\\n\\n
More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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In 1989, she graduated in Geological Sciences at the University of Naples 'Federico II”. In 1993, she earned a PhD degree\nin Sedimentary Geology at the University of Naples 'Federico II”,\nDepartment of Earth Sciences, Faculty of Geological Sciences. She\ncompleted a 2-year postdoctoral fellowship at the University of\nNaples 'Federico II”, a CNR-CEE fellowship, and several contracts\nat the Research Institute 'Geomare Sud”, CNR, Naples, Italy. Since 1998, she has\nbeen a full-time researcher at the Italian CNR. Dr. Aiello has 25 years’ experience in\nthe field of sedimentary geology, marine geology, and geophysics, participating in\ndifferent research projects for the Italian National Research Council (CARG, Vector,\nCentri Regionali di Competenza). 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Epiduroscopy, also known as spinal endoscopy, which is directly visualize the epidural space with a percutaneously minimal invasive inserted fiberoptic scope. Epiduroscopy is a relatively new diagnostic and therapeutic technique developed in the [1] performed to treat the low back pain, specifically radicular pain in which the epidural space is directly visualized on a video monitor. The development of epiduroscopy is connected to the integration of fiber‐optic technology with computer‐enhanced imaging for viewing the central nervous system that is miniaturized enough to be inserted into the epidural space. The fiber‐optic visualization would be easy and safe to apply in medical practice and has made a major contribution to advances in pain medicine. In this way, the epidural space can be identified for the cause of pain and other neurological signs by distinguishing the anatomic structures and pathological structures.
\nEpiduroscopy involves looking inside the epidural space that contains nerves who are pain generators inside of the spinal column that connect the spinal cord to the rest of the body. An epiduroscopy involves insertion of a tiny fiber‐optic camera attached to a catheter into the epidural space through a small incision in the sacral hiatus near the tail bone. The areas of concern can then be visualized by guided up towards the affected nerve roots. Afterward, the adhesions can be cut away and local anesthetic and steroid solutions can be injected.
\nThe increased attention has been paid to epiduroscopy to deliver accurate diagnosis and treatment for chronic pain. Recently, as a result of these efforts, epiduroscopically assisted laser therapy has been reported for multiple lesions such as discectomy [2]. Epiduroscopy is expected to provide successful outcomes in the diagnosis and treatment of intractable low back and leg pain where even epidural steroid injection is not efficacious for pain relief and pain recurs after operation.
\nEpiduroscopy was considered a method to study the spinal anatomy, and then improvements allowed its employment as therapeutic approach in the diagnosis and treatment of pain. Clinicians have been working with various types of endoscopes for over 80 years, with varying degrees of success.
\nIn the 1930s, Burman started the first study on epiduroscopy and reported direct visualization of the spinal canal with arthroscopic equipment to examine the anatomy of the vertebral column that were removed intact from human cadavers [3].
\nThe first use of the instrument on patients did by Stern in1936 for the direct observation of the posterior roots for rhizotomies and for the treatment of spastic conditions.
\nLater, Pool developed this system which did not have any recording and imaging system and applied the technique clinically on over 400 patients. He could diagnose conditions such as neuritis, herniated disc, neoplasms, adhesions, and venous congestion [4].
\nAfterward, researchers focused on visualizing the spinal canal, however, there was no further remarkable progress on endoscopy in the literature until the late 1950s.
\nThe key breakthrough for clinical application of this technology is the development of the first flexible endoscope in 1958 by Hirschowitz et al. [5] that gave rise to enormous advances in diagnostics and therapy.
\nIn the late 1960s and early 1970s, the Japanese researcher Ooi and Morisaki [6] developed an instrument for intradural and extradural examinations that combined a flexible light source with rigid optics. The fiber‐optic light source technology protected the tissues from heat injury, since the fibers absorb infrared rays and reflect visible rays.
\nIn 1991, Saberski and Kitahata [7] considered clinical use of these devices for the placement into the epidural space as a diagnostic tool where the caudal approach to the epidural space offer advantage over the paramedian lumbar approach. The authors reported that the caudal approach facilitated correct catheter positioning for administration of epidural steroid for the treatment of radiculopathy.
\nIn 1993, Leu et al. [8] used endoscopies for therapeutic intervention in addition to diagnostics, and performed peridural and intraductal endoscopies in patients.
\nSchutze et al. [9] conducted the first video‐optic examinations of the lumbar epidural space in chronic patients with a flexible catheter‐secured epiduroscopic unit.
\nEpiduroscopy received approval through the United States Food and Drug Administration (FDA) in 1996 for visualization of the epidural space.
\nRecently, minimal invasive and microsurgical techniques such as epiduroscopic laser discectomy have been introduced and used for chronic low back pain and post–lumbar surgery syndrome (PLSS) which was called before as false back surgery syndrome (FBSS). Considering the ongoing development trends in the area of microsystems technology, epidural endoscopy has an increasing significance of invasive intervention in pain medicine.
\nThe pain physician\'s major responsibilities involve treating unexplained pain symptoms and effective pain management. It can be difficult to classify and treat chronic spinal pain syndromes.
\nTherefore, the conformity between clinical examination, imaging results, diagnostic blocks, and epiduroscopy is the backbone to ascertain the cause of pain and to establish a diagnosis in clinical decision.
\nEpiduroscopy has the advantage of visually identified structures in the epidural space such as hyperemia, changes in vascularity, fibrosis and adhesions, lateral recess stenosis, disk herniation, and ligamentumflavum hypertrophy. Relative clinical indications for epiduroscopy consist in diagnostic and therapeutic of pain syndromes.
\nThe main indication for epiduroscopy used to be for diagnosis of the sources of pain. Recently, therapeutic is the main indication of the epiduroscopy due to the ability to the treatment of these sites with accuracy. Diagnostically, use of the procedure provides a better view of pathological and anatomical structures and circumstances. Obviously, success of treatment depends on the underlying pathology. Therefore, success or failure of treatment can be used as a measure of the validity of diagnostic parameters obtained through epiduroscopy [10, 12, 13].
\nAs a therapeutic technique, epiduroscopy includes procedures such as direct application of pharmacologic therapy, lysis of scar tissue, adhesions, catheter placement, implantation of stimulation electrodes under direct vision (radio frequency therapy, spinal cord stimulation) and discectomy. Additionally, conscious sedation in patients is administered in order to provide response to stimulated pain‐generating areas. Further, epiduroscopy has the potential not only to reduce the incidence of surgery but also to the treatment of post–lumbar surgery syndrome.
\nRadiculopathy associated with any of the following signs or symptoms is also an indication for epiduroscopy: failed response to epidural steroid injections, filling defects caused by adhesions, post‐laminectomy failed back syndrome, and failed conservative back therapy.
\nThe following indications were defined by the consensus committee of the foundation of World Initiative on Spinal Endoscopy (WISE) in 2006 [11]:
\nTo improve diagnosis:
Diagnosis of clinically relevant epidural pathology, if pain can be attributed to epidural space (spinal canal) structures based on current history, physical examination and supportive present‐day laboratory investigations
Biopsy for histopathological and/or histochemical analysis
Provocative stimulatory tests (e.g., electrical, light, mechanical)
To provide treatment:
Irrigation
Direct application of therapeutic agent
Direct lysis of adhesions/scar tissue with physical or chemical agents (e.g., mechanical, pharmacological, laser, radio frequency)
As a supportive tool:
Placing catheter systems (epidural, spinal)
Implanting stimulation electrodes (spinal cord stimulation)
As an adjunct in minimally invasive surgery
Retrieval of foreign bodies
(Potentially) for post‐operative assessment
Contraindications for epiduroscopy
\nThere is a need for confidence in diagnostic to consider contraindications for epiduroscopy, and in particular of the need to differentiate between low back pain of non‐spinal origin, such as cognitive affective disorder, and low back pain of psychological origin, for example, compensation psychosis.
\nThe contraindications for epiduroscopy correspond to those for epidural regional anesthesia techniques. The contraindications for regional anesthesia can be listed as skin infections in the area of a cut, hemorrhagic diathesis, anticoagulant therapy, exacerbation of intercurrent illness, flu‐like conditions, high cardio‐vascular risks, etc.
\nThe contraindications were defined by the consensus committee of the foundation of World Initiative on Spinal Endoscopy (WISE) in 2006 as absolute and relative [11].
\nThe absolute contraindications are stated as follows: psychiatric diseases that potentially interfere with informed consent and/or perception of pain, retinal disease, increased risk for or the presence of elevated intracranial pressure, manifest bowel and bladder, dysfunction and sensory disturbances in S2‐S4 area, cerebrovascular disease, advanced systemic diseases, septic or dystrophic skin lesions in the sacral areas (anal fistule, sacral osteomyelitis, etc.), meningeal cysts, meningocele, meningomyelocele, severe respiratory insufficiency (COPD), known allergy for drugs used in the procedure, instable angina, malignancy.
\nRelative contraindications are as follows: psychiatric diseases that potentially interfere with informed consent and/or perception of pain, inability to lie in a prone position for more than 60 min, severe respiratory insufficiency (COPD), drug or alcohol abuse, etc. [12, 11, 13, 10]
\nThe main application of epiduroscopy is in relation to the management and treatment of chronic radicular pain. The detailed anatomy of the epidural space and its surrounding bony and ligamentous structures is of great importance for clinicians who perform epiduroscopy. A clear understanding of the relevant anatomy and contents of the space is essential to perform epiduroscopy safely. Epiduroscopic screening with high video‐optic quality is enabling displaying of the corresponding morphological structures and visual understanding of this region.
\nThe epidural space is formed between the dural sheath and the spinal canal that extends from the foramen magnum of the skull to the sacral hiatus in combination with the sacrococcygeal ligament. It is bounded superiorly by the fusion of the spinal and periosteal layers of the dura mater at the foramen magnum, and inferiorly by the sacrococcygeal membrane. The epidural space contains the dural sac, the anterior and posterior spinal nerve roots, the extradural venous plexus, spinal arteries, lymphatics, filum terminale and fatty tissue. The anterior and posterior spinal nerve roots are within the dural sac. The dural sac generally ends at the level of the S2 vertebral body and its continuation known as the filum terminale [14].
\nAnterior or posterior approach to the lumbar epidural space must be used in epidurocopy. Although posterior epiduroscopy can theoretically be performed at any level of the spinal column and through the sacral hiatus, the anterior epiduroscopy must be via caudal approach. Anterior epiduroscopy is the most recent longitudinal approach to the entire lumbar epidural space and provides a significant improvement in the treatment of low‐back and leg pain [15].
\nThe sacrum is a wedge‐shaped triangular bone at the base of the spinal column that forms from the naturally fused five sacral vertebrae. The sacrum is held in place between the two iliac bones, articulating superiorly with the fifth lumbar vertebra and caudad with the coccyx.
\nThe lamina of the lowest segment of the sacrum is incomplete; therefore, there is a gap which is called the sacral hiatus in the anotomical structure. There are two bony projections that are called the sacral cornua, and the sacrococcygeal ligament which covers this U‐shaped space posteriorly. Both of these structures are represent important clinical landmarks when needles are placed into the caudal canal. Penetration of the sacrococcygeal ligament provides direct access to the epidural space of the sacral canal. A superiorly continuation of the sacral canal is the lumbar spinal canal.
\nSince the spinal cord ends near the level of the second lumbar vertebra, this canal does not carry the spinal cord but contains the epidural venous plexus and is filled with fat, which is subject to an age‐related increase in density [16]. Most of these vessels are intensified in the anterior portion of the canal. The advancement of needles or catheters cephalad into the sacral canal can lead to trauma of both the dural sac and epidural vessels.
\nThe epidural space contains prominent amount of epidural fat that distributes along the canal in a predictable pattern allows injected fluid to diffuse through the epidural space and have impact on nerve roots by the absorption of drugs. The fat in the epidural space is soft which surrounds dura mater and protects the neural structures, and facilitates the movement of the dural sac [21].
\nThe spinal dura mater is a strong connective tissue membrane surrounding the cerebral spinal fluid, the spinal cord, the anterior and posterior nerve roots, and spinal ganglia. It extends from the foramen magnum to the sacrum. The dura is being separated by the epidural space so is not attached to the vertebrae. Microscopic view of the dura mater consists of white fibrous and elastic tissues arranged in longitudinal bands or flattened lamellae. Characteristics of dura mater seen on epiduroscopic images are convex, tubular, and grey‐white with blood vessels on the surface, giving the appearance of a road map. In epiduroscopy, a fiber‐optic endoscope inserted into the sacral hiatus advanced upward into the epidural space. When the epiduroscope advanced in the sacral canal the exact position of dural sac must be ensured via image guidance to prevent dural sac injury because the dural sac terminates at S2 level.
\nThe epidural space contains arteries and veins supplying the spinal cord. The epidural arteries are relatively small and pass through the intervertebral foramina to supply adjacent vertebrae and ligaments. The arteries are located in the lateral epidural space hence not threatened by an advancing needle or epiduroscope. Inside, the spinal canal there is a network of large and valveless veins running along the entire length of the vertebral column. The epidural veins predominantly lie in the anterior epidural space and interconnected one to another to form a venous plexus and ultimately drain into the azygous system of veins. The vertebral plexuses with the veins of bones of the vertebral column form Batson\'s plexus. The intervertebral veins are responsible for the communication between the vertebral venous plexuses which run through the intervertebral foramina. In the lumbosacral part of the vertebral column, the ventral venous plexus is generally larger than the dorsal plexus. The vertebral venous plexus is subject to distension in case of increased intrathoracic or intra‐abdominal pressure because of ascites, pregnancy, large tumors. Thus the venous plexus is thought to be involved in a trauma during epiduroscope placement in the epidural space and increases the risk. [17, 18, 19].
\nThe arteries appear on epiduroscopic images as a thin red thread with pale opaque insulation while veins cannot detectable, and pulsatile flow can be seen [20].
\nThe epidural space communicates with the paravertebral spaces via the intervertebral foramina where major site of action for an epidural located to nerve roots. The nerve supply of the epidural space is via branch from the sinu‐vertebral nerves that originate from the rami communicantes. The nerve roots lie in the posterolateral part of the epidural space where they enter and exit the vertebral column at each level in a specific pattern. Nerve roots seen on epiduroscopic images as grey‐white tube shape with a vessel running longitudinally down the centre [20, 18].
\nThe lymphatics of the epidural space are present in the region of the dural nerve roots whereas they are absent in the nerve root itself and remove foreign materials from the subarachnoid and epidural spaces [21].
\nEpiduroscopy is the most recent, complete, and effective technique to approach the spine through minimal invasive access means for treating persistent low‐back pain.
\nSpinal pain and radicular pain syndromes are both characterized by pathological and anatomical changes in the epidural space and diagnosed via epiduroscopy such as arachnoiditis, fibrosis, stenosis, nerve root compression.
\nThe epidural space lies between the dura mater and the walls of the vertebral canal, containing fat and small blood vessels. The space is located just outside the dural sac which surrounds the spinal nerve roots and is filled with cerebrospinal fluid.
\nEpiduroscopic view under traditional white‐light endoscopy can give us a better understanding of the pathology. Dura mater appears as either a blue‐gray or gray‐white exterior with small blood vessels on its surface, epidural fat appears usually yellowish in color, globular, and glistening with small blood vessel on or in it, nerve roots are white tinged with yellow tube shape with a vessel running longitudinally down the center, ligamentum flavum seen as a white and concave tube without vessels.
\nThe formation of scar tissue near the nerve root spontaneously or after spine surgery thought to be the potential cause of the pain or radicular symptoms. If it binds the lumbar nerve root with fibrous adhesions that also called epidural fibrosis. Epidural fibrosis also may restrict the flow of medication to the nerve roots and limiting the effectiveness of epidural injections since mechanical deformation of spinal nerve roots and dorsal root ganglions. If the patient suffers from continued or recurrent pain directly after spine surgery epiduroscopic diagnostic imaging technique can often pinpoint the responsible pathology of pain. It was shown that possibility of experience to recurrent radicular pain with an extensive epidural scar is more than less extensive one, and the correlation is statistically significant [22]. None the less a correlation between the degree of epidural fibrosis and the intensity of post‐surgical pain was also reported [23, 24]. Epidural fibrosis is diagnosed not only in patients who have had low back surgery but also who have anatomical abnormalities such as stenosis, instabilities and herniated discs without surgery. There are many patients who having pathology with no pain therefore establishing a cause and effect relationship between pathology and pain is low [25]. In the endoscopic image, epidural fibroses appear clear white and are generally avascular.
\nEpidural adhesions most commonly occurs as a complication of spinal surgery that are related to inflammatory reactions and result in the entrapment of nerves within dense scar tissue. Beside this can also develop following disc herniation or infection without prior surgery taking place. Morphological changes in the supporting structures of the spine have been identified primarily in the form of epidural adhesions. They limit the pain‐free movement and function of structures in the intervertebral foramen and the bony vertebral canal, and prevent direct application of medications to the affected disc and nerve root. Epidural adhesions may or may not involve in the generation of pain therefore should be considered carefully [26, 53]. Adhesions or adhesive areas are easily visible fibrous bands of tissue with epiduroscopy that appear clear to white and often bizarre. Epiduroscopy is used to break down adhesions by infusion of a small amount of saline through the catheter with careful and gentle movement of the catheter.
\nThe visual function of epiduroscopy can be used to identify chronic inflammatory processes in the epidural space such as epiduritis and radiculitis. Chronic inflammatory condition increases levels of inflammatory mediators at the affected site and results increased pain.
\nRadiculitis is pain that originates from direct pressure on the nerve roots because of inflammation or other irritation of a nerve root at its connection to the spinal column. Disc herniation, osteophytes, thickening of surrounding ligaments, spinal stenosis, damaged intervertebral discs, degeneration of the spine, spondylolisthesis, or scoliosis could be one of the many causes of radiculitis.
\nRadiculitis symptoms start with radiating pain along the nerve path and usually accompanied with sensations of numbness, tingling, pins, and needles. The other incorporating symptoms of muscle weakness and loss of reflexes also present as the condition progresses. A variety of symptoms of radiculitis can be felt anywhere in the body depending on the location of the affected disc, and nerve root because each area of the body is controlled by nerves exit the spinal column in pairs. For example, cervical nerve root can cause pain and other symptoms through the arms, hands, and fingers, lumbar nerve root can radiate through the leg and into the foot and prompting leg pain and foot pain.
\nEpiduritis is an acute or chronic inflammatory process of epidural structures in the epidural space and on the outer surface of the dura mater of the spinal cord. Epiduroscopically it is characterized with cardinal symptoms such as swelling, redness, and a positive pain provocation test.
\nThe arachnoid mater is the middle one of the three protective membranes of the central nervous system that surrounds the brain and spinal cord. Inflammation of the arachnoid is called arachnoiditis that subdural processes take place on the caudal fibers and the nerve root sheaths, and characterized by severe burning pain, stinging, numbness, and neurological problems. In the case of arachnoiditis and perineural nerve sheath fibrosis, the spinal dura mater appears thickened and the tissue appeared to have increased vascularization. Arachnoiditis is a complex neuropathic pain disorder with a complex etiology that affects the nerves connecting to the lower back and legs. Adhesive arachnoiditis is most commonly present with associated epidural fibrosis whereas epidural fibrosis can occur alone. Arachnoiditis is most frequently seen in patients who have undergone multiple surgical procedures.
\nXanthosis is a yellowish degeneration with yellowish pigmentation which could be observed in the spinal epidural space in the literature by Heavner et al. [27]. This epiduroscopy finding in the peridural tissue adjacent to blood vessels at the left L5‐S1 intervertebral foramen associated with radiculopathy. They administered treatment with the same equipment and gained satisfactory reduction in the radicular pain with the treatment outcome. Thus, called as a novo epiduroscopy finding.
\nHypertrophy of the ligamentum flavum is a pathologic condition due to fibrosis and scar tissue formation that contribute to cord compression radiculopathy. Hypertrophy of the ligamentum flavum can be rarely encountered in the lumbar region however more common in cervical and thoracic regions. Hypertrophy of the ligamentum flavum is usually involved in the pathogenesis of spinal stenosis which can cause loss of disc height, reduce the diameter of the spinal canal and compress the dural sac and nerve roots. A multilevel detailed examination of the epidural space is now possible with epiduroscopy and directly observation of hypertrophied ligamentum flavum can be satisfactorily achieved [28, 29].
\nThe patients may suffer from recurrent pain and/or troublesome new symptoms such as failed back surgery syndrome after surgical treatment. Some cyst types may also be present in the different levels of the spinal canal such as synovial cyst of a lumbar facet joint, often cause spinal compression and radicular pain. Even if these cysts can be visualized in epiduroscopic imaging, due to the packed up anatomy and the inflamed cyst being not easily identified from adjacent structures confirmation of the diagnosis with fluoroscopy, MRI or CT may be necessary to assess the contents of spinal canal [30]. Minimally invasive technique such as cyst rupture by epiduroscopy has the potential for fenestration of cyst either post‐operative or not.
\nJin et al. successfully removed a lumbar facet joint cyst at L4/5 level by epiduroscopy. Epiduroscopy usage as a support to diagnose and therapy of the cyst that results compression on the radicular nerve would be favorably an alternative technique over conventional surgery in the future [31].
\nBefore the epiduroscopy process, the patient\'s history should be reviewed as expeditiously as possible and a comprehensive physical exam should be carried out. Detailed preoperative knowledge of the patient\'s neurological assessment is necessary to recognize the post‐operative neurological complications. The specialized nerve tests such as EMG, NCV and SSEP to investigate the functioning of the nervous system, and imaging studies like CT scans or MRI scans should be completed in the preoperative setting. The skeletal structures of the sacrum, the level of termination and position of the bottom of the dural sac particularly on T2‐weighted MRI, the evaluation of the anterior and posterior epidural spaces should be performed previously.
\nEpidural bleeding during epiduroscopy constitute extremely rare, however, taking conventional precautions to prevent is substantial. NSAIDs use should be stopped 24 h before and aspirin should be stopped 3–4 days before procedure in the perioperative period. It is also generally recommended to stop any oral anticoagulant before open surgery. In addition to complete blood count (CBC) that also called hemogram, an evaluation of basic coagulation parameters should be ordered for prothrombin time (PT) with a partial thromboplastin time (PTT), and the international normalized ratio (INR) calculation based on results of PT to monitor individuals in the perioperative period. The operating room is equipped with a fluoroscopy table, C‐armed scopy device, holmium laser, light source, and imaging device (Figures 1–3).
\nOptimum design of the operating room at which the epiduroscopy takes place.
Anesthesia device in front of the operating table.
C‐armed scope and video monitoring system to the right of operating table, Holmium laser device and tradle close to applicator.
Perioperative antibiotic prophylaxis therapy in general administration of ceftriaxone 1 g intravenously should be given within 1 h before epiduroscopy. The patient is admitted to the operation room and placed in the prone position on the fluoroscopy table with a pillow under the abdomen to correct the lumbar lordosis.
\nAfter setting aseptic conditions, sterile dressing gets covered over procedure area.
The practice of aseptic technique is maintained and patient and fluoroscopy are covered the sterile dressing (Figure 4). Intravenous 2 mg midazolam and 50 mcg fentanyl is administered for performing the procedure under conscious sedation.
\nInsertion of 22G spinal needle passing through sacral hiatus.
Fluoroscopy image of 22G spinal needle after passing through sacral hiatus.
Under C‐arm (fluoroscope) lateral image guidance, intradermal, and subdermal infiltration of local anesthetic is injected by a 22G spinal needle, then 8–10 mL 1% lidocaine injection is administered to epidural space by passing through the sacral hiatus (Figures 5 and 6). This will greatly reduce the abnormal pain and pressure feeling of patient during advancing the trocar through the narrow caudal canal, will prevent in vivo motion in patient and there will be no need to increase the sedation of prone‐positioned patient so that facilitates ease of application for clinician.
\n4.2 mm outer diameter and 3.5 mm inner diameter ranged trocar.
Image of trocar after its stilette is removed.
The lateral fluoroscopic image of trocar in the caudal epidural space after passing through sacral hiatus.
Lateral intradermal and subdermal incision of 0.5 cm is made in the skin with No. 11 sharp disposable scalpel where 22G spinal needle introduced. If you notice some bleeding from the incision simply apply firm pressure to the area with surgical gauze. The trocar is, outer diameter 4.2 mm and inner diameter 3.5 mm, and then advanced through sacral hiatus at the skin incision point with C‐armed scopy guidance (Figures 7–9). There is a slight loss of resistance as the trocar enters the caudal canal. Repeat antero‐posterior (AP) images will be taken during the trocar advancement and will assure that the trocar direction does not stray from midline. AP image confirmation of proper placement of the trocar in the mid‐line of sacral foramina will verify its position within the same line of pubic symphysis. The C‐armed scopy is rotated in a lateral direction once trocar is held on the posterior to dural sac, where termination and position of the bottom of the dural sac was determined previously on MRI, and the central stylet of the trocar is pulled out.
\nImage of epiduroscope catheter tip.
Spinaut‐V® epiduroscopy catheter is 33 cm in length and outer diameter 3.2 mm in width. The catheter has two working channel in 1.2 mm diameter where one is maintained on the top and the other is at the bottom of device. (Figure 10). The top canal is for using a high resolution fiber optic camera, and the bottom canal is for using a laser probe or biopsy forceps that can ablate a herniated disc or epidural scar tissue (Figures 11 and 12). The device has an ergonomic design for handling the epiduroscope. There is a controller gear on both sides of catheter to steer the catheter in 2‐way directions (right or left). There is a dual port on the back of controller gear look like a dual exhaust. (Figure 13). On the left input, the canal allows insertion of camera and physiological saline solution administration at the same time to give a clear view of the inside of the epidural space during the procedure (Figure 14). Extension tubing for extension line is connected to the left input and attached to physiological saline bag 150 mL via a 3‐way stop‐cock. A 20‐mL injector is also connected to the 3‐way stop‐cock. Physiological saline solution is injected either by exerting a light pressure on the injector or slow infusion. In the right input; there is a tube outlet that allows suction of blood or other given solutions. Non‐ionic radio‐opaque material is preferred to be administered through the right canal because it is highly dense and can stick to camera that results blurred image. This happens more frequently when it is administered through left canal. Additionally; injecting physiological saline along with radio‐opaque material will pull away the material away from the camera. The best way of avoiding the blurred image and obtaining good visualization of the epidural space is passing camera through the epiduroscope after application of the initial epidurography.
\nCamera and laser probe from superior and lateral taken from epiduroscope catheter tip.
Laser probe and camera are superposed in the upper shooting.
Fiberoptic camera advances from the left input (1), laser probe advances from the right input (2).
Physiologic saline line (1).
In the case of access to posterior epidural space, epiduroscopy is passed through the trocar and advanced to S1 vertebra level with guidance of C‐armed scopy. After the epiduroscopy is placed, 10 mL of radio‐opaque material is injected for epidurography. The monitoring of epidural space is started after re‐evaluating the clinical condition of patient, MRI, and epidurography results.
\nThe epiduroscope is rotated 90° laterally to gain access into the anterior epidural space and advanced through trocar under the guidance of C‐armed scopy lateral imaging. While attempting to introduce epiduroscopy into the anterior epidural space rotating the scope too much may lead folding of the catheter tip, an abrupt turn of epiduroscope to the left or right that cause sensation of pain may lead patient movement and induce loss of the position of the patient. Following the access into the anterior epidural space, epiduroscope is returned to original neutral position.
\nThe lateral fluroscopic image of epiduroscope tip at S1 level.
The AP fluroscopic image of epiduroscope tip at S1 level.
Once epiduroscope inserted into the anterior epidural space, the tip of the epiduroscope is introduced to the level of S1 (Figures 15 and 16). Initial epidurography is done at the same time to detect disc herniation or obstruction level, and compared to MRI and clinical findings. The bulging at targeted disc level is easily seen due to obstruction to the flow of the injected radio‐opaque material towards to cephal. By use of the AP fluoroscopy position, the end‐plates of targeted levels are straightened. The fiberoptic camera with light is connected to epiduroscope under sterile conditions and advanced through the left input until the epiduroscopic end point. The camera that the light source system controlled and white balanced prior to procedure to assure accurate tissue color is turned on. Injection of physiological saline through the catheter placed into the epidural space would keep distend the epidural space and keep clear the camera for a good view. The piston of physiological saline containing injector is slightly pushed (0.15–0.20 mL/s). The amount of given hidration must be tightly monitorized. The fiberoptic camera shouldnot get pass the end point of epiduroscope because the vision from the camera is designed to fit the opening of epiduroscope to point upwards. This way we obtain a crescent shaped edge beneath the monitorized view and use this as a kind of compass. Keeping the crescent edge at the bottom part of the image allows us proper orientation in the anterior epidural canal. While in the anterior epidural canal, as we get the crescent at the bottom the dura will be appear at the upper side of the image on the screen. As we are able to monitor both dura and lumbar disk at the same time, laser probe that is introduced into respective input canal does not harm the dura and placed in the targeted disk.
\nThe lateral fluoroscopic image of upward passing of radio‐opac material through anterior and posterior openings.
The final AP epidurography.
Before the termination of procedure, a final epidurography is performed to assess the efficiency of epiduroscopy (Figures 17 and 18). If the patient did not diagnosed with diabetes mellitus and the dura was not perforated, 80 mg of methyl prednisolone and 10–15 mg of bupivacaine in 5 mL total volume would be injected and the trocar along with the epiduroscopy catheter is removed.
\nWhen the procedure is over, a single suture for skin closure is applied and wound dressing is completed. The patient is admitted to post‐op care unit and evaluated. If no abnormality is observed the patient is discharged to the ward. The patient is immobilized for 3–4 h. Especially in patients with disc herniation is advised to use steel corset while mobilizing. The pain in the intervention point and headache are the most common complications of an epidural procedure. To manage this, intravenous hydration treatment and intravenous 1 gr of paracetamol are sufficient. If there is no problem in their general clinic condition, patients can be discharged at same day or can be admitted to the ward for one night then discharged the day after the procedure with antibiotics and NSAIDs prescription. Because of the administration of steroids to epidural region, 7–10 days of salt‐free diet is reasonable. Perineal care is advised cleaning of the perineum from dorsal to front without contacting the intervention point after defecation/urination is advised. Patients are permitted to take their first shower 1–2 days after the epiduroscopy
\nEpiduroscopy has been introduced as a new technique for treatment of chronic low back pain (LBP) syndromes or herniated disks. The clinical effectiveness and cost‐effectiveness of epiduroscopy have been described in multiple prospective and retrospective studies although the underlying mechanisms have not been fully investigated.
\nThe procedures used for determination of the pathology in chronic low back pain often have difficulty in making an accurate diagnosis. However, epidural endoscope allows visualization of the epidural space to potentially identify the reason of LBP, therefore, to address these problems attention has been drawn to epiduroscopy as a tool for an accurate diagnosis. In addition to more accurate diagnosis, usage as a therapy of any adhesion or inflammation, compression on the radicular nerve therein, and inject medications into the lesions.
\nDisc decompression is typically performed both surgically and non‐surgically to reduce pressure on the nerve root by removing disc nucleus while preserving disc strength with a high success rate, [1, 2] and low complication rate [32, 33].
\nTechnological innovations in the treatment of disc decompressions has improved the ability to treat pathology effectively through anterior epiduroscopy that requires only local anesthetic and conscious sedation (leading to reduced risk of accidental nerve damage), overcomes the possible complications of surgery and general anesthesia.
\nRecently, epiduroscopic laser neural decompression (ELND) as another minimal invasive technique have been introduced for chronic low back pain and radicular pain that cannot be solved by other non‐invasive conservative treatments, including the epidural steroid injection [34]. In spite of surgery is often considered as the next step in treating continuous chronic low back pain, it has potential risks of post–lumbar surgery syndrome that is difficult to manage. The incidence of post–lumbar surgery syndrome after back surgery ranges from 5 to 50% [35].
\nLaser is a source of monochromatic, coherent and unidirectional light that used in many fields of medicine with diagnostic and therapeutic purposes. Disc and neural decompression, rechanneling stenoses caused by adhesions are examples of the use of laser and expands the range of possibilities for epiduroscopy. Researches involving lasers have been conducted on the usefulness of epiduroscope for the patients with the post–lumbar surgery syndrome. Epiduroscopic laser application allows treatment of low back pain and radicular pain caused by herniated lumbar disc, adhesions or fibrosis in the epidural space depending on the particular pathological and anatomical circumstances [36, 37].
\nIn the treatment of patients with chronic refractory low back pain a two working channel system of video guided catheter and subsequent application of an optical laser fiber is established. As with the existing epiduroscopic adhesiolysis, epiduroscopic laser neural decompression (ELND) also provides non‐invasiveness, short operating time, elimination of the risks of general anesthesia, communication with the patient during the procedure, and short recovery time. ELND offers a variety of additional benefits that direct treatment of the origin of pathology by reducing the volume of the herniated disc in the affected area, direct removal of severely adhered areas with the laser, no occurrence of laser‐related oedema or adhesions.
\nHowever, an excellent visual control is compulsory for the use of laser where the endoscope with the flexible tip makes possible advancement fine navigation of the relatively rigid laser fiber. Further visual control has to assured and saline infusion has to be started prior to the laser activation.
\nBecause of the risks of heat damage to the nerve roots induced by laser disc decompression, treatment of adhesions near the nerve root should be avoided. Epiduroscopic laser neural decompression can easily remove painful adhesions in the area of the nerve root that cannot mobilized by mechanical movement of the tip of the epiduroscope.
\nIf motor nerve paralysis occurs due to thermal damage of nerve roots during the laser treatment as a complication, the procedure must be aborted immediately. Other complications those need particular caution have been reported as local sensory impairment, fiber breakage, and discitis during the laser procedure [38].
\nIn spite of epiduroscopy is a safe technique as a minimal invasive procedure to reduce post‐operative complications, the rates of complications will increase commensurate with its increasing usage.
\nComplications arising during epidurocsopy therapy are mainly reported as headache, cervicodynia, convulsions, dura tear, neurologic damage, visual impairment, infection, general back complaints, vomiting, meningitis, radicular radiating pain, bladder, dizziness, hypoacousia, and rectal disorders.
\nAccording to the literature, complications related to epiduroscopy are generally caused by puncture trauma, accidental dural injury, puncture of an epidural blood vessel or epidural bleeding, changes in the epidural pressure caused by saline infusion [39, 40, 42, 45, 49, 50]. The knowledge on the complications and accidental symptoms, using proper epiduroscopic equipment and ensuring optimal vision accompanied with sufficient experience in using the epiduroscopic technique can help prevention from complications.
\nPost–dural puncture headache are reported relatively frequently during epiduroscopy when attempting to carry out placement of the epiduroscopic catheter or from accidental perforation of the dura as a result of perforation of the spinal dura mater and attributed to a rapid loss of cerebrospinal fluid.
\nThe dural perforation is not a serious complication unless the accidental dural perforation is not recognized and is not responded to, otherwise, spontaneous closure of the perforated site has also observed. Epidural blood patches are reliable in order to treat the patients’ headache due to dural perforation during epiduroscopy within a short time [41, 43, 44, 47, 48].
\nIt is reported by Gill and Heavner [51] that a sudden increase in epidural pressure due to the epidural infusion causes compression of the optic nerve and compression of the vessels that results to a rupture and in turn to retinal haemorrhage.
\nAnother clinically relevant complication described by Mizuno et al. [46] in which encephalopathy and rhabdomyolysis was induced by the administration of the contrast agent iotrolan during epiduroscopy.
\nOur experience has also shown that the amount of liquids delivered to the spinal canal should be calculated precisely during implementation of the epiduroscopy procedure, and infusion rate of drug or radiopaque substances should be at a low speed to avoid from complications. When saline fluid was infused too quickly this leaded to hypertension, decreased oxygen saturation, respiratory arrest, and loss of consciousness where epiduroscopy was immediately terminated [52].
\nThe incidence of complications is inversely proportional to professional skills of practitioner and the number of years of experience. It should be bear in mind, there are risks associated with medical procedures in the spinal region, even when it is performed properly and conscientiously.
\nThe effective treatment for disease requires the improvement of diagnostic method, development of optimized drug loaded formulation and incorporation of optimized formulation in to suitable delivery system in terms of role of nanotechnology in drug discovery and development.
There has been challenging task for researchers to increase analytical capacity with improved data quality, consuming less sample volume for storage and screening of cell and tissue library at molecular level. In current scenario the innovative format of nanotechnology offers advancement in the technology, overcoming the initial challenges of unreliable data, consuming high sample and various other issues [1].
Pharmaceutical industries are continually facing a challenge to find better drug discovery technologies because of availability of various competitive other medicinal market. This industry requires discovering and developing new medicines for the effective treatment of wide range of diseases likely to grow regulatory challenges, costing revolution and various other barriers. Recently, all pharmaceutical companies giving importance to common processes including cloning and expressing human receptors and enzymes for discovering innovative drugs, that allow high throughput, automated screening and the application of combinatorial chemistries. Presently, the drug discovery industry should have massive amounts of data about life’s molecular components in the area of genomics and proteomics revolution [2].
The Pharmaceutical and biotechnology firms have spent billions of dollars on novel technologies in order to improve productivity, accelerate the drug discovery and development processes and sustain market share.
Nanotechnology refers to development of innovative research and technology at the atomic, molecular and macromolecular level with controlled manipulation, and the study of structures and devices are done in the 1 to 100 nanometers range. The conclusive remark at this scale, Nanoparticle take on beneficial novel properties and functions like small size, surface tailorability, improved solubility, and multifunctionality as compared to seen in the bulk scale. This nanofield may open many new avenues of research for biologists. The novel nanotechnology using nano-materials can interact with complex biological organ consuming low level of biomolecules.
The development and design of multifunctional nanoparticle offers new opportunity for interdisciplinary researchers that can target, diagnose and treat diseases such as cancer. Within the field of discovery and development of nanomaterials, nanotechnology focuses to improve diagnostic methods, improved drug loaded delivery system for the effective and enhanced therapy. Now a days, the scientific community is paying attention on the physical, chemical and biological properties of nano-sized materials so that development of new applications can be done in order to improve human health.
Earlier the nanotechnological concepts have been discussed in 1959 by physicist Richard Feynman during his talk “There’s Plenty of Room at the Bottom,” describing manipulation of atom is a key to possible different method of synthesis. In 1974, Norio Taniguchi used the term “nanotechnology.” The scanning tunneling microscope was invented in the year 1981, ensures the clear visibility of individual atoms and bonds. Initially the term nanotechnology was used in designing nanoscale devices studying about carbon nanotube [3]. The National Nanotechnology Initiative (NNI) defines nanotechnology as research and development of nanosized delivery system with novel functional properties. Subsequently manipulation of atoms could be possible to create efficient nanomaterials with characterized invitro and invivo parameters. Thus the inherent nanoscale functional properties to the biological tissues, proves that nanotechnology could be feasible for the application to the life sciences successfully. With growing research in the field of nanotechnology, large number of nanotechnologies using nanomaterials has been studied, but there is no study about safety and toxicity. For this purpose in vitro diagnostic use of nanotechnology without any safety risks to people and in vivo characterization of nanoparticles, ranging smaller size <50 nm in size, were studied. The smaller size of nanoparticle concerns over the entry and localization of the particles in to the cells, but there are still many unanswered questions related to huge diversity of materials used and its wide range in the sizes of nanoparticles, these effects will vary a lot. It has been conceived by many researchers that particular sizes might turn out to have toxic effects and consequently further investigation are required. The FDA approval is mandatory for clinically approval the applications of nanotechnology and substantial regulatory problems in the nanotechnology-based product. Consequently the term “nanobiotechnology,” has come in to existence as a unique fusion of biotechnology and nanotechnology [4]. This article will provide an integrated overview of application of nanobiotechnology based molecular diagnostics, drug discovery, and drug delivery in the development of nanomedicine with the relationships.
The word “Nanobiotechnology” is a combined study of “The Nanotechnology” including design, development and application of nanomaterials & devices and “The Biotechnology” including the various function of biological site like microorganisms [4]. The field of nanobiotechnology will grow in the development and discovery of drug in upcoming scenario at exponential rate, Where atom or molecule level devices can be constructed by incorporation of drug in to suitable biocompatible delivery system. Hence nanobiotechnology can help various aspects of biological problem with the help of nanotechnology and information technology. This technology has capacity to build bridge among different branches of sciences providing newer challenges and opening new door in the field of research & diagnostics, education in the near future [5]. Relation between nanobiotechnology, bionanotechnology, and nanobiology are the terms referring to the intersection of nanotechnology and biology. Nanobiotechnology includes recent advances in nanotechnology to improve biotechnology, and bionanotechnology, which aims to have advantage of natural/biomimetic approaches to create devices with nanosize range [6].
This article will focus on the principal trends and the implications of nanobiotechnology in drug discovery, development and molecular diagnostic.
Nanoformulation based on oral and topical drug delivery in biotechnology can stimulate molecular imaging for brain tissue engineering and drug delivery through blood brain barrier, Improvement of CNS directed neuroprotection or regeneration, drug uptake assistance, showing fewer side-effects compared to conventional molecules, more active therapeutically in treating brain tumors, Successful biodistribution, High bioavailability, DNA and RNA molecules provide high affinity and binding on specific target site, devoid of enzymatic degradation enriches lymphatic transport, development of biosensors, nontoxic and biodegradable nature, enhancement of the potency of anticancer drugs, in vivo and in vitro biomedical research and accomplishment of easy Drug targeting (Figure 1) [7, 8, 9, 10, 11, 12, 13].
Advantages of nanobiotechnology.
The application of nanobiotechnology has an impact on diagnostics and drug delivery. Currently, researchers are starting to use nanotechnology in the field of drug discovery and development. Nanocrystals (QDs) and other nanoparticles (gold colloids, magnetic nanoparticles, nanobarcodes, nanobodies, dendrimers, fullerenes, and nanoshells) have unique advantages for the development of drug and its discovery i.e. QDs and magnetic nanoparticles are being used for barcoding of specific analytes which are key components of the bio-barcode assay, can be future alternative to the protein chain reaction [1].
The term “Nanomolecular diagnostics” is the use of nanobiotechnology at molecular level to diagnose and treat chronic diseases”, extending the limits of molecular diagnostics to the nanoscale. The nanomolecular diagnostic field can meet the rigorous demands of the clinical laboratory and can be cost-effectiveness [6].
Nanoparticles have emerged as promising nanoplatforms for efficient diagnostics and therapeutics possessing characteristic properties at the nanometric scale. The feasible immobilization of specific ligands on the surface of biological site have become ideal candidates for molecularly sensitive detection, molecular imaging, and novel carriers for targeted drug and gene delivery, targeted photothermal therapy [6]. The nanoparticle in the form of nano-vesicle surrounded by a membrane or a layer holds convenient surface i.e. spherical, cylindrical, plate-like for molecular assembly of inorganic or polymeric materials and drug. The size and size distribution of nanoparticle becoming extremely critical and plays very significant role for penetration through a pore structure of a cellular membrane. The Biomarkers for occupying their distinguished color requires efficient fluorescent probes which depends upon the narrow distribution of average particle sizes. These narrow sizes particles emit a very wide range of wavelengths. The multifunctional nano particles core with several luminescent layers like magnetic nanoparticles can detect and manipulate the particles. Thus the Nanoparticles provides combine platform of biotechnology, nanotechnology and information technology facilitating molecular, biochemical and biological processes, e.g. genetics and pharmacogenomics.
The surface morphology of nanoparticles can be redesigned to reach at their target like blood brain barrier and dermal tight junctions more efficiently, overcoming the efficacy issues of drug on the physiological barriers. In case of malignant tumors Nanoparticles with leaky vasculature structure may penetrate the lesion. Nanoparticles may contain natural and synthetic polymer for coating an inorganic core of superparamagnetic materials. Some examples of nanoparticles as contrast agents in magnetic resonance for molecular diagnosis are given here [5].
Gold nanoparticles are the most typically used nanomaterial in diagnostics; they have many different uses as properly. They may be extensively utilized as a connecting factor and to construct biosensors to hit upon ailment DNA. Rather than a fluorescent molecule, a gold nanoparticle can be attached to an antibody and other molecules, consisting of DNA, can be brought to the nanoparticle to supply bar codes. The gold particles are very chemically reactive and make excellent catalysts at nanometer scale. Recently, gold nanostructures have found a very important role in a wide variety of applications, including bio-imaging, drug delivery, toxic gas detection, biosensors and to demonstrate multiphoton absorption-precipitated luminescence (mail) [14].
Quantum dots (QDs) are regarded as a unique class of fluorescent labels, with unique optical properties such as high brightness and long-term colloidal and optical stability; these are suitable for optical imaging, drug delivery and optical tracking, fluorescence immunoassay and other medicinal applications. The unique optical property of QDs allows one to investigate the real-time dynamic events in living cells and such events include interaction between intracellular proteins, the mechanisms of intracellular signal transmission and cell growth. Some benefits and downsides have been investigated more suitable optical residences compared with natural dyes like incredible imaging outcomes using organic dyes, absorption of numerous drug molecules for an extended time frame [15].
Conjugation Nanoparticle-DNA protein hold great promise in biomedical applications. Many Diverse strategies have been developed to conjugate nanoparticles and DNA proteins to assemble and purify nanoparticle-protein link. First, stable and biocompatible nanoparticles are synthesized. Conjugation of the nanoparticle to the DNA protein is then achieved via two different approaches that do not require heavy chemical modifications or cloning, cysteine-gold covalent bonding, or electrostatic attachment of the nanoparticle to charged groups of the protein. Co-functionalization of the nanoparticle with PEG thiols is recommended to help protein folding. Finally, structural characterization is performed with circular dichroism, as this spectroscopy technique has proven to be effective at examining protein secondary structure in nanoparticle-protein conjugates. In general, functionalization of NPs with proteins such as antibodies can be achieved by direct chemical covalent conjugation or electrostatic interactions. The Semi-artificial conjugates of nucleic acids and proteins by both covalent coupling chemistry, or else through noncovalent biomolecular recognition systems, which include receptor-ligands of complementary nucleic acids for immunological detection assays [15].
The Nano Chip System by utilizing electronically enhanced hybridization of complementary DNA strands, integrates advanced microelectronics and molecular biology into a platform technology with broad commercial applications in the fields of genomic diagnostics and has achieved 100% accuracy in the detection of nanoparticle. This technique helps in investigating DNA sequences or the pairing of separated strands of DNA with complementary DNA strands of the acknowledged collection that act as probes. Currently, DNA chips is known as DNA microarray assays that employs the energy of a digital contemporary that separates DNA probes to unique web sites at the array based on charge and size, then test sample (blood) can be analyzed for identifying DNA sequences via hybridization with these probes [16].
Microfluidics is the modern science of fluids on the nanometer scale. The nanodiagnostics involve microfluidic or “lab on a chip” structures, in which the combination of numerous approaches of DNA analysis is mixed on an unmarried chip composed of an unmarried glass and silicon substrate. Academically, it is a subdiscipline of fluid mechanics, as the fundamental equations describing the physics of fluids at larger length scales are identical to the equations underlying microfluidics. In general, the microfluidic biosensor platforms offer numerous advantages compared with other traditional methods such as ultracentrifugation, electrophoresis, nuclear magnetic resonance, chromatographic approaches, etc. for detection of bio-species molecules. This device have capable of measuring aqueous reagent and DNA-containing answers, mixing the solutions together, amplifying or digesting the DNA to shape discrete merchandise, Destiny possibilities for the utility of nanotechnology in healthcare and for the development of personalized remedy seem like amazing [17].
Among the new technologies, nano-biotechnology has evoked considerable interest for application in the pharmaceutical industry. Important applications of nano-biotechnology are in the areas of drug discovery, drug development, and drug delivery, and these are collectively referred to as nano-pharmaceuticals. Nano-biotechnology, particularly the use of nanoparticles, has made significant contributions to drug discovery and development [18]. In addition to the use of nano-biotechnology for drug discovery, some drugs are being developed from nano-materials. Well-known examples of these are dendrimers, fullerenes, and nano-bodies. At present time increasing the use of nano-biotechnology in many pharmaceutical and biotechnology industries is anticipated. In case of drug development from formulate to appropriate dose to administer with optimal delivery systems, nanotechnology is being utilized at all the stages. Nano-biotechnology applications are also involving in diagnosis of diseases. In future it may be possible to computers are connected with nano-biotechnology systems and provide the appropriate and complete knowledge about complete model or an individual cell. This virtual representation might be helpful for researcher or scientist to develop novel drugs with high rate of accuracy and precision without conducting any experiment in living organisms.
The major challenges in front of drug delivery scientists are poor solubility, high molecular size and low bioavailability for clinical candidates. Other challenges in this field are pediatric and geriatric drug administration, protein and peptide drug delivery etc. Today’s major demand in drug delivery field is to develop ideal, safe and effective, non-invasive drug delivery methods.
Nano-biotechnology sector play a significant role to overcome the above drug delivery problems. It provides the following solution related drug delivery problems: (a) With the help of this technology particle size of drugs is reduced in nanometer size range, it enhance the surface area and ultimately improve rate of dissolution, (b) Nano-meter size range of drug also useful to improve their solubility, (c) With the help of this technology scientists trying to develop noninvasive routes of drug administration method which can eliminates the use of injectable drugs, (d) developed nanoparticle formulations has better alternate for non-stable and lower shelf lives formulations, (e) nanotechnology based formulations improved the solubility of poorly soluble drug and enhance absorption capability, improved bioavailability and release rate of large molecules, reduced the optimum dose and enhance the safety margin by reducing the side effects, (f) Nano-biotechnology principles help in developing of Sustain and controlled release formulations with better patient compliance [19].
Nano technology has gained enormous popularity in recent past decades. In lay man language nano technology is defined as the use of least possible input to get maximum possible output. Nano word is used in terms of size. This technology is considered as wonderful amalgamation of physics and chemistry. When this technique is applied with biology, it brings about a new field termed as Nano-biotechnology; where biochemical processes are modified to get far better results than that of simple bio technological procedures.
As far as the medical field is concerned, the harness of nano- biotechnology for diagnostic purpose is successfully obtained (Figure 2). It assists to develop more sensitive diagnostic kits than that of existing one. Such instruments are suitable to probe the bodily problems at cellular pores and receptor level. Moreover, it is due to tiny sized diagnostic materials the degree of toxic and adverse effects have been markedly reduced. New dimensions of diagnostic tools have been explored with the aid of this cutting edge technique. Several modifications are still under developmental phase.
Application of nanobiotechnology for molecular diagnosis.
Gold nano-particles are also termed as metallic particles. These are produced from gold salts of either organic, aqueous or both origins. A suitable stabilizer is used to get stable particles with good ligand binding capacity. Usable size of particles is ranging between 3 and 100 nm. The major application is due to their electronic, optical, and thermal properties [20].
Magnetic nano particles are formulated from magnetic materials like Fe3O4, Fe2O3, and many other ferrites. Nanoparticles can be incorporated with bio- marker moieties so that they can be utilized to investigate various biomolecules and help in different processes like separation and purification. The involvement of surface coating materials is significant to ascertain the size and kinetics of these particles. That’s why the nature of coating materials should be examined before use [21].
Quantum dots are semiconductor nano-crystals that are easy to synthesize and have characteristic properties that are between those of bulk semiconductor and discrete molecules. Their diameter ranges from 2 to 10 nm. Their fluorescent property relies on size of the quantum dot [22].
Carbon nano tubes are composed of graphite. On the basis of number of graphite, these nano tubes are categorized into two classes- tubes with only one layer of graphite are known as mono walled carbon nano tubes on the other hand, tubes consist of multiple layers of graphite are termed as multi walled carbon nano tubes. The main advantage of such tubes is that they can conduct high electricity with less or no heating effect. This happens because of scattering free traveling of electrons throughout the tube [23].
Liposomes are spherical vesicles where an aqueous core is surrounded by a phospholipid bilayer and cholesterol. The phospholipid consists of a hydrophilic head and two oil-loving tails. The phospholipid that is predominantly used is phosphatidyl choline [24].
Dendrimers are the emerging and well defined polymeric architectures that are known for their large, complex and well defined structures, versatility in drug delivery and high functionality whose properties resemble with biomolecules. These nanostructured macromolecules have potential abilities to entrap and to conjugate the high molecular weight hydrophilic/hydrophobic drugs by host-guest interactions and covalent bonding (prodrug approach) around an inner core respectively. They have different Features like size, shape, branching length, and their surface functionality vary over the design of nanoparticles. For example, Polyamidoamine are usually used dendrimers [25].
Nano bio sensors are applied to investigate biochemical changes with the aid of electronic, optical or magnetic technology. Furthermore, detection and/or quantification of bio molecules like specific base pairs or proteins are also possible. Majority of biosensors work on the principle of key and lock theory or affinity based mechanism; where immobilized tool attaches to target molecule/analyte being sensed in this phenomenon, any change at a localized surface can be examined rather than detecting target in solution. This variation can be sensed by using one of the following methods; viral biosensors, light sensitive biosensors, resonant cantilever and quartz crystal microbalance [26].
A nano material can be perfectly examined by using same sized probe. This hypothesis is applied in molecular diagnosis with the help of biochips or microarrays. This is because the cell organelles/biological moieties exist in nano size and the biochips also falls under in almost similar tiny sized scale. Nano fluidic arrays and protein nano biochips are the examples of nanotechnology based biochips. These chips are capable to isolate and analyze living cell molecules such as genetic material DNA. In future this technique will certainly bring about revived investigation tool for cancer. Nano-fluidic technology is expected to have broad applications in systems biology, personalized medicine, pathogen detection, drug development, and clinical research [27].
Cytogenetic has been used mainly to elaborate spatial arrangement of the chromosome and screening of abnormalities related to disease. The use of fluorescent in situ hybridization (FISH) is now reaching its limit. Molecular cyto-genetics is now enhanced by use of biomedical nanotechnology, e.g., use of atomic force microscopy (AFM) and quantum dot (QD) FISH [28].
A comprehensive study including identification, characterization and analysis of a series of bio protein at a specified time is known as proteomics. Proteomics help to recognize the variations which are associated with various pathological conditions. These variations are identified on the basis of spatio-temporal position of protein molecules. A small change in molecular level can bring about such variations as a consequence proteome may be altered; which are further quantified for clinical diagnosis. Gel- based and gel- free are the common proteomics techniques, which work on separation, observation, analysis and marking the altered proteome [29].
Screening of pathogenic microorganism on the basis of genomic arrangement has become relevant in current clinical determination. It has been well established central dogma of life that each and every living organism has a peculiar set of DNA, which has been transferred from one generation to next without any sort of alteration; this can also be said to be the individualization by nature. In clinical diagnosis, this DNA fragment may help to check the availability of the microorganism in the test sample. This investigation opens the door for molecular detection. This is carried out by using polymerase chain reaction (PCR) or hybridization techniques, known as amplification method and non-amplification method respectively. Therefore, this technique is considered to be more sensitive and precise than that of other techniques [30].
Bio sensors are sophisticated probes, which are used to investigate the existence and/or concentration of a biological analyte, say for example bio molecule, histology of biological material or any microorganism. Biosensors comprise of following parts: amplifier that detects the analyte and generate a signal along with it a signal transducer that converts the signal into electric impulses and a reader to record and investigate the signal [31].
Nano-biotechnology is the fine amalgamation of multi disciplines of science. In pharmaceutical field, the scientists and researchers are trying to overcome the demerits of existing drug molecules with the aid of this wonderful technology. There are many expected potential benefits in bank. In spite of that safety is the main concern with the in- vivo application of nano engineered medicines yet.
It has been revealed that while production or use of nano medicines, such particles can easily get inside the human body and ultimately blood stream and then in various vital organs; where they exert unintended adverse effects, sometimes these effects are fetal for the user.
An in- vivo study on monkeys and rats have disclosed the aggregation of carbon and manganese nano materials in the olfactory bulb, which has produced severe pathological consequences pertaining to nervous and respiratory system.
Several animal studies have shown such sort of abnormal pathological disturbances.
In order to combat with this problem firstly, an efficient probe will have to develop for thorough assessment of risk associated with the use of nano medicine. Second and the most significant challenge would be to develop authentic validation protocol for testing nano medicines in animals so as to get the data of toxic effects in early stage of testing. A restructured, compact and integrated regulatory approach is much needed to look into the expected risks for delivering the promising and safe medicines [2].
In the event that we talk about the most recent decade, nano bio-innovation has generated some new impedance for the research community, industry, and regulators. Applicable techniques have some loopholes regarding fabrication and processing of nano medicines, that’s why special provisions would be required to tide-over such complications [32]. FDA and other regulatory authorities experience many unavoidable consequences for the release of such products. This is due to non-authentic validation program in clinical trial phase [11]. A wing of researchers proposes sturdy contentions, revealing both positive and negative aspects pertaining to the advancement of nano-materials. They suggest that vague protocol throttle research and product development, which represses the development and viability of new nano-medicines. Apart from that, a robust administrative body is made so as to push the business advancement by creating certainty for pharmaceutical firms and trust within the ultimate consumers [33]. Currently, the FDA, EMA (European medical agency), and other regulatory agencies examine each new nanoparticle individually. There is commonly an absence of benchmarks in the assessment of nano-medicines as a unique class of therapeutic agent [34]. Afterwards, administrative corporations might imagine of a complete listing of screening and a powerful approbate system that enclose the complete variety of particle characterization, pharmacology, and toxicology troubles.
In case we consider in trendy approximately the two major capabilities of nanobiotechnology, first is imaging and diagnostics (quantum dots) and second are proteomics. In proteomics especially study and detect about nucleic acids and proteins [35]. Currently, the Thermal Sensitive drug delivery system has been developed for the treatment of cancer. In this, drug is given in the injection form, which reaches inside the body and converts into insoluble form and accumulates in the tumor cells because the temperature of the tumor cell is more than the normal cell [36]. In spite of the tremendous credibility of nanobiotechology, its use has been considerable due to its toxicity and environmental problems. Despite all this, the drug delivery, drug discovery, gene therapy, molecular imaging, biomarkers, and biosensors fields are exploring possibilities in the nanobiotechnology. Nanobiotechnology has brought a bright future for the clinical diagnosis and targeted drug delivery sector. Now in the field of diagnosis, it has become easier to detect diseased cells rapidly, due to which it is possible to prevent diseased cells from spreading in the body [37]. There is a constant development in this field right now and it is possible that some incurable diseases in the future will actually be cured with the resources of nanobiotechnology.
Nano-biotechnology is in its primary stage in terms of development. Due to continuous innovative research and abundant use, nano-biotechnology is having a wide impact on the fields of science and technology. Nano-biotechnology is presenting some unique possibilities in medicine, diagnosis and biomedical sciences. The innovation of nano-biotechnology in drug delivery systems has led to the introduction of something new, and with the help of this, it seems possible to treat some incurable diseases. Although the potential for benefits from nano-biotechnology is high, the prospective of nanomedicine is not fully defined. In fact, regulatory bodies do not have appropriate guidelines that balance its risk and safety factors. It would be fair to say that in future nano-biotechnology will play an excellent and unique role in the treatment of human diseases and the study of human physiology. From the research conducted in nano-biotechnology in the last few years, it can be inferred that in future, nano-biotechnology will become an indispensable phase of our daily life.
IntechOpen's Authorship Policy is based on ICMJE criteria for authorship. An Author, one must:
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