CN103002815A - A device for translumenal diversion of bile - Google Patents

Abstract

A device (6) for diverting biliary fluid comprises a catheter (13) and an anastomotic coupler (32) connected to the catheter (13), the anastomotic coupler (32) having an expandable first compression portion (33) and an expandable second compression portion (34) adapted to clamp a first portion (17) of a hollow organ and a target portion (18) of the intestine to each other to cause anastomosis of the first portion (17) and the target portion (18), thereby immobilizing the catheter (13) with respect to the anastomosis.

Description

Device for transluminal transfer of bile

technical field

The present invention generally relates to devices and methods for surgically affecting digestion in a patient aimed at treating metabolic disorders such as morbid obesity and related co-morbidities such as diabetes, heart disease, stroke, lung disease and accidents.

Background technique

Various non-surgical treatments for morbid obesity have been attempted in the past with virtually no permanent success.

Surgical approaches to the treatment of morbid obesity, such as open, laparoscopic, and intracavitary gastric bypass for permanent food indigestion, have been progressively used with considerable success. However, existing methods for performing gastric bypass involve time-consuming and highly dexterity-dependent surgical techniques as well as significant and often highly invasive modifications to the patient's gastrointestinal anatomy. These procedures are reserved for severely obese patients because of their multiple significant complications, including the risk of death. In order to avoid the pitfalls of the gastric bypass surgery and to influence the patient's digestion in a more specific and targeted manner, the present invention focuses on methods and devices for influencing and modulating the enterohepatic bile circulation rather than the digestive tract itself . To this end, the following possible methods and mechanisms of action on the enterohepatic bile cycle are considered:

- adjust the frequency of enterohepatic bile circulation, especially the acceleration of bile circulation;

- modulation of physiological signals triggered by the contact and interaction of bile with food in the intestines and by the contact of bile with the intestinal wall;

- Adjustment of the absorbability of food by adjustment of the contact space and time between bile and intestinal food or chyme and by targeted separation of bile from food.

A known minimally invasive bypass system and method for modulating the location of interaction of bile and pancreatic secretions with nutrients in the gastrointestinal tract has been described in US Patent US 2005085787A1. Known systems include tubing having a first end that diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream of the gastrointestinal tract and a second end connected to the ampulla of Vater.

Said known conduit catheters extend in the intestine and tend to bind and become displaced by the peristalsis of the intestine so that the distal end of the catheter is frequently repositioned away from the surgeon's intended target location.

Furthermore, in order to follow the coiled path of the bowel, known endoluminal tubing must have significant length, which undesirably increases flow resistance and reduces bile flow in the gastrointestinal tract to distal target sites. Thus, the known conduits are not suitable for obtaining a significant acceleration of the bile circulation compared to the natural enterohepatic bile circulation speed.

In view of the deficiencies of the known art, the present invention aims to provide a minimally invasive device and method for diverting bile from the biliary system with the gallbladder into a part of the intestine distal to the papilla of Vater, which avoids the non-displacement of the bile duct at the target location. desired repositioning.

Contents of the invention

Another object of the present invention is to increase the flow of diverted bile towards a target location in the small intestine.

At least some of the above-identified objects are achieved by a method of diverting bile from the bile flow path to a target location in the bowel distal to the Vater's duodenal papilla, the method comprising the steps of:

a) forming a first stoma at the first part of the hollow organ;

b) creating a second stoma at a target portion of the bowel distal to the Vater's papilla;

c) placing the proximal portion of the catheter within the bile flow path;

d) extending a catheter through the first stoma and the second stoma from the bile flow path to said target location in the bowel;

e) placing the distal portion of the catheter in said target location in the intestine.

Since the transluminal catheter extends from the bile flow path to the target location in the bowel, at least part of the duodenum can be bypassed and the length of the bypass can be minimized. Furthermore, by extending the catheter through the stoma at the target portion of the bowel, the distal portion of the catheter does not bind and dislodge from the desired target location.

The target portion of the intestine may be a portion of the small intestine, such as the distal portion of the duodenum, a portion of the jejunum or ileum, or a portion of the large intestine, such as the transverse or sigmoid colon.

According to an aspect of the invention, the method comprises the steps of:

- creating a first stoma at the first part of the bowel; and

- Anastomosis of the first part of the bowel to the target part of the bowel.

The intestinal-intestinal anastomosis creates a luminal continuity that excludes the risk of leakage of intestinal material in the abdominal space through the gap between the catheter and the stoma.

Furthermore, due to the entero-intestine anastomosis, it is possible to extend the catheter from the bile duct through the first stoma and out of the duodenum and directly into the target portion of the bowel, creating a very short bypass path.

According to another aspect of the present invention, the method comprises the steps of:

- a first stoma is made at the first part of the gallbladder; and

-Anastomosis of the first part of the gallbladder to the target part of the intestine.

By creating a gallbladder-gut anastomosis instead of a bowel-gut anastomosis, the proximal portion of the catheter extends through the gallbladder wall, thereby avoiding insertion of the catheter through the Vater papilla into the very fragile common bile duct.

According to another aspect of the invention, the method includes the step of forming a first stoma at the first portion of the common bile duct.

This allows the proximal portion of the catheter to be placed in the bile flow path without entering the Vater's papilla and without manipulating the gallbladder.

At least some of the objects identified above are achieved by a device for diverting bile from a bile flow path to a target location in the bowel distal to the Vater's duodenal papilla, the device comprising:

- a catheter having a proximal portion and a distal portion and a tubing segment extending between the proximal portion and the distal portion,

- an anastomotic device connected to the catheter, said anastomotic device having an inflatable first compression part and an inflatable second compression part,

Therein, the first compression portion and the second compression portion are capable of clamping the first portion of the hollow organ and the target portion of the intestine to each other such that the first portion and the target portion are anastomosed and the catheter is secured relative to the anastomosis.

This allows placement of the catheter and formation of the anastomosis in a single step, and fixation of the catheter relative to the anastomosis so that the catheter is not withdrawn from the anastomosis site.

According to an aspect of the invention, the catheter includes an outer tubular wall, and the anastomotic device includes a first inflatable annular balloon formed in the outer wall and a second inflatable annular balloon formed in the outer wall and spaced apart from the first balloon.

According to another aspect of the invention, the distance between the first bladder and the second bladder is adjustable.

Description of drawings

These and other aspects and advantages of the invention will be apparent from the accompanying drawings and the description thereof, which show embodiments of the invention, and together with the general description of the invention given above and below The detailed description of the examples is given to explain the principles of the invention.

- Figure 1 shows a device and method for transluminal transfer of bile according to an embodiment of the present invention;

- Figure 2 shows an enlarged view of Figure 1;

- Figure 3 shows a method for transluminal transfer of bile according to another embodiment of the invention;

- Figure 4 shows an enlarged view of Figure 3;

- Figure 5 shows a method and device for transluminal transfer of bile according to another embodiment of the present invention;

- Figures 6-9 illustrate method steps, devices and instruments for transluminal transfer of bile according to embodiments of the present invention;

- Figure 10 shows the anastomotic device applicator used in the method of Figures 6-9;

- Figure 11 shows the anastomotic device after setting and retracting the applicator in Figure 10;

- figure 12 shows a device for transluminal transfer of bile according to another embodiment of the invention, wherein said device has a first collapsed configuration;

- Figure 13 shows the device of Figure 12 in a second expanded configuration;

- Figure 14 shows a method for transluminal transfer of bile using the device of Figures 12 and 13;

- Figure 15 shows a device for transluminal transfer of bile according to an embodiment of the invention, wherein said device is shown in a first contracted configuration (solid line) and a second expanded configuration (dashed line);

- Figure 16 shows a device for transluminal transfer of bile according to another embodiment of the invention, wherein said device is shown in a first contracted configuration (solid line) and a second expanded configuration (dashed line);

- Figure 17 shows a method and a device for transluminal transfer of bile according to another embodiment of the present invention.

Detailed ways

Referring to the Figures, in which like numerals represent like anatomy and components throughout the several figures, Figure 1 is a partial view of the abdominal cavity of a patient showing the stomach 1 , duodenum 2 , jejunum 3 , ileum 4 and The colon 5, along with the biliary system 7 with the gallbladder 8, the pancreatic duct 9 and the papilla of Vater's duodenum 10, through which bile and pancreatic juice normally pass into the duodenum 2. FIG. 1 also shows a method and device 6 for transluminal diversion of bile from the bile flow path defined by the biliary system 7 and gallbladder 8 to a target location in the intestine distal to the papilla 10 of Vater.

According to the general idea, the method includes the following steps:

- forming a first stoma 11 at the first part 17 of the hollow organ;

- Formation of a second stoma 12 at a target portion 18 of the bowel 2, 3, 4, 5 distal to the Vater's papilla 10;

- placing the proximal portion 14 of the catheter 13 within the bile flow path;

- extending the conduit 13 from the bile flow path through the first stoma 11 and the second stoma 12 to a target location in the bowel 2, 3, 4, 5;

- Placing the distal portion 15 of the catheter 13 in the target location in the bowel.

Since the transluminal catheter 13 extends from the bile flow path to the target location in the bowel, at least part of the duodenum can be bypassed and the length of the bypass can be minimized. Furthermore, by extending the catheter 13 through the stoma at the target portion 18 of the bowel, the catheter distal portion 15 does not bind and dislodge from the desired target location.

The target portion 18 of the intestine may be a portion of the small intestine, eg, the distal portion of the duodenum 2, a portion of the jejunum 3 or ileum 4, or a portion of the large intestine 5, eg, the transverse or sigmoid colon.

The proximal portion 14 of the catheter 13 may be anchored within the biliary system 7, eg the common bile duct, by means of a metallic stent 16 or alternative anchoring means connected to the proximal portion 14.

According to an embodiment ( FIGS. 1 , 2 , 5 ), a first stoma 11 is formed at a first part 17 of the intestine (in particular at the duodenum 2 close to the papilla 10 of Vater) and the first part of the intestine is 17 is anastomosed to a target portion 18 of the bowel. Such an entero-intestine anastomosis creates a luminal continuity which excludes the risk of leakage of intestinal material in the abdominal space through the gap between the catheter 13 and the stoma 11 , 12 . In this embodiment, a catheter 13 may extend from the biliary system 7 through the Vater's papilla 10 and the first stoma 11 and out of the duodenum 2 and directly into the target portion 18 of the bowel, forming a very short bypass path (Figure 2).

To place the catheter 13, an endoscope is inserted into the bowel to visualize the duodenum 2 close to the Oddi's sphincter and to identify the first portion 17 of the bowel for the first stoma 11 . The same endoscope can be used to identify the target portion 18 of the bowel for the second stoma 12 distal to the Vater's papilla 10 and the first stoma 11 . The first portion 17 of the bowel and the target portion 18 of the bowel then approach each other and form an intestinal-intestinal anastomosis therebetween. For the sake of clarity, it should be understood that the intestinal-intestinal anastomosis comprises a lumen formed by a first stoma 11 and a second stoma 12 accessible and accessible at a first portion 17 and a target portion 18 of the bowel. Executed before or after the connection.

Forming an intestinal-intestinal anastomosis may involve laparoscopic placement of an anastomotic ring device using an applicator and an anastomotic device as described in commonly owned US Pat. No. 7,452,363, the entire contents of which are incorporated herein by reference.

After the enteric-intestinal anastomosis is formed, the proximal part 14 of the catheter 13 and the stent 16 are introduced through the Vater's papilla 10 into the common bile duct using a similar technique such as ERCP (Endoscopic Retrograde Cholangiopancreatography). The ERCP procedure involves passing a flexible endoscope through the mouth, esophagus and stomach into the duodenum 2 adjacent to Vater's papilla 10 . The physician then passes the catheter 13 through the instrument channel in the endoscope and protrudes into the duodenum 2 for observation and inserts it into the Vater papilla 10 .

After the catheter proximal portion 14 is positioned at the desired location in the common bile duct, the stent 16 or other anchoring device is activated to connect to the bile duct and anchor the catheter 13 thereto.

The endoscope is then retracted from the stretched state and the distal portion 15 of the catheter 13 emerges from the instrument channel or the distal portion 15 of the catheter 13 is driven out of the instrument channel so that it is grasped by the endoscopic grasper and threaded. It is introduced into the target portion 18 of the bowel via a bowel-to-bowel anastomosis.

According to an embodiment, the catheter 13 may be additionally fixed to an anastomotic device or bowel-gut anastomosis, thereby fixing the catheter 13 relative to the target portion 18 of the bowel. The endoscope can then be withdrawn from the patient. The resulting situation is shown in FIGS. 1 and 2 .

In order to prevent retrograde infection of the biliary system 7 or pancreatitis, the catheter 13 may comprise an antimicrobial coating 19 containing eg silver.

According to another embodiment ( FIG. 9 ), the first stoma 11 is formed at the first part 17 of the gallbladder 8 and the first part 17 of the gallbladder 8 is anastomosed with the target part 18 of the bowel 2 , 3 , 4 , 5 . In this embodiment, a gallbladder-gut anastomosis is formed instead of a bowel-gut anastomosis, with the proximal portion 14 of the catheter 13 extending through the gallbladder wall, thereby avoiding insertion of the catheter 13 through the Vater's papilla into the very fragile common bile duct.

In this embodiment, the gallbladder 8 is brought into proximity to the target portion 18 of the bowel by percutaneously introducing a grasping instrument into the abdominal space, and grasping the gallbladder 8 by the grasping instrument and pulling the gallbladder 8 towards and away from the target portion 18 of the bowel. The grasping instrument may comprise opposing jaws attached to a rigid shaft, or the grasping instrument may comprise a distal end attached to a rigid shaft and an inflatable bladder having an inflated shape capable of engaging the gallbladder 8 and pushing it against the bowel. target section 18. To this end, the distal end of the grasping instrument together with an inflatable bladder can be introduced percutaneously into the gallbladder 8, and the bladder can be inflated inside the gallbladder to engage the latter.

Following the approximation of the first portion 17 of the gallbladder to the target portion 18 of the bowel, an intestinal-intestinal anastomosis is formed by using an applicator's anastomotic ring device and a laparoscopic arrangement of the anastomotic device described in commonly owned U.S. Patent No. 7,452,363 described, the entire contents of which are incorporated herein by reference. The anastomotic device may be fully bioabsorbable or biodegradable, or only the proximal (gallbladder side) compressed portion of the anastomotic device is bioabsorbable or biodegradable such that the anastomotic device can be expelled with feces.

After the gallbladder-bowel anastomosis is formed, the proximal portion 14 of the catheter 13 and the stent 16 are introduced into the gallbladder 8 through the gallbladder-bowel anastomosis (ie, through the second stoma and the first stoma), and possibly ascending into in the cystic duct. This is advantageously achieved by a modified ERCP (endoscopic retrograde cholangiopancreatography)-like procedure that involves passing a flexible side scope through the rectum and colon into the targeted portion of the bowel2,3,4,5 18, or make the flexible side scope enter the target portion 18 of the intestine through the oral cavity, then pass the catheter 13 through the instrument channel in the endoscope and protrude into the target portion 18 of the intestine for observation, and make the catheter proximal portion 14 It is inserted through the gallbladder-bowel anastomosis into the gallbladder 8 and possibly guided upwards into the cystic duct.

After the catheter proximal portion 14 is positioned at the desired location, the stent 16 or other anchoring device is activated to anchor the catheter 13 in the gallbladder 8 or cystic duct.

The side scope is then retracted from the stretched state, the distal portion 15 of the catheter 13 emerges from the instrument channel or the distal portion 15 of the catheter 13 is expelled from the instrument channel in the target portion 18 of the bowel.

If it is desired to divert all bile, a plug 20 can be placed in the common bile duct distal to the proximal end of the catheter (Fig. 9).

The catheter 13 may additionally be secured to an anastomosis device or gallbladder-bowel anastomosis, thereby immobilizing the catheter 13 relative to the target portion 18 of the bowel. The endoscope can then be withdrawn from the patient. The resulting situation is shown in FIG. 9 .

According to an embodiment, gallbladder-bowel anastomosis and placement of the transluminal catheter 13 can also be achieved using a laparoscopic approach, as shown in FIGS. 6-11 .

Figure 11 shows an exemplary anastomotic ring device 22 having a proximal ring 23, a central ring 24 and a distal ring 25 connected by proximal and distal articulating arms respectively, the anastomotic ring device 22 having a generally cylindrical shape when not activated. shape and has a rivet shape when activated. FIG. 10 shows an exemplary applicator 21 for an anastomotic ring device 22 . The applicator 21 includes an elongated tool portion 26, a handle 27 connected to the tool portion 26, an actuating member internally engaged to a selected one ring of the anastomotic device 22, a selected second ring internally engaged to the anastomotic device 22 The capture member and the control are connected to the handle 27 and can move the actuation member and the engagement ring towards the capture member and the selected second ring, thereby activating the plug-in articulating arm of the ring device 22 . Such an anastomotic device and applicator are described in the aforementioned US Patent No. 7,452,363.

The applicator 21 together with the ring device 22 is introduced into the abdominal space, through the laparoscopic portal and through the first 11 and second 12 stomas to be anastomosed. Applicator 21 may have a distal tip 28 capable of forming a stoma when the applicator is not forced through the walls of the bowel or gallbladder. Alternatively, the first 11 and second 12 stomas may be formed using standard laparoscopic cutting instruments.

As shown in FIG. 6 , applicator 21 may be inserted through third stoma 29 into a portion of the bowel distal to target portion 18 and then may be advanced proximally to target portion 18 . Then, the distal ring 25 of the anastomotic device 22 is inserted through the previously formed second stoma 12 while the proximal articulating arm of the anastomotic device 22 is activated to radially expand so that the device 22 does not slide completely through the second stoma. stoma12. By pushing the applicator 21 towards the gallbladder 8 , the target portion 18 of the bowel is brought into proximity with the first portion 17 of the gallbladder 8 . The distal ring 25 of the anastomotic device 22 is then inserted through the previously formed first stoma 11 in the gallbladder 8, and the distal articulating arms are activated to radially expand, thereby placing the first portion 17 of the gallbladder 8 against the bowel. The target portion 18 is clamped to form a fit therebetween (FIG. 7). The applicator 21 can then be withdrawn through the third stoma 29 and the catheter 13 can be inserted into the gallbladder 8 through the third stoma 29 as well as the second and first stomas 12, 11 at the gallbladder-intestinal anastomosis, and possibly Insert into the cystic duct (Figure 8).

After the catheter proximal portion 14 is positioned at the desired location, the stent 16 or other anchoring device can be activated to anchor the catheter 13 in the gallbladder 8 or cystic duct (Fig. 9). Additionally, the catheter 13 may be secured to the anastomotic device 22 to secure the catheter distal portion 15 relative to the target portion 18 of the bowel.

The resulting bypass allows bile originating from the liver to be diverted to its target location in the intestine.

According to another embodiment (Fig. 3, 17), the first stoma 11 is formed at the first part 18 of the common bile duct. This allows the proximal portion 14 of the catheter to be placed in the bile flow path without entering Vater's papilla 10 and without manipulating the gallbladder 8 .

In the embodiment of FIG. 17 , bile is bypassed through part of the small intestine 2 , 3 by placing the catheter 13 such that the catheter proximal portion 14 is positioned in the common bile duct and the catheter distal portion 15 is positioned in the jejunum 3 or ileum 5 .

In the embodiment of FIG. 3 , the catheter 13 is placed in the transcolonic access such that the proximal portion 14 of the catheter is positioned in the common bile duct and the distal portion 15 of the catheter is positioned in the large intestine 5 (e.g., in the transverse bowel). Bile bypasses the small intestine completely 2,3,4.

In a possible laparoscopic procedure, a laparoscopic portal is formed and a laparoscopic cutting instrument is inserted through the portal into the abdominal space to perform a first stoma 11 at the bile duct 7 and a second stoma 12 at the colon 5 . Then, the cutting instrument is retracted and the catheter 13 is inserted through the portal into the abdominal space. The proximal portion 14 of the catheter 13 is inserted through the first stoma 11 in the bile duct 7 in a retrograde direction (opposite the direction of natural flow of bile) and a stent 16 or other anchoring device is provided to anchor the proximal portion 14 of the catheter in the bile duct. 7 in. Then, a purse string suture is applied to the first stoma 11 around the catheter 13 to seal the first stoma 11 .

The distal portion 15 of the catheter 13 is inserted into the colon 5 through the second stoma 12 and a purse string suture is applied around the catheter 13 to the second stoma 12 to seal the first stoma 12 . The instrument is then withdrawn from the patient, the access port is removed and the hole in the abdominal wall is sutured.

By bypassing the entire small intestine, lipid absorption will be significantly reduced due to lack of bile.

Undesirable backflow of feces or chyme from the intestine can be prevented by providing a one-way valve 30 (shown in FIG. 17 ), such as a retractable low pressure flapper valve at the distal end of the catheter 13 . Valve 17 closes when bowel or colon peristalsis tends to push chyme or feces into conduit 13 and opens when bile flows down the conduit and the internal bile pressure at the conduit's distal exit orifice exceeds external pressure.

In order to reduce the risk of peritonitis and retrograde infection due to diversion of chyme or feces into the bile duct, it is contemplated to introduce a catheter 13 transhepatically through the liver into the bile duct 7 . In this case, the catheter distal part 15 is passed through the first stoma 11 , out of the bile duct 7 towards the perspective target part 18 of the colon 5 and into the colon 5 through the second stoma 12 .

According to another embodiment, the catheter 13 is inserted transhepatically through the liver into the bile duct 7 and the distal portion 15 of the catheter is fed into the duodenum 2 through the papillae of Vater 10 and through a previously formed cavity in the duodenal wall. The first stoma 11 , towards the perspective target portion 18 of the colon 5 protrudes from the duodenum 2 and is fed through the second stoma 12 into the colon 5 .

These embodiments require the use of purse string sutures at the first stoma 11 and the second stoma 12 to seal the latter relative to the catheter 13 to prevent leakage of intestinal material into the abdominal space.

The intestinal lumen continuity is re-established by the duodeno-colon anastomosis between the first stoma 11 and the second stoma 12 and the catheter 13 is extended from within the bile duct 7 through the papilla of Vater 10 and through the ten The duodenum-colon anastomosis into the targeted portion 18 of the colon 5 (Fig. 5) avoids such chronic trauma to the bowel wall. For this purpose, the devices and methods already described above for bowel-bowel anastomosis and gallbladder-bowel anastomosis can be used. Alternatively, a duodeno-colon anastomosis can be achieved using the anastomotic device and applicator described in US Pat. No. 7,618,427, which is incorporated herein by reference in its entirety.

12-16 show other embodiments of the device 6 for diverting bile from the bile flow paths 7, 8 to a target location in the intestine distal to the duodenal papilla 10 of Vater.

In the embodiment of FIGS. 12 and 13 , the device 6 comprises a catheter 13 and an anastomotic coupling 32 connected to the catheter 13 , the catheter has a proximal portion 14 , a distal portion 15 and between the proximal portion 14 and the distal portion 15 . Extended pipe segment 31 . The anastomotic coupling 32 includes a first expandable compression section 33 and a second expandable compression section 34, wherein the first expandable compression section 33 and the second expandable compression section 34 are capable of bringing together the first portion 17 of the hollow organ and the target portion of the intestine 18 are clamped to each other such that the anastomosis of the first portion 17 and the target portion 18 and fixation of the catheter 13 relative to the resulting anastomosis.

This allows placing the catheter 13 and forming said anastomosis in a single step, and securing the catheter 13 relative to the anastomosis so that the catheter is not withdrawn from the anastomosis site.

In the contracted and radially telescoping state, the compressed portions 33 , 34 allow endoscopic or laparoscopic placement of the catheter 13 through the first 11 and second 12 stomas.

According to an embodiment, catheter 13 includes an outer tubular wall 35 and anastomotic coupler 32 includes a first inflatable annular bladder formed in outer wall 32 and a second inflatable annular bladder formed in outer wall 32 at a distance from the first bladder.

According to an embodiment, a first marker 36 of visualization (e.g., a radiopaque region) is placed at the catheter bundle located between the constrictions 33, 44, and other markers 37 may be placed adjacent to the constriction opposite the first marker 36. Sections 33, 44. The markings 36 , 37 aid in the positioning of the compression portions 33 , 44 and in the correct positioning of the catheter 13 .

Figure 14 shows an exemplary non-limiting use of the device 6 for forming a gallbladder-intestine anastomosis and extending a catheter 13 through the lumen of the anastomosis, eg using one of the methods described above in connection with Figure 9 .

According to another embodiment, the distance between the first compression portion 33 and the second compression portion 34 is adjustable to adjust the compressive force acting on the first portion 17 and the target portion 18 in the anastomosis site. To this end, a threaded adjustment coupling 38 ( FIG. 15 ) or a ratchet adjustment coupling 39 ( FIG. 16 ) may be provided in the conduit 13 between the first compression section 33 and the second compression section 34 . The ratchet adjustment coupling 39 may also include a puller wire 40 having a first end connected to the first ratchet portion of the two engaging ratchet portions and a second end visible from the catheter 13. It is now on the side opposite the first ratchet part and can be grasped and pulled for further access to the ratchet part.

While the preferred embodiments of the invention have been described in detail, applicants do not intend to limit the scope of the claims to such specific embodiments, but intend to cover all modifications and alternative constructions within the scope of the invention. .

Claims (30)

1. A method for diverting bile from the bile flow path (7, 8) to a target location in the bowel (3, 4, 5) distal to the Vater's duodenal papilla (10) , the method includes the following steps: - forming a first stoma (11) at the first part (17) of the hollow organ; - formation of a second stoma (12) at a target portion (18) of said bowel (2, 3, 4, 5), said target portion (18) being distal to said papilla of Vater (10) ; - placing the proximal portion (14) of the catheter (13) within said bile flow path (7, 8); - extending said conduit (13) from said bile flow path (7,8) through said first stoma (11) and said second stoma (12) to said intestine (2,3 , 4, 5) in the target position. 2. The method according to claim 1, comprising the step of anchoring the proximal portion (14) of the catheter (13) within the biliary system (7). 3. The method according to claim 1 or 2, comprising the steps of: - forming said first stoma (11) at a first part (17) of the duodenum (2) close to said Vater's papilla (10); and - Anastomosis of the first part (17) of the duodenum (2) to the target part (18) of the intestine. 4. The method according to claim 3, comprising the steps of: - inserting an endoscope into said bowel to visualize the duodenum (2) close to the Oddi's sphincter; and - identifying a first portion (17) of the bowel for said first stoma (11) using said endoscope; - identifying a target portion (18) of bowel for said second stoma (12) using said endoscope; - bringing the first portion (17) of the duodenum (2) and the target portion (18) of the intestine close to each other and forming an intestinal-intestinal anastomosis therebetween; - by passing a flexible endoscope through the oral cavity, esophagus and stomach into the duodenum (2) adjacent to the Vater's papilla (10) and passing the catheter (13) through the duodenum The instrument channel of the endoscope in the intestine (2) and into the papilla of Vater (10), the proximal part (14) of the catheter (13) and the stent (16) are passed through the Vater The nipple (10) is inserted into the common bile duct; - positioning said stent (16) to anchor said catheter (13) to the bile duct; - grasping the distal portion (15) of said catheter (13) by an endoscopic grasper and introducing said distal portion (15) through said entero-intestinal anastomosis into a target portion (18) of said intestine middle. 5. The method according to claim 3, comprising the step of securing the catheter (13) to the anastomosis, thereby immobilizing the catheter (13) relative to the target portion (18) of the bowel. 6. The method of claim 1, comprising the steps of: - forming said first stoma (11) at said first portion (17) of said gallbladder (8); and - Anastomosis of the first part (17) of the gallbladder (8) to the target part (18) of the intestine (2, 3, 4, 5). 7. The method of claim 6, comprising the steps of: - percutaneous introduction of a grasping instrument into the abdominal space; and - grasping the gallbladder (8) by the grasping instrument and pulling the gallbladder (8) towards and away from the target portion (18) of the intestine. 8. The method of claim 7, comprising the steps of: - providing an inflatable bladder connected to the distal end of said grasping instrument; - introducing the distal end of the grasping instrument together with the inflatable bladder into the gallbladder (8); and - grasping the gallbladder by inflating the bladder within the gallbladder. 9. The method of claim 6, comprising the steps of: - Formation of the gallbladder-bowel anastomosis by laparoscopic placement of the anastomotic ring device. 10. The method of claim 6, comprising the steps of: - after forming the gallbladder-bowel anastomosis, by entering a flexible side scope into the target portion of the bowel (18) and passing the catheter (13) through the inner cavity in the target portion of the bowel (18) endoscope instrument channel and insert the catheter proximal portion (14) through the gallbladder-intestinal anastomosis into the gallbladder (8), insert the proximal portion (14) of the catheter (13) and the stent ( 16) inserting into said gallbladder (8) through said gallbladder-gut anastomosis; - activating said stent (16) to anchor said catheter (13) in said gallbladder (8). 11. The method according to claim 6, comprising the step of securing the catheter (13) to the anastomosis so as to fix the catheter (13) relative to the target portion (18) of the bowel. 12. The method of claim 6, comprising the steps of: - Formation of a laparoscopic portal; - forming a third stoma in said intestine adjacent to said second stoma; - introducing a laparoscopic applicator (21) together with a loop device (22) through said laparoscopic inlet and said third stoma into a target portion of the bowel; - placing said ring device (22) into said second stoma (12) and pushing the target portion (18) with said second stoma (12) towards said first stoma ( 11) of the first part (17), and then, placing said ring device (22) into said first stoma (11); - arranging said ring means (22) to fit said first part (17) to said target part (18); - withdrawing said applicator (21) through said third stoma (29); and - inserting said catheter (13) through said third stoma (29) and said second stoma (12) and first stoma (11) into said gallbladder at said gallbladder-gut anastomosis ( 8) in. 13. The method according to claim 2, comprising the step of forming said first stoma (11) at the common bile duct. 14. The method according to claim 13, comprising placing the catheter proximal portion (14) in the common bile duct and the catheter distal portion (15) in the duodenum (2 ) steps in the distal small intestine. 15. The method according to claim 13, comprising the steps of placing the catheter proximal part (14) in the common bile duct and the catheter distal part (15) in the colon (5). 16. The method of claim 15, comprising the steps of: - Formation of a laparoscopic portal; - inserting a laparoscopic cutting instrument into said abdominal space through said portal and using said cutting instrument, performing said first stoma (11) at said bile duct (7) and at said colon ( 5) performing said second stoma (12); - retracting said cutting instrument; - inserting said catheter (13) through said inlet into said abdominal space; and - inserting the proximal portion (14) of said catheter (13) and stent (16) through said first stoma (11) into said bile duct (7) in a retrograde direction; and - anchoring said proximal portion (14) by placing said stent (16) in said bile duct (7); - sealing said first stoma (11) by applying a purse string suture around said catheter (13) to said first stoma (11); - inserting the distal portion (15) of said catheter (13) into said colon (5) through said second stoma (12); - sealing said second stoma (12) by applying a purse string suture to said second stoma (12) around said catheter (13). 17. The method according to claim 1, comprising the step of arranging a one-way valve (30) at the distal end (15) of the catheter (13). 18. The method of claim 13, comprising the steps of: - introducing said catheter (13) transhepatically through the liver into said bile duct (7); - see through the target portion (18) of said colon (5); - passing the catheter distal part (15) through the first stoma (11), out of the bile duct (7) towards the fluoroscopy target part (18), and through the second stoma ( 12) sent to the colon (5). 19. The method of claim 1, comprising the steps of: - introducing said catheter (13) transhepatically through the liver into the bile duct (7); - see through the target portion (18) of said colon (5); - sending the catheter distal portion (15) through the Vater's papilla (10) into the duodenum (2) and through the previously formed The first stoma (11) protrudes from the duodenum (2) towards the fluoroscopy target portion (18) and passes through the second stoma (12) to the colon (5 )middle. 20. A device (6) for diverting bile from a bile flow path (7, 8) to a target location in the intestine (3, 4, 5), said device (6) comprising: - a catheter (13) having a proximal portion (14) and a distal portion (15) and a tubing segment extending between the proximal portion (14) and the distal portion (15) ( 31), - an anastomotic coupling (32) connected to said catheter (13), said anastomotic coupling (32) having an inflatable first compression part (33) and an inflatable second compression part (34), The first compression part (33) and the second compression part (34) are capable of clamping the first part (17) of the hollow organ and the target part (18) of the intestine to each other such that the first part (17) Anastomosis with said target portion (18) thereby immobilizing said catheter (13) relative to said anastomosis. 21. The device (6) according to claim 20, wherein said catheter (13) comprises an outer tubular wall (35), and said anastomotic coupling (32) comprises a second An inflatable annular bladder and a second inflatable annular bladder formed in said outer wall (32) at a distance from said first bladder. 22. The device (6) according to claim 20, wherein the catheter (13) comprises a visualization marker (36, 37) positioned at the catheter bundle close to the constriction portion (33, 44). 23. The device (6) according to claim 22, wherein the marker (36, 37) comprises a radiopaque substance. 24. The device (6) according to claim 20, wherein the distance between the first compression section (33) and the second compression section (34) is adjustable. 25. The device (6) according to claim 24, wherein a threaded adjustment coupling (38) is arranged in the conduit ( 13) in. 26. The device (6) according to claim 24, wherein a ratchet adjustment coupling (39) is arranged in the conduit ( 13) in. 27. The device (6) according to claim 26, wherein said ratchet adjustment coupling (39) comprises a puller wire (40) having a first end and a second end, said first end Connected to a first ratchet part of two engaging ratchet parts, said second end emerges from said conduit (13) on the side opposite said first ratchet part and can be grasped and pulled to access said Two engaging ratchet sections. 28. The device (6) according to any one of claims 20 to 27, comprising an anchoring stent (16) connected to the proximal portion (14) of the catheter (13). 29. The device (6) according to any one of claims 20 to 28, wherein the catheter (13) comprises an antimicrobial coating (19). 30. The device (6) according to any one of claims 20 to 29, comprising a one-way valve (30) arranged at the distal end of the catheter (13).

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