WO2011161418A1

WO2011161418A1 - A catheter device and a method of deploying a catheter device

Info

Publication number: WO2011161418A1
Application number: PCT/GB2011/000951
Authority: WO
Inventors: Robert Graham Urie
Original assignee: Mediplus Ltd
Priority date: 2010-06-25
Filing date: 2011-06-24
Publication date: 2011-12-29
Also published as: GB2481578A; GB201010707D0

Abstract

A catheter device (10) comprising a housing (12) having a catheter receiving portion (16), a lock receiving portion (17) and a tube receiving portion (18), a catheter (20) sealingly engageable with the catheter receiving portion, the catheter further comprising an inner sleeve (22), an outer sleeve (36) surrounding the inner sleeve, the inner and outer sleeves being longitudinally displaceable relative to one another to enable the catheter to move from an open state to a closed state, a lock mechanism, receivable in the lock receiving portion, having a tube receiving portion (88), and being engageable with the catheter to secure the catheter in the open state, a connecting tube (104) having a proximal end (106) and a distal end (108), the proximal end being receivable in the tube receiving portions of the housing and the lock mechanism, and a valve (116) connectable to the distal end of the connecting tube, whereby, in use, the catheter, lock mechanism and connecting tube are located in the housing, the catheter is locked in the open position and the catheter is in fluid communication with the connecting tube.

Description

A CATHETER DEVICE AND

A METHOD OF DEPLOYING A CATHETER DEVICE

This invention relates to a catheter device and particularly, but not exclusively, to a catheter device enabling a patient to control the drainage of urine from their bladder, together with a method of deploying such a catheter device.

A known technique for enabling a patient with long term bladder problems to control the drainage of urine from their bladder is Intermittent Self Catheterisation (ISC).

The ISC technique uses a catheter in the form of a simple tube where the distal end is domed and a hole is formed close to the distal end. The catheter is inserted through the urethra into the bladder in order to drain urine from the bladder. After the drainage is complete the patient removes the catheter and carries on with his life as usual.

ISC is a technique mainly used by patients having good manual dexterity. In addition, for anatomical reasons the technique is more suited to women than to men.

An alternative technique for patients who are unable to manage the ISC method is long term catheterisation using a Foley catheter. A Foley catheter has two lumens; one being used for drainage of the bladder and the second being used to inflate and deflate a retention balloon which secures the catheter in place in the bladder.

A Foley catheter may be positioned either urethrally or suprapubically. In either case, the insertion of the catheter is almost always carried out by a clinically trained person, which may include a relative or a carer. Such a catheter is rarely inserted by the patient themselves.

Whether urethrally or suprapubically inserted, the catheter may remain operable for a period of a few days to a few months before it requires replacement due to catheter blockage. Catheter blockage is generally caused by deposits, produced as a result of changes in the pH level of the urine, forming on the catheter.

Many patients who need to use a catheter on a long term basis prefer to have the catheter placed suprapubically as they find this to be less intrusive to their daily lives. l For example, the positioning of urethral catheters can make general everyday tasks, such as dressing, difficult and may cause discomfort if they become disturbed, for example when sitting down or standing up. A further disadvantage of extended use of a urethral catheter is that the urethra may become weakened or damaged, resulting in urinary leakage around the catheter. Additionally the urethral catheter can cause damage to the bladder neck, which may also lead to urinary leakage In addition, there is some evidence that urethral catheterisation can cause increased risk of infection in the patient in comparison to suprapubic techniques.

While suprapubic access to the bladder overcomes many of the problems associated with urethral catheterisation, the use of a suprapubically located Foley catheter may still be inconvenient for the patient. This is because there is typically 10cm or more of tube hanging outside the body, terminating in a connection funnel and valve which may be cumbersome for the patient.

A further problem with the use of a suprapubic catheter is that it is important for the clinician to be able to determine when the catheter has been inserted to the correct depth.

Injury to the patient may result not only from inserting the catheter too deeply, but also from not inserting it sufficiently far.

Whether the catheter is urethrally or suprapubically installed, the catheter is then connected to either a patient operated valve or to a drainage bag that collects the urine.

The valve is more convenient, since it eliminates the need for a drainage bag, but can only be used by patients having good manual dexterity and cognisance. The use of a valve enables the patient to drain his bladder at will.

However, since it can be difficult for non-dextrous patients to operate a valve, particularly when it is situated on their abdomen, the catheter is then usually connected to a drainage bag that the patient wears on their thigh or ankle. According to a first aspect of the invention there is provided a catheter device comprising a housing having a catheter receiving portion, a lock receiving portion and a tube receiving portion, a catheter sealingly engageable with the catheter receiving portion, the catheter further comprising an inner sleeve, an outer sleeve surrounding the inner sleeve, the inner and outer sleeves being longitudinally displaceable relative to one another to enable the catheter to move from an open state to a closed state, a lock mechanism, receivable in the lock receiving portion, having a tube receiving portion, and being engageable with the catheter to secure the catheter in the open state, a connecting tube having a proximal end and a distal end, the proximal end being receivable in the tube receiving portion of the housing and the lock mechanism, and a valve connectable to the distal end of the connecting tube, whereby, in use, the catheter, lock mechanism and connecting tube are located in the housing, the catheter is locked in the open position and the catheter is in fluid communication with the connecting tube. An advantage of the catheter device is that the housing has a catheter receiving portion, a lock receiving portion and a tube receiving portion, which enables each of the catheter, lock mechanism and connecting tube to be received in respective portions of the housing. Consequently, when the catheter is inserted into the bladder of a patient and the housing is assembled, the catheter is moved from the closed to the open position. This movement locks the catheter in place in the bladder of the patient and the catheter is brought into fluid communication with the connecting tube. The length of the catheter is predetermined based upon the age and physical characteristics of the patient. This means that when the assembled catheter device is fitted to the patient, the length of the catheter is such that it is located at the optimum insertion depth to enable drainage of urine from the patient's bladder. While the catheter device must be fitted by a medically trained person, subsequent refitting of replacement devices is made simpler by the predetermination of the length of the catheter. This makes the catheter device more convenient and easier to use than conventional suprapubic catheter devices. Furthermore, by placing the valve on the end of a connecting tube, it is easier for a non- dextrous patient to operate the valve to drain urine from their bladder without disturbing the point of ^" entry of the catheter into the patient's body. This reduces the risk of dislodging the catheter and/or causing infection to the entry site.

Optionally, the lock mechanism comprises a first lock component and a second lock component, the first and second lock components being engageable with one another when the catheter is in the open state.

In an embodiment of the invention, the engagement of the first and second lock components is achieved by snapping an annular ridge on the first lock component into a corresponding annular groove on the second lock component.

Since as mentioned above, the size of the catheter sleeves are pre-determined for an individual patient, the snap engagement of the first and second lock components makes the fitting of the catheter device to a patient a simple and quick process.

In other embodiments of the invention, the lock mechanism may take a different form and/or may operate in a different manner:

Optionally, the first lock component is formed on, or attachable to, the lock receiving portion, and the second lock component is formed on, or attachable to, the inner sleeve.

Optionally, the lock mechanism includes a frangible portion.

The removal of the frangible portion of the lock mechanism allows the catheter to move from an open state to a closed state and thus be withdrawn from the patient's body. This simplifies the withdrawal of the device from the patient's body

The incorporation of a frangible portion into the lock mechanism results in the catheter device being a disposable article, since without the frangible portion the lock mechanism is unable to secure the catheter in the open state.

This in turn reduces the risk of infection through reusing a catheter device which has previously been fitted to a patient.

In other embodiments of the invention, the lock mechanism may not incorporate a frangible portion. This would result in a reusable catheter device although it would be necessary to ensure the device is adequately sterilised between uses. According to a second embodiment of the invention there is provided a method of deploying a catheter device in a patient, the catheter device comprising a housing having a catheter receiving portion, a lock receiving portion and a tube receiving portion, a catheter sealingly engageable with the catheter receiving portion, the catheter further comprising an inner sleeve, an outer sleeve surrounding the inner sleeve, the inner and outer sleeves being longitudinally displaceable relative to one another to enable the catheter to move from an open state to a closed state, a lock mechanism, receivable in the lock receiving portion, having a tube receiving portion, and being engageable with the catheter to secure the catheter in the open state, a connecting tube having a proximal end and a distal end, the proximal end being receivable in the tube receiving portion of the housing and the lock mechanism, and a valve connectable to the distal end of the connecting tube, whereby, in use, the catheter, lock mechanism and connecting tube are located in the housing, the catheter is locked in the open position and the catheter is in fluid communication with the connecting tube, the lock mechanism comprising a first lock component and a second lock component, the first and second lock components being engageable with one another when the catheter is in the open state, the first lock component being formed on, or attachable to the lock receiving portion, and the second lock component being formed on, or attachable to the inner sleeve, the lock mechanism including a frangible portion, the method comprising the steps of:

selecting a catheter device based on the age and size of the patient;

sealingly engaging the catheter to the catheter receiving portion of the housing; inserting the catheter into a patient's body until a distal end thereof is positioned within the bladder of the patient and the housing contacts the patient's body;

connecting the proximal end of the connecting tube to the tube receiving portion; connecting the lock mechanism to the lock receiving portion so as to secure the catheter in its open position;

connecting the valve to the distal end of the connecting tube;

connecting the valve to a fluid collection device; and

allowing urine to drain from the bladder.

In the present embodiment, when the catheter is connected to the catheter receiving portion of the housing, the second lock component is fastened to the inner sleeve of the catheter, and the first lock component is fastened to the lock receiving portion of the housing.

The proximal end of the connecting tube is then connected to the tube receiving portion of the second lock component. The catheter is inserted into the patient's body until the housing abuts the patient's abdomen. Since the length of the catheter has been predetermined, the distal end of the catheter will be optimally positioned within the bladder of the patient. This enables the device to drain urine from the patient's bladder in a consistently optimum manner.

Once the catheter has been inserted into the patient's body, the catheter is secured in its open position by pulling on the connecting tube to move the inner sleeve relative to the outer sleeve and to secure the catheter in its open position.

Optionally, the step of connecting the lock mechanism to the lock receiving portion so as to secure the catheter in its open position, comprises the steps of:

connecting the second lock component to the inner sleeve;

connecting the first lock component to the housing; and

moving the connecting tube relative to the housing until the first and second lock components are securably engaged with one another.

There now follows a description of an embodiment of the invention, by way of non- limiting example, with reference being made to the accompanying drawings in which:

Figure 1 shows a perspective view of a catheter device according to an embodiment of the present invention;

Figures 2A and 2B show perspective views of a first lock component of the catheter device of Figure 1 ;

Figure 3A shows an elevational view of a second lock component of the catheter device of Figure 1 ; Figure 3B shows a cross-sectional view of the second lock component of Figure 3A; and

Figure 4 shows the first and second portions of the housing of Figure 1.

Referring to Figures 1 to 4, a catheter device according to a first embodiment of the invention is designated generally by the reference numeral 10. The catheter device 10 comprises a housing 12 having a first portion 14 and a second portion 15, and a catheter 20 extending from the first portion 14. The first portion 14 of the housing 12 further comprises a catheter receiving portion 16, a lock receiving portion 17 and a tube receiving portion 18. The second portion 15 of the housing 12 further comprises an opening 19.

The catheter 20 comprises an outer sleeve 36 together with an inner sleeve 22 extending through the outer sleeve 36. The inner and outer sleeves 22,36 are formed of a suitable material such as polymer compounds including PVC or polyurethane having an outer diameter suitable for suprapubic insertion of the catheter 20 into the bladder of the patient.

The catheter further comprises a lock mechanism for locking the inner and outer sleeves 22,36 in a predetermined axial displacement to retain the catheter device 10 in the patient's body.

The lock mechanism comprises a first lock component 60 and a second lock component 78. The first and second lock components 60,78 are engageable with one another when the catheter 20 is in its open position.

The first lock component 60 has a first end 62 and a second end 64 with the first end 62 being securable to the first portion 14 of the housing 12. The second end 64 of the first lock component 60 comprises a frangible portion 70 having an inwardly extending annular ridge 68 on an inner periphery thereof, a plurality of lock tabs 66, and a removeable releasing tab 72. The releasing tab 72 may be manually removed from the first lock component 60 so as to separate the frangible portion 70 from the first lock component 60.

In the embodiment shown, when installed, the first lock component 60 is retained in the lock receiving portion 18 of the housing 12 by the engagement of the lock tabs 66 with corresponding housing tabs 76 formed in the lock receiving portion 18. While, in the embodiment shown, the first lock component is retained in the lock receiving portion 18 by pairs of inter-engaging tabs 66,76, alternative retention means such as an interference fit or the use of adhesive bonding could equally be employed. The second lock component 78 has a first end 80 and a second end 82 and a bore 84.

In the present embodiment, the bore 84 has a first portion 86 and a tube receiving portion 88, corresponding to the first end 80 and second end 82 respectively. The first portion 86 is formed parallel to an axis of the second lock component 78, and the tube receiving portion 88 is formed at an angle to this axis.

The outer periphery of the first end 80 of the second lock component 78 is formed as a tapered annular surface 96.

The inner sleeve 22 of the catheter 20 is securely retained in the first portion 86 of the bore 84 in the second lock component 78. An annular groove 92 is formed around an external periphery of the second end 82 of the second lock component 78. This annular groove 92 is engageable in use with the inwardly extending annular ridge 68 of the first lock component 60.

A connecting tube 104 having a proximal end 106 and a distal end 108 is connected at its proximal end 106 to the tube receiving portion 88 of the bore 84 in the second lock component 78.

A valve 116 is connected to the distal end 108 of the connecting tubel 04. The valve 116 is operable by the user to enable urine to be drained from the bladder of the patient.

When the first portion 14 and second portion 15 of the housing 12 are assembled, they together define a tube receiving portion 18 and a recess 120 along a peripheral edge of the housing 12. The tube receiving portion 18 receives the connecting tube 104, while the recess 120 accommodates the valve 116.

As previously mentioned, the catheter 20 comprises an inner sleeve 22 and an outer sleeve 36 surrounding the inner sleeve 22.

The outer sleeve 36 of the catheter 20 has a proximal portion 38 that normally remains outside the patient's body, and a distal portion 40 that extends into the bladder. A plurality of slits 42 is cut through the walls of the outer sleeve 36 to define a deformable zone 44 along which the outer sleeve 36 is generally axially compressible. The deformable zone 44 effectively separates the proximal portion 38 and the distal portion 40 of the outer sleeve 36. The outer sleeve 36 defines a lumen therethrough extending from the proximal end 46 to the distal end 48.

The proximal portion 38 and distal portion 40 may be relatively axially displaced towards one another to effect longitudinal or axial compression such that the sleeve walls between the slits 42 will splay or bulge outwards to Open' the slits 42.

It will be recognised that to achieve this longitudinal compression, the slits 42 need not be aligned with the longitudinal axis of the lumen, but merely have a component in that direction. For example, the slits 42 may have a diagonal or spiral alignment, in which case longitudinal compression will still cause the sleeve walls between the slits 42 to buckle or bulge outwards.

In order to facilitate the desired longitudinal compression of the outer sleeve 36, relative displacement along the longitudinal axis of the proximal portion 38 and the distal portion 40 is required.

The inner sleeve 22 of the catheter 20 has a proximal end 24 and a distal end 26 and at least one aperture 28 positioned close to the distal end 26. More than one aperture 28 may be provided, for example, arranged circumferentially around the inner sleeve 22. The outside diameter of the inner sleeve 22 is less than the inner diameter of the outer sleeve 36. The inner sleeve 22 is also formed from a suitable material as indicated above. However, it is preferably sufficiently rigid that compression of the inner sleeve 22 along its longitudinal axis is not possible during normal use. The inner sleeve 22 is contained within the outer sleeve 36 and is generally in sliding engagement therewith. However, at the distal ends 26,48 the inner and outer sleeves 22,36 are coupled together, using some suitable attachment means, such as adhesive or other bonding compound. Alternatively, any mechanical fixing mechanism could be used to lock the distal ends 26,48 of inner and outer sleeves 22,36 together. For example, where the inner and outer sleeves 22,36 are formed as simple tubes with open ends, a closure device such as a plastic cap may be used to engage both the inner and outer sleeve 22,36 together while forming a closure of both. The walls of the outer sleeve 36 between the slits form the deformable zone 44 of the catheter 20 and thereby a retainer 50 which is described below. The aperture 28 of the inner sleeve 22 is generally longitudinally aligned with the slits 42, or possibly slightly displaced towards the distal end, for example, at least partially into the distal portion 40 of the outer sleeve 36.

Figure 1 shows the assembled catheter device 10 in its installed, or 'open', configuration, for example, after insertion into the patient's body and with the retainer 50 deployed.

In use, a corresponding pair of inner and outer sleeves 22,36 is selected on the basis of the age and size of the patient. This ensures that when the catheter device 10 is inserted into the patient's body, the insertion depth of the catheter 20 is appropriate for optimum drainage of urine from the patient's bladder.

After selection of the inner and outer sleeves 22,36, the first end 80 of the second lock component 78 is attached to the proximal end 24 of the inner sleeve 22. The catheter 20 is then inserted into the catheter receiving portion 16 of the first portion 14 of the housing 12, such that it extends from an outer surface of the housing 12.

The first end 62 of the first lock component 60 is secured to the lock receiving portion 17 of the housing 12, by means of corresponding pairs of inter-engaging tabs 66,76.

The proximal end 106 of the connecting tube 104 is than attached to the second end 82 of the second lock component 78.

The connecting tube 104 is passed through the opening 19 in the second portion 15 of the housing 12 and is then fastened to the first portion 14 of the housing 12 to seal the installed catheter device 10.

In the present embodiment, the first and second portions 14,15 of the housing 12 are secured to one another by a quarter turn screw fastening.

However, in alternative embodiments, the first and second portions 14,15 of the housing 12 may be secured together by another means, such as adhesive bonding At this point, the catheter 20 is then inserted into the abdomen of the patient such that the outer surface of the housing 12 abuts against the patient's body. Since the length of the catheter 20 has been chosen in advance, when the housing 12 contacts the patient's body, the catheter 20 is inserted to the correct depth, with the distal ends 26,48 being situated within the patient's bladder.

The connecting tube 104 is then pulled relative to the housing 12, with the housing held securely against the patient's abdomen.

The movement of the connecting tube relative to the housing is continued until the annular ridge 68 at the second end 64 of the first lock component 60 is secured in the annular groove 92 at the second end 82 of the second lock component 78.

The action of connecting together the first and second lock components 60,78 results in the inner sleeve 22 being displaced relative to the outer sleeve 36 in the proximal portion 38, in an axial direction. Because the distal portion 40 of the outer sleeve 36 is relatively fixed to the distal end 26 of the inner sleeve 22, the relative displacement of the inner and outer sleeves 22,36 in the proximal portion 38 causes the walls of the outer sleeve 36 to buckle or deform so as to bulge or splay outwardly.

The outward splaying of walls results in the slits 42 opening up into apertures, which apertures are coincident with the underlying aperture(s) 28 of the inner sleeve 22. It will be observed that this provides two functions.

Firstly, the splaying of the walls provides a retainer 50 that ensures that the catheter device 10 remains in situ within the bladder, the trailing edge of the splayed wall engaging with the wall of the bladder to prevent egress of the distal end 40 past the point of entry to the bladder.

Secondly, the splaying of the walls opens up the apertures in the outer sleeve 36 so that fluid communication between the outer surface of the catheter 20 and the lumen of the inner sleeve 22 is possible via the aperture(s) 28. Thus, urine may then drain out of the bladder via the catheter lumen. Preferably, the respective diameters of the inner and outer sleeves 22,36 are closely matched so that there is a very little gap between the sleeves 22,36, while still allowing sliding engagement of the walls of the inner and outer sleeves 22,36. Preferably, the gap is sufficiently small that no urine or other liquid can travel the length of the catheter between the walls of the inner and outer sleeves 22,36.

Removal of the catheter device 10 from the body of the patient is achieved by the removal of the second portion 15 of the housing 12 from the corresponding first portion 14, and the removal of the releasing tab 72 from the first lock component 60.

This results in the frangible portion 70 being detached from the first lock component 60, thus allowing the retainer 48 to be collapsed and the catheter 20 to be withdrawn from the body of the patient.

Claims

1. A catheter device comprising:

a housing having a catheter receiving portion, a lock receiving portion and a tube receiving portion;

a catheter sealingly engageable with the catheter receiving portion, the catheter further comprising:

an inner sleeve;

an outer sleeve surrounding the inner sleeve, the inner and outer sleeves being longitudinally displaceable relative to one another to enable the catheter to move from an open state to a closed state;

a lock mechanism, receivable in the lock receiving portion, having a tube receiving portion, and being engageable with the catheter to secure the catheter in the open state; a connecting tube having a proximal end and a distal end, the proximal end being receivable in the tube receiving portion of the housing and the lock mechanism; and

a valve connectable to the distal end of the connecting tube,

whereby, in use, the catheter, lock mechanism and connecting tube are located in the housing, the catheter is locked in the open position and the catheter is in fluid communication with the connecting tube.

2. A catheter device according to Claim 1 wherein the lock mechanism comprises a first lock component and a second lock component, the first and second lock components being engageable with one another when the catheter is in the open state.

3. A catheter device according to Claim 1 or Claim 2 wherein the first lock component is formed on, or attachable to the lock receiving portion, and the second lock component is formed on, or attachable to the inner sleeve

4. A catheter device according to any one of Claims 1 to 3 wherein the lock mechanism includes a frangible portion.

5. A method of deploying a catheter device in a patient according to any one of Claims 1 to 4 comprising the steps of:

selecting a catheter device based on the age and size of the patient;

sealingly engaging the catheter to the catheter receiving portion of the housing; inserting the catheter into a patient's body, until a distal end thereof is positioned within the bladder of the patient and the housing contacts the patient's body; connecting the proximal end of the connecting tube to the tube receiving portion; connecting the lock mechanism to the lock receiving portion so as to secure the catheter in its open position;

connecting the valve to the distal end of the connecting tube;

connecting the valve to a fluid collection device; and

allowing urine to drain from the bladder.

6. A method according to Claim 5 wherein the step of connecting the lock mechanism to the lock receiving portion so as to secure the catheter in its open position, comprises the steps of:

connecting the second lock component to the inner sleeve;

connecting the first lock component to the housing; and

7. A catheter substantially as hereinbefore described with reference to the accompanying drawings.

8. A method substantially as hereinbefore described with reference to the accompanying drawings.