Development of a radiopaque, long-term drug eluting bioresorbable stent for the femoral-iliac artery

Ha, Dong‐Heon; Kim, Jae Yun; Park, Tae Sik; Park, Jong Ha; Chae, Suhun; Kim, Byoung Soo; Lee, Han Cheol; Cho, Dong‐Woo

doi:10.1039/c9ra06179g

Cited by 10 publications

(25 citation statements)

References 26 publications

(25 reference statements)

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“…For the implantation in the coronary position, antiproliferative drugs such as paclitaxel and sirolimus (rapamycin) are favorite candidates as they hinder SMC migration and proliferation and thus prevent neo-intimal hyperplasia and restenosis. , In a recent study, a biodegradable stent was fabricated from PCL, paclitaxel (to suppress the inflammation), and iohexol (as a contrast powder) using a 3D printer with a rotating mandrel. The results of this study demonstrated a 1.5-year release of paclitaxel in vitro and adequate visibility without complications up to 8 weeks after stent implantation …”

Section: Implantable Controlled Release Systemsmentioning

confidence: 58%

Incorporation of Controlled Release Systems Improves the Functionality of Biodegradable 3D Printed Cardiovascular Implants

Kabirian,

Mozafari,

Mela

et al. 2023

ACS Biomater. Sci. Eng.

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New horizons in cardiovascular research are opened by using 3D printing for biodegradable implants. This additive manufacturing approach allows the design and fabrication of complex structures according to the patient’s imaging data in an accurate, reproducible, cost-effective, and quick manner. Acellular cardiovascular implants produced from biodegradable materials have the potential to provide enough support for in situ tissue regeneration while gradually being replaced by neo-autologous tissue. Subsequently, they have the potential to prevent long-term complications. In this Review, we discuss the current status of 3D printing applications in the development of biodegradable cardiovascular implants with a focus on design, biomaterial selection, fabrication methods, and advantages of implantable controlled release systems. Moreover, we delve into the intricate challenges that accompany the clinical translation of these groundbreaking innovations, presenting a glimpse of potential solutions poised to enable the realization of these technologies in the realm of cardiovascular medicine.

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Section: Implantable Controlled Release Systemsmentioning

confidence: 58%

Incorporation of Controlled Release Systems Improves the Functionality of Biodegradable 3D Printed Cardiovascular Implants

Kabirian,

Mozafari,

Mela

et al. 2023

ACS Biomater. Sci. Eng.

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“…A rotating rod combined with a 3D printing system composed of a driving unit and extrusion unit was used to manufacture biodegradable stents 16 . The driving unit was operated by a G-code-based robot that consists of two heads moving translationally in the z-direction on the moving parts of x and y.…”

Section: Methodsmentioning

confidence: 99%

“…Regarding biliary stricture, if it is possible to create a biliary stent after evaluation of the patient’s bile duct anatomy using computed tomography (CT) or magnetic resonance imaging (MRI), biliary strictures could be managed more effectively. In a previous study 16 , we established a rotating rod combined with a 3D printing system and successfully fabricated biodegradable stents with PCL for femoral-iliac artery treatment.…”

Section: Introductionmentioning

confidence: 99%

Feasibility and safety of a novel 3D-printed biodegradable biliary stent in an in vivo porcine model: a preliminary study

Kim

Han

et al. 2022

Sci Rep

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To assess the feasibility and safety of a novel 3D-printed biodegradable biliary stent using polycaprolactone (PCL) in an in vivo porcine model. In this animal study using domestic pigs, biodegradable radiopaque biliary stents made of polycaprolactone (PCL) and barium sulfate were produced using 3D printing and surgically inserted into the common bile duct (CBD) of pigs (stent group, n = 12). Another five pigs were allocated to the control group that only underwent resection and anastomosis of the CBD without stent insertion. To check the position and status of the stents and stent-related complications, follow-up computed tomography (CT) was performed every month. The pigs were sacrificed 1 or 3 months after surgery, and their excised CBD specimens were examined at both the macroscopic and microscopic levels. Three pigs (one in the stent group and two in the control group) died within one day after surgery and were excluded from further analysis; the remaining 11 in the stent group and 3 in the control group survived the scheduled follow-up period (1 month, 5 and 1; and 3 months, 6 and 2 in stent and control groups, respectively). In all pigs, no clinical symptoms or radiologic evidence of biliary complications was observed. In the stent group (n = 11), stent migration (n = 1 at 3 months; n = 2 at 1 month) and stent fracture (n = 3 at 2 months) were detected on CT scans. Macroscopic evaluation of the stent indicated no significant change at 1 month (n = 3) or fragmentation with discoloration at 3 months (n = 5). On microscopic examination of CBD specimens, the tissue inflammation score was significantly higher in the stent group than in the control group (mean ± standard deviation (SD), 5.63 ± 2.07 vs. 2.00 ± 1.73; P = 0.039) and thickness of fibrosis of the CBD wall was significantly higher than that of the control group (0.46 ± 0.12 mm vs. 0.21 ± 0.05 mm; P = 0.012). Despite mild bile duct inflammation and fibrosis, 3D-printed biodegradable biliary stents showed good feasibility and safety in porcine bile ducts, suggesting their potential for use in the prevention of postoperative biliary strictures.

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“…It was tried to blend biodegradable polymer with an iodinated contrast agent, − yet the mechanical properties of the resultant composites are not satisfactory or not reported in pertinent literatures. In light of polymer physics, it is difficult to mix a hydrophilic iodinated contrast agent with a hydrophobic biodegradable polymer, especially when a high ratio of a contrast agent is needed for radiopacity in deep tissue.…”

Section: Introductionmentioning

confidence: 99%

A Facile Composite Strategy to Prepare a Biodegradable Polymer Based Radiopaque Raw Material for “Visualizable” Biomedical Implants

Wang

Chen

et al. 2022

ACS Appl. Mater. Interfaces

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Enabling a biodegradable polymer radiopaque under X-ray is much desired for many medical devices. Physical blending of a present biodegradable polymer and a commercialized medical contrast agent is convenient yet lacks comprehensive fundamental research. Herein, we prepared a biodegradable polymer-based radiopaque raw material by blending poly(L-lactic acid) (PLLA or simply PLA) and iohexol (IHX), where PLA constituted the continuous phase and IHX particles served as the dispersed phase. The strong X-ray adsorption of IHX enabled the composite radiopaque; the hydrolysis of the polyester and the water solubility of the contrast agent enabled the composite biodegradable in an aqueous medium. The idea was confirmed by in vitro characterizations of the resultant composite, in vivo subcutaneous implantation in rats up to 6 months, and the clear visualization of a part of a biodegradable occluder in a Bama piglet under X-ray. We also found that the crystallization of PLA was significantly enhanced in the presence of the solid particles, which should be taken into consideration in the design of an appropriate biomaterial composite because crystallization degree influences the biodegradation rate and mechanical property of a material to a large extent. We further tried to introduce a small amount of poly(vinylpyrrolidone) into the blend of PLA and IHX. Compared to the bicomponent composite, the tricomponent one exhibited decreased modulus and increased elongation at break and tensile strength. This paves more ways for researchers to select appropriate raw materials according to the regenerated tissue and the application site.

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Development of a radiopaque, long-term drug eluting bioresorbable stent for the femoral-iliac artery

Abstract: A radiopaque, long-term drug eluting bioresorbable stent is developed for the treatment of femoral-iliac artery. The prepared materials are printed on a pre-designed rotating rod. The fabricated stent can be adapted for various clinical cases.

Cited by 10 publications

References 26 publications

Incorporation of Controlled Release Systems Improves the Functionality of Biodegradable 3D Printed Cardiovascular Implants

Incorporation of Controlled Release Systems Improves the Functionality of Biodegradable 3D Printed Cardiovascular Implants

Feasibility and safety of a novel 3D-printed biodegradable biliary stent in an in vivo porcine model: a preliminary study

A Facile Composite Strategy to Prepare a Biodegradable Polymer Based Radiopaque Raw Material for “Visualizable” Biomedical Implants

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