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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(1-2), 226-221 (2001).</li><li>Etemadi, M., Chung, P., Heller, J., Liu, J., Rand, L., Roy, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Towards+BirthAlert+-+A+Clinical+Device+Intended+for+Early+Preterm+Birth+Detection.">Towards BirthAlert - A Clinical Device Intended for Early Preterm Birth Detection.</a> IEEE Trans Biomed Eng. 10, (2013).</li><li>Etemadi, M., Chung, P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Novel+device+to+trend+impedance+and+fluorescence+of+the+cervix+for+preterm+birth+detection.">Novel device to trend impedance and fluorescence of the cervix for preterm birth detection.</a> Conf Proc IEEE Eng Med Biol Soc. 2013, 176&#8211;9, doi:10.1109/EMBC.2013.6609466. , (2013).</li><li>Owen, S. R., Harper, J. 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>

著者はいずれも、この記事で詳細な作業に関して、いかなる競合する金融利害関係はありません。

記載されているすべてのステップで、慎重な金型の設計が成功の最も重要である。型マスターは、最終的なデバイスと同等の外部形状を有する固形物として作成する必要があります。これらの形状は、どのような材料により選ばれたエラストマー収縮だけでなく、3Dプリンタの解像度と許容誤差を考慮して調整する必要があります。金型パーティングラインの配置と、貫通孔のねじロッドと?...

（また、反応射出成形とも呼ばれます）の液体射出成形（LIM）は、多くの場合、熱硬化性エラストマーからエラストマーデバイスを製造するために使用されるが、高額な開発や設備コストが先行設備投資1の多くを必要としている。さらに、LIMは複雑な形状やオーバーモールドの要件に例で実装することは技術的に挑戦し、高価になることができます。その結果、超低容量で反復又は頻繁に改訂を発生早期デバイス設計伝統的なLIMを使用することが典型的には非現実的である。 射出成形エラストマー材料の典型的な手順は、特殊な成形機2を用いて金型に150 psiの周りの圧力で液体モノマーを注入することを含む。温度および圧力は、層流を確保し、金型3内に捕捉された空気を防ぐために制御される。原材料は、典型的には、白金硬化シリコーン、トンなどの2つの部分からなる硬化系である帽子は、注射前に独立した温度制御室に保存されています。原料の両成分は、その後、金型キャビティ内に供給する高圧混合チャンバにポンピングされる。硬化は、触媒の存在下ならびに周辺温度150〜200℃C 4ことによって達成される。金型は、一般的にエッジ3,5別れを中心に良好なシールを作成するために精密な公差で鋼やアルミニウムから機械加工されています。残念ながら、この方法は、高い金型工具費だけでなく、専門的な注入とフィードバック制御システムの必要性与えられ、一般的に大規模な製造に適している。 ポリウレタン（PU）部品のラピッドプロトタイピングのためには、型マスターを作成して、シリコーンゴム金型6,7を生成するために、ステレオリソグラフィ（SLA）を使用することが可能である。シリコーンは、ことによるように、それがオーバーモールドされた構成要素の正確な位置合わせを達成することは困難であるので、この技術は、オーバーモールディングには適していないデザインではなく、剛性構造。さらに、このような陥入又は中空アウトセクションのような複雑な幾何学的形状を有するデバイスの製造は、困難または不可能である。複雑なまたは正確な金型パーティングラインや剛性の薄い要素に対する要求は、より多くの場合より液状ゴム成形プロセスと互換性がありません。 生産規模、前述または後期プロトタイピングプロセスは、多くの場合、多くの場合、学術の研究室の場合のように、いくつかのデバイスは、人間の研究で概念実証と実現可能性のために製造する必要がある中で、初期段階の医療機器の開発には実用的でないおよびスタートアップ企業環境を。選択肢の欠如は、多くの場合でも、初期段階の開発は、デバイスの機能を制限したり、追加の資金が調達されている間保留に開発を置くために、多くのデバイス開発者を必要とする、高いコストを負担することを意味します。医療機器の大部分は再ので、これは、開発プロセスの劇的な減速に寄与する<html>複雑な機能の帖実装。これは、概念実証データは、多くの場合、まだ確立されていないので、このような装置のコストのかかる開発に資金を供給することも困難である。我々は、指定された子宮頸部のジオメトリに適合するようにカップ状の先端を必要としたオーバーモールド電気的および光学センサを有するシリコーン膣内プローブの開発を伴っこのラボ内での最近のプロジェクトで、この障害が発生しました。この資料に記載されているプロセスは、この悪循環を回避し、急速に概念実証LIM医療機器に到達するための我々の試みを記録します。 （1）金型の設計·製作、（2）金型組立（3）エラストマー混合、（4）エラストマー注入、および（5）エラストマー硬化＆脱型： 図1に示されている技術では5つの主要な活動にLIMプロセスを解体。 PG &quot;幅=&quot; 600 &quot;/&gt; 図1プロトコルの概要が含まれたプロトコルの概要：（1A）（2）ネジ付きロッドとネジを使用して型片の組み立て、（1b）の 3次元型片を印刷し、コンピュータ支援設計ツールを使用して金型を作成し、（ 3）液状エラストマーを混合し、シリンジにそれをロードし、（4）修飾されたデシケータを用いて金型に液状エラストマーを注入し、（5a）の温度制御されたオーブン中でエラストマーを硬化させると、（ 図5b）から、硬化されたエラストマーデバイスを脱型型片。 金型設計は、コンピュータ支援設計（CAD）ソフトウェア、金型パーティングラインの固体ブロックと定義から型マスターの減算で型マスターの開発を伴う。金型片を作成し、金型キャビティ内に配置オーバーモールド部品とねじ、ロッド、及びナットを用いて組み立てられる。エラストマーミックスインGは、材料の潜在的な空隙を除去して原料と脱の部分AとBを結合することを含む。次に、エラストマーの注入は、ポリマー鎖の化学的架橋を確保するために、温度制御されたオーブン中でエラストマー硬化させ、金型キャビティの圧力駆動の​​充填を伴う。 これらのステップに射出成形プロセスを分解すると、低コストの代替手段を支持して、伝統的なLIM機器を放棄することを可能にします。例えば、代わりに、金型を機械加工または型マスターからのシリコーンゴム型にキャストする、本稿に記載されているプロトコルから作成された金型は、溶融堆積モデリング（FDM）3Dを使用して、アクリロニトリルブタジエンスチレン（ABS）プラスチックから作成されたプリンタ8,9。金型またはSLA金型を構築することに比べて、FDMは、一般的に安価で高速なプロセスです。かなり複雑な金型を内製3Dプリンタで迅速に印刷、または安く、多くの契約の3D printinの1で製造することができる利用可能なGのサービスを提供しています。例えば、複雑な八片3Dプリントモールドは代表的な結果の節において明らかに膣プローブをキャストするために使用し、そして図14および15に示す。この金型のためのすべての部品は内製3Dプリンタで約1.5日で印刷することができます。簡単な金型のターンアラウンド時間は数時間することができます。金型を作成するためにFDM 3Dプリンタを使用してデバイスを試作するために必要な時間の全体の長さは、シリコーンゴムから金型にキャストし、ポリウレタンのプロトタイプを作成するために必要な時間と同様である。しかし、金型を作成するためにFDM 3Dプリンタを使用して容易にシリコーンモールドを使用して達成することができないいくつかのことを可能にする：（1）多くの熱硬化性エラストマーを使用することができる3次元プリントモールドは、必要な硬化温度に耐えることができるが設けられ、（2）複雑な形状を多くの異なる型片と分割線を用いて作成され、（3）硬質モールド片の使用は、正確かつreproduci可能にすることができる金型キャビティ内にオーバーモールド部品のBLE整列。 代わりに、伝統的なLIMの混合組み合わせ機、注射、および硬化を用いたのではなく、均質な混合、注射用変性デシケーター、および硬化のための標準的な温度制御されたオーブンを確実にするために実験室用ミキサーを使用することが可能である。注入システムは、既製のコンポーネントを使用して作成した混合エラストマーで充填されたシリンジに接続したデシケーター内に正圧供給ラインの添加を伴うた。ベンチトップデシケーター内室の加圧は、典型的には、チャンバは、真空供給ラインと、大気との間に三方弁によって制御される。修飾されたデシケーターはシリンジプランジャの背面に供給する正圧供給ラインを追加する。これは、金型キャビティ内への液体材料の注入のために十分である40〜50 psiの圧力差の生成を可能にする。 この手法は、私たちはのproduを許可オーバーモールド電気および光センサを備えたCEシリコーン膣内プローブは、第I相臨床試験のための概念実証データを収集する。シリコーンは理由生物学的不活性と同様の方法10,11の様々な殺菌能力の必要性を選択した。さらに、デバイスは、センサが子宮頸部とインタフェースするように配置されたプローブの先端に複雑で、型にはまらないカップ状の幾何学を必要とした。記載された技術を使用することなく、これらのデバイスを製造するための多くの費用と時間のかかるプロセスであったであろう。それは実用的なエラストマーデバイスの設計に迅速かつ反復的なアプローチを採用すること、伝統的なLIMプロセスと比較すると、LIMプロセスのこの適応は、コストおよび装置の要件を軽減します。

<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

シリコーンのような生物学的に不活性エラストマーは、医療用デバイス製造のための有利な材料であるが、従来の液体射出成形プロセスを用いてこれらのエラストマーを形成し、硬化させて工具及び設備費用のために高価なプロセスであることができる。その結果、伝統的に、低コスト、ラピッドプロトタイピング用途のための液体射出成形を使用することは非現実的であった。我々は、金型設計及び注入システムのような修飾されたデシケータ用溶融堆積モデリング3Dプリンタを利用した液状エラストマーの射出成形装置を迅速かつ低コストで製造するための方法を考案した。低コストと、この技術の急速なターンアラウンドタイムは、反復的に複雑なエラストマーデバイスを設計し、プロトタイプを作成するために障壁を下げます。さらに、この過程で開発CADモデルは、後で従来の射出成形プロセスに容易に移行を可能にする、金型工具の設計に適合させることができる。我々は、製造するためにこの技術を使用しているintravag学術研究、実験室の中に一般的に利用可能なツールを使用して、複雑な形状だけでなく、金属部品の上オーバーモールドを含むinalプローブ。しかしながら、この技術は、容易に多くの他の用途のための液体射出成形装置を作成するために適合させることができる。

図14および15にカビや膣内プローブは、この記事で紹介した手順の代表的な結果を示しています。 <img alt="図14" fo:content-width="5in" src="/files/ftp_upload/51745/51745fig14highres.jpg" width="500" /> 図14。完全実装カビが。完全に膣内プローブ装置のための金型を組み立てた。 <p class="jove_content" fo:keep-together.within-page="a...

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

我々は、液体噴射装置として金型設計のために修飾されたデシケーター溶融堆積モデリング、3Dプリンターを使用することにより、低コストで液状エラストマーゴム射出成形装置のラピッドプロトタイピングのための方法を考案した。

液体射出成形用の3Dプリント金型を用いた医療機器を迅速かつ低コストプロトタイピング

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 ビュー.  University of California, San Francisco. 我々は、液体噴射装置として金型設計のために修飾されたデシケーター溶融堆積モデリング、3Dプリンターを使用することにより、低コストで液状エラストマーゴム射出成形装置のラピッドプロトタイピングのための方法を考案した。 

ビデオ: 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.

ハイスループットマイクロ流体の迅速かつ低コストのプロトタイピング包装方法

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

生物工学

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ペーパーマイクロ流体デバイスを構築するために接着剤パターニングを使用して、

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.

医療機器のための細菌撥ポリマーのハイスループット同定

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.

モジュラー DNA デバイスの液体ハンドリング アセンブリを自動化

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プリントガイドとリングスタッキング法を用いたエンジニア血管移植片のスケーリング

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空間の細胞培養のための細胞骨格などの生体適合性液晶エラストマー発泡体の合成

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.

細胞播種用カスタム Agarose 井戸とティッシュ リング自己組織型の 3 D プリントを使用しての作製

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.

組織再生用ゼラチンのウェット ベース回転成形プロセス

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.

3 D プリントされた多孔性セルロース ナノコンポジット型ヒドロゲル足場

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.

オープンソース、低コストのバイオインク、食品溶融物押出3Dプリンタの設計

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

液体射出成形用の3Dプリント金型を用いた医療機器を迅速かつ低コストプロトタイピング

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さらに動画を探す

この動画の章

ハイスループットマイクロ流体の迅速かつ低コストのプロトタイピング包装方法

3Dペーパーマイクロ流体デバイスを構築するために接着剤パターニングを使用して、

医療機器のための細菌撥ポリマーのハイスループット同定

モジュラー DNA デバイスの液体ハンドリングアセンブリを自動化

3Dプリントガイドとリングスタッキング法を用いたエンジニア血管移植片のスケーリング

3D空間の細胞培養のための細胞骨格などの生体適合性液晶エラストマー発泡体の合成

細胞播種用カスタム Agarose 井戸とティッシュリング自己組織型の 3 D プリントを使用しての作製

組織再生用ゼラチンのウェットベース回転成形プロセス

3 D プリントされた多孔性セルロースナノコンポジット型ヒドロゲル足場

オープンソース、低コストのバイオインク、食品溶融物押出3Dプリンタの設計

液体射出成形用の3Dプリント金型を用いた医療機器を迅速かつ低コストプロトタイピング

要約

さらに動画を探す

この動画の章

ハイスループットマイクロ流体の迅速かつ低コストのプロトタイピング包装方法

3Dペーパーマイクロ流体デバイスを構築するために接着剤パターニングを使用して、

医療機器のための細菌撥ポリマーのハイスループット同定

モジュラー DNA デバイスの液体ハンドリング アセンブリを自動化

3Dプリントガイドとリングスタッキング法を用いたエンジニア血管移植片のスケーリング

3D空間の細胞培養のための細胞骨格などの生体適合性液晶エラストマー発泡体の合成

細胞播種用カスタム Agarose 井戸とティッシュ リング自己組織型の 3 D プリントを使用しての作製

組織再生用ゼラチンのウェット ベース回転成形プロセス

3 D プリントされた多孔性セルロース ナノコンポジット型ヒドロゲル足場

オープンソース、低コストのバイオインク、食品溶融物押出3Dプリンタの設計

モジュラー DNA デバイスの液体ハンドリングアセンブリを自動化

細胞播種用カスタム Agarose 井戸とティッシュリング自己組織型の 3 D プリントを使用しての作製

組織再生用ゼラチンのウェットベース回転成形プロセス

3 D プリントされた多孔性セルロースナノコンポジット型ヒドロゲル足場