WO2018089413A1 - Méthodologie et appareil de simulation de dispositifs médicaux - Google Patents

Méthodologie et appareil de simulation de dispositifs médicaux Download PDF

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Publication number
WO2018089413A1
WO2018089413A1 PCT/US2017/060523 US2017060523W WO2018089413A1 WO 2018089413 A1 WO2018089413 A1 WO 2018089413A1 US 2017060523 W US2017060523 W US 2017060523W WO 2018089413 A1 WO2018089413 A1 WO 2018089413A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
sizer
specific physical
leaflets
internal cavity
Prior art date
Application number
PCT/US2017/060523
Other languages
English (en)
Inventor
James C. Weaver
Ahmed Hosny
Joshua D. DILLEY
Beth RIPLEY
Tatiana KELIL
Original Assignee
President And Fellows Of Harvard College
The General Hospital Corporation
The Brigham And Women's Hospital
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by President And Fellows Of Harvard College, The General Hospital Corporation, The Brigham And Women's Hospital filed Critical President And Fellows Of Harvard College
Publication of WO2018089413A1 publication Critical patent/WO2018089413A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length

Definitions

  • Aortic valve stenosis is the most common valvular heart disease in the developed world and in which stiff, fused, thickened, and inflexible valve leaflets lead to narrowing of the aortic valve and, as such, blood flow to the body is limited.
  • the increased pressures required to eject blood cause detrimental myocardial hypertrophy and increased oxygen consumption, leading to ischemia and cell death.
  • valve leaflets do not close completely. Regurgitation causes the blood that is ejected by the heart to immediately flow back onto the heart once the heart stops squeezing and relaxes. The volume overload of the left ventricle leads to eccentric hypertrophy and increased work of the left ventricle.
  • TAVR or TAVI procedures are safe alternatives to surgery in appropriately selected patients with aortic stenosis, the procedures suffer from known limitations. For example, there is no direct access to the patient's anatomy to provide precise prosthesis sizing, and the complex three-dimensional anatomy of the aortic root makes it difficult to predict how the prosthetic valve will adapt in the patient. Moreover, because the prosthetic valve is secured at the annular plane in a sutureless fashion, failure to achieve a circumferential seal can result in leaking of blood around the edges of the valve. Leakage results in paravalvular regurgitation or paravalvular leak, which is the most frequent complication after TAVR and which carries increased morbidity and mortality.
  • an expandable sizer is directed to accurately sizing stents or stent-like medical devices, including minimally invasive cardiac valves, on three-dimensional (3D) physical representations of anatomical body parts.
  • the sizer is utilized as a means of pre-surgically and physically simulating the deployment of such devices on patient-specific phantoms.
  • a system for simulating a medical procedure includes a controller configured to receive medical images of a patient body part and, based on the medical images, generate a three-dimensional digital model of at least a portion of the patient body part.
  • the system further includes a patient-specific physical phantom formed based on the three-dimensional digital model, the patient-specific physical phantom including an internal cavity.
  • the system also includes a sizer representative of a medical device being inserted within the internal cavity of the patient- specific physical phantom, the sizer being expandable between a plurality of sizes within the internal cavity.
  • a method for simulating a medical procedure includes receiving medical images of an aortic sinus, leaflets, and mineral (e.g., calcium) deposits of an aortic root, and, based on the medical images, generating, via a controller, a simulated three-dimensional digital model of the aortic root. Based on the three-dimensional digital model of the aortic root, the method further includes forming a patient-specific physical phantom having an internal cavity, and inserting a sizer within the internal cavity of the patient-specific physical phantom, the sizer being representative of a prosthetic valve.
  • mineral e.g., calcium
  • the method also includes expanding the sizer within the internal cavity between at least two different sizes of the sizer, and determining one or more pressure measurements in response to the expanding of the size.
  • the pressure measurements are indicative of pressure contact achieved at a plurality of locations between the sizer and the patient-specific physical phantom.
  • a prosthetic valve is formed based on the measurements.
  • FIG. 1 is a diagrammatic illustration of an overall workflow process and system of sizing simulation and leak prediction.
  • FIG. 2 is a screenshot showing a geometric model with a plurality of fiduciary points extracted from biomedical images.
  • FIG. 3 is a screenshot showing a geometric model representing controls of a first set of primary fiduciary points.
  • FIG. 4 is a screenshot showing a geometric model representing controls of a second set of primary fiduciary points.
  • FIG. 5 is a screenshot showing a geometric model representing adjustment of a third set of primary fiduciary points.
  • FIG. 6 is a screenshot showing a geometric model representing controls of free leaflet edges.
  • FIG. 7 is a screenshot showing a geometric model representing a set of secondary controls per leaflet.
  • FIG. 9A is a perspective view of a sizer.
  • FIG. 9B is a perspective view of the sizer of FIG. 9A in an expanded form and mounted to a stepper motor.
  • FIG. 9C is a perspective view of the sizer of FIG. 9A inserted into a patient phantom.
  • FIG. 10A is a perspective view of a sizer in a closed position, without a wrapped flexible sheet, according to another exemplary embodiment.
  • FIG. 10B is a perspective view of the sizer of FIG. 10A illustrated in an open position.
  • FIG. 12A is a perspective view illustrating a sizer in a closed position prior to insertion into a patient valve phantom.
  • FIG. 12B is a perspective view illustrating the sizer of FIG. 12A first inserted into a patient valve phantom, then set to a specific diameter.
  • FIG. 12C is a perspective view illustrating the sizer of FIG. 12B expanded to a different diameter for determining gaps between the sizer and the patient valve phantom.
  • FIG. 12D is a perspective view illustrating adjustment of sizer location of the sizer of FIG. 12C within the patient valve phantom.
  • FIG. 13 is a flowchart illustrating a sizing workflow process.
  • FIG. 14A is a diagrammatic illustrating a patient valve phantom cut open along an axial direction and flattened.
  • FIG. 14B is a diagrammatic illustrating pressure mapping of a contact zone between the sizer and the patient valve phantom of FIG. 14A.
  • FIG. 15 is a superior view of a leaky patient valve phantom for a patient V.
  • FIG. 17 is a superior view of the patient valve phantom of FIG. 15 with the sizer set at a diameter of 23 mm.
  • FIG. 18 is a superior view of the patient valve phantom of FIG. 15 with the sizer set at a diameter of 26 mm.
  • FIG. 19 is an inferior view of the patient valve phantom of FIG. 15 with the sizer set at a diameter of 26 mm.
  • FIG. 20A is an anterior/posterior view of the patient valve phantom of FIG. 15 with the sizer set at a diameter of 26 mm.
  • FIG. 20B is side view illustrating an ex-ray image of the sizer in the patient valve phantom of FIG. 15 with a leak on one side.
  • FIG. 20C is a contact zone mapping of patient V of FIGs. 15-20B.
  • FIG. 21 is a superior view of a non-leaky patient valve phantom for a patient J.
  • FIG. 22 is a superior view of the patient valve phantom of FIG. 21 with the sizer set at a diameter of 20 millimeters (mm).
  • FIG. 26B is a plot illustrating sizing and leak prediction data.
  • a system 100 includes a controller 103 that is configured to receive medical images of a patient body part and, based on the medical images, to generate a three-dimensional digital model of at least a portion of the patient body part.
  • the images are provided from a cardiac CT stack 101.
  • a reconstruction method allows the 3D modeling of leaflets based on fiduciary points of a leaflet parametric model 108 selected within the CT stack.
  • a sizer 1 12 is, then, inserted into an internal cavity 113 of the phantom 110 to simulate multiple prosthetic sizes while allowing for leak observation.
  • the sizer is representative of a medical device and is expandable between a plurality of sizes within the internal cavity 1 13 of the phantom 1 10.
  • the sizer 1 12 also maps out, via pressure mapping 114, the pressure exerted by the prosthetic sizes on the aortic sinus to identify areas of excessive contact or lack thereof, e.g., to identify leaks.
  • the XYZ coordinates of the fiduciary points P0-P6 are used as input into a parametric model in which curves are interpolated between the inputted fiduciary points to generate the leaflets.
  • Two sets of controls are used to adjust and/or align features of the parametric model.
  • a set of primary controls adjusts the fiduciary points and the free leaflet edges.
  • a set of secondary controls aligns the leaflets with the mineral deposits.
  • the primary controls are global and act on the model as illustrated in the exemplary Table 1 provided below. Table 1
  • geometric models represent respective ones of the six fiduciary point controls, while in FIG. 6 a geometric model represents the free leaflet edges controls.
  • the fiduciary points are moved in 3D space to ensure correct alignment with the aortic sinus anatomy. Adjusting the midpoint location of the free leaflet edge curve ensures it is correctly aligned with mineral deposits.
  • the goal of the primary controls (except freeEdge_midpoint) is to align parametrically generated leaflets with the aortic sinus.
  • the goal of the freeEdge_midpoint and the secondary points is to align parametrically generated leaflets with the mineral deposits.
  • a set of secondary controls per leaflet are used to align the leaflet with mineral deposits. Opacity of multiple elements is adjusted to allow unobstructed view during fiduciary point adjustment such that the resultant surface is midway through the mineral deposits.
  • the adjustment of secondary controls ensures that all deposits are well contained within the leaflet and are not "floating."
  • the leaflet geometry is constructed as a surface spanning the respective two free edges. Three curves between the free edges further define the leaflet geometry. The secondary controls, in turn, allow for adjusting these curves.
  • a sizer 130 is used for testing the patient phantom 110.
  • the size 130 is either manually adjustable for achieving the desired size or is motor-driven for accurate sizing.
  • the sizer 130 is in a contracted, or closed, form.
  • the sizer 130 is intended to be hand-driven to expand or contract the mechanism, which is achieved by holding a lower portion 132a of a stud 132 in one hand and using the other hand to rotate an upper portion 132b of the stud 132. Because the sizer is manually driven, scaled marks on the stud 132 provide visual cues to the diameter at which the sizer is set and, hence, allows for adjustment.
  • the sizer 130 is mounted onto a stepper motor 140 to allows for accurate rotation of the stud 132 and, hence, accurate expansion and contraction radii.
  • the motor-driven sizer 130 is controlled via a microprocessor that is connected to a graphical user interface (GUI) and by which a desired diameter is set.
  • GUI graphical user interface
  • FIG. 9C the sizer 130 is inserted into the patient phantom 110 for testing the fit.
  • a pressure-sensitive mat 160 is optionally placed on an outer surface of the flexible sheet 158 to record pressure exerted by the sizer 150 on the aortic sinus and crushed native leaflets.
  • the pressure-sensitive mat 160 is connected to a controller 162 to help generate a surface contact map between the replacement and diseased valves.
  • the surface contact map is generated based on output signals indicative of pressure sensed at various locations between the pressure-sensitive mat 160 and a patient phantom. Areas of low or no contact (i.e., low or no pressure) are more likely to develop into leaks.
  • Clockwise and anti-clockwise rotation of the central stud 152 causes the mechanism 154 and the flexible sheet 158 to radially increase and decrease, respectively.
  • the rotation allows for the simulation of a stent or stent-like devices at virtually any size.
  • Various other alternative embodiments include different geometries and/or materials, with a primary feature directed to increasing and decreasing the size of the sizer within a patient phantom.
  • the height of the sizer 180 is modeled after the mean of the height of the different valve sizes.
  • the sizer 180 is redesigned such that the height also changes as it is being opened and/or closed to increase simulation accuracy.
  • the position of the sizer 180 within the patient valve phantom 170 is adjusted axially slightly up or down to examine possibilities of better fit at the set diameter. Then, the sizing procedure illustrated and described in reference to FIGs. 12B-12D is repeated for each of the next available sizes.
  • a single sizer allows simulation of all four sizes in which a specific valve is purchased on the market.
  • the operator visually checks for gaps (which represent possible leaks) between the replacement valve and the aortic wall.
  • the operator also observes how the calcified leaflets react to the expanding replacement valve as it is deployed.
  • the operator moves the sizer up and down along the aortic sinus to explore better fitting locations that minimize possible leaks.
  • the operator refers to the digital pressure mat output to correlate with visual observation.
  • a decision-making flowchart illustrates a sizing workflow process.
  • the testing methodology is a trial-and-error approach in which no specific size is assumed as a testing starting point at step 200. Instead, the smallest available size is tested first. If the first size is loose, the next size is tested at step 202. If a first good fit is achieved at step 204, then leaks/no leaks are noted (visually and/or via a pressure sensor mat) and the next size is texted at step 206. If a second good fit is achieved at step 204, then leaks/no leaks are noted again and a potential excessive stretch of the valve is noted at step 208.
  • the sizer 212 is set at a 23 mm diameter, which also results in gaps around the sizer 212.
  • the sizer 212 is set at a 26 mm diameter, which also results in gaps 214 (i.e., leaks) around the sizer 212 at the 10 o'clock position.
  • FIG. 20B an x-ray image of the sizer 212 in the phantom 210 clearly shows a leak L on one side.
  • a contact zone mapping of patient V shows the original map on top, with a thresholded map on the bottom to show differences in pressures indicative of a leak position.
  • FIGs. 21-25C a sequence illustrates testing multiple sizes on a single patient valve phantom 220 for a patient without a leak.
  • the patient valve phantom 220 is without a sizer 222.
  • the sizer 222 is inserted within the patient valve phantom 220.
  • the sizer 222 is set at a 20 mm diameter, which results in gaps around the sizer 222.
  • the sizer 222 is set at a 23 mm diameter, which does not result in gaps around the sizer 222.
  • FIG. 25B an x-ray image of the sizer 222 in the phantom 220 clearly shows no leaks.
  • FIG. 25B an x-ray image of the sizer 222 in the phantom 220 clearly shows no leaks.
  • a contact zone mapping of patient J shows the original map on top, with a thresholded map on the bottom to show differences in pressures.
  • a grading system is directed to assessing the accuracy of leak prediction.
  • the flowchart of FIG. 26A is based on grades A-F and shows a 60% matched installed size and a 57% matched leak/no leak prediction at installed size.
  • the data of FIGs. 26B and 26C evidences predictions, if the installed size was guessed correctly or not, as well as the leak or absence thereof.

Abstract

L'invention concerne un système de simulation d'une procédure médicale qui comprend un dispositif de commande configuré pour recevoir des images médicales d'une partie du corps d'un patient et, sur la base des images médicales, pour générer un modèle numérique tridimensionnel d'au moins une partie de la partie de corps de patient Le système comprend en outre un fantôme physique spécifique au patient formé sur la base du modèle numérique tridimensionnel, le fantôme physique spécifique au patient comprenant une cavité interne. Le système comprend également un calibreur représentatif d'un dispositif médical inséré à l'intérieur de la cavité interne du fantôme physique spécifique au patient, le dispositif de dimensionnement étant extensible entre une pluralité de tailles à l'intérieur de la cavité interne. Sur la base de mesures du dispositif de dimensionnement, une carte de pression identifie des zones de contact excessif ou un manque de celles-ci pour présenter des fuites potentielles.
PCT/US2017/060523 2016-11-08 2017-11-08 Méthodologie et appareil de simulation de dispositifs médicaux WO2018089413A1 (fr)

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US201662419268P 2016-11-08 2016-11-08
US62/419,268 2016-11-08

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11234893B2 (en) 2019-02-27 2022-02-01 Steven A. Shubin, Sr. Method and system of creating a replica of an anatomical structure

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020168618A1 (en) * 2001-03-06 2002-11-14 Johns Hopkins University School Of Medicine Simulation system for image-guided medical procedures
US20080183274A1 (en) * 2005-01-10 2008-07-31 Duke Fiduciary, Llc Delivery devices for implanting devices at intersecting lumens
US20130132054A1 (en) * 2011-11-10 2013-05-23 Puneet Sharma Method and System for Multi-Scale Anatomical and Functional Modeling of Coronary Circulation
US20130211510A1 (en) * 2010-09-15 2013-08-15 The Government of the United of America, as Represented by the Secretary, Department of Health Methods and devices for transcatheter cerclage annuloplasty
US20150250934A1 (en) * 2014-03-07 2015-09-10 James K. Min Subject-Specific Artificial Organs and Methods for Making the Same
US20160228190A1 (en) * 2015-02-05 2016-08-11 Siemens Aktiengesellschaft Three-dementional quantitative heart hemodynamics in medical imaging

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020168618A1 (en) * 2001-03-06 2002-11-14 Johns Hopkins University School Of Medicine Simulation system for image-guided medical procedures
US20080183274A1 (en) * 2005-01-10 2008-07-31 Duke Fiduciary, Llc Delivery devices for implanting devices at intersecting lumens
US20130211510A1 (en) * 2010-09-15 2013-08-15 The Government of the United of America, as Represented by the Secretary, Department of Health Methods and devices for transcatheter cerclage annuloplasty
US20130132054A1 (en) * 2011-11-10 2013-05-23 Puneet Sharma Method and System for Multi-Scale Anatomical and Functional Modeling of Coronary Circulation
US20150250934A1 (en) * 2014-03-07 2015-09-10 James K. Min Subject-Specific Artificial Organs and Methods for Making the Same
US20160228190A1 (en) * 2015-02-05 2016-08-11 Siemens Aktiengesellschaft Three-dementional quantitative heart hemodynamics in medical imaging

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11234893B2 (en) 2019-02-27 2022-02-01 Steven A. Shubin, Sr. Method and system of creating a replica of an anatomical structure

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