Patent Application
20190336672
The present disclosure relates to a medical fluid-conducting cassette for a medical fluid treatment and to a method for producing a medical fluid-conducting cassette.
Fluid-conducting cassettes are used for medical fluid treatments and are a separate component from a medical fluid treatment machine. The fluid-conducting cassettes are connected to the medical fluid treatment machine prior to a medical fluid treatment. The fluid-conducting cassette includes connection points (fluid fittings) that are used for adding a fluid into the cassette during the treatment of the patient (in short: fluid addition point of the cassette). Typically, contamination of the connection points of the fluid-conducting cassettes is prevented using detachably adhered or strippable protective foils that cover the connection points.
A medical fluid-conducting cassette (short: “cassette” hereinafter), comprises a hard part, main body or hard body (hereinafter for short: “hard body”), e.g., made from hard resin.
The hard body defines channels, or parts of channels, for guiding fluids through, or within, the cassette.
The cassette further comprises a first film section (or flexible sheet). The first film section is attached to the hard body and arranged to cover parts of the hard body. At the same time, it is arranged to cover or form at least one of the channels and/or an interior of the hard body.
The hard body further comprises at least one connection point. The connection point is optionally configured to connect, for example, tubing in order to provide a fluid communication between the channel(s) defined by the hard body and an exterior of the cassette.
The cassette can further comprise at least one covering device. The covering device is attached to the hard body and arranged so as to cover the connection point. The covering device is attached to the hard body in a releasable or removable manner such that it can be removed from the cassette by a user when using the cassette.
Also, in some embodiments the covering device is a second film section (or flexible sheet) made from the same film material as the first film section. Alternatively, the covering device comprises such a second film section.
A method described herein relates to covering a hard body of a cassette or medical fluid-conducting cassette for a medical fluid treatment with a film material.
The method comprises providing a cassette, the cassette comprising: a hard body defining/comprising channels for guiding fluids through, or within, the cassette; at least one connection point configured to connect at least one of the channels with an exterior of the cassette in a fluid communication.
The method comprises also the steps: attaching a first film section to the hard body so as to cover parts of the hard body and so as to cover at least one of the channels against an exterior of the cassette; attaching a second film section to the hard body so as to cover the connection point in a releasable or removable manner, wherein the second film section comprises the same material as the first film section or consists thereof.
In the following and in all of the following embodiments, the use of the expression “may be” or “may have” and so on, is to be understood synonymously with “preferably is” or “preferably has”, respectively, and so on, and is intended to illustrate exemplary embodiments.
Whenever numerical words are mentioned herein, the person skilled in the art shall recognize or understand them as indications of numerical lower limits. Unless it leads the person skilled in the art to an evident contradiction, the person skilled in the art shall comprehend the specification for example of “one” encompassing “at least one”. This understanding is also equally encompassed by the present invention as the interpretation that a numeric word, for example, “one” may alternatively mean “exactly one”, wherever this is evidently technically possible for the person skilled in the art. Both are encompassed by the present invention and apply herein to all used numerical words.
Embodiments may comprise some or all of the following features in any desired combination.
In some exemplary embodiments, the covering device can be releasable or removable from the hard body without any tools or without being destructive beyond a pre-determined degree or measure.
In some exemplary embodiments, the first film section and the second film section are integrally formed or produced, e.g., as a common piece of film material.
In some exemplary embodiments, the first film section and the second film section are linked one to the other by at least one perforation section, e.g., a perforation line. Alternatively, or in addition, the first film section and the second film section are linked one to the other by at least two connectors which are integral with both the first film section and the second film section. The connectors preferably being spaced from each other, e.g., by spaces or gaps between corresponding sections thereof.
In some exemplary embodiments, the first film section and the second film section are being welded or have been welded one to the other.
In some exemplary embodiments, the first film section and the second film section are being glued or have been glued one to the other.
In some exemplary embodiments, both the first film section and the second film section are welded or are being welded to the hard body.
In some exemplary embodiments hereof, the welding method or intensity used (or being used) for welding the two film sections to the hard body differ for the first and the second film section. For example, the second film section may be welded or may have been welded to the hard body while using less energy for the welding process. It may be welded (or may have been welded) by a thinner welding seam or line. It may be welded or may have been welded not along a line but by some welding spots or points only. It may be welded or may have been welded by not forming a tight seal between the covered area of the hard body and the exterior.
In some exemplary embodiments, the second film section comprises an interconnecting element configured for connecting the second film section to a transport packaging of the cassette.
The transport packaging may be the packaging of the cassette that ensures that the cassette remains sterile until the packaging is opened and the cassette thus is exposed to the unsterile environment or exterior.
In some exemplary embodiments, the interconnecting element is being attached (or may have been attached) to the second film section only, that is, it is not being attached (or has not being attached) to the first film section at the same time.
In some exemplary embodiments, the interconnecting element may be attached to the side of the second film section facing the exterior of the cassette and/or to the side of the second film section not facing the hard body side.
In some exemplary embodiments, the cassette is packed into a transport packaging. The second film section is connected to the transport packaging of the cassette by the interconnecting element.
In some exemplary embodiments, the interconnecting element is an adhesive strip, material or layer.
In some exemplary embodiments, the interconnecting element is a strip with adhesive properties on both sides.
In some exemplary embodiments, the second film section was sterilized, or is being sterilized or has been sterilized, together with the first film section.
In some exemplary embodiments, at least one connection point is a connection point or coupling for a substituate line or a substituate addition site or a coupling.
In some exemplary embodiments, the cassette is a blood cassette.
In some exemplary embodiments the method encompasses attaching the first film section and the second film section to the hard body in the same working step or at the same time.
In some exemplary embodiments, the method encompasses attaching the first film section and the second film section which were produced integrally with each other.
In some exemplary embodiments, the method encompasses providing a perforation line or gaps or slits between the first film section and the second film section of the covering device.
In some exemplary embodiments, the method encompasses attaching at least one interconnecting element to the second film section on a side thereof that does not face the connection point.
In some exemplary embodiments, the method encompasses both the first film section and the second film section, which are welded, or are being welded, to the hard body of the cassette.
In some exemplary embodiments, the method encompasses both the first film section and the second film section, which are first welded, or are first being welded, to the hard body of the cassette and then provided with gaps or a perforation line between them.
In some embodiments, the second film section comprises a section which protrudes from the edge of the cassette.
In further exemplary embodiments, exactly one or only one of the film sections, in particular the one indicated herein as first film section, provided on the cassette or the hard body, is limited along a circumference by a circumferential sealing bar and/or welding seam or line, whereby the connection point is arranged outside this sealing bar.
In several exemplary embodiments, the connection point is or comprises a liquid addition site.
In some exemplary embodiments, the connection point is not provided under the surface created by the first film section, and therefore not within the circumferential sealing bar.
In further exemplary embodiments, the connection point is provided outside the circumferential sealing bar.
In several exemplary embodiments, the connection point serves as fluid connection, i.e., inlet and/or outlet. It does not comprise or constitute a pump chamber.
In some embodiments, the at least one connection point, which is or will be covered by the covering device, is a connection point, joint or interface for a substituate line.
In several exemplary embodiments, the connection point comprises no check valve.
In several exemplary embodiments, the connection point may represent an opening of the interior of the cassette or of an inner channel of the cassette to the exterior of the cassette (or vice versa).
In some exemplary embodiments, the connection point may not represent the connection between two channels in the interior of the cassette resp. between two channels both covered by the first film section.
In further exemplary embodiments, the connection point may be arranged at the end of an interior channel, i.e., not at a middle section of a channel.
In a further embodiment, the medical fluid-conducting cassette is designed as a blood cassette, for example for dialysis treatment, in particular for hemodialysis, hemofiltration, hemodiafiltration, peritoneal dialysis, acute dialysis, and so on.
Some or all embodiments may comprise one, more or all of the advantages mentioned above and/or hereinafter.
Detaching the contact protection apparatus is advantageously possible without considerable application of force due to the above-mentioned design of the covering device or the second film section.
In some advantageous embodiments, there is a reduced risk of unintentionally contaminating the connection point of the cassette, for example by touching it by hand, as the connection point is safely covered by the second film section.
Since the second film section may extend beyond the rim of the cassette, neither the connection point nor any point nearby the connection point has to be touched in order to detach the second film section from the cassette. In fact, using the interconnecting element described herein, the second film section covering the connection point may even be removed automatically, i. e., without any further action having to be taken by the user. Some second film sections may reduce the risk of unintended contamination during detachment of the device covering the connection point.
The second film section is made from the same material as the first film section needed for covering the hard body and, in some embodiments, for covering or completing the fluid-guiding channels of the cassette. Thus, the second film portion may advantageously undergo the same sterilization processes as the cassette comprising the first film section.
Also, since the first film section is cut from a film layer necessarily bigger or differently shaped than the hard body of the cassette, applying the first film section always means that some film material has to be cut off and disposed, however, parts of this waste film material is being used as the second film section. Hence, in some embodiments providing the second film section does not even require providing additional material. Rather, there are no additional material costs to be born for the second film section.
Detaching the contact protection apparatus from the cassette may in some embodiments be advantageously carried out with just one hand. The contact protection apparatus may reduce the amount of force required to detach the contact protection apparatus from the cassette.
The second film section is made of soft or flexible materials or rounded edges such that a risk of injury for the user during operation, as well as the risk of damaging other parts of the contact protection apparatus or the cassette, for example by sharp contours, may be reduced.
The second film section may reduce the potential for residual adhesive on the cassette when the second film section is detached from the cassette, and may reduce the risk that the adhesive gets into the interior of the cassette via the connection point.
The present disclosure is hereafter exemplarily explained by means of the appended drawing, in which identical reference numerals refer to identical or similar components. In the figures it applies that:
The hard body 1 is covered by a first film section 3.
The cassette 1000 comprises a connection point or a connection section 41 embodied, in this exemplary embodiment, as a substituate addition site 41.
For better understanding only, a second film section 3′ that is also comprised by the cassette 1000 is not shown in
As discussed above, the substituate addition site 41 needs to be protected against the environment in a manner such that it remains sterile until use of the cassette 1000.
The second film section 3′ is made from the same material as the first film section 3. It is arranged so as to cover the connection point, here the substituate addition site 41.
Thus, an unintended touching of the substituate addition site 41 (the connection point or fluid coupling fitting) of the cassette 1000 before use, i.e., before mounting the cassette 1000 to a fluid treatment apparatus, is prevented by the covering device. Since the second film section 3′ covers not only the very spot of the substituate addition site 41, but has been provided with a generous rim or overhang with respect to the hard body 1, unintended touching of the connection point 41 is prevented by the second film section 3′ even during removal of the second film section 3′.
As can be seen from
Likewise, the second film section 3′ can be welded to the hard body 1 as well. The weld can be a closed structure, it may be continuous or intermittent, it may follow both the sealing bar 4 and/or another sealing bar 4′ positioned on opposite sides of the substituate addition site 41 (connection point) and thus, together with the sealing bar 4, enclosing the substituate addition site 41 (connection point).
The aforementioned closed structure can be a combination of the sealing bar 4 and the further sealing bar 4′.
Alternatively, or in addition, the second film section 3′ can be glued to the hard body 1, preferably in a manner that allows easy removal of the second film section 3′ when required.
The first film section 3 and the second film section 3′ can be made from a common piece or layer of film. However, between the first film section 3 and the second film section 3′ a perforation line 6 can be provided. The perforation of the perforation line 6 may allow manual tearing the second film section 3′ off the first film section 3, or the remainder of the cassette 1000, in order to use the cassette 1000 and/or the substituate addition site 41.
A perforation may be a combination of a multitude of openings and interposed non-openings (e.g., film material). Likewise, if the second film section 3′ is interconnected to the first film section 3 one might also speak of a perforation.
The first film section 3 and the second film section 3′ may be interconnected or integral with each other by a perforation which is a sequence of subsequent openings separated from each other by a multitude of film sections in
The cassette 1000 may further comprise one or more of the following elements in any desired combination: A sealing bar 4, a sealing bar 4′, a peripheral weld 5, a peripheral weld 5′, a perforation line 6, an arterial patient connection 7, an arterial pressure measurement chamber 9, a connector 11 for the exit of blood from cassette 1000, a connector 13 for the entry of blood into cassette 1000; a chamber 15 with arterial post-pump, or pre-filter, pressure measurement site; an arterial filter conduit 17; a venous filter conduit 19; a venous blood chamber 21; an upper space 23 of the venous blood chamber 21; a lower space 25 of the venous blood chamber 21; a cross-sectional restriction 27 of the hard body 1 (hard body); a clot trap 29; a venous patient connection 31; an arterial addition site 33; a check valve 35 of the arterial addition site 33; a venous addition site 37; a check valve 39 of the venous addition site 37; a connector 43 for exit of substituate from the cassette 1000; a connector 45 for entry of substituate into the cassette 1000; a check valve 47 for addition of substituate; a pre-dilution addition valve 51 (phantom valve); a post-dilution addition valve 53 (phantom valve); a single-needle sterile membrane 55; a single-needle chamber 57; a blood surge redirection element 59; a single-needle blood valve 61 (phantom valve); an evacuation site 63 for vacuum coupling; a primary alignment center 65; a secondary alignment site 67; a pump tube segment 88 of blood pump; and a pump tube segment 90 of substituate pump.
Either one, or both, of sealing bar 4 and sealing bar 4′ may protrude from the hard body 1 or from the level of the first film section 3.
In
As can be seen in
Also, in
The interconnecting element 150 can be an adhesive, a sticky tape, a VELCRO′ fastener, a tape that is adhesive on both sides or double-sided adhesive tape, or the like.
The interconnecting element 150 serves to keep the second film section 3′ securely attached to a lid 201 of a transport packaging 200 only shown in
The second film section 3′ comprises a flap or removal flap 91 which extends from a rim of the second film section 3′ and may facilitate getting a grip on the second film section 3′ in order to tear it off the cassette 1000.
Also, two end sections or edge sections 93 and 95 are emphasized by circles in
At least one of the end or edge sections 93, 95, the second film section 3′ may be connected to the first film section 3 in a manner which differs from how the two film sections 3, 3′ are interlinked with each other. For example, in either of sections 93, 95, the two film sections 3, 3′ may be integral without perforation between them. That way, the second film section 3′ may be firmly connected to the first film section 3. A perforation between them, e.g., between the two edge sections 93, 95 may not be needed in those embodiments. In particular, the two film sections 3, 3′ may be cut into two separate pieces between the two edge sections 93, 95 that are solely responsible for keeping the second film section 3′ to the first film 3 or for connecting them with each other.
In some embodiments, the edge sections 93, 95 are chosen such that they do not cover a rib of the hard body 1 and/or are not supported by a rib or other hard body structure from underneath.
Another interconnecting element 150 is connected to the second film section 3′. It may be provided as a substitute or an alternative to the one shown in
Again, the interconnecting element 150 can be an adhesive, a sticky tape, a VELCRO® fastener, a tape that is adhesive on both sides or double-sided adhesive tape, or the like.
The interconnecting element 150 serves to keep the second film section 3′ securely to a lid 201 of a transport packaging 200 only shown in
As can be derived from the illustration of
| Number | Date | Country | Kind |
|---|---|---|---|
| 17153740.0 | Jan 2017 | EP | regional |
The present application is the national stage entry of International Patent Application No. PCT/EP2018/051902, filed on Jan. 25, 2018, and claims priority to Application No. EP 17153740.0, filed in the European Patent Office on Jan. 30, 2017, the disclosure of which are expressly incorporated herein in entirety by reference thereto.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2018/051902 | 1/25/2018 | WO | 00 |
