Academic literature on the topic 'Patent bioprinting'

A combination of 3D printing techniques and synthetic biology, 3D bioprinting is a promising field. It is expected that 3D bioprinting technologies will have applications across an array of fields, spanning biotechnology, medical surgery and the pharmaceutical industry. Nonetheless, the progress of these technologies could be hindered, unless there is adequate and effective protection for related applications. In this article, the authors examine the patent eligibility of 3D bioprinting technologies. This issue raises concern given that existing patent systems are generally averse to nature-derived inventions and many of them exclude products of nature or discoveries from patentability. This qualitative study analyses the current patent systems in key jurisdictions, particularly, the U.S. and the EU, and their applicability, as well as effectiveness, in the context of 3D bioprinting. The study argues that the main reason for the apathy of existing patent systems towards bio-inventions is that they were designed to deal with mechanical inventions. It suggests an innovation framework that encompasses both mechanical and biological inventions to cater adequately to emerging technologies.

This article examines the legal regulation of bioprinting (3D printing) and culture of tissues and organs in the BRICS countries through the prism of protection of intellectual property. The work demonstrates the means of protection of results acquired at each stage of bioprinting by the norms of copyright and patent law, as well as touches on the questions of the need (possibility) for patenting of “bioprinters”, “bioinks”, “biopapers”, etc. The goal of this research is to determine the necessary and possible boundaries for patenting (copyright law protection) of the means, products, processes and their moral-ethical acceptance in the society. The novelty of this work consists in a comprehensive analysis of the approaches of BRICS countries towards development, legal formalization and protection of bioprinting and culture of tissues and organs as medical and non-medical technologies from the perspective of intellectual property law. The author attempts to answer the question of (non)patentability of the process (means) and result (product) of bioprinting of tissues and organs, the “bioprinters” themselves, as well as the “bioinks” and “biopapers” they use. With regards to (non)patentability of tissues and organs acquired through 3D printing, a conclusion is made that there is an unfavorable environment for their patenting, though their production, in the author’s opinion, should the right to patenting providing that they meet the criteria (other conditions) set by patenting law of a particular country.

Abstract Here we report the 3D bioprinting of a simplified model of the heart, similar to that observed in embryonic development, where the heart is a linear tube that pumps blood and nutrients to the growing embryo. To this end, we engineered a bioinspired model of the human heart tube using freeform reversible of embedding of suspended hydrogels 3D bioprinting. The 3D bioprinted heart tubes were cellularized using human stem cell-derived cardiomyocytes and cardiac fibroblasts and formed patent, perfusable constructs. Synchronous contractions were achieved ∼3–4 days after fabrication and were maintained for up to a month. Immunofluorescent staining confirmed large, interconnected networks of sarcomeric alpha actinin-positive cardiomyocytes. Electrophysiology was assessed using calcium imaging and demonstrated anisotropic calcium wave propagation along the heart tube with a conduction velocity of ∼5 cm s−1. Contractility and function was demonstrated by tracking the movement of fluorescent beads within the lumen to estimate fluid displacement and bead velocity. These results establish the feasibility of creating a 3D bioprinted human heart tube and serve as an initial step towards engineering more complex heart muscle structures.

The paper is devoted to the issues of advisability of introducing amendments to the civil legislation in connection with the development of additive technologies or the possibility of effective application of the existing rules of law to the regulation of «innovative» civil relations.Digitization of objects of the material world associated with the creation of their digital prototypes constitutes a revolutionary element of 3D printing technology. A three-dimensional digital model (CAD file) can be easily modified, distributed and embodied in the form of a physical object by printing it on a 3D printer. This gives rise to new risks of infringement of exclusive rights to objects of patent law. In a foreign doctrine, a discussion has started regarding the possibility of qualifying the creation and circulation of digital models of patented products (inventions) as a direct infringement or indirect infringement of exclusive rights.The paper concluded that Russian patent law was not ready for the challenge generated by the development of 3D printing technology, since it was not aware of the concept of indirect infringement of the exclusive right. In Russian law enforcement practice, the concept of direct patent infringement is interpreted in a restrictive manner.The question of admissibility of patenting technical solutions in the field of bioprinting has been studied. It is concluded that in Russian law there are no fundamental obstacles to patenting technical solutions in the field of bioprinting technologies. Russian legislation provides for the possibility of patenting «natural products», as well as methods and means of treatment, which distinguishes the Russian approach from the American or European one. If the risk of genetic instability of pluripotent cells is leveled, the technology for creating bioprinted human organs will comply with the requirements of civil law. In particular, it will meet the requirements for the compliance of patented technical solutions with the public interest, the principles of humanity and morality.

AbstractVascular disease – including coronary artery disease, carotid artery disease, and peripheral vascular disease – is a leading cause of morbidity and mortality worldwide. The standard of care for restoring patency or bypassing occluded vessels involves using autologous grafts, typically the saphenous veins or internal mammary arteries. Yet, many patients who need life- or limb-saving procedures have poor outcomes, and a third of patients who need vascular intervention have multivessel disease and therefore lack appropriate vasculature to harvest autologous grafts from. Given the steady increase in the prevalence of vascular disease, there is great need for grafts with the biological and mechanical properties of native vessels that can be used as vascular conduits. In this review, we present an overview of methods that have been employed to generate suitable vascular conduits, focusing on the advances in tissue engineering methods and current three-dimensional (3D) bioprinting methods. Tissue-engineered vascular grafts have been fabricated using a variety of approaches such as using preexisting scaffolds and acellular organic compounds. We also give an extensive overview of the novel use of 3D bioprinting as means of generating new vascular conduits. Different strategies have been employed in bioprinting, and the use of cell-based inks to create de novo structures offers a promising solution to bridge the gap of paucity of optimal donor grafts. Lastly, we provide a glimpse of our work to create scaffold-free, bioreactor-free, 3D bioprinted vessels from a combination of rat vascular smooth muscle cells and fibroblasts that remain patent and retain the tensile and mechanical strength of native vessels.

Here, we present a concise review of current 3D bioprinting technologies applied to induced pluripotent stem cells (iPSC). iPSC have recently received a great deal of attention from the scientific and clinical communities for their unique properties, which include abundant adult cell sources, ability to indefinitely self-renew and differentiate into any tissue of the body. Bioprinting of iPSC and iPSC derived cells combined with natural or synthetic biomaterials to fabricate tissue mimicked constructs, has emerged as a technology that might revolutionize regenerative medicine and patient-specific treatment. This review covers the advantages and disadvantages of bioprinting techniques, influence of bioprinting parameters and printing condition on cell viability, and commonly used iPSC sources, and bioinks. A clear distinction is made for bioprinting techniques used for iPSC at their undifferentiated stage or when used as adult stem cells or terminally differentiated cells. This review presents state of the art data obtained from major searching engines, including Pubmed/MEDLINE, Google Scholar, and Scopus, concerning iPSC generation, undifferentiated iPSC, iPSC bioprinting, bioprinting techniques, cartilage, bone, heart, neural tissue, skin, and hepatic tissue cells derived from iPSC.

3D bioprinting is an additive manufacturing method, formulated with cells printed in bioinks of basic matrix such as hydrogels. Bioinks are relevant to precision medicine mainly due to recapitulation of tissue organoids with broad application. 3D bioprinting can address the issue of increased cost in drug development with overall benefit in healthcare. Despite research, solid and hematological cancer remain a clinical problem. Existing models such as patient-derived xenografts and organoids, although beneficial, have limitations. This perspective discusses 3D bioprinting in key clinical issues to hasten treatment to patients. The diseases addressed are aging, cancer metastasis, cancer dormancy and drug screening. The perspective also discusses the application for other diseases and the future for 3D bioprinting in medicine.

Tissue engineering provides a potential solution for the repair and regeneration of bone defects and fractures healing. A biomedical scaffold is one of the ideal approaches to achieve effective structure for bone cell growth and bone formation in the desired shape. This study has developed an ideal three-dimensional scaffold architecture with improved biological functionality, which has a physically stable and structurally porous shape, with interconnected channels and defined topography for guided bone regeneration.

For decades, researchers in the tissue engineering and regenerative medicine sphere have continuously worked to replicate naturally occurring tissues and organs for research and transplantation purposes. Whilst this has been met with a certain degree of success, it would appear that many engineered tissue products lack the structural and functional complexity found in their naturally occurring counterparts. To this end, the emergence of bioprinting with its promises to reproduce the complexity and intricacy of native tissues through precise placement of cells marks an important milestone not only in the advancement of tissue engineering, but also for the future of healthcare. In simple terms, bioprinting involves the use of a combination of living biological cells, and other living and non-living materials to print three-dimensional functional living tissue constructs such as breast, liver, kidney and skin tissue. It is anticipated that such bioprinted constructs1 will be used in the areas of disease modelling and research; drug discovery and animal testing; as well as treatment of chronic diseases and tissue/organ transplantation. Given these potential applications of bioprinting, it is pertinent that ethical, legal and socio-economic concerns regarding the technology are fully explored as the technology advances. This is especially so in light of the developing patent landscape for bioprinted constructs which are generally designed to replicate their naturally occurring counterparts - the latter being unpatentable subject matter. Accordingly, this thesis examines the law on patentability of bioprinted constructs (which are combinations of living and non-living materials) and questions whether they ought to be patentable given the implications of monopolising body parts. In particular, this thesis focuses on three jurisdictions with disparate approaches to patentability – Australia, Europe (under the European Patent Convention) and the United States of America. It considers whether the disparate approaches to patentable subject matter and morality of patenting yield similar or different results. Noting that the differences in legislative provisions appear to have limited impact on patentability, this thesis also considers the parameters of access to patented bioprinted constructs. It examines matters pertaining to access to bioprinted constructs in themselves, as well as access to the technology. In this regard, this thesis concludes that patent flexibilities in their current form are not particularly suited to the nature of bioprinted constructs. Accordingly, ensuring technological access is especially important in order to ameliorate the effects of a patent grant and ensure equitable access for all.

Tese de Doutoramento em Engenharia de Tecidos, Medicina Regenerativa e Células Estaminais<br>Organ shortage and transplantation needs have led to congestion in healthcare systems resulting in a huge socioeconomic impact. Tissue Engineering has been revolutionizing the engineering of functional tissues, making them great alternatives to achieve a better, faster and effective worldwide patient care. Fibrocartilage is an avascular and aneural tissue characterized by the reduced number of cells and can be found in different tissues, such as intervertebral disc (IVD) and meniscus. These tissues own poor regenerative properties where a massive number of individuals have been affected by their degeneration. The current available treatments have shown poor clinical outcomes and none of them can be consensually designated as the “gold” standard treatment. Tissue engineers have been trying to overcome all the current challenges by developing novel approaches where different biomaterials have been explored to achieve a suitable implant (Chap. I and II). However, the pursuit for the “perfect” biomimetic implant is still a big challenge. Therefore, the combination of high-resolution imaging techniques (magnetic resonance imaging and micro-computed tomography) with 3D printing can be a powerful tool to closely mimic the fibrocartilaginous native tissue. This approach can provide reproducibility of the produced scaffolds and allows the production of patient-specific implants, helping to improve patient recovery time and biofunctionality reestablishment (Chap. III). The concept of patientspecificity is explored in this thesis using natural-based materials, where silk fibroin (SF) plays the central role due to its high processing versatility and remarkable mechanical properties. In the first work, indirect printed patient-specific hierarchical scaffolds were produced combining SF with ionicdoped β-tricalcium phosphates (Chap. V). Furthermore, using a 3D printing extrusion-based technology, an innovative SF-based bioink was developed (Chap. VI). Using the previously developed horseradish peroxidase-mediated crosslinking system, 3D patient-specific memory-shape implants were produced (Chap. VII). As third work, a step forward in terms of mimicking the IVD native tissue was given, where the previously developed SF bioink was combined with elastin (Chap. VIII). Finally, an extrusion-based 3D printing hybrid system comprising a gellan gum/fibrinogen cell-laden bioink and a SF methacrylated bioink was developed to produce cell-laden patient-specific implants (Chap. IX). In summary, the proposed novel 3D printing approaches revealed to be promising alternatives for the production of patient-specific implants for fibrocartilage regeneration.<br>A escassez de órgãos e a necessidade de transplantação levaram ao congestionamento dos sistemas de saúde, resultando num enorme impacto socioeconómico. Engenharia de Tecidos tem revolucionado a fabricação de tecidos, tornando-se uma ótima alternativa para criar um melhor atendimento ao paciente. Fiibrocartilagem é um tecido avascular e aneural caracterizado pelo reduzido numero de células e pode ser encontrado em diferentes tecidos, como o disco intervertebral (DIV) e o menisco. Estes tecidos possuem fracas propriedades regenerativas, contribuindo para um elevado número de indivíduos afetado pela sua degeneração. Os tratamentos atualmente disponíveis revelam resultados inadequados e nenhum é consensualmente designado como o tratamento padrão. Engenheiros têm tentado superar os desafios encontrados, utilizando diferentes biomateriais para desenvolver novas estratégias para produzir implantes adequados (Cap. I e II). No entanto, a procura por um implante biomimético “perfeito” permanece um grande desafio. A combinação de técnicas de imagem de alta resolução (ressonância magnética e tomografia micro-computadorizada) com a impressão 3D pode ser uma ferramenta poderosa para mimetizar o tecido fibrocartilaginoso. Esta abordagem promove a produção de implantes reprodutiveis e específicos para cada paciente, ajudando a melhorar o tempo de recuperação e o restabelecimento da biofuncionalidade do tecido (Cap. III). O conceito de implantes específicos para cada paciente é explorado nesta tese usando materiais de origem natural, onde a fibroína de seda (SF) desempenha um papel central devido à sua elevada versatilidade de processamento e notáveis propriedades mecânicas. No primeiro trabalho, foram produzidos implantes hierárquicos específicos para cada paciente, impressos indiretamente, combinando SF com fosfatos de β-tricálcio dopados com iões (Cap. V). Para além disso, usando uma tecnologia de impressão 3D, desenvolveu-se uma “bioink” de SF usando um processamento rápido (Cap. VI). Utilizando um sistema de reticulao com base na enzima peroxidase, foram produzidos implantes 3D específicos para cada paciente (Cap. VII). No terceiro trabalho, foi feita uma melhoria em termos de mimetização do DIV cojungando elastina com a “bioink” de SF (Cap. VIII). Finalmente, foi desenvolvido um sistema híbrido de impressão 3D baseado em extrusão usando uma “bioink” de goma gelana/fibrinogénio com células encapsuladas e uma “bioink” de SF metacrilada (Cap. IX). Em resumo, estas novas abordagens de impressão 3D revelaram ser alternativas promissoras para a produção de implantes específicos para cada paciente visando a regeneração de fibrocartilagem.

The book you’ve been reading can only be a vignette, a brief description of an evolving field; life goes on. Most happily, so too has Nancy’s life. Her kidney transplant was in May 2016, and she was able to come back quickly to her old job as full-time office manager at a thriving physical therapy clinic where she’s highly esteemed by both staff and patients. She told me,...

In the clinical field, 3D Printing producing is a progressive innovation for various applications, specifically on account of its capacity to customize. From bioprinting to the making of clinical items, for example, inserts, prostheses, or orthoses, it is having a significant effect. Given that there are many energizing activities and organizations in every one of these territories today we will present to you a positioning of the best 3D printed orthoses. Dissimilar to prostheses that supplant a non-existent piece of the body, orthoses are clinical gadgets that are made to settle, soothe, immobilize, control, or right a piece of the body. Since every patient is unique, 3D printing is especially appropriate for these kinds of items and gadgets. Requiring an orthotic or prosthetic item likely methods a work concentrated, tedious, and chaotic procedure. For makers, creating great fitting orthotic and prosthetic gadgets is costly and requires profoundly gifted staff. Patients can anticipate that to a lesser degree a hold up should get their gadget, fewer fittings, and improved sturdiness. Developing a comfortable, properly fitting prosthesis is not just a science, it is also an art. 3D printing has the power to take today’s bespoke, artisanal manufacturing process and transform it into a highly repeatable and consistent process, which ultimately results in more effective clinics and better patient outcomes.

Abstract 3D bioprinting is a promising field in regenerating patient-specific tissues and organs due to its inherent capability of releasing biocompatible materials encapsulating living cells in a predefined location. Due to the diverse characteristics of tissues and organs in terms of microstructures and cell types, a multi-nozzle extrusion-based 3D bioprinting system has gained popularity. The investigations on interactions between various biomaterials and cell-to-material can provide relevant information about the scaffold geometry, cell viability, and proliferation. Natural hydrogels are frequently used in bioprinting materials because of their high-water content and biocompatibility. However, the dominance of liquid characteristics of only-hydrogel materials makes the printing process challenging. Polycaprolactone (PCL) is the most frequently used synthetic biopolymer. It can provide mechanical integrity to achieve dimensionally accurate fabricated scaffolds, especially for hard tissues such as bone and cartilage scaffolds. In this paper, we explored various multi-material bioprinting strategies with our recently proposed bio-inks and PCL intending to achieve dimensional accuracy and mechanical aspects. Various strategies were followed to co-print natural and synthetic biopolymers and interactions were analyzed between them. The dependence of scaffold geometry on the printing process parameters of synthetic polymer and the rheological properties of natural polymers were identified. The successful application of this research can help achieve dimensionally accurate scaffolds.

Abstract 3D bioprinting has recently gained popularity due to its inherent capability of releasing cell-seeded and cell-laden biomaterials in a defined location to fabricate patient-specific scaffolds. Multi-nozzle extrusion-based 3D bio-printing allows the fabrication of various natural and synthetic biopolymers and the investigations of material to material and cell to material interactions, and eventually with a high percentage of cell viability and proliferation. Although natural hydrogels are demanding candidates for bio-printing because of their biocompatibility and high-water content, ensuring the scaffold’s fidelity with only natural hydrogel polymers is still challenging. Polycaprolactone (PCL) is a potential synthetic bioprinting material that can provide improved mechanical properties for fabricated scaffolds, especially bone and cartilage scaffolds. In this paper, application-oriented structural viability such as 3D printability, shape fidelity, and mechanical properties of the scaffolds fabricated by PCL and other natural hydrogel materials will be investigated. Scaffolds will be fabricated using various natural hybrid hydrogels such as Alginate-Carboxymethyl Cellulose; Alginate-Carboxymethyl Cellulose-TEMPO NFC, and PCL simultaneously using various infill densities, applied pressures, print speeds, and toolpath patterns. Shape fidelities of printed scaffolds will be analyzed. This research can help identify optimum natural-synthetic polymer combinations based on the materials interaction, external and internal geometries, and mechanical properties for large-scale multi-material bio fabrication.