![]() packaged urinary catheter
专利摘要:
The present invention relates to a urinary catheter and a container. The urinary catheter may have a catheter rod attached to a cable, and a liner disposed on an external surface of the catheter rod. The coating can include a hydrogel, water and / or glycerin, and a polyethylene glycol (PEG). The PEG can have a molecular weight equal to or less than 600, for example, one or more of polyethylene glycol (PEG) 300 and PEG 400. The coating can be applied in a wet state and remain moist for an extended period of time in the container thus avoiding the need for a lubricant, such as a water sachet or gel pack, to accompany the catheter in the container. The container may include a gas-impermeable laminated material. The container may include an adhesive flap covering a perforated section, the adhesive flap including a pull handle. 公开号:BR112017004030B1 申请号:R112017004030-1 申请日:2015-08-26 公开日:2020-11-17 发明作者:Zhihui Yin;David Fish;Tom Roberts;Adam Silver 申请人:C.R. Bard, Inc; IPC主号:
专利说明:
PRIORITY [0001] This application claims the benefit of provisional US patent application No. 62 / 042,125, filed on August 26, 2014, which is in this application fully incorporated by reference. BACKGROUND OF THE INVENTION [0002] People suffering from neurogenic bladder disorders, such as spinal cord injury, multiple sclerosis or spina bifida, and non-neurogenic bladder disorders, such as obstruction due to enlarged prostate, urethral stricture or post-operative urinary retention, need to be continuously catheterized to empty the urinary bladder. However, continuous catheterization can lead to problems such as urinary tract infections (UTI), urethral strictures or male infertility. Intermittent catheterization at regular intervals avoids many of the negative effects of continuous long-term catheterization. There are four main categories of intermittent catheters: (1) Intermittent exposed, (2) Intermittent coated hydrophilic, (3) Pre-moistened intermittent and (4), Catheter attached to the bag or intermittent "non-contact". [0003] Exposed intermittent catheters require the use of an external lubrication method. These catheters are the cheapest and the most commonly used. Typical materials include natural rubber (latex) (NRL), polyvinyl chloride (PVC) and silicone. The common method of lubrication is gel application. The gel is applied to the urethral meatus or the tip of the catheter itself. Hydrophilic coated intermittent catheters have a lubricant coating typically applied to the first two thirds of the catheter shaft and are activated by breaking a water sachet located inside the package before opening the package. When activated, the catheter is lubricated for insertion into the urethra. Potential problems with exposed intermittent catheters and hydrophilic coated intermittent catheters include the amount of disorder they create (for example, from excess water in the water sachet and lubricant from the lubricant packs) and the time required for the user to complete the process emptying. [0004] Pre-moistened intermittent catheters can be packaged in a non-permeable packaging (for example, foil or rigid plastic) and suspended in water. Ideally, catheters will remain moist during their service life and can be very similar to intermittent hydrophilic coated ones that have been activated by water. Pre-moistened intermittent catheters can have a lubricant coating in addition to being packed in water. This can eliminate the catheter lubrication process step, but you may still have to deal with some disorder (for example, from the water stored in the package), and the liner can dry out over its useful life, making it unusable. [0005] Catheters coupled to the bag or intermittent "non-contact" can include both an exposed intermittent catheter and a hydrophilic coated intermittent catheter. There may be an insertion tip at the end of the bag with the distal end of the catheter captured at the insertion tip. During use, the user can move the catheter out of the bag using the insertion tip to help guide the catheter into the urethra. The bag can be used to collect urine. However, the use of a non-contact catheter can be impractical and difficult. [0006] The following references are for coatings: US Patent Publication No. 2002/0016574, US Patent Publication No. 2008/0179208 and US Patent No. 6,059,107, which are hereby incorporated by reference. SUMMARY OF THE INVENTION [0007] The urinary catheters described here provide an innovative type of intermittent catheter not currently available. The coating may exhibit hygroscopic characteristics, described in the present invention as the characteristic or intention of the coating not only to retain the moisture inherent in the coating, but also to attract moisture from the environment. The coating may have hydrophilic characteristics. The coating described here is an improved formulation that is applied in a wet state and that remains moist for an extended period of time. Consequently, the urinary catheters described herein do not require an additional lubricant or wetting component, such as a water sachet or gel pack, to accompany the catheters in the containers. The urinary catheters described here can be individually packed in a separate container, such as an opaque foil. These and other features of the modalities of the present invention will become more completely apparent with the description below and with the appended claims, or can be assimilated by practicing the modalities of the invention as presented later in this document. [0008] In one embodiment, a urinary catheter may include a rod attached to a cable. The urinary catheter may also include a hygroscopic and / or hydrophilic coating disposed on an external surface of the catheter shaft. The coating can include a hydrogel, glycerin or water, and a polyethylene glycol (PEG). In one embodiment, the hydrogel can be a LUBRAJEL® RR CG hydrogel or a LUBRAJEL® RR hydrogel, and the PEG can be one or both of PEG 300 and PEG 400. In the modalities described here that relate to specific hydrogels (for example, the LUBRAGEL® CG RR hydrogel), other hydrogels (for example, the LUBRAJEL® RR hydrogel) are contemplated to be replaced by or added to the specified hydrogel. Likewise, in the embodiments described herein with respect to specific polyethylene glycols (for example, PEG 300), other polyethylene glycols are contemplated to be replaced by or added to the specified polyethylene glycol. [0009] In one embodiment, a urinary catheter includes a catheter rod attached to a cable and a first liner disposed on an external surface of the catheter rod, the first liner including a hydrogel or polyacrylic acid (APA), glycerin and / or water, and polyethylene glycol (PEG), with the first coating exhibiting hygroscopic and / or hydrophilic characteristics. In one embodiment, the external surface of the catheter shaft includes a second coating on which the first coating is placed. In one embodiment, the second coating is a hydrophilic coating. [0010] In one embodiment, the coating formulations described in the present invention provide non-adherence (or anti-blocking) to the packaging material. In one embodiment, a coated catheter can be sterilized through electron beam sterilization ("e-beam") or ethylene oxide (EtO) sterilization. In one embodiment, an additional ultraviolet (UV) curable silicone film can be applied over a catheter with the coating described in the present invention. The silicone film can restrict the coating on the catheter. In one embodiment, the film can be moved, for example, towards the catheter cable, thereby acting as a non-contact layer, while maintaining the catheter's lubricity. In one embodiment, the UV curable silicone film is placed on the coating by means of a UV curing process. [0011] In a packaged urinary catheter embodiment, a coating formulation (for example, a formulation for a base coat and / or external coating) for the catheter may include the LUBRAJEL® RR CG hydrogel in a range of 15% in weight at 35% by weight, water in a range of 10% by weight to 45% by weight, and PEG in a range from 20% by weight to 75% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, water in a range of 20% by weight to 30% by weight, and PEG 400 in a range range from 40% by weight to 60% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR CG hydrogel in a range of 22% by weight to 26% by weight, water in 25% by weight, and PEG 400 in a range of 49% by weight at 53 % by weight. In one embodiment, the coating formulation may include the LUBRAJEL® RR CG hydrogel at 23.5% by weight, water at 25% by weight, PEG 400 at 51.5% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, glycerin in a range of 20% by weight to 30% by weight, and PEG 400 in a range range from 40% by weight to 60% by weight. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, glycerin in a range of 40% by weight to 60% by weight, and PEG 300 in a range range from 20% by weight to 30% by weight. In one embodiment, the coating formulation may include the LUBRAJEL® RR CG hydrogel in a range of 10% by weight to 35% by weight, glycerin in a range of 25% by weight to 75% by weight, PEG 300 in a range from 25% by weight to 65% by weight and PEG 400 in a range of 25% by weight to 50% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, glycerin in a range of 40% by weight to 60% by weight, propylene glycol (PEG) in a range from 10% by weight to 15% by weight and ethanol (anhydrous) in a range from 10% by weight to 15% by weight. In one embodiment, the LUBRAJEL® RR CG hydrogel is 50% by weight, glycerin is 25% by weight, and both ethanol and PEG are 12.5% by weight. [0012] In one embodiment, a coating formulation can include the LUBRAJEL® RR hydrogel in a range of 15% by weight to 35% by weight, glycerin in a range of 15% by weight to 30% by weight, and PEG 400 in a range of 35% by weight to 70% by weight. In one embodiment, the coating formulation may include the LUBRAJEL® RR hydrogel at 25% by weight, glycerin at 25% by weight, and both PEG 300 and PEG 400 are 25% by weight. In one embodiment, the coating formulation can include LUBRAJEL® RR hydrogel at 40% by weight, glycerin at 15% by weight, and PEG 300 at 15% by weight and PEG 400 at 30% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR hydrogel in a range of 20% by weight to 30% by weight, water in a range of 20% by weight to 30% by weight, and PEG 400 in a range from 40% by weight to 60% by weight. [0013] In one embodiment, a coating formulation can include polyacrylic acid (APA) in a range of 0.2% by weight to 3% by weight, glycerin in a range of 15% by weight to 25% by weight, water in a range of 20% by weight to 30% by weight and PEG 400 in a range of 40% by weight to 60% by weight. In one embodiment, a coating formulation can include APA in the range of 0.1% by weight to 2.5% by weight, water in a range of 10% by weight to 45% by weight and PEG, such as PEG 300 and / or PEG 400, in a range of 20% by weight to 65% by weight. [0014] In one embodiment, a silicone film can be formed on top of a catheter lining. In one embodiment, a method of forming a coated catheter includes immersing a coated catheter, such as a hydrophilic coated catheter, in a solution containing any of the coating formulations of the present invention, such as a coating formulation including APA, water and PEG, or a coating formulation including hydrogel, glycerin and / or water, and PEG, then immerse the coated catheter twice in a UV-curable solution, then expose the coated areas to a UV source and then , place the catheter directly inside a package. In one embodiment, the hydrophilic coated catheter is immersed in an APA / water / PEG solution for a residence time in the range of 0.1 seconds to 10 seconds. In one embodiment, after the catheter is immersed in the APA / water / PEG solution, it is immersed in a silicone solution with UV-curable agents several times to achieve a desired film thickness. In one embodiment, the desired thickness is 0.025 mm to 0.1 mm (0.001 in. To 0.004 in.). In one embodiment, the catheter is immersed in the silicone solution with UV-curable agents 2 to 6 times. In one embodiment, after being immersed in the silicone solution with UV-curable agents, the catheter is exposed to a UV source, such as UV light, in a 0.3 min time range. at 2.0 min. In one embodiment, after exposure to the UV source, the catheter is placed directly on a film, foil and / or Tyvek packaging without an additional drying process. [0015] In one embodiment, a method of making a urinary catheter includes applying a first coating to a catheter rod, the first coating comprising a hydrogel or polyacrylic acid (APA), glycerin and / or water, and polyethylene glycol (PEG) to form a coated catheter, and place the coated catheter in a package comprising a gas-impermeable laminated material. In one embodiment, the catheter shaft includes a hydrophilic base coating, and the first coating is applied over the hydrophilic base coating. In one embodiment, the application includes immersing the catheter shaft with the hydrophilic base coating in a solution containing a formulation of the first coating. In one embodiment, the first coating formulation comprises only APA, water and PEG, further comprising immersing the coated catheter in a silicone solution including ultraviolet (UV) curable agents to form a silicone film on the first coating. In one embodiment, the method includes exposing the silicone film to a UV light source for a period of time to cure the silicone solution. [0016] In one embodiment, the urinary catheter may include an eyelet or a plurality of opposed stepped eyelets (e.g., 3, 4, 5, 6, 7, 8, or more eyelets) proximal to a tip of the catheter, the eyelets they can be arranged in a variety of ways, including positioned circumferentially at 90 degrees to each other and positioned in a non-overlapping configuration. In one embodiment, the urinary catheter rod includes a funnel-shaped proximal end and ridges configured to facilitate grasping. In one embodiment, the urinary catheter may have a coating that exhibits hygroscopic characteristics. In another embodiment, the urinary catheter may have a coating that exhibits hydrophilic characteristics. [0017] In one embodiment, a packaged urinary catheter can include a container and a urinary catheter. The urinary catheter may include a catheter shaft attached to a cable and a liner disposed on an external surface of the catheter shaft. In one embodiment, the coating can include a hydrogel, glycerin or water, and PEG, as one or both of PEG 300 and PEG 400. In one embodiment, the coating can include an APA, glycerin, water and PEG, such as PEG 300 and / or PEG 400. In one embodiment, the coating may include APA, water and PEG, such as PEG 300 and / or PEG 400. [0018] In a packaged urinary catheter embodiment, the container may include a laminated gas-impermeable material. In a packaged urinary catheter embodiment, the container may include an adhesive flap that covers a perforated section of the laminated material, the adhesive flap may include a pull handle. In one embodiment, the container can include a water sachet, gel pack or other type of lubricant inside. In one embodiment, the container may include a source of moisture (in contact with or separate from the catheter) from which the hygroscopic coating and / or the hydrophilic coating on the urinary catheter can absorb or obtain moisture. In a packaged urinary catheter, the container does not include any water sachet, gel pack, or other type of lubricant or moisture source inside. [0019] In one embodiment, a catheterization method may include obtaining a urinary catheter that may include a catheter shaft and rod. The catheter rod may include a hydrophilic coating and / or a hygroscopic coating on an external surface thereof. In one embodiment, the coating can include a coating formulation described herein. The method may also include inserting the urinary catheter into a bladder. In one embodiment, the catheterization method may include obtaining the urinary catheter from a container in which the urinary catheter is stored. In one embodiment, the catheterization method does not include the application of a lubricant or water to the catheter shaft at any time prior to insertion into the bladder, including while in the package. BRIEF DESCRIPTION OF THE DRAWINGS [0020] The revealed systems and methods can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. It is noted that these drawings describe only typical modalities of the invention and should not, therefore, be considered to limit its scope. Examples of embodiments of the invention will be described and explained with additional specificity and detail through the use of the attached drawings in which: [0021] Figure 1 shows a modality of a urinary catheter according to the modalities described here and illustrates the exemplary use of a male urinary catheter, according to the modalities described here. [0022] Figure 2 shows a modality of a urinary catheter according to the modalities described here and illustrates the exemplary use of a female urinary catheter, according to the modalities described here. [0023] Figure 3a is a urinary catheter, according to the modalities described here. [0024] Figure 3b is a cross-sectional view of the urinary catheter rod, according to the modalities described here. [0025] Figure 4a is a first step in a method of manufacturing the container for a urinary catheter, according to modalities described here. [0026] Figure 4b is a second step in a method of manufacturing the container for a urinary catheter, according to modalities described here. [0027] Figure 4c is a third step in a method of manufacturing the container for a urinary catheter, according to modalities described here. [0028] Figure 5 is a container for a urinary catheter of the Figures described here, in a 4 to 7, in accordance with the closed ones. modalities [0029] Figure 6 is a container for a urinary catheter of Figures 4 to 7, being opened according to the modalities described here. [0030] Figure 7 is the container of Figures 4 to 7, in an open state, revealing the urinary catheter cable. [0031] Although the invention described here is susceptible to several modifications and alternative forms, specific embodiments of it are shown by way of example in the drawings and are described here in detail. It must be understood, however, that the description made here of specific modalities is not intended to limit the invention to the revealed specific forms, but, instead, the intention is to cover all the modifications, the equivalents and the alternatives that fall within the scope. spirit and scope of the invention as defined by the appended claims. DETAILED DESCRIPTION OF THE INVENTION [0032] The following description and the attached figures, which describe and show certain modalities, are made to demonstrate, in a non-limiting way, various possible configurations of a catheter, according to various aspects and characteristics of the present disclosure. Although the description of the present invention, by way of example, focuses primarily on a description of a urinary catheter and associated methods, the inventions described herein are not limited and the concepts can be applied to other types of catheters and devices. [0033] The urinary catheter described here is immediately ready for use when the container is opened, and can be inserted by the patient or the patient's caregiver in a home care setting, managed care / assisted living setting or in hospitals. In the home care setting, the catheter can be used in a variety of bathroom and non-bathroom environments. Figures 1 and 2 show urinary catheters and methods of using them according to the modalities described here. [0034] Figure 1 illustrates the male urinary catheter 10, the packaging 20 for the male urinary catheter 10 and the exemplary use (for example, steps 30 to 33) of them, according to modalities described here, and Figure 2 illustrates the female urinary catheter 50, the packaging 60 for the female urinary catheter 50 and the exemplary use (for example, steps 70 to 73) of them, according to modalities described herein. The methods shown in Figures 1 and 2 do not require the user to take action to apply a lubricant, such as water or a gel, directly to the catheter, while the catheter is in the package or after the package is opened. Consequently, the user can go directly from the catheter removal step from the packaging 30, 70 to the catheter insertion step 32, 72 without a direct hydration or lubrication intervention step (see example steps 31, 71, which indicate that the catheter is ready for use after removing the package, without requiring the addition of water or lubricant). The catheters used in Figures 1 and 2 can be the catheters according to any of the modalities discussed here, for example, the catheters can have a coating formulation that exhibits hygroscopic and / or hydrophilic characteristics (which eliminates the need for the user take the necessary measures to lubricate or hydrate the catheter). In the case of a catheter with a hygroscopic coating, although some water from the surrounding environment may be naturally attracted to the coating, this is not considered a hydration or direct lubrication step in the method. After use, catheter 10, 50 can be discarded according to the sanitary procedure. Exemplary disposal steps 33, 73 represent a possible process for disposal, including returning the catheter to the package and disposing of the package in a waste container or similar. The package can be sealable (for example, by adhesive, zip type, etc.), so that the package can be sealed after the urinary catheter is disposed inside. [0035] With reference to Figure 3a, in one embodiment, a urinary catheter 100 includes a cable 102 at a proximal end and a catheter rod 104 attached to cable 102. The urinary catheter can be one of a variety of different types of catheters urinary. The cable 102 can be shaped similar to a funnel 106 at the proximal end thereof, and can be adapted to connect to drainage bags, extension tubes, and / or the like. In addition, cable shapes in addition to a funnel-like shape can be used within the scope of the present disclosure. The cable 102 can indicate the size of the catheter and can have a color to indicate the sex (for example, pink for women, blue for men). In one embodiment, the catheter shaft 104 is made of a silicone material. In one embodiment, the silicone material has a Shore durometer in the range of 70A to 85A and a thickness in the range of 1.1 mm to 2.27 mm. It is envisaged that the composition of catheter rod 104 may include other materials that have similar physical properties that fall within the scope of the present disclosure. In one embodiment, the column resistance of catheter rod 104 is configured or designed to facilitate insertion, for example, requiring less force than current polyvinyl chloride (PVC) catheters. In one embodiment, catheter 100 may be at least partially transparent to a naked eye. [0036] Referring to Figures 3a and 3b, catheter 100 includes openings 114 at a distal end 110 that are in fluid communication with a lumen 150 that extends through the catheter shaft and cable. In one embodiment, the catheter includes four stepped eyelets opposite 114 proximal to a tip of catheter 108, eyelets 114 being positioned circumferentially at 90 degrees to each other and positioned in an overlapping configuration. It is understood that other numbers and other opening configurations fall within the scope of the present disclosure. Cable 102 includes ridges 112 to provide a gripping surface for easy gripping and handling. The catheter shaft 104 may include the lumen 150, a wall of the catheter 152, a hydrophilic base coat 154 (e.g., polyacrylic acid), and may also include a prehydrated outer coating applied to it 156 (e.g., on the base coat). The pre-hydrated coating can remain moist without the application of water or lubricating gel. [0037] In one embodiment, catheter 100 includes a hygroscopic coating 156 (for example, an upper or external pre-hydrated coating). In one embodiment, catheter 100 includes a hygroscopic coating 156 that includes a hydrogel, glycerin, water and a polyethylene glycol (PEG) with a molecular weight of 600 or less, for example, one or more among polyethylene glycol (PEG) 300 and PEG 400. In one embodiment, the hydrogel is a LUBRAJEL® hydrogel. For the coating modalities described here, the LUBRAGEL® hydrogel type may be the LUBRAJEL® RR CG hydrogel, which has the name INCI of glycerin (e) glyceryl acrylate / acrylic acid (e) propylene glycol copolymer. For the coating modalities described here, the LUBRAJEL® hydrogel type can be the LUBRAJEL® RR hydrogel. In one embodiment, the catheter includes a coating that includes a hydrogel (for example, LUBRAJEL® hydrogel), glycerin, propylene glycol (PEG) and ethanol. In one embodiment, the catheter includes a coating that includes a hydrogel (for example, LUBRAJEL® hydrogel), glycerin and propylene glycol (PEG), such as PEG 300 and / or PEG 400. In one embodiment, the catheter can be sold and packaged in sizes ranging in diameter from 8Fr to 24Fr (eg 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr) with a length L greater than 155 mm and intended for female use. However, other catheter sizes can also be used. In other modalities, the catheter can be sold and packaged in various sizes for male use. [0038] In one embodiment, the base liner 154 and / or the outer liner 156 can be applied to the catheter shaft in a method that involves dipping, brushing, spraying or extruding. It should be understood that other methods of applying one or both of the coatings to the catheter can be used and fall within the scope of the present description. In one embodiment, the catheter rod can be immersed in a volume of coating formulation. In one embodiment, the components of the coating formulation are mixed together, and then the catheter shaft is immersed in their volume. For example, the hydrophilic coating or the external coating can be produced by mixing LUBRAJEL® with water and PEG between 1.5 to 4.0 hours. The catheter (with or without a base coat) can be immersed in a coating solution and left to rest between 0.1 and 10 seconds. The catheter can then be removed from the coating solution and placed directly in the package without any further drying process. [0039] In one embodiment, the eyelets are drilled into the catheter prior to immersion in one or more coating formulations to form a coating (for example, a base coat and / or outer coat), so that both the inside as far as the outside of the catheter is coated, that is, at least a portion of the external surface of the catheter shaft and at least a portion of the internal wall that defines the lumen 150 of the catheter shaft are coated with the coating formulation. In other embodiments, one or more coating formulations can be brushed on an external surface of the catheter shaft (for example, blade scraping method). In one embodiment, the sheath (for example, the base sheath and / or the outer sheath) is only on the catheter shaft (the entire shaft of the catheter or a distal portion thereof), not on the handle. The coating described here provides the urinary catheter with a coefficient of friction (COE) in a range of 0.03 to 0.15. [0040] In one embodiment, a coating formulation (for example, a formulation for a base coat and / or external coating) for the catheter can include the LUBRAJEL® RR CG hydrogel in a range of 15% by weight to 35% by weight, water in a range of 10% by weight to 45% by weight and PEG in a range of 20% by weight to 75% by weight. In one embodiment, a coating formulation can include the LUBRAJEL® RR CG hydrogel in a range of 15% by weight to 35% by weight, water in a range of 2% by weight to 45% by weight and PEG in a range of 20% by weight to 75% by weight. In one embodiment, a coating formulation may include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, water in a range of 20% by weight to 30% by weight and PEG 400 in a range from 40% by weight to 60% by weight. In one embodiment, a coating formulation can include the LUBRAJEL® RR CG hydrogel in a range of 22% by weight to 26% by weight, water in 25% by weight and PEG 400 in a range of 49% by weight to 53% in weight. In one embodiment, the coating formulation may include the LUBRAJEL® RR CG hydrogel at 23.5% by weight, water at 25% by weight and PEG 400 at 51.5% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, glycerin in a range of 20% by weight to 30% by weight, and PEG 400 in a range range from 40% by weight to 60% by weight. In one embodiment, the coating formulation may include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, glycerin in a range of 40% by weight to 60% by weight, and PEG 300 in a range range from 20% by weight to 30% by weight. In one embodiment, the coating formulation may include the LUBRAJEL® RR CG hydrogel in a range of 10% by weight to 35% by weight, glycerin in a range of 25% by weight to 75% by weight, PEG 300 in a range from 25% by weight to 65% by weight and PEG 400 in a range of 25% by weight to 50% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR CG hydrogel in a range of 20% by weight to 30% by weight, glycerin in a range of 40% by weight to 60% by weight, propylene glycol (PEG) in a range from 10% by weight to 15% by weight and ethanol (anhydrous) in a range from 10% by weight to 15% by weight. In one embodiment, the LUBRAJEL® RR CG hydrogel is 50% by weight, glycerin is 25% by weight, and both ethanol and PEG are 12.5% by weight. [0041] In one embodiment, a coating formulation can include LUBRAJEL® RR hydrogel in a range of 15% by weight to 35% by weight, glycerin in a range of 15% by weight to 30% by weight and PEG 400 in a range of 35% by weight to 70% by weight. In one embodiment, the coating formulation may include the LUBRAJEL® RR hydrogel at 25% by weight, glycerin at 25% by weight, and both PEG 300 and PEG 400 at 25% by weight. In one embodiment, the coating formulation can include LUBRAJEL® RR hydrogel at 40% by weight, glycerin at 15% by weight, PEG 300 at 15% by weight and PEG 400 at 30% by weight. In one embodiment, a coating formulation can include LUBRAJEL® RR hydrogel in a range of 20% by weight to 30% by weight, water in a range of 20% by weight to 30% by weight, and PEG 400 in a range from 40% by weight to 60% by weight. [0042] In one embodiment, a coating formulation can include polyacrylic acid (APA) in a range of 0.2% by weight to 3% by weight, glycerin in a range of 15% by weight to 25% by weight, water in a range of 20% by weight to 30% by weight and PEG 400 in a range of 40% by weight to 60% by weight. In one embodiment, a coating formulation can include APA in the range of 0.1% by weight to 2.5% by weight, water in a range of 10% by weight to 45% by weight and PEG, such as PEG 300 and / or PEG 400, in a range of 20% by weight to 65% by weight. [0043] In one embodiment, a silicone film can be formed on top of a catheter lining. In one embodiment, a method of forming a coated catheter includes immersing a coated catheter, such as a hydrophilic coated catheter, in a solution containing any of the coating formulations of the present invention, such as a coating formulation including APA, water and PEG, or a coating formulation including hydrogel, glycerin and / or water, and PEG, then immerse the coated catheter twice in a UV-curable solution, then expose the coated areas to a UV source and then , place the catheter directly inside a package. In one embodiment, the hydrophilic coated catheter is immersed in an APA / water / PEG solution for a residence time in the range of 0.1 seconds to 10 seconds. In one embodiment, after the catheter is immersed in the APA / water / PEG solution, it is immersed in a silicone solution with UV-curable agents several times to achieve a desired film thickness. In one embodiment, the desired thickness is 0.025 mm to 0.1 mm (0.001 in. To 0.004 in.). In one embodiment, the catheter is immersed in the silicone solution with UV-curable agents 2 to 6 times. In one embodiment, after being immersed in the silicone solution with UV curable agents, the catheter is exposed to a UV source, such as UV light, in a time range of 0.3 min to 2.0 min. In one embodiment, after exposure to the UV source, the catheter is placed directly on a film, foil and / or Tyvek packaging without an additional drying process. The silicone with UV curable agents, after curing, forms a film that covers the catheter lining and can be moved when the catheter is ready for insertion. This acts to facilitate insertion without touching the lubricating coating, while maintaining the lubricity of the coating on the catheter. [0044] With reference to Figures 4a to 7, the urinary catheters described here can be individually packed in separate containers. For example, the package or container may be opaque and have the appearance of an item other than a urinary catheter, such as a food item, or the like. In one embodiment, the package or container 210 is formed and / or includes a laminated material. In other embodiments, container 210 includes a polyolefin film (e.g., polyethylene (PE)), an ethylene vinyl acetate (EVA) film, and / or a metallized polypropylene (PP) film. In one embodiment, the packaging material is impermeable to gases. In one embodiment, the lubricity of the coating is maintained or improved over time in the package while under normal ambient storage conditions. Package 200 may have a color to indicate gender (for example, pink for women, blue for men). In one embodiment, the packaging 200 can be sterilized either by electron beam processing (e-beam) or by treatment with ethylene oxide (ETO). [0045] Referring to Figures 4a to 4c, a method of manufacturing the package for a catheter, discussed here, is shown, which includes the following stages of packaging production, performed in any order: supply of a laminated material 211; providing a weakening area 224, such as a perforation or semi-cut (half cut) in the laminated material by cutting the material; folding and connecting the longitudinal edges 250 of the sheet 211 to form a rear junction 212 and a cavity 252 (Figure 4b). Position a catheter 100 inside cavity 252 and wrap inside it by sealing the ends to create a first end joint 213 and a second end joint 214 (Figure 4c). Adhesion of an adhesive flap 222 over the weakening area 224. [0046] In one embodiment, this arrangement may be similar to a packaging, such as one that can be used in a chocolate bar, with overlapping edges forming a joint along the back and the joints at the edges. The overlapping edges can be folded to one side or the other. The packaging material may have a smooth front. The front of the container can include a sealed opening 220, covered by an adhesive flap 222 (Figure 4c). The sealed opening may include a weakening area 224, such as a perforation and semi-cut (half cut), in the packaging material covered by an adhesive portion of the adhesive flap 222. The adhesive flap 222 may include features, such as a pull handle 226, to suspend the container after exposing catheter 100 in the package to facilitate user access to catheter 100 in container 210. Adhesive flap 222 can be formed of a material such as polyethylene terephthalate (PET) substrate, with a adhesive, such as an S6 adhesive, on part or all of the bottom surface of the adhesive flap. In one embodiment, the adhesive tab may include a label. The label may have illustrations printed or otherwise associated with a top surface of the label. The label can be stamped from a coil of material, and a varnish can be applied approximately 2.5 cm (1 inch) from the distal end 228 to facilitate lifting the label to begin the peeling process. [0047] The adhesive flap may include a pull handle 226 to facilitate opening of the container 210 which, after opening (Figure 7), can be positioned on a hook or the like, to suspend the container in order to facilitate use. Alternatively, the adhesive portion of the adhesive flap 222 can be pressed against a hard surface (for example, a wall, table, counter, equipment, etc.) to prevent movement of the container. In one embodiment, catheter 100 can be reinserted into container 210 and the adhesive flap, pressed 222 back through opening 220 to reseal container 210 for disposal at another location. The mode of Figures 4 to 7 is easy to open simply by placing a finger through the pull handle 226 (Figure 6) and pull the adhesive tab towards the proximal end of the container 216. The pulling action opens the container along of the weakening area 224 to reveal the cable 102 of the catheter 100, which has a gripping surface to facilitate handling. In addition, the container can be folded in half to minimize the space needed for transportation in a bag, backpack, or the like. [0048] Although the invention has been described in terms of specific variations and illustrative figures, those skilled in the art will recognize that the invention is not limited to the variations or figures described. Those skilled in the art will recognize that the invention is not limited to the application of catheters, but can be applied to any device that requires similar lubrication. In addition, where the methods and steps described above indicate certain events that occur in a certain order, those skilled in the art will recognize that the order of certain steps can be modified, and that such modifications are in accordance with the variations of the invention. In addition, some of the steps can be performed simultaneously in a parallel process when possible, as well as performed in sequence as described above. In addition, the characteristics described in one modality can generally be combined with the characteristics described in other modalities. Therefore, insofar as there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is intended that this patent also covers those variations.
权利要求:
Claims (23) [0001] 1. Packaged urinary catheter CHARACTERIZED by the fact that it comprises: a catheter having a catheter rod attached to a cable; a first coating disposed on an external surface of the catheter rod in a wet state, the first coating comprising a hydrogel or polyacrylic acid (APA), glycerin and / or water, and polyethylene glycol (PEG), the first coating exhibiting hygroscopic characteristics and / or hydrophilic; and a container including the catheter, in which the container does not include another source of moisture or lubricant for application to the catheter prior to insertion of the catheter into the urethra. [0002] 2. Packaged urinary catheter, according to claim 1, CHARACTERIZED by the fact that the hydrogel is a LUBRAJEL® RR CG hydrogel or a LUBRAJEL® RR hydrogel. [0003] 3. Packaged urinary catheter, according to claim 2, CHARACTERIZED By the fact that it comprises only the hydrogel, glycerin and PEG 400, the hydrogel being in a range of 20% by weight to 30% by weight, glycerin is in a range of 20% by weight to 30% by weight and the PEG 400 is in a range of 40% by weight to 60% by weight. [0004] 4. Packaged urinary catheter, according to claim 2, CHARACTERIZED by the fact that it comprises only hydrogel, glycerin and PEG 300, with the hydrogel being in a range of 20% by weight to 30% by weight, glycerin is in a range from 40% by weight to 60% by weight and the PEG 300 is in a range from 20% by weight to 30% by weight. [0005] 5. Packaged urinary catheter, according to claim 2, CHARACTERIZED by the fact that it comprises only hydrogel, glycerin, PEG 300 and PEG 400, the hydrogel being in a range of 10% by weight to 35% by weight, glycerin is in a range of 25% by weight to 75% by weight, PEG 300 is in a range of 25% by weight to 65% by weight and PEG 400 is in a range of 25% by weight to 50% in weight. [0006] 6. Packaged urinary catheter, according to claim 2, CHARACTERIZED by the fact that it comprises only hydrogel, water and PEG 400, the hydrogel being in a range of 15% by weight to 35% by weight, the water is in a range of 10% by weight to 45% by weight and the PEG 400 is in a range of 20% by weight to 75% by weight. [0007] 7. Packaged urinary catheter, according to claim 6, CHARACTERIZED by the fact that the hydrogel is in a range of 22% by weight to 26% by weight, water is 25% by weight and PEG 400 is in a range from 49% by weight to 53% by weight. [0008] 8. Packaged urinary catheter, according to claim 1, CHARACTERIZED by the fact that it comprises only APA, glycerin, water and PEG 400, with APA in a range of 0.2% by weight to 3% in weight, glycerin is in a range of 15% by weight to 25% by weight, water is in a range of 20% by weight to 30% by weight and PEG 400 is in a range of 40% by weight at 60 % by weight. [0009] 9. Packaged urinary catheter, according to claim 1, CHARACTERIZED by the fact that it comprises only APA, water and PEG, with APA ranging from 0.1% by weight to 2.5% by weight, the water is in a range of 10% by weight to 45% by weight and the PEG is in a range of 20% by weight to 65% by weight. [0010] 10. Packaged urinary catheter according to claim 1, CHARACTERIZED by the fact that it additionally comprises four staggered eyelets opposite to the tip of the catheter, the eyelets positioned circumferentially at 90 degrees to each other and positioned in an overlapping configuration. [0011] 11. Packaged urinary catheter, according to claim 1, CHARACTERIZED by the fact that the catheter rod includes a funnel-shaped proximal end and ridges configured to facilitate gripping. [0012] 12. Packaged urinary catheter according to claim 1, CHARACTERIZED by the fact that the external surface of the catheter rod comprises a second coating on which the first coating is arranged. [0013] 13. Packaged urinary catheter according to claim 12, CHARACTERIZED by the fact that the second coating is a hydrophilic coating. [0014] 14. Packaged urinary catheter, according to claim 12, CHARACTERIZED by the fact that a silicone film is applied over the first coating. [0015] 15. Packaged urinary catheter according to claim 14, CHARACTERIZED by the fact that the silicone film is applied as a solution curable by ultraviolet radiation (UV) and cured on the first coating by exposure to a UV source. [0016] 16. Packaged urinary catheter, according to claim 1, CHARACTERIZED by the fact that the container comprises a laminated material impermeable to gases. [0017] 17. Packaged urinary catheter according to claim 16, CHARACTERIZED by the fact that the container includes an adhesive flap that covers a perforated section of the laminated material, the adhesive flap including a pull handle. [0018] 18. Packaged urinary catheter according to claim 16, CHARACTERIZED by the fact that the container does not include a water sachet as a source of moisture or a gel pack as a lubricant. [0019] 19. Method for manufacturing and packaging a urinary catheter CHARACTERIZED by the fact that it comprises: the application of a first coating to a catheter rod in a wet state, the first coating comprising a hydrogel or polyacrylic acid (APA), glycerin and / or water, and polyethylene glycol (PEG) to form a coated catheter; and placing the coated catheter in a container comprising a laminated gas-impermeable material, wherein the container does not include another source of moisture or lubricant for application to the catheter prior to insertion of the catheter into the urethra. [0020] 20. Method, according to claim 19, CHARACTERIZED by the fact that the catheter rod includes a hydrophilic base coating, and the first coating is applied over the hydrophilic base coating. [0021] 21. Method, according to claim 20, CHARACTERIZED by the fact that the application includes immersing the catheter rod with the hydrophilic base coating in a solution containing a formulation of the first coating. [0022] 22. Method according to claim 21, CHARACTERIZED by the fact that the first coating formulation comprises only APA, water and PEG, further comprising immersing the coated catheter in a silicone solution that includes radiation-curable agents ultraviolet (UV) to form a silicone film on the first coating. [0023] 23. Method according to claim 22, CHARACTERIZED by the fact that it further comprises the exposure of the silicone film to a UV light source for a period of time to cure the silicone solution.
类似技术:
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同族专利:
公开号 | 公开日 BR112020005630A2|2020-10-13| WO2016033234A1|2016-03-03| AU2018346418A1|2020-04-09| JP6623216B2|2019-12-18| MX2017002457A|2017-05-19| AU2015306630A1|2017-02-23| US20180104444A1|2018-04-19| AU2019201673B2|2020-01-23| CN106659820A|2017-05-10| EP3691705A1|2020-08-12| KR20200066668A|2020-06-10| EP3169378A1|2017-05-24| CA3076543A1|2019-04-11| KR20170047266A|2017-05-04| AU2015306630B2|2018-12-13| ES2895849T3|2022-02-22| BR112017004030A2|2018-01-23| US20180021481A1|2018-01-25| WO2019070984A1|2019-04-11| US20210113808A1|2021-04-22| EP3691705A4|2020-12-09| US10857324B2|2020-12-08| JP2020536606A|2020-12-17| CN111182928A|2020-05-19| US10874825B2|2020-12-29| JP2017530747A|2017-10-19| AU2019201673A1|2019-04-04| EP3169378A4|2018-03-21| CA2957085A1|2016-03-03| EP3169378B1|2021-09-29|
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法律状态:
2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2020-09-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2020-11-17| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/08/2015, OBSERVADAS AS CONDICOES LEGAIS. |
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申请号 | 申请日 | 专利标题 US201462042125P| true| 2014-08-26|2014-08-26| US62/042,125|2014-08-26| PCT/US2015/047026|WO2016033234A1|2014-08-26|2015-08-26|Urinary catheter| 相关专利
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