PATIENT-SPECIFIC CARDIOVASCULAR SIMULATION DEVICE
A surgical simulation device is disclosed that allows a structural heart disease (SHD) team, including a surgeon and an imaging specialist to perform a simulated cardiac intervention procedure using a patient-specific model that replicates biomechanical and echogenic properties of a specific patient to be operated on. The surgical simulation device can include a station with a tank for receiving a patient-specific cartridge with the patient-specific model. The device can also include an esophageal access system in the station and a vascular access system that couples to an access port of the station.
This application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 62/734,223, entitled “PATIENT-SPECIFIC CARDIOVASCULAR SIMULATION DEVICE” and filed on Sep. 20, 2018, the disclosure of which is hereby incorporated by reference in its entirety for all purposes.
TECHNICAL FIELDThis disclosure is directed simulation devices, and more particularly, to patient-specific cardiovascular simulation devices.
BACKGROUNDHeart disease is the leading cause of mortality and morbidity in the modern world. Numerous mini-invasive therapies such as percutaneous or transcatheter interventions have recently been introduced for treatment of structural heart disease (SHD). However, currently, there are limited opportunities and tools for SHD teams to plan and practice any structural heart intervention in the cardiac catheterization laboratory environment.
SUMMARYA simulation device is disclosed that mimics cardiovascular anatomical structures for training and planning interventional cardiology procedures. The simulation device can include a frame and a multi-material patient-specific cardiac model with accurate biomechanical properties and variable echogenic materials. The variable echogenic materials may be visible on ultrasound imaging, with visual aspects close to those of biological tissues.
According to some aspects of the disclosure, a surgical simulation device is disclosed that includes a patient-specific cartridge that includes a patient-specific model of at least a portion of a heart of a patient, the patient-specific model including at least a portion configured to mimic an anatomical shape and a mechanical behavior of the portion of the heart of the patient; a station having a housing; a tank formed in the housing and configured to receive the patient-specific cartridge; an esophageal access system extending within the housing between an esophageal access port on the housing and a first port in the tank; and a vascular access system comprising a first end with a vascular access port and a second end configured to be fluidly coupled to a second port in the tank.
According to other aspects of the disclosure, a patient-specific cartridge for a surgical simulator device is provided, the patient-specific cartridge including a patient-independent frame having first, second, and third openings; and a patient-specific cardiac model. The patient-specific cardiac model includes a right atrium; a left atrium and a septum having mechanical and anatomical shape properties that correspond to the mechanical and anatomical shape properties of the left atrium and the septum of a patient; a superior vena cava interfacing portion that deviates from the anatomical shape of the superior vena cava of the patient and extends between the right atrium and the first opening in the patient-independent frame; an inferior vena cava interfacing portion that deviates from the anatomical shape of the inferior vena cava of the patient and extends between the right atrium and the second opening in the patient-independent frame; and an upper pulmonary vein interfacing portion that deviates from the anatomical shape of the pulmonary vein of the patient and extends between the left atrium and the third opening in the patient-independent frame.
According to other aspects of the disclosure, a surgical simulation device is provided that includes a station having a housing; a tank formed in the housing and configured to receive a patient-specific cartridge that includes a patient-specific model of at least a portion of a heart of a patient, wherein the tank comprises a bottom wall having a first surface that forms a bottom surface of the tank, and an opposing second surface; an esophageal access system extending within the housing between an esophageal access port on the housing and a first port in the tank; a vascular access system including a first end with a vascular access port and a second end configured to be fluidly coupled to a second port in the tank; and a spinal shadow simulation card disposed within the housing adjacent the opposing second surface of the bottom wall of the tank.
According to other aspects of the disclosure, a method is provided that includes providing a surgical simulation device having a station having a housing, a tank formed in the housing, and a vascular access system coupled to the housing; providing, in the tank, a patient-specific cartridge that includes a patient-specific model of at least a portion of a heart of a patient; inserting an imaging device through an esophageal access system within the housing from an esophageal access port on the housing, though a first port in the tank, and into a recess in a bottom surface of the tank beneath the patient-specific cartridge; and inserting a surgical element from a vascular access port of the vascular access system, through a main lumen of the vascular access system, and into a portion of the patient-specific model via a second port in the tank.
According to other aspects of the disclosure, a surgical simulation device is provided that includes a patient-specific cartridge that replicates anatomical and acoustic features of an organ of a specific patient; a station including a tank configured to receive the patient-specific cartridge; a surgical access system coupled to the station and including a lumen extending from a surgical access port to an access port for the tank, the lumen configured to simulate a blood vessel of a generic patient; and an imaging access system extending within the station from an imaging access port to the tank, the imaging access system comprising a lumen configured to simulate an imaging access pathway within the generic patient.
According to aspects of the disclosure, the imaging access system mimics an esophagus of a generic patient, and provides access to a transesophageal echocardiography probe.
It is understood that various configurations of the subject technology will become readily apparent to those skilled in the art from the disclosure, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.
The above and related objects, features, and advantages of the present disclosure will be more fully understood by reference to the following detailed description, when taken in conjunction with the following figures, wherein:
In the following detailed description, numerous specific details are set forth to provide a full understanding of the present disclosure. It will be apparent, however, to one ordinarily skilled in the art that embodiments of the present disclosure may be practiced without some of the specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the disclosure.
Interventional cardiologists work with fluoroscopy as the main tool for real-time guidance of catheter-based therapy. Since interventions in structural heart disease (SHD) are performed on the beating heart, visualization of the relevant structures with means other than direct visual inspection by the surgeon is crucial. Advances in cardiac imaging with three-dimensional transesophageal echocardiography (TEE) have proven particularly helpful in demonstrating the complex cardiac morphology and in performing necessary pre-interventional precise measurements for planning and tailoring of percutaneous therapies.
Virtual and physical simulators offer the opportunity to train for a procedure before actions can influence patient out-comes, insulating patients from risk during the novice operator period. The use of simulators also reduces training time and facilitates more structured, comprehensive skill acquisition when compared to the classical apprenticeship model. However, existing simulation devices for training and/or planning do not reproduce a realistic biomechanical behavior and/or are not visible on ultrasound imaging with visual aspects close to those of biological tissues.
Therefore, a need exists for a physical simulator device that can assist in training and planning for structural heart disease interventions, which can replicate the interaction (e.g., friction, feedback force, etc.) between the cardiovascular wall and the surgical tools in a mechanically accurate manner, and in a manner that is visible on ultrasound imaging with visual aspects close to those of biological tissues.
In the last several years, there has been an explosion in Structural Heart Diseases (SHD) interest, driven largely by the adoption of transcatheter aortic valve replacement, mitral valve interventions, and transcatheter left atrial appendage closure.
Structural heart interventions are performed with specially designed catheters, guides, sheaths, and implantation tools. For example,
To perform successful interventions (e.g., of the types shown in
The systems and methods disclosed herein provide a training and planning tool for SHD procedures, such as those illustrated in
For example,
Details of the physical simulator device 202 are shown in
As shown, the tank 306 is positioned relative to an esophageal access port 304 and vascular access port 310, in accordance with the relative positions of the patient's heart relative to the patient's mouth and a femoral vein puncture location. In this way, the arrangement of the physical simulator device 202 mimics the relative locations of the organ to be operated on (e.g., the heart), an ultrasound access point (e.g., the patient's mouth), and a vascular access port (e.g., along the femoral vein). For example,
In some implementations, the combination of the cartridge 308 and the station 300 aim to achieve the functionality of all the anatomical parts needed for a Left Atrial Appendage (LAA) closure intervention. The station 300 and a frame of the cartridge 308 may represent standard anatomical parts (e.g., of a generic patient) and a patient-specific model of the cartridge 308 may represent the patient-specific anatomical parts.
In this example, the LAA closure intervention starts with a puncture at a port 310 in the femoral vein replica (e.g., a standard-patient part), and then a guidewire is installed through the replica to the right atrium replica of the heart simulated by cartridge 308. The catheter enters the cartridge 308, which includes the patient-specific part of the system.
To access to the LAA, the cardiologist must cross the replicate septum of the cartridge 308 at a specific spot for the LAA procedure, within the fossa ovalis. For example,
Cartridge 308 includes a patient-specific model, in which the position and the shape of the fossa ovalis is patient specific. The mechanical features of the patient-specific model, such as the mechanical response of the modeled fossa ovalis to external forces (e.g., forces exerted by surgical instruments) may be patient-specific to mimic the mechanical response of the corresponding tissue of the patient's heart, responsive to the same forces. The thickness and/or material properties of portions of the model (e.g., the fossa ovalis) can be arranged to generate the desired patient-specific mechanical features, as described in further detail hereinafter. In the LAA example, once the catheter is in the left atrium, the cardiologist pushes the guidewire inside the patient-specific upper pulmonary vein replica of the cartridge 308. Then the surgeon pulls on the catheter, crosses the ridge between the replicated pulmonary vein and ends in the LAA, and deploys the device.
As shown in
In
The station 300 and/or vascular access system 302 may be arranged to represent certain standard (i.e., non-patient specific) anatomical parts involved in a simulated intervention. The primary functions of the station 300 are to hold the cartridge 308 (e.g., including the patient-specific cardiac model) in an anatomically relevant position, circulate fluid through the cartridge 308 to simulate blood flow, and provide anatomically realistic vascular and esophageal access.
The simulated vascular access provided by vascular access system 302 simulates the right femoral vein, iliac vein, and inferior vena cava access. The simulated esophageal access can be disposed within housing 309 and provides a path for insertion and placement of, for example, a transesophageal echocardiographic (TEE) ultrasound probe for imaging the simulated procedure. A pump (e.g., implemented as one of components 501 of
The station 300 and vascular access device 302 are designed to be positionable on a Cath Lab patient bed with all components being positioned in corresponding anatomical positions of a patient on the bed, as depicted in
Although various examples disclosed herein are described in connection with a simulator device for cardiac procedures, it should be appreciated that a physical simulator device for simulating procedures for other organs of bodily features can also be provided with station, a tank, a patient-specific cartridge corresponding to the organ, a surgical access device for simulating interventional access to the organ, and an imaging access device for simulating imaging component access to the organ, without departing from the scope of the disclosure. For example, the physical simulator device 202 may be implemented with as a surgical simulation device that includes a patient-specific cartridge 308 that replicates anatomical and acoustic features of an organ (e.g., a heart, a lung, a stomach, a urinary bladder, a bone, a lymph node, a larynx, a pharynx, muscle vasculature, a spinal column, an intestine, a colon, a rectum, or an eye) of a specific patient, a station 300 including a tank 306 configured to receive the patient-specific cartridge 308, a surgical access system 302 coupled to the station 300 and including a lumen 1700 extending from a surgical access port 310 to an access port 718 for the tank 306, the lumen 1700 configured to simulate a blood vessel of a generic patient, and an imaging access system 700 extending within the station 300 from an imaging access port 304 to the tank 306, the imaging access system comprising a lumen 900 configured to simulate an imaging access pathway within the generic patient.
For ergonomic and sealing reasons, the replicated esophageal access system/TEE approach system 700 may not be fully anatomical in terms of shape, size and angulation of a patient's esophagus 708. Instead, a standardized approach for the TEE approach system 700 may be used that allows a clinician to place a TEE probe 505 in a position in the station 300 that corresponds to the position a TEE probe would be positioned during an actual procedure, with similar, though not fully simulated tactile feedback provided to the clinician.
For example,
As illustrated in
In patient's body, a TEE probe will slide along the esophagus, which helps maintain the probe position during the manipulation. As the station esophagus system 700 is not anatomic, the system includes features that reproduce this esophagus “catch” in order to hold the probe in a realistic way. For example, esophageal access system 700 may combine two interchangeable membranes (e.g., latex membranes) located on the way to the tank 306 (e.g., a proximal membrane 711 at the top of the station 300 at the proximal end of the esophageal access system 700, and a distal membrane 712 just before the tank), as illustrated in
As seen in
As shown in
The vascular access system 302 can be constructed of multiple components joined together. The assembly is in some implementations semi-rigid to improve the stability of the device on a work surface (such as a Cath lab table), to reduce the likelihood of cantilevering of the device, and improve durability of the device. The main shaft 1510 includes an interior lumen (not visible in
The holes 1804 (shown in cutaway detail in
As illustrated in
Several studies have shown that cardiac physical models can be conveniently used to evaluate treatment strategies. Most previous studies have been carried out on models obtained using injection molds or additive manufacturing technology, using just one material. The presently disclosed systems and methods utilize a patient-specific cartridge 308 with a patient-specific cardiac model that has the advantages of being arranged for mounting to interface port 718 in tank 306 of station 300, and of being multi-material. For example, the cardiac model may be derived directly from a patient-specific anatomy into a biomechanical simplified model, approaching the biomechanical behavior of the anisotropic vascular wall material and as well as being, in some implementations, visible under echography.
In some implementations, the cardiac model 2502 may include either patient-specific or standardized portions for a replicated portion 2506 of the right atrium and non-patient specific portions of the left atrium 2504.
A method for fabricating a patient-specific physical cardiac simulation device such as patient-specific cartridge 308 may include segmenting the region of interest from typical medical imaging modalities such as MRI, CT; creating a 3D geometric model from the segmented images, integrating the 3D geometric model to a standard (patient-independent) frame, creating a 3D Finite Element model of the anatomical region of interest, assigning realistic material properties from a data-bases of biomechanical cardiovascular tissue model, creating a second 3D Finite Element model, applying a goal-based design optimization algorithm to the second 3D Finite Element model to assign the distribution of printable materials that can replicate the behavior of the first 3D Finite Element model, and printing (e.g., using additive manufacturing techniques) the multi-material model with the frame. More detailed descriptions of this process can be found in PCT Applications WO/2018/050915 and WO/2018/051162, each of which is hereby incorporated by reference in its entirety.
In the example of
The frame 2500 in all of
In some implementations, the standard frame 2500 includes the right atrium portion 2506 of the cardiac model 2502, other than the septum 112′ and fossa ovalis 400′ separating the right atrium from the left atrium portions of the model. In general, the artificial tissues may range in thickness from between about 0.5 cm to about 2.5 cm.
To help provide biomimetic mechanics of the replicated fossa ovalis 400′, in some implementations, additional structural reinforcements are introduced into the model structure. The additional structures allow for bio-realistic tenting and puncturing of the model fossa ovalis 400′ during procedures. For example,
The thickness and other material and/or mechanical properties of the patient-specific model 2502 may be selected and arranged to provide both a patient-specific flexible septum, and a patient-specific flexible fossa ovalis. More specifically, the flexibility of various portions of patient-specific model 2502 is based on both the shape of the anatomy of the specific patient, and on the mechanical properties of the whole septum structure. As would be understood by one of ordinary skill in the art, the fossa ovalis is a portion of the septum, being defined as an oval/round depression in the lower posterior part of the interatrial septum (e.g., in average 30% of the whole septum area), composed primarily by thin fibrous tissue.
For example, in order to form a simulated fossa ovalis 400′ for patient-specific model 2502, the simulated fossa ovalis may be provided with a superior-inferior diameter of, for example, 20.8±6.2 mm, an anterior-posterior diameter of, for example, 15.7±6.2 mm and thickness equal to, for example, 0.68±0.27 mm, the lowest in the whole septum anatomy. Then, moving anteriorly or posteriorly the thickness may increase, with an average value of about, for example, 1.8±0.7 mm. In particular, the simulated septum 112′ may be thickest above the fossa ovalis 400′ adjacent to superior vena cava entrance 2609 (e.g., 3.4 mm in average); e.g., 1.8 mm thick, in average, in the narrow isthmus anterior to the fossa and in the most inferior portion; e.g., 2.4 mm, in average, in the area immediately inferior to the fossa.
In order to provide the simulated fossa ovalis 400′ with an adequate flexibility towards a proper patient-specific tenting while providing a more realistic puncturing mechanical feedback to the surgeon during a simulated procedure, the thickness and the material properties of the simulated septum may be arranged to create a gradient zone moving from the outer part of the septum towards the center (fossa ovalis), progressively increasing (e.g., in a direction opposite the radial direction R indicated in
where I1 and I2 are invariants of strain, and cij are material constants such as the constants provided in Table 1 below.
The mechanical features of the simulated septum 112′ are arranged to mimic biological soft tissue, particularly with respect to the interatrial septum fibers, which have a hierarchical microstructure that results in hyperelastic properties. These mechanical features of the simulated septum 112′ allow the patient-specific cartridge 308 to mimic a patient's actual transseptal tenting and puncture for clinicians training and/or patient-specific rehearsal. The mechanical features of the simulated septum 112′ may be arranged to be nearly isotropic and hyperelastic. Accordingly, in some implementations, the simulated fossa ovalis 400′ of patient-specific model 2502 may be isotropic and hyperelastic with a flexibility gradient of decreasing flexibility with increasing radial distance from the center of the fossa ovalis.
The remaining patient-specific portions of the cardiac model 2502 can be made from a combination of materials determined using the above-referenced optimization process (discussed further in PCT Applications WO/2018/050915 and WO/2018/051162) to obtain tissues that have shapes and biomechanical characteristics substantially similar to that of the actual patient's anatomy. Typical replicated anatomical wall thicknesses range from about 0.5 to about 2.5 cm. In some implementations, as described further in U.S. patent application Ser. No. 16/417,151, hereby incorporated herein by reference in its entirety, the materials can further be selected to achieve an ultrasound aspect that is substantially similar to that of the actual specific patient.
For example, manufacturing the patient-specific portions of patient-specific model 2502 may include obtaining medical image data of an organ (e.g., the patient's heart) within a specific patient. The medical image data may then be processed to generate one or more data files including a volumetric model of the organ. Generating the data file(s) may include receiving one or more material data files specifying a configuration of one or more materials to be deposited by an additive manufacturing system. The patient-specific model may then be generated by dispensing at least one first material having lower acoustic impedance properties and a second material having higher acoustic impedance properties.
The medical image data of the organ may be obtained using common medical imaging modalities such as X-ray radiography, X-ray rotational angiography, MRI, CT scanning, ultrasound imaging (2D or 3D), or nuclear medicine functional imaging techniques such as positron emission tomography and single-photon emission computed tomography. The medical image data may be obtained for an organ within a specific patient or for part of a larger organ. For example, the organ may be a heart, a portion of a heart, or an artery. The medical image data may also include data associated with organs surrounding or located in close proximity to the organ being imaged such as bones, joints, fatty tissue, glands, or membranes which may exert mechanical feedback on the organ to be replicated.
The medical image data may be processed to generate a volumetric model of the specific organ to be replicated as the patient-specific model 2502. The volumetric model may be generated by converting the medical image data into a three dimensional data model describing the anatomic characteristics of the organ to be replicated. The anatomic characteristics may include various linear dimensions, volume dimensions, thicknesses, as well as other characteristics of the organ being replicated, such as tissue echogenicity. Such characteristics can be derived directly from the medical imaging data collected (e.g., from ultrasound images), or indirectly by reference to one or more databases or other electronic data sources of anatomical knowledge that stores reference information about representative tissue characteristics of various tissues in the body. The volumetric model includes a three dimensional set of nodes which define a plurality of elementary volumetric elements or voxels partitioning a space region (e.g., the space encompassed by the organ or portions of the organ) modeled by the volumetric model. The elementary volumetric elements may be defined as shapes of a tetrahedron, a pyramid, a triangular prism, a hexahedron, a sphere, or an ovoid. The volumetric model may be generated from a three dimensional surface mesh of the organ to be replicated which captured in the medical image data. In some implementations, the volumetric model may be generated by performing volumetric model generation on the surface mesh. In some implementations, the volumetric model is generated by performing finite-element volumetric model generation on the medical image data. In some implementations, the volumetric model is further processed to generate a deformed volumetric model of the organ to be replicated. In these implementations, the deformed volumetric model replicates the loads and constraints imposed on the in vivo organ tissue of a specific patient by one or more organ tissues surrounding the specific patient's in vivo organ tissue.
Defining the three dimensional set of nodes and the elementary volumetric elements or voxels associated with the imaged organ allows a plurality of materials to be assigned to each voxel so that the additive manufacturing system may form the patient-specific model 2502 such that the echogenic properties of the in vivo organ tissue at one or more locations are accurately replicated in the corresponding locations of the patient-specific model 2502. The assigned materials may include materials of differing acoustic impedance values, such as higher acoustic impedance materials, lower acoustic impedance material, or mixtures or suspensions of materials having different acoustic impedances.
Material assignment is performed using a cost function to minimize the error between the desired echogenic properties (determined based on the medical image data or from electronic databases or data sources storing representative tissue characteristic data) and the resulting echogenic properties of the combination of one or more of the materials selected for deposition in a location corresponding to a given voxel or cluster of voxels of the volumetric model. In some embodiments, the cost function may include additional cost functions, for example a cost function to minimize the error associated with the elastic material properties or other mechanical material properties of the organ being replicated. In these embodiments, material assignment may be achieved by solving the cost function using a joint search to minimize the sum of the errors between the mechanical material properties and the echogenicity material properties. In some implementations, weights may be applied to the respective constituent cost functions based on the desired application. For example, it may be desirable to apply a higher weight to the cost function associated with mechanical material properties when accurately simulating echogenicity in the patient-specific model 2502 is less important. Alternatively, it may be important to weight the cost function associated with echogenic material properties higher in situations where it is critical to accurately simulate echogenicity in the patient-specific model 2502. After performing a joint search as described above, a final volumetric model may be generated.
In some implementations, as an alternative to a joint search method, a predetermined number of best fitting echogenic (acoustic) property models could be evaluated using a mechanical property cost function to select an overall best fitting model. Additionally, or alternatively, a predetermined number of best fitting mechanical property models may be evaluated using an echogenicity cost function to identify an overall best fitting model. In some implementations, the cost function may include constraints to prevent aspects of the volumetric model from being assigned specific materials. For example, a constraint may be implemented to require lower acoustic impedance materials formed from sacrificial material to be fully encapsulated within one or more higher acoustic impedance materials.
The object materials to be assigned to each voxel that were determined as a result of applying the cost function(s) may be selected from a database of object materials. In some implementations, a particular material may be selected based on the results of minimizing a cost function for a given region (e.g., a cluster) or plurality of elementary volumetric elements of the volumetric model.
In some implementations, processing the medical image data includes converting the medical image data from a data or file format that is specific to the particular medical imaging modality used to obtain the medical image data into a data or file format that is compatible with an additive manufacturing system. For example, the medical image data may be processed and converted into one or more STL data files or other additive manufacturing system compatible file format. The STL file format may be utilized by the additive manufacturing system to generate a 3D patient-specific model 2502 based on the volumetric model included in the one or more data files.
One or more material data files may specify a configuration of one or more materials to be deposited by an additive manufacturing system. The one or more material data files may define an arrangement or configuration of a plurality of echogenic and non-echogenic materials (or higher acoustic impedance and lower acoustic impedance materials) to be deposited by the additive manufacturing system based on the processed image data. For example, based on the plurality of materials assigned to each voxel of the volumetric model included in the one or more material data files, the additive manufacturing system may determine the arrangement of one or more materials to be deposited in one or more layers to form the patient-specific model 2502.
The additive manufacturing system may form the patient-specific model 2502 by dispensing at least one material having lower acoustic impedance properties and a second material having higher acoustic impedance properties. The additive manufacturing system dispenses the plurality of materials to form the patient-specific model 2502. The plurality of materials includes at least one lower acoustic impedance material and a higher acoustic impedance material. The two materials may be dispensed simultaneously as a suspension of the higher acoustic impedance material within the lower acoustic impedance material, or as separate depositions of higher acoustic impedance material and lower acoustic impedance materials. Based on the configuration of materials assigned to each voxel of the volumetric model included in the one or more material data files, the additive manufacturing system dispenses the appropriate material determined for a given elementary volumetric element defined in the volumetric model of the organ to be replicated. For example, the additive manufacturing system dispenses amounts of at least one hypo-echogenic material at locations in the patient-specific model 2502 which map or correspond to the same locations in the volumetric model that were determined to be less echogenic areas or regions based on the medical image data. Similarly, hyper-echogenic materials (e.g., a suspension with a higher density of high acoustic impedance material) may be dispensed by the additive manufacturing system at locations in the patient-specific model 2502 which correspond to the same locations in the volumetric model that were determined to be more echogenic.
There need not be a one-to-one correspondence between a voxel and a given material deposition. A voxel is a logical construct which can be processed by an additive manufacturing device to determine an appropriate set of independent material depositions. For example, some volumetric models may be generated with lower resolution than a print-resolution of a 3D printer used to print the patient-specific model 2502. In such situations, the 3D printer may make multiple deposits of material to generate a single voxel. For example, in some implementations, each voxel may correspond to a 3×3×3, 4×4×4, 5×5×5, or other sized cuboid of material depositions. In other implementations, voxels may translate into ovoid or other shaped depositions, rather than cuboid depositions. The 3D printer used to fabricate the patient-specific model 2502 may translate an echogencity value assigned to each voxel to an appropriate pattern of material depositions within a given a corresponding cuboid or ovoid deposition. In other implementations, each voxel corresponds to a single material deposition, which may have a spherical, ovoid, rectangular or other regular or irregular shape depending on the equipment used to make the deposition. The at least one material having lower acoustic impedance properties and the second material having higher acoustic impedance properties may be dispensed by the additive manufacturing system using casting, 3D printing, mechanical linkages of disparate materials and material deposition manufacturing. A variety of additive manufacturing processes may be utilized by the additive manufacturing system to form the patient-specific model 2502 including binder jetting, directed energy deposition, material jetting, power bed fusion, fused deposition modeling, laser sintering, stereolithography, photopolymerization, and continuous liquid interface production. In some implementations, 3D printers using PolyJet Matrix™ technology (Stratasys, Ltd., Eden Prairie, Minn.) may be used to simultaneously dispense a plurality of materials having different elastic and acoustic impedance properties to form an patient-specific model 2502 with varying elastic and echogenic properties at one or more locations. In some implementations, the at least one material having higher acoustic impedance properties includes a polymerized material, such as PolyJet material having a polymerized density of 1.18-1.21 g/cm3. In some implementations, the lower acoustic impedance includes a hydrogel with acoustic properties similar to water. In some implementations, the lower acoustic impedance material includes a non-polymerized material such as water, a gel, an ion, or a bio-molecule.
In the example of
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Various examples discussed herein describe the advantages of providing a patient-specific model 2502 with acoustic features that mimic the acoustic features of the corresponding patient cardiac structures (e.g., for ultrasound imaging during a simulated surgical procedure). In some circumstances, it can also be beneficial to be able to provide a physical simulator device in which features of the patient's anatomy mimic the response of various anatomical features to other imaging technologies.
For example, during some cardiac interventions, x-ray imaging can be performed to help a surgeon more accurately understand the location of a guidewire or other surgical device.
In order to provide a patient-specific model 2502 that generates a cardiac shadow similar to cardiac shadow 4102 of
Additionally, or alternatively, hydrogel layer 4303 may be injected with an x-ray interactive material (e.g., a contrast liquid including calcium, iodine, and/or barium such as Iohexol).
The features described above in connection with
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As one illustrative example of a method of using the technology disclosed herein, a method is described that includes providing a surgical simulation device 202 having a station 300 having a housing 309, a tank 306 formed in the housing 309, and a vascular access system 302 coupled to the housing. The method may include providing, in the tank 306, a patient-specific cartridge 308 that includes a patient-specific model 2502 of at least a portion of a heart of a patient. The method may also include inserting an imaging device, such as an ultrasound probe 505, through an esophageal access system 700 within the housing from an esophageal access port 304 on the housing, though a first port 714 in the tank, and into a recess 1400 in a bottom surface 1402 of the tank 306 beneath the patient-specific cartridge 308. The method may also include inserting a surgical element (e.g., a guidewire and/or one or more cardiac interventional devices) from a vascular access port 310 of the vascular access system 302, through a main lumen 1700 of the vascular access system, and into a portion of the patient-specific model 2502 via a second port 718 in the tank 306. The method may also include, prior to providing the patient-specific cartridge 308 in the tank 306, coupling first, second, and third interfacing portions 3100, 3103, and 3102 of the patient-specific model 2502 to corresponding first, second, and third openings 2609, 2611, and 2613 in a frame 2500 of the patient-specific cartridge 308. The method may also include circulating a blood simulation fluid 307 through the tank 306 and at least portions of the patient-specific model 2502 (e.g., using fluid control system 909). The method may also include heating the blood simulation fluid 307 with a heater 4900 in the station 300. The method may also include, prior to heating the blood simulation fluid 307 with the heater 4900 in the station 300, pre-heating the blood simulation fluid 307 with an accessory heater (e.g., accessory heater 5100 or accessory heater 5300) configured to attach to at least one sidewall 5110 of the station 300. The method may also include obtaining fluoroscopy images of the patient-specific cartridge 308 using x-ray attenuating material in or one the patient-specific model 2502, while the patient-specific cartridge is in the tank.
The patient-specific model may include a right atrium, a septum, and a left atrium, and the method may include inserting, via the second port in the tank, the surgical element into the right atrium of the patient-specific model. The method may also include puncturing the septum of the patient-specific model with the surgical element. The method may also include passing a device through the punctured septum into the left atrium of the patient-specific model. The patient-specific model may also include a left atrial appendage, and the method may also include occluding the left atrial appendage of the patient-specific model with the device. The septum, the left atrium, and the left atrial appendage of the patient-specific model have mechanical and acoustic characteristics that correspond to mechanical and acoustic characteristics, respectively, of a septum, a left atrium, and a left atrial appendage of the patient. The method may also include generating an ultrasound image of the patient-specific cartridge using the imaging device.
While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any inventions or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular inventions. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.
Similarly, while operations may be described herein in a particular order, this should not be understood as requiring that such operations be performed in the particular order or in sequential order, or that all illustrated operations be performed, to achieve desirable results.
Moreover, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.
Implementations of portions of the subject matter and the operations described in this specification can be implemented in digital electronic circuitry, or in computer software embodied on a tangible medium, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Implementations of portions of the subject matter described in this specification can be implemented as one or more computer programs embodied on a tangible medium, i.e., one or more modules of computer program instructions, encoded on one or more computer storage media for execution by, or to control the operation of, a data processing apparatus. A computer storage medium can be, or be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. The computer storage medium can also be, or be included in, one or more separate components or media (e.g., multiple CDs, disks, or other storage devices). The computer storage medium may be tangible and non-transitory.
References to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms. The labels “first,” “second,” “third,” and so forth are not necessarily meant to indicate an ordering and are generally used merely to distinguish between like or similar items or elements.
Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the claims are not intended to be limited to the implementations shown herein, but are to be accorded the widest scope consistent with this disclosure, the principles and the novel features disclosed herein.
Claims
1. A surgical simulation device, comprising:
- a patient-specific cartridge that includes a patient-specific model of at least a portion of a heart of a patient, the patient-specific model including at least a portion configured to mimic an anatomical shape and a mechanical behavior of the portion of the heart of the patient;
- a station having a housing;
- a tank formed in the housing and configured to receive the patient-specific cartridge;
- an esophageal access system extending within the housing between an esophageal access port on the housing and a first port in the tank; and
- a vascular access system comprising a first end with a vascular access port and a second end configured to be fluidly coupled to a second port in the tank.
2. The surgical simulation device of claim 1, further comprising a recess in a bottom surface of the tank and aligned with the first port in the tank, wherein the recess has a width along the bottom surface of the tank that is wider than a transesophageal echocardiography probe.
3. The surgical simulation device of claim 1, wherein the portion of the heart includes a right atrium, a left atrium, a circumflex artery, an aorta, a left atrial appendage, and a septum of the heart.
4. The surgical simulation device of claim 3, wherein the right atrium of the patient-specific model is fluidically coupled to an internal lumen within the vascular access system that replicates at least a femoral vein, a common iliac vein, and an inferior vena cava of a generic patient.
5. The surgical simulation device of claim 1, wherein the vascular access system comprises a sealing membrane at a proximal end thereof, and wherein the station comprises an access port that extends from an interface with the vascular access system to the second port in the tank.
6. The surgical simulation device of claim 5, wherein the access port comprises a dual-lumen pipe that includes a central lumen and an outer toroidal chamber.
7. The surgical simulation device of claim 6, wherein the dual-lumen pipe further comprises an array of through holes that fluidically couple the central lumen to the outer toroidal chamber.
8. The surgical simulation device of claim 7, wherein each of the through holes is angled away from the tank to prevent catching of surgical instruments during insertion into the tank via the vascular access system.
9. The surgical simulation device of claim 7, wherein the housing of the station further comprises a return fluid channel that fluidically couples the outer toroidal chamber and the tank.
10. The surgical simulation device of claim 1, wherein the esophageal access system comprises first and second pipe sections within the housing, the first pipe section extending from the esophageal access port on the housing to the second pipe section, and the second pipe section extending from the first pipe section to the first port in the tank.
11. The surgical simulation device of claim 10, wherein the first pipe section includes a first bend at a proximal end, and a substantially straight conduit extending from the first bend to the second pipe section.
12. The surgical simulation device of claim 11, wherein the second pipe section includes a second bend.
13. The surgical simulation device of claim 12, wherein the second bend forms an angle of between one hundred thirty degrees and one hundred seventy degrees between the substantially straight conduit and a bottom surface of the tank.
14. The surgical simulation device of claim 13, wherein the esophageal access system further comprises a first membrane at the esophageal access port and a second membrane at an interface between the first pipe section and the second pipe section.
15. The surgical simulation device of claim 1, wherein the esophageal access port, the vascular access port, and the tank are relatively positioned to replicate relative positions, respectively, of a mouth, a femoral vein access location, and a heart of a generic patient.
16. The surgical simulation device of claim 1, wherein the patient-specific model comprises a fossa ovalis having a flexibility corresponding to a flexibility of a fossa ovalis of the heart of the patient.
17. The surgical simulation device of claim 16, wherein the fossa ovalis of the patient-specific model comprises two outer layers and an inner reinforced layer, the inner reinforced layer including an array of honeycomb structures.
18. The surgical simulation device of claim 17, wherein the fossa ovalis of the patient-specific model has a flexibility that decreases with increasing radial distance from a center thereof.
19. The surgical simulation device of claim 1, wherein the patient-specific cartridge comprises a frame configured to couple the patient-specific model to the tank.
20. The surgical simulation device of claim 19, wherein the frame comprises first, second, and third openings configured to align with first, second, and third access ports in the tank.
21. The surgical simulation device of claim 20, wherein the patient-specific model comprises:
- a patient-specific portion that corresponds to the anatomical shape of the portion of the heart of the patient; and
- first, second, and third interfacing portions that deviate from the anatomical shape of the corresponding portions of the patient's heart to extend between the patient-specific portion and the first, second, and third openings.
22. The surgical simulation device of claim 21, wherein the first, second, and third interfacing portions correspond, respectively, to a superior vena cava interfacing portion, an inferior vena cava interfacing portion, and an upper pulmonary vein interfacing portion of the patient-specific model.
23. The surgical simulation device of claim 21, wherein the patient-specific model comprises a simulated right atrium having a window.
24. The surgical simulation device of claim 20, wherein the frame comprises:
- a base portion configured to abut a bottom surface of the tank when the patient-specific cartridge is installed in the tank; and
- an opening configured to align with an access port on a first sidewall of the tank; and
- a proximal portion comprising at least one engagement member configured to engage with a corresponding engagement member on an opposing second sidewall of the tank.
25. The surgical simulation device of claim 24, wherein the at least one engagement member of the proximal portion of the frame and the corresponding engagement member on the opposing second sidewall of the tank each comprises a magnet.
26. The surgical simulation device of claim 1, wherein the patient-specific model comprises at least one wall portion having an x-ray attenuating coating.
27. The surgical simulation device of claim 1, wherein the patient-specific model comprises at least one wall portion having an outer layer, an inner layer, and an x-ray attenuating material interposed between the outer layer and the inner layer.
28. The surgical simulation device of claim 1, further comprising a spinal simulation card disposed outside the tank adjacent to a bottom wall of the tank.
29. The surgical simulation device of claim 1, further comprising a fluid control system in the station, configured to circulate a blood simulation fluid through the tank at least a portion of the patient-specific model.
30. The surgical simulation device of claim 29, wherein the fluid control system comprises:
- an outlet pipe coupled to a first opening in the tank;
- an inlet pipe coupled to a second opening in the tank; and
- a pump configured to move the blood simulation fluid through the inlet pipe, the tank, and the outlet pipe.
31. The surgical simulation device of claim 30, wherein the fluid control system further comprises a filter on the outlet pipe.
32. The surgical simulation device of claim 31, wherein the fluid control system further comprises a heater disposed between the pump and the second opening.
33. The surgical simulation device of claim 32, wherein the fluid control system further comprises a chamber having an air cavity disposed between the heater and the second opening.
34. The surgical simulation device of claim 33, wherein the fluid control system further comprises a flush valve, and a Y-pipe disposed between the flush valve and both the inlet pipe and the outlet pipe.
35. A patient-specific cartridge for a surgical simulator device, the patient-specific cartridge comprising:
- a patient-independent frame having first, second, and third openings; and
- a patient-specific cardiac model comprising: a right atrium; a left atrium and a septum having mechanical and anatomical shape properties that correspond to the mechanical and anatomical shape properties of the left atrium and the septum of a patient; a superior vena cava interfacing portion that deviates from the anatomical shape of the superior vena cava of the patient and extends between the right atrium and the first opening in the patient-independent frame; an inferior vena cava interfacing portion that deviates from the anatomical shape of the inferior vena cava of the patient and extends between the right atrium and the second opening in the patient-independent frame; and an upper pulmonary vein interfacing portion that deviates from the anatomical shape of the pulmonary vein of the patient and extends between the left atrium and the third opening in the patient-independent frame.
36. The patient-specific cartridge of claim 35, wherein the patient-specific cardiac model further comprises a left atrial appendage having mechanical and anatomical shape properties that correspond to the mechanical and anatomical shape properties of the left atrial appendage of the patient.
37. The patient-specific cartridge of claim 36, wherein the left atrial appendage includes a plurality of depressions on an internal surface thereof.
38. The patient-specific cartridge of claim 36, wherein the patient-specific cardiac model includes a wall having a least a portion that includes an x-ray attenuating material.
39. The patient-specific cartridge of claim 35, further comprising at least one magnet disposed on the patient-independent frame to facilitate plug-and-play installation and removal of the patient-specific cartridge in the surgical simulator device.
40. The patient-specific cartridge of claim 35, further comprising a window in the right atrium.
41. The patient-specific cartridge of claim 35, wherein the right atrium comprises mechanical and anatomical shape properties that correspond to the mechanical and anatomical shape properties of the right atrium of the patient.
42. The patient-specific cartridge of claim 35, wherein the right atrium comprises mechanical and anatomical shape properties that correspond to the mechanical and anatomical shape properties of the right atrium of a generic patient.
43. The patient-specific cartridge of claim 35, wherein the patient-independent frame comprises a curved support structure extending from beneath the second opening.
44. The patient-specific cartridge of claim 35, wherein the patient-specific cardiac model further comprises an aortic annulus having mechanical and anatomical shape properties that correspond to the mechanical and anatomical shape properties of the aortic annulus of the patient.
45. A surgical simulation device, comprising:
- a patient-specific cartridge that replicates anatomical and acoustic features of an organ of a specific patient;
- a station comprising a tank configured to receive the patient-specific cartridge;
- a surgical access system coupled to the station and including a lumen extending from a surgical access port to an access port for the tank, the lumen configured to simulate a blood vessel of a generic patient; and
- an imaging access system extending within the station from an imaging access port to the tank, the imaging access system comprising a lumen configured to simulate an imaging access pathway within the generic patient.
46. The surgical simulation device of claim 45, further comprising a blood simulation fluid in the tank.
47. The surgical simulation device of claim 46, further comprising a pump within the station arranged to circulate the blood simulation fluid through the tank.
48. The surgical simulation device of claim 47, further comprising a filter for the blood simulation fluid.
49. The surgical simulation device of claim 48, further comprising a within the station for the blood simulation fluid.
50. The surgical simulation device of claim 45, wherein the organ comprises a heart.
51. The surgical simulation device of claim 50, wherein the blood vessel comprises a femoral vein of the patient.
52. The surgical simulation device of claim 51, wherein the patient-specific cartridge that replicates the anatomical and acoustic features of at least a septum, a left atrium, and an aortic annulus of the specific patient.
53. The surgical simulation device of claim 45, wherein the tank comprises a recess in a bottom surface thereof, the recess configured to receive an ultrasound probe from simulated imaging access pathway.
54. The surgical simulation device of claim 53, wherein the simulated imaging access pathway comprises a simulated esophagus of the generic patient.
55. The surgical simulation device of claim 54, wherein the station includes a spinal shadow replication feature, and wherein the patient-specific cartridge includes an x-ray attenuating material.
56. A surgical simulation device, comprising:
- a station having a housing;
- a tank formed in the housing and configured to receive a patient-specific cartridge that includes a patient-specific model of at least a portion of a heart of a patient, wherein the tank comprises a bottom wall having a first surface that forms a bottom surface of the tank, and an opposing second surface;
- an esophageal access system extending within the housing between an esophageal access port on the housing and a first port in the tank;
- a vascular access system comprising a first end with a vascular access port and a second end configured to be fluidly coupled to a second port in the tank; and
- a spinal shadow simulation card disposed within the housing adjacent the opposing second surface of the bottom wall of the tank.
57. The surgical simulation device of claim 56, wherein the patient-specific model comprises mechanical and acoustic features that correspond to mechanical and acoustic features of the heart of the patient.
58. The surgical simulation device of claim 57, wherein the esophageal access system is configured to allow access to the tank by an ultrasound probe for ultrasound imaging of the patient-specific cartridge.
59. The surgical simulation device of claim 58, wherein the spinal shadow simulation card comprises a substrate and spinal simulation feature on the substrate.
60. The surgical simulation device of claim 59, wherein the spinal simulation feature comprises an x-ray interactive ink printed on a surface of the substrate.
61. The surgical simulation device of claim 59, wherein the spinal simulation feature comprises a pattern that corresponds to a shape of one or more vertebrae of a spine of the patient.
62. The surgical simulation device of claim 59, wherein the spinal simulation feature comprises a pattern that corresponds to a shape of one or more vertebrae of a spine of a generic patient.
63. The surgical simulation device of claim 59, wherein the bottom wall of the tank comprises a recess aligned with the first port in the tank.
64. The surgical simulation device of claim 56, wherein the second port in the tank is configured to align with an opening to a right atrium of the patient-specific model when the patient-specific cartridge is installed in the tank.
65. The surgical simulation device of claim 64, wherein the tank comprises two additional ports configured to align with two additional openings in the patient-specific model when the patient-specific cartridge is installed in the tank.
66. A surgical simulation device comprising any combination of claims 1-65.
67. A method, comprising:
- providing a surgical simulation device having a station having a housing, a tank formed in the housing, and a vascular access system coupled to the housing;
- providing, in the tank, a patient-specific cartridge that includes a patient-specific model of at least a portion of a heart of a patient;
- inserting an imaging device through an esophageal access system within the housing from an esophageal access port on the housing, though a first port in the tank, and into a recess in a bottom surface of the tank beneath the patient-specific cartridge; and
- inserting a surgical element from a vascular access port of the vascular access system, through a main lumen of the vascular access system, and into a portion of the patient-specific model via a second port in the tank.
68. The method of claim 67, further comprising, prior to providing the patient-specific cartridge in the tank, coupling first, second, and third interfacing portions of the patient-specific model to corresponding first, second, and third openings in a frame of the patient-specific cartridge.
69. The method of claim 67, further comprising circulating a blood simulation fluid through the tank and at least portions of the patient-specific model.
70. The method of claim 69, further comprising heating the blood simulation fluid with a heater in the station.
71. The method of claim 70, further comprising, prior to heating the blood simulation fluid with the heater in the station, pre-heating the blood simulation fluid with an accessory heater configured to attach to at least one sidewall of the station.
72. The method of claim 67, wherein the patient-specific model comprises a right atrium, a septum, and a left atrium, and wherein the method further comprises inserting, via the second port in the tank, the surgical element into the right atrium of the patient-specific model.
73. The method of claim 72, further comprising puncturing the septum of the patient-specific model with the surgical element.
74. The method of claim 73, further comprising passing a device through the punctured septum into the left atrium of the patient-specific model.
75. The method of claim 74, wherein the patient-specific model further comprises a left atrial appendage, and wherein the method further includes occluding the left atrial appendage of the patient-specific model with the device.
76. The method of claim 75, wherein at least the septum, the left atrium, and the left atrial appendage of the patient-specific model have mechanical and acoustic characteristics that correspond to mechanical and acoustic characteristics, respectively, of a septum, a left atrium, and a left atrial appendage of the patient.
77. The method of claim 76, further comprising generating an ultrasound image of the patient-specific cartridge using the imaging device.
78. The method of claim 77, further comprising capturing a fluoroscopic image of the patient-specific cartridge while the patient-specific cartridge is in the tank.
Type: Application
Filed: Sep 20, 2019
Publication Date: Nov 11, 2021
Inventors: Pierre-Benoît PIRLOT (Paris), Frédéric CHAMP (Paris), Noémi RENAUDIN (Paris), Frédéric PIASEK (Paris), Armand DOLUI (Paris), Clément JUBERT (Paris), Baptiste LUCIANI (Paris)
Application Number: 17/278,049