WO2025231549A1 - Modular anatomy simulator and method of manufacturing the same - Google Patents
Modular anatomy simulator and method of manufacturing the sameInfo
- Publication number
- WO2025231549A1 WO2025231549A1 PCT/CA2025/050618 CA2025050618W WO2025231549A1 WO 2025231549 A1 WO2025231549 A1 WO 2025231549A1 CA 2025050618 W CA2025050618 W CA 2025050618W WO 2025231549 A1 WO2025231549 A1 WO 2025231549A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- anatomy
- heart
- assembly
- pathology
- simulator
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
- G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
- G09B23/30—Anatomical models
- G09B23/34—Anatomical models with removable parts
Definitions
- the following relates generally to anatomy simulators, and more particularly to physical anatomy simulators simulating a chest.
- 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 as well as the demonstration of new techniques and technologies.
- Existing simulators are often purpose based, simulating various aspects of a potential patient that the medical professional may encounter during actual procedures (i.e. surgeries). As certain procedure interactions of the medical professional and the patient have been prioritized, corresponding aspects of the patient have been modeled in existing simulators to the exclusion of others.
- the simulator or a piece thereof is purpose built for a surgery on a specific patient.
- This patient specific element enables accurate replication of the anatomy and specific pathology of the patient.
- a scan of a heart valve of the patient may be used to produce replica model valve to simulate the particular features of the patient’s valve thereby facilitating practice of the surgeon and/or surgical team prior to the surgery.
- these replicas can accurately mimic patient valve pathology (mitral regurgitation MR) measured by Doppler ultrasound, the replicas do not accurately mimic actual valve shape and geometry, due to the spatial and temporal limitations of the ultrasound images from which the replicas are derived.
- These simulators also lack a generality necessary to train medical professionals to be qualified to treat a substantial range of multiple patients.
- the resources necessary to accommodate this customization a substantial and limit the availability, accessibility, and rate of use of the simulator.
- This customization can also limit the applicability of these simulators where the customization of a specific pathology is unavailable.
- resource limitations may require patient or medical professionals to travel significantly to utilize the simulator, further mitigating the simulator’s viability or effect.
- these simulators necessarily require replacement of at least a piece of the simulator to simulate each surgery, existing systems lack pieces of anatomy to facilitate the replacement. These absences reduce the effectiveness the simulator in simulating a real-world environment.
- these systems rely on accuracy of the modeling to the patient, these models can be limited to reduce modeling burden.
- the simulator may necessarily be limited to the anatomy of the patient to be operated and the immediately connected to or surrounding anatomy. These simulators are, therefore, ill suited to training medical professionals to be prepared for potential patients.
- the simulator or a piece thereof generalized to a single pathology.
- a simulator may be built to simulate a healthy mitral heart valve. Cadavers may also be used to practice procedures. Because of the general applicability of these systems and the intent to model only one pathology (i.e. a healthy mitral valve pathology), these simulators generally lack the means to exchange parts modeling varying pathologies without disassembly. Theses systems also are deficient in simulating feedback of features that other pathologies may present. For example, a simulator with a healthy valve model may not provide the haptic feedback of rigidity that a calcified heart valve will supply.
- the system includes a platform including chest anatomy.
- the system includes a first heart assembly configured to simulate a first heart anatomy corresponding to a plurality of first anatomy pathologies.
- the first heart assembly comprises includes a first simulated heart anatomy configured to simulate the first heart anatomy.
- the first simulated heart anatomy includes reference anatomy configured to simulate the first heart anatomy common to the plurality of first anatomy pathologies.
- the first heart assembly includes a heart assembly structure configured to interface with and be releasably secured to the platform and to receive and releasably secure, in the first heart assembly, an initial first pathology specific anatomy.
- the initial first pathology specific anatomy is configured to simulate heart anatomy corresponding to a first pathology selected from the first anatomy pathologies.
- the first simulated heart anatomy may further include the initial first pathology specific anatomy selected from a plurality of first pathology specific anatomies.
- Each of the first pathology specific anatomies may correspond to one of a plurality of first anatomy pathologies.
- the first anatomy pathologies may be predetermined based on commonality.
- the reference anatomy may be configured to remain unconsumed when a first procedure corresponding to the first pathology of the plurality of medical procedures is practiced.
- the system may include a second heart assembly configured to simulate a second heart anatomy selected from the plurality of predetermined heart anatomies.
- the second heart anatomy may correspond to a plurality of second anatomy pathologies.
- the second heart assembly may be interchangeable with the first heart assembly to accommodate a second procedure corresponding to a second pathology of the second anatomy pathologies.
- the first heart assembly may be selected from a plurality of predetermined heart assemblies.
- the predetermined heart anatomies may include one or more of a mitral anatomy, an aortic anatomy, and a coronary artery bypass graft (CABG) anatomy.
- CABG coronary artery bypass graft
- the initial first pathology specific anatomy may be consumable, at least in part, by a first procedure and interchangeable with an additional first pathology specific anatomy corresponding to the first pathology for replacing the consumed initial first pathology specific anatomy.
- the system may include an initial secondary pathology specific anatomy corresponding to a secondary pathology of the plurality of first anatomy pathologies.
- the initial secondary pathology specific anatomy may be interchangeable with the initial first pathology specific anatomy for simulating the secondary pathology corresponding to a second procedure.
- the first anatomy pathologies may include one or more of a typical pathology and a calcified pathology.
- the platform may include a base configured to form a base of the modular chest simulator.
- the base may include a simulator base plate configured to provide a platform of the base and at least one heart assembly securing mechanism.
- the chest simulating components may include a rib cage configured to simulate a human rib cage. The rib cage may be fixed to an anterior surface of the base.
- the at least one securing mechanism may include a superior clip disposed at a superior end of the simulator base plate configured to receive superior end of the heart assembly base plate.
- the at least one securing mechanism may include a plurality of base screws disposed at and threadingly connected to the inferior end of the simulator base plate.
- the heart assembly may include a receiving hole corresponding to each base screw for receiving the base screws. Sliding the heart assembly along the simulator base plate a sliding distance along one or more axes and tightening the base screws releasably secures the heart assembly to the simulator base plate.
- the sliding distance may be predetermined according to the first pathology.
- the rib cage may include a rib support assembly for supporting a plurality of ribs.
- the plurality of ribs may be flexibly and severably connected to the rib support assembly at an anterior end by an anterior junction and at a posterior end by a posterior junction.
- the rib cage may include a rib support assembly for supporting a plurality of ribs.
- the rib support assembly may include a sternum configured to simulate a human sternum.
- the sternum may include a right sternum piece and a left sternum piece.
- the rib support assembly may include a superior rib support disposed at a superior end of the rib support assembly and connected to and configured to support a superior end of the sternum.
- the superior rib support may include a superior right support connected to and configured to support a superior end of the right sternum piece, a superior left support connected to and configured to support a superior end of the left sternum piece, and an inferior clip configured to separably connect an inferior end of the right sternum piece and the left sternum piece.
- the right sternum piece and superior right support may be separable from the left sternum piece and the superior left support for simulating splitting the sternum.
- the rib cage may include an intercostal muscle for simulating the flexible interconnectivity of a plurality of ribs of the rib cage.
- the intercostal muscle may be composed of an elastic material corresponding to a predetermined elasticity of the simulated interconnectivity.
- the heart assembly may include a coronary artery bypass graft (CABG) heart assembly.
- the initial first pathology specific anatomy may include a heart surface and the at least one coronary artery.
- the modular chest simulator may further include a CABG assembly comprising simulated auxiliary CABG anatomy.
- the heart assembly structure may further include a stand.
- the stand may be configured to support and dispose the first simulated heart anatomy according to the first heart anatomy and accommodate, receive, and releasably secure the initial first pathology specific anatomy.
- the stand may include a holder configured to receive and secure the initial first pathology specific anatomy and arms configured to dispose the holder above the heart assembly base plate for positioning the simulated heart anatomy according to the first pathology.
- the holder may be rotatably connected to the arms for orienting the holder according to the first pathology.
- the initial first pathology specific anatomy may include a valve assembly.
- the stand may include a holder.
- the holder may include a frame configured to accommodate the valve assembly and a reference anatomy according to first heart anatomy.
- the holder may include a clamp adjustably connected to the frame.
- the frame and the clamp may define a slot for receiving the valve assembly. Adjusting the connection of the clamp to the frame may transition the holder from a receiving configuration for receiving the valve assembly to a secured configuration for securing the valve assembly.
- the initial first pathology specific anatomy may include a valve assembly.
- the valve assembly may include a valve assembly structure including a flange connected to valve assembly anatomy of the valve assembly and a proximal flange cover and a distal flange cover.
- the flange may be disposed and secured between the proximal and distal flange covers.
- the flange, distal flange cover, and proximal flange cover may be configured when secured together, to provide a structure for being received by the stand.
- the first heart anatomy may include a mitral anatomy and the initial first pathology specific anatomy may include a plurality of chordae tendineae. Each chordae tendineae may be secured at a first end to a corresponding valve leaflet and at a second end to an adjustment screw. Turning the adjustment screw may adjust an effective length of the chordae tendineae for simulating a chordae tendineae tension according to the first pathology.
- the system may include an endoscopic camera for capturing an internal image data and a video processing module for overlaying pre-captured, non-simulated endoscopic data corresponding to the first heart anatomy onto one or more surfaces of the internal image data. Each surface may correspond to a similar predetermined surface of the pre-captured non-simulated endoscopic data to obtain augmented image data.
- the system may include a display for displaying the augmented image data.
- Figure 1A is a block diagram of a modular chest simulator, according to an embodiment
- Figure 1 B is a perspective view schematic of the modular chest simulator of Figure 1A, according to an embodiment
- Figure 1 C is a photograph of the modular chest simulator of Figure 1A, according to an embodiment
- Figure 1 D is a perspective view schematic of the modular chest simulator of Figure 1 A, according to a further embodiment
- Figure 2A is a perspective view schematic of the base of Figure 1 B, according to an embodiment
- Figure 2B is a perspective view schematic of the base of Figure 1 B, according to a further embodiment
- Figure 3A is a perspective view schematic of the base of Figure 1 B with a heart assembly of Figure 1 B installed on the base, according to an embodiment
- Figure 3B is a photographic flow diagram of the installation of the heart assembly on the base of Figure 3A, according to an embodiment
- Figure 3C is a schematic flow diagram of the installation of the heart assembly on the base of Figure 3A, according to a further embodiment
- Figure 4A is a block diagram of a heart assembly structure of Figure 1A, according to an embodiment
- Figure 4B is a perspective view schematic of an aortic heart assembly structure of Figure 4A, according to an embodiment
- Figure 4C is a perspective view schematic of a mitral heart assembly structure of Figure 4A, according to an embodiment
- Figure 4D is a perspective view schematic of a post of Figure 4A, according to an embodiment
- Figure 5A is a block diagram of the rib cage of Figure 1A according to an embodiment
- Figure 5B is a perspective view schematic of the rib cage of Figure 5B, according to an embodiment
- Figure 5C is a perspective view schematic of the rib cage of Figure 5A, according to an embodiment
- Figure 6A is a block diagram of a rib support assembly of Figure 5A, according to an embodiment
- Figure 6B is a perspective view schematic of a rib support assembly of Figure 5A, according to an embodiment
- Figure 6C is a top view schematic of a sternum of Figure 6A, according to an embodiment
- Figure 7A is a perspective view schematic diagram of the skin of Figure 1 A, according to an embodiment
- Figure 7B is a perspective view schematic diagram of a partial rib cage of Figure 1 A with a skin holder, according to an embodiment
- Figure 8 is a block diagram of reference anatomy of Figure 1A, according to an embodiment
- Figure 9 is a perspective view schematic of the valve stand and reference anatomy of Figures 4 and 8, respectively, according to an embodiment
- Figure 10A is a perspective view schematic of the valve stand and aortic reference anatomy of Figures 4 and 8, respectively, according to an embodiment
- Figure 10B is a photograph of the valve stand and reference anatomy of Figure A, according to an embodiment
- FIG 11 is a block diagram of the valve stand of Figure 4A, according to an embodiment
- Figure 12 is a block diagram of the valve assembly of Figure 1A , according to an embodiment
- Figure 13A is a perspective view schematic of the valve assembly of Figure 12, according to an embodiment
- Figure 13B is a photograph of the valve assembly of Figure 13A being inserted into a valve stand of Figure 10B, according to an embodiment
- Figure 14A is a perspective view schematic of a valve assembly of Figure 12, according to an embodiment
- Figure 14B is a photograph of a valve assembly of Figure 12, according to an embodiment
- Figure 15 is a side view photograph of cross section of a valve of Figure 12, according to an embodiment
- Figure 16A is a an enface view of a valve of Figure 12, according to an embodiment
- Figure 16b is a an enface view of a valve of Figure 12 with a calcified pathology, according to an embodiment
- Figure 17A is a side view cross sectional schematic of a valve assembly anatomy of Figure 12, according to an embodiment
- Figure 17B is a enface view cross-sectional schematic of a valve assembly anatomy of Figure 12, according to an embodiment
- Figure 17C is a enface view photograph of cross-sectional of a valve assembly anatomy of Figure 12, according to an embodiment
- Figure 18 is a flow diagram of a method of setting up and practicing with the modular chest assembly Figure 1A, according to an embodiment
- Figure 19 is a photograph of a practice procedure setup including the modular chest simulator of Figure 1A, according to an embodiment
- Figures 20A, 20C, 20E, 20G, and 20I are video capture images of the procedure of Figure 18, according to an embodiment;
- Figures 20B, 20D, 20F, 20H, and 20J are augmented images corresponding to Figures 20A, 20C, 20E, 20G, and 201, according to an embodiment;
- Figure 21 A is an enface view photograph of a heart valve assembly of Figure 12, post procedure, according to an embodiment
- Figure 21 B is a side view photograph of the valve assembly of Figure 21 in a simulated ventricle, according to an embodiment
- Figure 22 is a flow diagram for forming a simulated valve assembly anatomy of Figure 12, according to an embodiment
- Figure 23A is a cross sectional side view schematic of a leaflet mold for forming a leaflet of Figures 17A through 17C, according to an embodiment
- Figure 23B is a perspective view schematic of the bottom piece of the leaflet mold of Figure 23A;
- Figure 23C is an enface view schematic of the leaflets of Figure 23A, according to an embodiment
- Figure 24A is a cutaway side view schematic of a mold for forming the aortic valve assembly of Figure 17A, according to an embodiment.
- Figure 24B is a perspective view schematic of an aorta side blood pool insert of the mold of Figure 24A, according to an embodiment.
- the following relates generally to an anatomy simulator and particularly to a chest anatomy simulator.
- the chest simulator is modular to enable practicing medical procedures on a range of pathologies.
- the simulator enables implementing the to be practiced pathology by mechanisms for exchanging at least one part of the simulator.
- the remaining pieces of the simulator are configured to enable this exchange.
- the simulator may also enable further adjustment of the base pathology (i.e. tuning the base pathology) with mechanisms that enable adjustment in addition to the exchange.
- the modularity of the simulator accommodates a range of pathologies to be practiced with physical replicas of anatomy, and particularly cardiac anatomy, that mimics to a high degree the diseases/pathologies commonly found in patients receiving surgical intervention.
- the anatomies include high fidelity pathology specific heart anatomies replicating heart valves and vessels.
- the simulator is configured to simulate minimally invasive and traditional cardiac surgery. This high fidelity is achieved with inorganic materials.
- This composition beneficially provides the simulator superiority over organic or semi-organic training tools such as cadavers. For example, using inorganic materials provides longevity and adaptability over training tools comprising organic materials.
- the pathologies replicated are actual pathologies, for example, for valves and coronary artery bypass tissues.
- the pathologies may simulate conditions such as tethering, prolapse, or stenosis causing insufficient flow in the proper direction across a heart valve.
- the configuration and composition of the simulator enables simulation representing a variety of heart valve pathologies. Most typical valve surgical repair procedures (approximately 90% or more).
- This modularity enabled variety in conjunction with adjustments enabled by the simulator facilitates medical professionals, after practicing or training using the simulator, to be prepared for a wide range of procedures. Therefore, the simulator enables medical professionals to accommodate a wide range of patients without significant resources allocation (i.e. time and money) to obtaining and maintaining many simulators or customizing an existing one. It will be appreciated that the simulate accommodates demonstration of new or unknown procedures and corresponding technologies over existing systems, for much of the same reasons.
- FIG. 1A through 1 C shown therein is a block diagram, perspective view schematic, and photograph of a modular chest simulator 100, according to an embodiment.
- FIG 1 D shown therein is a perspective view schematic of the modular chest simulator 100 according to a further embodiment.
- the modular chest simulator 100 is configured to provide a simulated human chest for practice and training of a medical professional 10.
- the medical professional 10 is a person who is training to perform or be involved in procedures on a patient that the modular chest simulator 100 is intended to simulate.
- the medical professional 10 may be a surgeon, physician, nurse or the like or a person such as a student training in the medical or health care field.
- the modular chest simulator 100 is configured to provide a high fidelity replica to the heart anatomy of a human patient as well as the surrounding environment to the chest.
- the high fidelity and modularity of the modular chest simulator enables training and practice of the medical professional 10 and demonstration of procedures and technologies in a variety of common pathologies while minimizing resource allocation involved.
- the modular chest simulator 100 beneficially facilitates the expansion and broadening of health care availability and accessibility.
- the modular chest simulator 100 is configured to simulate the chest of a patient when the patient is supine; the typical surgical disposition.
- the modular chest simulator 100 includes a base 102.
- the base provides the foundation for the simulator 100.
- FIG. 2A shown therein is are perspective view schematics of the base 102 in isolation, according to various embodiments.
- the base 102 includes a simulator base plate 104.
- the under surface of the simulator base plate 104 is flat to be set on a planar surface such as a table.
- FIG. 2B shown therein is a perspective view schematic of the base 202, according to an embodiment.
- Base 202 is configured similarly to the base 102 of Figures 1A through 2A.
- the base 202 includes a wedge 205.
- the wedge 205 is attached to the base plate 204, such as at the undersurface and/or edge.
- the wedge 205 props up a side of the base plate 204 for tilting the base 202 and the simulator 102 of Figure 1A through 1 C accordingly.
- the wedge 205 is adjustable for example to provide a tilt angle of twenty through thirty degrees.
- FIG. 3A shown therein is a perspective view schematic of a base 102 with a heart assembly 110 installed on the base 102, according to an embodiment.
- the base 102 further includes a superior clip 106.
- the superior clip 106 is fixedly connected to a top surface 107 of the base 102.
- the superior clip 106 is configured to receive and restrain the base plate 424 of the heart assembly 110, further described below.
- the superior clip 106 forms a U-channel 109 with the simulator base plate 104 that is open on the inferior side for receiving the heart assembly 110.
- the channel 109 may be elongated such that when the heart assembly 110 is shifted the heart assembly base plate 424 is still restricted from movement in the positive vertical direction by the superior clip 106.
- Base 102 further includes one or more base screws 108.
- the base screws 108 are threadingly connected to the simulator base plate 104.
- the base screws 108 extend vertically from a tail end at the simulator base plate 104 to a head end.
- the extension provides a rod.
- the head at the head end of the base screws 108 are wider than the rod for securing the heart assembly base plate 424, further described below, between the bottom of the head and the top surface 107 of the simulator base plate 104.
- the base screws 108 are thumb screws to facilitate toolless loosening and tightening of the base screws 108 sufficient to secure the heart assembly 110 against forces experienced during practice of the procedures.
- the base screws 108 are disposed at the posterior end of the base 102 to facilitate unobstructed accesses such as from the rib cage 130 further described below.
- the modular chest simulator 100 includes a heart assembly 110.
- the heart assembly 110 is configured to simulate a representative heart anatomy.
- the heart assembly 110 is modular in that it may be exchanged in the modular chest simulator 100 with a heart assembly 110 of a different heart anatomy.
- Each heart assembly 110 includes a simulated heart anatomy 112.
- the simulated heart anatomy 112 is configured to simulate anatomy of a human heart relevant to the intended practice procedure.
- Example embodiments of simulated heart anatomies 112 include mitral, aortic, and bypass heart surgery anatomies.
- the simulated heart anatomy 112 may also be configured to simulate one of a group of representative anatomies that vary in a predetermined dimension, such as diameter.
- the simulated heart anatomy 112 simulates an aorta with an inner diameter of 26mm selected from a range of available aorta.
- the simulated heart anatomy 112 includes reference anatomy 114.
- the reference anatomy 114 simulates heart anatomy 114 that the medical professional 10 would expect to encounter during the procedure but is not intended to be destructively altered. Simulating reference anatomy 114 beneficially contributes to the fidelity of the simulation as the reference anatomy 114 may need to be addressed (i.e. by displacement or avoidance) during practice of the procedure.
- the reference anatomy 114 is configured to realistically respond to interactions with the medical professional 10. This simulation reference anatomy 114 enables the medical professional 10 to beneficially receive realistic feedback from the reference anatomy 114 during the use of the simulator and evaluate the avoidance or mitigation of risks to the reference anatomy 114 during the procedure.
- the simulated heart anatomy 112 includes a valve assembly 116.
- the valve assembly 116 simulates the components of the simulated heart anatomy 112 that are intended to be altered, also known as consumed, during each practice attempt of the procedure.
- Each valve assembly 116 is configured to simulate a particular pathology. Example pathologies include a healthy and calcified valve pathologies as well as various leaflet pathologies such as aortic bi-valve versions.
- the valve assembly 116 is replaceable.
- the valve assembly 116 may be replaced after a procedure has been practiced or to change the pathology simulated.
- the replaceability of the valve assembly 116 beneficially enables a second level of modularity. This second level of modularity is in combination with and in addition to the modularity of provided by the exchanging of the heart assembly 110.
- valve assembly 116 As the pathologies simulated by the valve assembly 116 are common and predeterminable, a range of valve assemblies 116 simulating each of these pathologies may be produced and on hand prior to the identification of a specific patient corresponding to the pathology. For example, a medical school may order a full range of common valve assemblies 116 based on enrollment or a hospital may have a series of valve assemblies 116 on hand for pathologies they commonly treat. Replacement of the valve assemblies 116 can be made based on actual or anticipated use. This beneficially mitigates availability concerns typically associated with as need production. It will be appreciated, that as the valve assembly 116 predominately includes components likely to be consumed or pathology specific elements of the heart assembly the replaceability of the valve assembly 116 facilitates efficient and simple implementation of a range of anatomy and pathology combinations.
- the valve assembly 116 is configured to be installed in the heart assembly 110, as further described below, to accommodate simulating and practicing on a desired pathology. It will be appreciated, that in some embodiments, the valve assembly 116 may be anatomy specific in addition to pathology specific. For example, a calcified aortic valve assembly 116 may only be accommodated by an aortic heart assembly 110.
- a particular heart assembly 110 with a valve assembly 116 corresponding to a particular pathology enables practice on a wide range of anatomy-pathology combinations with one modular chest simulator 100. Only a heart assembly 110 for each major anatomy type and valve assemblies 116 for predetermined pathologies are obtained and maintained to accommodate this range. This facilitates training opportunities while providing a preparedness, awareness, and mitigation of training costs. For example, dedicated and just in time custom manufacturing or substantial reconfiguring of the model is beneficially mitigated.
- the heart assembly 110 includes components that provide the structure of the heart assembly 110 collectively referred to as heart assembly structure 120.
- the heart assembly structure 120 includes components that support, adjustably dispose, and hold the simulated heart anatomy 112.
- FIG. 4A shown therein is a block diagram of a heart assembly structure 120, according to an embodiment.
- FIG. 4B and 4C shown therein is a perspective view schematic of an aortic and mitral heart assembly structure 120, respectively, according to an embodiment.
- the heart assembly structure 120 includes a valve stand 422.
- the valve stand 422 is configured to receive and support the simulated heart anatomy 112. Specifically, the valve stand 422 is configured to receive the valve assembly 116 of Figure 1A.
- the heart assembly structure 120 further includes a heart assembly base plate 424.
- the heart assembly base plate 424 forms the foundation of the heart assembly structure 120.
- the valve stand 422 and posts 426, further described below, are physically secured to the heart assembly base plate 424. This physical connection to the heart assembly base plate 424 enables the heart assembly 110 to be taken out or installed on the base 102 of Figures 1 A through 1 C, as a single module or unit.
- the heart assembly base plate 424 includes at least one receiving hole 425a, 425b or 425c.
- Each receiving hole 425a, 425b, 425c is referred to herein generically as receiving hole 425 and collectively as receiving holes 425.
- Each receiving hole 425 corresponds to a base screw 108.
- Each receiving hole 425 at a first end is sized accommodate the head of the base screw 108 without obstruction. It will be appreciated that receiving hole 425 has sufficient size to clear the head during installation of the heart assembly 110 on the base 102.
- the receiving hole 425 at a second end is sized and shaped such to allow for adjustment in the disposition of the heart assembly base plate 424 but to prevent the head of the base screw 108 from passing through. It will be appreciated that the first end and second end of the receiving hole 425 are connected, in some embodiments by a channel larger than the nub or post of the base screw 108 but smaller than the head of the base screw 108.
- the receiving hole 425 at the second end is sized to accommodate adjustments of heart assembly base plate 424 20mm in left-right translation, 10mm or more of superior-inferior adjustment, and approximately 20 degrees of rotation about a vertical (anterior-posterior) axis.
- the receiving hole 425c may be a track shaped to accommodate other more substantial shifts.
- a given base plate 424 may be interchanged with another base plate 424 of a different receiving hole 425 configuration to accommodate various shifts. This may also include anterior-posterior shifts, for example of up to 15mm.
- the heart assembly 110 further includes one or more posts 426, 426b, or 426d.
- the posts are referred to herein generically as post 426 or posts 426.
- the posts 426 are disposed towards the superior end of the heart assembly 110.
- the posts 426 are configured to support features of the heart anatomy 112 that are disposed beyond the valve stand 422, such as an aorta 112.
- the post 426d includes a flare out 427 at the interface of the heart anatomy 112 with the post 426d for securing the heart anatomy 112.
- the posts 426 may be integrated into other parts of simulator such as the rib cage 130 of Figure 1 D.
- the posts 426 beneficially contribute to the fidelity of the simulator by mitigating unrealistic forces on heat anatomy of resulting from these otherwise unsupported features.
- the heart assembly 110 may further include a grip 428.
- the grip 428 is disposed and physically connected to the heart assembly base plate 424 to facilitate removal and insertion of the heart assembly structure 120.
- the modular chest simulator 100 further includes a rib cage 130.
- the rib cage 130 is configured to simulate the rib cage of a human chest with high fidelity.
- the rib cage 130 shown is simulated based on CT scans of a healthy 40-year old male. Simulating high fidelity also includes simulating a realistic response to the actions by the medical practitioner 10 during practice with chest simulator 100.
- the rib cage 130 is also beneficially configured to be restored, for example from the operations of the practice procedure, with minimal effort.
- the rib cage 130 includes a rib support assembly 532.
- the rib support assembly 532 provides a support structure for the rib cage 130.
- the rib support assembly 532 is secured to the base 102 of Figure 1 A through 1 C.
- the rib support assembly 532 includes a sternum 642.
- the sternum 642 is configured to simulate a human sternum.
- the sternum 642 is composed of rigid polyurethane plastic to simulate strength of the sternum 642 or lack thereof. It will be appreciated that the geometry of the sternum may be modified from adherence to the most accurate representation, for example to accommodate manufacturing considerations.
- the sternum 642 is split longitudinally into a right sternum piece 644 and a left sternum piece 646.
- the sternum pieces 644 and 646 are severably connected at their respective inferior ends by an inferior clip 648.
- the clip 648 is composed of silicon to simulate the splitting of the sternum 642. Accommodating a splitting of the sternum 642 enables the simulation (and therefore practice of) midsternotomy procedures.
- FIG. 6C shown therein is a top view schematic of a sternum 642c, according to an embodiment.
- the sternum 642c is similarly configured to the sternum 642 of Figures 6A and 6B.
- the right sternum piece 644c is split into a superior right sternum piece 647 and inferior right sternum piece 649. The split accommodates a partial sternotomy. It will be appreciated, that the left sternum piece 646c may be similarly configured with a split.
- the rib support assembly 532 further includes a right posterior support 662 and a left posterior support 664.
- the posterior supports 662, 664 provide a base for each right rib 534 and left rib 535, further described below, to, respectively, connect to.
- the posterior supports 662, 664 are fixedly attached to the base 102 of Figures 1A through 2.
- the rib support assembly 532 further includes a superior rib support 650, also known a superior rib wall 650.
- the superior rib support 650 supports the sternum 642 at the superior end of the sternum 642.
- the support of the superior rib support 650 is such that the sternum 642 is disposed in a realistic elevated position.
- the superior rib support 650 includes a superior right support 652 and a superior left support 654.
- the superior right support 652 and superior left support 654 correspond to the right and left sternum pieces 644 and 646, respectively and accommodates reversibly splitting the sternum 642.
- the rib support assembly 532 further includes at least one inferior rib support 660.
- the inferior rib support 660 supports the rib cage at the inferior end of the rib cage.
- the inferior rib support 660 is physically connected at a first end to the most inferior rib of a rib cage such as the left rib 535-6 or right rib 534-6 of Figures 5A and 5B, further described below.
- This connection may be a pinned connection.
- the inferior rib support 660 may be connected to the right or left posterior rib supports 662 or 664 at a second end.
- the connection may be by a cartilage junction similar to the junctions 536 and 538 of Figures 5A and 5B, further described below.
- the rib cage 130 further includes at least one right rib 534-n and one left rib 535-n.
- Each right rib 534-n or left rib 535-n is referred to generically as rib 534 and collectively as ribs 534.
- Each rib 534 is referred to specifically as rib 534-n, generically as rib 534, and collectively as ribs 534.
- Each right rib 534 is configured to start at a first end at a right posterior support 662 and at a second end at the sternum 642 of Figure 6B.
- Each left rib 534 is configured to start at a first end at a left posterior support 664 and at a second end at the sternum 642 of Figures 6A and 6B.
- each anterior or posterior junction 536, 538 is composed of silicone to mimic the costal cartilage of an actual patient.
- each anterior or posterior junction 536, 538 includes a connecting post 539 as shown in Figure 5C.
- the post 539 is configured to affect the rib attachment of the corresponding junction 536, 538.
- the post 539 may be composed of spring steel covered with silicone.
- This simulation of junctions 536, 538 provide realistic range of motion for the ribs 534.
- This configuration of the junctions 536, 538 may also be easily “dislocated” depending on the surgical procedure to be simulated.
- the rib cage 130 may include an intercostal muscle 540.
- the intercostal muscle 540 simulates the natural resistance to retracting ribs. Simulating retracing resistance beneficially increases the fidelity of the simulator 100 particularly for practicing a mini-thoracotomy.
- the intercostal muscle is a two cm high “intercostal muscle” band fitted around the right ribs 534.
- the intercostal muscle 540 is composed of stiff silicone.
- the modular chest simulator 100 further includes a coronary artery bypass graft (CABG) assembly 150.
- the CABG assembly 150 is configured to simulate anatomy beyond the heart assembly 110 corresponding to coronary artery bypass graft procedures.
- the CABG assembly 150 includes an internal mammary artery (IMA) 152.
- the internal mammary artery 152 may be embedded in polyvinyl alcohol cryogel (PVA-C).
- PVA-C IMA 152 beneficially enables the simulation of a standard IMA harvest surgery.
- the PVA-C IMA 152 also enables the simulation of anastomosis onto the coronary arteries on the heart surface, further described below.
- the IMA is mounted to the inside of the rib cage 130.
- the IMA 152 is mounted to the sternum 642 of Figures 6A and 6B further described below.
- the modular chest simulator 100 may further includes skin 170.
- skin 170 Referring also to Figure 7A, shown therein is a perspective view schematic diagram of the skin 170 according to an embodiment.
- the skin 170 simulates the skin of a patient.
- the skin 170 is configured to conform to the rib cage 130 and is composed of an accommodating material thereof.
- the skin 170 may be removably affixed to the rib cage 130 and particularly the rib support assembly 532 or component thereof by one or more skin screws 772.
- FIG. 7B shown therein is a perspective view schematic diagram of a partial rib cage 130, according to an embodiment.
- the rib cage 130 includes a skin holder 731 .
- the skin holder 731 is affixed to the at least one rib 734, each rib 734 similarly configured to a right rib 534 or left rib 535 of Figure 5A.
- the skin holder 731 is configured to removably secure the skin 170 of Figure 7A against movement, such as hiking up the chest, during the simulated procedure. It will be appreciated that this securement may be by any known means including by a higher friction surface than the surface of the rib 734.
- FIG. 8 shown therein is a block diagram of reference anatomy 114, according to an embodiment.
- the reference anatomy 114 includes a left atrium 880 and a right atrium 882.
- the right atrium 880 and left atrium 882 are configured to simulate the corresponding atriums of a human heart.
- the right atrium 880 and left atrium 882 are fixedly connected to the holder 1190, further describe below.
- the reference anatomy 114 further includes a superior vena cava (SVC) 884.
- the SVC 884 is fixedly connected at a proximal end to the right atrium 880.
- the SVC 884 extends significantly from the end connected to the right atrium 880.
- the SVC 884 is connected at the distal end to a post 426 of Figures 4A, 4B and 4C.
- the reference anatomy 114 is composed of pliable material, such as silicon.
- the pliability simulates the resistance and elasticity of the reference anatomy 114 for realistic interactions during use of the simulator 100 Figures 1A through 1 C.
- the reference anatomy 114 may be formed as single piece. Even where the reference anatomy 114 is formed as multiple pieces, each piece may be formed to include multiple parts of the reference anatomy.
- the right atrium and the SVC 884 form as a single piece.
- the reference anatomy 114 may include further reference lumina 886.
- the reference lumina 886 may simulate reference anatomy that in some embodiments are part of the valve assembly 116 of Figure 1A.
- the reference anatomy 114 is a mitral reference anatomy 114 and the reference lumen 886 include an aorta.
- each lumen of the reference lumina 886 as referred to herein is a tubular structure of the anatomy such a vessel, arteries or veins. It will be appreciated that the reference lumina 886 may include one or multiple lumens and the reference lumina 886 refers to structure in addition to the internal space or cavity.
- the reference anatomy 114 includes a unifier 888.
- the unifier 888 is configured to join the remainder of the reference anatomy 114.
- the unifier 888 is formed or cut out so that access to the reference anatomy 114 and the internal spaces thereof is obstructed or accessible according to the corresponding anatomy being simulated.
- the unifier 888 also serves as joining structure for the reference anatomy to the valve stand 422 of Figures 4 and 11 .
- FIG. 9 shown therein is a perspective view schematic of a mitral valve stand 922 and mitral reference anatomy 914, according to an embodiment.
- the mitral reference anatomy 914 includes a reference lumen 986.
- the reference lumen 986 is configured to simulate an aorta. Simulating an aorta with a reference lumen 986 beneficially enables the simulation of cross clamping.
- Ther mitral reference anatomy 914 also includes a unifier 988.
- the unifier 988 joins the remainder of the mitral reference anatomy 914 and provides a mounting structure of the mitral reference anatomy 914 to be mounted to the holder 990, further described below.
- FIG. 10A and 10B shown therein is a perspective view schematic and photograph, respectively, of an aortic valve stand 1022 and aortic reference anatomy 1014, according to an embodiment. It will be appreciated that the reference anatomy 1014 does not include an aorta reference lumen as the corresponding aortic valve assembly 1316 provides the aorta 1308 of Figures 13A and 13B.
- FIG. 11 shown therein is a block diagram of a valve stand 422, according to an embodiment.
- the valve stand 422 includes a holder 1190.
- the holder 1190 is configured to receive and releasably hold the valve assembly 116 of Figures 1A and 12.
- the holder 1190 further configured to provide attachment structures for the reference anatomy 114 of Figure 8.
- the holder 1190 includes a frame 1191.
- the frame 1191 provides the primary structure of the holder 1190 that receives the valve assembly 116 of Figure 1A.
- the reference anatomy 114 of Figure 8 is fixedly attached to the frame 1191. It will be appreciated that the attachment accommodates movement of the reference anatomy 114 of Figure 8 enabled by the flexibility or elasticity of the reference anatomy 114 of Figure 8.
- the frames 991 and 1091 may be shaped according to the anatomy being simulated.
- the frame 991 is shaped to facilitate reference lumen 986.
- the mitral frame 991 is shaped as a complete circle to support the reference anatomy 914 and particularly the aortic reference lumen 986.
- the frame 1091 is shaped to accommodate valve assemblies 116 of Figure 12.
- the frame 1091 is shaped as a frustro-circle, truncated to accommodate the aorta 1208 of Figures 13A and 13B.
- the holder 1190 includes a clamp 1192.
- the clamp 1192 is configured to be adjustably secured to the frame 1191 to form a slot 1193 for receiving the valve assemblies 116 of Figure 12.
- the clamp 1192 is adjustable to transition the slot 1193 from a receiving configuration to a securing configuration.
- the slot 1193 is sufficiently sized to accept the valve assembly 116.
- the size of the slot 1193 is reduced compared to the receiving condition such that any valve assembly 116 of Figure 12 disposed in the slot
- clamping of the holder 1190 accommodates movement of the valve assembly 116 of Figure 12 or part thereof based on flexibility, elasticity or rigidity.
- the holder 1190 includes a securing means 1194.
- the securing means 1194 are a securing means 1194.
- the securing means 1194 enables transitioning the clamp 1192 from the receiving configuration to the secured configuration and vice versa.
- the securing means 1194 includes two screws positioned on opposite ends of the clamp 1192 which are threadingly connected to the frame 1191. The screws may be thumb screws to facilitate toolless replacement of the valve assembly 16 of Figure 12.
- the valve stand 422 further includes arms 1195.
- the arms 1195 are configured to position the holder 1190 in the heart assembly 110 of Figure 1A.
- the holder 1190 is rotatably connected to the arms 1195.
- the rotatable connection facilitates adjustment of the orientation of the reference anatomy 114 of Figure 8 and the valve assembly 116 of Figure 12 within the heart assembly 110 of Figure 1A.
- This adjustable orientation contributes to the modularity of the simulator 100 of Figures 1A through 1 C and beneficially enables further anatomies and pathologies.
- the valve stand 422 further includes stand screws 1195.
- the stand screws secure the holder 1190 in a particular orientation or anatomy.
- the arms 1195 are fixedly connected to the heart assembly base plate 424 of Figure 4A.
- the arms 1195 are fixedly connected to a stand base plate 1197.
- the stand base plate 1197 connects the structural component so the valve stand such that the valve stand 422 may be handled as an independent unit from the remainder of the heart assembly 110 of Figure 1A.
- FIG. 12 shown therein is a block diagram of a valve assembly 116, according to an embodiment.
- the valve assembly 116 includes anatomic components, referred to herein a valve assembly anatomy 1210.
- the valve assembly anatomy 1210 is composed of materials to simulate the feel of the anatomy being simulated.
- the valve assembly anatomy includes those parts of the anatomy that may be consumed during the simulated procedure. It will be appreciated that the valve assembly anatomy 1210 may be configured to include consumable components consumed in some but not all procedures corresponding to the anatomy of the valve assembly 116.
- the valve assembly anatomy 1210 includes a heart valve 1212.
- the heart valve 1212 of is configured and disposed to simulate a valve corresponding to the anatomy being simulated.
- the valve assembly anatomy 1210 includes auxiliary anatomy 1214.
- the auxiliary anatomy 1214 simulates consumable anatomy related to the heart valve 1212 being simulated.
- FIG. 13A shown therein is a perspective view schematic of an aortic valve assembly 1316, according to an embodiment.
- FIG. 13B shown therein is a photograph of the aortic valve assembly 1316 being inserted into a valve stand 1022, according to an embodiment.
- the aortic valve assembly 1316 is configured similarly to the valve assembly 116 of Figure 12.
- the valve assembly anatomy 1320 includes an aortic heart valve 1322.
- the aortic heart valve is disposed in auxiliary anatomy 1324 of the valve assembly 1316, particularly an aorta 1324.
- FIG. 14A shown therein is a perspective view schematic of a mitral valve assembly 1416, according to an embodiment.
- Figure 14B shown therein is a photograph of the mitral valve assembly 1416, according to an embodiment.
- the mitral valve assembly 1416 is configured similarly to the valve assembly 116 of Figure 12.
- the valve assembly anatomy 1420 includes a mitral heart valve 1422.
- the mitral valve 1422 is connected directly to the flange 1432, further described below.
- the valve assembly anatomy 1420 includes auxiliary anatomy 1424 configured to simulate papillary anatomy (i.e. papillary anatomy 1424).
- the papillary anatomy 1424 includes papillary muscles 1426 supported by papillary posts 1428, and chordae tendineae 1430 simulating corresponding heart structures.
- the papillary muscles 1426 may be reinforced, for example with fibrous reinforcements. The reinforcements beneficially facilitate suturing.
- chordae tendineae 1430 at a first end, are connected to or embedded in the mitral heart valve 1422 and particularly the valve leaflets 1534 of Figure 15.
- the chordae tendineae 1430 pass through the papillary muscles 1426 and the papillary posts 1428.
- the chordae tendineae 1430 are connected at a second end to an adjustment screw 1432.
- the adjustment screw 1432 may be turned adjust the effective length of the chordae tendineae 1430. This beneficially enables adjustments to simulate or mimic a range of mitral valve pathologies. For example, the screw may be turned to reel in and shorten chordae tendineae 1430 for simulating tethering.
- the screw may be turned to loosen and lengthen the chordae tendineae 1430 for simulating prolapse.
- these pathologies are causes of regurgitation, i.e. blood flowing the wrong way across the mitral heart valve 1422
- simulating prolapse or tethering beneficially facilitates practicing procedures to address these pathologies. It will be appreciated that this adjustment may also be applicable to tricuspid valve anatomies.
- the valve assembly 116 includes a valve assembly structure 1250.
- the valve assembly structure 1250 connects and supports the valve assembly anatomy 1220.
- the valve assembly structure 1250 also provides a structure to be received by the holder 1190 of Figure 11 .
- the valve assembly structure 1250 includes a flange 1252.
- the flange 1252 supports the heart valve 1222. It will be appreciated that this support may be via the auxiliary anatomy 1224.
- the flange may be composed of the same material or formed a single piece with the heart valve 1222.
- the valve assembly structure 1250 includes a proximal flange cover 1254 and a distal flange cover 1256. It will be appreciated that proximal and distal with respect to the flange covers 1254 and 1256 refer to the covers’ 1254 and 1256 disposition relative where a left ventricle, if simulated, would be located.
- the flange covers 1254 and 1256 are rigid and configured to be received by the holder 1190 of Figure 1 .
- the flange covers 1254 and 1256 and disposed on either side of the flange 1252, sandwiching the flange 1252.
- the flange covers 1254 and 1256 may be fastened together to form the valve assembly into a single unit.
- the flange 1352 and flange covers 1354 and 1356 include a cutout 1358 to simulate access to the aorta 1324.
- the mitral heart valve 1422 is impregnated in the flange 1452.
- the flange covers 1454 and 1456 include a cutout 1458 to accommodate the mitral heart valve 1422.
- FIG. 15 shown therein is a side view photograph of a mitral valve 1522 cross section, according to an embodiment.
- the mitral valve 1522 is configured similarly to the mitral valve 1422 of Figures 14A and 14B.
- the mitral valve 1522 includes an annulus 1524.
- the annulus 1524 forms the wall of the mitral valve 1522.
- the anulus 1524 is configured in an annular or saddle shape. It will be appreciated that the shape of the anulus 1524 may vary according to the pathology being simulated.
- the anulus 1524 is connected to the flange 1452. It will be appreciated that the annulus 1524 and the flange 1452 may be formed as a single piece or as separate pieces and joined by existing suitable means.
- the mitral valve 1522 includes leaflets 1534-1 through 1534-3.
- the leaflets 1534-1 through 1534-3 and a fourth leaflet are referred to herein, collectively as leaflets 1534 and generically as leaflet 1534.
- Each leaflet 1534 is flexibly connected to the anulus 1524 at a first end.
- the leaflets are a configured to flex from an open configuration to a closed configuration to simulate the operation of a mitral valve.
- the mitral valve 1522 includes chordae tendineae 1530.
- the chordae tendineae 1530 are configured similarly to the chordae tendineae 1430 of Figure 14B. At least one chordae tendon 1530 is connected at a first end to each leaflet 1534.
- the length of the chordae tendineae 1530 may be adjusted, as described above, to configure the extent the leaflets 1534 close. This adjustability beneficially enables the simulations of various pathologies, such as normal, tethered, or prolapse pathologies, for a given mitral valve 1522.
- FIG. 16A and 16B shown therein is a plain mitral valve 1622a and a calcified mitral valve 1622b from an atrial enface view, according to an embodiment.
- the mitral valves 1622 are configured similarly to the mitral valve 1522 of Figure 15.
- the plain mitral valve 1622a is configured to simulate a healthy mitral valve or those pathologies achievable by adjusting a healthy mitral valve such as a mitral valve with a prolapse pathology.
- the atrium facing surfaces 1636a-1 through 1636a-4 of each leaflet 1634a-1 through 1634a-4, respectively, of the plain mitral valve 1622a are smooth.
- the calcified mitral valve 1622b is configured to simulate pathologies including a calcified valve.
- the calcified mitral valve 1622b includes calcium deposits 1638.
- the calcium deposits 1638 are disposed on the atrium facing surfaces 1636b of each leaflet 1634b-1 thorough 1634b-4.
- the calcium deposits 1638 create an uneven profile on the aortic facing surfaces 1636b.
- the calcium deposits 1638 are composed of materials, such as hard mineral deposits, that contribute rigidity to the leaflets 1634b-1 through 1634b-4.
- the calcium deposits 1638 may be coated in a thin layer of silicone to simulate a realistic surface of the calcium deposits 1638.
- FIG. 17A shown therein is a side view cross sectional schematic of an aortic valve assembly anatomy 1720, according to an embodiment.
- FIGs 17B and 17C shown therein is a schematic and photograph, respectively, from an enface atrial view of an aortic valve assembly anatomy 1720 cross section, according to an embodiment.
- the valve assembly anatomy 1720 may be an embodiment of the valve assembly anatomy 1220 of Figure 12.
- the valve assembly anatomy 1720 is calcified valve assembly anatomy 1720 configured to simulate aortic anatomy with a calcified aortic valve 1722.
- the leaflets 1734-1 and 1734-2 of the valve assembly anatomy 1720 include calcium deposits 1738.
- the aortic valve assembly 1722 include more leaflets 1734, such as 3 leaflets.
- the calcium deposits 1738 are disposed on the aorta facing surfaces 1736 of each leaflet 1734-1 and 1734-2.
- the calcium deposits 1738 create an uneven profile on the aorta facing surfaces 1736.
- the calcium deposits 1738 are composed of materials, such as hard mineral deposits, that contribute rigidity to the leaflets 1734-1 and 1734-2.
- the calcium deposits 1738 may be coated in a thin layer of silicone to simulate a realistic surface of the calcium deposits 1738.
- FIG. 18 shown therein is a flow diagram of a method 1800 of setting up and practicing with a modular chest assembly such as the modular chest assembly 100 of Figure 1A, according to an embodiment.
- method 1800 may include assembling the modular chest assembly.
- a modular chest assembly such as the simulator 100 of Figure 4D is beneficially packaged in a container such as box or briefcase such as for storage or transport.
- at 1801 includes removing the platform base from the container and connecting each of the ribs, a right superior rib support, and a right inferior rib support at a posterior end to the platform base and at an inferior end to a right sternum piece.
- At 1801 further includes attaching a heart assembly structure to the base. It will be appreciated that simulated heart anatomy may or may not be present in the heart assembly structure when it is attached to the platform base.
- At 1801 may further include attaching skin to the assembled rib cage at the right sternum piece and the posterior end of each rib. The attachments of at 1801 may be via magnets.
- method 1800 includes assessing if a heart assembly presently in the modular chest assembly corresponds to a desired heart anatomy of the to be practiced procedure.
- To be practiced procedures include but are not limited to mitral valve procedures, an aortic valve procedures and coronary artery bypass procedures and simulated anatomies include anatomies corresponding to such procedures.
- setting up the modular chest assembly 1800 includes replacing the heart assembly presently in the modular chest assembly with a heart assembly corresponding to the desired heart anatomy.
- Replacing the heart assembly includes removing the present heart assembly.
- the removal includes loosening base plate screws securing the heart assembly in place.
- the heart assembly is slid such that holes in a base plate of the heart assembly align with heads of the base plate screws and the heat assembly base plate clears a clip attached to a base plate of the modular chest simulator.
- the heart assembly is then not obstructed from being lifted clear of the base plate screws and clip and out of the modular chest simulator.
- the heart assembly may be removed in an inferior direction to avoid a rib cage.
- Replacing the heart assembly includes installing the desired heart assembly.
- the desired heart assembly is selected from a group of available heart assemblies corresponding to various anatomies.
- Example anatomies of heart assemblies include aortic, mitral and coronary artery bypass graft assemblies each corresponding to a to be practiced procedure. It will be appreciated that each heart assembly anatomy may accommodate a range of various procedures and that multiple heart assembly anatomies may be suitable for a given procedure.
- setting up the modular chest assembly 1800 includes installing a heart valve assembly. If there is a heart valve assembly is in the holder of the heart assembly and that heart valve assembly is consumed, in whole or in part, or does not correspond to the desired pathology, installing the heart valve assembly includes removing the present heart valve assembly and replacing it with one corresponding to the desired pathology. It will be appreciated that the correspondence with the desired pathology is with respect to pathologies accommodated by the heart valve assembly, including those requiring adjustments such as those described at 1808, further described below.
- replacing the heart valve assembly include loosening a clamp, such as by thumb screws, removing, if present, the previously clamped heart valve assembly, inserting the desired heart valve assembly into the holder, and tightening the clamp to secure the desired heart valve assembly.
- setting up the modular chest simulator 1800 includes adjusting pathology and anatomy parameters.
- the disposition (i.e. position and orientation) of the heart assembly may be adjusted based on the anatomy being modeled.
- the orientation of a holder of the heart assembly is adjusted based on the anatomy being simulated.
- parameters of the heart valve assembly such as chordae tendineae length, is adjusted to increase the fidelity of the simulation.
- At 1804 through 1808 or any part thereof may be performed in any order or simultaneously. It will be appreciated that one of 1804 through 1808 may be performed partially prior to and partially after the performance of one or more of the remainder of 1804 through 1808.
- chordae tendineae of the heart valve are tightened to simulate prolapse prior to 1806 the installation of the heart valve assembly in in the heart assembly. Then, again at 1808 the orientation of the heart assembly frame is adjusted to adjust the anatomy.
- setting up and practicing a procedure using the modular chest simulator 1800 includes performing the procedure with the simulator as the simulated patient.
- the procedure is laparoscopic.
- the simulated heart anatomy 112 of the modular heart assembly 110 is configured to simulate coronary arteries of the heart.
- the valve assembly 116 is configured to simulate a heart surface.
- Modeled coronary arteries are disposed on the heart surface.
- the coronary arteries are composed of silicone.
- the reference anatomy 114 includes a motorized cam underneath the coronary arteries. The motorized cam, when activated mimics the real motion of the heart surface in the region of the coronary arteries. Simulating the heart surface motion increases the contextual fidelity of the simulation beneficially improving the training for corresponding procedures.
- FIG. 19 shown therein a photograph of a practice procedure setup 1900, according to an embodiment.
- the setup 1900 includes the modular chest simulator 100 which is used to practice an endoscopic procedure.
- the endoscopic procedure includes inserting a camera 1902 into the simulator for visibility.
- the camera captures video imagery 1904 of the area of the heart assembly, not shown.
- the video imagery 1904 is displayed on a display 1906.
- the video imagery 1904 may be augmented, also known as augmented reality, to further enhance the fidelity of the simulation.
- the video imagery 1904 also known as physical phantoms 1904, is augmented to include realistic color and depth effects not simulated by the physical heart assembly. For example, equivalent textures & specularities, as seen in actual endoscope data of similar anatomy, may be overlaid onto silicone surfaces seen in the endoscope video imagery 1904.
- the predetermined nature of the modular chest simulator 100 modules facilitates the augmented reality.
- the real time endoscope video of modular chest simulator 100 modules may be calibrated and registered into a pre-defined 3D space.
- the modules may include the rib cage, heart assemblies of various anatomies, or predefined anatomical features such as the circumflex artery, Bundle of His, ribs, valves, left atrium and right atrium models.
- Augmented reality enables rendering of anatomical features below the endoscope line of sight in a realistic manner (e.g., “keyhole” and shading techniques for realistic depth for virtual features.
- Endoscope views from outside the chest, with skin covering in place, may be included. These views may beneficially help guide the optimal port & mini thoracotomy incision sites.
- Augmented reality may beneficially enable remote teaching and proctoring capability.
- Endoscope video can be shared remotely by two or more users, for example, via the internet.
- Each party may add virtual reality (VR) markers with corresponding text labels on a screen capture of the endoscope video. The added markers are fixed to the nearest surface in 3D space, as seen in the video capture. Thus, if the endoscope is moved, the marker remains in the same place in the 3D scene.
- VR virtual reality
- Augmented reality further enables, for a mitral valve annuloplasty procedure, the ability to measure the depth of needle insertion into the annulus, based on appropriate endoscope video data. This may be enabled by a second camera at a fixed location relative to the mitral valve stand.
- Augmented reality may be facilitated or improved via a dual lens endoscopic USB camera.
- the dual lens USB camera enables bifocal vision tracking of the location of surgical tools and sutures.
- the bifocal visions provides depth perception to machine learning algorithms.
- the tracking beneficially enables accurate evaluation of the performance of medical professionals during the procedures.
- the evaluation may be manual or software based.
- Cameras with properties corresponding to the anatomies simulated are integrated into the simulator at optimal locations and calibrated based on placement.
- the modularity of the simulator beneficially mitigates the resources for placement and camera property determination and calibration as the placement and calibration does not need to be repeated for each procedure.
- FIG. 20A through 20 J shown therein are video capture images 2004a, 2004c, 2004e, 2004g, and 2004i from a camera such as camera 1902 of Figure 19 and corresponding augmented images 2004b, 2004d, 2004f, 2004h, and 2004j, respectively, according to an embodiment.
- the modularity of the heart assembly and the modularity and replaceability of the heart valve assembly enables practicing substantive range of common anatomies and pathologies while minimizing inventory size necessary to have available to practice these anatomies and pathology combinations.
- Parameter adjustability and augmented reality further contributes to the range. This enabled range beneficially facilitates training and practice of medical professionals with efficient application of limited resources and including storage.
- setting up and practicing using the modular chest simulator includes determining if further practice is desired. If yes, at 1802 through 1810, are repeated. In some embodiments, determining if further practice is desired includes inspection or testing the heart valve post procedure. The removeable nature of the heart valve assembly facilitates the inspection or testing.
- FIG. 21 A and 21 B shown therein is an enface view photograph of a mitral heart valve assembly 2116 post procedure and a side view photograph of the valve assembly 2116 in a simulated ventricle 2114, respectively, according to an embodiment.
- the simulated ventricle 2114 is composed of a flexible material such as silicone and filled with a liquid, such as water.
- a liquid such as water.
- the simulated ventricle 2114 is squeezed or additional water is injected into the simulated ventricle 2124, such as with a syringe, the action causes the valve assembly 2116 to close and reveal any valve assembly 2116 regurgitation. Revealing regurgitation or lack thereof beneficially enables proficiency evaluations as diminished regurgitation is an indicator of procedure success.
- the modular chest simulator may be stored.
- the modular nature of the simulator facilitates storage of the simulator.
- the simulator base and rib cage, and secondarily the heart assembly except the heart valve assembly are the bulkier parts of the simulator.
- the bulkier parts support a range of pathologies, fewer instances of these parts support a desired library of anatomies and pathologies. Fewer bulkier parts, beneficially occupy less storage space than existing systems with these parts dedicated to each pathology.
- storing the simulator includes replacing or ordering the replacement heart valve assemblies.
- the replacing or ordering may be based on outside factors such as expected demand (i.e. based on class sizes or certification requirements) or as a replacement for those consumed during practice. As the pathologies available are predetermined, replacement or ordering may be done in advance of the need, rather than as needed for existing patient specific models. This advance replacement and ordering beneficially reduces wait times and availability and facilitates training medical professionals to be ready for likely procedures beneficially expanding health care responsiveness, access, and availability.
- FIG. 22 shown therein is a flow diagram 2200 for forming a simulated aortic valve assembly anatomy, according to an embodiment.
- the simulated aortic valve assembly anatomy may be an embodiment of the aortic valve assembly anatomy 1320 of Figures 13A and 13B.
- a secondary material is provided to the heart valve to affect the augmentation.
- the secondary material is arrayed on a surface of leaflets of the heart valve assembly’s heart valve.
- recesses also known as negative spaces or divots
- a tertiary material for forming a surface condition of the heart valve augmentation. It will be appreciated that the tertiary material and the primary material of leaflet may be the same material, such as silicone.
- the secondary material is placed in the recesses.
- the secondary material may be hard mineral deposits for simulating calcium deposits and particularly the rigidity of the calcium deposits.
- forming the aortic valve assembly anatomy includes forming the leaflet.
- the leaflet is formed by injecting the primary leaflet material into the leaflet mold.
- FIG. 23A through 23C shown therein is a cross sectional side view schematic of a leaflet mold 2300, a perspective view schematic of the bottom piece 2310 of the leaflet mold 2300, and an enface view schematic of leaflets 2334-1 and 2334-2, respectively, according to an embodiment.
- the leaflet mold 2300 is configured to form the leaflets 2334-1 for aortic valve assembly anatomies such as the aortic valve assembly anatomy 1220 of Figure 12.
- the leaflet mold 2300 is used to implement at 2202 through 2206 of Figure 22.
- the leaflet mold 2300 includes a leaflet mold top 2302.
- the leaflet mold top 2302 provides a structure for forming the ventricle facing surface of the leaflet 2334-1 .
- the leaflet mold 2300 includes a leaflet mold bottom 2310 for forming the aorta facing surface 2336 of the leaflet 2334-1.
- the leaflet mold bottom 2310 include recesses 2312.
- the recesses 2312 are configured for forming simulated calcium deposit 2338 on the aorta facing surface 2336 of the leaflet 2334-1 , for example, as described at 2202 through 2206 of Figure 22.
- forming the aortic valve assembly anatomy includes fitting completed leaflets into blood pool inserts of an aorta mold.
- forming the aortic valve assembly anatomy includes securing the blood pool inserts with the leaflets in the aorta mold.
- the leaflets are removed from the leaflet mold and fitted into blood pool inserts, such as the blood pool inserts 2410-1 and 2410-2 of Figure 24A and 24B, further described below.
- the blood pool inserts with the premade leaflets secured inside are secured in the aorta mold. It will be appreciated that while secured in the blood pool inserts, an exterior edge of each leaflet is exposed to the aorta void of the aorta mold.
- forming the aortic valve assembly anatomy includes forming the aorta.
- the aorta is formed by injecting the aorta material, such as silicone, into the aorta mold.
- the leaflets are connected to the interior surface of the aorta along the exposed edge of the leaflets.
- Forming the aortic valve assembly anatomy includes demolding the aortic valve assembly anatomy.
- the aorta including the leaflets is removed from the aorta mold.
- the blood pool inserts are also removed from the interior of the aorta.
- FIG. 24A and 24B shown therein is a cutaway side view schematic of an aorta mold 2400 and a perspective view schematic of an aorta side blood pool insert 2410-1 , according to an embodiment.
- the aorta mold 2400 is configured to facilitate the formation of an aorta such as the aorta 1324 of Figures 13A and 13B.
- the aorta mold 2400 includes an aorta mold bottom 2402 and an aorta mold top (not shown) for forming an aorta void 2404.
- the aorta mold 2400 includes a ventricle cap 2406 and an aortic cap 2408.
- the ventricle cap 2406 is disposed at first end of the aorta mold 2400 proximal end of the aorta which interfaces with a ventricle.
- the aortic cap 2408 is disposed at a second end of the aorta mold substantially opposite the first end.
- top, bottom 2402 and caps 2406, 2408 fully define and contain the void 2404.
- One or more of the top, bottom 2402 and caps 2406, 2408 are configured to be separated from the remainer to facilitate demolding of the aortic valve assembly anatomy.
- the aorta mold 2400 further includes aortic blood pool inserts 2410-1 and 2410-2.
- the blood pool inserts are configured to facilitate the luminal form of the aorta.
- the inserts 2410 when inserted into the void 2404 cause the void to be tubular in shape corresponding to the form of an aorta.
- a ventricle facing surface 2412-1 of the blood pool insert 2410-1 at ventricle end is configured to receive (i.e. is a relief of) the aortic facing surfaces of each leaflet 2434-1 and 2434-2.
- the opposing surface (not shown) of the blood pool insert 2410-2 is similarly configured to receive the ventricle facing surface surfaces of the leaflets 2436-1 and 2436-2. Where the surfaces of the leaflets 2436-1 or 2436-2 include augmentations such as simulated calcium deposits, the blood pool surfaces such as ventricle facing surface 2412-1 include recesses 2414-1 to receive the augmentations.
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Abstract
Provided is a modular chest simulator system and method of using and manufacturing the same. The system includes a platform including a chest anatomy. The system includes a first heart assembly configured to simulate a first heart anatomy corresponding to a plurality of first anatomy pathologies. The first heart assembly comprises includes a first simulated heart anatomy configured to simulate the first heart anatomy. The first simulated heart anatomy includes reference anatomy configured to simulate the first heart anatomy common to the plurality of first anatomy pathologies. The first heart assembly includes a heart assembly structure configured to interface with and be releasably secured to the platform and to receive and releasably secure, in the first heart assembly, an initial first pathology specific anatomy. The initial first pathology specific anatomy is configured to simulate heart anatomy corresponding to a first pathology selected from the first anatomy pathologies.
Description
MODULAR ANATOMY SIMULATOR AND METHOD OF MANUFACTURING THE SAME
Technical Field
[0001] The following relates generally to anatomy simulators, and more particularly to physical anatomy simulators simulating a chest.
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 as well as the demonstration of new techniques and technologies. Existing simulators, are often purpose based, simulating various aspects of a potential patient that the medical professional may encounter during actual procedures (i.e. surgeries). As certain procedure interactions of the medical professional and the patient have been prioritized, corresponding aspects of the patient have been modeled in existing simulators to the exclusion of others.
[0003] In some existing systems, the simulator or a piece thereof is purpose built for a surgery on a specific patient. This patient specific element enables accurate replication of the anatomy and specific pathology of the patient. For example, a scan of a heart valve of the patient may be used to produce replica model valve to simulate the particular features of the patient’s valve thereby facilitating practice of the surgeon and/or surgical team prior to the surgery. While these replicas can accurately mimic patient valve pathology (mitral regurgitation MR) measured by Doppler ultrasound, the replicas do not accurately mimic actual valve shape and geometry, due to the spatial and temporal limitations of the ultrasound images from which the replicas are derived. These simulators, also lack a generality necessary to train medical professionals to be qualified to treat a substantial range of multiple patients. Furthermore, the resources necessary to accommodate this customization a substantial and limit the availability, accessibility, and rate of use of the simulator. This customization can also limit the applicability of these simulators where the customization of a specific pathology is unavailable. Where a pathology is available, resource limitations may require patient or medical professionals to travel significantly to utilize the simulator, further mitigating the simulator’s viability or
effect. Also, as these simulators necessarily require replacement of at least a piece of the simulator to simulate each surgery, existing systems lack pieces of anatomy to facilitate the replacement. These absences reduce the effectiveness the simulator in simulating a real-world environment. Furthermore, as these systems rely on accuracy of the modeling to the patient, these models can be limited to reduce modeling burden. For example, the simulator may necessarily be limited to the anatomy of the patient to be operated and the immediately connected to or surrounding anatomy. These simulators are, therefore, ill suited to training medical professionals to be prepared for potential patients.
[0004] In some existing systems, the simulator or a piece thereof generalized to a single pathology. For example, a simulator may be built to simulate a healthy mitral heart valve. Cadavers may also be used to practice procedures. Because of the general applicability of these systems and the intent to model only one pathology (i.e. a healthy mitral valve pathology), these simulators generally lack the means to exchange parts modeling varying pathologies without disassembly. Theses systems also are deficient in simulating feedback of features that other pathologies may present. For example, a simulator with a healthy valve model may not provide the haptic feedback of rigidity that a calcified heart valve will supply. Particularly with cadavers, practicing with these systems is often destructive to the system and environmental effects such as decomposition can frustrate the reliability, repeatability, longevity, and realistic nature of these systems. Also, this type of simulator necessarily does not accommodate practicing a range of pathologies without acquiring and maintaining multiple independent simulators or significant potentially damaging or wearing modification between training.
[0005] Accordingly, there is a need for an improved chest simulators that overcomes at least some of the disadvantages of existing chest simulators.
Summary
[0006] Provided is a modular chest simulator system. The system includes a platform including chest anatomy. The system includes a first heart assembly configured to simulate a first heart anatomy corresponding to a plurality of first anatomy pathologies. The first heart assembly comprises includes a first simulated heart anatomy configured to simulate the first heart anatomy. The first simulated heart anatomy includes reference
anatomy configured to simulate the first heart anatomy common to the plurality of first anatomy pathologies. The first heart assembly includes a heart assembly structure configured to interface with and be releasably secured to the platform and to receive and releasably secure, in the first heart assembly, an initial first pathology specific anatomy. The initial first pathology specific anatomy is configured to simulate heart anatomy corresponding to a first pathology selected from the first anatomy pathologies.
[0007] The first simulated heart anatomy may further include the initial first pathology specific anatomy selected from a plurality of first pathology specific anatomies. Each of the first pathology specific anatomies may correspond to one of a plurality of first anatomy pathologies. The first anatomy pathologies may be predetermined based on commonality.
[0008] The reference anatomy may be configured to remain unconsumed when a first procedure corresponding to the first pathology of the plurality of medical procedures is practiced.
[0009] The system may include a second heart assembly configured to simulate a second heart anatomy selected from the plurality of predetermined heart anatomies. The second heart anatomy may correspond to a plurality of second anatomy pathologies. The second heart assembly may be interchangeable with the first heart assembly to accommodate a second procedure corresponding to a second pathology of the second anatomy pathologies.
[0010] The first heart assembly may be selected from a plurality of predetermined heart assemblies.
[0011] The predetermined heart anatomies may include one or more of a mitral anatomy, an aortic anatomy, and a coronary artery bypass graft (CABG) anatomy.
[0012] The initial first pathology specific anatomy may be consumable, at least in part, by a first procedure and interchangeable with an additional first pathology specific anatomy corresponding to the first pathology for replacing the consumed initial first pathology specific anatomy.
[0013] The system may include an initial secondary pathology specific anatomy corresponding to a secondary pathology of the plurality of first anatomy pathologies. The initial secondary pathology specific anatomy may be interchangeable with the initial first pathology specific anatomy for simulating the secondary pathology corresponding to a second procedure.
[0014] The first anatomy pathologies may include one or more of a typical pathology and a calcified pathology.
[0015] The platform may include a base configured to form a base of the modular chest simulator. The base may include a simulator base plate configured to provide a platform of the base and at least one heart assembly securing mechanism. The chest simulating components may include a rib cage configured to simulate a human rib cage. The rib cage may be fixed to an anterior surface of the base.
[0016] The at least one securing mechanism may include a superior clip disposed at a superior end of the simulator base plate configured to receive superior end of the heart assembly base plate. The at least one securing mechanism may include a plurality of base screws disposed at and threadingly connected to the inferior end of the simulator base plate. The heart assembly may include a receiving hole corresponding to each base screw for receiving the base screws. Sliding the heart assembly along the simulator base plate a sliding distance along one or more axes and tightening the base screws releasably secures the heart assembly to the simulator base plate.
[0017] The sliding distance may be predetermined according to the first pathology.
[0018] The rib cage may include a rib support assembly for supporting a plurality of ribs. The plurality of ribs may be flexibly and severably connected to the rib support assembly at an anterior end by an anterior junction and at a posterior end by a posterior junction.
[0019] The rib cage may include a rib support assembly for supporting a plurality of ribs. The rib support assembly may include a sternum configured to simulate a human sternum. The sternum may include a right sternum piece and a left sternum piece. The rib support assembly may include a superior rib support disposed at a superior end of the
rib support assembly and connected to and configured to support a superior end of the sternum. The superior rib support may include a superior right support connected to and configured to support a superior end of the right sternum piece, a superior left support connected to and configured to support a superior end of the left sternum piece, and an inferior clip configured to separably connect an inferior end of the right sternum piece and the left sternum piece. The right sternum piece and superior right support may be separable from the left sternum piece and the superior left support for simulating splitting the sternum.
[0020] The rib cage may include an intercostal muscle for simulating the flexible interconnectivity of a plurality of ribs of the rib cage. The intercostal muscle may be composed of an elastic material corresponding to a predetermined elasticity of the simulated interconnectivity.
[0021] The heart assembly may include a coronary artery bypass graft (CABG) heart assembly. The initial first pathology specific anatomy may include a heart surface and the at least one coronary artery. The modular chest simulator may further include a CABG assembly comprising simulated auxiliary CABG anatomy.
[0022] The heart assembly structure may further include a stand. The stand may be configured to support and dispose the first simulated heart anatomy according to the first heart anatomy and accommodate, receive, and releasably secure the initial first pathology specific anatomy.
[0023] The stand may include a holder configured to receive and secure the initial first pathology specific anatomy and arms configured to dispose the holder above the heart assembly base plate for positioning the simulated heart anatomy according to the first pathology. The holder may be rotatably connected to the arms for orienting the holder according to the first pathology.
[0024] The initial first pathology specific anatomy may include a valve assembly. The stand may include a holder. The holder may include a frame configured to accommodate the valve assembly and a reference anatomy according to first heart anatomy. The holder may include a clamp adjustably connected to the frame. The frame and the clamp may define a slot for receiving the valve assembly. Adjusting the
connection of the clamp to the frame may transition the holder from a receiving configuration for receiving the valve assembly to a secured configuration for securing the valve assembly.
[0025] The initial first pathology specific anatomy may include a valve assembly. The valve assembly may include a valve assembly structure including a flange connected to valve assembly anatomy of the valve assembly and a proximal flange cover and a distal flange cover. The flange may be disposed and secured between the proximal and distal flange covers. The flange, distal flange cover, and proximal flange cover may be configured when secured together, to provide a structure for being received by the stand.
[0026] The first heart anatomy may include a mitral anatomy and the initial first pathology specific anatomy may include a plurality of chordae tendineae. Each chordae tendineae may be secured at a first end to a corresponding valve leaflet and at a second end to an adjustment screw. Turning the adjustment screw may adjust an effective length of the chordae tendineae for simulating a chordae tendineae tension according to the first pathology.
[0027] The system may include an endoscopic camera for capturing an internal image data and a video processing module for overlaying pre-captured, non-simulated endoscopic data corresponding to the first heart anatomy onto one or more surfaces of the internal image data. Each surface may correspond to a similar predetermined surface of the pre-captured non-simulated endoscopic data to obtain augmented image data. The system may include a display for displaying the augmented image data.
[0028] 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
[0029] The drawings included herewith are for illustrating various examples of articles, methods, and apparatuses of the present specification. In the drawings:
[0030] Figure 1A is a block diagram of a modular chest simulator, according to an embodiment;
[0031] Figure 1 B is a perspective view schematic of the modular chest simulator of Figure 1A, according to an embodiment;
[0032] Figure 1 C is a photograph of the modular chest simulator of Figure 1A, according to an embodiment;
[0033] Figure 1 D is a perspective view schematic of the modular chest simulator of Figure 1 A, according to a further embodiment;
[0034] Figure 2A is a perspective view schematic of the base of Figure 1 B, according to an embodiment;
[0035] Figure 2B is a perspective view schematic of the base of Figure 1 B, according to a further embodiment;
[0036] Figure 3A is a perspective view schematic of the base of Figure 1 B with a heart assembly of Figure 1 B installed on the base, according to an embodiment;
[0037] Figure 3B is a photographic flow diagram of the installation of the heart assembly on the base of Figure 3A, according to an embodiment;
[0038] Figure 3C is a schematic flow diagram of the installation of the heart assembly on the base of Figure 3A, according to a further embodiment;
[0039] Figure 4A is a block diagram of a heart assembly structure of Figure 1A, according to an embodiment;
[0040] Figure 4B is a perspective view schematic of an aortic heart assembly structure of Figure 4A, according to an embodiment;
[0041] Figure 4C is a perspective view schematic of a mitral heart assembly structure of Figure 4A, according to an embodiment;
[0042] Figure 4D is a perspective view schematic of a post of Figure 4A, according to an embodiment;
[0043] Figure 5A is a block diagram of the rib cage of Figure 1A according to an embodiment;
[0044] Figure 5B is a perspective view schematic of the rib cage of Figure 5B, according to an embodiment;
[0045] Figure 5C is a perspective view schematic of the rib cage of Figure 5A, according to an embodiment;
[0046] Figure 6A is a block diagram of a rib support assembly of Figure 5A, according to an embodiment;
[0047] Figure 6B is a perspective view schematic of a rib support assembly of Figure 5A, according to an embodiment;
[0048] Figure 6C is a top view schematic of a sternum of Figure 6A, according to an embodiment;
[0049] Figure 7A is a perspective view schematic diagram of the skin of Figure 1 A, according to an embodiment;
[0050] Figure 7B is a perspective view schematic diagram of a partial rib cage of Figure 1 A with a skin holder, according to an embodiment;
[0051] Figure 8 is a block diagram of reference anatomy of Figure 1A, according to an embodiment;
[0052] Figure 9 is a perspective view schematic of the valve stand and reference anatomy of Figures 4 and 8, respectively, according to an embodiment;
[0053] Figure 10A is a perspective view schematic of the valve stand and aortic reference anatomy of Figures 4 and 8, respectively, according to an embodiment;
[0054] Figure 10B is a photograph of the valve stand and reference anatomy of Figure A, according to an embodiment;
[0055] Figure 11 is a block diagram of the valve stand of Figure 4A, according to an embodiment;
[0056] Figure 12 is a block diagram of the valve assembly of Figure 1A , according to an embodiment;
[0057] Figure 13A is a perspective view schematic of the valve assembly of Figure 12, according to an embodiment;
[0058] Figure 13B is a photograph of the valve assembly of Figure 13A being inserted into a valve stand of Figure 10B, according to an embodiment;
[0059] Figure 14A is a perspective view schematic of a valve assembly of Figure 12, according to an embodiment;
[0060] Figure 14B is a photograph of a valve assembly of Figure 12, according to an embodiment;
[0061] Figure 15 is a side view photograph of cross section of a valve of Figure 12, according to an embodiment;
[0062] Figure 16A is a an enface view of a valve of Figure 12, according to an embodiment;
[0063] Figure 16b is a an enface view of a valve of Figure 12 with a calcified pathology, according to an embodiment;
[0064] Figure 17A is a side view cross sectional schematic of a valve assembly anatomy of Figure 12, according to an embodiment;
[0065] Figure 17B is a enface view cross-sectional schematic of a valve assembly anatomy of Figure 12, according to an embodiment;
[0066] Figure 17C is a enface view photograph of cross-sectional of a valve assembly anatomy of Figure 12, according to an embodiment;
[0067] Figure 18 is a flow diagram of a method of setting up and practicing with the modular chest assembly Figure 1A, according to an embodiment;
[0068] Figure 19 is a photograph of a practice procedure setup including the modular chest simulator of Figure 1A, according to an embodiment;
[0069] Figures 20A, 20C, 20E, 20G, and 20I are video capture images of the procedure of Figure 18, according to an embodiment;
[0070] Figures 20B, 20D, 20F, 20H, and 20J are augmented images corresponding to Figures 20A, 20C, 20E, 20G, and 201, according to an embodiment;
[0071] Figure 21 A is an enface view photograph of a heart valve assembly of Figure 12, post procedure, according to an embodiment;
[0072] Figure 21 B is a side view photograph of the valve assembly of Figure 21 in a simulated ventricle, according to an embodiment;
[0073] Figure 22 is a flow diagram for forming a simulated valve assembly anatomy of Figure 12, according to an embodiment;
[0074] Figure 23A is a cross sectional side view schematic of a leaflet mold for forming a leaflet of Figures 17A through 17C, according to an embodiment;
[0075] Figure 23B is a perspective view schematic of the bottom piece of the leaflet mold of Figure 23A;
[0076] Figure 23C is an enface view schematic of the leaflets of Figure 23A, according to an embodiment;
[0077] Figure 24A is a cutaway side view schematic of a mold for forming the aortic valve assembly of Figure 17A, according to an embodiment; and
[0078] Figure 24B is a perspective view schematic of an aorta side blood pool insert of the mold of Figure 24A, according to an embodiment.
Detailed Description
[0079] 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.
[0080] Further, although process steps, method steps, algorithms or the like may be described (in the disclosure and / 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.
[0081] 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.
[0082] The following relates generally to an anatomy simulator and particularly to a chest anatomy simulator. The chest simulator is modular to enable practicing medical procedures on a range of pathologies. The simulator enables implementing the to be practiced pathology by mechanisms for exchanging at least one part of the simulator. The remaining pieces of the simulator are configured to enable this exchange. The simulator may also enable further adjustment of the base pathology (i.e. tuning the base pathology) with mechanisms that enable adjustment in addition to the exchange.
[0083] The modularity of the simulator accommodates a range of pathologies to be practiced with physical replicas of anatomy, and particularly cardiac anatomy, that mimics to a high degree the diseases/pathologies commonly found in patients receiving surgical intervention. The anatomies include high fidelity pathology specific heart anatomies replicating heart valves and vessels. The simulator is configured to simulate minimally invasive and traditional cardiac surgery. This high fidelity is achieved with inorganic materials. This composition beneficially provides the simulator superiority over organic or semi-organic training tools such as cadavers. For example, using inorganic materials provides longevity and adaptability over training tools comprising organic materials.
[0084] The pathologies replicated are actual pathologies, for example, for valves and coronary artery bypass tissues. The pathologies may simulate conditions such as tethering, prolapse, or stenosis causing insufficient flow in the proper direction across a heart valve. The configuration and composition of the simulator enables simulation
representing a variety of heart valve pathologies. Most typical valve surgical repair procedures (approximately 90% or more). This modularity enabled variety, in conjunction with adjustments enabled by the simulator facilitates medical professionals, after practicing or training using the simulator, to be prepared for a wide range of procedures. Therefore, the simulator enables medical professionals to accommodate a wide range of patients without significant resources allocation (i.e. time and money) to obtaining and maintaining many simulators or customizing an existing one. It will be appreciated that the simulate accommodates demonstration of new or unknown procedures and corresponding technologies over existing systems, for much of the same reasons.
[0085] Referring to Figures 1A through 1 C, shown therein is a block diagram, perspective view schematic, and photograph of a modular chest simulator 100, according to an embodiment. Referring also to Figure 1 D, shown therein is a perspective view schematic of the modular chest simulator 100 according to a further embodiment. The modular chest simulator 100 is configured to provide a simulated human chest for practice and training of a medical professional 10. The medical professional 10 is a person who is training to perform or be involved in procedures on a patient that the modular chest simulator 100 is intended to simulate. For example, the medical professional 10 may be a surgeon, physician, nurse or the like or a person such as a student training in the medical or health care field.
[0086] The modular chest simulator 100 is configured to provide a high fidelity replica to the heart anatomy of a human patient as well as the surrounding environment to the chest. The high fidelity and modularity of the modular chest simulator enables training and practice of the medical professional 10 and demonstration of procedures and technologies in a variety of common pathologies while minimizing resource allocation involved. The modular chest simulator 100 beneficially facilitates the expansion and broadening of health care availability and accessibility.
[0087] The modular chest simulator 100 is configured to simulate the chest of a patient when the patient is supine; the typical surgical disposition.
[0088] The modular chest simulator 100 includes a base 102. The base provides the foundation for the simulator 100.
[0089] Referring also to Figure 2A, shown therein is are perspective view schematics of the base 102 in isolation, according to various embodiments.
[0090] The base 102 includes a simulator base plate 104. In some embodiments, as shown in Figure 2A, the under surface of the simulator base plate 104 is flat to be set on a planar surface such as a table.
[0091] Referring to Figure 2B, shown therein is a perspective view schematic of the base 202, according to an embodiment. Base 202 is configured similarly to the base 102 of Figures 1A through 2A. The base 202 includes a wedge 205. The wedge 205 is attached to the base plate 204, such as at the undersurface and/or edge. The wedge 205 props up a side of the base plate 204 for tilting the base 202 and the simulator 102 of Figure 1A through 1 C accordingly. In an embodiment, the wedge 205 is adjustable for example to provide a tilt angle of twenty through thirty degrees.
[0092] Referring also to Figure 3A, shown therein is a perspective view schematic of a base 102 with a heart assembly 110 installed on the base 102, according to an embodiment. The base 102 further includes a superior clip 106. The superior clip 106 is fixedly connected to a top surface 107 of the base 102. The superior clip 106 is configured to receive and restrain the base plate 424 of the heart assembly 110, further described below. In some embodiments the superior clip 106 forms a U-channel 109 with the simulator base plate 104 that is open on the inferior side for receiving the heart assembly 110. The channel 109 may be elongated such that when the heart assembly 110 is shifted the heart assembly base plate 424 is still restricted from movement in the positive vertical direction by the superior clip 106.
[0093] Referring also to Figures 3B and 3C, respectively, shown therein is a photographic and schematic flow diagram of the installation of a heart assembly 110 on a base 102, according to various embodiments. Base 102 further includes one or more base screws 108. The base screws 108 are threadingly connected to the simulator base plate 104. The base screws 108 extend vertically from a tail end at the simulator base plate 104 to a head end. The extension provides a rod. The head at the head end of the base screws 108 are wider than the rod for securing the heart assembly base plate 424, further described below, between the bottom of the head and the top surface 107 of the
simulator base plate 104. In an embodiment, the base screws 108 are thumb screws to facilitate toolless loosening and tightening of the base screws 108 sufficient to secure the heart assembly 110 against forces experienced during practice of the procedures. The base screws 108 are disposed at the posterior end of the base 102 to facilitate unobstructed accesses such as from the rib cage 130 further described below.
[0094] Referring back to Figures 1A, 1 B, 1 C and 3A, the modular chest simulator 100 includes a heart assembly 110. The heart assembly 110 is configured to simulate a representative heart anatomy. The heart assembly 110 is modular in that it may be exchanged in the modular chest simulator 100 with a heart assembly 110 of a different heart anatomy.
[0095] Each heart assembly 110 includes a simulated heart anatomy 112. The simulated heart anatomy 112 is configured to simulate anatomy of a human heart relevant to the intended practice procedure. Example embodiments of simulated heart anatomies 112 include mitral, aortic, and bypass heart surgery anatomies. The simulated heart anatomy 112 may also be configured to simulate one of a group of representative anatomies that vary in a predetermined dimension, such as diameter. In an example, the simulated heart anatomy 112 simulates an aorta with an inner diameter of 26mm selected from a range of available aorta.
[0096] The simulated heart anatomy 112 includes reference anatomy 114. The reference anatomy 114 simulates heart anatomy 114 that the medical professional 10 would expect to encounter during the procedure but is not intended to be destructively altered. Simulating reference anatomy 114 beneficially contributes to the fidelity of the simulation as the reference anatomy 114 may need to be addressed (i.e. by displacement or avoidance) during practice of the procedure.
[0097] The reference anatomy 114 is configured to realistically respond to interactions with the medical professional 10. This simulation reference anatomy 114 enables the medical professional 10 to beneficially receive realistic feedback from the reference anatomy 114 during the use of the simulator and evaluate the avoidance or mitigation of risks to the reference anatomy 114 during the procedure.
[0098] The simulated heart anatomy 112 includes a valve assembly 116. The valve assembly 116 simulates the components of the simulated heart anatomy 112 that are intended to be altered, also known as consumed, during each practice attempt of the procedure. Each valve assembly 116 is configured to simulate a particular pathology. Example pathologies include a healthy and calcified valve pathologies as well as various leaflet pathologies such as aortic bi-valve versions.
[0099] The valve assembly 116 is replaceable. The valve assembly 116 may be replaced after a procedure has been practiced or to change the pathology simulated. The replaceability of the valve assembly 116 beneficially enables a second level of modularity. This second level of modularity is in combination with and in addition to the modularity of provided by the exchanging of the heart assembly 110.
[0100] As the pathologies simulated by the valve assembly 116 are common and predeterminable, a range of valve assemblies 116 simulating each of these pathologies may be produced and on hand prior to the identification of a specific patient corresponding to the pathology. For example, a medical school may order a full range of common valve assemblies 116 based on enrollment or a hospital may have a series of valve assemblies 116 on hand for pathologies they commonly treat. Replacement of the valve assemblies 116 can be made based on actual or anticipated use. This beneficially mitigates availability concerns typically associated with as need production. It will be appreciated, that as the valve assembly 116 predominately includes components likely to be consumed or pathology specific elements of the heart assembly the replaceability of the valve assembly 116 facilitates efficient and simple implementation of a range of anatomy and pathology combinations.
[0101] The valve assembly 116 is configured to be installed in the heart assembly 110, as further described below, to accommodate simulating and practicing on a desired pathology. It will be appreciated, that in some embodiments, the valve assembly 116 may be anatomy specific in addition to pathology specific. For example, a calcified aortic valve assembly 116 may only be accommodated by an aortic heart assembly 110.
[0102] The variations and combinations of anatomies and pathologies replicated constitute a representative library for simulating typical heart pathologies. A particular
heart assembly 110 with a valve assembly 116 corresponding to a particular pathology enables practice on a wide range of anatomy-pathology combinations with one modular chest simulator 100. Only a heart assembly 110 for each major anatomy type and valve assemblies 116 for predetermined pathologies are obtained and maintained to accommodate this range. This facilitates training opportunities while providing a preparedness, awareness, and mitigation of training costs. For example, dedicated and just in time custom manufacturing or substantial reconfiguring of the model is beneficially mitigated.
[0103] The heart assembly 110 includes components that provide the structure of the heart assembly 110 collectively referred to as heart assembly structure 120. Particularly, the heart assembly structure 120 includes components that support, adjustably dispose, and hold the simulated heart anatomy 112.
[0104] Referring to Figure 4A shown therein is a block diagram of a heart assembly structure 120, according to an embodiment. Referring also to Figures 4B and 4C, shown therein is a perspective view schematic of an aortic and mitral heart assembly structure 120, respectively, according to an embodiment.
[0105] The heart assembly structure 120 includes a valve stand 422. The valve stand 422 is configured to receive and support the simulated heart anatomy 112. Specifically, the valve stand 422 is configured to receive the valve assembly 116 of Figure 1A.
[0106] The heart assembly structure 120 further includes a heart assembly base plate 424. The heart assembly base plate 424 forms the foundation of the heart assembly structure 120. The valve stand 422 and posts 426, further described below, are physically secured to the heart assembly base plate 424. This physical connection to the heart assembly base plate 424 enables the heart assembly 110 to be taken out or installed on the base 102 of Figures 1 A through 1 C, as a single module or unit.
[0107] Referring also to Figures 3A, 3B and 3C, the heart assembly base plate 424 includes at least one receiving hole 425a, 425b or 425c. Each receiving hole 425a, 425b, 425c is referred to herein generically as receiving hole 425 and collectively as receiving holes 425. Each receiving hole 425 corresponds to a base screw 108. Each receiving
hole 425 at a first end is sized accommodate the head of the base screw 108 without obstruction. It will be appreciated that receiving hole 425 has sufficient size to clear the head during installation of the heart assembly 110 on the base 102. The receiving hole 425 at a second end is sized and shaped such to allow for adjustment in the disposition of the heart assembly base plate 424 but to prevent the head of the base screw 108 from passing through. It will be appreciated that the first end and second end of the receiving hole 425 are connected, in some embodiments by a channel larger than the nub or post of the base screw 108 but smaller than the head of the base screw 108.
[0108] In an example, as shown in Figures 3A and 3B, the receiving hole 425 at the second end is sized to accommodate adjustments of heart assembly base plate 424 20mm in left-right translation, 10mm or more of superior-inferior adjustment, and approximately 20 degrees of rotation about a vertical (anterior-posterior) axis. In a further example, as shown in Figure 3C, the receiving hole 425c may be a track shaped to accommodate other more substantial shifts. A given base plate 424 may be interchanged with another base plate 424 of a different receiving hole 425 configuration to accommodate various shifts. This may also include anterior-posterior shifts, for example of up to 15mm. Accommodating these adjustments enables variability in the disposition of the heart assembly 110 and, by connection, the heart anatomy 112. This facilitates simulation by the simulator 100 of Figure 1 of conditions of various anatomies and pathologies in addition to the aspects intrinsically simulated by the heart assembly 110. These variations may be accommodated even if they are determined post construction of simulator (i.e. not predetermined) and if they vary during the procedure. In an example, the track configuration of receiving hole 425c accommodates simulation of a heart falling over towards a head during a procedure which may result in a 30-40mm shift of the heart. It will be appreciated that simulated shifts resulting, for example, from collapsing the left or right lung may also be accommodated by these hole 425 configurations.
[0109] Referring also to Figure 4D, shown therein is a perspective view schematic of a post 426d, according to an embodiment.
[0110] The heart assembly 110 further includes one or more posts 426, 426b, or 426d. The posts are referred to herein generically as post 426 or posts 426. The posts 426 are disposed towards the superior end of the heart assembly 110.
[0111] The posts 426 are configured to support features of the heart anatomy 112 that are disposed beyond the valve stand 422, such as an aorta 112. In some embodiments, as shown in Figure 4D, the post 426d includes a flare out 427 at the interface of the heart anatomy 112 with the post 426d for securing the heart anatomy 112. The posts 426 may be integrated into other parts of simulator such as the rib cage 130 of Figure 1 D. The posts 426 beneficially contribute to the fidelity of the simulator by mitigating unrealistic forces on heat anatomy of resulting from these otherwise unsupported features.
[0112] The heart assembly 110 may further include a grip 428. In some embodiments, the grip 428 is disposed and physically connected to the heart assembly base plate 424 to facilitate removal and insertion of the heart assembly structure 120.
[0113] Referring again to Figures 1A, 1 B, and 1 C, the modular chest simulator 100 further includes a rib cage 130. The rib cage 130 is configured to simulate the rib cage of a human chest with high fidelity. Particularly, the rib cage 130 shown is simulated based on CT scans of a healthy 40-year old male. Simulating high fidelity also includes simulating a realistic response to the actions by the medical practitioner 10 during practice with chest simulator 100. The rib cage 130 is also beneficially configured to be restored, for example from the operations of the practice procedure, with minimal effort.
[0114] Referring to Figures 5A and 5B, shown therein is a block diagram and perspective view schematic, respectively, of the rib cage 130 according to an embodiment. The rib cage 130 includes a rib support assembly 532. The rib support assembly 532 provides a support structure for the rib cage 130. The rib support assembly 532 is secured to the base 102 of Figure 1 A through 1 C.
[0115] Referring to Figures 6A and 6B, shown therein is a block diagram and perspective view schematic, respectively, of a rib support assembly 532, according to an embodiment.
[0116] The rib support assembly 532 includes a sternum 642. The sternum 642 is configured to simulate a human sternum. In an example, the sternum 642 is composed of rigid polyurethane plastic to simulate strength of the sternum 642 or lack thereof. It will be appreciated that the geometry of the sternum may be modified from adherence to the most accurate representation, for example to accommodate manufacturing considerations. The sternum 642 is split longitudinally into a right sternum piece 644 and a left sternum piece 646. The sternum pieces 644 and 646 are severably connected at their respective inferior ends by an inferior clip 648. In some embodiments, the clip 648 is composed of silicon to simulate the splitting of the sternum 642. Accommodating a splitting of the sternum 642 enables the simulation (and therefore practice of) midsternotomy procedures.
[0117] Referring to Figure 6C, shown therein is a top view schematic of a sternum 642c, according to an embodiment. The sternum 642c is similarly configured to the sternum 642 of Figures 6A and 6B. The right sternum piece 644c is split into a superior right sternum piece 647 and inferior right sternum piece 649. The split accommodates a partial sternotomy. It will be appreciated, that the left sternum piece 646c may be similarly configured with a split.
[0118] The rib support assembly 532 further includes a right posterior support 662 and a left posterior support 664. The posterior supports 662, 664 provide a base for each right rib 534 and left rib 535, further described below, to, respectively, connect to. The posterior supports 662, 664 are fixedly attached to the base 102 of Figures 1A through 2.
[0119] The rib support assembly 532, further includes a superior rib support 650, also known a superior rib wall 650. The superior rib support 650 supports the sternum 642 at the superior end of the sternum 642. The support of the superior rib support 650 is such that the sternum 642 is disposed in a realistic elevated position. The superior rib support 650 includes a superior right support 652 and a superior left support 654. The superior right support 652 and superior left support 654 correspond to the right and left sternum pieces 644 and 646, respectively and accommodates reversibly splitting the sternum 642.
[0120] The rib support assembly 532 further includes at least one inferior rib support 660. The inferior rib support 660 supports the rib cage at the inferior end of the rib cage.
[0121] In an embodiment, the inferior rib support 660 is physically connected at a first end to the most inferior rib of a rib cage such as the left rib 535-6 or right rib 534-6 of Figures 5A and 5B, further described below. This connection may be a pinned connection. The inferior rib support 660 may be connected to the right or left posterior rib supports 662 or 664 at a second end. The connection may be by a cartilage junction similar to the junctions 536 and 538 of Figures 5A and 5B, further described below.
[0122] Referring again to Figures 5A and 5B, the rib cage 130 further includes at least one right rib 534-n and one left rib 535-n. Each right rib 534-n or left rib 535-n is referred to generically as rib 534 and collectively as ribs 534. Each rib 534 is referred to specifically as rib 534-n, generically as rib 534, and collectively as ribs 534. Each right rib 534 is configured to start at a first end at a right posterior support 662 and at a second end at the sternum 642 of Figure 6B. Each left rib 534 is configured to start at a first end at a left posterior support 664 and at a second end at the sternum 642 of Figures 6A and 6B.
[0123] Referring also to Figure 5C, shown therein is a cut away perspective view schematic of a rib cage 130 with right ribs 534-3 and 534-4. At the interface of each rib 534 with the sternum 642 of Figures 6A and 6B, the rib 134 is removably connected via an anterior junction 536. At the interface of each rib 534 with the corresponding (left or right) posterior rib support 662, 664 of Figures 6A and 6B, the rib 534 is removably connected via a posterior junction 538. In some embodiments, each anterior or posterior junction 536, 538 is composed of silicone to mimic the costal cartilage of an actual patient. In some embodiments each anterior or posterior junction 536, 538 includes a connecting post 539 as shown in Figure 5C. The post 539 is configured to affect the rib attachment of the corresponding junction 536, 538. The post 539 may be composed of spring steel covered with silicone. This simulation of junctions 536, 538 provide realistic range of motion for the ribs 534. This configuration of the junctions 536, 538 may also be easily “dislocated” depending on the surgical procedure to be simulated.
[0124] The rib cage 130 may include an intercostal muscle 540. The intercostal muscle 540 simulates the natural resistance to retracting ribs. Simulating retracing resistance beneficially increases the fidelity of the simulator 100 particularly for practicing a mini-thoracotomy. In an example the intercostal muscle is a two cm high “intercostal muscle” band fitted around the right ribs 534. In some embodiments, the intercostal muscle 540 is composed of stiff silicone.
[0125] Referring again to Figure 1A, in some embodiments, the modular chest simulator 100 further includes a coronary artery bypass graft (CABG) assembly 150. The CABG assembly 150 is configured to simulate anatomy beyond the heart assembly 110 corresponding to coronary artery bypass graft procedures. In some embodiments, the CABG assembly 150 includes an internal mammary artery (IMA) 152. The internal mammary artery 152 may be embedded in polyvinyl alcohol cryogel (PVA-C). The PVA- C IMA 152 beneficially enables the simulation of a standard IMA harvest surgery. The PVA-C IMA 152 also enables the simulation of anastomosis onto the coronary arteries on the heart surface, further described below.
[0126] The IMA is mounted to the inside of the rib cage 130. In an embodiment the IMA 152 is mounted to the sternum 642 of Figures 6A and 6B further described below.
[0127] The modular chest simulator 100 may further includes skin 170. Referring also to Figure 7A, shown therein is a perspective view schematic diagram of the skin 170 according to an embodiment.
[0128] The skin 170 simulates the skin of a patient. The skin 170 is configured to conform to the rib cage 130 and is composed of an accommodating material thereof. The skin 170 may be removably affixed to the rib cage 130 and particularly the rib support assembly 532 or component thereof by one or more skin screws 772.
[0129] Referring to Figure 7B, shown therein is a perspective view schematic diagram of a partial rib cage 130, according to an embodiment. The rib cage 130 includes a skin holder 731 . The skin holder 731 is affixed to the at least one rib 734, each rib 734 similarly configured to a right rib 534 or left rib 535 of Figure 5A. The skin holder 731 is configured to removably secure the skin 170 of Figure 7A against movement, such as hiking up the chest, during the simulated procedure. It will be appreciated that this
securement may be by any known means including by a higher friction surface than the surface of the rib 734.
[0130] Referring to Figure 8, shown therein is a block diagram of reference anatomy 114, according to an embodiment.
[0131] The reference anatomy 114 includes a left atrium 880 and a right atrium 882. The right atrium 880 and left atrium 882 are configured to simulate the corresponding atriums of a human heart. The right atrium 880 and left atrium 882 are fixedly connected to the holder 1190, further describe below.
[0132] The reference anatomy 114 further includes a superior vena cava (SVC) 884. The SVC 884 is fixedly connected at a proximal end to the right atrium 880. The SVC 884 extends significantly from the end connected to the right atrium 880. To support this extension, the SVC 884 is connected at the distal end to a post 426 of Figures 4A, 4B and 4C.
[0133] In an embodiment, the reference anatomy 114 is composed of pliable material, such as silicon. The pliability simulates the resistance and elasticity of the reference anatomy 114 for realistic interactions during use of the simulator 100 Figures 1A through 1 C. The reference anatomy 114 may be formed as single piece. Even where the reference anatomy 114 is formed as multiple pieces, each piece may be formed to include multiple parts of the reference anatomy. In an example, the right atrium and the SVC 884 form as a single piece.
[0134] The reference anatomy 114 may include further reference lumina 886. The reference lumina 886 may simulate reference anatomy that in some embodiments are part of the valve assembly 116 of Figure 1A. In an example, the reference anatomy 114 is a mitral reference anatomy 114 and the reference lumen 886 include an aorta.
[0135] Each lumen of the reference lumina 886 as referred to herein is a tubular structure of the anatomy such a vessel, arteries or veins. It will be appreciated that the reference lumina 886 may include one or multiple lumens and the reference lumina 886 refers to structure in addition to the internal space or cavity.
[0136] In some embodiments, the reference anatomy 114 includes a unifier 888. The unifier 888 is configured to join the remainder of the reference anatomy 114. The unifier 888 is formed or cut out so that access to the reference anatomy 114 and the internal spaces thereof is obstructed or accessible according to the corresponding anatomy being simulated. The unifier 888 also serves as joining structure for the reference anatomy to the valve stand 422 of Figures 4 and 11 .
[0137] Referring to Figure 9, shown therein is a perspective view schematic of a mitral valve stand 922 and mitral reference anatomy 914, according to an embodiment. The mitral reference anatomy 914 includes a reference lumen 986. The reference lumen 986 is configured to simulate an aorta. Simulating an aorta with a reference lumen 986 beneficially enables the simulation of cross clamping.
[0138] Ther mitral reference anatomy 914 also includes a unifier 988. The unifier 988 joins the remainder of the mitral reference anatomy 914 and provides a mounting structure of the mitral reference anatomy 914 to be mounted to the holder 990, further described below.
[0139] Referring to Figures 10A and 10B, shown therein is a perspective view schematic and photograph, respectively, of an aortic valve stand 1022 and aortic reference anatomy 1014, according to an embodiment. It will be appreciated that the reference anatomy 1014 does not include an aorta reference lumen as the corresponding aortic valve assembly 1316 provides the aorta 1308 of Figures 13A and 13B.
[0140] Referring to Figure 11 , shown therein is a block diagram of a valve stand 422, according to an embodiment.
[0141] The valve stand 422 includes a holder 1190. The holder 1190 is configured to receive and releasably hold the valve assembly 116 of Figures 1A and 12. The holder 1190 further configured to provide attachment structures for the reference anatomy 114 of Figure 8.
[0142] The holder 1190 includes a frame 1191. The frame 1191 provides the primary structure of the holder 1190 that receives the valve assembly 116 of Figure 1A.
[0143] The reference anatomy 114 of Figure 8 is fixedly attached to the frame 1191. It will be appreciated that the attachment accommodates movement of the reference anatomy 114 of Figure 8 enabled by the flexibility or elasticity of the reference anatomy 114 of Figure 8.
[0144] Referring to Figures 9 through 10B, the frames 991 and 1091 may be shaped according to the anatomy being simulated. In an embodiment, as shown in Figure 9, the frame 991 is shaped to facilitate reference lumen 986. For example, as shown, the mitral frame 991 is shaped as a complete circle to support the reference anatomy 914 and particularly the aortic reference lumen 986. In an embodiment, as shown in Figures 10A and 10B, the frame 1091 is shaped to accommodate valve assemblies 116 of Figure 12. For example, as shown in Figures 10A and 10B, the frame 1091 is shaped as a frustro-circle, truncated to accommodate the aorta 1208 of Figures 13A and 13B.
[0145] Referring back to Figure 11 , the holder 1190 includes a clamp 1192. The clamp 1192 is configured to be adjustably secured to the frame 1191 to form a slot 1193 for receiving the valve assemblies 116 of Figure 12. The clamp 1192 is adjustable to transition the slot 1193 from a receiving configuration to a securing configuration. In the receiving configuration, the slot 1193 is sufficiently sized to accept the valve assembly 116. In the securing configuration the size of the slot 1193 is reduced compared to the receiving condition such that any valve assembly 116 of Figure 12 disposed in the slot
1193 is clamped or secured in the holder 1190. It will be appreciated that clamping of the holder 1190 accommodates movement of the valve assembly 116 of Figure 12 or part thereof based on flexibility, elasticity or rigidity.
[0146] The holder 1190 includes a securing means 1194. The securing means
1194 enables transitioning the clamp 1192 from the receiving configuration to the secured configuration and vice versa. In an embodiment, the securing means 1194 includes two screws positioned on opposite ends of the clamp 1192 which are threadingly connected to the frame 1191. The screws may be thumb screws to facilitate toolless replacement of the valve assembly 16 of Figure 12.
[0147] The valve stand 422 further includes arms 1195. The arms 1195 are configured to position the holder 1190 in the heart assembly 110 of Figure 1A.
[0148] The holder 1190 is rotatably connected to the arms 1195. The rotatable connection facilitates adjustment of the orientation of the reference anatomy 114 of Figure 8 and the valve assembly 116 of Figure 12 within the heart assembly 110 of Figure 1A. This adjustable orientation contributes to the modularity of the simulator 100 of Figures 1A through 1 C and beneficially enables further anatomies and pathologies.
[0149] The valve stand 422 further includes stand screws 1195. The stand screws secure the holder 1190 in a particular orientation or anatomy.
[0150] The arms 1195 are fixedly connected to the heart assembly base plate 424 of Figure 4A. In an embodiment, the arms 1195 are fixedly connected to a stand base plate 1197. The stand base plate 1197 connects the structural component so the valve stand such that the valve stand 422 may be handled as an independent unit from the remainder of the heart assembly 110 of Figure 1A.
[0151] Referring to Figure 12, shown therein is a block diagram of a valve assembly 116, according to an embodiment.
[0152] The valve assembly 116 includes anatomic components, referred to herein a valve assembly anatomy 1210. The valve assembly anatomy 1210 is composed of materials to simulate the feel of the anatomy being simulated. The valve assembly anatomy includes those parts of the anatomy that may be consumed during the simulated procedure. It will be appreciated that the valve assembly anatomy 1210 may be configured to include consumable components consumed in some but not all procedures corresponding to the anatomy of the valve assembly 116.
[0153] The valve assembly anatomy 1210 includes a heart valve 1212. The heart valve 1212 of is configured and disposed to simulate a valve corresponding to the anatomy being simulated.
[0154] The valve assembly anatomy 1210 includes auxiliary anatomy 1214. The auxiliary anatomy 1214 simulates consumable anatomy related to the heart valve 1212 being simulated.
[0155] Referring to Figure 13A, shown therein is a perspective view schematic of an aortic valve assembly 1316, according to an embodiment. Referring also to Figure
13B, shown therein is a photograph of the aortic valve assembly 1316 being inserted into a valve stand 1022, according to an embodiment. The aortic valve assembly 1316 is configured similarly to the valve assembly 116 of Figure 12.
[0156] The valve assembly anatomy 1320 includes an aortic heart valve 1322. The aortic heart valve is disposed in auxiliary anatomy 1324 of the valve assembly 1316, particularly an aorta 1324.
[0157] Referring to Figure 14A, shown therein is a perspective view schematic of a mitral valve assembly 1416, according to an embodiment. Referring also to Figure 14B, shown therein is a photograph of the mitral valve assembly 1416, according to an embodiment. The mitral valve assembly 1416 is configured similarly to the valve assembly 116 of Figure 12.
[0158] The valve assembly anatomy 1420 includes a mitral heart valve 1422. The mitral valve 1422 is connected directly to the flange 1432, further described below.
[0159] The valve assembly anatomy 1420 includes auxiliary anatomy 1424 configured to simulate papillary anatomy (i.e. papillary anatomy 1424). The papillary anatomy 1424 includes papillary muscles 1426 supported by papillary posts 1428, and chordae tendineae 1430 simulating corresponding heart structures. The papillary muscles 1426 may be reinforced, for example with fibrous reinforcements. The reinforcements beneficially facilitate suturing.
[0160] The chordae tendineae 1430, at a first end, are connected to or embedded in the mitral heart valve 1422 and particularly the valve leaflets 1534 of Figure 15. The chordae tendineae 1430 pass through the papillary muscles 1426 and the papillary posts 1428. The chordae tendineae 1430 are connected at a second end to an adjustment screw 1432. The adjustment screw 1432 may be turned adjust the effective length of the chordae tendineae 1430. This beneficially enables adjustments to simulate or mimic a range of mitral valve pathologies. For example, the screw may be turned to reel in and shorten chordae tendineae 1430 for simulating tethering. In a further example, the screw may be turned to loosen and lengthen the chordae tendineae 1430 for simulating prolapse. As these pathologies are causes of regurgitation, i.e. blood flowing the wrong way across the mitral heart valve 1422, simulating prolapse or tethering beneficially
facilitates practicing procedures to address these pathologies. It will be appreciated that this adjustment may also be applicable to tricuspid valve anatomies.
[0161] Referring back to figure 12, the valve assembly 116 includes a valve assembly structure 1250. The valve assembly structure 1250 connects and supports the valve assembly anatomy 1220. The valve assembly structure 1250 also provides a structure to be received by the holder 1190 of Figure 11 .
[0162] The valve assembly structure 1250 includes a flange 1252. The flange 1252 supports the heart valve 1222. It will be appreciated that this support may be via the auxiliary anatomy 1224. The flange may be composed of the same material or formed a single piece with the heart valve 1222.
[0163] The valve assembly structure 1250 includes a proximal flange cover 1254 and a distal flange cover 1256. It will be appreciated that proximal and distal with respect to the flange covers 1254 and 1256 refer to the covers’ 1254 and 1256 disposition relative where a left ventricle, if simulated, would be located. The flange covers 1254 and 1256 are rigid and configured to be received by the holder 1190 of Figure 1 . The flange covers 1254 and 1256 and disposed on either side of the flange 1252, sandwiching the flange 1252. The flange covers 1254 and 1256 may be fastened together to form the valve assembly into a single unit.
[0164] Referring to back to Figures 13A and 13B, the flange 1352 and flange covers 1354 and 1356 include a cutout 1358 to simulate access to the aorta 1324.
[0165] Referring back to Figures 14A and 14B, the mitral heart valve 1422 is impregnated in the flange 1452. The flange covers 1454 and 1456 include a cutout 1458 to accommodate the mitral heart valve 1422.
[0166] Referring to Figure 15, shown therein is a side view photograph of a mitral valve 1522 cross section, according to an embodiment. The mitral valve 1522 is configured similarly to the mitral valve 1422 of Figures 14A and 14B.
[0167] The mitral valve 1522 includes an annulus 1524. The annulus 1524 forms the wall of the mitral valve 1522. The anulus 1524 is configured in an annular or saddle shape. It will be appreciated that the shape of the anulus 1524 may vary according to the
pathology being simulated. The anulus 1524 is connected to the flange 1452. It will be appreciated that the annulus 1524 and the flange 1452 may be formed as a single piece or as separate pieces and joined by existing suitable means.
[0168] The mitral valve 1522 includes leaflets 1534-1 through 1534-3. The leaflets 1534-1 through 1534-3 and a fourth leaflet (not shown) are referred to herein, collectively as leaflets 1534 and generically as leaflet 1534. Each leaflet 1534 is flexibly connected to the anulus 1524 at a first end. The leaflets are a configured to flex from an open configuration to a closed configuration to simulate the operation of a mitral valve.
[0169] The mitral valve 1522 includes chordae tendineae 1530. The chordae tendineae 1530 are configured similarly to the chordae tendineae 1430 of Figure 14B. At least one chordae tendon 1530 is connected at a first end to each leaflet 1534. The length of the chordae tendineae 1530 may be adjusted, as described above, to configure the extent the leaflets 1534 close. This adjustability beneficially enables the simulations of various pathologies, such as normal, tethered, or prolapse pathologies, for a given mitral valve 1522.
[0170] Referring to Figures 16A and 16B, shown therein is a plain mitral valve 1622a and a calcified mitral valve 1622b from an atrial enface view, according to an embodiment. The mitral valves 1622 are configured similarly to the mitral valve 1522 of Figure 15.
[0171] The plain mitral valve 1622a is configured to simulate a healthy mitral valve or those pathologies achievable by adjusting a healthy mitral valve such as a mitral valve with a prolapse pathology. The atrium facing surfaces 1636a-1 through 1636a-4 of each leaflet 1634a-1 through 1634a-4, respectively, of the plain mitral valve 1622a are smooth.
[0172] The calcified mitral valve 1622b is configured to simulate pathologies including a calcified valve. The calcified mitral valve 1622b includes calcium deposits 1638. The calcium deposits 1638 are disposed on the atrium facing surfaces 1636b of each leaflet 1634b-1 thorough 1634b-4. The calcium deposits 1638 create an uneven profile on the aortic facing surfaces 1636b. The calcium deposits 1638 are composed of materials, such as hard mineral deposits, that contribute rigidity to the leaflets 1634b-1
through 1634b-4. The calcium deposits 1638 may be coated in a thin layer of silicone to simulate a realistic surface of the calcium deposits 1638.
[0173] Referring to Figure 17A, shown therein is a side view cross sectional schematic of an aortic valve assembly anatomy 1720, according to an embodiment. Referring also to Figures 17B and 17C, shown therein is a schematic and photograph, respectively, from an enface atrial view of an aortic valve assembly anatomy 1720 cross section, according to an embodiment. The valve assembly anatomy 1720 may be an embodiment of the valve assembly anatomy 1220 of Figure 12.
[0174] The valve assembly anatomy 1720 is calcified valve assembly anatomy 1720 configured to simulate aortic anatomy with a calcified aortic valve 1722. The leaflets 1734-1 and 1734-2 of the valve assembly anatomy 1720 include calcium deposits 1738. It will be appreciated that some embodiments, not shown, the aortic valve assembly 1722 include more leaflets 1734, such as 3 leaflets. The calcium deposits 1738 are disposed on the aorta facing surfaces 1736 of each leaflet 1734-1 and 1734-2. The calcium deposits 1738 create an uneven profile on the aorta facing surfaces 1736. The calcium deposits 1738 are composed of materials, such as hard mineral deposits, that contribute rigidity to the leaflets 1734-1 and 1734-2. The calcium deposits 1738 may be coated in a thin layer of silicone to simulate a realistic surface of the calcium deposits 1738.
[0175] Referring to Figure 18, shown therein is a flow diagram of a method 1800 of setting up and practicing with a modular chest assembly such as the modular chest assembly 100 of Figure 1A, according to an embodiment.
[0176] At 1801 , method 1800 may include assembling the modular chest assembly. In an example, a modular chest assembly such as the simulator 100 of Figure 4D is beneficially packaged in a container such as box or briefcase such as for storage or transport. In this example, at 1801 includes removing the platform base from the container and connecting each of the ribs, a right superior rib support, and a right inferior rib support at a posterior end to the platform base and at an inferior end to a right sternum piece. At 1801 further includes attaching a heart assembly structure to the base. It will be appreciated that simulated heart anatomy may or may not be present in the heart assembly structure when it is attached to the platform base. At 1801 may further include
attaching skin to the assembled rib cage at the right sternum piece and the posterior end of each rib. The attachments of at 1801 may be via magnets.
[0177] At 1802, method 1800 includes assessing if a heart assembly presently in the modular chest assembly corresponds to a desired heart anatomy of the to be practiced procedure. To be practiced procedures include but are not limited to mitral valve procedures, an aortic valve procedures and coronary artery bypass procedures and simulated anatomies include anatomies corresponding to such procedures.
[0178] At 1804, if the heart assembly anatomy does not correspond to the to be practiced procedure, setting up the modular chest assembly 1800 includes replacing the heart assembly presently in the modular chest assembly with a heart assembly corresponding to the desired heart anatomy.
[0179] Replacing the heart assembly includes removing the present heart assembly. In an embodiment, the removal includes loosening base plate screws securing the heart assembly in place. The heart assembly is slid such that holes in a base plate of the heart assembly align with heads of the base plate screws and the heat assembly base plate clears a clip attached to a base plate of the modular chest simulator. The heart assembly is then not obstructed from being lifted clear of the base plate screws and clip and out of the modular chest simulator. The heart assembly may be removed in an inferior direction to avoid a rib cage.
[0180] Replacing the heart assembly includes installing the desired heart assembly. The desired heart assembly is selected from a group of available heart assemblies corresponding to various anatomies. Example anatomies of heart assemblies include aortic, mitral and coronary artery bypass graft assemblies each corresponding to a to be practiced procedure. It will be appreciated that each heart assembly anatomy may accommodate a range of various procedures and that multiple heart assembly anatomies may be suitable for a given procedure.
[0181] At 1806, setting up the modular chest assembly 1800 includes installing a heart valve assembly. If there is a heart valve assembly is in the holder of the heart assembly and that heart valve assembly is consumed, in whole or in part, or does not correspond to the desired pathology, installing the heart valve assembly includes
removing the present heart valve assembly and replacing it with one corresponding to the desired pathology. It will be appreciated that the correspondence with the desired pathology is with respect to pathologies accommodated by the heart valve assembly, including those requiring adjustments such as those described at 1808, further described below.
[0182] In some embodiments, replacing the heart valve assembly include loosening a clamp, such as by thumb screws, removing, if present, the previously clamped heart valve assembly, inserting the desired heart valve assembly into the holder, and tightening the clamp to secure the desired heart valve assembly.
[0183] At 1808, in some embodiments, setting up the modular chest simulator 1800 includes adjusting pathology and anatomy parameters. In an example, the disposition (i.e. position and orientation) of the heart assembly may be adjusted based on the anatomy being modeled. In a further example, the orientation of a holder of the heart assembly is adjusted based on the anatomy being simulated. In a further example, parameters of the heart valve assembly, such as chordae tendineae length, is adjusted to increase the fidelity of the simulation.
[0184] It is expressly contemplated that in some embodiments, at 1804 through 1808 or any part thereof may be performed in any order or simultaneously. It will be appreciated that one of 1804 through 1808 may be performed partially prior to and partially after the performance of one or more of the remainder of 1804 through 1808. In an example, at 1808 chordae tendineae of the heart valve are tightened to simulate prolapse prior to 1806 the installation of the heart valve assembly in in the heart assembly. Then, again at 1808 the orientation of the heart assembly frame is adjusted to adjust the anatomy.
[0185] At 1810, setting up and practicing a procedure using the modular chest simulator 1800 includes performing the procedure with the simulator as the simulated patient. In some embodiments, the procedure is laparoscopic.
[0186] Referring again to Figure 1A, in embodiments simulating the coronary artery bypass grafts, the simulated heart anatomy 112 of the modular heart assembly 110 is configured to simulate coronary arteries of the heart. In this embodiment, the valve
assembly 116 is configured to simulate a heart surface. Modeled coronary arteries are disposed on the heart surface. The coronary arteries are composed of silicone. The reference anatomy 114 includes a motorized cam underneath the coronary arteries. The motorized cam, when activated mimics the real motion of the heart surface in the region of the coronary arteries. Simulating the heart surface motion increases the contextual fidelity of the simulation beneficially improving the training for corresponding procedures.
[0187] Referring to Figure 19, shown therein a photograph of a practice procedure setup 1900, according to an embodiment. The setup 1900 includes the modular chest simulator 100 which is used to practice an endoscopic procedure. The endoscopic procedure includes inserting a camera 1902 into the simulator for visibility. The camera captures video imagery 1904 of the area of the heart assembly, not shown. The video imagery 1904 is displayed on a display 1906.
[0188] In some embodiments, the video imagery 1904 may be augmented, also known as augmented reality, to further enhance the fidelity of the simulation. In an example, the video imagery 1904, also known as physical phantoms 1904, is augmented to include realistic color and depth effects not simulated by the physical heart assembly. For example, equivalent textures & specularities, as seen in actual endoscope data of similar anatomy, may be overlaid onto silicone surfaces seen in the endoscope video imagery 1904.
[0189] The predetermined nature of the modular chest simulator 100 modules facilitates the augmented reality. In an example, the real time endoscope video of modular chest simulator 100 modules may be calibrated and registered into a pre-defined 3D space. The modules may include the rib cage, heart assemblies of various anatomies, or predefined anatomical features such as the circumflex artery, Bundle of His, ribs, valves, left atrium and right atrium models.
[0190] Augmented reality enables rendering of anatomical features below the endoscope line of sight in a realistic manner (e.g., “keyhole” and shading techniques for realistic depth for virtual features. Endoscope views from outside the chest, with skin covering in place, may be included. These views may beneficially help guide the optimal port & mini thoracotomy incision sites.
[0191] Augmented reality may beneficially enable remote teaching and proctoring capability. Endoscope video can be shared remotely by two or more users, for example, via the internet. Each party may add virtual reality (VR) markers with corresponding text labels on a screen capture of the endoscope video. The added markers are fixed to the nearest surface in 3D space, as seen in the video capture. Thus, if the endoscope is moved, the marker remains in the same place in the 3D scene.
[0192] Augmented reality further enables, for a mitral valve annuloplasty procedure, the ability to measure the depth of needle insertion into the annulus, based on appropriate endoscope video data. This may be enabled by a second camera at a fixed location relative to the mitral valve stand.
[0193] Augmented reality may be facilitated or improved via a dual lens endoscopic USB camera. The dual lens USB camera enables bifocal vision tracking of the location of surgical tools and sutures. The bifocal visions provides depth perception to machine learning algorithms. The tracking beneficially enables accurate evaluation of the performance of medical professionals during the procedures. The evaluation may be manual or software based. Cameras with properties corresponding to the anatomies simulated are integrated into the simulator at optimal locations and calibrated based on placement. The modularity of the simulator beneficially mitigates the resources for placement and camera property determination and calibration as the placement and calibration does not need to be repeated for each procedure.
[0194] Referring to Figures 20A through 20 J, shown therein are video capture images 2004a, 2004c, 2004e, 2004g, and 2004i from a camera such as camera 1902 of Figure 19 and corresponding augmented images 2004b, 2004d, 2004f, 2004h, and 2004j, respectively, according to an embodiment.
[0195] The modularity of the heart assembly and the modularity and replaceability of the heart valve assembly enables practicing substantive range of common anatomies and pathologies while minimizing inventory size necessary to have available to practice these anatomies and pathology combinations. Parameter adjustability and augmented reality further contributes to the range. This enabled range beneficially facilitates training
and practice of medical professionals with efficient application of limited resources and including storage.
[0196] Referring back to Figure 18, at 1812, setting up and practicing using the modular chest simulator includes determining if further practice is desired. If yes, at 1802 through 1810, are repeated. In some embodiments, determining if further practice is desired includes inspection or testing the heart valve post procedure. The removeable nature of the heart valve assembly facilitates the inspection or testing.
[0197] Referring to Figures 21 A and 21 B shown therein is an enface view photograph of a mitral heart valve assembly 2116 post procedure and a side view photograph of the valve assembly 2116 in a simulated ventricle 2114, respectively, according to an embodiment. In some embodiments, the simulated ventricle 2114 is composed of a flexible material such as silicone and filled with a liquid, such as water. When the simulated ventricle 2114 is squeezed or additional water is injected into the simulated ventricle 2124, such as with a syringe, the action causes the valve assembly 2116 to close and reveal any valve assembly 2116 regurgitation. Revealing regurgitation or lack thereof beneficially enables proficiency evaluations as diminished regurgitation is an indicator of procedure success.
[0198] Referring back to Figure 18, at 1814, where further practice is not desired, the modular chest simulator may be stored. The modular nature of the simulator facilitates storage of the simulator. Firstly the simulator base and rib cage, and secondarily the heart assembly except the heart valve assembly are the bulkier parts of the simulator. As the bulkier parts support a range of pathologies, fewer instances of these parts support a desired library of anatomies and pathologies. Fewer bulkier parts, beneficially occupy less storage space than existing systems with these parts dedicated to each pathology.
[0199] In some embodiments, storing the simulator includes replacing or ordering the replacement heart valve assemblies. The replacing or ordering may be based on outside factors such as expected demand (i.e. based on class sizes or certification requirements) or as a replacement for those consumed during practice. As the pathologies available are predetermined, replacement or ordering may be done in advance of the need, rather than as needed for existing patient specific models. This
advance replacement and ordering beneficially reduces wait times and availability and facilitates training medical professionals to be ready for likely procedures beneficially expanding health care responsiveness, access, and availability.
[0200] Referring to Figure 22, shown therein is a flow diagram 2200 for forming a simulated aortic valve assembly anatomy, according to an embodiment. The simulated aortic valve assembly anatomy may be an embodiment of the aortic valve assembly anatomy 1320 of Figures 13A and 13B.
[0201] At 2202 and 2204, where the heart valve anatomy simulates an augmented pathology, a secondary material is provided to the heart valve to affect the augmentation. In an example, the secondary material is arrayed on a surface of leaflets of the heart valve assembly’s heart valve.
[0202] At 2202 specifically, in some embodiments, recesses, also known as negative spaces or divots, of a leaflet mold are coated with a tertiary material for forming a surface condition of the heart valve augmentation. It will be appreciated that the tertiary material and the primary material of leaflet may be the same material, such as silicone.
[0203] At 2204, in some embodiments, the secondary material is placed in the recesses. The secondary material may be hard mineral deposits for simulating calcium deposits and particularly the rigidity of the calcium deposits.
[0204] At 2206, forming the aortic valve assembly anatomy includes forming the leaflet. The leaflet is formed by injecting the primary leaflet material into the leaflet mold.
[0205] Referring to Figures 23A through 23C, shown therein is a cross sectional side view schematic of a leaflet mold 2300, a perspective view schematic of the bottom piece 2310 of the leaflet mold 2300, and an enface view schematic of leaflets 2334-1 and 2334-2, respectively, according to an embodiment. The leaflet mold 2300 is configured to form the leaflets 2334-1 for aortic valve assembly anatomies such as the aortic valve assembly anatomy 1220 of Figure 12. In some embodiments, the leaflet mold 2300 is used to implement at 2202 through 2206 of Figure 22.
[0206] The leaflet mold 2300 includes a leaflet mold top 2302. The leaflet mold top 2302 provides a structure for forming the ventricle facing surface of the leaflet 2334-1 .
[0207] The leaflet mold 2300 includes a leaflet mold bottom 2310 for forming the aorta facing surface 2336 of the leaflet 2334-1. The leaflet mold bottom 2310 include recesses 2312. The recesses 2312 are configured for forming simulated calcium deposit 2338 on the aorta facing surface 2336 of the leaflet 2334-1 , for example, as described at 2202 through 2206 of Figure 22.
[0208] Referring again to Figure 22, at 2208, forming the aortic valve assembly anatomy includes fitting completed leaflets into blood pool inserts of an aorta mold.
[0209] At 2208, forming the aortic valve assembly anatomy includes securing the blood pool inserts with the leaflets in the aorta mold. The leaflets are removed from the leaflet mold and fitted into blood pool inserts, such as the blood pool inserts 2410-1 and 2410-2 of Figure 24A and 24B, further described below. The blood pool inserts with the premade leaflets secured inside are secured in the aorta mold. It will be appreciated that while secured in the blood pool inserts, an exterior edge of each leaflet is exposed to the aorta void of the aorta mold.
[0210] At 2210, forming the aortic valve assembly anatomy includes forming the aorta. The aorta is formed by injecting the aorta material, such as silicone, into the aorta mold. In forming the aorta, the leaflets are connected to the interior surface of the aorta along the exposed edge of the leaflets.
[0211] At 2212, Forming the aortic valve assembly anatomy includes demolding the aortic valve assembly anatomy. The aorta including the leaflets is removed from the aorta mold. The blood pool inserts are also removed from the interior of the aorta.
[0212] Referring to Figures 24A and 24B, shown therein is a cutaway side view schematic of an aorta mold 2400 and a perspective view schematic of an aorta side blood pool insert 2410-1 , according to an embodiment. The aorta mold 2400 is configured to facilitate the formation of an aorta such as the aorta 1324 of Figures 13A and 13B. The aorta mold 2400 includes an aorta mold bottom 2402 and an aorta mold top (not shown) for forming an aorta void 2404.
[0213] The aorta mold 2400 includes a ventricle cap 2406 and an aortic cap 2408. The ventricle cap 2406 is disposed at first end of the aorta mold 2400 proximal end of the
aorta which interfaces with a ventricle. The aortic cap 2408 is disposed at a second end of the aorta mold substantially opposite the first end.
[0214] The top, bottom 2402 and caps 2406, 2408 fully define and contain the void 2404. One or more of the top, bottom 2402 and caps 2406, 2408 are configured to be separated from the remainer to facilitate demolding of the aortic valve assembly anatomy.
[0215] The aorta mold 2400 further includes aortic blood pool inserts 2410-1 and 2410-2. The blood pool inserts are configured to facilitate the luminal form of the aorta. The inserts 2410, when inserted into the void 2404 cause the void to be tubular in shape corresponding to the form of an aorta. A ventricle facing surface 2412-1 of the blood pool insert 2410-1 at ventricle end is configured to receive (i.e. is a relief of) the aortic facing surfaces of each leaflet 2434-1 and 2434-2. The opposing surface (not shown) of the blood pool insert 2410-2 is similarly configured to receive the ventricle facing surface surfaces of the leaflets 2436-1 and 2436-2. Where the surfaces of the leaflets 2436-1 or 2436-2 include augmentations such as simulated calcium deposits, the blood pool surfaces such as ventricle facing surface 2412-1 include recesses 2414-1 to receive the augmentations.
[0216] 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
1 . A modular chest simulator system comprising: a platform comprising a chest anatomy; and a first heart assembly configured to simulate a first heart anatomy corresponding to a plurality of first anatomy pathologies, wherein the first heart assembly comprises: a first simulated heart anatomy configured to simulate the first heart anatomy, the first simulated heart anatomy comprising: reference anatomy configured to simulate the first heart anatomy common to the plurality of first anatomy pathologies; and a heart assembly structure configured to: interface with and be releasably secured to the platform; and receive and releasably secure in the first heart assembly an initial first pathology specific anatomy configured to simulate heart anatomy corresponding to a first pathology selected from the first anatomy pathologies.
2. The system of claim 1 , wherein the first simulated heart anatomy further comprises the initial first pathology specific anatomy selected from a plurality of first pathology specific anatomies each corresponding to one of a plurality of first anatomy pathologies, the first anatomy pathologies predetermined based on commonality.
3. The system of claim 1 , wherein the reference anatomy is configured to remain unconsumed when a first procedure corresponding to the first pathology of the plurality of medical procedures is practiced.
4. The system of claim 1 , comprising a second heart assembly configured to simulate a second heart anatomy selected from the plurality of predetermined heart anatomies, the second heart anatomy corresponding to a plurality of second anatomy pathologies the second heart assembly interchangeable with the first heart assembly to accommodate a second procedure corresponding to a second pathology of the second anatomy pathologies.
5. The system of claim 1 , wherein the first heart assembly is selected from a plurality of predetermined heart assemblies.
6. The system of claim 5, wherein the predetermined heart anatomies comprises one or more of a mitral anatomy, an aortic anatomy, and a coronary artery bypass graft (CABG) anatomy.
7. The system of claim 1 , wherein the initial first pathology specific anatomy is consumable at least in part by a first procedure and wherein the initial first pathology specific anatomy is interchangeable with an additional first pathology specific anatomy corresponding to the first pathology for replacing the consumed initial first pathology specific anatomy.
8. The system of claim 1 , comprising an initial secondary pathology specific anatomy corresponding to a secondary pathology of the plurality of first anatomy pathologies, wherein the initial secondary pathology specific anatomy is interchangeable with the initial first pathology specific anatomy for simulating the secondary pathology corresponding to a second procedure.
9. The system of claim 1 , wherein the first anatomy pathologies comprise one or more of a typical pathology and a calcified pathology.
10. The system of claim 1 , wherein the platform comprises a base configured to form a base of the modular chest simulator, the base comprising a simulator base plate
configured to provide a platform of the base and at least one heart assembly securing mechanism, and wherein the chest anatomy comprise a rib cage configured to simulate a human rib cage, the rib cage fixed to an anterior surface of the base.
11 . The system of claim 10, wherein the at least one securing mechanism comprises: a superior clip disposed at a superior end of the simulator base plate configured to receive superior end of the heart assembly base plate; and a plurality of base screws disposed at and threadingly connected to the inferior end of the simulator base plate, and wherein the heart assembly comprises a receiving hole corresponding to each base screw for receiving the base screws, and wherein sliding the heart assembly along the simulator base plate, a sliding distance along one or more axes and tightening the base screws releasably secures the heart assembly to the simulator base plate.
12. The system of claim 11 , wherein the sliding distance is predetermined according the first pathology.
13. The system of claim 10, wherein the rib cage comprises a rib support assembly for supporting a plurality of ribs, the plurality of ribs flexibly and severably connected to the rib support assembly at an anterior end by an anterior junction and at a posterior end by a posterior junction.
14. The system of claim 10, wherein the rib cage comprises a rib support assembly for supporting a plurality of ribs, the rib support assembly comprising:
a sternum configured to simulate a human sternum, the sternum comprising a right sternum piece and a left sternum piece; and a superior rib support disposed at a superior end of the rib support assembly and connected to and configured to support a superior end of the sternum, the superior rib support comprising: a superior right support connected to and configured to support a superior end of the right sternum piece; and a superior left support connected to and configured to support a superior end of the left sternum piece; and an inferior clip configured to separably connect an inferior end of the right sternum piece and the left sternum piece, wherein the right sternum piece and superior right support is separable from the left sternum piece and the superior left support for simulating splitting the sternum.
15. The system of claim 10, wherein the rib cage comprises an intercostal muscle for simulating the flexible interconnectivity of a plurality of ribs of the rib cage, the intercostal muscle composed of an elastic material corresponding to a predetermined elasticity of the simulated interconnectivity.
16. The system of claim 1 , wherein the heart assembly comprises a coronary artery bypass graft (CABG) heart assembly and wherein the initial first pathology specific anatomy comprises a heart surface and the at least one coronary artery and wherein the modular chest simulator further comprises a CABG assembly comprising simulated auxiliary CABG anatomy.
17. The system of claim 1 , wherein the heart assembly structure further comprises a stand configured to:
support and dispose the first simulated heart anatomy according to the first heart anatomy; and accommodate, receive, and releasably secure the initial first pathology specific anatomy.
18. The system of claim 17, wherein the stand comprises: a holder configured to receive and secure the initial first pathology specific anatomy; and arms configured to dispose the holder above the heart assembly base plate for positioning the simulated heart anatomy according to the first pathology, wherein the holder is rotatably connected to the arms for orienting the holder according to the first pathology.
19. The system of claim 18, wherein the initial first pathology specific anatomy comprises a valve assembly and the stand comprises a holder, the holder comprising: a frame configured to accommodate the valve assembly and a reference anatomy according to first heart anatomy; a clamp adjustably connected to the frame, wherein the frame and the clamp define a slot for receiving the valve assembly and wherein adjusting the connection of the clamp to the frame transitions the holder from a receiving configuration for receiving the valve assembly to a secured configuration for securing the valve assembly.
20. The system of claim 1 , wherein the initial first pathology specific anatomy comprises a valve assembly, the valve assembly is comprising a valve assembly structure comprising: a flange connected to valve assembly anatomy of the valve assembly; and a proximal flange cover and a distal flange cover, wherein the flange is disposed and secured between the proximal and distal flange covers, and wherein the flange, distal flange cover, and proximal flange cover are configured when secured together, to provide a structure for being received by the stand.
21 . The system of claim 1 , wherein the first heart anatomy comprises a mitral anatomy and the initial first pathology specific anatomy comprises a plurality of chordae tendineae, each chordae tendineae secured at a first end to a corresponding valve leaflet and at a second end to an adjustment screw and where turning the adjustment screw adjust an effective length of the chordae tendineae for simulating a chordae tendineae tension according to the first pathology.
22. The system of claim 1 , further comprising: an endoscopic camera for capturing an internal image data; a video processing module for overlaying pre-captured, non-simulated endoscopic data corresponding to the first heart anatomy onto one or more surfaces of the internal image data wherein each surface corresponds to a similar predetermined surface of the pre-captured non-simulated endoscopic data to obtain augmented image data; and a display for displaying the augmented image data.
23. The systems and methods as generally and specifically described herein.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202463643223P | 2024-05-06 | 2024-05-06 | |
| US63/643,223 | 2024-05-06 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025231549A1 true WO2025231549A1 (en) | 2025-11-13 |
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ID=97674132
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CA2025/050618 Pending WO2025231549A1 (en) | 2024-05-06 | 2025-04-29 | Modular anatomy simulator and method of manufacturing the same |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025231549A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5634797A (en) * | 1995-05-05 | 1997-06-03 | Montgomery; Mary B. | Heart defect teaching aid |
| US20200160753A1 (en) * | 2018-09-21 | 2020-05-21 | Vascular Simulations, Inc. | Cardiac simulation device |
| US20220327964A1 (en) * | 2010-06-30 | 2022-10-13 | Strategic Operations, Inc. | Simulated torso for an open surgery simulator |
-
2025
- 2025-04-29 WO PCT/CA2025/050618 patent/WO2025231549A1/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5634797A (en) * | 1995-05-05 | 1997-06-03 | Montgomery; Mary B. | Heart defect teaching aid |
| US20220327964A1 (en) * | 2010-06-30 | 2022-10-13 | Strategic Operations, Inc. | Simulated torso for an open surgery simulator |
| US20200160753A1 (en) * | 2018-09-21 | 2020-05-21 | Vascular Simulations, Inc. | Cardiac simulation device |
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