Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening
Cervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and...
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| creator | Asiedu, Mercy Nyamewaa Agudogo, Júlia Krieger, Marlee S Miros, Robert Proeschold-Bell, Rae Jean Schmitt, John W Ramanujam, Nimmi |
| description | Cervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and the POCkeT Colposcope, a miniature pen sized-colposcope, for comfortable, speculum-free and potentially self-colposcopy.
We explored different designs using 3D computer-aided design (CAD) software and performed mechanical testing simulations on each. Designs were rapid prototyped and tested using a custom vaginal phantom across a range of vaginal pressures and uterine tilts to select an optimal design. Two final designs were tested with fifteen volunteers to assess cervix visualization, comfort and usability compared to the speculum and the optimal design, the curved-tip inserter, was selected for testing in volunteers.
We present a vaginal inserter as an alternative to the standard speculum for use with the POCkeT Colposcope. The device has a slim tubular body with a funnel-like curved tip measuring approximately 2.5 cm in diameter. The inserter has a channel through which a 2 megapixel (MP) mini camera with LED illumination fits to enable image capture. Mechanical finite element testing simulations with an applied pressure of 15 cm H2O indicated a high factor of safety (90.9) for the inserter. Testing of the device with a custom vaginal phantom, across a range of supine vaginal pressures and uterine tilts (retroverted, anteverted and sideverted), demonstrated image capture with a visual area comparable to the speculum for a normal/axial positioned uteri and significantly better than the speculum for anteverted and sideverted uteri (p |
| doi_str_mv | 10.1371/journal.pone.0177782 |
| format | Article |
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We explored different designs using 3D computer-aided design (CAD) software and performed mechanical testing simulations on each. Designs were rapid prototyped and tested using a custom vaginal phantom across a range of vaginal pressures and uterine tilts to select an optimal design. Two final designs were tested with fifteen volunteers to assess cervix visualization, comfort and usability compared to the speculum and the optimal design, the curved-tip inserter, was selected for testing in volunteers.
We present a vaginal inserter as an alternative to the standard speculum for use with the POCkeT Colposcope. The device has a slim tubular body with a funnel-like curved tip measuring approximately 2.5 cm in diameter. The inserter has a channel through which a 2 megapixel (MP) mini camera with LED illumination fits to enable image capture. Mechanical finite element testing simulations with an applied pressure of 15 cm H2O indicated a high factor of safety (90.9) for the inserter. Testing of the device with a custom vaginal phantom, across a range of supine vaginal pressures and uterine tilts (retroverted, anteverted and sideverted), demonstrated image capture with a visual area comparable to the speculum for a normal/axial positioned uteri and significantly better than the speculum for anteverted and sideverted uteri (p<0.00001). Volunteer studies with self-insertion and physician-assisted cervix image capture showed adequate cervix visualization for 83% of patients. In addition, questionnaire responses from volunteers indicated a 92.3% overall preference for the inserter over the speculum and all indicated that the inserter was more comfortable than the speculum. The inserter provides a platform for self-cervical cancer screening and also enables acetic acid/Lugol's iodine application and insertion of swabs for Pap smear sample collection.
This study demonstrates the feasibility of an inserter and miniature-imaging device for comfortable cervical image capture of women with potential for synergistic HPV and Pap smear sample collection.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0177782</identifier><identifier>PMID: 28562669</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acetic acid ; Biology and Life Sciences ; Biomedical engineering ; CAD ; CAD software ; Cancer ; Cancer screening ; Cervical cancer ; Collection ; Colposcopy ; Comfort ; Computer aided design ; Computer aided testing ; Computer programs ; Computer simulation ; Design ; Design analysis ; Diagnosis ; Discomfort ; Disinfection & disinfectants ; Domestic violence ; Engineering ; Engineering and Technology ; Equipment Design ; Fear ; Feasibility Studies ; Female ; Finite element method ; Gynecology ; Health facilities ; Humans ; Illumination ; Imaging ; Insertion ; Iodine ; Mathematical analysis ; Mechanical properties ; Mechanical tests ; Medical equipment ; Medical screening ; Medicine and Health Sciences ; Optimization ; Pain ; Patients ; People and Places ; Physical Sciences ; Pressure ; Rapid prototyping ; Research and Analysis Methods ; Responses ; Safety ; Software ; Surgical Instruments ; Tests ; Uterine Cervical Neoplasms - diagnosis ; Uterus ; Vagina ; Visual perception ; Volunteers ; Womens health</subject><ispartof>PloS one, 2017-05, Vol.12 (5), p.e0177782-e0177782</ispartof><rights>COPYRIGHT 2017 Public Library of Science</rights><rights>2017 Asiedu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2017 Asiedu et al 2017 Asiedu et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-5343de18dc9b5539b5f373dd532608a9bd43f41c1fcc18797b674bbcb2ff5e313</citedby><cites>FETCH-LOGICAL-c692t-5343de18dc9b5539b5f373dd532608a9bd43f41c1fcc18797b674bbcb2ff5e313</cites><orcidid>0000-0002-0230-5022</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5451045/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5451045/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27344,27924,27925,33774,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28562669$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Grce, Magdalena</contributor><creatorcontrib>Asiedu, Mercy Nyamewaa</creatorcontrib><creatorcontrib>Agudogo, Júlia</creatorcontrib><creatorcontrib>Krieger, Marlee S</creatorcontrib><creatorcontrib>Miros, Robert</creatorcontrib><creatorcontrib>Proeschold-Bell, Rae Jean</creatorcontrib><creatorcontrib>Schmitt, John W</creatorcontrib><creatorcontrib>Ramanujam, Nimmi</creatorcontrib><title>Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Cervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and the POCkeT Colposcope, a miniature pen sized-colposcope, for comfortable, speculum-free and potentially self-colposcopy.
We explored different designs using 3D computer-aided design (CAD) software and performed mechanical testing simulations on each. Designs were rapid prototyped and tested using a custom vaginal phantom across a range of vaginal pressures and uterine tilts to select an optimal design. Two final designs were tested with fifteen volunteers to assess cervix visualization, comfort and usability compared to the speculum and the optimal design, the curved-tip inserter, was selected for testing in volunteers.
We present a vaginal inserter as an alternative to the standard speculum for use with the POCkeT Colposcope. The device has a slim tubular body with a funnel-like curved tip measuring approximately 2.5 cm in diameter. The inserter has a channel through which a 2 megapixel (MP) mini camera with LED illumination fits to enable image capture. Mechanical finite element testing simulations with an applied pressure of 15 cm H2O indicated a high factor of safety (90.9) for the inserter. Testing of the device with a custom vaginal phantom, across a range of supine vaginal pressures and uterine tilts (retroverted, anteverted and sideverted), demonstrated image capture with a visual area comparable to the speculum for a normal/axial positioned uteri and significantly better than the speculum for anteverted and sideverted uteri (p<0.00001). Volunteer studies with self-insertion and physician-assisted cervix image capture showed adequate cervix visualization for 83% of patients. In addition, questionnaire responses from volunteers indicated a 92.3% overall preference for the inserter over the speculum and all indicated that the inserter was more comfortable than the speculum. The inserter provides a platform for self-cervical cancer screening and also enables acetic acid/Lugol's iodine application and insertion of swabs for Pap smear sample collection.
This study demonstrates the feasibility of an inserter and miniature-imaging device for comfortable cervical image capture of women with potential for synergistic HPV and Pap smear sample collection.</description><subject>Acetic acid</subject><subject>Biology and Life Sciences</subject><subject>Biomedical engineering</subject><subject>CAD</subject><subject>CAD software</subject><subject>Cancer</subject><subject>Cancer screening</subject><subject>Cervical cancer</subject><subject>Collection</subject><subject>Colposcopy</subject><subject>Comfort</subject><subject>Computer aided design</subject><subject>Computer aided testing</subject><subject>Computer programs</subject><subject>Computer simulation</subject><subject>Design</subject><subject>Design analysis</subject><subject>Diagnosis</subject><subject>Discomfort</subject><subject>Disinfection & disinfectants</subject><subject>Domestic violence</subject><subject>Engineering</subject><subject>Engineering and Technology</subject><subject>Equipment Design</subject><subject>Fear</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Finite element method</subject><subject>Gynecology</subject><subject>Health facilities</subject><subject>Humans</subject><subject>Illumination</subject><subject>Imaging</subject><subject>Insertion</subject><subject>Iodine</subject><subject>Mathematical analysis</subject><subject>Mechanical properties</subject><subject>Mechanical tests</subject><subject>Medical equipment</subject><subject>Medical screening</subject><subject>Medicine and Health Sciences</subject><subject>Optimization</subject><subject>Pain</subject><subject>Patients</subject><subject>People and Places</subject><subject>Physical Sciences</subject><subject>Pressure</subject><subject>Rapid prototyping</subject><subject>Research and Analysis Methods</subject><subject>Responses</subject><subject>Safety</subject><subject>Software</subject><subject>Surgical Instruments</subject><subject>Tests</subject><subject>Uterine Cervical Neoplasms - diagnosis</subject><subject>Uterus</subject><subject>Vagina</subject><subject>Visual perception</subject><subject>Volunteers</subject><subject>Womens 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and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening</title><author>Asiedu, Mercy Nyamewaa ; Agudogo, Júlia ; Krieger, Marlee S ; Miros, Robert ; Proeschold-Bell, Rae Jean ; Schmitt, John W ; Ramanujam, Nimmi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-5343de18dc9b5539b5f373dd532608a9bd43f41c1fcc18797b674bbcb2ff5e313</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Acetic acid</topic><topic>Biology and Life Sciences</topic><topic>Biomedical engineering</topic><topic>CAD</topic><topic>CAD software</topic><topic>Cancer</topic><topic>Cancer screening</topic><topic>Cervical cancer</topic><topic>Collection</topic><topic>Colposcopy</topic><topic>Comfort</topic><topic>Computer aided design</topic><topic>Computer aided testing</topic><topic>Computer programs</topic><topic>Computer simulation</topic><topic>Design</topic><topic>Design analysis</topic><topic>Diagnosis</topic><topic>Discomfort</topic><topic>Disinfection & disinfectants</topic><topic>Domestic violence</topic><topic>Engineering</topic><topic>Engineering and Technology</topic><topic>Equipment Design</topic><topic>Fear</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Finite element method</topic><topic>Gynecology</topic><topic>Health facilities</topic><topic>Humans</topic><topic>Illumination</topic><topic>Imaging</topic><topic>Insertion</topic><topic>Iodine</topic><topic>Mathematical analysis</topic><topic>Mechanical properties</topic><topic>Mechanical tests</topic><topic>Medical equipment</topic><topic>Medical screening</topic><topic>Medicine and Health Sciences</topic><topic>Optimization</topic><topic>Pain</topic><topic>Patients</topic><topic>People and Places</topic><topic>Physical Sciences</topic><topic>Pressure</topic><topic>Rapid prototyping</topic><topic>Research and Analysis Methods</topic><topic>Responses</topic><topic>Safety</topic><topic>Software</topic><topic>Surgical Instruments</topic><topic>Tests</topic><topic>Uterine Cervical Neoplasms - diagnosis</topic><topic>Uterus</topic><topic>Vagina</topic><topic>Visual perception</topic><topic>Volunteers</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Asiedu, Mercy Nyamewaa</creatorcontrib><creatorcontrib>Agudogo, Júlia</creatorcontrib><creatorcontrib>Krieger, Marlee S</creatorcontrib><creatorcontrib>Miros, Robert</creatorcontrib><creatorcontrib>Proeschold-Bell, Rae Jean</creatorcontrib><creatorcontrib>Schmitt, John W</creatorcontrib><creatorcontrib>Ramanujam, Nimmi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In 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one</jtitle><addtitle>PLoS One</addtitle><date>2017-05-31</date><risdate>2017</risdate><volume>12</volume><issue>5</issue><spage>e0177782</spage><epage>e0177782</epage><pages>e0177782-e0177782</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Cervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and the POCkeT Colposcope, a miniature pen sized-colposcope, for comfortable, speculum-free and potentially self-colposcopy.
We explored different designs using 3D computer-aided design (CAD) software and performed mechanical testing simulations on each. Designs were rapid prototyped and tested using a custom vaginal phantom across a range of vaginal pressures and uterine tilts to select an optimal design. Two final designs were tested with fifteen volunteers to assess cervix visualization, comfort and usability compared to the speculum and the optimal design, the curved-tip inserter, was selected for testing in volunteers.
We present a vaginal inserter as an alternative to the standard speculum for use with the POCkeT Colposcope. The device has a slim tubular body with a funnel-like curved tip measuring approximately 2.5 cm in diameter. The inserter has a channel through which a 2 megapixel (MP) mini camera with LED illumination fits to enable image capture. Mechanical finite element testing simulations with an applied pressure of 15 cm H2O indicated a high factor of safety (90.9) for the inserter. Testing of the device with a custom vaginal phantom, across a range of supine vaginal pressures and uterine tilts (retroverted, anteverted and sideverted), demonstrated image capture with a visual area comparable to the speculum for a normal/axial positioned uteri and significantly better than the speculum for anteverted and sideverted uteri (p<0.00001). Volunteer studies with self-insertion and physician-assisted cervix image capture showed adequate cervix visualization for 83% of patients. In addition, questionnaire responses from volunteers indicated a 92.3% overall preference for the inserter over the speculum and all indicated that the inserter was more comfortable than the speculum. The inserter provides a platform for self-cervical cancer screening and also enables acetic acid/Lugol's iodine application and insertion of swabs for Pap smear sample collection.
This study demonstrates the feasibility of an inserter and miniature-imaging device for comfortable cervical image capture of women with potential for synergistic HPV and Pap smear sample collection.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>28562669</pmid><doi>10.1371/journal.pone.0177782</doi><tpages>e0177782</tpages><orcidid>https://orcid.org/0000-0002-0230-5022</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2017-05, Vol.12 (5), p.e0177782-e0177782 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1904766437 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Sociological Abstracts; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Acetic acid Biology and Life Sciences Biomedical engineering CAD CAD software Cancer Cancer screening Cervical cancer Collection Colposcopy Comfort Computer aided design Computer aided testing Computer programs Computer simulation Design Design analysis Diagnosis Discomfort Disinfection & disinfectants Domestic violence Engineering Engineering and Technology Equipment Design Fear Feasibility Studies Female Finite element method Gynecology Health facilities Humans Illumination Imaging Insertion Iodine Mathematical analysis Mechanical properties Mechanical tests Medical equipment Medical screening Medicine and Health Sciences Optimization Pain Patients People and Places Physical Sciences Pressure Rapid prototyping Research and Analysis Methods Responses Safety Software Surgical Instruments Tests Uterine Cervical Neoplasms - diagnosis Uterus Vagina Visual perception Volunteers Womens health |
| title | Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-20T13%3A11%3A50IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Design%20and%20preliminary%20analysis%20of%20a%20vaginal%20inserter%20for%20speculum-free%20cervical%20cancer%20screening&rft.jtitle=PloS%20one&rft.au=Asiedu,%20Mercy%20Nyamewaa&rft.date=2017-05-31&rft.volume=12&rft.issue=5&rft.spage=e0177782&rft.epage=e0177782&rft.pages=e0177782-e0177782&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0177782&rft_dat=%3Cgale_plos_%3EA493757197%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1904766437&rft_id=info:pmid/28562669&rft_galeid=A493757197&rft_doaj_id=oai_doaj_org_article_4d3439b4dcb2403f9e242befb478da52&rfr_iscdi=true |