SE1650363A1 - A catheter assembly - Google Patents

Abstract

A catheter assembly comprising a urinary catheter having a first lumen having a first cross sectional diameter, where the tubular member has at least a first longitudinal rigidity a guide having an elongated body where the guide is adapted to be inserted coaxially into a lumen of the urinary catheter to increase the rigidity of the catheter assembly during insertion of the catheter, wherein the proximal end of the guide is provided with a bendable section where the curvature of the section may be changed from a first state where the section is extends substantially parallel the longitudinal axis of the guide and a second state where the section bends in a radial direction away from the longitudinal axis, where the bendable section is connected to a control section to control the bending of the bendable section.Fig. 1

Description

TITLEA CATHETER ASSE|\/IBLYFIELD OF INVENTION A catheter assembly comprising a urinary catheter having a tubular member, the tubularmember having a proximal end for insertion into the urethra and a distal end having adrainage outlet, , the tubular member further having a first lumen having a first crosssectional diameter and providing a fluid communication from the proximal end to the distalend, where the tubular member has at least a first longitudinal rigidity, a guide having anelongated body having a longitudinal axis with a proximal end and a distal end, where thebody has a second cross sectional diameter that is equal to or smaller than the first crosssectional diameter of the first lumen of the catheter and where at least part of theelongated body has a second longitudinal rigidity that is higher than the first rigidity of thetubular member, where the guide is adapted to be inserted coaxially into a lumen of theurinary catheter to increase the rigidity of the catheter assembly during insertion of the cath eter.BACKG ROU N D Catheters have been used for a very long time as a device for treating deceases orperforming surgical procedures. Catheters are usually thin tubes, that may be used toinject or drain fluids and/or liquids from the body, such as for draining blood or for injecting medicine into the body.

A common use of a catheter is in the form of a urinary catheter, where a thin hollow tubeis inserted into the urinary bladder via the urethra in order to void the bladder of urine thathas been collected in the urinary bladder. There are two general usages of urinarycatheters, where the first use is intermittent catheterization and the second use ispermanent catheterization. lntermittent catheterization is where an intermittent catheter isinserted by the user into the urethra to drain the bladder, and after use the catheter isremoved from the body. An intermittent catheter is a relatively stiff catheter having ahydrophilic or gel coating for lubrication and allows the users to perform the insertion ontheir own. Permanent catheterization is where a relatively soft and flexible catheter(indwelling catheter) is inserted into the body, and is anchored inside the body using e.g. a balloon at the tip of the catheter, so that the catheter is maintained in place for a significant period, i.e. days or weeks at a time, in order to have permanent drainage of thebladder and to reduce the need of multiple insertions of catheters for healthcare personnel. lndwelling catheters are often made of a tubular material, that has one or more lumenswhere one of the lumens is for providing a fluid communication from the proximal end tothe distal end in order to drain fluids, and a second lumen is often provided in order toallow a balloon or a fixation device which is attached in the vicinity of the tip (proximalend) to be activated in order to ensure that the catheter is fixed in place inside the urinarybladder. The tubular material of an indwelling catheter is often made of a very flexible andsoft material, so that the catheter does not restrict, prevent or oppose any movement ofthe urinary tract, and is designed to follow the movement of the anatomical structuresurrounding the catheter, such as the urethra, urinary bladder, or the external structures of the urinary system, such as the genitalia.

The softness of the tubular material of the urinary indwelling catheter means that it maybe quite difficult to insert the indwelling catheter into the urinary bladder, via the genitaliaand the urethra, as the insertion of the catheter is performed from the outside of the body,pushing the catheter towards the urinary bladder, where the softness of the materialmeans that the forces applied to the distal end of the catheter may not be directlytransferred to the proximal end of the catheter and/or the tip of the catheter. The tip of thecatheter may therefore, during insertion, be relatively difficult to control, meaning that theinsertion of the catheter may require numerous attempts to ensure that the catheter tiphas entered the correct pathway on its route to the urinary bladder. These numerousattempts may result in an increased risk of urinary tract infections, increased risk of damage to the surrounding anatomical structures, and may lead to tissue damage.

US 3,867,945 shows a catheter stiffener and former made of a plastic rod which has theproperties of being a flexible, resilient member capable of properly stiffening a urethralcatheter or the like while also being sufficiently compliant to preshaping into various andmultiple curvatures to facilitate insertion into a body cavity. However, in order to ensurethat the health personnel can utilize the stiffener, the health personnel must have anumber of different stiffeners available, and may have to switch between them depending on the anatomical structure of the individual being catheterized.

Thus, there is a need to improve the insertion of an indwelling catheter, to reduce the risks of complications regarding the insertion of the indwelling catheter.

GENERAL DESCRIPTION ln accordance with the invention, there is provided a catheter assembly comprising aurinary catheter having a tubular member, the tubular member having a proximal end forinsertion into the urethra and a distal end having a drainage outlet, the tubular memberfurther having a first lumen having a first cross sectional diameter and providing a fluidcommunication from the proximal end to the distal end, where the tubular member has atleast a first longitudinal rigidity, the assembly further comprising a guide having anelongated body having a longitudinal axis with a proximal end and a distal end, where thebody has a second cross sectional diameter that is equal to or smaller than the first crosssectional diameter of the first lumen of the catheter and where at least part of theelongated body has a second longitudinal rigidity that is higher than the first longitudinalrigidity of the tubular member, where the guide is adapted to be inserted coaxially into alumen of the urinary catheter to increase the rigidity of the catheter assembly duringinsertion of the catheter, wherein the proximal end of the guide is provided with abendable section where the curvature of the section may be changed from a first statewhere the section is extends substantially parallel the longitudinal axis of the guide and asecond state where the section bends in a radial direction away from the longitudinal axis,where the bendable section is connected to a control section to control the bending of the bendable section.

The catheter assembly allows that a relatively soft catheter may be inserted into theurethra without the risk of the catheter collapsing during the insertion. A soft catheter,such as an indwelling catheter, is in most cases not rigid enough to so that the tip of thecatheter may be manipulated by gripping the opposite distal end of the catheter. A softcatheter will have a high risk of buckling if the urinary channel (urethra) causes anyinsertion resistance, which may be caused by blockage, tightness of the urethra, lack oflubrication, or any other resistance. The guide facilitates the insertion, by providing aninner support to a soft catheter, similar to what the skeletal system does in the body.Thus, having the guide inserted coaxially into a lumen of the catheter, ensures that the tip and the joint assembly has enough rigidity to allow insertion into the urethra.

Furthermore, the front part and/or the tip of catheter assembly is adapted to be selectivelycontrolled during insertion, via the guide, so that the tip is capable of being bent from itsnatural position, which is substantially straight, to a curved state. This selective bending ensures that the insertion of the catheter may be done with relative ease, and if the tip of the catheter assembly in its natural (straight) state comes across an obstacle duringinsertion, such as an enlarged prostate, tumours, etc., the tip of the catheter may bemanipulated to bend, so that the tip of the assembly can pass the obstacle easily, byadjusting the shape of the assembly to resemble the shape of the urethra in that area.Thus, if there is a bend in the urethra, the assembly may be bent, so that the tip of theassembly follows the bend in the urethra. When the bend has been passed by the tip ofthe assembly, the assembly may be manipulated into its natural state (straight) so that thetip can subsequently follow the curvature of the urethra. Furthermore, should there be ahindrance in the pathway towards the urinary bladder, the bendable tip may be bent in order to pass the hindrance.

As an example, when a healthcare professional is in the midst of inserting the catheter,the professional may feel that the catheter is facing a resistance due to an obstacle suchas an enlarged prostate, the professional can respond by bending the tip of the catheterassembly and thereby the tip of the catheter, away from the obstacle, which means thatthere is less risk that the tip of the catheter is capable of rupturing the urethra or otherorgans during insertion. Thus, the bending of the catheter will reduce the angle of attacktowards the obstacle or the bend in the urethra, so that the tip of the catheter and/or theassembly will point in a direction that is closer to being parallel to the central axis of theurethra, and thereby reducing the risk that the tip of the catheter applies increased pressure to the side wall of the urethra. lf the bending of the tip does not reduce resistance, there is a risk that the tip is being bentin a direction that is not the same as the bending of the urethra, the professional mayrotate the catheter and/or the guide along the longitudinal axis of the guide/assembly, in order to manipulate the tip in a direction that matches the bend of the urethra.

Within the meaning of the present invention the term “longitudinal rigidity” means theelastic flexibility of a material or a body and its ability to maintain its shape in a longitudinaldirection, and resist deformation. Thus an elongated body having a low longitudinalrigidity, may e.g. have a flexibility that is of the kind that the gravitational forces applied tothe body are enough to make the body bend on its own, without applying any additionalexternal forces to the body, while an elongated body having a high longitudinal rigiditymay maintain its longitudinal shape so that it does not flex or deform due to gravitationalforces in any direction. Thus, an elongated body having a high longitudinal rigidity deforms less than an elongated body of the same length having a low longitudinal rigidity.

The guide may have sections that have a different degree of longitudinal rigidity, wherethe bendable section may have one longitudinal rigidity, a middle section may have ahigher or lower, longitudinal rigidity and the distal part may have a higher or lower longitudinal rigidity compared to the other sections of the guide. ln one embodiment the urinary catheter may have a fixation device provided in the vicinityof the proximal end and a second lumen providing a physical communication bet\Neen thefixation device and the tubular member allowing the fixation device to be selectively activated and deactivated.

This means that the urinary catheter may be provided with a fixation device, such as aballoon, which can be inflated and/or deflated via a second lumen, which is isolated fromand not in fluid communication with the first lumen of the catheter. When the catheter isinserted into the urinary bladder, the balloon may be inflated, so that the tip of thecatheter, having the balloon, is prevented from passing outwards past the urinarysphincter, and ensuring that the catheter does not exit the urethra. Thus, the catheter willprovide an artificial communication into the bladder, where the voidance of urine is notdependent on the physical activities of the urethra or the urinary sphincter. The urinarycatheter may be a urinary catheter as known in the art, such as a Foley catheter, whichhas one urinary drainage port and one inflation port on one end, while it has a tip and e.g.eyelets on the opposite end for drainage of fluids from the urinary bladder as well as aballoon. Such catheters are often made out of soft material such as silicone and/or latex,in order to be capable of following the contours and the chicanes of the urethra without inducing discomfort to the user.

The fixation device may be provided in the ultimate proximal third of the length of thecatheter, or alternatively in the ultimate proximal 25% of the length, or alternatively in thelast 20% of the length of the catheter, or alternatively in the last 15% of the length of thecatheter, or alternatively in the last 10% of the length of the catheter, or alternatively in thelast 5% of the length of the catheter. The closer the fixation device is to the tip of thecatheter (ultimate proximal end), and thereby the eyelets or inlets of the catheter, thebetter, as this facilitates the draining of the urinary bladder, and allows the inlets of thecatheter to be as close to the bottom of the urinary bladder as possible, as traditionalcatheter have a fixation device that is distal to the drainage inlets or eyelets of the cath eter.

Within the meaning of the present invention, physical communication may be any type ofmethod to allow the fixation device to be activated. The communication may bemechanical, liquid, gas, or any type of suitable communication betvveen the fixation device and the distal end of the catheter. ln one embodiment the bendable section may be provided with a free end and a fixedend, where the free end is adapted to coaxially abut the inserter tip of the urinary catheter.Thus, the bendable section may be the ultimate part of the proximal end of the guide,where the distal end of the bendable section is attached or integrated with the elongatedbody of the guide, while the opposite (proximal end) is a free end. Thus, the bendablesection may be adapted to start the curvature at the distal end of the bendable section and terminate at the proximal free end. ln one embodiment the angle of the bend may increase incrementally from the distal endof the bendable section towards the proximal end, so that the bend will be substantiallysmooth along the bendable section. This ensures that the bendable section will not have astepped angle which might damage any tissue surrounding the guide and the catheter, orwhere the stepped angle might put a kink in the tubular material of the catheter, and thereby possibly damaging the catheter. ln one embodiment the angle of the proximal end of the guide relative to the longitudinalaxis of the guide may be between 1 and 180 degrees, or more specifically between 1 and135 degrees, or more specifically between 1 and 90 degrees. When the angle is around180 degrees, the bendable section will be U-shaped where the proximal end may bepointing in a direction that is parallel to the longitudinal axis of the guide. When the angleis around 90 degrees, the proximal end is pointing in a direction that may be substantially orthogonal to the longitudinal axis of the guide. ln one embodiment the guide may be provided with a guide line having a first end that isattached to and/or extends from the tip of the guide and towards the distal end of theguide. The guide line extends towards the distal end of the guide, so that when the guideline is pulled in a direction away from the tip of the guide (in a direction from the proximal end towards the distal end) the forces applied to the guide line will be transferred to the tip of the guide, causing the tip to move to the side, and bend in a radial direction away fromthe longitudinal axis of the guide. The extent of the force will be translated to the tip, sothat an increased force will increase the bending of the tip, and therefore the bendable section.

The guide line may be any type of mechanical connection that is capable of providingpulling force to the tip (proximal end) of the guide. The guide line may be a metal wire, asynthetic thread, such as nylon, a telescopic line or a combination of materials.Furthermore, it may be alternatively be advantageous that the guide line may be stiff, sothat a pulling force will cause the bendable section to bend, while a pushing force may assist and/or force the tip to extend into its natural (straight) shape. ln one embodiment, the guide line is attached to the proximal end, where the attachmentis radially offset from a central axis of the bendable section. Thus, when a pulling force isapplied to the guide line, the proximal end (the tip) will bend in the direction of the offset,and cause one side of the bendable section to compress (the side wall will be shortened) while the opposite side will extend (the side wall will be lengthened). ln one embodiment a second end of the guide line may be attached to the control sectionof the guide. The control section may be utilised to control the bending of the guide. Thecontrol section may be adapted to be moved in a direction that is parallel to thelongitudinal axis of the guide, so that a movement in a direction towards the distal end ofthe guide pulls on the guide line and causes the guide to bend, while the oppositemovement will release the guide line and cause the guide to return to its natural (straight) position. ln one embodiment the guide may be provided with a guide lumen which extends from thetip of the guide in a direction towards its distal end to accommodate a device forcontrolling the bend of the bendable section. Thus, the guide line may be introduced intoan inner volume of the guide, ensuring that the guide line does not come into contact withan inner wall of the catheter during insertion. This means that there is less risk that theguide line will damage the catheter during manipulation of the guide line. Furthermore, theguide lumen may protect the guide line from coming into contact with any fluids inside thecatheter, where the guide lumen may be seen as having only one opening, which is at the distal end of the guide. ln one embodiment the guide lumen may be at least partly offset in a radial direction awayfrom a central axis of the bendable section. Thus, when a pulling force is applied to theguide line inside the guide lumen, the proximal end (the tip) will bend in the direction ofthe offset, and cause one side of the bendable section to compress (the side wall will beshortened) while the opposite side will extend (the side wall will be lengthened). Thus, theguide line will stay inside the guide lumen during the bending, as the guide lumen prevents the guide line from extending beyond the side wall of the guide. ln one embodiment the bendable section may be adapted to bend in one radial directionrelative to the elongated body. The bendable section may advantageously be adapted tobend in only one direction, which means that one side wall of the bendable section maybe adapted to contract while the opposite side wall may be adapted to extend (lengthen).Alternatively, it is possible to obtain the bending movement of the bending section byutilizing only one of the above, i.e. that one side wall is adapted to contract, while theopposite side wall maintains its length during the bending, or that one side wall is adaptedto lengthen while the other wall is adapted to maintain its length. Thus, the bending maybe achieved by having two opposing walls having different lengths, where the shorter wallwill be on the side that faces the direction of the bend while the longer wall is on the opposite side, i.e. the side facing away from the direction of the bend.

The bendable section is adapted to bend only in one direction relative to the elongatedbody. ln one embodiment, the guide comprises a material that has a relatively high torque. l.e.that the guide is designed to resist twisting. Thus, it may be possible rotate the guide, sothat the direction of the bend may be changed relative to the anatomy of the user, withoutchanging the direction of the bend relative to the remaining parts of the guide. Thus, if theurethra has an S-shaped bend, i.e. two bends in opposing directions (seen on a plane)the guide may initially be pointed in the same direction as the first bend, and when the tiphas passed the first bend, the guide may be straightened and subsequently rotated 180degrees to allow it to bend in the opposite direction to point in the direction of the secondbend. ln one embodiment a radial part of the bendable section may be provided with at leastone groove that is substantially orthogonal to the longitudinal axis of the elongated bodyand/or where an opposing radial part of the bendable section is uninterrupted. By adding a groove on the bendable section, it is possible to facilitate the bending of bendable section in the direction of the groove. ln one embodiment the bendable section may beprovided with a plurality of grooves, so that when the bendable section forced to bend,side wall is capable of folding into the flexible grooves, which thereby reduces the forcesneeded to manipulate the proximal end of the bendable section to bend. The offset of theguide lumen may especially be advantageous in the bending section of the guide, while itmay not be necessary to offset the guide lumen in the remaining elongated body of the guide, which is distal to the bendable section.

The invention also relates to a guide having an elongated body having a longitudinal axiswhere the guide has a proximal end and a distal end, where the body has a second crosssectional diameter that is adapted to be equal to or smaller than a first cross sectionaldiameter of a lumen of a catheter and where at least part of the elongated body has asecond longitudinal rigidity that is higher than a first rigidity of the tubular member of acatheter, where the guide is adapted to be inserted into a lumen of the urinary catheter toincrease the rigidity of the catheter assembly during insertion of the catheter, wherein theproximal end of the guide is provided with a bendable section where the curvature of thesection may be changed from being substantially parallel the longitudinal axis distal to thebendable section to bend in a radial direction away from the longitudinal axis, where thebendable section is connected to a control section via a transmission part, allowingmanoeuvring of the control section to be translated towards the bendable section to control the bending of the bendable section. ln accordance with the invention, the technical features of the guide which is disclosedalong with the catheter as part of a catheter assembly may also be applied to a guide as a stand-alone device.BRIEF DESCRIPTION OF THE DRAWINGSFig. 1 shows a perspective view of a catheter assembly in accordance with the invention, Fig. 2 shows a sectional side view of a catheter assembly taken along the central axis of the assembly, and Fig. 3A and 3B show a side view of a guide in a straight state and a bend state, respectively.

DETAILED DESCRIPTION Fig. 1 is a perspective view of a catheter assembly 1 in accordance with the invention.The catheter assembly comprises a catheter 2 and a catheter guide 12. The catheter 2comprises a tubular body 3, having a proximal end 4 and a distal end 9. The proximal end4 may be an inserter tip 7 of the catheter 2, where the inserter tip has a rounded end 8 tofacilitate insertion of the catheter 2, and reduces the risk of damage to the body openingwhich the catheter 2 is to be inserted into. The inserter tip may also have a drainageeyelet 5, which allows fluid enclosed in the body of the user to be transferred from theoutside of the catheter and into an inner volume (not shown) of the catheter 2 allowing thefluid to be drained via a drainage outlet 10 located at the distal end of the catheter 2. Theinserter tip may also comprise a fixation device 6, such as a balloon, which is deflatedduring insertion of the catheter, ensuring that the fixation device 6 does not increase thediameter of the catheter 2 during insertion, and is inflated when the insertion tip 7 and/orthe fixation device 6 has been introduced into the desired location, such as the urinarybladder. This ensures that the inserter tip 7 does not pass the opening of the urinarybladder and is fixed into position inside the bladder, allowing continuous drainage of the urine collected in the bladder.

The distal end 9 of the catheter 2 comprises a gripping handle 11, which is not intendedfor insertion into the body opening, as well as a drainage outlet 10 allowing fluids to bepassed from an inner volume of the catheter 2 and out of the catheter, either directly orvia a tubular connection, e.g. of a tube leading to a urine bag, which may be attached to the drainage outlet 10.

The assembly 1 also comprises a guide 12 comprising an elongated body 13 and aproximal end 14 having a tip end 15 and a bendable section 16. The guide 12 is adaptedto be inserted into the distal end 9 of the catheter, so that the guide is introduced coaxiallyinto the catheter. The bendable section 16 comprises a plurality of grooves 17, which maybe seen as a portion where the side wall 18 of the bendable section 16 has numerousinterruptions (or material that has been removed) and an opposite side wall 19 which issubstantially uninterrupted, i.e. where the material is somewhat smooth. The guide furthercomprises a guide line 20, which extends from the proximal end 14 of the catheter guide12 towards the distal end 21 of the catheter guide 12. The bending section 16 is shown in greater detail in Fig. 3A and Fig. 3B.

The distal end 21 of the guide 12 comprises a control section 22, which comprises a stationary part 23 and a moveable part 24. The stationary part 23 is rigidly attached to the 11 elongated body 13 of the guide 12, so that any forces applied to the stationary part 23 isdirectly transferred to the elongated body 13, such as movement in the longitudinaldirection to insert and withdraw the guide from the catheter, or rotationa| movement inorder to rotate the guide inside the catheter 2. The moveable part 24 may be movedrelative to the stationary part 23 and the elongated body, and is adapted to be attached to the guide line 20.

Fig. 2 shows a longitudinal sectional view of the catheter assembly 1 in accordance withthe invention. The parts shown in Fig. 1 have the same reference numbers in Fig. 2 and 3.This view, shows the catheter assembly 1 where the guide 12 has been introduced intothe drainage lumen 25 (inner volume) of the catheter 2, where the tip 15 of the guide hasbeen introduced into the drainage opening 10 and manipulated in a direction along thelongitudinal axis A towards the inserter tip, so that the tip of the guide abuts the innersurface 26 of the rounded end 8 and the guide 12 and the catheter 2 are coaxiallyconfigured, allowing the rigidity of the elongated body 13 of the guide 12 to be transferredto the soft elongated body 3 of the catheter 2.

The elongated body 13 of the guide 12 comprises a guide lumen 27, that carries the guideline 20 from the proximal end 14 of the guide towards the distal end 21 of the guide,where the guide line 20 is on one end attached to the tip 15 of the guide, via e.g. a tipattachment anchor 28 and is attached to the moveable part 24 at the distal end of theguide, via e.g. a base attachment anchor 29. The guide lumen 27 is formed so that theguide line 20 is capable of being moved in both directions along the longitudinal axis A, sothat movement of the moveable part 24 is translated via the guide line to the tip 15. Theguide lumen is adapted to be at least partly radially offset to a central axis of the guide,ensuring that the guide line 20 in the bendable section 16 is forces the tip to move in apredefined radial direction, when pulling force is applied to the guide line in the direction shown by the arrow B. ln Fig. 2 the catheter is shown as having a second lumen 30 which extends between ainflation port 31 which is located on the distal end of the catheter towards the balloon 6 orthe fixation part which is located on the proximal end 4 of the catheter 2. The inflation portmay thereby be used to inject fluids into the second lumen 30 in order to fill up the balloon6 allowing the balloon to be inflated when the catheter has been inserted into the body,and alternatively to remove fluids from the second lumen and the balloon 6 when the catheter is to be removed from the body. 12 Fig. 3A shows a side view of the proximal end 14 of the guide 12 in a straight state. |.e.the bendable section 16 follows the longitudinal axis C of the guide 12 and the tip 15points in a direction that is substantially parallel to the longitudinal axis C. The bendablesection 16 is shown as having a first side wall 18 and an opposite side wall 19, where thefirst side wall 18 comprises a number of depressions, grooves or areas where materialhas been removed from the side wall, while the opposite side wall 19 is shown as beinguninterrupted. By removing material, or providing grooves in one side wall, this facilitatesthat the bendable section can more easily bend in a direction that is parallel to a planewhich intersects the first side wall and the second side wall. Thus, the grooves assist theside wall either in contracting, (i.e. shortening) by reducing the distance between edges ofthe grooves (as shown in Fig. 3B), or extracting (i.e. lengthening) by increasing thedistance between the edges of the grooves (not shown). Thus, such configuration ensuresthat the bendable section is more flexible than the remaining part of the elongated body13 of the guide 12, with the assumption that the material stiffness and hardness of the body 13 and the bendable section 16 is similar to that of the bendable section. ln this configuration, the guide line 20 is shown as being offset in a direction that is closerto the first side wall 18, where proximal end of the guide line is attached to the tip, at aradial distance from the longitudinal axis C. The guide line which is distant from the tip canmove freely inside the guide line channel 27, so that when the guide line is pulled in adirection away from the tip 15, the offset guide line ensures that the tip 15 is bent in thesame or similar direction as the direction of the offset. Thus, by pulling the guide line, it ispossible to force the tip to bend in a radial direction away from the longitudinal axis, wherean increased pulling force increases the bend of the tip away from the longitudinal axis, asshown in Fig. 3B. The direction which the tip points in D, in relation to the longitudinal axisof the guide, may be shown as the Angle oi, where the tip is capable of bending between1- 180 degrees from the longitudinal axis. During insertion it is highly likely that the angleoi will not exceed approximately 45-60 degrees, as it is unlikely that a urethra will have asteep angle, but should it be necessary, the bendable section may be bent significantly more than the aforementioned degrees.

The length of bendable section 16 may be adjusted so that the increase in angle may beadjusted accordingly. Should the bendable section be made short, the bend in thecatheter may be relatively sharp, as the angle oi is obtained over a short distance X, while a longer bendable section increase the smoothness of the bend, as the angle oi may be 13 obtained over a distance that is greater than distance X, which means that the change in angle pr. unit of length is less when the length is greater.

Claims (10)

1. A catheter assembly comprising - a urinary catheter having a tubular member, the tubular member having a proximalend for insertion into the urethra and a distal end having a drainage outlet, thetubular member further having a first lumen having a first cross sectional diameterand providing a fluid communication from the proximal end to the distal end, where the tubular member has at least a first longitudinal rigidity (definition) - a guide having an elongated body having a longitudinal axis with a proximal endand a distal end, where the elongated body has a second cross sectional diameterthat is equal to or smaller than the first cross sectional diameter of the first lumenof the catheter and where at least part of the elongated body has a secondlongitudinal rigidity that is higher than the first longitudinal rigidity of the tubularmember, where the guide is adapted to be inserted coaxially into a lumen of theurinary catheter to increase the rigidity of the catheter assembly during insertion of the catheter, wherein the proximal end of the guide is provided with a bendable section where thecurvature of the section may be changed from a first state where the section extendssubstantially parallel to the longitudinal axis of the guide and a second state where thesection bends in a radial direction away from the longitudinal axis, where the bendablesection is connected to a control section to control the bending of the bendable section.

2. A catheter assembly in accordance with claim 1, wherein the urinary catheter has afixation device provided in the vicinity of or at the proximal end and a second lumenproviding a physical communication [definition] between the fixation device and the tubular member allowing the fixation device to be selectively activated and deactivated.

3. A catheter assembly in accordance with any of the preceding claims wherein thebendable section is provided with a free end and a fixed end, where the free end is adapted to coaxially abut the inserter tip of the urinary catheter.

4. A catheter assembly in accordance with any of the preceding claims wherein the guideis provided with a guide line having a first end that is attached to and/or extends from the tip of the guide and towards the distal end of the guide.

5. A catheter assembly in accordance with claim 4, wherein a second end of the guide line is attached to the control section of the guide.

6. A catheter assembly in accordance with any of the preceding claims, wherein the guideis provided with a guide lumen which extends from the tip of the guide in a directiontowards its distal end to accommodate a device for controlling the bend of the bendable section.

7. A catheter assembly in accordance with claim 6, wherein the guide lumen is at least partly offset in a radial direction away from a central axis of the bendable section.

8. A catheter assembly in accordance with any of the preceding claims, wherein the bendable section is adapted to bend in one radial direction relative to the elongated body.

9. A catheter assembly in accordance with any of the preceding claims, wherein a radialpart of the bendable section is provided with at least one groove that is substantiallyorthogonal to the longitudinal axis of the elongated body and/or where an opposing radial part of the bendable section is uninterrupted.

10. A guide having an elongated body having a longitudinal axis with a proximal end anda distal end, where the body has a second cross sectional diameter that is equal to orsmaller than a first cross sectional diameter of a first lumen of a catheter and where atleast part of the elongated body has a second longitudinal rigidity that is higher than a firstrigidity of a tubular member of the catheter, where the guide is adapted to be inserted intoa lumen of the urinary catheter to increase the rigidity of the catheter assembly duringinsertion of the catheter, wherein the proximal end of the guide is provided with abendable section where the curvature of the section may be changed from beingsubstantially parallel the longitudinal axis distal to the bendable section to bend in a radialdirection away from the longitudinal axis, where the bendable section is connected to acontrol section via a transmission part, allowing manoeuvring of the control section to be translated towards the bendable section to control the bending of the bendable section.