Hemodialyzer

Abstract

The utility model provides a hemodialyzer. The hemodialyzer comprises a shell, a hollow fiber membrane tow and a laminated membrane, a blood inlet and a blood outlet are formed in the two ends of the shell in the axial direction respectively, and a dialysate inlet and a dialysate outlet are formed in the side wall of the shell; the plurality of hollow fiber membrane tows are arranged in the shell and are communicated with the blood inlet and the blood outlet; a laminated membrane is arranged between the hollow fiber membrane tow and the shell, dialysate is conveyed to the laminated membrane from the dialysate inlet, the laminated membrane is used for filtering the dialysate, and the filtered dialysate is conveyed to the hollow fiber membrane tow for hemodialysis. The hemodialysis device solves the problem that in the existing hemodialysis process, unclean dialysate is introduced into a dialyzer, and the infection risk of a patient is increased.

Description

Technical Field

[0001] The utility model relates to the technical field of blood purification, in particular to a hemodialyzer. Background Art

[0002] Hemodialyzers are mainly used for hemodialysis and blood filtration in the treatment of kidney diseases. Hemodialyzers mainly use the principle of semipermeable membranes to introduce the patient's blood and dialysate into the hemodialyzer at the same time. The two flow in opposite directions on both sides of the dialysis membrane. With the help of the solute gradient, osmotic gradient and water pressure gradient on both sides of the membrane, to remove toxins and excess water retained in the body, while replenishing the substances needed by the body and maintaining electrolyte and acid-base balance.

[0003] In the process of hemodialysis, in order to ensure the quality of the dialysate, the dialysate in the hemodialysis circulation is generally filtered through a dialysate filter before being introduced into the dialyzer for use. However, the dialysate filter is a Class III medical device and is generally replaced after 3 to 6 months of clinical use. As a result, the filtration performance of the dialysate filter is greatly reduced in the later stage of use, and the dialysate may carry endotoxins and microorganisms. If the endotoxins and microorganisms carried in the dialysate cannot be filtered out, the unclean dialysate will be introduced into the dialyzer, increasing the risk of infection for the patient. Utility Model Content

[0004] The utility model aims to solve the problem that unclean dialysate is introduced into the dialyzer during the existing hemodialysis process, thereby increasing the risk of infection for the patient.

[0005] In order to solve the above problems, the utility model provides a hemodialyzer, comprising a housing, a hollow fiber membrane bundle and a laminated membrane;

[0006] The two ends of the shell in the axial direction are respectively provided with a blood inlet and a blood outlet, and the side wall of the shell is provided with a dialysate inlet and a dialysate outlet;

[0007] A plurality of hollow fiber membrane bundles are arranged inside the housing, and the hollow fiber membrane bundles are connected to the blood inlet and the blood outlet;

[0008] A laminated membrane is arranged between the hollow fiber membrane bundle and the shell, and the dialysate is transported from the dialysate inlet to the laminated membrane. The laminated membrane is used to filter the dialysate, and the filtered dialysate is transported to the hollow fiber membrane bundle for hemodialysis.

[0009] Furthermore, the laminated film comprises a support layer, a sustained-release layer and a protective layer which are sequentially arranged from the inside to the outside along the radial direction of the shell, and the surface of the sustained-release layer is coated with glucose sustained-release gel.

[0010] Furthermore, the glucose sustained-release gel is evenly distributed on the sustained-release layer, and the proportion of the glucose sustained-release gel on the sustained-release layer is 8 to 10 g / m 2 .

[0011] Furthermore, the sustained-release layer has a plurality of periodically formed convex portions, and a concave portion is formed between any two adjacent convex portions.

[0012] Furthermore, the glucose sustained-release gel is coated on the surface of the convex portion, and / or the glucose sustained-release gel is coated on the surface of the concave portion.

[0013] Furthermore, the molecular weight cutoffs of the support layer, the sustained-release layer and the protective layer increase in sequence.

[0014] Furthermore, the molecular weight cutoff of the support layer is 11500-13000Da, the molecular weight cutoff of the sustained-release layer is 13000-14500Da, and the molecular weight cutoff of the protective layer is 14500-30000Da.

[0015] Furthermore, the thickness of the protective layer is 80-100 μm, and the thickness of the supporting layer is 50-80 μm.

[0016] Furthermore, it also includes end covers and packaging glue, wherein two end covers are respectively arranged at two ends of the shell in the axial direction, one end cover is provided with the blood inlet, and the other end cover is provided with the blood outlet;

[0017] The packaging glue is respectively provided at both ends of the hollow fiber membrane bundle along the axial direction, and the packaging glue is bonded to the inner wall of the shell. The two ends of the hollow fiber membrane bundle along the axial direction respectively penetrate the packaging glue, so that the hollow fiber membrane bundle is connected with the blood inlet and the blood outlet, and the two ends of the laminated membrane along the axial direction are both located inside the packaging glue.

[0018] Furthermore, the laminated membrane is bound to the outer peripheral surface of the plurality of hollow fiber membrane bundles.

[0019] The hemodialyzer described in the utility model provides a laminated membrane between the hollow fiber membrane bundle and the outer shell. The laminated membrane can filter the dialysate, so that the dialysate filtered by the dialysate filter is subjected to secondary purification, and residual impurities, bacteria and endotoxin molecules in the dialysate are filtered out, so as to avoid a substantial decrease in the filtering performance of the dialysate filter in the later period of use, so that unclean dialysate is not introduced into the hemodialyzer. The hemodialyzer can ensure the quality of the dialysate, and is conducive to reducing the risk of infection in patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1This is a front cross-sectional structural schematic diagram of a hemodialyzer provided in an embodiment of the utility model;

[0021] Figure 2 It is a schematic diagram of the side cross-sectional structure of the hemodialyzer provided in the embodiment of the utility model;

[0022] Figure 3 This is a schematic diagram of the first structure of the laminated film provided in the embodiment of the utility model;

[0023] Figure 4 A second structural schematic diagram of the laminated film provided in an embodiment of the utility model;

[0024] Figure 5 This is a schematic diagram of the third structure of the laminated film provided in the embodiment of the utility model. DETAILED DESCRIPTION

[0025] The technical solution of the utility model is described clearly and in detail below in conjunction with the accompanying drawings. In the description of the utility model, it should be noted that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate the orientation or position relationship based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the utility model. In addition, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the said features.

[0026] In the description of this specification, the term "as an optional implementation" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one optional embodiment or optional example of the utility model. In this specification, the schematic representation of the above terms does not necessarily refer to the same implementation or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0027] Combination Figure 1 and Figure 2 As shown, this embodiment provides a hemodialyzer, including a housing 1, a hollow fiber membrane bundle 2, a laminated membrane 3, an end cap 4 and a packaging glue 5, wherein:

[0028] The shell 1 is a hollow shell, and end caps 4 are respectively provided at both ends of the shell 1 in the axial direction. The end caps 4 and the shell 1 can be connected by threads, or by snap-fit ​​connections; openings are provided on the end caps 4, one of which is a blood inlet 41, and the other is a blood outlet 42. A dialysate inlet 11 and a dialysate outlet 12 are provided on the side wall of the shell 1 between the two end caps 4. The dialysate entering the shell 1 can only flow between the two end caps 4. The dialysate inlet 11 is provided close to one end cap 4, and the dialysate outlet 12 is provided close to the other end cap 4. The dialysate inlet 11 is provided close to the blood outlet 42, and the dialysate outlet 12 is provided close to the blood inlet 41, that is, the dialysate inlet 11 is provided close to the lower end cap 4, and the dialysate outlet 12 is provided close to the upper end cap 4, thereby making the flow direction of the dialysate opposite to the flow direction of the blood;

[0029] A plurality of hollow fiber membrane bundles 2 are arranged inside the housing 1, and the hollow fiber membrane bundles 2 are connected to the blood inlet 41 and the blood outlet 42. The hollow fiber membrane bundles 2 have a blood channel inside, and blood is transported from the blood inlet 41 to the inside of the hollow fiber membrane bundles 2 and output through the blood outlet 42;

[0030] A laminated membrane 3 is arranged between the hollow fiber membrane bundle 2 and the outer shell 1. The dialysate is transported from the dialysate inlet 11 to the laminated membrane 3. The laminated membrane 3 is used to filter the dialysate. The filtered dialysate is transported to the hollow fiber membrane bundle 2 to exchange substances with the blood. The dialysate after the exchange of substances is output from the dialysate outlet 12.

[0031] In this embodiment, by arranging a laminated membrane between the hollow fiber membrane bundle and the outer shell, the laminated membrane can filter the dialysate, so that the dialysate filtered by the dialysate filter is subjected to secondary purification, and residual impurities, bacteria and endotoxin molecules in the dialysate are filtered out, thereby avoiding a substantial decrease in the filtering performance of the dialysate filter in the later stage of use, and causing unclean dialysate to be introduced into the hemodialyzer. The hemodialyzer can ensure the quality of the dialysate and help reduce the risk of infection in patients.

[0032] In this embodiment, the material of the shell 1 can be at least one of polycarbonate, polypropylene and polystyrene. The material of the hollow fiber membrane bundle 2 is a medical material with high biocompatibility. Specifically, the material of the hollow fiber membrane bundle 2 can be at least one of polyethersulfone, polysulfone, polyacrylonitrile-sodium methyl propylene sulfonate, polyacrylonitrile and polymethyl methacrylate. The molecular weight cutoff of the hollow fiber membrane bundle 2 is 3000-10000Da. The specific molecular weight cutoff of the hollow fiber membrane bundle 2 can be selected according to actual use requirements.

[0033] In the present embodiment, the laminated membrane 3 is bound to the outer circumferential surface of the plurality of hollow fiber membrane bundles 2, that is, the outer circumferential surfaces of the plurality of hollow fiber membrane bundles 2 can be wrapped by the laminated membrane 3 and then placed in the interior of the outer shell 1. Therefore, when assembling the hollow fiber membrane bundles 2, the laminated membrane 3 can replace the traditional disposable silk wrapping membrane to wrap the hollow fiber membrane bundles 2, and after assembly, the process of manually pulling out the disposable silk wrapping membrane can be eliminated, which is not only conducive to reducing the difficulty of automated assembly of the hemodialysis machine, improving the efficiency of assembling the hollow fiber membrane bundles 2, but also can save material costs.

[0034] In this embodiment, the packaging glue 5 is also arranged inside the shell 1, and two packaging glues 5 are respectively arranged at the two ends of the hollow fiber membrane bundle 2 in the axial direction, and the two ends of the hollow fiber membrane bundle 2 in the axial direction respectively penetrate the packaging glue 5, so that the hollow fiber membrane bundle 2 is connected with the blood inlet 41 and the blood outlet 42 respectively, so as to facilitate the blood to flow into the hollow fiber membrane bundle 2; the packaging glue 5 is bonded to the inner wall of the shell 1 to realize the fixed connection between the hollow fiber membrane bundle 2 and the shell 1, and the two ends of the laminated membrane 3 in the axial direction are both located inside the packaging glue 5, that is, the two ends of the laminated membrane 3 do not pass through the packaging glue 5, and the two ends of the laminated membrane 3 are blocked by the packaging glue 5 to avoid direct contact between the laminated membrane 3 and the blood, thereby avoiding direct contact between the blood and the dialysate.

[0035] In this embodiment, the material of the packaging glue 5 can be a non-toxic medical polyurethane adhesive, which is safe and non-toxic, and is conducive to improving the safety of the entire device.

[0036] Combination Figure 2 As shown, in this embodiment, the laminated membrane 3 includes a support layer 31, a sustained-release layer 32 and a protective layer 33 arranged in sequence from the inside to the outside along the radial direction of the shell 1, that is, the protective layer 33 is closest to the inner wall of the shell 1, the support layer 31 is closest to the hollow fiber membrane bundle 2, and the molecular weight cutoffs of the support layer 31, the sustained-release layer 32 and the protective layer 33 increase in sequence. As an optional embodiment, the molecular weight cutoff of the support layer 31 is 11500-13000Da, the molecular weight cutoff of the sustained-release layer 32 is 13000-14500Da, and the molecular weight cutoff of the protective layer 33 is 14500-30000Da. Therefore, the outermost protective layer 33 has the largest molecular weight cutoff. After the dialysate flows in from the dialysate inlet 11, it first contacts the protective layer 33. The protective layer 33 can filter out the impurities and large molecular endotoxins remaining in the dialysate. The sustained-release layer 32 arranged in the middle layer can filter out the impurities and small and medium molecular endotoxins that the protective layer 33 cannot filter out. The support layer 31 arranged in the innermost layer can filter out bacteria and small molecular endotoxins in the dialysate. The dialysate is filtered in turn by the protective layer 33, the sustained-release layer 32 and the support layer 31, and various types of impurities, bacteria and endotoxins in the dialysate can be filtered out in stages to ensure the cleanliness of the dialysate, so as to ensure that the hemodialyzer has a better dialysis treatment effect.

[0037] In this embodiment, the hollow fiber membrane bundle 2 occupies 50% to 70% of the internal space of the shell 1, and the laminated membrane 3 occupies 10% to 30% of the internal space of the shell 1, thereby ensuring that the hemodialyzer has a better dialysis effect.

[0038] In this embodiment, the material of the laminated film 3 can be at least one of medical grade polyamide, polypropylene, butadiene-butyl acrylate polymer, polyethylene and polyurethane, and the molecular weight cutoff of the laminated film 3 is 11500-30000Da. As an optional embodiment, the material of the support layer 31 and the protective layer 33 can be at least one of polypropylene, butadiene-butyl acrylate polymer and polyethylene, and the material of the sustained-release layer 32 can be at least one of medical grade polyamide, polyurethane, polyether sulfone and polysulfone.

[0039] As an optional embodiment, the surface of the slow-release layer 32 is coated with a glucose slow-release gel 321. Thus, while the laminated membrane 3 filters the dialysate, the glucose slow-release gel 321 on the surface of the slow-release layer 32 can slowly release glucose molecules to replenish the glucose molecules in the dialysate, thereby maintaining the stability of the glucose concentration in the dialysate and alleviating the patient's discomfort during the hemodialysis process, so as to ensure that the hemodialyzer has a better dialysis treatment effect. Preferably, the glucose slow-release gel 321 is evenly distributed on the surface of the slow-release layer 32, and the proportion of the glucose slow-release gel 321 on the slow-release layer 32 is 8 to 10 g / m 2 , in order to better maintain the stability of glucose concentration in the dialysate.

[0040] As an optional embodiment, the protective layer 33 and the supporting layer 31 are both planar membrane layers, the thickness of the protective layer 33 is 80-100 μm, and the thickness of the supporting layer 31 is 50-80 μm, thereby achieving a better filtering effect and further improving the cleanliness of the dialysate.

[0041] As an optional embodiment, the sustained-release layer 32 is a non-planar film layer. Specifically, the sustained-release layer 32 has a plurality of periodically formed convex portions, and a concave portion is formed between any two adjacent convex portions. The cross-sectional shape of each convex portion can be set to a triangle, rectangle, trapezoid or arc shape, and the cross-sectional shape of each concave portion can also be set to a triangle, rectangle, trapezoid or arc shape. Thus, setting the surface of the sustained-release layer 32 to an undulating structure can increase the surface area of ​​the sustained-release layer 32, thereby increasing the membrane area of ​​the sustained-release layer 32 in contact with the dialysate, which is not only conducive to enhancing the release effect of glucose, but also conducive to improving the filtration efficiency of the sustained-release layer.

[0042] Combination Figures 3 to 5 As shown, the glucose sustained-release gel 321 is coated on the surface of the convex part, and / or the glucose sustained-release gel 321 is coated on the surface of the concave part. Figure 3 The glucose sustained-release gel 321 is coated on the bottom of each recess. Figure 4 The medium glucose sustained-release gel 321 is applied on the top of each convex part. Figure 5 The glucose slow-release gel 321 is coated on the bottom of the concave portion and the top of the convex portion at the same time. Preferably, the glucose slow-release gel 321 is coated on the bottom of the concave portion and the top of the convex portion at the same time to enhance the slow-release effect of glucose.

[0043] When the hemodialyzer provided in this embodiment is in use, the pipes on the blood inlet 41, the blood outlet 42, the dialysate inlet 11 and the dialysate outlet 12 are correspondingly connected, and the patient's blood enters the interior of the shell 1 from the blood inlet 41, flows downward through the hollow fiber membrane bundle 2, and finally flows out through the blood outlet 42; at the same time, the dialysate enters the laminated membrane 3 from the dialysate inlet 11, and the dialysate filtered by the laminated membrane 3 flows upward along the outer wall of the hollow fiber membrane bundle 2, and exchanges substances with the blood through the outer wall of the hollow fiber membrane bundle 2. The dialysate after the exchange of substances is finally output from the dialysate outlet 12.

[0044] Although the disclosure is as above, the protection scope of the disclosure is not limited thereto. Those skilled in the art may make various changes and modifications without departing from the spirit and scope of the disclosure, and these changes and modifications will fall within the protection scope of the utility model.

Claims

1. A hemodialyzer, characterized in that: including a housing, a hollow fiber membrane bundle, and a laminated membrane; The two ends of the shell in the axial direction are respectively provided with a blood inlet and a blood outlet, and the side wall of the shell is provided with a dialysate inlet and a dialysate outlet; A plurality of hollow fiber membrane bundles are arranged inside the housing, and the hollow fiber membrane bundles are connected to the blood inlet and the blood outlet; A laminated membrane is arranged between the hollow fiber membrane bundle and the shell, and the dialysate is transported from the dialysate inlet to the laminated membrane. The laminated membrane is used to filter the dialysate, and the filtered dialysate is transported to the hollow fiber membrane bundle for hemodialysis.

2. The hemodialyzer according to claim 1, characterized in that: The laminated film comprises a support layer, a sustained-release layer and a protective layer which are sequentially arranged from the inside to the outside along the radial direction of the shell, and the surface of the sustained-release layer is coated with glucose sustained-release gel.

3. The hemodialyzer according to claim 2, characterized in that: The glucose sustained-release gel is evenly distributed on the sustained-release layer, and the proportion of the glucose sustained-release gel on the sustained-release layer is 8 to 10 g / m 2 .

4. The hemodialyzer according to claim 2, characterized in that: The sustained-release layer has a plurality of periodically formed convex portions, and a concave portion is formed between any two adjacent convex portions.

5. The hemodialyzer according to claim 4, characterized in that: The glucose sustained-release gel is coated on the surface of the convex part, and / or the glucose sustained-release gel is coated on the surface of the concave part.

6. The hemodialyzer according to claim 2, characterized in that: The molecular weight cutoffs of the support layer, the sustained-release layer and the protective layer increase in sequence.

7. The hemodialyzer according to claim 6, characterized in that: The molecular weight cutoff of the support layer is 11500-13000Da, the molecular weight cutoff of the sustained-release layer is 13000-14500Da, and the molecular weight cutoff of the protective layer is 14500-30000Da.

8. The hemodialyzer according to claim 2, characterized in that: The thickness of the protective layer is 80-100 μm, and the thickness of the supporting layer is 50-80 μm.

9. The hemodialyzer according to claim 1, characterized in that: It also includes end covers and packaging glue, wherein two end covers are respectively arranged at two ends of the shell in the axial direction, one end cover is provided with the blood inlet, and the other end cover is provided with the blood outlet; The packaging glue is respectively provided at both ends of the hollow fiber membrane bundle along the axial direction, and the packaging glue is bonded to the inner wall of the shell. The two ends of the hollow fiber membrane bundle along the axial direction respectively penetrate the packaging glue, so that the hollow fiber membrane bundle is connected with the blood inlet and the blood outlet, and the two ends of the laminated membrane along the axial direction are both located inside the packaging glue.

10. The hemodialyzer according to claim 1, characterized in that: The laminated membrane is bound to the outer peripheral surface of the plurality of hollow fiber membrane bundles.

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