EP1018947A1

EP1018947A1 - Anastomosis of the small intestine and the rectum

Info

Publication number: EP1018947A1
Application number: EP98944346A
Authority: EP
Inventors: Cornelis Johannes H. M. Van Laarhoven
Original assignee: Utrecht Universitair Medisch Centrum
Current assignee: Utrecht Universitair Medisch Centrum
Priority date: 1997-09-23
Filing date: 1998-09-23
Publication date: 2000-07-19
Also published as: WO1999015087A1; CA2304149A1; NL1007101C2; AU9190498A

Abstract

Method and device for surgical joining the small intestine and the rectum. After the large intestine has been removed from the small intestine, the mucosa, a part of the small intestine, is prepared in such a manner that it is free. This is achieved by introducing a tube which is curved through approximately 20° and has a length of approximately 20 cm into the small intestine. The mucosa and submucosa is removed from the rectum and then the curved tube, with the freed small intestinal mucosa on it, is introduced into the rectum. These parts are then joined together and the tube is removed via the anus.

Description

ANASTOMOSIS OF THE SMALL INTESTINE AND THE RECTUM

The present invention relates to a method for surgical joining together the small intestine and the rectum according to the preamble of claim 1.

A method of this kind is known from the prior art and is referred to as ileorectal anastomosis. In the event of certain diseases, such as ul- cerative colitis or adenomatous polyposis coli, it is necessary at least to remove the large intestine.

The surgical treatment of both ulcerative Colitis and familial polyposis aims to remove the diseased tissue. In the case of ileorectal anastomosis, the large intestine is removed completely, but at least part of the rectum remains in place. This is joined to the free end of the small intestine. This intervention has considerably fewer complications than the ileo-pouch- anal anastomosis to be discussed below, and in addition the results achieved are better. However, unlike ileo-pouch-anal anastomosis, this intervention does not remove the entire diseased tissue, i.e. including the relevant part of the rectum: the mucosa. For this reason, this operation can only be a temporary solution.

As an alternative, currently the standard solution which is used is the abovementioned ileo-pouch-anal anastomosis. In this procedure, both the large intestine and the rectum are removed, and the free end of the small intestine is firstly used to form a reservoir and secondly to provide a join to the anus. The removal of the rectum and the ileo-anal anastomosis in particular represent critical phases of the ileo-pouch-anal procedure.

Current opinion is that the ileo pouch anal anastomosis has been fully developed, and there is no expectation of it being improved much further.

The object of the present invention is to provide a procedure which does not have the drawbacks described above, but with which the entire diseased mucosa is nevertheless removed. Moreover, the aim is to restore the intestinal continuity, with defecation per vias naturales. Moreover, it is intended to avoid septic complications and sexual dysfunctions, while retaining the reservoir function of the (new) rectum. This object is achieved using a method as described above having the characterising features of claim 1.

The invention is based on the insight that only the mucosa of the rectum is affected, while in particular the surrounding muscular wall is healthy. Therefore, in the method according to the invention, this muscular wall is left intact, and the mucosa of the rectum is replaced by the freed mucosa of the small intestine. Surprisingly, it has been found that after a certain time this mucosa adapts itself to the conditions prevailing inside the muscular tunic, which takes over the slightly modified function there. The method according to the invention combines the advantages of the above- described ileorectal anastomosis and ileo-pouch-anal anastomosis, while avoiding their drawbacks, i.e. the most complicated phase of the ileo- pouch-anal procedure. It has been found that the procedure according to the invention can considerably reduce "pelvic sepsis", by avoiding the rectum excision, which causes bleeding/haematoma formation in the lesser pelvis and puts the ileo- anal anastomosis at risk. Anastomosis leakage, with bleeding in the lesser pelvis, leads to what is known as "pelvic sepsis". In the procedure accord- ing to the present invention, the muscular wall of the rectum remains in place. As a result, the risk of pelvic bleeding falls drastically, and also the risk of "pelvic sepsis" is reduced considerably owing to the fact that the ileorectal anastomosis lies above the entry to the pelvis. Bladder and sexual dysfunctions are avoided, owing to the fact that there is no excision in the rectum carried out in the procedure according to the invention. Due to the fact that the muscle wall of the rectum and its innervation are retained, as is the ano-rectal muscle junction, improved rectum evacuation function should be expected. In the case of ileo-anal anastomosis, stricture formation occurs in the ischaemic musculature of the ileum wall. In the method according to the present invention, the mucosa of the small intestine grows into the richly vascularized muscle wall of the rectum, with the result that ischaemic stricture formation is unlikely. For the reasons mentioned above, in the event of ingrowth of the mucosa, pouch failure becomes less likely. According to an advantageous embodiment of the invention, the distance over which the mucosa of the small intestine is prepared in such a manner that it is made free, i.e. at least the muscle tissue is removed, is approximately 20 cm. This distance corresponds to the length of the remaining part of the rectum. In addition to the mucosa tissue, the connective tissue is also removed from the rectum.

In order to allow the healing process to proceed under optimum conditions, a temporary stoma is made in the small intestine. In order to pro- mote this healing process further, after the mucosa of the small intestine has been introduced into the rectum, a supportive plug is temporarily introduced into this mucosa in the rectum from outside.

The invention also relates to a device for making free the free end of the small intestine and joining it to the rectum. A tube for locating (human) organs is generally known in the art. WO 89/0741 describes a probe for locating an endo-tracheal or endo-oesophageal tube in the trachea or oesophagus . Such tube is not suitable for realising the method as described above. This tube is closed at one end and has a diameter of 10 mm maximum. Otherwise such a tube can not introduced in the trachea or oesophagusa.

EP-0 771 5^5 Al describes a disposable rectoscope. This rectoscope comprises a rigid tube to be introduced in a human being. However, the method according to the invention cannot be realized with such a rectoscope because of the presence of gripping means making removing of the rectoscope after the procedure of the invention impossible. EP 0 478 358 Al describes a suture guide for urethral surgery. This guide comprises a rigid tube having a curvature of around 45° and the diameter of 6-7 mm. The ends of the tubes are closed. US-A-4,530,354 describes a tracheal tube in which an inflatable cuff member is provided. No communication between the free ends of the tube in view of the presence of the cuff. The diameter for its intended use will be around 10 mm.

The subject invention provides a device for joining two intestine parts comprising a rigid tube, which is to be introduced into the separated intestine and has an outer diameter between 1 and 25 mm and a length of 18- 30 cm, the opposed ends of said tube being open and in communication with each other, said tube having a curvature of about 20°, the outer shape of the tube being substantially continuous. The outer diameter of the tube should correspond with the inner diameter of the parts to be connected and on the other hand the inner diameter of the tube should be as large as pos- sible to provide for introduction of several items such as a betadine immersed tampon to be positioned near the place of connection.

It is also possible to realise the device according to the invention as a flexible tube which is to be introduced into the separated intestine and has an outer diameter between 15 and 25 mm and a length of 18-30 cm, the opposed ends of said tube being open and in communication with each other, the outer shape of the tube being substantially continuous.

Such flexible tube can be bent into the desired curvature but it is also possible that it has been (partially) curved in advance. To improve the positioning and maintaining in position of the tube as described above according to a preferred embodiment of the invention disconnectable gripping means are provided. For example, the tube can be provided with a treated hole to receive a rod being provided with a cooperating thread. It is also possible to provide one end of the tube with a gripping means, such as a groove, to cooperate with pliers having jaws, wherein the related tissue is placed in between and clamped in position. Both measures described above improve handling of the tissue material to be connected. This device comprises a tube with a diameter of between 15 and 25 mm and a length of approximately 18 - 30 cm. This tube is preferably curved in accordance with the shape of the rectum. The diameter of the tube is more particularly between 19 and 23 mm, while its length is approximately 20 cm. The curvature of the tube is preferably approximately 20° , and the tube is preferably a somewhat flexible tube, in order to be able to adapt to the particular conditions of the body. The material from which the tube is produced may be any material which is known from the prior art. Examples are flexible plastic material as well as rigid thin walled metal tubing. This material is preferable chosen such that during cutting no material of the tube frees from the tube material. Through the use of a thin walled large diameter tube the inner dimensions of the tube are as large as possible allowing for introduction of for example a tampon after the operation has been succeeded.

The invention will be explained below with reference to an exemplary embodiment which is illustrated in the drawings, in which: Fig. 1 diagrammatically depicts part of the human intestinal system;

Fig. 2 diagrammatically shows a first step of the operational technique according to the invention;

Fig. 3 shows a second step of the procedure according to the present invention; Fig. 4 shows the join according to the present invention; and

FIG. 5 shows a further embodiment of the tube shown in Figs. 2-4. Part of the human intestinal system is shown in Fig. 1. It comprises the small intestine 1, large intestine 2, rectum and anus 4. 5 shows the blood vascular system for the small intestine. Certain diseases , such as ulcerative colitis or familial adenomatous Polyposis, affect the large intestine (colon) and the rectum. The invention is based on the insight that not all of the colon and rectum tissue is affected, but rather only the colo-rectal mucosa, which in Fig. 3 is denoted by 14. Surprisingly, it has been found that the connective tissue 13 and the muscle tissue 12 are not affected.

Use is made of this insight. At dissection locations 10 and 11, the large intestine is separated from the small intestine (ileum) and the rec- turn, respectively. The large intestine part is removed. Then, the device according to the invention, which is denoted overall by 20, is inserted into the remaining part of small intestine 1. Then, the muscle tissue 6 is removed over the distance b, so that only intestine mucosa 8 and the connective tissue 7 remain. In a preferred embodiment, this distance b is approximately 20 cm.

This end of the small intestine is then introduced into the prepared remainder of the rectum. The remainder of the rectum is illustrated in Fig. 3 and comprises muscle tissue 12, connective tissue 13 and mucosa 14. The preparation involves removing the original layer of mucosa 14 and the layer of connective tissue 13 from the rectum. This is because it has been found that only this tissue 14 bears the disease. Then, device 20 with the surrounding mucosa tissue of the small intestine is introduced into the rectum. Owing to the particular shape of the device 20, it fits the shape of the remainder of the rectum. After the introduction has been carried out, the distal end of muscle tissue 6 is joined to the proximal end of muscle tissue 12. Then, device 20 is removed and the mucosa tissue of the small intestine is attached transanally to the connective tissue of the remainder of the rectum. Then, after the device 20 has been removed anally, the new rectum is filled with a gynaecological tampon or plug (not shown) which has been soaked in 0.1% Betadine. An auxiliary stoma is made in the small intestine, in a manner not shown in more detail, which stoma can be removed after the mucosa tissue has been grown into the rectum wall, after which the patient can evacuate normally.

The above-described device 20 is preferably a tube made of plastic, which more particularly is slightly flexible. The angle of curvature ^" is preferably approximately 20°, and this tube has a length of at least 20 cm. The diameter of the tube lies between 20 and 22 mm. This tube preferably consists of a material which can be sterilized, and more particularly of a (flexible) plastic, such as polyvinyl chloride a thin walled rigid metal tube.

Fig. 5 Shows an alternative embodiment of a device according to the invention and the tube according to the invention is generally referred to by 30. As in the embodiment according to the previous figures the opposed ends 31.32 are open and in communication with other. Tube 0 is provided with a threaded bore 33 to receive a rod 34 being provided with a corresponding male thread. This connection is only necessary during connection of the related organs. After connection has been completed rod 3 is removed and tube 30 is removed through the rectum of the related patient. In this way the position of the tube can be accurately fixed during operation. Further fixing of the tissue material can be realised by gripping it at extremity 32. As example a set of pliers 37 is shown having jaws 38. These jaws have a stepped design and the protruding portion thereof is able to enter groove 36 of tube 30. By positioning the jaws around the tissue this tissue is forced inside the groove and its position is fixed.

The procedure and device described above were tested in the following way:

Eight 'Dutch' porkers of 55 kg (11 weeks old) were subjected to the procedure according to the invention. Postoperatively, the pigs were fed low-fibre meal, in order to counteract quick passage and malabsorption. After three days, the gynaecological tampon was removed. After one, three and six weeks , a proctoscopy was performed and biopsies taken from the neo- rectum mucosa. After six weeks, the ileostomy was eliminated, after which faeces began to pass along the neo-rectum. The points examined were the technical feasibility of the operation, macroscopic and histological ingrowth of the neo-rectum mucosa and premature morbidity/mortality.

Results: The method according to the invention was found to be highly feasible on a technical level without the need for major changes to the procedure. Macroscopic ingrowth of the mucosa of the ileum was observed in all eight pigs after one week. The median percentage of mucosa coverage of the neo- rectum surface, assessed during the proctoscopy, was 75% after 1 week (spread 50 - 90%), 90% after three weeks (75 - 100%) and 100% after six weeks (60 - 100%) .

The histological changes in the transplanted mucosa and submucosa can be divided into three phases:

Phase 1: (= immediately after performing the Ileo Neo-Rectal Anastomosis (INRA) until three weeks after the operation) :

In most of the pigs, the mucosa has normal villi, with a virtually completely intact brush border. There is a considerable increase in the number of inflammation cells in the mucosa.

Phase 2: (=three to six weeks after the INRA was performed): There is a subtotal to total villus atrophy of the mucosa. The brush border is absent. The infiltration of inflammation has increased conside- rably in the mucosa and in the submucosa. Moreover, there is now young, vessel-rich connective tissue to be seen in the submucosa. Phase 3:

(4 MONTHS and more after the INRA was performed) :

The mucosa has completely restored itself, and the length of the villi is normal again. The brush border is absent only at the tips of the villi. The infiltration of inflammation has decreased and disappears over the course of time.

After an initial increase in the vessel-rich connective tissue in the submucosa, subsequently virtually nothing more was found of this. There is no scar tissue and no increase in nerve tissue .

All the pigs resumed the growth curve of an average of 5 kg increase in weight per week, both after the join according to the invention had been made, together with an ileostomy, and after the ileostomy had been eliminated. The neo-rectum related complications were limited. Two pigs had a stenosis of the mucosa-anal anastomosis, which was rectified by one anal dilatation. One pig had an occlusion of the distal neo-rectum, which required surgical correction. Mucosa ingrowth occurred in all pigs and was complete after 6 to 8 weeks . There were no complications of the ileorectal anastomosis .

After these experiments a human pilot study was carried out. Up to the state of filing this application nine patients received a procedure according to the invention with a temporary deviating ileostomy. No pouch/ neorectum related complications occurred. Endoscopy revealed complete mucosal ingrowth in all. Histological biopsies showed viable ileal mucosa without colonic metaplasia or submucosal fibrosis . Six patients had their ileostomy closed after three months , while closure in the remaining three patients is planned at the moment of filing this application. During the short follow up period (1-5 months) the bowel/urge frequency decreased from 15*/24 hours to 6-7x/24 hours and is still decreasing in all. All six patients are fully continent and remained their normal evacuation capacity. It must be emphasized that the above text only describes a test as an embodiment of the invention. It should be understood that numerous variants are possible and will be obvious to the person skilled in the art after reading the description and lie within the scope of the appended claims.

Claims

1. Method for surgical joining together the small intestine and the rectum, comprising the removal of the large intestine and at least part of the rectum and connecting at least part of the small intestine to the re- maining part of the rectum, characterized in that, after the small intestine has been separated from the large intestine, at least the muscle tissue is removed from the free end of the small intestine over a certain distance, in that the replacement of at least part of the rectum comprises at least removing the mucosa therefrom, and in that the free end of the small intestine is then introduced into the remaining part of the rectum and the edge of the muscle tissue of the small intestine is joined to the edge of the muscle tissue of the rectum.

2. Method according to Claim 1, in which said certain distance comprises approximately 20 cm.

3- Method according to one of the preceding Claims, in which the muscle tissue is removed from the free end of the small intestine.

4. Method according to one of the preceding Claims, in which a stoma is made in the small intestine.

5. Method according to one of the preceding Claims, in which, after the small intestine part has been introduced into the rectum, a plug, which supports the rectum from inside, is introduced into the mucosa of the small intestine.

6. Device (20,30) for joining two intestine parts comprising a rigid tube , which is to be introduced into the separated intestine and has an outer diameter between 15 and 25 mm and a length of 18-30 cm, the opposed ends of said tube being open and in communication with each other, said tube having a curvature of about 20┬░ , the outer shape of the tube being substantially continuous.

7. Device (20,30) for joining two intestine parts comprising a flexible tube, which is to be introduced into the separated intestine and has an outer diameter between 15 and 25 mm and a length of 18-30 cm, the opposed ends of said tube being open and in communication with each other, the outer shape of the tube being substantially continuous.

8. Device according to Claim 7. wherein said tube is curved with a curvature of about 20┬░.

9. Device according to Claim 6 or 7. in which the diameter of the tube is between 19 and 23 mm and the length is approximately 20 cm.

10. Device according to one of the claims 6-9. wherein said tube is provided with disconnectable gripping means (34) .

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