Urinary catheter suite

Abstract

The present invention provides a urine collection bag comprising a cavity for containing urine, the bag comprising a three-layer laminated film comprising, in order: a first ethylene-vinyl acetate layer, a polyethylene layer and a second ethylene-vinyl acetate layer.

Description

Technical Field

[0001] This invention relates to urine collection bags and catheter sleeves comprising laminated membrane materials. Background Technology

[0002] Urinary catheterization is a common medical procedure used to drain urine from patients who cannot urinate naturally. Typically, a catheter is inserted into the patient's urethra and connected to a urine collection bag to allow for the collection and monitoring of urine output. To ensure patient comfort and hygiene, it is essential to develop catheter kits with components such as urine collection bags and catheter cannulas that offer a range of beneficial features.

[0003] A key consideration in designing catheter kit components is material selection. Traditional urine collection bags and catheter sheaths are typically made of thick plastic materials, resulting in bulkiness, increased weight, and patient discomfort. Furthermore, the extensive use of plastic contributes to environmental problems. Other known drawbacks of traditional materials include discoloration or degradation when exposed to sterilization methods such as steam or chemical reagents. Additionally, traditional materials are known to produce disruptive noises, such as hissing, during movement, which can reduce patient comfort and privacy during catheter insertion.

[0004] There is a need for new and improved materials for catheter insertion applications that overcome or mitigate one or more of the problems of the prior art described above.

[0005] The purpose of these embodiments is to overcome or mitigate at least one problem of the prior art, whether or not it is explicitly described herein. Summary of the Invention

[0006] According to a first aspect of the invention, a urine collection bag is provided, comprising a cavity for containing urine, the bag comprising a three-layer laminated film comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer.

[0007] This three-layer laminated membrane offers several advantages over conventional materials. The layer combination used in the three-layer membrane imparts exceptional strength to the material, even in the case of a thin film. Therefore, even thin layers of the three-layer membrane can be successfully used in the construction of catheter kit components, significantly reducing the amount of plastic required in manufacturing. This reduction in plastic usage helps minimize waste and contributes to environmental sustainability. The membrane also achieves lightweight construction without sacrificing strength, thus allowing the development of lightweight urine collection bags that still effectively hold large volumes of urine. The membrane is also relatively quiet during handling or transport and produces no noticeable rustling or other disruptive noises during movement, enhancing patient comfort and privacy. Furthermore, the three-layer laminated membrane is believed to offer excellent resistance to discoloration during sterilization processes. Sterilization is a critical step in maintaining the hygiene and safety of catheter kit components, and the membrane is believed to maintain its appearance and integrity even after repeated sterilization cycles.

[0008] In some embodiments, at least 50 wt.% (by weight) of the bag may comprise a three-layer film, or at least 60 wt.%, at least 70 wt.%, at least 80 wt.%, at least 90 wt.%, or at least 96 wt.% of the bag may comprise a three-layer film. Preferably, the bag may be made entirely of a three-layer film.

[0009] In some embodiments, the cavity of the bag is defined by the three-layer membrane.

[0010] In some embodiments, the bag includes a front wall and a rear wall, wherein the front wall and the rear wall are sealed together to form a cavity between them, and wherein the front wall and the rear wall include a three-layer membrane.

[0011] In some embodiments, the front and rear walls are sealed together at their peripheries to form a cavity. The front and rear walls may be fused together at their peripheries to form the cavity. The fused portion may extend through all layers of the membrane of the front and rear walls.

[0012] In some embodiments, the front or rear wall includes an inlet for receiving urine.

[0013] In some embodiments, the bag includes an attachment element for attaching the bag to a catheter. In some embodiments, the attachment element includes a mechanical fastening mechanism. The attachment element may include a check valve to prevent urine from flowing back from the bag into the catheter during use.

[0014] The bag may be configured to hold at least 400 ml of urine, or at least 450 ml, at least 500 ml, at least 550 ml, at least 600 ml, at least 650 ml, at least 700 ml, or at least 750 ml of urine. The bag may also be configured to hold 500-2000 ml of urine, or 750-1500 ml of urine.

[0015] In some embodiments, the thickness of at least one layer of the membrane is at least 2 micrometers, or at least 3 micrometers, at least 4 micrometers, at least 5 micrometers, at least 6 micrometers, at least 7 micrometers, at least 8 micrometers, at least 9 micrometers, or at least 10 micrometers. In some embodiments, the thickness of at least one layer of the membrane is not greater than 80 micrometers, not greater than 75 micrometers, not greater than 70 micrometers, not greater than 65 micrometers, not greater than 60 micrometers, not greater than 55 micrometers, not greater than 50 micrometers, not greater than 45 micrometers, or not greater than 40 micrometers. The thickness of at least one layer of the membrane may be in the range of 10-40 micrometers, or in the range of 15-35 micrometers, or in the range of 20-30 micrometers.

[0016] In some embodiments, at least one ethylene-vinyl acetate layer of the membrane has a thickness of at least 2 micrometers, or at least 3 micrometers, at least 4 micrometers, at least 5 micrometers, at least 6 micrometers, at least 7 micrometers, at least 8 micrometers, at least 9 micrometers, or at least 10 micrometers. In some embodiments, the thickness of at least one ethylene-vinyl acetate layer of the membrane is not greater than 80 micrometers, not greater than 75 micrometers, not greater than 70 micrometers, not greater than 65 micrometers, not greater than 60 micrometers, not greater than 55 micrometers, not greater than 50 micrometers, not greater than 45 micrometers, or not greater than 40 micrometers. The thickness of at least one ethylene-vinyl acetate layer of the membrane may be in the range of 10-40 micrometers, or in the range of 15-35 micrometers, or in the range of 20-30 micrometers. The first and / or second ethylene-vinyl acetate layers may have the thicknesses described above.

[0017] In some embodiments, the thickness of the polyethylene layer of the membrane is at least 2 micrometers, or at least 3 micrometers, at least 4 micrometers, at least 5 micrometers, at least 6 micrometers, at least 7 micrometers, at least 8 micrometers, at least 9 micrometers, or at least 10 micrometers. In some embodiments, the thickness of the polyethylene layer of the membrane is not greater than 80 micrometers, not greater than 75 micrometers, not greater than 70 micrometers, not greater than 65 micrometers, not greater than 60 micrometers, not greater than 55 micrometers, not greater than 50 micrometers, not greater than 45 micrometers, or not greater than 40 micrometers. The thickness of the polyethylene layer of the membrane may be in the range of 10-40 micrometers, or in the range of 15-35 micrometers, or in the range of 20-35 micrometers, or in the range of 25-35 micrometers.

[0018] In some embodiments, the first and second ethylene-vinyl acetate layers each have a thickness of 10-40 micrometers; and the thickness of the polyethylene layer is in the range of 10-40 micrometers, or in the range of 15-35 micrometers, or in the range of 20-35 micrometers, or in the range of 25-35 micrometers.

[0019] In some embodiments, the first and second ethylene-vinyl acetate layers each have a thickness of 15-35 micrometers; and the thickness of the polyethylene layer is in the range of 10-40 micrometers, or in the range of 15-35 micrometers, or in the range of 20-35 micrometers, or in the range of 25-35 micrometers.

[0020] In some embodiments, the first and second ethylene-vinyl acetate layers each have a thickness of 20-30 micrometers; and the thickness of the polyethylene layer is in the range of 10-40 micrometers, or in the range of 15-35 micrometers, or in the range of 20-35 micrometers, or in the range of 25-35 micrometers.

[0021] In some embodiments, the membrane has a total thickness of at least 40 micrometers, at least 45 micrometers, or at least 50 micrometers. The total thickness of the membrane may not exceed 150 micrometers, or not exceed 145 micrometers, 140 micrometers, 135 micrometers, 130 micrometers, 125 micrometers, 120 micrometers, 115 micrometers, 110 micrometers, 105 micrometers, or 100 micrometers. The total thickness of the membrane may be in the range of 40-100 micrometers, or in the range of 45-100 micrometers, or in the range of 50-100 micrometers, or in the range of 55-95 micrometers, or preferably in the range of 60-90 micrometers, or in the range of 65-85 micrometers, or preferably in the range of 70-80 micrometers.

[0022] In some embodiments, the total thickness of the membrane may be in the range of 40-95 micrometers, or in the range of 45-90 micrometers.

[0023] In some embodiments, the first and second ethylene-vinyl acetate layers of the membrane have the same thickness. The first and / or second ethylene-vinyl acetate layers may have the same thickness as the polyethylene layer. In some embodiments, all three layers of the three-layer membrane have the same thickness.

[0024] In several other embodiments, the ethylene-vinyl acetate layer of the membrane has a different thickness than the polyethylene layer. The polyethylene layer may be thicker than the ethylene-vinyl acetate layer. In some embodiments, all three layers of the three-layer membrane have different thicknesses.

[0025] The polyethylene layer may contain at least 80 wt.% polyethylene, or at least 85 wt.%, at least 90 wt.%, or at least 95 wt.% polyethylene. In some embodiments, the polyethylene layer is made entirely of polyethylene.

[0026] In some preferred embodiments, a urine collection bag is provided, which includes a cavity for containing urine. The bag includes a three-layer laminated film, which sequentially includes: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the polyethylene layer of the film contains at least 80 wt.% polyethylene in total, preferably the polyethylene layer is made entirely of polyethylene.

[0027] In some preferred embodiments, the polyethylene layer of the membrane contains less than 10 wt.% or less than 5 wt.% ethylene-vinyl acetate in total. In several preferred embodiments, the polyethylene layer does not contain ethylene-vinyl acetate.

[0028] In some preferred embodiments, a urine collection bag is provided, which includes a cavity for containing urine. The bag includes a three-layer laminated film, which sequentially includes: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the polyethylene layer of the film contains less than 10 wt.% ethylene-vinyl acetate in total. Preferably, the polyethylene layer does not contain ethylene-vinyl acetate.

[0029] At least one ethylene-vinyl acetate layer may comprise at least 80 wt.%, or at least 85 wt.%, at least 90 wt.%, or at least 95 wt.% of ethylene-vinyl acetate in total. In some embodiments, the ethylene-vinyl acetate layer is made entirely of ethylene-vinyl acetate.

[0030] In some preferred embodiments, a urine collection bag is provided, comprising a cavity for containing urine. The bag comprises a three-layer laminated film, which sequentially comprises: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein at least one ethylene-vinyl acetate layer of the film contains at least 95 wt.% ethylene-vinyl acetate in total, and preferably, the at least one ethylene-vinyl acetate layer is made entirely of ethylene-vinyl acetate.

[0031] In some preferred embodiments, at least one ethylene-vinyl acetate layer of the membrane comprises polyethylene in a total amount less than 10 wt.% of the ethylene-vinyl acetate layer, or in a total amount less than 5 wt.% of the ethylene-vinyl acetate layer. In several preferred embodiments, neither at least one ethylene-vinyl acetate layer, nor preferably the first and second ethylene-vinyl acetate layers, comprises polyethylene.

[0032] In some preferred embodiments, a urine collection bag is provided, which includes a cavity for containing urine. The bag includes a three-layer laminated film, which sequentially includes: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein at least one ethylene-vinyl acetate layer of the film contains less than 10 wt.% polyethylene in total. Preferably, at least one ethylene-vinyl acetate layer does not contain polyethylene.

[0033] In some preferred embodiments, the first and second ethylene-vinyl acetate layers of the membrane are each made entirely of ethylene-vinyl acetate, and the polyethylene layer of the membrane is made entirely of polyethylene.

[0034] In some preferred embodiments, a urine collection bag is provided, which includes a cavity for containing urine. The bag includes a three-layer laminated film, which sequentially includes: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the first and second ethylene-vinyl acetate layers of the film are each made entirely of ethylene-vinyl acetate, and the polyethylene layer of the film is made entirely of polyethylene.

[0035] It has been found that providing a layered membrane structure (in which ethylene-vinyl acetate is largely separated from polyethylene, and both materials exist in discontinuous layers with polyethylene layers sandwiched between ethylene-vinyl acetate) allows the membrane to not only possess excellent strength but also operate quietly during handling / processing, producing minimal hissing or other destructive noise. Furthermore, this membrane structure provides excellent resistance to discoloration, even when the membrane undergoes multiple sterilization processes.

[0036] In some embodiments, the membrane comprises a total amount of at least 2 wt.% or at least 3 wt.%, at least 4 wt.% or at least 5 wt.% of polyethylene. In some embodiments, the membrane comprises a total amount of not more than 80 wt.%, not more than 75 wt.%, not more than 70 wt.%, or not more than 60 wt.%, not more than 50 wt.%, not more than 40 wt.%, not more than 30 wt.%, not more than 20 wt.%, or not more than 15 wt.% of polyethylene.

[0037] In some embodiments, the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the total amount of polyethylene contained in the membrane is in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0038] In some preferred embodiments, the total amount of polyethylene contained in the membrane is in the range of 5-50 wt.% or preferably in the range of 10-45 wt.%.

[0039] In some preferred embodiments, a urine collection bag is provided, which includes a cavity for containing urine. The bag includes a three-layer laminated film, which sequentially includes: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the film contains polyethylene in a total amount in the range of 5-50 wt.% or preferably in the range of 10-45 wt.%.

[0040] In some embodiments, the membrane comprises at least 2 wt.% or at least 3 wt.%, at least 4 wt.%, at least 5 wt.%, at least 10 wt.%, at least 15 wt.%, at least 20 wt.%, or at least 25 wt.% of ethylene-vinyl acetate in total. In some embodiments, the membrane comprises no more than 95 wt.%, or no more than 90 wt.%, no more than 85 wt.%, no more than 80 wt.%, no more than 75 wt.%, or no more than 70 wt.%, or no more than 60 wt.%, no more than 50 wt.%, no more than 40 wt.%, no more than 30 wt.%, no more than 20 wt.%, or no more than 15 wt.%.

[0041] In some embodiments, the total amount of ethylene-vinyl acetate contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the total amount of ethylene-vinyl acetate contained in the membrane is in the range of 80-98 wt.%, or in the range of 75-95 wt.%, or in the range of 87-93 wt.%.

[0042] In some preferred embodiments, the total amount of ethylene-vinyl acetate contained in the membrane is in the range of 50-95 wt.% or preferably in the range of 55-90 wt.%.

[0043] In some preferred embodiments, a urine collection bag is provided, which includes a cavity for containing urine. The bag includes a three-layer laminated film, which sequentially includes: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of ethylene-vinyl acetate contained in the film is in the range of 50-95 wt.% or preferably in the range of 55-90 wt.%.

[0044] In some embodiments, the membrane comprises 10-70 wt.% polyethylene and 30-90 wt.% ethylene-vinyl acetate. The membrane may comprise 20-60 wt.% polyethylene and 40-80 wt.% ethylene-vinyl acetate. The membrane may comprise 30-50 wt.% polyethylene and 50-70 wt.% ethylene-vinyl acetate.

[0045] In several other embodiments, the membrane comprises polyethylene in a total amount ranging from 2 to 20 wt.%, and the membrane comprises ethylene-vinyl acetate in a total amount ranging from 80 to 98 wt.%. The membrane may comprise polyethylene in a total amount ranging from 5 to 15 wt.%, and the membrane may comprise ethylene-vinyl acetate in a total amount ranging from 85 to 95 wt.%. The membrane may comprise polyethylene in a total amount ranging from 7 to 13 wt.%, and the membrane may comprise ethylene-vinyl acetate in a total amount ranging from 87 to 93 wt.%.

[0046] In some embodiments, the total thickness of the membrane is in the range of 50-100 micrometers; and the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the membrane may have a total thickness in the range of 50-100 micrometers; and the total amount of polyethylene contained in the membrane may be in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0047] In some embodiments, the total thickness of the membrane is in the range of 60-90 micrometers; and the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the membrane may have a total thickness in the range of 60-90 micrometers; and the total amount of polyethylene contained in the membrane may be in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0048] In some embodiments, the total thickness of the membrane is in the range of 70-80 micrometers; and the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the membrane may have a total thickness in the range of 70-80 micrometers; and the total amount of polyethylene contained in the membrane may be in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0049] In some embodiments, the polyethylene layer comprises low-density polyethylene. The polyethylene layer may comprise linear low-density polyethylene.

[0050] In some embodiments, the ethylene-vinyl acetate content of the first and / or second ethylene-vinyl acetate layers may be in the range of 10-20 wt.% of the copolymer, or in the range of 15-20 wt.% of the copolymer.

[0051] In some preferred embodiments, the three-layer film is symmetrical. In several other embodiments, the first ethylene-vinyl acetate layer may be thicker or thinner than the second ethylene-vinyl acetate layer.

[0052] In some embodiments, the three-layer film is a cast film. Alternatively, the three-layer film may be a blown film.

[0053] According to a second aspect of the present invention, a catheter sheath is provided, comprising a three-layer laminated film, the three-layer laminated film comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer.

[0054] The three-layer laminated film of the second aspect of the present invention can be the three-layer film of the first aspect of the present invention described above. The above description of the three-layer film of the first aspect of the present invention can be modified as necessary and applied to the second aspect of the present invention. The following description of the second aspect of the present invention can also be modified as necessary and applied to other aspects of the present invention.

[0055] In some embodiments, the cannula may include a tubular body comprising a three-layer membrane and a hollow lumen extending longitudinally therethrough. The hollow lumen may preferably be adapted to receive a catheter in use.

[0056] In some embodiments, at least 50 wt.% of the sheath may comprise a three-layer membrane, or at least 60 wt.%, at least 70 wt.%, at least 80 wt.%, at least 90 wt.%, or at least 96 wt.% of the sheath may comprise a three-layer membrane. Preferably, the sheath may be made entirely of a three-layer membrane.

[0057] The film thickness of the sleeve in the second aspect of the present invention can be as described in the bag of the first aspect of the present invention. Alternatively, the film of the sleeve in the second aspect of the present invention can have a different thickness than the film of the bag of the first aspect of the present invention. The film of the sleeve in the second aspect of the present invention can be thinner than the film of the bag of the first aspect of the present invention.

[0058] In some embodiments, the thickness of at least one layer of the membrane is at least 1 micrometer, or at least 2 micrometers, at least 3 micrometers, at least 4 micrometers, or at least 5 micrometers. In some embodiments, the thickness of at least one layer of the membrane is not greater than 50 micrometers, or not greater than 45 micrometers, not greater than 40 micrometers, not greater than 35 micrometers, or not greater than 30 micrometers. The thickness of at least one layer of the membrane may be in the range of 5-30 micrometers, or in the range of 10-25 micrometers, or in the range of 15-20 micrometers.

[0059] In some embodiments, at least one ethylene-vinyl acetate layer of the membrane has a thickness of at least 1 micrometer, or at least 2 micrometers, at least 3 micrometers, at least 4 micrometers, or at least 5 micrometers. In some embodiments, the thickness of at least one ethylene-vinyl acetate layer of the membrane is not greater than 50 micrometers, or not greater than 45 micrometers, not greater than 40 micrometers, not greater than 35 micrometers, or not greater than 30 micrometers. The thickness of at least one ethylene-vinyl acetate layer of the membrane may be in the range of 5-30 micrometers, or in the range of 10-25 micrometers, or in the range of 10-20 micrometers. The first and / or second ethylene-vinyl acetate layers may have the thicknesses described above.

[0060] In some embodiments, the thickness of the polyethylene layer of the membrane is at least 1 micrometer, or at least 2 micrometers, at least 3 micrometers, at least 4 micrometers, or at least 5 micrometers. In some embodiments, the thickness of the polyethylene layer of the membrane is not greater than 60 micrometers, or not greater than 55 micrometers, not greater than 50 micrometers, not greater than 45 micrometers, not greater than 40 micrometers, not greater than 35 micrometers, or not greater than 30 micrometers. The thickness of the polyethylene layer of the membrane may be in the range of 5-30 micrometers, or in the range of 10-25 micrometers, or in the range of 15-25 micrometers.

[0061] In some embodiments, the total thickness of the membrane is at least 20 micrometers, or at least 25 micrometers, at least 30 micrometers, at least 35 micrometers, or at least 40 micrometers. The total thickness of the membrane may not exceed 100 micrometers, or not exceed 90 micrometers, not exceed 80 micrometers, or not exceed 70 micrometers. The total thickness of the membrane may be in the range of 40-95 micrometers, or in the range of 40-90 micrometers, or in the range of 40-70 micrometers, or in the range of 45-65 micrometers, or preferably in the range of 45-60 micrometers, or preferably in the range of 45-55 micrometers.

[0062] In some embodiments, the total thickness of the membrane is in the range of 40-95 micrometers, or in the range of 45-90 micrometers.

[0063] In some embodiments, the first and second ethylene-vinyl acetate layers of the membrane have the same thickness. The first and / or second ethylene-vinyl acetate layers may have the same thickness as the polyethylene layer. In some embodiments, all three layers of the three-layer membrane have the same thickness.

[0064] In several other embodiments, the ethylene-vinyl acetate layer of the membrane has a different thickness than the polyethylene layer. The polyethylene layer may be thicker than the ethylene-vinyl acetate layer. In some embodiments, all three layers of the three-layer membrane have different thicknesses.

[0065] In some embodiments, the total thickness of the membrane is in the range of 40-70 micrometers; and the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the membrane may have a total thickness in the range of 40-70 micrometers; and the total amount of polyethylene contained in the membrane may be in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0066] In some embodiments, the total thickness of the membrane is in the range of 45-65 micrometers; and the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the membrane may have a total thickness in the range of 45-65 micrometers; and the total amount of polyethylene contained in the membrane may be in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0067] In some embodiments, the total thickness of the membrane is in the range of 45-60 micrometers; and the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the membrane may have a total thickness in the range of 45-60 micrometers; and the total amount of polyethylene contained in the membrane may be in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0068] In some embodiments, the total thickness of the membrane is in the range of 45-55 micrometers; and the total amount of polyethylene contained in the membrane is in the range of 5-70 wt.%, or in the range of 10-70 wt.%, or in the range of 15-70 wt.%, or in the range of 20-70 wt.%, or in the range of 30-60 wt.%, or in the range of 30-50 wt.%. In several other embodiments, the membrane may have a total thickness in the range of 45-55 micrometers; and the total amount of polyethylene contained in the membrane may be in the range of 2-20 wt.%, or in the range of 5-15 wt.%, or in the range of 7-13 wt.%.

[0069] In some preferred embodiments, a catheter sheath is provided, comprising a three-layer laminated film comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of polyethylene contained in the polyethylene layer of the film is at least 80 wt.%, preferably, the polyethylene layer is made entirely of polyethylene.

[0070] In some preferred embodiments, a catheter sheath is provided, comprising a three-layer laminated film, the three-layer laminated film comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of ethylene-vinyl acetate contained in the polyethylene layer of the film is less than 10 wt.% of the polyethylene layer, and preferably, the polyethylene layer does not contain ethylene-vinyl acetate.

[0071] In some preferred embodiments, a catheter sheath is provided, comprising a three-layer laminated film comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein at least one ethylene-vinyl acetate layer of the film contains at least 95 wt.% ethylene-vinyl acetate of the total amount of ethylene-vinyl acetate in the ethylene-vinyl acetate layer, preferably, at least one ethylene-vinyl acetate layer is made entirely of ethylene-vinyl acetate.

[0072] In some preferred embodiments, a catheter sheath is provided, comprising a three-layer laminated film, the three-layer laminated film comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of polyethylene contained in at least one ethylene-vinyl acetate layer of the film is less than 10 wt.% of the total ethylene-vinyl acetate layer, preferably, at least one ethylene-vinyl acetate layer does not contain polyethylene.

[0073] In some preferred embodiments, a catheter sheath is provided, comprising a three-layer laminated membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the first and second ethylene-vinyl acetate layers of the membrane are each made entirely of ethylene-vinyl acetate, and the polyethylene layer of the membrane is made entirely of polyethylene.

[0074] In some preferred embodiments, a catheter sheath is provided, comprising a three-layer laminated film, which sequentially comprises: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of polyethylene contained in the film is in the range of 5-50 wt.% or preferably in the range of 10-45 wt.%.

[0075] In some preferred embodiments, a catheter sheath is provided, comprising a three-layer laminated film, which sequentially comprises: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of ethylene-vinyl acetate contained in the film is in the range of 50-95 wt.% or preferably in the range of 55-90 wt.%.

[0076] According to a third aspect of the invention, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter sheath configured to surround at least a portion of the length of the catheter from proximal to distal end, wherein the urine collection bag and the catheter sheath comprise a three-layer laminated membrane, the membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer.

[0077] The urine collection bag of the third aspect of the present invention can be the urine collection bag of the first aspect of the present invention.

[0078] The sleeve in the third aspect of the present invention can be the sleeve in the second aspect of the present invention.

[0079] The three-layer membrane of the third aspect of the present invention may preferably be the three-layer membrane of the first and / or second aspects of the present invention.

[0080] The above-described inventive statements regarding the first and second aspects of the present invention may also be modified as necessary and applied to the third aspect of the present invention.

[0081] The three-layer film of the sleeve may be the same as the three-layer film of the bag. Alternatively, the three-layer film of the sleeve may have a different film thickness than the three-layer film of the bag. The three-layer film of the sleeve may be thinner than the three-layer film of the bag. The three-layer film of the bag may have the film thickness as described in the inventive statement of the first aspect of the present invention. The three-layer film of the sleeve may have the film thickness as described in the inventive statement of the second aspect of the present invention.

[0082] In some embodiments, the cannula may be configured to surround at least 5% of the length of the catheter from the proximal end to the distal end, or at least 10%, at least 20%, at least 30%, at least 40%, or at least 50% of the length of the catheter from the proximal end to the distal end.

[0083] In some embodiments, the cannula may be configured to surround the entire length of the catheter from proximal to distal. In some embodiments, the cannula may not surround the entire length of the catheter from proximal to distal. In such embodiments, during use, the cannula may slide along the entire length of the catheter.

[0084] The catheter can be an intermittent catheter. This type of catheter is typically inserted into the body for a short period of time, such as less than a day. Alternatively, the catheter can be a foley catheter. This type of catheter is typically inserted and left in the body for a longer period of time, such as several days to several months.

[0085] The catheter can be a disposable catheter or a reusable catheter.

[0086] In some embodiments, the catheter comprises a hollow tubular body, preferably a hollow polymer tubular body. The hollow polymer tubular body may contain a base polymer.

[0087] In some embodiments, the conduit further comprises at least one additive, preferably at least one lubricating additive. Preferably, the hollow tubular body comprises at least one additive.

[0088] In some embodiments, at least one additive is a hydrophilic or amphiphilic additive.

[0089] In some preferred embodiments, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter sheath configured to surround at least a portion of the length of the catheter from the proximal end to the distal end, wherein the urine collection bag and the catheter sheath comprise a three-layer laminated membrane, the membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the polyethylene layer of the membrane comprises a total amount of polyethylene of at least 80 wt.%, preferably, the polyethylene layer is made entirely of polyethylene.

[0090] In some preferred embodiments, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter sheath configured to surround at least a portion of the length of the catheter from the proximal end to the distal end, wherein the urine collection bag and the catheter sheath comprise a three-layer laminated membrane, the membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the polyethylene layer of the membrane contains less than 10 wt.% of ethylene-vinyl acetate in total, and preferably, the polyethylene layer does not contain ethylene-vinyl acetate.

[0091] In some preferred embodiments, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter sheath configured to surround at least a portion of the length of the catheter from the proximal end to the distal end, wherein the urine collection bag and the catheter sheath comprise a three-layer laminated membrane, the membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein at least one ethylene-vinyl acetate layer of the membrane comprises an ethylene-vinyl acetate content of at least 95 wt.% of the total ethylene-vinyl acetate content of the ethylene-vinyl acetate layer, preferably, at least one ethylene-vinyl acetate layer is made entirely of ethylene-vinyl acetate.

[0092] In some preferred embodiments, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter sheath configured to surround at least a portion of the length of the catheter from the proximal end to the distal end, wherein the urine collection bag and the catheter sheath comprise a three-layer laminated membrane, the membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein at least one ethylene-vinyl acetate layer of the membrane contains less than 10 wt.% polyethylene in total, preferably, at least one ethylene-vinyl acetate layer does not contain polyethylene.

[0093] In some preferred embodiments, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter cannula configured to surround at least a portion of the length of the catheter from the proximal end to the distal end, wherein the urine collection bag and the catheter cannula comprise a three-layer laminated membrane, the membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the first and second ethylene-vinyl acetate layers of the membrane are each made entirely of ethylene-vinyl acetate, and the polyethylene layer of the membrane is made entirely of polyethylene.

[0094] In some preferred embodiments, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter sheath configured to surround at least a portion of the catheter length from the proximal end to the distal end, wherein the urine collection bag and the catheter sheath comprise a three-layer laminated membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the membrane contains polyethylene in a total amount ranging from 5-50 wt.% or preferably from 10-45 wt.%.

[0095] In some preferred embodiments, a urinary catheter kit is provided, comprising: a catheter including a distal end and a proximal end for insertion into the body; a urine collection bag including an inlet adapted to fluidly communicate with the distal end of the catheter; and a catheter sheath configured to surround at least a portion of the length of the catheter from the proximal end to the distal end, wherein the urine collection bag and the catheter sheath comprise a three-layer laminated membrane, the membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of ethylene-vinyl acetate contained in the membrane is in the range of 50-95 wt.% or preferably in the range of 55-90 wt.%.

[0096] According to a fourth aspect of the present invention, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0097] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, sequentially: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer; and

[0098] (b) The front and rear walls are sealed together to form a cavity therebetween for containing urine;

[0099] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b).

[0100] The urine collection bag of the fourth aspect of the present invention is preferably the urine collection bag of the first aspect of the present invention. The above description of any other aspect of the present invention may be modified as necessary to apply to the fourth aspect of the present invention.

[0101] The method may include an additional step prior to step (a) of forming a three-layer film with a front wall and / or a rear wall. Forming the film with the front wall and / or rear wall may include: providing a polymer composition for first and second ethylene-vinyl acetate layers; providing a polymer composition for a polyethylene layer; and co-extruding the polymer composition for the first and second ethylene-vinyl acetate layers and the polymer composition for the polyethylene layer to provide a three-layer film, such that the film sequentially comprises: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer. The polymer composition may comprise a polymer melt. Alternatively, the polymer composition may comprise solid polymer sheets or granules. The extrusion method may include multilayer cast extrusion molding.

[0102] Step (b) may include fusing the front wall and the rear wall together, preferably as described in the first aspect of the invention above.

[0103] Welding can be performed using a method that can be independently selected from the group consisting of ultrasonic welding, heat sealing, radio frequency welding, laser welding, and any combination thereof.

[0104] In some embodiments, the method includes providing an entrance in the front or rear wall prior to step (b). In several other embodiments, the method includes providing an entrance in the front or rear wall after step (b). The entrance may take the form of an opening in the front or rear wall.

[0105] The method may include the step of providing an attachment element in the anterior or posterior wall for attaching the bag to the catheter. The step of providing the attachment element may occur before or after step (b). In some embodiments, the attachment element includes a mechanical fastening mechanism. The attachment element may include a check valve to prevent urine from flowing back from the bag into the catheter during use. The check valve may be positioned between layers of the membrane. The check valve may be positioned in an orifice including an inlet in the anterior or posterior wall.

[0106] In some preferred embodiments, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0107] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of polyethylene contained in the polyethylene layer of the membrane is at least 80 wt.%, preferably, the polyethylene layer is made entirely of polyethylene; and

[0108] (b) The anterior and posterior walls are sealed together to form a cavity therebetween for containing urine.

[0109] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b).

[0110] In some preferred embodiments, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0111] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the total amount of ethylene-vinyl acetate contained in the polyethylene layer of the membrane is less than 10 wt.%, and preferably, the polyethylene layer does not contain ethylene-vinyl acetate; and

[0112] (b) The front and rear walls are sealed together to form a cavity therebetween for containing urine;

[0113] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b).

[0114] In some preferred embodiments, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0115] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein at least one ethylene-vinyl acetate layer of the membrane comprises a total amount of ethylene-vinyl acetate of at least 95 wt.% of the ethylene-vinyl acetate layer, preferably, the at least one ethylene-vinyl acetate layer is made entirely of ethylene-vinyl acetate; and

[0116] (b) The front and rear walls are sealed together to form a cavity therebetween for containing urine;

[0117] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b).

[0118] In some preferred embodiments, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0119] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, sequentially: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein at least one ethylene-vinyl acetate layer of the membrane contains less than 10 wt.% of polyethylene in the total amount of polyethylene in the ethylene-vinyl acetate layer, and preferably, the at least one ethylene-vinyl acetate layer does not contain polyethylene; and

[0120] (b) The front and rear walls are sealed together to form a cavity therebetween for containing urine;

[0121] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b).

[0122] In some preferred embodiments, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0123] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the first and second ethylene-vinyl acetate layers of the membrane are each made entirely of ethylene-vinyl acetate, and the polyethylene layer of the membrane is made entirely of polyethylene; and

[0124] (b) The front and rear walls are sealed together to form a cavity therebetween for containing urine;

[0125] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b).

[0126] In some preferred embodiments, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0127] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the membrane contains polyethylene in a total amount ranging from 5-50 wt.% or preferably from 10-45 wt.%; and

[0128] (b) The front and rear walls are sealed together to form a cavity therebetween for containing urine;

[0129] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b).

[0130] In some preferred embodiments, a method for manufacturing a urine collection bag is provided, the method comprising the following steps:

[0131] (a) Providing a front wall and a rear wall, wherein the front wall and the rear wall comprise a three-layer membrane, the three-layer membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer, wherein the membrane contains ethylene-vinyl acetate in a total amount ranging from 50 to 95 wt.%, or preferably in the range of 55 to 90 wt.%; and

[0132] (b) The front and rear walls are sealed together to form a cavity therebetween for containing urine;

[0133] The method further includes providing an inlet for receiving urine in the anterior or posterior wall before or after step (b). Invention Details Attached Figure Description

[0135] To better understand the present invention, embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, wherein:

[0136] Figure 1 A perspective view of one embodiment of the urinary catheter kit of the present invention is shown, which includes one embodiment of the urine collection bag and catheter cannula of the present invention.

[0137] Figure 2 It shows Figure 1 A cross-sectional view of the catheter cannula.

[0138] Figure 3 It shows Figure 1 A side sectional view of the urine collection bag.

[0139] Figure 4 It shows Figure 1 A cross-sectional view of the three-layer laminated membrane of the conduit sleeve.

[0140] Figure 5 It shows Figure 1 A cross-sectional view of the three-layer laminated film of the urine collection bag. Detailed Implementation

[0141] The catheter kit of the present invention

[0142] Figure 1 An embodiment of the urinary catheter kit 1 of the present invention is shown, which includes an embodiment of the catheter sheath 2 and the urine collection bag 3 of the present invention.

[0143] The catheter kit 1 includes an intermittent catheter 4, which includes a distal end 6 and a proximal end 5 for insertion into the body. The kit 1 also includes a urine collection bag 3, which includes an inlet 7 adapted for fluid communication with the distal end 6 of the catheter. The distal end 6 of the catheter 4 is attached to the bag 3 at the inlet 7. The kit 1 also includes a catheter sheath 2, which wraps around and surrounds approximately one-third of the length of the catheter 4 from the proximal end 5 to the distal end 6. The catheter sheath 2 is slidable along the length of the catheter 4, so that it can be moved from the proximal end 5 to the distal end 6 during use, and vice versa.

[0144] Both the catheter sheath 2 and the urine collection bag 3 include three-layer laminated membranes 8 and 9. The membrane 8 of the catheter sheath 2 and the membrane 9 of the bag 3 each include, in sequence: a first ethylene-vinyl acetate layer 10 and 100, a polyethylene layer 11 and 110, and a second ethylene-vinyl acetate layer 12 and 120.

[0145] Figure 2 The cross-sectional view in the image shows the structure of the catheter cannula 2 more clearly. The cannula 2 includes a tubular body 13, which comprises a three-layer membrane 8. (See image for details.) Figure 1 As shown, the tubular body 13 includes a hollow lumen 14 extending longitudinally through it, through which the conduit 4 is received. The sheath 2 is formed entirely of a three-layer membrane 8.

[0146] The structure of urine collection bag 3 is achieved through Figure 3 A side sectional view of the middle bag 3 is shown more clearly. The bag 3 includes a front wall 15 and a rear wall 16. Both the front wall 15 and the rear wall 16 include a three-layer laminated film 9. The front wall 15 and the rear wall 16 are sealed together to form a cavity 17 of the bag 3 therebetween for holding urine. The front wall 15 and the rear wall 16 are sealed together by a weld 18 formed around their periphery to form the cavity 17 of the bag 3. The weld 18 extends through all layers of the film 9 of the front wall 15 and the rear wall 16 to hold the front wall 15 and the rear wall 16 together.

[0147] The front wall 15 of the bag 3 also includes an inlet 7 adapted for fluid communication with the distal end 6 of the conduit. The inlet 7 includes an opening formed in the front wall 15.

[0148] The catheter kit 1 is used in the conventional manner.

[0149] The structure of the three-layer laminated membrane 8 of the catheter sheath 2

[0150] Figure 4 A cross-sectional view of the three-layer laminated membrane 8 of the catheter sheath 2 is shown.

[0151] The three-layer membrane 8 has the layer structure described in Table 1 below. The arrangement order of the layers of membrane 8 is shown in Table 1.

[0152] Table 1

[0153] Layer number Layer type Layer material Layer thickness (µm) 10 First ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 20 11 polyethylene layer Polyethylene: 100% 20 12 Second ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 20

[0154] The weight percentage of polyethylene in membrane 8 is approximately 33 wt.% and the weight percentage of ethylene-vinyl acetate in membrane 8 is approximately 66 wt.%.

[0155] The three-layer film 8 is produced by multilayer cast extrusion, comprising polymer compositions provided in the form of polymer melts: first and second ethylene-vinyl acetate layers corresponding to layers 10 and 12, and a polymer composition corresponding to a polyethylene layer 11. These polymer compositions for the film layers are then co-extruded to form the three-layer film 8.

[0156] The structure of the three-layer laminated film 9 of the urine collection bag 3

[0157] Figure 5A cross-sectional view of the three-layer laminated film 9 of the urine collection bag 3 is shown.

[0158] The three-layer membrane 9 has the layer structure described in Table 2 below. The arrangement order of the layers of membrane 9 is shown in Table 2.

[0159] Table 2

[0160] Layer number Layer type Layer material Layer thickness (µm) 100 First ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 25 110 polyethylene layer Polyethylene: 100% 25 120 Second ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 25

[0161] The weight percentage of polyethylene in membrane 9 is approximately 33 wt.% and the weight percentage of ethylene-vinyl acetate in membrane 9 is approximately 66 wt.%.

[0162] For the membrane 8 above, the three-layer membrane 9 is also produced by multilayer cast extrusion, which comprises polymer compositions provided in the form of polymer melts: polymer compositions for the first and second ethylene-vinyl acetate layers corresponding to layers 100 and 120, and a polymer composition for the polyethylene layer corresponding to layer 110. These polymer compositions for the layers of the membrane are then co-extruded to form the three-layer membrane 9.

[0163] Replacement for three-layer laminated film

[0164] Tables 3 and 4 below describe examples of alternative three-layer laminated membranes, which can also be used in several other embodiments of the urine collection bags and catheter cannulas of the present invention.

[0165] Table 3 describes a three-layer membrane particularly suitable for constructing the catheter sheath of the present invention, and Table 4 describes a membrane particularly suitable for constructing the urine collection bag of the present invention. The order of the membrane layers is as described in each table.

[0166] Table 3

[0167] Layer number Layer type Layer material Layer thickness (µm) 200 First ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 15 210 polyethylene layer Polyethylene: 100% 20 220 Second ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 15

[0168] Table 4

[0169] Layer number Layer type Layer material Layer thickness (µm) 300 First ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 22.5 310 polyethylene layer Polyethylene: 100% 30 320 Second ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 22.5

[0170] Both films contain approximately 40 wt.% polyethylene and approximately 60 wt.% ethylene-vinyl acetate.

[0171] Tables 5 and 6 below describe two other examples of alternatives to the three-layer laminated membrane, which can also be used in several other embodiments of the urine collection bag and catheter cannula of the present invention.

[0172] Table 5 describes a three-layer membrane particularly suitable for constructing the catheter sheath of the present invention, and Table 6 describes a membrane particularly suitable for constructing the urine collection bag of the present invention. The order of the membrane layers is as described in each table.

[0173] Table 5

[0174] Layer number Layer type Layer material Layer thickness (µm) 400 First ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 20 410 polyethylene layer Polyethylene: 100% 5 420 Second ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 20

[0175] Table 6

[0176] Layer number Layer type Layer material Layer thickness (µm) 500 First ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 40 510 polyethylene layer Polyethylene: 100% 10 520 Second ethylene-vinyl acetate layer Ethylene-vinyl acetate: 100% 40

[0177] Both films contain approximately 11 wt.% polyethylene and approximately 89 wt.% ethylene-vinyl acetate.

[0178] result

[0179] The three-layer laminated film of the present invention offers several advantages over conventional materials. The combination of layers imparts excellent strength, even when the film is very thin, for example, films 8 and 9 have thicknesses of 60 micrometers and 75 micrometers, respectively. The fact that such thin films can be successfully used significantly reduces the amount of plastic required in film manufacturing, which helps minimize plastic waste and contributes to environmental sustainability.

[0180] Despite their high strength, these membranes are also lightweight, which reduces the unnecessary strain on the user during catheter insertion. For example, in the case of membrane 9, membrane 9 allows for the construction of a lightweight urine collection bag 3 that can still effectively hold a large amount of urine.

[0181] Unlike the various conventional materials previously used to manufacture catheter kit components, this membrane is also relatively quiet during handling / transportation and does not produce noticeable hissing or other disruptive noises during movement. This significantly improves patient comfort and privacy, especially in cases of self-insertion of catheters.

[0182] The membrane also provides excellent resistance to discoloration during the sterilization process. Sterilization is a critical step in maintaining the hygiene and safety of catheter kit components, and the membrane retains its appearance and integrity even after repeated sterilization cycles.

[0183] The above embodiments are described by way of example only. Many variations are possible without departing from the scope of the invention as defined by the appended claims.

Claims

1. A urine collection bag comprising a cavity for containing urine, the bag comprising a three-layer laminated film, the film comprising, in sequence: First ethylene-vinyl acetate layer, polyethylene layer, and second ethylene-vinyl acetate layer.

2. The urine collection bag according to claim 1, wherein, The cavity of the bag is defined by the three-layer membrane.

3. The urine collection bag according to any one of the preceding claims, wherein, The bag includes a front wall and a rear wall, wherein the front wall and the rear wall are sealed together to form a cavity therebetween, wherein the front wall and the rear wall include the three-layer membrane.

4. The urine collection bag according to any one of the preceding claims, wherein, The thickness of at least one layer of the membrane is in the range of 10 micrometers to 40 micrometers.

5. The urine collection bag according to any one of the preceding claims, wherein, The thickness of at least one ethylene-vinyl acetate layer is in the range of 10 micrometers to 40 micrometers.

6. The urine collection bag according to any one of the preceding claims, wherein, The thickness of the polyethylene layer is in the range of 10 micrometers to 40 micrometers.

7. The urine collection bag according to any one of the preceding claims, wherein, The total thickness of the membrane is in the range of 50 micrometers to 100 micrometers.

8. A catheter cannula comprising a three-layer laminated membrane, the three-layer laminated membrane comprising, in sequence: First ethylene-vinyl acetate layer, polyethylene layer, and second ethylene-vinyl acetate layer.

9. The catheter cannula according to claim 8, wherein, The thickness of at least one layer of the membrane is in the range of 5 micrometers to 30 micrometers.

10. The catheter cannula according to claim 8 or 9, wherein, The thickness of at least one ethylene-vinyl acetate layer is in the range of 5 micrometers to 30 micrometers.

11. The catheter cannula according to any one of claims 8 to 10, wherein, The thickness of the polyethylene layer is in the range of 5 micrometers to 30 micrometers.

12. The catheter cannula according to any one of claims 8 to 11, wherein, The total thickness of the membrane is in the range of 40 micrometers to 70 micrometers.

13. The urine collection bag according to any one of claims 1 to 7, or the catheter cannula according to any one of claims 8 to 12, wherein, The polyethylene layer of the membrane contains a total amount of polyethylene of at least 80 wt.% of the polyethylene layer, and preferably, the polyethylene layer is made entirely of polyethylene.

14. The urine collection bag according to any one of claims 1 to 7 or claim 13, or the catheter cannula according to any one of claims 8 to 13, wherein, The total amount of ethylene-vinyl acetate contained in the polyethylene layer of the membrane is less than 10 wt.% of the polyethylene layer, and preferably, the polyethylene layer does not contain ethylene-vinyl acetate.

15. The urine collection bag according to any one of claims 1 to 7 or claim 13 or 14, or the catheter cannula according to any one of claims 8 to 14, wherein, The total amount of ethylene-vinyl acetate contained in at least one ethylene-vinyl acetate layer of the membrane is at least 95 wt.% of the ethylene-vinyl acetate layer, and preferably, the at least one ethylene-vinyl acetate layer is made entirely of ethylene-vinyl acetate.

16. The urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 15, or the catheter cannula according to any one of claims 8 to 15, wherein, The total amount of polyethylene contained in at least one ethylene-vinyl acetate layer of the membrane is less than 10 wt.% of the ethylene-vinyl acetate layer, and preferably, the at least one ethylene-vinyl acetate layer does not contain polyethylene.

17. The urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 16, or the catheter cannula according to any one of claims 8 to 16, wherein, The first and second ethylene-vinyl acetate layers of the membrane are each made entirely of ethylene-vinyl acetate, and the polyethylene layer of the membrane is made entirely of polyethylene.

18. A urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 17, or a catheter cannula according to any one of claims 8 to 17, wherein, The first ethylene-vinyl acetate layer and the second ethylene-vinyl acetate layer of the membrane have the same thickness, and optionally, all three layers of the three-layer membrane have the same thickness.

19. A urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 18, or a catheter cannula according to any one of claims 8 to 18, wherein, The total amount of polyethylene contained in the membrane is in the range of 5-50 wt.%, or preferably in the range of 10-45 wt.%.

20. The urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 19, or the catheter cannula according to any one of claims 8 to 19, wherein, The total amount of ethylene-vinyl acetate contained in the membrane is in the range of 50-95 wt.%, or preferably in the range of 55-90 wt.%.

21. The urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 20, or the catheter cannula according to any one of claims 8 to 20, wherein, The polyethylene layer comprises low-density polyethylene.

22. The urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 21, or the catheter cannula according to any one of claims 8 to 21, wherein, The three-layer membrane is symmetrical.

23. The urine collection bag according to any one of claims 1 to 7 or any one of claims 13 to 22, or the catheter cannula according to any one of claims 8 to 22, wherein, The three-layer film is a cast film.

24. A catheter kit, comprising: A catheter, comprising a distal end and a proximal end for insertion into the body; A urine collection bag, which includes an inlet adapted for fluid communication with the distal end of a catheter; The urine collection bag and the catheter cannula are configured to surround at least a portion of the length of the catheter from the proximal end to the distal end, wherein both the urine collection bag and the catheter cannula comprise a three-layer laminated membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer.

25. A method for manufacturing a urine collection bag, the method comprising the following steps: a. Providing a front wall and a rear wall, wherein both the front wall and the rear wall comprise a three-layer barrier membrane, the three-layer barrier membrane comprising, in sequence: a first ethylene-vinyl acetate layer, a polyethylene layer, and a second ethylene-vinyl acetate layer; and b. Seal the front wall and the rear wall together to form a cavity therebetween for containing urine; The method further includes providing an inlet for receiving urine in the front wall or the rear wall before or after step (b).

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