WO2007034427A2

WO2007034427A2 - A catheter

Info

Publication number: WO2007034427A2
Application number: PCT/IB2006/053405
Authority: WO
Inventors: Mehmet Haberal; Fatih Boyvat
Original assignee: Baskent Universitesi
Priority date: 2005-09-20
Filing date: 2006-09-20
Publication date: 2007-03-29
Also published as: WO2007034427A3

Abstract

The present invention relates to a catheter used to minimize and check complications in bile ducts after liver transplantation and if necessary, to allow percutaneous intervention.

Description

A CATHETER

Technical Field

Prior Art

In the embodiments known in the prior art, various kinds of catheters are provided to be used for diagnosis, examination, treatment and reducing the amount of fluid in the body by placing it in a gap or space in the body in fields of cardiology, urology, radiology and the like.

Complications of bile ducts after the liver transplantation range between 5,8% and 24,5%. The most important complications are biliary fistulas and anastomotic stricture (Transplantation Proceeding 35, 2316-2317, 2003). Applications like T- tube drainage catheter, transcvtic stent, choledochocholedochostomy (with or without internal stent) and choledochoieiunostomy are well know in the prior art in order to prevent the said complications. (Transplantation 66, 1201-1201, 1988; Transplantation 65, 193-196, 1988).

T-tube catheter, which is known in the art, is placed in the choleduct during conventional liver transplantation and it is possible to acquire biliary drainage after the operation and to assess the condition of bile ducts and the relation of choleduct with duodenum or jejunum by inserting contrast material through the tube. However there are some specific complications of the T-tube. These are:

- Cholangitis,

- Biliary fistula around the T-tube catheter, - Breaking of the T-tube during withdrawal,

- Risk and difficulty of percutaneous intervention to bile ducts from T-tube tract, if there occurs an early complication in the bile ducts, and

- Pains during and after the tube withdrawal. And it is very likely to suffer the same problems during transcystic stent application.

Choledochocholedochostomy can be performed by leaving or not leaving internal stent in the bile ducts. However, bile duct dilatation through percutaneous intervention is difficult and not likely if there is biliary fistula or stricture from anastomosis after the said method.

An intervention with ERCP (Endoscopic Retrograde Cholangiopancreatography) can be performed, but this method causes morbidity and mortality and the possibility to be successful is very low.

Another catheter used in the conventional liver transplantation is an angiographic catheter which is commercially available under the trademark of "Soft- Vu" of the firm named "AngioDynamics" and is disclosed in the US Patent No. 5,584,821. The said catheter is a polyether block amid (PEBA) catheter of which the end bears openings for drainage purposes and is covered with tungsten with radiopaque features and which includes internal, middle and external layers (lumen). The internal lumen of the catheter is stated as 0,038 inch, length is 40 cm and size is 5F.

However, when used in the liver transplantation known in the art the abovementioned catheter causes biliary fistula and may break when removing. When it is necessary to intervene in the bile ducts after the operation it causes intervention difficulties. Consequently, serious problems that lead to late recovery of the patient or death of the patient cannot be avoided. Short Description of the Invention

The object of the present invention is to provide a catheter which will be used in the liver transplantation and will not leave the place when withdrawn purposely or accidentally.

Another object of the invention is to provide a catheter which will reduce the biliary fistulas after the liver transplantation and thus lead to more rapid recovery of the patients.

Another object of the invention is to provide a catheter which will check the parts under intervention with the help of its radioopaque distal end during the operation and determine the biliary fistulas.

Detailed Description of the Invention

The catheter performed to achieve the objects of the invention is illustrated in the accompanying figures in which,

Figure 1 shows a schematic view of one embodiment of the catheter to be used in the adult patients, and

Figure 2 shows a schematic view of one embodiment of the catheter to be used in the child patients.

The parts in the figures are given numerals and the numerals are as follows:

1. Catheter

2. The distal end 3. Hole

4. Shaft 5. Balloon

6. Hub

Occurrence rate of bile duct complications after the liver transplantation from live donors varies between 15% and 64%. The rate of complications alters according to the type of anastomosis and use of T-tube or stent. In the early period of liver transplantation hepatico-jejunostomy (HJ) is performed, but today ductus-ductus (DD) anastomosis is much more preferred.

The applicant carried out a total of 81 liver transplantation operations, 58 of which were men and 23 were women between April 2001 and May 2005, and average age range 30 ± 19 (minimum 10 months and maximum 65 years). 35 of the total number were pediatric cases, and HJ was applied to 11 pediatric patients and DD anastomosis was applied to the remaining 70 patients. What are the most frequently encountered disorders as transplantation indications were cholestatic and metabolic diseases in pediatric patients and viral hepatitis in adult patients. Transplantation from cadavers were applied to 19 of the said patients and 38 patients are transplanted right lobe of the liver from live donors and 24 are transplanted left lateral segment.

The first 61 out of the 81 patients were subjected to conventional methods known in the art, and T-tube or transcystic stent used was placed in the choleduct with incision. The average follow-up period was 16 ± 13 and 8 patients exhibited stenosis and 16 exhibited fistula.

The last 20 patients were subjected to the new method developed by the applicant. In the mentioned technique, after the graft was perfused in the back-table a guide wire was placed through the hepatic channel. After the graft was implanted the guide wire was removed from the abdominal wall and drainage catheter proceeded percutaneously towards the receiver choleduct over the guide wire. The most problematic posterior part of the choledochal anastomosis can be more easily anastomozed by means of drawing the guide wire within the choleduct forward during anastomosis and thus good visualization of posterior wall of choledochal anastomosis.

The inventive catheter (1) has been developed for minimizing the biliary fistulas and obtaining better results during the application of the new method of the applicant.

The said catheter (1) is manufactured from a biocompatible plastic material, polymers, copolymers or other durable materials which can be applied to adult and child patients. The inventive catheter (1) comprises a catheter shaft (4) with 2 cm radiopaque feature and a distal end (2) forming a 20⁰C angle. The catheter (1) for adults comprises a side hole (3) of 5 cm segment (Ll) and for children a side hole (3) of 3 cm (Ll) following the distal end (2) for drainage purposes. The catheter (1) for adults comprises a durable silicone balloon (5) in 25 cm distance

(L2) and for children in 20 cm distance (L2), which can be inflated up to 1 cm.

Both of the catheters (1) comprise two internal lumens (not shown), one of which allows removing the fluids out of the body and the other inflates the balloon (5). There is provided 2 hubs for balloon and the catheter internal lumen after 20 cm distance (L3) in the catheter (1) for adults and after 15 cm distance (L3) in the catheter (1) for children following the balloon (5). The catheter shaft (4) between the balloon (5) and the distal end (2) of the catheter (1) is 5 French (F) sizes and the catheter shaft (4) between the balloon (5) and the hub (6) is 5 or 6 French (F) sizes.

The internal lumen of the catheter is manufactured in an appropriate size for the guide wire of 0,097 cm (0,038 inch) to pass through. An apparatus (not shown) acting as a valve in the inflating of the balloon is placed in the hub (6) of the catheter (1) and prevents draining off the fluids in the balloon (5) when it is inflated. The inventive catheter (1) is manufactured for one-time use and preserved in a sterile package with an expiration date.

Biliary fistula was observed in two patients out of 20 patients to whom the inventive catheter (1) of the new technique was applied for decreasing the biliary complication rates. The catheter accidentally came out in the first week and biliary fistula was observed in the patient in the first month. Minor biliary fistula was observed only in one patient and the fistula was fixed in a short time upon opening the catheter for external biliary drainage.

The complication rates between the patients subjected to HJ and DD anastomosis and patients subjected to the new technique were compared. Two square test of Fisher was used for comparing the complication rates and p< 0,05 was considered significant.

In the prior art, 3 patient with complication were subjected to percutaneous drainage due to bilioma and others percutaneous transhepatic biliary drainage, and it is observed that there is a statistical significant decrease in the complication rates (p=0,03). The biliary stents prevent the development of the biliary complications and facilitate the treatment of the complications since it provides a way for percutaneous intervention. It is thus shown that implanting percutaneous stent is an alternative secure method in liver transplantation for biliary drainage.

Claims

1. A one-time use catheter (1) manufactured from a biocompatible material used in adult and child patients, and implanted percutaneously in the biliary system during liver transplantation, comprising

- a distal end (2) with radioopaque feature,

- side holes (3) for drainage purposes,

- a reinforced catheter shaft (4), and characterized by - a durable silicone balloon (5) inflatable up to 1 cm, following the distal end (2) in a 20 to 25 cm distance (L2),

- 2 hubs (6) for the balloon (5) and the catheter internal lumen (not shown) in a 15 to 20 cm distance (L3) following the balloon (5),

- an apparatus (not shown) placed in the hub (6) acting as a valve in the inflating of the balloon and preventing drainage of the fluids in the balloon (5) when it is inflated.

2. A catheter (1) according to claim 1, characterized in that the catheter (1) comprises a catheter shaft (4) in 5 French (F) sizes between the distal end (2) and balloon (5) and 5 or 6 French (F) sizes between the hub (6) and the balloon (5).

3. A catheter (1) according to any of the foregoing claims, characterized in that the catheter (1) comprises a distal end (2) forming a 20⁰C angle with the catheter shaft (5) and showing a radioopaque feature in 2 cm length.

4. A catheter (1) according to any of the foregoing claims, characterized in that the catheter (1) comprises side holes (3) for drainage purposes in 3 to 5 cm lengths (Ll) following the distal end (2).

5. A catheter (1) according to any of the foregoing claims, characterized in that the catheter (1) comprises an internal lumen in an adequate thickness for the guide wire of 0,097 cm (0,038 inch) to pass through.