APPLICATIONS OF ARTIFICIAL HEART TECHNOLOGY TO PULSATILE LIFESUPPORT SYSTEM AND HOMEDIALYSISFILTRATI

1
APPLICATIONS OF ARTIFICIAL HEART TECHNOLOGY TO
PULSATILE LIFE-SUPPORT SYSTEM AND
HOME-DIALYSIS/FILTRATION
European Society for Artificial Organs Conference
2005 Oct 5-10, 2005

• Byoung Goo Min, Ph.D
• Dept. of Biomedical Engineering, College of
  Medicine,
• Seoul National University, Seoul, Korea

2
ABSTRACT

• BACKGROUND
• We have developed many mechanical circulatory
  support systems for last twenty years. Various
  models of VAD, artificial heart and artificial
  valve were developed, and were applied to animal
  tests and clinical trials. Recently a fully
  implantable pulsatile BiVAD, AnyHeart, has been
  developed, and AnyHearts technologies are
  applied to the development of a pulsatile flow
  extracoporeal life support system.
• METHODS AND RESULTS
• T-PLS has simple blood circuit, biocompatible
  dual blood sacs, four polyurethane valves,
  automation control algorithm and alternating mild
  pushing mechanism. T-PLS provides a
  physiologically suitable pulsatile blood
  perfusion for percutaneous heart-lung bypass.
  T-PLS has a steady drainage and a pulsatile
  outflow with dual blood sacs.
• Pulsatile blood flow by T-PLS showed the better
  peripheral perfusion in kidney and coronary
  artery over non-pulsatile blood pump systems.
  T-PLS has been used as a pulsatile extracorporeal
  life support system and cardiopulmonary bypass
  pump (central and percutaneous cannulations) in
  110 surgical patients (CABG and Valves) and 50
  emergency patients (cardiogenic shocks,
  hemoperfusion).
• In acute cardiogenic shock or arrest cases,
  T-PLSs consecutive application are useful for
  three-stage treatments from emergency
  life-saving, to surgery of PTCA or CABG, then, to
  the long-term recovery support. Also, the
  pulsatile blood pump technology is used for
  research on the renal replacement treatment and
  artificial liver support system.
• Comparative animal tests of pulsatile and
  non-pulsatile flow showed advantages of pulsatile
  blood perfusion system with higher rate of toxin
  removals in the hollow-fiber membrane system. The
  pulsatile hemofiltration machine for home-renal
  cares system with higher convection effects are
  developed and evaluated in animal experiments.

3
CONTENTS

• Mechanical Circulatory Support Technologys in
  Korea
• Hemopulsa
• AnyHeart
• Application of Artificial Heart Technology to
  Life-Support System
• T-PLS
• Extends of T-PLSs Technology to Artificial
  Kidney and Liver Support
• Home-dialysis/filtration system
• Liver Support

4
Mechanical Circulatory Support Technology in
Korea
5
Hemopulsa

• Koreas Fisrt Extracorporeal Ventricular Assist
  Device
• Developed in 1991 by Seoul National University
  and Biomedlab, Inc.

6
Hemopulsa

• Disposable Unit and Main Console (Hemopulsa II)

7
Technologies of AnyHeart

• Development of Implantable Artificial Heart
• Since 1984
• Biomedlab, Inc., Seoul National University, Korea
  University, Jeju University, etc.
• KAH, Seoul National Univ.
• First Total Artificial Heart
• Moving Actuator Type

8
Technologies of AnyHeart

• Moving Actuator Mechanism of KAH
• Actuator containing energy converter (motor) and
  reduction gear train rotates CW CCW around
  fixed shaft

9
Technologies of AnyHeart

• New Design for Totally Implantable Bi-Ventricle
  Assist Device
• First Design of AnyHeart
• L 167 mm
• W 170 mm
• T 68 mm
• Volume 600 cc
• Weight 750 g (est.)
• Max. stroke volume 75cc (design value)
• Max. ejection fraction 64.7 (design value)
• Max. output 9 L/min

10
Technologies of AnyHeart

• AnyHeart Totally Implantable BiVAD

11
Technologies of AnyHeart

• Control Electrical Technologies of AnyHeart
• Integrated Controller
• 70 mm diameter ? 35 mm x 30 mm size
• TET
• Efficiency average 80
• Maximum supply output 90 W
• Li-ion battery system
• Telemetry
• RF communication

12
Technologies of AnyHeart

• Remote Monitoring and Control using PDA and WEB

13
Technologies of AnyHeart

• SNU Polymer Valve
• Since late 1980s
• Floating Polyurethane Valve FPV
• Membrane
• partially-open shape in resting state
• to minimize the pressure difference across the
  artificial valve
• Membrane frame concave shape
• quickly open and completely close when working
• Spokes of valve frame wedge shape
• minimize thrombus formation due to flow
  separation
• Biocompatible Materials and Surface Modifications
• Polyurethane membrane and frame
• Lumbrokinase coating with plasma process

14
Technologies of AnyHeart

• SNU Polymer Valve

15
Application of Artificial Heart Technology to
Life-Support System
16
T-PLS Application of Artificial Heart
Core Technology of AnyHeart
Moving Actuator Type Pumping Mechanism
T-PLS
Biocompatible Polymer Valve
Pulsatile Flow Control Safety Management
Animal Clinical Experiences
17
T-PLSBrief Specifications

• Weight 30 kg
• Dimension (main body) 456437665(mm)
• Performance specification
• Designed stroke volume 70 cc
• Priming volume 300 cc (Adult)
• Maximum flow rate 7 L/min
• Pump rate control 080 BPM(1/-1 step)
• Functional modes
• Main/sub mode
• SSL(Short stroke Length) mode
• Auto control functions

18
T-PLSBrief Specifications
Arterial Filter
Display Control Panel
Pump Head
Reservoir
Membrane Oxygenator
19
T-PLSBrief Specifications
20
T-PLSConcept of Device
TWIN
PULSE
LIFE SUPPORT
21
T-PLSTwin

• Twin Blood Sacs Alternating Pumping Mechanism
• Alternating Inflow Reservoir and Ejecting Blood
  Sacs, functions as Alternating Atriums and
  Ventricles
• Natural Hydrostatic Blood Inflow for
  Physiological Preload control and for No-Air
  Embolism System
• Alternating Filling / Ejecting System for Minimal
  Hemodilution without extra reservoir in Pumping
  Phase
• ? Increased Maximum Blood Flow

22
T-PLSPulse

• Pulsatile Blood Flow Generation
• Pulsatile Blood Flow for improving oxygenation
  and peripheral blood perfusion in Brain and Heart
• Low Blood Cell damage in gentle pushing-sac
  mechanism
• Full-ejection system for maintaining Constant
  Blood Flow, independent of the Fluctuations in
  Arterial pressure changes
• Tubular design for optimal blood flow pathway
  simplified manufacturing High Reliability
• Improving Peripheral Blood Circulation and
  increasing Venous Return
• Effective Blood supply to internal Organs
• Minimizing MOF (Multi-organ Failure) and
  complications
• Maintaining normal Physiological functions

23
T-PLSPulse

• Benefits of T-PLS Pulsatile Perfusion
• T-PLS blood flow is similar to the natural
  heart pulsatile flow The normal pulse pressure
  can be maintained.
• Pulsatile perfusion has advantages in acute
  conditions.
• Maintaining Normal Physiologic Function
• Improvement of Renal Tissue Perfusion
• Kim HK, Son HS, Fang YH, Park SY, Hwang CM, Sun
  K, The Effects of Pulsatile Flow Upon Renal
  Tissue Perfusion During Cardiopulmorary Bypass A
  Comparative Study of Pulsatile and Nonpulsatile
  Flow, ASAIO J 5130-36, 2005
• Improvement of Coronary Perfusion
• - H.S. Son, K.Sun et.al ASAIO June ,2005
  (to be published)
• Minimizing complications and malfunctions due to
  extra-corporeal circulation

24
T-PLSLife Support

• New Versatile ECLS
• T-PLS can be used conveniently, percutaneously,
  by only the nursing/medical staff (without
  specialists) in Emergency Room for versatile
  purposes such as PCPS, ECMO, Hemoperfusion.
• T-PLS can be used to provide the physiologic,
  pulsatile aortic pressure/flows waveforms during
  cardiopulmonary operations and recovery in OR and
  ICU, as the simple pump.
• T-PLS can be used to save the life of the
  cardiac arrest (standstill) patient more
  effectively than AED.

25
T-PLSComparison with major pump systems
26
T-PLSAdvantages of T-PLS

• Simple
• Achieved user friendly interface
• Compact
• Approximately 30 kg and easily transportable
• Integrated disposable pack for quick set-up
• Safe
• Realization of Physiologically natural blood
  filling mechanism
• Lower cell damage in gentile pushing-sac
  mechanism
• Auto-regulated control functions
• Effective
• Designed to maintain normal physiological status
  with 2025 less blood flow than non-pulsatile
  pump

27
T-PLSSafety and Biocompatibility of T-PLS

• Auto-Priming
• Integrated Disposable Unit
• Quick Setup Auto-Priming within 5 minutes
• Alarm
• Suction Tube Clamping Detection
• Low Battery Alarm
• Biocompatible Polymer Valve
• Floating Valve
• Polyurethane Membrane
• Polycarbonate Frame

28
T-PLSSpecific Functions of T-PLS

• SSL(Short Stroke Length) Mode
• The SSL mode is the safety control method that
  decreases the angle of the actuator to avoid
  excessive suction
• SSL-mode correlates to flow rate
• Normal SSL(100)
• SLL1 75
• SLL2 50

29
T-PLS Self-Synchronization of T-PLS

• Self-Synchronization
• Why 80 of beats are self-synchronized during
  T-PLS support without external synchronization
  device?

low pulse pressure (below 10mmHg) and constant
LVP level
natural range pulse pressure (above 40mmHg) and
LVP unloading
The ABP and LVP of T-PLS showed
self-synchronization. The pulsatile blood flow of
T-PLS have LVP unloading effect.
30
T-PLSSelf-Synchronization of T-PLS

• PHASE 1
• LV Eject starts
• Pump zero flow

LV Eject Flow Lowered - Bypass Unloading - Weak
Heart

• PHASE 3
• LV zero flow
• Aortic Valve Closed
• Pump Ejecting
• High ABP

• PHASE 2
• LV Ejecting
• Pump Eject Starts
• Peak Flow gt 10 L/min

31
T-PLS Self-Synchronization of T-PLS

• Factors for Self-Synchronization of T-PLS with
  Native Heart
• High Peak Pulse Power of T-PLS during Ejection
  Phase causes Aortic Valve Closing and LVs
  Diastolic Phase with High Coronary Perfusion
  Pressure
• LV Ejection starts at T-PLSs Diastolic Phase for
  reduced LV Afterloading
• LV Ejection/Diastolic Phase adapts to T-PLSs
  Diastolic/Ejection Phase
• T-PLSs Maximum Pump Rate of 80 corresponds to
  Heart rate of 160 BPM with Twin-Pulse
• Shorter Stroke Length during Pumps Weaning Phase
  to Reduce Pumps Effects on LV Contraction

32
T-PLSMajor Indications

• Cardiopulmonary bypass (CPB) during open heart
  surgery
• Extracorporeal membrane oxygenation (ECMO) for
  patients of respiratory failure
• Ventricular Assist Device (VAD) for heart failure
  patients
• Percutaneous cardiopulmonary bypass (PCPS) in
  emergency situations
• Supported Percutaneous Transluminal Coronary
  Angiography (S-PTCA)
• Hemoperfusion to eliminate toxic substances
• Hemodialysis for patients of acute or chronic
  renal failure
• Other related situations

33
T-PLSThree-stage Successive Treatment from
Cardogenic Shock to Recovery
Emergent Cardiopumonary Support As PCPS
Heart and Lung Support As ECMO
Cardiogenic Shock
Treatment (PTCA, CABG or Stent Insertion)
T-PLS
Surgical Support As CPB
Recovery
Heart Recovery Assist As VAD
34
T-PLSThree-stage Successive Treatment from
Cardogenic Shock to Recovery
35
Extends of T-PLSs Technology to Artificial
Kidney and Liver Support
36
Pulsatile Dialysis
Pulsatile Pump Design
Pulsatile Flow Control
Pulsatile Daily Home Dialysis
Sensor and Safety Management
Web Monitoring and Control
Biocompatible Valve and Catheter
37
Pulsatile Dialysis

• Study of Pulsatile Flow Effects on HD/HF
• Mock Study
• Urea/Creatinine/Vitamin B12 Clearance Study
• Ultrafiltration Comparison Study
• Comparative study between pulsatile flow and
  non-pulsatile flow
• Using T-PLS pump and conventional HD machine

38
Pulsatile Dialysis

• Study of Pulsatile Flow Effects on HD/HF
• Animal Study
• Comparative study between pulsatile flow and
  non-pulsatile flow
• Using T-PLS pump and conventional HD machine

QB120cc/min
Blood Pump
Flow Meter
P1
Pressure Sensor
P4
Hemodialyzer
QD400cc/min
Dialysate Pump
P3
P2
Heater
39
Pulsatile Dialysis

Pulse Group 4 Cases Roller Group 3 Cases
Enhanced urea reduction with pulsatile pump
after 4-hour hemodialysis About 10 (Plt0.05)
40
Pulsatile Dialysis

Pulse Group 3 Cases Roller Group 2 Cases
Enhanced creatinine reduction with pulsatile
pump after 4-hour hemodialysis About 17
(Plt0.01)
41
Pulsatile Dialysis
Midsize molecular concentration doesnt
substantially reduced, regardless of the pump
type B2M - Invalid parameters with ARF model
42
Pulsatile Dialysis
Pulse Pump
Roller Pump
Pulse Linear Fitting
Roller Linear Fitting
One-Way ANOVA

Dataset N
Mean SD SE
P-value ------------------------------------
--------------------------------------------------
-------------- Pulse 42
8.77262 2.3798 0.36721
6.92208E-5 Roller 27
5.72963 3.58446 0.68983
--------------------------------------------
--------------------------------------------------
------
43
Pulsatile Dialysis
After 4-Hour Hemodialysis, TCV and UFR of
dialyzers were measured
Plt0.0001
Plt0.0001
Significantly Lower Protein Layer In Hollow
Fibers With a Pulsatile Pump
44
Pulsatile Dialysis

• Develoment of Pulsatile Daily Home HD/HF Device
• Pulsatile Blood Pump for HD/HF
• Low blood flow rate ( 0 300 ml/min )
• Fine flow rate control required
• Small Roller Pump for Dialysate/Replacement Fluid
• Flow rate ( 0 500 ml/min )
• TMP control required
• Sensor and Control System
• Blood flow/pressure
• Dialysate temperature/flow/pressure/conductivity
• Replacement fluid flow
• Implantable Catheter
• Web Monitoring and Control System

45
Pulsatile Dialysis

• Design Concept for Portable Hemofiltration Machine

SUIT CASE
CASE OPEN
FLUID CONNECTION
BLOOD CONNECTION
46
Pulsatile Dialysis

• Design Concept for Portable Hemofiltration
  Machine
• C-PAK(Carrier-Pulse Artificial Kidney)

Replacement Fluid Bag
Replacement Fluid Pump
Effluent Pump
Hemofilter
Pulsatile Blood Pump
Display
Control Panel
Air Bubble Detector / Clamp
Blood Detector
Blood Line
Effluent Wight / Conductivity Sensor
Effluent Line
Effluent Bag
VASCULAR ACCESS
47
Pulsatile Dialysis

• Web Monitoring and Control System for Home-Care
  Hemodialysis

Database

• Expert Terminal
• Patient information
• browsing
• Device status browsing
• I/O for reporting.

• Communication Terminal
• Microcomputer embedded
• with TCP/IP Protocol Stack
• -Basic I/O for reporting

HL7 TCP/IP
-Device op. parameters
- Experts order or answer - Information
TCP/IP
- conversation
DSL
DSL/LAN
Model for the Next therapy

• Server System
• Database Management system
• Arbitration of reporting
• DSS (fail-safe determination)

Expert group
Home-Care System
Remote Server
48
Pulsatile Liver Support with T-PLS

• Liver Support System using Whole Liver with T-PLS

PV
Whole Liver
IVC
Pulse pump (T-PLS)
JV
PV
FV
49
Acknowledgment
Dr. Y.S. Won Dept. of Thoracic and Cardiovascular
Surgery, Soonchunhyang University, Bucheon,
Korea Dr. K.K. Lee Dept. of Department of
Veterinary Medicine, Cheju National University ,
Cheju, Korea Dr. K. Sun, Dr. J.S. Shin, Dr.
H.S. Son Dept. of Thoracic and Cardiovascular
Surgery, Korea University, Seoul,
Korea NewheartBio, Inc. This study was
supported by a grant of the Korea Health 21 R
Project, Ministry of Health Welfare, Republic of
Korea. (02-PJ3-PG6-EV09-0001)
50
(No Transcript)