Vacuum-Assisted Sternotomy Retractor

Improving Surgical Field Visibility in Cardiac Procedures

Problem

During open-heart surgery, sternotomy procedures require constant suction to clear blood from the operating site, often demanding a second nurse/tech to manually vacuum the chest cavity. This complicates workflow and reduces surgical efficiency and increases risk of infection. The goal of these procedures is to have as close to 100% cell recovery as possible. Patient outcomes are improved when a patient does not need to have a transfusion with donor blood. 

Solution

HaA PD partnered with Mass General surgeons to develop an innovative retractor system with integrated passive blood removal. We began by reviewing dozens of initial concepts developed at MGH with internal staff and local universities. We concluded that none of the existing designs met the necessary performance or usability standards required for a safe and effective procedure. This feedback drove the future designs of the product.

We then observed Dr. Dalessandro in the operating room during complex open-heart surgeries, such as valve replacements and bypasses. We watched as he led each procedure with precision, teaching us what he valued in a surgical tool and sharing detailed performance expectations. We also toured the MGH prototype lab, examining several variations of RIB spreaders. 

We then built a test system using artificial anatomy that simulated real bleeding, sourced appropriate gauze and vacuum systems, and rapidly prototyped designs. The result was a vacuum-assisted retractor with blood-wicking foam and tubing routed to a standard cell saver. Using the testing model we developed in our lab the product proved to be effective. 

We then returned to MGH and presented the system we developed to the team. They tested it and provided feedback which we then implemented to achieve the final design.

Outcome

HaA PD’s final design eliminated the need for most manual suction, improved visibility, and seamlessly fit within existing surgical protocols. This not only significantly improved the clinical workflow, but increased patient safety and outcomes.

Services Provided to Develop Vacuum-Assisted Sternotomy Retractor

Services Provided 

Research

  • Collaborated with the team to conduct market research, document challenges experienced by end users and understand the requirements for a successful system.

  • Analyzed failure modes in current procedures and ensured that we captured critical needs.

Usability

  • Observed Dr. Dalessandro in the operating room during complex open-heart surgeries, such as valve replacements and bypasses. We watched as he led each procedure with precision, teaching us what he valued in a surgical tool and sharing detailed performance expectations. 

  • Toured the MGH prototype lab, examining several variations of RIB spreaders. 

  • Reviewed dozens of initial concepts developed at MGH with internal staff and local universities.

Workflow Optimization

  • Mapped the full surgical procedure to pinpoint failure points.

  • Streamlined workflow to reduce complexity and enhance efficiency.

Program Management

  • Based on experience and simple math, we were capable of estimating part cost at the onset of the project allowing for proper budgetary planning.

  • Developed a detailed summary of the project, including milestones, product cost targets, pre-engineering tooling costs, and estimated testing costs.

  • Engaged with partner vendors early to ensure realistic, real-world cost projections.

Project Management

  • Managed the project timeline from start to finish, assigning roles and responsibilities of both internal and external resources.

Regulatory Compliance

  • Supported and provided regulatory documentation and work instruction development to ensure regulatory compliance.

Industrial Design

  • Sketched initial concepts and built CAD models as part of the industrial design exploration

  • Down-selected designs based on human factors, environmental needs, and product workflow

  • Developed graphics, color material finish and branding 

  • Final designs balanced form, fit, and function

Engineering

  • Selected a mechanism that maintained a compact form factor while ensuring full functionality

CAD Development

  • Developed detailed 3D CAD models based on final product specifications

Prototyping

  • HaA PD provided prototyping services to build a test system using artificial anatomy that simulated real bleeding, sourced appropriate gauze and vacuum systems, and rapidly prototyped designs. The result was a vacuum-assisted retractor with blood-wicking foam and tubing routed to a standard cell saver. 

  • Using the testing model we developed in our lab the product proved to be effective. 

  • We then returned to MGH and presented the system we developed to the team. They tested it and provided feedback which we then implemented to achieve the final design. 

Intellectual Property

  • Assisted with securing IP