Beating anatomy simulator system and method

Abstract

Provided is a beating anatomy actuator system and methods of manufacturing and using the same. The system includes a first cord. The first cord configured to be attached at a first cord second end to a simulated anatomy at a first attachment point via an interior of the simulated anatomy. The simulated anatomy is configured to simulate a beating anatomy, composed of a resilient material, and configured to be resiliently in diastole. The first cord is configured to be attached at a first cord first end to a timing assembly. The system also includes the timing assembly. The timing assembly, when set in motion, is configured to vary the tension of the first cord to induce at least one simulated beating motion in the simulated anatomy. The system also includes a movement means configured to move the timing assembly in a controllable manner.

Description

BEATING ANATOMY SIMULATOR SYSTEM AND METHOD Technical Field

[0001] The following relates generally to medical simulators, and more particularly to simulators that mechanically simulate a beating anatomy.Introduction

[0002] Anatomy simulators enable medical professionals such as physicians, surgeons, nurses and those training for these professions to practice and expand their skills and knowledge base. Simulators also provide for the demonstration and testing of new procedures, techniques and technologies. Increasingly, the procedures being practiced, demonstrated or tested include when the anatomy in a dynamic state often cyclically beating between diastole and systole states.

[0003] For example, Coronary artery bypass grafting (CABG) is the most commonly performed major cardiac surgery in North America. Historically, this surgery is performed on pump. Accordingly, existing training simulators include those using human cadavers and porcine carcasses which simulate the anatomy of a bypassed non-pumping heart.

[0004] Existing cadaver based systems suitable for surgical practice are scarce, offer limited utility, and raise ethical concerns that hinder their widespread usage. Additionally, human cadavers as well as porcine models, are static and are therefore deficient in modeling the dynamic conditions of beating anatomy surgeries such as off-pump CABG surgery. Additionally, some existing organic surgical simulators are fully single use and specific to a predetermined procedure without facilitating the replacement of only non-reuseable components such as an exhausted simulated heart anatomy.

[0005] Advances in surgical technology and techniques have made the option of performing CABG without putting the patient on bypass and stopping the heart to be a far more viable strategy. The off-pump method (OP-CABG) provides patients with superior long-term results and is thus desirable. Due to the novel nature and complexity of the off-pump method and range of cardiac motion that may occur during a single procedure oracross similar procedures, the demand for surgical training in these procedures and the corresponding simulators has increased.

[0006] Some existing simulators include a digital portion that illustrates this beating heart motion. These simulators may also interact with physical systems to provide a certain level of feedback. However, particularly because of the complexity of beating heart procedures, it has become increasingly beneficial to have mechanical simulators that simulate the physical aspects of the procedural environment.

[0007] In some existing systems, the heart anatomy is configured to be, by default, resiliently in a systolic state such that the simulator is simulating the anatomy in contraction, and a forcing mechanism is used to expand the heart anatomy to simulate diastole. When the forcing mechanism is released the elasticity of the resilient heart anatomy causes the heart anatomy to return to systole.

[0008] In an example, the forcing mechanism acts on the outside of the heart anatomy and pulls the anatomy into expansion. Positioning the forcing mechanism to interact and / or interface with the external surface of the heart mechanism can interfere with certain procedures such as those using mechanical depressors that suppress motion of the heart via placement on the external surface to the heart. These systems may also include complex systems of gears and cams.

[0009] In another example of a resiliently systole simulator, a compressed air system supplies a fluidic pressure to the interior of the heart anatomy or the surface of the heart anatomy via, for example compliant tubing embedded in the tissue media. For certain procedures, including those using a mechanical depressor, the modeling of the beating motion via pressure may be complicated by the changes to the heart surface during the simulated procedure.

[0010] Additionally, calculating and controlling the pressure necessary to model various desired heartbeats can be complex and may include active management, reliant on costly or unavailable potentially real time technical understanding, and / or use complex or costly hydraulic or pneumatic systems.

[0011] Furthermore, a relaxed unsimulated heart is naturally in diastole. Simulating a heart resiliency in systole state and forcing the heart anatomy into diastole introduces the opportunity for simulated conditions inconsistent with a heart it is intended to simulate. This may lead to complications when the procedure is being performed on the corresponding heart.

[0012] Furthermore, some existing systems, such as the fluidic pressure system described above, affect the cardiac movement across the entire heart anatomy. The complexity of determining and controlling the simulated cardiac movement typically corresponds to the size of the area over which it is being simulated. Therefore, simulating cardiac movement of heart anatomy outside of areas particular to the procedure being practiced can reduce efficiency or accuracy of the simulated cardiac movement at the areas of interest.

[0013] Accordingly, there is a need for an improved beating anatomy simulator that overcomes at least some of the disadvantages of existing anatomy simulators.Summary

[0014] Provided is a beating anatomy actuator system. The system includes a first cord. The first cord configured to be attached at a first cord second end to a simulated anatomy at a first attachment point via an interior of the simulated anatomy. The simulated anatomy is configured to simulate a beating anatomy, composed of a resilient material, and configured to be resi liently in diastole. The first cord is configured to be attached at a first cord first end to a timing assembly. The system also includes the timing assembly. The timing assembly, when set in motion, is configured to vary the tension of the first cord to induce at least one simulated beating motion in the simulated anatomy. The system also includes a movement means configured to move the timing assembly in a controllable manner.

[0015] The attachment of the first cord first end to the timing assembly may be at a first timing mechanism and the attachment of the first cord at the timing mechanism may be adjustable to facilitate calibration of an initial tension in the first cord.

[0016] The timing assembly may be a crankshaft configured to be rotated by the movement means. The timing mechanism may be a cam configured to asynchronously increase and release tension in the cord when the timing assembly is rotated by the movement means through a cardiac cycle.

[0017] The system may include a second cord attached at a second cord first end to a second timing mechanism of the timing assembly and at a second cord second end to the simulated anatomy at a second attachment point.

[0018] The system may include a controller preset to variably control one or more of the speed and direction of the movement means.

[0019] The system may include a routing mechanism configured to direct the route of the first cord.

[0020] The simulated anatomy may be configured to be disposed in a predetermined disposition relative to the beating anatomy actuator system by a support assembly.

[0021] The first cord second end may be secured on the exterior surface of the simulated anatomy and covered by a material matching the simulated anatomy.

[0022] The simulated anatomy may simulate a human heart or portion thereof. The simulated anatomy may be composed of synthetic materials.

[0023] In another aspect, provided is a method of manufacturing a beating anatomy simulator. The method includes configuring a simulated anatomy resiliently in diastole. The method further includes predetermining a cord configuration for a first simulated procedure corresponding to at least one simulated beating motion to be induced in the simulated anatomy. The method further includes attaching a first cord at a second end of the first cord to the simulated anatomy at an attachment point according to the cord configuration. The method further includes affixing the first cord at a first end of the first cord to a timing assembly of the beating anatomy simulator at a first cord initial tension according to a first cord predetermined tension of the cord configuration. The timing assembly when set in motion is configured to vary the tension of the first cord toinduce a first simulated beating motion of the at least one beating motion in the simulated anatomy.

[0024] The method may include mounting the simulated anatomy to dispose the simulated anatomy relative to a timing mechanism of the timing assembly according to the cord configuration.

[0025] The method may include calibrating the first cord tension according to a second initial tension according to a second cord configuration corresponding to a second simulated procedure.

[0026] The method may include calibrating the first cord initial tension. The calibration may include securing the first cord at a point beyond the first end of the first cord to a cord securement means of a winding mechanism of a cord calibrator. The first cord may pass over the timing assembly at the first end. The method may include winding or unwinding the first cord about the winding mechanism for adjusting the location of the first end along the first cord until one or more of the initial tension and the simulated beating motion is achieved according to a prescribed tolerance.

[0027] In another aspect, provided is a method of using a beating anatomy simulator. The method includes activating a beating anatomy actuator of the beating anatomy simulator comprising, the activation comprising setting a timing assembly of a beating anatomy actuator in motion to induce a first beating anatomy motion in a simulated anatomy of the beating anatomy simulator and performing the first simulated procedure. The simulated anatomy is configured to be resiliently in diastole. The first beating anatomy motion is induced via a first cord attached at a first cord second end to a simulated anatomy at a first attachment point of the simulated anatomy via an interior of the simulated anatomy and at a first cord first end to the timing assembly. A location of the attachment point and the tension of the first cord is according to a predetermined first cord configuration corresponding to a first simulated procedure.

[0028] The beating anatomy simulator may include a controller for controlling beating motion parameters. The method may include adjusting the beating motion parameters to vary the beating motion of the simulated anatomy from the first beating anatomy motion to a second beating anatomy motion.

[0029] The controller may automatically vary the motion based on one or more of predetermined settings, predetermined triggers and manual triggers.

[0030] The method may include replacing the simulated anatomy with a replacement simulated anatomy corresponding to a second simulated procedure.

[0031] The second simulated procedure and the first simulated procedure simulate the same medical procedure, and the simulated anatomy is exhaustibly modified during the performance of the first simulated procedure.

[0032] Other aspects and features will become apparent to those ordinarily skilled in the art, upon review of the following description of some exemplary embodiments. Brief Description of the Drawings

[0033] The drawings included herewith are for illustrating various examples of articles, methods, and apparatuses of the present specification. In the drawings:

[0034] Figure 1 is a block diagram of a beating anatomy simulator, according to an embodiment;

[0035] Figure 2 is a perspective view schematic to the beating anatomy simulator of Figure 1 with a simulated heart anatomy, according to an embodiment;

[0036] Figure 3A is a side view cross-sectional schematic of the beating heart simulator of Figure 2, according to an embodiment;

[0037] Figure 3B is a second side view cross-sectional schematic of the beating heart simulator of Figure 2, according to an embodiment;

[0038] Figure 4 is a perspective view schematic of the heartbeat actuator of Figure 2, according to an embodiment;

[0039] Figure 5A is a block diagram of the support assembly of Figure 2, according to an embodiment;

[0040] Figure 5B is a perspective schematic of the support assembly of Figure 5A, according to an embodiment;

[0041] Figure 6A is a block diagram of a cord calibrator for calibrating the cords of Figure 2, according to an embodiment;

[0042] Figure 6B is a perspective view schematic of the cord calibrator of Figure 6A, according to an embodiment;

[0043] Figure 7 is a flow diagram of a method of assembling a beating anatomy simulator, according to an embodiment;

[0044] Figure 8 is a flow diagram of a method of using a beating anatomy simulator, according to an embodiment;

[0045] Figure 9A is a photograph of the beating anatomy simulator of Figure 1 in diastole viewed from the heart’s apex, according to an embodiment; and

[0046] Figure 9B is a photograph of the beating anatomy simulator of Figure 1 in systole viewed from the heart’s apex, according to an embodiment.Detailed Description

[0047] Various apparatuses or processes will be described below to provide an example of each claimed embodiment. No embodiment described below limits any claimed embodiment and any claimed embodiment may cover processes or apparatuses that differ from those described below. The claimed embodiments are not limited to apparatuses or processes having all of the features of any one apparatus or process described below or to features common to multiple or all of the apparatuses described below.

[0048] Further, although process steps, method steps, algorithms or the like may be described (in the disclosure and I or in the claims) in a sequential order, such processes, methods and algorithms may be configured to work in alternate orders. In other words, any sequence or order of steps that may be described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order that is practical. Further, some steps may be performed simultaneously.

[0049] When a single device or article is described herein, it will be readily apparent that more than one device I article (whether or not they cooperate) may be used in place of a single device I article. Similarly, where more than one device or article is described herein (whether or not they cooperate), it will be readily apparent that a single device I article may be used in place of the more than one device or article.

[0050] The following relates generally to medical simulators, and more particularly to simulators that mechanically simulate a beating anatomy. The beating simulator is a mechanical training device for simulating medical procedures such as off pump coronary artery bypass grafting (OP-CABG) surgeries. Where a heart is described as the simulated anatomy herein, it will be understood that portions of a heart or any other beating anatomy of any animal and the like is expressly contemplated.

[0051] Cardiac movement is simulated via targeted and timed tensioning and releasing of one or multiple cords attached to a simulated anatomy. Accordingly, the beating anatomy simulator beneficially provides a realistic representation of cardiac movement that responds accurately during a simulated procedure and facilitates the use of tools such as motion suppression devices in the simulated procedure. This realistic simulation beneficially facilitates optimal practice and demonstration of operations or surgeries by medical professionals, particularly off pump heart procedures and improves training and development of medical personnel and procedure testing and development over existing systems.

[0052] Referring to Figures 1 shown therein is a block diagram of a beating anatomy simulator 100; according to an embodiment. Referring also to Figures 2, 3A, and 3B shown therein is a perspective view schematic and cross sectional schematics, respectively, of the beating anatomy simulator 100; according to a beating heart embodiment.

[0053] The beating heart simulator 100 simulates the anatomy and motion of an anatomy, such as a human heart, on which a medical procedure is intended to be performed.

[0054] The beating heart simulator 100 includes a support assembly 102. The support assembly 102 supports or holds the remaining elements of the beating heart simulator 100.

[0055] The beating anatomy simulator 100 includes a simulated anatomy 120. The simulated anatomy 120 simulates an anatomy such as a human heart or portion thereof. In an example, the simulated anatomy simulates the left coronary artery resting on a silicon heart surface, embedded in surface fat.

[0056] In some embodiments, the simulated anatomy 120 is composed of synthetic materials such as silicone. Using synthetic materials mitigates ethical, sourcing, and disposal concerns and reduces costs of replacing the simulated anatomy 120 thereby facilitating the replacement or disposal of the simulated anatomy 120. Facilitating replacement and disposal facilitates a range of procedures that may be simulated with a single beating anatomy simulator 100 as well as the practice of procedures that include the destruction of the replaceable simulated anatomy 120.

[0057] In some embodiments, the simulated anatomy 120 is organic in whole or in part. In an example, organic tissue is mounted on a corresponding frame such as frame 506 of Figure 5.

[0058] The simulated anatomy 120 is configured to be, by default, resiliently in a simulated diastolic state when disposed in the support assembly 102. It will be appreciated that while the simulated anatomy 120 is described in diastole, the simulated diastole may be localized for example along a feature of interest 127, further described below. The simulated anatomy 120 therefore is configured to return to a diastole state once tension in the cords 131 , further described below, is released.

[0059] In some embodiments, the simulated anatomy 120 is composed in whole or in part of resilient materials such as silicone. The silicone may be stiff and molded to achieve the resiliently diastole configuration. The resiliency may be purely elastic deformation in the magnitude of 5 mm to 10 mm for hundreds of thousands of cycles.

[0060] The simulated anatomy 120 forms at least one cavity with an interior surface 122 and exterior surface 124.

[0061] The simulated anatomy 120 further includes a port 128. The port 128 is an opening in the wall of the simulated heart anatomy 120 that provides access to the interior surface 122. While one port 128 is shown, multiple ports 128, a non-contiguous port 128, or an irregularly shaped port 128 is expressly contemplated.

[0062] In an example, the port 128 allows the cords 131 , further described below, to pass into the interior of the simulated heart anatomy 120 and be attached in or through the interior surface 122.

[0063] The simulated heart anatomy 120 includes at least one attachment point 126. Each attachment point 126 is referred to generically as attachment point 126 collectively as attachment points 126 and specifically as attachment point 126-n. In an example, as shown in Figures 2 through 3B, the simulated anatomy 120 includes three attachment points 126-1, 126-2, and 126-3. Any number of attachment points 126 are contemplated. Each attachment point 126 is located on or in the simulated anatomy 120 at a location that contributes when pulled to the contraction of the simulated anatomy 120.

[0064] In some embodiments, the selection of the location of each attachment point 126 corresponds to the localization or isolation of movements to a particular section 127 of the simulated anatomy 120. This section 127 is referred to herein as a feature of interest 127 or area of interest 127. In some embodiments the feature of interest 127 is consumable and replaceable. Localizing the movements to a feature or area of interest 127 reduces the task of mimicking the motion of the anatomy being simulated to the isolated area of interest 127. This beneficially minimizes the resources expended on determining and implementing this motion and facilitates the modularity of the replaceable feature of interest 127.

[0065] In an example, as shown in Figures 2 through 3B, the procedure to be simulated is a CABG including a left internal thoracic artery (LITA) (not shown) to left anterior descending (LAD) artery anastomosis. The LITA may also be known as an internal mammary artery (IMA). In some embodiments, the IMA is held in place by recesses in a simulated LAD artery 127 and particularly simulated fat bumps of the simulated LAD 127. Cardiac motion is mimicked along a simulated LAD artery 127 as a feature of interest 127. Each attachment point 126-1, 126-2, and 126-3 is located alongthe path of the LAD 127 to localize the affect the movement about the LAD 127. Accordingly, the task of mimicking the motion of the heart is beneficially and efficiently minimized to the isolated movements of certain sections 127 of the coronary arteries during the cardiac cycle. As left internal thoracic artery (LITA) to left anterior descending (LAD) grafts are prevalent a beating heart simulator 100 that mimics cardiac motion along features of interest 127 such as the LAD 127 minimizes the effort and expertise involved in determining parameters involved in achieving a realistic simulation cardiac motion over systems providing broader cardiac movement.

[0066] Referring also to Figure 4, shown therein is a perspective view schematic of a beating actuator 130, according to an embodiment. The beating anatomy simulator 100 includes the beating actuator 130. The beating actuator 130 is a motion activation system for cardiac simulation. The beating actuator 130 induces the motion in the simulated anatomy 120, such as a cardiac motion or cardiac movement.

[0067] The beating actuator 130 provides realistic cardiac replication throughout the entirety of the cardiac cycle and for the duration of the simulated procedure. Realistic simulated conditions for cardiac replication such as a low noise (below 25 dB), realistic heart rate (70 beats per minute (BMP)) with a variability + or - 10 BPM based on manual input are simulatable with the beating actuator 130. Dampened motion that occurs when surgical tools such as mechanical heart stabilisers are also accommodated by the configuration of the beating actuator 130. Furthermore, simulated output electrical signals corresponding to the simulated anatomy’s 120 signaling are also supported. Supporting output electrical signals beneficially facilitates the use of procedure equipment that relies on such signals such as computer tomography (CT) imaging devices.

[0068] The beating actuator 130 includes at least one cord 131. The cords 131 are referred to generically as cord 131 , collectively as cords 131 and specifically as cord 131-n. The cords 131, when put into tension pull the simulated anatomy 120 to simulate a movement of the simulated anatomy 120. The movement is also referred to herein as a cardiac movement or cardiac motion and when in tension, may be known as a contraction. Collectively a simulated systole of the simulated anatomy 120 or of a feature or area of interest 127 of the simulated anatomy 120 is induced via putting one or more cords 131in tension. It will be appreciated that extent and timing tension of each cord to induce the desired cardiac movement may vary for each cord and across the cardiac cycle.

[0069] Each cord 131 is attached at a second end 133 to the simulated heart anatomy 120. In an example, as shown in Figures 2 through 3B, cords 131-1, 131 -2, and 131-3 at second ends 133-1, 133-2, and 133-3 are attached to the simulated heart anatomy 120 at attachment points 126-1, 126-2 and 126-3, respectively. The attachment may be by any known means sufficient to secure the cord 131 to the simulated heart anatomy 120 sufficiently to accommodate the desired tension.

[0070] In an example, the second end 133 of a cord 131 is passed through the interior surface 122 and exterior surface 124 of the simulated anatomy 120 and provided at the second end 133 with a means of preventing the second end 133 from being pulled back through the simulated anatomy 120. For example, the second end may be provided with a knot or fraying, as shown in Figure 4. In some embodiments, a layer of material, such as silicone, consistent with the simulated anatomy 120 is provided over the second end 133 to cover the second end 133 and maintain a contiguous exterior surface 124. In some embodiments the second end 133 is embedded in the simulated anatomy 120, for example during the formation or molding of the simulated anatomy 102.

[0071] It will be appreciated that these attachment means avoid exposure on the exterior surface 124 of the simulated anatomy 120 and facilitate disposing the attach points 126 away from features of interest 127 or areas that will be manipulated during the practiced procedure. Accordingly, these cord configurations minimize interference of the beating actuator 130 with the simulated procedure beneficially facilitating complex and varied procedures such as off-pump procedures.

[0072] The heartbeat actuator 130 includes a timing assembly 134. The timing assembly 134 is a fixture configured to implement the timing and extent of the tensioning and releasing of the cord tension. In some embodiments, the timing assembly 134 is a cammed-crankshaft. This timing assembly 134 provides non-linear and asynchronous tensioning and releasing across the cords 131. In an example, the feature of interest 127 is an LAD 127 and this timing assembly 134 provides non-linear and asynchronous motion of the proximal, mid, and distal portions of the LAD 127.

[0073] In some embodiments, the timing assembly 134 includes at least one timing mechanism 135. Each cord 131 corresponds to and is affixed to a corresponding timing mechanism 135. The point along the cord 131 affixed to the timing mechanism 135 is referred to herein as a first end 132.

[0074] In an example, as shown in Figures 2 through 4, cords 131-1, 131-2, and 131-3 are attached, respectively to timing mechanisms 135-1, 135-2, 135-3 at first ends 132-1, 132-2, and 132-3, respectively. It will be appreciated that first ends 132 along a cord 131 in addition to at the termination of a cord 131 are expressly contemplated.

[0075] In some embodiments, the timing assembly 134 varies the timing across the various cords 131. In an example, as shown in Figures 2 through 4, each timing mechanisms 135-n is oriented relative to the remaining timing mechanisms 135 to offset the timing of the tensioning and releasing of the corresponding cord 131-n relative to the remaining cords 131.

[0076] The heartbeat actuator 130 includes a movement means 136. The movement means 136 is coupled with and provides the motive force to the timing assembly 134.

[0077] In some embodiments, the movement means 136 is an oscillating servomotor 136. In this embodiment, the oscillating servomotor 136 is coupled with a cam-shaft timing assembly 134. The oscillating servomotor 136 may be used to replicate motion suppression without changing gears, for example where a motion suppression device is not available to practice with.

[0078] It will be appreciated that that combination of the movement means 136 and the timing assembly 134 facilitates mimicking the surface motion pattern of the heart surface (completely or at an area of interest) with a single movement means 136 such as a single motor.

[0079] In some embodiments, as shown in Figures 2 through 4, the movement means 136 is a rotary motor 136. The rotary motor 136 is coupled with crank shaft 134 to provide realistic simulation of the cardiac movement through the cardiac cycle. It will beappreciated that a rotary motor movement means provides 136 provides the cardiac movement with less noise over an oscillating servomotor movement means 136.

[0080] It will be appreciated that the speed and direction of the movement means 136 may be varied to simulate various anatomy movements. For example, the speed of the movement means 136 may be varied to induce various simulated heart rates. This variation may be across simulated procedures or at various stages within a particular simulated procedure.

[0081] In some embodiments, the heartbeat actuator 130 includes a power source 138. The power source 138 provides power to the movement means 136. The power source 138 may further provide power to other elements of the beating heart simulator 100 such as the controller 140, further described below. The power source 138 may be an independent power source such as a battery.

[0082] In some embodiments, the heartbeat actuator 130 includes a routing mechanism 139. The routing mechanism 139 redirects one or more of the cords 131. Redirection of the routing mechanism disposes the cord 131 such that the tension is along in the desired direction. While a single routing mechanism 139 is shown in Figures 2 through 4 for directing multiple cords 131 multiple routing mechanisms 139 are expressly contemplated and it is further contemplated that one cord 131 may be directed by more than one routing mechanism 139, such as to avoid obstructions or creating interference.

[0083] In some embodiments, the beating heart simulator 100 includes a controller 140. The controller 140 may be known as a microcontroller 140. The controller 140 controls parameters of the beating actuator 130 to affect a desired cardiac movement.

[0084] In an example, the controller 140 is a programable control board (PCB), the movement means 136 is a stepper motor and controller 140 controls the speed and direction of rotation of the movement means 136 based on a predetermined sequence corresponding to the desired cardiac movement. It will be appreciated the controller 140 may vary these parameters over the course of the practiced procedure. This variation may be, for example, passive such as based on an amount of time elapsed, event triggered such based on a monitored condition or state simulated heart anatomy indicating, or manually triggered such as by a facilitator or the practicing professionalwhen a stage of the procedure is initiated or completed. This beneficially accommodates the simulating of the dynamic nature of cardiac cycles during any particular medical procedure.

[0085] In some embodiments, the controller 140 includes connector pins 142 and a port 144 by which a pulse is output. The pulse may be a 5-volt pulse mimicking an R-wave, such as those produced by a heart at the start of systole. The pulse beneficially facilitates the use of devices such as CT imaging devices in the simulated procedure.

[0086] Referring to Figures 5A and 5B, shown therein is a block diagram and perspective view schematic of a support assembly 102, according to an embodiment. The support assembly 102 supports the simulated heart anatomy 120 and the beating actuator 130. The support assembly 120 is configured to provide this support to dispose the simulated anatomy 120 and beating actuator 130 in a relative disposition for the simulated procedure.

[0087] The support assembly 102 includes a base plate 504. The base plate 504 is configured to provide a foundation for the frame 506, further described below.

[0088] The support assembly 102 includes a frame 506. The frame 506 is configured to support the simulated heart anatomy 120 in a predetermined disposition.

[0089] In some embodiments, the frame 506 is configured to accommodate various simulated anatomies 120. Adjustments or replacement of components of the frame 506 may be made to accommodate or calibrate the disposition of the simulated anatomy 120 in the support assembly 102

[0090] In some embodiments, the frame 506 or support assembly 102 may be modular. In these embodiments, the frame 506 or support assembly 102 may be replaced with a frame 506 or support assembly 102 corresponding to the intended simulated anatomy 120. The modularity of the frame 506 or support assembly 102 beneficially accommodate a range of simulated heart anatomies 120 with a single beating heart simulator 100. This minimizes the ratio of beating simulators 100 to available simulated procedures beneficially maximizing the range of practice and development with limited resources.

[0091] In some embodiments, the frame 506 includes a holder 510 disposed on one or more posts 508. The posts 508 dispose the holder 510 at a height above the base plate 504.

[0092] In some embodiments, the holder 510 includes an inner holder 512 and outer holder 514. The inner and outer holders 512, 514 clamp the simulated anatomy 120 to dispose the simulated anatomy 120 at a predetermined height and orientation relative to the base plate 504.

[0093] The inner holder 512 and outer holder 514 may be disposed to interface with inner surface 122 and outer surface 124 respectively of the simulated anatomy 120. The interface may be at or near a port 128. Disposing the holder 510 at a port 128 beneficially distances the holder from features of interest 127. Disposing the holder 510 at a port 128 may also provide additional support at the port 128 and compensate for the effects of the opening of the port 128 on the simulated anatomy movement.

[0094] Referring to Figures 6A and 6B, shown therein is a block diagram and perspective view schematic, respectively, of a cord calibrator 600, according to an embodiment. The cords 131 are secured to the beating actuator 130 of Figures 1 through 4 at a predetermined initial tension. This tension provides the initial cord tension conditions for the predetermined beating movement. The cord calibrator 600 is configured to provide a measurable tension to the cords 131 of Figures 1 through 4 to achieve the predetermined initial tension.

[0095] The cord calibrator 650 includes any number of winding mechanisms 652. Winding mechanisms 652 are referred to generically as winding mechanism 652, collectively as winding mechanisms 652 and specifically as winding mechanism 652-n. The winding mechanism 652 is configured to provide a structure for the cords 131 of Figures 1 through 4 to wind or wrap around during calibration. Winding or unwinding the cords 131 adjusts the tension of the cords 131, accordingly. This adjustment is controllable and measurable which facilitates accurate configuration of the initial tension to the predetermined tension.

[0096] In some embodiments, as shown in Figure 6B, the cord winding mechanism 652 is a multi-sectional cylinder, the sections delineated by different diameters. It will be appreciated that the diameter of each section may vary.

[0097] In some embodiments, the cord calibrator 650 includes a cord winding mechanism 658-1 corresponding to each cord 131 of Figure 1. In an example, as shown in Figure 6B, the cord calibrator 650 includes winding mechanism 650-1 , 650-2 and 650-3 corresponding to cords 131-1, 131-2, 131-3 of Figures 2 through 4.

[0098] Each winding mechanism 652 includes a cord securement means 654. The cord securement means 654 is configured to receive and secure a cord 131 of Figures 1 through 4 to the cord winding mechanism 650. In an example, as shown in Figure 6B, the cord securement means 654-1 , 654-2, 654-3 are holes configured to secure, respectively, the cords 131-1, 131 -2, 131 -2 of Figures 2 through 4.

[0099] Each winding mechanism 652 may include a winding coupler 656. The winding coupler 656 couples the winding mechanism 652 to the adjustment mechanism 658 further described below. In some embodiments, as shown in Figure 6B, the winding coupler 656 is a gear such as a sprocket gear.

[0100] The cord calibrator 650 includes adjustment mechanisms 658. Each adjustment mechanism 658-n corresponds to a winding mechanism 652-n. Each adjustment mechanism 658-n is adjustable to cause a corresponding cord 131-n of Figures 1 through 4 to wind or unwind about the corresponding winding mechanism 652-n. Each adjustment mechanism 658 for example, may be rotated to rotate winding mechanism 652 thereby winding or unwinding the corresponding cord 131 or 131-n of Figures 1 through 4. It will be appreciated that the winding mechanism 652-n and corresponding adjustment mechanism 658-n may be one consistent piece such as where the adjustment mechanism 658-n is in-line with the winding mechanism 652-n.

[0101] In some embodiments, as shown in Figure 6B, the adjustment mechanism includes an adjustment coupler 660. The adjustment coupler 660 couples the adjustment mechanism 658 to the corresponding winding mechanism 652. In particular, the adjustment coupler 660 is configured to interface and couple with the corresponding winding coupler 656.

[0102] In an example, as shown in Figure 6B, the cord calibrator 650 includes adjustment mechanisms 658-1 , 658-2, and 658-3 with adjustment couplers 660-1 , 660-2, and 660-3 respectively. The adjustment couplers 660 are worm gears. The worm gears 660-1 , 660-2, and 660-3 couple respectively with sprocket gears 656-1 , 656-2, of winding mechanisms 652-1, 652-2, and 663-3, respectively. Through the coupling, when an adjustment mechanism 658-n is rotated the corresponding winding mechanism 652 rotates thereby affecting the winding or unwinding and corresponding change in tension. It will be appreciated that based on the known parameters of the winding mechanism 652 and the adjustment mechanism 658, such as gear ratios and diameters, the change in the tension is beneficially controllable and measurable.

[0103] The cord calibrator 650 includes a mount 662. The mount 662 is configured to provide a structure for the cord calibrator 650. The mount 662 may be configured based on the amount of pairs of winding mechanism 652 and adjustment mechanisms 658. The mount 662 is configured to space these pairs of winding mechanism 652 and adjustment mechanisms 658 to correspond, for example, with timing mechanisms 135-1 through 135-3 of Figure 4.

[0104] Referring to Figure 7, shown therein is a flow diagram 700 of a method of assembling a beating anatomy simulator, according to an embodiment. The beating anatomy simulator may be the beating anatomy simulator 100 of Figure 1.

[0105] At 702, a cord configuration is predetermined. Predetermining the cord configuration includes analyzing the cardiac movement of an unsimulated heart. The analysis may be of a particular portion of the unsimulated heart such as at a feature or area of interest. The analysis is tailored to the cardiac motion to the unsimulated heart for predetermined procedures. The modular, synthetic, and versatilely configurable nature of the simulated heart anatomy facilitates availability and variability to beneficially accommodate modeling a wide range of procedures and corresponding cardiac movements.

[0106] In some embodiments, the analysis includes obtaining motion data corresponding to the positions and velocities of the features of interest. This motion data may be from known sources such as published literature or video, for example, of one ormore hearts during unsimulated procedures. These videos may be used to generate dynamic three dimensional (3D) digital models of the heart. The models may be used to determine parameters such as forces, attachment points, and quantity of attachment points that will achieve the desired fidelity of the unsimulated cardiac motion. In some embodiments, motion patterns are discerned from gated dynamic CT, magnetic resonance imaging (MRI), or ultrasound images of an unsimulated heart.

[0107] In an example, recreation of cardiac kinematics includes establishing a datum and coordinate system for both the body and the heart. The displacement and velocity data collected corresponding of a feature of interest such as an LAD may be in the anatomical coordinate system (cranial-caudal, anterior-posterior, and left-right directions) with the heart oriented obliquely in the thoracic cavity with respect to anatomical coordinate system. To effectively interpret anatomical data, a separate cardiac coordinate system and a transformation between systems is established. In this example, the datum chosen is the coronary ostia at the aorta, a position on the heart that moves very little during systole and diastole making it effective for a fixed reference point. The chosen coordinate system is three dimensional to replicate the three dimensional movement of the surface of the left ventricle, which the LAD rests upon. These dimensions consist of the cranial-caudal direction, the anterior-posterior direction, and the left-right direction. The kinematics of the LAD during the cardiac cycle, including its velocity and displacement in all three directions facilitate the design of an appropriately dimensioned CAM profile. The cyclic rhythm characteristic of cardiac motion is able to be mimicked accurately by the simple harmonic motion associated with CAM movement, making the CAM an effective choice for this purpose.

[0108] Instances with multiple viable configuration solutions (i.e. the solution is not necessarily fully constrained) are expressly contemplated. Accordingly, cord configurations may be predetermined based on other factors such as potential for the cord to interfere with the practice of the simulated procedure, simplification of manufacturing or implementation, reduction of costs, and the like.

[0109] In some embodiments, the feature of interest is an LAD. Irregularity in heart rate, organ placement, blood flow rate and many other variables tend to make cardiacmotion an inexact science. In some examples, while consistent and verifiable kinematic data in the cranial-caudal direction is available, error in cases of the movement in the anterior-posterior and left-right directions are large, and the magnitude of movement is small such that the standard deviation of the motion is greater than the mean. In these examples, motion in these directions, up to a certain magnitude, is effectively random and insignificant. Configuring the simulator to simulate the cardiac movement only in the cranial-caudal direction accommodates simplified determination of the cardiac kinematics and their implementation with the beating heart simulator and particularly the heartbeat actuator. In other examples, the LAD motion patterns are oblique (i.e. not limited to the cranial-caudal direction). In these examples, the motion may be primarily towards the central axis of the left ventricle. This axis may vary between patients and may change, for example, when a patient’s left lung is collapsed for surgery. In these cases, configuring the simulator for movement in any direction beneficially accommodates the complexity of the intended simulated procedure.

[0110] At 704, the cords are affixed to the simulated heart anatomy. The cords are affixed at the attachment points, for example, as determined at 702. The cords may be affixed by any known means sufficient to withstand the tension predetermined at 702.

[0111] In an example, an end of each cord is embedded in the simulated heart anatomy at an attachment point when the simulated heart anatomy is formed. In a further example, an end of each cord is passed from the interior to the exterior of the simulated heart anatomy, through the simulated heart anatomy at a corresponding attachment point. The end of the cord is then provided with a means that prevents the cord from passing back through the simulated heart anatomy and covered with additional material such as matching the exterior surface of the simulated heart anatomy, such as silicone, for covering the end of the cord. The prevention means may be a knot of or fraying of the end of the cord. It will be appreciated that the prevention means is also consistent with embodiments where the cord end is embedded in the simulated heart anatomy.

[0112] At 706, the simulated heart anatomy is mounted. In an example, the simulated heart anatomy is secured in a support assembly such as shown in Figure 5B. A frame and holder may be adjusted to dispose (i.e. position and orient) the simulatedheart anatomy relative to a timing assembly. This disposition may be an assumption or adjustable parameter of the predetermination at 702.

[0113] At 708, the cords are affixed to the timing assembly. In some embodiments, each cord is affixed to a corresponding timing mechanism. It will be appreciated that affixing the cords to the timing mechanism may occur prior to or following calibration, as described at 710 below.

[0114] At 710, the cords are calibrated. The tension of each cord is calibrated to the tension predetermined as described at 702 for an initial state of the simulated heart anatomy. It will be appreciated that as the heart is resiliently in a diastolic state the calibration is according to achieving a systolic configuration via tension. It is expressly contemplated that the timing of an individual cord at maximum tension may be offset from when the remaining cords are at maximum tension.

[0115] In some embodiments, the cords are calibrated or tuned to the desired tension by adjusting an adjustment mechanism of a cord calibrator, as shown in Figures 6A or 6B, thereby, winding or unwinding cords. The cords are fixed (i.e. knotted) at the through-hole securement means 654-1 through 654-3 of Figure 6B. The cords pass freely over the timing assembly and particularly the timing mechanisms. It will be appreciated that if present, the affixation described at 708 may be reversed to allow this free movement. As the timing mechanism rotates, the cords are pulled in tension, causing the simulated anatomy to contract.

[0116] Each adjustment mechanism is adjusted until the contraction of the simulated anatomy simulates the intended cardiac movement. It will be appreciated that the calibration may be to a prescribed accuracy or range corresponding to acceptable deviation for the simulated procedure. The calibration beneficially accommodates factors beyond the those considered in determining the predetermined cord configuration.

[0117] Referring to Figure 8, shown therein is a flow diagram of a method 800 of using a beating anatomy simulator, according to an embodiment. The beating anatomy simulator may be the beating anatomy simulator 100 of Figure 1.

[0118] At 812, the beating anatomy simulator is set up, for example, as described at method 700 of Figure 7. In embodiments with a programable controller, setting up the heart anatomy simulator may further include programing the controller according to the analysis at 702 of Figure 7.

[0119] At 814, a beating actuator is activated. For example, a movement means may be conductively connected to a power source or a controller causing the movement means to be set in motion. Activating the beating actuator initiates the cardiac movement that the cords and controller, if present, are configured to simulate. In an example, the beating actuator provides low noise (below 25 dB) cardiac replication at a realistic heart rate such as 70 beats per minute (BPM) + or - 10 BPM the variation of which may be based on manual input.

[0120] At 816, the practicing professional initiates the simulated procedure. The simulated procedure may include applying surgical tools such as existing mechanical heart stabilizers used in the procedure which the simulated procedure is simulating. The configuration of the beating anatomy simulator beneficially accommodates such use, as described above, simulating the damping motion that occurs with the surgical tool is applied. The beating anatomy simulator may also output electrical signals corresponding to a human heart’s signaling. This singling beneficially accommodates the use and practice therewith of surgical tools and imaging systems such as CT that function based on these signals.

[0121] At 818, the cardiac movement may be evaluated to determine if it is consistent with a desired cardiac movement. For example, the initial calibration may have drifted or a change in the cardiac cycle may be warranted based on the progression of the simulated procedure. The evaluation may be manual, for example, by the practicing professional based on the progress of the simulated procedure. The evaluation may be automatic, for example, by a triggered sensor or a predetermined passage of time.

[0122] At 820, where the cardiac movement is determined to be adjusted the adjustment is made. In some embodiments, the adjustment is made by selecting predetermined settings corresponding to predetermined cardiac cycles. In someembodiments, such as with a preprogrammed controlled, the adjustment may be automated.

[0123] At 822, the practicing professional continues with the simulated procedure.

[0124] At 824, at 818 through 822 are repeated until the procedure is completed. The variability and controllability of the cardiac motion provides a simulated cardiac motion that mimics actual cardiac motion throughout the entirety of the cardiac cycle for the duration of the practiced procedure.

[0125] At 826, once a practice procedure is completed, the simulated heart anatomy may be evaluated to determine what would accommodate the next practiced procedure. If a change or replacement would facilitate such next procedure, the change or replacement is facilitated. The replaceable, configurable and calibratable simulated anatomy beneficially facilitates the use of the beating heart simulator for a wide range of highly dynamic procedures while minimizing the extent of replacement and expertise required to implement this range.

[0126] Referring to Figures 9A and 9B, shown therein are photographs of a simulated heart anatomy 920 in a diastole and systole state, respectively, from a heart’s apex perspective, according to an embodiment. The simulated heart anatomy 920 is an embodiment of the simulated heart anatomy 120 of Figure 1. Based on optical tracking system measurements, literature values of step displacements and range of motion in 3D of beating hearts are simulated in the simulated heart anatomy 920 when transitioned between diastole and systole by a heartbeat actuator such as the heartbeat actuator 130 of Figure 1.

[0127] While the above description provides examples of one or more apparatus, methods, or systems, it will be appreciated that other apparatus, methods, or systems may be within the scope of the claims as interpreted by one of skill in the art.

Claims

Claims:

1. A beating anatomy actuator system comprising:a first cord, the first cord:configured to be attached at a first cord second end to a simulated anatomy at a first attachment point via an interior of the simulated anatomy, wherein the simulated anatomy is configured to simulate a beating anatomy, composed of a resilient material, and configured to be resiliently in diastole; andconfigured to be attached at a first cord first end to a timing assembly;the timing assembly, wherein the timing assembly, when set in motion, is configured to vary the tension of the first cord to induce at least one simulated beating motion in the simulated anatomy; anda movement means configured to move the timing assembly in a controllable manner.

2. The system of claim 1, wherein the attachment of the first cord first end to the timing assembly is at a first timing mechanism and the attachment of the first cord at the timing mechanism is adjustable to facilitate calibration of an initial tension in the first cord.

3. The system of claim 2, wherein the timing assembly is a crankshaft configured to be rotated by the movement means and the timing mechanism is a cam configured to asynchronously increase and release tension in the cord when the timing assembly is rotated by the movement means through a cardiac cycle.

4. The system of claim 2 comprising a second cord attached at a second cord first end to a second timing mechanism of the timing assembly and at a second cord second end to the simulated anatomy at a second attachment point.

5. The system of claim 1 comprising a controller preset to variably control one or more of the speed and direction of the movement means.

6. The system of claim 1 comprising a routing mechanism configured to direct the route of the first cord.

7. The system of claim 1 , wherein the simulated anatomy is configured to be disposed in a predetermined disposition relative to the beating anatomy actuator system by a support assembly.

8. The system of claim 1 , wherein the first cord second end is secured on the exterior surface of the simulated anatomy and covered by a material matching the simulated anatomy.

9. The system of claim 1, wherein the simulated anatomy simulates a human heart or portion thereof and is composed of synthetic materials.

10. A method of manufacturing a beating anatomy simulator comprising:configuring a simulated anatomy resiliently in diastole;predetermining a cord configuration for a first simulated procedure corresponding to at least one simulated beating motion to be induced in the simulated anatomy;attaching a first cord at a second end of the first cord to the simulated anatomy at an attachment point according to the cord configuration; andaffixing the first cord at a first end of the first cord to a timing assembly of the beating anatomy simulator at a first cord initial tension according to a first cord predetermined tension of the cord configuration wherein the timing assembly when set in motion is configured to vary the tension of the first cord to induce a first simulated beating motion of the at least one beating motion in the simulated anatomy.

11. The method of claim 10 comprising mounting the simulated anatomy to dispose the simulated anatomy relative to a timing mechanism of the timing assembly according to the cord configuration.

12. The method of claim 10 comprising calibrating the first cord tension according to a second initial tension according to a second cord configuration corresponding to a second simulated procedure.

13. The method of claim 10 comprising calibrating the first cord initial tension the calibration comprising:securing the first cord at a point beyond the first end of the first cord to a winding mechanism of a cord calibrator wherein, the first cord passes over the timing assembly at the first end; andwinding or unwinding the first cord about the winding mechanism for adjusting the location of the first end along the first cord until the simulated beating motion is achieved according to a prescribed tolerance.

14. A method of using a beating anatomy simulator comprising:activating a beating anatomy actuator of the beating anatomy simulator comprising, the activation comprising setting a timing assembly of a beating anatomy actuator in motion to induce a first beating anatomy motion in a simulated anatomy of the beating anatomy simulator, wherein:the simulated anatomy is configured to be resiliently in diastole,the first beating anatomy motion is induced via a first cord attached at a first cord second end to a simulated anatomy at a first attachment point of the simulated anatomy via an interior of the simulated anatomy and at a first cord first end to the timing assembly, anda location of the attachment point and the tension of the first cord is according to a predetermined first cord configuration corresponding to a first simulated procedure; andperforming the first simulated procedure.

15. The method of claim 14, wherein the beating anatomy simulator includes a controller for controlling beating motion parameters and the method comprises adjusting the beating motion parameters to vary the beating motion of the simulated anatomy from the first beating anatomy motion to a second beating anatomy motion.

16. The method of claim 15, wherein the controller automatically varies the motion based on one or more of predetermined settings, predetermined triggers and manual triggers.

17. The method of claim 14 comprising replacing the simulated anatomy with a replacement simulated anatomy corresponding to a second simulated procedure.

18. The method of claim 17, wherein the second simulated procedure and the first simulated procedure simulate the same medical procedure, and the simulated anatomy is exhaustibly modified during the performance of the first simulated procedure.

19. The systems and methods as generally and specifically described herein.

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