We demonstrate the design, manufacture, and deployment of the first custom-made 3-dimensional (3D)-printed hand retractor for the pollicization procedure. Radiological images of the patient’s hand were taken preoperatively to measure anatomical dimensions and guide the design of the device in a patient-precise manner. The 3D-printed, sterilizable, device was autoclaved and successfully used on a patient that underwent a pollicization procedure in our unit. The radiolucency of the device and the fluency enabled by the ability to exchange between different positions demonstrated the potential of this device in increasing the overall autonomy afforded to the lead-surgeon during the operation and demonstrated the potential of rapid-prototyping techniques such as 3D printing for producing patient-precise tools on-the-fly that taken account the specific needs of the patient

Buck-Gramcko

Caiti

Chen

Dodziuk

Ibrahim

Kozin

Littler

Malik

Neches

Papavasiliou

Rogala

Zancolli

Plastic & Reconstructive Surgery Global Open

English

PubMed

Papavasiliou, T

Chatzimichail, S

Yoshimura, R

Sivakumar, B

Spiral - Imperial College Digital Repository

Downloadedfromhttps://journals.lww.com/prsgobyBhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8KKGKV0Ymy+78=on06/15/2021Downloadedfromhttps://journals.lww.com/prsgobyBhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8KKGKV0Ymy+78=on06/15/2021 www.PRSGlobalOpen.com 1Related Digital Media are available in the full-text ver-sion of the article on www.PRSGlobalOpen.com.INTRODUCTIONThe prevalence of congenital hand deformities has been estimated to be 30 cases per 10,000 live births and the incidence 22.5 cases per 10,000 births, as reported by the birth registry study of Rogala et al.1 Thumb hypo-plasia, in particular, is estimated to be as frequent as 1 for every 100,000 live births. The most frequently per-formed surgical procedure to treat the complete aplasia of a thumb is the pollicization technique.2 The technique has undergone several developments over the years. The earliest known case of pollicization was described by Guermonprez in 1885, where the middle finger was used to create a thumb.3 In 1960, Zancolli performed the first pollicization of the index finger on a 10-year-old child. In addition, he differentiated the problems of a reconstructed thumb post-trauma to that of a congeni-tally absent or underdeveloped thumb.4 Buck-Gramcko, based on their experience of the thalidomide incident, published his revolutionary article on his approach to the index finger’s pollicization.5Regardless of their technique of preference, the lead-surgeon will require adequate, static positioning of the hand during the prolonged dissection as well as to exchange between positions. This makes it almost impossible for the procedure to proceed without 1 or more (often 2) assistants. In this article, we demonstrate the design, man-ufacturing, and application of a novel single-use custom-ized device that provides stabilization of the hand during dissection and improves autonomy and access to the surgi-cal field.ProductionUsing patient XRs, we extracted the anatomical dimen-sions of the patient’s hand, and a stereolithography file (.stl) of the device was designed on Blender (Amsterdam, the Netherlands) and then manufactured on a commercial Fusion Deposition Modelling Ender 5 3-dimensional (3D) printer (Creality, Shenzhen, China) using a polylactic acid variant (PLA) sourced from RS UK (1.75-mm filament by RS, Northants, UK). (See figure, Supplemental Digital Content 1, Preoperative XRs of the 2-year-old patient with type V thumb hypoplasia. (A, B) AP and lateral XR from which we extracted Disclosure: Dr. Papavasiliou and Dr. Chatzimichail own Stelth, a company that specializes in 3D printing, and have no interest in commercializing this device. All the other authors have no financial interest to declare in relation to the content of this article.Hand/Peripheral NerveFrom the *Department of Plastic Surgery, Great Ormond Street Hospital for Children NHS Trust, Great Ormond St, Holborn, London, UK; †Department of Surgery and Cancer, Imperial College London, London, UK; and ‡Hull York Medical School, University of York, Heslington, York, UK.Received for publication February 28, 2021; accepted April 14, 2021.Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.DOI: 10.1097/GOX.0000000000003632Theodora Papavasiliou, MD*Stelios Chatzimichail, PhD†Ryo Yoshimura, MSc‡Branavan Sivakumar, FRCS*  Summary: We demonstrate the design, manufacture, and deployment of the first custom-made 3-dimensional (3D)-printed hand retractor for the pollicization pro-cedure. Radiological images of the patient’s hand were taken preoperatively to measure anatomical dimensions and guide the design of the device in a patient-precise manner. The 3D-printed, sterilizable, device was autoclaved and successfully used on a patient that underwent a pollicization procedure in our unit. The radio-lucency of the device and the fluency enabled by the ability to exchange between different positions demonstrated the potential of this device in increasing the over-all autonomy afforded to the lead-surgeon during the operation and demonstrated the potential of rapid-prototyping techniques such as 3D printing for producing patient-precise tools on-the-fly that taken account the specific needs of the patient. (Plast Reconstr Surg Glob Open 2021;9:e3632; doi: 10.1097/GOX.0000000000003632; Published online 10 June 2021.)PolliRS: A 3D-printed Pollicization Retractor  System that Improves Access and Autonomy  during the Surgical ProcedureIdeas aNd INNovatIoNsPRS Global Open • 20212the dimensions of the customized 3D printed device. (C) Exact measurements required for the design of the device. http://links.lww.com/PRSGO/B672.) The 4-part construct required a total of 110 g of PLA material and 500 minutes of total printing time. The compression mechanism of the clamp component of the device consisted of 2 zinc-plated stainless-steel compression springs (Table 1).Resulting DeviceThe 3D printed parts were autoclaved at 121°C under 15 psi of steam pressure for 30 minutes before the opera-tion. During the sterilization process, biological indicators were used to confirm sterility of the instruments post-process.6 Approval for clinical use of the customized 3D printed retractor was subjected to a rigorous approval pro-cess as class I devices as per the UK government Medicines and Healthcare Products Regulatory Agency guidelines (Low-risk, Non-invasive, Non-implantable) and was then successfully used in vivo (Figs. 1, 2).DISCUSSIONApplications of 3D printing in the healthcare sector have been described in many recent instances, including the use of customized jigs for use in orthopedic surgery during osteotomies.7–9 Chen et al have studied the different materials and patterns available for manufacturing surgical army retractors using 3D printing technologies and provide evidence for their strength tolerance being in equal range to the stainless steel instruments currently used.10 We our-selves, we have previously applied this technology to make customized surgical instruments for congenital hand defor-mities, skin preparation aiding devices, as well as simulation training tools for hand-fracture fixation training.11–13Three-dimensional printing technologies pose an ele-gant toolmaking solution for low-prevalence cases such as congenital hand deformities. While techniques that lend themselves to mass-manufacturing of instruments are not economically appealing for such a small number of cases, the low-volume yet highly customized manufactur-ing capabilities of rapid-prototyping technologies such as those afforded by 3D printing fulfill exactly these require-ments for this demographic of patients.Here, we have developed a device for a 2-year-old patient with a left-sided radial dysplasia with congenital posterior dislocation of the radius and complete aplasia of the thumb who underwent a pollicization procedure (type V thumb hypoplasia, as classified by Blauth). The device was custom-ized to work optimally not only to the anatomical dimensions of the patient but also to the operating setting itself where the procedure was to take place. For instance, the clamp component (component 2) of the device was attached over the drapes on the assistant’s side of the operating table (away from the leading surgeon’s field). When the sur-geon was to dissect with the hand in pronation, the device was assembled with the finger retractor (component 1) as well as the wrist stabilizer (component 4) attached on the clamp (component 4 on superior and part 1 on infe-rior insert points). Once the patient’s hand was correctly positioned on the device, the wrist cap (component 3) was assembled to component 4 for extra stabilization of the wrist (Fig.  1A). These components can be reassembled when the hand is required to be in supination, by assem-bling component 1 and 4 vice versa. To minimize the risk of pressure points when the device was applied, we have reinforced component 4 with a layer of surgical gauze.The device is lightweight (110 g), radiolucent, easy to assemble and is able to provide stability throughout the pol-licization operation. Using an image intensifier machine, XRs can be taken without the instrument interfering oper-ating view. Stay sutures were also positioned to hold the soft tissue retracted as per the surgeon’s preference, using the 6 engraved channels found on the clamp and part 1 of the device. (See figure, Supplemental Digital Content 2, PolliRS device after autoclave cycle. (A) Four parts of the multi-com-ponent device. Component 1: finger retractor; component 2: spring clap; component 3; stabilizing wrist cap; compo-nent 4: wrist stabilizer. (B) The device assembled. The red arrows show the engraved channels which can be used for stay sutures that can provide automated retraction of the soft tissue. http://links.lww.com/PRSGO/B673.)CONCLUSIONSIn this study, we showcased the development of a pol-licization retractor for use in a patient with a type V thumb hypoplasia. We show that 3D printing technologies are ide-ally suited for toolmaking in these types of operations, which are low prevalence and require a high degree of customiza-tion. The bespoke retractor can provide enhanced surgical Table 1. Printing Parameters on Each Component of the Device Part 1 Part 2 Part 3 Part 4Material PLA (1.75-mm filament) PLA (1.75-mm filament) PLA (1.75-mm filament) PLA (1.75-mm filament)Max speed (mm/s) 200 200 200 200Nozzle diameter (mm) 0.4 0.4 0.4 0.4Filling density (%) 20 20 20 20Infill pattern Cubic Cubic Cubic CubicPrinting time (min) 120 200 20 160Layer height (mm) 0.28 0.28 0.28 0.28Weight (g) 27 45 6 32Nozzle temperature (°C) 210 210 210 210Bed temperature (°C) 70 70 70 70Cost (GBP) 0.5 0.9 0.12 0.64Total cost (GBP) 2.16Part 1: finger retractor, Part 2: spring clamp, Part 3: stabilizing wrist cap, Part 4: wrist stabilizer. NB: printer, software, and autoclave costs are excluded from the cost estimate. Papavasiliou et al. • A New Pollicization Device3autonomy to the lead the surgeon during the procedure and allow for more effective use of surgical assistants.The prototyping capabilities of 3D printing technolo-gies allow for the development of cost-effective, customized and innovative surgical instrumentation solutions which can be manufactured in-house. We believe and remain hopeful that further developments of these technologies will increase both their accessibility and their adoption, and bring forth an era where customized toolmaking plat-forms will be a part of every surgical laboratory.14Theodora Papavasiliou, MDGreat Ormond St Holborn London WC1N 3JH United Kingdom E-mail: theodora.papavasiliou@nhs.net Twitter: @DocTheodoraACKNOWLEDGMENTSThe study conforms to the Declaration of Helsinki. The authors thank Christina Lipede for her assistance during the pol-licization procedure on the case presented in this article.REFERENCES 1. Rogala EJ, Wynne-Davies R, Littlejohn A, et al. Congenital limb anomalies:frequency and aetiological factors. Data from the Edinburgh Register of the Newborn (1964–68). J Med Genet. 1974;11:221–233.  2. Kozin SH. Pollicization: the concept, technical details, and out-come. Clin Orthop Surg. 2012;4:18–35.  3. Littler JW. On making a thumb: one hundred years of surgical effort. J Hand Surg Am. 1976;1:35–51.  4. Zancolli E. Transplantation of the index finger in congenital absence of the thumb. J Bone Joint Surg Am. 1960;42-A:658–660. 5. Buck-Gramcko D. Pollicization of the index finger. Method and results in aplasia and hypoplasia of the thumb. J Bone Joint Surg Am. 1971;53:1605–1617. 6. Neches RY, Flynn KJ, Zaman L, et al. On the intrinsic sterility of 3D printing. PeerJ. 2016;4:e2661.  7. Caiti G, Dobbe JGG, Loenen ACY, et al. Implementation of a semiautomatic method to design patient-specific instruments for corrective osteotomy of the radius. Int J Comput Assist Radiol Surg. 2019;14:829–840.  8. Dodziuk H. Applications of 3D printing in healthcare. Kardiochir Torakochirurgia Pol. 2016;13:283–293.  9. Malik HH, Darwood AR, Shaunak S, et al. Three-dimensional printing in surgery: a review of current surgical applications. J Surg Res. 2015;199:512–522.  10. Chen JV, Dang ABC, Lee CS, et al. 3D printed PLA army-navy retractors when used as linear retractors yield clinically accept-able tolerances. 3D Print Med. 2019;5:16.  11. Papavasiliou T, Chatzimichail S, Chan JCY, et al. A standard-ized hand fracture fixation training framework using novel 3D printed ex vivo hand models: our experience as a unit. Plast Reconstr Surg Glob Open. 2021;9:e3406.  12. Papavasiliou T, Lipede C, Chatzimichail S, et al. Development of a customized three-dimensional printed paediatric hand retrac-tor for patient-precise dimensions and enhanced surgical auton-omy. J Hand Surg Eur Vol. 2020;45:982–984.  13. Papavasiliou, T, Chatzimichail S, Kolaityte V, et al. A novel custom-ized 3D printed arm stand improving skin preparation efficiency in hand surgery. Plastic Reconstr Surg Glob Open. 2020;8: e3249.  14. Ibrahim AM, Jose RR, Rabie AN, et al. Three-dimensional printing in developing countries. Plast Reconstr Surg Glob Open. 2015;3:e443. Fig. 1. the PolliRs device on the patient providing evidence of good fitting. device assembled to assist hand in (a, B) pronation and (C) supination.Fig. 2. a, the use of the PolliRs device during fluoroscopy imaging. B, artery clip demonstrating the shadow of our radiolucent device.

PolliRS: A 3D Printed Pollicization Retractor System that improves access and autonomy during the surgical procedure.

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PolliRS: A 3D-printed Pollicization Retractor System that Improves Access and Autonomy during the Surgical Procedure

http://dx.doi.org/10.1097/GOX.0000000000003632

PolliRS: A 3D Printed Pollicization Retractor System that improves access and autonomy during the surgical procedure.

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