sections of an inserted catheter and/or its attachments. These acquire data in large part from regions of interest that are assigned to specific, associated regions of the hand held haptic display or interface of the haptic handle 12. Thus, the operator perceives tangible haptic sensations associated with locales and appreciates regional information. By way of example, during deployment of intravascular stents or prosthetic heart valves, cryotherapy of cardiac tissue with inflatable balloons, valvuloplasty and the like, sensors located in areas where there is inadequate contact between the delivery mechanism (e.g. inflatable balloon) and/or deployed therapeutic device and the tissue undergoing treatment will generate a different signal (e.g. piezoelectric voltage) due to less force, deformation, displacement than neighboring regions of interest. This is palpable at the haptic interface 16 (e.g., balloon shaped or ellipsoid handle portion). In one embodiment, the operator can adjust force manually (e.g., pneumatic, hydraulic, electric), automatically or robotically in these regions by selectively controlling the pressure or force generated along different anatomic segments via one or more controllers on the haptic interface 16 or in a separate location. This is of particular benefit when the treated areas have anisotropic anatomic (i.e. geometric) or physical properties (e.g, elasticity, rigidity). For example, the pulmonary venous os may be shaped in a non-circular fashion and require cryoablation balloons to exert different degrees of atmospheric pressure in neighboring regions in order to effectively ablate tissue, and certain stenotic vessels or cardiac valvular tissue may require greater expansion due to calcified intravascular plaque along a portion of the circumference of the treated vessel or valve. Certain segments will require more pressure during stent or prosthetic valve deployment in order to avoid future restenosis, or regurgitation of blood, respectively. It is not mandatory for the user to know the precise anatomic location the tangible sensations are associated with, though in one embodiment of the invention, external positioning systems or navigational systems (e.g., electric, magnetic) could be used to localize specific segments of the inserted treating member. In one embodiment, blood flow properties are appreciated. For example, laminarity, turbulence, regional regurgitant blood flow jets are palpable.
In one embodiment, the sensor(s) is/are situated between two or more layers of material (i.e. sandwiched between two balloons) or one layer (or balloon) is composed of sensor material (e.g. piezoelectric material/composite) or, by way of example, disposed of as segments located at specific locations about or within the balloon that has a length of between 5 and 15 mm.
In another embodiment, wires deployed via the catheter assembly are capable of sensing tissue motion and/or blood flow as known as those experienced in the art (e.g., Doppler flowires). These wires can serve the purpose of acquiring data and guiding the catheter assembly into the correct anatomic position (e.g., within the coronary sinus and its branches, pulmonary venous os, coronary arteries, peripheral vasculature, etc.) and measure physiologically relevant signals such as blood flow velocity outside of an inserted catheter and within an inserted catheter (Guiding Catheters with Side Holes Relieve Pressure Damping and Improve Coronary Blood Flow: Assessment with the Doppler Flowire. Schecter et. al. Circulation 1994; 90: 4, part 2: I-164.) This physiologically relevant data is then recreated in real time at the level of the hand held haptic interface using haptic feedback.
In another embodiment, multiple microfabricated sensors (e.g. MEMS based or nanosensors) are located about the inflatable balloon and “innervate” multiple conductors and transducers at the operator's haptic handle 12. The advantage of this construct is that such a sensor design enables information about contact uniformity to be palpable. By way of example, multiple miniaturized strain gauges or four ZnOxide nanoribbon constructs or arrays of nanowires (Hansoo Kim and Wolfgang Sigmund. Zinc oxide nanowires on carbon nanotubes. Appl. Phys. Lett. 81, 2085 (2002)) are positioned 90 degrees apart along the long axis of the balloon 20. Each separate sensor construct acquires motion data and generates a current signal along multiple (e.g. four) separate conductors (e.g. carbon nanotube conductors (CNTC), hybrid conductors). Each conductor activates a different actuator in the haptic handle 12 and thus imparts a reciprocating haptic effect (e.g., vibrotactile and/or force signal) representative of regional motion information along each of the individual segments (e.g., four quadrants 70) of the haptic handle 12, as shown in
Referring now to
In yet another embodiment, balloon inflation occurs in response to the operator squeezing the haptic handle 12 or segments of the handle as to modify the regional delivery of pressure along specific portions of the balloon 20 that may require more or less inflation due to anisotropic geometry or variable tissue properties. This can occur with a variety of mechanisms including electronic, hydraulic, pneumatic systems and when a haptic interface is present, it can be accomplished manually by the user's response to palpable sensations at the handle 12 that are representative of real time events. Forces and vibrations are reciprocal between the in situ end-effector 14 and hand held haptic handle 12. Multiple sensor technologies can be utilized to acquire force and vibration data at both the end effector 14 and haptic handle 12 as discussed in more detail below.
Actuating Sensor Design
Referring to
Actuators that utilize the piezoelectric effect have very fast reaction times and high dynamics as well as durability. Examples of actuators that can be implemented for generating tangible sensations representative of intra-atrial and pulmonary venous anatomy, blood flow and physiology include linear actuators, piezotronics, piezoactuators, stacked actuators, ending actuators, ultrasonic actuators, uchinomotors, stepper motors (Kern TA. Engineering Haptic Devices. (Ed.) 2009, XXXI, 472 p. 243-276). Though specific piezoelectric actuators are discussed in detail herein, embodiments of the present invention are not limited to any specific type of actuator and alternate actuators (e.g. electrostatic, electrodynamic, electromagnetic, magnetic, magnetorheologic, electrorheologic, linear actuators, rotary motors).
In one preferred embodiment, the actuator and sensor/transducer are both piezoactuators possessing high degree of precision, high bandwidth, fast response times, and submicron precision. As an actuator, these piezoactuators function by the inverse piezo effect and deform when a voltage is applied (e.g., DuraAct patches, Physik Instrumente). This contraction/deformation is controlled by affixing the actuator to a substrate material that confines and directs the deformation to conform to certain geometric shapes (profile or shape control). For example, the piezoactuator is affixed in between or underneath elastic thermoplastic polymer inlays or similar material which is positioned along key portions of a hand held handle as depicted in
In one embodiment, the handle 12 is comprised in part with an outer material balloon segment 160 circumferentially positioned about the handle exterior constructed of composite material that has similar properties to cardiac tissue and vasculature. The texture of the material (rubber, silicone, ridged, etc.) may be fabricated as to enable the operator to feel as if his or her hand is the actual anatomic tissue being treated. In one application of an embodiment of the invention, the inside of the outer material balloon segment 160 has acoustically conductive material or gel. Smart fluids and/or smart materials can be utilized to accomplish this as described in more detail below. In one embodiment, the balloon-like haptic interface 16 of the handle 12, is attached to a segment 162 that enables the catheter to be detachable from the inner components/actuators, so the haptic handle 12 can undergo sterilization and be separated from a disposable outer exoskeleton/catheter construct. Thus, in this embodiment, the main working components of the handle 12 are reusable and need not be sterilized. An outer sheath or glove can encase the handle 12 if needed for additional protection from blood and body fluids and to maintain sterility if needed. The detachment mechanism is not limited to any particular construct.
In one embodiment, a multi-fingered haptic glove and/or outer envelope with additional actuators encasing the user's hand is implemented to extend the properties of the haptic display. By way of example, such a construct will enable the operator to have a sense of enclosure or experience compressive forces along the outer surface of the hand and in between the digits.
The tail 164 of the handle 12 in yet another embodiment, contains any needed hardware, firmware or software and can be detachable. Alternatively, the control unit can be in a separate location wired or wirelessly connected to the haptic handle 12. In an alternate embodiment, the tail 164 of the handle 12 is fitted with actuators, position sensors, gyroscopes and the like to provide additional haptic and/or force feedback, and to counteract geodesic forces thereby rendering the haptic handle 12 virtually weightless, while monitoring three dimensional handle position in real time.
In yet another embodiment, the handle 12 can be attached or an integral part of a force feedback tele-robotic interventional system and provide more detailed and subtle tactile/haptic feedback.
Volumetric Reciprocating Haptic Handle
Haptic effects used to recreate the feel of moving biological tissue can be realized with a handle design and actuator assembly that anatomically mimics human phasic, tactile mechanoreceptors that are found in skin tissue. An illustration 170 showing Meissner's corpuscles is shown in
In order to enable the user to feel as if her or his hand is actual human tissue, the end effector 14 and haptic handle 12 are constructed with a design that is similar to human anatomy.
Global positioning systems or alternate navigational systems (e.g. electromagnetic, magnetic, admittance, thermal, impedance based, visual, handle based position sensors etc.) enable an accurate 3D representation between end-effector 14 and the haptic handle 12 during active manipulation of the handle 12 in real time. Thus, for example, superior located sensors relative to patient position are represented in the superior most quadrant 202 of the haptic handle 12. Likewise, as seen in
In one embodiment, the regionally located actuators consist of ultrasonic or piezoelectric actuators with circular resonators 72 (Kern TA. Engineering Haptic Devices. (Ed.) 2009, XXXI, 472 p. 254) or linear actuators 74 that produce standing waves within each of multiple fluid filled compartments in the haptic handle 12. For example, four compartments are shown in
Parametric imaging can be used to visually display anatomic data with superimposed physiological data (e.g. elastance of pulmonary os, regional properties of the atrial antrum, pulmonary venous fluid dynamics) along with conventional imaging data (e.g. 3D CTA reconstruction).
In an alternate embodiment, the handle 12 is encompassed by a layer of conductive medium 210 such as smart fluid (e.g. magneto-rheological fluid or electro-rheological fluid) or smart material which serves as an active interface between haptic signals (e.g. standing waves) generated from juxtaposed actuators (e.g. circular resonators) coupled to the underlying handle 12, as shown in the cross sectional view 200 of the handle 12 in
Grant et al. describes a handheld computer interface with haptic feedback in U.S. Pat. Pub. 2011/0121953 that combines an impact actuator with smart materials to simulate various sporting activities such as hitting a tennis ball with a racquet; this publication incorporated by reference herein. The tangible sensations generated at the handle are “controlled” by the sensed internal events at the end-effector (e.g. piezoelectric sensor on distal most aspect of a guiding catheter proximate to internally deployed catheter with distally located cryoablation balloon). The application of a variety of sensors and actuators along with encompassing haptic elements about the user's hand and fingers will optimize the users experience and enable him or her to feel as if they are experiencing the forces from the inserted instrument. Thus, the sensors in their hand, fingers, wrist etc “tactually appear” to be the tissue and surrounding structures being treated and intervened on in real time. In such an embodiment, the haptic interface affects cutaneous tactile sensors, proprioceptive sensors, and kinesthetic sensors.
Any number of sensors and actuators can be used in the end effector 14 to generate the blend of tangible sensations that enable the operator to feel as if her or his fingers and hand are actually one or more segments of cardiovascular tissue (e.g. pulmonary vein endothelial lining, left atrial OS, left atrial appendage, coronary artery vessel or aortic endothelial lining etc.). Tangible sensations are sensed by activation of a multitude of cutaneous and non-cutaneous human receptors providing kinesthetic, proprioceptive and tactile sensations.
For example, low frequency standing wave actuators 322, depicted in the cross-sectional view 300 of the handle 12, receive signals (data) from haptic corpuscle sensors 318 and force sensors 320. These signals are band pass filtered in a control unit 324 so that a low to mid frequency range signal produces a representative haptic sensation in form of a palpable waveform that moves across the internal most surface of the handle 12, tangentially across the hand of the operator holding the handle 12. This sensation is primarily caused by one or more low frequency actuators 322 (e.g. circular resonators) that displace a liquid medium 326 (e.g. viscoelastic material, electrorheological fluid) as one or more standing wave(s) at the appropriate frequencies and with the appropriate velocity and amplitude proportionate to the sensed signal (e.g. intravascular blood flow). Accordingly, expansive movement can be made possible in the superior 331, inferior 333, medial 335, or lateral 337 directions. Higher frequency sensed signals are likewise generated by one or more high frequency actuators 328 (e.g. vibrotactile motor).
In some embodiments, inflation of balloon 20 occurs in preparation of cryoablation by an operator triggering a command switch 330. Command switch 330 can be a conventional switch, trigger and the like. In one preferred embodiment, the command switch 330 is activated by a forceful squeeze upon a portion of the handle 12 or the body of the handle 12 itself. As balloon inflation occurs at balloon 20, a reciprocating effect occurs at the expandable catheter handle haptic interface 16 of handle 12 where a current or magnetic field is generated across smart fluid or smart material 326, such as electrorheological fluid, causing a reciprocal expansion of the outer portion of the handle 12. Alternate means of providing the operator with a tangible sensation as if his or her hand were actually the endothelial surface of the contacted anatomic structure (e.g. pulmonary venous os, coronary or peripheral vasculature) are contemplated in further embodiments of the invention. In other embodiments, inflation of balloon 20 occurs automatically or semi-automatically based on time delays, sensed events or some combination thereof.
The amplitude of the degree of inflation is proportionate at the balloon 20 and the expandable haptic interface 16 of the handle 12 and correlates with the transmitting signal amplitude (e.g. current amplitude) between balloon 20 and haptic interface 16 (a synchronizing calculator serves to tune the signals as discussed in detail below). Sensing and actuation ideally occurs in multiple subsegmental volumes and provides the operator with anatomic and physiologically relevant signals reproducing the events with physiologic and anatomic accuracy occurring in situ (e.g. at the end-effector atrial interface). Force sensors 320 and/or alternate sensor technology (e.g. manometers) at the balloon 20 of end effector 14 generate one or more signals that are transmitted to the expandable haptic interface 16 of handle 12 via conductor 332 which can be amplified at amplifier 316 as needed. Thus, the operator appreciates the pulsatile properties of pulmonary venous inflow simultaneous with palpable sensations representative of balloon inflation and the properties at the interface between the balloon 20 and contacted tissue (e.g. geometry, elastance, vibration etc). Vibrotactile and displacement information due to atrial arrhythmia and atrial mechanical function is sensed at piezoelectric sensor 312 and likewise transmitted to one or more variable frequency vibrotactile actuators at 322 for low frequency data and at actuator(s) 328 for high frequency data. Band pass filtering of specific sensor signals at band pass filter 340 and processing at processor 350 serve to direct the appropriately acquired data to the appropriate actuator(s) at haptic handle 12. The higher frequency generated vibration at actuator(s) 328 matches the frequency and amplitude of sensed vibration at piezoelectric sensor 312 and/or haptic corpuscle sensor(s) 318 and is thus, reciprocating (synchronizing calculator serves to fine tune signals at the actuator).
In one embodiment, haptic rendering techniques are added to provide the operator with a tangible sensation representative of a change in temperature at balloon 20 during application of ablative energy (e.g. cryotherapy, radiofrequency energy) or to sense the high frequency chaotic effect of microbubbles during delivery of ablation energy. This is done by causing variable but high frequency vibrations via one or more of high frequency vibrotactile actuators 328 in handle 12 (psychophysical haptic rendering). Ridges on the exterior of the handle 12 will improve such haptic rendering techniques as tangential motion will be appreciated (active haptic feedback). Additional sensor technology along the surface of the handle 12 can be implemented to accomplish this. Thus, the handle 12 implements both a non-virtual haptic display with total passivity transparently recreating actual events in real time and haptic rendering techniques to provide psychophysical simulation. The former can be done purely with analog signals (as well as with digitized data) while the latter will necessitate digitization of data in processor 350 as described in more detail below.
In one embodiment, adjustment of the amplitude of the haptic effect is accomplished by modifying material properties by altering the viscosity of smart material/fluid by adjusting the current delivered to smart material/fluid. This can be done manually by the user, be programmed with user preferred default settings or in a preferred embodiment, accomplished automatically dependent on the nature of the signals driving the haptic components within the handle 12. In an advanced mode of an embodiment of the invention, mechanisms similar to those used for automatic adjustment of palpable haptic effects also serve to control or dampen application of force by the user upon biological tissues as to avoid deleterious effects (e.g., cardiac perforation). Thus, a dampening mechanism that uses smart fluid/material serves to eliminate the application of excessive force to cardiac tissue and reduces the range of force applied, eliminating peaks and valleys in force amplitude. The effects of cardiac contraction, rotation and translation as well as respiration are thus minimized in real time. Closed loop control systems, predictor algorithms and other processing techniques can be applied to adjust the viscosity of smart material/fluid within a dampening mechanism and mitigate the cyclical properties in force that would otherwise occur from patient motion, gross changes in applied force of the user upon the catheter, and the effects of the cardiac and respiratory cycles.
Processor 350 is utilized to gather acquired sensor data and process such data (e.g. A/D conversion, filtering, noise reduction). Processor 350, amplifier 316 and filter 340 can be contained in control unit 324. Control unit 324 is preferably not within the handle 12 in various embodiments, but is in a separate enclosure that is wired to, or wirelessly communicates with, handle 12. When both analog and digital signals are used for the final haptic display a time delay can be incorporated at processor 350 to adjust for the timing delays that occur due to signal processing, even though the final haptic representation will remain near instantaneous. Maintaining a natural differential in times between the onset of differing sensed signals and thus actuator generated signals will better recreate physiologically relevant tangible sensations just as slow and fast neural fibers transmit with varying conduction times. Such delays can be programmed in 350 and be based on specific characteristics of sensor generated signals (i.e. current waveforms) and dependent upon which sensors are activated (e.g. Meissner's corpuscles generated signals transmit slower than high frequency/vibrotactile signals). Both impedance and admittance type of haptic interfaces can be used (e.g. at processor 350) depending on the nature of the sensed signal and generated haptic signals such as force/motion data.
Parallel Limb Data Digitization and Storage
In order to process or store the data acquired at control unit 324 during procedures (e.g. ablation) with the technologies described herein it will be necessary to digitize the acquired analog data. In one mode of the invention, a separate, parallel circuit (parallel limb), is employed where current signals are A/D converted at 352 and processed at control unit 324. Specific metrics related to the affect of pulmonary venous flow (e.g. turbulence, laminarity, velocity, waveforms) on acquired signals at the end-effector transducers (e.g. piezoelectric sensor 312) can be derived. Likewise, corresponding tactile metrics at handle 12 (e.g. tissue displacement amplitude, blood flow velocity, acceleration, frequency and temporal characteristics, balloon inflation force) are acquired at sensors(s) 354 within or about handle 12 and then analyzed and compared to correlative signals from piezoelectric sensor 312, haptic corpuscle sensor(s) 318, force sensors 320, etc. (e.g. piezoelectric voltage, conducted current, balloon geometry during inflation, force measurements etc.).
Tactual metrics and sensed data at the end effector 14 relate directly to cardiovascular health. In particular, the acquired information can be used to analyze pulmonary venous blood flow and atrial mechanical function. Thus, a means has been designed in embodiments of the present invention for storing the data for future comparisons, especially if repeat procedures are required. Findings representative of advanced pathologic changes in pulmonary venous anatomy include higher velocity and turbulent pulmonary venous inflow (e.g. due to pulmonary venous stenosis) which would cause higher frequency, chaotic motion characteristics, as well as, pathologic changes in the geometry of the atrial antrum and pulmonary venous os, which will cause characteristic changes in the dimensions of subsegmental volumes within handle 12 and a variety of pathologic haptic representations.
By way of example, Fourier analysis, application of chaos theory and finite element analysis of acquired motion data (e.g. vibrotactile) will provide insights into specific pathophysiological processes. Data consistent with LA diastolic abnormalities will include lower amplitude displacement of antral atrial tissue during atrial systole (e.g. reflected by lower amplitude haptic signals), changes in pulmonary venous inflow patterns and changes in the elastance or compliance of a cryoballoon during inflation. Many of these pathophysiologic findings will be represented in the haptic display by changes in tangible sensations.
Storage of tangible sensation data for future analysis and comparisons will improve the diagnostic acumen of operators performing repeat procedures in patients with recurrent arrhythmia and reduce the likelihood of complications and educate clinicians as to what specific findings are indicative of specific pathologic processes (e.g. lower amplitude atrial motion, low amplitude/high frequency LAA motion indicative of higher stroke risk). Such data will also help troubleshoot diagnostic work-ups for patients who develop dyspnea or other symptoms post-procedure. Likewise the haptic representations of specific patients can be reviewed prior to repeat procedures and be made available at academic centers for educational purposes as well. Virtual recreation of pathophysiological data can be made available as a virtual reality game for data storage and education purposes and in one application, the handle 12 is implemented as a game controller, as described in more detail below.
Synchronizing Calculator/Closed Loop Control System
In one embodiment, a synchronizing calculator 360, is employed to perform cross comparisons between the sensed signals at end effector 14 and sensed signals at haptic handle 12, as shown in
The composite of data acquired at control unit 324 is used for data storage and tactile metrics are derived. Input from externally located diagnostic equipment 370 is used to better assign values of physiological significance to acquired tactile metrics derived at control unit 324 by using input auxiliary information 372 such as echo derived measurements of pulmonary venous flow, atrial mechanical function, etc. stored at diagnostic equipment 370. Alternatively, diagnostic equipment 370 can be used as the sole input of sensor data into control unit 324 effecting the handle 12, without a need for internally deployed sensor technology. In such an embodiment, diagnostic equipment 370 can be an externally located navigational system that detects the location of inserted instruments in real time (e.g. impedance based, admittance, ultrasonic, visual, electromagnetic-based etc.) or other non-contact sensor technology.
Haptic Element Uniformly Driven by Linear Actuator
Linear actuators are optimal components for driving the haptic signals in the handle 12. These can be constructed in small dimensions, have dynamic reaction times, high velocities, large stroke distances, and excellent frequency characteristics. It is recognized that individual actuators may be limited in the ability to handle side loads generated from both displacement and externally applied forces from the fingers and hand of a user (i.e. upon a mounted haptic element). In one embodiment of the invention, one or more actuators (e.g. linear actuators/stepper motors) are integrated with an apparatus designed and structured to apply a uniform load distribution to the haptic element. This can be accomplished with one or more linear actuators control unit 324. Such actuators are known by those experienced in the art and manufactured by companies such as Ultramotion LLC (Cutchogue, N.Y.).
Quad Mode Haptic Actuators
In still yet another embodiment, the haptic element(s) is/are operational in one of four modes. A static mode where there is no actuation or haptic feedback and haptic element is neither haptic nor actuating, a haptic mode where haptic element provides haptic feedback, an actuating mode where haptic element is used to deform or maneuver one or more aspects of the catheter as known by those experienced in the art and a haptic-actuating mode where haptic element provides haptic feedback and is used to deform and modify the characteristics of the inserted catheter. The user can switch modes depending on individual preferences. The gain of haptic feedback is adjustable and when programmed to zero gain haptic element will not provide haptic feedback. Various handles can be used during interventional procedures and exchanged as needed. One embodiment of the invention includes a lower cost handle that does not provide haptic feedback but is equipped with a means for acquiring regional sensor data from the inserted end-effector of the balloon and optimizing regional inflation pressure at 20 as depicted in
Electrical and Contact Uniformity Confirmation System
In another embodiment of the invention, sensed intra-cardiac electrical depolarizations at the end-effector 14 are palpable at the haptic handle 12. By way of example, electrodes positioned at the distal end of the inserted catheter/instrument 546 detect localized electrical activity. Such sensed intra-cardiac electrograms confirm tissue contact, provide diagnostic information and identify when specific pathways are interrupted (e.g. after ablation about the pulmonary veins).
Referring to
Bimanual Handle Design
In an embodiment shown in
Referring to
This volumetric, bimanual haptic handle display will enable multiple sensors and sensor types (e.g., pressure, force, strain, displacement, etc.) on the inserted catheter assembly and attached end effector to correspond to multiple actuators on the handle thereby providing the user with a realistic recreation of events in vivo. Such an advanced design will enable an operator to appreciate the complex interaction between inserted instrumentation and moving biological tissue in real time including the effects of contacting and crossing tissue planes (e.g., interatrial septum), and modifications that are made to anatomic structures, physical and physiological properties of tissue, and blood flow properties (e.g., stent deployment, left atrial appendage occlusion, valvular replacement/repair) as therapeutic interventions are delivered.
Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with an enabling disclosure for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope of the invention as set forth in the appended claims and the legal equivalents thereof.
The embodiments above are intended to be illustrative and not limiting. Additional embodiments are within the claims. Although the present invention has been described with reference to particular embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
Various modifications to the invention may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant art will recognize that the various features described for the different embodiments of the invention can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations, within the spirit of the invention. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the invention. Therefore, the above is not contemplated to limit the scope of the present invention.
For purposes of interpreting the claims for the present invention, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.
The present application claims the benefit of U.S. Provisional Application No. 61/628,551 filed Nov. 2, 2011, which is incorporated herein in its entirety by reference.
Number | Date | Country | |
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61628551 | Nov 2011 | US |