Clot catcher, external functional device, blood circuit and treatment device

0001The present invention relates to a clot catcher according to the preamble of claim 1. It further relates to an external functional device according to claim 13, a blood circuit as disclosed herein, and a treatment device according to claim 15.

0002Clot traps are used, among other things, in extracorporeal blood circuits to capture or retain clots or thrombi that are present in the extracorporeal bloodstream.

0003A clot catcher is made of document<patcit id="pcit0001" dnum="DE29706807U1"><text>DE29706807U1</text></patcit> known.

0004An object of the present invention is to provide a further clot catcher.

0005This object is achieved by a clot catcher having the features of claim 1. The invention is defined by the appended claims.

0006The clot catcher according to the invention has a sieve surface or a clot catcher surface which is suitable and intended for collecting clots of a fluid flowing through the sieve surface.

0007The term "screening surface" as used herein refers to a device or component of the clot catcher designed to prevent the passage of the clot through the clot catcher.

0008Preferably, the screening surface is a device with a mechanically effective screening or filtering effect, without being limited thereto.

0009Alternatively or additionally, the sieve surface may also be suitable and intended to retain or dissolve clots, for example by physical and/or chemical means.

0010The sieve surface is disc-shaped.

0011The term "disk-shaped" as used herein means that the screening surface is - preferably substantially or entirely - in the shape of a disc.

0012Advantageous further developments of the present invention are the subject of the subclaims.

0013The following applies: A fluid flowing through the clot catcher enters the clot catcher – completely or partially – on an inflow side, flows through the sieve surface, and exits the clot catcher on an outflow side. According to the invention, clots are understood to include, for example, thrombi, solid contaminants, and the like.

0014The term "fluid" as used herein includes, but is not limited to, liquids such as medical fluids, e.g., blood, gases, emulsions, suspensions, dispersions, and the like, as well as mixtures thereof.

0015In any embodiment of the invention, the disc shape of the screen surface can be uneven and/or wavy, curved, or the like. Alternatively, it can be flat—in the sense of being flat or lying in a single plane.

0016The disc shape indicates a structure which is significantly larger in a first dimension (the main extension) than in a direction perpendicular to it.

0017The clot catcher is arranged during or for its use essentially vertically - preferably relative to the main extension of the sieve surface - as is the case, for example, in<figref idref="f0006">Fig. 6</figref> is shown.

0018The term "substantially vertical" as used herein means that the inclination of the clot catcher against the vertical in all directions may not exceed approximately 15°, or a maximum inclination of +/- 15° is particularly preferred. An inclination of less than +/- 15° is also preferred. Such a possibility of inclination by, for example, 15° clockwise or 15° counterclockwise or forwards or backwards, or to one side (against any direction) is partly in the<figref idref="f0003">Fig. 4</figref> and<figref idref="f0007">7</figref> indicated.

0019The terms "vertical" and "horizontal" preferably refer to the center of the Earth.

0020During use, the clot catcher can be positioned at any angle or incline relative to the center of the earth.

0021A chemical filtering or sieving effect can be achieved by chemically binding the clots to the sieve surface and/or within the sieve surface, for example, in its pores. The clots can be reversibly or irreversibly bound to the sieve surface. The clots can be physically adsorbed to the sieve surface. The clots can also be completely or partially dissolved on the sieve surface.

0022The screen surface has openings through which the fluid can flow from the inflow side to the outflow side. These openings can be used to achieve a mechanical filtering or screening effect. The dimensions of the openings or the mesh size of the screen surface can be selected such that the clots are retained on the inflow side of the inflowing fluids due to their size.

0023The passage openings of the sieve surface together form an open total passage area of ​​the sieve surface.

0024The dimensions of the passage openings can be selected such that clots, agglomerates, solid particles and the like present in the flowing fluid or fluid stream are retained from the fluid stream due to their size on the inflow side of the fluid and do not reach the outflow side of the clot catcher.

0025In a further preferred embodiment, all passage openings are arranged on - in particular concentric - circles or circular segments. An exemplary arrangement is shown below in<figref idref="f0001">Fig. 1</figref> shown.

0026Alternatively, a plurality of passage openings are arranged on - particularly concentric - circles.

0027In a further preferred embodiment, all or only some of the passage openings are arranged radially relative to a center point of the clot catcher or the sieve surface.

0028The term "center point" refers to a center point or a point in a central region of the disc-shaped sieve surface and/or the clot catcher. This center point may correspond to the center of gravity or geometric center of gravity of the sieve surface and/or the clot catcher and/or a circle center point of a round sieve surface and/or the clot catcher.

0029In comparison to a concentric arrangement of the passage openings, the passage openings are provided in a "radial" arrangement such that they extend from the center of the sieve surface or the clot catcher in a radial direction, in particular in one or more planes which are parallel to a main extension plane of the sieve surface.

0030In an embodiment not claimed, a number of passage openings are arranged over the entire sieve surface.

0031The openings can be arranged at equal distances from each other across the screen surface. The openings can be offset from each other, as is the case, for example, in<figref idref="f0001">Fig. 2</figref> is shown.

0032The openings can be arranged symmetrically on the sieve surface relative to the center of the sieve surface and/or the clot catcher. However, they can also be arranged asymmetrically on the sieve surface.

0033According to the invention, at least one section of the screen surface has no passage openings or a smaller number of them compared to other areas of the screen surface.

0034An example of such an arrangement is shown in<figref idref="f0002">Fig. 3</figref> and<figref idref="f0003">Fig. 4</figref> shown.

0035The section without - or with comparatively few - passage openings can face the outflow area of ​​the clot catcher or a housing in which the clot catcher is accommodated.

0036This section may be in the shape of a circular segment. Preferably, the circumference of the partial circular arc lies downstream of a tip of the partial circular arc in a use position of the clot catcher.

0037The passage opening(s) may have any suitable geometric shape. For example, they may be square, round, and/or elliptical, or the like.

0038A number of passage openings can, for example, be designed with sharp edges on at least one of the two sides of the screen surface (inflow side and outflow side), as for example in<figref idref="f0008">Fig. 8A</figref> is shown.

0039Alternatively or additionally, a number of passage openings on at least one side of the screen surface may be rounded or deburred. An exemplary embodiment is shown in<figref idref="f0008">Fig. 8B</figref> shown.

0040The openings can be rounded on both sides. An example design is shown in<figref idref="f0008">Fig. 8C</figref> shown.

0041The length and/or width of the passage openings can be varied, for example, depending on the radial distance or a distance from a central area to the edge of the screen surface. For example, the length and/or width of the passage openings can also increase with increasing radial distance outwards.

0042The length and/or width of the passage openings can, for example, be changed depending on the angular orientation.

0043An "angle" can be an angle of a circular segment between a straight line through the center or a point of a central region of the clot catcher or the sieve surface and another straight line through the center of the sieve surface along the circular arc of the clot catcher or the sieve surface.

0044The clot catcher can be made at least partially from a hemocompatible base material. The clot catcher can be made entirely from a hemocompatible base material.

0045Examples of suitable hemocompatible base materials include, but are not limited to, PVP (polyvinylpyrrolidone), which is preferably particularly hemocompatible, and PP (polypropylene).

0046In a further preferred embodiment, the clot catcher is made of a base material. Suitable base materials include, but are not limited to, polypropylene, polyethylene, polycarbonate, polyvinyl chloride (PVC), polyamide (PA), and the like.

0047The base material is preferably coated with one or more hemocompatible materials.

0048The clot catcher can be an injection-molded component or an injection-molded element.

0049The screen surface can be a screen fabric. It can be configured substantially or entirely as a grid structure and/or mesh structure. The screen surface can be configured or manufactured from filter paper, filter fleece, or the like.

0050The screen surface or clot catcher can be supported or carried by a supporting structure, such as a housing, a grid, or the like. A supporting structure can also have a screening or filtering effect.

0051For example, a supporting grid may be provided on or at each side of the screening surface.

0052In a further preferred embodiment, the clot catcher is arranged in a housing.

0053A housing can be used to protect the clot catcher or the sieve surface and/or to attach it to other structures.

0054In a preferred embodiment, the clot catcher is connected to the housing.

0055The clot catcher can be detachably connected to the housing. For example, it can be snapped or latched to the housing, or something similar.

0056Alternatively, the clot catcher can also be permanently connected to the housing. For example, it can be welded or glued to the housing, or something similar.

0057The ratio between the total open passage area and the total area of ​​the sieve area or the total area of ​​the clot catcher can be varied before using the clot catcher.

0058For example, the ratio between the total open passage area and the total area of ​​the sieve area or the total area of ​​the clot catcher can be varied by designing or forming passage openings of different sizes or of different sizes, possibly with different shapes, and/or designing or arranging or providing the section without passage openings or varying the size and/or shape thereof.

0059The clot catcher can be integrated into a housing in such a way that it and/or its sieve surface separate the inflow area of ​​the housing from the outflow area.

0060In a further preferred embodiment, the clot catcher has a covering device in at least one section of an upper side thereof.

0061The cover device can serve as a coupling surface for at least one sensor, as for example in<figref idref="f0007">Fig. 7</figref> as illustrated in the accompanying drawing. It may be prepared for this purpose. It may comprise corresponding devices for receiving the sensor or a connector equipped therewith, such as clamps, clip devices, and/or the like.

0062The object of the invention is also achieved by an external functional device according to claim 13. All advantages of the clot catcher according to the invention can also be achieved without reduction with the external functional device according to the invention.

0063An external functional device according to the invention has at least one clot catcher according to the invention.

0064An "external functional device" can be a single-use component or a disposable item. It can be made of a plastic material.

0065The external functional device according to the invention can be intended for use in a treatment method. Treatment methods within the meaning of the present invention include medical or medical-technical treatment methods as well as laboratory technology treatment methods.

0066In a preferred embodiment, the external functional device according to the invention is designed as a blood cassette.

0067A blood cassette, in the sense of the present invention, is described, for example, in the application filed by the applicant of the present invention with the DPMA on 23 April 2009<patcit id="pcit0002" dnum="WO102009018664A1"><text>10 2009 018 664.6 A1 and on 10 June 2009</text></patcit> submitted application<patcit id="pcit0003" dnum="WO102009024468A1"><text>10 2009 024 468 A1</text></patcit>, each with the title "<i>External functional device, blood treatment device for receiving an external functional device according to the invention, and method</i>", the disclosures of which are hereby incorporated by reference in their entirety.

0068The object of the invention is equally achieved by a blood circuit according to the invention as disclosed herein. All advantages of the clot catcher according to the invention can also be achieved without any reduction with the blood circuit according to the invention.

0069A blood circuit according to the invention has at least one clot catcher according to the invention.

0070The term "blood circulation" as used herein refers to a tubing system which is suitable for the treatment of blood in the form of an extracorporeal blood circulation.

0071Both the external functional device and the blood circuit may be intended for use in or on a treatment device.

0072The object of the invention is equally achieved by a treatment device according to the invention according to claim 15. All advantages of the clot catcher according to the invention can also be achieved without reduction with the treatment device according to the invention.

0073A treatment device according to the invention comprises at least one clot catcher according to the invention and/or at least one external functional device according to the invention and/or at least one blood circuit according to the invention.

0074For example, the treatment device may be a blood treatment device, such as a dialysis device for performing a dialysis treatment such as hemodialysis, hemofiltration, hemodiafiltration and the like.

0075In comparison to conventional clot catcher, in which the active sieve surface is cylindrical or conical, the flow guidance achievable by the clot catcher according to the invention can advantageously prevent clogging of the clot catcher or the sieve surface thereof.

0076The disc-shaped design also allows for a space-saving installation of the sieve surface within the clot catcher, compared for example to the conventional cylindrical clot catcher mentioned above.

0077The disc-shaped design can also advantageously contribute to the fact that a blood cassette or a blood tube or the like, in which the clot catcher according to the invention is installed, can be realized with little installation space requirement.

0078In particular, if the clot catcher according to the invention is designed with a partial area without passage openings or with only a few passage openings, a closure of the outflow area on the back of the clot catcher can be advantageously slowed down in the event of potential growth of a clot stopped by the clot catcher.

0079Furthermore, by changing the length and width of the passage openings and/or by varying the ratio between the total open passage area and the total area of ​​the sieve area or the total area of ​​the clot catcher, the flow through the passage openings can be advantageously modified and optimized so that the flow through the clot catcher is optimal. For this purpose, the total passage area of ​​the passage openings can also be advantageously optimized. An optimized flow can lead to improved flow conditions and have a positive influence, among other things, on further clot growth at the clot catcher.

0080Rounding the passage openings can advantageously contribute to significantly reducing or preventing flow separation of the fluids flowing through the passage openings.

0081In this way, it may be advantageously possible to reduce hemolysis and/or coagulation activation of the blood.

0082The housing to which the clot catcher according to the invention is attached can advantageously be designed so that air bubbles located on the inflow side of the fluid flow can rise. The air bubbles can thus advantageously leave the inflow area of ​​the clot catcher. This is particularly advantageous if the sieve surface of the clot catcher is designed with a sufficient gradient relative to a horizontal line. For this purpose, it can be tilted at approximately 45 to 90 degrees. It is preferably positioned vertically.

0083Furthermore, in certain designs, a vertical or substantially vertical arrangement of the sieve surface can result in space savings compared to a horizontal arrangement. This is particularly true if the vertically arranged sieve surface is arranged parallel or substantially parallel to a cover (such as a film) of a blood cassette into which it is integrated. The blood cassette mentioned above is again an example of such a blood cassette.

0084The inflow to the clot catcher can advantageously be arranged in such a way that the inflow side is flushed as thoroughly as possible. For example, this can be advantageously achieved with an inflow that is as tangential as possible.

0085''Tangential" can mean a flow towards the clot catcher essentially in a plane parallel to the main extension plane of the sieve surface. Tangential can be defined as in the<figref idref="f0003">Fig. 4</figref>, <figref idref="f0004">5A</figref> and<figref idref="f0005">5B</figref> and 6. Likewise, as in the<figref idref="f0004">Fig. 5A</figref> and<figref idref="f0005">5B</figref> As shown, the outflow can also be tangential or lateral or in an edge area of ​​the housing or not centrally.

0086By arranging the passage openings on concentric (partial) circles, it can also be advantageously achieved that a rotational movement of the fluids - especially in the case of tangential inflow or inflow - also continues on the downstream side and can thus further improve the flushing of the downstream side.

0087The present clot catcher can therefore be advantageously suited to counteract the formation of blood clots - in the sense of Virchow's triad - in a single or multiple way.

0088The present invention will now be described with reference to the accompanying drawings. In the drawings, identical reference numerals designate identical or similar elements. It shows:<dl id="dl0001"><dt>Fig. 1</dt><dd>a front view of the clot catcher according to a first unclaimed embodiment;</dd><dt>Fig. 2</dt><dd>a front view of the clot catcher according to a second unclaimed embodiment;</dd><dt>Fig. 3</dt><dd>a front view of the clot catcher according to the invention according to a third embodiment;</dd><dt>Fig. 4</dt><dd>a front view of the clot catcher of the<figref idref="f0002">Fig. 3</figref>which is arranged in a first housing;</dd><dt>Fig. 5A</dt><dd>a front view of the clot catcher according to the invention of the<figref idref="f0001">Fig. 2</figref> in a second housing;</dd><dt>Fig. 5B</dt><dd>a front view of the clot catcher according to the invention of the<figref idref="f0001">Fig. 2</figref> in a third housing;</dd><dt>Fig. 6</dt><dd>a longitudinal section of the clot catcher<figref idref="f0003">Fig. 4</figref>;</dd><dt>Fig. 7</dt><dd>a longitudinal section of the clot catcher according to the invention, which is coupled to a sensor; and</dd><dt>Fig. 8A-C</dt><dd>Designs of passage openings of a sieve surface.</dd></dl>

0089<figref idref="f0001"><b>Fig. 1</b></figref> shows a clot catcher 100 according to a first unclaimed embodiment with a sieve surface 1 in a front or front view.

0090In the sieve surface 1, passage openings 3 are arranged on concentric partial circles.

0091<figref idref="f0001"><b>Fig. 2</b></figref> shows the clot catcher 100 according to a second embodiment, not claimed, in whose sieve surface 1 the passage openings 3 are provided offset from one another on circles – partial circles are also possible. This offset can result in an overlap in the radial direction. However, this is not required.

0092<figref idref="f0002"><b>Fig. 3</b></figref> shows a clot catcher 100 according to a third embodiment.

0093The clot catcher 100 has passage openings 3 in the sieve surface 1, which are located on concentrically arranged partial circles. The partial circles subdivide the sieve surface 1 into segments. The passage openings 3 are also arranged in segments.

0094In section 5, no passage openings are provided.

0095The length of the passage openings 3 changes as already in<figref idref="f0001">Fig. 1</figref> depending on the radial distance r of the passage openings 3 from a center point 7 of the screen surface 1.

0096The length of the passage openings 3 changes in the circumferential direction of the screen surface 1 depending on the angular orientation ϕ of the passage openings 3 from a center point 7 of the screen surface 1.

0097<figref idref="f0003"><b>Fig. 4</b></figref> shows a front view of the clot catcher 100 from<figref idref="f0002">Fig. 3</figref> , which is arranged here in a first housing 200.

0098In an inflow area 9 of the housing 200, a tangential inflow of a fluid is provided—that is, directed toward an edge area or a circumference (which is not to be understood as the end face) of the screen surface 1. The fluid flow or its flow direction are indicated here and below by arrows.

0099The fluid or fluid flow enters the clot catcher 100 through the inflow area 9 and exits the clot catcher 100 at an outflow area 11. The fluid typically enters the clot catcher at the highest point 13 and exits the clot catcher 100 at the lowest point 15. The position designations "highest" point 13 and "lowest" point 15 preferably refer to an orientation of the clot catcher 100 during its use.

0100As indicated by the dashed lines N (inclination), an inclination of the clot catcher 100 according to the invention during or for its use by - preferably - up to about 15° degrees, relative to a vertical or perpendicular to the center of the earth or relative to the drawing, is permissible.

0101<figref idref="f0004"><b>Fig. 5A</b></figref> shows a front view of the clot catcher 100 according to the invention in a second housing 200.

0102In contrast to the first case 200, as it is for example in<figref idref="f0003">Fig. 4</figref> As shown, the outflow area 11 is in<figref idref="f0004">Fig. 5A</figref> arranged offset to the left relative to a central axis 17, ie an axis through the center point 7 of the clot catcher.

0103The outflow is tangential.

0104<figref idref="f0005">Fig. 5B</figref> shows a front view of the clot catcher according to the invention in a third housing 200.

0105In contrast to the representation in<figref idref="f0004">Fig. 5A</figref> or in<figref idref="f0003">Fig. 4</figref> is the outflow area 11 - related to the representation in<figref idref="f0005">Fig. 5B</figref> - offset to the right relative to the central axis 17.

0106In the fifth embodiment, a tangential outflow of the fluid flowing through the clot catcher is also provided.

0107<figref idref="f0006"><b>Fig. 6</b></figref> shows a sagittal or longitudinal section along S1-S1 from<figref idref="f0003">Fig. 4</figref> through the center 7. The line S1-S1 corresponds, as in<figref idref="f0003">Fig. 4</figref> shown, the central axis 17 through a center of the clot catcher 1.

0108The clot catcher 100 is arranged vertically in the housing 200.

0109Section 5 without passage openings is located in<figref idref="f0006">Fig. 6</figref> below, facing or adjacent to the outflow area 11.

0110<figref idref="f0007"><b>Fig. 7</b></figref> shows a longitudinal section of the clot catcher 100 according to the invention in a differently designed housing 200.

0111The housing 200 has, as in<figref idref="f0007">Fig. 7</figref> shown, has steps or slopes 19.

0112The clot catcher 100 is provided with a covering device, e.g., a film 21.

0113The film 21 can serve as a coupling surface for a sensor 23 above the clot catcher 100. The sensor 23 can be a pressure sensor. For example, the pressure of a fluid located in the inflow area 9 of the clot catcher 100 can be measured using the sensor 23.

0114The sensor 23 is connected via a connector 25 to, for example, a treatment device (not shown) or a control or regulating device (not shown) thereof.

0115Also in<figref idref="f0007">Fig. 7</figref> the dashed lines N (inclination) indicate that the clot catcher 100 according to the invention can be inclined during or for its use by - preferably - up to about 15° degrees, relative to a vertical or perpendicular to the center.

0116The<figref idref="f0008"><b>Fig. 8A to 8C</b></figref> show possible designs of passage openings 3 of the screen surface 1.

0117The<figref idref="f0008">Fig. 8A-C</figref> show configurations of the passage openings 3 along a section S2-S2 through the screen surface 1 according to<figref idref="f0001">Fig. 1</figref>.

0118The passage openings 3 are in<figref idref="f0008">Fig. 8A</figref> sharp-edged.

0119The passage openings 3 are in<figref idref="f0008">Fig. 8B</figref> rounded on one side (in the<figref idref="f0008">Fig. 8B</figref> above).

0120In<figref idref="f0008">Fig. 8C</figref> the passage openings 3 are rounded on both sides.