Hydro-gravitational method and device for lung refurbishment
20200306476 ยท 2020-10-01
Assignee
Inventors
Cpc classification
A61M2205/3396
HUMAN NECESSITIES
G16H20/40
PHYSICS
A61G10/023
HUMAN NECESSITIES
A61M16/00
HUMAN NECESSITIES
A61M16/0404
HUMAN NECESSITIES
A61M16/044
HUMAN NECESSITIES
A61H1/00
HUMAN NECESSITIES
A61M16/0006
HUMAN NECESSITIES
International classification
A61M16/00
HUMAN NECESSITIES
A61M16/20
HUMAN NECESSITIES
Abstract
Many pneumonia diseases and lung malfunctions can be quickly repaired using an improved lung lavage technique where the patient is rotated in specific 3D orientations to increase the efficiency of the lavage procedure. The process involves filling and emptying the lungs with fluid and rotating the patient makes this process natural and effective. Supplementary, a hydro-pneumatic system facilitates the operations with the patient sustained in various positions such as being immersed in water and having various control mechanisms such as variable pressures, temperatures, and performing assisted breathing. Additionally, immersed devices are implanted that shake-up of alveolar wall and other devices perform ultrasound imaging with a 0.1 mm resolution, a resolution in competition with stereoscopic X-ray. The bio-medical data acquisition system allows physicians to completely assess patient status in real time and guide the treatment to ensure optimum patient care, under quality assurance procedures.
Claims
1) A system to improve lung lavage operation comprising: a.Adjustable position in 3D patient bed, made of: Ipower and control box; IIarticulated arms with gears and actuator boxes; IIIfluidic reservoirs and mixers; IVBed positioning system; VPatient lock in position cuffs; b)System to hold the patient floating on the bed comprising: IA set of hydro-pneumatic cuffs, working together air tight to control pressure, applied to patient, embedded into hinged cylinders, where each cuff is including: *A half cylinder with a half cuff fixed on the bed, operating as a water bed supporting the patient all along; **Two quarter cylinders on lateral hinges that are surrounding the patient, making the flotation feeling, split over torso and abdomen also varying pressure for helping the patient breathing; ***Quarter cylinders covering basin legs, and arms for pressure equalizing; ****Helmet half cylinder covering the face, and accommodating the hoses that are inserted in the mouth; IISafety brackets for setting patient secure in place; IIICable passage for instruments, being water and air tight; c)A plurality of fluidic systems to lavage the patient, comprising: IA set of gas and lavage liquids tanks, placed adjacent to power box; IIA plurality of gas preparation units placed near the tanks; IIIA plurality of tubes carrying lavage liquids, joining in a common bunch to go up near articulated bed arm, to the helmet entry; IVA plurality of lavage fluid drain tanks, for waste fluids recovery; VA plurality of measurement instrumentation and control valves comprising: A. Flow meter; B. Volume meter; C. Temperature; D. Pressure; E. Sampler for laboratory analysis; F. Optical spectrometry; d)A system to assist patient breathing, made of: IRespirator gas preparation unit; IIControl system synchronized with patient; IIIPressurized thoracic and abdominal cuffs; IVExhaust gas analyzer; VLaboratory analyses sampler; e)A system to visualize inside lungs, comprising: ICT, PET, MRI compatible display unit; IIStereoscopic X ray visualization device; IIIA plurality of Ultrasound phased arrays; IVA plurality of hydrophones inside hydraulic cuffs, locating the sound sources inside the lung; f)A system to vibrate the alveoli made of: IA plurality of underwater tweeter loudspeakers, working as phased arrays; IIA ultrasound imaging and location systems that controls the aiming; g)A system to measure and analyze patient bio-parameters, comprising: IA data acquisition system with computing simulation and visualization capabilities; IIA set of wearable electronics placed in all compartments holding the patient, measuring temperatures, pulse rate, oxygen, pressures, blood flow, etc.; IIIA system to measure inside lung parameters at the bronchiole level that may comprise: A)Video camera, illumination system; B)Optic fiber spectrometer; C)Bronchiole pressure; D)Gas analyzer at sub-lobe level; E)Temperature; F)Conductivity and pH; IVA optic fiber to apply optic power to selectively worm up or excite tissue; h)A system to control process, comprising: I.A computer system integrating all information; II.Communication interfaces with other process computers; III.Process visualization and control with quality assurance; IV.Emergency procedures control with activation of: A)Defibrillator; B)Release patient procedure; C)Emergency communication.
2) A system to improve lung lavage operation according claim 1, where the patient is hydraulically supported like on his buoyancy and rotated in all positions to guide naturally fluid movement inside the desired lung lobe.
3) A system to improve lung lavage operation according claim 1, where the patient may be treated in hypobaric conditions, to increase expectoration, or hyperbaric conditions to increase the oxygen exchange or nitrogen absorption to create favorable treatment conditions.
4) A system to improve lung lavage operation according claim 1, that monitors continuously all necessary bio-medical parameters for quality assurance purposes;
5) A system to improve lung lavage operation according claim 1, where lung-lobe loading with lavage liquid is monitored versus lung's elasticity in order to avoid any alveolar damage;
6) A system to improve lung lavage operation according claim 1, where radioactive goniometry, and gamma ray absorption scanning is used to profile the lung lavage liquid loading;
7) A system to improve lung lavage operation according claim 1, that uses pseudo-buoyancy to float the patient in contained liquids, and rotate gently in order to avoid any lung excessive stress;
8) A system to improve lung lavage operation according claim 1, where the lavage solution is a mixture, gas fluid, applied at various temperatures and pressure regimes;
9) A system to improve lung lavage operation according claim 1, where laser pushes power inside at various frequencies, to heat up solution or alveolar walls or to attack various molecular compounds inside;
10) A system to improve lung lavage operation according claim 1, where, the efficacy of lungs gas exchange is measured continuously based on gas analysis;
11) A method for lung lavage that has the following steps: a)Have the preliminary imagery and diagnosis transferred in process control computer; b)Elaborate lung treatment process plan; c)Bring patient and transfer in the lavage bed under anesthesia; d)Connect the bio-parameter measurement system; e)Close the hydro-pneumatic cuffs and lock patient in position; f)Introduce the process tube via mouth and trachea in the lungs; g)Make every tube advance using the bending and stepper/rotator mechanisms on tube; h)Monitor the advancement of tubes inside bronchiole using X-ray goniometry; i)Use the breathing tube to maintain normal respiration of patient; j)With the tubules in place make a X-ray stereoscopic radiography, in various positions to check the accuracy of tubule placement, digitize and overlap on CT, MRI, PET pre-existent data; k)Place each tubule in place and inflate cuffs sealing air tight the lung regions; l)Rotate the patient until the selected lung lobe for lavage have the alveoli placed in the right position for being filled with lavage prewash liquid; m)Start liquid filling, while assisting breathing, and monitoring bio-parameters (vitals included); n)Use ultrasound phased arrays to image the lung flooded zone, and vibration generator to make the liquid wash alveolar walls, and proceed for a prescribed time, while rotating patient to cover all alveolar surface and washing angles; p)Flip patient in the drainage position and gently drain liquid while introducing fulfillment gases for the first step; q)Flip back the patient and start next step, with the other set of prescribed liquids; r)Repeat points m, n, p; s)Repeat q, r as needed according to treatment procedure; t)When procedure completed, set the patient in initial position, and measure the lobe with had lavage functionality, than switch on the next lobe scheduled for lavage; u)Start the lavage procedure and repeat m-t; v)Bring patient in the initial position and reposition the hoses inside lungs, and repeat g-u; x)When finish, bring the patient in the initial position and measure image and make all end of procedure tests and quality assurance measurements; y)Bring all parameters to ambient pressure, measure and check again, withdraw the tubes from patient, and measure again the global functionality; z)Release the patient and transfer on the transport bed.
12) A method for lung lavage according claim 11, that may be customized on various lung clogging diseases, using various treatment procedures;
13) A method for lung lavage according claim 11, which may have four main phases of lavage, that are: a) pre-clean and clean the lung lobe from mucus and other depositions; b) kill the viruses and bacteria; c) heal alveolar wall and bronchi; d) rinse the lung's lobe and apply enhancers and measure the functionality;
14) A method for lung lavage according claim 11, where the patient may be rotated on any azimuthal and polar angle in order to allow a lavage liquid inserted in alveoli to wash and cover naturally all the walls and remove and train the depositions towards exhaust hole;
15) A method for lung lavage according claim 11 than uses pressures in both hyperbaric and hypobaric domain, in order to increase the effectiveness of the treatment;
16) A method for lung lavage according claim 11, that is measuring and mapping the lung's performances and bio-medical parameters during the entire procedure;
17) A method for lung lavage according claim 11, that uses vibration to increase the lung's lobes lavage efficiency;
18) A method for lung lavage according claim 11, that uses gamma ray goniometry and imaging in order to set the position of hoses inside lung with high accuracy;
19) A method for lung lavage according claim 11, that uses sound listening and localization in order to diagnose potential issues, of lung functionality;
20) A method for lung lavage according claim 11, that uses laser lung irradiation in order to kill bacteria and viruses during lavage procedure.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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FIGURES DETAILS
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DETAILED DESCRIPTION OF THE INVENTION
[0520] The inventors consider the developments in medical electronics, wearable electronics, hydraulics and pneumatics and medical lung therapy procedures. In parallel progress in aero-space technology, micro gravity flight simulators make possible revolutionary improvements in the lung lavage procedure, allowing high performance alveolar washing and treatment with fast recovery. One problem we intend to solve is to have a full controlled liquids management inside lungs, to provide liquid micro-agitation in order to wash better, without damaging the alveolar wall, but removing chronical depositions, virus and bacterial generated mucus, treat the cause and apply therapy procedures to make it better.
[0521] In order to provide a right therapy, it is good to have as much exploratory data in advance, but in emergency situations the system have to be able to extract those data as it goes, using bio-medical data acquisition system onboard.
[0522] It will come as a requirement or recommendation, to develop redundant communication systems as well as redundant power supply systems in order to be able to maintain a holistic knowledge and process control functions as long as possible during high severity events, or disasters, making the control process bring no contribution or to increase the impact factor, by aggravating the consequences/outcome of an accident or malfunction.
[0523] Having in mind that this system have to be operational in crisis time, too, that the ambient where augmented reality devices work, will have its own, redundant communication system, from, wire, optical to wireless, to local instruments, able to assure unperturbed operation. There are connected X ray stereoscopic imager, ultrasound phased array, that increases visualization depth inside the lung as much as it is fulfilled with fluid, due to propagation issues, in spongy environments, a sound analyzer/locator that may track the trachea sounds or defect alveoli falling sounds, laser spectral analyses, laser heating using micro-tubules and optic fibers, illuminating and imaging, UV/IR treatment, pressure, glow, temperature, gas content measurement and all necessary data processing and visualization.
[0524] We need the fluid suspension system, to assure a kind of micro-gravity like for the patient, obtained by his body buoyancy in water, but intend to have a dry environment, easy to be sanitized, and where the patient to be installed in minutes, and released in seconds in case of need, therefore water filled cuffs were used, that seal on patient body, being air tight.
[0525] It is there possible to use the patient suspension system as a hyper/hypo-bar enclosure, applying the treatments on a large range of pressures, from 0.5 bar up to 3 bar, if there is any reasonable purpose in doing this.
BEST MODE OF THE INVENTION
[0526]
[0527] The invention corrects previous deficiencies of the previous method, as follows;
[0528] a)Improves the effectiveness of the lung lavage, by orienting the alveolar sac, together with the patient, similar to a bottle, in one position to be fulfilled with liquid and in other position to be emptied; shaking, rotating it such as to collect everything and take out, eliminating the need that to be absorbed via lung and removed as urine.
[0529] b)Makes a system that allows operators a wide range of treatment procedures, from using a large variety of lavage mixtures, made from liquid and gases, and respiratory, healing mixtures, a large range of pressures, liquid gas agitation inside lungs, making possible not only diversification of existent treatments, but a research and continuous improvements in the field of medical lung research.
[0530] c)Is easy, upgradeable being modular in structure, and having a virtual reality control room (one or several) upon the needs, and several augmented reality devices as wearables on operators, for real-time inside lungs immersive views;
[0531] d)Has a complex sensor applicator on patient's body structure, easy removable, and with self-control of good operation, transmitting also patient's bio-parameters related to patient's state of wellbeing;
[0532] e)Is redundant, have several internal pressure, temperature measurements, optical measurements, bio sampling from extracted liquids, mapping the lung and overlapping over 3D X ray image and ultrasound.
[0533] f)Is developed in various functional approaches, from the threshold detection to anticipation, with different complexities and redundancy level, in agreement with the necessity, being more complex for a sick patient than for someone making a lung performance increase treatment;
[0534] g) Improves the medical personnel and patient access to a large variety of new treatment technologies, that may heal some patients in an exposure to this improved lavage technology, that may reduce medical equipment stress based on long term need of life assistance systems.
[0535] Best application of the invention is explained in
HOW TO MAKE THE INVENTION
[0536] It was necessary to build a similar device as air-control simulator seat, able to bring the pilot in any position relative to room coordinates, but in this case when replacing the cockpit with a hospital bed with a patient in, the only important acceleration that remained is the gravitational force, and in relation to this the entire positioning system is coordinated.
[0537] As
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[0543] What we have to do, is just to treat that hyperfine structure without harming, by soaking first to soften or dissolve the solid and viscous agents, making them liquid effluents, drain that and then treat, rinse, and reinvigorate the structure, and finally measure and certify the quality of intervention.
[0544] How to accomplish the mission, is basically described I
[0545] When one uses a flight simulator, bringing a pilot upside down is not a big deal, even if the general centrifugal movement stops and the pilot hang in the belts under his weight. Doing the same to a lung patient might trigger death, and the easy way to suspend a patient in any position is to use water generated micro-gravity by buoyancy, but immersing full body underwater requires tight sealing on respiratory system, and the presence of septic water over the entire body. Therefore, as
[0546] Due to this hydraulic developments there is now possible to rotate a patient inserted in a set of hydraulic tube sections, that add to the patient weight that may be up to 330 lb. (150 kg) adds another 150 kg of liquid, and the hardware it makes the weight that has to be rotated in space of about 500 kg (1100 lb.), which requires a strong mechanism in place, as shown in
[0547] Another important technical development is the connection of the lavage tubes assembly to helmet and mouth-piece, where all the bunch of tubes have to penetrate through mouth into larynges than inside trachea and split on the 5 bronchioles as shown in
[0548] More, the desire is to use foamy solutions that not to completely fulfil the lobe's alveolar space, in order not to introduce too much weight and stress inside lung's structure showed in
[0549] Partially fulfilling the lung with lavage liquid, agitating the liquid inside using the pressure waves generated by electro-acoustic and vibration transducers immersed in the outside supporting fluid will, as seen in
[0550] The simplest way to perform the operation is to have the mouth-bronchiole piece as seen in
[0551] There is another way to do all at once, but in order to have lung spared of any interlobe contamination, but that requires a complex insert into bronchiole and trachea, acting as a rotary switch, more complex and different of what is the simple case presented in
[0552] It is desired to perform measurements all along the process to assure that vitals and all operating parameters are good, and no risk for the patient may occur, and
[0553] As patients' medical history varies, there are various lavage recipes that mainly provides a prewashing stage, with a liquid meant to dissolve, dislocate and fluidize the residues and solid deposits inside alveoli, than after the first content was drained out of lung, a second washing solution is applied, than a medical treatment solution and a final reinforcement solution meant to increase the lung's performances is applied. To assure the progress bio-parameters measurement is continuously performed. In order to increase the washing sounds and vibrations are used, directed by interference among multiple sources, used as a phased array towards the washed area as was presented in
[0554] X ray and computed tomography, or stereoscopic 3D visualization may be obtained in real time but not all systems are needed.
[0555] The tubes may also have small radioactive sources in order to accurately localize their position inside lung, by using a goniometry process and also for density imaging, using internal point spectrometric source, similar to gamma radiography but performed with the radioactive source inside.
[0556] Modularity is desired for both method and equipment in order to be flexible and in any point to be able to add or remove a procedure or device to better serve the final goal, everything performed under quality assurance protocols, leaving no room for hazard.
DETAILED DESCRIPTION OF THE FIGURES
[0557] The improvements of lung lavage processes, envisioned in this patent, starts from the idea that liquids already introduced inside lung alveoli are hard to be removed by the traditional manners based on blood absorption and removal by kidneys, where the micron size solid particulates remain and accumulates reducing the oxygen exchange capability and damaging the alveolar wall, triggering infections. The use of gravitational force turns out to be an easy solution to fill and drain a lung lobe, by gently rotating the body around gravitational vector direction, than refill and repeat the process until medical goals are obtained.
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[0559] In the left lung, the lumen carrying oxygenated air is sealed by an inflatable bellow, 106, inserted in primary bronchus of the left lung. In the right lung, washing lumen, 107, is now inserting the washing liquid, but due to gravitational field, a liquid deposition, 108, is occurring on the lower part of right lung.
[0560] All along the washing process, left lung, 109, is ventilated, using compressed air, oxygen, at normal or higher pressure. The operational tube, 110, is inserted through mouth containing several lumens, each performing a well-defined function.
[0561] The hydraulic circuit has the liquid source coming from several bags of infusion fluid, 118, most often a saline solution being used, placed on a medical fluid bags support, 119, and connected in parallel via an infusion fluid mixer, 117, into an infusion fluid flow adjustment, 116, being delivered to a flow splitter, 121. The flow direction is regulated using a pair of medical valves, 115, that may direct the flow through the drain tube towards the drain liquid collector, 120, placed on a stool, or towards the hydraulic pump, 114, passing through a lumen mixer-splitter, 111, towards the pumping unit liquid input, 113, that has adjustable flow, 114, and delivers it at pump's exhaust, 112,
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[0563] Right lung, 206, is lavaged, by inserting the lumen in the primary right bronchus, 207, and inflating the cuff, while Left lung, 208, is ventilated, by inserting the lumen via trachea, 209, inside left primary bronchus, 210, using an air tube, 211, coming from a ventilator, 212, and having pressure limited by aeration valves, 213, that are also used to establish the clean right air concentration.
[0564] The lung's washing is made using, lavage solution, 214, usually made of 0.9% saline solution, that passes through a medical on/off valve, 215, to a y mixer/router, 216, that can switch towards lungs, or from lungs towards drain bottle, 218, via drainage tube, controlled by a medical on/off valve, 217.
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[0566] A liquid tube, 307, is pouring a saline solution into the left lung, 306, while an air tube, 308, is introducing air from a ventilator, 309, into the right lung, 301.
[0567] The fluidic circuit is made of a lavage fluid tank, 312, that holds enough saline solution that flows gravitationally through a fluid lock, 313, into a fluid warmer, 314, that brings it to the right temperature exiting the lavage fluid tube, 315, into lavage limb, 311, that meets the drainage limb with lock, 310 that sets the flow direction towards the patient via the fluid tube, 307, when the lock, 310, is closed, or to the drainage fluid collector vessel, 317, via a drainage fluid tube, 316, accumulated as collected drainage fluid, 318, mixing with the fluid extracted from the patient.
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[0569] The lavage solution is set in a bottle, 405, on a support, flowing down via a tube, 406, meeting the joint with drainage tube, 407.
[0570] The air tube, 408, is also introduced in trachea, having remained outside patient's mouth aeration, pressure limiter, 409, extensions.
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[0572] The lung is also divided in parts named after their position in the standing up body, as right upper lung, 505, and left upper lung, 506, as an example, but no matter where the alveolus are they are fed with blood coming from pulmonary artery 515, carrying out oxygen and veins bringing carbon dioxide to lung.
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[0576] During illness a normal epithelium, 603, that border the micro-bronchial tube, becomes bended, covered by mucus buildup, 604, making the pressure drop grow, and leave less air inside.
[0577] The normal tissue, 605, becomes inflamed, 606, swallows, and sometimes is affected by necrosis and lose of tissue, 608, making air flow whistle.
[0578] Smooth muscle, 607, is tightening around bronchial tubes, 618, shrinking them, and the same around bronchioles, 609, making air penetration inside alveoli, 610, 611, very difficult. Healthy alveoli, 613, are affected and collapse, 612, having walls stick on each other due to mucus buildup.
[0579] Other alveoli, that are initially healthy, 611, may remain overinflated with trapped air, 614, due to collapsing of lateral lobes. Inside overinflated alveoli, 614, liquid may be trapped, 616, that is hard to be eliminated, and as normal lung mechanism it is transferred into blood, that carries it to kidneys and so it is eliminated, but hydrophilic mucus does not allow this process to take place, and lung remains out of use. In order that liquid trapped in a certain alveoli to be released, the lung have to turn around until the arrow pointing direction to bronchial orifice, 616, is align with gravitational field's direction. This is the typical tissue that will be the subject of patent application, where a sick lung tissue as shown in
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[0581] Oxygen molecule, 628, in excess is diffusing in bronchial wall blood vessel and gets trapped in a red cell, 623, liberated from CO2 that diffused into alveolar space to balance the partial pressure distribution. One has to note the fine construction of the alveolar device, very sensitive to mechanical stress while it is as robust as possible made by nature.
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[0585] Alveolar wall stress T.sub.ij, 654; is given by the pressure difference inside alveoli, 655, that determines the modification of the, 656, alveolar space, by the action of pleural membrane, 657, extra pleural pressure, 658, determined by inter-rib muscles action.
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[0587] Patient's arm, 704, is included inside a pressurizing cuff, and contains various bio-medical parameter measurement devices, as blood pressure, pulse rate, oxygen content in fingers' blood vessels, etc., and is part of the hyperbaric system.
[0588] Patient's bed, 705, is mobile, mounted on a system with multi-freedom degrees, able to place the patient in any desired position, relative to gravitational field, in order to assure the fulfillment and drainage of the lavage liquid from any alveolar path, under the effect of gravity and vibrations from, electromagnetic to pressure wave transducers placed outside the patient's body, but inside hyperbaric enclosure.
[0589] Patient's shoulder and torso are placed inside the segment of hydro-pneumatic enclosure, 706, that is continued with an abdominal segment, 707, of the hydro-pneumatic enclosure, followed by hips and legs hydraulic support, 708, that provides legs immobilization and measurement via a bracket, 709 and also has included an inferior leg hydraulic support and massage device, 710, all rigid connected to bed's infrastructure, 711. The reasoning behind this complex structure was to provide a dry environment for the patient, able to use fluids for pressure wave applications and ultrasound imaging, as well to provide a massage for circulatory purposes, in limbs, everything easy and fast to open, and release the patient. It is also important that no part of the patient's body to be left outside of the controlled pressure area, because that may drastically affect patient's safety.
[0590] A hydro-proof power system, 712, for bed actuators, which is connected by cables, 713, to a computer control unit, 714, for bed's positioning control. The operator, using computer's keyboard, 715, may perform lung's alveoli location and vectorization, such as the fluids, gases and liquid mixtures, coming from utilities and fluids pumping box, 716, to act in harmony with gravitational forces at alveolar level, to fulfil it with liquid, when the alveoli is placed under the filling tube, and get empty when the body is rotated by the bed actuators until the alveoli is placed above the bronchi and extraction tube, all content leaking towards the outtake tube. Body rotation is used such as the lavage liquid to gently wash all alveolar surface, being agitated by the pressure wave, that improves the cleaning of the alveolar walls. The lavage liquid is controlled in pressure, temperature, chemical content, gas mixture and flow, such as to maximize the cleanup effect. It will be possible to have some inner visualization by micro camera, laser illumination and fluorescence spectral analysis, as well to transport power radiation on absorption bands of the targeted lung infestation agents, to supplementary warm them up. This equipment now base on the usage of few saline and antibiotics doped lavage solutions will open the way for intensive new research.
[0591] The local computer also receives imaging and analytical signals, that are further sent via cables, 717, from computer to imaging and auxiliary units that are specialized in generating 3D ultrasound images, or stereoscopic X ray images, generating immersive virtual reality for operator, helping operator to control tubes placement as well the lavage process. Other equipment is measuring the efficiency of alveolar membrane gas exchange monitoring the oxygen and carbon oxides concentrations, as well other gases specific to the lung expectoration materials being cleaned.
[0592] At the beginning, normal pressure operation, a patient supplementary liquid system, 718, may be used, but as soon as hyperbaric treatment starts, all pressures have to be controlled by an auxiliary power and service system, 719, that also powers bed actuators, 720, rotational gearbox actuator, 721, correlating pressures with patient's position, in order to avoid any internal undesired stress.
[0593] The quality of lavage procedure is assured using 3D stereoscopic X ray visualization system, where the information is transmitted by cables, 722, from X ray devices to 3D visualization unit, that integrates it with vibration, ultrasound and sound control and visualization unit, 723, and breathing, and lung measurement and simulation unit; 724, and sends them as virtual and augmented reality to operator's helmet.
[0594] Operators, may also access on augmented reality helmets, or on screens, general procedure control menus, 725, general procedure control and visualization unit, 726, fluid control and lung performances assessment unit, 727, and 3D X ray unit for real time fluid control, 728, integrated in a holistic process control and quality assurance.
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[0596] Patient's arm, 804, is inside a hyperbaric enclosure and is on measurement devices, for blood pressure, heart rate, oxygen concentration.
[0597] The patient is installed on a mobile bed, 805, having several/multiple freedom degrees, that allow it to place patient orientation in any position against gravitational field, and continuously pass through various position such as to assure the complete leakage of the washing fluid from any alveoli, no matter how intricate the bronchiole is. The patient shoulder, 806, and torso are placed inside a hydro-pneumatic enclosure, another one contains the abdomen, 807 than is followed by basin and legs hydraulic support, 808, that also has leg immobilization and measurement brackets, 809, and contains an inferior leg hydraulic support and massage device, 810, all fixed tight on bed's infrastructure, 811.
[0598] The bed is moved by a power system, 812, for bed actuators, 820, controlled by a bed's position and pressure control system, 814, and uses a rotational gearbox actuator, 821. A support arm and connections, 815, for utility fluid box, 816, which contains inside fluids pumping box, powered by an auxiliary power and service system, 819, that contributes to the success of the procedures.
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[0600] Ribs, 908, are surrounding the thoracic cavity therefore we have to accommodate their presence and rhomboids major, 909, ink, imaging systems and vibration application systems.
[0601] On the upper front there are clavicular part of trapezius major, 915, coracoid, 916, cephalic vein, 917, sternal part of pectoralis major, 918, axillary artery, 919, brachial nerves, 920, axillary vein, 921, ribs, 922, and pectoralis minor, 923, above and covering the upper lung lobe, 924, making the access from this direction difficult, too.
[0602] The technologic part of breathing assistance comprises a torso breading compressed air membrane and sound/ultrasound and vibration generator support, 910, contained inside an external torso hyperbaric tube, 912, that adjusts the pressure applied on whole body in harmony with the other units, and in order to apply fluid pressure while the patient remain dry it has a inner hydro-bag foil on skin contact, 913, that is permeable for ultrasound, vibrations and X rays leaving a good visualization and vibration energy transmission to lung lower lobe, 911.
[0603] Upper arms and helmet hyperbaric seal, 914, is connecting air tight to the upper torso and shoulder support, 934, that helps maintain the body head down in liquid flotation like suspension, by adjusting pressure inside.
[0604] Left lung lobes, 925, section is showed in the drawing, and the breathing is made by diaphragm movement, 930, and torso assisted compression synchronous with the diaphragm, that is helped by belly region hyperbaric enclosure, 932, which is making the pressure uniform along the body, and is contributing to the breathing process. Because human body is a fluidic system, hyperbaric pressure has to be applied uniformly over whole body in order to prevent tissue damage and blood dislocation.
[0605] A compressed air bag, 926, for breathing and pressure regulation is helping with fast response, and is lighter than water, moving up and down less than psi. Inside the water bag are immersed electromagnetic actuated membranes, 927, for vibration generation in audio and ultrasound spectrum, working as phased array of vibration generators, 928.
[0606] For imaging purposes in nearby vicinity of the ribs, longitudinal ultrasound visualization phased array, 929, is used being aware of weak propagation through lungs, inflated with air, and gooey covered membranes, where ultrasound generation phased array, 931, and ultrasound visualization phased array, 933, are placed along body. Sound and sound time of flight is also received in electromagnetic transducers, 929, in part placed near the skin separation membrane, analyzing sound coming through liquid, if that lung lobe is flooded with lavage liquid, or through air, indicating the areas with problems, the physicians have to focus next.
[0607]
[0608] We intend to use esophagus, 1009, thoracic duct, 1010, external lock of thoracic hyperbaric enclosure, 1011 to insert the tubes, via secondary bronchi, 1013, upper left lung lobe, 1014, for a tubule carrying gas to upper left lung alveoli, 1015, sealing them air tight through secondary bronchi inflatable cuff plug, 1016, and producing liquid puddle accumulation in the alveoli, 1017, that affects breathing In order to support the body, we use a big cuff with external liquid pressuring the body, 1018, that is made in several segments connected by hinges at the outer containment, 1019, such as to be easy to introduce the patient inside, and take him out dry.
[0609] Pressure wave aiming in phased array, 1020, is used to be focusing in lavage region, 1021, to agitate the washing liquid inside the alveoli, to improve the washing factor.
[0610] The idea is to produce lavage only in small sections of the lung, by using tertiary bronchiole, 1022, sealed by a tertiary bronchiole cuff plug, 1023, through multiple tubes are passing through, some bringing liquid mixtures for lavage liquid fulfilled alveoli, 1024, that is agitated by directed pressure wave from a phased array, 1025, that uses a plurality of electromagnetic to pressure wave transducer, 1026, a kind of underwater tweeter-loudspeaker, aiming direction of the pressure cardioid distribution, 1027, making a lateral moving pressure wave, 1028, by gently tuning the phase shill and transducers' orientation, in order to wash upper alveoli partially filled with liquid, 1029. As everything from pleura to alveoli is filled with liquid, ultrasound may propagate without significant attenuation, and an ultrasound imaging phased array, 1030, may be used to see in depth, much better than in a radiographic image. For more complex inside analysis, technological tube passing in secondary bronchiole, 1031, may have a camera, for inside imaging, while a micro tubes is used for light and spectral analysis, 1032, in various modes, as Raman, fluorescence, absorption and reflection bands, and other tubules passing in secondary bronchioles for oxygenation purposes, 1033, may also carry other gases, used for therapeutic or antibacterial purposes.
[0611] A tertiary bronchiole, 1034, is used, after being plugged with a bronchiole sealing cuff, 1035, with technological tubule passage, for multiple purposes among which measuring the oxygen exchange efficiency of the lobe, before and after the procedure application.
[0612] While a part of the left lung lobe is on lavage, right upper lung, 1036, is on gas feed, breathing normally or in oxygen enriched atmosphere, being assisted by the hydraulic system.
[0613] Upper right side of hydraulic compression membrane, 1038, has several hydraulic separation membranes, 1037, and an inner cuff, 1039, for separation between the pressure and breathing volume and hydraulic medium, that also houses inside a support structure, 1040, for electromagnetic to vibration transducers, hydrophones and ultrasound imaging arrays, electromagnetic to vibration transducer, 1041, hydrophone, 1043, array, localizing sound generated by air movement in lungs, ultrasonic imaging phased array, 1044, working together to assist the lavage process diagnose interior of the lung, alveolar walls, and more.
[0614] Because, patient inter-rib muscles, 1045, are most often weakened by disease, an intermediary liquid; 1042, is used, to assist breathing, by gentle pressure variation in synchronism with patient's diaphragm, to make possible breathing even if the lung is fulfilled with liquid by tertiary bronchiole, 1046, using complex technologic tubes split, 1047, from the secondary bronchiole insulation cuff; 1048, that is air tight, in order to control liquid separation from gas, and insulate the lavage lobe, until the entire restoration procedure is accomplished. For extreme situation, of cardiac arrest, a hart defibrillator is connected to specialized electrodes, 1049.
[0615] All the system is developed and operated giving in mind the complexity and fine operation in place aiming to restore functionality in lobe walls 1 micron thick.
[0616]
[0617] A lavage fluid pump, 1110, takes the mixture, and adjusts the fluid pressure, flow function, delivering it into lavage fluid pipe, 1111, were a supplementary pressure, flow, temperature adjustment, 1112, is made and fluid goes into lavage mixture delivery pipe, 1113.
[0618] An advanced measurement tub; 1114, is measuring the liquids parameter inside lung.
[0619] After lavage, the patient body, is rotated from a position where trachea was superior to lung's lobe in inverse position, such as lavage liquid to drain into trachea that becomes inferior to alveoli sachet, and from there in drain pipe, 1115, to drain tanks, 1116. A fluids valves block, 1117, is making all the valves switches to guide the drain lavage fluid from lungs pipe, 1118.
[0620] Input for lavage fluid with parameters adjustment, 1119, is the final control for the lavage fluid before entering the patient's lungs, that is placed on a bed infrastructure, 1120, that has a patient associated coordinate system for position control, 1125, able to align a secondary bronchi operation tube, 1124, containing a measurement input tube, 1122, and an optical and drug delivery tubule, 1123, to gravitational field direction; 1121, such as the liquid naturally flow in and out alveolar sac.
[0621]
[0622] A trachea tube contains a set of inner functional tubules, 1205, are carrying all necessary equipment for dedicated operations as tubule for bronchiole lavage, 1206, breathing tubule, 1207, respiratory mixture carrying tubule, 1208, bronchiole tubule, 1209, that are splitting, being introduced each in a bronchiole of the lung's lobe is desired to be washed or in meant to maintain body's oxygenation during the process. After lavage was performed at the desired lung lobes the tubes are withdrawn and a new trachea tube is introduced to lavage the rest of the lung, if the lavage process is designed to be done in one session.
[0623] Each tubule has an external wall, 1210, that incorporates stiff steering channels, and inside channels there are stirring strings, one or more left stirring string, 1211, and others for all directions, that act up to bronchiole sealing cuff, 1212 that when inflating has the role to seal the lung-lobe, and allow the lavage procedure to be performed without influencing other parts of the lung. The tubule ends after the cuff separating into more functional tubules, as one for drainage fluid flow, 1214, that have been used for washing, and is directed in the drain tube, 1215.
[0624] Nearby there is as a longer tubule a respiratory gas filling flow on tubule, 1216, that brings a mixture of gas and lavage liquid, that is aimed to certain group of alveoli. Care have to be taken to the amount of liquid loaded in the alveoli, in order to prevent that its weight to harm lung's structure, that was not developed to support large amounts of liquid inside. The weight, washing and whole body rotation will be controlled by the process computer.
[0625] Several optical cables, 1217, will be used for various purposes, as optical spectroscopy for various components fast, in-situ identification and concentration measurement, fluorescence spectroscopy and illumination. In some cases IR (infra-red) power may be introduced to warm up the alveolar wall or liquid, or a frequency selectively absorbed by a designed molecular compound present inside. A micro-imaging tubule, 1219, may carry a micro camera used as endoscope, and a measurement multi-micro-wire cable, 1218, used to further acquire more data during the lavage process, to assure success and controllability of the operation.
[0626] Optional, each cable may be equipped with a kind of myriapoda like advancement micro-motor, 1220, that may contain translational spikes, 1221, and rotational spikes, 1222, which assure cables better positioning inside and their stability, by anchoring themselves inside bronchiole.
[0627] Optional, cables may contain a radioactive tip made of different isotopes, and their position inside the body will be determinate from outside by a goniometer system with nuclear spectrometer, being important to correct the 3D images obtained by CT, MRI, or PET in agreement with patient's 3D position.
[0628]
[0629] As the system is hydro-pneumatic it requires cables and fluidics coming from power supply, 1302, to actuators, that are many, starting from a central arm turret, 1303, that is placed near center of mass, and contains a set of bearings with gear and actuators for two freedom degrees, 1304, that moves a telescopic inferior arm, 1305, which ends with an intermediary gear and actuator, 1306, which moves a secondary telescopic arm, 1307, which ends with a final gear and actuatorbed turret, 1308, with a two freedom degree articulation, 1309, that holds the bed structure, 1315, with everything that have to be on it.
[0630] As everything with patient is moving, the feed with necessary ingredients for lavage is made using respiratory gas tubes, 1310, placed near power box, as making the distances shorter is important, which are connected using feed pipes to lavage solution preparation, 1311, that drives the fluids to a plurality of mixer and pumping system, 1312, at least one for a lavage section. Return from lungs, coming from an exhaust pipe to the central hose, 1313, is connected to a central hose, carrying fluids, measurement tubes, 1314.
[0631] As bed and patient have to follow the liquid flow after a desired path in the alveoli, bed positioning system, 1316, have to be redundant and accurate in order to relate that to the room coordinate system and to patient lock in position cuffs, 1317, is such a manner that patient internal organs repositioning with the movement to be considered.
[0632]
[0633] Patient, 1401, is embedded into hinged cylinders, with the head near the hose containing technologic tubules, 1402, connected to patient's bed structure, 1403.
[0634] Patient is positioned on a pseudo-water bed made of a half cylinder with a half cuff fixed on the bed, 1404, operating as a water bed supporting the patient all along, and covered by two quarter cylinders, 1405, on lateral hinges that are surrounding the patient, making the flotation feeling, split over torso and abdomen also varying pressure for helping the patient breathing.
[0635] When intending to work with hypo or hyper-bar regimes, as the human body is visco-plastic containing moving fluids inside, the pressure has to be equal all over within 1 Pa accuracy.
[0636] A helmet structure, 1406, holds the head in position, while a mouth piece, 1407, is passing technologic hose through helmet half cylinder covering the face, and is accommodating the hoses that are inserted in the mouth and cable passage for instruments, being water and air tight in the same time. It also have to be easy to be removed In case of emergency, or normal routine without inflicting any damage or discomfort for the patient. Vacuum may be applied to cuffs and outer tube, to make it shrink and be easily removed or introduced.
[0637] A thoracic tube and pressurized thoracic and abdominal cuffs, 1408, works together with an abdominal compression tube, 1409, to perform augmented breathing. The patient's body has to be surrounded by liquid, to provide buoyancy effect, and hip compression quarter cylinders, 1410, are placed in extension of the abdominal ones, and quarter cylinders covering basin legs, 1411, and arms for pressure equalizing are used to have all body coverage with the right pressure. Leg safety brackets, 1412, are used inside for setting patient secure in place, that are applied on hip too as hip safety brackets, 1414, for setting patient secure in place and arm safety brackets, 1415, are contributing to setting patient secure in place when the bed is rotating.
[0638] The bed movement is assured by a bed turret and gear actuator, 1416, connected to an upper arm with telescopic capability, 1417, to a middle joint, actuator and gearbox, 1418, and then to a lower telescopic arm, 1419, moved by a lower turret gearbox actuator and lower arm joint, 1421, placed over a power and hydraulics box, 1420, that hosts all actuator drivers and power boxes, 1422, assuring the smooth operation of the whole system.
[0639] The respiratory and lavage solutions are prepared using gas and liquids tubes, 1423, that are connected via connection fittings, 1425, to lavage and respiratory fluid preparation and gas preparation units, 1424, placed near the tanks.
[0640] Quality is assured by accurate measurements, and a flowmeter, volumeter, thermometer, manometer measuring unit, 1426, measuring continuously.
[0641] A plurality of tubes carrying lavage liquids, 1427, is joining in a common bunch to go up near articulated bed arm, to the helmet entry, and exhaust pipes going to liquid collector tanks that assures the fluidic good operation.
[0642] A plurality of lavage fluid drain tanks, 1428, are used for waste fluids recovery, and a good partitioning is needed for post process patient diagnosis, because these expectorates, with liquid together with a measurement system made of a plurality of measurement instrumentation and control valves, 1429, comprising a flow meter, volume meter, thermometer, manometer, sampler for laboratory analysis, optical spectrometry, and a sampling and measurement unit, contribute to the success of the operation and patient's long range treatment.
[0643] A control system, 1430, is synchronized with patient breathing helping patient breathe, is also measuring pressures, temperatures, flow, volume, composition, etc., and has an exhaust gas analyzer, that measures oxygen concentration, carbon dioxide, other gases, and transmits all data via a computer connection cable and data bus, 1431, for process control computer, 1432, connected to data acquisition units, that also acquires data from vibration, ultrasound and X Ray processing unit, 1433, performing complex calculations, mapping lung's efficiency by lobes, and making further predictions on patient's evolution in real time as controlling the good operation of lavage process. It is desired that an old lavaged patient to get younger lungs after the process being successfully performed, eliminating the damage from previous exposures.
[0644]
[0645] A system to visualize inside lungs for stereoscopic X ray imaging, 1504, comprises a pair of X-Ray generator tubes, 1505, mounted on a Gantry arm, 1506, rotating around patient, for stereoscopic and CT modes, generating images augmenting the previous examination results.
[0646] It is known that ultrasound propagates well in water, liquids and solids, even body tissue, but is strongly attenuated in the lung, except in this case of lavage where we adding water in the lung, and that allows a visualization inside the near pleura, up to 1 above, therefore the usage of a plurality of Ultrasound Phased Array (USPA), 1507, for imaging, connected to an USPA image processing box, 1508, is highly recommended in order to indirectly detect the amount of water introduced in the lung, complementary to gamma ray attenuation measurement and imaging made using low radioactivity gamma sources placed on tubules tips.
[0647] Complementary, hydrophone receivers, 1509, connected to a hydrophone data processing box, 1510, for sound generator localization and sound partitioning, will detect and analyze any sound produced inside lungs, during breathing and lavage process, making the operators aware where are the chocking points in the wind channels.
[0648] Using liquid gravitational flow, is an enhancement compared with actual technology, but still not enough for a good comprehensive washing of the alveolar walls, therefore a plurality of Electromagnetic Hydro-tweeter (EHT), 1511, for vibration waves generation, connected to art EHT control unit, 1512, for phased array controlled washing pressure wave generation, that will be able to generate a moving wave in a lung's lobe fulfilled with lavage liquid, 1514.
[0649] Process control is performed by computer unit, 1515, containing a control panel and communication unit, 1516, a menu board on display unit, 1517, and is working networked with a lung immersion imaging unit, 1518, with a WiFi transmitter, 1519 to a WiFi receiver, 1521, of an Augmented Reality (AR) display, 1522, placed on the head of a mobile operator, 1520, acting together in the same room with a supervisor, 1523 that monitors the entire process.
[0650]
[0651] There are many bio-parameters to measure, with distributed sensors that may be customized as a function of the complexity of the operations but among those most common and important are, temperatures measurement, 1603, in various locations, 1604, pulse rate measurement, oxygen concentration in blood measurement, 1605, using simple sensors or combined sensor for oxygen concentration, pulse rate and temperature measurement, 1606, blood flow measurement by Doppler ultrasound, in exposed arteries as neck, arm, leg, 1607, if clogs are suspected as probably to form, due to anesthesia, breathing air gas concentration measurement, 1608, and other multiple pressure measurement sensors, 1609, for blood pressure on arms, and air pressure, other pressures in cuffs in real time, all ending up in a large data acquisition architecture.
[0652] A system to measure inside lung parameters, 1610, at the bronchiole level that may comprise many additional measurement and imaging devices, like a video camera, with optic fiber illumination system, 1611, acting as an endoscope, an optic fiber spectrometer, 1612, a manometer, 1613, for bronchiole pressure, gas analyzers, 1614, for each lavage tube ramification and breathing tube, very important to continuously measure the improvement in alveolar membrane gas exchange efficiency, and benchmarking the success of the operation, lavage temperature measurement, 1615, lavage liquid conductivity measurement, 1616, lavage liquids pH measurement, 1617, laser for fluorescence spectroscopy measurement, 1618, all these modules connected via a data bus, 1619, large band connection to computer.
[0653] For heating or sterilizing inside, a power IR laser, 1620, or any other tunable laser in vis and UV may be connected to fiber optic embedded in technologic lavage hose, 1621, in order to illuminate alveoli walls, 1622, in a consistent mode with prescribed lavage treatment.
[0654] A data fusion computer system, 1623, is used for integrating all information, coming via communication interfaces, 1624, with other process computers, for process visualization and control with quality assurance module, 1625, emergency procedures control with activation of emergency routines module, 1626, which may activate an automated defibrillator, 1627, and trigger emergency communication module, 1628, to make all necessary connections.
[0655] The entire concept is to monitor and interpret as many parameters as necessary to predict preemptive actions.
EXAMPLES OF THE INVENTION
[0656] The current idea was to adapt a 3D flight simulator cockpit, to an operational room, where to use the degrees of mobility of the simulator, cockpit, now transformed into a bed infrastructure, that holds the patient in buoyancy in water, contained in pressurized bags, in any position needed for the liquid to fully fulfil an alveolar sac or a lung lobe, in and out carrying with it all residues, a surfactant solution might remove from the alveolar walls.
[0657] The present patent is not intended to drastically change how the lavage is made, it does not bring new solutions in spite it highlights the need for a more sustained research in this direction, but offers the possibility of applying a sequence of washing, rinsing, healing and improving, placing the patient in any desired position, for optimal process. It also allows a large variety of pressures from 0.5 bar up to 2-3 bar as deemed optimal for the medical treatment.
[0658] When the present invention is applied to a patient, with lung damage, first in the absence of a CT, a stereoscopic X ray visualization is performed from various angles to best identify the lobes first to treat and lobes used for blood oxygenation. Then the patient is placed under anesthesia, and tubes are introduced through the mouth in the lungs, down to tertiary trachea and air tight there, while the liquids are tighten around the body, and air pressure is applied to assist breathing. The bed with the patient is rotated in the desired position, prescribed lavage liquid is pouring in the alveolar sac, fulfilling it, and from outside a vibration is applied to agitate the liquid inside alveoli, to better wash the mucus and residues there. Taking advantage that that lung area is full with liquid ultrasound visualization is used for inside imaging.
[0659] The procedure starts with the patient in a position aligning the lung's lobe bronchiole with gravitational acceleration, such as the lavage liquid to fall freely on the bottom of the alveoli, and fulfill them up to top, in the bronchiole plug, where during this operation air is gradually removed. Than ultrasound visualization, and vibration shake-up the liquid is applied in order to improve the washing factor. Simultaneously the hydrophones are used to detect if any other sounds are produced, due to collateral liquid leakage in damaged lung during breathing.
[0660] After few cycles the patient is flipped in the opposite position with the cuff and leakage rubes down, such as the lavage liquid to drain naturally, while air is added and vibration is maintained to remove all solid, viscous and fluid effluents. The input fluid and output fluid volumes are measured. Other chemical and bio-medical measurements may be performed on output fluid, with positional assignation of the findings, as to map the lungs.
[0661] Process is repeated several times, until the entire lobe zone restoration procedure is completed.
[0662] Finally the lung zone efficiency is measured by measuring the gas parameters before and after respiration. This is important information to control the near-by lobes operation, because
[0663] During the lavage of one lobe partition the rest of the lung is oxygenated, and used for patient's breathing. The pneumatic cuff around the hydraulic cuff is helping breathing pressurizing and depressurizing over the abdomen and ribs to assist the muscles.
[0664] The hydraulic cuff may create pressure or negative pressure in agreement with outside breathing gas and lavage liquid supply, in order to apply the treatment at the most effective pressure. Blood pressure and health of the blood transport system have to be analyzed when negative pressures are used, to prevent any blood spill accident.
[0665] When successful, this technology may reduce the thickness time and improve life expectancy, by bringing back to initial values or better the lung operating parameters.