Compositions and articles

Abstract

Compositions and methods of making the same are provided. The composition comprises a composite powder material and an elastomer, where the composite powder material comprises a) tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, d) metal oxide particles, and e) a binder, and where a), b), c), and d) have a size of 5 [mu] m or less. Articles and methods of making articles are also provided. Further provided are methods of use and uses of an article in the form of a catheter, in particular a catheter.

Description

[0001] Citation of Related Applications

[0002] This application claims priority to Singapore Application No. 10202250483R, filed with the Intellectual Property Office of Singapore on July 15, 2022, the content of which is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to compositions and methods of making compositions. The present invention further relates to articles and methods of making articles. The present invention further relates to methods of use and uses of catheters, particularly articles in the form of urinary catheters. Background Art

[0004] Urinary tract infection (UTI) is an infection in any part of the urinary system, including the kidneys, ureters, bladder, and urethra. Most infections involve the lower urinary tract (bladder and urethra). Among hospital-acquired UTIs, approximately 75% are catheter-related. Catheter-associated urinary tract infections (CAUTIs) account for more than 1 million cases in the United States alone and nearly 80% of hospital infections worldwide. The annual treatment cost exceeds $350 million, which illustrates the urgency of this situation.

[0005] Crusting and biofilm formation are two major problems that plague conventional catheters and make CAUTIs more difficult to treat. They may overlap and exacerbate the situation in infections. Although crusting and biofilm formation are caused by different factors, crusting begins with the colonization of urease-positive pathogens. Urease is an enzyme that catalyzes the hydrolysis of urea into ammonia and carbamate. The presence of urine in conventional catheters creates a suitable environment for urease-positive pathogens. Ammonia is alkaline and increases the pH of urine, leading to the deposition of calcium phosphate and magnesium phosphate crystals on the catheter, which ultimately results in complete occlusion of the catheter through crusting. Free-floating or planktonic bacteria may encounter a surface immersed in a fluid and attach to that surface within minutes. The attached bacteria produce viscous extracellular polymeric substances (EPS), which colonize the surface and form a conditioning biofilm. The production of extracellular polymeric substances allows emerging biofilm communities to develop complex three-dimensional structures that are influenced by various environmental factors. The thickness of the biofilm has been reported to be approximately 200 μm, and it occasionally reaches a thickness of 500 μm.

[0006] A variety of conventional methods have been evaluated to prevent CAUTIs, including improving catheter design, making catheter coatings, and emphasizing short-term use. Despite many efforts to address CAUTIs, most conventional methods fail due to microbial resistance. According to the WHO, microorganisms develop resistance after exposure to antimicrobial agents. Antibiotic resistance has led to the formation of "superbugs" that are resistant to many antimicrobial therapies used to treat hospital infections.

[0007] Accordingly, there is a need to provide a urinary catheter that ameliorates or solves the problems described above.

[0008] Overview

[0009] In one aspect, there is provided a composition comprising a composite powder material and an elastomer, wherein the composite powder material comprises:

[0010] a) tourmaline particles;

[0011] b) rare earth mineral particles;

[0012] c) silicate mineral particles;

[0013] d) metal oxide particles; and

[0014] e) a binder, and

[0015] wherein the sizes of a) tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, and d) metal oxide particles are 5 μm or less.

[0016] In another aspect, there is provided a method for preparing a composition, which includes the step of mixing a composite powder material and an elastomer, wherein the composite powder material comprises:

[0017] a) tourmaline particles;

[0018] b) rare earth mineral particles;

[0019] c) silicate mineral particles;

[0020] d) metal oxide particles; and

[0021] e) a binder, and

[0022] wherein the sizes of a) tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, and d) metal oxide particles are 5 μm or less.

[0023] In another aspect, there is provided an article comprising the composition described herein.

[0024] In another aspect, there is provided a method for preparing an article, the method comprising the steps of:

[0025] a) heating the composition described herein to form a blend;

[0026] b) extruding the blend of step (a) in an extruder to form composite fibers; and

[0027] c) forming an article from the composite fibers of step (b).

[0028] In another aspect, a method for preventing or treating an infection in the urinary tract, blood system, implanted device, in vivo or intracavitary drainage system of a subject is provided, the method comprising the step of applying a catheter as described herein to the subject.

[0029] In another aspect, a method for releasing urine from a subject is provided, the method comprising the step of applying a urinary catheter as described herein to the urinary tract of the subject.

[0030] In another aspect, a method for preventing or treating a urinary tract infection in a subject is provided, the method comprising the step of applying a urinary catheter as described herein to the urinary tract of the subject.

[0031] In another aspect, a urinary catheter as described herein is provided for preventing or treating a urinary tract infection.

[0032] In another aspect, a urinary catheter as described herein when used for preventing or treating a urinary tract infection is provided.

[0033] Definitions

[0034] The following words and terms as used herein shall have the indicated meanings:

[0035] As used herein, the term "elastomer" when referring to a substance describes a substance that is capable of returning to its original shape after being stretched to a great extent.

[0036] As used herein, the term "biodegradable" when referring to a substance describes a substance whose chemical and physical characteristics undergo degradation and which completely degrades when exposed to microorganisms, aerobic and anaerobic processes.

[0037] As used herein, the term "antifouling" when referring to a substance describes a substance that repels or prevents the attachment of proteins or microorganisms that attach to the substance.

[0038] The word "substantially" does not exclude "completely", for example, a composition that is "substantially free" of Y may be completely free of Y. Where necessary, the word "substantially" may be omitted from the definitions of the present invention.

[0039] Unless otherwise specified, the terms "comprising" and its grammatical variants are intended to be "open-ended" or "inclusive" terms such that they include the recited elements and also permit the inclusion of additional, unrecited elements.

[0040] As used herein, the term "about" generally means + / - 5% of the recited value, more typically + / - 4% of the recited value, more typically + / - 3% of the recited value, more typically + / - 2% of the recited value, even more typically + / - 1% of the recited value, and even more typically + / - 0.5% of the recited value.

[0041] Throughout this disclosure, certain embodiments may be disclosed in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of the disclosed range. Thus, the description of a range should be considered to have specifically disclosed all possible sub-ranges and individual numerical values within that range. For example, the description of a range such as 1 to 6 should be considered to have specifically disclosed sub-ranges within that range (such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc.) and individual numbers (e.g., 1, 2, 3, 4, 5, and 6). This applies regardless of the width of the range.

[0042] Certain embodiments may also be described herein in broad and general terms. Each narrower class and sub-generic grouping that falls within this general disclosure also forms part of this disclosure. This includes the general description of the embodiments, with provisos or negative limitations removing any subject matter from the generality, regardless of whether the removed content is specifically recited herein.

[0043] Detailed disclosure of embodiments

[0044] Exemplary non-limiting embodiments of the composition will now be disclosed. The composition comprises a composite powder material and an elastomer, wherein the composite powder material comprises

[0045] a) tourmaline particles;

[0046] b) rare earth mineral particles;

[0047] c) silicate mineral particles;

[0048] d) metal oxide particles; and

[0049] e) a binder, and

[0050] wherein the a) tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, and d) metal oxide particles have a size of 5 μm or less.

[0051] The composition may consist of the composite powder material and the elastomer. The composition may consist essentially of the composite powder material and the elastomer.

[0052] The composite powder material can generate negative ions through the Jules-Renard effect, and utilize the natural energy of tourmaline or other negative ion mineral materials to stimulate air ionization to generate negative ions. Using natural negative ion generating materials to obtain negative ions is an economical production method with the advantage of low cost.

[0053] The composite powder material can be evenly distributed within the composition.

[0054] Advantageously, the composition can be made into an article in which the composite powder material is evenly distributed within the article. This can prevent the composite powder material from leaking out of the article. Since the composite powder material has antibacterial properties, the article made from the composition can be exposed to bacteria for a long time while maintaining the desired antibacterial performance.

[0055] The article can kill bacteria without substantially forming resistance in the bacteria. As another example, the article can kill bacteria without forming resistance in the bacteria. As another example, the article can be substantially non-carcinogenic or non-mutagenic. As another example, the article can be non-carcinogenic or non-mutagenic. Therefore, the article can be considered safe for mammals (including humans).

[0056] a) Tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, and d) metal oxide particles can have dimensions in the range of about 0.01 μm to about 5 μm, about 0.05 μm to about 5 μm, about 0.1 μm to about 5 μm, about 0.5 μm to about 5 μm, about 1 μm to about 5 μm, about 3 μm to about 5 μm, about 0.01 μm to about 3 μm, about 0.01 μm to about 1 μm, about 0.01 μm to about 0.5 μm, about 0.01 μm to about 0.1 μm, or about 0.01 μm to about 0.05 μm. The dimensions can refer to the average dimensions of a) tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, and d) metal oxide particles. The dimensions can be regarded as the diameter or equivalent diameter (such as the equivalent spherical diameter) of a) tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, and d) metal oxide particles.

[0057] Based on the total weight of the composite powder material, the tourmaline particles can have a weight percentage in the range of about 20 wt% to about 60 wt%, about 25 wt% to about 60 wt%, about 30 wt% to about 60 wt%, about 35 wt% to about 60 wt%, about 40 wt% to about 60 wt%, about 45 wt% to about 60 wt%, about 50 wt% to about 60 wt%, about 55 wt% to about 60 wt%, about 20 wt% to about 55 wt%, about 20 wt% to about 50 wt%, about 20 wt% to about 45 wt%, about 20 wt% to about 40 wt%, about 20 wt% to about 35 wt%, about 20 wt% to about 30 wt%, about 20 wt% to about 25 wt%.

[0058] Based on the total weight of the composite powder material, the rare earth mineral particles can have a weight percentage in the range of about 20 wt% to about 40 wt%, about 25 wt% to about 40 wt%, about 30 wt% to about 40 wt%, about 35 wt% to about 40 wt%, about 20 wt% to about 35 wt%, about 20 wt% to about 30 wt%, or about 20 wt% to about 25 wt%.

[0059] The rare earth mineral particles can be selected from the group consisting of monazite, bastnasite, xenotime, and mixtures thereof.

[0060] Based on the total weight of the composite powder material, the silicate particles can have a weight percentage in the range of about 20 wt% to about 50 wt%, about 25 wt% to about 50 wt%, about 30 wt% to about 50 wt%, about 35 wt% to about 50 wt%, about 40 wt% to about 50 wt%, about 45 wt% to about 50 wt%, about 20 wt% to about 45 wt%, about 20 wt% to about 40 wt%, about 20 wt% to about 35 wt%, about 20 wt% to about 30 wt%, or about 20 wt% to about 25 wt%.

[0061] The silicate particles can be muscovite. The silicate particles can also include zeolite, diatomaceous earth, bentonite, or other silicate particles in an amount required to form the composite material. The silicate particles can also contain zeolite.

[0062] Based on the total weight of the composite powder material, the metal oxide particles can have a weight percentage in the range of about 1 wt% to about 30 wt%, about 1 wt% to about 30 wt%, about 3 wt% to about 30 wt%, about 5 wt% to about 30 wt%, about 7 wt% to about 30 wt%, about 10 wt% to about 30 wt%, about 15 wt% to about 30 wt%, about 20 wt% to about 30 wt%, about 25 wt% to about 30 wt%, about 1 wt% to about 25 wt%, about 1 wt% to about 20 wt%, about 1 wt% to about 15 wt%, about 1 wt% to about 10 wt%, about 1 wt% to about 7 wt%, about 1 wt% to about 5 wt%, or about 1 wt% to about 3 wt%.

[0063] The metal oxide can be zinc oxide, copper oxide, titanium oxide, or zinc peroxide. The metal oxide can be an enhancer of the antibacterial property of the composite powder material. Tourmaline particles and rare earth mineral particles can kill bacteria without physical contact. The metal oxide can kill bacteria upon physical contact. These types of antibacterial actions complement each other. The metal oxide can also be a binder and a photocatalyst for air purification. The metal oxide can also include rare earth oxides selected from the group consisting of cerium oxide, ytterbium oxide, lanthanum oxide, neodymium oxide, holmium oxide, thulium oxide, lutetium oxide, and mixtures thereof. The rare earth oxide can also be an enhancer of the antibacterial property of the composite powder material.

[0064] Based on the total weight of the composite powder material, the binder can have a weight percentage in the range of about 1 wt% to about 20 wt%, about 1 wt% to about 20 wt%, about 3 wt% to about 20 wt%, about 5 wt% to about 20 wt%, about 10 wt% to about 20 wt%, about 15 wt% to about 20 wt%, about 1 wt% to about 15 wt%, about 1 wt% to about 10 wt%, about 1 wt% to about 5 wt%, about 1 wt% to about 3 wt%.

[0065] The binder can be selected from the group consisting of acrylic acid, polyvinylpyrrolidone (PVP), acrylate, acrylamide, and their copolymers / mixtures. Any other polymer that can be used as a binder is also applicable. The binder can be a film-forming agent.

[0066] The composite powder material can also contain other mineral particles, such as silica, germanium oxide, arsenic oxide, boron oxide. The other mineral particles can be used as carriers for the components constituting the composite powder material. The composite powder material can also contain silica.

[0067] The composite powder material can also contain silver particles or other antibacterial particles known in the art.

[0068] The composite powder material can contain:

[0069] 20 to 60 wt% of tourmaline particles;

[0070] 20 to 40 wt% of monazite;

[0071] 20 to 40 wt% of muscovite;

[0072] 1 to 10 wt% of zeolite;

[0073] 1 to 10 wt% of silica

[0074] 1 to 10 wt% of zinc oxide; and

[0075] 1 to 20 wt% of acrylic acid.

[0076] In the composition, based on the total weight of the composition, the composite powder material may have a weight percentage in the range of about 0.01 wt% to about 50 wt%, about 1 wt% to about 50 wt%, about 10 wt% to about 50 wt%, about 0.01 wt% to about 10 wt% or about 0.01 wt% to about 1 wt%. Advantageously, based on the total weight of the composition, maintaining the weight percentage of the composite powder material at less than or equal to about 50 wt% can prevent phase separation in the composition, thereby improving the properties of the article formed from the composition.

[0077] Non-limiting examples of elastomers include thermoplastic polyurethane (TPU), polyurethane (PU), silicone, latex, and combinations thereof. The elastomer can be thermoplastic polyurethane (TPU).

[0078] The composition can be in the form of pellets.

[0079] Exemplary non-limiting embodiments of a method for preparing the composition will now be disclosed. The method includes the step of mixing a composite powder material and an elastomer, wherein the composite powder material comprises

[0080] a) tourmaline particles;

[0081] b) rare earth mineral particles;

[0082] c) silicate mineral particles;

[0083] d) metal oxide particles; and

[0084] e) a binder, and

[0085] wherein the sizes of a) tourmaline particles, b) rare earth mineral particles, c) silicate mineral particles, and d) metal oxide particles are 5 μm or less.

[0086] The method may further include the following steps to prepare the composite powder material before the mixing step:

[0087] a) grinding a mixture of tourmaline particles, rare earth mineral particles, silicate mineral particles, and metal oxide particles having a particle size of 5 μm or less to form a ground mixture;

[0088] b) adding a binder to the ground mixture of step a); and

[0089] c) drying the ground mixture of step b) to obtain the composite powder material.

[0090] The mixing step can be carried out by mechanical stirring of the composite powder material and the elastomer. The mixing step can optionally or additionally be carried out using a two-roll rubber mixing mill.

[0091] Exemplary non-limiting embodiments of the article will now be disclosed. The article comprises a composition as described herein.

[0092] The article can be in the form of a film, tubing, catheter, stent, implant device, etc. The article can be a urinary catheter, bladder drainage catheter, urinary tract stent, renal drainage catheter, intravenous access plug, intravascular catheter, intravascular stent, implant device (such as a cardiac device, such as a cardiac pacemaker, implantable cardioverter defibrillator or coronary stent; a reconstructed joint replacement, such as a hip or knee joint; a functional implant, such as an artificial urinary sphincter, penile prosthesis, cochlear implant or spinal nerve regulator; a device for access, such as an intraocular lens, portacath, central venous catheter or peripherally inserted central catheter; an electrical lead; a battery; a nerve regulator; a tissue engineered construct; a drug delivery system; a device for drainage, such as an abdominal drain, chest tube, nephrostomy tube, suprapubic catheter or peritoneal venous shunt or a cosmetic implant (such as a breast implant or testicular implant)) or an in vivo or intracavitary drainage system (such as a postoperative surgical drain or a percutaneous drainage catheter).

[0093] Advantageously, the article can have a uniform distribution of the composite powder material. This can prevent the composite powder material from leaking out of the article. Since the composite powder material has antibacterial properties, the article can maintain the desired antibacterial performance when exposed to bacteria for a long time.

[0094] The article can also comprise a coating on the surface.

[0095] The coating can be single-layer or multi-layer.

[0096] The coating can comprise a biodegradable polymer, an anti-fouling polymer or a combination thereof.

[0097] When a biofilm forms on the surface of the coated article, the biodegradable polymer can degrade and slough off. This can prevent or reduce the formation of the biofilm.

[0098] The anti-fouling polymer may not directly kill microorganisms. The anti-fouling polymer can prevent microorganisms from attaching to the surface of the coated article. This can prevent the formation of the biofilm by mechanisms such as steric repulsion, electrostatic repulsion and low surface energy.

[0099] Non-limiting examples of the biodegradable polymer include poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), poly(L-lactide-co-ε-caprolactone) (PLC) and combinations thereof.

[0100] Non-limiting examples of antifouling polymers include poly(ethylene glycol) (PEG), poly(acrylamide), poly(acrylate), betaine-based zwitterionic polymers, amphiphilic polymers, and combinations thereof.

[0101] The coating may also contain additives. The additives can be urological beneficial agents. The additives can be nitric oxide (NO), nitric oxide-releasing materials, nitric oxide donors, or combinations thereof. The additive can be the NO donor sodium nitroprusside (SNP).

[0102] The urological beneficial agent can be released from the coating at a controlled release rate. The release rate can be controlled via diffusion and degradation control. Approximately 80% of the urological beneficial agent can be released within about 4 weeks to about 12 weeks.

[0103] Exemplary non-limiting embodiments of a method for preparing an article will now be disclosed. The method comprises the following steps:

[0104] a) Heating a composition as described herein to form a blend;

[0105] b) Extruding the blend of step a) in an extruder to form composite fibers; and

[0106] c) Forming an article from the composite fibers of step b).

[0107] The heating step a) can be carried out at a temperature in the range of about 180 °C to about 210 °C, about 190 °C to about 210 °C, about 200 °C to about 210 °C, about 180 °C to about 200 °C, or about 180 °C to about 190 °C.

[0108] The extruder in the extrusion step b) can be a twin-screw extruder. The extrusion step b) can be carried out by feeding the blend of step a) into the twin-screw extruder. The twin-screw extruder can rotate at a rotational speed of about 10 revolutions per minute to about 15 revolutions per minute, about 12 revolutions per minute to about 15 revolutions per minute, or about 10 revolutions per minute to about 12 revolutions per minute.

[0109] The extrusion step b) and the forming step c) can be carried out for a total duration in the range of about 10 minutes to about 20 minutes, about 15 minutes to about 20 minutes, or about 10 minutes to about 15 minutes.

[0110] Exemplary non-limiting embodiments of a method for preventing or treating an infection in the urinary tract, hematological system, implanted device, in vivo or intracavitary drainage system of a subject will now be disclosed. The method comprises the step of applying a catheter as described herein to the subject.

[0111] Exemplary non-limiting embodiments of a method for releasing urine from a subject will now be disclosed. The method comprises the step of applying a urinary catheter as described herein to the urinary tract of the subject.

[0112] Exemplary non - limiting embodiments of a method for preventing or treating urinary tract infections in a subject will now be disclosed. The method includes the step of applying a catheter as described herein in the urinary tract of the subject.

[0113] Exemplary non - limiting embodiments of a catheter as described herein for preventing or treating urinary tract infections will now be disclosed.

[0114] Exemplary non - limiting embodiments of a catheter as described herein when used for preventing or treating urinary tract infections will now be disclosed. Brief Description of the Drawings

[0116] The drawings illustrate the disclosed embodiments and are used to explain the principles of the disclosed embodiments. However, it should be understood that the drawings are designed for illustrative purposes only and not as a limitation on the scope of the invention.

[0117] Figure 1

[0118] Figure 1 Shows a schematic view of the bladder (11) and urethra (12) in which a catheter (21) having an inflatable balloon (22) according to one embodiment of the present disclosure is deployed.

[0119] Figure 2

[0120] Figure 2 Shows a schematic view of a catheter (21) having a balloon (22), a balloon port (23), a bladder opening (24), and a urine drainage port (25) according to one embodiment of the present disclosure.

[0121] Figure 3

[0122] Figure 3 Shows a cross - sectional view of a catheter (21) having a multi - layer coating according to one embodiment of the present disclosure.

[0123] Figure 4

[0124] Figure 4 Shows a cross - sectional view of a catheter (21) according to one embodiment of the present disclosure, the catheter (21) comprising a biostable catheter tubing (31) loaded only with the composite powder material (34) of the present disclosure.

[0125] Figure 5

[0126] Figure 5 ​​​​​Shows a cross-sectional view of a urinary catheter (21) including a bio-stable catheter tubing (31) and a biodegradable layer (32) according to an embodiment of the present disclosure.

[0127] Figure 6

[0128] Figure 6 Shows a cross-sectional view of a urinary catheter (21) including a bio-stable catheter tubing (31) and a zwitterionic layer (33) according to an embodiment of the present disclosure.

[0129] Figure 7

[0130] Figure 7 Shows a cross-sectional view of a urinary catheter (21) having a multi-layer coating according to an embodiment of the present disclosure.

[0131] Detailed Description of the Drawings

[0132] Figure 3

[0133] Figure 3 Shows a cross-sectional view of a urinary catheter (21) having a multi-layer coating according to an embodiment of the present disclosure. The multi-layer coating includes a bio-stable catheter tubing (31), a biodegradable layer (32), and a zwitterionic layer (33) as a topcoat. The bio-stable catheter tubing (31) is loaded with the composite powder material (34) of the present disclosure.

[0134] Figure 7

[0135] Figure 7 Shows a cross-sectional view of a urinary catheter (21) having a multi-layer coating according to an embodiment of the present disclosure. The multi-layer coating includes a bio-stable catheter tubing (31), a biodegradable layer (32), and a zwitterionic layer (33) as a topcoat; and a hydration layer (35) formed when the urinary catheter is in contact with a liquid. The bio-stable catheter tubing (31) is loaded with the composite powder material (34) of the present disclosure. Examples

[0136] The non-limiting embodiments of the present invention will be further described in more detail by reference to specific examples, which should not be construed as limiting the scope of the present invention in any way.

[0137] Example 1 - Preparation of Composite Powder Material

[0138] ​​​​40 g of tourmaline (purchased from Hebei Longcai Mineral Co., Ltd., Hebei, China), 30 g of monazite (purchased from Hebei Longcai Mineral Co., Ltd., Hebei, China), 30 g of muscovite (purchased from Hebei Longcai Mineral Co., Ltd., Hebei, China), 5.5 g of zeolite (purchased from Jiangxi Xintao Tech Pte Ltd, Hebei, China), 5.5 g of zinc oxide (purchased from Chong Qing Yumeco Import & Export Co., Ltd., Chongqing, China) and 5.5 g of silicon dioxide (purchased from Taiwan Haiweisheng Biotechnology Pte Ltd, Taiwan, China) were mixed and ground in a ball mill (Simoloyer CM08) until the particle size was less than 5 μm. Zirconia (purchased from Chong Qing Yumeco Import & Export Co., Ltd., Chongqing, China) was used as the grinding medium. The mixture was ground for 8 to 12 hours, and the powder was removed from the bottle wall every 2 hours because the powder would adhere to the bottle wall. The total amount of zirconia beads used was 28% to 35% of the tank volume ratio. The ratio of 80 mm beads was 80% to 100%, and the ratio of 20 mm beads was 20% to 0%.

[0139] Subsequently, 26.25 mL of 40 wt% acrylic acid in water (purchased from Ningbo Meichengjiahe Pharmaceutical Technology Co., Ltd., Zhejiang, China) was added. The mixture was dried at 80 °C for 120 minutes to obtain a composite powder material.

[0140] Example 2 - Preparation of a urinary catheter

[0141] First, polyurethane (PU, purchased from Lubrizol Corporation, Ohio, USA) was mechanically mixed with the composite powder material as described in Example 1 in a ratio of 10:1 to form a blend.

[0142] Second, the blend was heated and further blended in a twin-screw extruder using shear force in the molten state of the blend.

[0143] Specifically, a composite powder material weighing less than 1% by weight (based on the total weight of the catheter to be formed) is weighed and blended with 10% by weight of polyurethane (based on the total weight of the catheter to be formed) throughout the compounding process. The core of the compounding machine is a vertically placed liquid-tight barrel with two easily removable conical mixing screws. Both the screws and the housing are specially engineered to minimize wear and resist chemicals over a wide temperature range. The robust design ensures the generation of reproducible and stable data over the years. The vertical position of the liquid-tight barrel allows for the handling of low-viscosity fluids as low as approximately 10 Pa.s. The liquid-tight barrel containing the two easily removable conical mixing screws is then heated to 180 to 210 °C to improve the mixing and extrusion of the composite material. Polyurethane and the composite powder material are manually fed through the twin-screws at a rotational speed of 12 revolutions per minute (RPM). A continuous composite fiber is pulled out using a Cast Film Device (35 mm), and the total duration of compounding and extrusion is set within 15 minutes. The duration of compounding is crucial for improving the mixing of the polyurethane and the composite powder material, which requires at least 5 minutes. The fiber is cut into small pieces for a second extrusion.

[0144] Third, the extruded fiber is blended with the remaining polyurethane greater than 89% by weight (based on the total weight of the catheter to be formed) in a predetermined ratio according to the previous step, and the second step is repeated.

[0145] Finally, a long and thin tube is made by pouring the blended material into a room temperature vulcanizing (RTV) mold, which has the desired shape and diameter of the catheter.

[0146] The material is then cured with heat for a duration of 0.5 to 40 hours and subsequently cooled. Once cooled, the tube is pulled out of the mold.

[0147] The tube has an opening formed by the mold, and another small opening is punched at the distal end of the tube. A thin layer of cured latex tape is manually covered over the tube such that it forms a sheath at the formed opening.

[0148] To hold the catheter in place within the body, a balloon is made along one opening of the tube. The balloon is formed by dipping the entire length of the tube into latex, thereby creating an outer coating and bonding to the distal and proximal ends of the cured latex tape.

[0149] At the proximal end of the cured latex tape, the tube bifurcates into two shorter tubes: one for attaching a urine bag, and the other for injecting sterile water via a needleless syringe to inflate the balloon.

[0150] Example 3 - Antibacterial Test Results

[0151] Methods and Materials:

[0152] Sample: PU loaded with composite powder material (≤1%)

[0153] Sample size: L×W×T = 5×5×1 cm (n = 3)

[0154] Method: ISO 22196:2011

[0155] Result: The antibacterial activity value of the test sample after being treated with Escherichia coli 8099 for 18 hours is greater than 6.6, and the antibacterial activity value of the test sample after being treated with Staphylococcus aureus ATCC 6538 for 18 hours is greater than 5.9. This indicates that the antibacterial rate is greater than 99% (the antibacterial value of a product treated with an antimicrobial agent > 2.0 (≥99% killing rate) can be considered an "antibacterial product").

[0156] Table 1. Antibacterial Test I

[0157]

[0158]

[0159] Methods and Materials:

[0160] Sample: PU loaded with composite powder material (≤1%)

[0161] Sample size: L×W×T = 5×5×1 cm (n = 3)

[0162] Method: ISO 22196:2011

[0163] Result: The antibacterial rate of the test sample after being treated with Klebsiella pneumoniae ATCC 4352 for 24 hours is greater than 99.9%, the antibacterial rate of the test sample after being treated with Pseudomonas aeruginosa ATCC 9027 for 24 hours is 99.9%, and the antibacterial rate of the test sample after being treated with Enterococcus faecalis ATCC 29212 for 24 hours is 99.5%.

[0164] Table 2. Antibacterial Test II

[0165]

[0166] The positive results of the antibacterial tests indicate that when used, for example, as a catheter, the compositions and products of the present invention are capable of killing bacteria, reducing the attached bacteria and ultimately reducing biofilm formation (as shown in the in vitro anti-biofilm formation test described below).

[0167] In vitro anti-biofilm formation test

[0168] The anti-biofilm ability of the compositions and articles of the present invention was evaluated using the submerged suspension method for 24 or 48 hours. As a urinary tract infection (UTI)-associated strain, Klebsiella pneumoniae ( 700603 TM ) was used for the evaluation. At both the 24-hour and 48-hour time points, a significant reduction (at least 1-log or 10-fold) in biofilm formation was observed in the articles as described herein, compared to the control material (which did not show a significant reduction in biofilm formation). This result confirms that the compositions and articles of the present invention can effectively reduce biofilm formation.

[0169] Industrial applicability

[0170] The compositions and articles of the present disclosure can be used for various applications (such as catheters) for the prevention or treatment of infections (such as urinary tract infections) in the urinary tract, blood system, implanted devices, in vivo or intracavitary drainage systems of a subject.

[0171] It will be apparent that various other modifications and adaptations of the present invention will be apparent to those skilled in the art after reading the above disclosure and are intended to be within the scope of the appended claims without departing from the spirit and scope of the present invention.

Claims

1. A composition, the composition comprising a composite powder material and an elastomer, wherein the composite powder material comprises a) tourmaline particles; b) rare earth mineral particles; c) silicate mineral particles; d) metal oxide particles; and e) a binder, and wherein the a) tourmaline particles, the b) rare earth mineral particles, the c) silicate mineral particles and the d) metal oxide particles have a size of 5 μm or less.

2. The composition according to claim 1, wherein the composition consists of the composite powder material and the elastomer.

3. The composition according to claim 1 or 2, wherein, based on the total weight of the composition, the composite powder material has a weight percentage in the range of 0.01 wt% to 50 wt%.

4. The composition according to any one of claims 1 to 3, wherein the elastomer is selected from the group consisting of thermoplastic polyurethane (TPU), polyurethane (PU), silicone and combinations thereof.

5. The composition according to any one of claims 1 to 4, wherein the composition is in the form of pellets.

6. A method for preparing a composition, the method comprising the step of mixing a composite powder material and an elastomer, wherein the composite powder material comprises a) tourmaline particles; b) rare earth mineral particles; c) silicate mineral particles; d) metal oxide particles; and e) a binder, and wherein the a) tourmaline particles, the b) rare earth mineral particles, the c) silicate mineral particles and the d) metal oxide particles have a size of 5 μm or less.

7. The method according to claim 6, wherein the method further comprises the following steps before the mixing step: a) grinding a mixture of tourmaline particles, rare earth mineral particles, silicate mineral particles and metal oxide particles having a particle size of 5 μm or less to form a ground mixture; b) adding a binder to the ground mixture of step a); and c) drying the ground mixture of step b) to obtain the composite powder material.

8. An article comprising the composition according to any one of claims 1 to 5.

9. The article according to claim 8, wherein the article is in the form of a catheter.

10. The article according to claim 9, wherein the catheter is a urinary catheter.

11. The article according to any one of claims 8 to 10, wherein the article further comprises a coating on the surface.

12. The article according to claim 11, wherein the coating comprises a biodegradable polymer, an anti-fouling polymer or a combination thereof.

13. The article according to claim 12, wherein the coating further comprises a urological beneficial agent.

14. A method for preparing an article, the method comprising the following steps: a) heating the composition according to any one of claims 1 to 5 to form a blend; b) extruding the blend of step a) in an extruder to form composite fibers; and c) forming the article from the composite fibers of step b).

15. The method according to claim 14, wherein the extrusion step b) and the forming step c) are carried out for a total duration in the range of 10 minutes to 20 minutes.

16. A method for preventing or treating an infection in the urinary tract, blood system, implanted device, in vivo or intracavitary drainage system of a subject, the method comprising the step of applying a catheter as defined in claim 9 in the subject.

17. A method for releasing urine from a subject, the method comprising the step of applying a urinary catheter as defined in claim 10 in the urinary tract of the subject.

18. A method for preventing or treating a urinary tract infection in a subject, the method comprising the step of applying a urinary catheter as defined in claim 10 in the urinary tract of the subject.

19. A urinary catheter as defined in claim 10, which is used for preventing or treating a urinary tract infection.

20. A urinary catheter as defined in claim 10 when used for preventing or treating a urinary tract infection.

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