Establishing a point-of-care additive manufacturing workflow for clinical use

Daoud, Georges; Pezzutti, Dante; Dolatowski, Calvin J.; Carrau, Ricardo L.; Pancake, Mary; Herderick, Edward D.; VanKoevering, Kyle K.

doi:10.1557/s43578-021-00270-x

Cited by 17 publications

(6 citation statements)

References 139 publications

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“…Point-of-care, patient-specific device manufacturing, particularly 3D modeling and printing, allows for better device customization, and lower time to treatment with potential for rapid production [ 26 , 27 ]. In-house manufacturing of personalized medical devices also allows for more adjustments to each device in rapidly changing clinical scenarios such as NF.…”

Section: Discussionmentioning

confidence: 99%

Use of 3-dimensional printing at the point-of-care to manage a complex wound in hemifacial necrotizing fasciitis: a case report

et al. 2023

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Background Complex facial wounds can be difficult to stabilize due to proximity of vital structures. We present a case in which a patient-specific wound splint was manufactured using computer assisted design and three-dimensional printing at the point-of-care to allow for wound stabilization in the setting of hemifacial necrotizing fasciitis. We also describe the process and implementation of the United States Food and Drug Administration Expanded Access for Medical Devices Emergency Use mechanism. Case presentation A 58-year-old female presented with necrotizing fasciitis of the neck and hemiface. After multiple debridements, she remained critically ill with poor vascularity of tissue in the wound bed and no evidence of healthy granulation tissue and concern for additional breakdown towards the right orbit, mediastinum, and pretracheal soft tissues, precluding tracheostomy placement despite prolonged intubation. A negative pressure wound vacuum was considered for improved healing, but proximity to the eye raised concern for vision loss due to traction injury. As a solution, under the Food and Drug Administration’s Expanded Access for Medical Devices Emergency Use mechanism, we designed a three-dimensional printed, patient-specific silicone wound splint from a CT scan, allowing the wound vacuum to be secured to the splint rather than the eyelid. After 5 days of splint-assisted vacuum therapy, the wound bed stabilized with no residual purulence and developed healthy granulation tissue, without injury to the eye or lower lid. With continued vacuum therapy, the wound contracted to allow for safe tracheostomy placement, ventilator liberation, oral intake, and hemifacial reconstruction with a myofascial pectoralis muscle flap and a paramedian forehead flap 1 month later. She was eventually decannulated and at six-month follow-up has excellent wound healing and periorbital function. Conclusions Patient-specific, three-dimensional printing is an innovative solution that can facilitate safe placement of negative pressure wound therapy adjacent to delicate structures. This report also demonstrates feasibility of point-of-care manufacturing of customized devices for optimizing complex wound management in the head and neck, and describes successful use of the United States Food and Drug Administration’s Expanded Access for Medical Devices Emergency Use mechanism.

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Section: Discussionmentioning

confidence: 99%

Use of 3-dimensional printing at the point-of-care to manage a complex wound in hemifacial necrotizing fasciitis: a case report

et al. 2023

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“…16 Point-of-care manufacturing allows for better patient customization, and even more rapid production and time to treatment with more flexibility and access to swift adjustments when necessary; commercial manufactures have limited adaptability and can require weeks for model delivery. 17,18 When printing from an in-house model, the laryngectomy tubes can be delivered in as little as 36 hours in an emergency situation. At the University of Michigan and The Ohio State University, the physicians and engineers have created an in-house 3D printing workflow, that allows for accelerated production of emergency and compassionate use devices, and thus, quicker therapeutic patient benefit that can be widely applied for cancer patients especially at tertiary care centers.…”

Section: Discussionmentioning

confidence: 99%

The Larry Tube: Customized 3D Printed Laryngectomy Tubes Following Total Laryngectomy

Daoud

Windheim

Alfayez

et al. 2023

Ann Otol Rhinol Laryngol

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Objective: To determine whether a custom laryngectomy tube can improve airway symptoms in total laryngectomy patients with atypical anatomy who are unable to use commercial laryngectomy tubes. Furthermore, to exemplify the power of customizable 3D printed medical devices when combined with the expanded access pathway through the FDA. Methods: A custom-fabricated laryngectomy tube, manufactured at in-house clinical engineering labs, was utilized for each patient following typical laryngectomy tube protocols. All participants had previously undergone a total laryngectomy. Patients were selected based on critical airway obstruction posing potentially life-threatening scenarios while using commercially available laryngectomy tubes. Results: For all patients involved, there were no further airway obstruction complications or events, and they reported a subjective, significant improvement in comfort after placement of the custom laryngectomy tube. Conclusion: Custom laryngectomy tubes can provide patients with atypical anatomy relief from airway obstructions and improve comfort when commercial options fail to address the anatomic restriction. The process used to develop custom laryngectomy tubes may be relevant for other diseases and patients with atypical anatomies through the expanded access pathway.

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“…To this end, in-house CAD/CAM workflow is considered an alternative to current outsourcing practices ( 34–36 ). Here, obtaining adequate funding and the current European Union Medical Device Regulation (EU MDR) as some of the biggest challenges in setting up an in-house 3D-printing core ( 35 ). However, once established, an in-house 3D-printing program may reduce costs with no differences in the accuracy of the reconstruction results ( 37 ).…”

Section: Preoperative Planning – How To Optimize Procedures Planning?mentioning

confidence: 99%

From bench to bedside – current clinical and translational challenges in fibula free flap reconstruction

Baecher,

Hoch,

Knoedler

et al. 2023

Front. Med.

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Fibula free flaps (FFF) represent a working horse for different reconstructive scenarios in facial surgery. While FFF were initially established for mandible reconstruction, advancements in planning for microsurgical techniques have paved the way toward a broader spectrum of indications, including maxillary defects. Essential factors to improve patient outcomes following FFF include minimal donor site morbidity, adequate bone length, and dual blood supply. Yet, persisting clinical and translational challenges hamper the effectiveness of FFF. In the preoperative phase, virtual surgical planning and artificial intelligence tools carry untapped potential, while the intraoperative role of individualized surgical templates and bioprinted prostheses remains to be summarized. Further, the integration of novel flap monitoring technologies into postoperative patient management has been subject to translational and clinical research efforts. Overall, there is a paucity of studies condensing the body of knowledge on emerging technologies and techniques in FFF surgery. Herein, we aim to review current challenges and solution possibilities in FFF. This line of research may serve as a pocket guide on cutting-edge developments and facilitate future targeted research in FFF.

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Establishing a point-of-care additive manufacturing workflow for clinical use

Cited by 17 publications

References 139 publications

Use of 3-dimensional printing at the point-of-care to manage a complex wound in hemifacial necrotizing fasciitis: a case report

Use of 3-dimensional printing at the point-of-care to manage a complex wound in hemifacial necrotizing fasciitis: a case report

The Larry Tube: Customized 3D Printed Laryngectomy Tubes Following Total Laryngectomy

From bench to bedside – current clinical and translational challenges in fibula free flap reconstruction

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