Marketing, research and development of new technologies in the electro-medical surgical and diagnostic field
Marketing, research and development of new technologies in the electro-medical surgical and diagnostic field
Marketing, research and development of new technologies in the electro-medical surgical and diagnostic field
Who we are
RC Medical is an Italian company based in Lombardy that deals with the marketing and recruitment of instrumentation and technology representatives in the electromedical field for the national and foreign market.
The Company is mainly active in the research, development and manufacture of new instruments equipped with innovative technologies in the medical surgical and electro-medical diagnostic field. In particular, social activity is focused on the application of new instrumental findings in the specialist surgical field.
This research activity led to the licensing and use of patented articles and tools related to the electromedical field.
The research and development activity is carried out in collaboration with the main Italian universities; with the main technical and scientific laboratories present in Italy and abroad; with medical specialists in the sectors of application of the invention; as well as with Italian and international companies that develop the main components on the indication of the RC Medical research and development partner area.
The constant commitment of the Company and of the partners that collaborate daily in the search for technologically innovative and scientifically recognized solutions at an international level make RC Medical a new Italian reality dedicated to the care and health of the human body.
INTRAOCULAR MONITORING SYSTEM
Detection and monitoring of intraocular pressure during the surgical procedure
1 IOMS Sum up.
“Je n’ai fait cette lettre-ci plus longue que parce que je n’ai pas eu le loisir de la faire plus courte”
“This letter is longer than the others because I have not had the chance to make it shorter”
The importance of synthesis according to Blaise Pascal.
The purpose of this chapter is to summarize the scope and motivations that led to the development of the IOMS project and to the profound conviction that it could become the new state of the art.
The intended use of the IOMS project will be the detection and monitoring of intraocular pressure in the field of cataract surgery, vitreoretine surgery and glaucoma surgery.
The trait d’union of these surgical procedures appears to be the introduction of various surgical instruments, inside the anterior chamber or in the vitreous chamber of the eyeball, thus generating functional and non-functional outlets, through which the leakage of aqueous humor and consequent loss of pressure of the eyeball itself.
The nominal and expected ocular pressure (IOP) in the surgical phase is established in a range between 20 and 30 mmHg.
The leakage of liquid during surgical procedures generates pressure losses that, if not promptly managed, are possible due to choroidal detachments of the vitreous chamber. For this reason, there is a need for the surgeon to compensate for this loss by inflowing liquid or air into the eyeball in such a way as to allow the IOP to stabilize.
The inflow of liquid or air inside the eyeball if not correctly and promptly managed, could result in the excessive increase of the IOP with consequent possible optic nerve ischemia.
From now on it is therefore possible to support the importance of obtaining a pressure not only as punctual as possible but also of rapid management. as the damage indicated above can develop into xxx with IOP of xxx.
The medical devices used today, allow the surgeon to pre-set a desired pressure, keeping the same through SW algorithms. The sophistication of these devices and the experience gained in the ophthalmic field have allowed to obtain ever more precise instrumentation which, however, has non-optimal reaction times and above all an uncertainty of the excessively marked pressure.
The dissonant and introducing possible errors, in fact, turns out to be precisely the pressure data that, although the most significant variable for the management of the IOP, to date is estimated and not measured inside the eyeball.
The indirect detection of the same does not allow an active and instantaneous regulation of the IOP pressure, this method of management, in fact, involves significant delays in pressure compensation with consequent wide positive and negative pressure variations that subject the eyeball to unwanted pressure stress.
Evidences of the above in the continuation of this document.
In conclusion, the IOMS project, introducing the possibility of detecting pressure directly inside the eyeball, has the aim of remedying a technical gap, allowing the surgeon to base his decisions, during the surgical procedure, on a real and not estimated data.
2 STATE OF THE ART OF OPHTHALMIC SURGERY
In the last 10 years ophthalmic surgery has had a remarkable scientific development and innovation both from the point of view of surgical technique and from the technological point of view due to the research and presentation of new instruments by the companies in the sector.
Mainly ophthalmic surgery finds its greatest application in the act of cataract, vitrectomy with all the applications to the retina and glaucoma surgery.
In recent times the surgeon has increasingly taken into account the course and post-operative result optimizing the surgical procedure and increasingly looking for a minimally invasive surgery, this can allow the patient to undergo surgery under local anesthesia and no longer general, of not needing hospitalization (if not in case of complications), to have a post-operative course with important results already from the first days of surgery. (to)
2.1 CATARACT SURGERY
Cataract surgery is now performed with instruments (phacoemulsifiers) that allow the removal of the crystalline quickly and accurately and allow the surgeon to proceed with minimal incisions to perform the operation.
With incisions of 1.8 mm and with the availability of having the artificial crystalline lens (IOL) foldable and implantable by means of special injectors in such reduced and minimally invasive openings, the surgeon is able to guarantee the patient an excellent post-operative course already the day after the cataract surgery.
2.2 VITREORETINE SURGERY
Vitreoretinal surgery is the one that has really made great strides in recent years.
All that is related to the retina has found in the doctor’s request to have available new tools for increasingly less invasive surgical approaches and in the research and development of companies the field with the highest presence of new operating techniques and new tools with more and more technologies avant-garde and in particular with increasingly frequent updates.
It has gone from traditional surgery, which implied having to have the patient in a state of general anesthesia, to the possibility to intervene even under local anesthesia with all the advantages both for the patient and for the operators and not least also for the time of execution of the operative act.
Traditional surgery is performed with instruments (vitrectomes) using vitrectomy handpieces with a gauge of 20 Gauge (0.9 mm), implying an invasive surgery as it operates by ungluing the patient’s conjunctiva to access the sclera and from there to the chamber vitrea through a sclerotomy
Vitreoretinal mini-invasive surgery is now carried out at about 80% thanks to tools that allow the operator to perform the intervention by means of trocars of different sizes, 23 Ga (0.6 mm), 25 Ga (0.5 mm) and 27 Ga (0.41 mm).
The trocar finds trans-conjunctival application and then accesses directly the vitreous chamber without having to unstick the conjunctiva. Through the guide that is left in situ the surgeon has the possibility to insert different surgical accessories such as the infusion torch, the source of illumination, the handpiece for vitrectomy and alternating with the latter the insertion of pliers and surgical instruments needed at the moment or laser fibers for specific treatments.
All these surgical accessories are disposable and, given the minimum dimensions, guarantee the surgeon to perform the operation in a less invasive way and to have reliability in every phase of the surgical operation.
2.3 GLAUCOMA SURGERY
Glaucoma surgery is performed in the traditional way with intervention of Trabeculectomy or with less invasive intervention thanks to the use of stents or valves of the latest generation. This type of intervention does not use dedicated equipment but is performed with simple surgical instruments and scalpels dedicated to the dissection of the conjunctiva.
Glaucoma surgery is performed as a result of increased intraocular pressure due to the lack of outflow of aqueous humor.
3 CURRENT MEASURING OF THE IOP DURING THE SURGICAL ACT
With a brief mention of current surgical procedures, we analyze whether and how intraocular pressure is measured and monitored during such interventions.
The intraocular pressure (IOP) is a data that today is estimated and regulated by means of algorithms, but not measured and monitored in real time, by the surgical equipment used for cataract surgery:
Facoemulsificatori – “faco”
The estimation and regulation of the pressure data is managed by software from the instruments, the data is detected within the
instrument that is usually placed at a distance of 2-3 meters from the patient, the surgeon can decide to set a desired working pressure during the execution of the intervention and the instrument through its own calculation algorithms manages the data requested by the surgeon.
In general, the surgeon tends to set the normal physiological intraocular pressure data of the eye (20-30 mmHg), the instruments based on the analysis of the suction and irrigation flows try to compensate for the removal with fluids or air infusion to maintain the required data.
In some cases the surgeon can act on the cutting and suction times of the masses to try to speed up the compensation time but in no case can the calculation algorithms set on the instruments be modified.
During the operation, the surgeon performs actions that go beyond the use of the instrument for vitrectomy or phacoemulsification, so it remains clear that any external action can not be detected to estimate and regulate the pressure data from the instrument itself.
Keep in mind the time of detection, analysis and correction of data by the instrument which is placed at a considerable distance from the eyeball, consequently they are not immediate but must take into account the latency due to the connection lines of infusion and suction between the eyeball and the instrument itself.
3.1 IOP IN CATARACT SURGERY
The intervention is carried out by removing the cataract crystalline with the emulsification method by means of ultrasounds and removal of the masses with suction of the same by the instrument for phacoemulsification.
The faco has different adjustment modes to maintain, but not to measure and monitor, a certain pressure within the anterior chamber of the eye.
The gravity system can be used by raising and lowering the rod on which the balanced salt solution bowl (BSS) is positioned, used to regulate the fluids removed during the surgical operation from the facet. If during surgery the surgeon notices emptying and collapsing or increases in the anterior chamber of the eye acts on the rod control to adjust the height of the BSS bowl.
Another system of regulation and in any case not of measurement of the IOP, is that of pressurizing the BSS bowl by the instrument. At the beginning of the intervention the operator sets a desired value in mmHg which must be kept inside the BSS bowl and the instrument maintains the value set during the operative act. A known pressure is maintained inside the BSS bowl placed at a distance from the eyeball.
The system of last innovation is based on algorithms for calculating the instrument of the removed fluids and introduced during the operative act, but also in this case the real IOP is not measured and monitored.
From the latest market sources it seems that a company in the sector could present a paro-emulsification handpiece with a sensor inside to detect the IOP during cataract surgery.
At the moment they are only market rumors, there is nothing commercialized related to this innovation, but even if it were presented we believe that it would only be a partial monitoring because the handpiece is used only for the part of emulsification and removal of the crystalline lens , all the other parts related to the intervention would not have the possibility to monitor the IOP
3.2 IOP IN VITREORETINE SURGERY
Also in this case the equipment on the market does not have the possibility to measure and monitor the IOP in real time.
The equipment used are based on the same principles of operation of the facoemulsifiers with some extra care that we analyze below.
IOP during vitreoretinal surgery is of primary importance because pressure values too high or too low can cause undesirable effects on the part of the surgeon, such as expulsive hemorrhage and / or choroidal detachment (Tabandeh, 1999), optic nerve ischemia (Hayred, 2013 ), visus deficiency (Taban, 2007).
The companies producing vitrectomes have used more and more advanced technological resources to develop the system for calculating and measuring the removed fluids and introduced during surgery to try to keep the pressure as reliable and close as possible to the pre-set data .
In most cases the analysis of the removed liquids and masses is carried out inside the instrument in the collection box.
More innovative technologies use sensors placed along the irrigation and suction lines to monitor the passage of fluid removed during the intervention and consequently accelerate the analysis times with algorithm by the instrument.
Despite the efforts and use of the best technologies, even today the real IOP data during surgery is not known to the doctor.
The vitrectomes available today for interventions use the best technologies, but they can take into consideration only the surgical steps that transit through the vitrectome itself during the operation.
During the intervention phases to inject particular principals the vitrectome instrument is not used but rather normal syringes and one of the three accessory trocar pathways.
When the surgeon needs to inject buffered fluids (Perfluoro, silicone oil, etc.), dye liquids of the retinal membranes (Blue) or apply external indentations to reach the different peripheral retinal areas, pressure rises are created which the surgeon only becomes aware of because it feels the eyeball much more resistant to touch or because it observes a lack of pulsation in the vessels of the optic nerve, detecting an ischemic area.
The same method of detection by the surgeon in the case of lowering of the IOP with sudden emptying of the vitreous chamber which in some cases involves choroidal detachment.
Some instruments can only detect pressure surges but not immediately, with long response times, can not intervene to solve the problem in case of high pressure peaks and in any case in no case are able to detect and monitor the IOP.
3.3 IOP IN GLAUCOMA SURGERY
To perform glaucoma surgery, no special equipment is used, surgery is performed by the doctor using surgical instruments, sometimes with insertion of miniaturized stents or implantable valves.
This surgery is performed in patients suffering from elevated IOP, even during this operation the value of IOP is not known, no instrument is available on the market that can detect and monitor this data.
To date the intraocular pressure is measured by means of an applanation tonometer only during the diagnosis phase, there is no method to detect the IOP during the surgical procedure and before the intervention is closed to verify that the blood pressure is optimal.
4 THE IOMS PROJECT - GENESIS AND DEVELOPMENT
IntraOcular Monitoring System
The project started in 2012 and in particular in conjunction with the release of new surgical equipment for vitrectomy, retina and cataract surgery. With the advent of these new instruments, which were presented as revolutionary systems for the control of intraocular pressure during operations, it was expected to have an innovative support and in particular an instrument that could prevent and manage the elevations and pressures during the interventions especially of vitreous retina.
Over time it has been realized that the instruments presented do not detect the actual data of IOP, but rather can detect a difference in pressure between the set and the return one only through membranes and sensors placed inside the instrument itself , along the irrigation and aspiration route, there is no sensor inside the eyeball, do not take into account external agents (indentations and surgical steps, infusions of coloring liquids, buffering agents etc that do not pass through the instrument itself), consequently they do not detect the real intraocular pressure but rather estimate this data through algorithms.
The variations in pressure during the surgical procedure can not be estimated by the doctor, they depend on the pathology, the surgical maneuvers, the use of buffering liquids, the timing and also the systemic pressure of the patient.
These variations in pressure can be tolerated by the patient for very minimal times, in addition to which problems may occur during surgery and certainly not to be underestimated in the post-operative even after 4-6 months.
Today the surgeon’s experience and practice are fundamental to prevent ischemia of the optic nerve if too high and lasting pressure is reached and / or choroid detachment in case of glass chamber collapses due to too low pressures during the retinal surgery.
It is clear that the instruments marketed today compared to the previous generation are of great support and have greatly improved the physician’s approach, but the actual IOP data is not yet provided during the surgical procedure.
Considering the current state of the art we tried to go deeper into the evaluation of new clinical methods and techniques made available by the market because it had been perplexed that the new systems presented and the unbridled marketing developed on this data by the companies of the sector it did not generate a revaluation even in the method of detection and control of the intraocular pressure state.
Clearly we could not go this route alone and we involved Dr. Stefano Ciaccia (Istituto Auxologico Italiano), Prof. Mario Romano (Humanitas Gavazzeni Institute) and the Polytechnic of Milan, faculty of Computer Electronics and Bioengineering ( Prof. Guido Baroni and Prof. Beniamino Fiore with their team).
To them we expressed our doubts and the perplexities found and asked for the usefulness of being able to have the real IOP data during the intervention.
Given the interest shown in this respect, we have pursued the objective of developing a first prototype that could provide this data.
The realized prototype is an independent system that allows to detect the intraocular pressure through a very small size disposable fiber optic sensor (0.26mm) that is inserted in one of the three trocar accesses already used for the intervention, coupled also at source of illumination or the infusion path in 23Ga or 25Ga trocars.
The detection of the system signal is in real time with sampling of 250 Hz, accuracy of +/- 2 mmHg and pressure range from -50 to + 300 mmHg
The first tests were carried out in the laboratory and given the results obtained we continued the development by testing the prototype on enucleated pig eyes.
But the data that could make the difference was the systemic pressure of the patient and then we continued the tests in vivo surgery on 5 pigs at the AIMS Foundation center in Milan with excellent results.
The IOMS system, developed in addition to detecting the real intraocular pressure, also allows to level in active feedback, the expected value desired by the surgeon.
The surgeon can therefore set the maximum and minimum pressure alarm limits and in both cases the system compensates and returns to the value preset by the doctor the intraocular pressure through the detection system that interacts with the pressure feedback system through the intervention. of a peristaltic pump.
To complete the automatic action of the IOMS system, there is a graphic display able to represent both in graphical and numerical form the function f (x) of the feedback action carried out automatically by the IOMS system.
Given the excellent results obtained and the important interest that was arousing in the surgical medical category, it was decided to protect the project both for the part related to the system and for the method and on 6 September 2017 the Italian Patent Office issued the concession with the N ° 0001429004, consequently the European States, the USA, Russia and India were chosen for the international extension.
Dr Ciaccia presented this innovation at 2 Italian congresses (Monza and Vitreochirurgia di Verona in 2015) and 2 International (ARVO in Seattle and ASRS in San Francisco in 2016), finding great interest and arousing reflections on the current state of the art.
Following these presentations and the consultative work carried out with the medical audience, many surgeons have begun to place particular interest in this that could in fact represent a new measurement technique with a consequent and significant reduction of adverse and post-operative events with reduction of consequent and potential insurance costs.
What is particularly interesting is that the doctors themselves have brought us to know that the missing element in the current surgical technique is the value of the optic nerve perfusion (OPP).
The OPP value refers to the perfusion pressure of the optic nerve, which is closely linked to the detection of intraocular pressure as an interested part of the vascularization which, in the event of excessively high pressures, may fail with consequent ischemia of the optic nerve itself.
Since the only missing data to be applied to the formula already known in the literature for the calculation of the OPP is the real IOP, and our system is able to detect it, we have planned the realization of the second prototype with the evolution for measurement in real time of both values: IOP and optic nerve perfusion value.
Knowing therefore that in the current surgical practice the values of IOP and OPP are not known to the doctor during the operative act, we want to pursue the objective of providing the future IOMS system with the complete measurability of all the parameters necessary to make the calculation algorithm present in the scientific bibliography. (Jurgens, 2012)
Since at this point, the surgical methodology will be objectivable it will also be possible to generate a recorded path of the surgery exogursus with the logic and consequent sustainability of the occurred.
In addition, doctors using this system will have important data on which to study new methods of surgical approach, publish scientific data, follow up on interventions performed with this system and relate them to the past.
5 OBJECTIVES OF THE IOMS PROJECT
In relation to the feedback obtained in the presentations implemented, we are counting on the diffusion of the IOMS system towards the young surgeons, who are definitely more interested in new technologies and moldable towards the measurability of the surgical act and to which an important opportunity will open for research. and the study of this new frontier that will surely bring advantages first and foremost to the costs of the surgical technique itself and post-operative and which may correlate adverse events and post-operative course to the exursus of the implemented surgical act.
Develop the engineering of the IOMS system to make it marketable and certifiable as a medical device.
Develop dissemination seminars for the internationalization of the system as a true “new surgical technique”.
Promote the pressure detection system as a method also in other specialties that require miniaturized and highly reliable tools, such as neurosurgery, cardiology, neonatal pathology.
The realization of the final prototype that allows to detect, monitor and visualize both the values expressed in numerical form and trends in the form of a sinusoid is essentially composed in two steps and related times.
6.1 IMPLEMENTATION OF PROTOTYPE IOMS
• Integration with non-invasive automatic measurement of patient systolic and diastolic pressure (ABP) at regular intervals chosen by the surgeon.
• Application of the resulting value to the known formula to obtain the perfusion value of the optic nerve
(OPP) = [2/3 (2/3 DBP + 1/3 SBP) – IOP] – (Jurgens, 2012)
• In the case of low intraocular pressure compensation by means of automatic BSS infusion using a latest generation peristaltic system.
• In the event of a high pressure venting valve opening located along the infusion path in real time with three safety systems:
or command directly managed by the surgeon
o automatic command managed by the system based on the pre-set alarm threshold
or hydraulic safety valve in case of malfunction of the previous commands.
• Preliminary in-vitro tests (eg enucleated pig eyes) and in-vivo tests (at AIMS Academy Milan).
• Consolidation and optimization of the IOMS system according to the results of the preliminary tests
o analysis of the needs and requests of medical surgeons to make the system complete with the necessary information and simple and intuitive use (eg graphic display for real-time visualization of IOP – OPP, settings of acoustic and visual alarm signals in case exceeding the pre-set alarm limits, adding a foot control for the surgeon that allows the operator to open in case of high pressure or to enable or disable the system compensation automation, etc.) .
• Final in-vivo animal tests at AIMS Academy Milan.
The videos were made for prototype phase studies in the field of in vivo animal surgery at the AIMS Academy Milan center
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