Abstract: A urinary catheter assembly is described which includes a urinary catheter having a catheter shaft, and an introducer device. The introducer device includes a splitable tubular sheath, and is arranged to accommodate at least a part of the catheter shaft for insertion into the urethra, and subsequent removal. At least a part of an outer surface of the tubular sheath is provided with a hydrophilic coating or surface.

Abstract: A disposable medical device assembly for measuring a physiological parameter in a urinary or gastrointestinal tract of a mammal being is disclosed, comprising a probe, such as a catheter, for insertion into a bodily opening of the mammal being. The probe comprises at least one sensor, such as a pressure sensor. The medical device further comprises an energy source, in the form of a biofuel cell, connected to the at least one sensor.

Abstract: A catheter assembly is disclosed, comprising a catheter, such as a urinary catheter, which at least a partly is provided with hydrophilic coating. The catheter assembly further comprises a wetting fluid. The receptacle is in direct contact with the hydrophilic coating of the catheter over the part of the catheter with the hydrophilic coating. This may, for example, 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.

Abstract: A urinary catheter and a method of its manufacture are disclosed. The urinary catheter comprises a tubular shaft extending between an insertion end and a discharge end, the tubular shaft being formed of at least two materials having different properties. The materials are arranged substantially separated from each other in distinct zones, wherein at least one of the width and thickness of said zones varies over the length of the tubular shaft, to form two or more uniform sections of the tubular shaft having various relative amounts of said materials, and wherein at least one transition between two such uniform sections is formed by at least one transition section providing a gradual transition between the uniform sections. The catheter can e.g. be produced by intermittent extrusion.

Abstract: A sterilized medical device assembly comprises a medical device having a hydrophilic surface on at least a part thereof, such as a hydrophilic urinary catheter, and a package forming a closed compartment accommodating the medical device. The medical device is arranged in an activated state in the package, with the hydrophilic surface being wetted with a wetting fluid. In addition, a small amount of wetting liquid is freely arranged in the closed compartment of the package, and in direct contact with the hydrophilic surface of the medical device. The volume of the wetting liquid corresponds to between 0.01% and 10% of a volume of the closed compartment. The medical device assembly is steam sterilized, and it has been found that the extra small amount of free liquid is very efficient in ensuring a reliable and efficient steam sterilization.

Abstract: A method for producing a urinary catheter comprises the steps: providing a tubular catheter shaft having an axially extending lumen therein; thermoforming an end of the tubular catheter shaft into a closed end; inserting said closed end of the tubular catheter shaft into an injection mold cavity; and injecting thermoplastic polymer material into the mold cavity to form a tip on the thermoformed end of the tubular catheter shaft. Hereby, a very effective method is obtained, forming securely attached tips. Alternatively, an end of the tubular catheter shaft with a non-closed opening may be inserted into the injection mold cavity; and thermoplastic polymer material be injected into the mold cavity to form a tip on the end of the tubular catheter shaft, whereby the injecting is controlled so that a limited amount of thermoplastic polymer enters into the lumen.

Abstract: A urethral stent for arrangement in the urethra of a patient is disclosed. The ethereal stent includes a tubular body having first and second openings, retention elements connected to the tubular body at the first opening and to the tubular body at a distance from the first retention element, and a valve. The valve includes a valve seat formed by the first opening and a valve element that is pivotably connected to the tubular body and/or the valve seat. The valve is pivotable between a closed position and an open position to close and open the lumen, respectively. The valve is at least partly made of a ferromagnetic material and has an area which exceeds the area of the first opening. A bladder control assembly comprising the urethral stent is also disclosed.

Abstract: A urethral stent for arrangement in the urethra of a patient is disclosed. The ethereal stent includes a tubular body having first and second openings, retention elements connected to the tubular body at the first opening and to the tubular body at a distance from the first retention element, and a valve. The valve includes a valve seat formed by the first opening and a valve element that is pivotably connected to the tubular body and/or the valve seat. The valve is pivotable between a closed position and an open position to close and open the lumen, respectively. The valve is at least partly made of a ferromagnetic material and has an area which exceeds the area of the first opening. A bladder control assembly comprising the urethral stent is also disclosed.

Abstract: A catheter assembly is disclosed, comprising a catheter, such as a urinary catheter, which at least a partly is provided with hydrophilic coating. The catheter assembly further comprises a wetting fluid. The receptacle is in direct contact with the hydrophilic coating of the catheter over the part of the catheter with the hydrophilic coating. This may, for example, 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.

Abstract: 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.

Abstract: A sterilized medical device assembly comprises a medical device having a hydrophilic surface on at least a part thereof, such as a hydrophilic urinary catheter, and a package forming a closed compartment accommodating the medical device. The medical device is arranged in an activated state in the package, with the hydrophilic surface being wetted with a wetting fluid. In addition, a small amount of wetting liquid is freely arranged in the closed compartment of the package, and in direct contact with the hydrophilic surface of the medical device. The volume of the wetting liquid corresponds to between 0.01% and 10% of a volume of the closed compartment. The medical device assembly is steam sterilized, and it has been found that the extra small amount of free liquid is very efficient in ensuring a reliable and efficient steam sterilization.

Abstract: A urinary catheter and a method of its manufacture are disclosed. The urinary catheter comprises a tubular shaft extending between an insertion end and a discharge end, the tubular shaft being formed of at least two materials having different properties. The materials are arranged substantially separated from each other in distinct zones, wherein at least one of the width and thickness of said zones varies over the length of the tubular shaft, to form two or more uniform sections of the tubular shaft having various relative amounts of said materials, and wherein at least one transition between two such uniform sections is formed by at least one transition section providing a gradual transition between the uniform sections. The catheter can e.g. be produced by intermittent extrusion.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A medical device assembly is disclosed, comprising: a medical device; a fluid and a package forming a storage compartment, which at least partly accommodates the medical device, and a fluid compartment, housing the fluid, wherein a first joint separates the storage compartment and the fluid compartment, the first joint forming a first rupture zone.

Abstract: A method for producing a medical device comprising the steps of: providing a tubular substrate, said tubular substrate enclosing an internal lumen and being provided with at least one recess in the outer surface, wherein said recess does not form a through going hole into the internal lumen; treating the outer surface of said tubular substrate, preferably by means of surface modification and/or by coating; and forming, after said treating of the outer surface, an opening within said at least one recess to form an access opening to said internal lumen.

Abstract: 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.

Abstract: A medical device assembly is disclosed, comprising: a medical device; a fluid and a package forming a storage compartment, which at least partly accommodates the medical device, and a fluid compartment, housing the fluid, wherein a first joint separates the storage compartment and the fluid compartment, the first joint forming a first rupture zone.

Abstract: 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.