Epiduroscopy has been extensively developed over the last few years and is now an important part of modern international medicine in both diagnostic and therapeutic interventions in spinal column surgery.
A new, decisive method of epiduroscopy according to Prof. Babayan expands the spectrum of epiduroscopic procedures and opens up basic, innovative possibilities of spinal column surgery:
The most important novelties of epiduroscopy according to Prof. Babayan are:
- on the application of newly conceived, technical devices and instruments,
- the specialized MIBRAR® methodology successfully practiced by Prof. Babayan for years and
- the possible combination of epiduroscopy according to Prof. Babayan with the existing techniques of microinvasive spinal column surgery according to MIBRAR®, which lead to new diagnostic and therapeutic results in their symbiosis.
The technical development according to Prof. Babayan provides a further developed micro-dimensioned size of the epiduroscope with a very powerful camera system which is not only flexible in the spinal canal but can be controlled in a controlled manner.
This controllable micro-epiduroscope achieves significantly greater depths and narrower spaces within the spinal canal and epidural space, thus extending the optical examination and diagnosis as well as the therapeutic range of action. Correspondingly, micro-dimensioned working instruments, which can be guided by the shaft of the micro-epiduroscope, substantially support the surgeon’s work.
A special side effect of the technically expanded micro epiduroscope according to Prof. Babayan is the lower tissue injury risks due to the minimally dimensioned devices and instruments. This innovative epiduroscopic approach makes an outpatient procedure possible without anesthesia, which is an extraordinary advantage for the patient, especially in anesthesia and drug incompatibilities.
In addition, the introduction as well as the control of the course of the controllable micro-epiduroscope must no longer be carried out solely by the radiographic X-ray images but is supported by the MIBRAR-OP Navigation™ system on a mechanical as well as computer-controlled level (3D software, Planning system, Cyber-Navi-Hand™).
Also in this context, one recognizes an advantage for the patient in the lower radiation load during the overall intervention. The technical advancement of epiduroscopy according to Prof. Babayan makes it clear that modern spinal surgery offers decisive perspectives for the treatment of more complex pathologies, which for technical as well as methodological reasons were difficult or impossible to treat.
In the case of the MIBRAR® method, it is important to emphasize that only the body’s own substances are used, and that no medicines or other body-borne active ingredients are used, which means less stress and a lower risk for the patient.
It is a world-wide novelty that according to the MIBRAR® method it is possible to obtain an autologous, regenerative concentrate from the conditioned blood plasma of the patient, with a high concentration of anti-inflammatory factors, growth factors and regenerative substances according to the CGF method.
The CGF (concentrated growth factors) system is a procedure for the production of platelet concentrates of the second generation for medicine. CGF is an internationally recognized, scientifically supported therapy for several years. It cannot be compared with the usual pure blood treatment, since in the case of CGF treatment, plasma with enriched growth factors, anti-inflammatory factors and regenerative substances is specifically used.
The treatment concept with autologous growth factors has been applied internationally in more than 11,000 cases over the last 10 years. Relevant side effects or intolerance reactions have not been observed. Since the treatment is carried out with portions of the patient’s own blood, allergic reactions also remained as expected. The use of autologous plasma, growth factors and regenerative substances leads ultimately to the morphological regeneration of the degenerated body tissue as well as to the macroscopic reconstruction of the missing tissue due to degenerative processes and trauma.
Because of the special epiduroscopic application after MIBRAR® in the spinal canal and epidural space, very positive and long-term results are achieved – in the case of an outpatient procedure which usually takes place without anesthesia.
The MIBRAR® method used in epiduroscopy according to Prof. Babayan has an excellent and long-lasting mechanical, bio-chemical, regenerative and reconstructive effect, without side effects.
The combination of the flexible, controllable micro-epiduroscope with the use of existing techniques of micro-invasive spinal surgery, e.g. the placement of a portal using a rigid endoscope – this combination allows the therapeutic treatment of complex pathologies in hard-to-reach areas of the epidural space under optical control using the micro-epiduroscope and the MIBRAR Navigation System™.
A targeted and controlled use of endoscopes, working appliances and applied active ingredients is thus possible. Epidurally, the entire operation can be controlled. The symbiosis of proven and new surgical techniques after MIBRAR® opens the door to numerous complex therapeutic treatments of modern spinal surgery.
The operative procedure of the endoscopic interventions on the spine such as e.g. on spinal canal stenosis, or on foraminal stenosis is nowadays endoscopic, i.e. minimally invasive and has been practiced for about 20 years.
This technique is used in all spine areas (neck, chest and lumbar spine area) in combination with different access routes and using different, operational-specific endoscopes.
The present state of the art of minimally invasive spinal endoscopy is associated with a standard surgical procedure, as the instruments and methods developed so far require a certain space, including an incision, access, and overall intervention using a general anaesthesia or analog-sedation and corresponding OP environment.
In contrast, spinal endoscopy does not require such an intensive procedure according to the MIBRAR® method and can usually be performed ambulatory, without anesthesia or under local anesthesia or under analog-sedation.
In the case of spinal endoscopy according to MIBRAR®, the great advantages are:
- that the operation can be realized without cutting, through a small needle opening, it can be penetrated into the relevant disc compartment and through the consistent use of micro-dimensional instruments the entire procedure can be performed in a micro-dimensional manner;
- that the MIBRAR® method allows the entire operation to be performed microinvasively by the use of a micro-endoscope equipped with a special high-resolution micro-dimensional optics.
- In comparison to the conventional minimally invasive spinal endoscopy and microinvasive spinal endoscopy according to MIBRAR®, the following should be emphasized.
Basically, for example, a herniated disc can have two causes:
- a traumatically deformed disc;
- or long-term degeneration of the intervertebral disc tissue, which can ultimately be the cause of the extrusion of the tissues.
Especially in the presence of the degenerative intervertebral disc tissue, a recurrence i.e. a new intervertebral disc disease can occur. For the degenerative intervertebral disc tissue represents an existing instability of the segment and this is not cured or eliminated by the sole removal of the intervertebral disc disease.
Another important aspect is the fact that the intervertebral disc compartment in question loses its former shape or height and can lead to other pathologies of the spine.
In such pathologies, further complications may arise, e.g.:
- a spinal canal stenosis,
- a foraminal stenosis,
- a segment instability
- a scoliosis or
- a defect in the sagittal balance
In this context, according to today’s standard methods, long-term measures are inevitable, such as, for example, spondylosis, the use of intervertebral disc prostheses or even a stiffening of spinal segments by the use of screws, titanium, etc.
This, in turn, in many cases causes not only a feeling of strangeness in the non-particulate material, but also the formation of undefined secondary defects over time. For example, the stiffness of the movable spine (rolling over 4-5 floors) can lead to other, unnatural movements (fail-biodynamics) which can now reload and possibly damage the previously healthy regions of the spine.
Spinal endoscopy according to the MIBRAR® method is not only used to remove the symptoms of the intervertebral disk, for example the removal of an intervertebral disc disease, but also – and this is of decisive importance – for the most complete reconstruction and regeneration of the affected segment regardless of the cause of the pathology whether trauma or degeneration. And this can lead to complete restoration of the disc shape, height, and function.
For example, if an inevitable, unclear indication of intervertebral disc resection is present or is exhausted in the event of acute neurological deficits and all the usual conservative or minimally invasive pain therapy methods or blockages, then this problem is to be treated effectively by the MIBRAR® method and goes even an important step further. Using the microinvasive intervertebral disk endoscopy according to MIBRAR®, not only the intervertebral disc disease is removed, but intervertebral and segmental reconstruction is carried out at the same time, and intervertebral disk regeneration is initiated.
This is done with autologous intradiscal transplantation:
- anti-inflammatory factors,
- growth factors and
- endogenous regenerative substances
These body-active substances are extracted from the body’s blood and the subcutaneous fat of the patient directly before the outpatient intervention of the spinal endoscopy after MIBRAR® and processed according to the CGF technology for the subsequent application.
In summary, the advantages of spinal endoscopy using the MIBRAR® method are as follows:
Not only the sequelae (eg, disc herniation), but also the cause (degenerated disc, or chronically or traumatically damaged tissue) is remedied.
The old shape, functionality and resilience of the segment are restored.
The procedure according to MIBRAR® without incision prevents the formation of a larger tissue injury that normally only heals in a week-long process.
In order to effectively perform the reconstruction and regeneration by the body’s active substances, the tissue injury should be minimal so that the regenerative concentrate can be used with the maximum effect for the correlate. For, of course, the mesenchymal cells have the tendency to migrate to the place where they are “used most”. Fresh tissue injury attracts many regenerative factors, with the result that the regenerative effect of the concentrate is largely lost to the original problem (e.g., elimination of the intervertebral disc disease).
It makes a big difference, therefore, whether valuable body-active substances are administered minimally invasively with the formation of a tissue injury or micro-invasively with avoiding a tissue injury. The lower the tissue injury, the more intense is the successful effect of the body’s active ingredients.
In general – as with all outpatient micro-therapeutic procedures according to MIBRAR® – the saving of the anesthesia and the operating costs, which is the case with the usual treatment methods, not only gained a lot of time here, but also the physical stress or the potential risks of a larger procedure are considerably lower for the patient.
The long-term effect differs in that not only the current pain state and the functional problem are solved, but by the pure administration of body-active substances, side effects or possible long-term negative sequences by medicaments, prostheses or other non-particulate materials do not occur. For example, a frequently unknown side-effect of the pain reliever Cortisone, which appears to be helpful at first, results in an increasing weakening of the spinal tissue, which can be the cause of future vertebral damage.
On the contrary: the application of the body’s active ingredients stimulates the active reconstruction and regeneration of the original spine functions until the natural resilience is restored.
Contrary to the conventional treatment methods, which do not rule out possible stiffening of spinal segments, the natural mobility of the spine is not restricted by the natural, regenerative reconstruction by the granting of body-active substances and the stability of the spinal column is not diminished.
Overall, the particularly lasting effect of spinal endoscopy according to MIBRAR® has to be emphasized. Because a unique, outpatient procedure and the awarding of the multifunctional, body-active substances often result in an excellent result with a lasting effect over many years and gives the patient a long-lasting natural quality of life.
Sono Control Arm™
Sonography or ultrasound is the use of ultrasound as an imaging method for diagnostic purposes and visual inspection in therapeutic interventions. The greatest advantage of sonography is certainly the complete harmlessness of diagnostic ultrasound waves, especially in comparison to x-ray procedures, which can often be associated with a high radiation load for the patient. Significant information enhancement (visualization of tissues) compared to other imaging procedures (MRI, CT, X-ray) a dynamic, function evaluation more detailed visualization, reduced technical effort and ease of access.
The ever-faster development of today’s sonography offers an ever-more sophisticated image quality with respect to image clarity, resolution and the possibility of distinguishing between tissue types and structures.
This excellent image quality now allows the visualization of tissue structures in the body, which were previously not detectable by means of sonography, such as ultrasound analysis or precise spinal canal or epidural imaging.
The image resolution of today’s sonography has thus gained in visual, image contrasts and depth of the visible tissue structures, so that the range of applications for sonography has significantly expanded for the medical fields.
Particularly in orthopedics, accident surgery, neuro-surgery, intensive neurosurgery and regional anesthesia, the optical requirements and the increased use of sonography are to be found here.
Sonography can represent the most diverse tissue structures much more accurately and more securely than by the commonly used methods such as radiography, MRI, CT.
Most imaging methods provide static images. Using ultrasound, you can create “moving images” for movement sequences for the functional assessment of tissues and structures. Movable images are also possible for video recordings and also for visual inspection of the overall movement of the instruments during the course of the operation.
Thus a dynamic examination and visual inspection with representation of structures of all tissues in different body parts in real time is possible.
Nowadays, sonography is used not only for diagnosis, but also for intra-operative therapeutic use to control the operation, i.e. to perform surgery under ultrasound.
During the surgical procedure – particularly in the micro-therapeutic field – the image presentation of the sonography is particularly important for the safe orientation and the ongoing control of the surgical instruments used.
In the reverse sense, this means that without the imaging of the sonography, many surgical procedures – particularly in the micro-therapeutic area – would not be possible or very severely restricted.
With the today`s practice of freehand realized Sonography-intervention or Sonography-control, exist the following disadvantages:
First, a surgeon’s hand is always occupied with the ultrasonic head probe and permanently busy with the post-correction to create and maintain a qualified, sonographic image. This is done with simultaneous, constant monitoring of the monitor on which the sonographic images are displayed.
Secondly, the continuous visual inspection (in the sound width of micro-dimensions) of the manually guided ultrasonic head means a tremendous strain on the surgeon who must simultaneously focus on two instruments: the ultrasonic head and the surgical instrument.
Such uncertainties and complex processes have hitherto prevented the intra-operative use of the ultrasound in difficult interventions, and the clear advantages of the ultrasound visualization which is superior today are obviously not used for intra-operative interventions.
From this years of experience, the Sono Control Arm™ has been developed by Prof. Babayan with a special holder for the ultrasound head, which is highly mobile for the most varied areas of operation in the OP in flowing, easy movements and at the same time with maximum precision in every position. Furthermore, with a handle it is securely fixable in order not to lose the sound layer of the ultrasound imaging.
The surgeon thus has both hands free and is relieved from the internal tension, which entails constant manual guidance and visual inspection of the ultrasound head. Instead, the operator can concentrate all his attention on the operation and the instrumental use.
A further advantage of the Sono Control Arm™ is the fundamental safety of maintaining a desired position and imaging of the ultrasound head – especially during surgery, which can hardly be ensured by handholding in this exact position over an extended period of time.
This method of operation and use of the Sono Control Arm™ also allows much more complicated surgical procedures to be performed than hitherto possible.
Thanks to this Sono Control Arm™ device, the valuable and qualified imaging of the ultrasound can be used optimally intra-operatively in order to perform much more precise and safe interventions, whereby the secure ultrasound head guidance is achievable in 0.1 mm dimensions.
The sonography, applied by the Sono Control Arm™ safely, is a very crucial aid to realize under precise visual inspection:
- the planning of the operations accesses and
- the performance of the operations or
- the introduction of an endoscope
and the entire operating sequence without the risk of uncontrollably violating important tissue structures or organs.
According to the present state of the art, such interventions are carried out using a permanent X-ray control, which can have a harmful radiation exposure for the patient. The X-ray-based visualization also has the great disadvantage of the not possible representation of numerous tissues and organs (nerves, vessels, musculature, tendons, ligaments, volume, and parenchymatous organs, cartilage). Which is the prerequisite for an accurate and safe execution of an intervention.
Due to the optimal use of the sonography by the targeted use of the Sono Control Arm, the micro-therapeutic MIBRAR® method can safely and successfully perform all joint or spinal surgery operations without having to open the body and still with complete visual inspection.
This technical advancement is the prerequisite for performing an ankle or spinal surgery with the aid of the MIBRAR® method without the usual anesthesia and the usual operating expenditure with hospital stay.
The safe imaging of sonography using the Sono Control Arm™ and the MIBRAR® method has many advantages:
- There is no radiation exposure to the patient due to intra-operative imaging instruments such as image transducer / X-ray / C-arm.
- The microinvasive procedure according to the MIBRAR® method is enormously time-saving, so that the overall procedure is less stressful for the patient.
- The time saving with the use of the microinvasive MIBRAR® method and the help of modern sonography makes it possible to carry out more complex and complex procedures in the joint or spinal area.
These interventions are carried out as efficiently and gently as possible in a wide range of areas, such as e.g.:
- for intra-spinal interventions in the spinal canal,
- for intervertebral discs
- or in microinvasive interventions on joints, e.g. the microinvasive arthroscopy.
This innovation revolutionizes today’s existing worldwide surgery.
RRDSS - Regenerative Reconstruction of Discs and Segments of Spine
Degenerative changes in spine and their treatment in modern medical conditions
Spine-is the center of musculoskeletal system, and the same time, important protection for central nervous system (spine cord), which goes along the whole spine. Degenerative changes in spine- are the most often diseases, that have heavy chronic effects. Degenerations, traumas, or other pathologic changes of separate vertebrae’s, discs, also other structures of spine, have negative influence on spine cord functions. That leads to pains or neurologic disorders of different organs and body structures. Degenerative diseases of spine or its traumas often lead to deformation and limitation of segment mobility that usually have progressive character. Mobility of the spine is due to elasticity of intervertebral discs and mobility of facet joints. Degeneration of intervertebral discs or their traumas leads to deformation, destruction, and then to disc’s dysfunction, what after can cause anatomical and functional pathologic changes of the whole spine.
Depends on the pathology, in modern medicine used different appropriate conservative or surgical treatment methods. Conservative treatment methods can lead to the elimination or alleviation of symptoms. Wherein, they can’t stimulate reverse condition or stop the degenerative processes, which is the reason for that pathology. With severe degree of degeneration processes, that accompanied by disc’s or the whole segment’s deformation, where conservative methods are not effective, surgical methods are used, in order to reconstruct intervertebral disc, intervertebral space and segments of spine.
Summing up, one can say, that modern level of medicine doesn’t allow reverse degenerative changes and deformation of spine segments and ensure natural regeneration or reconstruction of different spine structures. Besides, conservative and especially surgical treatment methods can lead to complications and have risks of side effects.
New method RRDSS
In 2004 professor Dr. MD. Arsen Babayan suggested regenerative reconstruction method of vertebral discs that contributed to the beginning of a series of studies in this area. In 2014 MIBRAR® method, developed by professor Babayan, aimed at regenerative reconstruction of all the musculoskeletal structures, first time in the world was successfully applied with unique way on intervertebral discs and facet joints. These surgical interventions performed during degeneration and deformation of intervertebral discs and spine segments, have all the advantages of MIBRAR® method, which confirm the effectiveness of the method.
Course of surgery
Under C-arm X-ray machine control or with help of Cyber-Navi-Hand™ into the intervertebral disc inserted rigid hollow probe with 0,8 mm diameter. With its help necessary micro perforations are performed by MIBRAR® method. Simultaneously, through the canal of the spine cord, in intervertebral disc area, under pressure autologous concentrate is injected.
The process of autologous concentrate implantation is controlled under intraoperative C-arm X-ray regime with simultaneous height increase and shape recovery of the intervertebral disc and space.
Due to implantation, intervertebral disc restores its original height and shape that calculated in advance by programming of Cyber-Navi-Hand™.
This method allows to restore height and shape of intervertebral disc during any degenerative or traumatic deformation; not only during height loss of the disc, but also during displacement of vertebrae (slipped vertebrae / spondylolisthesis, pseudospondylolisthesis, ventrolisthesis, retrolisthesis). Displaced vertebrae restores its original position because of height increase by vertical pressure, arising at the moment of implantation of autologous concentrate, and also tension of stretched anterior and posterior longitudinal ligaments during dilatation of intervertebral space.
In most cases it is possible to restore the height and shape of intervertebral disc, and also of the whole segment already during implantation of autologous concentrate.
After completion of transplantation of regenerative autologous concentrate into intervertebral disc under X-ray or Cyber-Navi-Hand™ control, another intra-articular transplantation of autologous concentrate carries out into facet joints using spinal probe. At the same time micro perforations and irritations of degenerated surface of facet joint are performed. Then autologous concentrate is injected in facet joint. X-ray control allows precisely observe the process of transplantation of the concentrate in facet joint; also clearly seen an increase in the joint space. Autologous transplant promotes reconstruction already during surgery, and also stimulates regenerative processes.
Autologous transplant consists of plasma, derived from venous blood of the patient, enriched with growth factors, anti-inflammatory factors and mesenchymal growth factors, and also from separated highly concentrated lipogenic stem cells, derived from subcutaneous fat tissue of the patient. During transplantation only fresh autologous concentrate is used, derived from venous blood of the patient and his subcutaneous fat tissue, immediately before surgery.
Cyber-Navi-Hand™ help can perform this procedure with special precision and shorter time.
X-ray control doesn’t show soft tissues and inner organs. That’s why planning of the surgical intervention based on MRI images of the patient, where all the body structures and inner organs well represented. Merger of the surgical plan, based on MRI images with X-ray images, done from positioned patient immediately before surgery, helps to avoid collateral dangerous damages of soft tissues and organs during surgery, and also provides reconstruction of spine segments according to a pre calculated plan.
Cyber-Navi-Hand™ especially necessary for severe spine segment deformations, where high accuracy needed and consideration of individual characteristics of deformation.
Indications for use of RRDSS
Method has indications for use for following diseases:
- Degeneration of the intervertebral discs
- Acute traumas of intervertebral discs
- Spondylolisthesis (slipped disc)
- Instability of spine segments
- Arthrosis of facet joints
- Stenosis of spinal canal
- Foramina stenosis
- Arthrosis of atlantooccipital joint
- Postoperative complications on intervertebral discs
Reason for intervertebral hernias is as degenerative processes, as acute traumas. During classical surgical interventions, different structures and tissues are removed or damaged, that stabilizing the spine, which in turn leads to destabilization of the spine segments. In this case RRDSS method successfully used. Initial volume of the disc and its stability are restored because of the tissue growth in the regeneration process that leads to the stability of the whole spine segment.
RRDSS indicated for pathologies, that by modern standards are treated with big invasive surgeries and under general anesthesia. In most cases patient gets implantation of intervertebral prosthesis, screws or other artificial implants that often leads to side effect complications, chronic pain syndromes, affection of the nervous system and musculoskeletal apparatus limitations. This in turns negatively affects the patient’s quality of life.
In order to avoid all of the above complications, those surgeries could be replaced by RRDSS method. RRDSS method allows to achieve effective anatomical and stable functional restoration of the intervertebral discs and spine segments, thereby providing an opportunity for unlimited physical exercises and full-fledged maintenance of quality of life.
According to the statistics, patients get rid of complaints and symptoms during one to thirty days after the surgery, although much research shows complete regeneration with complete reconstruction minimum after three month after the surgery. Postoperative regenerative effect can progress over a year. Performed radiological examinations done from three month to year and a half, evidence of a permanent process of improving condition of the intervertebral disc and the whole spine segment.
Comparison of the images made during completion of the surgery and three month after the surgery, showing volume increase of the intervertebral discs, and also complete anatomical spine discs and segments restoration during scoliosis or other vertebrae deformations in sagittal plane, and also during this combination. Following radiological examinations done in half a year, year and year and a half, indicate further progress in recovery of volume and shape of the discs, and also progress in anatomical recovery of the whole segment.