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Archive for the ‘4D Printing and Meta Materials’ Category

CentraCare First in World to Use 4D Hologram Technology to Successfully Complete Structural Heart Procedure

Posted in 4D Printing and Meta Materials, Atrial Fibrilation (a-Fib), Cardiac Pacing and Arrhythmias, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders on July 20, 2021| Leave a Comment »

CentraCare First in World to Use 4D Hologram Technology to Successfully Complete Structural Heart Procedure

Reporter: Aviva Lev-Ari, PhD, RN

Published Jun 23, 2021 in Heart & Vascular, Media ReleasesAuthor: CentraCare

EchoPixel’s Pre-Planning and Intra-Operative Technologies

EchoPixel’s pre-planning and intra-operative technologies reduced complex heart procedure time while improving quality of outcomes

CentraCare, one of the largest health systems in Minnesota, has successfully completed the first structural heart procedure in the world using 4D hologram technology, which was developed by EchoPixel. Jacob Dutcher, MD, an interventional cardiologist and director of the structural heart program at CentraCare Heart & Vascular Center, conducted the WATCHMAN implant, which is a one-time, minimally invasive procedure for people with atrial fibrillation who need an alternative to blood thinners to protect them from a stroke. Approximately six million people in the U.S. suffer from atrial fibrillation and many of them are intolerant to blood thinners.

This new approach to the WATCHMAN procedure combines both EchoPixel’s pre-planning True3D software with its intra-operative Holographic Therapy Guidance (HTG) software platform. By leveraging mixed reality capabilities, EchoPixel brings precision to structural heart procedures by utilizing HTG, a transformative 4D technology that enables the entire heart team to interact with a patient’s specific organs and tissues as if they were actual, physical objects. These technologies reduce procedure time, improve accuracy of the procedure, reduce risk of complication and hasten recovery.

CentraCare Heart & Vascular Center is the first in the world to use EchoPixel’s technology both before and during a structural heart procedure. “EchoPixel pre-planning True3D software helped us reduce our procedure times by more than 27% and increase optimal procedure outcome by 20%. EchoPixel-HTG is taking us to the next level,” says Dr. Dutcher. “As one of the world’s largest WATCHMAN implanting sites, we are always looking for new ways to advance and improve patient care, and are proud to be the first center in the world to offer this novel imaging technology.”

“Dr. Dutcher has been very influential in the development and evolution of our HTG technology,” says Sergio Aguirre, CEO of EchoPixel. “Having him on board has helped us hone our device and approach as we draw on his vast experience with this procedure. We are looking forward to continuing to work with him and CentraCare to adapt our software to other structural heart procedures, providing an even greater benefit to patients.”

About CentraCare Heart & Vascular Center

CentraCare Heart & Vascular Center is one of the largest cardiovascular programs in Minnesota, offering the latest advancements in care, technology and treatment. In 2020 U.S. News & World Report rated the program as #41 in the nation for cardiology and heart surgery. It is part of CentraCare, a Minnesota health system that includes eight hospitals in St. Cloud, Long Prairie, Melrose, Monticello, Paynesville, Redwood Falls, Sauk Centre and Willmar. The health system also owns more than 30 clinics along with 18 senior housing facilities and long-term care facilities throughout the region. Learn more about CentraCare Heart & Vascular Center

About EchoPixel

Headquartered in Silicon Valley, EchoPixel is a venture capital-backed startup and a pioneer in creating the operating room of the future. The company’s technologies include the first pre-operative True3D planning platform and intra-operative Holographic Therapy Guidance (HTC) software, which allow physicians to interact with patient-specific organs and tissues as if they were actual, physical objects. EchoPixel’s True3D software platform has already become the standard of care at world-leading congenital heart defect and structural heart centers. Learn more at echopixeltech.com.

Media Contacts:

Birgit Johnston, EchoPixel
birgitjohnston@me.com

SOURCE

https://www.centracare.com/blog/2021/june/centracare-first-in-world-to-use-4d-hologram-tec/

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Medical MEMS, BioMEMS and Sensor Applications

Posted in 3D Plotting Scaffolds, 3D Printing for Medical Application, 4D Printing and Meta Materials, Artificial Vascular Structures, Bio-MEMS, Biopolymer Blend Open Porous, BioPrinting in Regenerative Medicine, Cardiovascular and Vascular Systems, Cardiovascular Tissue, Drug Development using MultiOrgan Chip, MEMS, MicroEngineering Cell-Tissue & Systems, Organ-on-a-Chip, Programmable Sensors (Carbon Nano Tubes) on March 10, 2016| Leave a Comment »

Medical MEMS, BioMEMS and Sensor Applications

Curator and Reporter: Aviva Lev-Ari, PhD, RN

 

Contents for Chapter 11

Medical MEMS, BioMEMS and Sensors Applications

Curators: Justin D. Pearlman, MD, PhD, FACC, LPBI Group, Danut Dragoi, PhD, LPBI Group and William H. Zurn, Alpha IP

FOR

Series E: Patient-centered Medicine

Volume 4:  Medical 3D BioPrinting – The Revolution in Medicine

Editors: Larry H Bernstein, MD FCAP and Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/biomed-e-books/series-e-titles-in-the-strategic-plan-for-2014-1015/volume-four-medical-3d-bioprinting-the-revolution-in-medicine/

Work-in-Progress

ContactLens

Image Source

http://www.memsjournal.com/2010/05/medical-applications-herald-third-wave-of-mems.html

Image is courtesy of Google Images

 

WirelessPressure

Image Source

Stanford Engineering Team Invents Pressure Sensor That Uses Radio Waves | CytoFluidix

Image is courtesy of Google Images

 

Introduction by Dr. Pearlman

 

Chapter 1: Blood Glucose Sensors

1.1       MINIATURIZED GLUCOSE SENSOR – Google

  • Tiny wireless chip and miniaturized glucose sensor
  • Embedded between two layers of soft contact lens material
  • Accurate glucose monitoring for diabetics
  • Using bodily fluids, i.e. tears
  • Prototypes can generate one reading per second
  • Experimenting with LEDs
  • Early warning for the wearer

 

Chapter 2: Blood Chemistry Tests – up to 100 Samples

2.1       NON-INVASIVE BLOOD MONITOR- UCSD

  • Digital tattoo monitors blood below the skin
  • Tattoos are needle-less
    • Sensor-laden transdermal patch
  • Painless for the user Tiny sensors “ink”
  • Can read blood levels of:
    • Sodium, glucose, kidney function
  • Prototypes contain probes
  • Wireless, battery-powered chip
  • Continually test up to a hundred different samples

 

2.3       CELLPHONE-BASED RAPID-DIAGNOSTIC-TEST (RDT) READER – UCLA

  • Lateral flow immuno-chromatographic assays
  • Sense the presence of a target analyte in a sample
  • Device connects to the camera on a cell phone
  • Weighs only 65 grams

 

2.4       IMPLANTABLE BLOOD ANALYZER CHIP – EPFL

  • Implantable device for instantaneous blood analysis
  • Wireless data transmission to a doctor
  • Applications include monitoring general health
  • Tailor drug delivery to a patient’s unique needs
  • Includes five sensors and a radio transmitter
  • Powered via inductive coupling from a battery patch
  • Worn outside the body

 

Chapter 3: Motion Sensors for Head-Impact

3.1       HEAD-IMPACT MONITORING PATCH – STMicro & X2Biosystems

  • Wearable electronic contains MEMS motion sensors
  • Microcontroller, low-power radio transmitter, and power management circuitry
  • Cloud-based system combines athlete concussion history
  • Pre-season neurocognitive function, balance, and coordinate-performance data
  • Creates a baseline for comparison after a suspected injury event

 

Chapter 4: Drug Delivery & Drug Compliance Monitoring Systems

4.1       Smart Pill delivers Therapeutic Agent Load to target – ELECTRONIC PILL – Phillips

  • Electronic pill to treat gastrointestinal cancer
  • An ingestible pill is swallowed by the patient, finds its way to the tumor, dispenses the drugs and passes harmlessly from the body
  • Smart pill contains reservoir for drug supply, fluid pump for drug delivery, pH sensor (for navigation), thermometer, microprocessor, communication

 

4.2       Drug Compliance Monitoring Systems

4.2.1    INGESTIBLE BIOMEDICAL SENSOR – Proteus Digital Health

  • Biomedical sensor that monitors medication adherence
  • Embedded into a pill, the sensor is activated by stomach fluid
  • Transmits a signal through the body to a skin patch
  • Indicates whether a patient has ingested material

 

4.2.2    MICROPUMP DEVICES – Purdue University

  • Device based on skin contact actuation for drug delivery
  • Actuation mechanism only requires body heat
  • Induced actuation can result to a gradient of 100 Pa/oC
  • Sufficient to drive liquid drug through micro-needle arrays
  • Prototypes exhibit low fabrication costs, employment of biocompatible materials and battery-less operation Suitable for single- or multiple-use transdermal drug dispensers

 

4.2.3    IMPLANTABLE MEMS DRUG DELIVERY SYSTEM – MIT

  • Device can deliver a vasoconstrictor agent
  • On demand to injured soldiers to prevent hemorrhagic shock
  • Other applications include medical implants
  • For cancer detection and monitoring
  • Implant can provide physicians and patients
  • Real-time information on the efficacy of treatment

 

Chapter 5: Remove Monitoring of Food-related Diseases

5.1       LASER-DRIVEN, HANDHELD SPECTROMETER

  • For analyzing food scanned
  • Information to a cloud-based application
  • Examines the results Data is accumulated from many users
  • Used to develop warning algorithms
  • For Allergies, Bacteria

 

Chapter 6: Skin Protection and Photo-Sensitivity Management

6.1       WEARABLE-UVEXPOSURESENSOR – Gizmag

  • Wristband for monitoring UV exposure
  • Allows user to maximize vitamin D production
  • Reducing the risk of sun
  • Over-exposure and skin cancer
  • LED indicators light up as UV exposure accumulates
  • Flashes once the safe UV limit has been reached

 

6.2       WEARABLE SKIN SENSOR KTH – Chemistry 2011

  • Bio-patch for measuring and collecting vital information through the skin
  • Inexpensive, versatile and comfortable to wear
  • User Data being gathered depends on where it is placed on the body

 

Chapter 7: Ophthalmic Applications

7.1       INTRAOCULAR PRESSURE SENSOR – Sensimed & ST Microelectronics

  • Smart contact lens called Triggerfish
  • Contact lens can measure, monitor, and control
  • Intra-ocular pressure levels for patients
  • Catch early cases of glaucoma
  • MEMS strain gage pressure sensor
  • Mounted on a flexible substrate MEMS

 

7.2       MICRO-MIRRORS ENABLING HANDHELD OPHTHALMIC – OCT News

  • Swept source OCT model for retinal 3D imaging
  • Replaces bulky galvanometer scanners in a handheld OCT probe for primary care physicians
  • Ultrahigh-speed two-axis optical beam steering gimbal-less MEMS mirrors
  • MEMS Actuator with a 2.4 mm bonded mirror and an angular reach of +6°
  • Low power consumption of <100mW including the MEMS actuator driver Retinal 3D Imaging

 

Chapter 8: Hearing Assist Technologies

8.1       MEMS TECHNOLOGY FOR HEARING RESTORATION – University of Utah

  • Eliminates electronics outside the ear
  • Associated with reliability issues and social stigma
  • Accelerometer-based microphone
  • Successfully tested in cadaver ear canals
  • Prototype measures 2.5 x 6.2mm, weighs 25mg

 

Chapter 9: Lab-on-a-Chip

9.1       ORGAN-ON-A-CHIP – Johns Hopkins University

  • Silicon substrate for living human cells
  • Controlled environment
  • Emulate how cells function inside a living human body
  • Replace controversial and costly animal testing
  • Lab-on-a-chip: a cost effective end to animal testing

 

Chapter 10: Intra-Cranial Studies: Pressure Measurement, Monitoring and Adaptation

10.1:   CEREBRAL PRESSURE SENSOR – Fraunhofer Institute

  • Sensor to monitor cerebral pressure that can lead to dementia
  • Pressure changes in the brain can be measured and transmitted
  • Reading device outside the patient’s body
  • Operating at very low power, the sensor module
  • Powered wirelessly by the reading device

 

10.2    WIRELESS, IMPLANTABLE BRAIN SENSOR – National Institute of Biomedical Imaging and Bioengineering

  • Fully implantable within the brain
  • Allow natural studies of brain activity
  • Cord-free control of advanced prosthetics

Wireless charging Prototypes transmitted brain activity data

 

Chapter 11: Cardiac and Cardiovascular Monitoring System

11.1    IMPLANTABLE MICRO DEVICE FOR MONITORING AND TREATING ANEURISMS – Electronic Design

  • RF-addressed wireless pressure sensor are powered by inductive coupling
  • Do not need batteries MEMS pressure sensor
  • Wireless antenna are inserted near the heart
  • With a catheter, Blood-pressure readings
  • Are sent to a wireless scanner for monitoring Pressure changes
  • Deflect the transducer’s diaphragm
  • Change the LC circuit’s resonant

 

11.2    CUSTOM- FITTED, IMPLANTABLE DEVICE FOR TREATMENT AND PREDICTION OF CARDIAC DISORDERS – Washington University

  • Working prototypes were developed on inexpensive 3D printers
  • The 3D elastic membrane is made of a soft, flexible, silicon material
  • Precisely shaped to match the outer layer of the heart

 

Chapter 12: microfluidic chips

12.1    MICROFLUIDIC MEMS FOR DIABETES TREATMENT – Micronews

  • Watertight pump mounted on a disposable skin patch
  • Provides continuous insulin infusion
  • Controlled by a dedicated smart phone device
  • Incorporating a BGM (blood- glucose meter)

 

12.2    ACOUSTIC RECEIVER ANTENNA/SENSOR PDMS MEMBRANE – Purdue

POLY-DI-METHYL-SILOXANE (PDMS)

Polydimethylsiloxane called PDMS or dimethicone is a polymer widely used for the fabrication and prototyping of microfluidic chips.

It is a mineral-organic polymer (a structure containing carbon and silicon) of the siloxane family (word derived from silicon, oxygen and alkane). Apart from microfluidics, it is used as a food additive (E900), in shampoos, and as an anti-foaming agent in beverages or in lubricating oils.

For the fabrication of microfluidic devices, PDMS (liquid) mixed with a cross-linking agent is poured into a microstructured mold and heated to obtain a elastomeric replica of the mold (PDMS cross-linked).

 

Why Use PDMS for Microfluidic Device Fabrication?

 

PDMS was chosen to fabricate microfluidic chips primarily for those reasons:

Human alveolar epithelial and pulmonary microvascular endothelial cells cultured in a PDMS chip to mimick lung functions

  • It is transparent at optical frequencies (240 nM – 1100 nM), which facilitates the observation of contents in micro-channels visually or through a microscope.
  • It has a low autofluorescence [2]
  • It is considered as bio-compatible (with some restrictions).

The PDMS bonds tightly to glass or another PDMS layer with asimple plasma treatment. This allows the production of multilayers PDMS devices and enables to take advantage of technological possibilities offered by glass substrates, such as the use of metal deposition, oxide deposition or surface functionalisation.

PDMS, during cross-linking, can be coated with a controlled thickness on a substrate using a simple spincoat. This allows the fabrication of multilayer devices and the integration of micro valves.

It is deformable, which allows the integration of microfluidic valves using the deformation of PDMS micro-channels, the easy connection of leak-proof fluidic connections and its use to detect very low forces like biomechanics interactions from cells.

SOURCE

http://www.elveflow.com/microfluidic-tutorials/microfluidic-reviews-and-tutorials/the-poly-di-methyl-siloxane-pdms-and-microfluidics/

 

  • Ferrite RF radiation Acoustic wave Rectifier
  • Buried in PDMS Implantable miniature pressure sensor
  • Powered by an acoustically actuated cantilever
  • No battery required
  • Acoustic waves in the 200-500 hertz range
  • Cause cantilever to vibrate
  • Scavenging energy to power pressure sensor

 

Chapter 13: Peropheral Neuropathy Management

13.1    WIRELESS SHOE INSERT – Mobile Health News

  • WIRELESS SHOE INSERT – Mobile Health News
  • Help diabetics manage peripheral nerve damage
  • Insole collects data of where wearers
  • Putting pressure on their feet
  • Transmits wirelessly to a wristwatch-type display
  • Prevent amputations that often stem from diabetic foot ulcers

 

Chapter 14: Endoscopic Diagnostics Tools

14.1    ENDOSCOPE USING MEMS SCANNING MIRROR

  • For gastrointestinal and urological imaging
  • Alternative to biopsies in cancer detection
  • A laser beam pointed at the mirror is precisely deflected
  • Steered by the scanning mirror to reach a target

 

Chapter 15: MEMS guided Surgical Tools

15.1    MICROMACHINED SURGICAL TOOLS; SILICON MEMS TWEEZERS – ElectrolQ Used for minimally invasive surgical (MIS)

  • Procedures where diagnosis, monitoring, or treatment of diseases are performed
  • Performing with very small incisions MEMS
  • Based microsurgical tools is a key enabling technology for angioplasty, catheterization, endoscopy, laparoscopy, and neurosurgery

 

Summary by Dr. Pearlman

  • Multiple projects by Academia & Industry
  • Multiple MEMS devices for measuring body activities.
  • Many patch type devices attached to the skin
  • Devices attached to the eye
  • Smaller is better, lower footprint, lower power

 

 

 

 

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Third Annual BioPrinting and 3D Printing in the Life Sciences, 21-22 July 2016 at Academia, Singapore General Hospital Campus

Posted in 3D Printing for Medical Application, 4D Printing and Meta Materials, Artificial Vascular Structures, BioPrinting in Regenerative Medicine on January 18, 2016| Leave a Comment »

Third Annual BioPrinting and 3D Printing in the Life Sciences, 21-22 July 2016 at Academia, Singapore General Hospital Campus

Reporter: Aviva Lev-Ari, PhD, RN

 

Overview

Select Biosciences South East Asia are pleased to present Bioprinting and 3D Printing in the Life Sciences, taking place on the 21-22 July 2016 at Academia, the state-of-the-art conference facilities housed within the Singapore General Hospital Campus.

Building on the success of the 2013 and 2014 meetings The International Bioprinting Congress, we have decided to increase the scope of the event for 2016 to include the latest advances within 3D Printing for the Life Science arena.

We are honoured to again be working in partnership with our Conference Chairman, Professor Chua Chee Kai, Executive Director, Singapore Centre for 3D Printing (SC3DP), School of Mechanical and Aerospace Engineering, Nanyang Technological University, Singapore.

We welcome Professor Martin Birchall, from University College London and Assistant Professor Wai Yee Yeong, from Nanyang Technological University as our Keynote Speakers for 2016.

The meeting will include scientific presentations from the leading international experts covering the latest advances developments and techniques within these allied fields, two highly topical panel discussions which will also highlight the views of the international regulatory authorities plus a tour of the facilities at the Centre for 3D Printing, hosted by Professor Chua.

We will provide you with a balanced overview of the industry from the varied perspectives of the leading researchers, solution providers and legislative authorities.

Attending this meeting will give you an excellent opportunity for networking and help you to build long term collaborations within this rapidly developing field.

We hope you can join us.

 

AGENDA

https://selectbiosciences.com/conferences/index.aspx?conf=BIO3D

@SelectBioSEA

#BIO3D2016

@NTUsg

@SelectBio

#bioprinting

#3dprinting

Join the Third Annual Bioprinting and 3D Printing in the Life Sciences, taking place on the 21-22 July 2016 at Academia, Singapore General Hospital Campus.

Working in partnership with our Conference Chairman, Professor Chua Chee Kai, Executive Director, Singapore Centre for 3D Printing (SC3DP), Nanyang Technological University, Singapore.

We welcome Professor Martin Birchall, from University College London, Assistant Professor Wai Yee Yeong, Programme Director, SC3DP, Nanyang Technological University and Associate Professor Roger Narayan, University of North Carolina at Chapel Hill, as our Keynote Speakers for 2016.

The meeting will include scientific presentations from the following international experts who have already confirmed their participation.

Paulo Jorge Bártolo,

Chair of Advanced Manufacturing Processes & Director of the Manchester Biomanufacturing Centre, University of Manchester

Goh Bee Tin,

Senior Consultant, Department of Oral and Maxillofacial Surgery (OMS), Research Director and Deputy Director, Research and Education , National Dental Centre Singapore

Jerry Fuh,

Professor, National University of Singapore

Michael Golway,

President & CEO, Advanced Solutions, Inc.

Nazia Mehrban,

Post-Doctoral Researcher, University College London

L.P. Tan,

Associate Professor, School of Materials Science and Engineering, Nanyang Technological University

William G Whitford,

Senior Manager, GE Healthcare

Shoufeng Yang,

Associate Professor, University of Southampton

We are still accepting abstract submissions, if you would like to be considered for an oral presentation at this meeting, Submit an abstract for review now!

Oral Presentation Submission Deadline: 31 March 2016

We will address the following subject areas;

•

3D-Printing Applications in the Life Sciences

•

4D Bioprinting

•

Additive Manufacturing Technologies and Substrates

•

Bio-Ink and Bioprintable Hydrogels

•

Biofabrication and 3D-Bioprinting Technologies and Tools

•

Blueprints (Digital Models of Organs in STL Files)

•

Emerging Trends in Bioprinting

•

Intellectual Property and Patent Landscape in the Bioprinting Field

•

Laser Printing

•

Medical and Non-Medical Applications of Bioprinted Products

•

New Bioprinters

•

Organ Printing

•

Scaffolds and Biomaterials for Tissue Engineering

•

Technology Platforms for 3D-Printing

•

The application of Additive Manufacturing and Medical Devices

We hope you can join us for this exciting event, for further details please do not hesitate to contact me.

Best Regards

Linda

Linda Eriksson

Conference Manager

Select Biosciences South East Asia Pte. Ltd.

16 Raffles Quay, #33-03 Hong Leong Building,

Singapore 048581

l.eriksson@selectbio.com

www.SelectBio.com

  • SOURCE
  • From: “Select Biosciences South East Asia Pte. Ltd” <conference@noreply.selectbio.com>
  • Reply-To: “Select Biosciences South East Asia Pte. Ltd” <conference@noreply.selectbio.com>
  • Date: Monday, January 18, 2016 at 5:29 PM
  • To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
  • Subject: 3rd Annual Bioprinting and 3D Printing in the Life Sciences, 21-22 July, Singapore

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Lab Grown Brains and more from Twittersphere on 3D Bio-Printing News

Posted in 3D Plotting Scaffolds, 3D Printing for Medical Application, 4D Printing and Meta Materials, BioPrinting in Regenerative Medicine, tagged 3-D bioprinting, 3D printing, artificial artery, brain, conservation, ethical issues, health, medicine, Social media, Twitter on November 16, 2015| Leave a Comment »

Lab Grown Brains and more from Twittersphere on 3D Bio-Printing News

Curator: Stephen J. Williams, Ph.D

How Tiny Lab-Grown Human Brains Are Giving Big Insights Into Autism and more from the Twittershpere

 

https://twitter.com/singularityhub/status/664508353771610112

(more…)

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New FDA Draft Guidance On Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products – Implications for 3D BioPrinting of Regenerative Tissue

Posted in 3D Plotting Scaffolds, 3D Printing for Medical Application, 4D Printing and Meta Materials, BioInks, Biopolymer Blend Open Porous, BioPrinting in Regenerative Medicine, Dental Applications, FDA, FDA Regulatory Affairs, MicroEngineering Cell-Tissue & Systems, Tissue Engineering, tagged 3D bioprinting, autologous transplant, FDA, Food and Drug Administration, human tissue, regenerative medicine, regulation, Stem Cell Biology and Regenerative Medicine on November 8, 2015| Leave a Comment »

New FDA Draft Guidance On Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products – Implications for 3D BioPrinting of Regenerative Tissue

Reporter: Stephen J. Williams, Ph.D.

The FDA recently came out with a Draft Guidance on use of human cells, tissues and cellular and tissue-based products (HCT/P) {defined in 21 CFR 1271.3(d)} and their use in medical procedures. Although the draft guidance was to expand on previous guidelines to prevent the introduction, transmission, and spread of communicable diseases, this updated draft may have implications for use of such tissue in the emerging medical 3D printing field.

A full copy of the PDF can be found here for reference but the following is a summary of points of the guidance.FO508ver – 2015-373 HomologousUseGuidanceFinal102715

In 21 CFR 1271.10, the regulations identify the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria (21 CFR 1271.10(a)):

  • The HCT/P is minimally manipulated;
  • The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
  • The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
  • Either:
  1. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
  2. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
  3. Is for autologous use;
  4. Is for allogeneic use in a first-degree or second-degree blood relative; or
  5. Is for reproductive use.

If an HCT/P does not meet all of the criteria in 21 CFR 1271.10(a), and the establishment that manufactures the HCT/P does not qualify for any of the exceptions in 21 CFR 1271.15, the HCT/P will be regulated as a drug, device, and/or biological product under the Federal Food, Drug and Cosmetic Act (FD&C Act), and/or section 351 of the PHS Act, and applicable regulations, including 21 CFR Part 1271, and pre-market review will be required.

1 Examples of HCT/Ps include, but are not limited to, bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue. The following articles are not considered HCT/Ps: (1) Vascularized human organs for transplantation; (2) Whole blood or blood components or blood derivative products subject to listing under 21 CFR Parts 607 and 207, respectively; (3) Secreted or extracted human products, such as milk, collagen, and cell factors, except that semen is considered an HCT/P; (4) Minimally manipulated bone marrow for homologous use and not combined with another article (except for water, crystalloids, or a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the bone marrow); (5) Ancillary products used in the manufacture of HCT/P; (6) Cells, tissues, and organs derived from animals other than humans; (7) In vitro diagnostic products as defined in 21 CFR 809.3(a); and (8) Blood vessels recovered with an organ, as defined in 42 CFR 121.2 that are intended for use in organ transplantation and labeled “For use in organ transplantation only.” (21 CFR 1271.3(d))

Contains Nonbinding Recommendations
Draft – Not for Implementation

Section 1271.10(a)(2) (21 CFR 1271.10(a)(2)) provides that one of the criteria for an HCT/P to be regulated solely under section 361 of the PHS Act is that the “HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” As defined in 21 CFR 1271.3(c), homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. This criterion reflects the Agency’s conclusion that there would be increased safety and effectiveness concerns for HCT/Ps that are intended for a non-homologous use, because there is less basis on which to predict the product’s behavior, whereas HCT/Ps for homologous use can reasonably be expected to function appropriately (assuming all of the other criteria are also met).2 In applying the homologous use criterion, FDA will determine what the intended use of the HCT/P is, as reflected by the the labeling, advertising, and other indications of a manufacturer’s objective intent, and will then apply the homologous use definition.

FDA has received many inquiries from manufacturers about whether their HCT/Ps meet the homologous use criterion in 21 CFR 1271.10(a)(2). Additionally, transplant and healthcare providers often need to know this information about the HCT/Ps that they are considering for use in their patients. This guidance provides examples of different types of HCT/Ps and how the regulation in 21 CFR 1271.10(a)(2) applies to them, and provides general principles that can be applied to HCT/Ps that may be developed in the future. In some of the examples, the HCT/Ps may fail to meet more than one of the four criteria in 21 CFR 1271.10(a).

III. QUESTIONS AND ANSWERS

  1. What is the definition of homologous use?

Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor (21 CFR 1271.3(c)), including when such cells or tissues are for autologous use. We generally consider an HCT/P to be for homologous use when it is used to repair, reconstruct, replace, or supplement:

  • Recipient cells or tissues that are identical (e.g., skin for skin) to the donor cells or tissues, and perform one or more of the same basic functions in the recipient as the cells or tissues performed in the donor; or,
  • Recipient cells that may not be identical to the donor’s cells, or recipient tissues that may not be identical to the donor’s tissues, but that perform one or more of the same basic functions in the recipient as the cells or tissues performed in the donor.3

2 Proposed Approach to Regulation of Cellular and Tissue-Based Products, FDA Docket. No. 97N-0068 (February. 28, 1997) page 19. http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ ucm062601.pdf.

3“Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products” 63 FR 26744 at 26749 (May 14, 1998).

Contains Nonbinding Recommendations
Draft – Not for Implementation

1-1. A heart valve is transplanted to replace a dysfunctional heart valve. This is homologous use because the donor heart valve performs the same basic function in the donor as in the recipient of ensuring unidirectional blood flow within the heart.

1-2. Pericardium is intended to be used as a wound covering for dura mater defects. This is homologous use because the pericardium is intended to repair or reconstruct the dura mater and serve as a covering in the recipient, which is one of the basic functions it performs in the donor.

Generally, if an HCT/P is intended for use as an unproven treatment for a myriad of

diseases or conditions, the HCT/P is likely not intended for homologous use only.4

  1. What does FDA mean by repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues?

Repair generally means the physical or mechanical restoration of tissues, including by covering or protecting. For example, FDA generally would consider skin removed from a donor and then transplanted to a recipient in order to cover a burn wound to be a homologous use. Reconstruction generally means surgical reassembling or re-forming. For example, reconstruction generally would include the reestablishment of the physical integrity of a damaged aorta.5 Replacement generally means substitution of a missing tissue or cell, for example, the replacement of a damaged or diseased cornea with a healthy cornea or the replacement of donor hematopoietic stem/progenitor cells in a recipient with a disorder affecting the hematopoietic system that is inherited, acquired, or the result of myeloablative treatment. Supplementation generally means to add to, or complete. For example, FDA generally would consider homologous uses to be the implantation of dermal matrix into the facial wrinkles to supplement a recipient’s tissues and the use of bone chips to supplement bony defects. Repair, reconstruction, replacement, and supplementation are not mutually exclusive functions and an HCT/P could perform more than one of these functions for a given intended use.

  1. What does FDA mean by “the same basic function or functions” in the definition of homologous use?

For the purpose of applying the regulatory framework, the same basic function or functions of HCT/Ps are considered to be those basic functions the HCT/P performs in the body of the donor, which, when transplanted, implanted, infused, or transferred, the HCT/P would be expected to perform in the recipient. It is not necessary for the HCT/P in the recipient to perform all of the basic functions it performed in the donor, in order to

4 “Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing” 66 FR 5447 at 5458 (January 19, 2001).

5 “Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement” 69 FR 68612 at 68643 (November 24, 2004) states, “HCT/Ps with claims for “reconstruction or repair” can be regulated solely under section 361 of the PHS Act, provided the HCT/P meets all the criteria in § 1271.10, including minimal manipulation and homologous use.”

Contains Nonbinding Recommendations
Draft – Not for Implementation

meet the definition of homologous use. However, to meet the definition of homologous use, any of the basic functions that the HCT/P is expected to perform in the recipient must be a basic function that the HCT/P performed in the donor.

A homologous use for a structural tissue would generally be to perform a structural function in the recipient, for example, to physically support or serve as a barrier or conduit, or connect, cover, or cushion.

A homologous use for a cellular or nonstructural tissue would generally be a metabolic or biochemical function in the recipient, such as, hematopoietic, immune, and endocrine functions.

3-1. The basic functions of hematopoietic stem/progenitor cells (HPCs) include to form and to replenish the hematopoietic system. Sources of HPCs include cord blood, peripheral blood, and bone marrow.6

  1. HPCs derived from peripheral blood are intended for transplantation into an individual with a disorder affecting the hematopoietic system that is inherited, acquired, or the result of myeloablative treatment. This is homologous use because the peripheral blood product performs the same basic function of reconstituting the hematopoietic system in the recipient.
  2. HPCs derived from bone marrow are infused into an artery with a balloon catheter for the purpose of limiting ventricular remodeling following acute myocardial infarction. This is not homologous use because limiting ventricular remodeling is not a basic function of bone marrow.
  3. A manufacturer provides HPCs derived from cord blood with a package insert stating that cord blood may be infused intravenously to differentiate into neuronal cells for treatment of cerebral palsy. This is not homologous use because there is insufficient evidence to support that such differentiation is a basic function of these cells in the donor.

3-2. The basic functions of the cornea include protecting the eye by forming its outermost layer and serving as the refracting medium of the eye. A corneal graft is transplanted to restore sight in a patient with corneal blindness. This is homologous use because a corneal graft performs the same basic functions in the donor as in the recipient.

3-3. The basic functions of a vein or artery include serving as a conduit for blood flow throughout the body. A cryopreserved vein or artery is used for arteriovenous access during hemodialysis. This is homologous use because the vein or artery is supplementing the vessel as a conduit for blood flow.

3-4. The basic functions of amniotic membrane include covering, protecting, serving as a selective barrier for the movement of nutrients between the external and in utero

6 Bone marrow meets the definition of an HCT/P only if is it more than minimally manipulated; intended by the manufacturer for a non-homologous use, or combined with certain drugs or devices.

Contains Nonbinding Recommendations
Draft – Not for Implementation

environment, and to retain fluid in utero. Amniotic membrane is used for bone tissue replacement to support bone regeneration following surgery to repair or replace bone defects. This is not a homologous use because bone regeneration is not a basic function of amniotic membrane.

3-5. The basic functions of pericardium include covering, protecting against infection, fixing the heart to the mediastinum, and providing lubrication to allow normal heart movement within chest. Autologous pericardium is used to replace a dysfunctional heart valve in the same patient. This is not homologous use because facilitating unidirectional blood flow is not a basic function of pericardium.

  1. Does my HCT/P have to be used in the same anatomic location to perform the same basic function or functions?

An HCT/P may perform the same basic function or functions even when it is not used in the same anatomic location where it existed in the donor.7 A transplanted HCT/P could replace missing tissue, or repair, reconstruct, or supplement tissue that is missing or damaged, either when placed in the same or different anatomic location, as long as it performs the same basic function(s) in the recipient as in the donor.

4-1. The basic functions of skin include covering, protecting the body from external force, and serving as a water-resistant barrier to pathogens or other damaging agents in the external environment. The dermis is the elastic connective tissue layer of the skin that provides a supportive layer of the integument and protects the body from mechanical stress.

  1. An acellular dermal product is used for supplemental support, protection, reinforcement, or covering for a tendon. This is homologous use because in both anatomic locations, the dermis provides support and protects the soft tissue structure from mechanical stress.
  2. An acellular dermal product is used for tendon replacement or repair. This is not homologous use because serving as a connection between muscle and bone is not a basic function of dermis.

4-2. The basic functions of amniotic membrane include serving as a selective barrier for the movement of nutrients between the external and in utero environment and to retain fluid in utero. An amniotic membrane product is used for wound healing of dermal ulcers and defects. This is not homologous use because wound healing of dermal lesions is not a basic function of amniotic membrane.

4-3. The basic functions of pancreatic islets include regulating glucose homeostasis within the body. Pancreatic islets are transplanted into the liver through the portal vein,

7 “Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing” 66 FR 5447 at 5458 (January 19, 2001).

6

Contains Nonbinding Recommendations
Draft – Not for Implementation

for preservation of endocrine function after pancreatectomy. This is homologous use because the regulation of glucose homeostasis is a basic function of pancreatic islets.

  1. What does FDA mean by “intended for homologous use” in 21 CFR 1271.10(a)(2)?

The regulatory criterion in 21 CFR 1271.10(a)(2) states that the HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.

Labeling includes the HCT/P label and any written, printed, or graphic materials that supplement, explain, or are textually related to the product, and which are disseminated by or on behalf of its manufacturer.8 Advertising includes information, other than labeling, that originates from the same source as the product and that is intended to supplement, explain, or be textually related to the product (e.g., print advertising, broadcast advertising, electronic advertising (including the Internet), statements of company representatives).9

An HCT/P is intended for homologous use when its labeling, advertising, or other indications of the manufacturer’s objective intent refer to only homologous uses for the HCT/P. When an HCT/P’s labeling, advertising, or other indications of the manufacturer’s objective intent refer to non-homologous uses, the HCT/P would not meet the homologous use criterion in 21 CFR 1271.10(a)(2).

  1. What does FDA mean by “manufacturer’s objective intent” in 21 CFR 1271.10(a)(2)?

A manufacturer’s objective intent is determined by the expressions of the manufacturer or its representatives, or may be shown by the circumstances surrounding the distribution of the article. A manufacturer’s objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by the manufacturer or its representatives. It may be shown by the circumstances that the HCT/P is, with the knowledge of the manufacturer or its representatives, offered for a purpose for which it is neither labeled nor advertised.

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Advances in 3D Printing of the human heart for surgical planning: MRI vs CT

Posted in 3D Printing for Medical Application, 4D Printing and Meta Materials, BioInks, tagged 3D printer, Arizona, Children's Heart Center, computer generated images, congenital heart surgery, Daniel Velez MD, heart defects, heart surgery, pediatric cardiology, Phoenix, Phoenix Children's Hospital, Stephen G Pophal MD, three dimensional imaging on November 4, 2015| Leave a Comment »

Advances in 3D Printing of the human heart for surgical planning: MRI vs CT

Curator and Author: Justin Pearlman MD PhD

3D printing converts a computer file to one or more 3D objects by deposition of material according to type and locations specified in the data file, as detailed here. The data file for the 3D printing can be based on images, e.g. of the beating heart, which can be obtained by Computed Tomography (CT), Magnetic Resonance Imaging (MRI), UltraSound/Echocardiography (US/Echo), or nuclear imaging. CT and MRI offer significantly better definition of boundary locations needed for 3D modeling than do the other imaging modalities. This article discusses the methods accompanying several real world applications of 3D printing used successfully to assist the plan for open heart surgery.

3D Printing File Formats:

  • 3MF
  • ACIS
  • AMF
  • DXF
  • CKD
  • DWF
  • DWFX
  • DWG
  • OpenDWG now DWGdirect
  • Pspice
  • STL
  • STEP
  • IGES

Steps for obtaining 3D printed hearts:

  1. Select a suitable patient (e.g., a child with unique congenital structural abnormalities who merits 3D assist planning for a customized surgical approach)
  2. Apply an imaging method that identifies the important tissue boundaries in sufficient detail and accuracy as a 3D data set, typically as a stack of 2D images (e.g., MRI or CT)
  3. Apply computer analysis tools to convert stacks of gray-scale image arrays to tissue boundaries and tissue character suitable for 3D model generation
    1. Edit and review boundary extraction, boundary connections in-plane and slice-to-slice and assign character (labels) to boundary surfaces and interiors
    2. Optionally generate one or more renderings (3D visuals: lighting, transparancies, reflections, cut-aways, rotations, fly-line camera trajectories and angles) for review of 3D structures on 2D screens
    3. Optionally enable simulated surgery and simulated outcomes (what would the face surface look like after surgical extension of the jaw, measurements, mechanics)
    4. Apply printer graphic conversion that re-slices the boundaries into coordinates and material selection according to the specification requirements of a 3D printer device
  4. Submit data to 3D printer, monitor for jamming, wait for the material to print and cool
  5. Pick up the printed 3D heart(s), inspect for artifacts from curling or other print aberrations, modify object or re-print as needed, deliver printed product(s) to end user (e.g., to surgeon for examination and surgical planning)

Surgical planning:

  1. Examine the 3D interactive computer graphics, derived video fly-throughs, printed 3D object(s)
  2. Consider deriving and optionally printing other derived 3D objects (e.g., representing different stages of surgery)
  3. Make measurements, delineate surgical plan

Currently, the best two competing methods to image the beating heart at sufficient detail are CT scan and MRI.

A  CT scan uses ionizing radiation, typically equivalent to more than 200 chest xrays, which can increase the lifetime risk of cancer by as much as 1/1000. The imaging can be completed in less than 10 minutes, an important issue when working with squirming children. The images offer fine resolution (smallest distances that can be distinguished) on the order of 1 millimeter in the cross sections with 1-5 mm section thickness, so the picture elements (Pixels) may be 1 mm x 1 mm x 1 mm covering the heart in 200 slices of 512 x 512 image elements. Each location is characterized by a Hounsfield number that represents the attenuation of x-rays due to the density of the predominant atomic nuclei in each location. Metal implants produce serious artifacts. The Hounsfield numbers group into four tissue types: air, water, bone, metal. Fortunately for planning repair of congenital abnormalities of heart structure, the boundaries of interest are often water density versus fat. An injected radiocontrast agent such as iohexol enhances contrast by generating a distinction from water density for arterial and venous blood conveying the higher density atomic nuclei versus blood vessel or heart walls which are predominantly water density. Iodine contrast may be used to provide a higher atomic Z number for x-ray attenuation, but it can cause a serious allergy and/or renal failure.

MRI uses non-ionizing radiation (magnetic wave energy that does not knock electrons out of orbit to cause damage to the tissues), so it does not pose a future risk of cancer. Also, MRI offers a variety of methods to make signal from flowing blood in arteries and veins each distinct from chamber walls without requiring injection of a contrast agent (though some applications of MRI do use contrast agents). MRI is distorted by metal implants, and by materials with strong differences in magnetic susceptibility, and has complex artifacts if motion occurs at an inopportune time. Both CT and MRI utilize ECG signals to synchronize and effectively “freeze” cardiac motion. A method by the author cancels the magnetic and flow artifacts to enable diagnostic ECG in MRI for safety of potentially deep sedation to further reduce motion artifacts. MRI has many ways to generate signal intensities that characterize tissue differences, so it is over 10 times better at distinguishing differences within soft tissues. MRI thus has advanges identifying boundaries of abnormal tissues such as right ventricular dysplasia, scar tissue (collagen), myxoma, etc. While there are many distinct ways to apply MRI to define the structure of an individual’s heart, commonly a form of fast spin echo, with parallel imaging, is utilized. It generates images representing a slice thickness typically of 2-5 mm each corresponding typically to 128 x 256 picture elements.  Thus the volume elements (voxels) tend to be as much as 16-fold larger than from CT, but the ability to distinguish soft tissue differences is an order of magnitude better by MRI. With faster MRI enabled by parallel imaging (multiple slice data obtained concurrently), and with stronger magnets to provide more signal vs noise, the voxels can be smaller and the number of slices covering the heart may be increased, e.g. from 20 to 200.

Even with smaller  datasets from MRI versus CT, it can take a technician many hours to trace the tissue boundaries of interest in order to convert the data from slices, rows and columns of grayscale numbers to computer datafiles representing the surface boundaries and assigned surface and interior character delineating a 3D model (some models also require characterization of articulations between parts, elasticity, and other properties). Thus one area of research development (which the author has worked on) has focused on various means to facilitate, automate and speed up that image processsing.

To understand the challenges, consider a doughnut emerged vertically in a tank of milk, imaged as a stack of horizontal slices (completed before the doughnut dissolves). The desired 3D model is a description of the surface of the doughnut. Slices near the top delineate an elliptical boundary, which changes to a figure-of-eight when you examine the first slice that borders on the dougnut hole. Deeper slices reveal the doughnut surface boundary as two circular shapes, until the you encounter the slice bordering on the lower limit of the doughnut hole, which reports another figure of eight. The remaining slices that define the doughnut boundary consist of diminishing sizes of of a single ellipsoid.

Now consider additional complexities such as a chocolate covered doughnut with filling and raisins. If the slice thicknesses are not sufficiently close, the contours of a series of raisins may get mistakenly connected into a branching tube, like a vascular tree. Conversely, if resolution is insufficient, an image of a vascular tree may get segmented into isolated components, and it may confound artery versus vein.

Thus, complex structures with aberrant connections require an astute experienced technologist to help achieve a correct labeling and delineation of structures, their boundaries and connections. The degree of anatomic correctness required depends on the decisions to be made.

Examples of research teams who create 3D printed heart models for surgical planning include:

  • Louisville Kentucky – Kosair Children’s Hospital
  • Boston MA – Children’s Hospital
  • Phoenix AZ – Children’s Hospital
  • Boston MA – Mass General Hospital
  • Miami FL – Nicklaus Children’s Hospital

3D Printing of Congenital Heart Disease at Kosair Children’s Hospital in Louisville Kentucky

Louisville Kentucky cardiothoracic surgeon Erle Austin has performed successful heart repair surgery on a 14 month old infant named Roland Lian Cung Bawi after planning the surgical approach on a 3D printed flexible double sized reproduction of the patient’s congenitally abnormal and unique anatomy.

Researchers at the University worked with radiologists at Kosair Children’s Hospital to create a means for converting data from a CT scan of Roland’s heart to data that could be used with a 3D printer.  The 3D printing team used a MakerBot Replicator 2X, to print the heart (in three pieces) at twice its normal size—they also used a flexible type of plastic known as “Ninja Flex” instead of ABS—it allowed the surgeon to bend the finished heart in ways that resembled a real human heart. Printing the heart took approximately 20 hours at a cost of roughly $600. Dr. Austin told local news reporters that the printed heart helped him plan the surgery in ways he’d never experienced before—it allowed for a single surgery (this past February 10) and greatly for reduced cutting and suturing in a signle surgical session, which ultimately led to a much , promoting a quicker recovery.

Young Roland had been born with four congenital heart defects—doctors had known since before he was born that his heart had problems. Fixing them all would prove to be a challenge. When it came time to plan the surgery, Austin consulted with other surgeons and found each of them had different ideas on the best way to fix the heart. The ideal approach would involve the least amount of cutting and suturing—but that can be hard to plan using only conventional scanning techniques. Looking for more precision, Austin turned to the engineering school at the University of Louisville—they’d been researching different kinds of 3D printing technology. Researchers at the University worked with radiologists at Kosair Children’s Hospital to create a means for converting data from a CT scan of Roland’s heart to data that could be used with a 3D printer. The two seemed a perfect match as CT scanning uses the same basic idea as 3D printing—it takes pictures of slices and puts them together on a computer screen to form a whole, and 3D printing is achieved by laying down one layer or “slice” of material at a time.

The 3D printing team used a MakerBot Replicator 2X, to print the heart (in three pieces) at twice its normal size—they also used a flexible type of plastic known as “Ninja Flex” instead of ABS—it allowed the surgeon to bend the finished heart in ways that resembled a real human heart. Printing the heart took approximately 20 hours at a cost of roughly $600.

Austin told local news reporters that the printed heart let him plan the surgery in ways he’d never experienced before—it allowed for a single surgery (this past February 10) and greatly reduced cutting and suturing, which ultimately led to a much quicker recovery for Roland, who by all accounts is now doing just fine.

video: http://bcove.me/zlxvd038

3D Printing of Congenital Heart Disease at the Children’s Heart Center at Phoenix Children’s Hospital in Phoenix Arizona

Doctors gather as much information as possible when preparing to correct heart defects in pediatric patients. They read images from CT scans on computers. They may even use software to study abnormalities in three dimensions, moving a picture of the heart around on a computer screen to analyze and plan a surgical strategy.

But what if they could take the process one step further? What if they could simply press “print” to create a perfect, color-coded, three-dimensional plastic model of a child’s heart before the surgical procedure even begins?

Tags:

At the Children’s Heart Center at Phoenix Children’s Hospital, Justin Ryan, a biomedical engineering graduate research associate at Arizona State University, is doing just that. Ryan, who has a background in animation studies, uses those same technical skills to change the two-dimensional images from CT scans to a three-dimensional object.

“It’s very similar to what you might see in a CGI (computer-generated images) in a movie, or in a video game character,” he says. After the image is created on his laptop, Ryan sends it to a three-dimensional printer that creates the model.

The printer, about the size of a pastry case at a coffee shop, contains a cinderblock-sized chunk of Super Glue combined with gypsum, a common material used in drywall construction. Ink jets slowly spray super-thin layers of color on the powdery block, forming the model according to the precise specifications of the data. Ryan equates it to building a house, from the bottom up, brick by brick.

The printing process itself takes about three hours. When it is finished, Ryan brushes the excess powdery material away to reveal the model. “From there, we do a bit of post-processing, but in another hour after that, we can hand it off to the doctor. They can view it, and make their decisions on surgery.”

Using a heart model to prepare for surgery is like finding your way with a GPS instead of a paper map, says Daniel Velez, M.D., a congenital heart surgeon at PCH. With the models, a surgeon can see, and touch, the actual size of the structure before surgery even begins. “To be able to tell the parents more precisely what I’m going to do, and what I’m going to encounter—even though I do tell them about variations and variabilities to the plan—I’m more at ease and more certain,” he says.

Each part of the heart, from chambers to vessels, is assigned a different color. Studies show that color coding helps medical teams better understand the tiny anatomical structures they will work with during surgery, says John Nigro, M.D., director of cardiothoracic surgery and co-director of the heart center. In babies, he adds, the heart is about the size of a walnut. As a child grows, it is about the size of their fist. “You can imagine the size of a child’s fist is pretty small,” says Nigro.

The technology is so new that it is almost too early to know what kind of impact it will have, says Stephen G. Pophal, M.D., division chief of pediatric cardiology at PCH. Pophal, who specializes in pediatric cardiac catheterization procedures, says it could change medicine.

Pophal teamed up with ASU engineering professor David Frakes to start the project at PCH. Frakes says is a “first of its kind” application for modeling congenital heart disease. “We hope that very soon any doctor who is doing an operation here is going to be carrying one of these models into the operating room—and being better prepared to perform because of it.”

Prophal hopes that using models will give doctors a head start in correcting defects. Knowing more in advance could also cut down on the number of images needed as procedures are performed, lowering radiation exposure. The tough job of visualizing a defect in three dimensions based on a two-dimensional image—sort of like imagining what a house will look like based on architectural plans—would be eliminated, says Pophal. “If I had the model in my hand, I would save half the time, and have half of the worries.”

Learning that a child has a heart defect can be overwhelming for parents, says pediatric nurse practitioner Courtney Howell, CPNP. “I think that is the hard part for some families to understand. They have this beautiful baby, and they expected all the things to go perfectly. Now they have this huge diagnosis.”

Howell says that the heart models help parents understand their child’s defect—it offers complex medical terminology in a context they can understand. And if everyone on the team understands the nature of the defect, patients are likely to do better, Pophal says. “The major impact is that we will be able to teach people more about their heart problems. This makes it very simple.”

SOURCE

http://www.raisingarizonakids.com/2013/02/modeling-the-heart/

3D Printing of Congenital Heart Disease at Mass General Hospital in Boston Massachusetts

http://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=111445

MGH saves money and time printing 3D hearts

By Eric Barnes, AuntMinnie.com staff writer

July 17, 2015 — Researchers at Massachusetts General Hospital (MGH) in Boston say that having a 3D rapid prototyping printer in the cardiac imaging department is a potential boon for procedure planning and patient education — and it doesn’t break the bank.

After installing the printer and learning how to edit the cardiac CT images, they found they can build accurate and useful models using rigid or flexible materials, said co-author Phillip Kim in a presentation at the Society for Imaging Informatics in Medicine (SIIM) meeting held in May at National Harbor, MD.

Phillip Kim

Phillip Kim of MGH.

“An in-house 3D rapid prototyping printer provides the user with accurate and affordable models with fast turnaround times,” Kim said in his presentation. “Other potential benefits include use as an educational tool for patients, medical students like me, and residents.”

The technology can be used to create digital-to-analog study models from CT images for a variety of applications, from surgical planning to regenerative medicine, he said.

The current study looked at reproducibility, turnaround time, and cost-effectiveness for an in-house 3D rapid prototyping printer.

Getting images printer-ready

At MGH, the process begins with the selection of DICOM images of interest. Once selected, the DICOM images are modified using image processing software from TeraRecon or OsiriX. The OsiriX software is used for simpler models, while the other software is used for more complicated ones, to crop, change Hounsfield Unit thresholds, or add or erode images, among other tasks. The programs are then used to export the images as stereolithography (STL) files, Kim said.

The STL files are processed with an application called Replicator G, which converts the image data to a language called gcode. From there, another open-source application, MakerWare (MakerBot), is used to convert the data to x3g format, which is recognized by the MakerBot printer.

The researchers acquired images of coarctation of the aorta with or without stenting, aortic dissection, anomalous origin of coronary arteries, and aortic aneurysms.

All scans were performed on a 128-detector-row dual-source CT scanner (Somatom, Siemens Healthcare). The group acquired 128 contiguous 0.6-mm slices with a gantry rotation time of 280 msec and 75-msec temporal resolution.

Aortic valve

Normal aortic valve. All heart model images courtesy of Phillip Kim.

Coarctation of aorta

Coarctation of aorta. Right image is poststenting.

Rigid or flexible plastic

Two different types of plastic, extruded as 0.1-mm thick filaments, can be used in the printer, depending on the desired application:

  • Acrylonitrile butadiene styrene (ABS) is extruded as a solid filament and is “very durable and beautiful,” Kim said.
  • For a more malleable planning tool, NinjaFlex (Fenner) has a flexible filament that creates soft, pliable models.

As for printers, several 3D rapid prototyping methods are available, including selective laser sintering, stereolithography, and finally fused deposition modeling, which was MGH’s method of choice.

“It requires little maintenance and is affordable and user-friendly,” Kim said.

anomalous coronary arteries

Anomalous coronary arteries, above and below.
anomalous coronary arteries

Outsourcing is costly

Kim and colleagues Dr. Harshna Vadvala and Dr. Brian Ghoshhajra did a time and cost analysis on 10 of the printed models, and there was good news on that front as well. The costs amounted to a few dollars per model — a small fraction of the cost of outsourcing.

For example, for one of the anomalous origin models, the printer took less than 12 hours at an approximate cost of $2 for supplies, excluding the cost of filament, which was free for the project.

“If you were to outsource it, it would have cost at least $400 and would have taken more than 24 hours to have it delivered to the office,” Kim said.

When they tried to compare outsourcing costs among three vendors for printing an entire heart, two were unable even to load the files because they were too large to process, he said.

“In the case where the file wasn’t too large, it would have cost us at least $500,” Kim said.

Having a rapid prototyping 3D printer in-house in a cardiac imaging department provides users with accurate and affordable models that can be created quickly, Kim concluded. Further study is needed to find all of the ways such models might benefit students, patients, and clinicians, he said.

Source: http://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=111445

3D Printing of Congenital Heart Disease at Children’s Hospital and MIT in Boston Massachusetts

http://fortune.com/2015/09/17/better-heart-models-save-lives/

http://scitechdaily.com/tag/harvard-university/

Danielle Pace at MIT , an MIT graduate student in electrical engineering and computer science and Medhi Mogan. a physicist at Boston Children’s Hospital teamed up to develop a means of constructing 3D image boudaries from cardiac MRI,

They segmented just 14 slices from cardiac MRI, letting an algorithm infer the rest. They report 90 percent agreement with expert segmentation of the entire collection of 200 cross sections.

To eliminate as much guesswork as possible in advance of surgery, researchers have been constructing accurate heart models using 3D printers and measurement data from scans. The problem: The process is slow. It can take up to 10 hours to finesse the internal boundaries that separate the heart chambers and vessels. Those intersections don’t necessarily show up clearly so doctors relied on a manual process to fill in the blanks, so to speak. And that takes time.

Now, researchers from MIT and Boston Children’s Hospital say they’ve come up with a better, faster way to build heart models, according to MIT Tech News. Part of their work relies on new processes that enhance the precision of the scans, which are basically a set of cross sections that together comprise a 3D image of the heart or other structure.

But even the scan data is not enough. Researchers often used generic heart representations to supply additional data needed to build the full model. The problem there is generic models aren’t much help in recreating what is likely a heart with anomalies all its own.

The proposed solution, as is often the case with complex data problems, still draws on human expertise, but in a much more curtailed way than before.

According to the report, project leader Polina Gollan, professor of engineering and computer science at MIT, said this limited human input greatly increases accuracy of the model.

The “strongest results came when they asked the expert to segment only a small patch—one-ninth of the total area—of each cross section,” she said.

With these advances, the team can create the algorithm needed and print the model in three or four hours, compared to the 10 needed before.

The team, which also includes Medhi Moghari, a physicist who came up with new processes to enhance the MRI scan precision; Andrew Powell, a cardiologist; and Danielle Pace, an MIT grad student in electrical engineering and computer science, will put their work to test in a study kicking off this fall using MRIs from 10 patients at Children’s Hospital. Pace will also present a related paper at a medical conference next month.

This is just the latest application of advanced 3D printing and materials to create medical devices including prosthetic devices.

3D printed heart.
Photograph by Bryce Vickmark

3D Printing of Congenital Heart Disease at Nicklaus Children’s Hospital in Miami Florida


3D printing mia gonzalez's heart model

3D Printing Aids Surgery to Repair 5-Year-Old Mia’s Heart

Tyler Koslow BY TYLER KOSLOW ON THU, OCTOBER 8, 2015 · 3D MODELING, 3D PRINTERS, 3D PRINTING, 3DP APPLICATIONS, MEDICAL & DENTAL, NEWS,RESEARCH

When she first stepped foot in Nicklaus Children’s Hospital, five-year-old Mia Gonzalez was suffering from an extremely rare heart malformation diagnosed as a double aortic arch, a condition in which the airflow is restricted by the vascular ring wrapping around the trachea or esophagus. Dr. Redmond Burke, the director of Pediatric Vascular Surgery and the Nicklaus Children’s Hospital in Miami, Florida, had an extremely challenging operation in his hands. This was a surgical procedure that needed intensive preparation, so Burke and his team decided to plan for the complex heart surgery on a 3D modeled replica of Gonzalez’s own heart, printed courtesy of Stratasys reseller AdvancedRP.

3dprinting_mia2

“By making a 3D model of her very complex aortic arch vessels, we were able to further visualize which part of her arch should be divided to achieve the best physiological result,”said Burke. “It’s very powerful when you show a family ‘this is your baby’s heart and this is how I’m going to repair it.”

3dprinting_objetAdvancedRP is a supplier of 3D printed anatomical models for surgical preparation, using a Stratasys Objet500 Connex3 Multi-Material 3D Printer. These 3D models not only replicate the physicality of  the patient in question, but with flexibility similar to human organs, flesh, and bone, due to the Objet500 Connex3’s ability to combine multiple textures and material types in a single print.

In order to replicate the patient’s organ accurately, MRI or CT scan data is translated into a 3D model, which is then prepped for 3D printing on the Objet500. This allows for extremely efficient surgical preparation; Burke and his team were able to practice the advanced surgery ahead of time, ensuring that no damage or pain be inflicted upon little Mia Gonzalez and her heart. Preparing on the 3D printed heart model helped to decrease operation time, too.

3dprinting_mia1

“Once patient scan data from MRI or CT imaging is fed into the Stratasys 3D Printer, doctors can create a model with all its intricacies, specific features and fine detail,” said Stratasys’ GM of Medical Solutions Scott Rader. “This significantly enhances surgical preparedness, reduces complications and decreases operating time.”

http://3dprintingindustry.com/2015/10/08/3d-printing-aids-surgery-to-repair-5-year-old-mias-heart/?utm_source=3D+Printing+Industry+Update&utm_medium=email&utm_campaign=4a3d0d5078-RSS_EMAIL_CAMPAIGN&utm_term=0_695d5c73dc-4a3d0d5078-64583721

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4D Printing as a Time Dependent 3D Printing

Posted in 4D Printing and Meta Materials on September 26, 2015| Leave a Comment »

4D Printing as a Time Dependent 3D Printing

Curator: Danut Dragoi, PhD
The 4D printing can be explained based on 3D printing, whose concept is shown in here.

It has an extra added dimension like time, or any implicit time variable included in any environmental physical parameter like

  • temperature,
  • pressure,
  • moisture or humidity,
  • external/internal electric field and or
  • magnetic field.

This is not a true 4D space in the sense X,Y,Z,t — it is a parameterized printing process in which each variable X(t), Y(t), Z(t)  is a function of time. Therefore,it is an object that has its shape defined by a surface with variables that depends of time. This reminds us about smart shape memory  materials. Today there are not only metallic smart materials but also shape-memory polymers that have similar behavior of smart metallic shape memory materials. It is interesting to add that many  polymeric smart materials have a response to a given stimuli like moisture, electric field, etc. To produce some 3D objects with a shape dependent of time we just need these special polymers. The reason for adding a new parameter as an extra dimension is in the need to reach complex topological object. Skylar Tibbits, who is a mathematician at MIT, proposed 4D printing in a TED talk. The 4D printing concept can be better understood from examples. The folding of a strand of eight segments can transform from a line to a cube shape. The researcher in Australia created a valve using 4D printing  The valve is sensitive to temperature, it closes when the water is hot and opens when it is cold. A graphical explanation of 4D printing is explained here. All these examples show a promising starting level of technology readiness. The authors published their 4D printing concepts and results on TED events. As the main characteristic of these events is the entertainment of the audience, the right assessment of the 4D technology is awaiting the words of the specialists through the scientific pair reviewed papers. One important question for 4D printed human organs is that of life time circle of the printed organ and possible rejection. Since the material of the 4D printed objects is a polymer or a combination of polymers, we expect a low time cicle due to low fatigue characteristic of these materials.The question arises as to what exactly 4D printing will add as extra to the already existing technology of 3D printing at hand? The answer is the whole new dimension i.e time we added. If we consider a smart combination of materials that produce periodic shape change, such as the case of the heart, than we have a possible solution for 4D printing of the heart. But again the fatigue issue has to be taken into consideration again. The scientists can also give an object the ability to alter its shape and to fold itself  through self assembling molecules when the effect of temperature and pressure is considered. Other impact factors should be considered when the environment is the interior of the human body where the influence of temperature, pressure or other variable factors such as vibrations, etc. can play an important role. As a conclusion of this posting we can state that the 4D printing is at its beginning, it is not a true 4 dimensional space as the title of this method suggests.The fourth dimension time in 4D tittle is lost in the polymeric material behavior when it is influenced by a stimuli such as moisture, temperature, pressure, etc. The property of molecules, large or small to self-assemble is associated with the shape change that is exploited in the 4D printing.

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Agenda for 4D Printing & Meta Materials Conference, 10/6/2015 at AMOLF in Amsterdam, The Netherlands

Posted in 4D Printing and Meta Materials on August 24, 2015| Leave a Comment »

Agenda for 4D Printing & Meta Materials Conference, 10/6/2015 at AMOLF in Amsterdam, The Netherlands

 

Reporter: Aviva Lev-Ari, PhD, RN

 

Venue

FOM Institute AMOLF is one of the research laboratories of the Foundation for Fundamental Research on Matter (FOM), part of the Netherlands Organization for Scientific Research (NWO).
AMOLF employs about 130 FTE research staff and 70 FTE support staff. AMOLF’s yearly budget is 14 million euro. The institute is located in Science Park Amsterdam.

Program

The seminar program for the first edition of the 4D Printing & Meta Materials Conference is being developed.

9:45 10:20 Registration and coffee
10:20 10:30 Opening and Welcome
10:30 11:00 Prof. Dr. Martin van Hecke, Leiden Institute of Physics / AMOLF Amsterdam. More information
11:00 11:30 Prof. Dr. Dirk J. Broer, Institute for Complex Molecular Systems (ICMS), Eindhoven University of Technology about ‘Morphing dynamics in light-triggered liquid crystal networks’ More information
11:30 12:00 Prof. Dr. Martin Wegener, Institute of Applied Physics, Karlsruhe Institute of Technology about ‘3D optical laser lithography for 3D metamaterial’. More information
12:00 12:30 Panel discussion about future applications
12:30 13:30 Lunch
13:30 15:00
Daniel Dikovsky, Digital Materials R&D Manager, Stratasys, about ‘Fabrication of 4D Printing Systems by PolyJet Technology’ More information
Prof. Dr. Ir. Jo Geraedts, Mechatronic Design chair, Section head of Reliability and Durability, TU Delft / Faculty Industrial Design Engineering,’4D Printing: Integrated Properties and Mechatronic Elements in Products’  More information
Panel discussion about future applications
15:00 15:30 Break
15:30 17:00
Fergal Coulter , PhD Candidate, Nottingham Trent University about ‘3D Printing of Inflatable Elastomeric Tensegrity Structures’ More information
Ignacio García, Founder, Recreus
Panel discussion about future applications
17:00 18:30 Networking reception

If you want to be part of this coming edition, by presenting your view on/project about/experience with 4Dprinting/ mechanical meta materials as a speaker, please contact us by filling in this form.

Stay up to date about new speakers and latest developments by following @4DPrintingForum, and join the discussion at the  LinkedIn group.

 

SOURCE

http://www.4dpmmconference.com/program/

Dr. Daniel Dikovsky presents: Fabrication of 4D Printing Systems by PolyJet Technology

Posted on 04/08/2015 by Diana Macovei

Daniel Dikovsky

Dr. Daniel Dikovsky presents at the 4D Printing & Meta Materials Conference: Fabrication of 4D Printing Systems by PolyJet Technology

In the recent years the Stratasys PolyJet 3D printing systems were used to fabricate multi-material devices capable of changing their 3D shape in response to an external trigger. A collaboration project between MIT and Stratasys yielded promising results and the term 4D printing, suggesting an additional dimension of form transformation that became possible by this approach. Dr. Daniel Dikovsky will speak about the materials and systems that were used to fabricate these 4D devices and suggest possible developments for the future.

About Daniel Dikovsky:

Daniel Dikovsky holds a Ph.D. degree in Biomedical Engineering from The Technion – Israel Institute of Technology and a M.Sc. degree in Applied Chemistry from The Hebrew University of Jerusalem, Israel.

He is a materials scientist and worked as R&D Manager for Stratasys Ltd., a manufacturer of 3D printing equipment and materials for creating physical objects directly from digital data. The Israeli branch of Stratasys (formerly Objet Ltd.) utilizes ink-jet technology for printing three-dimensional polymer objects. Daniel’s research focuses on Multi-Material 3D Printing technology enabling the generation of Digital Materials. These materials are created by simultaneous deposition of multiple material components onto the printing tray.

SOURCE
http://www.4dpmmconference.com/4dpmm-conference/dr-daniel-dikovsky-presents-fabrication-of-4d-printing-systems-by-polyjet-technology/

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Scientists take “4D printing” a step further

Posted in 3D Printing for Medical Application, 4D Printing and Meta Materials on November 8, 2013| Leave a Comment »

Scientists take “4D printing” a step further

Reporter: Aviva Lev-Ari, PhD, RN

 

See on Scoop.it – Cardiovascular and vascular imaging

 

Using a 3D printer, people can already determine the length, width and depth of an object that they create. Thanks to research being conducted at the University of Colorado, Boulder, however, a fourth dimension can now be included – time. And no, we’re not talking about how long it takes to 3D-print an item. Instead, it’s now possible to print objects that change their shape at a given time.

 

The scientists, led by Prof. H. Jerry Qi, have developed a “4D printing” process in which shape-memory polymer fibers are deposited in key areas of a composite material item as it’s being printed. By carefully controlling factors such as the location and orientation of the fibers, those areas of the item will fold, stretch, curl or twist in a predictable fashion when exposed to a stimulus such as water, heat or mechanical pressure.

 

The concept was proposed earlier this year by MIT’s Skylar Tibbits, who used his own 4D printing process to create a variety of small self-assembling objects. “We advanced this concept by creating composite materials that can morph into several different, complicated shapes based on a different physical mechanism,” said Martin L. Dunn of the Singapore University of Technology and Design, who collaborated with Qi on the latest research.

 

This means that one 4D-printed object could change shape in different ways, depending on the type of stimulus to which it was exposed. That functionality could make it possible (for example) to print a photovoltaic panel in a flat shape, expose it to water to cause it to fold up for shipping, and then expose it to heat to make it fold out to yet another shape that’s optimal for catching sunlight.
See on www.gizmag.com

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