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Surgical Suture Assembled with Polymeric Drug-Delivery Sheet for Sustained, Local Pain Relief

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Surgical Suture Assembled with Polymeric Drug-Delivery Sheet for Sustained, Local Pain Relief Acta Biomaterialia 9 (2013) 8318–8327 Contents lists available at SciVerse ScienceDirect Acta Biomaterialia journal homepage: www.elsevier.com/locate/actabiomat Surgical suture assembled with polymeric drug-delivery sheet for sustained, local pain relief Ji Eun Lee a,1, Subin Park b,1, Min Park a, Myung Hun Kim a, Chun Gwon Park a, Seung Ho Lee a, ⇑ ⇑ Sung Yoon Choi a, Byung Hwi Kim b, Hyo Jin Park c, Ji-Ho Park d, Chan Yeong Heo e,f, , Young Bin Choy a,b, a Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul 110-799, Republic of Korea b Department of Biomedical Engineering, College of Medicine and Institute of Medical & Biological Engineering, Medical Research Center, Seoul National University, Seoul 110-799, Republic of Korea c Department of Pathology, Seoul National University Bundang Hospital, Seongnam 463-707, Republic of Korea d Department of Bio and Brain Engineering, Korea Advanced Institute of Science and Technology, Daejeon 305-701, Republic of Korea e Department of Plastic Surgery and Reconstructive Surgery, Seoul National University College of Medicine, Seoul 110-799, Republic of Korea f Department of Plastic Surgery and Reconstructive Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Republic of Korea article info abstract Article history: Surgical suture is a strand of biocompatible material designed for wound closure, and therefore can be a Received 23 January 2013 medical device potentially suitable for local drug delivery to treat pain at the surgical site. However, the Received in revised form 21 May 2013 preparation methods previously introduced for drug-delivery sutures adversely influenced the mechan- Accepted 3 June 2013 ical strength of the suture itself – strength that is essential for successful wound closure. Thus, it is not Available online 14 June 2013 easy to control drug delivery with sutures, and the drug-delivery surgical sutures available for clinical use are now limited to anti-infection roles. Here, we demonstrate a surgical suture enabled to provide con- Keywords: trolled delivery of a pain-relief drug and, more importantly, we demonstrate how it can be fabricated to Drug delivery maintain the mechanical strength of the suture itself. For this purpose, we separately prepare a drug- Surgical suture Pain relief delivery sheet composed of a biocompatible polymer and a pain-relief drug, which is then physically Mechanical strength assembled with a type of surgical suture that is already in clinical use. In this way, the drug release pro- Biocompatibility files can be tailored for the period of therapeutic need by modifying only the drug-loaded polymer sheet without adversely influencing the mechanical strength of the suture. The drug-delivery sutures in this work can effectively relieve the pain at the surgical site in a sustained manner during the period of wound healing, while showing biocompatibility and mechanical properties comparable to those of the original surgical suture in clinical use. Ó 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved. 1. Introduction tially be used as a suitable medical device for treatment of pain by drug delivery to the local site of surgery. Post-operative pain originating from the wound is an inevitable Previously, surgical sutures have been processed in several dif- inconvenience for patients after surgery. To treat the pain, a pain- ferent ways for drug delivery: the drug being coated on the su- relief drug is often administered via the oral route or injection; this ture surface by solution dipping [3,4] or grafting [5], or being approach, however, is limited because of low drug bioavailability encased in the suture thread itself [6]. However, such fabrication at the site of action, as well as unnecessary systemic exposure to procedures can be damaging to the suture and its component the drug [1]. The strategy of local drug delivery can resolve this materials, adversely influencing the mechanical strength of the to a large extent [2], and in this sense a surgical suture – a strand suture, which needs to be retained for the purpose of wound clo- of biocompatible material designed for wound closure – can poten- sure. For example, when a suture of a poly(p-dioxaonone) mono- filament was dip-coated with the required drug load, the breaking strain was reported to decrease by more than 30% [4]. Thus, it is ⇑ Corresponding authors. Address: Department of Plastic Surgery and Recon- structive Surgery, Seoul National University College of Medicine, Seoul 110-799, not easy to control drug delivery, and the drug-delivery surgical Republic of Korea. Tel.: +82 31 787 7222 (C.Y. Heo). Address: Department of sutures available in clinical use currently are limited to anti-infec- Biomedical Engineering, College of Medicine and Institute of Medical & Biological tion purposes [7]. Engineering, Medical Research Center, Seoul National University, Seoul 110-799, In this work, for the first time to our knowledge, we demon- Republic of Korea. Tel.: +82 2 740 8597 (Y.B. Choy). strate the sutures enabled with controlled delivery of a pain-relief E-mail addresses: [email protected] (C.Y. Heo), [email protected] (Y.B. Choy). 1 These authors contributed equally as first authors in this work. drug and evaluate their in vivo efficacy and biocompatibility. More 1742-7061/$ - see front matter Ó 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.actbio.2013.06.003 J.E. Lee et al. / Acta Biomaterialia 9 (2013) 8318–8327 8319 a 2.2. Preparation of drug-delivery sutures Drug delivery sheet Original surgical suture We first prepared the drug-delivery sheets by electrospinning (Nano NC, Siheung, Korea) [13]. PLGA was dissolved in a mixed sol- vent of DCM, THF and DMF to prepare a 30% w/v PLGA solution, where 0, 10 and 15% w/w ibuprofen was dissolved to give a sheet of PLGA only (PLGA_S), a sheet of PLGA and ibuprofen (PLGA_IB_S) Drug delivery sheet and a multi-layered one of PLGA and ibuprofen (M_PLGA_IB_S), b respectively. To prepare the PLGA_IB_S, a PLGA and drug solution (10% w/w drug) was electrospun for 100 min. The M_PLGA_IB_S was prepared by electrospinning a PLGA solution without the drug Barrier sheet for 50 min, a PLGA and drug solution (15% w/w drug) for 100 min and a PLGA solution without the drug for 50 min. In this way, the 10 % drug 15 % drug M_PLGA_IB_S was composed of the PLGA sheet loaded with the drug in the middle, which was sandwiched between the sheets Fig. 1. Schematic procedure for preparation of the drug-delivery sutures. (a) The of PLGA only (Fig. 1b). The PLGA_S was prepared by electrospin- drug-delivery sheet composed of PLGA and ibuprofen was separately prepared; it ning a PLGA solution without the drug for 100 min. The following was braided and physically attached on top of the surgical suture in clinical use. (b) conditions were used for all electrospinning procedures: applied Two different types of the drug-delivery sheets were prepared for controlled drug delivery: a single-layered sheet (PLGA_IB_S) of PLGA loaded with 10% w/w voltage: 15 kV; tip-to-collector distance: 10 cm; and flow rate: ibuprofen and multi-layered sheets (M_PLGA_IB_S), where a sheet of PLGA loaded 0.6 ml hÀ1. Each sheet was then each cut by a hand-held scalpel with 15% w/w ibuprofen was sandwiched between the sheets of PLGA only. The to give a strand, 1.5 ± 0.5 mm in width, which was then braided single-layered sheet of PLGA without the drug (PLGA_S) was also prepared for around the surface of the surgical suture, as described in Fig. 1a. comparison. In this laboratory-scale study, the braiding was conducted care- fully by hand under an optical microscope to minimize the overlap importantly, we report the fabrication method herein in an effort or gap between the braided sheets (Fig. S.1). The sheets were used to maintain the mechanical strength of the original surgical suture. as obtained from the electrospinning, without further treatment, Thus, a sheet of poly(lactic-co-glycolic acid) (PLGA) loaded with a where their mechanical properties were acceptable for braiding. pain-relief drug, ibuprofen, was separately prepared as the delivery The sutures covered with the sheet were incubated at 47 °C for carrier (i.e. as a drug-delivery sheet), which was then braided 1 h while the suture and sheet were slightly strained. around a surgical suture that had already been approved for clini- ⁄ cal use (VICRYL W9114, Ethicon, USA) (Fig. 1a). The assembled su- 2.3. Characterizations tures were cured at a temperature slightly above the glass transition temperature (Tg) of PLGA (41–47 °C) but much below The sutures and the sheets (i.e. PLGA_S, PLGA_IB_S and the decomposition temperature of ibuprofen (180–300 °C) [8], for M_PLGA_IB_S) prepared in this work were imaged by scanning better attachment of the sheet around the suture. PLGA is known electron microscopy (SEM; 7501F, Jeol, Japan). The X-ray diffrac- to be highly biocompatible and biodegradable [9], and it is already tion (XRD) patterns of the sheets were examined by an X-ray dif- one of the major materials forming the biodegradable surgical su- fractometer (D/MAX RINT 220-Ultima, Rigaku, Japan) equipped ture [10]. Ibuprofen, a non-steroidal anti-inflammatory drug, re- with Ni-filtered Cu Ka radiation (k = 1.5418 Å), where the samples duces activity of cyclooxygenase producing prostaglandins, which located on a glass substrate were each continuously scanned in a contribute to hyperalgesia at the wounded site [11]. The drug em- constant rate (2° min–1) at a tube voltage of 40 kV and a current ployed for pain relief in this work is already approved by the US of 30 mA [14].
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