CN103221089A

CN103221089A - Biliary shunts, delivery systems, and methods of using the same

Info

Publication number: CN103221089A
Application number: CN2010800703100A
Authority: CN
Inventors: 雅克·范达姆; 克里斯·朱利安; 马克·克赖德勒; 埃里克·尼斯利; 詹姆斯·克雷格·米尔罗伊; 罗伯特·马修·奥莱恩; 查尔斯·斯温哈特
Original assignee: TREUS MEDICAL Inc
Current assignee: TREUS MEDICAL Inc
Priority date: 2010-11-23
Filing date: 2010-11-23
Publication date: 2013-07-24
Anticipated expiration: 2030-11-23
Also published as: EP2643044A1; EP2643044A4; WO2012071031A1; CN103221089B

Abstract

The application discloses devices, delivery tools, systems, and methods for treating biliary disease. Device comprise, for example, a component configured for deployment between a gallbladder and location within a gastrointestinal tract of a patient which has a proximal end and a distal end with a lumen extending therethrough. A method of deploying the device can be achieved by, for example, creating a duct or fistula between a gallbladder lumen and a portion of a gastrointestinal tract; and providing for drainage from the gallbladder to the gastrointestinal tract.

Description

Bile diverter, delivery system and using method thereof

Cross reference

The application has relevant theme with following application: Jacques Van Dam, the U.S. utility number of patent application of submitting on November 25th, 2,008 12/277 that is entitled as " bile diverter, delivery system and using method thereof and kit " of J.Craig Milroy and R.Matthew Ohline, 491 and the PCT application PCT/US2008/84888 that submits on November 26th, 2008; Jacques Van Dam, the number of patent application of submitting on November 25th, 2,008 12/277 of being entitled as of J.Craig Milroy and R.Matthew Ohline " be used to make gallbladder lose function method, equipment, kit and system ", 443 and the PCT application PCT/US2008/84830 that submits on November 26th, 2008; And Jacques Van Dam, the number of patent application of submitting on November 25th, 2,008 12/277 of being entitled as of J.Craig Milroy and R.Matthew Ohline " be used to make cystic duct lose function method, equipment, kit and system ", 338 and the PCT application PCT/US2008/84865 that submits on November 26th, 2008, described application is incorporated herein by reference.

Invention field

That describes in the present patent application the invention solves the challenge that runs in the biliary tract in treatment.Biliary tract comprises influences gallbladder, cystic duct and choledoch-disease.

Biliary system function and anatomy:

Bile is the Digestive system of breen, and it is produced by the liver that shows among Fig. 1-2 10, and is important for the digestion of fat food.Bile is collected by the hepatocyte secretion and by the conduit network that compiles at common hepatic duct 12 places.Though a spot of bile flows directly into the inner chamber of duodenum 30 (being right after the small intestinal part in the stomach downstream), great majority pass common hepatic duct 12 and accumulate in the inner chamber of gallbladder 14.Healthy gallbladder is the capsule of pyriform, and it has muscular wall, average length be 10cm and within it intracavity can store the fluid of about 50ml.When fat food was ingested, hormone cholecystokinin (CCK) was released, and it causes gallbladder 14 to shrink.The contraction of gallbladder 14 forces bile to flow to the common bile duct 18 by cystic duct 16 from gallbladder 14, flows out nipple 28, and flows into the duodenum 30 of small intestinal at last.Herein, it mixes with the food that leaves stomach (chyme) and reacts.Oddi's sphincter (Sphincter of Oddi) 26 controls are from the secretion to the duodenum 30 of small intestinal of liver 10, pancreas 24 and gallbladder 14.Opening on the inside of duodenum 30 bottoms after Oddi's sphincter 26 is called as major duodenal papilla 28 (Vater nipple).Bile duct, gallbladder 14, cystic duct 16 and common bile duct 18 are formed biliary system (Fig. 1) together.

Pancreas 24 is the body of gland organs in vertebrate digestion and the hormonal system.It is endocrine gland (produces multiple important hormone, comprise insulin, glucagon and Somat), is again exocrine gland, and secretion contains the pancreatic juice of the digestive enzyme that flows to small intestinal.These enzymes help further to decompose carbohydrate, protein and the fat in the chyme.Ductus pancreaticus 22 or Wirsung pipe are such conduits, and it links to each other pancreas 24 with supply pancreatic juice with common bile duct 18, and the digestion that provided by exocrine gland is provided pancreatic juice.Ductus pancreaticus 22 just in time engaged with common bile duct 18 before major duodenal papilla 28, and two kinds of conduits penetrate the middle side of the second portion of duodenum 30 at major duodenal papilla 28 places afterwards.

Biliary tract:

The modal problem that produces in the biliary system is the formation (a kind of disease that is called as cholelithiasis (cholelithiasis)) of cholelithiasis.About 2,000 ten thousand American has cholelithiasis, and about 1-3% will reveal symptom at any given chronological table.In the U.S., cholelithiasis is more common in the women, to 60 years old 25% women cholelithiasis is arranged and to 75 years old 50% women cholelithiasis is arranged.Conceived and Hormone Replacement Therapy has increased the risk that forms cholelithiasis.For U.S. male, popularity is lower: about 25% cholelithiasis with developing by 75 years old.In the U.S., because serious stomachache, cholelithiasis is the reason of being in hospital that causes maximum quantity.

Cholelithiasis 20,20 ' (Fig. 2) the most normally is made up of cholesterol, but also can be formed by calcium bilirubinate, and wherein they are known as pigment stone.The scope of its size is several millimeters to several centimetres, and is the erose solid of picture gravel.They can form in gallbladder 14, cystic duct 16 and/or common bile duct 18.Cholelithiasis self not necessarily causes morbid state.Be such in 90% time.Yet stone can cause infecting and inflammation, a kind of disease that is called as cholecystitis, and it normally limits or blocks from the bile of gallbladder 14 and common bile duct 18 or by the mobile result of pancreas 24 secreted fluid.

Gallbladder disease can be chronic, and suffers from this sick patient and may periodically experience biliary colic.Symptom comprises the pain at the nearly thorax of upper right abdomen place, feels sick, and/or vomiting.This pain may alleviate in a hour of outbreak, may show nonprescription drugs reactionlessly, and may not can weaken along with change in location or ventilation.Recurrence is general, and pain recurs one day same time usually, but frequency is lower than once in a week.Greasiness or a large amount of dining may cause recurrence in several hours after the meal, at night the patient are waken up usually.The patient may select to suffer from these symptoms and reach for a long time, as several years or even many decades.

The patient who suffers from chronic cholecystitis has cholelithiasis and rudimentary inflammation.If do not treat, gallbladder 14 may become in time scar and hardening cause being called as the disease of dysfunction gallbladder.The patient who suffers from chronic cholecystitis or dysfunction gallbladder may experience gas after the dining, feel sick and abdominal discomfort, and chronic diarrhea.

Acute cholecystitis (surgery emergency) develops in the people of the Symptomatic cholelithiasis disease of suffering from of 1-3%, and is because due to common bile duct 18 or cystic duct 16 blocked by stone or precipitate.Symptom is similar to biliary colic, but more serious and lasting.The pain of upper right abdomen may be continue with serious, intensity may increase when breathing, and may continue a couple of days.Pain may be radiated to the back, under breastbone or scapula, and may perceive it in the left side of abdominal part.Except nausea and vomiting, 1/3rd patient experience heating and shiver with cold.The complication of acute cholecystitis may be serious and the possibility threat to life, and comprise gangrene, abscess, the perforation of gallbladder 14, it may cause biliary peritonitis, pus in the gallbladder wall (empyema (empyema)), fistula (fistulae), and gallstone intestinal obstruction (gallstone ilius) (when cholelithiasis produces obstruction in small intestinal).

When cholelithiasis 20 ' become is deposited in the common bile duct 18 (Fig. 2), this disease is called as choledocholithiasis (choledocholithiasis).This sick symptom comprises pain, nausea and vomiting, and some patient develops and jaundice, has melanuria and/or light stool, heart beating fast, and the unexpected decline of experience blood pressure.These symptoms also may accompany by the severe pain of heating, shiver with cold and/or upper right abdomen.The complication of choledocholithiasis also may be very serious, and comprises the infection (cholangitis) of common bile duct 18 and the inflammation (pancreatitis) of pancreas 24.

Less patient colony suffers the gallbladder disease that takes place under the situation that does not have cholelithiasis.This disease is called as non-calculus gallbladder disease, also can be chronic or acute.Chronic non-calculus gallbladder disease is also referred to as biliary dyskinesia (biliary dyskinesia), is considered to by influencing gallbladder storage and discharging due to mobility's obstacle of biliary ability.Acute non-calculus gallbladder disease occurs among such patient, and described patient suffers may cause owing to weaken to the blood supply minimizing of gallbladder 14 or contraction and emptying bile to the ability in the duodenum 30 other serious diseases of gallbladder 14 inflammation.

Cancer also may develop in gallbladder 14, though this situation is rare.In 80% the patient who suffers from carcinoma of gallbladder, found cholelithiasis.Development is from polyp usually for carcinoma of gallbladder, and it is the hypertrophy in the gallbladder 14.When observing about 15mm or during bigger polyp, removing gallbladder as preventive measure.Generally believed less than the polyp of 10mm and to cause low risk and be not removed usually.When in early days when cancer diffusion surpasses preceding being detected of mucosa (liner) of gallbladder, the survival rate in 5 years is about 68%.Yet carcinoma of gallbladder just is detected when the patient has symptom usually, and this disease is late period more till that time.

The treatment of biliary tract:

The most effective treatment is an exenterate gallbladder 14 for biliary tract, and this method is called as cholecystectomy (cholecystectomy).Exenterate gallbladder 14 is applicable to the cholelithiasis outbreak that the many seriousness of experience are lower, cholecystitis, choledocholithiasis, pancreatitis, the patient of non-calculus biliary tract pain with evidence of impaired gallbladder 14 emptyings, be in the high risk patient of developing carcinoma of gallbladder, and the patient who has carried out endoscope's sphincterotomy (sphincterotomy) before for choledocholithiasis.Exist other treatment form and its often to be used, but gallbladder disease is tended to recur abandoning cholecystectomy and pursue in the Most patients of alternative.Removing gallbladder 14 can permanent like a bomb elimination biliary tract.Cholecystectomy is the most general a kind of method that the women is carried out.Gallbladder 14 is not an essential organs, and after adjusting a period of time after the operation, the patient tends to recover similar normal digestive function.

Cholecystectomy can be used as open operation (its need in upper right abdomen single bigger otch) or carries out as laparoscopic surgery (wherein some little apparatuses are inserted in the abdominal part by much smaller otch).About 80% cholecystectomy is carried out in the peritoneoscope mode.The major advantage of this minimally-invasive method is the faster recovery of patient, and whole medical expense reduces.The patient who accepts laparoscopic cholecystectomy is leaving hospital usually on the same day.On the contrary, the patient who receives open cholecystectomy will spend 5-7 days usually in hospital before leaving hospital.When difficulty increases, as main vascular injury, unsuitable inlet, inadequate visual, endoscope's sphincterotomy before, and the gallbladder wall that thickens, then the laparoscopic procedures of 5-10% changes open method into.The complication of cholecystectomy (open or abdominal cavity mirror) comprise bile duct injury (open be 0.1-0.5%, the abdominal cavity mirror be 0.3-2%, it has the trend that reduces), pain, fatigue, feel sick, vomiting and infection.In the case of as many as 6%, the surgeon can not discern and remove the cholelithiasis of all existence.

In some cases, the degree of infection and inflammation makes the patient can not carry out cholecystectomy immediately.In these situations, must treat gallbladder 14 with antibiotic and anti-inflammatory agent, and drain in the outer reservoir (reservoir) of abdominal part by pipe.The placement of such pipe occurs in the method that is called as percutaneous cholecystotomy (cholecystostomy), wherein pin is incorporated into gallbladder 14 by abdominal part, extracts liquid out, and inserts drainage catheter.This catheter drainage is in the bag of outside, and must empty several times with described sack and be removed up to pipe every day.Drainage catheter can be stayed the original place and reach 8 weeks of as many as.In the situation of not inserting drainage catheter, described method is called as the gallbladder suction.Because do not place the conduit of indwelling, so the complication rate of gallbladder suction is lower than the complication rate of percutaneous cholecystotomy.

Therapeutic Method except that cholecystectomy comprises expectation treatment (expectant management), litholytic therapy (dissolution therapy), the endoscope retrogradation ERCP (endoscopic retrograde cholangiopanctreatograpy) that uses endoscope's sphincterotomy (ERCP), and extracorporeal shock-wave lithotripsy (extracorporeal Shockwave lithotripsy) is (ESWL).

But the expectation treatment is fit to have cholelithiasis does not have the patient of symptom, and is fit to have the nonemergency of more not serious symptom.When the patient was in excessive risk classification (for example high carcinoma of gallbladder risk) or has very large cholelithiasis (for example greater than 3cm), this method was not recommended.

The litholytic therapy of per os relates to the tablet that administration contains the bile acid that can dissolve cholelithiasis.This method only is that appropriateness is effective, and finishes the cholelithiasis relapse rate height after the treatment.It is not suitable for having the patient of the calculus (more serious disease) in acute inflammation or the common bile duct.Litholytic therapy is tended to for the patient with cholesterol calculus more effective, and uses together with lithotrity sometimes.Although the poor efficiency that it is relative, but expensive: treatment may reach 2 years, and the thousands of units of the annual cost of medicine.

Relevant with the litholytic therapy of per os is contact lithodialysis (contact dissolution), and this method relates to solvent such as methyl tertiary butyl ether(MTBE) (MTBE) are injected directly in the gallbladder 14.This method is very effective aspect the dissolving cholelithiasis, but the patient may experience serious causalgia.

ERCP (endoscope's endoscope retrogradation ERCP) is such method, and wherein endoscope introduces by patient's mouth, arrives nipple 28 (Fig. 2) by stomach, and common bile duct 18 injects duodenum 30 herein.The overall goals of this method is that apparatus and instrument are inserted in the common bile duct 18 so that the treatment biliary tract via nipple 28.Typically, carry out endoscope's sphincterotomy, it is such method: the opening that increases the nipple 28 in small intestinal.This can finish by operation or via air bag expansion.Contrast agent is introduced in the common bile duct 18 and makes biliary system (biliary tree) visual in the mode by cryptoscope.Can use the instrument that is used to remove obstruction, as mechanical lithotripsy equipment, to pulverize cholelithiasis and to remove the fragment of gained.Also can insert conduit and support discharges by hindering to promote bile.The complication of this challenge method takes place with the ratio of 5-8%, and comprises lithogenous recurrence, and pancreatitis is infected, and is hemorrhage, and perforation.

Extracorporeal shock-wave lithotripsy (ESWL) is such technology, wherein will focus on, high-energy ultrasonic aims at gallbladder 14.Ultrasound wave passes health soft tissue and broken cholelithiasis.The calculus fragment of gained is enough little usually then enters small intestinal to pass bile duct.The litholytic therapy of per os is used with ESWL usually.This kind treatment is not commonly used, because be good candidate less than 15% patient colony.Yet ESWL is used to treat the patient who is not surgical candidates.The complication of ESWL comprises the pain in gallbladder zone, and pancreatitis and cholelithiasis fragment can not enter small intestinal.

Summary of the invention

An aspect of present disclosure relates to the equipment that is used for the treatment of biliary tract.Suitable device comprises: be configured for and set up the assembly that fluid is communicated with between the target location in mammiferous gallbladder and gastrointestinal tract, the inner chamber that described assembly has near-end and far-end and runs through its extension, the tubular portion that has radially proximal rim of extending and the distal end flange of radially extending, at least one in wherein said proximal rim and the distal end flange are that in discoidal and described proximal rim and the described distal end flange at least one has a plurality of radially elements of extension.This equipment can be configured for by endoscope, pin, seal wire, guide catheter and/or expanded balloon and launch.Endoscope can also be transformed into and comprise ultrasonic device.Expect that also such system that is used for the treatment of biliary tract, described system comprise the equipment that is used for configuring pipes between patient's gallbladder and gastrointestinal tract, described equipment has the inner chamber that near-end and far-end and between run through extension.In certain aspects, this equipment can be configured to also comprise the delivery mechanism that is used for delivered substance.In some cases, the expansion of these equipment can cause forming conduit between the target location in gallbladder inner chamber and gastrointestinal tract.

Present disclosure relate to the biliary tract therapeutic equipment on the other hand, described equipment comprises: be configured to set up between the target location in mammiferous gallbladder and gastrointestinal tract the assembly that fluid is communicated with, the inner chamber that described assembly has near-end and far-end and runs through its extension, the tubular portion that has radially proximal rim of extending and the distal end flange of radially extending, at least one in wherein said proximal rim and the distal end flange are that in discoidal and described proximal rim and the described distal end flange at least one has a plurality of radially elements of extension.This conduit can, for example, between the inner chamber of gallbladder and the target location in the gastrointestinal tract (as contiguous duodenum place), form.

Present disclosure relate to the equipment that is used for the treatment of biliary tract on the other hand.Suitable device comprises sets up the assembly that fluid is communicated with between the target location that is configured in mammiferous gallbladder and gastrointestinal tract, the inner chamber that described assembly has near-end and far-end and runs through its extension, have the tubular portion of proximal rim of radially extending and the distal end flange of radially extending, at least one in wherein said near-end and the distal end flange is made up of first material and described tubular portion is made up of second material.This equipment can be configured for by endoscope, pin, seal wire, guide catheter and/or expanded balloon and launch.Endoscope can also be transformed into and comprise ultrasonic device.The such system that is used for the treatment of biliary tract of same expection, this system comprises the equipment that is used for configuring pipes between gallbladder and patient's gastrointestinal tract, described equipment has the inner chamber that near-end and far-end and between run through extension.In certain aspects, this equipment can be configured to also comprise the delivery mechanism that is used for delivered substance.In some cases, the expansion of these equipment can cause forming conduit between the target location in gallbladder inner chamber and gastrointestinal tract.

Equipment according to disclosed arbitrary configuration can be by forming by biological resorbent material.In addition, this equipment can be removable and/or distensible.This equipment also can be configured to be selected from one or more following configurations: deployed configuration, delivery configuration and final configuration.In addition, this equipment can be configured to like this so that the section (profile) of this equipment changes between described configuration.In addition, or in alternative, the cross-sectional area of this equipment can be variable along the length of this equipment.In some configurations, assembly or implant can be configured to like this so that its have can flared (flareable) end, be as general as hemispheric end suitable can flared end comprising.In addition, assembly or implant can comprise configurable retainable parts (feature).In certain aspects, assembly or implant can comprise one or more clips, and described one or more clips are configured to described assembly or implant are fixed on one or more positions.In some configurations, can provide one or more windowing (fenestration).In addition, inner chamber or conduit can be configured to provide the liquid stream that can limit or valve is provided, as current limiter or check valve.Any configuration of described equipment can be configured so that described equipment is flexible.Described system or equipment also can be configured to comprise the pipe that is generally elongation, and the pipe of described elongation is transformed and is configured to and reaches in the gastrointestinal tract.The configuration that comprises the pipe of elongation can be configured to like this so that described pipe is unfolded (patent) in first end; Described unfolded first end can be close to gallbladder and place.In other configurations, the pipe of elongation is not unfolded in second end.In addition, described pipe can be configured to like this so that it has adjustable length.In addition, can provide one or more fluid Control Components to described design.In addition, can be provided with comprise two with top set (leg) but enlarged.

Present disclosure relate to the kit (kit) that is used for the treatment of biliary tract on the other hand, it comprises that the pipeline that is placed between gallbladder and the gastrointestinal tract forms assembly.Described kit can comprise any equipment as herein described or system.In addition, can provide chemical compound to send to tissue being used for.Chemical compound or material for example include, but not limited to, each in one or more sclerosing agent, antibiotic, inflammatory medicament, anti-inflammatory agent, biocompatibility gel and the biocompatible foam.In addition, can provide conduit, seal wire, pin, guide catheter or balloon catheter.In some respects, described kit also can comprise (ablation) equipment that melts.The other assembly of kit comprises, for example, and each in one or more scissors, scalpel, swab, syringe, mosquito forceps (hemostat), lubricant, pin, snare (snare), antibacterial and the anesthetis.

Present disclosure relate to the method that is used for the treatment of biliary tract on the other hand.The method of treatment biliary tract comprises: (a) use endoscope so that in seal wire, pin, guide catheter and the dilating catheter at least one is placed between intravital entrance cavity and the gallbladder; (b) delivery catheter is inserted in seal wire, pin, guide catheter and the dilating catheter at least one and is inserted in the gallbladder; (c) send the assembly of setting up the fluid connection between the target location that is configured in mammiferous gallbladder and gastrointestinal tract, the inner chamber that described assembly has near-end and far-end and runs through its extension, the tubular portion that has radially proximal rim of extending and the distal end flange of radially extending, at least one in wherein said proximal rim and the distal end flange are that in discoidal and described proximal rim and the described distal end flange at least one has a plurality of radially elements of extension; And (d) described assembly is placed between intravital entrance cavity of body and the gallbladder to set up inner chamber betwixt.In addition, this method can comprise the step that material is delivered to gallbladder via pipeline.Other method step comprises equipment is delivered to gallbladder by pipeline.The suitable equipment that will be sent comprises following one or more: support, coating stent of medicine, conduit, pin, guide catheter, balloon dilatation catheter and/or seal wire.In some cases, the step of setting up pipeline comprises that also the equipment that will be communicated with inserts between gastrointestinal tract and gallbladder inner chamber.Can also comprise step between the described part that conduit is inserted in gallbladder inner chamber and biliary system in the step of setting up pipeline between a gallbladder inner chamber and the gastrointestinal part.In some respects, this method also comprises the step that forms pipeline biology from the patient tissue original position.As the skilled person will appreciate, the step that conduit is inserted between the part in gallbladder inner chamber and gallbladder road can occur in the very first time, and occurs in second time away from the described very first time from the step that the patient tissue original position forms pipeline biology.In addition, this method can also comprise provides sealing in case the fluid stopping body is leaked to the step in the peritoneum.In addition, gallbladder can be gone functionalization in position, as by with in material or the material delivery space in the gallbladder.Suitable material or material include, but not limited to gel and foam.In some cases, substance for delivery can be activated in position.In addition, can send a certain amount of material, or fill the gallbladder inner chamber basically with filling.In addition, in some cases, realize the step of functionalization by making in the hardening of tissue in the gallbladder or the necrosis (it can for example be realized by ablation techniques) one or more.

Present disclosure relate to the method for delivery device on the other hand with the treatment biliary tract, described method comprises: (a) use endoscope seal wire is placed between intravital entrance cavity and the gallbladder; (b) delivery catheter is inserted on the described seal wire and is inserted in the gallbladder; (c) with catheter delivery to described conduit; And (d) described conduit is placed between intravital entrance cavity and the gallbladder to set up inner chamber betwixt.This method also can comprise the step that forms pipeline biology from the patient tissue original position.In addition, the step of placing conduit can occur in the very first time and occur in second time away from the described very first time from the step that the patient tissue original position forms pipeline biology.Certain methods can also may further comprise the steps: when seal wire being used to send other element, the far-end with described seal wire remains in the gallbladder passively.In some cases, described method comprises that far-end with described seal wire remains on the step in the gallbladder.In certain methods, cholelithiasis is removed by the inner chamber that produces.In additive method, substance delivery is arrived gallbladder via the inner chamber that produces.In some cases, described material occupy the gallbladder inner chamber and can be following one or more: antibiotic, inflammatory medicament, and anti-inflammatory agent.Method can also comprise and prevents that bile from entering the gallbladder inner chamber.In addition, in some cases, can be via endoscope's localization by ultrasonic gallbladder.What come in handy in addition, is to insert gallbladder by gastrointestinal tract.The correct position that inserts gallbladder via gastrointestinal tract will be to insert gallbladder at the duodenum place.Utilize any described method, it is desirable to change and/or remove cholelithiasis.In addition, also can remove other interior barriers of biliary system.By the conduit sent can be, for example, one or more supports and coating stent of medicine.In some application of described method, under the situation of not removing gallbladder, treat biliary tract.In other application of described method, as the part of described method, area for treatment is by visual.In certain methods, conduit is fixed on the appropriate location.In additive method, conduit becomes deployed configuration from delivery configuration, becomes final configuration or becomes final configuration from deployed configuration from delivery configuration.Additive method provides the cross-sectional profiles that reduces conduit, provides sealing to be leaked in the peritoneum to prevent liquid, and/or limits from the gallbladder inner chamber to the gastrointestinal liquid stream.Additive method comprises that the operation valve is with the restriction liquid stream.

Present disclosure relate to conduit on the other hand.Consequently it comprises can to form conduit like this: the shape memory line, it is configured for sets up fluid and is communicated with between the target location in mammiferous gallbladder and gastrointestinal tract, described shape memory line is made into the inner chamber that forms near-end and far-end and run through its extension, has the tubular portion of proximal rim of radially extending and the distal end flange of radially extending.Therefore, conduit is by forming by biological resorbent material.In addition, conduit can be one or more removable or distensible conduits.The conduit configuration can be selected from deployed configuration, delivery configuration and final configuration.Typically, described conduit also comprises variable section and/or has along its adjustable length cross-sectional area.In addition, can be configured for pin, seal wire, at least one expansion in guide catheter and the dilating catheter by endoscope.In addition, described conduit can have can flared end, be flexible, has adjustable length, to small part from shape-memory material, transformed and be configured to valve member, and/or had one or more holding members of being transformed and being configured to described conduit is remained on original position or its any combination at interior intracavity conjugation tube shape.

In other respects, provide conduit, it comprises: at one or more rings of near-end and far-end, it is transformed and is configured to engage forms run through it basic and is the plasticity of piped structure (compliant) material.Described conduit can be by forming by biological resorbent material, can be configured to flexible, removable and/or distensible, has the deployed configuration of being selected from, one or more configurations of delivery configuration and final configuration, has variable section and/or along adjustable length cross-sectional area, adjustable length or its combination.In addition, described conduit can be configured for by endoscope, pin, seal wire, at least one expansion in guide catheter and the dilating catheter.Described conduit also can be configured to be derived from shape-memory material to small part.In addition, one or more holding members are transformed and are configured to conduit is remained on original position.

Other aspects of present disclosure comprise delivery catheter, described delivery catheter comprises: delivery catheter comprises: control handle, the flexible shaft of elongation, center-pole, with delivery elements with first conduit maintenance assembly and second conduit holding element, wherein the part of conduit keeps between the assembly being sandwiched between delivery period, thereby and keeps assembly to leave described second being released when keeping assembly release to remain on conduit on the far-end of delivery catheter when described first.

Another kind of delivery catheter comprises joystick, the flexible shaft of elongation, center-pole and at least one expansion electrosurgical electrode.The expansion electrode of at least one leading edge electrode (leading edge electrode) and/or one or more radial arrangement can be provided.The expansion electrode can be placed with the optimised in the hole that makes gained.

Also can provide delivery catheter, it comprises central component, and it is transformed and be configured to and moves with respect to the far-end of coaxial sleeve pipe to described conduit, also has one or more flexible members.Flexible member can be configured to have one or more hinges, and strain is transformed and be configured to reduce to described one or more hinges.In addition, flexible hinge can outwards enlarge to fix and to keep delivery catheter at interior intracavity.Therefore, for example, flexible member can be configured to umbrella shape.When opening, flexible member can also limit work space.

Delivery catheter tool passage equipment can be configured to comprise piped structure, and the far-end of delivery catheter is transformed and be configured to engage securely to described piped structure.Described instrument can also be configured to comprise near-end and far-end and centre bore, and described centre bore is transformed and is configured to be positioned on the far-end of described delivery catheter.Can also provide the hole of elongation of the centralized positioning of the equipment that departs from elongation, to be used to hold other instrument or assembly.In at least some configurations, provide the localized one or more holes of main body of the instrument of passing.

Delivery catheter tool passage equipment can also be provided, and it comprises: first assembly, described first assembly are transformed and are configured to be engaged in securely in the passage of delivery catheter; With second assembly, described second assembly is transformed and is configured to provide the hole, passes described hole and can place accessory (secondary) equipment, and wherein said first and second assemblies link to each other via bridge joint mechanism.

Combination by reference

All publications, patent and the patent application mentioned in this manual are incorporated herein by reference, and bonded degree is with following identical: each individual publication, patent or patent application clearly and independently are designated as combination by reference.

The accompanying drawing summary

Will be with the characteristic description new feature of the present invention in any claim that proposes based on the application.By can obtain better understanding with reference to the following detailed description of describing the exemplary wherein utilized principle of the present invention and accompanying drawing, wherein to the features and advantages of the present invention:

Fig. 1 shows scanning of biliary system;

Fig. 2 shows the biliary system with cholelithiasis;

Fig. 3 shows the far-end that is placed on the intravital endoscope of mammal via intestinal system access biliary system;

An embodiment of Fig. 4 display device, described equipment is transformed between two body cavitys conduit is provided;

Fig. 5 A-B shows another embodiment by the equipment of forming above a kind of material;

Fig. 6 A-D shows an embodiment of the equipment that utilizes stitching thread or T-tag maintenance;

Fig. 7 shows another embodiment of the equipment of being made up of curved line;

Fig. 8 shows another embodiment of the equipment of being made up of the coupling part of far-end and near-end supporting ring and thin flexible material;

Fig. 9 shows another embodiment of the equipment of being made up of the line with a plurality of cross sections that forms coil;

Figure 10 shows can be inserted into the element that is transformed in the equipment that conduit is provided between two body cavitys;

Figure 11 A-G shows the configuration of a plurality of SMA holding members be used for described equipment and they is arranged in scheme on the described equipment;

Figure 12 A-E shows via catheter delivery according to equipment of the present invention;

Figure 13 A-B shows an embodiment of the delivery catheter that is used for described equipment;

Figure 14 shows another embodiment in conjunction with the delivery catheter of electrosurgical electrode;

Figure 15 A-C is presented at far-end another embodiment in conjunction with the delivery catheter of maintenance and space producing component;

Figure 16 shows an embodiment of the equipment on the far-end of the endoscope be installed in the tool passage that provides other or towing point;

Figure 17 shows another embodiment of the equipment on the far-end of the endoscope be installed in the tool passage that provides other or towing point; And

Figure 18 shows another embodiment of the equipment on the far-end of the endoscope be installed in the tool passage that provides other or towing point.

Detailed Description Of The Invention

Equipment provided herein, system, method and kit can be eliminated the needs to several different methods, described method comprises, for example: 1) percutaneous cholecystotomy, 2) cholecystectomy, 3) endoscope retrogradation ERCP (ERCP) percutaneous transhepatic cholangiography (PTHC) and 4).In addition, disclosed therapeutic modality makes it possible to treat far-end common bile duct 18 and blocks, and the far-end common bile duct 18 that for example is secondary to cancer of pancreas, cancer of biliary duct (cholagiocarcinoma) and/or carcinoma of ampulla (ampullary carcinoma) blocks.As the skilled person will appreciate, the conventional criteria treatment that is used for the treatment of biliary tract is exenterate gallbladder 14 and closed cystic duct 16.Though proving this is effective mechanism for permanent elimination biliary tract and recurrence thereof, the present invention manages to obtain identical result in the mode of less intrusion and less cost.This can be by realizing not needing to remove under the situation of gallbladder 14 the treatment biliary tract.The method and apparatus of describing among the application is intended to treat effectively biliary tract by the following method and keeps gallbladder 14 and cystic duct 16 is stayed original position: provide diverter to gallbladder, make it possible to be communicated with from the gallbladder fluid, or be communicated with from gallbladder selectivity fluid, for example, fluid can enter the small intestinal from gallbladder via diverter.

The method of treatment biliary tract comprises use endoscope 310 with the zone 350 (Fig. 3) in gastrointestinal (GI) road that inserts next-door neighbour's gallbladder 14, and location gallbladder 14 inserts gallbladder, and treats the relevant disease that causes needs to be intervened then.As the skilled person will appreciate, because the variation of anatomical terms, the physical location of target area, treatment can also comprise, but be not limited to: for gallbladder 14 and/or biliary system provide drainage, with suitable material or material, as antibiotic, inflammatory reagent, (wherein any can be fugitive to anti-inflammatory agent, quick-acting or time-delay discharges), and/or other materials (binding agent for example, biological adhesive etc.) be delivered to gallbladder 14 and/or biliary system, remove cholelithiasis 20, promote to destroy and remove subsequently cholelithiasis, remove and block, delivery catheter, delivering stent (medication coat or do not have medication coat) temporarily or permanently makes cystic duct 16 go functionalization, temporarily or permanently makes gallbladder 14 go functionalization.Can be in single therapy delivery device and therapy, make the probability of follow-up or repetitive process and necessity minimize.

Can assess gallbladder by any suitable mechanism or method, comprise percutaneously, through endoscope ground, through peritoneoscope ground etc.In addition, any material and material that is delivered to gallbladder can be sent simultaneously or be sent in succession.The order that the sending of material can be recurred or send in time can be at interval with several seconds, several minutes or a few hours.

The location of gallbladder 14 can ultrasonic via endoscope (EUS), undertaken by the wall that utilizes endoscope 310 assessment GI roads, as shown in FIG. 3.Described method such as fluoroscopic examination, x ray can also be realized by making visual any other method of anatomical features in the location, nuclear magnetic resonance (MRI), the axial tomography of computer (CT) scanning, from the external supersonic imaging, or any anatomy imaging and method for visualizing.

Behind the gallbladder 14 of location, can utilize the instrument sent by for example endoscope 310 and equipment (for example pin, seal wire, guide catheter, dilator, Deng) wall (or any inner chamber of contiguous gallbladder 14) by the GI road, in the target area or site 350 insert and/or treat.Such instrument and equipment can insert downwards along the length of the service aisle 312 of endoscope, perhaps be loaded on the far-end of endoscope 310 or near.Alternatively, can tool using and other equipment, its help that does not need endoscope is to be used for navigation or to send.Can be in described process and flushing, provide directly visual by endoscope 310 during aspirating and being blown into.

Though preferably insert the position of gallbladder inner chamber is duodenum 30, and it also can be easily by other zones in GI road, and for example the wall of stomach or jejunum is realized.Therefore, the inner chamber of any next-door neighbour's gallbladder 14 all is the candidate that inserts and treat other members of gallbladder 14 and biliary system.

Device description:

In the present invention, can make original position treatment gallbladder 14 become possibility by between gallbladder inner chamber and next-door neighbour's inner chamber (for example in duodenum or its vicinity), setting up passage.This passage or pipeline can be set up by implantable devices 420, as shown in FIG. 4.

Described passage can be temporary transient or nonvolatil.It can be considered to be in the fistula (fistula) of having a mind to foundation between another inner chamber of gallbladder 14 and contiguous gallbladder, as mentioned above.Alternatively, it can be considered to be in the aperture (stoma) between gallbladder 14 and contiguous another inner chamber.This passage serves as conduit, access interface, can finish multiple action by it, can realize drain, and can delivery treatments.

The equipment 420 that forms described passage can be stayed in the patient in short-term such as in a few hours, a few days or several weeks, perhaps it can stay put (in place) reach time of prolongation, as several weeks, several months or several years.Equipment 420 can also for good and all be stayed put.If it stays put for a long time, then tissue can form around equipment 420, sets up the fistula that gallbladder 14 is linked to each other with entrance cavity, and it can continue, therefore even under channel unit 420 removed situations, form original position equipment 420 biology by patient's oneself tissue.Fistula can be favourable and useful, because it can continue to allow the content of gallbladder 14 to drain in the small intestinal.For example, it can provide main or less important mechanism to be used for bile is delivered to digestive system.In needing the situation of repetitive therapy, the access that it can also be provided convenience.Though may not need the fistula of closed gained, it also can be by clinician's (if this needs) closure at any time.After removing the initial equipment 420 that forms passage, fistula can be held open that to reach a period of time closed voluntarily then, and can not increase other risk, and is proved to be acceptable thing development.Tube apparatus 420 does not stay put or is removed, and no matter fistula is held open or closure, if program is in the future arranged, then the evidence of site can be in order to the position of labelling treatment.

Be the sending and launching of promotion equipment 420, what come in handy is to reconfigure its shape.For example, can be reduced at the cross-sectional area that diverse location presents, therefore, for example, reduce its overall profile by equipment 420.In the situation of the change of configuration that causes equipment 420, what come in handy is the equipment 420 that imagination has one or more configurations, for example: when it is sent is a configuration (" delivery configuration "), be another configuration (" deployed configuration ") when it launches, and in place and performance during function another configuration (" final configuration " or " a functional configuration ") when it.Other configurations also can be necessity or useful.For delivery configuration, advantageously change (for example reducing) cross-sectional area or section, so that it more easily cooperates delivery mechanism, as the service aisle (being presented among Fig. 3) of endoscope 310.In expansion process, the configuration of equipment 420 can change so that help being placed among the patient.By delivery configuration and final configuration, this may all be difficult, though not necessarily come to this.As the skilled person will appreciate, one or more configurations can be identical or substantially the same.

The description of conduit:

The preferred embodiment of conduit is the conduit with short tube, described short tube all has the flared holding member of organizing at two ends, as shown in FIG. 4, the described holding member of organizing is fixed on gallbladder 14 and the interior desired location of entrance cavity (for example duodenum 30) with catheter device 420.Conduit 420 forms (proposed) passage 424 (Fig. 2) of suggestion between gallbladder 14 and body cavity (it will insert from here, as passing through duodenum 30).The length h1 of the tubular portion 430 (Fig. 4) of conduit 420 is generally about 4-10mm, and the first diameter w1 of this equipment typically is 2-10mm enough greatly to help drain and access.Yet, can use other sizes and not deviate from scope of the present invention.In its final configuration, the second diameter w2 of the tubular portion 430 of conduit 420 is typically greater than about 3mm (10 French).This equipment has internal diameter w3, and it limits from first end, 421 to second terminal 423 inner chamber or passages 424 by this equipment.Passage 424 is communicated with the fluid from an end of described equipment to the other end of described equipment becomes possibility.The shape of holding member can be identical at two ends, perhaps they can be different at each end, as shown in FIG. 4, wherein far-end 422 is divided at least one finger piece so that its and is similar to star, and near-end 425 is flat disk linear element basically, and has the parts of slight bending at the edge so that described equipment can be with no damage near tissue.Holding member is divided at least one finger piece to be helped parts are folding forward or backward so that the section that can reduce equipment is sent being used to.Conduit can make up from any suitable material (for example silicone, urethane, polyurethane, Teflon, TFE, PTFE, ePTFE, Nitinol (Nitinol), rustless steel etc.), yet molded (the soft durometer molded) silicone material of soft durometer is preferred in this embodiment.

Be presented at another embodiment among Fig. 5 A-B by surpassing the multicompartment molectron that a kind of material is formed with cross sectional view and top view.In the embodiment illustrated, soft flexible material (for example soft silicone) comprises the tubular portion 530 of conduit, and be connected to form at far-end 522, near-end 524 or two ends flared holding member 534,534 ' different materials.Described material can be connected by any suitable mechanism, element, device or design part that described end is fixed together.Alternatively, other materials can be used to connect them, as binding agent, clip, anchor clamps or other nextport hardware component NextPorts.

The variation of any embodiment of the conduit of being made up of any material comprises uses other element equipment is fixed on the appropriate position with respect to the tissue 657 of nearby device 620, and with any power or the tractive (pull-through) of physics load distribution of equipment and tissue to prevent equipment, displacement or move is as shown in Fig. 6 A-D.This can use suitable material, carries out as suture 691 (as shown in Fig. 6 A) or T-tag692 (Fig. 6 C).Can make to keep and conduit that the load distribution material is passed in far-end 622 and/or near-end 625 places keeps hole or hole 634 in flange, the edge that stretches out, the collar (collar) or the ring, and these holes or the hole can be produced when described maintenance of application and load distribution material (for example suture) or they can integrally be designed and manufacture the parts of equipment.Alternatively, can arrange like this keep and load distribution material (for example suture) so that its around, catch or otherwise keep the element of conduit.

Another embodiment of conduit is made by the elastomeric material of linear piece (wireform) form.Described linear piece can be formed by suitable shape memory elastomeric material such as Nitinol (being also referred to as Nitinol).Described line is configured or is adjusted to the general shape of taking conduit, and is described in the whole text as this description, and wherein the zigzag pattern is longitudinal extension ((end-to-end) joins end to end), as shown in FIG. 7.For sending, described line can be crushed, stretching or overall size is reduced.In unfolded or final configuration, this embodiment comprises far-end 722 holding members at least, and described far-end 722 holding members have the axial protuberance that stretches out from the central shaft that extends (for example, by passage, if there is passage) along the length of equipment more than two; Near-end 725 holding members, described near-end 725 holding members have axial protuberance more than two; And tubular portion 730.

Another embodiment of the far-end of conduit or near-end holding member is presented among Fig. 8, and the ring (or other shapes of all or part of enclosing region) 893 by material is formed, ring 893 can be constrained for littler profile and send being used to, and has bigger profile when unfettered.Described material can be a metal, as Nitinol, and rustless steel or spring steel, perhaps it can be elastomeric or plastics, as silicone, urethane etc.Ring 893,893 ' can be placed on the near-end 802 of equipment 820, the far-end 804 of equipment 820, perhaps near-end and far-end two places.Link to each other with ring be plastic material 894 as ePTFE or biocompatibility fabric, sheet material or thin film, the tubular portion 830 of its formation conduit, and generation runs through its inner chamber, hole or passage 824.

Fig. 9 shows another embodiment of catheter device, wherein coil by having that enough elastic material is made so that its elongation is a straight line and do not cause plastic deformation.Suitable material comprises marmem, as Nitinol, or other suitable shape-memory materials.When unfettered and permission relaxed, this line presented the general shape of conduit 920, and was made up of the ring of the line that coils fully.Any other section shape that the section of this line can be circular, foursquare, leg-of-mutton, trapezoid, polygonal or line can be configured to.In the situation of circular section, this line is the easiest manufacturing and acquisition.In the situation of square cross-section, the successive circle (turn) of together forming the coil of conduit can not pass through its mobile space and do not open material (for example bile, chyme) with respect to the astragal slip of adjacent coils.This equipment is included in far-end and has radially far-end and the near-end and the cervical region therebetween (neck) of extension, and the radius of described cervical region is less than one or two the radius in the extension radially.In addition, passage can be configured to provide the fluid between far-end and the near-end to be communicated with.

Different embodiments can be benefited from element 1051 is inserted in its inner chamber, hole or the path 10 24, as shown in Figure 10.This element can randomly comprise such parts, and these parts serve as valve (for example disk valve, duckbill valve, two points (bicuspid) valve, tricuspid (tricuspid) valve, n point (n-cuspid) valve, ball valve or other valve configurations) with flow (for example check valve, check-valves or the standard valve) of control material between gallbladder and GI road.The element that inserts can be used to be provided for the rigidity and/or the support of tubular portion 1030, so that its shape or configuration do not change in undesirable mode in the length of life of this equipment.This element can also be used for conduit is fixed to position with respect to adjacent tissue, for example by making this equipment outwards enlarge or otherwise increase its external dimensions, perhaps alternatively pass through in conjunction with such parts, described parts otherwise are used for grappling or the element that keep to insert (for example O type ring recess, protuberance (ridge), tooth, pump etc.).Provide in the situation of structural intergrity or support at the element that inserts, the inner chamber of conduit or path 10 24 can completely or partially lack the structural intergrity of himself, and the element that rely on to insert fully is to keep the connection (example as shown in FIG. 8) between gallbladder and the GI road.In such a case, the element that comprises the tubular portion of conduit can be sleeve pipe, flat pipe/sleeve pipe, air bag (expansible or dwindle), coil or any other shape that wherein can insert this element.Randomly, the element of insertion and piped element can be by other holding elements 1036, as elastic webbing, O type ring or adhesive together.

Figure 11 A-G shows a plurality of embodiments of the holding member 1122 of the conduit be positioned at the arbitrary end of conduit, and holding member 1122 can be made up of shape-memory material (for example Nitinol) or other suitable elasticity or elastic material.No matter the tubular portion 1130 of conduit 1120 is to be formed or formed by different materials by identical materials, be not always the case.Such holding member can be taked multiple shape and configuration.Figure 11 A to F shows the some embodiments in many possible embodiments, wherein holding member 1122 similar finger pieces (for example Shen Chang epitaxial part).How Figure 11 G shows and can finger arrangement be become radial starlike pattern from the end of the tubular portion 1130 of conduit.Between delivery period, finger piece to pipe 1130 central shaft x bending to reduce section.After expansion, allow finger piece outwards to launch to bring into play the function of holding member.If such holding member is incorporated into the two ends of tubular portion, then the layout on arbitrary end can relative to each other be rotated the tissue contracts that remains between them to avoid making, and is beneficial to the possibility that reduces to give the load of this tissue and reduce tissue necrosis.This is presented among Figure 11 G, and it shows such example, wherein manage each end of 1130 and have four such maintenance finger pieces, and at the maintenance finger piece of far-end with respect to maintenance finger piece rotation 45 degree at the near-end of the tubular portion of conduit.The number of degrees of rotation depend on the number at the holding member of each end, and can have equal interval (as shown in Figure 11 G) or variable interval.

Conduit can be made by any suitable resilient and soft biocompatible materials.Silicone is a preferable material.Can randomly use other materials, polytetrafluoroethylene (PTFE) for example, expanded PTFE (expanded PTFE), other members in the fluoropolymer family, urethane, polyurethane etc.Material under body temperature can, for example, be soft, its hardness typically is 20-90A.Softer material is easier to send and reduce to damage the risk of adjacent tissue.Suitable material for example, is enough soft to be used to send and unfolded tight size to be compressed into.

The embodiment of holding member can be made up of plasticity polymeric material (for example silicone).If they are made up of soft, plastic material, then holding member can be easily crooked and distortion to allow the conduit of big article by formation between first body cavity and second body cavity (for example gallbladder and duodenum).Alternatively, holding member can be formed by plasticity lower material or metal (for example Nitinol or rustless steel).Holding member can so that this assembly is made into to serve as single component with uniform way, perhaps can separate with other elements of whole catheter device with other element global formations of whole catheter device.Holding member can be incorporated in the entire combination part during manufacture, and perhaps part can be installed to before use among the patient or during equipment is launched by clinician's user and be installed in the patient.

This equipment or other equipment as herein described can also by Biodegradable material, bioabsorbable material or again absorbing material form, wherein it can be dissolved in the mammalian body in desirable and useful time span.This can get rid of in order to remove the needs of the subsequent process of described equipment when therapeutic process finishes.Yet, can not hinder the clinician whenever necessary on one's own initiative with its removal by such material preparation equipment.On the contrary, it has avoided initiatively removing its needs in the situation that does not need other treatment.

Conduit can be made up of single component and homogenous material, and perhaps it can be the molectron of different assemblies, and wherein some can be different materials, thereby its global formation plays a role or finishes the work with uniform way after expansion.For example, conduit can be made up of SMA spring-loaded floating die (spring form), at described SMA spring-loaded floating die top casting silicone (or other suitable polymers materials).This spring-loaded floating die is used to give guide-tube structure and spatial stability, and silicone (or other polymer) shell is set up soft surface, the surperficial unlikely tissue injury that causes that this is soft, and help in position water-tight equipment and prevent to reveal.If use the SMA material, then its transition temperature can be chosen as and be lower than body temperature slightly, so that they can be designed to be kept for sending and unfolded a kind of shape, and after transformation, they will have the required shape of function that is used to optimize conduit.Alternatively, the SMA material can be used with its superelastic.

The description of delivery mechanism:

Can realize sending of conduit in many ways.

An exemplary delivery method is presented among Figure 12.The exemplary delivery method that is presented among Figure 12 A to E comprises that use endoscope 1210 inserts between body cavity (for example duodenum, stomach or jejunum) and the gallbladder 14 so that one or more induction elements 1280 (for example pin, seal wire and/or guide catheter) are placed on.In the situation of using pin, seal wire and/or guide catheter, guide catheter can be in patient's gastrointestinal tract in the target area or the position, usually (but not necessarily) advances in the service aisle 1212 of endoscope 1210, until the far-end of the guide catheter desirable placement location near equipment 1220.Pin may be advanced to outside the far-end of guide catheter, and (for example duodenum 30 places) wall by in the gastrointestinal tract continues the wall by gallbladder 14, and enters the inner chamber of gallbladder.As optional step, can draw bile to reduce the pressure in the gallbladder 14 by pin or any other induction element 1280, reduce bile and overflow gallbladder to endoperitoneal risk.In order to help this, induction element (for example pin, seal wire, guide catheter) can far-end along the surface or wall Anywhere in conjunction with inspiration port one 286.As another optional step, seal wire can be inserted in the gallbladder chamber by pin.In the situation of using seal wire, after inserting, pin can be regained seal wire.When needs, can make have distensible air bag, mechanical tissue dilator (expander) or advance on pin of introducing before or seal wire at the guide catheter of other expansion tools on its distal portions or independent dilating catheter and to be placed suitably by the wall of gastrointestinal wall and gallbladder 14 until expansion member.In case be in ideal position, dilating catheter around can dilating catheter tissue so that its expansion with housing apparatus 1220.Usually, the diameter in the hole of being expanded in the wall of gallbladder 14 and gastrointestinal tract entrance cavity is slightly smaller than the external diameter of the tubular portion 1230 of the equipment 1220 that will insert by this hole.In one approach, then, can go up by the hole in the wall of gastrointestinal wall and gallbladder 14 to the required degree of depth at induction element 1280 (for example pin, seal wire, guide catheter, delivery catheter) and come guiding device 1220 to suitable position.In case be in the desired position, equipment 1220 can launch and remain on the appropriate location by its holding member 1222 and the tissue of vicinity.

Can dispose the delivery catheter that is used for conduit in many ways.Those skilled in the art will be familiar with the details that conduit makes up, and comprise the variation in near-end and axle zone.Referring to, for example, following document:

Patent No. title

7,727,225 are used for the coaxial conduit system (Coaxial catheter systems for transference of medium) of the transfer of medium

7,722,629 are used for the system and method (System and method for catheter-based septal defect repair) based on the barrier film defect repair of conduit

7,717,936 are used for protecting filter membrane to be loaded into the equipment (Device for loading an embolic protection filter into a catheter) of conduit on embolus

7,717,871 are used for the system and method (System and method for site specific therapy) of site-specific Sex therapy

7,704,245 major diameter delivery catheter/sleeve pipes (Large diameter delivery catheter/sheath)

7,704,223 are used for the system and method (System and method for delivering a substance to a body cavity) of substance delivery to body cavity

7,670,364 have the stent delivery system (Stent delivery system having stent securement apparatus) of bracket fixing device

7,647,891 are used for setting up animal the method and apparatus (Method and apparatus for creating a pathway in an animal) of passage

7,645,259 multi-functional conduits and use thereof (Multi-function catheter and use thereof)

7,641,645 combined-type dissolved thrombosis infusion catheters and dilator system (Combination thrombolytic infusion catheter and dilator system)

Method and deadman that 7,634,319 medical implants are placed, and the method (Method and anchor for medical implant placement, and method of anchor manufacture) for preparing deadman

In order to understand present disclosure, the exemplary delivery conduit is presented among Figure 13 A, this figure shows the view of whole delivery catheter system, described delivery catheter system combination the control handle at near-end 1302 places, the flexible shaft 1363 (its length is enough to reach site required in the entrance cavity, and can be longer or shorter than what drawn herein) of elongation and the delivery elements 1364 at far-end 1304 places.Yet present disclosure focuses on the details that relates to far-end.But near-end control handle 1361 has been integrated button push element 1362, is incorporated into movable-component in the delivery elements 1364 at far-end 1304 places but button push element 1362 makes center push rod 1368 move with driving with respect to control handle handle 1369 and extension rod 1363.This delivery elements is integrated with two tapered assemblies, inner conical thing 1365 and male-tapered thing 1366.Button 1362 in the pushing handle 1361 will promote male-tapered thing 1366 forward and away from inner conical thing 1365.The distal end flange (make its to front curve and reduce its section) that the taperer of distal-most end is clamped conduit with the taperer of most proximal end.The taperer that promotes distal-most end forward discharges and opens the flange of the distal-most end of conduit (in case after it has been inserted into by described wall and is positioned at us and wishes its unfolded position).Conduit 1320 is loaded on the delivery elements 1364 of delivery catheter 1353, and the far-end of conduit is clipped together and flared holding member 1322 is fixed on to inner conical thing 1365 and male-tapered thing 1366 herein.Taperer 1365 and 1366 configuration also be fit to forward and the flared holding member 1322 of inwardly placing far-end reducing its section and to help to be delivered to implantation site, and taper helps to be inserted in the hole that forms between the entrance cavity in gallbladder 14 and GI road.When conduit has been inserted in the described hole and has been in desired location, can drive delivery elements 1364 by the button in the pushing handle 1,361 1362, this makes taperer 1365 separate and launch the far-end holding member 1322 of conduit 1320 with 1366.This is presented among Figure 13 B.Equipment is firmly held under the situation of appropriate location at far-end holding member 1322, near-end holding member 1322 remains on equipment in the entrance cavity (for example duodenum, stomach, perhaps jejunum), and is recoverable to delivery catheter 1353.

Another embodiment of delivery catheter is presented among Figure 14.Far-end in delivery elements 1402, this embodiment is combined with at least one electrosurgical electrode 1470 so that can utilizes the same equipment sending and launch conduit 1420 at entrance cavity (duodenum for example, stomach, jejunum etc.) produce the hole in wall and the gallbladder wall and make it have certain size (sized).Can be attached in the far-end of delivery catheter surpassing an electrosurgical electrode, and can comprise the expansion electrode 1472 of leading edge electrode 1471 and one or more radial arrangement.The expansion electrode can be configured to be placed by the clinician (for example, by pressing or spur the button 1462 at handle 1461 places), so that the size in the hole of gained is optional.Can use any proper tools and manipulation then, utilize delivery elements 1464 to carry out the expansion of conduit 1420.

Another embodiment of delivery catheter is presented among Figure 15.In this embodiment, far-end 1504 is configured to like this so that moving to pulling back on central component (for example drag-line or line) 1573 will make the far-end of equipment 1504 move with respect to coaxial sleeve pipe 1574.What be connected to coaxial sleeve pipe and central component is one or more flexible members 1575, and it is made by elasticity or elastic material such as Nitinol, perhaps alternatively mechanically with hinge joint so that do not produce big mechanical strain.When sleeve pipe 1574 and central component 1573 are relative to each other mobile, flexible member 1575 expands outwardly, this can be used for grappling and remain on the delivery catheter of interior intracavity, in gallbladder, produce working volume, and make the clinician can to pull back moving conduit with and with putting maintenance gallbladder 14 and entrance cavity (as duodenum, stomach, jejunum etc.) wall.In addition, if flexible member 1575 can be configured to like this so that further regain central component 1573 and cause flexible member 1575 doublings and produce umbrella shape, this umbrella shape then can limit the volume (" work space ") that can operate within it, and described operation is as launching conduit.Randomly, flexible member can engage electrosurgical electrode 1576 to be used for the hole cutting and to expand into required configuration.

Figure 16 display device 1677, equipment 1677 can help to send by endoscope 1610 and be unsuitable for the element sent by the tool passage 1612 of endoscope, perhaps help sending when tool passage is additionally occupied.This can be considered to the auxiliary tools passage, perhaps in certain situation, can be considered to towing point or " hook (hitch) ", by means of it, element can be brought to the site by endoscope and also use and need not repeat insertion and regain endoscope or instrument in the service aisle of endoscope.Can equipment 1677 be added into the far-end of endoscope 1610 by clamping, bonding or otherwise connection, but preferably not change endoscope self or only it is had minimum change.The shape of this equipment is level and smooth so that reduce or eliminate the damage of any tissue that it is contacted, and reduces to clamp or catch on the probability of tissue.Equipment 1677 randomly is combined with at least one " junction point (hitching point) " or aid channel outlet 1678, element (for example pipe, line, conduit etc.) can be connected with described " junction point " or aid channel outlet 1678, and can utilize curvature section of endoscope to divide or be attached to component controls far-end in the described element, the mode of the mode of control and the position of control tool when in the main tool passage that is inserted into endoscope much at one.

Another embodiment of equipment 1779 is presented among Figure 17.This equipment is fixed to the far-end of the endoscope 1710 at the remote outlet place that is positioned at tool passage 1712.This equipment is arranged to thin ring, and it partly or entirely is inserted in the outlet of tool passage 1712 to keep during the course and to fix this equipment.This equipment randomly on member or axostylus axostyle 1781 in conjunction with at least one junction point or aid channel outlet 1778, member or axostylus axostyle 1781 extend outwardly beyond the outer rim of the far-end of endoscope.Element such as pipe, line, conduit etc. can be connected to junction point or tool passage outlet, as mentioned above.

Another embodiment of equipment is presented among Figure 18.In this embodiment, equipment 1879 is configured to be engaged in the lid on the far-end of endoscope 1810, and wherein the far-end that covers endoscope of at least one hole in this part is with the photographing unit of the integration that allows endoscope, illumination, tool passage, flushing, the function of suction etc.Equipment 1879 temporarily or permanently is connected to the far-end of endoscope 1810, and randomly at the periphery place in conjunction with at least one junction point or aid channel outlet 1878.Element such as pipe, line, conduit etc. can be connected to junction point or tool passage outlet, as mentioned above.

The description of other purposes:

Technology and equipment described in the application can show benefit in the application that exceeds its initial use in the treatment biliary tract.

For example, they can prove the efficient mechanism of treatment cholangitis (common bile duct 18 infects).This disease is normally bacteroidal, and is stopped up the back generation at bile duct by cholelithiasis 20 or tumor.Conventional therapy comprises and will drain into the duodenum from blocking above position with permission bile in support or the conduit insertion common bile duct 18.Place the conduit to and to allow in the gallbladder 14 bile and/or other fluid conductions alternative approach in the duodenum.Can treat in this way at any obstruction in common bile duct 18 between Choledochal inlet and the duodenum.See Fig. 2.

Other purposes of described equipment in other places in this application and technology can cause coincideing between any body cavity located adjacent one another.This can include, but are not limited to: small intestinal is to small intestine anastomosis, and small intestinal coincide to large intestine, and large intestine to large intestine coincide, and stomach is to small intestine anastomosis.In addition, between the intrasystem inner chamber of GI (as between other body cavitys of harmonization of the stomach, between esophagus and other body cavitys, between duodenum and other body cavitys, etc.) set up conduit, for treatment and/or to handle obesity can be useful and effective.

Other purposes of equipment as herein described and technology are to be used for the drain of any body cavity to other contiguous body cavitys, for example, and the drain of pancreatic pseudocyst.

Kit:

Equipment disclosed herein can be provided in the suitable packing, as the skilled person will appreciate with the form of kit.This kit can comprise one or more equipment, is used to send one or more assemblies of described equipment, and in the operation of sending described one or more equipment useful one or more pharmacological agents.

Though this paper has shown and has described embodiment preferred of the present invention that these embodiments only are provided as an example clearly to those skilled in the art.In the case of without departing from the present invention, those skilled in the art will expect multiple variation, change and substitute.Should be appreciated that the multiple alternative that when enforcement is of the present invention, can adopt embodiment of the present invention as herein described.What have a mind to is: following claim limits scope of the present invention, and covers the interior method and structure of scope of these claim and equivalent thereof thus.

Claims

1. equipment that is used for the treatment of biliary tract, it comprises:

Be configured for and set up the assembly that fluid is communicated with between the target location in mammiferous gallbladder and gastrointestinal tract, the inner chamber that described assembly has near-end and far-end and runs through its extension, tubular portion with the proximal rim of radially extending and the distal end flange of radially extending, in wherein said proximal rim and the distal end flange at least one is discoidal, and in described proximal rim and the described distal end flange at least one has a plurality of elements that radially extend.

2. equipment according to claim 1, wherein said equipment is by forming by biological resorbent material.

3. equipment according to claim 1, wherein said equipment is removable.

4. equipment according to claim 1, wherein said equipment is distensible.

5. equipment according to claim 1, it also comprises the one or more configurations that are selected from deployed configuration, delivery configuration and the final configuration.

6. equipment according to claim 5, it also comprises variable section.

7. equipment according to claim 1, the cross-sectional area of wherein said equipment are variable along length.

8. equipment according to claim 1, wherein said equipment are configured for by at least one expansion in endoscope, pin, seal wire, guide catheter and the dilating catheter.

9. equipment according to claim 1, it also comprises can flared end.

10. equipment according to claim 1, wherein said assembly has one or more clips, and described one or more clips are configured to described assembly is fixed on one or more positions.

11. equipment according to claim 1, it also comprises one or more windowing.

12. equipment according to claim 1, wherein said equipment is flexible.

13. equipment according to claim 1, wherein said pipe has adjustable length.

14. equipment according to claim 1, wherein said equipment is disposed by shape-memory material at least in part.

15. equipment according to claim 1, wherein said equipment is disposed by one or more line.

16. the valve member of intracavity conjugation tube shape in described is transformed and be configured to equipment according to claim 1, wherein said equipment.

17. equipment according to claim 1, it also comprises one or more holding members, and described one or more holding members are transformed and are configured to remains on original position with described equipment.

18. at least one in the equipment according to claim 1, wherein said distal end flange and proximal rim extended from described tubular portion is vertical.

19. equipment according to claim 1, at least one in wherein said distal end flange and the proximal rim extended from described tubular portion, and towards described tubular portion to the back bending song.

20. a biliary tract therapeutic equipment, it comprises:

Be configured to set up between the target location in mammiferous gallbladder and gastrointestinal tract the assembly that fluid is communicated with, the inner chamber that described assembly has near-end and far-end and runs through its extension, tubular portion, described tubular portion has proximal rim of radially extending and the distal end flange of radially extending, and it is transformed into the gastrointestinal position that is delivered to contiguous gallbladder by endoscope.

21. equipment according to claim 20 wherein forms between the target location of conduit in gallbladder inner chamber and described gastrointestinal tract.

22. the contiguous duodenum in the target location in the equipment according to claim 21, wherein said gastrointestinal tract.

23. equipment according to claim 20, wherein said equipment is by forming by biological resorbent material.

24. equipment according to claim 20, wherein said equipment is removable.

25. equipment according to claim 20, wherein said equipment is distensible.

26. equipment according to claim 20, further, wherein said equipment can be configured to be selected from the one or more configurations in deployed configuration, delivery configuration and the final configuration.

27. equipment according to claim 26, it also comprises variable section.

28. equipment according to claim 20, the cross-sectional area of wherein said equipment are variable along length.

29. equipment according to claim 20, it also comprises can flared end.

30. equipment according to claim 20, wherein said equipment is flexible.

31. equipment according to claim 20, wherein said equipment is disposed by shape-memory material at least in part.

32. equipment according to claim 20, wherein said equipment is disposed by one or more line.

33. the valve member of intracavity conjugation tube shape in described is transformed and be configured to equipment according to claim 20, wherein said equipment.

34. equipment according to claim 20, it also comprises one or more holding members, and described one or more holding members are transformed and are configured to remains on original position with described equipment.

35. a delivery device is to treat the method for biliary tract, described method comprises:

A. use endoscope so that in seal wire, pin, guide catheter and the dilating catheter at least one is placed between intravital entrance cavity and the gallbladder;

B. delivery catheter is inserted at least one in described seal wire, pin, guide catheter and the dilating catheter and is inserted in the gallbladder;

C. send and set up the assembly that fluid is communicated with between the target location that is configured in mammiferous gallbladder and gastrointestinal tract, the inner chamber that described assembly has near-end and far-end and runs through its extension, the tubular portion that has radially proximal rim of extending and the distal end flange of radially extending, at least one in wherein said proximal rim and the distal end flange are that in discoidal and described proximal rim and the described distal end flange at least one has a plurality of radially elements of extension; And

D. described assembly is placed between described intravital entrance cavity and the gallbladder to set up inner chamber betwixt.

36. method according to claim 35, it is further comprising the steps of: when described seal wire was used to send other element, the far-end with described seal wire remained in the gallbladder passively.

37. method according to claim 35, it is further comprising the steps of: the far-end of described seal wire is remained in the gallbladder.

38. method according to claim 35, it is further comprising the steps of: the inner chamber that passes through to be set up is removed cholelithiasis.

39. method according to claim 35, it is further comprising the steps of: via the inner chamber of being set up substance delivery is arrived gallbladder.

40. according to the described method of claim 39, wherein said material occupies the gallbladder inner chamber.

41. method according to claim 35, wherein said material are in antibiotic, inflammatory medicament and the anti-inflammatory agent one or more.

42. method according to claim 35, it is further comprising the steps of: prevent that bile from entering the gallbladder inner chamber.

43. method according to claim 35, it is further comprising the steps of: via endoscope's localization by ultrasonic gallbladder.

44. method according to claim 35, it is further comprising the steps of: insert gallbladder via gastrointestinal tract.

45. according to the described method of claim 44, the step of wherein said access is to carry out in the gastrointestinal tract at duodenum place.

46. method according to claim 35, it is further comprising the steps of: remove cholelithiasis.

47. method according to claim 35, it is further comprising the steps of: change cholelithiasis.

48. according to the described method of claim 47, it is further comprising the steps of: the cholelithiasis of removing change.

49. method according to claim 35, it is further comprising the steps of: remove the obturator in the gallbladder.

50. method according to claim 35, the wherein described biliary tract of treatment under the situation of not removing gallbladder.

51. method according to claim 35, it is further comprising the steps of: make area for treatment visual.

52. method according to claim 35, it is further comprising the steps of: described assembly is anchored on the appropriate location.

53. method according to claim 35, it is further comprising the steps of: described assembly is become deployed configuration from delivery configuration.

54. method according to claim 35, it is further comprising the steps of: described assembly is become final configuration from delivery configuration.

55. method according to claim 35, it is further comprising the steps of: described assembly is become final configuration from deployed configuration.

56. method according to claim 35, it is further comprising the steps of: the cross-sectional profile that reduces described assembly.

57. conduit, it comprises: the shape memory line, described shape memory line is configured to set up between the target location in mammiferous gallbladder and gastrointestinal tract fluid and is communicated with, described shape memory line is made into the inner chamber that forms near-end and far-end and run through its extension, has the tubular portion of proximal rim of radially extending and the distal end flange of radially extending.

58. according to the described conduit of claim 57, wherein said conduit is by forming by biological resorbent material.

59. according to the described conduit of claim 57, wherein said conduit is removable.

60. according to the described conduit of claim 57, wherein said conduit is distensible.

61., also comprise the one or more configurations that are selected from deployed configuration, delivery configuration and the final configuration according to the described conduit of claim 57.

62., also comprise variable section according to the described conduit of claim 61.

63. according to the described conduit of claim 57, the cross-sectional area of wherein said conduit is variable along length.

64. according to the described conduit of claim 57, wherein said conduit is configured for by at least one expansion in endoscope, pin, seal wire, guide catheter and the dilating catheter.

65. according to the described conduit of claim 57, also comprising can flared end.

66. according to the described conduit of claim 57, wherein said conduit is flexible.

67. according to the described conduit of claim 57, wherein said pipe has adjustable length.

68. according to the described conduit of claim 57, wherein said conduit is disposed by shape-memory material at least in part.

69. according to the described conduit of claim 57, valve member at interior intracavity conjugation tube shape is transformed and be configured to wherein said conduit.

70. according to the described conduit of claim 57, also comprise one or more holding members, described one or more holding members are transformed and are configured to remains on original position with described conduit.

71. a conduit, it comprises: at one or more rings of near-end and far-end, it is transformed and is configured to engage forms run through it basic and is the plastic material of piped structure.

72. according to the described conduit of claim 71, wherein said conduit is by forming by biological resorbent material.

73. according to the described conduit of claim 71, wherein said conduit is removable.

74. according to the described conduit of claim 71, wherein said conduit is distensible.

75., also comprise the one or more configurations that are selected from deployed configuration, delivery configuration and the final configuration according to the described conduit of claim 71.

76., also comprise variable section according to the described conduit of claim 75.

77. according to the described conduit of claim 71, the cross-sectional area of wherein said conduit is variable along length.

78. according to the described conduit of claim 71, wherein said conduit is configured for by at least one expansion in endoscope, pin, seal wire, guide catheter and the dilating catheter.

79. according to the described conduit of claim 71, wherein said conduit is flexible.

80. conduit according to claim 17, wherein said pipe has adjustable length.

81. according to the described conduit of claim 71, wherein said conduit is disposed by shape-memory material at least in part.

82. according to the described conduit of claim 71, also comprise one or more holding members, described one or more holding members are transformed and are configured to remains on original position with described conduit.

83. delivery catheter, it comprises: the flexible shaft of control handle, elongation, center-pole and delivery elements, described delivery elements has first conduit and keeps the assembly and the second conduit holding element, wherein the part at conduit between delivery period is sandwiched between the described maintenance assembly, thereby and is released when described first part that keeps assembly to leave the described second described conduit when keeping assembly to discharge conduit on the far-end that remains on described delivery catheter.

84. a delivery catheter, it comprises: the flexible shaft of control handle, elongation, center-pole and at least one expansion electrosurgical electrode.

85. 3 described delivery catheters according to Claim 8, it also comprises the leading edge electrode.

86. 3 described delivery catheters according to Claim 8, it also comprises the expansion electrode of one or more radial arrangement.

87. 3 described delivery catheters according to Claim 8, wherein said expansion electrode can be placed with the big or small optimization in the hole that makes gained.

88. a delivery catheter, it comprises central component, and described central component is transformed and is configured to and moves with respect to the far-end of coaxial sleeve pipe to described conduit; With one or more flexible members.

89. 8 described delivery catheters according to Claim 8, wherein said flexible member has one or more hinges, and strain is transformed and be configured to reduce to described one or more hinges.

90. 8 described delivery catheters according to Claim 8, wherein said flexible member are transformed and are configured to expand outwardly with described delivery catheter grappling with remain on interior intracavity.

91. 8 described delivery catheters according to Claim 8, wherein said flexible member can be configured to umbrella shape.

92. according to the described delivery catheter of claim 91, wherein said flexible member limits work space.

93. a delivery catheter tool passage equipment, it comprises piped structure, and the far-end of delivery catheter is transformed and be configured to engage securely to described piped structure, and at least one other tool passage is transformed and be configured to provide to wherein said equipment.

94. according to the described delivery catheter tool passage of claim 93 equipment, it also comprises near-end and far-end and centre bore, described centre bore is transformed and is configured to be positioned on the far-end of described delivery catheter.

95. according to the described delivery catheter tool passage of claim 93 equipment, it also comprises the hole of elongation, the hole of described elongation is placed the center of the equipment that departs from described elongation.

96. according to the described delivery catheter tool passage of claim 93 equipment, it also comprises and runs through its localized one or more holes.

97. a delivery catheter tool passage equipment, it comprises first assembly, and described first assembly is transformed and is configured to be engaged in securely in the passage of delivery catheter; With second assembly, described second assembly is transformed and is configured to provide the hole, passes described hole and can locate accessory equipment, and wherein said first and second assemblies link to each other via bridge joint mechanism, and further, at least one other tool passage is transformed and be configured to provide to wherein said equipment.

98. an equipment that is used for the treatment of biliary tract, it comprises:

Be configured to set up between the target location in mammiferous gallbladder and gastrointestinal tract the assembly that fluid is communicated with, the inner chamber that described assembly has near-end and far-end and runs through its extension, tubular portion with the proximal rim of radially extending and the distal end flange of radially extending, in wherein said near-end and the distal end flange at least one is made up of first material, and described tubular portion is made up of second material.

99. according to the described equipment of claim 98, at least one in wherein said flange and the tubular portion is by forming by biological resorbent material.

100. according to the described equipment of claim 98, wherein said equipment is removable.

101. according to the described equipment of claim 98, wherein said equipment is distensible.

102. according to the described equipment of claim 98, it also comprises the one or more configurations that are selected from deployed configuration, delivery configuration and the final configuration.

103. according to the described equipment of claim 102, it also comprises variable section.

104. according to the described equipment of claim 98, the cross-sectional area of wherein said equipment is variable along length.

105. according to the described equipment of claim 98, wherein said equipment is configured for by at least one expansion in endoscope, pin, seal wire, guide catheter and the dilating catheter.

106. according to the described equipment of claim 98, it also comprises can flared end.

107. according to the described equipment of claim 98, wherein said assembly has one or more clips, described one or more clips are configured to described assembly is fixed on one or more positions.

108. according to the described equipment of claim 98, it also comprises one or more windowing.

109. according to the described equipment of claim 98, wherein said equipment is flexible.

110. according to the described equipment of claim 98, wherein said pipe has adjustable length.

111. according to the described equipment of claim 98, wherein said equipment is disposed by shape-memory material at least in part.

112. according to the described equipment of claim 98, wherein said equipment is disposed by one or more line.

113. according to the described equipment of claim 98, the valve member of intracavity conjugation tube shape in described is transformed and be configured to wherein said equipment.

114. according to the described equipment of claim 98, it also comprises one or more holding members, described one or more holding members are transformed and are configured to remains on original position with described equipment.

115. according to the described equipment of claim 98, at least one in wherein said distal end flange and the proximal rim extended from described tubular portion is vertical.

116. according to the described equipment of claim 98, at least one in wherein said distal end flange and the proximal rim extended from described tubular portion, and towards described tubular portion to the back bending song.