RU2720821C1 - System for irrigation and aspiration of ophthalmic apparatus for cataract and vitreal surgery - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Irrigation system is intended for supply of eye solution of irrigation solution from replaceable reservoir and consists of interconnected series of pre-cassette hose, replaceable cassette with channel and distributing rotary valve, post-cassette hose, irrigation channel of cannula or chopper, or surgical instrument. Solution is supplied by three methods to choose from: gravitational - vertical movements of the reservoir by a telescopic tripod; preventive - pump discharge; or gravitational-preventive, which are combined and provided with the cartridge design. System is equipped with irrigation pump with pre-pump and post-pump chambers, which is built-in into cassette. Chambers are connected by channel, which is divided into pre-pump and post-pump sleeves by valve. Valve is made inlet and is equipped with front-end hole communicating on one side with pre-cassette hose, and on the other side changing into transverse distributing branches, which in amount of two to four extend to side surface of valve and diverge so that when valve sleeve turns channel sleeves are shut off and flow is interrupted, or simultaneously or alternately open and solution is supplied either by gravity, bypassing pump, wherein the pressure, flow rate and volume of the flow are set and adjusted by differences in the height of the reservoir and eye, and the value of the opening of the lumen of the post-pump sleeve of the canal. Either solution is pumped by pump, which regulates pressure, flow rate and volume. Either solution is simultaneously fed by gravity and pumped by pump, wherein height of container position is set to basic minimum, and pump maintains optimum pressure level. Aspiration system is intended for pumping by negative pressure of the used solution and internal mediums of the eyeball and consists of interconnected successively the cannula or the movable tip passing into the aspiration tube of the handle, the aspiration hose, replacement of the cassette with the polymeric sack-receiver for remote masses. Cartridge comprises an aspiration pump with pre-pump and post-pump chambers, a channel with an inlet distribution swing valve, which are made similar to a pump, channel and valve irrigation system, wherein the pre-cassette aspirating hose coming from the surgical instrument is connected to the pre-pump chamber by means of a valve and a canal. Irrigation and aspiration systems are additionally connected to each other via irrigation and/or aspiration valves and cassette channels with possibility of quick interaction, wherein the aspiration and irrigation flows are mixed, the pressure in the systems is equalized, the breakthrough of the occlusion is compensated instantly and the intraocular pressure is maintained stably.

EFFECT: using the invention enables higher rate, accuracy, technological and biological safety of intraocular surgical interventions with a reduced risk of complications.

4 cl, 2 dwg

Description

The invention relates to medicine, medical equipment, namely to ophthalmology, section - eye microsurgery and can be used to supply the eyeball inside and remove an irrigation solution from it, aspirate fragments of the lens and / or vitreous body.

In ophthalmology, the largest number of operations is performed on the lens and vitreous body. Why are modern ophthalmic surgical devices phacoemulsifiers and vitreotomes used, including irrigation and aspiration systems (modules) pre-programmed and controlled by a microprocessor unit using a remote foot controller, containing from the end of the eye a container with an irrigation solution for supplying the eyeball inside and a container for disposal from it waste fluid connected by means of a cartridge (cartridge) and hoses with a surgical instrument from the other end, directly penetrating into the eyeball to destroy and remove the lens or vitreous body.

The task of ophthalmic surgical apparatus, in particular during operations on the lens, is to provide the necessary intraocular actions by maintaining the specified values of the irrigation and aspiration rate, reducing pulsation in the aspiration system, stabilizing the work at the necessary levels of intraocular pressure without critical drops to maintain the volume of the anterior chamber of the eye, fast set and maintain a high vacuum for stable fixation of the lens nucleus during crushing, compensation for a sharp drop in intraocular pressure during breakthrough occlusion of the aspiration system to prevent eye injury and postoperative complications.

The solution of problems at the present stage is carried out by improving both the technical elements of irrigation and aspiration systems, as well as the algorithms of their programmatic interaction.

However, existing devices due to technological imperfections are still not without drawbacks, such as:

- the starting shock wave of the irrigation flow, since many systems use pressure valves that abruptly interrupt and resume the flow;

 - constant pulsation of the suction flow, since peristaltic pumps with sharp compressions and expansions of the hose or diaphragm of the cartridge by the rollers of the rotor part of the pump are mainly used due to the coincidence of their radii of curvature;

- the effect of an occlusion breakthrough, since the response of the control unit to the difference in aspiration pressure is slowed down due to a decrease in the sensitivity of the device settings in order to suppress false alarms due to flow pulsations.

The development of modern ophthalmic surgical apparatus is aimed at eliminating the above disadvantages. In different devices, this is carried out in different ways, so the technical solution is known (see patent RU 2434608 C1, A61F9 / 00, F04B43 / 12, A61M1 / 00, published on 11/27/2011, http://www.findpatent.ru/patent / 243 / 2434608.html) aimed at reducing the disadvantages of the aspiration system, where a double-circuit peristaltic pump is used. The invention reduces the traumatic hydrodynamic effect on eye tissue by reducing pulsation and creating a more uniform aspiration flow. However, the authors in positive moments attributed the possibility of re-sterilization and repeated use of the suction hose, which is a disadvantage from the standpoint of ensuring the biological and infectious safety of the system for the patient.

Two technical solutions have been applied to reduce pressure surges in irrigation and aspiration systems: the first is an aspiration system with small diameter tubes (US Patent Application No. 61/423752 Small Bore Aspiration System, 2010, by Gary P. Sorensen and Eric Lee); the second, where selectively movable rotary valves are used for the suction and irrigation channels (see patent RU 2618902, http://www.findpatent.ru/patent/ 261 / 2618902.html ) integrated in the cartridge. The cassette is made in the form of a polymer parallelepiped inside which the irrigation and aspiration systems are topologically combined, is detachably attached to the corresponding socket of the device and contains an elastic-elastic membrane of the peristaltic pump, bypass channels with rotary valves, two metal membranes for laser displacement sensors built into the device by which pressure is measured in systems.

 The advantage of this solution is to increase speed and reduce pressure surges during operations. The disadvantage is the connection of the suction valve to the ventilation line, i.e. air cavity of the cartridge, this can lead to a sharp decrease in pressure in the aspiration system up to atmospheric level, and it takes time to resume the vacuum, which slows down the operation.

 The cassette itself also has a number of drawbacks: it is composed of at least three different polymeric materials, has a complex configuration, which complicates the manufacturing process and therefore has a relatively high cost, in particular in the Russian market, which forces surgeons to use the cartridge more than once to reduce the cost of the operation the patient, as recommended by the manufacturer, for at least three or more, significantly reducing the biological safety of the operation for each subsequent patient; has large dimensions and weight, which makes a negative contribution to environmental pollution during disposal; the irrigation and aspiration systems in the cassette are combined topologically, but not functionally, which reduces the effectiveness of the interaction of the systems.

Technical solutions implemented in Centurion Vision System devices (Alkon, Novartis, USA) (https://www.myalconestore.com/ cataract-surgery / centurion-phacoemulsification system ) and Stellaris Elite Vision Enhancement System (Waush and Lomb, USA) ( https://www.stellariselite.com, https://www.bausch.ru) designed to maintain the necessary tone and replace the removed media of the eyeball by feeding gravitationally and / or preventively under its necessary sterile irrigation balanced solution under the necessary variables or constant pressure , the speed and volume of pre-programmed technical and / or medical personnel servicing in which irrigation systems are improved - liquid active modules where the irrigation flow is supplied by gravity and the active forced method with automatic level control based on the state of pressure in the irrigation and aspiration systems, in the first case preventive fluid injection is carried out I’m pumping air into a container with an irrigation solution, in the second by mechanical compression of a polymer elastic bag with a plate driven by an electric motor of the device. The positive aspect of these inventions is that the system of active supply of irrigation solution from the container inside the eyeball, controlling three parameters - infusion pressure, aspiration level and preset vacuum, reacts to the slightest pressure drops and compensates for them, which stabilizes the anterior chamber of the eye and allows for more safely.

Despite this, the principle of supplying liquid by compression retains such disadvantages as the starting shock wave at the beginning of the flow and its pulsation, the inability to create a reverse (reverse flow) in the irrigation system and there is no direct communication between the systems, as well as incompatibility with containers of another shape and / or material (glass - plastic).

 In fact, the above-described irrigation and aspiration systems (modules) with an active supply of irrigation solution through a cartridge (cartridge) into which pump elements and rotary control valves are integrated are the prototype of the claimed invention, the essence of which is aimed at eliminating the above-mentioned disadvantages.

The technical problem is to increase the speed, accuracy, technological and biological safety of intraocular surgery with a reduced risk of complications in the claimed invention is solved by the fact that:

The essence of the invention lies in the fact that the irrigation and aspiration system of the ophthalmic apparatus for cataract and vitreous surgery, of which the irrigation system consisting of a removable container with a solution, removably attached to the top of a telescopic tripod, which moves vertically, an irrigation pre-cassette hose connected to the container inextricably or detachable by means of a hollow needle, a removable cartridge connected to the hose permanently or detachably by means of a fitting made in the form of a parallelepiped made of solid polymer, comprising a housing with channels and a bypass valve rotating around the longitudinal axis to distribute the solution, a cover with fittings on the front side and fasteners on a back, sealing elastic gasket located between the cover and the body, while the cartridge is installed in the socket of the device body with the detachable adjoining of its moving parts to the rollers of the electric drives, an irrigation post-cassette hose with connected to the cassette inseparably or detachably by means of a fitting, an irrigation channel of a cannula or auxiliary chopper, or the main surgical instrument connected to a hose by means of a fitting, through which a solution is supplied to the anterior and / or posterior and / or vitreous chambers of the eyeball through the appropriate location, size and profile sections of the fibrous membrane, while the irrigation system is made with the possibility of feeding the solution with three options to choose from: gravitational - vertical movements of the tank with a telescopic tripod; preventive - pumping with an irrigation pump; gravitationally-preventive; which are combined and provided by the design of the cassette, for which the system is equipped with an irrigation pump, which is built into the cassette, equipped with a pre-pump and post-pump irrigation chambers, the latter is connected to the irrigation post-cassette hose through the nozzle of the cassette cover, and the cameras are interconnected by an irrigation channel made rectilinearly or curved in an arc and / or angle optimally 90 degrees, the channel is divided into pre-pump and post-pump hoses by an irrigation valve, which is installed optimally at the top of the channel angle and is functionally inlet and rotary-distributive, and cylindrical in shape or t -shaped bicylindrical or conic-cylindrical, preferably its rear conical part is hermetically inserted into the congruent through window of the rear wall of the cassette body and is disconnected from a similar profile by the end of the apparatus drive roller through a groove made on its rear end, and the front cylindrical part l contains on the front end an inlet central longitudinal hole that, on the one hand, communicates via a nozzle of the cassette cover with an irrigation pre-cassette hose, and on the other hand, goes to the lateral surface of the middle of the cylinder through transverse distribution branches, the number and direction of which depends on the shape of the channel - two diverging at an angle of 90 degrees, three diverging perpendicular or equidistant, or four diverging like a bird’s foot so that by turning the irrigation valve the lumens of the sleeves of the irrigation channel either overlap at the same time and the flow is interrupted, or open simultaneously or alternately to the required size and flow is guided in such a way that: by gravity, the solution is supplied only by gravity from the tank moved vertically by a telescopic tripod through the irrigation pre-cassette hose, irrigation valve and post-pump sleeve of the irrigation channel to the irrigation post-pump chamber m Inuya pump, then through the irrigation post-cassette hose, the irrigation channel of the cannula or chopper, or surgical instrument inside the eyeball, while the parameters of the irrigation system - pressure, speed, flow volume are set and regulated by the difference in the heights of the levels of capacity and eyes, and the magnitude of the opening irrigation valve clearance of the post-pumping sleeve of the irrigation channel; preventively, the solution is pumped by the irrigation pump from a fixed container through the irrigation pre-cassette hose, valve and pre-pump sleeve of the irrigation channel into the irrigation pre-pump chamber, pump, post-pump chamber, post-cassette hose, cannula or chopper channel, or surgical instrument inside the eyeball, while the pressure, speed and volume of the flow are set and regulated by the irrigation pump; the gravitationally-preventive solution is supplied by gravity at the same time and is pumped by the irrigation pump from the tank, which is stationary at a given height or dynamically moved by a telescopic tripod, into the irrigation pre-cassette hose, through the valve is simultaneously sent to both arms of the irrigation channel and through the post-pump sleeve immediately into the post-pump chamber, and through the pre-pump sleeve, first into the pre-pump chamber, irrigation pump, into the post-pump chamber and then the total flow through the irrigation post-cassette hose and the cannula or chopper or surgical instrument into the eyeball , in this case, the baseline pressure level is set by the height of the tank position, beyond which the system does not go beyond, and the optimum level is dynamically maintained by the irrigation pump.

The irrigation and aspiration system in this case, the irrigation system contains an irrigation pump, which is made in the options - cam, gear, impeller or peristaltic diaphragm or wound pipe, while: the cam or gear pump contains from two to four rotating mating elements, the height of which is the same and it can be equal to the height of the cylindrical part of the irrigation valve, mounted tightly in congruent recesses of the cassette body, one of which is leading and equipped with a central coaxial star-shaped through or through groove for detachable connection through the window of the back wall of the cassette with the corresponding surface shape by an electric drive roller located in the apparatus body, while in the gear irrigation pump, cylindrical involute spur or helical or chevron gears made of hard or elastic polymers are used; The peristaltic pump is made of two parts - the rotor and the stator, while the rotary pump is either mounted on the electric drive shaft built into the device’s body, or mounted in the cassette’s body and detachably connected to the electric drive shaft, and consists of two parallel disks with equidistant central longitudinal mounted between them axes whose ends are built into rolling bearings mounted in disks with the coincidence of their planes, with the possibility of rotation around the axes by cylindrical or oval rollers or bearings, and the stator is built into the cassette and consists of a pump elastic-elastic pipe located in the cassette plane, communicating with the irrigation end pre-pump and post-pump chambers made in the cartridge case, and above the nozzle in the cover or cartridge case a movable pressure bar is mounted on the side and / or end guides with the ability to move to the nozzle, its surface facing the nozzle is arcuate, while the radius of the arc is chosen greater than the radius of the trajectory of the rollers, and from the side opposite from the nozzle of the cartridge is fixed to the casing or cover of the cartridge by springs that dampen the pulsations during compression and uncleaning of the nozzle by rollers, in an amount of two to five, optimally three, each spring from the end face it is equipped with an adjusting screw to the casing or the cover of the cartridge, the rotation of which sets the compression ratio of the pump nozzle by the rollers, the number of rollers and the radii of curvature of the clamping bar and the trajectory of the rollers are selected so that at least one and periodically two rollers completely cover the nozzle clearance.

An irrigation and aspiration system of which an aspiration system consisting of: an aspiration channel of a cannula or a surgical instrument tip is first a system that is introduced into the corresponding cavity of the eyeball through the appropriate location, profile and size of the fibrous sheath incision, while the tip is movable and is activated by a drive built into the handle and directly affect the lens or vitreous body, the aspiration of the inner tube of the handle connected indivisibly to the cannula or tip, the aspiration pre-cassette hose connected to the handle detachably by means of a nozzle, the change of cassette connected to the aspiration pre-cassette hose indivisibly or detachably by means of the nozzle, , channel, valve and polymer bag-receiver for remote masses at the end of the system, is designed so that the suction pump is integrated into a removable cartridge, made similar to the pump of the irrigation system and is equipped with n aspiration pre-pump and post-pump chambers, while the aspiration pre-cassette hose coming from the suction channel of the handle is connected to the aspiration pre-pump chamber by means of an aspiration valve and a channel, which are similar to the valve and channel of the irrigation system, and the aspiration post-pump the camera is connected to the bag-receiver.

 In this case, the irrigation and aspiration system in this case, in the aspiration system, all the components are made with an increase from the tip of the surgical instrument to the cassette of the cross-sectional areas of the gaps with a growth gradient ranging from 1% to 10% and the resulting increase optimally up to 30%, up to a maximum of 50%, or optimally two, three times maximum, so that the lumen area of the aspiration channel of the tip is greater than the lumen area of its end entrance, the lumen area of the aspiration tube of the handle of the surgical instrument is greater than or equal to the lumen area of the aspiration channel of the tip, the lumen area of the aspiration pre-cassette hose greater than or equal to the lumen area of the suction tube of the handle of the surgical instrument, the lumen area of the nozzle of the cassette cover is greater than or equal to the lumen area of the aspiration pre-cassette hose, the lumen area of the opening of the suction valve is greater than or equal to the lumen area of the nozzle of the cartridge cover; the lumen area of the suction channel is greater than or equal to the lumen area of the opening of the suction valve; b) carries out reflux - the return of the suction stream during occlusion of the aspiration system by two methods that are pre-set by the processor unit of the device: by pressing the corresponding part of the pedal control panel, or by automatically operating the device, while briefly pressing or triggering causes a momentary volumetric, and long-term multiple pulsed or continuous gradual smooth or increasing return flow in the aspiration system, which is available in the following options: until the initial levels of the depth of the anterior chamber of the eye and / or tonus of the eyeball and / or pressure in the irrigation system and / or pressure equalization in the systems are restored.

The irrigation and aspiration system are interconnected by means of irrigation and / or suction valves and channels, which are integrated into a single cartridge, and are made with the possibility of: quick interaction of systems in which the aspiration and irrigation flows are mixed, the pressure in the systems is equalized and breakthrough of occlusion of the aspiration channel is instantly compensated the tip of the surgical instrument, for which the irrigation and suction pumps of the systems are integrated into one cartridge and are functionally combined by communication of the post-pump chamber of the irrigation pump with the pre-pump chamber of the suction pump through the irrigation channel and the valve from which the sleeve leaves to the suction pre-pump chamber and / or through an aspiration channel and a valve, from which the sleeve leaves to the irrigation post-pump chamber, and / or through both valves, a connecting sleeve is made between them, so that by turning the valve the aspiration channel either overlaps and the aspiration flow is abruptly interrupted, or opens and communicates an irrigation post-pump chamber with an aspiration pre-pump chamber and / or an aspiration pre-cassette hose and / or rotations of the irrigation valve, the irrigation pre-cassette hose communicates with the aspiration pre-pump chamber provided that the aspiration channel communicates with the aspiration - a cassette hose, and / or irrigation and aspiration pre-cassette hoses communicate directly with each other through a connecting sleeve; quick compensation for sharp drops in intraocular pressure during breakthroughs of the occlusion of the aspiration system with three interaction options to choose from: the first - with gravitational supply of the solution - a sharp increase in the level of capacity above the level of the eyeball and an increase in the clearance of the irrigation valve of the post-pumping sleeve of the irrigation canal cassette of the irrigation system, and / or reflux - return fluid injection by an aspiration system in the direction of the eye; the second - with preventive - accelerating the operation of the irrigation pump and / or triggering reflux in the aspiration system; or the third - with gravity-preventive - a sharp increase in the position of the tank and increase the clearance of the post-pumping sleeve of the irrigation canal by the irrigation valve, and / or by accelerating the operation of the irrigation pump, and / or by triggering reflux in the aspiration system; a combination of various options of irrigation and aspiration pumps to choose from: peristaltic for the irrigation system and cam or gear for the aspiration system, or vice versa; at the same time, pumps can optionally operate synchronously or asynchronously, the operation of pumps and valves is provided by stepwise reversible electric drives equipped with electronic controllers of direction and speed of rotation, interconnected by the processor unit of the apparatus; double control of pressure in each system, for which the apparatus is equipped with pressure and displacement sensors that detect displacements of membranes hermetically embedded between two elastic gaskets in round through windows of the rear wall of the cassette in communication with the post-pump irrigation and pre-pump aspiration chambers; can work at a choice in the automatic or controlled modes synchronously or asynchronously, in addition: all components of the systems are made of disposable bioinert metals and polymers for the operation of only one patient; system hoses are equipped with the same type of detachable nipple connection with surgical instruments that allow changing instruments without changing the cassette during two operations - cataract and vitreal on one eye; all hoses of the systems are made of the same type with the minimum permissible clearance diameter from 1.0 mm to 2.0 mm, optimal 1.5 mm, wall thickness from 0.5 mm to 1.5 mm, optimally 1.0 mm and flexible resilience material ensuring the resistance of hoses to pressure drops; all channels of the cartridge are made with a choice of the minimum allowable diameter from 1.0 mm to 3.0 mm, optimally 2.0 mm.

The invention is illustrated by drawings, which are depicted in: figure 1 - General diagram, figure 2 - cassette in direct projection.

In the figures, the numbers denote: 1 - the apparatus, 2 - the eyeball, 3 - the foot pedal remote control, 4 - the capacity with the irrigation solution, 5 - the telescopic tripod, 6 - the pre-cassette irrigation hose, 7 - the cassette, 8 - the irrigation channel of the cassette, 9 - cassette irrigation valve, 10 - post-cassette irrigation hose, 11 - surgical instrument, 12 - cassette irrigation pump, 13 - pre-pump chamber of the irrigation pump, 14 - post-pump chamber of the irrigation pump, 15 - pre-pump sleeve of the irrigation channel, 16 - post-pumping sleeve of the irrigation channel, 17 - pump elements (gears in the variant), 18 - suction pump, 19 - tip, 20 - handle, 21 - pre-cassette suction hose, 22 - cartridge suction channel, 23 - cassette suction valve, 24 - cassette receiver bag s, 25 - the pre-pump chamber of the suction pump, 26 - the post-pump chamber of the suction pump, 27 - the connecting sleeve from the irrigation valve, 28 - the connecting sleeve from the suction valve, 29 - the connecting sleeve between the irrigation and suction valves, 30 - the membrane.

In the figures, arrows indicate the directions of flows in the systems.

 The irrigation system of the ophthalmic apparatus (1) for cataract and vitreous surgery is designed to maintain the necessary tone and replace the removed media of the eyeball (2) by feeding inside its sterile irrigation solution in automatic and / or controlled by the surgeon modes under the necessary variables or constant pressure, speed and volume, the parameters of which are pre-set by the processor unit of the apparatus (1), are selected and adjusted during the operation by the pedal remote control (3), consists of: a) a removable tank (4) with a solution, removably attached to the top of the telescopic tripod (5) which moves vertically, b) an irrigation pre-cassette hose (6) connected to the container (4) indivisibly or detachably by means of a hollow needle, c) a removable cassette (7) connected to the pre-cassette hose (6) indivisibly or detachably by means of a nozzle, made in the form of a parallelepiped of solid polymer, contains a sleep housing poured by an irrigation channel (8) with a rotary valve (9) rotating around the longitudinal axis, a cover with fittings on the front side and fasteners on the back, a sealing elastic gasket located between the cover and the body; at the same time, the cartridge (7) is installed in the socket of the apparatus (1) with the detachable adjoining of its moving parts to the rollers of the electric drives, d) the irrigation post-cassette hose (10) connected to the cartridge (7) is indivisible or detachable by means of a nozzle, e) the irrigation channel cannula or auxiliary chopper, or the main surgical instrument (11) connected to the post-cassette hose (10) detachably via a fitting through which the solution is fed into the anterior and / or posterior and / or vitreous chambers of the eyeball (2) through the appropriate location, size and profile sections of the fibrous membrane, made in such a way that the solution is supplied by three methods of choice: a) gravitational - vertical movements of the container (4) with a telescopic tripod (5); b) preventive - forcing the cassette (7) by irrigation pump (12); c) gravitationally-preventive; which are combined and provided by the design of the cartridge (7), for which the system is equipped with an irrigation pump (12), which is located in the cartridge and equipped with irrigation pre-pump (13) and post-pump (14) cameras, the latter through the nozzle of the cartridge cover (7) communicates with the irrigation post-cassette hose (10), and the chambers (13, 14) are interconnected by the irrigation channel (8) made in a straight line or bent along an arc and / or an angle of optimally 90 degrees, and divided into a pre-pump (15) and the post-pumping (16) sleeve with an irrigation valve (9), which is optimally mounted on the apex of the channel angle (8) and is made functionally-inlet rotary-distributive, and in the shape of a t-shaped bicylindrical or conical-cylindrical, its rear, preferably conical part, is hermetically sealed inserted into the congruent through window of the rear wall of the cassette body (7) and through the groove made on its rear end, is disconnectedly connected from the same profile by the end of the electric drive roller The ode of the apparatus (1), the front cylindrical part contains at its front end an inlet central longitudinal hole, which, on the one hand, communicates via the nozzle of the cassette cover (7) with an irrigation pre-cassette hose (6), and, on the other hand, extends to the side surface of the cylinder center through transverse distribution branches, the number and direction of which depends on the shape of the irrigation canal (8) - two diverging at an angle of 90 degrees, three diverging perpendicular or equidistant, or four diverging like a bird’s foot, so that by turning the irrigation valve (9) the gaps of the sleeves (15, 16) of the irrigation canal (8) either overlap at the same time and the flow is interrupted, or open simultaneously or alternately by the desired amount and the flow is directed in such a way that: a) gravity is supplied by gravity only from the tank (4) that is moved vertically by telescopic tripod (5) through irrigation pre-cassette hose (6), class pan (9) and the post-pump sleeve of the irrigation channel (8) into the post-pump chamber (14) bypassing the pump (12), then through the irrigation post-cassette hose (10), the cannula or chopper channel, or surgical instrument (11) inside the eyeball (2), while the operating parameters of the irrigation system - pressure, speed, flow volume are set and regulated by the difference in the heights of the capacities (4) and the eye (2), and the value of the valve (9) opening the lumen of the post-pump sleeve (16) ) irrigation canal (8); b) preventively, the solution is pumped by the irrigation pump (12) from the stationary tank (4) through the irrigation pre-cassette hose (6), valve (9) and the pre-pump sleeve (15) of the irrigation channel (8) into the irrigation pre-pump chamber ( 13), pump (12), post-pump chamber (14), post-cassette hose (10), cannula or chopper channel, or surgical instrument (11) inside the eyeball (2), while the pressure, speed and volume of flow set and regulated by an irrigation pump (12); c) the gravitationally-preventive solution is simultaneously fed by gravity and is pumped by an irrigation pump (12) from a tank (4), which is stationary at a given height or dynamically moved by a telescopic tripod (5), into an irrigation pre-cassette hose (6), a valve (9) and simultaneously sent to both sleeves (15, 16) of the irrigation canal (8) and through the post-pumping sleeve (16) directly to the post-pumping chamber (14), and through the pre-pumping sleeve (15), first to the - a pump chamber (13), an irrigation pump (12), into a post-pump chamber (14) where the flow is connected through an irrigation post-cassette hose (10), a cannula or chopper channel, or a surgical instrument (11) inside the eyeball ( 2), while the baseline minimum pressure level is set by the height of the tank position (4), beyond which the system does not go beyond, and the optimum level is dynamically maintained by the irrigation pump (12).

In addition, the irrigation system contains an irrigation pump (12), which is made in the variants - cam, gear, impeller or peristaltic with a winding pipe, while:

a) the cam or gear pump contains from two to four rotating mating elements (17), the height of which is the same and can equal the height of the cylindrical part of the irrigation valve (9), mounted tightly in congruent recesses of the cassette body (7), one of which is leading and equipped a central coaxial star-shaped through or non-through groove for detachable connection through the window of the rear wall of the cartridge case (7) with the corresponding surface shape by an electric drive roller located in the device case (1), while cylindrical involute spur or helical or chevron gears are used in the gear pump (12) (17) made of rigid or elastic polymers;

b) the peristaltic pump is made of two parts of the rotor and stator, while the rotary pump is either mounted on the electric drive shaft built into the device body (1), or mounted in the cassette body (7) and is detachably connected to the electric drive shaft, and consists of two parallel disks with mounted between them equidistantly on the central longitudinal axes, the ends of which are built into the rolling bearings mounted in disks with the coincidence of their planes, with the possibility of rotation around the axes by cylindrical or oval rollers or bearings, and the stator is built into the cartridge (7) and consists of a pump elastic a nozzle located in the plane of the cartridge (7), communicating with the irrigation pre-pump and post-pump chambers made in the cartridge case (7), and a movable pressure clamp is mounted on the side and / or end guides above the pipe in the cover or cartridge case (7) bar with the ability to move to the nozzle, its surface facing the nozzle on an arcuate one, while the radius of the arc is chosen larger than the radius of the trajectory of the rollers, and from the opposite side from the nozzle side it is fixed to the casing or cover of the cartridge (7) by springs that dampen the pulsations during compression and unloading of the nozzle by rollers, in an amount from two to five, optimally - three, each spring from the end facing the casing or the cover of the cartridge (7) is equipped with an adjusting screw, the rotation of which sets the compression ratio of the pump nozzle by the rollers, the number of rollers and the radii of curvature of the bar and the trajectories of the rollers are selected so that at least one and two rollers are constantly completely blocked the lumen of the pipe.

The aspiration system of the ophthalmic apparatus (1) for cataract and / or vitreous surgery is designed to remove pathologically altered and / or localized internal environments of the eyeball (2) by pumping it with an aspiration pump (18) in automatic and / or controlled by the surgeon under the necessary variables or constant negative pressure, speed and volume of flow, the parameters of which are previously set by the processor unit of the apparatus (1), are selected and adjusted during the operation by the pedal remote control (2), consists of: a) the suction channel of the cannula or tip (19) of the surgical instrument ( 11) at the beginning of the system, which is inserted into the corresponding cavity of the eyeball (2) through the appropriate location, profile and size, the incision of the fibrous membrane, while the tip (19) is movable, activated by a drive built into the handle (20) and directly affects the lens or vitreous, b) aspir of the internal handle tube (20), which is connected indivisibly to the cannula or tip (19), c) of the aspiration pre-cassette hose (21) which is connected detachably by means of a nozzle to the suction tube of the handle (18), d) by changing the cartridge (7) connected to the aspiration pre-cassette hose (21) is indivisible or detachable by means of a fitting equipped with an aspiration pump (18), a channel (22), a valve (23) and a bag-receiver (24) for remote masses at the end of the system where the aspiration pump (18) is made similar to the pump (12) of the irrigation system and is equipped with aspiration pre-pump (25) and post pump (26) chambers, while the aspiration pre-cassette hose (21) coming from the suction tube of the handle (20) is connected to the pre-pump chamber (25) through the suction valve (23) and channel (22), which are made similar to the valve (9) and channel (8) of the irrigation system, and the post-pump chamber (26) is connected to the bag-receiver (24).

In addition, the aspiration system is made:

a) with an increase from the tip (19) of the surgical instrument (11) to the cassette (7) of the cross-sectional areas of the gaps of the components with a growth gradient ranging from 1% to 10% and the resulting increase optimally to 30%, to a maximum of 50%, or optimally two, maximum three times, so that the lumen area of the aspiration channel of the tip (19) is larger than the lumen area of its end entrance; the lumen area of the suction tube of the handle (20) of the surgical instrument (11) is greater than or equal to the lumen area of the aspiration channel of the tip (19); the lumen area of the suction pre-cassette hose (21) is greater than or equal to the lumen area of the suction tube of the handle (20) of the surgical instrument (11), the lumen area of the nozzle of the cassette cover (7) is greater than or equal to the lumen area of the aspiration pre-cassette hose (21), the area the lumen of the hole of the suction valve (23) is greater than or equal to the lumen area of the nozzle of the lid of the cartridge (7); the lumen area of the suction channel (22) is greater than or equal to the lumen area of the opening of the suction valve (23);

b) with the possibility of reflux — returning the suction stream during occlusion of the aspiration system using two methods that are pre-set by the processor unit of the device (1): by pressing the corresponding part of the pedal control panel (2), or by automatically operating the device (1), while short-term pressing or triggering causes simultaneous volumetric flow, and long-term repeated pulsed or continuous gradual smooth or increasing return flow in the aspiration system, which operates in the options of choice: until the initial levels of the anterior chamber depth and / or eyeball tone are restored (2) and / or pressure in the irrigation system and / or pressure equalization in the systems.

 Irrigation and aspiration systems are interconnected by means of irrigation and suction valves (9, 23) and channels (8, 22), which are integrated in a single cartridge (7), made with the possibility of:

a) rapid interaction of systems in which the aspiration and irrigation flows are mixed, the pressure in the systems equalizes, which instantly compensates for the breakthrough of occlusion of the aspiration channel of the tip (19) of the surgical instrument (11) and the intraocular pressure is stably maintained, for which irrigation (12) and aspiration (18) ) the pumps of the systems are integrated into one cartridge (7) and are functionally combined by communication of the post-pump chamber (14) of the irrigation pump (12) with the pre-pump chamber (25) of the suction pump (18) through the irrigation channel (8) and valve (9) from which the sleeve (27) leaves to the suction pre-pump chamber (25) and / or through the suction channel (20) and the valve (21), from which the sleeve (28) leaves to the irrigation post-pump chamber (14), and / or through both valves (9, 23) between which a connecting sleeve (29) is made, so that by turning the suction valve (23) the channel (22) either closes and the suction flow is abruptly interrupted or opens and communicates the irrigation post-pump chamber (14) with the aspiration pre-pump chamber (25) and / or the aspiration pre-cassette hose (21), and / or the rotations of the irrigation valve (9) the irrigation pre-cassette hose (6) communicates with the - the pump suction chamber (25) provided that the suction channel (22) communicates with the suction pre-cassette hose (21), and / or the irrigation (6) and suction (21) pre-cassette hoses communicate with each other through the sleeve (29);

b) quick compensation of sharp drops in intraocular pressure during breakthroughs of occlusion of the aspiration system with three interaction options to choose from: the first - with gravitational supply of the solution - a sharp increase in the level of capacity (4) above the level of the eyeball (2) and an increase in the clearance of the irrigation valve (9) pumping sleeve (16) of the irrigation channel (8), and / or reflux - reverse operation of the aspiration pump (18), which pumps liquid back in the direction of the eye (2); the second - with preventive - accelerating the operation of the irrigation pump (12) and / or triggering reflux in the aspiration system; or the third - with gravity-preventive - a sharp increase in the position of the tank (4) and an increase in the opening of the lumen of the post-pumping sleeve (16) of the irrigation channel (8) with the valve (9), and / or acceleration of the operation of the irrigation pump (12), and / or triggering reflux in the aspiration system;

c) a combination of various options of irrigation (12) and aspiration (18) pumps to choose from: peristaltic for an irrigation system and cam or gear for an aspiration system, or vice versa; the pumps (12, 18) of the systems can operate synchronously or asynchronously, the operation of the pumps (12, 18) and valves (9, 23) of the systems is provided by stepwise reversible electric drives equipped with electronic controllers of direction and speed of rotation, interconnected by the processor unit of the apparatus (1 );

d) double pressure control in each system, for which the apparatus (1) is equipped with pressure and displacement sensors that record the displacements of the membranes (30) hermetically embedded between two elastic gaskets in the round through windows of the rear wall of the cassette (7) communicating with the irrigation post-pump (14) and suction pre-pump (25) chambers;

e) can work at choice in the automatic or controlled modes synchronously or asynchronously.

 In addition, in irrigation and aspiration systems:

a) all components of the systems are made of disposable bioinert metals and polymers for surgery in only one patient;

b) the hoses (10, 21) of the systems are equipped with the same type of detachable nipple connection with the handles (20) of surgical instruments (11), which allows changing instruments (11) without changing the cassette (7) during two operations - cataract and vitreous in one eye;

c) all hoses (6, 10, 21) of the systems are made of the same type with the minimum permissible clearance diameter from 1.0 mm to 2.0 mm, optimal 1.5 mm, wall thickness from 0.5 mm to 1.5 mm , optimally 1.0 mm and flexible with elasticity of the material, ensuring the stability of the hoses to pressure drops;

d) all channels (10, 21) of the cassette systems are made with a choice of the minimum allowable diameter from 1.0 mm to 3.0 mm, optimally 2.0 mm.

The advantages of the claimed invention are the implementation of irrigation and aspiration systems:

a) in the form of a single disposable kit for surgery to only one patient, which ensures complete infectious and biological safety;

b) in three options for supplying irrigation solution, which expands the possibilities of the operation for different clinical conditions of the eyes - hypotension, normotonia or hypertension;

c) with an increase in the gaps of the components of the aspiration system, which prevents or makes rarer obturation and the subsequent effect of an occlusion breakthrough;

d) with emergency connection of systems through their channels and valves, which allows you to instantly compensate for pressure drops in systems during breaks in occlusion and to stably maintain a given level of intraocular pressure;

e) with channels of the cassette case and connecting hoses having the minimum allowable diameters and elasticity, which eliminates the pulsation and accelerates the operation of the systems by reducing the idle period;

f) with double control of the pressure in the pump chambers, which increases the reliability, speed of interaction of the systems in automatic mode and reduces the dependence of the systems on the delayed reactions of the surgeon and prevents iatrogenic complications;

g) with compactness and simplification of the design of the cartridge, which reduces the cost of production and, consequently, the operation, and the load on the environment during production and disposal.

Thus, a combination of positive aspects of the claimed invention achieves a single end result - improving the accuracy, speed and safety of surgical intervention.

Claims (4)

1. Irrigation and aspiration systems of an ophthalmic apparatus for cataract and vitreous surgery, of which an irrigation system consisting of a removable container with a sterile biologically balanced solution, detachably attached to the top of a telescopic tripod, which moves vertically, an irrigation pre-cassette hose connected to the container or detachable by means of a hollow needle, a removable cartridge connected to the hose, one-piece or detachably by means of a fitting made in the form of a parallelepiped made of solid polymer, comprising a housing with channels and a bypass valve that rotates around the longitudinal axis to distribute the solution, a cover with fittings on the front side and fasteners elements on the back, a sealing elastic gasket located between the cover and the body, while the cartridge is installed in the socket of the device body with the detachable adjoining of its moving parts to the rollers of the electric drives, an irrigation post-cassette hose a, connected to the cartridge inseparably or detachably by means of a fitting, an irrigation channel of a cannula or auxiliary chopper, or the main surgical instrument, connected to the hose by means of a nozzle, through which the solution is supplied to the anterior and / or posterior and / or vitreous chambers of the eyeball through a section of the fibrous membrane corresponding to the localization, size and profile, and an aspiration system consisting of an aspiration channel of the cannula or the tip of a surgical instrument, which is inserted into the corresponding cavity of the eyeball through the corresponding location, profile and size of the section of the fibrous membrane, while the tip is movable and is activated by a drive built into the handle, and directly affects the lens or vitreous body, the suction inner tube of the handle connected to the tip, the suction pre-cassette hose connected to the handle detachably by means of a fitting, changing the cassette, with connected to the suction pre-cassette hose inseparably or detachably by means of a fitting equipped with an aspiration pump, channel, valve and a plastic bag-receiver for remote masses at the end of the system, characterized in that the irrigation system is made with the possibility of supplying the solution with three options to choose from: gravity - vertical movements of the tank with a telescopic tripod; preventive - pumping with an irrigation pump; gravitationally-preventive; which are combined and provided by the design of the cassette, for which the system is equipped with an irrigation pump, which is built into the cassette, equipped with a pre-pump and post-pump irrigation chambers, the latter is connected to the irrigation post-cassette hose through the nozzle of the cassette cover, and the cameras are interconnected by an irrigation channel made in a straight line or curved along an arc and / or an optimum angle of 90 degrees, the channel is divided into pre-pump and post-pump sleeves by an irrigation valve, which is installed optimally at the apex of the channel angle and is functionally inlet and rotary-distributive, and cylindrical in shape or t-shaped bicylindrical or conic-cylindrical, preferably its rear conical part is hermetically inserted into the congruent through window of the rear wall of the cassette body and through the groove made on its rear end is detachably communicated with a similar profile by the end of the apparatus drive roller, and the front cylindrical h The part contains at the front end an inlet central longitudinal hole, which, on the one hand, communicates via a nozzle of the cartridge cover with an irrigation pre-cassette hose, and on the other hand, goes to the lateral surface of the middle of the cylinder through transverse distribution branches, the number and direction of which depends on the shape of the channel - two diverging at an angle of 90 degrees, three diverging perpendicular or equidistant, or four diverging like a bird’s foot so that by turning the irrigation valve the lumens of the sleeves of the irrigation channel either overlap at the same time and the flow is interrupted, or open simultaneously or alternately to the required size and flow is guided in such a way that: by gravity, the solution is supplied only by gravity from a container moved vertically by a telescopic tripod through an irrigation pre-cassette hose, an irrigation valve and a post-pump sleeve of the irrigation channel to the irrigation post-pump chamber, bypassing the pump, then through the irrigation post-cassette hose, the irrigation channel of the cannula or chopper, or surgical instrument inside the eyeball, while the parameters of the irrigation system pressure, speed, flow volume are set and regulated by the difference in the heights of the levels of the capacitance and the eye, and the magnitude of the opening of the irrigation valve clearance of the post-pumping sleeve of the irrigation canal; preventively, the solution is pumped by the irrigation pump from a fixed container through the irrigation pre-cassette hose, valve and pre-pump sleeve of the irrigation channel into the irrigation pre-pump chamber, pump, post-pump chamber, post-cassette hose, cannula or chopper channel, or surgical instrument inside the eyeball, while the pressure, speed and volume of the flow are set and regulated by the irrigation pump; the gravitationally-preventive solution is fed simultaneously by gravity and is pumped by the irrigation pump from the tank, which is stationary at a given height or dynamically moved by a telescopic tripod, into the irrigation pre-cassette hose, through the valve is simultaneously directed to both arms of the irrigation channel and through the post-pump sleeve immediately into the post-pump chamber, and through the pre-pump sleeve, first into the pre-pump chamber, irrigation pump, into the post-pump chamber and then the total flow through the irrigation post-cassette hose and the cannula or chopper or surgical instrument into the eyeball , in this case, the baseline pressure level is set by the height of the tank position, beyond which the system does not go beyond, and the optimum level is dynamically maintained by the irrigation pump; and in the aspiration system, the suction pump is integrated into the removable cartridge, is similar to the pump of the irrigation system and is equipped with aspiration pre-pump and post-pump chambers, while the aspiration pre-cassette hose coming from the suction channel of the handle is connected to the aspiration pre-pump chamber an aspiration valve and a channel, which are made similar to the valve and channel of the irrigation system, and the aspiration post-pump chamber is connected to the receiver bag; in general, irrigation and aspiration systems are interconnected by means of irrigation and / or suction valves and channels built into a single cassette. 2. Irrigation and suction systems of claim 1, characterized in that they contain irrigation and suction pumps, which are made in the options - cam, gear, impeller, peristaltic diaphragm or with a winding pipe, while: the cam and gear pump contains from two to four one of the leading elements is provided with a central coaxial star groove for detachable connection through the window of the rear wall of the cassette with an electric drive roller of a suitable shape placed on the back of the casing of the cassette, placed one of them; it can be equal to the height of the cylindrical part of the valves in the casing of the apparatus, while in the gear pump, cylindrical involute spur or helical or chevron gears made of hard or elastic polymers are used; The peristaltic pump is made of two parts - the rotor and the stator, while the rotary pump is either mounted on the shaft of the electric drive built into the casing of the device, or mounted in the cassette and detachably connected to the shaft of the electric drive, and consists of two parallel disks with equidistant centrally mounted between them longitudinal axes, the ends of which are built into the rolling bearings, mounted in disks with the coincidence of their planes, with the possibility of rotation around the axes by cylindrical or oval rollers or bearings, and the stator is built into the cartridge and consists of a pump elastic-elastic pipe located in the plane of the cartridge, the ends communicating with the pre-pump and post-pump chambers made in the cartridge case, and above the nozzle in the cover or cartridge case, a movable clamping bar is mounted on the side and / or end guides with the ability to move to the nozzle, its surface facing the nozzle is arched while the radius of gi is chosen larger than the radius of the trajectory of the rollers, and from the side opposite from the nozzle of the cartridge is fixed to the casing or the cover of the cartridge by springs that dampen the pulsations during compression and unloading of the nozzle by rollers, in an amount of two to five, optimally three, each spring from the end face to the casing or the cover of the cartridge, it is equipped with an adjusting screw, the rotation of which sets the compression ratio of the pump nozzle by the rollers, the number of rollers and the radii of curvature of the clamping plate and the trajectory of the rollers are selected so that at least one and periodically two rollers completely cover the nozzle clearance. 3. Irrigation and aspiration systems according to claim 1, characterized in that in the aspiration system all components are made with an increase from the tip of the surgical instrument to the cassette of the cross-sectional areas of the gaps with a growth gradient ranging from 1% to 10% and the resulting increase optimally to 30%, up to a maximum of 50%, or optimally two, a maximum of three times, so that the lumen area of the aspiration channel of the tip is larger than the lumen area of its end entrance, the lumen area of the suction tube of the handle of the surgical instrument is greater than or equal to the lumen area of the aspiration channel tip, the lumen area of the suction pre-cassette hose is greater than or equal to the lumen area of the suction tube of the handle of the surgical instrument, the lumen area of the nozzle of the cassette lid is greater than or equal to the lumen area of the aspiration pre-cartridge hose, the lumen of the opening of the aspiration valve is greater than or equal to the lumen area of the nozzle of the box lid you, the lumen area of the suction channel of the cartridge is greater than or equal to the lumen area of the opening of the suction valve; b) carries out reflux - the return of the suction stream during occlusion of the suction system using two methods that are pre-set by the processor unit of the device: by pressing the corresponding part of the pedal control panel, or by automatically operating the device, while briefly pressing or triggering causes a momentary volumetric, and long-term multiple pulsed or continuous gradual smooth or increasing return flow in the aspiration system, which is available in the following options: until the initial levels of the depth of the anterior chamber of the eye and / or tonus of the eyeball and / or pressure in the irrigation system and / or pressure equalization in the systems are restored. 4. Irrigation and aspiration systems according to claim 1, characterized in that they are made with the possibility of: quick interaction of the systems in which the suction and irrigation flows are mixed, the pressure in the systems equalizes and the breakthrough of occlusion of the suction channel of the tip of the surgical instrument is instantaneously compensated, for which the irrigation and The system’s aspiration pumps are integrated into one cartridge and are functionally combined by connecting the post-pump chamber of the irrigation pump with the pre-pump chamber of the aspiration pump through the irrigation channel and valve, from which the hose leaves to the aspiration pre-pump chamber and / or through the aspiration channel and valve, which leaves the sleeve to the irrigation post-pump chamber, and / or through both valves, between which the connecting sleeve is made, so that by turning the valve the suction channel either closes and the suction flow is abruptly interrupted, or the irrigation post-pump chamber with the aspiration -pump chamber and / or aspiration pre-cassette hose and / or rotation of the irrigation valve, the irrigation pre-cassette hose communicates with the aspiration pre-pump chamber provided that the aspiration channel communicates with the aspiration pre-cassette hose and / or irrigation and aspiration pre-cassette hoses communicate directly with each other through a connecting sleeve; quick compensation of sharp drops in intraocular pressure during breakthroughs of the occlusion of the aspiration system with three interaction options to choose from: the first - with gravitational supply of the solution - a sharp increase in the level of capacity above the level of the eyeball and an increase in the clearance of the irrigation valve of the post-pumping sleeve of the irrigation canal of the cassette of the irrigation system, and / or reflux - return fluid injection by an aspiration system in the direction of the eye; the second - with preventive - acceleration of the irrigation pump and / or reflux in the aspiration system; or the third - with gravity-preventive - a sharp increase in the position of the tank and increase the irrigation valve clearance of the post-pump sleeve of the irrigation channel, and / or accelerate the operation of the irrigation pump, and / or triggering reflux in the aspiration system; a combination of various options of irrigation and aspiration pumps to choose from: peristaltic for the irrigation system and cam or gear for the aspiration system, or vice versa; at the same time, pumps can optionally operate synchronously or asynchronously, the operation of pumps and valves is provided by stepwise reversible electric drives equipped with electronic controllers of direction and speed of rotation, interconnected by the processor unit of the apparatus; double control of pressure in each system, for which the apparatus is equipped with pressure and displacement sensors that detect displacements of membranes hermetically embedded between two elastic gaskets in round through windows of the rear wall of the cassette in communication with the post-pump irrigation and pre-pump aspiration chambers; can work at a choice in the automatic or controlled modes synchronously or asynchronously, in addition: all components of the systems are made of disposable bioinert metals and polymers for the operation of only one patient; system hoses are equipped with the same type of detachable fitting with surgical instruments that allow changing instruments without changing the cassette during two cataract and vitreous operations on one eye; all hoses of the systems are made of the same type with the minimum permissible clearance diameter from 1.0 to 2.0 mm, optimally 1.5 mm, wall thickness from 0.5 to 1.5 mm, optimally 1.0 mm and flexible with elasticity of the material , ensuring the stability of the hoses to pressure drops; all channels of the cartridge are made with a choice of the minimum allowable diameter from 1.0 to 3.0 mm, optimally 2.0 mm.

Images