WO1995002368A1

WO1995002368A1 - Percutaneous colostomy catheter

Info

Publication number: WO1995002368A1
Application number: PCT/GB1994/001538
Authority: WO
Inventors: Aws Shakir Mustafa Salim
Original assignee: Aws Shakir Mustafa Salim
Priority date: 1993-07-15
Filing date: 1994-07-15
Publication date: 1995-01-26
Also published as: GB9314638D0; AU7191194A

Abstract

A colostomy catheter having a catheter (1) defining a drainage and irrigation channel has a balloon (2) attached to its outer surface. A skirt (5) is attached to the catheter above the balloon and is releasably folded against the catheter by a sleeve (10) or clip. A balloon inflation channel (2a) is provided for supplying fluid to inflate the balloon after insertion of the catheter and balloon into the colon and to thereby trap a portion of the colon wall between the balloon and the released skirt, sealing the colon wall about the catheter.

Description

PERCUTANEOUS COLOSTOMY CATHETER The present invention relate- to a new system which enables the decompression of an obstructed large bowel from the skin of the anterior abdominal wall, thereby avoiding emergency surgery and enabling an elective procedure to be carried out at a later date during the same hospital admission.

Complete large bowel obstruction may lead to systemic problems thereby producing a seriously ill patient which renders the management of the obstructed bowel only one part of the treatment of a patient with multi-system failure. It is sometimes argued that, in the very seriously ill patient with left-sided large bowel obstruction, the fashioning of only a transverse loop colostomy or a caecostomy should be carried out because this represents minimal treatment. However, it is this type of patient who should have complete decompression of the bowel which effects an immediate improvement in respiratory function, with resection of its plethoric part to ensure improvement in cardiac function as well. Regrettably such an objective may not always be feasible because of the limited experience of the emergency surgeon.

It is an object of the present invention to avoid or minimise one or more of the above disadvantages.

The present invention introduces a major breakthrough in the management of the completely obstructed large bowel, namely percutaneous colostomy, which is designed to overcome the urgency of the obstruction regardless of whether it is produced by colonic or rectal disorders and lesions, thus providing the extremely valuable additional time needed to attend to the patient's general condition before embarking upon colorectal or colonic surgery.

The present invention provides a colostomy catheter system for connection to a colon and having a principal channel for drainage and optionally irrigation; inflatable balloon means in proximity to the distal end of the principal catheter channel and provided with an inflation fluid supply channel; and skirt means in proximity to the rear of said balloon means for trapping of an annular portion of the colon wall therebetween when the device is in use and the skirt is in a deployed condition, whereby, in use of the device, the distal end of the main catheter channel and the balloon means are introduced into the colon with the balloon means in a deflated condition while retaining the skirt in a radially contracted condition, outside of the colon in proximity thereto, the balloon means is inflated and the skirt means extended for trapping an annular colon wall portion between the balloon means and skirt means thereby to secure the catheter in substantially sealed connection to the colon and to minimise the risk of leakage of colonic contents whereupon the colon may then be evacuated via the principal drainage channel.

Preferably the catheter is provided with annular flange means rearwardly spaced from the skirt means for securing to the abdominal wall, e.g. by stitching or adherence thereof to the abdominal wall.

For manufacturing, the size may vary to suit paediatric or adult purposes. The catheter can also be manufactured in sizes to suit veterinary uses. The colostomy catheter or system may be made in total or in part from silicones, plastics and/or rubber materials. Optionally, certain parts may be made of metals such as silver, stainless steel, aluminium, titanium or alloys etc. Advantageously, an antiseptic or antibiotic may be incorporated into the material of one or more parts of the catheter, or system.

For a better understanding of the present invention and in order to show how the same may be carried into effect referer -.e will now be made, by way of example, to the accompanying drawings, in which:

Fig. l shows a colostomy catheter in its operatins configuration with a deployed skirt;

Fig. 2 shows the mode of operation of a slidable skirt release mechanism with the catheter of Fig.l;

Figs 3 and 4 show alternative skirt release mechanisms;

Suitable patients for treatment with embodiments of the present invention are those who present an emergency with abdominal distension caused by colorectal obstruction.

Distension caused by faecal impaction should be excluded by two successive phosphate enemas one hour apart. The procedure may not be suitable for those patients who are found to have one or more of the following: dementia or patients moribund on admission, pyrexia, septicaemia, peritonitis, previous gastrointestinal surgery, concurrent cardiorespiratory disease or any disorder making the patient unfit for laparotomy.

After physical examination and appropriate investigations including plain abdominal X-Rays, sigmoidoscopic examination with or without biopsies and emergency barium enema, the patient is fasted and nasogastric aspiration with intravenous hydration commenced. A suitable intravenous antibiotic is given for prophylaxis then the site of colon entry from the abdominal wall is determined ultrasonically. The right iliac fossa into the caecum is preferred for right sided colonic obstruction, the supraumbilical region in the midline into the transverse colon is preferred for left sided colonic and for rectal obstruction, and the left iliac fossa into the sigmoid colon is also applicable for rectal and rectosigmoid obstruction.

With reference to Figure 1, the colostomy catheter 1 comprises an elongate tube 10 defining a central channel 11 for colon drainage and, optionally, irrigation. The central channel 11 opens at a distal end 8 for insertion into the colon and at the opposite end 6 for connection to a drainage receptacle/irrigation fluid source (not shown) . The distal end 8 has formed therein a number of perforations 9 which enhance fluid communication between the central channel 11 and the interior of the colon. An annular balloon 2 is attached to the tube 10 and is coupled to a secondary channel 2a for receiving fluid therefrom.

A skirt 5 is attached, at a waist end, around the tube 10 its hem portion 5b held in close against the tube 10 until it is required to be released as described in more detail below.

In order to locate the catheter, the skin port of entry is cleaned and draped, then infiltrated with a local anaesthetic (e.g. 1% plain xylocaine) . Parenteral sedation (e.g. benzodiazepines or midazolam) may optionally be used to supplement the local anaesthetic. An 18G x 7cm introducer needle is inserted through the abdominal wall for 5cm. Once gas begins to escape indicating successful entry into the colon, a guide wire is inserted for no more than 5cm beyond the skin port of entry and the needle removed. The colostomy catheter device 1 is then passed over a guide wire (not shown) into the colon.

The balloon 2, towards the distal end 3 of the catheter, is then inflated with 5ml distilled water via a balloon inflation channel 2a, 2b, the guide wire removed and the colostomy catheter's opening spigotted (not shown) . The skirt 5 is formed and arranged so that when released it can open out (preferably with inversion) so as to come into more or less close proximity with the surface of the inflated balloon 2 so as to trap part of the colonic wall between the skirt 5 and balloon 2. The spigot is removed from the proximal end 6 of the cε ter 1 which is then connected to a closed or open dr __ge system and allowed to evacuate the colonic contents. The catheter 1 is pulled against the abdominal wall and a flange 7 surrounding the tube is stitched or attached to the anterior abdominal wall which is then suitably dressed. An abdominal X-Ray is taken after some contrast material is instilled into the colon via the catheter 1 to check that all is well regarding the catheter's position and leakage.

Although the catheter's tip 8 is multi-perforated 9, it is advisable that irrigation by instillation using 5 to 100 ml of suitable solutions such as physiological saline, preferably 10-20 ml, be carried out every few hours, preferably every 2 hours, to prevent catheter blockage. It is also advisable to carry out colonic lavage after the initial deflation where a litre of normal saline (physiological NaCl) at 37°C is instilled from n overhead receptacle into the colon then allowed to drain by gravity when the empty receptacle is placed on the ground or at least below the colon level. This lavage may be carried out once or twice daily and for several days. Various crystalloid, colloid and mannitol containing solutions are also suitable for the lavage. The catheter 1 may be left in place for many days and until such time as the patient is suitable for surgery. The nasogastric tube may be withdrawn once the percutaneous colostomy has been established, and the patient allowed oral intake whereupon, if well tolerated, the intravenous line can be taken out.

The colostomy catheter may be in total or in part silver impregnated or incorporate a silver-impregnated protective sheath. Similarly, bacterial resistant materials may be advantageously used in the manufacturing of all or part of the catheter. This includes the use of antibiotic bonded catheter material.

The colostomy catheter may be made of plastic, rubber or any other material suitable for in vivo use. Metals such as silver, stainless steel, titanium and others or alloys may be used to manufacture various parts of the catheter. The most preferred are latex, polyvinylchloride and biocompatible silicone.

The overall length of the colostomy catheter may range between 5 to 100 cm, preferably around 25 cm long for adults and 6 to 10 cm for paediatric cases. The diameter of the colostomy catheter may range from 4 to 34F. For paediatric cases the preferred size is 6 to 8F and that for adults is 16 to 2OF.

The fenestrated or multi-perforated end 8 of the catheter is normally bevelled having a diagonal slant of an angle ranging between 10 to 80°, preferably 30 to 45° to facilitate perforation of the colon wall. The overall length of this segment generally ranges between 0.5 to 10cm, preferably 1.5 to 3 cm. The fenestrations conveniently range from 2 to 12, preferably 2 to 4, in number. Their diameter is generally 1 to 10 mm when round, preferably 2 to 6 mm. When made substantially oval, these fenestrations may be 2 to 30 mm long and 1 to 10 mm wide.

The balloon's capacity when more or less fully distended with fluid (such as distilled -^*ater or saline or air) ranges from 1 ml to 30 ml, pre:arably 5 ml.

The portion of catheter tube 10 between the balloon 2 and flange 7 may vary in length depending on whether a relatively small diameter skirt 5 is incorporated sufficient to seal the point of catheter entry into the large bowel, or whether this skirt 5 is of relatively large size extending to cover at least a substantial part of the rear face 2a of the balloon 2. This length also depends on the type of skirt retaining means (see below) used. Generally the length is from 5 mm to 10 cm, preferably 1 to 4 cm.

The maximum (hem) diameter of the skirt 5 varies depending on whether it is intended to cover only a few millimetres beyond the point of catheter entry into the colon or to extend to cover the rear face 2a of the balloon 2 when the latter is fully inflated. The outer diameter of the skirt when opened out is generally at least 2 mm larger than that of the outer diameter of the catheter tube 10, and may extend to 10 cm.

The skirt 5 is provided with a built in self-supporting snap-action hinge means 5c at its point of attachment to the catheter for inverting and then retaining the skirt 5 in an inverted position (shown in dashed outline in Fig.l). The thickness of the skirt 5 may vary from 0.5 mm to 10 mm and it can be made of varied thickness with its portion next to the catheter tube 10 being thicker than its periphery and vice versa.

Either surface or both surfaces of the skirt 5 may be smooth or otherwise configured e.g. beaded, corrugated, guttered, railed etc. The free edge 5b of the skirt 5 may be smooth or uneven in any geometrical or non-geometrical shape. The surface and edge designs are generally directed at maximizing effectiveness of the sealing provided by the skirt 5 and balloon 2 to prevent leakage of colonic contents and to keep the catheter 1 in place.

Figure 2 shows one possible skirt retaining and release system which comprises an outer sleeve 12 covering part or all of the portion of catheter between the flange 7 and balloon 2 which serves to keep the skirt 5, at introduction of the colostomy catheter 1 into the colon, oriented with its closed, waist, end 5a_ towards the catheter tip 8 thus remaining outside the wall of the colon until the outer sleeve 12 is removed to allow the skirt 5 to open out towards the bottom, and desirably invert to press down against the outer surface of the colon thereby pressing the colon wall against the rear balloon surface 2a.

The length of the outer sleeve 12 may be the same as the length of the closed skirt 5 so that it can be pulled upwards towards the flange 7 freeing the skirt 5 and left underneath the flange 7 without obstructing any part of the skirt 5. A cord 13 attached to the upper end 14 of this sleeve 12 may help retraction of the sleeve 12.

With larger skirts other skirt remaining means shown in Fig 3 and 4 may be used. A modified sleeve 120 has one or more reduced thickness portions 13 along its length to allow breaking open thereof (Figure 3). Two cords 14, one attached to each half of the top end 15 of the sleeve 120, can facilitate the breaking-open process. The sleeve 120 is pulled up over the flange 7, which for these cases is made of thin flexible material, on its way to lie over the portion of catheter above the flange (not shown in the drawings) . The inner diamter of the sleeve 120 (where not fully broken open) should be large enough to allow it to slide over the flange 7 when the latter is folded upwardly.

Optionally, the outer sleeve 12 may be replaced with a ring 16 placed over the closed skirt 5 (Figure 4) . Advantageously, a cord 13 may be attached to this ring 16 to allow it to be pulled up or broken-off and thus free the skirt 5.

Generally, the length of the outer sleeve 12 is from

5 mm to 10 cm. The diameter may range from 1 mm longer than the outer diameter of the colostomy catheter to 30 mm longer than this diameter.

The flange 7 may be of a smooth or roughened surface. Optionally this surface may be beaded, corrugated, railed or guttered. It may be of a uniform thickness or thinned out towards the periphery or vice versa. This thickness varies between 0.5 mm to 15 mm, preferably 1 to 5 mm. The diameter of the flange 7 may range from 1 to 20 cm longer than the outer diameter of the colostomy catheter. One to 10 or more fenestrations may be added to the flange to facilitate stitching to the anterior abdominal wall skin. Optionally an adhesive matter can be incorporated onto the under surface 7a of the flange 7 to enable adhesion to the abdominal skin. The colostomy catheter may be made to be flexible or stiff. Its wall may vary in thickness from 0.1 mm to 10 mm.

The guide wire is manufactured from any suitable metal or metal alloys, preferably stainless steel in the form of a spring guide wire or a solid wire. The length range is generally from 10 to 100 cm preferably 50 to 60 cm. Optionally, the tip of the guide wire may be flexible over a few centimetres. The end point is preferably blunted round or spherical.

The introducer needle may be mounted on a syringe or be equipped with a handle and an obturator. The length ranges from 2 to 30 cm, preferably 6 to 8 cm. The size depends on whether it is for paediatric, adult or veterinary uses and may range from 6 to 24 gauge (G) , preferably 16 to 18G.

The closed drainage system generally comprises a bag made of any of the substances already mentioned for the colostomy catheter, conveniently having a capacity of from 200 ml to 2 litres and optionally provided with an adhesive pad to enable attachment onto the abdominal skin. This bag is connected to a tube of any suitable length e.g. from 1 cm to 200 cm, preferably 20 to 50 cm. The size of the tube ranges from 4 to 34F and is provided at its end with a stiff portion, which may be advantageously conical in shape, to enable insertion into the end of the colostomy catheter. Such a system is conveniently made for a single use i.e. is disposable.

Optionally, the bag 11 may be provided with an evacuation mechanism to enable emptying without disconnecting from the colostomy catheter. This may involve an open bottom end of bag sealed by a clip-on mechanism.

The closed drainage system may be made of soft flexible material or hard stiff material. Such material may comprise rubbers, silicones and plastics with or without metals and alloys and with or without incorporated antibiotics or antiseptics.

When made of stiff material, the collecting bag may be in the shape of a bottle or any suitable fluid container. Additionally, an evacuation means may be incorporated such as a side tap. Advantageously, the container's or bottle's neck may have a screw-on or clip-on cap which is itself the ntainer end of the draining tube. Thus the drainage tube is connected to the principal catheter channel then its capped end attached to the container portion of the drainage system. When full, the cap is removed from the latter to allow evacuation.

The drainage receptacle may be provided with means 16 for sticking onto the patient's skin or attachment mechanism to connect to the patient (portable) . Alternatively the receptacle may be connected to the patient's bed or placed in his surroundings.

Since dependent drainage is crucial, the receptacle should be placed at a level lower than that of the colonic point of entry to enable a gravity effect to promote drainage.

The colostomy catheter is preferably disposable (Figure 8) *rjr labour saving and hygiene considerations. However, if necessary it can be washed then sterilised by ethylene oxide gas or autoclaving. Percutaneous colostomy has been found during preliminary clinical trials to be a simple, safe, and effective procedure which offers advantages in the emergency management of large bowel and rectal obstruction regardless of the cause, particularly in the elderly and the very seriously ill patient. The procedure is associated with no complications and allows patients to be properly investigated and prepared for definitive colonic or colorectal surgery which may be carried out a few days later. This colostomy therefore provides the following gains:

1. avoiding emergency surgery

2. avoiding surgery by an operator of limited experience

3. avoiding surgery on patients who are too ill on presentation

4. gaining valuable time to continue preparing patients for surgery

5. undertaking a more in depth investigation of the cause of the obstruction thereby planning the surgical approach

6. safely carrying out a one stage definitive procedure during the hospital admission.

It follows that percutaneous colostomy not only reduces the overall morbidity and mortality caused by colorectal obstruction, but also shortens the overall hospital stay of patients, an extremely important point regarding the bed pressure situation and reducing costs.

Claims

1. A colostomy catheter system for connection to a colon and having a principal channel for drainage and optionally irrigation* inflation balloon means in proximity to the distal end of the principal catheter channel and provided with an inflation fluid supply channel; and skirt means in proximity to the rear of said balloon means doe trapping of an annular portion of the colon wall therebetween when the device is in use and the skirt is in a deployed condition, whereby, in use of the device, the distal end of the main catheter channel and the balloon means are introduced into the colon with the balloon means in a deflated condition while retaining the skirt, in a radially contracted condition, outside of the colon in proximity thereto, t.- balloon means is inflated and the skirt means extended for trapping an annular colon wall portion between the balloon means and skirt means thereby to secure the catheter in substantially sealed connection to the colon and to minimise the risk of leakage of colonic contents whereupon the colon may then be evacuated via the principal drainage channel.

2. A system according to claim 1 and having retaining means for maintaining the ε}-ιrt folded against the exterior of the catheter, the retaining means being releasable to allow the skirt to be expanded.

3. A system according to claim 2, wherein the retaining means comprises a sleeve or ring arranged concentrically about the catheter, the sleeve or ring being slideable over the skirt between a first position in which the skirt is held folded against the catheter and a second posit,-on in which the skirt is released.

4. A system according to claim 2, wherein the retaining means comprises a sleeve which, prior to insertion of the catheter, surrounds the skirt and maintains it folded against the catheter, the sleeve being provided with a weakened zone for allowing at least partial breaking open of said sleeve upon the application of an appropriate force thereto, so as to release the skirt.

5. A system according to claim 2, wherein the retaining means comprises a clip extending partially around the circumference of the skirt.

6. A system according to any one of claims 3 to 5, wherein the retaining means includes an attached cord means for facilitating manipulation thereof so as to release the skirt.

7. A system according to any one of claims 2 to 6 wherein the skirt is formed and arranged so as extended away from the balloon means in its folded position and be inverted upon release from the retaining means to extend towards the balloon means.

8. A system according to claim 7 when appended to claim 2, wherein the skirt is attached by means of a hinge means pretensioned to exert an expansion force on said skirt.

9. A system according to claim 8 wherein said hinge means is pretensioned to exert an inversion force on said skirt.

10. A system according to any one of the preceding claims and having a flange rearwardly of said skirt for attachment to the abdominal wall, in use of the system, to secure the catheter in place.

11. A method of drainage of the colon comprising the steps of: providing a catheter system according to claim 1; inserting the colon insertion end region of the catheter through the colon wall into the colon untill the balloon means enters the colon; and introducing fluid via said inflation fluid supply channel so as to inflate said balloon means so as to trap a portion of the colon wall between the balloon and skirt substantially to seal the colon wall around the catheter.