Patent Application
20160158713
The object of this development is the economical preparation, storage and mobile administration of flushing solutions by using Purisol, Ringer's and common salt concentrates, which are mixed with a chemically and microbiologically ultrapure liquid prepared in situ to form ready-to-use flushing solutions for surgical operations, e.g. gynaecology, urology and arthroscopy.
A mobile liquid store, which is equipped with a sterile disposable item, enables precise volumetric determination and sterile removal and simple and economical usage and administration.
The use of this development for other fields, such as general surgery, veterinary medicine, in the laboratory or in biology and pharmacy as an ultrapure flushing liquid or as a starting medium for the production of medicines, cell cultures and the like is conceivable and practicable.
Flushing solutions are generally processed from distilled water constituting the base material which is produced centrally, in a central production process to form flushing solutions and transported with considerable logistical cost to the place of use.
For medicinal use, industrially produced flushing solutions, for instance, in volumes of 3 l, 5 l, 10 l are made available to hospitals and are temporarily or permanently stored with large in-house, logistical staff input.
These bag volumes are not sufficient for the duration of the operation or examination, for instance with a bladder operation with ca. 60 l flushing liquid, so that a reserve must be available outside the central operation region in order to prepare, heat and provide the bag.
The administration is effected in part gravimetrically or with bag pressure sleeves. Expensive disposable items, such as pump segments or for the bag heater are additionally often necessary. A considerable disadvantage, e.g. with endoscopic examinations, is the lack of visibility as a result of floating tissue or pulsating flushing liquid because, for instance, the necessary flushing liquid pressure is not maintained constant between 0.1 bar to 0.3 bar.
Flushing mush be performed liberally in order to improve the wound hygiene. This results in staff and material costs.
The regulatory and normative requirements on the quality of the basic material, namely water, are so high that it was previously not possible to produce the verifiable, medicinal flushing solutions, when required, in situ, e.g. in a hospital. It is, on the one hand, the high microbiological requirements and, on the other hand, the necessary chemical requirements as regards the basic material, namely water, which work against any verifiable and detectable, normatively required quality of the in situ production controlled by requirements.
The decentralised production of medicinal flushing solutions by hospital personnel requires reliable procedures both in the operation and also in the reliability of the technology as regards the flushing solution quality.
The object of the invention are necessary improvements and therefore the economical, user-friendly in situ production of a flushing solution with low staff input and a flushing volume which corresponds to the examination or a number of operations.
The storage, long term stability and as low as possible a volume of the concentrates assumes a particular significance. Further requirements are uninterrupted administration without additional effort by the staff whilst maintaining the use temperature and hygiene of the solution.
A space-saving technique for producing, the flushing solution and a mobile flushing solution container are to be employed, which includes the important components for high hygiene, reliability, simple operation and a constant flow and pressure for administering the flushing liquid.
Residues should be disposed of as simply as possible.
High availability of the devices for all measuring and monitoring tasks as regards their intrinsic safety and only a remote probability of failure is important in order to avoid a catastrophic impact on the patient or to correctly monitor the quality or toxicity of the liquid produced within the warranted acceptance criteria.
This object is solved effectively by the invention if, to produce the flushing solution, the combination of a reverse osmosis membrane and two further filter stages, for instance ultrafilters or Sterifilters, preferably in the form of capillary membranes, is used. This filter combination and further components will be referred to below as a filling station.
In order to produce, for instance, ca. 60 l ready-to-use Purisol solution, ca. 56 l sterile filtered permeate should be proportionally diluted or mixed with ca. 3.6 l high concentration Purisol concentrate so that the flushing solution which is produced can be used without further tests for intra-operative and post-operative bladder flushing.
For Purisol concentrates, a formulation is required in a final dilution of 27.0 g sorbitol and 5.4 g mannitol per 1 litre ultrapure liquid. In practice, a tolerance range of 25.65-28.35 g sorbitol and 5.13-5.67 g mannitol plus ca. 1litre liquid is acceptable.
By experiments and tests, with a concentrate volume of 1 l the sorbitol concentration was raised to ca. 443.6 g and the mannitol concentration to ca. 88.7 g with a liquid volume of ca. 648.7 g to a concentration factor of ca. 16.43 and a density of ca. 11806 g/cm3 (20° C.)
A concentrate volume of ca. 3652 l+56.38 l ultrapure liquid results in ca. 60 l ready-to-use Purisol flushing solution. This concentrate then contains ca. 1620 g sorbitol, ca. 324 g mannitol and ca. 2369 g liquid.
The solubility of the substances in the production of the concentrate and a lasting solution of the same without precipitation at low temperatures, e.g. 5° C., suggest the concentration factor of ca. 16-17 times as a result of tests.
The aforementioned flushing solution can be used in place of e.g. Ringer's solutions and/or other sodium chloride solutions, which can be used, in particular, in the field of surgery and also in other medicinal or mentioned fields. The concentrates and their mixing ratios should be adapted to the particular uses.
E.g. 0.9% sodium chloride solutions are frequently used as a flushing solution. In order to prepare ca. 100 l of this solution, a concentrate volume of ca. 2.9 l is sufficient at a ratio of 1:35. Ringer's flushing solutions may be produced with slight variations from the aforesaid. For instance, with a mixing ratio of 1:34.6, 100l Ringer's solution may be prepared with ca. 2.872 l Ringer's concentrate. The increase in concentration to ca. 30-35 times with a solubility temperature of ca. 10° C. shows the potential for logistical, handling and space savings.
The described method and the components and volumes used are, however, not reduced thereto. Determined by the ultrapure active agent and the precise mixing and diluting, a large spectrum of flushing solutions may be produced.
As a result of the high concentration, the growth of microbes in the concentrate is advantageously nearly prevented.
In order to prepare the flushing solution, the concentrate container, which is advantageously constructed in the form of a bag, is suspended on prepared mountings on the filling station concentrate scales and the mixing process initiated. The scales are initially verified by the known bag weight.
The connections on the filling station for the concentrate and also for the flushing solution bag which is yet to be described, are effected by the user at self-cleaning connectors free from risk of confusion on the filling station, which are constructed in this application, for instance, in the form of valve solutions, but can also be constructed on the device in the form of flexible conduits.
A mobile flushing solution container, which is preferably constructed in the form of a pressure container, is equipped with great advantage with an insertable, sterile flushing liquid bag, which is filled with an appropriately large volume.
The flushing solution bag includes a permanent connector, which can be pushed through the lockable cover of the pressure container and fixed in position. The connector can be provided with flexible hose conduits which continue on and are constructed in the form of filling or transfer conduits. The connector can advantageously be constructed in the form of only one hose, which is to be used selectively and, in dependence on the sterility requirements, both as a filling hose and also as a transfer hose.
For the purpose of administering the flushing liquid at the place of use, a transfer system, for instance with an endoscopy system, can be connected to the transfer connection of the flushing solution connector. A connection to other systems conventional in surgery, for instance to flushing-suction systems, is also practicable and possible.
The object of simple operation and administration with constant flushing flow and pressure is solved by the introduction of compressed gas (air) either preferably into the pressure container or also selectively directly into the flushing liquid bag,
The control and monitoring of the compressed gas is advantageously arranged within the mobile flushing solution container. The production and supply of the compressed gas can be produced, for instance, by an on-site source or by the device.
The proportioning of the concentrate and permeate is effected by means of a concentrate scales and a flushing solution container scales, whereby the concentrate scales in the filling station is verified each time the filled concentrate container is attached.
For this purpose, the mobile flushing solution container advantageously also includes a scales, which monitors the filling state and should automatically be tested for security reasons by means of a reference weight.
For the purpose of homogenising and tempering, ultrapure or nearly sterile permeate is heated and mixed with concentrate added in a metered amount in a mixing block.
Before introduction into a sterile flushing solution container/bag, a second sterile filtration of the mixed solution is effected. The cleaning of the system or prevention and reduction of microbes is performed by the combination of a disinfecting and cleaning agent, which is of low toxicity and based on citrate, with a water heating. Both the primary and also the secondary side of the reverse osmosis should be disinfected or cleaned separately from one another by means of an additional pump, also without transmembrane flow.
All process-relevant data are in principle gathered by the operational computer and also the safety computer and optionally processed. The measurement results are sent from the operational computer to the safety computer and vice versa. Each computer compares the measurement results with its own and sends back a confirmation.
After the confirmation from the operational and safety computers, the data are written together with a check total into the trend data store, which can preferably be constructed in the form of an Eprom but also as another storage medium.
The electronic system of the mobile flushing solution container can be operated by means of a rechargeable accumulator and all necessary parameters and also their deviations, such as weight, temperature and container, pressure, are indicated on the indicator of the mobile flushing solution container.
By establishing a wireless data exchange between the filling station and mobile flushing solution container there is, for instance, the monitoring of the filling, the proportionality and the temperature.
Further details and advantages are described in the figures described below.
When the flushing solution valve (36) is closed and an appropriate flushing program is selected and initiated, the connector on the device is flushed or disinfected with sterile liquid or cleaning solution via flushing outlet (99). The test of the filters (3/30) is effected with valves (20/36) closed by supplying filtered air by means of air pump (6) and can apply air selectively, by valve switching, to the secondary side of the filter (3) or the primary side of the filter (30). The liquid is thereby partially displaced by the air. Due to the hydrophilic character of the filter membrane, when the filter characteristic is intact only a very small pressure drop will occur, which can be registered or monitored by means of pressure sensor (14) and electronic system (58). As a result of this test, both the filters (3/30) and also the fluid tightness of the valves (20, 36) can be verified or checked. Also shown schematically in
It will be understood that units other than endoscopic systems, such as the flushing suction systems conventional in surgery, are also connectable to system (56).
It is observed additionally that a further Sterifilter, which is not shown here, would be connectable to conduit (56).
There would also be the possibility of introducing the controlled compressed gas medium directly into the flushing solution bag (41) or conducting the transfer via a pump with a disposable hose segment.
The mobile flushing solution container (40) consists of a transport carriage (46) with a puffing and pushing handle (61), the pressure container (45), a cover (44) and an infusion rod (63). Components of the mobile flushing solution container (40) are a pressure control unit (47), whose outlet communicates directly via a flexible hose connection (66) with the pressure container (45), and an electronic system (62) with a communication indicator (65), for instance for indicating the filling level, the temperature, compressed air and other relevant values and an indicating signal light (64).
The communication between the flushing solution container (40) and the filling station (60) is effected wirelessly by means of sensors in the roller region below the base plate (104) of the transport carriage (40).
The detection of the parking and docking positions of the flushing solution container (40) at the filling station (60) is predetermined by the position of the preferably infrared sensors.
Mounted on the filling station at the same level is a corresponding sensor. The docking angle and position at the filling station may thus be influenced by selection and position of the sensors.
The further components are explained in part by the drawing or will be described later. It will be clear that the construction of the components is of space-saving type and their arrangement can differ from that illustrated and is also possible in other embodiments. Reference is also not made in all points to the labelling.
It will be understood that the bag (41/82) is to be inserted into the container. Two lateral guides (73) are attached to the pressure container (45) for the purpose of vertical support.
The compressed air supply (66) is attached, for instance, in the hinge region (75) by means of connector (84). Connector lock (79) may be opened in the event of a defect from the exterior by means of rotary shaft (85). Also shown in this figure is the filling conduit (39) with connector (38), which is to be connected in the filling process to connector (35). After the filling process, clamp (72) can be closed. In order to differentiate between the filling conduit (39) and transfer conduit (55), these are equipped with different connectors and constructed in different lengths, as shown.
When the flushing valve (17) is open, liquid flows via conduit (18) into a rear annular gap (97) in the connector (22) and from there through flushing bores at the periphery to the flushing space (103). When the pump (23) is running, the connector (22) is completely cleaned internally and externally and, after the cleaning process, can be cleared of liquid residues during the pressure holding test.
When the valve (22) is open, the concentrate connection (24), which is equipped, for instance, in the form of a female connector with an inner cone 1/18 and a two-start external screw thread 10×6, into which concentrate bag connector (22) with the corresponding cones and screw threads is screwed in. The frangible cone (112) should be broken. A form-locking, sealing connection, for instance by the inner and outer cones and the screw thread is ensured in the coupled state. The supply of the permeate via conduit (11) into mixing chamber (15) and of the concentrate via pump (23) is illustrated schematically. The mixed flushing solution is led away via conduit (29). In order to produce the appropriate homogeneity, the conduit feeds occur tangentially or in a suitable manner.
In order to rule out the risk of confusion for the usage, the technical format of the flushing solution connections is constructed differently to that of the concentrate connections.
Legends
| Number | Date | Country | Kind |
|---|---|---|---|
| 102014017420.4 | Nov 2014 | DE | national |
