Alexander H Feng

AM Lacy

BJ Sandler

CH Klingler

Edward Chekan

LP Msezane

LS Feldman

M Pai

Richard L Whelan

RS Baker

SD Schwaitzberg

T Makino

Y Nakamura

Annals of Surgical Innovation and Research

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Chekan et al. Annals of Surgical Innovation and Research 2013, 7:10http://www.asir-journal.com/content/7/1/10REVIEW Open AccessDevice-tissue interactions: a collaborativecommunications systemEdward Chekan1*, Richard L Whelan2 and Alexander H Feng3AbstractMedical devices, including surgical staplers, energy-based devices, and access enabling devices, are used routinelytoday in the majority of surgical procedures. Although these technically advanced devices have proved to be ofimmense benefit to both surgeons and patients, their rapid development and continuous improvement have hadthe unintended consequence of creating a knowledge gap for surgeons due to a lack of adequate training andeducational programs. Thus, there is an unmet need in the surgical community to collect existing data on device-tissue interactions and subsequently develop research and educational programs to fill this gap in surgical training.Gathering data and developing these new programs will require collaboration between doctors, engineers, andscientists, from both clinical practice and industry. This paper presents a communications system to enable thisunique collaboration that can potentially result in significantly improved patient care.Keywords: Access-enabling device, Education, Energy device, Patient outcome, Stapler, Surgeon, TissueIntroductionTechnological advancements in the highly specializedfield of operative surgical management have been occur-ring at an unprecedented pace. More specifically, thecontinuous introduction of novel devices and instru-ments are changing the way surgeons perform manytasks, and, in some cases, creating entirely new surgicaltechniques and possibilities [1-6]. This is particularlyevident when new devices are combined with previouslyexisting therapeutic modalities. At the same time, thescientific basis for the optimal use of these new deviceshas frequently not been established, and there is oftenan educational gap in surgeons’ understanding of mod-ern tissue management [7]. A fundamental scientific un-derstanding of how these surgical devices interact withtissues should be a universal requirement for all sur-geons [8,9]. As a first step in this process, the existingdata on the topic, as known to surgeons and as availablein literature, should be collected, collated, and organizedinto a simple structure as recommended below, to beexpanded upon with information made available bymanufacturers. A systematic research program can thenfollow, and educational programs to fill this gap in* Correspondence: EChekan@its.jnj.com1Ethicon Endo-Surgery, Inc. (EC), 4545 Creek Road, Cincinnati, OH 45242, USAFull list of author information is available at the end of the article© 2013 Chekan et al.; licensee BioMed CentralCommons Attribution License (http://creativecreproduction in any medium, provided the orsurgical training should be developed. Such programswill require collaboration between doctors, engineers,and scientists, from both clinical practice and industry.A panel discussion at a recent Society of AmericanGastrointestinal and Endoscopic Surgeons (SAGES)Annual Meeting was held to explore surgery device andtissue interactions [10]. During this discussion, the au-thors specifically addressed the use of stapling and en-ergy devices, and frequently polled the audience to assesstheir understanding of how these devices and tissuesinteract. Numerous questions were asked by the panel,including queries such as “Do you routinely oversewstaple lines?” and “How do you choose a staple cartridgeduring a gastric bypass procedure?” Though unscientific,the collective polling results of the evening were reveal-ing, in that they brought to light a knowledge gap in sur-geons’ understanding of the interaction between moderntissue management devices and tissue, indicating a ne-cessity for additional education. After the SAGES event,we agreed to collaborate in an effort to help bridge thisknowledge gap: the first necessary steps were (1) to agreeon a framework to house the available information re-garding device-tissue interaction; and (2) to jointly pub-lish a paper calling for the community of surgeons,researchers, and device makers to provide information inthe framework in order to improve patient outcomes.Ltd. This is an Open Access article distributed under the terms of the Creativeommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andiginal work is properly cited.Chekan et al. Annals of Surgical Innovation and Research 2013, 7:10 Page 2 of 3http://www.asir-journal.com/content/7/1/10Achieving optimal patient outcomes is the goal of everysurgeon. The successful outcome of a surgical problem ul-timately involves many layers of interactions, includinginteracting with third party payers, the patients and theirfamilies. At the deepest level, there is the complex inter-action of numerous devices with tissue. Here, there is acomplex web of technologies that must be managed inorder to achieve the desired overall therapeutic result.Moreover, during the moments in which each device is ap-plied to a specific piece of tissue, there is a specific resultfor each of these actions. These are the actions that we aredescribing as the device/tissue interaction.The purpose of this paper is to define the framework fordiscussion around the device/tissue interaction in order toorganize the scientific literature that is currently availableon the topic. A framework, or common ground, will helpto drive conversation, collaboration, and innovation, andultimately result in positive/optimal patient outcomes. Inaddition, it will serve to point out areas requiring furtherstudy.Device-tissue interactions – a frameworkDeviceAn unwieldy list of devices and device characteristicscan be created if all devices used in the operating roomare considered (e.g., staplers, cautery instruments, tro-cars, mesh, sponges, scissors, scalpels, hand instruments,cameras, implants, bags, manipulators, and many more,not to mention those instruments which do not havedirect patient contact). Consequently, in order to ad-dress the most immediate educational gaps first, thispaper will focus on those device groups that are consid-ered to be: (1) critical (used in important operativetasks); (2) compound (used for more than one operativejob and across most operative procedures); and (3) com-plex (comprised of many interconnecting components).To this end, three specific device categories familiar tomost surgeons can be used as examples: namely, stapl-ing, energy-based, and access-enabling devices. Staplingdevices are defined as those instruments designed tosimultaneously appose two edges of tissue and deliver aline of staples, thus securing the tissue apposition and,in turn, promoting healing (these devices may also tran-sect tissue as part of their function). Energy devices arethose devices that are electrically activated and serve totransfer electrical, or ultrasonic, energy from the deviceto the tissue; their function is to cut and/or coagulatetissue in surgery. Finally, access-enabling devices aredesigned to provide access to the specific operative space(e.g., abdominal, thoracic) and adequate domain to per-form necessary tissue manipulation while minimizingtissue trauma.Although stapling, energy-based, and access-enablingdevices are designed to perform distinctly differentfunctions, there exist certain knowledge elements com-mon to each category that when utilized in practice canhelp to achieve an optimal patient outcome, irrespectiveof the specific device. However, a lack of awareness ofthese elements by many surgeons constitutes part of thepreviously described knowledge gap that needs to beaddressed. In the simplest form, these common elementsare as follows: knowing what type of unit the deviceuses, understanding the intended outcome of the device,and knowing which type of device embodies that func-tion. (See Additional file 1: Table S1 for this list).TissueA wide variety of tissues are encountered in every opera-tive procedure and the characteristics of these tissues canvary based on a patient’s co-morbid conditions. Categoriesthat help to differentiate tissue include intrinsic tissueproperties and extrinsic blood supply (i.e., perfusion).Tissue properties can then be broken down into mechan-ical (i.e., liquid versus air versus solid components) andbiochemical properties (i.e., protein content, metabolicprofile). Manipulating adequately perfused tissue can beexpected to have a different outcome versus poorly per-fused tissue.Device-tissue interactionFinally, there is the dynamic and complex process thatoccurs when devices and tissues interact. The goal ofthis interaction is to achieve the desired patient outcomethrough the gentle and precise manipulation of varioustypes of tissue, which will reduce tissue injury and pro-mote healing. Consideration of this kinematic involve-ment by itself adds another layer of knowledge that is anopportunity for exploration– for example, the resultanttissue compression or tension during the use of staplingdevices [11] or resultant heat and/or motion for energydevices during surgery.A more complete list of questions and knowledgeareas for each of the areas described above are presentedin Additional file 2: Table S2, Additional file 3: Table S3and Additional file 4: Table S4.By exploring these areas in detail, clinicians, biologists,and engineers can contribute to better patient care byexpanding the collective knowledge base of device-tissueinteractions. Indeed, we believe this endeavor requiresboth clinicians and industry working together in concert,as neither has appropriate resources when working inisolation. When surgeons and industry pool their re-spective knowledge and experience, a successful devicecan be created that will be more effective for the sur-geon and benefit patients by improving clinical out-comes. This endeavor represents an opportunity for aunique collaboration that can potentially result in sig-nificantly improved patient care.Chekan et al. Annals of Surgical Innovation and Research 2013, 7:10 Page 3 of 3http://www.asir-journal.com/content/7/1/10ConclusionsThe technology of operative surgical management is rap-idly evolving, with the introduction of devices and in-struments that are changing the way surgeons performmany tasks, as well as creating novel techniques andnew possibilities. Unfortunately, the scientific foundationand protocols for the optimal use of these technologicallyadvanced devices has not been established. Moreover,there is an educational gap in surgeons’ understandingof modern tissue management. A fundamental scientificunderstanding of how devices interact with tissues isrequired. The existing data on the topic, as known tosurgeons and as available in literature, should be col-lected, collated, and organized into a simple structureas recommended here, to be expanded upon with infor-mation made available by manufacturers. The data-organizing phase should set the stage for systematicresearch programs (the results of which can be pub-lished and added to this structure), followed by the de-velopment of educational programs to fill this gap insurgical training. Development of these important andnecessary programs will require collaboration betweendoctors, engineers, and scientists, from both clinicalpractice and industry, and would serve to tabulate andsummarize the collected information, with a goal ofperiodic evidence summaries to be released on a bian-nual basis.Additional filesAdditional file 1: Table S1. Device-tissue interactions.Additional file 2: Table S2. Review of stapling devices and potentialinformation required to address the existing surgical knowledge gap.Additional file 3: Table S3. Review of energy devices and potentialinformation required to address the existing surgical knowledge gap.Additional file 4: Table S4. Review of access devices and potentialinformation required to address the existing surgical knowledge gap.Competing interestsEdward Chekan, MD, is an employee of Ethicon Endo-Surgery and holdsstock in Johnson & Johnson. Richard L. Whelan, MD, serves as a consultantfor Ethicon Endo-Surgery. Alexander H. Feng serves as a consultant forEthicon Endo-Surgery.Authors’ contributionsEC, MD, participated in creating, drafting, editing, and reviewing themanuscript. RLW, MD, participated in editing and reviewing the manuscript.AHF participated in creating, drafting, editing, and reviewing the manuscript.All authors read and approved the final manuscript.AcknowledgementsEditorial and medical writing support was provided by Alan J. Klopp, PhD, ofinScience Communications, Yardley, PA, and funded by Ethicon Endo-Surgery.Author details1Ethicon Endo-Surgery, Inc. (EC), 4545 Creek Road, Cincinnati, OH 45242, USA.2St. Luke’s Roosevelt Hospital (RLW), New York, NY, USA. 3the dd+p group,Cincinnati, OH, USA.Received: 26 February 2013 Accepted: 22 July 2013Published: 29 July 2013References1. Makino T, Shukla PJ, Samuels JD, Rubino F, Milsom JW: Identifying specificsurgical tools and methods for laparoscopic colorectal operations inobese patients. J Gastrointest Surg 2012, 16:2304–2311.2. Nakamura Y, Kiaii B, Chu MWA: Minimally invasive surgical therapies foratrial fibrillation. ISRN Cardiol 2012, 2012:606324.3. Sandler BJ, Horgan S: Robotic surgical outcomes and safety. In The SAGESManual of Quality, Outcomes and Patient Safety. Edited by Tichansky DS,Morton J, Jones DB. New York: Springer Science+Business Media, LLC;2012:335–346.4. Msezane LP, Katz MH, Gofrit ON, Shalhav AL, Zorn KC: Hemostatic agentsand instruments in laparoscopic renal surgery. J Endourol 2008,22:403–408.5. Lacy AM, Adelsdorfer C, Delgado S, Sylla P, Rattner DW: Minilaparoscopy-assisted transrectal low anterior resection (LAR): a preliminary study. SurgEndosc 2013, 27:339–346.6. Pai M, Spalding D, Jiao L, Habib N: Use of bipolar radiofrequency inparenchymal transection of the liver, pancreas and kidney. Dig Surg 2012,29:43–47.7. Feldman LS, Fuchshuber P, Jones DB, Mischna J, Schwaitzberg SD, the FUSE(Fundamental Use of Surgical Energy™) Task Force: Surgeons don't knowwhat they don't know about the safe use of energy in surgery. SurgEndosc 2012, 26:2735–2739.8. Schwaitzberg SD, Jones DB: Don't get burned from lack of knowledge.Ann Surg 2012, 256:219–220.9. Klingler CH, Remzi M, Marberger M, Janetschek G: Haemostasis inlaparoscopy. Eur Urol 2006, 50:948–956. discussion 956–957.10. Innovating to improve patient outcomes: exploring surgeon, device and tissueinteraction. Program presented at: 2011 SAGES annual meeting andpostgraduate course. Texas: San Antonio; 2011.11. Baker RS, Foote J, Kemmeter P, Brady R, Vroegop T, Serveld M: The scienceof stapling and leaks. Obes Surg 2004, 14:1290–1298.doi:10.1186/1750-1164-7-10Cite this article as: Chekan et al.: Device-tissue interactions: acollaborative communications system. Annals of Surgical Innovation andResearch 2013 7:10.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color ﬁgure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submit

Device-tissue interactions: a collaborative communications system

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Device-tissue interactions: a collaborative communications system

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