摘要:
A use in a medical device of at least one salt of organic acid(s), and preferably a benzoate or a sorbate, as an antimicrobial agent is disclosed, and in particular for the manufacturing of an antimicrobial coating for a medical device, e.g., hydrophyllic urinary catheters, for the prevention of bacterial infection. The pH of the hydrophilic coating may be controlled to be in the range 4.0-8.0, preferably in the range 5.0-6.0, and preferably to be below 7.0. The pH of the hydrophilic coating could be controlled by means of a pH buffer, and preferably a citrate or phosphate buffer. A salt of organic acid in combination with a pH buffer has proven surprisingly efficient for inhibition of bacterial growth, and for prevention of bacterial infections.
摘要:
A catheter assembly includes a hydrophilic catheter; a wetting fluid for wetting of the catheter; and a receptacle enclosing at least the insertable part of the catheter and the wetting fluid. The wetting fluid is a solution incorporating at least one osmolality-increasing compound, and the total concentration of the osmolality-increasing compound(s) preferably exceeds 600 mOsm/dm3. The wetting fluid could either be arranged in contact with the hydrophilic surface layer of the catheter in the receptacle, for preservation of the hydrophilic surface layer in a wetted state during accommodation in said receptacle and provision of a ready-to-use catheter assembly, or be arranged to keep the wetting fluid separated from the hydrophilic surface layer of the catheter during storage, but to be brought into contact with said hydrophilic surface layer upon activation before an intended use of the catheter.
摘要:
A catheter assembly is disclosed comprising: a hydrophilic catheter; a wetting fluid for wetting of the catheter; and a receptacle enclosing at least the insertable part of the catheter and the wetting fluid. Further, the wetting fluid is a solution incorporating at least one osmolality-increasing compound, and the total concentration of the osmolality-increasing compound(s) is very high, preferably exceeding 600 mOsm/dm3. The wetting fluid could either be arranged in contact with the hydrophilic surface layer of the catheter in the receptacle, for preservation of the hydrophilic surface layer in a wetted state during accommodation in said receptacle and provision of a ready-to-use catheter assembly, or be arranged to keep the wetting fluid separated from the hydrophilic surface layer of the catheter during storage, but to be brought into contact with said hydrophilic surface layer upon activation before an intended use of the catheter. A similar method and wetting fluid is disclosed as well. The provision of the osmolality-increasing compound in the wetting fluid provides several advantages per se, such as a improved properties of the hydrophilic coating, a more predictable and controllable wetting process, a more expedient and cost efficient production, etc. Further, the use of this very high concentration of osmolality-increasing compound in the wetting fluid has proven remarkably efficient.
摘要:
A catheter assembly is disclosed, comprising a catheter, such as a urinary catheter, which at least a partly is provided with a hydrophilic coating. The catheter assembly further comprises a wetting fluid. The receptacle is in direct contact with the hydrophilic coating of the catheter over essentially the entire length of the part of the catheter being provided with the hydrophilic coating. This may e.g. be achieved by using a shrink wrap material. In order to accomplish adequate wetting, channels or the like may be provided on the inner surface of the receptacle or the outer surface of the catheter.
摘要:
A wetting apparatus (1) for wetting a hydrophilic urinary catheter (3), comprising: a wetting fluid container (4) containing a wetting fluid and being openable by the application of a pulling force thereto; a wetting receptacle (2); and a hydrophilic urinary catheter (3) to be wetted by said wetting fluid and being arranged within said wetting receptacle (2). The wetting fluid container (4) is arranged within the wetting receptacle (2), and the wetting receptacle is extendable, for opening the wetting container without rupturing a sealed condition of the wetting receptacle.
摘要:
A catheter package (10; 110; 210) comprising a catheter (1; 101; 201) positioned within an inner container (2; 102; 202) permeable to a sterilizing agent, for example an ethylene oxide gas. An outer container (3; 103; 203) which prevents access of moisture to the interior thereof encloses the inner container and catheter assembly. Two or more catheters may be stored in individual inner containers within the outer container.
摘要:
A medical device is disclosed, comprising a substrate, having on its surface, on at least a part thereof, a hydrophilic surface layer providing low-friction surface character of the medical device when wetted by a wetting fluid. The substrate is made of a polymer blend comprising a polyolefin and a composition having molecules with active hydrogen(s), such as polyamide or polyurethane. The hydrophilic surface layer is preferably adhered to the substrate by a polyurea network, whereby said polyurea network forms a covalent bond to said active hydrogen(s) in the substrate. The new substrate material is environmentally acceptable and cost effective, has adequate mechanical and chemical properties and enables the hydrophilic coating to be adequately adhered.
摘要:
A medical device is disclosed, comprising a substrate, having on its surface, on at least a part thereof, a hydrophilic surface layer providing low-friction surface character of the medical device when wetted by a wetting fluid. The substrate is made of a polymer blend comprising a polyolefin and a composition having molecules with active hydrogen(s), such as polyamide or polyurethane. The hydrophilic surface layer is preferably adhered to the substrate by a polyurea network, whereby said polyurea network forms a covalent bond to said active hydrogen(s) in the substrate. The new substrate material is environmentally acceptable and cost effective, has adequate mechanical and chemical properties and enables the hydrophilic coating to be adequately adhered.
摘要:
A medical device is disclosed, comprising a substrate, having on its surface, on at least a part thereof, a hydrophilic surface layer providing low-friction surface character of the medical device when wetted by a wetting fluid. The substrate is made of a polymer blend comprising a polyolefin and a composition having molecules with active hydrogen(s), such as polyamide or polyurethane. The hydrophilic surface layer is preferably adhered to the substrate by a polyurea network, whereby said polyurea network forms a covalent bond to said active hydrogen(s) in the substrate. The new substrate material is environmentally acceptable and cost effective, has adequate mechanical and chemical properties and enables the hydrophilic coating to be adequately adhered.