A Better Bladder for ECMO Controls Pump Flow as a Function of Inlet Pressure Yehuda Tamari1,2*, Kerri Lee-sensiba1, and Shane King1 1 North Shore University Hosp., Manhasset, NY 2 Circulatory Technology Inc. Oyster Bay, NY Supported by NIH NHLBI Grant # R44HL-46057 cirtec.com The Roller Pump The most popular pump used for ECMO is the roller pump. The RP is a positive Pull displacement pump that is insensitive to inlet or outlet pressure. The pump can generate: • Pin –600 mmHg • Pout > 2,000 mmHg cirtec.com Pin Pout Push What does the Bladder do? Patient The Bladder protects the patient from the excess negative pressure the pump can generate and that can damage the blood as well as the cannulated blood vessel. cirtec.com Pump Silicone Bladder How does the Bladder/Bladder Box Work? When inlet pressure to the pump falls below ambient pressure, the silicone bladder empties. A microswitch senses an empty bladder and switches off the power to the pump. When the bladder refills the pump restarts. Pump Bladder Box Bladder cirtec.com Patient Silicone Bladder/Bladder Box Limitations Flow Control • Gravity Drainage Dependent = Bladder on Floor • On - Off cirtec.com Flow Control PATIENT Gravity Drainage Silicone Bladder Additional tubing length Silicone Bladder + Bladder Box Limitations Long Tubing (Patient to Floor) • Greater prime volume • Larger foreign surface • Blood resides in tubing for a longer time (greater heat loss and greater blood/surface interaction) cirtec.com Silicone Bladder + Bladder Box Limitations Poor Flow Dynamics Blood cells Blood Cells Settle settle cirtec.com Limitations of the Silicone Bladder, Summary 1. Maximum flow is limited to the height of the patient above the floor 2. On/Off control does not takes advantage of computer controlled roller pumps 3. Poor flow dynamics - more prone to clotting. 4. Placement on the floor can be hazardous 5. Difficult to use when transporting a patient cirtec.com What to do? cirtec.com Develop a Better-Bladder System that provides: • VAVD for roller pumps that increases flow • On/Off or Continuous flow control • Flow pattern less conducive to cell settling • Shorter tubing • Need not be placed on the floor cirtec.com Control pump speed as a function of inlet pressure Pressure Monitor and Controller Negative pressure = Gravity Drainage cirtec.com Patient The Inlet Pressure of a Roller Pump is Pulsatile Pull Push 50 W/O -Bladder (120RPM) Pin (mmHg) 25 Pulsatile pressure at pump inlet prevents smooth pump control 0 -25 -50 -75 -100 0.0 0.4 0.8 Time (s) cirtec.com 1.2 How the Better-BladderTM is Made Tube Form Tube cirtec.com Balloon + Housing = BB + = The Better-Bladder • Senses Pressure • Provides Compliance Pressure port Air Blood cirtec.com Functional Tests: Experimental Setup INLET PRESSURE INDIRECT -2 0 0 mmHg INLET PRESSURE DIRECT -2 0 0 mmHg cirtec.com Reservoir DIGITAL COMPUTER DATA AQUISATION DATA ANALYSIS PUMP SPEED CONTROL mmHg Pinlet Pressure (mmHg) -30 BB Provides a High Fidelity Pressure Signal BB -50 -70 Direct Avg. Pin= -100mmHg -90 -110 -130 0.20 0.40 0.60 0.80 1.00 Time (sec) cirtec.com 1.20 1.40 1.60 The Inlet Pressure of a Roller Pump is Pulsatile Pull Push 50 W/O -Bladder (120RPM) Pin (mmHg) 25 Pulsatile pressure at pump inlet prevents smooth pump control 0 -25 -50 -75 -100 0.0 0.4 0.8 Time (s) cirtec.com 1.2 Roller Pump + BB Inlet Pulse Pressure is Dampened 50 W/O -Bladder (120RPM) 0 -25 -50 0 -25 -50 -75 -75 -100 -100 0.0 0.4 0.8 Time (s) cirtec.com With Better-Bladder (120RPM) 25 Pin (mmHg) 25 Pin (mmHg) 50 1.2 0.0 0.4 0.8 Time (s) 1.2 Pump Control with the Better-Bladder: Inlet pressure signal controls pump speed: • On/Off or • Continuos (e.g. CAPS) cirtec.com Pressure Monitor and/or Pump Controller Patient Negative pressure = Gravity Drainage Better Bladder Better Flow Dynamics Silicone Bladder Better-BladderTM Blood cells wash through Blood cells settle cirtec.com The BB Allows Increased Flow Flow = ∆P/Resistance Pressure Monitor Patient The older bladder collapsed and/or at ambient pressure. The BB Pump Controller collapses at the negative Negative pressure pressure set by the user. = Blood can be actively pulled Gravity Drainage Better Bladder from the patient. No need to raise the bed or drop the bladder to the floor. cirtec.com High Pressure Tests of Balloon • Housing side is open to atmosphere • 1500 mmHg applied to blood side • Balloon expands to housing • Housing supports thin section Water cirtec.com 20 25 30 15 35 10 40 5 45 psi 0 Ma de in 50 U.S .A. t# P ar G CC VPR Internal Pressure (mmHg) The BB W ithstands Large Internal Pressures 2000 1600 1200 800 Repressurized 400 0 0 48 96 144 Time (hrs) cirtec.com 192 240 The BB Requires Shorter Tubing PATIENT Gravity Drainage Silicone Bladder Additional tubing length cirtec.com Pressure Monitor and/or Pump Controller Patient Negative pressure = Gravity Drainage Better Bladder The Better-Bladder Provides: • “Adjustable” gravity drainage - VAVD • Flow less conducive to cell settling • On/off or continuous flow control (e.g. CAPS system) • Shorter circuit tubing cirtec.com Pressure Monitor and/or Pump Controller Patient Negative pressure = Gravity Drainage Better Bladder The Better-Bladder Provides Shorter Tubing • Lower prime volume • Reduced foreign surface • Blood resides in tubing for a shorter time (lowers heat loss and blood/surface interaction) cirtec.com 510(k) Number K98-1284 Device Name Better-BladderTM http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm Indications for Use – The Better-BladderTM is a device that isolates pressure transducers form blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term term procedures. cirtec.com To Bladder or not to Bladder? Yehuda Tamari Circulatory Technology Inc. Oyster Bay, NY cirtec.com Why use a Bladder for ECMO? O2 Venous Cannula cirtec.com Bladder Arterial Cannula Computerized Roller Pumps Blood flow is controlled as a function pump inlet pressure. Jostra When inlet pressure drops below a settable pressure the pump slows down or stops. When inlet pressure increases above the set point, pump flow returns to its set value. Stockert cirtec.com Recent comments/questions from the ECLS-Net • “Is anyone removing or considering removing the bladder out of their ECMO circuit that uses roller pumps?” • “We have PVC tubing in place of the bladder and it has worked very well.” • “We have a collapsible Silastic bridge.” No reasons were given for eliminating the bladder. Cost? Complexity? reliability? There were no mentions of using a bladder with centrifugal pumps. cirtec.com When making changes to a circuit Practice Caution • What follows are results of some tests that we conducted with and without a bladder under ECMO settings. • Serve as an outline for the type of tests that should be conducted prior to removing or replacing the bladder. cirtec.com Pump flow is controlled as a function of inlet pressure Should we pump with a bladder or without a bladder Pressure Monitor and/or Pump Controller Patient Negative pressure = Gravity Drainage Better Bladder cirtec.com Pressure Monitor and Controller Negative pressure = Gravity Drainage Patient Pump flow is controlled as a function of inlet pressure Compliance can be provided by The Silicone Bladder The Better Bladder Pressure Monitor and Controller Patient Pressure Monitor and/or Pump Controller Patient Negative pressure = Gravity Drainage Better Pump Bladder Box Bladder cirtec.com Bladder Experimental Setup Pump Controlled by Venous Line Pressure Pressure Cannula Clamp Sample rate- Data Acquisition Measure pressure at: 1000/sec Bladder Controller set to stop flow at Pin = -30mmHg Reduce venous flow below pump flow and record the pressures Cannula tip Pump inlet Control Pump flow cirtec.com "Patient" venous side "Patient" Arterial side "LV" ECMO Roller Pump Pump Controlled by the Instantaneous Inlet Pressure: w/o a Bladder Results in Erratic Pump Flow 600 150 500 100 Pump Flow (ml/min) Pump inlet (mmHg) Pavg 0.05sec [email protected] 125 75 50 25 0 400 300 Pump setting Patient Flow Pump flow w/o Bladder 200 -25 100 -50 8 cirtec.com 9 10 Time (s) 11 12 8 10 12 Time (s) 14 16 Pump Controlled by the Instantaneous Inlet Pressure: Electronic Pressure Averaging Pump inlet (mmHg) 150 50 -50 [email protected] [email protected] -150 Avg 1.5sec, W/O Bladder -250 10 cirtec.com 11 12 13 14 Time (s) 15 16 Pump Controlled by Electronically Averaged Inlet Pressure Pump inlet (mmHg) 150 50 -50 [email protected] -150 P Lo=-30mmHg Qpump=500ml/min, Qpt.=400ml/min W/O Bladder -250 -350 0 cirtec.com 4 8 12 Time (s) 16 20 24 Pump Controlled by Electronically Averaged Inlet Pressure Pump inlet (mmHg) 150 50 -50 [email protected] [email protected] P Lo=-30mmHg -150 Qpump = 500 ml/min, Qpt. = 400 ml/min Avg 1.5sec, W/O Bladder -250 -350 0 cirtec.com 4 8 12 16 Time (s) 20 24 Pump Controlled by Electronically Averaged Inlet Pressure Pump inlet (mmHg) w/o a Bladder 100 50 0 -50 -100 -150 -200 -250 -300 -350 16.4 P inst. [email protected] P Lo-30mmHg 16.8 17.2 17.6 18.0 Time (sec) cirtec.com 18.4 18.8 19.2 19.6 The BB at the Pump Inlet Provides compliance and reduces pressure pulsation. cirtec.com Pressure Monitor and/or Pump Controller Patient Negative pressure = Gravity Drainage Better Bladder Roller Pump with a Bladder at its Inlet Pump inlet (mmHg) 150 100 50 0 P inst No BB P inst.+ BB [email protected]+BB -50 -100 -150 10.5 11.0 11.5 Tim e (s) cirtec.com 12.0 12.5 Bladders Absorb the Pressure Fluctuations of the Roller Pump cirtec.com Pump inlet (mmHg) Pump Controlled by Electronically Averaged Inlet Pressure With a Bladder 50 -50 W/O Bladder With Bladder P Lo -30mmHg -150 Qpump=500 ml/min Qpt.=400ml/min Avg 1.5sec -250 -350 1.0 2.0 3.0 4.0 5.0 6.0 Time (sec) cirtec.com 7.0 8.0 9.0 10.0 11.0 High Negative Pump Inlet Pressure is also Seen at the Tip of the Venous Cannula Pressure (mmHg) 150 50 -50 -150 Qpump = 750 ml/min Abrupt Venous Flow Cessation -250 Avg 0.05sec -350 NO BB Pin NO BB Pcan -450 27 cirtec.com 28 29 30 BB Pin BB Pcan 31 32 Time (s) 33 34 35 200 160 120 80 40 0 -40 -80 -120 -160 -200 Pump Set = 600ml/min Patient = 410ml/min P instantaneous 0 cirtec.com 5 10 15 20 Time (s) 500 450 400 350 300 250 200 150 100 50 0 P w/o BB Flow w/o BB 25 30 35 Flow (ml/min) P (mmHg) Pump Controlled by the Instantaneous Inlet Pressure: Results in Erratic Pump Flow 200 160 500 450 120 80 40 0 400 350 300 250 -40 -80 -120 200 150 100 Pump Set = 600ml/min Patient = 410ml/min P instantaneous -160 -200 0 cirtec.com 5 10 15 20 Time (s) P w/o BB P + BB Flow w/o BB Flow +BB 25 30 50 0 35 Flow (ml/min) P (mmHg) Pump Controlled by the Instantaneous Inlet Pressure Minimum Pressure (mmHg) Maximum Suction due to Abrupt Stoppage of Venous Flow. Using the Jostra roller pump with and w/o a bladder cirtec.com 0 200 Pump Flow (ml/min) 300 -100 -200 -300 -400 -500 No BB +BB 500 Are Bladders Required When Centrifugal Pump are Used for ECMO? Effects of a bladder placed at the pump inlet on: • the maximum negative pressure at pump inlet due to abrupt stoppage of venous flow. • the pump outlet pressure due to abrupt stoppage of venous flow. • the air handling of a CP. cirtec.com "Patient" arterial side Experimental Setup: CP Tubing Clamp "Patient" venous side Data Acquisition Measure pressure at: C o n tr o l P r essu r e Bladder Clamp M icr o P o r o u s M em b. O xy. Clamp Centrifugal pump cirtec.com O x y g e n a to r P ressu re M P M O Inlet Pressure to a CP - Abrupt blockage of Venous Flow Pressure drops faster and lower w/o a bladder 100 CP Pvenous w/o BB Pvenous + BB 0 P (mmHg) Bladder V en o u s L in e P ressu re -100 -200 -300 Flow = 2.5 LPM Pump = 3700RPM -400 -500 9.4 9.6 9.8 10.0 Time (sec) cirtec.com 10.2 10.4 Inlet Pressure to a CP - Abrupt Blockage of Venous Flow Pressure drops faster and lower w/o a bladder 50 CP Pvenousw w/o BB Pvenous with BB -50 P (mmHg) Bladder V en o u s L in e P ressu re Flow = 5.5 LPM Pump = 3000RPM -150 -250 -350 -450 -550 1.4 cirtec.com 1.6 1.8 2.0 Time (sec) 2.2 2.4 Pressure at Oxygenator can Become NEGATIVE Bladder M P M O CP P (mmHg) A rt. L in e P ressu re 300 250 200 150 100 50 0 -50 -100 -150 Poxy w/o BB Poxy with BB Flow = 2.5 LPM Pump = 3700RPM 9.4 9.6 9.8 10.0 Time (sec) cirtec.com 10.2 10.4 Abrupt stoppage of Venous Flow can Cause the Pressure at Oxygenator to go NEGATIVE Bladder M P M O CP P (mmHg) A rt. L in e P ressu re 300 250 200 150 100 50 0 -50 -100 -150 Poxy w/o BB Poxy with BB Flow = 5.5 LPM Pump = 3000RPM 1.4 1.6 1.8 2.0 2.2 Time (sec) cirtec.com 2.4 2.6 Abrupt stoppage of Venous Flow can Cause the Pressure at Oxygenator can Become NEGATIVE When pressure on blood side of a MPMO falls below the gas pressure then there is a significant possibility that gas will flow across the porous membrane into the blood side of the oxygenator and into the arterial line. Blood Side Pblood < Gas Side M icro P o r o u s M e m . O x y cirtec.com Pgas Air handling of roller pumps Heat Exchanger A B RP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B RP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B RP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B RP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B RP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B RP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of roller pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter Air handling of centrifugal pumps Heat Exchanger A B CP cirtec.com Bubble Counter ?? Bladders Trap Air Bladders trap large bubbles Large Bubbles CP cirtec.com Micro Bubbles CP Air handling of centrifugal pumps – Experimental setup "Patient" Air in (1, 5, 8cc) Outlet Pressure Vacuum -400mmHg 500 MP ml/min Flow meter Oxy.Micorporous memb oxyg 300 Bladder mmHg Large Bubbles Air removal cirtec.com B Heat Exchanger A Clamp Centrifugal Pump PRV Small Bubbles Gas port Closed 000 Bubble Counter (15u to 95u) Bubble counted here 15 u Bubble count cirtec.com Centrifugal Pump for ECMO – The Air Study 800 700 CP Flow = 500ml/min 600 Air in = 3cc 500 Water W/O a bladder 400 With a bladder 300 200 100 0 2000 2500 3000 3500 Pump Speed (RPM) Centrifugal Pump for ECMO – The Air Study (Blood Flow = 500 ml/min, 1 cc Air) 15u Bubbles Count 300 250 200 150 100 268 Heat Exchanger Inlet Heat Exchanger Outlet Flow = 500mlmin Poutlet = 300mmHg Air in inlet = 1cc *Bubbles >100u were not counted 50 0 0 2 2 0 With BB w/o BB Roller Pump cirtec.com 1 159 0 With BB w/o BB Centrifugal Pump Bladders Add a Safety to Centrifugal Pumps Used for ECMO • Provide compliance that reduces rate of change in • • • pressure and allow better pump control as a function of venous line pressure. Reduce the maximum negative pressure due to abrupt stoppage of venous flow. Eliminate negative pressure at the outlet of the pump due to abrupt stoppage of venous flow. Reduce microbubbles generation by the pump. cirtec.com To Bladder or not to Bladder? - Costs Considerations Avg. cost for a neonatal ECMO ~ $100,000/wk. Peds, post-op cardiac cases, adults, etc. are much higher. Avg. Cost of ECMO pt. - entire hospital stay …….... $300,000 West Coast hospital Average hospital cost during ECMO ………………... $195,860 Avg. Cost of ECMO pt. - entire hospital stay ………. $427,027 The bladder cost is about 0.1% of the total cost. cirtec.com To Bladder or not to Bladder? - Costs Considerations Costs of post hospital care are also significant. 52% ECMO infant survivors have abnormal neuro-imaging (Bulas &Glass Semin Perinat 29:58-65 2005) 12 % have severe mental handicap (FSIQ < 70) and 37% are at risk for school failure. (Rais-Bahrami et. al. Clin Pediatr: 39(3):145-52, 2000) The bladder cost is less then 0.1% of the total cost. cirtec.com To Bladder or not to Bladder? Costs Considerations Since the bladder’s cost less then 1/1000 of the total cost of ECMO, If the bladder prevents a single patient from being exposed to microbubbles or vessel damage due to excess negative pressure at the cannula Then its cost has been justified for hundreds of patients. cirtec.com Bladders placed at the pump inlet • Dramatically reduce the maximum negative • • • • pressure at the pump inlet and at the tip of the venous cannula. Reduced vessel damage? Reduce pressure pulsations at the pump inlet and at the tip of the venous cannula. More Physiological? Provide smoother pump operation. Less clotting? Cleared by the FDA for that purpose. Standard of care - reduce liability. cirtec.com To change a circuit/procedure the user must answer to the affirmative the following : • • • • • cirtec.com Is it as safe or safer then current practice? Is it standard of care? Is it supported by publications in a peer reviewed journal? Could it introduce other problems? Do we have the team with the educational background to properly evaluate the effects of the change? Blood damage: The Centrifugal Pump Depends on shear stress (i.e. RPM) and exposure time. The greater the shear and the longer the exposure time the greater the damage. cirtec.com Pinlet Poutlet CP’s Flow Characteristics* 745 Revolution dP (mmHg) 740 735 730 25 mmHg 725 720 715 0.0 *Courtesy cirtec.com of Cobe Lab. 1.0 2.0 3.0 Flow (LPM) 4.0 5.0 Blood damage: The Centrifugal Pump Since the line pressure in the adult and neonate circuits are similar. And, since the pump speed varies little with flow but is mostly dependent on line pressure. Then, we can conclude that the shear stress within the pump for neonates approximates that for adults. Any difference in blood damage between adults and neonates flow conditions is due to differences in exposure times to that shear. cirtec.com Blood damage by CPs Pinlet Poutlet Patient Adult Neonate Pout Flow Time mmHg LPM sec 250 250 5.0 0.5 0.6 6.0 For a CP with a prime volume of 50 ml, the residence time at 5.0 LPM is 0.6 sec. At 0.5 LPM it is 10 times longer or 6.0 sec. cirtec.com The finger damage test = Exposure to 0.6 sec cirtec.com Little or no damage. The finger damage test = Major damage Exposure to 6.0 sec cirtec.com Serotonin released from sheared platelets relates to exposure time* Serotonin Release (%) 70% 60% 50% 40% Shear Stress = 150 (Dynes/cm2) 30% 20% 10% 0% 0 100 200 300 400 Exposure Time (sec) cirtec.comet.al. Trans. ASAIO 21:35, ‘75 *Brown 500 600 Blood damage: Comparing RP to CP Hemolysis: Shear stress (i.e. RPM) Exposure time. Pinlet Poutlet RPM = f (pressure) Exposure time = f (1/Flow) Shear x Time ≅ Pressure x (1/Flow) cirtec.com The effects of pressure and flow on hemolysis caused by BioMedicus centrifugal pumps and roller pumps. Guidelines for choosing a blood pump. Tamari Y, Lee-Sensiba K, Leonard EF, Parnell V, Tortolani AJ. J Thorac Cardiovasc Surg. 1993 Dec;106(6):997-1007. cirtec.com IH ratio (RP/CP) 6 5 4 3 2 Guidelines for choosing a blood pump: RP v. CP Occlusive RP v CP Regression line NonOcclusive RP Da ta ta ke n fro m: Oku, Ja ko b, P a lde r, Eng le ha r, Ig o , Kre s s , a nd 1 0 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 cirtec.com Pressure/Flow (mmHg/(ml/min)) Guidelines for choosing a blood pump: RP v. CP Hemolysis for the Biopump is higher than that of the roller pump when the ratio of the pressure divided by the flow is less than 0.35 When: Pressure(mmHg)/Flow(ml/min) > 0.35 use the roller pump. cirtec.com Flow (ml/min) Hemolysis – Choosing between RP and CP 1200 1000 800 600 400 200 0 Use CP Use RP 0 cirtec.com 50 100 150 200 250 300 350 Pressure (mmHg) Hemolysis – Choosing between RP and CP It is important to note that in later studies, when the RP was set nonocclusively, the RP was always less hemolytic than the CP*. *A dynamic method for setting roller pumps nonocclusively reduces hemolysis and predicts retrograde flow. Tamari Y, Lee-Sensiba K, Leonard EF, Tortolani AJ. ASAIO J. 1997 Jan-Feb;43(1):39-52. cirtec.com Questions? [email protected] cirtec.com
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