DIALYSER, DIALYSIS EQUIPMENT AND KIT AND METHOD FOR PRODUCING A DIALYSER

Abstract

A dialyzer, a dialysis machine, a kit and a process for producing the dialyzer. The dialyzer includes a plurality of hollow fibers disposed in a housing of the dialyzer. The hollow fibers are wrapped with a textile fabric that is fluid-permeable and/or at least partly water-soluble.

Claims

1.-15. (canceled)

16. A dialyzer comprising: a housing; and a plurality of hollow fibers disposed in the housing, the plurality of hollow fibers being wrapped with a textile fabric, the textile fabric being fluid-permeable and/or at least partly water-soluble in design, the textile fabric comprising textile fibers each having a fiber core and a fiber sheath at least partly surrounding the fiber core, each fiber core comprising a fiber core polymer having a first melting point, each fiber sheath comprising a fiber sheath polymer having a second melting point, the first melting point being higher than the second melting point.

17. The dialyzer according to claim 16, wherein the textile fabric has a mean pore diameter of 0.1 mm to 10 mm.

18. The dialyzer according to claim 16, wherein the textile fabric has a mean pore diameter of 200 μm to 1 mm.

19. The dialyzer according to claim 16, wherein the textile fabric is a nonwoven fabric.

20. The dialyzer according to claim 16, wherein the textile fabric is a woven fabric.

21. The dialyzer according to claim 16, wherein the textile fibers are bicomponent fibers.

22. The dialyzer according to claim 16, wherein the fiber core polymer is selected from the group consisting of polyterephthalates, polyalkylene terephthalates, polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, polyolefins, polyethylene, high-density polyethylene, low-density polyethylene, linear low-density polyethylene, high molecular mass polyethylene, ultra-high molecular mass polyethylene, polypropylene, and any combination thereof.

23. The dialyzer according to claim 16, wherein the fiber sheath polymer is selected from the group consisting of polyamides, copolyamides, polyamide 6, polyamide 6.6, polyamide 6T, polyamide 6.9, polyamide 6.12, polyamide 11, polyamide 12, polyamide 4.6, polyamide 12.12, polyamide 10.10, and any combination thereof.

24. The dialyzer according to claim 16, wherein the fiber core polymer is a polyalkylene terephthalate and/or the fiber sheath polymer is a polyamide.

25. The dialyzer according to claim 16, wherein the fiber core polymer comprises polyethylene terephthalate.

26. The dialyzer according to claim 16, wherein the fiber sheath polymer comprises polyamide 6.

27. The dialyzer according to claim 16, wherein the textile fabric is functionalized by DNA-binding groups and/or enderotoxin-binding groups and/or microbe-binding groups.

28. The dialyzer according to claim 16, wherein the textile fabric comprises an at least partly water-soluble polymer selected from the group consisting of: polyvinyl alcohol, polyethylene glycol, gelatin, starch, amylose, amylopectin, dextran, methylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxybutylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, hyaluronic acid, chondroitin 4-sulfate, chondroitin 6-sulfate, keratan sulfate, alginate, alginic acid, heparin, heparan sulfate, chitin, chitosan, salts of the aforesaid at least partly water-soluble polymers, derivatives of the aforesaid at least partly water-soluble polymers, and any combination thereof.

29. The dialyzer according to claim 16, wherein the textile fabric wraps the plurality of hollow fibers to form a wrapped construction which is a three-ply construction at least in sections.

30. The dialyzer according to claim 29, wherein the three-ply construction comprises an outer ply and a middle ply, the outer ply and the middle ply being joined to one another through a materially bonded connection.

31. The dialyzer according to claim 30, wherein the materially bonded connection is a welded connection.

32. A dialysis machine comprising a dialyzer according to claim 16.

33. A kit for producing the dialyzer according to claim 16, the kit comprising: the plurality of hollow fibers; and an insertion aid for inserting the plurality of hollow fibers into the housing.

34. A method for producing the dialyzer according to claim 16, the method comprising the steps of: wrapping the plurality of hollow fibers with the textile fabric; and inserting the plurality of hollow fibers into the housing.

35. A dialyzer comprising: a housing; and a plurality of hollow fibers disposed in the housing, the plurality of hollow fibers being wrapped with a textile fabric, the textile fabric being fluid-permeable and/or at least partly water-soluble in design, and the textile fabric comprising an at least partly water-soluble polymer.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0092] Further features and advantages of the invention are apparent from the description hereinafter of preferred exemplary embodiments of the invention, which are represented using the drawings.

[0093] FIG. 1 shows a schematic longitudinal-sectional representation of one embodiment of a dialyzer of the invention,

[0094] FIG. 2 shows schematically an enlarged detail of a wound textile fabric of a dialyzer of the invention in a region A according to FIG. 1,

[0095] FIG. 3 shows schematically an enlarged detail of an alternative wound textile fabric of a dialyzer of the invention in a region A according to FIG. 1,

[0096] FIG. 4 shows a schematic cross-sectional representation of a dialyzer of the invention along a section line IV-IV according to FIG. 1, and

[0097] FIG. 5 shows schematically one embodiment of a kit of the invention.

DETAILED DESCRIPTION

[0098] FIG. 1 shows schematically a longitudinal-sectional representation of one embodiment of a dialyzer 10 according to the present invention.

[0099] The dialyzer 10 comprises a multiplicity of hollow fibers 12. The hollow fibers 12 are disposed in a housing 14 of the dialyzer 10. These hollow fibers 12 are extended in the longitudinal direction of the housing 14 and disposed alongside one another transverse to the longitudinal direction of the housing 14. The hollow fibers 12 are preferably disposed parallel or substantially parallel to one another. Axial end portions of the hollow fibers 12 are preferably accommodated in a hollow fiber embedment (not shown), made of polyurethane, for example.

[0100] The housing 14 is preferably tubular, more particularly round-tubular, in design. The housing 14 may further be produced of a plastic.

[0101] The hollow fibers 12 in the housing 14 are wrapped with a textile fabric 16. The textile fabric 16 wound around the hollow fibers 12 therefore forms a textile casing wrap or textile wrapped structure. The wound textile fabric 16 is preferably fastened by a material-bonded connection, preferably welded connection, 22 which extends in the longitudinal direction of the wound fabric 16 (see FIG. 4).

[0102] The hollow fibers 12 are collected together by the textile fabric 16 preferably to form a hollow fiber bundle, having more particularly a circular cross section.

[0103] The textile fabric 16 is fluid-permeable, more particularly water- and/or dialysate-permeable, and/or at least partly, preferably completely, water-soluble in design. The textile fabric 16 can consequently remain in the dialyzer housing 14. There is therefore no need for the textile fabric 16 to be removed from the dialyzer housing 14, hence enabling avoidance of the bent fiber-related disadvantages that are known in the context of generic dialyzers.

[0104] The textile fabric 16 preferably possesses a pore diameter, more particularly mean pore diameter, of 0.1 μm to 10 mm, more particularly 200 μm to 1 mm, preferably 1 mm to 5 mm. As a result of the aforesaid pore diameters, in particular, it is possible with particular advantage to ensure that the textile fabric 16 presents significant resistance neither when sealing the hollow fibers 12 with a casting compound to produce a hollow fiber embedment nor on dialysate flow during as-intended use of the dialyzer 10.

[0105] It may further be preferable for the textile fabric 16 to comprise fibers having a core-sheath construction, i.e., fibers having a fiber core and a fiber sheath that surrounds the fiber core at least partly, preferably completely. The fiber core preferably comprises a fiber core polymer and the fiber sheath a fiber sheath polymer, with the fiber core polymer preferably having a higher melting point than the fiber sheath polymer. The fiber core polymer may more particularly be a polyalkylene terephthalate, preferably polyethylene terephthalate, and the fiber sheath polymer may more particularly be a polyamide, preferably polyamide 6. As a result it is possible in the case, for example, of welded fastening of the wound textile fabric 16, using a welding temperature at which the fiber sheath polymer does melt but the fiber core polymer does not, to prevent weld penetration of the wound textile fabric 16 and hence damage to the hollow fibers 12.

[0106] The textile fabric 16 may alternatively be manufactured at least partly, more particularly completely, of a water-soluble polymer, preferably polyvinyl alcohol.

[0107] FIG. 2 shows schematically an enlarged detail of a wound textile fabric 16 of a dialyzer 10 of the invention in a region A according to FIG. 1. The textile fabric 16 is designed as a nonwoven fabric. The nonwoven fabric may comprise, for example, fibers having a core-sheath construction, as described in the context of FIG. 1, and may have a basis weight of 30 g/m.sup.2, a thickness of 0.25 mm, an air permeability (1 mbar) of 4500 l/m.sup.2s, a breaking strength of 55 N/5 cm, an elongation at break of 16%, a tear resistance of 40 N, a stiffness of 0.3 mN, and a fiber diameter of 37 μm. A nonwoven fabric of this kind is available commercially under the registered trademark COLBACK® WA 30.

[0108] FIG. 3 shows schematically an enlarged detail of an alternative wound textile fabric 16 of a dialyzer 10 of the invention in a region A according to FIG. 1. The textile fabric 16 is designed as a woven fabric. The above-stated mesh sizes in particular represent advantageously a resistance which is negligible both toward a casting compound used for producing a hollow fiber embedment and toward a dialysate flow.

[0109] FIG. 4 shows schematically a cross-sectional representation of a dialyzer 10 according to FIG. 1. The textile fabric 16 wraps the hollow fibers 12 to form a wrapped construction 15 which is three-ply at least in sections, more particularly only in sections, having an outer ply 17, a middle ply 19, and an inner ply 21. Preferably only the outer ply 17 and the middle ply 19 are connected to one another by a material-bonded connection, preferably welded connection, 22. In other words, the inner ply 21 is preferably not included in the material-bonded connection, more particularly welded connection, 22. The inner ply 21 therefore serves preferably exclusively as a protective layer for the hollow fibers 12. This makes it possible to prevent damage to the hollow fibers 12 when fastening or closing the wound textile fabric 16. The wound textile fabric 16 preferably bears gaplessly against the inside of the wall 13 of the housing 14.

[0110] FIG. 5 shows schematically one embodiment of a kit 20 of the invention.

[0111] The kit 20 comprises a textile fabric 16, which wraps a multiplicity of hollow fibers 12. The kit 20 further comprises an insertion aid 21 for inserting the multiplicity of hollow fibers 12 wrapped with the textile fabric 16 into a housing of a dialyzer. The insertion aid is preferably funnel-shaped in design.

[0112] With regard to further features and advantages of the textile fabric 16 and also of the multiplicity of hollow fibers 12, reference is made fully, in order to avoid repetitions, to the figure descriptions for FIGS. 1 to 4. The features and advantages described there especially in relation to the textile fabric 16, the hollow fibers 12, and the dialyzer 10 are also valid, mutatis mutandis, for the kit 20.