Surgical kit, catheter and aspirator used in same

Abstract

The inventions relate to medical equipment and characterize a ventilated ozonizing drainage and lavage kit, and a drainage catheter, an aspirator and an ozonator contained in said kit, as well as a method for the prophylaxis and treatment of destructive inflammatory processes. The inventions are intended to provide reliable thorough long-term atraumatic active and passive drainage, as well as ease of use.

Description

[0001] Description of the invention

[0002] SURGICAL COMPLEX, CATHETER AND ASPIRATOR USED IN IT

[0003] IPC: A61B 17 / 00 Surgical instruments, devices or methods

[0004] A61B 1 / 012 .characterized by internal channels or auxiliary structural elements for them

[0005] A61B 1 / 015..control of liquid supply or pumping out [6]

[0006] A61B 1 / 313 .for insertion through surgical openings, such as laparoscopes

[0007] The invention relates to medical technology, in particular to surgery, and can be used for closed sanitation in the prevention and treatment of inflammatory-destructive diseases of various localizations in the postoperative period.

[0008] The surgical ventilated ozonizing drainage and sanitation complex by I.S. Orekhovsky is distinguished by the design of the drainage catheter, which allows the use of purified and ozonized air for ventilation, and the drainage and storage line with an aspirator, and their design requires consistent consideration.

[0009] 1. Drainage catheter.

[0010] There are many known multichannel drains based on the principle of Chaffin's ventilated drainage (1940), intended for lavage with aspiration of purulent and other cavities (see Kanshin N.N. Closed aspiration-lavage treatment of suppurative processes. Moscow, 1993; patents CN 202459748 U, 10 / 03 / 2012; CN 103055410 A, 04 / 24 / 2013; N 2292922 C2, 02 / 10 / 2007; RU 89393 U, 12 / 10 / 2009). They are made in the form of a tubular element with side openings, an aspiration channel with a channel for lavage and a ventilation gap between them with or without a cuff. All of them are based on the fact that the side openings are made along the air channel. The disadvantages of these solutions include the presence of conditions for blocking the side openings of the ventilation channel with large particles and deposits of quickly drying contents of the drained cavity. This leads to suction of the aspiration tube with subsequent tissue trauma and cessation of the drainage function.The same applies to the three-lumen drainage tube DSKHOZ, produced by ZAO Medsil. Also, these drainage systems do not allow their step-by-step removal for the purpose of consistent healing of the drained cavity.

[0011] A multichannel drainage device is known (US 86299593 B109.20.2001), which is an external tubular element of square cross-section with lateral openings (perforation) of round or oval shape, inside the tubular element there are longitudinal partitions forming internal channels, as well as a central channel of round cross-section communicating with openings with internal lateral channels. Openings for communication of internal channels with each other are also made in the partitions. The distal end of the multichannel drainage device is closed with a solid radiopaque tip to facilitate the introduction of the drainage. There is also a connecting element with a flange fixed to the proximal end of the internal tubular element. This device has the same disadvantages as the analogs described above.

[0012] Silicone drains made in the form of a tourniquet, having open longitudinal aspiration channels in the working area, located on the surface of the tourniquet (Brochure of Johnson & Johnson Ethicon (USA) for BLAKE drains). BLAKE drains have quite effective drainage due to the fact that four extended channels located around a solid core provide extended contact with the patient's tissues. BLAKE drains are made of silicone and contain a PVC insert in the center to increase strength. Several paths for outflow help to reduce the likelihood of clot blockage. The X-ray-positive insert helps to accurately place the drain. The absence of lateral aspiration holes in this solution allows to significantly reduce the risk of blockage of the aspiration channels. However, due to the lack of the possibility of simultaneous rinsing of the channel lumens, the risk of blockage remains in this design.The instructions for use of BLAKE drains recommend that if the drain becomes blocked, the aspiration process be interrupted and flushed.

[0013] Medical silicone aspiration-washing multichannel drainage proposed by Kolotov M.A. and K. RU20140110199U, made in the form of a flexible round or flat tourniquet having longitudinal aspiration channels open outward along the tourniquet surface and an additional median longitudinal through channel used as an irrigator. The cavities of the longitudinal aspiration and additional channels can be connected by openings. This tourniquet is inserted into a tube with longitudinal openings along the channels. Despite its originality, this design is not protected from suction and blockage of the drainage channels, which leads to the cessation of drainage and damage to surrounding tissues.

[0014] The following three devices are closest to the proposed utility model in terms of technical solution:

[0015] The drainage device proposed by I. S. Orekhovsky (patent SU No. 1445736 dated 24.12.1992, priority dated 24.06.1986) is distinguished by the fact that it contains three channels: a drainage channel, a ventilation channel, connected to each other by a fistula at the distal end, and a microirrigator. Its distal end is open, which does not exclude the possibility of tissue trauma and tissue ingress into the lumen of the drainage channel above the fistula between the channels in the distal section, leading to suction of the drainage channel to the tissues, which stops evacuation.

[0016] The drainage device proposed by I. S. Orekhovsky (patent SU No. 1521491 dated 12 / 24 / 1992, priority dated 12 / 26 / 1986) is distinguished by the fact that the distal end of the microirrigator extends beyond the edge of the plugged distal end of the main channels, which can lead to its bending with a kink, which will lead to a disruption of irrigation.

[0017] The prototype can be considered the Triple-lumen drainage tube (NTDT) (RU 2343940 C2), containing a base made of silicone tube, having holes at the working end, with two capillary channels in the wall of the tube along the entire length, separated from the main lumen of the tube by membranes, the working end of the tube ends blindly. One capillary channel opens outward at the top of the blind-ending working end, and the other capillary channel opens at the top into the main lumen of the tube.

[0018] The disadvantage of this device is the discrepancy between the declared property of “non-suction of drainage to tissues” and reality, since the microirrigator does not solve this problem, which leads to a disruption of the drainage function and tissue damage due to suction during active drainage.

[0019] In addition to insufficient reliability and atraumatic™, well-known drainage devices are declared as universal, but in fact this does not correspond to reality, due to the fact that different topics of use have their own characteristics and corresponding requirements.

[0020] The objective of the invention is to create a surgical sanitation catheter that provides the possibility of reliable, full-fledged, long-term, atraumatic active and passive drainage with multiple and constant adapted and adaptable irrigation, easy to use, allowing for its step-by-step removal as it heals and its effective use in closed sanitation in the postoperative period in order to reduce treatment times, save time and personnel effort, and reduce dressing costs. And based on this, to create three versions of specialized designs: for soft tissues and abscesses (drawing 1), for the abdominal cavity (drawing 2), and for the retroperitoneal space (drawing 3), corresponding to the special requirements of different application topics and the method of treatment using these surgical catheters.

[0021] The task is achieved by the fact that on the basis of a three-channel analogue made of medical silicone, having a drainage channel with drainage holes at the working end and two intra-wall channels for irrigation, located on opposite sides, a four-channel catheter is made by dividing the drainage channel with a longitudinal bridge, as a result of which a ventilation channel is added, communicating with the drainage channel at the distal end of a proportionate anastomosis, providing an unimpeded air flow, entraining diluted drained masses that entered the catheter through the side holes in the distal section of the ventilation and drainage channels of the catheter. Irrigation channels are located equidistant from the bridge. The shape of the catheter cross-section, the device of the drainage and irrigation holes are changed.A radiopaque strip is used with a sealed or open distal end of the catheter, or a conical radiopaque plug made of hard apyrogenic plastic with ribbing and fixation of the contact zone with glue.

[0022] For ease of use, the proximal ends of the irrigation channels are equipped with Luer connectors on a leg with a removable plug for connecting the irrigation system, the drainage channel is equipped with a straight or curved rigid adapted connector for connecting the aspiration system with accumulators, and the ventilation channel is equipped with a straight or curved connector for connecting the aseptic filter and flow-through ozonizer using connecting tubes. The connector docking zones are ribbed. The catheter is equipped with a hat-shaped elastic circular cuff for fixing it to the skin or bandage with an adhesive bandage, and the catheter is fixed with a roller adhesive tape to the cuff. This catheter is installed through the counter-aperture with its distal end in a sloping place, placing it so that the ventilation channel is located above the drainage one.

[0023] Based on the listed changes in the design of the surgical catheter analogue, a new basic design of a surgical catheter was created, which was named "Surgical drainage aspiration-washing ventilated four-channel specialized adaptable catheter by I.S. Orekhovsky"

[0024] Taking into account the special requirements of different topics of use, three specialized models of catheters have been created, each with its own additional differences and corresponding names: for soft tissues, including the perirenal and mediastinal space (Figure 1), for the abdominal cavity (Figure 2) and for the retroperitoneal space (Figure 3):

[0025] 1. Ventilated surgical sanitation catheter (VSCSC-M) for soft tissues, including the perirenal space and mediastinum,

[0026] (see drawings sheet 1 / 4 figure 1 View 1: in lateral projection; View 2: cross-section).

[0027] Where 1 is a drainage channel; 2 is a ventilation channel; 3 is a partition separating the drainage and ventilation channels; 4 is the main irrigation channel (from the side of the ventilation channel); 5 is the distal outlet of the main irrigation channel into the drained cavity; 6 is an additional irrigation channel; 7 are drainage holes in the outer wall of the drainage and ventilation channels; 8 is a Luer connector on a leg; 9 is a hat-shaped cuff; 10 is the proximal outlet of the main irrigation channel into the drained cavity; 11 is the outlet of the additional irrigation channel into the drained cavity; 12 is a cone-shaped plug.

[0028] The purpose of this model is active ventilated drainage with full irrigation of the drained cavity, drainage holes and outflow paths in order to prevent the possibility of reducing their clearance due to deposits.

[0029] The solution to the problem is achieved by the fact that this catheter is distinguished by the fact that it is of oval cross-section (type 2), the distal end of the catheter is plugged with a cone-shaped radiopaque plug (12) made of hard plastic with a ribbed docking zone and fixation with glue, or sealed or open with or without a longitudinal radiopaque strip, drainage holes (7) are made in the distal section of the ventilating and drainage channels in four lateral planes of the catheter not opposite each other. The irrigation channel, located on the side of the ventilating channel, which is taken as the main one (4), opens into the drained cavity above the drainage holes (10) and in the distal end (5), and the additional channel (6), located on the side of the drainage channel, is open into the drained cavity in the distal end of the catheter (11), irrigation adaptation is performed intraoperatively by creating additional holes in the additional channel.

[0030] 2. Surgical ventilated peritoneal sanation catheter (SVC-P)

[0031] (see drawings sheet 2 / 4 figure 1 View 1: in lateral projection; View 2: cross-section) where 1 - drainage channel; 2 - ventilation channel; 3 - partition separating the drainage and ventilation channels; 4 - main irrigation channel; 5 - outlet opening in the additional irrigation channel; 6 - additional irrigation channel; 7 - drainage openings in the outer wall of the distal section of the drainage and ventilation channels; 8 - Luer connector on a leg; 9 - hat-shaped cuff; 10 - through opening through the main irrigation channel into the cavity of the ventilation channel.

[0032] The purpose of this model is to enable complete drainage of the drained abdominal cavity without irrigating fluid entering it, as well as to ensure the possibility of turning on irrigation of the abdominal cavity in case of local complications of the postoperative period with their conservative management, during the sanitation of intra-abdominal abscesses and peritonitis.

[0033] The solution to the problem is achieved in that the catheter is of oval cross-section (View 2), the distal end of the catheter is sealed or plugged with a cone-shaped plug (11) made of hard radiopaque plastic with a ribbed docking zone and fixation with glue, the drainage holes (7) are made in the distal section of the ventilating (2) and drainage (1) channels in four lateral planes not opposite each other, the irrigation channel (4), located on the side of the ventilating channel (2), which is taken as the main one, has a through hole above the drainage holes (10), which leads to the suction of the irrigation fluid into the ventilating channel above the drainage holes, and the additional irrigation channel (6), located on the side of the drainage channel (1), is open into the drained cavity in the distal end of the catheter (5), the adaptation of irrigation is performed intraoperatively by creating additional holes in the additional channel;

[0034] 3. Surgical ventilated retroperitoneal sanation catheter (SVC-R) (see drawings sheet 3 / 4 figure 1 View 1: in the lower-lateral projection; View 2: cross-section intersecting the drainage holes in the side walls)

[0035] Where: 1 - drainage channel; 2 - ventilation channel; 3 - partition separating the ventilation and drainage channels; 4 - irrigation channels; 5 - openings in the irrigation channels opening into the drained cavity; 6 - drainage openings in the side walls of the drainage channel; 7 - hat-shaped cuff; 8 - Luer connector on a leg; 9 - cone-shaped plug; 10 - catheter dome.

[0036] The purpose of this model is uniform dilution and more complete atraumatic evacuation of the aggressive contents of the retroperitoneal space formed as a result of inflammatory and destructive processes in the pancreas during pancreatic necrosis, as well as prevention of the formation of bedsores and trauma to the pancreas, often caused by a drainage catheter.

[0037] The solution to the set problem is achieved by creating a catheter, characterized in that the catheter is made of a rectangular-dome-shaped cross-section (View 2), where the longitudinal bridge (3) is arched with ends fastened to the inner surface of the dome (10), and the irrigation channels (4) are located at the lower corners, open at the distal end into the drained cavity, and the drainage holes (6) are made in two lateral planes, shifted toward the upper edge, and are larger in size, ), the distal end of the catheter is plugged with a cone-shaped radiopaque plug (9) made of hard plastic with a ribbed docking zone and fixation with glue, the outer end of the drainage channel is equipped with a transitional adapted connector made of hard plastic with a ribbed contact zone with fixation with glue and a ribbed docking zone with the tube of the aspiration line.

[0038] This model enables improvement of evacuation of various fractions of rejected necrotic tissues by means of constructive possibility of increasing the size of drainage holes at their specified location, significantly reducing the risk of their closure by adjacent tissues, and also, in combination with the distal end plugged with a rigid cone-shaped plug, create a "floating effect" in the claimed catheter, facilitating uniform dilution and removal of drained masses, preventing local enzymatic and toxic aggression, tissue trauma and formation of bedsores, which significantly reduces the risk of complications, mortality and treatment time. In addition, this catheter is brought out through the left lumbar region, without requiring removal of the 11th rib, as was required previously. It also enables intraoperative adaptation of irrigation, by creating additional holes in the outer wall of both irrigation channels, and allows for step-by-step removal of the catheter.

[0039] The surgical drainage aspiration-washing ventilated four-channel specialized adaptable catheter by I. S. Orekhovsky operates as follows: when inserted through a counter-aperture with the distal end in a sloping place with the ventilation channel located on top, the process of evacuation of the contents of the drained cavity is carried out from the bottom through the drainage holes in the distal section due to its involvement in the movement of the air flow circulating from the external environment through the ventilation, and then, through the drainage channel to the system of the aspiration-storage line with a slight vacuum without suction to the surrounding tissues. At the same time, the irrigation system dilutes the contents of the drained cavity, washing it out, and also irrigates the outflow tract, preventing the possibility of narrowing their lumen due to the adhesion of drying deposits, preventing disruption of the drainage process.The design and operating principle of this catheter not only ventilates the catheter, but also ventilates the cavity being drained, using air that has undergone not only aseptic cleaning, but also ozonized when the ventilation channel is connected to an aseptic filter (35) and a flow-through ozonizer (Зб) (see drawing sheet 4 / 4 figure 5), which protects against secondary infection during ventilated drainage and creates additional conditions for significantly accelerating recovery.

[0040] 2, Drainage and storage line with an aspirator.

[0041] The drainage aspirator OP-2 of NPP VNIIEM (RU 24635 U1 from 2002.08.20) is known, containing a membrane-type vacuum pump with a shut-off valve, a power supply circuit and a switch, a receiving tank and an automatic vacuum regulator by switching off the engine when the set vacuum in the air sensor of the drainage liquid collection system is reached, based on a modification of the popular aspirator OP-1, having changed the design of the automatic vacuum regulator. In the mentioned OP-1, as well as OP-2, in order to reduce noise and vibration, the engine is enclosed in a massive box equipped with springs. ",

[0042] Also known:

[0043] EOSH-01 "TRIUMPH" universal, weighing 5 kg, dimensions 350x300x200 mm, vacuum 0-0.9 kgf / cm2 (up to 9 meters of water column), power 30 / 40 VA;

[0044] "Elema-N PRO1" postoperative wearable

[0045] The vacuum setting range is 0-29.4 kPa (0-300 mm H2O). The vacuum values ​​and current information are displayed using the LCD display. The built-in membrane-type vacuum pump creates a vacuum to a specified value, after which the vacuum pump is switched off.

[0046] Automatic round-the-clock operation for up to 30 days when operating from an AC network while maintaining the set vacuum value in a stationary position. In a portable position, continuous operation for 12 hours with subsequent recharging of the built-in batteries without stopping the aspiration process. Free air flow is 2 l / min. Sound pressure level is 40 dB. Power supply built-in AA batteries (4 pcs.); power supply from an AC network 220 V, 50 Hz. Power consumption 2 VA. Overall dimensions are 260x150x260 mm Weight 2 kg;

[0047] NP OOO "VISMA-PLANAR" B-40A (Drainage) 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20 kPa; Water capacity 2 l / min; Air capacity 3 l / min; Power supply - 230 V, 50 Hz; Power consumption - 15 W; Overall dimensions - 255x230x270 mm; Weight 3.8 kg.

[0048] The common disadvantages of the listed models are that:

[0049] 1. When the electric motor is switched off, the current circuit containing the electric motor inductance is broken, which leads to the burning of the switch contacts and, ultimately, to a reduction in service life.

[0050] 2. Quite noticeable noise load and energy consumption at low vacuum values, since the speed of the electric motor driving the pump remains constant and has a maximum value, and a weak vacuum is maintained by manually regulating the suction of atmospheric air and stopping the engine.

[0051] 3. Most of them have significant dimensions, weight and extra power reserve.

[0052] As a prototype free from these shortcomings, we can consider the Aspirator APD-200-03 MT (patent RU 12973 from 2000.03.20), powered both from the AC network in stationary conditions and from direct current, for example, from a battery, containing three levels of protection from induction current, an electronic control device that supplies a small average voltage to the winding of the 12 V electric motor, determined by a signal from the vacuum setter with a drain set of small vacuums from 0 to 10 kPa, as a result of which the membrane vacuum pump operates at a low rotation speed of the electric motor. The filling sensor causes the engine to stop.

[0053] The disadvantage of this model is:

[0054] 1. use of a membrane pump, which, when the speed is reduced, reduces, but does not eliminate, the noise load, and when using a ventilated drainage catheter, the positive anti-noise effect is reduced to a minimum;

[0055] 2. The model does not create a sound signal when filling the second collection can;

[0056] 3. Emergency shutdown of the engine when filling the second collection jar stops the process of active drainage during ongoing irrigation, which can lead to undesirable consequences;

[0057] 4. A complex electronic system increases the risk of breakdown;

[0058] 5. There is no protection of the electronics from condensate formed due to increased evaporation under vacuum conditions and its entry into the cavity of the aspirator;

[0059] 6. The sequential connection of the collection jars of the drainage and storage line, used in all known models, leads to the need to stop the operation of the complex for a significant period of time when filling and replacing with processing overflowing collection jars, and also contributes to an increase in the resistance of the flask and increases the risk of clogging of the tubes with floating clots;

[0060] 7. There is no protection against electronic overheating.

[0061] The objective of the invention is to create a portable medical drainage ward aspirator with minimal dimensions and weight, noiselessness, and, in combination with a drainage and storage line, to ensure reliable, full-fledged, atraumatic, long-term, continuous evacuation of media and washing fluid from a drainage catheter, adapted to the possibility of using a drainage catheter with constant irrigation and ventilation, easy to operate, allowing to reduce costs, time and personnel effort, and create more comfortable conditions.

[0062] The task is achieved by the fact that the invention differs from the prototype, which contains an aspirator with a 12 V adjustable electric motor and a drainage and storage line, where there is an additional can with a duplicate liquid ingress sensor, an antibacterial filter, in that a new design is declared, which has significant differences:

[0063] 1. Portable medical drainage aspirator for ward use by I. S. Orekhovsky, designed to create a vacuum in the active evacuation of drained masses from a drainage catheter in the postoperative period, in order to create a vacuum in the line and forced ventilation of the electronics to protect it from overheating, a flat centrifugal fan with a built-in 12 V and 1 A motor measuring 50x50x15 mm is used, characterized by high traction force and very quiet operation, controlled by a built-in analog PWM speed controller for a 12 V and 3 A motor with an external knob for adjusting the set vacuum, having additional protection against liquid ingress into the electrical network, a battery charge indicator, a switchable sound signaling of filling, a fuse, and an external power supply. See drawings sheet 4 / 4 figure 1: diagram of the aspirator device

[0064] 1 - vacuum compartment; 2 - centrifugal fan; 3 - PWM of the engine speed controller; 4 - signal buzzer; 5 - battery charge indicator; 6 - condensate drain chute with slope and drain hole; 7 - control compartment pocket; 8 - sealed connector for the centrifugal fan power cable; 9 - connector for the alarm electrical network; 10 - external handle for adjusting the set vacuum; 11 - external power input connector; 12 - vacuum outlet nipple; 13 - ventilation holes; 14 - control compartment.

[0065] The aspirator body measuring 65x100x50 mm is made of durable ABS-750 plastic, divided by an L-shaped partition into a vacuum compartment (1) and a control compartment (14). The source of vacuum is a centrifugal fan (2), characterized by increased traction properties in contrast to blade fans with similar dimensions and parameters. The vacuum intensity is determined by the fan rotation speed (2), which is regulated and set using the external knob for adjusting the set vacuum, controlling (10) the PWM controller (3), which changes the rotation speed without changing the fan power. On the bottom of the body along the rear wall of the body there is an internal protection against possible ingress of condensate and fractions of the drained liquid in the form of a condensate outflow gutter (6) with a slope, a side and a drain hole in a sloping place.The ventilation holes (13) in the far corner of the control compartment bottom provide, together with the fan, full ventilation and cooling of the electrical circuit elements. The fan is located horizontally above the vacuum outlet nipple (12) with the blades facing down to allow liquid to be transferred to the trough without it getting on the fan motor and electrics, which, together with the trough and drain hole, creates additional protection, including from condensation. The sealed connector for the power cable of the centrifugal fan (8) is located above the fan in the partition between the compartments on the control unit side in a safe place, maintaining the vacuum created by the fan. A two-key switch allows for isolated activation of the aspiration and battery charge indicator (5). The fuse has separate access through a window in the housing. The buzzer (4) is activated automatically when the alarm sensor (22) of the second (16) and third (17) collection cans is triggered.An external power source, which is a power supply unit (33) that converts alternating current from the external network into direct current with a voltage of 12 V and a current of 1 A, or a battery (30) with a charger (31), is connected by a cable (34) with an output connector to the external power input connector (11) of the aspirator body, where a 5.5 mm 2.1 mm socket panel connector is used.

[0066] The aspirator uses an external power source, connected via a power supply connector to a power supply unit with an output voltage of 12 V and a current of 1 A, adapted to the existing AC network, or a lithium-ion battery with an output of 12 V and 1 A with the desired capacity, equipped with protection against overcharging, overload and rapid discharge with a resistance of 250 ohms, with a charger connected to it for lithium-ion batteries with an output voltage of 12 V, operating from the existing AC network.

[0067] 2. Drainage and storage main line by I.S. Orekhovsky see drawings sheet 4 / 4 figure 2: aspiration drainage and storage main line

[0068] 15 - first storage jar; 16 - second storage jar; 17 - third storage jar; 18 - aspirator; 19 - outflow tee; 20 - aspiration tee; 21 - float valve; 22 - alarm sensors; 23 - antiseptic; 24 - aseptic hydrophobic filter; 25 - vacuum pressure gauge; 26 - drainage catheter outlet; 27 - detachable air fittings with a tap of the tubes of the first jar; 28 - detachable air fittings with a tap of the tubes of the first jar; 29 - detachable air fitting with a tap on the tube of the outlet nipple of the third collection jar; 30 - lithium-ion battery; 31 - charger for lithium-ion batteries; 32 - hydrophobic antibacterial filter; 33 - power supply; 34 - cable with output connector; 35 - aseptic air filter; 36 - air flow ozonizer; 37 - tube from drainage catheter.consists of a 6 / 10 mm silicone tube, four identically sized collection jars made of polypropylene or another material, such as glass, with a sealed lid, three of which are equipped with inlet and outlet connectors, and one is equipped with a lid without connectors.In this case, a four-can system with a parallel-sequential scheme for linking three collection cans has been invented and applied, providing the ability to first fill the first collection can (15) due to the movement of liquid through the lower sleeve of a vertically located three-way outflow tee (19) connecting the outflow tube from the drainage catheter (37) with the outflow tubes into the first and second collection cans along the path of least resistance, and after it is filled, the float valve (21) shuts off the aspiration from the first collection can and the drained masses are directed through the upper sleeve of the vertically located outflow tee (19) into the second collection can (16), carried away by the vacuum in it, bypassing the filled first collection can along a parallel path. In this case, the aspiration tubes coming from the outlet connectors of the lids of the first and second collection jars are connected by a straight tee to the tube going to the inlet connector of the third collection jar.After filling the second collection jar to the level specified by the length of the alarm sensor (22) of the second collection jar, the alarm sensor of the second collection jar is triggered, turning on the alarm buzzer in the aspirator (4), to which the medical staff responds, promptly taking the required measures. The third collection jar (17) acts as a safety container and the first antibacterial filter due to the addition of an antiseptic solution (24) to it, and it also contains a duplicate alarm sensor (22) in case of failure of a similar sensor of the second jar. The filling sensors of the second and third jars are connected to the electrical alarm circuit in parallel. The electrical alarm circuit is equipped with a switch with an indicator, which is used during maintenance of the main line.Dismountable fittings with a tap (27 and 28) located on the outflow tubes and aspiration tubes above the corresponding nipples of the lids of the first (27) and second (28) collection jars are used to close their channels in the event of filling and for the step-by-step replacement of the filled collection jar with the fourth collection jar while maintaining the continuity of the process of evacuating the contents from the drainage tube (26). The fourth collection jar is equipped with a sealed lid without nipples. A dismountable air fitting with a tap on the outlet nipple tube of the third collection jar (29) is used to adjust the vacuum limit set for the aspirator. A vacuum pressure gauge (25) with a sensitivity in the range of 0-9.8 kPa (from 0 to 100 cm of water column) is used to set the vacuum limit and control the state of the working clearance of the outflow paths and is installed on a three-way tee with a thread on the side sleeve.The hydrophobic antibacterial filter (32) is used to protect the aspirator and the environment from bacteria and moisture. The air flow ozonizer (36) and aseptic air filter (35) are connected sequentially to the ventilation channel of the drainage and sanitation catheter in the desired sequence. Dismountable air fittings are used as tees, nipples and connectors.

[0069] The complex is equipped with a plastic stand for 4 cans with can clamps with a carrying handle and a raised platform for an aspirator and battery, equipped with sides, a dividing partition, ventilation holes and a support leg.

[0070] Example of use.

[0071] 1. Working with external power sources:

[0072] 1.1 When using the aspirator under conditions of stable power supply from the AC network, a power supply unit adapted to the voltage in the AC network with a voltage output of 12 V and a current of 1 A is used, connected to the power input of the aspirator (11), using the left key of the switch to turn on / off the aspiration.

[0073] 1.2. In conditions of unstable power supply in the main network, the previously mentioned 12 V battery is used, which is connected to the switched off aspirator fully charged to the power connector of the aspirator, and the battery itself is connected to the power supply from the network via a second connector through a charger for lithium-ion batteries with a voltage output of 12 V and a current of 1 A.

[0074] It is connected in the following order:

[0075] 1.2.1. When the left and right keys of the aspirator switch are turned off, the battery is connected first.

[0076] 1.2.2. Then the right switch button turns on the charging indicator (5). After making sure that the battery is fully charged, the charging indicator turns off with the right switch button and you can turn on the aspirator with the left switch button, after which you need to connect the battery charger to recharge from the network.

[0077] 1.3. In order to control the battery charge level in the absence of power in the network, without turning off the aspirator, the battery charge indicator is turned on by the right key of the switch. After the battery is discharged to one cube of the indicator in the absence of power in the main network, the battery must be replaced with a charged one with the same characteristics of the output current.

[0078] 2. Setting the vacuum range and its operation: after switching on the aspirator by pressing the left key of the switch and closing the valve of the detachable air fitting (29) on the outlet tube of the third can, the upper limit of the set vacuum is set based on the readings of the vacuum manometer in decimeters of water column (kPa) by rotating the external knob for adjusting the set vacuum (10), based on the difference in heights from the distal end of the drainage catheter to its exit to the surface. Then the valve is opened. After 10 minutes of operation, the readings of the vacuum manometer are taken. An increase in vacuum during operation indicates the appearance of an obstruction in the outflow tract and requires flushing the drainage catheter and the system. An increase in vacuum is a mechanism for self-cleaning the system from clots and cannot rise above the initially set vacuum level, which also serves as protection against suction trauma.

[0079] 2. Maintenance of the drainage and accumulation main:

[0080] By means of the switch of the electric circuit of the alarm (9), located on the external section of the wire or on the body of the aspirator, the buzzer (4) is switched off. After closing the taps of the tubes of the first collection jar (27), the first collection jar (15) is replaced with the fourth collection jar with rinsing of the float valve in a 3% solution of hydrogen peroxide, after which the taps are opened and filling of the first jar is resumed. After that, the disconnected jar is closed with the released lid from the fourth collection jar and taken away for emptying and processing in a specialized room. Then, in the same sequence of manipulations with the taps of the tubes of the second collection jar (28), it is replaced, after processing which the released clean jar is covered with its lid and placed on the common stand as the fourth. After that, the power supply of the alarm sensors is turned on.

[0081] The listed manipulations are performed without stopping aspiration during emptying of the accumulation system, which ensures the continuity of the irrigation and drainage process.

[0082] The positive result is as follows:

[0083] 1. The aspirator is reduced in size, lightweight, simplified, noise-free, reliable, economical and easy to maintain.

[0084] 2. The aspirator has multi-level protection against liquid ingress onto the electrical circuit, including an internal drainage system, as well as internal forced flow ventilation, protecting against overheating.

[0085] 3. The aspirator provides dynamic protection against clogging by clots, increasing the vacuum to a specified limit, which protects the tissues adjacent to the drainage catheter from trauma.

[0086] 4. The aspirator informs by increasing the vacuum, determined by the vacuum manometer, about the narrowing of the outflow path due to overlaps.

[0087] 5. The four-can assembly of the drainage and storage main, equipped with a parallel-series scheme of the device of connections of tubes, fittings, tees and taps allows the main to spontaneously redirect the evacuation paths of the drained liquid to the second collection can, bypassing the filled first collection can, and also signals with a sound signal about the filling of the second collection can, but at the same time, there is a third collection can, performing the function of the first stage of the antibacterial filter and a safety function. The fourth collection can serves for quick replacement of the filled collection can without stopping active drainage.

[0088] 6. Using an external battery allows you to use it when necessary. If the battery fails or is discharged, you can replace it without any difficulties. You can also replace a damaged power supply.

[0089] 7. The combination of the declared ventilated specialized surgical sanitation catheters using purified and ozonized air, in combination with the declared drainage and storage line with an aspirator, used in this complex, creates conditions for ease of use, helps optimize the treatment process, which reduces the risk of complications and treatment times, and increases the chances of recovery.

[0090] 8. The invention is applicable in production.

[0091] A method of surgical prevention and treatment of inflammatory and destructive processes.

[0092] It differs from known methods using various designs of drainage catheters, sequentially connected collection jars of the drainage-storage line and an aspirator equipped with a membrane pump, including prototypes, by the use of the declared Surgical ventilated ozonizing drainage-sanitary complex of I.S. Orekhovsky, the use of which creates not only convenience in work, but also reliably provides a full range of active atraumatic sanitation measures in cavities of various topics for the prevention and treatment of inflammatory-destructive processes in the postoperative period in a closed manner with the possibility of step-by-step removal of the catheter, which together provides conditions for optimizing the treatment process, significantly reducing the risks of complications, mortality, costs and treatment times, which contributes to a significant improvement in the prognosis and effectiveness of the treatment process.

[0093] Similar patents:

[0094] Bibliography:

[0095] 1. GAGUSHIN VA et al. Extraperitoneal approaches to the pancreas in acute pancreatitis. / Surgery, 1985, No. 8, pp. 12-13.

[0096] 2. Gulman M.I., Vinnik Yu.S., Miller S.V. - Atlas of drainage in surgery

[0097] 3. Chaffin RC Surgical Drainage. Amer. J. Suig., 1934, v.24, p.100-104.

[0098] 4. Chaffin RC Surgical suction drainage and crigation tube. Patent June 16, 1942, No. 2, p.286, 462.

[0099] 5. Kanshin N.N. Closed aspiration-washing treatment of suppurative processes. Moscow, 1993.

Claims

The AMENDED CLAUSE OF THE INVENTION was received by the International Bureau on March 20, 2025 (03 / 20 / 2025) Formula 1. Surgical ventilated ozonizing drainage and sanitation complex by I. S. Orekhovsky, characterized in that it uses: a surgical drainage catheter, aspiration and rinsing, ventilated, four-channel, adaptable by I. S. Orekhovsky, presented in three design versions, allowing the use of purified and ozonized air for ventilation, a portable ward medical drainage aspirator by I. S. Orekhovsky with a drainage and storage line by I. S. Orekhovsky, a closed flow-through air ozonizer by I. S. Orekhovsky and an aseptic air filter, connected to each other into a single whole, fulfilling a single concept, and a method based on its use for surgical prevention and treatment of inflammatory and destructive processes in the postoperative period.

2. The surgical drainage catheter, aspiration and irrigation, ventilated, four-channel, specialized, adaptable, by I.S. Orekhovsky according to paragraph 1 is intended for sanitizing a drained cavity, from the prototype which is a three-lumen tube made of medical silicone containing a drainage channel having lateral openings at the blind-ending working end and two oppositely located intramural channels in the wall of the tube along the entire length, differs in that the drainage channel is divided by a longitudinal partition into ventilation and drainage channels communicating with each other in the distal section through a proportionate anastomosis, and the intramural channels are located equidistant from the partition, the arrangement of the openings of the irrigation channels is changed, the cross-sectional shape of the catheter is changed to oval or rectangular-dome-shaped, an X-ray contrast strip is used with a sealed or open distal end of the catheter,or a conical radiopaque transition end plug made of allyrogenic plastic or the most elastic silicone (M 70), equipped with two pins in the proximal direction of 10 mm for additional fastening of the plug inside the irrigation channels of the catheter, with fixation of the contact zone with glue; the proximal section of the catheter is equipped with an elastic movable angular circular cuff; the outer end of the ventilation duct is equipped with a rigid ribbed transition connector for connection to a closed flow-through air ozonizer, the outer end of the drainage duct is equipped with a rigid transition connector with a ribbed contact zone for connection to the drainage and storage line, and the irrigation channels in the outer part are connected by soldering with a Luer connector on the leg, which, in combination, can be combined into a transition four-channel coupling made of plastic or silicone, where the connecting part of the outlet of the drainage duct is bent downwards at an angle of 45 degrees,and the Luer connectors are fixed in the irrigation channels of the coupling.

3. The surgical ventilated sanation catheter (KSVSVO-M) according to paragraph 2 for use in soft tissues, including the perirenal space and mediastinum, is characterized in that the catheter is of oval cross-section, the distal end of the catheter is capped with a conical shape: A radiopaque end adapter with adhesive fixation, sealed or open with or without a longitudinal radiopaque strip, drainage holes are made in the distal section of the ventilation and drainage channels in four lateral planes of the catheter not opposite each other, the main irrigation channel, located on the side of the ventilation channel, opens into the drainage cavity above the drainage holes, and an additional irrigation channel, located on the side of the drainage channel, opens into the drainage cavity at the distal end of the catheter, adaptation of irrigation to local conditions is performed intraoperatively by the operating surgeon by creating with scissors, or in factory conditions, additional slit-shaped, upwardly beveled transverse holes in the irrigation channels closer to the dome of the drainage cavity, used for multiple irrigation.

4. The surgical ventilated sanation catheter (SSCVC-B), according to paragraph 2 for use in the abdominal cavity, is characterized in that the catheter is of oval cross-section, the distal end of the catheter is plugged with a cone-shaped radiopaque end transition plug with fixation with glue, or sealed with a longitudinal radiopaque strip, drainage holes are made in the distal section of the ventilation and drainage channels in four lateral planes of the catheter not opposite each other, the irrigation channel located on the side of the ventilation channel, which is taken as the main one, has a through hole above the drainage holes, and the irrigation channel located on the side of the drainage channel, which is taken as an additional one, is open into the drained cavity in the distal end of the catheter, adaptation of irrigation to local conditions is performed in the postoperative period by involving an additional irrigation channel in irrigation, and also,In case of diffuse peritonitis, the operating surgeon makes additional slit-shaped, upward-slanted transverse openings in the irrigation channels closer to the exit of the catheter from the abdominal cavity, which are used for multiple irrigation, using scissors.

5. The retroperitoneal ventilated surgical catheter (VSC) according to paragraph 2 is distinguished by the fact that the catheter has a rectangular-domed cross-section, where the longitudinal partition is of an arcuate shape with the ends fastened to the inner surface of the dome, the irrigation channels are located at the lower corners of the catheter, open in the distal section and between the drainage holes in the cavity to be drained, and the drainage holes are made in two lateral planes along their upper edge, three on each side at an interval of 5 cm not opposite each other, the distal end of the catheter is necessarily plugged with a cone-shaped radiopaque transitional end plug with fixation with glue, which creates the effect of a "floating catheter".

6. The closed flow-through air ozonizer according to paragraph 1 is distinguished by the fact that a closed housing made of hard opaque plastic ABC 750 or metal is used, equipped with an inlet and outlet fittings located remotely and not opposite each other, where the inlet fitting is connected by a tube to an aseptic air filter; inside the housing there is a mercury quartz lamp with a power of 3 W from a direct current of 12 V with a ballast, a wire with a switch and an external 5.5x2.1 mm output connector for connection to a branch from the wire of the aspirator's power source with an input connector; In this case, the aseptic air filter is connected by a tube to the inlet fitting of the ozonizer.

7. The portable medical drainage aspirator by I.S. Orekhovsky according to paragraph 1, intended to create a vacuum for active evacuation of drained masses from a drainage catheter in the postoperative period, from the prototype containing a 12 V electric motor, a 2 A fuse and a drainage line with protection against overflow and liquid ingress into the aspirator, differs in that the aspirator uses a flat centrifugal fan for 12 V and 1 A, measuring 50x50x15 mm, characterized by high traction force and very quiet operation, controlled from a built-in analog PWM speed controller for a 12 V and 3 A motor with an external knob for adjusting the set vacuum, a high-sensitivity vacuum gauge in the range of no more than 0 - 9.8 kPa (0-100 mBar (cm of water column)), located in a separate housing connected by a lock to the aspirator housing, additional protection against ingress liquids on the electrical network, battery charge indicator, external power supply,adjustable sound and light signaling of filling of collecting jars of the drainage and storage main; wherein the aspirator body measuring 65x100x50 mm is made of durable ABS-750 plastic, divided by an L-shaped partition into a vacuum compartment and a control compartment, where the vacuum compartment is equipped with a vacuum outlet nipple and a centrifugal fan located horizontally above the vacuum outlet nipple, with a sealed air flow outlet into the pocket of the control compartment, a sealed connector for the power cable of the centrifugal fan is installed in the partition above the fan, a condensate drain gutter with a slope, a side and a drain hole is made along the lower surface of the pocket of the control compartment, and the control compartment contains a connector, an external DC power input female panel connector 5.5 X 2.1 mm, an automatic fuse for 2A, a power switch adjustable by a handle on the body of the alarm buzzer,PWM fan motor speed controller; the cover contains an alarm switch, an alarm lamp, an alarm connector, a remote vacuum adjustment knob, a battery charge indicator with an indicator switch button; the lower surface of the aspirator body is equipped with vibration-damping rubber feet, and the control compartment has ventilation holes; an external DC power source is used - a power supply with an output voltage of 12 V and a current of 1 A, adapted to the AC mains voltage, or a battery with or without an appropriate charger; removable vacuum gauge compartment; an engine speed indicator can be added.

8. The drainage and storage main line, according to paragraph 7, differs from the drainage and storage main lines used, consisting of 1-2 collection jars and a smaller control jar with a filling sensor, made of polypropylene or glass, with a sealed lid, connected to each other in series with the help of a connecting tube of the same or different sizes, by the use of four identically sized collection jars, three of which are equipped with inlet and outlet fittings, and the fourth is equipped with a lid without fittings; in this case, a parallel- a sequential circuit for connecting three collection jars, where the outflow tube from the drainage catheter is connected to the outflow tubes into the first and second collection jars by means of a vertically positioned outflow tee, and the flask tube to the second collection jar is connected by the upper sleeve of the tee, while the aspiration tubes running from the outlet fittings of the lids of the first and second collection jars are connected by a straight aspiration tee to a tube running to the inlet fitting of the third collection jar; wherein the aspiration fitting of the lid of the first jar is equipped with a float outlet valve, and the lids of the second and third jars are equipped with a float filling sensor, connected in parallel to the connector of the aspirator signaling circuit, equipped with a switch; wherein ball valves are installed on the tubes suitable for the fittings of the lids of the first and second jars, and also, on the aspiration tube from the third jar, a three-way tee is used for the vacuum gauge;In this case, detachable air fittings are used as tees, cap fittings and the vacuum outlet fitting of the aspirator body, and other connections; the aspiration line is equipped with an aseptic hydrophobic filter, connected by a tube to the tee of the vacuum gauge, connected by an angular fitting to the vacuum outlet fitting of the aspirator body; in this case, the complex is equipped with a translucent container and devices for placing and carrying the listed devices.

9. The method of surgical prevention and treatment of inflammatory and destructive processes by I.S. Orekhovsky, according to paragraph 1, differs from known methods using various designs of drainage catheters, sequentially connected collection jars of the drainage-storage line and various aspirators, including prototypes, in that the Surgical ventilated ozonizing drainage-sanitary complex by I.S. Orekhovsky is used, based on the use of a surgical drainage aspiration-washing ventilated four-channel adaptable catheter by I.S. Orekhovsky., presented in three specialized versions of its implementation, adapted for use in different requirements of different application areas, installed through a counter-aperture with the distal end in a sloping place with the ventilation channel located on top, ensuring evacuation from the bottom of the drained cavity, carried out by the circulation of purified, sterilized and ozonized air with a constantly established minimum sufficient vacuum, provided by a specially developed silent compact aspirator by I. Orekhovsky.With, protecting from the addition of a secondary infection and eliminating the existing one due to the associated ventilation of the drained cavity, protecting against the suction of the catheter to the tissues, accompanied by constant and multiple irrigation of the outflow tract and the walls of the drained cavity, as well as a newly designed, adapted drainage and storage line of increased capacity, which together creates not only ease of use, but also reliably ensures a full range of continuous, long-term active, atraumatic local sanitation measures in open and closed cavities of various topics with the possibility of staged removal of the catheter, creating conditions for accelerated healing, which optimizes the treatment process, significantly reducing labor costs and inconvenience, the risk of complications, mortality, costs and treatment time.

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