Patient-specific cardiovascular simulation device

Abstract

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.

What is claimed is: 
     
         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.