WO1995002367A1

WO1995002367A1 - Percutaneous sigmoid colon volvulus deflation device

Info

Publication number: WO1995002367A1
Application number: PCT/GB1994/001535
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: AU7231294A; GB9314639D0

Abstract

The present invention relates to a percutaneous sigmoid volvulus deflation device comprising a catheter means 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 the 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. To use 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, the balloon means inflated and the skirt released for trapping an annular colon wall portion between the balloon means and skirt thereby to minimise the risk of leak of the colonic contents. The high pressure in the generated by gas entrapment colon may be relieved by venting through the principal catheter channel.

Description

PERCUTANEOUS SIG OID COLON VOLVULUS DEFLATION DEVICE

This invention introduces a new system which enables b _ deflation of sigmoid colon volvulus through the skin of the left iliac fossa to allow successful sigmoidoscopic tube decompression and thus avoiding emergency surgery with its depressingly high mortality rate. The system also avoids the use of rectal tubes as a means of preventing recurrence after successful sigmoidoscopic

10 decompression thereby easing the nursing of the patient.

The management of patients with acute volvulus of the sigmoid colon is still controversial and the mortality remains high. This volvulus is primarily encountered in

15 aged patients where the mortality rate of emergency surgery in such patients may be as high as 50%. Thus it is preferable that non-operative treatment should be offered first provided there is no clinical suspicion of gangrene. Emergency ope^rative treatment is therefore 0 reserved for those cases with a non-viable bowel or when conservative treatment by sigmoidoscopic decompression has failed. This failure occurs in some 20% of cases.

It is an object of this invention to avoid or minimise 5 one or more of the above disadvantages.

The present invention offers a method which overcomes failure of sigmoidoscopic decompression thereby avoiding the need for emergency surgery and allowing the patient 0 to be properly and adequately prepared for elective surgery a few days later. This major breakthrough in the management of sigmoid volvulus is achieved by a percutaneous sigmoid volvulus deflation system. The invention is based on the understanding that volvulus 5 produces a closed compartment of high pressure generated by the entrapment of gas which resists tube decompression. The use of percutaneous deflation of the volvulus can enable completely successful sigmoidoscopic decompression. The system may moreover be left in place until elective surgery is carried out a few days later 5 in order to avoid recurrence of the volvulus during this period.

Thus the present invention provides a percutaneous sigmoid volvulus deflation device comprising a catheter

I_Q means 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

15 balloon means for trapping of an annular portion of the colon wall therebetween in use of the device, in a deployed condition of said skirt, 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

2_Q balloon means in a deflated condition, the balloon means inflated for trapping an annular colon wall portion between the balloon means and skirt thereby to secure the catheter in a substantially sealed connection to the colon, whereupon pressure in the colon may be relieved

__ by venting through said principal catheter channel.

To use 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,

30 the balloon means inflated and the skirt released for trapping an annular colon wall portion between the balloon means and skirt thereby to minimise the risk of leak of the colonic contents. The high pressure in the generated by gas entrapment colon may be relieved by venting through the principal catheter channel.

35 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.

Regarding manufacturing details, the size may vary to suit paediatric or adult purposes. The catheter can also be manufactured in sizes to suit veterinary uses.

The sigmoid volvulus deflation system or device 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 stainless steel, aluminium, titanium etc or alloys. Advantageously, an anticeptic or antibiotic may be incorporated into the device's substances and parts.

Further preferred features and advantages of the invention will appear from the following detailed description of the use of a percutaneous sigmoid volvulus deflation device of the invention illustrated with reference to the accompanying drawings in which: Fig. 1 shows a one embodiment of a sigmoid volvulns deffection device of the invention in its operating configuration with a deployed skirt;

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

Figs 3 and 4 show alternative skirt release mechanisms; and Fig. 5 shows a bag for use with the device of Fig.l.

The diagnosis of sigmoid volvulus is made from the patient's medical history, physical examination, plain abdominal radiographs (volvulus is recognised by the appearance of a distended ahaustral or featureless loop of bowel extending to the left hemidiaphragm with convergence of its walls towards the left iliac fossa) , and emergency barium enema both for diagnostic and therapeutic purposes. Patients who may not be suitable for the percutaneous deflation procedure are:

1. those patients moribund on admission to the hospital

2. demented patients

3. patients with septicaemia

4. patients cases with peritonitis

5. those patients whose volvulus was decompressed by the barium enema examination

It must be pointed out that emergency surgery is absolutely indicated if there is evidence of mucosal ischaemia at sigmoidoscopy or if the fluid obtained on decompression is blood-stained.

Patients are informed that failure of the decompression procedure means proceeding to a laparotomy. A suitable antibiotic is given intravenously as a single prophylactic dose. The most suitable point to enter the sigmoid colon via the anterior abdominal wall at the left iliac fossa between the umbilicus and anterior superior iliac spine is chosen ultrasonically while the patient is supine. This point is infiltrated with a few millilitres of local anaesthetic (e.g. 1% plain xylocaine) then the area is cleaned and suitably draped. Parenteral sedation (e.g. benzodiazepines or midazolam) may optionally be used to supplement the local anaesthetic. The skin at the port of entry is incised with a small blade to provide an entry point for the device of the present invention.

As shown in Figure 1, the device comprises an elongate tube 10 defining a central channel 11 for sigmoid colon drainage and, optionally, irrigation. The central channel 11 opens at a distal end 8 for insertion into the sigmoid 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 2b 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.

Once a suitable entry point has been prepared, the percutaneous catheter 1 is advanced for 5 cm into the abdomen and the introducer needle 20 removed. Successful entry into the sigmoid colon is indicated by gas escaping out through the main catheter channel 11. The decompression catheter 11 is conveniently connected to an open or closed drainage system. This may comprise a plastic bag 14 provided with an adhesive patch 15 for securing the bag 14 directly to the abdominal wall to collect the colonic gases via a connecting tube 16 (see Fig.5). The bag 14 may need to be replaced frequently if it is not provided with evacuation means. The bag 14 may also be attached to the bed side or placed beside the patient. Conversely, a bottle or any suitable shaped container may form the receptacle portion of the drainage system.

The balloon 2 in proximity to the distal end 3 of the main catheter channel 11 is inflated with 5ml distilled water and then the outer catheter sleeve or ring is retracted or peeled off or the ring mechanism pulled up or off to allow the inverted plastic skirt 5 to fall onto the balloon 2 thereby trapping a segment of colonic wall (not shown) in between and preventing leakage. The catheter's flange 7 is stitched or stuck to the anterior abdominal wall which is then suitably dressed.

The patient is now placed in the left lateral position and the volvulus decompressed sigmoidoscopically using either a rigid sigmoidoscope with a well lubricated rectal tube or a flexible sigmoidoscope and in either event no rectal tube is left in place as the percutaneous deflation will prevent recurrence of the volvulus until surgery is carried out a few days later. During this period, the catheter is flushed every four to six hours with a few millilitres (5 to 100, preferably 5 to 10ml) of normal saline (physiological sodium chloride solution) or any other suitable liquid to prevent blockage of its multi-perforated 9 end 3. After successful sigmoidoscopic decompression a second abdominol X-Ray using dye instilled through the percutaneous catheter into the sigmoid colon is taken to exclude leakage or perforation. No oral intake or physical movement restrictions are necessary.

The patient can be now prepared for elective sigmoid surgery to be carried out during the same hospital admission some 4 to 5 days after the percutaneous deflation and sigmoidoscopic decompression. Any anaemia or nutritional deficiencies can be corrected and the patient properly prepared for definitive surgery.

Percutaneous deflation of acute sigmoid volvulus was initially developed in experimental animals then successfully applied to the clinical situation. It proved to be a simple, safe and reliable method which incurred no additional inconvenience to the patient.

After the deflation no oral intake or physical movement restrictions were necessary thereby easing the overall management of the patient. It is particularly important to note that this procedure was not associated with any evidence of colonic contents leakage. Thus, the ability of the percutaneous deflation to empower complete success of sigmoidoscopic decompression of sigmoid volvulus is crucial in avoiding emergency surgery and in allowing an elective procedure to be carried out later on during the same admission. The additional advantage of offering definitive surgery during the same admission in terms of easing the bed pressure situation by avoiding multiple hospital admissions and the savings in costs cannot be over-emphasised.

Since the mechanism of volvulus of any part of the large bowel (e.g. caeaum, splenic flexure, sigmoid colon) is essentially the same, the device presented in this invention can be applied percutaneously for the deflation of any large bowel volvulus. In other than sigmoid volvulus, a barium enema must fellow the percutaneous deflation to devolve the colon while the percutaneous catheter remains in place until elective surgery is carried out a few days later.

The principal channel 11 of the device normally initially contains an introducer needle 20 within it, as the initial means of performing the abdominal wall skin to gain access to the distended area of the colon. The device also generally comprises: a. a principal channel to allow gases to be removed from the blocked colonic segment. b. means within this channel to irrigate the site of blockage if necessary. c. an inflatable balloon at the distal end of the channel to provide the internal member of a sealing device across the wall of the colon. d. an invertible skirt, operated by retracting or peeling off a sleeve or ring to form the outer sealing member as protection against leakage. e. a flange for attachment to the outer surface of the abdomen to form an external seal.

In operation, the device is pushed into the volvulus through the abdominal wall and the introducer needle is removed. The device is connected to a drainage system which may be a soft bag attached to the abdominal wall, the bed or placed beside the patient, or a stiff container in the shape of a bottle or any other fluid collecting container that can be attached to the patient, his bed or placed in his surroundings. Closed drainage is more preferable.

The skirt which is initially oriented with its closed end towards the tip of the catheter, remains outside the wall of the colon. The balloon is inflated and a sleeve or ring retracted or removed to invert the skirt which then presses against the perosal surface of the colon. The combination of the inflated balloon inside, and the skirt outside, provides an effective means of sealing the catheter in place and preventing leakage.

Finally, the flange of the catheter is stitched or adhered (stuck) to the abdominal skin.

The system can be made totally or partly from plastics, silicones and rubber material. Optionally an antiseptic or antibiotic agent may be incorporated in the substance matter of the system. One or more parts of the system may be made of metals of their alloys.

The deflation device or system can be applied for animal or human uses. The latter includes both adult and paediatric models.

The introducer needle should be made longer than the deflation catheter to allow protrusion beyond the catheter's tip at the multi-perforated end for 1 to 10mm while fitting snugly to the proximal end of catheter via a spigot. This spigot may be made of metals such as silver, steel, titanium, aliminum etc; alloys such as stainless steel, silicones, rubbers, plastics or any other suitable material that enables it to fit and occlude the catheter's orifice. The spigot may be shaped as a cone or sphere or other similar suitable shapes. The introducer needle is preferably made aε a solid or flexible needle or in the shape of a spring wire. The size may vary depending on whether it is for adult or paediatric use or for veterinary applications, and may range from 6 to 24 gauge (G) , preferably 18 to 22G. The needle's tip may be pointed, angled, or multi-faceted having 3 to 10 surfaces. This tip refers to the needle's portion extending beyond the catheter's end. The rest of the needle is generally circular in cross section.

The fenestrated or multi-perforated end of the catheter is made to suit a firm grip at its tip onto the needle. This tip is circular, conical or bevelled having a diagonal slant of an angle ranging between 10° to 80°, preferably 30° to 45°. The overall length of this segment generally ranges from 0.5cm to 10cm, preferable 1.5cm to 3cm. The fenestrations generally range in a number from 2 to 12, preferably 2 to 4. Their diameter is generally from 1 to 10mm when made circular, preferably 2 to 6mm, but when oval, these fenestrations may be 2 to 20mm long and 1 to 10mm wide.

The deflation 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 device. This includes the use of antibiotic bonded catheter material.

The deflation device may be made of plastic, rubber or any other material suitable for use. Metals such as silver, stainless steel, titanium and others or alloys may be used to manufacture parts of the catheter. The most preferd substances to be used are Teflon, Dacron, (Trade Names) latex, polyvinychloride and biocompatible silicone.

The overall length of the deflation device may range in lehgth from 5 to 100cm, preferably 25cm long for adults and 6 to 10cm for paediatric cases.

The size of the catheter generally ranges from 4 to 34F, for paediatric cases the prefered size is 6 to 8F and that for adults is 16 to 2OF.

The balloon's capacity when more or less fully distended with fluid (such as distilled water or saline or air) ranges from 1ml to 30ml, preferably 5ml.

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 sv "face or both surfaces of the jirt 5 may be smooth or otherwise configured e.g. beaded, corrugate-., guttered, railed etc. The free edge 5b of the skirt 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 tc 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 f-nge 7 and balloon 2 which serves to keep the skirt 5, „t introduction of the device 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. TMs 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 antr or abdominal wall skin. Optionally an adhesive mat:. can be incorporated onto the under surface 7a of the flange 7 to enable adhesion to the abdominal skin.

The deflation device may be made to be flexible or stiff. Its wall may vary in thickness from 0.1 mm to 10 mm.

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.

The deflation device is preferably disposable for labour saving and hygiene. considerations. However, if necessary it can be washed then sterilised by ethlene oxide gas or autoclaving.

Optionally, the bag may be provided with an evacuation mechanism to enable emptying without disconnecting from the catheter. This may involve an open button 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 container end of the drainage 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 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 the colonic point of entry to enable a gravity effect to promote drainage.

Claims

1. A percutaneous sigmoid volvulus deflation device comprising a catheter means 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 in use of the device, in a deployed condition of said skirt, 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, the balloon means inflated for trapping an annular colon wall portion between the balloon means and skirt thereby to secure the catheter in a substantially sealed connection to the colon, whereupon pressure in the colon may be relieved by venting through said principal catheter channel.

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

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

4. A device according to claim 2, wherein the retaining means comprises a sleeve which, prior to insertion of the catheter means, surrounds the skirt and maintains it folded against the catheter means, 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 device according to claim 2, wherein the retaining means comprises a clip extending partially around the circumference of the skirt.

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

10. A device 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 means in place.

11. A method of sigmoid volvulus deflation comprising the steps of: providing a deflation device according to claim 1; inserting the distal end region of the catheter means through the sigmoid colon wall into the sigmoid colon until the balloon means enters the sigmoid colon but not the skirt means; and introducing fluid via said inflation fluid supply channel so as to inflate said balloon means so as to trap a portion of the sigmoid colon wall between the balloon and skirt means substantially to seal the sigmoid colon wall around the catheter means .