WO2017158069A1

WO2017158069A1 - A catheter assembly

Info

Publication number: WO2017158069A1
Application number: PCT/EP2017/056193
Authority: WO
Inventors: Maja Hedlund; Joakim BERGBOM
Original assignee: RAMSTEDT, Madeleine
Priority date: 2016-03-17
Filing date: 2017-03-16
Publication date: 2017-09-21
Also published as: SE1650363A1

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.

Description

TITLE

A CATHETER ASSEMBLY FIELD OF INVENTION

A catheter assembly comprising a urinary catheter having a tubular member, the tubular member having a proximal end for insertion into the urethra and a distal end having a drainage outlet, , the tubular member further having a first lumen having a first cross sectional diameter and providing a fluid communication from the proximal end to the distal end, where the tubular member has at least a first longitudinal rigidity, a guide having an elongated body having a longitudinal axis with a proximal end and a distal end, where the body has a second cross sectional diameter that is equal to or smaller than the first cross sectional diameter of the first lumen of the catheter and where at least part of the elongated body has a second longitudinal rigidity that is higher than the first rigidity of the tubular member, 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.

BACKGROUND

Catheters have been used for a very long time as a device for treating deceases or performing surgical procedures. Catheters are usually thin tubes, that may be used to inject 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 tube is inserted into the urinary bladder via the urethra in order to void the bladder of urine that has been collected in the urinary bladder. There are two general usages of urinary catheters, where the first use is intermittent catheterization and the second use is permanent catheterization. Intermittent catheterization is where an intermittent catheter is inserted by the user into the urethra to drain the bladder, and after use the catheter is removed from the body. An intermittent catheter is a relatively stiff catheter having a hydrophilic or gel coating for lubrication and allows the users to perform the insertion on their 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 the bladder and to reduce the need of multiple insertions of catheters for healthcare personnel.

Indwelling catheters are often made of a tubular material, that has one or more lumens where one of the lumens is for providing a fluid communication from the proximal end to the distal end in order to drain fluids, and a second lumen is often provided in order to allow a balloon or a fixation device which is attached in the vicinity of the tip (proximal end) to be activated in order to ensure that the catheter is fixed in place inside the urinary bladder. The tubular material of an indwelling catheter is often made of a very flexible and soft material, so that the catheter does not restrict, prevent or oppose any movement of the urinary tract, and is designed to follow the movement of the anatomical structure surrounding 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 may be quite difficult to insert the indwelling catheter into the urinary bladder, via the genitalia and 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 material means that the forces applied to the distal end of the catheter may not be directly transferred to the proximal end of the catheter and/or the tip of the catheter. The tip of the catheter may therefore, during insertion, be relatively difficult to control, meaning that the insertion of the catheter may require numerous attempts to ensure that the catheter tip has entered the correct pathway on its route to the urinary bladder. These numerous attempts 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 the properties of being a flexible, resilient member capable of properly stiffening a urethral catheter or the like while also being sufficiently compliant to preshaping into various and multiple curvatures to facilitate insertion into a body cavity. However, in order to ensure that the health personnel can utilize the stiffener, the health personnel must have a number 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

In accordance with the invention, there is provided a catheter assembly comprising a urinary catheter having a tubular member, the tubular member having a proximal end for insertion into the urethra and a distal end having a drainage outlet, the tubular member further having a first lumen having a first cross sectional diameter and providing a fluid communication from the proximal end to the distal end, where the tubular member has at least a first longitudinal rigidity, the assembly further comprising a guide having an elongated body having a longitudinal axis with a proximal end and a distal end, where the body has a second cross sectional diameter that is equal to or smaller than the first cross sectional diameter of the first lumen of the catheter and where at least part of the elongated body has a second longitudinal rigidity that is higher than the first longitudinal rigidity of the tubular member, 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. The catheter assembly allows that a relatively soft catheter may be inserted into the urethra 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 the catheter may be manipulated by gripping the opposite distal end of the catheter. A soft catheter will have a high risk of buckling if the urinary channel (urethra) causes any insertion resistance, which may be caused by blockage, tightness of the urethra, lack of lubrication, or any other resistance. The guide facilitates the insertion, by providing an inner 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 selectively controlled during insertion, via the guide, so that the tip is capable of being bent from its natural 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 during insertion, such as an enlarged prostate, tumours, etc., the tip of the catheter may be manipulated to bend, so that the tip of the assembly can pass the obstacle easily, by adjusting 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 the assembly follows the bend in the urethra. When the bend has been passed by the tip of the assembly, the assembly may be manipulated into its natural state (straight) so that the tip can subsequently follow the curvature of the urethra. Furthermore, should there be a hindrance 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 such as an enlarged prostate, the professional can respond by bending the tip of the catheter assembly and thereby the tip of the catheter, away from the obstacle, which means that there is less risk that the tip of the catheter is capable of rupturing the urethra or other organs during insertion. Thus, the bending of the catheter will reduce the angle of attack towards the obstacle or the bend in the urethra, so that the tip of the catheter and/or the assembly will point in a direction that is closer to being parallel to the central axis of the urethra, and thereby reducing the risk that the tip of the catheter applies increased pressure to the side wall of the urethra.

If the bending of the tip does not reduce resistance, there is a risk that the tip is being bent in a direction that is not the same as the bending of the urethra, the professional may rotate 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 the elastic flexibility of a material or a body and its ability to maintain its shape in a longitudinal direction, and resist deformation. Thus an elongated body having a low longitudinal rigidity, may e.g. have a flexibility that is of the kind that the gravitational forces applied to the body are enough to make the body bend on its own, without applying any additional external forces to the body, while an elongated body having a high longitudinal rigidity may maintain its longitudinal shape so that it does not flex or deform due to gravitational forces 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, where the bendable section may have one longitudinal rigidity, a middle section may have a higher or lower, longitudinal rigidity and the distal part may have a higher or lower longitudinal rigidity compared to the other sections of the guide. In one embodiment the urinary catheter may have a fixation device provided in the vicinity of the proximal end and a second lumen providing a physical communication between the fixation 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 a balloon, which can be inflated and/or deflated via a second lumen, which is isolated from and not in fluid communication with the first lumen of the catheter. When the catheter is inserted into the urinary bladder, the balloon may be inflated, so that the tip of the catheter, having the balloon, is prevented from passing outwards past the urinary sphincter, and ensuring that the catheter does not exit the urethra. Thus, the catheter will provide an artificial communication into the bladder, where the voidance of urine is not dependent on the physical activities of the urethra or the urinary sphincter. The urinary catheter may be a urinary catheter as known in the art, such as a Foley catheter, which has 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 a balloon. 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 the catheter, or alternatively in the ultimate proximal 25% of the length, or alternatively in the last 20% of the length of the catheter, or alternatively in the last 15% of the length of the catheter, or alternatively in the last 10% of the length of the catheter, or alternatively in the last 5% of the length of the catheter. The closer the fixation device is to the tip of the catheter (ultimate proximal end), and thereby the eyelets or inlets of the catheter, the better, as this facilitates the draining of the urinary bladder, and allows the inlets of the catheter to be as close to the bottom of the urinary bladder as possible, as traditional catheter have a fixation device that is distal to the drainage inlets or eyelets of the catheter. Within the meaning of the present invention, physical communication may be any type of method to allow the fixation device to be activated. The communication may be mechanical, liquid, gas, or any type of suitable communication between the fixation device and the distal end of the catheter.

In one embodiment the bendable section may be 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. 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 elongated body of the guide, while the opposite (proximal end) is a free end. Thus, the bendable section may be adapted to start the curvature at the distal end of the bendable section and terminate at the proximal free end.

In one embodiment the angle of the bend may increase incrementally from the distal end of the bendable section towards the proximal end, so that the bend will be substantially smooth along the bendable section. This ensures that the bendable section will not have a stepped angle which might damage any tissue surrounding the guide and the catheter, or where the stepped angle might put a kink in the tubular material of the catheter, and thereby possibly damaging the catheter. In one embodiment the angle of the proximal end of the guide relative to the longitudinal axis of the guide may be between 1 and 180 degrees, or more specifically between 1 and 135 degrees, or more specifically between 1 and 90 degrees. When the angle is around 180 degrees, the bendable section will be U-shaped where the proximal end may be pointing in a direction that is parallel to the longitudinal axis of the guide. When the angle is around 90 degrees, the proximal end is pointing in a direction that may be substantially orthogonal to the longitudinal axis of the guide.

In one embodiment the guide may be 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. The guide line extends towards the distal end of the guide, so that when the guide line 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 from the longitudinal axis of the guide. The extent of the force will be translated to the tip, so that 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 providing pulling force to the tip (proximal end) of the guide. The guide line may be a metal wire, a synthetic 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, so that 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.

In one embodiment, the guide line is attached to the proximal end, where the attachment is radially offset from a central axis of the bendable section. Thus, when a pulling force is applied 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).

In one embodiment a second end of the guide line may be attached to the control section of the guide. The control section may be utilised to control the bending of the guide. The control section may be adapted to be moved in a direction that is parallel to the longitudinal axis of the guide, so that a movement in a direction towards the distal end of the guide pulls on the guide line and causes the guide to bend, while the opposite movement will release the guide line and cause the guide to return to its natural (straight) position.

In one embodiment the guide may be provided with a guide lumen which extends from the tip of the guide in a direction towards its distal end to accommodate a device for controlling the bend of the bendable section. Thus, the guide line may be introduced into an inner volume of the guide, ensuring that the guide line does not come into contact with an inner wall of the catheter during insertion. This means that there is less risk that the guide line will damage the catheter during manipulation of the guide line. Furthermore, the guide lumen may protect the guide line from coming into contact with any fluids inside the catheter, where the guide lumen may be seen as having only one opening, which is at the distal end of the guide. In one embodiment the guide lumen may be at least partly offset in a radial direction away from a central axis of the bendable section. Thus, when a pulling force is applied to the guide line inside the guide lumen, 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). Thus, the guide 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.

In one embodiment the bendable section may be adapted to bend in one radial direction relative to the elongated body. The bendable section may advantageously be adapted to bend in only one direction, which means that one side wall of the bendable section may be 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 by utilizing only one of the above, i.e. that one side wall is adapted to contract, while the opposite side wall maintains its length during the bending, or that one side wall is adapted to lengthen while the other wall is adapted to maintain its length. Thus, the bending may be achieved by having two opposing walls having different lengths, where the shorter wall will 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 elongated body.

In one embodiment, the guide comprises a material that has a relatively high torque. I.e. that the guide is designed to resist twisting. Thus, it may be possible rotate the guide, so that the direction of the bend may be changed relative to the anatomy of the user, without changing the direction of the bend relative to the remaining parts of the guide. Thus, if the urethra 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 tip has passed the first bend, the guide may be straightened and subsequently rotated 180 degrees to allow it to bend in the opposite direction to point in the direction of the second bend. In one embodiment a radial part of the bendable section may be provided with at least one groove that is substantially orthogonal to the longitudinal axis of the elongated body and/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. In one embodiment the bendable section may be provided 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 forces needed to manipulate the proximal end of the bendable section to bend. The offset of the guide lumen may especially be advantageous in the bending section of the guide, while it may 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 axis where the guide has a proximal end and a distal end, where the body has a second cross sectional diameter that is adapted to be equal to or smaller than a first cross sectional diameter of a lumen of a catheter and where at least part of the elongated body has a second longitudinal rigidity that is higher than a first rigidity of the tubular member of a catheter, where the guide is adapted to be inserted 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 being substantially parallel the longitudinal axis distal to the bendable section to bend in a radial direction away from the longitudinal axis, where the bendable section is connected to a control 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.

In accordance with the invention, the technical features of the guide which is disclosed along 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 DRAWINGS Fig. 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 2 comprises a tubular body 3, having a proximal end 4 and a distal end 9. The proximal end 4 may be an inserter tip 7 of the catheter 2, where the inserter tip has a rounded end 8 to 5 facilitate insertion of the catheter 2, and reduces the risk of damage to the body opening which the catheter 2 is to be inserted into. The inserter tip may also have a drainage eyelet 5, which allows fluid enclosed in the body of the user to be transferred from the outside of the catheter and into an inner volume (not shown) of the catheter 2 allowing the fluid to be drained via a drainage outlet 10 located at the distal end of the catheter 2. The

10 inserter tip may also comprise a fixation device 6, such as a balloon, which is deflated during insertion of the catheter, ensuring that the fixation device 6 does not increase the diameter of the catheter 2 during insertion, and is inflated when the insertion tip 7 and/or the fixation device 6 has been introduced into the desired location, such as the urinary bladder. This ensures that the inserter tip 7 does not pass the opening of the urinary

15 bladder 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 1 1 , which is not intended for insertion into the body opening, as well as a drainage outlet 10 allowing fluids to be passed from an inner volume of the catheter 2 and out of the catheter, either directly or 20 via 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 a proximal end 14 having a tip end 15 and a bendable section 16. The guide 12 is adapted to be inserted into the distal end 9 of the catheter, so that the guide is introduced coaxially

25 into the catheter. The bendable section 16 comprises a plurality of grooves 17, which may be seen as a portion where the side wall 18 of the bendable section 16 has numerous interruptions (or material that has been removed) and an opposite side wall 19 which is substantially uninterrupted, i.e. where the material is somewhat smooth. The guide further comprises a guide line 20, which extends from the proximal end 14 of the catheter guide

30 12 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 elongated body 13 of the guide 12, so that any forces applied to the stationary part 23 is directly transferred to the elongated body 13, such as movement in the longitudinal direction to insert and withdraw the guide from the catheter, or rotational movement in order to rotate the guide inside the catheter 2. The moveable part 24 may be moved relative 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 with the 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 into the drainage lumen 25 (inner volume) of the catheter 2, where the tip 15 of the guide has been introduced into the drainage opening 10 and manipulated in a direction along the longitudinal axis A towards the inserter tip, so that the tip of the guide abuts the inner surface 26 of the rounded end 8 and the guide 12 and the catheter 2 are coaxially configured, allowing the rigidity of the elongated body 13 of the guide 12 to be transferred to 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 guide line 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 tip attachment anchor 28 and is attached to the moveable part 24 at the distal end of the guide, via e.g. a base attachment anchor 29. The guide lumen 27 is formed so that the guide line 20 is capable of being moved in both directions along the longitudinal axis A, so that movement of the moveable part 24 is translated via the guide line to the tip 15. The guide 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 a predefined radial direction, when pulling force is applied to the guide line in the direction shown by the arrow B.

In Fig. 2 the catheter is shown as having a second lumen 30 which extends between a inflation port 31 which is located on the distal end of the catheter towards the balloon 6 or the fixation part which is located on the proximal end 4 of the catheter 2. The inflation port may thereby be used to inject fluids into the second lumen 30 in order to fill up the balloon 6 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. Fig. 3A shows a side view of the proximal end 14 of the guide 12 in a straight state. I.e. the bendable section 16 follows the longitudinal axis C of the guide 12 and the tip 15 points in a direction that is substantially parallel to the longitudinal axis C. The bendable section 16 is shown as having a first side wall 18 and an opposite side wall 19, where the first side wall 18 comprises a number of depressions, grooves or areas where material has been removed from the side wall, while the opposite side wall 19 is shown as being uninterrupted. By removing material, or providing grooves in one side wall, this facilitates that the bendable section can more easily bend in a direction that is parallel to a plane which intersects the first side wall and the second side wall. Thus, the grooves assist the side wall either in contracting, (i.e. shortening) by reducing the distance between edges of the grooves (as shown in Fig. 3B), or extracting (i.e. lengthening) by increasing the distance between the edges of the grooves (not shown). Thus, such configuration ensures that the bendable section is more flexible than the remaining part of the elongated body 13 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.

In this configuration, the guide line 20 is shown as being offset in a direction that is closer to the first side wall 18, where proximal end of the guide line is attached to the tip, at a radial distance from the longitudinal axis C. The guide line which is distant from the tip can move freely inside the guide line channel 27, so that when the guide line is pulled in a direction away from the tip 15, the offset guide line ensures that the tip 15 is bent in the same or similar direction as the direction of the offset. Thus, by pulling the guide line, it is possible to force the tip to bend in a radial direction away from the longitudinal axis, where an increased pulling force increases the bend of the tip away from the longitudinal axis, as shown in Fig. 3B. The direction which the tip points in D, in relation to the longitudinal axis of the guide, may be shown as the Angle a, where the tip is capable of bending between 1 - 180 degrees from the longitudinal axis. During insertion it is highly likely that the angle a will not exceed approximately 45-60 degrees, as it is unlikely that a urethra will have a steep 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 be adjusted accordingly. Should the bendable section be made short, the bend in the catheter may be relatively sharp, as the angle a is obtained over a short distance X, while a longer bendable section increase the smoothness of the bend, as the angle a may be 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

1 . A catheter assembly comprising

- a urinary catheter having a tubular member, the tubular member having a proximal end for insertion into the urethra and a distal end having a drainage outlet, the tubular member further having a first lumen having a first cross sectional diameter and 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 end and a distal end, where the elongated body has a second cross sectional diameter that is equal to or smaller than the first cross sectional diameter of the first lumen of the catheter and where at least part of the elongated body has a second longitudinal rigidity that is higher than the first longitudinal rigidity of the tubular member, 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 characterized in that the curvature of the section may be changed from a first state where the section extends substantially parallel to 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, wherein the guide is provided with a guide lumen which extends from the tip of the guide in a direction towards its distal end to accommodate a device for controlling the bend of the bendable section, and wherein the guide lumen is at least partly offset in a radial direction away from a central axis of the bendable section.

2. A catheter assembly in accordance with claim 1 , wherein the urinary catheter has a fixation device provided in the vicinity of or at the proximal end and a second lumen providing 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 the bendable 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 guide is 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 bendable section is adapted to bend in one radial direction relative to the elongated body.

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

8. A guide having an elongated body having a longitudinal axis with a proximal end and a distal end, where the body has a second cross sectional diameter that is equal to or smaller than a first cross sectional diameter of a first lumen of a catheter and where at least part of the elongated body has a second longitudinal rigidity that is higher than a first rigidity of a tubular member of the catheter, where the guide is adapted to be inserted 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 being substantially parallel the longitudinal axis distal to the bendable section to bend in a radial direction away from the longitudinal axis, where the bendable section is connected to a control 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, wherein the guide is provided with a guide lumen which extends from the tip of the guide in a direction towards its distal end to accommodate a device for controlling the bend of the bendable section, characterized in that the guide lumen is at least partly offset in a radial direction away from a central axis of the bendable section.