Dialysate preparation and supply device for dialysate systemTechnical Field
The invention belongs to the technical field of medical instrument manufacturing, and particularly relates to a dialysate preparation and supply device for a dialysate system.
Background
Hemodialysis is mainly used for treating diseases such as chronic renal failure, acute renal failure, drug poisoning and the like, and is widely applied clinically. Hemodialysis utilizes the principle of a semipermeable membrane to introduce blood and dialysate of a patient into a hemodialyzer at the same time, flows in opposite directions on two sides of the dialysis membrane, and depends on the solubility gradient, the osmotic gradient and the water pressure gradient on two sides of the semipermeable membrane. Removing toxins by dispersion, convection and adsorption; removing excessive water in vivo by ultrafiltration and osmosis; meanwhile, the required substances are supplemented, and electrolyte and acid-base balance disorder is corrected.
In the hemodialysis process, the dialysis machine has the functions of preparing dialysate, pumping blood and dialysate to the dialyzer, providing accurate ultrafiltration control, controlling the blood, dialysate flow and transmembrane pressure in the hemodialysis process, controlling the treatment parameters of patient diafiltration in the treatment process, and finishing dialysis treatment.
The dialysate used for hemodialysis mainly contains sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium bicarbonate, citric acid or acetic acid.
The existing dialysate supply mode is that a dialysate manufacturer uses the raw materials to mix the raw materials into dry powder or saturated solution to supply the dry powder or the saturated solution to a dialysis center in consideration of transportation and storage cost, and sodium bicarbonate and other components react and crystallize. The sodium bicarbonate solution may grow bacteria, the liquid supply mode at present is a mode of separating the sodium bicarbonate from other components into A, B components, and A, B is provided with solution and dry powder, hospitals need to configure the dry powder into concentrated solution, then supply the A/B concentrated solution to a dialysis machine for use, and the dialysis machine dilutes and mixes the A/B components on line according to the proportion provided by the concentrate to the solution which permeates blood and the like, and then supplies the solution to patients for use.
The liquid supply mode undoubtedly increases the design and development difficulty of the dialysis machine, the dialysate is diluted on line, the internal large space of the dialysis machine needs to be occupied, the whole dilution process must be accurately regulated and controlled, and excessive fluctuation cannot occur in the dialysis process. The dialysis machine is also provided with a blood pumping device, a dialysate pumping device, an ultrafiltration control device, a matched heating and heat-preserving device, a sterilizing device and the like, the electromagnetic environment inside the whole dialysis machine is complex, the monitoring and regulation devices are more, and the dialysis machine is not beneficial to design, development and maintenance.
The existing liquid supply mode not only increases the development difficulty of the dialysis machine, but also has the following defects: first, dialysis concentrate formulators, who purchase raw materials for processing, inevitably introduce new contamination, which, although mitigated by production in clean rooms and various means of purification and filtration, is an objective. Secondly, a part of the used raw materials is hydrate, and the proportioning accuracy is influenced by the increase and decrease of the water content in the storage and configuration processes. The prepared product needs to be transported to a treatment center, the unit mass is large, and the storage and transportation cost is high. In the dialysis center, medical care is needed to prepare the concentrated powder into concentrated solution again, and then the concentrated solution is prepared into diluent by a dialysis machine for use by a patient.
Disclosure of Invention
In order to solve the technical problems in the prior art, the invention provides an improved dialysate distribution and supply device for a dialysate system.
In order to solve the technical problems, the invention adopts the following technical scheme:
the utility model provides a dislysate solution preparation confession liquid device for dislysate system, the device be used for with the dialysis machine passes through the pipeline and links to each other, the device includes batching mechanism, batching mechanism is used for right a plurality of or all raw and other materials components in the raw and other materials that the dislysate used are independent respectively and water mixes the saturated solution who prepares into corresponding raw and other materials components, batching mechanism is including parallelly connected a plurality of being used for respectively preparing correspond the material unit of the saturated solution of raw and other materials components and respectively with each the infusion pipeline that the material unit links to each other sets up the flowmeter respectively in the infusion pipeline with each the transfer line that the material unit links to each other, the device still include respectively with the control unit that the flowmeter electricity is connected.
According to some embodiments of the present invention, the raw material components to be prepared into the saturated solution are fed in the form of powder of each raw material component, the apparatus further includes a water conveying pipeline connected to each of the preparation units, and electromagnetic valves are respectively disposed on water pipes connected to the preparation units in the water conveying pipeline, and each electromagnetic valve is electrically connected to the control unit.
Furthermore, each of the batching units respectively includes a bucket for storing each of the raw material components, a chamber for installing each of the buckets, and a first heating unit for heating the chamber to keep the material in the bucket at a certain temperature, the water conveying pipeline and the liquid conveying pipeline are respectively connected with each of the buckets, and water is introduced into each of the buckets through the water conveying pipeline to dissolve the corresponding powder in the bucket to prepare a saturated solution of the corresponding raw material component.
According to some embodiments of the invention, the plurality of chambers are provided, one charging barrel is correspondingly arranged in each chamber, and the heating unit is respectively arranged in each chamber, so as to ensure that the temperature of the charging barrel material is kept between 36 ℃ and 38 ℃, preferably around 37.5 ℃, and is closer to the temperature of blood in a human body.
Furthermore, the infusion pipeline is respectively connected with the bottoms of the charging barrels, the bottoms of the charging barrels are respectively provided with a filter screen, and the feed liquid in the charging barrels enters the infusion pipeline after being filtered by the filter screens.
According to some embodiments of the invention, the filter screen divides the barrel into a raw material storage area and a saturated solution area; the raw material storage area of the charging bucket is provided with a stirring structure.
According to some embodiments of the invention, the apparatus further comprises a fluid concentration sensor for detecting the concentration of fluid in the fluid line connected to each of the dosing units;
or each batching unit comprises a charging basket for storing each raw material component, each liquid conveying pipeline is connected with the bottom of each charging basket, a filter screen is arranged at the bottom of each charging basket, and the liquid in each charging basket enters the liquid conveying pipeline after being filtered by the filter screen; the filter screen divides the charging basket into a raw material storage area and a saturated solution area; the apparatus also includes a liquid concentration sensor to monitor a liquid concentration of a saturated solution region of the barrel.
Further, the device further comprises an alarm device; when the liquid concentration monitored by any one of the liquid concentration sensors is less than a preset value, the alarm device can be triggered.
According to some implementation aspects of the present invention, the batching mechanism is provided with 2 groups, each group of batching mechanism comprises the batching units for preparing the saturated solution of the corresponding raw material component, the water conveying pipeline and the liquid conveying pipeline are respectively connected with all the batching units, and the batching units for preparing the same solution in the 2 groups of batching mechanisms are used alternately.
According to some embodiments of the invention, the device further comprises a disinfection mechanism connected to the water conduit by a conduit. Preferably, the disinfection mechanism is a thermal disinfection mechanism and/or a chemical disinfection mechanism.
According to some embodiments of the invention, the apparatus further comprises a heat exchanger disposed on the water conveying pipeline for heating the dosing water.
According to some embodiments of the invention, the infusion line comprises a common infusion tube and a plurality of branch infusion tubes connected between the common infusion tube and each dosing unit, respectively, and the flow meter is disposed on each branch infusion tube.
According to some implementation aspects of the present invention, each branch infusion tube is further provided with a temperature sensor for monitoring a temperature of a liquid in the corresponding branch infusion tube, and a conductivity meter for monitoring a conductivity of the liquid in the corresponding branch infusion tube, or each branch infusion tube is further provided with a conductivity meter with a temperature monitor, the apparatus further includes a monitoring unit for monitoring a conductivity of the liquid in each dosing unit and having an alarm function, and the monitoring unit is electrically connected to the control unit.
Furthermore, a mixing pipe is also arranged on the common infusion pipe.
According to some embodiments of the present invention, the apparatus further comprises a dilution tank unit connected to the infusion pipeline, the dilution tank unit comprising a dilution tank with a stirrer connected to the infusion pipeline, a circulation pipe connected to the dilution tank, a circulation pump disposed on the circulation pipe, and a second heating unit for heating the dilution tank so as to maintain the feed liquid in the dilution tank at a certain temperature.
According to some embodiment aspects of the present invention, the raw materials used for the dialysate include sodium chloride powder, potassium chloride powder, calcium chloride powder, magnesium chloride powder, citric acid powder or acetate powder, and sodium bicarbonate powder, and the plurality of the dosing units include a sodium chloride dosing unit for preparing a sodium chloride saturated solution, a potassium chloride dosing unit for preparing a potassium chloride saturated solution, a calcium chloride dosing unit for preparing a calcium chloride saturated solution, a magnesium chloride dosing unit for preparing a magnesium chloride saturated solution, an acid dosing unit for preparing a citric acid saturated solution or acetate saturated solution, and a sodium bicarbonate dosing unit for preparing a sodium bicarbonate solution.
The dialysate preparation and supply device for the dialysate system can be directly arranged in a dialysis center, raw materials used by dialysate are directly distributed on site to prepare saturated solutions corresponding to the raw materials, and then the saturated solutions corresponding to the raw materials are mixed according to the required proportion.
In the present invention, the raw material used for the dialysate may be raw material purchased from raw material manufacturers without further processing, such as sodium chloride dry powder, potassium chloride dry powder, calcium chloride dry powder, magnesium chloride dry powder, citric acid dry powder, or sodium acetate dry powder and sodium bicarbonate dry powder.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
the dialysate preparation and supply device for the dialysate system can be directly arranged in a dialysis center, raw materials (such as various raw material powders used by dialysate) of the dialysate are directly used on site to prepare saturated solutions corresponding to the raw materials on line, the flow of each flowmeter is controlled according to the characteristic that each raw material saturated solution is a fixed value, the outflow flow of the saturated solution of each raw material is regulated and controlled by the control unit, the preparation amount of each raw material component can be accurately controlled, the aim of accurately preparing the dialysate meeting treatment requirements is fulfilled, the dialysate is supplied to a dialyzer for use, intermediate links are effectively reduced, new pollution risks cannot be introduced from the raw materials to the dialyzer, and the formula proportion of the rapid dialysate can be adjusted according to different treatment requirements.
Drawings
FIG. 1 is a schematic diagram of a dialysis system that uses one embodiment of the present invention for a dialysate dispenser to supply dialysate;
FIG. 2 is a schematic diagram of a dialysis system that uses another embodiment of the present invention for supplying dialysate to a dialysate supply device of the dialysis system.
In the figure:
100. a dialysate dispensing and supplying device for the dialysate system; 200. a dialysis machine;
1. a charging bucket; 2. a temperature sensor; 3. a conductivity meter; 4. a flow meter; 5. an electromagnetic valve; 6. a vent; 7. diluting and filling; 8. a stirrer; 9. a circulation pump; 10. a pH monitor; 11. a heat exchanger; 12. a filter screen; 13. a pressure gauge; 14. a raw material storage area; 15. a solution zone; 16. a stirring structure;
a. a common water pipe; b. a branched water pipe; c. a common infusion tube; d. a branch infusion tube; e. a circulation pipe; f. a vacuum tube; g. a dialysate delivery tube; h. a mixing tube; i. a return pipe.
Detailed Description
The invention is further described below with reference to the drawings of the specification:
referring to fig. 1, the dialysate preparation andsupply device 100 for a dialysate system according to an embodiment of the present invention includes a dosing mechanism, where a plurality of or all raw material components in raw materials used by a dialysate are mixed with water independently to prepare a saturated solution of the corresponding raw material components. It should be noted that the dialysate solution preparing and supplyingdevice 100 for the dialysate system is used to be connected to the dialysis machine through a pipeline, that is, the dialysate solution provided by the dialysate solution preparing and supplyingdevice 100 for the dialysate system is directly used in the dialysis operation of the dialysis machine.
The batching mechanism comprises a plurality of batching units which are connected in parallel and used for respectively batching saturated solution corresponding to raw material components, infusion pipelines which are respectively connected with the batching units to convey the saturated solution in the batching units, flow meters are respectively arranged on infusion pipelines which are respectively connected with the batching units in the infusion pipelines, and the device further comprises control units which are respectively electrically connected with theflow meters 4. The control unit controls theflow meter 4 to control the liquid outlet amount of the saturated solution in each dosing unit, thereby achieving the purpose of accurately preparing the dialysate meeting the treatment requirements.
In addition, compared with a mode of directly proportioning powder or concentrated solution of raw materials, the raw materials are respectively prepared into corresponding saturated solutions. Because the mass fraction contained in the saturated solution is a fixed value and the using amount of the liquid is easy to control, the proportion of each raw material is controlled by controlling the flow of the saturated solution, so that the amount of the raw materials can be more accurately controlled, and the error of the configured dialysate is reduced.
The feeding form of each raw material component for preparing the saturated solution is preferably powder of each raw material component, the device also comprises a water conveying pipeline, the water conveying pipeline is connected with each proportioning unit, electromagnetic valves are respectively arranged on water pipes connected with each proportioning unit in the water conveying pipeline, and each electromagnetic valve is electrically connected with the control unit.
Each batching unit respectively includesstorage bucket 1 for depositing each raw and other materials component, is used for installing the cavity of eachstorage bucket 1 and is used for heating this cavity so that the material keeps the first heating unit under certain temperature instorage bucket 1, and this certain temperature can be 36 ~ 38 ℃, preferably is about 37.5 ℃, more is close to human blood temperature. In this embodiment, a plurality of chambers (not shown) are provided, a chargingbarrel 1 is correspondingly provided in each chamber, and a heating unit is provided in each chamber to ensure that the temperature of the chargingbarrel 1 is maintained at about 37.5 ℃, which is closer to the temperature of the blood in the human body. Everystorage bucket 1 corresponds and sets up a cavity, and the temperature is more stable. The top of each chargingbasket 1 is also provided with anair vent 6 to prevent negative pressure from being generated in the chargingbasket 1.
In this example, the raw materials used for the dialysate include sodium chloride dry powder, potassium chloride dry powder, calcium chloride dry powder, magnesium chloride dry powder, citric acid dry powder, and sodium bicarbonate dry powder, and the plurality of dosing units include a sodium chloride dosing unit for preparing a sodium chloride saturated solution, a potassium chloride dosing unit for preparing a potassium chloride saturated solution, a calcium chloride dosing unit for preparing a calcium chloride saturated solution, a magnesium chloride dosing unit for preparing a magnesium chloride saturated solution, a citric acid dosing unit for preparing a citric acid saturated solution, and a sodium bicarbonate dosing unit for preparing a sodium bicarbonate saturated solution.
In this example, the plurality ofbuckets 1 include a sodium chloride bucket for storing sodium chloride dry powder, a potassium chloride bucket for storing potassium chloride dry powder, a calcium chloride bucket for storing calcium chloride dry powder, a magnesium chloride bucket for storing magnesium chloride dry powder, a citric acid bucket for storing citric acid dry powder, and a sodium bicarbonate bucket for storing sodium bicarbonate dry powder, respectively. The water conveying pipeline comprises a public water pipe a and a plurality of branch water pipes b which are respectively connected between the public water pipe a and each batching unit, wherein each branch water pipe b is respectively provided with an electromagnetic valve 5, in the embodiment, the plurality of branch water pipes b are respectively connected with the tops of a sodium chloride charging basket, a potassium chloride charging basket, a calcium chloride charging basket, a magnesium chloride charging basket, a citric acid charging basket and a sodium bicarbonate charging basket in a one-to-one correspondence mode, and water is introduced into corresponding powder in the easily-dissolvingcharging basket 1 in each chargingbasket 1 through the water conveying pipeline so as to prepare saturated solution corresponding to raw material components.
The infusion pipeline comprises a common infusion tube c and a plurality of branch infusion tubes d respectively connected between the common infusion tube c and each batching unit, in the embodiment, the branch infusion tubes d are respectively connected with the bottoms of a sodium chloride charging bucket, a potassium chloride charging bucket, a calcium chloride charging bucket, a magnesium chloride charging bucket, a citric acid charging bucket and a sodium bicarbonate charging bucket in a one-to-one correspondence manner, filter screens 12 are respectively arranged at the bottoms of the sodium chloride charging bucket, the potassium chloride charging bucket, the calcium chloride charging bucket, the magnesium chloride charging bucket, the citric acid charging bucket and the sodium bicarbonate charging bucket, and saturated solution in each charging bucket enters the branch infusion tubes d after being filtered by the filter screens 12.
And a mixing pipe h is also arranged on the common liquid conveying pipe c, and the mixing pipe h adopts the existing mixing pipe with swirl vanes in the pipe, so that the saturated solutions are premixed in the mixing pipe h.
And aflowmeter 4, atemperature sensor 2 for monitoring the temperature of the liquid in the corresponding branch infusion tube d and aconductivity meter 3 for monitoring the conductivity of the liquid in the corresponding branch infusion tube d are respectively arranged on each branch infusion tube d, and theflowmeter 4, thetemperature sensor 2 and theconductivity meter 3 are respectively and electrically connected with the control unit.
The batching mechanism can be provided with 2 groups, each group of batching mechanism comprises the sodium chloride batching unit, the potassium chloride batching unit, the calcium chloride batching unit, the magnesium chloride batching unit, the citric acid batching unit and the sodium bicarbonate batching unit, the water conveying pipeline and the liquid conveying pipeline are respectively connected with all batching units, the batching units for preparing the same solution in the 2 groups of batching mechanisms are alternately used, one is used for another, when one material barrel is used, water is introduced into the other material barrel in advance (the adopted water is reverse seepage water), and the water is heated to a set value to form a saturated solution, if the electromagnetic valve 5 can be set to be a three-way electromagnetic valve, the open circuit of the electromagnetic valve 5 is controlled through the control unit.
The device also comprises a monitoring unit which is used for monitoring the conductivity of the feed liquid in each dosing unit and has an alarm function, and the monitoring unit is electrically connected with the control unit. In the charging barrels for preparing the same solution in the 2 groups of proportioning mechanisms, when the conductivity of the feed liquid in one charging barrel in use is monitored to change (because the saturated solution of each raw material component at a certain temperature corresponds to a fixed value), the solute in the charging barrel is close to or finishes dissolving, the control unit controls the electromagnetic valve to automatically switch to another standby charging barrel, and sends out a photoelectric alarm signal to the monitoring unit, so that a photoelectric alarm is given to remind a worker to replace the charging barrel in time.
The apparatus further comprises a heat exchanger 11 arranged on the common water pipe a to heat the water introduced into the chargingbasket 1 to a certain temperature, typically to about 37.5 ℃.
The device also comprises a disinfection mechanism which is connected with the water pipeline through a pipeline, in particular, the disinfection mechanism can be a thermal disinfection mechanism or a chemical disinfection mechanism or a combination of the two mechanisms. After the dialysate is prepared, if equipment such as a proportioning mechanism and the like is not needed, hot water or ozone or other chemical disinfectants without residues are introduced from the inlet of the water conveying pipeline to disinfect and flush the whole system so as to meet the microbial requirements of hemodialysis.
In this embodiment, the device further comprises a dilution tank unit connected to the infusion pipeline, the dilution tank unit comprises adilution tank 7 with astirrer 8 connected to a common infusion pipe c, a circulation pipe e connected to thedilution tank 7, acirculation pump 9 disposed on the circulation pipe e, and a second heating unit for heating thedilution tank 7 to maintain the feed liquid in thedilution tank 7 at a certain temperature, one end of the circulation pipe e is connected to the bottom of thedilution tank 7, and the other end of the circulation pipe e is connected to the upper portion of thedilution tank 7. The device further comprises a branch water pipe b connected between the common water pipe a and the common infusion pipe c or thedilution tank 7 to pass water to the mixed solution of the saturated solution of each raw material component for dilution to obtain diluted dialysate. In this example, a branch water pipe b is connected to the common liquid pipe c upstream of the mixing pipe h in the flow direction of the liquid in the pipe, so that water and each saturated solution are premixed in the mixing pipe h and then enter thedilution tank 7.
The second heating unit heats thedilution tank 7 so that the feed liquid in thedilution tank 7 is kept at about 37.5 ℃, is closer to the blood of a human body, and is used for assisting the mixing and constant temperature of the feed liquid in thedilution tank 7 through the arrangement of the circulating pipe e and the circulatingpump 9.
In this example, referring to fig. 1, the dialysate is fed from thedilution tank 7 to eachdialysis machine 200 through the dialysate feed pipe g for use, and the dialysate feed pipe g is further provided with atemperature sensor 2 for monitoring the temperature of the feed liquid in the pipe, aconductivity meter 3 for monitoring the conductivity of the feed liquid in the pipe, apH detector 10 for monitoring the pH of the feed liquid in the pipe, and a flow meter, and thetemperature sensor 2, theconductivity meter 3, thepH detector 10, and the flow meter are electrically connected to the control unit, respectively.
A return line i is also provided between the dialysate delivery line g and thedilution tank 7 to maintain a steady supply of dialysate. When the dialysate delivered from thedilution tank 7 is supplied to a plurality of dialyzers, different dialyzers are opened for different periods of time, and the flow rate is increased or decreased, but in order to maintain stable supply of the dialysate, the flow rate of the dialysate flowing out of the dialysate delivery pipe g is substantially constant, and the excess dialysate not taken by the dialyzers flows back to thedilution tank 7.
Thedilution tank 7 is also connected with a vacuum tube f for vacuumizing, atemperature sensor 2 for monitoring the temperature of the feed liquid in thedilution tank 7 and a barometer 13 for monitoring the air pressure in thedilution tank 7.
In other embodiments, for dialysis centers with large usage and needing redundancy, after the dialysate blending is completed, a liquid storage tank is connected between thedilution tank 7 and thedialysis machine 200, the dialysate is drawn out from the liquid storage tank and supplied to the dialysis machine for use, and a liquid outlet pipe of the liquid storage tank is provided with a temperature sensor, a pH monitor and a conductivity meter.
In another embodiment, the device does not need a dilution tank unit, and the mixed liquid with high concentration flowing out from the mixing pipe h can be directly introduced into a conventional dialysis machine with a dilution tank for use, and water is introduced into the mixed liquid with high concentration in the dialysis machine to dilute the mixed liquid to obtain dialysate for dialysis.
In other embodiments, theconductivity meter 3 used on the device may be a conductivity meter with temperature monitoring, i.e. a conductivity meter can monitor both temperature and conductivity.
Alternatively, referring to fig. 2, in other embodiments, thefilter screen 12 divides the chargingbasket 1 into a rawmaterial storage area 14 and a saturatedsolution area 15, and the rawmaterial storage area 14 of the chargingbasket 1 is provided with a stirringstructure 16. Due to the arrangement of the stirringstructure 16, on one hand, raw materials can be fully contacted with water, so that the raw materials can be dissolved conveniently, and the saturation degree of the solution can be ensured exactly; on the other hand, the raw materials can be prevented from hardening, so that the formed saturated solution can smoothly pass through thefilter screen 12 to the saturatedsolution area 15.
Optionally, in other embodiments, the dialysate dispensing and supplying device for a dialysate system further includes a fluid concentration sensor for detecting a concentration of fluid in a fluid line connected to each of the dispensing units;
or each batching unit comprises a charging basket for storing each raw material component, each liquid conveying pipeline is connected with the bottom of each charging basket, a filter screen is arranged at the bottom of each charging basket, and the liquid in each charging basket enters the liquid conveying pipeline after being filtered by the filter screen; the filter screen divides the charging basket into a raw material storage area and a saturated solution area; the apparatus also includes a liquid concentration sensor to monitor a liquid concentration of a saturated solution region of the barrel.
The setting of liquid concentration sensor can implement the saturation degree of the saturated solution of every saturated solution configuration unit configuration of control to can in time carry out the replenishment of raw and other materials when the raw and other materials in the storage bucket are not enough, thereby the saturation degree of the saturated solution of assurance configuration that can be better.
Further, optionally, the dialysate dispensing and supplying device for the dialysate system further comprises an alarm device. When the liquid concentration monitored by any one of the liquid concentration sensors is less than a preset value, the alarm device can be triggered. Therefore, people can be reminded of the shortage of raw materials in the charging basket more timely, and raw materials can be added more timely.
Still further, optionally, a dialysate dispensing and supply apparatus for a dialysis system includes a control system. When the liquid concentration sensor detects that the liquid concentration is less than the preset value, the control system can also send a signal to the control system of the dialysate preparation and supply device for the dialysis system so as to control the dialysate preparation and supply device for the dialysis system to temporarily stop the liquid preparation operation, thereby avoiding the phenomenon of reduction of the precision of the prepared dialysate caused by the solution unsaturation of a certain raw material.
The above embodiments are merely illustrative of the technical concept and features of the present invention, and the purpose thereof is to enable those skilled in the art to understand the content of the present invention and implement the invention, and not to limit the scope of the invention, and all equivalent changes or modifications made according to the spirit of the present invention should be covered by the scope of the present invention.