Shape-memory polymers as a technology platform for biomedical applications
Open accessAbstract
Polymeric materials are clinically required for medical devices, as well as controlled drug delivery systems. Depending on the application, the polymer has to provide suitable functionalities, for example, mechanical functions or the capability to actively move, so that an implant can be inserted in a compact shape through key-hole incisions and unfold to its functional shape in the body. Shape-memory polymers, as described herein regarding their general principle, compositions and architectures, have developed to a technology platform that allows the tailored design of such multifunctionality. In this way, defined movements of implants triggered either directly or indirectly, tailored mechanical properties, capability for sterilization, biodegradability, biocompatibility and controlled drug release can be realized. This comprehensive review of the scientific and patent literature illustrates that this technology enables the development of novel medical devices that will be clinically evaluated in the near future.
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Written from the paper’s full text.
TL;DR
This review presents shape-memory polymers as a tunable materials platform for biomedical devices, combining programmable shape change with functions such as biodegradability, sterilization compatibility, and controlled drug release. It surveys polymer architectures, device prototypes, biocompatibility testing, and regulatory considerations, while noting that most applications remain preclinical or patent-stage.
Key findings
- Thermally triggered shape-memory polymers can be fixed in a temporary shape and later recover a permanent shape when heated; the effect depends on a polymer network with netpoints and switchable segments, and can be quantified by shape fixity (Rf) and shape recovery (Rr).
- Reported material examples include a polyetherurethane with a glass transition near 74°C, Rf of 100%, and Rr of 80% after the third cycle at 50% elongation; PDC multiblock copolymers with hard-segment contents from 0 to 83 wt%, elongation at break up to 1000%, Rf of 98–99.5%, and Rr approaching 100%; polydepsipeptide/PCL copolymers with Rf and Rr above 96% and switching near body temperature; N-PCLDMA networks with Rr of 92–97% and Rf of 86–97% after five cycles; and N-PCGDMA networks with Rf above 96% and Rr of 86% after five cycles at 150% elongation.
- Drug-loaded SMP matrices have been demonstrated: PCGDMA networks showed low swelling-based loading below 0.8 wt% but up to about 6 wt% when drug was suspended during crosslinking; oLG networks reached up to 2.6 wt%; one PCL-derived system released about 20% of loaded drug in the first day and then released over five weeks.
- Sterilization and biocompatibility findings are mixed: ethylene oxide is described as the low-temperature standard, while low-temperature plasma sterilization caused cytotoxic effects in some acrylate-based SMPs and plasma-treated PCL/BA was toxic to L929 cells; other sterilized PCL- or polyurethane-based SMPs showed promising non-cytotoxic and histocompatible results, and PCL/BA-based SMPs supported angiogenesis and regeneration of a stomach wall defect in rats.
Methods
- Design: narrative review of scientific and patent literature, with no primary experimental study or systematic search protocol reported.
- Data/sample: published polymer chemistry, shape-memory characterization, sterilization and cytotoxicity studies, in vivo animal studies, device prototypes, and patent applications.
- Main analysis: the authors describe the general mechanism of thermally induced shape memory, categorize SMP architectures by crosslinking type and thermal transition, and discuss biomedical device concepts, drug-release matrices, regulatory classification, and future translation.
Limitations
- The paper states that only a few studies address cell and histocompatibility of SMPs after sterilization, that drug-loaded SMP contributions remain limited with few practical examples, and that some device applications are described only briefly in patent literature.
- The paper also states that no single animal species is an ideal general model for humans and that in vitro systems cannot replicate whole-body biodynamics, biotransformation, or excretion.
- Evident from the text: this is a narrative review without a described systematic search or inclusion criteria, and many device concepts are prototypes or patent-stage ideas rather than clinically evaluated products, so reported performance may not generalize across materials, sterilization methods, or anatomical sites.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
9 of 104 cited sources checked · 4 supported · 0 flagged · accuracy not yet measured
- Premisecitation§ Multiblock copolymers with T trans = T g
Incorporation of silica-coated magnetic nanoparticles of iron(III)oxide core into Tecoflex enabled the remote actuation of the thermally induced shape-memory effect in alternating magnetic fields.
“The incorporation of silica-coated magnetic nanoparticles of iron(III)oxide core into Tecoflex ® enabled the remote actuation of the thermally induced SME in alternating magnetic fields [19].”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [19] Mohr, 2006, Proc. Natl Acad. Sci. USA source
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
Ethylene oxide sterilization is the gold standard of low-temperature sterilization methods.
“The gold standard of the LTS methods is the EO sterilization [66].”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [66] Goveia, 2007, Rev. Lat. Am. Enfermagem source
- Premisecitation§ External applications
Indirect heating by laser with optimized coupling of laser light into a dye-loaded SMP corkscrew has in principle been proven suitable to induce shape recovery in air.
“In further detailed studies with thermoplastic SMPs, indirect heating by laser with an optimized coupling of laser light into a dye-loaded SMP corkscrew has in principle been proven as suitable to induce shape recovery in air [114].”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [114] Small, 2005, IEEE J. Sel.Top. Quant. Electron. source
The Laser Actuation section reports complete recovery of an ICG-dyed SMP corkscrew in air, supporting the proof-of-principle claim. But it also reports intermittent failures from overheating at the fiber–SMP joint; the Heat Distribution section describes tests to improve that joint, not a demonstrated optimized coupling. Page numbers are not available in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measured
- Premisecitation§ Vascular applications
When setting water flow rates to values relevant for in vivo applications, the required temperature and complete shape recovery of laser-activated SMP stents has not yet been obtained, even at laser powers up to approximately 8 W, due to cooling by the surrounding medium.
“While working in principle, when setting the water flow rates to values relevant for in vivo applications, the required temperature and, therefore, a complete shape recovery, has not yet been obtained, even at laser powers up to approximately 8 W due to cooling by the surrounding medium.”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [105] Baer, 2007, Biomed. Eng. Online source
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
- Findingcitation§ Multiblock copolymers with T trans = T g
In a commercially available polyetherurethane synthesized from methylene bis(p-cyclohexyl isocyanate), 1,4-butanediol, and poly(tetramethyleneoxide) diol, the glass transition temperature is at 74°C.
“In a commercially available PEU synthesized from methylene bis(p-cyclohexyl isocyanate) (H12 MDI), 1,4-butanediol, and PTMO diol, T g is at 74°C.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] Guignot, 2001, Nucl. Instrum. Meth. B source
- Findingcitation§ Miscellaneous internal applications
Slow shape recovery has been realized with a neuronal probe microactuator from an amorphous SMP.
“In contrast to immediate shape recovery, which is useful in several applications, slow shape recovery has been realized with a neuronal probe microactuator from an amorphous SMP [121].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [121] Sharp, 2006, J. Neural Eng. source
- Findingcitation§ Potential of SMP as intelligent matrix material for controlled drug-release systems
Drug release rates over weeks or months could be established in some cases in first studies of SMP matrices, depending on the drug physicochemical properties and the network architecture.
“As reviewed in detail [133], drug release rates over weeks or months could be established in some cases in these first studies, depending on the drug physicochemical properties and the network architecture.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [133] Wischke, 2010, Adv. Polym. Sci.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Findingcitation§ Miscellaneous internal applications
In a dental arch model, only a much too fast shape recovery has been realized that would not allow proper remodeling of bone around the roots of the teeth.
“However, in a dental arch model, so far only a much too fast shape recovery has been realized that would not allow proper remodeling of bone around the roots of the teeth.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [122] Jung, 2008, J. Mater. Sci. Mater. Med. source
- Findingcitation§ Miscellaneous internal applications
Programming of the 1.5-mm long neuronal probe device at 50°C, below the polymer's Tg (70°C) but above body temperature, results in very slow movement of the probe tip at 37°C.
“Programming of the 1.5-mm long device has been conducted at 50°C, which is clearly below the polymers T g (70°C), but also clearly above body temperature, resulting in very slow movement of the probe tip at 37°C (Figure 8).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [121] Sharp, 2006, J. Neural Eng. source
- Findingcitation§ Miscellaneous internal applications
In a thermoplastic SMP containing PCL building blocks, maintenance of the wire's recovery forces over months was observed at least in a water-free environment.
“In the present example with a thermoplastic SMP containing PCL building blocks, a maintenance of the wire's recovery forces over months was observed at least in a water-free environment.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [122] Jung, 2008, J. Mater. Sci. Mater. Med. source
- Findingcitation§ SMPs investigated as drug-loaded matrix material
Drug loading of totally amorphous oLG tetrole-derived networks by swelling was conducted for model drugs with different physicochemical properties: hydrophilic ethacridine lactate and less soluble enoxacin and nitrofurantoin.
“Drug loading of totally amorphous oLG tetrole-derived networks by swelling was conducted for model drugs with different physicochemical properties: hydrophilic ethacridine lactate and less soluble enoxacin and nitrofurantoin.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
- Findingcitation§ SMPs investigated as drug-loaded matrix material
Drug-loading levels of PCGDMA-derived networks obtained by the swelling technique remained low (<0.8 wt.%), at least for the studied model drugs.
“However, drug-loading levels of this network as obtained by the swelling technique remained low (<0.8 wt.%), at least for the studied model drugs [46].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [46] Neffe, 2009, Adv. Mater. source
- Findingcitation§ point of view.
A ureteral stent that can be anchored in the ureter has been recently demonstrated.
“One of these is a ureteral stent that can be anchored in the ureter, as recently demonstrated (Figure 11) [46].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [46] Neffe, 2009, Adv. Mater. source
- Findingcitation§ SMPs investigated as drug-loaded matrix material
The absence of any impact of drug incorporation on the thermal properties of the semi-crystalline polymer network has been shown for a library of PCGDMA-derived networks.
“The absence of any impact of drug incorporation on the thermal properties of the semicrystalline polymer network has clearly been shown for a library of PCGDMA-derived networks [137].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [137] Neffe, 2009, Mat. Res. Soc. Symp. Proc. source
- Findingcitation§ SMPs investigated as drug-loaded matrix material
A substantial increase of release rates for more hydrophobic drugs of initially low diffusibility was associated with the breakdown of the cross-linked network architecture by bulk erosion.
“A substantial increase of release rates for more hydrophobic drugs of initially low diffusibility was associated with the breakdown of the cross-linked network architecture by bulk erosion.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
- Findingown data§ SMPs investigated as drug-loaded matrix material
Water uptake into the polymer was at least initially no more than slightly increased in drug-loaded oLG films.
“In addition, water uptake into the polymer was at least initially no more than slightly increased in drug-loaded films (Figure 10B).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
- Findingnone given§ Key issues
Several prototypes and device designs of SMP-based medical devices have been described, including applications in general surgery, as well as intravascular, urogenital, cerebral, ocular and other internal and external applications.
“Several prototypes and device designs of SMP-based medical devices have been described, including applications in general surgery, as well as intravascular, urogenital, cerebral, ocular and other internal and external applications.”
Quote in the paperNot a substantial claim - Findingcitation§ SMPs investigated as drug-loaded matrix material
In PCL-derived networks, drug loading resulted in a slight increase in the melting temperature of PCL segments, assumed to derive from a drug-induced phase separation with improved interaction and crystallization of PCL segments.
“In this material, drug loading resulted in a slight increase in the melting temperature of PCL segments, which was assumed to derive from a drug-induced phase separation with an improved interaction and crystallization of PCL segments.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [132] Nagahama, 2009, Biomacromolecules source
- Findingcitation§ SMPs investigated as drug-loaded matrix material
Compared with PCGDMA SMP networks, higher loading levels (up to 2.6 wt.% depending on the drug) were achieved for oLG tetrole-derived networks.
“Compared with the aforementioned PCGDMA SMP networks, in this case higher loading levels (up to 2.6 wt.% depending on the drug) were achieved [131].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
- Findingcitation§ SMPs investigated as drug-loaded matrix material
For oLG tetrole-derived networks, drug loading did not impact the mass loss of small, water-soluble SMP degradation products from the matrix.
“For oLG tetrole-derived networks, drug loading did not impact the mass loss of small, water-soluble SMP degradation products from the matrix (Figure 10A).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
- Findingcitation§ SMPs investigated as drug-loaded matrix material
Drug incorporation by suspension before cross-linking was described for semi-crystalline PCL-derived networks and led to a homogeneous distribution of drug aggregates.
“Drug incorporation by suspension before cross-linking was also described for semicrystalline PCL-derived networks, and lead to a homogeneous distribution of drug aggregates (Figure 9A) [132].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [132] Nagahama, 2009, Biomacromolecules source
- Findingnone given§ SMPs investigated as drug-loaded matrix material
These drug-releasing SMP networks were of amorphous (oLG-derived) and semi-crystalline (PCGDMA- and oCl-derived) morphology.
“These networks were of amorphous (oLG derived) and semi-crystalline (PCGDMA and oCl derived) morphology.”
Quote in the paperNot a substantial claim - Findingnone given§ Key issues
These cytotoxicity data could also be confirmed in vivo for PCL-based SMPs.
“Moreover, these data could also be confirmed in vivo for PCL-based SMPs.”
Quote in the paperNot a substantial claim - Findingnone given§ Key issues
A SMP composed of PCL and BA proved able to induce the auto-regeneration of a critical stomach wall defect in a rat.
“Interestingly a SMP composed of PCL and BA proved to be able to induce the auto-regeneration of a critical stomach wall defect in a rat.”
Quote in the paperNot a substantial claim - Premisecitation§ Sterilization & in vitro cytotoxicity testing
Strong surface changes are seen after low-temperature plasma sterilization of polyurethane catheters and tubing, polyvinylchloride tubing and films, and SMP polyurethane foams.
“Strong surface changes were seen after LTP sterilization of polyurethane catheters and tubing, polyvinylchloride tubing and films [62], and SMP polyurethane foams [63].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [62] Lerouge, 2002, Biomed. Mater. Eng.
- cites [63] De Nardo, 2009, Acta Biomater. source
- Premisereasoning§ General principle of SMPs
Suitable polymer materials enabling the shape-memory effect require a polymer network architecture consisting of netpoints and molecular switches sensitive to an external stimulus.
“Suitable polymer materials enabling SME require a polymer network architecture consisting of netpoints (dots in Figure 1B) and molecular switches (lines in Figure 1B), which are sensitive to an external stimulus.”
Quote in the paperNot a substantial claim - Premisereasoning§ General principle of SMPs
Reversible fixation can be realized by formation of additional reversible netpoints that can be formed and cleaved on demand.
“Such a reversible fixation can be realized by the formation of additional reversible netpoints, which can be formed and cleaved on demand.”
Quote in the paperNot a substantial claim - Premisecitation§ Sterilization & in vitro cytotoxicity testing
Irradiation reduces the glass temperature and molecular weight of PLG (80:20) and PCL (Mw = 80 kDa).
“Irradiation, for instance, is known to reduce the glass temperature (T g ) and the molecular weight of PLG (80:20) and PCL (M w = 80 kDa) [56][57][58][59][60].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [56][57][58][59][60]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisereasoning§ Examples for shape-memory polymer systems intended for biomedical applications
When actuated, thermoplastic shape-memory polymers are able to develop much higher stresses compared with covalent shape-memory polymers due to the much higher Young's moduli achieved during the shape-memory creation process.
“When actuated, thermoplastic SMPs are able to develop much higher stresses compared with covalent SMPs due to the much higher Young's moduli, which can be achieved during the SMCP.”
Quote in the paperNot a substantial claim - Premisenone given§ Examples for shape-memory polymer systems intended for biomedical applications
A covalent shape-memory polymer network in which the temporary shape is fixed only by one switching domain displays a high decrease in mechanical properties when the temperature exceeds the transition temperature and the shape-memory effect is triggered.
“An example is a covalent SMP network in which the temporary shape is fixed only by one switching domain.Such SMP networks display a high decrease in the mechanical properties, such as Young's modulus or strain at break, when the temperature is exceeding T trans and the SME is triggered.”
Quote in the paperNot a substantial claim - Premisecitation§ Multiblock copolymers with T trans = T m
Biocompatible and simultaneously biodegradable multiblock copolymers with shape-memory properties could be synthesized via co-condensation of diols from poly(p-dioxanone)diol and poly(e-caprolactone) segments using TMDI as a bifunctional coupling agent.
“Biocompatible and simultaneously biodegradable multiblock copolymers with shapememory properties could be synthesized via a co-condensation of diols from poly(p-dioxanone)diol and PCL segments using an isomeric mixture of 1,6-diisocyanato 2,2,4-trimethylhexane and 1,6-diisocyanato-2,4,4-trimethylhexane (TMDI) as a bi functional coupling agent [20].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [20] Lendlein, 2002, Science source
- Premisenone given§ Multiblock copolymers with T trans = T g
An important group of physically cross-linked shape-memory polymers are linear block copolymers.
“An important group of physically cross-linked shape-memory polymers are linear block copolymers.”
Quote in the paperNot a substantial claim - Premisereasoning§ General principle of SMPs
The temporary shape is stable until an appropriate stimulus induces recovery of the original shape.
“This temporary shape is stable until an appropriate stimulus is applied to the shaped body, which induces the recovery of the original shape (Figure 1A).”
Quote in the paperSubstantial claim - Premisereasoning§ General principle of SMPs
In thermoplastic shape-memory polymers, domains associated with polymer chain segments with the second highest thermal transition temperature act as switching domains.
“Therefore, in thermoplastic SMPs, the domains associated to the polymer chain segments with the second highest T trans are acting as switching domains.”
Quote in the paperNot a substantial claim - Premisecitation§ Sterilization & in vitro cytotoxicity testing
E-beam sterilization at 50-200 kGy alters the degradation properties of PLG.
“In addition, e-beam sterilization (50-200 kGy) is described to alter the degradation properties of PLG [57,61].”
Quote in the paperNot a substantial claim0 of 2 sources checked - Premisereasoning§ Multiblock copolymers with T trans = T g
Multiblock copolymers with a glass transition as the transition temperature can be obtained because most polymer segments with a sufficient difference in molecular structure are not mixable with each other.
“As most polymer segments with a sufficient difference in the molecular structure are not mixable with each other, multiblock copolymers, in which T trans relies on a glass transition temperature (T trans = T g ), can be obtained.”
Quote in the paperNot a substantial claim - Premisereasoning§ General principle of SMPs
The shape-memory effect requires temporary fixation of the chain segments' conformation in the deformed shape for stabilizing the temporary shape.
“As a consequence, the SME requires the temporary fixation of the chain segments' conformation in the deformed shape for stabilizing the temporary shape.”
Quote in the paperNot a substantial claim - Interpretationreasoning§ Sterilization & in vitro cytotoxicity testing
Newly formed covalent bonds might prevent a shape-memory polymer from displaying the shape-memory effect.
“In addition, newly formed covalent bonds might also prevent the capability of material to display a SME.”
Quote in the paperSubstantial claim - Premisereasoning§ Examples for shape-memory polymer systems intended for biomedical applications
Thermoplastic shape-memory polymers in which a second phase provides the physical cross-links determining the permanent shape do not show such a drastic change in mechanical properties, as the remaining crystalline domains reinforce the amorphous switching domains.
“In contrast, thermoplastic SMPs, in which a second phase provides the physical cross-links determining the permanent shape, do not show such a drastic change in the mechanical properties, as the remaining crystalline domains reinforce the amorphous switching domains.”
Quote in the paperSubstantial claim - Premisecitation§ Motivation for introduction of SMP to biomedical applications
Shape-memory polymers can change their shape in a predefined way on demand when exposed to a suitable stimulus.
“Shape-memory polymers (SMPs) can change their shape in a predefined way on demand when exposed to a suitable stimulus.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [2][3][4][5][6][7][8][9][10][11][12][13]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisenone given§ General principle of SMPs
The shape-memory effect results from a suitable molecular polymer network architecture in combination with a tailored processing and programming technology.
“The SME results from a suitable molecular polymer network architecture in combination with a tailored processing and programming technology.”
Quote in the paperSubstantial claim - Premisecitation§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymers
The same SMP proved its capability for autoinduced regeneration of a radical stomach wall defect in rats.
“The same SMP proved its capability for autoinduced regeneration of a radical stomach wall defect in rats [75,76].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [75] Rickert, 2005, Biomed. Tech. (Berl.) source
- cites [76] Rickert, 2005, Clin. Hemorheol. Microcirc.
- The authors state this as an assumption: The incorporation of a biomaterial in vivo requires regular wound-healing mechanisms.
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
V79 fibroblasts showed a strong decrease of vitality after exposure to extracts of poly(methyl methacrylate) and poly(2-hydroxyethyl methacrylate) for 3 days after vapor-phase H2O2 sterilization because of left H2O2 residuals.
“V79 fibroblast showed a strong decrease of vitality (crystal violet vital staining) after exposure to extracts of poly(methyl methacrylate) and poly(2-hydroxyethyl methacrylate) for 3 days after vapor-phase H 2 O 2 sterilization (3 mg/l H 2 O 2 , Review Shape-memory polymers as a technology platform for biomedical applications 39 min, 55°C) because of left H 2 O 2 residuals [64].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [64] Ikarashi, 1995, Biomaterials source
- Premisereasoning§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymers
An in vitro system cannot replicate exactly the biodynamics of the whole human body due to the lack of mitigating systems and the lack of biotransformation and excretion pathways for elimination in vitro.
“Hence, an in vitro system cannot replicate exactly the biodynamics of the whole human body due to the lack of possible mitigating systems (e.g., hormones, nervous system and immunity), and the lack of biotransformation and excretion pathways for their elimination in vitro.”
Quote in the paperSubstantial claim - Interpretationreasoning§ Sterilization & in vitro cytotoxicity testing
Under shear conditions such as vascular flow, the SMPs do not enhance platelet adhesion and activation.
“This suggests that under shear conditions, such as those seen with vascular flow, the SMPs do not enhance platelet adhesion and activation.”
Quote in the paperSubstantial claim - Interpretationnone given§ Sterilization & in vitro cytotoxicity testing
The biocompatibility of sterilized SMPs can be limited by residues, such as endotoxins, of microorganisms that contaminated the SMPs prior to sterilization.
“The biocompatibility of sterilized SMPs can be limited by residues (e.g., endotoxins) of microorganisms that contaminated the SMPs prior to sterilization.”
Quote in the paperSubstantial claim - Premisecitation§ Sterilization & in vitro cytotoxicity testing
Cytotoxicity testing by agarose overlay assay with L929 mouse fibroblasts revealed no adverse effects of these materials on these cells.
“Cytotoxicity testing by use of the agarose overlay assay with L929 mouse fibroblasts revealed no adverse effects of the materials on these cells [73].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [73] source
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
Rough modification of the SMP surface supported cell growth dependent on the cell type and the time of cell growth, rather than the smooth surface modification.
“The rough modification of the SMP surface supported the cell growth dependent on the cell type and the time of cell growth, rather than the smooth surface modification.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [74][75][76][77]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
In response to shear stress, no significant difference in platelet adhesion was noted.
“In response to shear stress, no significant difference in platelet adhesion was noted.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [81] Cabanlit, 2007, Macromol. Biosci. source
- Premisecitation§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymers
N-PCLDMA-BA was able to induce angiogenesis and strong tissue integration in male Naval Medical Research Institute mice 1 week after subcutaneous implantation.
“A SMP, N-PCLDMA-BA, based on PCLDMA and BA, was able to induce angiogenesis and strong tissue integration in male Naval Medical Research Institute mice 1 week after subcutaneous implantation [47].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [47] Lendlein, 2001, Proc. Natl Acad. Sci. USA source
- The authors state this as an assumption: The incorporation of a biomaterial in vivo requires regular wound-healing mechanisms.
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
Polyurethane-based SMPs can be sterilized using 10% ethylene oxide at 54°C, at 65% relative humidity for 130 min, followed by 12 h aeration at 132°C.
“For instance, polyurethanebased SMPs can be sterilized using 10% EO at 54°C, at 65% relative humidity for 130 min, followed by 12 h aeration at 132°C [67].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [67] Lucas, 2003, J. Biomed. Mater. Res. B Appl. Biomater. source
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
The cytotoxic effect was not observed after using steam-, gas-(EO, Noxilizer), and irradiation (gamma-, e-beam)-based sterilization techniques for those materials.
“The cytotoxic effect was not observed after using steam-, gas-(EO, Noxilizer), and irradiation (g-, e-beam)-based sterilization techniques for those materials [65].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [65] Yakacki, 2008, Biomed. Mater. source
- Premiseown data§ Sterilization & in vitro cytotoxicity testing
24 h after cell seeding, different surface characteristics resulted in an opposite pattern of the kinetics of appearance and activity levels of MMPs and TIMPs of primary epithelial cells of the upper aerodigestive tract.
“24 h after cell seeding, the different surface characteristics also resulted in an opposite pattern of the kinetics of appearance and activity levels of MMPs and TIMPs of primary epithelial cells of the upper aerodigestive tract.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [74][75][76][77]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
Plasma-treated PCL/BA exhibited a significant toxic effect on L929 cells in both the phenol red uptake test and the MTT test.
“The plasma-treated PCL/BA exhibited a significant toxic effect on L929 cells in both tests [69][70][71].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [69][70][71]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
Incubation of PESU and PEU with human plasma for up to 4 h did not lead to evidence of contact activation, thrombin or plasmin generation, or platelet activation.
“Incubation of both materials with human plasma for up to 4 h did not lead to any evidence of contact activation, thrombin or plasmin generation or platelet activation.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [81] Cabanlit, 2007, Macromol. Biosci. source
- Interpretationcitation§ Sterilization & in vitro cytotoxicity testing
H2O2 residuals left on or in materials can have a negative effect on cells.
“However, H 2 O 2 residuals left on/in the materials can have a negative effect on cells.”
Quote in the paperNot a substantial claim - Premisecitation§ Sterilization & in vitro cytotoxicity testing
On polyurethane-based SMPs synthesized using methylene diphenylene diisocyanate, PTMO and N,N-bis(2-hydroxyethyl)isonicotinamide, effective nonleaching biocidal properties could be shown.
“In addition, on polyurethane-based SMPs synthesized using methylene diphenylene diisocyanate (MDI), PTMO and N,N-bis(2-hydroxyethyl)isonicotinamide, effective nonleaching biocidal properties could be shown [72].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [72] Grapski, 2001, Biomaterials source
- Premisecitation§ Sterilization & in vitro cytotoxicity testing
Plasma treatment had no significant cytotoxic effect on L929 cells in vitro.
“Additionally, plasma treatment had no significant cytotoxic effect on L929 cells in vitro.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [63] De Nardo, 2009, Acta Biomater. source
- Interpretationreasoning§ Potential of SMP as intelligent matrix material for controlled drug-release systems
Drug-releasing SMPs have led to multifunctional materials for biomedical applications that combine biodegradability, controlled drug release and shape-memory capability.
“This has led to multifunctional materials for biomedical applications that combine biodegradability, controlled drug release and shape-memory capability.”
Quote in the paperSubstantial claim - Interpretationcitation§ Miscellaneous internal applications
Softening of the SMP after insertion may occur as a consequence of warming up close to or above the SMP's Tg and the plasticization of SMPs by water in the physiological environment.
“This may happen as a consequence of both warming up close to or above the SMP's T g , and the plasticization of SMPs by water in the physiological environment [131].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
- Interpretationreasoning§ Miscellaneous internal applications
The mechanical incompatibility of brain tissue and stiff neuronal probes may be overcome by softening of the SMP after completed insertion.
“Additionally, the mechanical incompatibility of brain tissue and stiff neuronal probes may be overcome by softening of the SMP after completed insertion.”
Quote in the paperSubstantial claim - Premisecitation§ External applications
A hybrid system consisting of a permanently corkscrew-shaped nitinol wire, thin insulated copper wires connected to each end of the nitinol, and a final SMP coating has been developed.
“Recently, a hybrid system consisting of a permanently corkscrew-shaped nitinol wire, thin insulated copper wires connected to each end of the nitinol (one of the copper wires was wound back around the nitinol so that both of them emerge from the same end of the nitinol) and a final SMP coating has been developed [117].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [117] Small, 2007, IEEE Trans. Biomed. Eng. source
- Premisecitation§ External applications
In simulations at medium laser powers of 4.5 W, the energy input resulted in a temperature increase of the surrounding blood to 49°C, which was concluded to be in a safe range.
“In simulations at medium laser powers of 4.5 W (i.e., approximately half of what has been barely enough in an aforementioned study for stent deployment under physiological flow conditions [105]), the energy input already resulted in a temperature increase of the surrounding blood to 49°C, which in this case was concluded to be in a safe range [115].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [115] Small, 2005, Optics Express source
- Interpretationcitation§ Miscellaneous internal applications
Slow movement of the neuronal probe is required to avoid insertion-induced tissue damage that leads to the formation of astrocyte scars as insulating layers around the electrodes.
“This slow movement is required to avoid insertion-induced tissue damage that, among other things, leads to the formation of astrocyte scars as insulating layers around the electrodes.”
Quote in the paperSubstantial claim - Interpretationreasoning§ External applications
For systems employing activation by lasers or other external heating, substantial cooling of the device by circulating blood in vivo requires high laser energies, at least for common commercial SMPs with Tg in the range of 55-65°C.
“However, as is the case for all systems that employ activation by lasers or other sources of external heating, a substantial cooling of the device by circulating blood in vivo requires high laser energies, at least for common commercial SMPs with T g 's in the range of 55-65°C.”
Quote in the paperSubstantial claim - Interpretationnone given§ Shape-memory polymers as a technology platform for biomedical applications
The chemical composition of the polymer, the nature of bonds in the polymer, and their sensitivity to biodegradation may affect the timeframe and pathway of matrix erosion and potentially induce erosion-controlled drug release.
“The chemical composition of the polymer, the nature of bonds in the polymer and their sensitivity to biodegradation, such as hydrolytic cleavage, may affect the timeframe and pathway of matrix erosion and potentially induce erosion-controlled drug release as discussed above.”
Quote in the paperNot a substantial claim - Interpretationreasoning§ Shape-memory polymers as a technology platform for biomedical applications
Semi-crystalline SMPs might be less sensitive to drug-induced plasticization due to exclusion of drugs in the crystalline switching domains.
“On the contrary, semi-crystalline SMPs might, for example, be less sensitive to drug-induced plasticization due to exclusion of drugs in the crystalline switching domains.”
Quote in the paperNot a substantial claim - Interpretationreasoning§ Shape-memory polymers as a technology platform for biomedical applications
Semi-crystalline SMPs might be less flexible in modifying degradation rates by varying co-monomer ratios and crystallinity, since the crystalline phase needs to be preserved to maintain SMP functionality.
“However, they might also be less flexible in terms of modifying degradation rates by varying co -monomer ratios and crystallinity, since the crystalline phase needs to be preserved in order to maintain SMP functionality.”
Quote in the paperNot a substantial claim - Interpretationreasoning§ Shape-memory polymers as a technology platform for biomedical applications
Noncovalent drug-polymer interactions may increase drug solubility in the polymer.
“Such interactions may increase drug solubility in the polymer.”
Quote in the paperNot a substantial claim - Premisenone given§ Key issues
Shape-memory polymers enable medical devices to actively change their shape in a complex, predefined manner upon stimulation.
“Shape-memory polymers (SMPs) enable medical devices to actively change their shape in a complex, predefined manner upon stimulation.”
Quote in the paperNot a substantial claim - Premisenone given§ Shape-memory polymers as a technology platform for biomedical applications
Swelling-based drug loading of covalently cross-linked SMP networks has limitations in the maximum possible drug loading, depending on polymer swellability, drug solubility and drug-polymer interactions.
“This technique has limitations in the maximum possible drug loading, depending on the polymer swellability, drug solubility and drug-polymer interactions.”
Quote in the paperNot a substantial claim - Interpretationreasoning§ Shape-memory polymers as a technology platform for biomedical applications
The morphology of thermosensitive SMP materials, being either amorphous or semi-crystalline, could have a large impact on loading levels by the swelling technique, since drug incorporation is not expected to occur in the crystalline phase.
“The morphology of thermosensitive SMP materials, being either amorphous or semi-crystalline, could have a large impact, for example, on loading levels by the swelling technique, since drug incorporation is not expected to occur in the crystalline phase.”
Quote in the paperNot a substantial claim- Rests on an assumption: Drug incorporation is not expected to occur in the crystalline phase.
- Interpretationreasoning§ Expert commentary
Systematic synthesis of polymers derived from different building blocks and architectures led to a wide spectrum of material properties, in which the elastic properties can be adjusted over a broad range.
“As a consequence, systematic synthesis of polymers derived from different building blocks and architectures led to a wide spectrum of material properties in which, for example, the elastic properties can be adjusted over a broad range.”
Quote in the paperNot a substantial claim - Premisenone given§ Shape-memory polymers as a technology platform for biomedical applications
To exhibit a shape-memory effect, polymer networks need to be established, either by physical netpoints or covalent cross-linking of the polymer chains.
“In order to exhibit a SME, polymer networks need to be established that can be obtained either by physical netpoints or covalent cross-linking of the polymer chains.”
Quote in the paperNot a substantial claim - Premisecitation§ Shape-memory polymers as a technology platform for biomedical applications
Thermoplastic materials with physical cross-links are suitable for processing into a device, implant or other drug carrier of a specific shape by numerous techniques in the dissolved or, if stable, in the molten state.
“Thermoplastic materials with physical cross-links bear the big advantage of being suitable for processing into a device, implant or other drug carrier of a specific shape by numerous techniques in the dissolved or, if stable, in the molten state [24,[226][227][228][229].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [24,[226][227][228][229]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Interpretationown data§ SMPs investigated as drug-loaded matrix material
For oLG tetrole-derived materials, usage would be appropriate for applications where mechanical strength is required for 1 or 2 weeks only.
“In the case of oLG tetrolederived materials, usage of this material would be appropriate for applications where mechanical strength is required for 1 or 2 weeks only.”
Quote in the paperSubstantial claim
- May combine two claims. 64
- Classified as probably not a substantial claim. 88
- The quote only partly states this claim. 1
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingIrradiation-based sterilization techniques such as gamma and e-beam sterilization are instantaneous, penetrating and nontoxic, but may be associated with changes in molecular structure.
“Irradiation-based sterilization techniques such as gand e-beam sterilization are instantaneous, penetrating and nontoxic, but may be associated with changes in the molecular structure [55].”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [55] Freeman, 1960, J. Hyg. (Lond.) source
The Conclusion and Sterilizing technique sections discuss ethylene oxide sterilization, including its long exposure time and the gas’s penetrating power. Searches for irradiation, gamma rays, electron beams, and molecular-structure changes found no passage addressing the claimed properties of irradiation-based sterilization. (LLM, conf=0.75)
Experimental — accuracy not yet measured
Classified as probably not a substantial claim.
Interpretationreasoning§ External applicationsIt might be useful to customize polymers to a lower switching temperature in a narrow range of 45-50°C, rather than using materials of relatively high Tg, to enable activation at lower laser power.
“Thus, it might be useful to customize polymers to a lower switching temperature in a narrow range of 45-50°C, rather than using materials of relatively high T g in order to enable activation at lower laser power [116].”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [116] Wilson TS, Small W, Benett WJ, Bearinger JP, Maitland D. Shape memory polymer therapeutic devices for stroke. In:Smart Medical and Biomedical Sensor Technology III. Cullum BM, Carter JC (Eds). SPIE, WA, USA, 60070R (2005). source
The Conclusions (page unavailable) report polymers with glass transitions ranging from 34 to 87°C and very narrow transitions, supporting the possibility of tailoring a lower switching temperature. The Coil Stroke Devices section (page unavailable) describes laser actuation, but the paper does not specify a 45–50°C target or say that choosing it would enable activation at lower laser power. (LLM, conf=0.85)
Experimental — accuracy not yet measured
May combine two claims.
Findingcitation§ Miscellaneous internal applicationsShape recovery from a thin stretched rod to a more compact-shaped rod allows fixation of ligaments in bone tunnels, and the rod's radial recovery forces depend on the material composition, such as the cross-linker content.
“In this application, shape recovery from a thin stretched rod to a more compact-shaped rod allows fixation of ligaments in bone tunnels, in which the rod's radial recovery forces depend on the material composition, such as the cross-linker content [27].”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [27] Yakacki, 2008, Adv. Funct. Mater. source
The Introduction describes an orthopedic-fixation prototype reduced to a smaller diameter and then heated to recover its shape. The Results and Conclusions link constrained recovery stress to rubbery modulus and crosslink density, which can be adjusted through crosslinking-monomer composition. Our copy does not specify ligament fixation in bone tunnels or measure radial recovery forces in that setting. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisecitation§ Vascular applicationsBy using triple-shape thermosensitive SMP materials, temporary stents could be designed that are implanted in their first temporary shape, expand upon heating to their required functional shape, and upon further heating shrink for easy removal.
“By using triple-shape thermosensitive SMP materials, temporary stents could be designed that are implanted in their first temporary shape, expand upon heating to their required functional shape (second temporary shape) and, upon further heating, shrink for easy removal if required [102].”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [102] Bellin, 2006, Proc. Natl Acad. Sci. USA source
May combine two claims.
Premisecitation§ Vascular applicationsTubular SMP devices were laser etched for more flexible stents that could navigate through small tortuous vessels; however, resistance to withstand the critical collapse pressure in the vessel at elevated body temperature may not be given in all cases.
“In addition, tubular SMP devices were laser etched for more flexible stents that also could navigate through small tortuous vesselshowever, it has been revealed that resistance to withstand the critical collapse pressure in the vessel at elevated body temperature may not be given in all cases [106].”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [106] Baer, 2009, J. Biomed. Mater. Res. B Appl. Biomater. source
May combine two claims.
Findingown data§ SMPs investigated as drug-loaded matrix materialIn cyclic thermomechanical tests, congruent curves were observed for drug-loaded oLG materials during different cycles, meaning that drug loading did not affect the shape-memory functionality.
“In cyclic thermomechanical tests, congruent curves were observed for drug-loaded materials during the different cycles of testing, meaning that drug loading did not affect the shape-memory functionality.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
May combine two claims.
Findingcitation§ SMPs investigated as drug-loaded matrix materialControlled drug release has been established for covalent SMP networks based on different chemistries: PCGDMA cross-linked by photopolymerization, oligo[(rac-lactide)-co-glycolide]tetroles cross-linked by low-molecular-weight aliphatic diisocyanates, and branched oligo(ε-caprolactone)octols cross-linked by low-molecular-weight aliphatic diisocyanates.
“So far, controlled drug release has been established for covalent SMP networks that were based on different chemistries: PCGDMA as telechelics that were cross-linked by photo polymerization [46,137], oligo[(rac-lactide)-co-glycolide]tetroles (oLG) cross-linked by lowmolecular-weight aliphatic diisocyanates [131,138], and branched oligo(e-caprolactone)octols (oCl) cross-linked by low-molecular”
Quote in the paperNot a substantial claim0 of 5 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone given§ Expert commentaryA variety of polymers exhibiting a shape-memory effect were prepared and characterized.
“A variety of polymers exhibiting a SME were prepared and characterized.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingcitation§ SMPs investigated as drug-loaded matrix materialCorresponding to the drugs' physicochemical properties, differences in release profiles were observed, with higher release rates for hydrophilic drugs.
“Corresponding to the drugs' physicochemical properties, differences in the release profiles were observed with higher release rates for hydrophilic drugs.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Findingnone given§ Expert commentaryShape-memory polymers have attracted substantial scientific and technological interest, especially for biomedical applications, reflected in the rapidly increasing number of publications on SMPs during the last decade.
“Shape-memory polymers have attracted substantial scientific and technological interest, especially for biomedical applications, which is reflected in the rapidly increasing number of publications on SMPs during the last decade.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Findingnone given§ point of view.Due to a so far limited number of contributions in this field, only a few practical examples of potential applications have been given.
“Due to a so far limited numbers of contributions in this field, only a few practical examples of potential applications have been given.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingnone given§ Key issuesSelected sterilized SMP devices were shown to be non-cytotoxic, as well as cell- and histo-compatible in vitro and in vivo.
“Selected sterilized SMP devices were shown to be non-cytotoxic, as well as cell-and histo-compatible in vitro and in vivo.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone given§ Key issuesCurrently, only few studies are available that address the cell- and histo-compatibility of SMPs after sterilization.
“Currently, only few studies are available that address the celland histo-compatibility of SMPs after sterilization.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingcitation§ SMPs investigated as drug-loaded matrix materialA clear acceleration of the breakdown of the cross-linked network architecture was observed at least in the presence of some drugs, and the elastic modulus experienced a strong loss during degradation in all drug-loaded samples.
“However, a clear acceleration of the breakdown of the cross-linked network architecture was observed at least in the presence of some drugs (Figure 10C), and the elastic modulus experienced a strong loss during degradation in all drug-loaded samples (Figure 10D).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [131] Wischke, 2009, J. Control. Release source
May combine two claims.
Findingcitation§ SMPs investigated as drug-loaded matrix materialSubstantial amounts (up to ~6 wt.%) of suspended drug were incorporated during cross-linking, with only minor effects on the materials' stress-strain curves.
“Still, substantial amounts (up to ~6 wt.%) of suspended drug were incorporated during cross-linking, with only minor effects on on the materials' stress-strain curves.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [46] Neffe, 2009, Adv. Mater. source
May combine two claims.
Findingcitation§ SMPs investigated as drug-loaded matrix materialAfter an initial release of 20% of the loaded drug in the first day, a smooth subsequent release profile was observed over 5 weeks.
“After an initial release of 20% of the loaded drug in the first day, a smooth subsequent release profile was observed over 5 weeks (Figure 9B).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [132] Nagahama, 2009, Biomacromolecules source
May combine two claims.
Findingnone given§ Key issuesSo far, cytotoxicity was evaluated mainly for sterilized polyurethanes or poly(ε-caprolactone)-based SMPs, and showed promising results.
“So far, cytotoxicity was evaluated mainly for sterilized polyurethanes or poly(e-caprolactone)-based SMPs, and showed promising results.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based). May combine two claims.
Findingnone given§ Five-year viewStent technology has been, and certainly will be, one of the most intensively studied fields of SMP applications.
“Stent technology has been, and certainly will be, one of the most intensively studied fields of SMP applications.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone given§ Key issuesWithin the different strategies to sterilize SMPs, the most commonly used method is low-temperature sterilization with ethylene oxide (EO).
“Within the different strategies to sterilize SMPs (g-or e-beam-irradiation, hydrogen peroxide vapor-, low-temperature gas plasma-and low-temperature gas-sterilization), the most commonly used method is the low-temperature sterilization with EO.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Findingnone given§ Key issuesVery recently, some first reports were published proving the general capability of SMPs for controlled drug release, and led to multifunctional materials that combine shape-memory, biodegradability and controlled drug release.
“Very recently, some first reports were published proving the general capability of SMPs for controlled drug release, and led to multifunctional materials that combine shape-memory, biodegradability and controlled drug release.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone given§ Five-year viewThe economic significance of this market is reflected in a forecasted revenue of US$4-5 billion in the USA in 2009.
“The economic significance of this market is reflected in a forecasted revenue of US$4-5 billion in the USA in 2009.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone given§ Key issuesAn evaluation strategy has been established to allow the transfer of shape-memory materials into pharmaceutical sciences.
“An evaluation strategy has been established to allow the transfer of shape-memory materials into pharmaceutical sciences.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ ReviewShape-memory properties are quantified in cyclic, stimuli-specific mechanical tests that consist of the shape-memory creation process and the recovery of the original, permanent shape.
“The shape-memory properties are quantified in cyclic, stimuli-specific mechanical tests that consist of the SMCP and the recovery of the original, permanent shape [2,[14][15][16].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [2,[14][15][16]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Classified as probably not a substantial claim.
Premisenone given§ Motivation for introduction of SMP to biomedical applicationsThermally induced shape-memory polymers are triggered by heat.
“Here, we focus on thermally induced SMPs, which are triggered by heat.”
Quote in the paperSubstantial claimMay combine two claims.
Premisenone given§ Examples for shape-memory polymer systems intended for biomedical applicationsCovalent shape-memory polymer networks provide in many cases higher shape fixity and shape recovery ratios compared with similar thermoplastic architectures, while thermoplastic shape-memory polymers provide the advantage of processing by extrusion.
“While covalent SMP networks provide in many cases higher R f and R r compared with similar thermoplastic architectures, thermoplastic SMPs provide the advantage of processing by extrusion.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ ReviewDifferent test protocols differ in the shape-memory creation process, which can be performed under constant strain or constant stress conditions.
“Different test protocols have been developed.They differ in SMCP, which can be performed under constant strain or constant stress conditions.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Premisenone given§ Motivation for introduction of SMP to biomedical applicationsOften the shape-memory effect needs to be combined with other functions, such as degradability or drug release.
“Often the SME needs to be combined with other functions, such as degradability or drug release.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationreasoning§ Sterilization & in vitro cytotoxicity testingOxidation reactions can occur between amine groups and hydrogen peroxide, and cross-linking reactions can occur between ethylene oxide and hydroxyl or amine groups in shape-memory polymers.
“Possible examples are oxidation reactions, for example, between amine groups and hydrogen peroxide, or cross-linking reactions between EO and hydroxyl or amine groups.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisereasoning§ General principle of SMPsPhysical cross-linking is realized by solidification on cooling, such as vitrification or crystallization.
“Physical cross-linking is realized by solidification, which occurs on cooling, such as vitrification or crystallization.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisereasoning§ ReviewFrom the data obtained, the shape fixity ratio and the shape recovery ratio can be determined.
“From the data obtained, the shape fixity ratio (R f ) and the shape recovery ratio (R r ) can be determined.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingThe molecular weight of PLG decreases after gamma-irradiation, and this degradation process continues on storage for 4 weeks.
“The molecular weight of PLG, which is known as a candidate material for SMP synthesis, decreases after g-irradiation, and this degradation process continues on storage for 4 weeks [57,58,61].”
Quote in the paperNot a substantial claim0 of 3 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ Examples for shape-memory polymer systems intended for biomedical applicationsShape-memory polymers can be considered as multifunctional materials when the shape-memory effect and hydrolytic degradability are present in one material.
“Additionally, SMPs can be considered as multi functional materials when, for example, the SME and hydrolytic degradability are present in one material.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Premisenone given§ Examples for shape-memory polymer systems intended for biomedical applicationsBiomedical applications require certain properties or functionalities that can be fulfilled by the appropriate choice of suitable shape-memory polymer architectures.
“With respect to SMPs, biomedical applications require certain properties or functionalities, which can be fulfilled by the appropriate choice of suitable SMP architectures.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisereasoning§ General principle of SMPsIn multiphase polymers, domains related to the highest thermal transition temperature are hard domains and act as physical netpoints.
“In such multiphase polymers, the domains related to the highest thermal transition temperature (T perm ) are called hard domains and are acting as physical netpoints.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ General principle of SMPsThe deformation creating the temporary shape necessitates a sufficient elastic deformability of the polymer network.
“The deformation creating the temporary shape necessitates a sufficient elastic deformability of the polymer network.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ General principle of SMPsThermosensitive shape-memory polymers are presently the most prominent class of shape-memory polymers.
“Thermosensitive SMPs, which is presently the most prominent class of SMPs, can be additionally classified according to the thermal transitions related to the solidification of the polymer chain segments.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Interpretationreasoning§ Motivation for introduction of SMP to biomedical applicationsThe temporary shape of a shape-memory polymer implant can be adjusted to the individual needs of the patient.
“Furthermore, the temporary shape can be adjusted to the individual needs of the patient.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ ReviewThe shape fixity ratio is a measure for the ability of the switching segment to fix a mechanical deformation applied during the shape-memory creation process when the temporary shape is created.
“R f is a measure for the ability of the switching segment to fix a mechanical deformation -for example, an elongation to e m , applied during SMCP, when the temporary shape is created.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ Sterilization & in vitro cytotoxicity testingFor PCL, e-beam irradiation at 9.0 kGy/min broadens the molecular weight distribution through combined chain scission and cross-linking.
“For PCL, Filipczak et al. demonstrated by e-beam irradiation (9.0 kGy/min) that the molecular weight distribution becomes broadened through combined chain scission and cross-linking [56].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [56] Filipczak, 2006, Macromol. Biosci. source
Probably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ Multiblock copolymers with T trans = T gThe application of the prepolymer method enabled the production of thermoplastic polyurethane elastomers on an industrial scale.
“The application of the prepolymer method enabled the production of thermoplastic polyurethane elastomers on an industrial scale.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisenone given§ Multiblock copolymers with T trans = T gThermoplastic shape-memory polymers can be synthesized by direct coupling of presynthesized polymer blocks with a reactive linker, by applying the prepolymer method, or by melt blending.
“Thermoplastic SMPs can be synthesized by direct coupling of presynthesized polymer blocks with a reactive linker, by applying the prepolymer method or by melt blending.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationnone given§ Examples for shape-memory polymer systems intended for biomedical applicationsAppropriate sterilization of shape-memory polymers requires a transition temperature higher than the temperature attained during the sterilization technique.
“This requires, for example, a T trans of the SMP, which is higher than the temperature attained during the sterilization technique.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ Multiblock copolymers with T trans = T gThis polyetherurethane material is used in artificial hearts, wound dressings and pacemaker leads.
“This material is used in artificial hearts, wound dressings and pacemaker leads [18].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] Guignot, 2001, Nucl. Instrum. Meth. B source
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ Multiblock copolymers with T trans = T gThe quality of phase separation between the polyurethane segments and the polyetherurethane is determined by the molecular weight of the polytetrahydrofurandiols used as educt.
“The quality of phase separation between the polyurethane segments and the PEU is determined by the molecular weight of the polytetrahydrofurandiols used as educt.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone given§ Examples for shape-memory polymer systems intended for biomedical applicationsFor sterilization techniques using reactive components, building blocks nonreactive towards these components have to be used.
“Furthermore, in case of sterilization techniques using reactive components, building blocks, which are nonreactive towards these components, have to be used.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationreasoning§ Sterilization & in vitro cytotoxicity testingSuch reactions might shift the transition temperature of a shape-memory polymer, causing actuation during sterilization or preventing actuation at the application site.
“While these effects might be neglected for materials not intended to change their shape, in case of SMPs, such reactions might result in an undesired shift of T trans , either resulting in actuation of the SME during sterilization or preventing it at the application site, when stimulated by exposure to the intended temperature range.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ General principle of SMPsShape-memory polymers are polymer materials that can be temporarily stabilized in a second, temporary shape by application of external stress and subsequent fixation.
“SMPs are polymer materials, which can be temporarily stabilized in a second, temporary shape by application of external stress and subsequent fixation [2][3][4][5][6][7][8][9][10][11][12][13].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [2][3][4][5][6][7][8][9][10][11][12][13]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
Premisereasoning§ General principle of SMPsWhen the shape-memory polymer is reheated, crystallites melt or glassy polymer chain segments return to the viscous state.
“When the SMP is reheated, the crystallites will melt or the glassy polymer chain segments will return to the viscous state.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisereasoning§ General principle of SMPsPhysical crosslinks require a morphology consisting of at least two segregated domains, for example a crystalline and an amorphous phase.
“physical crosslinks require a morphology consisting of at least two segregated domains -for example, a crystalline and an amorphous phase.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationreasoning§ Motivation for introduction of SMP to biomedical applicationsA bulky implant with a switching temperature between room temperature and body temperature can be inserted through a small incision in a compressed or elongated temporary shape and, upon heating to body temperature, changes into its bulky application-relevant shape.
“A bulky implant having a switching temperature (T sw ) between room temperature and body temperature could be inserted into the body through a small incision in a compressed or elongated temporary shape.As soon as the implant is placed in the body, it is heated to body temperature and changes into its bulky application-relevant shape.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisereasoning§ Examples for shape-memory polymer systems intended for biomedical applicationsSeveral shape-memory polymer network architectures have been invented, each having certain advantages.
“As a result, several SMP network architectures have been invented, each having certain advantages.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisereasoning§ ReviewIf additional cross-links are based on physical interaction, a further distinction according to thermal transition can be made: glass transition, melting transition, or liquid crystalline transition.
“If these additional cross-links are based on physical interaction, a further distinction according to T trans can be made, which can be a glass transition T g , a melting transition T m or a liquid crystalline transition.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
Premisecitation§ Examples for shape-memory polymer systems intended for biomedical applicationsMultifunctionality is the unexpected combination of material functions.
“Multifunctionality is the unexpected combination of material functions [17].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17] Lendlein, 2005, Clin. Hemorheol. Micro.
May combine two claims.
Premisenone given§ Multiblock copolymers with T trans = T mIn polyesterurethanes, the oligourethane segments act as hard segments, while the polyester segments, for example poly(e-caprolactone), form the switching segments.
“In PESU, the oligourethane segments are acting as hard segments, while the polyester segments, for example, poly(e-caprolactone) (PCL), are forming the switching segments.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Premisenone given§ ReviewMelting transitions mostly extend over a temperature range between 15 and 20 K, while liquid crystalline transitions can occur in a temperature interval between 1 and 5 K.
“Melting transitions mostly extend over a temperature range between 15 and 20 K, while liquid crystalline transitions can even occur in a temperature interval between 1 and 5 K.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ ReviewThe shape recovery ratio determines the ability of the material to memorize its permanent shape.
“R r determines the ability of the material to memorize its permanent shape.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ Multiblock copolymers with T trans = T gIn most cases these polymers form a mixed domain acting as a switching phase.
“In most cases these polymers form a mixed domain acting as a switching phase.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisereasoning§ General principle of SMPsThe netpoints of the polymer network determine the permanent shape of the shape-memory polymer and can be of chemical or physical nature.
“The netpoints of the polymer network, which are connected by the chain segments, determine the permanent shape of the SMP and can be of chemical (covalent bonds) or physical (intermolecular interactions) nature.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisereasoning§ ReviewWhen the recovery process is performed under stress-free conditions, for thermally induced shape-memory polymers the switching temperature can be determined.
“When the recovery process is performed under stress-free conditions, for thermally induced SMPs the switching temperature T sw , triggering the macro scopic SME, can be determined.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationreasoning§ Sterilization & in vitro cytotoxicity testingHydrogen peroxide vapor or ethylene oxide may react with certain chemical groups of shape-memory polymers, so careful selection of sterilization method is required.
“Among them, a careful selection has to be made, as hydrogen peroxide vapor or EO may react with certain chemical groups of the SMP.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ ReviewThe temperature at which maximum stress is developed can be determined from recovery processes under constant strain.
“In addition, the temperature at which maximum stress is developed (T smax ) can be determined from recovery processes under constant strain.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ Multiblock copolymers with T trans = T mProminent examples for block copolymers with a melting transition as the transition temperature are polyetherurethane, polyesterurethanes and polyetheresterurethanes.
“Prominent examples for block copolymers with T trans = T m are PEU, polyesterurethanes (PESU) and polyetheresterurethanes.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Interpretationnone given§ Sterilization & in vitro cytotoxicity testingTests with organotypic and regiospecific primary cells are suited to provide more detailed systematic information about SMP-cell interaction in the later medical approach.
“Tests with organotypic and regiospecific primary cells are suited to provide more detailed systematic information about the SMP-cell interaction in the later medical approach.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Interpretationcitation§ Sterilization & in vitro cytotoxicity testingThese results were supposed to be affected by different mechanical loading by surface roughness, and besides chemical composition, also by resulting surface properties such as hydrophobicity, which are main predictors of protein adsorption and cell adhesion.
“These results were supposed to be affected by different mechanical loading by the surface roughness, and besides the chemical composition of the material surface, also by the resulting surface properties, often expressed in terms of hydrophobicity, that are the main predictors of protein adsorption and, thus, cell adhesion [77-79].”
Quote in the paperSubstantial claim0 of 3 sources checkedMay combine two claims.
Premisecitation§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymersNo gas leakage after gas insufflation could be detected, and fast and unfavorable degradation of the polymer did not occur.
“No gas leakage after gas insufflation could be detected, and fast and unfavorable degradation of the polymer did not occur.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [75] Rickert, 2005, Biomed. Tech. (Berl.) source
- cites [76] Rickert, 2005, Clin. Hemorheol. Microcirc.
Not checked in the free run.
- The authors state this as an assumption: The incorporation of a biomaterial in vivo requires regular wound-healing mechanisms.
May combine two claims. The quote only partly states this claim.
Premisecitation§ Sterilization & in vitro cytotoxicity testingEndothelial cells proved to adhere, grow and form confluent monolayers on PDC after EO sterilization during increasing time periods.
“The endothelial cells proved to adhere, to grow and to from confluent monolayers on the material during increasing time periods.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [80] Rickert, 2003, Clin. Hemorheol. Microcirc.
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingN-PCLDMA polymer proved biocompatible for all tested cell types, supporting cell viability and proliferation.
“The polymer proved biocompatibility for all tested cell types, supporting cell viability and proliferation.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [86] Neuss, 2009, Biomaterials source
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingN-PCLDMA supported osteogenic and adipogenic differentiation of human mesenchymal stem cells 3 weeks after induction, and SME activation did not affect the majority of adherent cells.
“N-PCLDMA also supported the osteogenic and adipogenic differentiation of human mesenchymal stem cells 3 weeks after osteogenic and adipogenic induction, and the SME activation did not affect the majority of adherent cells.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [86] Neuss, 2009, Biomaterials source
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingPESU showed higher TNF-a production and a higher potential for macrophage and endothelial activation compared with PEU.
“The PESU showed higher TNF-a production and a higher potential for macrophage and endothelial activation, respectively, compared with PEU.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [81] Cabanlit, 2007, Macromol. Biosci. source
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingPCL-based shape-memory polyurethane ionomers with quaternarized pyridine moieties reduced the bacterial activity of Klebsiella pneumoniae by 96.2% and Staphylococcus aureus by 100%.
“In addition, PCL-based shape-memory polyurethane ionomers with quaternarized pyridine moieties proved to be suited to reduce the bacterial activity of Klebsiella pneumoniae (-96.2%) and Staphylococcus aureus (-100%).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [73] source
May combine two claims.
Premisecitation§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymersThe in vivo degradation process of PDC is characterized by a release of microparticles, which were supposed to primarily consist of PPDO, and which did not negatively affect strong integration of the SMP in the subcutis of rats and mice.
“The study demonstrated that the in vivo degradation process of PDC is characterized by a release of microparticles, which were supposed to primarily consist of PPDO, and which didn't negatively affect a strong integration of the SMP in the subcutis of rats [97] and mice [99].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [97] Hiebl, 2009, Mat. Res. Soc. Symp. Proc. source
- cites [99] Binzen, 2003, Clin. Hemorheol. Microcirc.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- The authors state this as an assumption: The incorporation of a biomaterial in vivo requires regular wound-healing mechanisms.
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingVariations in PEU blood compatibility have been observed, with improved thromboresistance correlating to more alkylated soft segments, higher soft segment content on the surface, and surface treatment such as grafted sulfonate groups.
“Variations in PEU blood compatibility have been observed, with improved thromboresistance correlating to more alkylated soft segments [82], higher soft segment content on the surface [83] and surface treatment, such as grafted sulfonate groups [84,85].”
Quote in the paperNot a substantial claim0 of 4 sources checked- cites [82] Coury A, Levy R, McMillin Cet al.Biomaterials Science: An Introduction to Materials in Medicine. Ratner B, Hoffman A, Schoen F, Lemons J (Eds). Academic Press, NY, USA (1996).
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [83] Silver, 1994, Biomaterials source
- cites [84] Lelah, 1985, J. Biomed. Mater. Res. source
- cites [85] Lelah, 1983, J. Biomed. Mater. Res. source
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingPolyurethane ionomers possessed good bactericidal activity against Staphylococcus aureus and bacteriostatic activity against Escherichia coli.
“It was found that the polyurethane ionomers possessed good bactericidal activity against Staphylococcus aureus and bacteriostatic activity against Escherichia coli.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [72] Grapski, 2001, Biomaterials source
May combine two claims.
Premisecitation§ Sterilization & in vitro cytotoxicity testingAfter plasma sterilization with Sterrad-100St, H2O2, for 52 min, PU foams have increased open porosity but no effects on shape-memory recovery.
“After plasma sterilization (Sterrad-100St, H 2 O 2 , 52 min) PU foams are described to have an increased open porosity, but no effects on shape-memory recovery were observed [63].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [63] De Nardo, 2009, Acta Biomater. source
Classified as probably not a substantial claim.
Interpretationreasoning§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymersTherefore, in vivo testing in animal models is necessary prior to human clinical testing.
“Therefore, in vivo testings in animal models are necessary prior to human clinical testing.”
Quote in the paperSubstantial claimMay combine two claims.
Premisecitation§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymersThe angiogenic effect of PDC was shown in the hen's egg chorioallantoic membrane test and after subcutaneous implantation in rats and mice.
“This might be explained by the angiogenic effect of the PDC, which was shown in the hen's egg chorioallantoic membrane test (HET-CAM-test) [71], and also after subcutaneous implantation in rats [97] (Figure 3) and mice [99].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [71] Rickert, 2006, Eur. Arch. Otorhinolaryngol. source
- cites [97] Hiebl, 2009, Mat. Res. Soc. Symp. Proc. source
- cites [99] Binzen, 2003, Clin. Hemorheol. Microcirc.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- The authors state this as an assumption: The incorporation of a biomaterial in vivo requires regular wound-healing mechanisms.
May combine two claims.
Premisenone given§ Sterilization & in vitro cytotoxicity testingThe highest MMP-1 and MMP-2 levels corresponded with the highest TIMP levels, and vice versa.
“The highest MMP-1 and MMP-2 levels corresponded with the highest TIMP levels, and vice versa.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [74][75][76][77]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
Interpretationcitation§ Vascular applicationsBy using polymers instead of Pt coils, improved cell adhesion may be achievable, since polymers can be tailored to preferentially allow adhesion of certain cell types by selection of building blocks.
“By using polymers instead of Pt coils, an improved cell adhesion may be achievable [108], since polymers can be tailored to preferentially allow adhesion of certain cell types by the selection of building blocks for the polymer.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [108] Hampikian, 2006, Mater. Sci. Eng. C source
May combine two claims.
Interpretationreasoning§ External applicationsEnergy input from laser activation also causes heating and potential damages to blood cells and the surrounding tissue.
“However, at the same time, energy input also causes heating and potential damages to blood cells and the surrounding tissue.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ The concept of controlled drug release from biodegradable polymersFor hydrolytic cleavage as the most commonly followed biodegradation strategy, the erosion mechanism depends on the combination of the rate of water uptake into the matrix and the rate of hydrolytic polymer cleavage.
“For example, for hydrolytic cleavage as the most commonly followed biodegradation strategy, the erosion mechanism depends on the combination of both the rate of water uptake into the matrix and the rate of hydrolytic polymer cleavage.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ The concept of controlled drug release from biodegradable polymersThe concept of a controlled and sustained release of drugs from biodegradable implants was developed more than 30 years ago.
“The concept of a controlled and sustained release of drugs from biodegradable implants was developed more than 30 years ago [134,135].”
Quote in the paperNot a substantial claim0 of 2 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ The concept of controlled drug release from biodegradable polymersDiffusion of water into the polymer matrix typically occurs when the dry implant matrix is transferred into a physiological environment.
“Typically this is the case when the dry implant matrix is transferred into a physiological environment.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ The concept of controlled drug release from biodegradable polymersDepending on the application, drug release can be adjusted to be fast, slow or pulsatile.
“Depending on the application, the release can be adjusted to be, for example, fast, slow or pulsatile.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ External applicationsFDA approval was received in the USA for a microcatheter system that is guided to the occluded vessel and passed beyond the thrombus; a nitinol wire deploys to a helical corkscrew shape and captures the clot.
“Accordingly, FDA approval was received in the USA for a microcatheter system that is guided to the occluded vessel and passed beyond the thrombus.A nitinol wire is advanced through the catheter, deploys at the end of the catheter in a spring-like manner to a helical corkscrew shape, and captures the clot [129].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [129] Gobin, 2004, Stroke source
Probably not a substantial claim: may not pass S3 (load-bearing).
Premisereasoning§ The concept of controlled drug release from biodegradable polymersWhen drug release and degradation/erosion overlap, diffusion and erosion both contribute to the drug's release profile.
“In this common scenario, diffusion and erosion both contribute to the drug's release profile.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisenone given§ The concept of controlled drug release from biodegradable polymersIn contrast to daily peroral medication, implants can reduce the frequency of administration and provide constant levels of bioactive molecules either locally or systemically over an extended period of time (sustained release).
“In contrast to daily peroral medication, for example, with tablets, implants can reduce the frequency of administration, and provide constant levels of bioactive molecules either locally or systemically over an extended period of time (sustained release).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ The concept of controlled drug release from biodegradable polymersPolymer erosion can occur either at the surface of the material (surface-eroding) or in the entire matrix (bulk-eroding).
“In principle, this erosion can either occur at the surface of the material (surface-eroding) or in the entire matrix (bulk-eroding).”
Quote in the paperNot a substantial claimMay combine two claims.
Premiseown data§ In vivo tests for histo-compatibility & biofunctionality of shape-memory polymersA tight connection between the polymer and the adjacent stomach was found, resulting in adequate mechanical stability under the extreme pathophysical conditions of the stomach milieu.
“A tight connection between the polymer and the adjacent stomach was found, resulting in adequate mechanical stability under the extreme pathophysical conditions of the stomach milieu (Figure 4).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [75] Rickert, 2005, Biomed. Tech. (Berl.) source
- cites [76] Rickert, 2005, Clin. Hemorheol. Microcirc.
Not checked in the free run.
- The authors state this as an assumption: The incorporation of a biomaterial in vivo requires regular wound-healing mechanisms.
Probably not a substantial claim: may not pass S3 (load-bearing).
Premisereasoning§ The concept of controlled drug release from biodegradable polymersDepending on the speed and pathway of polymer erosion, drug release and degradation/erosion may overlap.
“Depending on the speed and pathway of polymer erosion, drug release and degradation/erosion may overlap.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ External applicationsDue to Joule heating by applying current to the copper wires, the SMP switching temperature is exceeded and super elastic recovery of the nitinol is enabled.
“Due to Joule heating by applying current to the copper wires, the SMP switching temperature is exceeded and super elastic recovery of the nitinol is enabled.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [117] Small, 2007, IEEE Trans. Biomed. Eng. source
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Interpretationnone given§ Miscellaneous internal applicationsA fast shape recovery may be useful when immediate fixation of a device or tissue is required during an intraoperative scenario.
“Often, a fast shape recovery may be useful when immediate fixation of a device or tissue is required during an intraoperative scenario.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ The concept of controlled drug release from biodegradable polymersFor drugs with relevant diffusion coefficients, a solely diffusion-controlled drug release can be realized.
“For drugs with relevant diffusion coefficients, a solely diffusioncontrolled drug release can be realized.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ External applicationsPreliminary in vivo data in dogs for aneurysms of the common carotid artery showed successful closure, at least macroscopically, in this well-healing vessel model, although no information on the cell types of the neointima was provided.
“Preliminary in vivo data in dogs for aneurysms of the common carotid artery showed a successful closure, at least macroscopically, in this well-healing vessel model, although no information on the cell types of the neointima was provided (Figure 7) [107].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [107] Metcalfe, 2003, Biomaterials source
May combine two claims.
Premisecitation§ External applicationsAfter turning off the current, the SMP vitrifies, enforces the nitinol and allows clot removal in vivo without the need of otherwise common guide wires.
“After turning off the current, the SMP vitrifies, enforces the nitinol and allows clot removal in vivo without the need of otherwise common guide wires [118].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [118] Hartman, 2007, AJNR Am. J. Neuroradiol.
Probably not a substantial claim: may not pass S3 (load-bearing).
Premisereasoning§ The concept of controlled drug release from biodegradable polymersA solely erosion-controlled drug release can be observed for molecules that do not possess diffusibility in the polymer matrix, for example due to high molecular weight.
“A solely erosion-controlled drug release can be observed for molecules that do not possess diffusibility in the polymer matrix; for example, for sterical reasons due to a high molecular weight.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone given§ Miscellaneous internal applicationsShape recovery produces forces that are typically required to enable the biomedical functionality of SMP devices.
“Shape recovery produces forces that are typically required to enable the bio medical functionality of SMP devices.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Interpretationnone given§ Miscellaneous internal applicationsBy employing SMP devices rather than common metal screws, damage of ligaments by the screw threads may be avoided during fixation.
“Moreover, by employing SMP devices rather than common metal screws, damage of ligaments by the screw threads may be avoided during fixation.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ The concept of controlled drug release from biodegradable polymersDiffusion of water from the release medium into the polymer matrix is essential to initiate drug release.
“It should be pointed out that the diffusion of water from the release medium into the polymer matrix is essential to initiate drug release.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ The concept of controlled drug release from biodegradable polymersIn SMPs capable of biodegradation, substantial alterations of polymer properties will occur after exposure to a physiological environment.
“In the preferred case of SMPs with the capability to undergo biodegradation, substantial alterations of polymer properties will occur after exposure to a physiological environment.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ The concept of controlled drug release from biodegradable polymersDissolved drug molecules can diffuse with a certain rate out of a polymer matrix.
“Generally, dissolved drug molecules can diffuse with a certain rate out of a polymer matrix.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
Interpretationreasoning§ Potential of SMP as intelligent matrix material for controlled drug-release systemsAdding a new capability to a device is not trivial, since it may impair an already established functionality.
“Adding a new capability to a device is not trivial, since it is not unlikely that this may impair an already established functionality.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ Vascular applicationsIncorporation of higher amounts of cross-linker into the network, or reducing the Tg of the switching segment, resulted in faster shape recovery of stent prototypes at body temperature in vitro.
“Incorporation of higher amounts of the cross-linker into the network, or reducing the T g of the switching segment, resulted in faster shape recovery of stent prototypes at body temperature in vitro.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26] Yakacki, 2007, Biomaterials source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisereasoning§ The concept of controlled drug release from biodegradable polymersFollowing water diffusion, small-molecule drugs with some water solubility get dissolved and typically can diffuse through the matrix in order to be released.
“Following this, small-molecule drugs, at least those with some extent of water solubility, get dissolved and typically can diffuse through the matrix in order to be released.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisecitation§ The concept of controlled drug release from biodegradable polymersA controlled-release formulation may prevent drug degradation, reduce side effects, or improve patients' adherence to the treatment.
“Besides ensuring delivery of the correct amount of drug, a controlled-release formulation may prevent drug degradation, reduce side effects, or improve patients' adherence to the treatment [136].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [136] source
Probably not a substantial claim: may not pass S3 (load-bearing).
Premisereasoning§ The concept of controlled drug release from biodegradable polymersAs a consequence of polymer degradation, implants lose structural integrity, undergoing erosion.
“As a consequence of polymer degradation, implants lose structural integrity -that is, they undergo erosion.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ Vascular applicationsIn another study, solid and perforated stents were compared, and a faster onset of recovery was found for the perforated devices.
“In another study, solid and perforated stents were compared, and a faster onset of recovery was found for the perforated devices [104].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [104] Yakacki CM, Shandas R, Lanning C, Gall K. Free recovery effects of shape-memory polymers for cardiovascular stents. In:Mechanical Behavior of Biological and Biomimetic Materials. Bushby AJ, Ferguson VL, Ko C-C, Oyen ML (Eds). Material Research Society, PA, USA (2006). source
Probably not a substantial claim: may not pass S4 (based).
Interpretationnone given§ Potential of SMP as intelligent matrix material for controlled drug-release systemsIncorporation of drugs may result in a disturbance of the polymer morphology or thermomechanical properties, and thus in an impaired shape-memory of a temperature-induced SMP.
“For example, incorporation of drugs may result in a disturbance of the polymer morphology or thermomechanical properties, and thus in an impaired shape-memory of a temperature-induced SMP.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Premisenone given§ Key issuesBiomedical applications require specific combinations of properties or functionalities, which can be realized by the appropriate choice of suitable SMP architectures.
“Biomedical applications require specific combinations of properties or functionalities, which can be realized by the appropriate choice of suitable SMP architectures.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationnone given§ Key issuesMultifunctional SMPs that combine shape-memory, biodegradability and controlled drug release are highlighted as matrices of drug carriers with relevance for both medical devices and pharmaceutical products.
“Multifunctional SMPs that combine shape-memory, biodegradability and controlled drug release are highlighted as matrices of drug carriers with relevance for both medical devices and pharmaceutical products.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationreasoning§ Shape-memory polymers as a technology platform for biomedical applicationsIncreased drug solubility in the polymer may increase maximum loading by swelling techniques but may also result in incomplete drug release due to trapping of drug in the polymer phase.
“This, on the one hand, may increase maximum loading, for example, by swelling techniques, but, on the other hand, may result in incomplete drug release due to trapping of drug in the polymer phase.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Premisenone given§ Key issuesThe shape-memory effect results from a suitable molecular network architecture in combination with a tailored processing and programming technology.
“The shape-memory effect (SME) results from a suitable molecular network architecture in combination with a tailored processing and programming technology.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
Interpretationreasoning§ point of view.If a SMP stent releases drugs and subsequently is removed from the tissue by biodegradation, the stent product might be considered to act mainly as a drug reservoir, and therefore as a pharmaceutical product.
“If, on the other hand, a SMP stent releases drugs and subsequently is removed from the tissue by biodegradation, the stent product, although providing mechanical stabilization of a tissue for a certain period of time, might be considered to act mainly as a drug reservoir, and therefore as a pharmaceutical product.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisenone given§ Relevance of SMP architecture & morphology for drug-release applicationsThere are several different methods to incorporate drugs in a polymeric matrix, but their applicability depends on the polymer properties.
“In principle, there are several different methods to incorporate drugs in a polymeric matrix; however, their applicability will depend on the polymer properties.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Premisenone given§ Key issuesSelection of building blocks and polymer architectures allows tuning of SMP mechanical properties over a wide range.
“Selection of building blocks and polymer architectures allows tuning of SMP mechanical properties over a wide range.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ point of view.During the consultation process, according to the medical device directive 93/42/EEC, the relevant national authorities will independently review in each specific case whether inclusion of drugs has led to changes in product classification.
“During the consultation process, according to the medical device directive 93/42/EEC, the relevant national authorities will independently review in each specific case whether inclusion of drugs has led to changes in product classification.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites medical device directive 93/42/EEC
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
Interpretationcitation§ Shape-memory polymers as a technology platform for biomedical applicationsAmorphous covalent SMP networks might advantageously show more homogeneous biodegradation, slower changes of mechanical properties during degradation, and easier adjustment of degradation and possibly drug release rates by changing co-monomer ratios in the network precursors.
“Besides being capable of drug loading in the entire matrix, amorphous covalent SMP networks might advantageously show a more homogeneous biodegradation, slower changes of mechanical properties during degradation and an easier adjustment of degradation, and possibly of drug release rates, by changing the co-monomer ratios in the network precursors [133].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [133] Wischke, 2010, Adv. Polym. Sci.
Not checked in the free run.
May combine two claims.
Premisenone given§ Shape-memory polymers as a technology platform for biomedical applicationsDrug loading of thermoplastic materials will typically be time-independent from polymer synthesis and can be carried out with different loading levels.
“Drug loading will typically be time-independent from polymer synthesis and could be carried out with different loading levels.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone given§ Shape-memory polymers as a technology platform for biomedical applicationsCross-linking a macromolecular network precursor in the presence of dispersed drug might cause chemical alterations of drug molecules that should be strictly avoided.
“Cross-linking macromolecular network precursor in the presence of dispersed drug might possibly cause chemical alterations of drug molecules that should be strictly avoided.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Interpretationnone given§ point of view.Such stents might be useful to keep the ureter open, for example in patients with abdominal tumors.
“Such stents might be useful to keep the ureter open, for example in patients with abdominal tumors.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationnone given§ Shape-memory polymers as a technology platform for biomedical applicationsA possibly broader temperature interval of thermal transition or a potential drug-induced plasticization of the SMP, and consequent alterations of the switching temperature, might be drawbacks of amorphous SMP networks.
“However, a possibly broader temperature interval of thermal transition or a potential drug-induced plasticization of the SMP and, as a consequence of this, alterations of the switching temperature, might be potential drawbacks of amorphous SMP networks.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based). May combine two claims.
Interpretationreasoning§ Expert commentaryDue to SMP biodegradability, the need for a second surgery for explantation can be avoided, which is beneficial for the patient and reduces treatment costs and intraoperative risks.
“Due to SMP biodegradability, the need of a second surgery for explantation can be avoided, which is beneficial for the patient and reduces treatment costs, as well as intraoperative risks.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisenone given§ Relevance of SMP architecture & morphology for drug-release applicationsCommon strategies to incorporate drugs in a polymeric matrix include casting of drug/polymer solutions, processing polymers in the molten state with dissolved or suspended drug, swelling of preformed networks, or cross-linking a macromolecular network precursor in the presence of dispersed drug.
“Common strategies include casting of drug/polymer solutions, processing polymers in the molten state with dissolved or suspended drug, swelling of preformed networks or cross-linking a macromolecular network precursor in the presence of dispersed drug.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Interpretationnone given§ Expert commentaryThe introduction of biodegradable building blocks into SMPs enabled a wider evaluation of SMPs for biomedical applications.
“Importantly, the introduction of biodegradable building blocks into the SMPs enabled a wider evaluation of SMPs for biomedical applications.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone given§ Shape-memory polymers as a technology platform for biomedical applicationsNoncovalent interactions, such as ionic bonds or hydrophobic interactions between drug and polymer, may take place when dissolved drug molecules are brought into contact with the polymer during drug loading.
“In addition, noncovalent interactions, such as ionic bonds or hydrophobic interactions between drug and polymer, may take place when dissolved drug molecules are brought into contact with the polymer during drug loading.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone given§ point of view.According to the common definition, at least in Europe, a product will no longer be considered a medical device but a pharmaceutical product whenever a principal intended action of the device in the human body is achieved by pharmacological, immunological or metabolic means.
“According to the common definition and, at least in Europe, the product will no longer be considered as a medical device, but a pharmaceutical product whenever a principal intended action of the device in the human body is achieved by pharmacological, immunological or metabolic means.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone given§ Shape-memory polymers as a technology platform for biomedical applicationsDrug loading of covalently cross-linked SMP networks can be conducted by swelling the network in drug solutions with subsequent drying.
“Drug loading of covalently cross-linked SMP networks can be conducted by swelling the network in drug solutions with subsequent drying.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
Premisereasoning§ point of view.To evaluate the significance of the drug payload in a specific product, the purpose and application of the product need to be considered.
“In order to evaluate the significance of the drug payload in a specific product, the purpose and application of the product need to be considered.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone given§ Five-year viewBiodegradable SMP stents are considered as a future strategy that might overcome complications in treatment, such as late thrombosis.
“Biodegradable SMP stents are considered as a future strategy that might overcome complications in treatment, such as late thrombosis.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
Interpretationreasoning§ Key issuesThis stresses the potential of SMP applications in the field of regenerative therapies.
“This stresses the potential of SMP applications in the field of regenerative therapies.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Interpretationreasoning§ Five-year viewThese requirements could be fulfilled by materials that are able to perform more than one predetermined shift.
“These requirements could be fulfilled by materials that are able to perform more than one predetermined shift.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Premisenone given§ Key issuesBesides the advantages of EO, including efficacy at low temperatures, high penetration and compatibility with a wide range of materials, residual EO can have severe cytotoxic effects.
“However, besides the advantages of EO, including efficacy at low temperatures, high penetration and compatibility with a wide range of materials, residual EO can have severe cytotoxic effects.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Premisenone given§ Five-year viewEspecially for applications in minimally invasive medicine, there is a strong demand for implants that are able to perform complex movements.
“Especially for applications in minimally invasive medicine, there is a strong demand for implants that are able to perform complex movements.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based). May combine two claims.
Interpretationnone given§ Five-year viewBy combining the SME with biodegradability and controlled drug release in one polymeric system, multifunctional materials can be obtained that open up biomedical applications beyond medical devices.
“By combining the SME with biodegradability and controlled drug release in one polymeric system, multifunctional materials can be obtained that open up biomedical applications beyond medical devices.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Interpretationnone given§ Five-year viewIn terms of an individual treatment of patients, SMPs might be necessary that can be adapted to the specific conditions of an individual patient.
“In addition, in terms of an individual treatment of patients, SMPs might be necessary that can be adapted to the specific conditions of an individual patient.”
Quote in the paperNot a substantial claim
The authors state this as an assumption.
In nonfunctional in vivo tests, acute toxic or inflammatory reactions are nonspecific and may therefore be evaluated in soft tissues such as subcutaneous, intramuscular and intraperitoneal sites.
“In these tests, it is assumed that acute toxic or inflammatory reactions are nonspecific, and thus may be evaluated in soft tissues (e.g., subcutaneous, intramuscular and intraperitoneal), because implantation in soft tissue requires minor surgery.”
The authors state this as an assumption.
The incorporation of a biomaterial in vivo requires regular wound-healing mechanisms.
“The incorporation of a biomaterial in vivo is generally assumed to require regular wound-healing mechanisms.”
The paper relies on this without support.
No single animal species represents an ideal general model for the human species.
“No single animal species represents an ideal general model for the human species.”
The paper relies on this without support.
Drug incorporation is not expected to occur in the crystalline phase.
“since drug incorporation is not expected to occur in the crystalline phase”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The paper achieved a 4D printable shape memory hydrogel that operates via spinodal decomposition, with shape-shifting dominated by internal mass diffusion instead of thermal conduction.
“Here, we achieve this seemingly unrealistic goal with a 4D printable shape memory hydrogel that operates via spinodal decomposition, with its shape-shifting dominated by internal mass diffusion instead of thermal conduction for common shape memory polymers8-10,13.”
From Shape memory polymer with programmable recovery onset (2023) · cites this paper as [8]
The citation attaches to the comparison with common shape-memory polymers, not to the citing authors’ claim that they achieved a 4D-printable hydrogel. The source’s ‘Motivation for introduction of SMP to biomedical applications’ section says it focuses on polymers triggered by heat, supporting the thermal comparison broadly. It does not establish that their shape-shifting is dominated specifically by thermal conduction; nor does it report the citing authors’ hydrogel, spinodal decomposition, or internal mass diffusion. (LLM, conf=0.78)
Experimental — accuracy not yet measuredAccessing external stimulation under realistic scenarios has become the biggest bottleneck for increasingly demanding applications such as implantable medical devices.
“Ironically, accessing external stimulation (e.g. heating or light) under realistic scenarios has become the biggest bottleneck for increasingly demanding applications such as implantable medical devices8.”
From Shape memory polymer with programmable recovery onset (2023) · cites this paper as [8]
The Five-year view (page unavailable) identifies direct access to implanted materials as a challenge and calls for on-demand actuation independent of body temperature. The Vascular applications section (page unavailable) also reports difficulty achieving light-triggered recovery under flow conditions relevant to in vivo use. The paper does not characterize access to external stimulation as the biggest bottleneck. (LLM, conf=0.86)
Experimental — accuracy not yet measured
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“They have been used to develop smart sutures or wound closures, for aneurysm treatment as well as to develop blood clot removal tools (Lendlein et al., 2010).”
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4D polycarbonates via stereolithography as scaffolds for soft tissue repair
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Biocompatible electrically conductive nanofibers from inorganic-organic shape memory polymers
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Biocompatible shape memory polymer actuators with high force capabilities
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Shape memory materials and 4D printing in pharmaceutics
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Design of Triple-Shape Memory Polyurethane with Photo-cross-linking of Cinnamon Groups
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Recent Trends in the Chemistry of Shape‐Memory Polymers
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A Metallosupramolecular Shape‐Memory Polymer with Gradient Thermal Plasticity
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Smart scaffolds: shape memory polymers (SMPs) in tissue engineering
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A Survey of Surface Modification Techniques for Next-Generation Shape Memory Polymer Stent Devices
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Switchable information carriers based on shape memory polymer
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Triple Shape Memory Effect of Star-Shaped Polyurethane
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“Shape memory polymers are a class of smart materials that can be programmed to fix at one temporary shape and then recover to their permanent shape upon appropriate stimulation [1].”
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Design of multistimuli-responsive shape-memory polymer materials by reactive extrusion
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“Nowadays, SMPs and SMPCs are widely used in aerospace [13], biomedicine [14], and textiles [15], information carriers [16] and smart sensors [17].”
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A novel constitutive model of shape memory polymers combining phase transition and viscoelasticity
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Healable shape memory (thio)urethane thermosets
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Porous shape memory polymers: Design and applications
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The evolution of mechanical actuation: from conventional actuators to artificial muscles
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“A translational stage is lowered to produce consecutive layers of the final part, (2) a 3D printed shape memory spring, (3) the sample is programmed to form a straight strand and, then heated to 60°C to recover the original spring shape, (4) experimental and finite element simulations were carried out to develop a rel…”
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An annulus fibrosus closure device based on a biodegradable shape-memory polymer network
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- Authors
- Lendlein, A., Behl, M., Hiebl, B., & Wischke, C.
- Affiliations
- Berlin-Brandenburger Centrum für Regenerative Therapien (DE)
- Venue
- Expert Review of Medical Devices
- Publisher
- Informa UK Limited
- Published
- 2010-05
- Volume
- 7
- Issue
- 3
- Pages
- 357-379
- ISSN
- 1743-4440 (ISSN-L)
- 1745-2422
- OpenAlex
- W2165293299
- Cited by
- 469
- References
- 164
- Citations by year
- 2026: 17 · 2025: 21 · 2024: 34 · 2023: 27 · 2022: 35 · 2021: 31 · 2020: 37 · 2019: 39 · 2018: 25 · 2017: 26 · 2016: 32 · 2015: 29 · 2014: 26 · 2013: 22 · 2012: 23
- FWCI
- 54.07
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Expert Review of Medical Devices (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Engineering › Mechanical Engineering › Advanced Materials and Mechanics
- Physical Sciences › Materials Science › Polymers and Plastics › Polymer composites and self-healing
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Medicine › Hydrogels: synthesis, properties, applications
- Keywords
- shape memory polymers, biomedical applications, medical devices, controlled drug delivery, biomedical implants, polymer composition, polymer architecture, biodegradability, biocompatibility, sterilization, controlled drug release, patent landscape
- MeSH terms
- Animals, Equipment and Supplies, Humans, Materials Testing, Polymers, Sterilization, Drug Delivery Systems, Biomedical Technology
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