Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010–2021

Palazzolo, Thomas; Hirschhorn, Matthew; Garven, Ellen; Day, Steven W.; Stevens, Randy; Rossano, Joseph W.; Tchantchaleishvili, Vakhtang

doi:10.1111/aor.14242

Cited by 13 publications

(9 citation statements)

References 91 publications

(218 reference statements)

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“…MCS devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs) have been employed to support pediatric patients with some success ( 12 ). The Berlin Heart EXCOR (Berlin Heart, Berlin Germany) has been employed for thousands of pediatric patients, and Abbott Laboratories received U.S. FDA labeling for use of the HeartMate III in older pediatric patients with advanced refractory left ventricular HF in December 2020.…”

Section: Clinical Significance and Motivationmentioning

confidence: 99%

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Fox

Palazzolo

Hirschhorn

et al. 2022

Front. Cardiovasc. Med.

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Clinically-available blood pumps and total artificial hearts for pediatric patients continue to lag well behind those developed for adults. We are developing a hybrid, continuous-flow, magnetically levitated, pediatric total artificial heart (TAH). The hybrid TAH design integrates both an axial and centrifugal blood pump within a single, compact housing. The centrifugal pump rotates around the separate axial pump domain, and both impellers rotate around a common central axis. Here, we concentrate our development effort on the centrifugal blood pump by performing computational fluid dynamics (CFD) analysis of the blood flow through the pump. We also conducted transient CFD analyses (quasi-steady and transient rotational sliding interfaces) to assess the pump's dynamic performance conditions. Through modeling, we estimated the pressure generation, scalar stress levels, and fluid forces exerted on the magnetically levitated impellers. To further the development of the centrifugal pump, we also built magnetically-supported prototypes and tested these in an in vitro hydraulic flow loop and via 4-h blood bag hemolytic studies (n = 6) using bovine blood. The magnetically levitated centrifugal prototype delivered 0–6.75 L/min at 0–182 mmHg for 2,750–4,250 RPM. Computations predicted lower pressure-flow performance results than measured by testing; axial and radial fluid forces were found to be <3 N, and mechanical power usage was predicted to be <5 Watts. Blood damage indices (power law weighted exposure time and scalar stress) were <2%. All data trends followed expectations for the centrifugal pump design. Six peaks in the pressure rise were observed in the quasi-steady and transient simulations, correlating to the blade passage frequency of the 6-bladed impeller. The average N.I.H value (n = 6) was determined to be 0.09 ± 0.02 g/100 L, which is higher than desired and must be addressed through design improvement. These data serve as a strong foundation to build upon in the next development phase, whereby we will integrate the axial flow pump component.

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Section: Clinical Significance and Motivationmentioning

confidence: 99%

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Fox

Palazzolo

Hirschhorn

et al. 2022

Front. Cardiovasc. Med.

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“…The shortage of donor organs and the further difficulty of donor-recipient size matching create hurdles for cardiac transplantation and extend patients' waiting periods. To address these challenges, alternative treatment strategies are employed to provide bridge-to-transplant circulatory support in the form of a blood pump [13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Practical Comparison of Two- and Three-Phase Bearingless Permanent Magnet Slice Motors for Blood Pumps

Lawley,

Matlis,

Throckmorton

et al. 2024

Actuators

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The majority of bearingless permanent magnet slice motors (BPMSMs) used in commercially available rotary blood pumps use a two-phase configuration, but it is unclear as to whether or not a comparable three-phase configuration would offer a better performance. This study compares the performance of two-phase and three-phase BPMSM configurations. Initially, two nominal designs were manufactured and empirically tested for their performance characteristics, namely, the axial stiffness, radial stiffness, and current force. Subsequently, finite element analysis (FEA) models were developed based on these nominal devices and validated against the empirical results. Simulations were then employed to assess the sensitivity of performance characteristics to variations in seven different geometric features of the models for both configurations. Our findings indicate that the nominal three-phase design had a higher axial stiffness and radial stiffness, but resulted in a lower axial-to-radial-stiffness ratio when compared to the nominal two-phase design. Additionally, while the nominal two-phase design shows a higher current force, the nominal three-phase design proves to be slightly superior when the force generated is considered relative to the power usage. Notably, the three-phase configuration demonstrates a greater sensitivity to dimensional changes in the geometric features. We observed that alterations in the air gap and rotor length lead to the most significant variations in performance characteristics. Although most changes in specific geometric features entail equal tradeoffs, increasing the head protrusion positively influences the overall performance. Moreover, we illustrated the interdependent nature of the head height and rotor height on the performance characteristics. Overall, this study delineates the strengths and weaknesses of each configuration, while also providing general insights into the relationship between specific geometric features and performance characteristics of BPMSMs.

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“…The usage of adult blood pumps for pediatric patients leads to “off-design” pressures and flows, which increases the risk of hemolysis, thromboemboli, and neurologic insult. 8,10…”

mentioning

confidence: 99%

“…5,6 Implementation of pediatric MCS is expected to continue due to the high survival rate (74% at 6 months). [7][8][9][10] The lack of appropriately designed pediatric devices, however, forces clinical teams to utilize adult-intended blood pumps. The usage of adult blood pumps for pediatric patients leads to "offdesign" pressures and flows, which increases the risk of hemolysis, thromboemboli, and neurologic insult.…”

mentioning

confidence: 99%

“…The usage of adult blood pumps for pediatric patients leads to "offdesign" pressures and flows, which increases the risk of hemolysis, thromboemboli, and neurologic insult. 8,10 To address this unmet clinical need for design-specific pediatric MCS technology, we are developing an operationally versatile, hybrid, continuous-flow, magnetically levitated, total artificial heart (TAH) for pediatric patients, the "Dragon Heart." 11,12 Here, two magnetically levitated blood pumps are located within a single device housing; one axial flow and one centrifugal flow.…”

mentioning

confidence: 99%

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Next Generation Development of Hybrid Continuous Flow Pediatric Total Artificial Heart Technology: Design–Build–Test

Hirschhorn,

Lawley,

Roof

et al. 2023

ASAIO Journal

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To address the unmet clinical need for pediatric circulatory support, we are developing an operationally versatile, hybrid, continuous-flow, total artificial heart (“Dragon Heart”). This device integrates a magnetically levitated axial and centrifugal blood pump. Here, we utilized a validated axial flow pump, and we focused on the development of the centrifugal pump. A motor was integrated to drive the centrifugal pump, achieving 50% size reduction. The motor design was simulated by finite element analysis, and pump design improvement was attained by computational fluid dynamics. A prototype centrifugal pump was constructed from biocompatible 3D printed parts for the housing and machined metal parts for the drive system. Centrifugal prototype testing was conducted using water and then bovine blood. The fully combined device (i.e., axial pump nested inside of the centrifugal pump) was tested to ensure proper operation. We demonstrated the hydraulic performance of the two pumps operating in tandem, and we found that the centrifugal blood pump performance was not adversely impacted by the simultaneous operation of the axial blood pump. The current iteration of this design achieved a range of operation overlapping our target range. Future design iterations will further reduce size and incorporate complete and active magnetic levitation.

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Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010–2021

Cited by 13 publications

References 91 publications

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Development of the Centrifugal Blood Pump for a Hybrid Continuous Flow Pediatric Total Artificial Heart: Model, Make, Measure

Practical Comparison of Two- and Three-Phase Bearingless Permanent Magnet Slice Motors for Blood Pumps

Next Generation Development of Hybrid Continuous Flow Pediatric Total Artificial Heart Technology: Design–Build–Test

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