The authors thank Sungwon Lim for intellectual contributions to device and mold design as well as Jambu Jambulingam and Rebecca Grossman-Kahn for creating intravaginal silicone probes using this process. This work is supported by the Bill and Melinda Gates Foundation, the Vodafone Americas Foundation, and the FDA (2P50FD003793).

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K. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Rapid+investment+casting:+direct+and+indirect+approaches+via+fused+deposition+modelling.">Rapid investment casting: direct and indirect approaches via fused deposition modelling.</a> The International Journal of Advanced Manufacturing Technology. 23 (1-2), 1-2 (2004).</li><li>Harris, A., Wild, P., Stopak, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Silicone+Rubber+Substrata:+A+New+Wrinkle+in+the+Study+of+Cell+Locomotion.">Silicone Rubber Substrata: A New Wrinkle in the Study of Cell Locomotion.</a> Science. 208 (4440), (1980).</li><li>Moisan, M., Barbeau, J., Moreau, S., Pelletier, J., Tabrizian, M., Yahia, L. 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F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Mechanical,+microscopical+and+fire+retardant+studies+of+ABS+polymers.">Mechanical, microscopical and fire retardant studies of ABS polymers.</a> Polymer Degradation and Stability. 64, 449-455 (1999).</li><li>Cassidy, P. E., Mores, M., Kerwick, D. J., Koeck, D. J., Verschoor, K. L., White, D. F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Chemical+Resistance+of+Geosynthetic+Materials.">Chemical Resistance of Geosynthetic Materials.</a> Geotextiles and Geomembranes. 11, 61-98 (1992).</li><li>Akay, M., Ozden, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+influence+of+residual+stresses+on+the+mechanical+and+thermal+properties+of+injection+moulded+ABS+copolymer.">The influence of residual stresses on the mechanical and thermal properties of injection moulded ABS copolymer.</a> Journal of Materials Science. 30 (13), (1995).</li></ol>

Yazarların hiçbiri bu makalede ayrıntılı çalışma ile ilgili herhangi bir rekabet mali çıkarları var.

Açıklanan tüm adımları dikkatli kalıp tasarımı başarı için en kritik. Kalıp ustası nihai cihaza eşit dış geometriye sahip katı bir cisim olarak oluşturulmalıdır. Bu geometri herhangi bir malzeme nedeniyle seçilen elastomere çekme hem de 3D yazıcı çözünürlük ve toleransları hesaba ayarlanmalıdır. Kalıp ayırma hatları ve delik dişli çubuklar ve vidalar için Yerleştirme birbirine bağlıdır. Ayrılık çizgileri ekleme kalıp toplanma özgürlüğü doğrusal ve dönme derece sayıs?...

(Ayrıca reaksiyon enjeksiyon kalıplama olarak bilinir) likit enjeksiyon kalıplama (LMT) genellikle termoset elastomerler elastomerik cihazların üretimi için kullanılan, ancak yüksek kalıp ve ekipman maliyetleri kadar ön sermaye yatırımı 1 büyük bir ihtiyaç olduğunu. Ayrıca, LIM karmaşık geometri ve üstkaplama için gereklerine durumlarda uygulamak için teknik olarak zor ve pahalı olabilir. Bunun bir sonucu olarak, bu ultra düşük hacimli ya da sık sık tekrarlanan düzeltmeleri tabi erken evre cihaz tasarımları ile geleneksel LIM kullanmak için tipik olarak pratik değildir. Enjeksiyon elastomerik malzemeler için tipik bir prosedür, özel bir döküm makinesi 2 ile bir kalıp içine 150 psi basınç altında yaklaşık sıvı enjekte monomerler içerir. Sıcaklık ve basınç laminar akışını sağlamak ve kalıp 3 sıkışıp hava önlemek için kontrol edilir. Ham malzeme tipik olarak, platin tedavi silikon, t olarak iki parçalı bir kür sistemleridirhat enjeksiyondan önce, ayrı ve ısı kontrollü odalarına tutulur. Hammaddenin Her iki bileşen, daha sonra kalıp boşluğu içine besleyen bir yüksek basınçlı karıştırma odasına pompalanır. Tedavi edici bir katalizör varlığında hem de sıcaklık yaklaşık 150-200 ° C 4 elde edilir. Kalıplar genellikle kenarlara 3,5 Kesme çevresinde iyi bir mühür oluşturmak için hassas toleranslar için çelik veya alüminyumdan imal edilmektedirler. Ne yazık ki, bu süreç genellikle büyük ölçekli üretim verilen yüksek kalıp kalıp maliyetleri yanı sıra özel enjeksiyon ve geri besleme kontrol sistemleri için gereksinimi için daha uygundur. Poliüretan (PU) parçaların hızlı prototipleme için, bir ana kalıp oluşturmak ve bir silikon kauçuk kalıp 6,7 üretmek için stereolitografi (SLA) kullanmak mümkündür. Bu kalıplanmış parçaların hassas hizalama elde etmek zordur çünkü silikon ile Ancak, bu teknik, üstkaplama için uygun değildirdeğil, katı bir yapı tasarımı. Ayrıca, bu tür invajinasyonları veya oyularak bölümler gibi karmaşık geometriye sahip cihazların üretimi, zor veya imkansızdır. Karmaşık veya hassas kalıp ayırma hatları ve sert ince elemanlar için gereksinimi, daha sık değil, sıvı kauçuk kalıplama süreci ile uyumsuz. Yukarıda belirtilen üretim ölçekli veya geç evre prototipleme süreçleri genellikle akademik laboratuvarda genellikle olduğu gibi bir kaç cihazlar, ispat-of-concept insan çalışmalarında ve fizibilite için üretilen gerekir ki erken evre tıbbi cihaz geliştirilmesi için pratik değildir ve start-up şirketi ortamları. Alternatiflerin eksikliği genellikle hatta erken evre geliştirme ek fonlar yükseltilmiş ise cihaz işlevselliği sınırlamak veya beklemeye gelişimini koymak için pek çok cihaz geliştiriciler gerektiren, yüksek masraf demektir. Bu tıbbi cihazların yeniden büyük bir kısmını bu yana gelişim süreci dramatik bir yavaşlama katkıda<html> Karmaşık özellikler forma uygulanması. Bu proof-of-concept veriler genellikle henüz kurulmuş değil çünkü bu tür cihazların pahalı gelişimini finanse etmek de zordur. Biz belirtilen servikal geometrileri uymak için bir bardak gibi ucu gerekli üstkalıplanmış elektriksel ve optik sensörler ile bir silikon vajina prob geliştirilmesi dahil bu laboratuvar içinde yeni bir proje, bu barikatı ile karşılaştı. Bu makalede açıklanan süreç, bu kısır döngüyü aşmak ve hızla proof-of-concept LMT tıbbi cihazlar için ulaşmak için bizim girişimi belgelemektedir. (1) kalıp tasarım ve üretim, (2) kalıp takımı (3) elastomer karıştırma, (4) elastomer enjeksiyon, ve (5) elastomer sertleşme ve kalıptan: Şekil 1&#39;de gösterilen tekniği 5 ana faaliyetleri içine LIM sürecini dekonstürüksiyon. pg &quot;width =&quot; 600 &quot;/&gt; (1a), bilgisayar destekli tasarım araçlarını kullanarak bir kalıp oluşturma, (1b) 3D kalıp parçaları baskı, (2), dişli çubuklar ve vidalar kullanılarak kalıp parçalarını birleştirirken (:.. Içeren protokol, Şekil 1. Protokol Genel Bakış 3), sıvı elastomer karıştırılması ve bir şırınga yüklemeden, (4) bir tadil edilmiş desikatörde kullanarak kalıba sıvı elastomer enjekte edilmesi, (5a), bir sıcaklık kontrollü bir fırında elastomer sertleştirme ve (5b) arasındaki vulkanize elastomer cihazı deforme kalıp adettir. Kalıp tasarım, bilgisayar destekli tasarım (CAD) yazılımı, kalıp ayırma hatları sağlam bir blok ve tanımından kalıp ustanın çıkartmada bir kalıp ustası geliştirme içerir. Kalıp parçaları oluşturulabilir ve daha sonra kalıp boşluğu içinde yer alan şekil verilmiş bileşenleri ile vida, çubuklar ve fındık kullanılarak monte edilir. Elastomer mixing malzeme potansiyel boşluk alanları kaldırmak için ham madde ve gaz giderme bölümleri A ve B birleştirerek içerir. Daha sonra, enjeksiyon elastomer polimer zincirlerinin kimyasal çapraz bağlanmasını sağlamak için sıcaklık kontrollü bir fırında elastomer işlemeden sonra, kalıp boşluğunun basınçla çalışan dolgu içerir. Bu adımların içine enjeksiyon süreci parçalayarak düşük maliyetli alternatifler lehine geleneksel LMT ekipman vazgeçmek için bize sağlar. Bunun yerine, bir metal kalıp ya da işleme bir kalıp ana bir silikon kauçuk kalıp döküm, örneğin, bu yazıda tarif edilen protokole oluşturulan kalıplar, bir erimiş birikim modelleme (FDM) 3B kullanılarak akrilonitril butadien stiren (ABS) ikinci plastik oluşturulan Yazıcı 8,9. Metal kalıplar veya SLA kalıpları bina ile karşılaştırıldığında, FDM genellikle daha ucuz ve daha hızlı bir süreçtir. Oldukça karmaşık kalıplar içi bir 3D yazıcı hızla basılı ya da ucuza birçok sözleşme 3D printin biri tarafından üretilebilirMevcut g hizmetleri. Örneğin, kompleks, sekiz parçalı baskılı 3D kalıp temsil sonuç bölümünde gösterilen vajina prob döküm için kullanılmış ve Şekiller 14 ve 15&#39;te gösterilmektedir. Bu kalıp için tüm parçalar bir in-house 3D yazıcı yaklaşık 1,5 gün basılabilir. Basit kalıplar için geri dönüş süreleri birkaç saat olabilir. Kalıp oluşturmak için FDM 3D yazıcılar kullanan bir cihazı prototip için gerekli zamanın toplam uzunluğu silikon kauçuk dışında bir kalıp döküm ve poliüretan prototip oluşturmak için gereken zaman benzer. Ancak, kalıp oluşturmak için FDM 3D yazıcılar kullanarak kolayca bir silikon kalıp kullanılarak başarılı olamaz çeşitli şeyler için izin verir: (1) bir çok termoset elastomerler (2) karmaşık geometriler, 3D baskılı kalıp gerekli kür sıcaklığa dayanabilen temin kullanılabilir Birçok farklı kalıp parçaları ve ayırma çizgilerinin kullanımı ile oluşturulan ve katı kalıp parçalarının (3) kullanma imkanı sağlar edilebilir hassas ve reproducikalıp boşluğu içinde kalıplanmış parçaların ble hizalama. Bunun yerine, geleneksel karıştırma LIM birleştiren makine, enjeksiyon ve kür kullanarak, bu homojen karışım, enjeksiyon için bir modifiye edilmiş desikatörde ve tedavi için standart bir sıcaklık kontrollü bir fırın sağlamak için bir laboratuar karıştırıcı kullanmak mümkündür. Enjeksiyon sistemi off-the-shelf bileşenler kullanılarak oluşturulur ve karışık elastomer ile dolu bir şırıngaya bağlanır kurutma cihazı içine pozitif basınçlı besleme hattının eklenmesini içerir edildi. Tezgah üstü desiccators Chamber basınçlandırma tipik olarak odaları, bir vakum besleme hattı ve atmosfer arasında üç yönlü bir valf ile kontrol edilir. Modifiye edilmiş kurutma cihazı, bir şırınga pistonunun arkasına besleyen bir pozitif basınç kaynağı bir çizgi ekler. Bu, kalıp boşluğu içine sıvı madde enjeksiyon için yeterli olan 40-50 psi basınç farkı oluşturulmasını sağlar. Bu teknik bize süreden izinüstkalıplanmış elektriksel ve optik sensörler ile ce silikon vajina sondalar bir Faz I klinik deneme için proof-of-concept verilerine toplamak için. Silikon, çünkü biyolojik eylemsizlik gibi yöntemleri de 10,11 çeşitli sterilize etmek yeteneği için ihtiyaç seçildi. Bundan başka, cihaz sensörler serviks arayüzü için bulunan sondanın ucunda karmaşık ve geleneksel olmayan tas benzeri geometri gerekmektedir. Açıklanan teknik kullanmadan, bu cihazlar üretmek için çok daha pahalı ve uzun bir süreç olurdu. Pratik elastomerik cihazları tasarlamak için hızlı ve yinelemeli bir yaklaşım benimseyen, geleneksel LIM sürecine kıyasla LMT sürecinin bu adaptasyon maliyeti ve ekipman gereksinimlerini azaltır.

<table border="0" cellpadding="0" cellspacing="0" width="1434">
	<tbody>
		<tr>
			<td>ABS Model Material</td>
			<td>Stratasys</td>
			<td>P430</td>
			<td>Model Material for uPrint Plus SE (Step: Mold Design &#38; Production)</td>
		</tr>
		<tr>
			<td>Soluble Support Material</td>
			<td>Stratasys</td>
			<td>SR-30</td>
			<td>Support Material for uPrint Plus SE (Step: Mold Design &#38; Production)</td>
		</tr>
		<tr>
			<td>Underwater Silicone Sealant, 2.8 Oz Tube, Clear</td>
			<td>McMaster-Carr Supply Company</td>
			<td>7327A21</td>
			<td>Silicone RTV for sealing gaps at mold parting lines (Step: Mold Assembly)</td>
		</tr>
		<tr>
			<td>Tubing, 1/8&#34; ID, 1/4&#34; OD, 1/16&#34; Wall Thickness, Ultra-chemical-resistant Tygon PVC, Clear</td>
			<td>McMaster-Carr Supply Company</td>
			<td>5046K11</td>
			<td>Forms runner/sprue adapter between mold and syringe with elastomer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Coupling, Adapter, Straight, Male Quick-turn (Luer lock) X 1/8&#34; Tube Barb, Nylon</td>
			<td>McMaster-Carr Supply Company</td>
			<td>51525K123</td>
			<td>Connect runner/sprue between mold and syringe with elastomer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Coupling, Adapter, Staight, Female Quick-turn (Luer lock) X 1/8&#34; Tube Barb, Nylon</td>
			<td>McMaster-Carr Supply Company</td>
			<td>51525K213</td>
			<td>Connect runner/sprue between mold and syringe with elastomer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Cap, Female Quick-turn (Luer lock), Nylon</td>
			<td>McMaster-Carr Supply Company</td>
			<td>51525K315</td>
			<td>Cap to prevent silicone from leaking out of mold after injection (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Liquid Silicone Rubber (LSR) 30 - 10:1, Implant Grade</td>
			<td>Applied Silicone Corporation</td>
			<td>PN40029</td>
			<td>Substitute with the elastomer of your choice.&#160; This is the one used for the intravaginal probe (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Syringes (BD), 1mL Slip-Tip, non-sterile clean, bulk</td>
			<td>Cole-Parmer</td>
			<td>WU-07945-00</td>
			<td>Syringes for transfering elastomer material (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Syringes (BD), 1mL Slip-Tip, non-sterile clean, bulk</td>
			<td>Cole-Parmer</td>
			<td>WU-07945-04</td>
			<td>Syringes for transfering elastomer material (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Syringe, 20mL, Open Bore, Solid Ring Plunger and Grip</td>
			<td>Qosina Corporation</td>
			<td>C1200</td>
			<td>Syringes for transfering elastomer material.&#160; Open bore is used for very viscous elastomers. (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Needle (BD), Non-sterile Clean with Shields, 18 gauge X 1.5&#34; Lg., Stainless Steel, BD Bulk&#160;</td>
			<td>Cole-Parmer</td>
			<td>WU-07945-76</td>
			<td>Used for removing air column between syringe plunger and elastomer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Plastic Cups, 12 Oz., Clear</td>
			<td>Safeway</td>
			<td>N/A</td>
			<td>Used for mixing silicone in THINKY Mixer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Polyethylene Bag, Open-Top, Flat, 5&#34; Width X 6&#34; Height, 2-MIL Thk.</td>
			<td>McMaster-Carr Supply Company</td>
			<td>1928T68</td>
			<td>Used for mixing silicone in THINKY Mixer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Rubber Band, Latex Free, Orange, Size 64, 3-1/2&#34; L X 1/4&#34; W</td>
			<td>McMaster-Carr Supply Company</td>
			<td>12205T96</td>
			<td>Used for mixing silicone in THINKY Mixer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Parafilm Wrap, 4&#34;W</td>
			<td>Cole-Parmer</td>
			<td>EW-06720-40</td>
			<td>Used for mixing silicone in THINKY Mixer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Syringe Barrels with Stoppers, Luer Lock, Air Operated,&#160; 50mL</td>
			<td>EWD Solutions</td>
			<td>JEN-JG50A-15</td>
			<td>Smaller syringes can be used if less elastomer is required, but make sure it is compatible with Air Operated Syringe Adapter in injection chamber (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Sealant Tape, Pipe Thread, 50&#39;Lg X 1/4&#34; W, .0028&#34; Thk, 0.5 G/CC Specific Gravity&#160;</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4591K11</td>
			<td>Teflon Tape for air-tight seals around at threads (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Scalpel Blades, Disposable, No. 22</td>
			<td>VWR</td>
			<td>21909-646</td>
			<td>Used for cutting tubing and demolding (Step: Curing &#38; Demolding)</td>
		</tr>
		<tr>
			<td>Kimwipes</td>
			<td>VWR</td>
			<td>21903-005</td>
			<td>&#160;(Step: Curing &#38; Demolding)</td>
		</tr>
		<tr>
			<td>2-Propanol, J. T. Baker</td>
			<td>VWR</td>
			<td>JT9334-3</td>
			<td>&#160;(Step: Curing &#38; Demolding)</td>
		</tr>
		<tr>
			<td>uPrint Plus SE 3D Printer</td>
			<td>Stratasys</td>
			<td>uPrint Plus SE</td>
			<td>Other 3D printers can be used (Step: Mold Design &#38; Production)</td>
		</tr>
		<tr>
			<td>Screw, Cap, Hex Head,&#160; 1/4&#34;-28 , 2-1/2&#34; Lg, 18-8 Stainless Steel</td>
			<td>McMaster-Carr Supply Company</td>
			<td>92198A115</td>
			<td>Screws used with nuts to compress mold (Step: Mold Assembly)</td>
		</tr>
		<tr>
			<td>Nut, Hex, 1/4&#34;-28, 7/16&#34; Wd, 7/32&#34; Height, 18-8 Stainless Steel&#160;</td>
			<td>McMaster-Carr Supply Company</td>
			<td>91845A105</td>
			<td>Screws used with nuts to compress mold (Step: Mold Assembly)</td>
		</tr>
		<tr>
			<td>Stud, Fully Threaded, 1/4&#34;-28, 1&#34; Lg, 18-8 Stainless Steel&#160;</td>
			<td>McMaster-Carr Supply Company</td>
			<td>95412A567</td>
			<td>Threaded-rods can be cut to desired length and are used with nutes to compress mold (Step: Mold Assembly)</td>
		</tr>
		<tr>
			<td>Planetary Centrifugal Mixer</td>
			<td>THINKY USA Inc.</td>
			<td>ARE-310</td>
			<td>Mixers are strongly recommended for fine mixing and to reduce degassing time, but hand mixing is fine (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Laboratory Weigh Scale</td>
			<td>Mettler-Toledo International Inc.</td>
			<td>EL602</td>
			<td>&#160;(Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Desiccant Vacuum Canister, Reusable,&#160; 10-3/4&#34; OD</td>
			<td>McMaster-Carr Supply Company</td>
			<td>2204K7</td>
			<td>This desiccator is used for degassing the elastomer (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Custom 3D-Printed Mixer-to-Cup Adapter</td>
			<td>N/A</td>
			<td>N/A</td>
			<td>Modeled in Solidworks CAD and 3D printed (Step: Elastomer Mixing)</td>
		</tr>
		<tr>
			<td>Tubing, Smooth Bore, 1/4&#34; ID, 1/2&#34; OD, 1/8&#34; Wall Thickness, High Purity Tygon PVC, Clear</td>
			<td>McMaster-Carr Supply Company</td>
			<td>5624K51</td>
			<td>Tubing outside of Desiccator (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Tubing, Smooth Bore, 3/8&#34; ID, 5/8&#34; OD, 1/8&#34; Wall Thickness, High Purity Tygon PVC, Clear</td>
			<td>McMaster-Carr Supply Company</td>
			<td>5624K52</td>
			<td>Tubing to adapt to Air/Vacuum Supply (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Reducer, Straight, Vacuum Barb 3/8&#34; Tube ID X Vacuum Barb 1/4&#34; Tube ID, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>44555K188</td>
			<td>Adapt Tubing outside Desiccator to Tubing leading to Air/Vacuum Supply (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Clamp, Hose &#38; Tube, Worm-Drive, for 7/32&#34; to 5/8&#34; OD tube, 5/16&#34; Wd., 316 SS</td>
			<td>McMaster-Carr Supply Company</td>
			<td>5011T141</td>
			<td>Used on tubing to create Air/Vacuum-tight seal at junctions (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Clamp, Hose, Smooth-Band Worm-Drive, for 1/2&#34; to 3/4&#34; OD tube, 3/8&#34; Wd., 304 SS</td>
			<td>McMaster-Carr Supply Company</td>
			<td>5574K13</td>
			<td>Used on tubing to create Air/Vacuum-tight seal at junctions (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Tee, Vacuum Barb 1/4&#34; Tube ID, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>44555K138</td>
			<td>Tee Junction between Vacuum, Three-way T-valve on Desiccator, and Three-way L-valve (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Tee, 1/4 NPT Female X Female X Male, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>50785K222</td>
			<td>Tee Junction between Pressure Gauge, Chamber, and Three-way L-valve (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Valve, Ball, Straight, T-Handle, 1/4 NPT Female X Male, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4082T42</td>
			<td>Three-way L-valve (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Adapter, Straight, Vacuum Barb 1/4&#34; ID Tube X 1/4 NPT Male, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>44555K132</td>
			<td>Adapter for Three-way L-valve-to-Tubing (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Saw, Hole, Bimetal. 1-3/8&#34; OD, 1-1/2&#34; Cutting Depth</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4066A25</td>
			<td>Used to cut holes in Desiccator for throughwall fittings (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Arbor, 9/16&#34; to 1-3/16&#34; Saw, 1/4&#34; Hex</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4066A76</td>
			<td>Used to cut holes in Desiccator for throughwall fittings (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Arbor Adapter for 1-1/4&#34; Thru 6&#34; Dia Hole Saws</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4066A77</td>
			<td>Used to cut holes in Desiccator for throughwall fittings (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Straight, Through-Wall, 1/2 NPT Female, Polypropylene</td>
			<td>McMaster-Carr Supply Company</td>
			<td>36895K141</td>
			<td>Throughwall fittings leading to Pressure/Vacuum Gauges (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Adapter, Straight, Reducing,&#160; Bushing, Hex, 1/2 NPT Male X 1/4 NPT Female, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4429K422</td>
			<td>Reducing tube diameter inside the Desiccator to adapt to Air-operated Syringe System (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Adapter, Straight, Reducing, Bushing, Hex, 1/4 NPT Male X 1/8 NPT Female, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4757T91</td>
			<td>Reducing tube diameter inside the Desiccator to adapt to Air-operated Syringe System (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Coupling, Adapter, Straight, Vacuum Barb 1/4&#34; ID Tube X 1/8 NPT Female, Brass</td>
			<td>McMaster-Carr Supply Company</td>
			<td>44555K124</td>
			<td>Reducing tube diameter inside the Desiccator to adapt to Air-operated Syringe System (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Syringe Adapters, Air Operated, 30/50mL</td>
			<td>EWD Solutions</td>
			<td>JEN-JG30A-X6</td>
			<td>Air operated syringe adapter on the inside of the Desiccator; must be compatible with syringes used to hold elastomer (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Gauge, Dual-Scale Vacuum, 2-1/2&#34; Dial, 1/4 NPT Male, Bottom Connector, 30&#34; Hg-0, Steel Case</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4002K11</td>
			<td>Vacuum Gauge (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Gauge, Dual-Scale Vacuum and Compound, 3-1/2&#34; Dial, 1/4 NPT Male, Center Back, 30&#34; Hg-0, 100 PSI, Steel Case</td>
			<td>McMaster-Carr Supply Company</td>
			<td>4004K616</td>
			<td>Pressure Gauge leading to Air-operated Syringe System (Step: Elastomer Injection)</td>
		</tr>
		<tr>
			<td>Oven, Vacuum, Isotemp, Economy&#160;</td>
			<td>Fisher Scientific</td>
			<td>280A</td>
			<td>Standard non-vacuum oven can be used (Step: Curing &#38; Demolding)</td>
		</tr>
		<tr>
			<td>Solidworks CAD</td>
			<td>Dassault Syst&#232;mes</td>
			<td>Solidworks Research Subscription</td>
			<td>Other CAD Software can be used for mold master and mold design (Step: Mold Design &#38; Production)</td>
		</tr>
	</tbody>
</table>

rapid and low-cost prototyping of medical devices using 3d printed molds for liquid injection molding

Silikon gibi biyolojik olarak hareketsiz elastomerleri tıbbi cihaz üretimi için uygun malzemelerdir, fakat şekillendirme ve geleneksel sıvı enjeksiyon kalıplama işlemleri kullanılarak, bu elastomerlerin sertleştirme nedeniyle alet ve ekipman maliyetleri için pahalı bir işlem olabilir. Bunun bir sonucu olarak, geleneksel olarak, düşük maliyetli, hızlı prototipleme uygulamalar için sıvı enjeksiyon kalıplama kullanımı pratik olmuştur. Kalıp tasarımı ve bir enjeksiyon sistemi gibi bir tadil edilmiş kurutucuda için erimiş birikim modelleme 3D yazıcılar kullanır sıvı elastomer enjeksiyon kalıp cihazları, hızlı ve düşük maliyetli bir üretim için bir yöntem geliştirdik. Düşük maliyetleri ve bu tekniğin hızlı gerçekleştirme süresi tekrarlanarak tasarımı ve karmaşık elastomer cihazları prototip için bariyer düşük. Ayrıca, bu işlemde gelişmiş CAD model, daha sonra geleneksel bir enjeksiyon kalıplama işlemi kolay geçiş sağlayan, metal kalıp kalıp tasarımı için uyarlanabilir. Biz intravag üretmek için bu tekniği kullanmışbir akademik araştırma laboratuvarında içinde sık mevcut araçları kullanarak, karmaşık geometrik, hem de metal parçaları üzerinde overmolding içeren inal sondalar. Ancak, bu teknik kolayca birçok başka uygulamalar için sıvı enjeksiyon kalıp cihazlar oluşturmak için adapte edilebilir.

Şekiller 14 ve 15&#39;de kalıp ve vajina içi prob bu yazıda anlatılan prosedür temsili sonuçlarını gösterir. <img alt="Şekil 14" fo:content-width="5in" src="/files/ftp_upload/51745/51745fig14highres.jpg" width="500" /> Şekil 14. Tam Montajlı Kalıp. Tamamen vajina prob cihaz için kalıp toplandı. <img alt="Şekil 15" fo...

Watch this Scientific Journal Video about Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding at JoVE.com

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

Biz bir sıvı enjeksiyon sistemi olarak kalıp tasarımı ve modifiye desikatöre için erimiş birikimi modelleme 3D yazıcılar kullanarak düşük maliyetli ve sıvı elastomer kauçuk enjeksiyon kalıp cihazların hızlı prototipleme için bir yöntem geliştirdiler.

Sıvı Enjeksiyon için 3D Baskılı Kalıpları Kullanma Tıbbi Cihazlar hızlı ve düşük maliyetli Prototip

Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using ...

rapid-low-cost-prototyping-medical-devices-using-3d-printed-molds-for

Research

JoVE Journal

Bioengineering

19.7K Görüntüleme.  University of California, San Francisco.  Biz bir sıvı enjeksiyon sistemi olarak kalıp tasarımı ve modifiye desikatöre için erimiş birikimi modelleme 3D yazıcılar kullanarak düşük maliyetli ve sıvı elastomer kauçuk enjeksiyon kalıp cihazların hızlı prototipleme için bir yöntem geliştirdiler. 

Video: Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

High Throughput Microfluidic Rapid and Low Cost Prototyping Packaging Methods

In this work, 3 different packaging and assembly techniques are presented. They can be classified into two categories: one-time use and reusable packaging techniques.
The one-time use packaging technique employs UV-based and temperature curing epoxies to connect microtubes to access holes, wire-bonding for integrated circuit connections, and silver epoxy for electrical connections. This method is based on a robust assembly technique that can support relatively high pressure close to 1 psi and does not need any support to strengthen the microfluidic architecture.
Reusable packaging techniques consist of PDMS-based microtube interconnectors and anisotropic adhesive films for electrical connections. These devices are more sensitive and fragile. Consequently, Plexiglas support is added to the microfluidic structure to improve the electrical contact when anisotropic adhesive films are used, and also to strengthen the microfluidic architecture. In addition, a micromanipulator is needed to maintain tubes while using a thin PDMS layer to connect them to the access holes. Different PDMS layer thicknesses, ranging from 0.45-3 mm, are tested to compare the best adherence versus injection rates. Applied injection rates are varied from 50-300 &#956;l/hr for 0.45-3 mm PDMS layers, respectively. These techniques are mainly applicable for low-pressure applications. However, they can be extended for high-pressure ones through plasma-oxygen process to permanently seal the PDMS to glass substrates. The main advantage of this technique, besides the fact that it is reusable, consists of keeping the device observable when the microchannel length is very short (in the range of 3 mm or lower).

In this article we describe different techniques for microfluidic rapid prototyping platforms. The proposed techniques are based on ultraviolet (UV) sensitive and temperature curing epoxies, polydimethylsiloxane (PDMS) based tubing, wire-bonding, and anisotropic adhesive films. The assembling procedures presented are developed for both one-time use devices as well as reusable microfluidic systems.

In this work, 3 different packaging and assembly techniques are presented. They can be classified into two categories: one-time use and reusable packaging ...

Biyomühendislik

Using Adhesive Patterning to Construct 3D Paper Microfluidic Devices

We demonstrate the use of patterned aerosol adhesives to construct both planar and nonplanar 3D paper microfluidic devices. By spraying an aerosol adhesive through a metal stencil, the overall amount of adhesive used in assembling paper microfluidic devices can be significantly reduced. We show on a simple 4-layer planar paper microfluidic device that the optimal adhesive application technique and device construction style depends heavily on desired performance characteristics. By moderately increasing the overall area of a device, it is possible to dramatically decrease the wicking time and increase device success rates while also reducing the amount of adhesive required to keep the device together. Such adhesive application also causes the adhesive to form semi-permanent bonds instead of permanent bonds between paper layers, enabling single-use devices to be non-destructively disassembled after use. Nonplanar 3D origami devices also benefit from the semi-permanent bonds during folding, as it reduces the likelihood that unrelated faces may accidently stick together. Like planar devices, nonplanar structures see reduced wicking times with patterned adhesive application vs uniformly applied adhesive.

We demonstrate the use of patterned aerosol adhesives to construct 3D paper microfluidic devices. This method of adhesive application forms semi-permanent bonds between layers, enabling single-use devices to be non-destructively disassembled after use and to ease folding complex nonplanar structures.

3D Kağıt mikroakışkan Cihazlar Construct Yapışkan Desenlendirme kullanma

We demonstrate the use of patterned aerosol adhesives to construct both planar and nonplanar 3D paper microfluidic devices. By spraying an aerosol ...

High-throughput Identification of Bacteria Repellent Polymers for Medical Devices

Medical devices are often associated with hospital-acquired infections, which place enormous strain on patients and the healthcare system as well as contributing to antimicrobial resistance. One possible avenue for the reduction of device-associated infections is the identification of bacteria-repellent polymer coatings for these devices, which would prevent bacterial binding at the initial attachment step. A method for the identification of such repellent polymers, based on the parallel screening of hundreds of polymers using a microarray, is described here. This high-throughput method resulted in the identification of a range of promising polymers that resisted binding of various clinically relevant bacterial species individually and also as multi-species communities. One polymer, PA13 (poly(methylmethacrylate-co-dimethylacrylamide)), demonstrated significant reduction in attachment of a number of hospital isolates when coated onto two commercially available central venous catheters. The method described could be applied to identify polymers for a wide range of applications in which modification of bacterial attachment is important.

A high-throughput microarray method for the identification of polymers which reduce bacterial surface binding on medical devices is described.

Tıbbi Cihazlar Bakterilerin yüksek verimlilik Kimlik Savar Polimerler

Medical devices are often associated with hospital-acquired infections, which place enormous strain on patients and the healthcare system as well as ...

Automated Robotic Liquid Handling Assembly of Modular DNA Devices

Recent advances in modular DNA assembly techniques have enabled synthetic biologists to test significantly more of the available &#34;design space&#34; represented by &#34;devices&#34; created as combinations of individual genetic components. However, manual assembly of such large numbers of devices is time-intensive, error-prone, and costly. The increasing sophistication and scale of synthetic biology research necessitates an efficient, reproducible way to accommodate large-scale, complex, and high throughput device construction.
Here, a DNA assembly protocol using the Type-IIS restriction endonuclease based Modular Cloning (MoClo) technique is automated on two liquid-handling robotic platforms. Automated liquid-handling robots require careful, often times tedious optimization of pipetting parameters for liquids of different viscosities (e.g. enzymes, DNA, water, buffers), as well as explicit programming to ensure correct aspiration and dispensing of DNA parts and reagents. This makes manual script writing for complex assemblies just as problematic as manual DNA assembly, and necessitates a software tool that can automate script generation. To this end, we have developed a web-based software tool, http://mocloassembly.com, for generating combinatorial DNA device libraries from basic DNA parts uploaded as Genbank files. We provide access to the tool, and an export file from our liquid handler software which includes optimized liquid classes, labware parameters, and deck layout. All DNA parts used are available through Addgene, and their digital maps can be accessed via the Boston University BDC ICE Registry. Together, these elements provide a foundation for other organizations to automate modular cloning experiments and similar protocols.
The automated DNA assembly workflow presented here enables the repeatable, automated, high-throughput production of DNA devices, and reduces the risk of human error arising from repetitive manual pipetting. Sequencing data show the automated DNA assembly reactions generated from this workflow are ~95% correct and require as little as 4% as much hands-on time, compared to manual reaction preparation.

Here, an automated workflow to perform modular DNA &#34;device&#34; assembly using a modular cloning DNA assembly method on liquid-handling robots is presented. The protocol uses an intuitive software tool for generating liquid handler picklists for combinatorial DNA device library generation, which we demonstrate using two liquid handling platforms.

Robot sıvı işleme derleme modüler DNA cihazların otomatik

Recent advances in modular DNA assembly techniques have enabled synthetic biologists to test significantly more of the available &#34;design space&#34; ...

Scaling of Engineered Vascular Grafts Using 3D Printed Guides and the Ring Stacking Method

Coronary artery disease remains a leading cause of death, affecting millions of Americans. With the lack of autologous vascular grafts available, engineered grafts offer great potential for patient treatment. However, engineered vascular grafts are generally not easily scalable, requiring manufacture of custom molds or polymer tubes in order to customize to different sizes, constituting a time-consuming and costly practice. Human arteries range in lumen diameter from about 2.0-38 mm and in wall thickness from about 0.5-2.5 mm. We have created a method, termed the "Ring Stacking Method," in which variable size rings of tissue of the desired cell type, demonstrated here with vascular smooth muscle cells (SMCs), can be created using guides of center posts to control lumen diameter and outer shells to dictate vessel wall thickness. These tissue rings are then stacked to create a tubular construct, mimicking the natural form of a blood vessel. The vessel length can be tailored by simply stacking the number of rings required to constitute the length needed. With our technique, tissues of tubular forms, similar to a blood vessel, can be readily manufactured in a variety of dimensions and lengths to meet the needs of the clinic and patient.

Scalable engineered blood vessels would improve clinical applicability. Using easily sizable 3D-printed guides, rings of vascular smooth muscle were created and stacked into a tubular form, forming a vascular graft. Grafts can be sized to meet the range of human coronary artery dimensions by simply changing the 3D-printed guide size.

3D Baskılı Kılavuzları ve Halka İstifleme Yöntemiyle Engineered Vasküler Greft ölçeklendirme

Coronary artery disease remains a leading cause of death, affecting millions of Americans. With the lack of autologous vascular grafts available, ...

Synthesis of Biocompatible Liquid Crystal Elastomer Foams as Cell Scaffolds for 3D Spatial Cell Cultures

Here, we present a step-by-step preparation of a 3D, biodegradable, foam-like cell scaffold. These scaffolds were prepared by cross-linking star block co-polymers featuring cholesterol units as side-chain pendant groups, resulting in smectic-A (SmA) liquid crystal elastomers (LCEs). Foam-like scaffolds, prepared using metal templates, feature interconnected microchannels, making them suitable as 3D cell culture scaffolds. The combined properties of the regular structure of the metal foam and of the elastomer result in a 3D cell scaffold that promotes not only higher cell proliferation compared to conventional porous templated films, but also better management of mass transport (i.e., nutrients, gases, waste, etc.). The nature of the metal template allows for the easy manipulation of foam shapes (i.e., rolls or films) and for the preparation of scaffolds of different pore sizes for different cell studies while preserving the interconnected porous nature of the template. The etching process does not affect the chemistry of the elastomers, preserving their biocompatible and biodegradable nature. We show that these smectic LCEs, when grown for extensive time periods, enable the study of clinically relevant and complex tissue constructs while promoting the growth and proliferation of cells.

This study presents a methodology to prepare 3D, biodegradable, foam-like cell scaffolds based on biocompatible side-chain liquid crystal elastomers (LCEs). Confocal microscopy experiments show that foam-like LCEs allow for cell attachment, proliferation, and the spontaneous alignment of C2C12s myoblasts.

3D Mekansal Hücre Kültürleri için hücre yapı iskeleleri olarak biyo-uyumlu sıvı kristal Elastomer Köpüklerin sentezi

Here, we present a step-by-step preparation of a 3D, biodegradable, foam-like cell scaffold. These scaffolds were prepared by cross-linking star block ...

Fabrication of Custom Agarose Wells for Cell Seeding and Tissue Ring Self-assembly Using 3D-Printed Molds

Engineered tissues are being used clinically for tissue repair and replacement, and are being developed as tools for drug screening and human disease modeling. Self-assembled tissues offer advantages over scaffold-based tissue engineering, such as enhanced matrix deposition, strength, and function. However, there are few available methods for fabricating 3D tissues without seeding cells on or within a supporting scaffold. Previously, we developed a system for fabricating self-assembled tissue rings by seeding cells into non-adhesive agarose wells. A polydimethylsiloxane (PDMS) negative was first cast in a machined polycarbonate mold, and then agarose was gelled in the PDMS negative to create ring-shaped cell seeding wells. However, the versatility of this approach was limited by the resolution of the tools available for machining the polycarbonate mold. Here, we demonstrate that 3D-printed plastic can be used as an alternative to machined polycarbonate for fabricating PDMS negatives. The 3D-printed mold and revised mold design is simpler to use, inexpensive to produce, and requires significantly less agarose and PDMS per cell seeding well. We have demonstrated that the resulting agarose wells can be used to create self-assembled tissue rings with customized diameters from a variety of different cell types. Rings can then be used for mechanical, functional, and histological analysis, or for fabricating larger and more complex tubular tissues.

This protocol describes a platform for fabricating self-assembled tissue rings in variable sizes using a customized 3D-printed plastic mold. PDMS negatives are cured in the 3D-printed mold; then agarose is cast in the cured PDMS negatives. Cells are seeded into the resulting agarose wells where they aggregate into tissue rings.

Hücre tohum için özel özel Wells ve kendinden montajlı 3D baskı kalıpları kullanarak doku yüzük imalatı

Engineered tissues are being used clinically for tissue repair and replacement, and are being developed as tools for drug screening and human disease ...

Wet-spinning-based Molding Process of Gelatin for Tissue Regeneration

This article presents an inexpensive method to fabricate gelatin, as a natural polymer, into monofilament fibers or other appropriate forms. Through the wet spinning method, gelatin fibers are produced by smooth extrusion in a suitable coagulation medium. To increase the functional surface of these gelatin fibers and their ability to mimic the features of tissues, gelatin can be molded into a tube form by referring to this concept. Examined by in vitro and in vivo tests, the gelatin tubes demonstrate a great potential for application in tissue engineering. Acting as a suitable filling gap material, gelatin tubes can be used to substitute the tissue in the damaged area (e.g., in the nervous or cardiovascular system), as well as to promote regeneration by providing a direct replacement of stem cells and neural circuitry. This protocol provides a detailed procedure for creating a biomaterial based on a natural polymer, and its implementation is expected to greatly benefit the development of correlative natural polymers, which help to realize tissue regeneration strategies.

We developed and describe a protocol based on the wet spinning concept, for the construction of gelatin-based biomaterials used for the application of tissue engineering.

Islak eğirme esaslı kalıplama işlemi doku rejenerasyonu için jelatin

This article presents an inexpensive method to fabricate gelatin, as a natural polymer, into monofilament fibers or other appropriate forms. Through the ...

3D Printed Porous Cellulose Nanocomposite Hydrogel Scaffolds

This work demonstrates the use of three-dimensional (3D) printing to produce porous cubic scaffolds using cellulose nanocomposite hydrogel ink, with controlled pore structure and mechanical properties. Cellulose nanocrystals (CNCs, 69.62 wt%) based hydrogel ink with matrix (sodium alginate and gelatin) was developed and 3D printed into scaffolds with uniform and gradient pore structure (110-1,100 &#181;m). The scaffolds showed compression modulus in the range of 0.20-0.45 MPa when tested in simulated in vivo conditions (in distilled water at 37 &#176;C). The pore sizes and the compression modulus of the 3D scaffolds matched with the requirements needed for cartilage regeneration applications. This work demonstrates that the consistency of the ink can be controlled by the concentration of the precursors and porosity can be controlled by the 3D printing process and both of these factors in return defines the mechanical properties of the 3D printed porous hydrogel scaffold. This process method can therefore be used to fabricate structurally and compositionally customized scaffolds according to the specific needs of patients.&#160;

The three critical steps of this protocol are i) developing the right composition and consistency of the cellulose hydrogel ink, ii) 3D printing of scaffolds into various pore structures with good shape fidelity and dimensions and iii) demonstration of the mechanical properties in simulated body conditions for cartilage regeneration.

3D gözenekli selüloz Nanocomposite hidrojel iskele baskılı

This work demonstrates the use of three-dimensional (3D) printing to produce porous cubic scaffolds using cellulose nanocomposite hydrogel ink, with ...

Design of an Open-Source, Low-Cost Bioink and Food Melt Extrusion 3D Printer

Three-dimensional (3D) printing is an increasingly popular manufacturing technique that allows highly complex objects to be fabricated with no retooling costs. This increasing popularity is partly driven by falling barriers to entry such as system set-up costs and ease of operation. The following protocol presents the design and construction of an Additive Manufacturing Melt Extrusion (ADDME) 3D printer for the fabrication of custom parts and components. ADDME has been designed with a combination of 3D-printed, laser-cut, and online-sourced components. The protocol is arranged into easy-to-follow sections, with detailed diagrams and parts lists under the headings of framing, y-axis and bed, x-axis, extrusion, electronics, and software. The performance of ADDME is evaluated through extrusion testing and 3D printing of complex objects using viscous cream, chocolate, and Pluronic F-127 (a model for bioinks). The results indicate that ADDME is a capable platform for the fabrication of materials and constructs for use in a wide range of industries. The combination of detailed diagrams and video content facilitates access to low-cost, easy-to-operate equipment for individuals interested in 3D printing of complex objects from a wide range of materials.

The aim of this work is to design and construct a reservoir-based melt extrusion three-dimensional printer made from open-source and low-cost components for applications in the biomedical and food printing industries.

Bir Açık Kaynak Tasarımı, Düşük Maliyetli Bioink ve Gıda Melt Extrusion 3D Yazıcı

Three-dimensional (3D) printing is an increasingly popular manufacturing technique that allows highly complex objects to be fabricated with no retooling ...