WO2022219545A1

WO2022219545A1 - Patient specific aortic procedure simulation device

Info

Publication number: WO2022219545A1
Application number: PCT/IB2022/053451
Authority: WO
Inventors: Samuel ORRU; Mohamed Mehdi GHANNEM; Pierre GOUTARD
Original assignee: Biomodex, S.A.S.
Priority date: 2021-04-13
Filing date: 2022-04-13
Publication date: 2022-10-20

Abstract

A vascular access pad includes a pad stand including a vascular access port. A pad connector is connectable to a patient-specific anatomical model, with a sealing membrane secured to the pad connector with a sealing cap. The vascular access pad is connected to the patient-specific anatomical model to facilitate vascular simulation, such as for surgical simulation activities. The vascular access pad is patient-generic, thereby allowing it to be used for multiple different patient-specific anatomical models.

Description

PATIENT SPECIFIC AORTIC PROCEDURE SIMULATION DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and the benefit of United States Provisional Patent Application No. 63/174,357, filed on April 13, 2021, United States Provisional Patent Application No. 63/179,691, filed on April 26, 2021, and United States Provisional Patent Application No. 63/294,633, filed on December 29, 2021, which applications are hereby incorporated by reference in their entireties.

FIELD OF THE INVENTION

[0002] This disclosure is directed simulation devices, and more particularly, to patient- specific endovascular simulation devices.

BACKGROUND

[0003] 3D endovascular simulation models for research and commercial purposes exist. Such endovascular simulators use silicon molding or 3D printing to replicate at least the thoracic part of the cardiovascular system but always in mono-material. Moreover, such conventional simulators can be connected to an external pump thanks to connectors integrated into the patient-specific model.

SUMMARY

[0004] The invention relates to a plug and play endovascular simulator for thoracic procedures using 3D printed patient-specific models and an external pump mimicking realistic blood flow throughout the models. The invention simulates several different endovascular procedures and includes several puncture locations: femoral, radial, transapical, subclavian (non-exhaustive list) approaches to simulate arterial or venous accesses.

BRIEF DESCRIPTION OF THE DRAWINGS [0005] FIG. 1 is a representation of a vascular access system, according to at least one embodiment of the present disclosure;

[0006] FIG. 2 is a representation of a vascular access system, according to at least one embodiment of the present disclosure; [0007] FIG. 3A-FIG. 3D are a representations of patient-specific anatomical models, according to at least one embodiment of the present disclosure;

[0008] FIG. 4A-FIG. 4E are representations of a patient-specific anatomical model, according to at least one embodiment of the present disclosure; [0009] FIG. 5A-FIG. 5B-2 are representations of assembled vascular simulation systems, according to at least one embodiment of the present disclosure;

[0010] FIG. 6A - FIG. 6D are representations of a vascular access pad, according to at least one embodiment of the present disclosure;

[0011] FIG. 7 is a representation of a fluted tip connection, according to at least one embodiment of the present disclosure;

[0012] FIG. 8A-FIG. 8D are representations of a vascular access pad, according to at least one embodiment of the present disclosure;

[0013] FIG. 9 is a representation of a screw hole of a vascular access pad;

[0014] FIG. 10 is a representation of a fluid flow path through a vascular simulation system, according to at least one embodiment of the present disclosure;

[0015] FIG. 11 is a representation of fluid recirculation around a vascular simulation system, including a venturi system, according to at least one embodiment of the present disclosure;

[0016] FIGS. 12A and 12B are representations of a threaded casing for a camera, according to at least one embodiment of the present disclosure;

[0017] FIG. 13 is a representation of a connector plug connected to a vascular simulation system, according to at least one embodiment of the present disclosure;;

[0018] FIG. 14 is a representation of a bioprosthetic valve, according to at least one embodiment of the present disclosure; [0019] FIG. 15 is a representation of a vascular simulation system, according to at least one embodiment of the present disclosure; and

[0020] FIG. 16 is a schematic showing fluid flow throughout a vascular simulation system, according to at least one embodiment of the present disclosure. DETAILED DESCRIPTION

[0021] Disclosed is a simulation device that mimics thoracic vascular anatomical structures for training and planning interventional vascular procedures. The simulation device may include a multi-material patient-specific vascular model (anatomical model) with accurate biomechanical properties and/or biomechanical properties that mimic the properties of the patient.

[0022] The vascular simulation device disclosed herein uses 3D printing to replicate patient-specific thoracic parts of the cardiovascular system mimicking tissue biomechanics. This is done using the algorithm described in the BIOMODEX Invivotech patent application entitled “METHOD AND APPARATUS FOR GENERATING A 3D MODEL OF AN OBJECT”, Serial No.: 16/333,872, Filed: January 23, 2020. This algorithm may also be used to simulate the impact of existing devices like artificial valves, sleeves, or the like. The present invention also offers more realistic vascular approaches re-using a concept described in the BIOMODEX patent: Patient-specific cardiovascular simulation device.

[0023] Throughout the disclosure the term proximal is intended to refer to the portion which is closer to the operator, and distal is intended to refer to the portion which is further away from the operator. The terms anatomy, anatomical model and patient- specific anatomical model are used interchangeably throughout the disclosure. An anatomical model may be generic or it may be patient specific. A generic anatomical model may be constructed by combining features from two or more anatomical models. A generic model may be used for physician training whereas a patient-specific model may be used to rehearse a procedure for a specific patient using a model created from scans (e.g., MRIs, radiological, ultrasonic) of the patient’s own anatomy.

[0024] FIG. 1 shows a partially exploded view of an exemplary vascular access system, and FIG. 2 shows a fully assembled version of the system of FIG. 1. The proximal end 1500 (e.g., the end configured to be proximal to the clinician during a simulated procedure) of a vascular access system 302 includes a sealing membrane 1502 formed of a resilient self-healing material such as latex or the like that can be punctured by a vascular access tool (e.g., a catheter, a dilator, a needle) to simulate the introduction of a catheter into the right femoral artery of a patient (e.g., through the skin and into the femoral artery). As shown in FIG. 2, a vascular access port 310 formed at the proximal end 1500 may be wide enough to allow for the use of an introducer, which may be needed for certain difficult to catheterize patients. As can be seen in FIG. 1, the sealing membrane 1502 may be accessed for replacement by removing seal cap 1504 that covers the proximal end 1500 of the vascular access system 302. The sealing membrane 1502 itself may optionally include several alignment holes 1506 that are aligned with one or more alignment posts (e.g., posts 1508) extending upwards from a portion of the proximal end of the vascular access system to ensure proper seal placement.

[0025] The patient-specific model comes from the segmentation of the medical image of the patient (CT, MRI, 3D angiography) whereas a patient agnostic training model may be compiled from portions of medical images from one or more patients. The patient- specific model includes at least a portion of the thoracic cardiovascular system of a patient and mimics an anatomical shape and mechanical behavior of the portion of the thoracic cardiovascular system of the patient. The simulation device enables a user to access the model via vascular access pads 302. The vascular access pads 302 include a first end 1500 provided with a vascular access port 310 and a second port configured to be fluidly connected to the patient-specific model.

[0026] According to other aspects of the disclosure, the simulation device is provided with several vascular access pads which may be coupled or fixed to a bench for support. The vascular access pads allow the insertion of at least one endovascular device through a vascular access port of one of the vascular pads, through a main lumen of the vascular pad, and into a portion of the patient-specific model via a second port in the vascular pad. The vascular access pads are based on the vascular access pad 302 of FIG. 1 and FIG. 2. However, the assembly of the vascular access pads 302, including the sealing membrane 1502, the seal cap 1504, the alignment holes 1506, and the posts 1508 may be adapted to the requirements of the puncture location. For example, the shape, height, angle of puncture, mechanical interlock, diameter, any other characteristic of the vascular access pad, and combinations thereof, may be modified to match a particular puncture location of a simulation device.

[0027] According to other aspects of the disclosure, the patient-specific vascular model may allow a physiological fluid flow through the anatomy. For example, a left ventricle of the patient-specific vascular model may include a port which may be coupled to the inlet of a pump (static or pulsatile, industrial or medical), while the outlet may be done through several ports on the different vascular pads.

[0028] The patient-specific vascular model may include a left ventricle (or a portion thereof), an aortic valve (or a portion thereof), an ascending aortic arch, coronary arteries (or a portion thereof) including at least a main left coronary artery, a left anterior descending coronary artery (or a portion thereof) and left circumflex coronary artery (or a portion thereof) and a right coronary artery, a supra-aortic trunk (or a portion) including a left subclavian artery (or a portion), a common carotid artery and right subclavian artery (or a portion), a right carotid artery (or a portion) and a thoracic aorta (or a portion) having mechanical and anatomical shape properties.

[0029] In accordance with at least one embodiment of the present disclosure, a patient specific anatomical model may include one or more materials having different material properties, such as stiffness and/or material type. Material distribution may be processed using Invivotech®. Existing medical devices may be defined by the user to allow the algorithm to adapt the material distribution according to the stiffness of the devices. For example, in FIG. 3A, 3B, 3C, and D3, different materials may be used to form different portions of an anatomical model. The anatomical model of FIG. 3 A may have a stiffer or softer aortic valve 8.13 than the aortic valve shown in FIG. 3B. Similarly, the anatomical model of FIG. 3A may have a stiffer or softer sleeve 8.21 than the model of FIG. 3B. [0030] The model could be also processed using Echotech® to be compatible with ultrasound imaging. This feature allows the user to follow the procedure in real-time with transthoracic or transesophageal echocardiography system (TTE or TEE) as it is for endovascular procedures.

[0031] The model could be also used under a Cath lab C-ARM to use fluoroscopy to follow the procedure in real-time as it is for endovascular procedures. The model may include radio opacity for some parts such as sleeves 8.27 or valve structure of the aortic valve 8.13.

[0032] The input of the algorithm includes biomechanical properties of the aortic wall and mechanical properties of the model such as a biological valve for the aortic valve 8.13 and sleeve 8.27 (as an example: cobalt-chromium alloy) and a literature-based wall thickness. In some implementation the input of the algorithm can also include anatomical information regarding the valve of the patient; including its condition, such as healthy, prolapsed or calcified.

[0033] Since 3D printing of biological models requires a minimum thickness to allow post-processing (removing support of the printed model) and to increase the lifetime of the printed model, the thickness may be increased for the optimized model. The algorithm may then optimize the material distribution to compensate for this difference in thickness. As an example, following simple uniaxial force and Hooke’s law, as may be seen below in Eq. (1), the material distribution algorithm may assign softer materials if the thickness is increased from the input to the output or stiffer if the thickness is decreased. In Eq. (1), s stands for stress in MPa, e stands for strain, F stands for the force in N, S stands for the section in mm² and E stands for Young’s Modulus in MPa. ^{s =} ? ^{= Ee => e =} Is ⁽¹⁾

[0034] Since the optimization is done targeting a deformation regardless of the thickness, e, F and s are constants. If S increases then E is decreased, and if S decrease then E is increased. The Young’s Modulus may be associated with the stiffness of a material. By increasing the section area S, the stiffness of the material may be decreased, to maintain a constant stress. In this manner, the stiffness of the material may be based, at least in part, on the section thickness, which may allow for a similar feel while maintaining sufficient minimum thicknesses of material to allow post-processing and increase the model lifetime.

[0035] Endovascular procedures may be performed with specially designed catheters, guides, sheaths, and implantations tools. In some embodiments, the procedure may be performed, in part, by inserting one or more of the specially designed catheters, guides, sheaths, and implantations tools into the femoral artery (e.g., the simulated femoral artery 1510 shown in FIG. 1 and FIG. 2). In the embodiment shown in FIG. 4 A through FIG. 4E, the procedure may be performed, in part, by inserting one or more of the specially designed catheters, guides, sheaths, and implantations tools into the subclavian arteries 8.18 and 8.19. In some embodiments, the procedure may be performed, in part, by inserting one or more of the specially designed catheters, guides, sheaths, and implantations tools from the left ventricle 8.16 into the aorta (such as the ascending aorta 8.14 or descending aorta 8.15). In some embodiments, the procedure may be performed, in part, by inserting one or more of the specially designed catheters, guides, sheaths, and implantations tools into any other anatomical feature, including the left coronary artery 8.20, the right coronary artery 8.21, and/ or the left ventricle (8.16) through the aortic valve 8.13.

[0036] The disclosed patient-specific vascular model accurately replicates a specific patient’s anatomy and vascular wall mechanical behavior. One feature of replicating the mechanical behavior of the vascular wall may be to mimic the presence of implanted devices such as mechanical or biological valve 8.13 including biological leaflets 8.15 and metallic structure 8.14 (as may be seen in FIG. 14), sleeve 8.21 (as an example). To do so, a multi-material patient-specific vascular model with realistic biomechanical properties is implemented. Generating a patient-specific vascular model may allow (1) realistic haptic feedback while manipulating the tool, (2) pulsatility using cardiopulmonary bypass pump, (3) post-processing of the printed model, (4) increase 3D printed model durability.

[0037] FIG. 4A through FIG. 4E are representations of patient-specific vascular models. As may be seen, the patient-specific vascular models include a plurality of model connectors. The model connectors may be configured to connect to one or more vascular access pads, pumps, or other elements of a vascular simulation system, as discussed in further detail herein. The patient-specific vascular models may be mounted onto a stand or fixture (such as a bench, worktable, surgical table) using one or more of the model connectors 8.1, 8.2, 8.3, 8.4, 8.8, 8.9, 8.10, 8.11, 8.12, 8.24 (as may be seen in FIG. 4A and FIB. 4B).

[0038] In some embodiments, the patient-specific vascular model may include a pump port or an inlet port which the inlet of a pump can be fluidically coupled. For example, the model connectors 8.1 or 8.3 may be representative of an inlet port or pump port. In some embodiments, the patient-specific vascular model may include a model port or model connector which may be configured to mate with or couple to a vascular pad 4. For example, as may be seen in FIG. 5A, the port 8.2 may be representative of a model port. Other connectors, including 8.5, 8.6, 8.7, 8.8, 8.9, 8.10, 8.11, 8.12, may connect the patient-specific model to the pump (e.g., the inlet or outlet of the pump) or to connect to a vascular pad 4, 5, 6, or 302. Such connectors may be representative of arteries or veins, depending on their specific anatomical location.

[0039] In a specific non-limiting example, the ventricle 8.2 shown in FIG. 4A may include external screw threads 8.24 or the like on which an external 3D printed part such may be threaded to allow connection to the inlet of a pump. For example, the connector 7 shown in greater detail in FIG. 13 may be connected to the ventricle 8.2 to connect to the inlet of a pump.

[0040] FIG. 5A through FIG. 5B-2 are representations of a vascular simulation system including vascular access pads 4, 5, 6 and a patient-specific anatomical model 8. The vascular access pads 5 and 6 may include at least one vascular access port 6.1 (as may be seen in FIG. 8C) to be connected to the patient-specific anatomical model 8 using connectors.

[0041] In some embodiments, the connectors between the anatomical model 8 and the vascular access pads may include a fluted tip connection, such as the fluted tip 4 illustrated in FIG. 7. It should be understood that the model connector of the patient- specific anatomical model may include either the male or the female end of the fluted tip connection, and the pad connector configured to mate with the model connector may include the complementary male or female end of the fluted connection. In some examples, a model to access pad connector may include a cone-like tip 6 as may be seen in FIGS. 8A-8D, with either the model connector or the pad connector including the male or female end.

[0042] FIG. 8C illustrates vascular access pads 5 and 6 that include a second port 6.2 to connect the anatomical model 8 to the pump. The second port 6.2 may be outlet ports. [0043] In accordance with at least one embodiment of the present disclosure, the vascular access pads 4, 5, 6 may be based on a generic patient. In contrast to the patient-specific anatomical model 8, the generic vascular access pads 4, 5, 6 may be re-usable between different vascular simulation systems, or connectable to different patient-specific anatomical models 8. Each of the vascular access pads 4, 5, 6, may be associated with a particular vascular access structure, such as a transapical pad 4, a left subclavian pad 5, or a right subclavian pad 6. This may help to maintain the angle and the topology of the artery without impacting the navigation of the devices. For example, the pad stand 3 may be configured with a height and/or angle for the access port 310 that may simulate the particular vascular access structure. In this manner, when the patient-specific anatomical model 8 is connected to the vascular access pad, the vascular access pad may simulate the entry into the patient-specific anatomical model 8, including the relevant angles, distances, and membrane puncture characteristics.

[0044] In some embodiments, the connection between the vascular access pad 5, 6 and the anatomical model 8 may be smooth to allow smooth sliding of the catheter through the connection. For example, the interior surface of the pad connector may transition to the interior surface of the model connector smoothly, without a change in angle or diameter that may cause the catheter to catch. This may help to further increase the realism of a vascular simulation system, thereby improving the effectiveness of the simulation.

[0045] FIG. 5A through FIG. 5B-2 show the assembly of anatomy 8 with the three vascular access pads 4, 5, 6. Each vascular access pad 4, 5, 6 allows an approach through an artery. For the transapical approach (seen in FIGS. 5A-B and FIGS. 6A-C), the anatomy may be connected to the transapical pad 4 which is supported by the transapical pad stand 3. A sealing membrane 1502 and a sealing cap 1 may be mounted to transapical pad 4. Transapical pad stand 3 may be securable (e.g., secured by two screws or the like) on its base. Anatomical model 8 may be connected to the left subclavian pad 5 for the left subclavian approach or the right subclavian pad 6 for the right subclavian approach. Left subclavian pad 5 and right subclavian pad 6 are both assembled with a seal cap 1 and a sealing membrane 1502. Left subclavian pad 5 and right subclavian pad 6 may be attached to a support plate using screws or the like. Both left subclavian pad 5 and right subclavian pad 6 have outlets on the side (as may be seen in FIG. 5 and FIG. 8) to ensure fluid flow recirculation.

[0046] FIG. 5B-1 and FIG. 5B-2 illustrate the assembly of the anatomical model 8 with two vascular access pads 5, 6. The anatomical model 8 is connected to the right subclavian pad 6 (FIG. 5A) for the right subclavian approach. Right subclavian pad 6 is assembled with a seal cap 1 and a sealing membrane 1502. Right subclavian pad 6 may be attached to a support plate using screws or the like. Right subclavian pad 6 has outlets on the side (as may be seen in FIG. 5 and FIG. 8) to ensure fluid flow recirculation.

[0047] FIG. 6A is a cross-sectional view of a vascular access pad 4 shown in FIG. 6B, according to at least one embodiment of the present disclosure. FIG. 6C is a rear exploded view of the vascular access pad. In FIG. 6D, the vascular access pad 4 is connected to a patient-specific anatomical model 8. The vascular access pad 4 includes a pad stand 3 that is connectable to a base or a table. A sealing membrane 1502 is secured to the pad stand 3 with a sealing cap 1. The vascular access pad 4 includes a pad connector that is configured to mate with the patient-specific anatomical model 8. The pad connector is in fluid communication with a vascular access port on the pad stand. The sealing membrane 1502 may be placed over the vascular access port. In this manner, the user may insert a catheter or other tool through the sealing membrane 1502 and into the patient-specific anatomical model through the vascular access port. The patient-specific anatomical model may further include a secondary port 10, which may connect to a pump or to a separate vascular access pad. FIG. 7 is another representation of a cross-sectional view of a vascular access pad.

[0048] FIG. 8A is a representation of a perspective view of a vascular access pad 6, according to at least one embodiment of the present disclosure. The vascular access pad 6 includes a sealing membrane 1502 secured to the vascular access pad 6 with a sealing cap 1. As may be seen, the sealing membrane 1502 is oriented at a different angle than a pad connector. This may simulate the entry of the catheter or other tool into a vascular system. FIG. 8B is a cross-sectional view of the vascular access pad 6, in which the relative angle of the entry into the vascular access pad 6 is shown as different from the angle of entry into the patient-specific vascular model. [0049] As may be seen in FIG. 8C, the vascular access pad 6 includes an inlet port 6.1 and an outlet port 6.2. The inlet port 6.1 may receive fluid from the patient-specific anatomical model, and the outlet port 6.2 may direct the blood mimicking fluid to the pump. The vascular access pad 6 may be part of the left subclavian pad 5 and right subclavian pad 6 to be connected to a pump (static or pulsatile, industrial or medical) using a tube to provide fluid flow.

[0050] The vascular pads of the present disclosure may include a pad connector to connect an anatomical model (veins, arteries, heart, etc.). The pad connector may be any type of connector, depending on the anatomical model outputs. For example, the pad connector may include a fluted tip (see, e.g., FIG. 7), which may be used to a connect silicone-like tube without any leaks. In some examples, cone-like connectors (see, e.g., FIG. 8A-8C) may be used to connect the right subclavian pad 6 to the anatomical model 8. The connection may be implemented using a tube.

[0051] In accordance with at least one embodiment of the present disclosure, the vascular access pads of the present disclosure may be fixed to a support plate or base. For example, the vascular access pads may be connected to the support plate or base using a mechanical fastener, such as a bolt or a screw. The mechanical fastener may be inserted into the screw hole 6.3 on the base of the vascular access pad (as may be seen in FIG. 8C and FIG. 9).

[0052] In some embodiments, the vascular access pads of the present disclosure may include a mounting portion such as screw threads or the like to connect a camera 8.23. Because of 3D printing flexibility, any endoscope camera may be attached to the anatomy using the threaded casing seen in FIG. 12A and FIG. 12B.

Fluid-compatible bench

[0053] The simulation device disclosed may be mounted to a base or a bench compatible with a fluid system connected to a pump (static or pulsatile, industrial or medical). The inlet of the vascular model will be connected directly to the port of the ventricle while the outlet of the model will be connected to the ports of the different vascular access pads.

Physiological flow path

[0054] In some examples, the system mimics physiological flow path through the patient- specific model from the ventricle to the outlets of the model using water or blood mimicking fluid having the same rheological properties as the blood. Physiological flow rate through the coronaries

[0055] FIG. 10 and FIG. 16 show examples of fluid flow through a sample vascular simulation system. As may be seen, the patient-specific anatomical model includes an inlet and a plurality of outlets. The outlets may be representative of the various arteries or vessels of the patient-specific anatomical model.

[0056] In some embodiments, the physiological blood flow filling the coronaries may include 5-10% of the total blood flow that comes from the aortic valve. In accordance with at least one embodiment of the present disclosure, to ensure that the right flow passes through the coronaries of our model, a venturi system may be added to the fluid system to provide an extra-suction through the coronaries. FIG. 11 is a representation of a fluid flow system including a venturi control system, according to at least one embodiment of the present disclosure. In some embodiments, the selected reduction ratio of the venturi is approximately 9:6. Put another way, the inlet diameter may be approximately 9 mm and the reduction diameter may be approximately 6 mm. This may help to regulate the blood mimicking fluid through the patient-specific anatomical model. [0057] FIG. 15 is a representation of a fluid flow system including a valve 9, according to at least one embodiment of the present disclosure. In some embodiments, the flow rate of the blood mimicking fluid may be adjustable in any artery using a valve 9 connected to each artery. The valve 9 may be used to adjust the resistance though each artery to mimic the flow through the patient’s vascular system. Parameters for each valve is patient- dependent. In some embodiments, the valves 9 may be adjusted until 8-12% of the total blood flow (e.g., the flow of the blood mimicking fluid) in the coronary artery.

[0058] An example of the full system is displayed in FIG. 10, FIG. 11, FIG. 15, and FIG. 16. The blood mimicking fluid enters the vascular simulation system through the left ventricle 8.2 and splits in the different peripherical arteries 8.17, 8.18, and 8.19 (i.e. supra aortic trunks, descending aorta, coronary arteries, respectively). A bladder or sealed bag may be used to maintain a minimal pressure within the system (as an example, minimal pressure in the aorta should be 80 mmHg). For each artery, the flow rate may be adjusted using the individual valve. [0059] One or more specific embodiments of the present disclosure are described herein.

These described embodiments are examples of the presently disclosed techniques. Additionally, in an effort to provide a concise description of these embodiments, not all features of an actual embodiment may be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous embodiment-specific decisions will be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one embodiment to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0060] The articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements in the preceding descriptions. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. For example, any element described in relation to an embodiment herein may be combinable with any element of any other embodiment described herein. Numbers, percentages, ratios, or other values stated herein are intended to include that value, and also other values that are “about” or “approximately” the stated value, as would be appreciated by one of ordinary skill in the art encompassed by embodiments of the present disclosure. A stated value should therefore be interpreted broadly enough to encompass values that are at least close enough to the stated value to perform a desired function or achieve a desired result. The stated values include at least the variation to be expected in a suitable manufacturing or production process, and may include values that are within 5%, within 1%, within 0.1%, or within 0.01% of a stated value.

[0061] A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the spirit and scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the spirit and scope of the present disclosure. Equivalent constructions, including functional “means-plus-function” clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words ‘means for’ appear together with an associated function. Each addition, deletion, and modification to the embodiments that falls within the meaning and scope of the claims is to be embraced by the claims. [0062] The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to an amount that is within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount. Further, it should be understood that any directions or reference frames in the preceding description are merely relative directions or movements. For example, any references to “up” and “down” or “above” or “below” are merely descriptive of the relative position or movement of the related elements. [0063] The present disclosure may be embodied in other specific forms without departing from its spirit or characteristics. The described embodiments are to be considered as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. Changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

What is claimed is:

1. A vascular access pad for a vascular simulation, comprising: a pad stand securable to a base, the pad stand including a vascular access port; a connector connectable to a patient-specific anatomical model and fluidly connected to the vascular access port; a sealing membrane configured to be punctured by a vascular access tool, the sealing membrane covering the vascular access port; and a sealing cap supported by the pad stand and securing the sealing membrane over the vascular access port.

2. The vascular access pad of claim 1, further comprising a pump port connectable to a blood mimicking fluid pump.

3. The vascular access pad of claim 2, the pump port being an inlet for a blood mimicking fluid.

4. The vascular access pad of claim 2 or 3, the pump port being an outlet for a blood mimicking fluid.

5. The vascular access pad of any of claims 1-4, wherein the sealing membrane is formed of a resilient self-healing material to simulate introduction of a catheter into a vein or artery of a patient.

6. The vascular access pad of any of claims 1-5, wherein the sealing membrane includes one or more alignment holes and the pad stand includes one or more alignment posts, the one or more alignment posts being inserted into the one or more alignment holes to align the sealing membrane over the vascular access port.

7. The vascular access pad of any of claims 1-6, wherein the connector includes a fluted tip.

8. The vascular access pad of any of claims 1-7, wherein the connector includes a cone.

9. The vascular access pad of any of claims 1-8, wherein the pad stand is based on a generic patient.

10. The vascular access pad of any of claims 1-9, wherein the connector has a smooth connection with the patient-specific anatomical model.

11. A vascular simulation system, comprising: a patient-specific anatomical model including a model connector; and a vascular access pad, the vascular access pad including: a pad connector configured to mate with the model connector; and a pad stand securable to a base and supporting the pad connector, the pad stand including a vascular access port in fluid communication with the pad connector, wherein the vascular access pad is based on a generic patient.

12. The vascular simulation system of claim 11, wherein the patient-specific anatomical model is 3D printed based on scans of a patient’s anatomy.

13. The vascular simulation system of claim 12, wherein a stiffness of the patient- specific anatomical model is based on a minimum thickness.

14. The vascular simulation system of any of claims 11-13, wherein the model connector and the pad connector include a fluted tip connection.

15. The vascular simulation system of any of claims 11-14, wherein the patient- specific anatomical model is coupled to an external pump.

16. A vascular simulation system, comprising: a patient-specific anatomical model including a model connector; a vascular access pad, the vascular access pad including: a pad connector configured to mate with the model connector; and a pad stand supporting the pad connector, the pad stand including a vascular access port in fluid communication with the pad connector, wherein the vascular access pad is based on a generic patient; and a pump in fluid communication with the patient-specific anatomical model, the pump being configured to pump a blood mimicking fluid through the patient-specific anatomical model.

17. The vascular simulation system of claim 16, wherein the pump is connected to an inlet at the vascular access pad.

18. The vascular simulation system of claim 16 or 17, wherein the pump is connected to an inlet at the patient-specific anatomical model.

19. The vascular simulation system of any of claims 16-18, wherein the patient- specific anatomical model includes a plurality of outlets.

20. The vascular simulation system of any of claims 16-19, further comprising a venturi system to regulate the blood mimicking fluid through the patient-specific anatomical model.