INFLATABLE TRANSLUMENAL SHUNTS AND METHODS AND DEVICES FOR DELIVERY

Devices and methods for treating biliary disease including an inflatable shunt configured for deployment between one of a lumen of a gallbladder or gallbladder duct and a second body lumen.

BACKGROUND

Field of the Invention

The disclosed solutions address challenges confronted in the use of shunts as in interconnect between two lumens within a body. More specifically, the shunt designs target the biliary system and target the treatment of biliary disease. Biliary disease includes conditions affecting the gallbladder, cystic duct, and common bile duct. More generally, the shunt designs are useful for interconnecting any two sufficiently proximal lumens within a body in a variety of medical fields.

Background

Several conditions within the body give rise to the need for treatment, drainage, and/or elimination of calculi within the biliary system, as well as other locations within the body of a patient. Treatments for biliary disease are the focus of the following discussion, though the devices and methods described herein are generally applicable in a wide variety of medical applications.

Biliary System Function and Anatomy:

Bile is a greenish-brown digestive fluid produced by the liver10illustrated inFIG. 1, and is vital for the digestion of fatty foods. Bile is secreted by liver cells and collected by a network of ducts that converge at the common hepatic duct12. While a small quantity of bile drains directly into the duodenum30(the first portion of the small intestine, immediately downstream of the stomach), the majority of the bile travels through the common hepatic duct12and accumulates in the gallbladder14. Healthy gallbladders are pear-shaped sacs with a thin muscular wall that, on average, measure 10 cm in length and can store approximately 50 ml of fluid. When fatty foods are ingested, the hormone cholecystokinin is released, which causes the gallbladder14to contract. Contraction of the gallbladder14forces bile to flow from the gallbladder14, through the cystic duct16, into the common bile duct18, out the papilla28, and finally into the duodenum30of the small intestine. Here, it mixes and reacts with the chyme (partially digested food) that exits the stomach. The Sphincter of Oddi26controls secretions from the liver10, pancreas24, and gallbladder14into the duodenum30of the small intestine. The opening on the inside of the descending duodenum30after the Sphincter of Oddi26is called the major duodenal papilla28(of Vater). Together, the biliary ducts, the gallbladder14, the cystic duct16and the common bile duct18comprise the biliary system (FIG. 1).

The most common problem that arises in the biliary system is the formation of gallstones, a condition called cholelithiasis. Approximately 20 million Americans have gallstones, and about 1-3% will exhibit symptoms in any given year. In the US, gallstones are more common among women, with 25% of women having gallstones by the age of 60 and 50% by the age of 75. Pregnancy and hormone replacement therapy increase the risk of forming gallstones. Prevalence is lower for American men: approximately 25% will develop gallstones by the age of 75. In the US, gallstones are responsible for the largest number of hospital admissions due to severe abdominal pain.

Gallstones20,20′ are most often composed of cholesterol, but may also be formed from calcium bilirubinate, in which case they are called pigment stones, as shown inFIG. 2. They range in size from a few millimeters to several centimeters, and are irregularly shaped solids resembling pebbles. They can form in the gallbladder14, cystic duct16, and/or the common bile duct18. By themselves, gallstones20do not necessarily result in disease states. This is the case 90% of the time. However, stones can cause infection and inflammation, a condition known as cholecystitis, which is generally the result of restricting or blocking the flow of bile from the gallbladder14and common bile duct18, or the fluids secreted by the pancreas24via the pancreatic duct22.

Gallbladder disease may be chronic, and patients who suffer from this may periodically experience biliary colic. Symptoms include pain in the upper right abdomen near the ribcage, nausea, and/or vomiting. The pain may resolve within an hour of onset, may prove unresponsive to over-the-counter medicines, and may not decrease with changes of position or the passage of gas. Recurrence is common, with pain often recurring at the same time of day, but with frequency of less than once per week. Fatty or large meals may cause recurrence several hours after eating, often awakening the patient at night. Patients may elect to suffer from these symptoms for extended periods of time, such as years or even decades.

Patients with chronic cholecystitis have gallstones and low-grade inflammation. Untreated, the gallbladder14may become scarred and stiff over time, leading to a condition called dysfunctional gallbladder. Patients who have chronic cholecystitis or dysfunctional gallbladder may experience gas, nausea, and abdominal discomfort after meals, and chronic diarrhea.

In contrast to patients with chronic gallbladder disease, a small fraction (in the range of 1-3%) of patients symptomatic for gallstones develop acute cholecystitis (inflammation of the gallbladder) due to obstruction of the common bile duct18or cystic duct16by stones20,20′ or bile sludge. Symptoms are similar to biliary colic, though they are more severe and persistent. Pain in the upper right abdomen can be constant and severe, the intensity may increase when drawing breath, and it may last for days. Pain may radiate to the back, under the breastbone or the shoulder blades, and it may be perceived on the left side of the abdomen. In addition to nausea and vomiting, one third of patients experience fever and chills. Complications from acute cholecystitis can be serious and life-threatening, and include gangrene, abscesses, perforation of the gallbladder14which can lead to bile peritonitis, pus in the gallbladder wall (empyema), fistulae, and gallstone ileus (wherein a gallstone creates a blockage in the small intestine).

When gallstones20′ become lodged in the common bile duct18, the condition is known as choledocholithiasis. Symptoms for this condition include pain, nausea and vomiting, and some patients develop jaundice, have dark urine and/or lighter stools, rapid heartbeat, and experience an abrupt drop in blood pressure. These symptoms can also be accompanied by fever, chills, and/or severe pain in the upper right abdomen. Complications from choledocholithiasis can also be very serious, and include infection of the common bile duct18(cholangitis) and inflammation of the pancreas24(pancreatitis).

Treatment of Biliary Disease:

The most effective treatment for biliary disease has been surgical removal of the gallbladder14, a procedure called cholecystectomy. Surgical removal of the gallbladder14is indicated for patients who experience a number of less severe gallstone attacks, cholecystitis, choledocholithiasis, pancreatitis, acalculous biliary pain with evidence of impaired gallbladder14emptying, those at high risk for developing gallbladder cancer, and those who have previously undergone endoscopic sphincterotomy for common bile duct stones. Other treatment modalities exist and are frequently used, but gallbladder disease tends to recur in the majority of patients who forgo cholecystectomy and pursue alternatives. Removal of the gallbladder14is highly successful at permanently eliminating biliary disease. Cholecystectomy is one of the most commonly performed procedures on women. The gallbladder14is not an essential organ, and after a period of adjustment post-surgery, patients tend to return to more or less normal digestive function.

Cholecystectomy can be performed either as open surgery, which requires a single large incision in the upper right abdomen, or laparoscopic surgery, in which several small instruments are inserted through much smaller incisions in the abdomen. Over 90% of cholecystectomies are performed laparoscopically. The primary benefits of this minimally invasive approach are faster recovery for the patient and a reduction in overall healthcare costs. Patients who receive laparoscopic cholecystectomy are usually released from a hospital the same day as the procedure. By contrast, patients receiving open cholecystectomies typically spend 5-7 days in a hospital before release. 5-10% of laparoscopic procedures convert to open procedures when difficulties arise, such as injury to major blood vessels, inadequate access, inadequate visualization, previous endoscopic sphincterotomy, and thickened gallbladder wall. Complications from cholecystectomy (open or laparoscopic) include bile duct injuries (0.1-0.5% for open, 0.3-2% with a declining trend for laparoscopic), pain, fatigue, nausea, vomiting, and infection. In up to 6% of cases, surgeons fail to identify and remove all gallstones present.

In some cases, the degree of infection and inflammation prevents patients from undergoing immediate cholecystectomy. In these cases, the gallbladder14must be treated with antibiotics and anti-inflammatory agents, and drained through a tube into a reservoir outside the abdomen. Placement of this tube occurs in a procedure called percutaneous cholecystostomy, in which a needle is introduced to the gallbladder14through the abdomen, fluid is withdrawn, the needle puncture is dilated, and a drainage catheter is inserted. This catheter drains into an external bag which must be emptied several times a day until the tube is removed. The drainage catheter may be left in place for up to 8 weeks. In cases where no drainage catheter is inserted, the procedure is called gallbladder aspiration. Since no indwelling catheter is placed, the complication rate for gallbladder aspiration is lower than that of percutaneous cholecystostomy.

Treatment methodologies for gallbladder disease other than cholecystectomy include 1) expectant management, and 2) treatments that focus on the elimination of gallstones in the gallbladder, such as dissolution therapy and extracorporeal shockwave lithotripsy (ESWL). Lithotripsy is a general term referring to the act of breaking up stones. Tools used to break up stones are known as lithotripters. Lithotripsy may be performed using any of a variety of tools and methods, including mechanical lithotripsy (in which a mechanical tool is used to physically cut or break stones into smaller pieces), laser lithotripsy (in which laser energy is applied to stones to cause their destruction), electro-hydraulic lithotripsy or EHL (in which electrically produced shockwaves are applied directly to stones via a probe), and extracorporeal shockwave lithotripsy or ESWL (in which externally produced acoustic waves are focused on gallstones within the body).

When gallstones are present in the bile duct18, rather than the gallbladder14, other treatment methodologies are employed. The most common of these include: endoscopic retrograde cholangiopanctreatograpy (ERCP), with or without endoscopic sphincterotomy; mechanical lithotripsy; laser lithotripsy; and electro-hydraulic shockwave lithotripsy (EHL). For gallstones20located in the gallbladder14, these treatments are generally infeasible, since the gallbladder is not accessible via endoscopy (e.g., endoscopic retrograde cholangiopancreatography).

ERCP (endoscopic retrograde cholangiopancreatograpy) is an endoscopic procedure for treating gallstones, obstructions, strictures, and other conditions in the common bile duct18and pancreatic duct22. During ERCP, an endoscope is introduced through the mouth of a patient, past the stomach to the papilla28, where the common bile duct18empties into the duodenum30. The procedure most commonly involves inserting instruments and tools into the common bile duct18via the papilla28in order to treat biliary disease. Often, especially in cases where relatively large gallstones are removed via the bile duct, endoscopic sphincterotomy is performed, which is a procedure that enlarges the opening of the papilla28in the small intestine30surgically or via balloon dilation. Radiographic contrast agent is introduced into the common bile duct18to visualize the biliary tree fluoroscopically.

During ERCP, tools for clearing gallstones20,20′ and other blockages, such as endoscopic baskets, lithotripters, and balloon catheters, may be deployed to capture, break up, and extract gallstones20,20′ and/or the resulting debris, and remove bile sludge. Drainage catheters and stents may also be inserted to facilitate the drainage of bile past obstructions. ERCP is a technically challenging procedure, and complication rates of 5-8% have been reported. Complications include pancreatitis, infection, bleeding, and perforation.

SUMMARY

An aspect of the disclosure is directed to inflatable shunts. Suitable inflatable shunts comprise: a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween; a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween; and an inflation port. Shunts can also comprise: a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween; a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween; a connecting section positioned between the first inflatable anchor and the second inflatable anchor; and an inflation port. The first inflatable anchor lumen and second inflatable anchor lumen can be contiguous such that only a single lumen is formed throughout the device. In some configurations, the inflation port is positionable on at least one of the first inflatable anchor exterior, the second inflatable anchor exterior, and the connecting section. One or more inflation ports can be provided which are positionable on a non-tissue contacting surface. The inflatable shunt can have a central lumen and/or be inflatable. Additionally the inflation port can have a central lumen. One or more activatable materials can be provided within at least one of the first inflatable anchor lumen, the second inflatable anchor lumen, and the connecting section. The inflatable shunt is inflated by one or more of a filling material and activation of an expandable material. At least one of the filling material and expandable material can be chosen based on a material characteristic which changes hardness of the material. The filling material can be one or more of each of a compressible material and an incompressible material. Moreover, the compressible material can be one or more of air, inert gases, carbon dioxide, foam and gel. The incompressible material can be one or more of liquid and gel. The exterior surface of the shunt can be configured to have one or more of each of a surface texture, a ridge, a rib, an aperture, and a barb. Additionally, a plug can be provided. The plug can be part of an inflation port or positioned within a central lumen. Additionally, the inflation port can be self-healing. In some configurations, at least a portion of the shunt is biodegradable. In other configurations, a radial expansion of the inflatable shunt is selectable. Additionally, a valve can be provided which is positionable within a lumen of the connecting section. A structural component can be provided or activated wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor, and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section. The first inflatable anchor and the second inflatable anchor can be configurable so that the anchors apply pressure to tissue positioned between a first inflatable anchor surface that is adjacent a second inflatable anchor surface. Thus the space between the surfaces of the anchors is less than the uncompressed thickness of the tissue.

Another aspect of the disclosure is directed to a collapsible inflatable shunt. Suitable collapsible inflatable shunts comprise: a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween; a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, wherein the inflatable shunt has a delivery configuration and a deployed configuration. Additional collapsible inflatable shunts comprise: a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween; a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween; a connecting section positioned between the first inflatable anchor and the second inflatable anchor, wherein the inflatable shunt has a folded delivery configuration and an unfolded deployed configuration. Additionally, an inflation port can be provided. The inflation port can be positionable on at least one of the first inflatable anchor exterior, the second inflatable anchor exterior, and the connecting section. The first inflatable anchor lumen and second inflatable anchor lumen can be contiguous such that only a single lumen is formed throughout the device. In some configurations, the inflation port is positionable on at least one of the first inflatable anchor exterior, the second inflatable anchor exterior, and the connecting section. One or more inflation ports can be provided which are positionable on a non-tissue contacting surface. The inflatable shunt can have a central lumen and/or be inflatable. Additionally the inflation port can have a central lumen. One or more activatable materials can be provided within at least one of the first inflatable anchor lumen, the second inflatable anchor lumen, and the connecting section. The inflatable shunt is inflated by one or more of a filling material and activation of an expandable material. At least one of the filling material and expandable material can be chosen based on a material characteristic which changes hardness of the material. The filling material can be one or more of each of a compressible material and an incompressible material. Moreover, the compressible material can be one or more of air, inert gases, carbon dioxide, foam and gel. The incompressible material can be one or more of liquid and gel. The exterior surface of the shunt can be configured to have one or more of each of a surface texture, a ridge, a rib, an aperture, and a barb. Additionally, a plug can be provided. The plug can be part of an inflation port or positioned within a central lumen. Additionally, the inflation port can be self-healing. In some configurations, at least a portion of the shunt is biodegradable. In other configurations, a radial expansion of the inflatable shunt is selectable. Additionally, a valve can be provided which is positionable within a lumen of the connecting section. A structural component can be provided or activated wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor, and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section. The first inflatable anchor and the second inflatable anchor can be configurable so that the anchors apply pressure to tissue positioned between a first inflatable anchor surface that is adjacent a second inflatable anchor surface. Thus the space between the surfaces of the anchors is less than the uncompressed thickness of the tissue.

Yet another aspect of the disclosure is directed to an inflatable shunt comprising: a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween; a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween; and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section. Additional embodiments of inflatable shunt can comprise: a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween; a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween; a connecting section positioned between the first inflatable anchor and the second inflatable anchor; and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section. The first inflatable anchor lumen and second inflatable anchor lumen can be contiguous such that only a single lumen is formed throughout the device. In some configurations, the inflation port is positionable on at least one of the first inflatable anchor exterior, the second inflatable anchor exterior, and the connecting section. One or more inflation ports can be provided which are positionable on a non-tissue contacting surface. The inflatable shunt can have a central lumen and/or have an inflatable connecting section. Additionally the inflation port can have a central lumen. One or more activatable materials can be provided within at least one of the first inflatable anchor lumen, the second inflatable anchor lumen, and the connecting section. The inflatable shunt is inflated by one or more of a filling material and activation of an expandable material. At least one of the filling material and expandable material can be chosen based on a material characteristic which changes hardness of the material. The filling material can be one or more of each of a compressible material and an incompressible material. Moreover, the compressible material can be one or more of air, inert gases, carbon dioxide, foam and gel. The incompressible material can be one or more of liquid and gel. The exterior surface of the shunt can be configured to have one or more of each of a surface texture, a ridge, a rib, an aperture, and a barb. Additionally, a plug can be provided. The plug can be part of an inflation port or positioned within a central lumen. Additionally, the inflation port can be self-healing. In some configurations, at least a portion of the shunt is biodegradable. In other configurations, a radial expansion of the inflatable shunt is selectable. Additionally, a valve can be provided which is positionable within a lumen of at least one of the inflatable shunt and the inflation port. A structural component can be provided or activated wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor, and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section. The first inflatable anchor and the second inflatable anchor can be configurable so that the anchors apply pressure to tissue positioned between a first inflatable anchor surface that is adjacent a second inflatable anchor surface. Thus the space between the surfaces of the anchors is less than the uncompressed thickness of the tissue.

Still another aspect of the disclosure is directed to a method of treating biliary disease. Suitable methods comprise: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt to the first otomy and the second otomy wherein the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, and an inflation port; inflating the inflatable shunt; anchoring the first inflatable anchor on a first tissue surface; and anchoring the second inflatable anchor on a second tissue surface which does not contact the first tissue surface. Additional methods can comprise: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt to the first otomy and the second otomy wherein the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, a connecting section positioned between the first inflatable anchor and the second inflatable anchor, and an inflation port; inflating the inflatable shunt; anchoring the first inflatable anchor on a first tissue surface; and anchoring the second inflatable anchor on a second tissue surface which does not contact the first tissue surface. An otomy includes a cut into a part of the body by making an incision into or a cut through the body, such as a cut through the duodenum or a cut through the gallbladder which enables an inflatable shunt to be passed through the wall of the duodenum and the wall of the gallbladder. Additionally, the method can include delivering a filling material to the inflatable shunt. The filling material can be at least one of compressible and incompressible. Additionally a structural component can be delivered or activated. The shunt can also be delivered via an endoscope. Some methods include necrosing tissue in contact with the inflatable shunt by causing cell injury or cell death by applying pressure to the target tissue. Where the tissue is necrosed, the method can include removing the inflatable shunt and the necrosed tissue.

Still another method includes methods of treating biliary disease comprising: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt to the first otomy and the second otomy wherein the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, wherein the inflatable shunt has a delivery configuration and a deployed configuration; inflating the inflatable shunt; anchoring the first inflatable anchor on a first tissue surface; and anchoring the second inflatable anchor on a second tissue surface which does not contact the first tissue surface. Additional methods can comprise: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt to the first otomy and the second otomy wherein the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, a connecting section positioned between the first inflatable anchor and the second inflatable anchor, wherein the inflatable shunt has a folded delivery configuration and an unfolded deployed configuration; inflating the inflatable shunt; anchoring the first inflatable anchor on a first tissue surface; and anchoring the second inflatable anchor on a second tissue surface which does not contact the first tissue surface. Additionally, the method can include delivering a filling material to the inflatable shunt. The filling material can be at least one of compressible and incompressible. Additionally a structural component can be delivered or activated. The shunt can also be delivered via an endoscope. Some methods include necrosing tissue in contact with the inflatable shunt by causing cell injury or cell death by applying pressure to the target tissue. Where the tissue is necrosed, the method can include removing the inflatable shunt and the necrosed tissue.

Yet another method of treating biliary disease comprises: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt comprising a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section; inflating the inflatable shunt; anchoring the first inflatable anchor on a first tissue surface; and anchoring the second inflatable anchor on a second tissue surface which does not contact the first tissue surface. Another method can include creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt comprising a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, a connecting section positioned between the first inflatable anchor and the second inflatable anchor, and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section; inflating the inflatable shunt; anchoring the first inflatable anchor on a first tissue surface; and anchoring the second inflatable anchor on a second tissue surface which does not contact the first tissue surface. Additionally, the method can include delivering a filling material to the inflatable shunt. The filling material can be at least one of compressible and incompressible. Additionally a structural component can be delivered or activated. The shunt can also be delivered via an endoscope. Some methods include necrosing tissue in contact with the inflatable shunt by causing cell injury or cell death by applying pressure to the target tissue. Where the tissue is necrosed, the method can include removing the inflatable shunt and the necrosed tissue.

Another aspect of the disclosure is directed to a method for removing an inflatable shunt, comprising locating the inflatable shunt delivered to a first otomy and a second otomy adjacent the first otomy, and changing a profile of the inflatable shunt from a deployed profile at a removal profile wherein the deployed profiled has a larger circumference at a cross-section than the removal profile. The method can be achieved by, for example, deflating the inflatable shunt. Additionally, the method may include removing the inflatable shunt.

Still another aspect of the disclosure is directed to shunt inflation devices comprising: an inflation element wherein the inflation element engages an inflation port of an inflatable shunt at a distal end of the inflation element, wherein the inflatable shunt is at least one of the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, and an inflation port; the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, and a shunt, wherein the inflatable shunt has a delivery configuration and a deployed configuration; and the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, an inflation port and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section. The inflation element can be an elongated tubular member. Another configuration can include shunt inflation devices comprising: an inflation element wherein the inflation element engages an inflation port of an inflatable shunt at a distal end of the inflation element, wherein the inflatable shunt is at least one of the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, a connecting section positioned between the first inflatable anchor and the second inflatable anchor, and an inflation port; the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, a connecting section positioned between the first inflatable anchor and the second inflatable anchor, and a shunt, wherein the inflatable shunt has a folded delivery configuration and an unfolded deployed configuration; and the inflatable shunt comprises a first inflatable anchor at a first end having a first inflatable anchor interior surface and a first inflatable anchor exterior surface forming a first inflatable anchor lumen therebetween, a second inflatable anchor at a second end having a second inflatable anchor interior surface and a second inflatable anchor exterior surface forming a second inflatable anchor lumen therebetween, a connecting section positioned between the first inflatable anchor and the second inflatable anchor, an inflation port and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor and the connecting section. The inflation element can be an elongated tubular member. Additionally, the inflation element can be configured to be connectable to the inflatable shunt. In at least some configurations, the shunt inflation device further comprises a threaded distal end. The inflation element may also be removable from the inflation port by at least one of sliding, twisting, and severing. Additionally, the shunt inflation device can further comprise a one way flow control element and/or a removable distal end. The one way flow control element can be incorporated into an inflation port. In some configurations a stopper is provided. The shunt inflation device can further comprise a wire positioned within a central lumen of the inflation element and/or a collar positioned around at least a portion of an exterior wall of the inflation element. Additionally, the distal end of the shunt inflation device can have an angled distal end.

Another aspect of the disclosure is directed to a shunt inflation device comprising: an inflation element wherein the inflation element engages an inflation port of an inflatable shunt at a distal end of an elongated tubular member connectable to the inflatable shunt wherein the inflation element is removable from the inflation port of the inflation port by at least one of sliding, twisting and severing. The shunt inflation device can further comprise a threaded distal end and/or a one way flow control element and/or a removable distal end. The one way flow control element can be incorporated into an inflation port. In some configurations a stopper is provided. In other configurations, a wire positioned within a central lumen of the inflation element. The shunt inflation device can further comprise a collar positioned around at least a portion of an exterior wall of the inflation element. Additionally, the distal end of the shunt inflation device can be configured to have an angled distal end.

Yet another aspect of the disclosure is directed to a deliver system comprising: a needle; a dilation component; an inflatable shunt; an shunt delivery device. Additionally, the dilation component includes a cutting tool. In some configurations, the delivery system further comprises electrodes.

An aspect of the disclosure is directed to inflatable shunts. Suitable inflatable shunts comprise: a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween; a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween; and an inflation port. A connecting section means can be positioned between the first inflatable anchor means and the second inflatable anchor. The first inflatable anchor means lumen and second inflatable anchor means lumen can be contiguous such that only a single lumen is formed throughout the device. In some configurations, the inflation port means is positionable on at least one of the first inflatable anchor means exterior, the second inflatable anchor means exterior, and the connecting section means. One or more inflation port means can be provided which are positionable on a non-tissue contacting surface. The connecting section means can have a central lumen and/or be inflatable. Additionally the inflation port means can have a central lumen. One or more activatable materials can be provided within at least one of the first inflatable anchor means lumen, the second inflatable anchor means lumen, and the connecting section means. The inflatable shunt is inflated by one or more of a filling material and activation of an expandable material. At least one of the filling material and expandable material can be chosen based on a material characteristic which changes hardness of the material. The filling material can be one or more of each of a compressible material and an incompressible material. Moreover, the compressible material can be one or more of air, inert gases, carbon dioxide, foam and gel. The incompressible material can be one or more of liquid and gel. The exterior surface of the shunt can be configured to have one or more of each of a surface texture means, a ridge means, a rib means, an aperture, and a barb means. Additionally, a plug means can be provided. The plug means can be part of an inflation port means or positioned within a central lumen. Additionally, the inflation port means can be self-healing. In some configurations, at least a portion of the shunt is biodegradable. In other configurations, a radial expansion of the inflatable shunt is selectable. Additionally, a valve means can be provided which is positionable within a lumen of the connecting section means. A structural component can be provided or activated wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor, and the connecting section means, or is incorporated into a portion of a wall of at least one of the first inflatable anchor means, the second inflatable anchor means and the connecting section means. The first inflatable anchor means and the second inflatable anchor means can be configurable so that the anchor means apply pressure to tissue positioned between a first inflatable anchor means surface that is adjacent a second inflatable anchor means surface. Thus the space between the surfaces of the anchor means is less than the uncompressed thickness of the tissue.

Another aspect of the disclosure is directed to a collapsible inflatable shunt. Suitable collapsible inflatable shunts comprise: a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween; a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween; wherein the inflatable shunt has a delivery configuration and a deployed configuration. The inflatable shunt can also comprise a connecting section means positioned between the first inflatable anchor means and the second inflatable anchor means. Additionally, an inflation port means can be provided. The inflation port means can be positionable on at least one of the first inflatable anchor means exterior, the second inflatable anchor means exterior, and the connecting section. The first inflatable anchor means lumen and second inflatable anchor means lumen can be contiguous such that only a single lumen is formed throughout the device. In some configurations, the inflation port means is positionable on at least one of the first inflatable anchor means exterior, the second inflatable anchor means exterior, and the connecting section means. One or more inflation port means can be provided which are positionable on a non-tissue contacting surface. The connecting section means can have a central lumen and/or be inflatable. Additionally the inflation port means can have a central lumen. One or more activatable materials can be provided within at least one of the first inflatable anchor means lumen, the second inflatable anchor means lumen, and the connecting section. The inflatable shunt is inflated by one or more of a filling material and activation of an expandable material. At least one of the filling material and expandable material can be chosen based on a material characteristic which changes hardness of the material. The filling material can be one or more of each of a compressible material and an incompressible material. Moreover, the compressible material can be one or more of air, inert gases, carbon dioxide, foam and gel. The incompressible material can be one or more of liquid and gel. The exterior surface of the shunt can be configured to have one or more of each of a surface texture means, a ridge means, a rib means, an aperture, and a barb means. Additionally, a plug means can be provided. The plug means can be part of an inflation port means or positioned within a central lumen. Additionally, the inflation port means can be self-healing. In some configurations, at least a portion of the shunt is biodegradable. In other configurations, a radial expansion of the inflatable shunt is selectable. Additionally, a valve means can be provided which is positionable within a lumen of the connecting section. A structural component can be provided or activated wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor, and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section. The first inflatable anchor means and the second inflatable anchor means can be configurable so that the anchors apply pressure to tissue positioned between a first inflatable anchor means surface that is adjacent a second inflatable anchor means surface. Thus the space between the surfaces of the anchors is less than the uncompressed thickness of the tissue.

Yet another aspect of the disclosure is directed to an inflatable shunt comprising: a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween; a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween; and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section. Additionally, the shunt can comprise a connecting section means positioned between the first inflatable anchor means and the second inflatable anchor means, The first inflatable anchor means lumen and second inflatable anchor means lumen can be contiguous such that only a single lumen is formed throughout the device. In some configurations, the inflation port means is positionable on at least one of the first inflatable anchor means exterior, the second inflatable anchor means exterior, and the connecting section means. One or more inflation port means can be provided which are positionable on a non-tissue contacting surface. The connecting section means can have a central lumen and/or be inflatable. Additionally the inflation port means can have a central lumen. One or more activatable materials can be provided within at least one of the first inflatable anchor means lumen, the second inflatable anchor means lumen, and the connecting section. The inflatable shunt is inflated by one or more of a filling material and activation of an expandable material. At least one of the filling material and expandable material can be chosen based on a material characteristic which changes hardness of the material. The filling material can be one or more of each of a compressible material and an incompressible material. Moreover, the compressible material can be one or more of air, inert gases, carbon dioxide, foam and gel. The incompressible material can be one or more of liquid and gel. The exterior surface of the shunt can be configured to have one or more of each of a surface texture means, a ridge means, a rib means, an aperture, and a barb means. Additionally, a plug means can be provided. The plug means can be part of an inflation port means or positioned within a central lumen. Additionally, the inflation port means can be self-healing. In some configurations, at least a portion of the shunt is biodegradable. In other configurations, a radial expansion of the inflatable shunt is selectable. Additionally, a valve means can be provided which is positionable within a lumen of the connecting section. A structural component can be provided or activated wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor, and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section. The first inflatable anchor means and the second inflatable anchor means can be configurable so that the anchors apply pressure to tissue positioned between a first inflatable anchor means surface that is adjacent a second inflatable anchor means surface. Thus the space between the surfaces of the anchors is less than the uncompressed thickness of the tissue.

Still another aspect of the disclosure is directed to a method of treating biliary disease. Suitable methods comprise: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt to the first otomy and the second otomy wherein the inflatable shunt comprises a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween, a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween, and an inflation port; inflating the inflatable shunt; anchoring the first inflatable anchor means on a first tissue surface; and anchoring the second inflatable anchor means on a second tissue surface which does not contact the first tissue surface. The inflatable shunt can further comprise a connecting section means positioned between the first inflatable anchor means and the second inflatable anchor. An otomy includes a cut into a part of the body by making an incision into or a cut through the body, such as a cut through the duodenum or a cut through the pancreas which enables an inflatable shunt to be passed through the wall of the duodenum and the wall of the pancreas. Additionally, the method can include delivering a filling material to the inflatable shunt. The filling material can be at least one of compressible and incompressible. Additionally a structural component can be delivered or activated. The shunt can also be delivered via an endoscope. Some methods include necrosing tissue in contact with the inflatable shunt by causing cell injury or cell death by applying pressure to the target tissue. Where the tissue is necrosed, the method can include removing the inflatable shunt and the necrosed tissue.

Still another methods includes methods of treating biliary disease comprising: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt to the first otomy and the second otomy wherein the inflatable shunt comprises a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween, a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween, wherein the inflatable shunt has a delivery configuration and a deployed configuration; inflating the inflatable shunt; anchoring the first inflatable anchor means on a first tissue surface; and anchoring the second inflatable anchor means on a second tissue surface which does not contact the first tissue surface. Additionally, the method can include delivering a filling material to the inflatable shunt. The filling material can be at least one of compressible and incompressible. Additionally a structural component can be delivered or activated. The shunt can also be delivered via an endoscope. Some methods include necrosing tissue in contact with the inflatable shunt by causing cell injury or cell death by applying pressure to the target tissue. Where the tissue is necrosed, the method can include removing the inflatable shunt and the necrosed tissue.

Yet another method of treating biliary disease comprises: creating a first otomy and a second otomy adjacent the first otomy; delivering an inflatable shunt comprising a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween, a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween, and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section means; inflating the inflatable shunt; anchoring the first inflatable anchor means on a first tissue surface; and anchoring the second inflatable anchor means on a second tissue surface which does not contact the first tissue surface. The inflatable shunt can also include a connecting means. Additionally, the method can include delivering a filling material to the inflatable shunt. The filling material can be at least one of compressible and incompressible. Additionally a structural component can be delivered or activated. The shunt can also be delivered via an endoscope. Some methods include necrosing tissue in contact with the inflatable shunt by causing cell injury or cell death by applying pressure to the target tissue. Where the tissue is necrosed, the method can include removing the inflatable shunt and the necrosed tissue.

Still another aspect of the disclosure is directed to shunt inflation devices comprising: an inflation element wherein the inflation element engages an inflation port means of an inflatable shunt at a distal end of the inflation element, wherein the inflatable shunt is at least one of the inflatable shunt comprises a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween, a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween, and an inflation port; the inflatable shunt comprises a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween, a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween, and a shunt, wherein the inflatable shunt has a delivery configuration and a deployed configuration; and the inflatable shunt comprises a first inflatable anchor means at a first end having a first inflatable anchor means interior surface and a first inflatable anchor means exterior surface forming a first inflatable anchor means lumen therebetween, a second inflatable anchor means at a second end having a second inflatable anchor means interior surface and a second inflatable anchor means exterior surface forming a second inflatable anchor means lumen therebetween, an inflation port means and a structural component wherein the structural component either surrounds at least a portion of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section, or is incorporated into a portion of a wall of at least one of the first inflatable anchor, the second inflatable anchor means and the connecting section. The inflatable shunt can further include a connecting means between the first inflatable anchor means and the second inflatable anchor means. The inflation element can be an elongated tubular member. Additionally, the inflation element can be configured to be connectable to the inflatable shunt. In at least some configurations, the shunt inflation device further comprises a threaded distal end. The inflation element may also be removable from the inflation port means by at least one of sliding, twisting, and severing. Additionally, the shunt inflation device can further comprise a one way flow control element and/or a removable distal end. The one way flow control element can be incorporated into an inflation port. In some configurations a stopper is provided. The shunt inflation device can further comprise a wire positioned within a central lumen of the inflation element and/or a collar positioned around at least a portion of an exterior wall of the inflation element. Additionally, the distal end of the shunt inflation device can have an angled distal end.

Another aspect of the disclosure is directed to a shunt inflation device comprising: an inflation element wherein the inflation element engages an inflation port means of an inflatable shunt at a distal end of an elongated tubular member connectable to the inflatable shunt wherein the inflation element is removable from the inflation port means of the inflation port means by at least one of sliding, twisting and severing. The shunt inflation device can further comprise a threaded means at a distal end and/or a one way flow control means and/or a removable distal end. In some configurations a stopper means is provided. In other configurations, a wire means positioned within a central lumen of the inflation element. The shunt inflation device can further comprise a collar means positioned around at least a portion of an exterior wall of the inflation element. Additionally, the distal end of the shunt inflation device can be configured to have an angled distal end.

Yet another aspect of the disclosure is directed to a deliver system comprising: a needle means; a dilation means; an inflatable means; an shunt delivery means. Additionally, the dilation means includes a cutting means. In some configurations, the delivery system further comprises electrode means.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. See, for example, U.S. Pat. No. 9,282,968 issued Mar. 15, 2016, to Van Dam et al. for Applicator for Endoscopic Treatment of Biliary Disease; US2006/01677482 A1 published Jul. 27, 2006, by Swain et al. for Device for Transfixing and Joining Tissue; US 2009/0143713 A1 published Jun. 4, 2009 by Van Dam et al., for Biliary Shunts, Delivery Systems, Methods of Using the Same and Kits therefor; US2012/013041 A1 published May 24, 2012, by Lepulu et al. for Apparatus and Method for Penetrating and Enlarging Adjacent Tissue Layers; US2014/0018722 A1 published Jan. 16, 2014 by Scott et al. for Apparatus and Method for Creating a Lumen of a Desired Shape and Size in a Hollow Viscous Organ from Tissue of the Organ; WO 2012/007044 A1 published Jan. 19, 2012 by Pastorelli et al. for A Device for Translumenal Diversion of Bile; and WO 2012/007047 A1 published Jan. 19, 2012, by Stokes et al. for A Device and Method for Directing Bile from the Gallbladder in the Intestine.

DETAILED DESCRIPTION

The disclosed shunts are anastomotic devices that join two physiological lumens. The disclosed shunts can obviate the need for a variety of procedures, including: (1) percutaneous cholecystostomy, (2) cholecystectomy, (3) percutaneous trans-hepatic cholangiography (PTHC), and (4) endoscopic retrograde cholangiopancreatography (ERCP). Additionally, new treatment modalities are enabled for distal common bile duct obstruction secondary to pancreatic carcinoma, cholagiocarcinoma, and/or ampullary carcinoma. A conventional standard of care for treating biliary disease has been surgical removal of the gallbladder and closure of the cystic duct. While this has proven to be an effective way of permanently eliminating biliary disease and its recurrence, the present disclosed devices and methods accomplish the same end in a less invasive and less costly way. This may be achieved by treating biliary disease without requiring the removal of the gallbladder. Methods and apparatus are described in this application that are intended to effectively treat biliary disease with the gallbladder and cystic duct left in situ.

Treating biliary disease can employ using an endoscope to access a region in the gastrointestinal (GI) tract to which the gallbladder lumen is in close proximity (preferably the duodenum or stomach), locating the gallbladder, accessing the gallbladder through the wall, and then treating the underlying condition that led to the need for intervention. Treatments may include, but are not limited to, the following: providing drainage of the gallbladder and/or the biliary tree, delivering antibiotics and/or anti-inflammatory agents (short-term acting, fast acting, or time release) to the gallbladder and/or biliary tree, removing gallstones, facilitating the destruction and subsequent removal of gallstones, clearing obstructions, delivering catheters, delivering stents, temporarily or permanently defunctionalizing the gallbladder, temporarily or permanently defunctionalizing the cystic duct, and/or providing an alternate route for bile and/or other materials and fluids to be delivered to the intestine. Devices and therapies are preferably delivered in a single treatment, with minimal likelihood of or necessity for follow-up or repeat procedures.

Localization of the gallbladder can be performed via endoscopic ultrasound (EUS) through the wall of the GI tract, but may also be achieved by any other method that visualizes anatomical features, such as fluoroscopy, x-rays, magnetic resonance imaging (MM), computed axial tomography (CT) scans, ultrasound imaging from outside the body, or any other suitable method of anatomical imaging and visualization.

Once the gallbladder has been located, it may be accessed and/or treated through the wall of the GI tract (or any lumen in proximity to the gallbladder) by using tools and devices delivered preferably by means of the endoscope. Such tools and devices may be inserted down the length of the endoscope's working channel, or loaded onto or near the distal end of the endoscope. Alternately, tools and other devices may be used that do not require the aid of the endoscope for navigation or delivery. Direct visualization may be provided by the endoscope during the procedure, as well as irrigation, suction, and insufflation.

Though a location for accessing the gallbladder lumen is the duodenum, it may also be readily achieved through the wall of other regions of the GI tract, such as the stomach or the jejunum. Any lumen in close proximity to the gallbladder is a candidate for access to and treatment of the gallbladder and other members of the biliary system.

Description of the Devices:

The present devices and methods enable in situ treatment of the gallbladder via the creation of a passageway between the gallbladder lumen and a lumen in close proximity, preferably the duodenum or stomach. This passageway may be created by use of device such as an inflatable implantable shunt device. Such a device would also enable connection of any two lumens in close proximity, such as a pancreatic pseudocyst and stomach, stomach and jejunum, and the like.

The passageway created by the device may be temporary or permanent. It may be thought of as a fistula that is intentionally created between a first lumen (e.g., the gallbladder) and a second lumen in proximity (e.g., the duodenum). Alternately, it may be thought of as a stoma between the first lumen (e.g., gallbladder) and second lumen (e.g., duodenum). The passageway created serves as a conduit, and also optionally as an access port through which a number of actions may be accomplished, drainage may be achieved, and treatments may be delivered.

A device forming the passageway may be left in the patient for a short period of time, such as a few days or weeks, or it may be left in place for extended periods of time, such as several weeks, months, or years. The device may also be left in place permanently. Tissue may form around the device, creating a fistula (e.g., passage or duct) that joins the connected lumens which may persist even if the connecting device is removed. The fistula may be beneficial and useful, as it may continue to drain the contents of one lumen (e.g., the gallbladder) into another lumen (e.g., the duodenum). It may provide either the primary or a secondary mechanism of delivering bile into the digestive system, for example. It may also provide convenient access in cases where repeated treatments are required. Though there may be no need to close the resulting fistula, it may also be closed at any time by a clinician should this become desirable. After removal of the shunt device that initially created the passageway, a fistula may remain open for some period of time and then close on its own, and may pose no additional risk and prove to be an acceptable course of events. Whether the device is left in place or removed, and whether the fistula is left open or closed, evidence at the site may serve to mark the location of treatment in the event of future procedures.

To facilitate delivery and deployment of a device, it may be useful to reconfigure its shape. For example, the cross-sectional area presented by the device at various locations (its “profile”) may be reduced. Inflatable shunt designs are especially suitable for this, since their profile may be quite small when deflated and carefully “packed”. In cases where the configuration of the device is caused to change, it may be helpful to conceive of the device having at least two configurations, for example: one configuration when it is delivered (a “delivery” or “initial” configuration), and another configuration when it is deployed in place and functional (a “deployed” or “final” configuration). Still other configurations may also be necessary or useful. For the delivery configuration, it may be advantageous to alter the cross-sectional area or profile (e.g. reduce the profile by deflating, folding, pleating, or otherwise packing the device), so that it more easily fits delivery mechanisms, such as the working channel of an endoscope. During deployment, the configuration of the device may be altered so that placement into the patient is facilitated and the intended function of the device achieved by the device in its final or deployed configuration.

Description of the Inflatable Transluminal Shunt:

A transluminal shunt that is inflatable is disclosed, e.g., a balloon, or an arrangement of one or more balloons. The inflatable portion(s) of the device may be inflated by introducing a filling material, or by activating an expandable material that is either introduced during the procedure or is resident within the device prior to the procedure. In cases where material is introduced during a procedure, this may be done through a single inflation port, or separately through multiple ports.

The inflatable elements of the shunt may be inflated by introducing compressible materials (e.g., air, inert gases, carbon dioxide, foams, gels), or incompressible or nearly incompressible materials (e.g., water, saline, other liquids, gels). Alternately, the inflatable elements may be filled with an activatable substance that initially occupies a small volume during device delivery, and which may be selectively activated to occupy a larger volume during or after delivery. Materials may also be selected so that they change hardness or stiffness or state of matter (liquid-to-solid, for example), rather than or in addition to changes in volume that inflate the balloon elements. In this way, the shunt may be delivered in a soft configuration, and then changed into a stiffer configuration during delivery. Material used to alter the volume or stiffness of the inflatable elements may be biocompatible, so that exposing body tissue or fluids to the materials will not cause injury, toxicity, or other harm. However, biocompatibility is not a strict requirement, as long as the material is kept away from body tissue. Materials may be further selected so that they are radio-opaque and may be clearly visualized with fluoroscopy or other X-ray imaging technique, and/or are echogenic, so that they may be visualized with ultrasound.

The material used to fabricate the inflatable shunt may be elastic (e.g., elastomeric, latex, silicone, polyurethane) or inelastic (e.g., polyethylene terephthalate (Mylar®, from Dupont), nylon, polyethylene). The material is selected so that the uninflated and packed configuration allows the device to be made to be compact enough to facilitate delivery (e.g., through the tool channel of an endoscope) in its initial or delivery configuration, and the inflated (e.g., deployed or final) configuration may be made to assume the desired shape, and, in some cases, become rigid, and in still other cases, apply a desired degree of pressure to the lumen walls approximated by the anchors.

Many configurations of the proposed inflatable transluminal shunt are possible, and several representative arrangements are enumerated herein. An embodiment of the proposed inflatable shunt device300shown inFIGS. 3A-3Dis comprised of inflatable anchors310,320located at either end of a central connecting section330. The central connecting section330may be configured in a number of ways, such as having length sufficient to span the thickness of the tissue walls to be joined (e.g., 10 mm, as shown inFIG. 3C), and optionally an inner lumen340with diameter sufficient for desired material(s) to pass through (e.g., 10 mm, as shown inFIG. 3D), and also optionally to provide access between lumens for endoscopes or tools. The outer diameter of the inflatable anchors310,320is approximately 25 mm, with an approximate inner diameter of 10 mm as shown inFIG. 3D. The dimensions given in the figures and this description are representative, and only serve to indicate a typical size. It will be understood that these dimensions may vary slightly or substantially, without deviating from the disclosure.

The inflatable anchors310,320, once inflated, hold the device securely in position across the lumen walls, and may be configured to apply pressure to at least a portion of the adjacent tissue so that the anchors more firmly approximate the walls and better seal the newly created junction shown inFIG. 4. In the configuration ofFIG. 4, the pressure applied to adjacent tissue450,460contacted by the anchors410,420which is sufficient to prevent blood circulation in the adjacent tissue450,460, inducing pressure necrosis in the approximated tissue. Once necrosis occurs, the necrosed tissue detaches from the surrounding viable tissue, and the necrosed region, including the inflatable shunt400, separates entirely from the lumen walls. The detached tissue and inflatable shunt400may then pass out of the body (e.g., by peristalsis in the intestine), obviating the need to perform additional procedures to manipulate, maintain, or remove the shunt.

The anchors410,420may optionally be independently inflatable, so that, for example, when the distal end of the device is positioned as desired within the mammalian body, one anchor410may be inflated first, the device position may then be adjusted to ensure that it is in the desired location within the body, and subsequently the second anchor420may be inflated, securing the device in position across the walls of the joined lumens of the adjacent tissue450,460. Alternatively, both anchors410,420may be inflated at the same time. For example, they may share a common interior volume that, when filled, inflates both anchors together.

The body lumens joined by the shunt (e.g., the gallbladder and the duodenum) may be used to guide the selection of the length of the central connecting section430. For example, when connecting the gallbladder to the duodenum, a short (e.g., 2-4 mm) central connecting section430may be desired, whereas a central connecting section430which is longer (e.g. 5-10 mm) may be desired for connecting the stomach to the gallbladder.

In some cases, it may be desirable for the surfaces of the inflatable shunt400that is contacting the adjacent tissue450,460to be smooth, have gentle radii, and not incorporate any sharp features, to avoid causing trauma to the tissue. For example, any seams and inflation ports could be located in areas on the device where they do not make contact with tissue (e.g., outer (non-tissue contacting) surfaces abutting the anchors410,420, or the inner lumen440of the central connecting section430). Similarly, rough surfaces and/or sharp corners, if any are included in the device, may be located in these regions (or, more generally, apart from tissue-contacting elements of the device), away from tissue whenever possible, or to the maximum extent possible.

In other cases, it may be desirable for the surfaces of the inflatable shunt400that contacts the adjacent tissue450,460to incorporate features that accommodate, encourage, or stimulate tissue ingrowth and/or attachment. For metallic stent technology, uncovered metallic stents allow for ingrowth of tissue, and are thus less likely to migrate over time. For the present inflatable shunt400, features may be incorporated into the material comprising the inflatable shunt400, or at least a part of the surface of the device, that produce an analogous result. Such surface features may include textures, ridges, ribs, holes, barbs, and the like, any or all of which would serve to engage the adjacent tissue and prevent migration of the inflatable shunt400from the implanted location. Similarly, substances may be inserted into the material comprising the outer layer of the inflatable shunt400, or coatings applied to the surface of the inflatable shunt400, that encourage or stimulate tissue growth and/or scar tissue formation, analogous to the construction and action of a drug eluting stent in cardiac applications.

Over time, scar tissue surrounds the junction in the tissue (e.g., as shown inFIG. 4, the region where the wall tissue of a first lumen450and the wall tissue of a second lumen460contact the central connecting section430) and a fistula forms, after which the risk of leakage at the site is minimized. Removal of the shunt may be achieved by piercing or otherwise deflating the inflatable elements (e.g., first anchor410, second anchor420, and central connecting section430) so that the cross-sectional area of the inflatable shunt400and/or its stiffness is reduced, after which the device may be withdrawn from the body. Further, the inflatable shunt400, or at least some portion of the inflatable shunt400(e.g., a separate region, such as a “plug”470) may optionally be comprised of a biodegradable or resorbable material, so that after a desired residence time within a body, the balloon will deflate and be expelled from the body without requiring additional intervention. It should be appreciated that such a region or construction may be incorporated into any of the designs described herein, including similar devices not specifically included, described, or enumerated.

Minimizing the volume, stiffness, and/or cross-sectional profile of the inflatable elements or anchors410,420, and central connecting section430of the inflatable shunt400will facilitate removal or repositioning of the shunts when desired. When inflation media or materials480such as compressible materials (which may or may not be biocompatible, e.g., gases, foams, gels), and/or incompressible or nearly incompressible materials (e.g., water, saline, gels), are used to inflate the anchors410,420, and central connecting section430of the inflatable shunt400, the inflatable elements may be pierced, ruptured, or otherwise compromised to release the enclosed inflation material(s) in order to reduce or minimize their size for withdrawal. When the materials480used to fill or stiffen the inflatable elements are non-biocompatible materials, the materials may be withdrawn through a syringe, tube, catheter, or the like, without allowing the material(s)480to come in contact with patient tissue. When activatable material(s)480are selected, the material(s) and activation process may be selected such that the process is reversible, or multi-step, so that, for example, one step may activate the activatable material480and inflate the inflatable shunt400, and a subsequent step may deactivate the activatable material480and deflate the inflatable shunt400. If the activatable material480introduced into or resident within the inflatable shunt400is a polymer or substance containing nanotubes (for example, one that is initially in a liquid state), it may be activated or cross-linked by exposing it to light that causes it to transform into a gel or some more dense material. Subsequently, the activatable material480may be re-liquefied or changed into some other more easily withdrawable condition by, for example, again exposing it to light. This may be done, for example, via an optical fiber placed inside the lumen of the inflatable shunt400or in the vicinity of (e.g., adjacent to) the shunt. Depending on the activatable material480, changes in the characteristics of the material may be achieved by exposing it to various wavelengths of light, changes in temperature or pressure, exposure to chemical substances, or other material or energy transport processes, that cause activation or deactivation of the activatable material480for the purpose of selectably inflating or deflating the inflatable shunt400.

The central connecting section430may optionally be comprised of an inflatable element, or it may be constructed from a material and with a design that is not inflatable, e.g., a tube, a sheet, or a film. In embodiments where the central connecting section430is inflatable, it may optionally be configured to expand radially when it is inflated. Further, the degree of radial expansion may be selectable and related to the quantity of, or optionally the pressure of, the inflating material480contained within. Additionally, depending on the characteristics of the inflating material (i.e., inflatability or how much inflation the inflating material will achieve), the amount of radial expansion can also be controlled. In this way, the central connecting section430can expand to fill and seal the passageway through the tissue walls450,460. This reduces the chances that material may leak out of the connected lumens around the inflatable shunt400, and into the space external to either lumen. The central connecting section430of the inflatable shunt400may further be configured to expand forcefully as the internal pressure or volume is increased, so that it is capable of dilating the adjacent tissue450,460surrounding it. In this way, it may be used as a dilation balloon, in addition to its other functions described herein.

Further, the central connecting section430may optionally be configured so that it may be incrementally inflated over time, which may be used, for example, to progressively dilate a tract through lumen wall(s)450,460by selectively controlling the pressure inside at least the central connecting section430. For example, the device may be configured so that the outer diameter of the central connecting section430is 10 mm when it is inflated to a pressure of 1 atm, 12 mm when it is inflated to 1.5 atm, and 14 mm when it is inflated to 2 atm. In this way, the degree and forcefulness of dilation may be selected and adjusted. Further, the dilation may be selected and adjusted during a single procedure, or over a longer period of time, such as multiple procedures which may be separated by days, weeks, or months. This would allow for the progressive dilation of a tract from an initially small value (e.g., 10 mm) to a large value (e.g., 15 mm, 20 mm) that would not be possible to achieve at a single point in time or over a short time duration (e.g., minutes or hours) without risking damage to the tissue.

Turning now toFIG. 27A, to ensure that material is only allowed to travel through the device2700, having a first inflatable anchor2710and a second inflatable anchor2720, in a single direction (e.g., from a first lumen such as a gallbladder14through lumen wall13, into a second lumen such as a duodenum30through lumen wall11) and not in the reverse direction, a valve27400may be incorporated into or attached onto the device2700. For instance, it may be desirable to deliver bile into the digestive tract, and to drain pus or other fluids, but undesirable for partially digested food to move from the small intestine into the gallbladder14. A valve27400may be used to prevent flow into the gallbladder14from sources other than the biliary system. Among the purposes of the valve: allow the movement of material from a first lumen to a second lumen (e.g., gallbladder14to duodenum30), prevent flow in the reverse direction (e.g., duodenum30to gallbladder14), and control the level of pressure that is allowed to develop between the connected lumens. Controlling the pressure within the upstream lumen (e.g., the gallbladder14), and ensuring that the pressure differential between the connected lumens remains low, reduces the risk of the contents of either lumen leaking into surrounding regions (e.g., bile leaking into the peritoneum). The valve may be incorporated or added at any location within the device2700, from the most distal end to the most proximal end, or at any point within the central connecting section2730. The valve may be made of any suitable material, such as the materials used to construct the device2700, or unlike materials that are better suited to the function of the valve (e.g., silicone, urethane, and the like). A suitable material for this purpose is silicone. However, it may also be made of any other suitably biocompatible compliant material (in cases where bending characteristics of the material are used to create the flow control feature) or non-compliant material such as stainless steel, nickel-titanium alloy, or titanium (in cases where mechanical elements are used to create the flow control feature(s)). In one embodiment a duckbill valve is used, illustrated inFIG. 27B, with a slit in a cone-shaped compliant material that supplies elastic forces that cause it to be closed under normal circumstances, open when the pressure inside the upstream lumen (e.g., gallbladder14) exceeds the pressure in the connected downstream lumen (e.g., duodenum30) by a desired amount (e.g., during contraction of the gallbladder14), and closed if the pressure in the connected downstream lumen (e.g., duodenum30) is higher than the pressure in the upstream lumen (e.g., gallbladder14), a condition that might otherwise result in flow in the undesirable direction). In an alternate embodiment, the valve may be designed as a sprung flap shown inFIG. 27C, with functional characteristics similar to those of the duckbill valve described above. Another embodiment is that of a bicuspid valve (closed and not allowing flow in andFIGS. 27D(1); open and allowing flow in the desired direction in andFIG. 27D(2)) or tricuspid valve (FIG. 27E), which also exhibits the desired characteristics described above. Each of these embodiments, and other valve embodiments not specifically described herein, share the flow control characteristics of a) allowing flow from a first lumen (e.g., gallbladder14) into a connected downstream lumen (e.g., duodenum30) through the device2700when the pressure in the first lumen (e.g., gallbladder14) is greater than the pressure in the connected downstream lumen (e.g., duodenum30) by a desired amount, b) not allowing flow from the downstream connected lumen (e.g., duodenum30) into the first, upstream lumen (e.g., gallbladder14) when the pressure in the downstream lumen (e.g., duodenum30) exceeds the pressure in the upstream lumen (e.g., gallbladder14), and c) not allowing flow from the downstream connected lumen (e.g., duodenum30) into the first, upstream lumen (e.g., gallbladder14) when little or no pressure differential exists between the two lumens.

A valve27400which is adjustable may also be incorporated into or added to a device2700. Such a valve27400would enable practitioners or patients to adjust the difference in pressure between the connected lumens (e.g., the gallbladder14and duodenum30) at which the valve27400opens. Adjustability may be incorporated into the valve body in such a way that a clinician may adjust it endoscopically, or it may be incorporated in such a way that a clinician or a patient may adjust the valve27400without requiring additional endoscopy or invasive procedure.

FIG. 5A-FIG. 5Fillustrate features that enable the creation and maintenance of complex desired shapes of the device500. As inflation material580is introduced into an inflatable region590or activated and, in some cases, internal pressure is created and increased, internal connections between walls may be incorporated, such as seam (see, spot or seam connection585inFIG. 5A, linear seam connections587inFIG. 5C, curved seam connections588inFIG. 5D, spiral seam connections589inFIG. 5Epositioned between a first inflatable anchor510and a second inflatable anchor520on a connecting section530, and spiral seam connections on a flat section591inFIG. 5F) or spot connections (e.g., welds586shown inFIG. 5B), between a first wall of the inflatable elements581and a second wall of the inflatable elements582of the device500. It should also be appreciated that more than two walls may be joined using this approach. By joining layers at strategically selected points, (e.g., “spot welds”585inFIG. 5Aand spot connections586inFIG. 5Band arrangements or arrays of any linear or curved connections (e.g., “seam welds”); areas (e.g. “region welds”), or combinations of any or all of the various internal connections), the internally increasing volume, pressure, or stiffness of the inflation material580will cause the first wall of the inflatable elements581and the second wall of the inflatable elements582(as well as additional walls, if included in the connections between walls) of the devices500to create and maintain a desired shape. Additionally, the thickness of the walls of the inflatable elements581,582, and/or other wall material properties, such as stiffness, elasticity, durometer, and the like, may be selected to differ in selected regions of the inflatable region590, enabling them to achieve a desired configuration and/or shape when inflated.

In cases where the shunt device600shown inFIG. 6is inflated during a procedure by introduction or injection of a inflation material680(e.g., fluid, gas, activation component) that causes the inflatable shunt device600having a first inflatable anchor510and a second inflatable anchor520, to assume its final or deployed configuration (e.g., by expansion), an inflation element6100, such as a tube, may be used that introduces or enables the activation of the inflation material680. The inflation material680that causes the inflation of the shunt (e.g., fluid, gas, activation component) may be introduced by a variety of inflation elements6100, e.g., a tube or syringe, when the material is a liquid or a gas, or by a mechanism that grips, repositions, pushes, crushes, mixes, etc., in cases where solids (which may be comprised of a large number of small solid elements, such as grains or powders), liquids, gases, or mixtures of solids, liquids, or gases are introduced, repositioned, or reconfigured, or by an optical fiber, in cases where a material is caused to transition when illuminated with light energy between a small volume and a large volume, or a low viscosity to a high viscosity, or from a fluid to a solid.

The inflation element6100may optionally be disconnected from the inflatable shunt device600at some time during a procedure. For example, once the inflatable shunt device600is inflated and caused to assume its final or deployed configuration, the inflation element6100may be detached from the inflatable shunt device600and withdrawn from the body of the patient. This may be achieved in a variety of ways. For example, in an embodiment shown inFIG. 7A, an inflation element (such as a tube)7100is used to introduce an inflation material780into an inflatable region790within an inflatable shunt700, the inflation element7100may be secured to the inflation port7110by use of a friction fit/seal. In such an embodiment, the inflation element7100may be removed from the inflation port7110by applying tension to the inflation element7100to slide it out of the inflation port7110. Alternatively as shown inFIG. 7B, a twist-lock or threading feature7120may be used to engage the inflation element7100and the inflation port7110, in which the inflation element7100may be rotated, preferably counterclockwise, to detach it from the inflation port7110.

Yet another alternate approach to detaching from the inflatable shuntFIG. 7Cinvolves severing the inflation element7100. For example, once inflation is complete, applying sufficient tension or torque to a break-away section of an inflation tube7130may cause it to detach from the inflatable shunt700. Alternatively as shown inFIG. 7D, a cutting device7140may be used to cut an inflation element7100at a desired location7150, leaving a portion7160(which may be very small, or even flush with the wall of the inflatable shunt700) of the inflation element attached to the inflatable shunt700.

Prior to detaching the inflation element7100, in some embodiments shown inFIG. 7A-7Dit may be beneficial to seal the inflation port7110or section of inflation element7100(e.g., proximal to the inflation port7110). In an embodiment, the inflation material780is a fluid (e.g., saline), and the inflation port7110is a small diameter (e.g., about 1 mm) tube. For this embodiment, a small one-way flow control element7170, such as one-way valve (e.g., duck-bill valve, ball valve, flap valve, sleeve valve) may be incorporated into the inflatable shunt700or inflation port7110that allows inflation material780to flow into an inflatable region790of the inflatable shunt700, but does not allow reverse flow of the inflation material780, out of the inflation port7110. In this case, once the inflatable shunt700has been inflated through the inflation port7110, the inflation element7100(e.g., a tube) may be removed, and the inflation material780(e.g., saline) will remain inside the inflatable region790of the inflatable shunt700, which then retains the desired shape and characteristics. In one example, shown inFIG. 7B, the inflation element7100can be removed from the inflation port7110by rotating the inflation element7100(e.g., releasing via the threads7210).

In still other embodiments (FIG. 8A,FIG. 8B), retention of the inflation material880may be achieved by eliminating flow within the inflation element8100(e.g., by closing off or “stopping” a tube with a stopper8180) or the inflation port8110prior to disconnecting the inflation element8100from the inflatable shunt. The location of the stoppage8190of the closure or stoppage of the inflation element8100may be selected so that the section of the element containing the stoppage8190, and optionally a portion of the inflation element8160remains attached to the inflatable shunt after a removable portion8161of the inflation element8100is detached at a detachment location8200and removed. In this way, the inflation material880remains inside the shunt and the shunt maintains the deployed or final configuration. This may be achieved, for example, by introducing a stopper8180into a mating and/or retaining feature within the inflation element8100(e.g., tube), the inflation port, or the inflatable region of the inflatable shunt. The stopper8180may be positioned, for example, by pushing it into position with a wire8210, or, alternatively, by pulling it into position with a wire8220shown inFIG. 8B. The stopper8180may be any suitable shape, such as a bullet-shape inFIG. 8A, a ball inFIG. 8B, and a cone (with or without rounded edges). Once the stopper8180has been positioned in the desired location of the stoppage8190to prevent the flow of inflation material880, for example, a location of the stoppage8190with a mating feature that conforms to and presses around the exterior of the stopper8180, such as a notch or a region with a reduced inner diameter, the stopper8180will prevent flow within the inflation element8100in either direction.

In another embodiment shown inFIG. 9, the inflation element9100(e.g., a tube) may be folded, kinked, or otherwise clamped shut at a desired location9220. Once the inner lumen of the inflation element9100has been closed, an additional component such as a collar9210may be introduced to maintain this condition. For example, in cases where the inflation element9100comprises a tube and it has been kinked to cause it to close9220, a collar9210may be positioned over the kinked portion, locking it in this condition indefinitely, or until the collar9210is removed.

In yet another embodimentFIG. 10A, the inflation port10110may be sealed with a material10230, such as an adhesive, for which a desirable characteristic is that it transitions from an initially deliverable configuration (e.g., a liquid), may be activated (e.g., via exposure to ultra-violet light, oxygen, or the absence of oxygen), and subsequently transforms into a material with a final configuration that remains in position (e.g., a solid or near-solid which fills or blocks the port, and, in some cases, adheres or bonds to the adjacent surface(s)) and prevents the flow of inflation material1080into or out of the shunt device1000. This blockage may likewise be selectably positioned within the inflation element10100shown inFIG. 10B. In some configurations, the inflation element10100comprises a tube, and the blocking material10240may be selectably positioned along some portion or all of the length of the inflation element10100. Any suitable type of adhesive or other activatable material may be used to create a blockage from the blocking material10240in the inflation element10100, or the inflation port10110provided it seals the inflation element10100, inflation port10110, or inflatable region of the shunt device1000, at a desired time, in a desired location, and under the control of the user.

FIG. 11illustrates at least the inflation port11110comprises a self-healing region of material11250(e.g., a low durometer silicone) which may be incorporated into the wall of the inflatable shunt1100(or make up a portion of the inflatable shunt1100, or the entire inflatable shunt1100) and designated as the site through which a sharp inflation tip11260at a distal end of an elongated tubular member11100may be inserted to introduce inflation material(s). This may be done, for example, though a hypodermic needle or a fine needle aspiration (FNA) needle. Further, the self-healing region may be formulated to be radio-opaque, echogenic, or otherwise designed to be easily distinguishable from other proximal materials, so that the user may accurately guide the inflation tip11260to the desired target.

A wide variety of geometries and configurations may be used for the inflatable shunt. In addition to the embodiment comprising inflatable disc-shaped anchorsFIG. 3, another embodimentFIG. 12A-12Dillustrates a configuration that incorporates one or more anchors1210,1220, that are toroidal donut-shaped inflatable/deflatable anchors, on either end of a central connecting section1230. As with previously described embodiments, such a variation may incorporate a central connecting section1230that may be inflatable or non-inflatable. The length of the central connecting section1230may be varied, depending on the procedure and the specific anatomy of the patient. A central aperture1240may be provided. The dimensions shown inFIG. 12BandFIG. 12Dare representative, and the suitable range of dimensions may vary substantially from those shown. In some cases (e.g., when the gallbladder is connected to the duodenum with the shunt1200), the length of the central connecting section1230may be selected so that the anchors1210,1220are relatively close together, e.g., 1-10 mm. In other cases (e.g., when the gallbladder is connected to the stomach with the shunt1200), the length of the central connecting section1230may be selected so that the anchors are further apart, e.g., 5-15 mm, or more.

In a variation of the configuration ofFIG. 13, the anchors1310,1320are positioned on either side of a connecting member1330and have different sizes (e.g., one or both of height and diameter). By altering the size of the anchors1310,1320(e.g., differing inner diameters, outer diameters, and the like), the location of the optional application of forces to the tissue held between the anchors may be selected, as discussed above relative toFIG. 4. In cases where pressure is applied to the tissue held between the anchors, with the goal of causing pressure necrosis and eventual detachment of the necrosed tissue, the anchors1310,1320shown inFIG. 13are configurable so that the smaller anchor1320is initially placed within the lumen from which the shunt1300is to move out of (e.g., the gallbladder) and the larger anchor1310placed within the lumen into which the shunt1300is to move into after detaching (e.g., the duodenum). The shunt1300will move out of the lumen which contains the smaller anchor1320and into the lumen that contains the larger anchor1310once pressure necrosis occurs. This characteristic and effect may be exploited for any of the configurations of inflatable shunt described herein: each may include a larger and a smaller anchor, and the direction of motion of the shunt upon the occurrence of pressure necrosis thereby selected.

Other embodiments involve the incorporation of at least one spherical, or near-spherical, anchor as shown inFIG. 14A-B. In one case, spherical anchors1410,1420are incorporated on both ends of a central connecting section1430, the spherical anchors1410,1420and the central connecting section1430optionally incorporate a lumen1440through the device1400, connecting the distal end of the spherical anchor1410is distal to the proximal end of the spherical anchor1420.

Still other embodiments involve different types of anchors. In a variation of an embodiment of an inflatable shunt as shown inFIG. 15A-B, the proximal anchor1510is configured as a toroid, and the distal anchor1520is configured as a round or spherical shape. An optional inner lumen1540may optionally be included through the center of the anchors to allow for the passage of material and/or tools. In this configuration, the spherically shaped distal anchor1520may be placed in the distal lumen, through the lumen wall1560(e.g., the gallbladder) and the toroidal balloon forming the proximal anchor1510placed in the proximal lumen, proximal to the lumen wall1550(e.g., the duodenum). The optional inner lumen1540of the inflatable shunt device1500creates a communication between the distal and the proximal lumen. Further, the optional pressure applied to the tissue of the lumen walls1550,1560(as discussed above relative toFIG. 4) may be selected to be sufficient for the creation of pressure necrosis, after which the necrosed tissue will detach from the healthy surrounding tissue, carrying the inflatable shunt device1500away with it. In this configuration, the outer diameter of the toroidal balloon forming the proximal anchor1510is larger than the spherically shaped distal anchor1520, so the inflatable shunt device1500and tissue will move in the direction of the toroidal balloon forming the proximal anchor1510, into the more proximal lumen (e.g., the duodenum), where it can be cleared from the body by a natural process, such as peristalsis. The inflatable shunt device1500is depicted positioned on an elongated tubular member15270with a sharp distal end15280suitable for piercing.

Another variation is shown inFIGS. 16A-Bwhich involves exchanging the position of the spherical anchor1610and the toroidal anchor1620. In this variation, the spherical anchor1610is again delivered to the distal lumen (e.g., the gallbladder) through the first lumen wall1650and the second lumen wall1660, and the toroidal anchor1620in the proximal lumen (e.g., the duodenum). However for this variation the tissue of the first lumen wall1650and the second lumen wall1660are pulled back around and over the spherical anchor1610and secured in this position by the toroidal anchor1620, which acts as a ring around the spherical anchor1610. The spherical anchor1610is configured to be larger in diameter when inflated than the inner diameter of the toroidal anchor1620when inflated so that the spherical anchor1610is prevented from pulling through, and thus clamps the first lumen wall1650and the second lumen wall1660of the connected lumens in place. Substantial clamping force, and thus pressure, may be created and imparted to the tissue of the first lumen wall1650and the second lumen wall1660held between the spherical anchor1610and the toroidal anchor1620, and this may be selected to be sufficiently high that pressure necrosis results (as discussed above relative toFIG. 4). Again, since the spherical anchor1610is smaller within the distal lumen (e.g., the gallbladder), and the toroidal anchor1620is larger within the proximal lumen (e.g., the duodenum), the necrosed tissue and inflatable shunt1600will pass into the proximal lumen upon detachment. As with the subsequently described embodiment (below), a layer of material, or connecting component (e.g., a sleeve, a net, a mesh, or more than one cord, thread, ribbon, or strip) may be used to attach the spherical anchor1610to the toroidal anchor1620, e.g., through the central connection component and/or optional inner lumen1640, however in the embodiment illustrated, one end of the connecting component1630is attached to the proximal end of the spherical anchor1610and is arranged along the inside of the spherical anchor1610, forming an inner lumen. The other end of the material is attached to the inner diameter of the toroidal anchor1620. When both the spherical anchor1610and the toroidal anchor1620are inflated, the connecting component transmits tension forces and pulls the toroidal anchor1620snugly against the spherical anchor1610, securely clamping the anchors together around the lumen wall tissue, and the clamping pressure may optionally be selected to be sufficient to cause pressure necrosis. Other arrangements for the connecting component are possible, such as positioning it so that it connects to the proximal end of the spherical anchor1610as before, but is routed along the outer surface of the sphere, connecting to the inner diameter of the toroidal anchor1620. The inflatable shunt device1600is depicted positioned on an elongated tubular member16270with a sharp distal end16280suitable for piercing.

In order to generate and impart more substantial clamping pressure to the first lumen wall1650and the second lumen wall1660, a connecting component or components comprised of materials dissimilar to and less flexible than the materials used to construct the inflatable/deflatable balloon elements of the inflatable shunt1600may be incorporated (such as a sleeve, a net, a mesh, or more than one cord, thread, ribbon, or strip) that either passes though, or serves as, the connecting component1630which can be centrally positioned, or, alternately, an inner lumen. The connecting component1630may be attached on one end at the furthermost point of the spherical anchor1610and on the other end to the inner diameter of the toroidal anchor1620, with the length of the connecting1630component running through the center of the spherical anchor1610and the center of the toroidal anchor1620. In this way, inflation of either anchor will serve to apply tension and hence clamping forces between the anchors, transmitted by the connecting component.

As shown inFIGS. 17A-Ban inflatable shunt1700is one in which there are two primary components: an inflatable component17290and a structural component17300. The inflatable component17290is constrained by the structural component17300(for example, the inflatable component17290may fill a cavity defined by the structural component17300), and the structural component17300will define the desired shape and cause the inflatable component17290to conform to that shape.

Turning toFIG. 18, a device1800is shown with an inflatable component18290and one or more structural components18300involves containing the inflatable component18290within the structural component18300, such as an outer sheath, housing, or covering. This provides structure and constrains the anchoring flanges so that they take on the desired shape once inflated. In one example of this variation, the structural component18300defines a concave space, and as the anchors of the inflatable component18290inflate, they initially occupy and fill the concave space within the structural component18300, and once the available volume has been filled, further inflation of the anchors causes them to expand inward toward each other, resulting in the application of pressure to the tissue held between the anchoring balloons. The structural component18300may be rigid, semi-rigid, or flexible, and collapsible to a small profile for delivery before the balloons are inflated within them. The structural component18300may be integrally formed with the surface of the inflatable component18290(e.g., formed with thicker sections of balloon material, co-molded with disparate materials, encapsulated or bonded Nitinol wire, stainless steel, spring metal, other polymers, etc.), or they may be separate components (e.g., baskets as illustrated inFIG. 18, which may be comprised of polymers, shape metals like Nitinol, stainless steel, etc.). The structural component18300may be held a fixed distance away from each other, so that as the inflatable component's18290anchor balloons inflate and expand inward, the structural component18300do not move away from the tissue. In this case, they provide reaction forces that resist the forces created by the inflatable anchors as they inflate. This may be achieved through the use of a component that fixes the distance between the structural elements, such as a wire or tube attached to either structural element which sets the maximum spacing between them, and resists loads that would otherwise push them apart.

An aspect of an inflatable shunt is how its profile (cross-sectional area) is minimized for delivery into a patient. The inflatable anchoring features may be deflated to minimize their overall size, and, together with the central connecting section, the profile of the device will be further reduced, in some cases, to the point where it will fit through the tool channel of an endoscope. Typical endoscope tool channels range from about 2.8 mm to about 5 mm in diameter. One method for reducing the packed profile of the balloon shunt is to flatten at least the central connecting section and roll it into a smaller configuration.

FIG. 19Ashows the unconstrained initial shape of the central connecting section1930.FIGS. 19B-Cshow the central connecting section1930being progressively flattened.

FIG. 19Dshows the central connecting1930section rolled to further reduce its profile. The inflatable anchors at either end of the central connecting section1930may be similarly rolled. Further, they may be rolled around the central connecting section1930, either prior to or subsequent to when it is rolled. Once the inflatable anchors are wrapped around the central connecting section1930which has been rolled, they may be used to hold the central connecting section1930in this configuration. Thus, elements of the design itself are employed to constrain the device when it is made compact for delivery. Alternately, the anchors they may be axially extended away from the central connecting section1930, either by folding them over or by pulling axially at either end of the anchors, and they may then be subsequently flattened and rolled, so that their profile is minimized to the desired extent. If the central connecting section1930comprises a balloon, it may be deflated prior to flattening. Further, to maximally reduce the size of any balloon component within the device, vacuum may be applied to the balloon lumen(s) to evacuate and collapse it (them) further than may be achieved without actively withdrawing material under vacuum. Once evacuated, the inflation/evacuation port or inflation device may optionally be closed and kept closed during delivery, or until such time that the user desires to increase the size of the shunt.

Delivery of the inflatable shunt to the desired site of implantation within the body may be achieved in a variety of ways. For example, the desired implantation site may be identified and accessed with a flexible endoscope. When an endoscope is used to access the site for shunt delivery, the site may be identified through the use of direct endoscopic visualization, endoscopic ultrasound, external ultrasound, fluoroscopy, magnetic resonance (MR) imaging, computed tomography (CT) imaging, or any combination of these or other medical imaging modalities. Preferably, endoscopic ultrasound is used because it provides visualization through the wall of the gastrointestinal tract without the use of ionizing radiation. Once the desired implantation site has been accessed and identified, the process of implanting the inflatable shunt may be initiated. An exemplar delivery method is shown inFIG. 20which illustrates a method including: (1) using an endoscope to access and identify the desired implantation site; (2) advancing the delivery system through the tool channel of the endoscope until it emerges from the tool channel at the distal tip of the endoscope; (3) advancing a needle component of a delivery system and puncture the lumen wall tissue of the access lumen (e.g., the duodenum) and the lumen wall tissue of the target lumen (e.g., the gallbladder), so that the tip of the needle resides within the target lumen (e.g., the gallbladder); (4) optionally aspirating fluid with the needle (which may be performed in this or any subsequent step); (5) enlarging the puncture through the walls of the lumens so that they will accommodate larger components (such as an inflatable shunt) by advancing an initial dilation component of the delivery system (preferably, but not limited to, the application of RF energy to electro-surgically enlarge the puncture) through the tissue; (6) advancing the deflated shunt through the enlarged puncture, until its distal anchor is positioned inside the target lumen (e.g., gallbladder), preferentially by further advancing the initial dilation component to which the inflatable shunt is also mounted; (7) inflating at least the distal anchor of the inflatable shunt; (8) applying tension to the inflatable shunt though a positioning component (e.g., the component which positions the initial dilation component) so that the distal anchor contacts and applies tension to the inner surface of the target lumen wall (e.g., gallbladder), the central connecting section extends through both lumen walls, and the proximal anchor resides within the access lumen (e.g., duodenum); (9) verifying or ensuring the desired position of the inflatable shunt's proximal anchor inside the access lumen (e.g., duodenum), readjusting its position if necessary; (10) inflating the shunt's proximal anchor; (11) optionally performing a second dilation step, either by inflating the shunt's center connecting section or by positioning and activating a second dilation element inside the shunt's inner lumen, further opening the tract through the lumen walls; (12) inflating the shunt's center connecting section (if configured for inflation, and if not already inflated in a previous step); (13) detaching the inflation elements from the fully inflated shunt; (14) withdrawing the delivery system; and (15) withdrawing the endoscope.

The delivery system can be configured as a single, multi-purpose tool such as that shown inFIG. 21which incorporates all of the components for performing the necessary steps and delivering the inflatable shunt2100. Alternatively, more than one tool may be used to deliver the inflatable shunt. Each tool may be used to perform a single step, or each tool may perform two or more steps, together comprising a kit of tools for delivering the proposed inflatable shunt.

A delivery system that combines all necessary components into a single device for delivering the inflatable shuntFIG. 21is configured to be insertable through the tool channel of the endoscope. The inner diameter of typical endoscopic tool channels range from about 2.8 mm and 5 mm. The delivery system preferably incorporates at least some of: a needle21280; a dilation component21310, or cutting tool, for the initial enlargement of the needle puncture (if said dilation component is an electro-surgical component, it may incorporate one or more electrodes21350to advance through tissue and enlarge the puncture); an inflatable shunt2100in its initial/deflated configuration; an advancement mechanism21320that positions the dilation component21310and the inflatable shunt2100relative to the needle21280; inflation element(s)21330that deliver(s) inflation material, energy, or component(s) that causes the inflation of the inflatable shunt2100or separately inflatable sections of a first inflatable anchor2110a second inflatable anchor2120and a connecting section2130; an optional second dilation element for enlarging the tract through the lumen walls occupied by the shunt's central connecting section31340, which may itself be slidably positionable relative to the inflatable shunt2100, the dilation component21310, and/or the needle21280; and a handle for user controls. For a configuration of a delivery system, the needle21280serves as both the initial access element and the guidance element for all subsequent steps. After the needle21280punctures from the access lumen into the target lumen, the components that perform subsequent steps optionally slide axially over the needle shaft (e.g., the dilation component21310, the inflatable shunt2100, the second dilation component21340). An optional exception to the use of the needle as the guidance element for all steps is the insertion of the second dilation component21340, which may optionally be performed without using the needle21280to guide the second dilation component21340.

The inflatable shunt2200shown inFIG. 22has a first inflatable anchor2210, a second inflatable anchor2220and a connecting section2230, and may optionally be covered by a sheath22360during delivery, in which case a positioning component22320may be incorporated that moves the sheath22360relative to the shunt. In a further variation, a separate advancement mechanism independently positions the inflatable shunt2200relative to the needle22280, the dilation component(s)22310, and/or the sheath22360for the inflatable shunt2200, should one be used.

Preferably, the initial dilation component21310shown inFIG. 21comprises an electro-surgical tool, and enlarges the puncture through the tissue made by the needle by selectively applying radio frequency (RF) energy. In such an embodiment, the initial dilation component incorporates at least one or more electrodes21350for electro-surgical cutting, which is electrically connected to an electro-surgical RF energy source outside the body of the patient. Alternatively, mechanical dilation components may be used instead of electro-surgical electrodes (e.g., a conical or progressively stepped dilator, Savary dilator, Maloney dilator, Hurst dilator, Soehendra dilator, Bougie-over-wire dilators).

The dilation component21310may incorporate at least one or more electrodes21350at or near its leading (distal) tip so that radio-frequency (RF) energy may be applied to the tissue to create a larger path through the tissue walls. Incorporating electrodes21350that are radially arrayed helps ensure that at least one electrode, of the more than one electrodes incorporated, contacts tissue and thus enlarges the puncture and enables the dilation component to advance into the target lumen. The initial dilation component may be positioned coaxially over the needle21280, and slideable over the needle shaft, which acts as a guide. An advancement mechanism21320that positions the dilation component21310extends from the delivery system handle to the dilation component21310so that the user may manipulate and control the position of the dilation component21310during a procedure. Once the dilation component21310has been advanced over the needle shaft, through the wall of the access lumen (e.g., duodenum), and through the wall of the target lumen (e.g., gallbladder), the tract through the tissue walls accommodates the insertion of the inflatable shunt2100.

In a configuration of the delivery system shown inFIG. 21, the inflatable shunt2100, in its initial/deflated configuration, is positioned behind the leading edge of the dilation component21310, and mounted in such a way that the advancement mechanism for positioning the dilation component21310also positions the inflatable shunt2100. That is, advancing the dilation component21310into the target lumen (e.g., gallbladder) also advances at least a portion of the inflatable shunt2100(e.g., the distal anchor) into the target lumen (e.g., gallbladder). Inflation of the inflatable shunt's distal anchor may be performed with an inflation element21330, which in the embodiment is a tube.

As shown inFIG. 23A, when the distal anchor2320is in position and inflated, tension may be applied to the shunt positioning component21320, either individually or together with the needle21280, so that the shunt's distal anchor2320is pulled against the inner surface of the lumen wall tissue (e.g., the inside surface of the gallbladder). With the distal anchor2320inflated, the risk of pulling the inflatable element2300back out through the dilated needle tract is reduced. When the proximal anchor2310of the inflatable shunt is in the desired position within the access lumen (e.g., the duodenum), the proximal anchor2310may be inflated with an inflation element23330(in an embodiment, a tube). Together, the distal anchor2320and proximal anchor2310, when inflated, secure the inflatable element2300across the walls of the connected lumens, with the proximal anchor2310and the distal anchor2320positioned within one of each of the lumens. The central connecting section2330of the inflatable element2300may be inflated with an inflation element23330(in an embodiment, a tube).

In a variation of this method, the inflatable element2300may be inflated in a single step. In some cases, the inflatable element2300is configured with a single interior lumen for inflationFIG. 23B. In such cases, the initial position of the inflatable element2300is such that the distal anchor2320is inside the target lumen (e.g., gallbladder), the proximal anchor2310is inside the access lumen (e.g., duodenum), and the central connecting section2330extends across the tract in the walls of both the access and target lumens. Alternatively, an optional slideable sheath22360shown inFIG. 22) may be used to cover and constrain all or part of the inflatable element2300, preventing individual portions from inflating, while other portions are uncovered and allowed to inflate. Further, in cases where all the inflatable sections of the inflatable shunt illustrated inFIG. 23are connected and inflated together, the timing of the inflation of each section may be controlled and sequenced by connecting the sections with channels23370of varying size, inner cross-sectional area, and/or length adding a desired degree of resistance to the flow of the inflation material from the first chamber to a second chamber, and, if desired, a third chamber. In one example, if it is desired to inflate the distal anchor first2320, followed by the proximal anchor2310, or flange, and finally the central connecting section2330, a single inflation port23110may be positioned to connect directly to the distal anchor2320with minimal flow restrictions. The distal anchor2320inflation chamber may be connected to the second inflatable anchor2310via a small channel23370(e.g., about 0.001″-0.010″), and this may in turn be connected to the inflation chamber of the central connecting section2330via another channel23370of similar, or dissimilar, size. In general, when a first chamber is inflated through the inflation port, it will first fill with inflation material at low pressure (insufficient to cause significant flow of inflation material to the second chamber). The introduction of additional inflation material into the first chamber will cause the pressure in the inflation chamber to increase to the point where the flow of inflation material into the second chamber occurs at a useful, selectable, rate (e.g., between about 1 second and 60 seconds). Once the second inflation chamber has filled with inflation material and pressure increases within the chamber to a desired amount, flow of inflation material into the third chamber increases to a desired amount, and the third chamber inflates at a desired rate (e.g., between about 1 second and 60 seconds). In this way, the process of sequentially inflating sections of an inflatable element2300that share a common inflation chamber, or more than one chamber connected via small channels, may be made to inflate sequentially in a controlled, timed, and selectable manner.

A small tract connecting the target and access lumens through the inner lumen of the inflatable shunt may be sufficient for the drainage of fluids, however larger tracts will provide improved drainage, and/or accommodate the insertion of items such as endoscopes or endoscopic tools into the target lumen (e.g., gallbladder), or for the extraction of material, such as gallstones, bile sludge, and the like. An inner diameter of the inner lumen of the inflatable element2300of at least 5 mm is desirable for enabling drainage and providing access for procedures through the inflatable element2300, with still larger inner diameters of approximately 8-12 mm providing still better drainage and access, thereby enabling a greater number and variety of such treatments.

As depicted inFIG. 24, when the inflatable shunt2400having a first inflatable anchor2410and a second inflatable anchor2420and an aperture2440therethrough, is in position across the walls of the access and a first target lumen2450and a second target lumen2460, if the connecting section2430of the inflatable shunt2400is configured to be inflatable, and further configured so that it forcefully expands when it is inflated, this may be sufficient to dilate the tract through the walls of the first target lumen2450and the second target lumen2460to the desired extent. Further, the forceful expansion of the connecting section2430may serve to seal the interface between the tissue of the first target lumen2450and the second target lumen2460and the connecting section2430of the inflatable shunt2400, reducing the risk of leaks of fluid or other materials from the inside of a lumen to the outside (e.g., preventing the leakage of bile from the gallbladder into the peritoneum), or in the reverse direction. The connecting section2430can be centrally positioned. The characteristic expansion of the connecting section2430may be controlled so that the internal pressure delivered to the connecting section2430when inflated correlates to a known degree of expansion/dilation or dimensional size (e.g., inflating the center connecting section to a pressure of 5 atm may be selected to result in an outer diameter of 12 mm). Optionally, dilation may be achieved by a dilation balloon that is separate from the connecting section2430of the inflatable shunt2400but integral with it, so that it may be activated to dilate the tissue, and then deactivated, after which point the connecting section2430of the inflatable shunt2400holds the tract open and connects the access and target lumens.

FIG. 25shows a configuration where the connecting section2530is configured to expand radially outward when inflated, but not so forcefully as to dilate the tract through the tissue, which may serve to seal the interface between the tissue2550,2560and the connecting section2530of the inflatable shunt device2500An additional component (e.g., a separate dilation balloon25380) may be used to dilate the tract through the tissue once the inflatable shunt device2500is securely in place. For example, with the distal anchor2520and proximal anchor2510inflated in the desired locations, for delivery systems configured with at least a second dilation element (e.g., as shown in21340), this is positioned within the inner lumen2540of the connecting section2530of the inflatable shunt device2500and activated to dilate the tissue surrounding the inflatable shunt device2500. In an alternate embodiment, for a delivery system that does not incorporate a second dilation element, a separate dilation balloon (e.g., a Boston Scientific 10-11-12 CRE dilation balloon) may be inserted into the inner lumen2540of the inflatable shunt device2500and inflated to the desired pressure and related outer diameter (e.g., about 10-12 mm), to dilate the tissue2550,2560surrounding the connecting section2530. The dilation balloon25380may then be withdrawn from the inflatable shunt device2500, and, in cases where the connecting section2530is inflatable, it may then be inflated. In other cases, the connecting section2530is not an inflatable component, and the procedure does not include a step for inflating it. This dilation step may be performed by other suitable dilation tools and methods, such as conical or progressively stepped dilators, Savary dilators, Maloney dilators, Hurst dilators, Soehendra dilators, Bougie-over-wire dilators).

With the inflatable shunt in position and fully inflated, the delivery system may then be removed from the patient as shown inFIG. 26. The first step in the removal process is to detach the inflation element(s) from the inflated shunt. Depending on the configuration of the inflatable shunt and the mechanism(s) by which the shunt is inflated, this may involve, for example, detaching a tube or tubes through which fluid is caused to flow. In these cases, this may be achieved by applying tension to the inflation element, which pulls it free from the inflatable shunt. A number of inflation materials have been described elsewhere in this application, as well as the inflation elements used to deliver, manipulate, mix, and/or activate them, and it shall be understood that each of these embodiments will have its own mechanisms for sealing and detaching the inflation element from the inflated shunt. Once the inflation element is detached from the inflated shunt, the delivery system or separate tools comprising the delivery system, including the initial dilation component and the needle, may be withdrawn from the shunt. In an optional step, the needle is first withdrawn into a protective sheath, which may comprise at least a portion of the dilation component, so that the sharp tip of the needle does not injure tissue that it comes into contact with, nor damage the inflatable shunt. Once the initial dilation component and needle have been withdrawn from the inflated shunt, the delivery system may be withdrawn into the endoscope, and, in a final step, the endoscope may be withdrawn from the patient. At this point, the delivery procedure is complete.

It should be understood that the delivery method and delivery system are representative of only one approach for delivering the inflatable shunt, and that other devices and methods are possible and shall also be considered to be incorporated in this application. For example, rather than delivering the inflatable shunt over a needle, a guidewire may first be placed (for example, with a needle), and the guidewire may serve as the guide for a delivery system or a number of delivery tools that together comprise a delivery system. Alternatively, a guidance catheter may slide over the guidewire, and the guidance catheter may provide the access for a delivery system or a number of delivery tools that together comprise a delivery system. Alternatively, the inflatable shunt may be surgically implanted, rather than endoscopically, in which case, the surgeon delivers the shunt through an incision (which may be a minimally invasive incision, e.g., through a port or cannula) to a site for implantation. Though the delivery systems or tools and the implantation processes described throughout this application use the duodenum as the exemplar access lumen and the gallbladder as the exemplar target lumen, any two lumens that are initially in suitable proximity to each other (e.g., the stomach and a pancreatic pseudocyst, the stomach and the jejunum), and accessible by surgical, endoscopic, laparoscopic, or other suitable procedures, shall be considered as alternate and applicable examples of intended uses for the proposed devices.

Numerous methods and tools may be employed to remove the inflatable shunt from the implantation site when it is no longer needed or desired within the body. In cases where the shunt is inflated with material that is tolerated by the body (e.g., biocompatible materials, such as saline, CO2), the balloon may be pierced, cut, punctured, ruptured, or otherwise compromised, so that the inflating material is released from the shunt. In some cases, the inflation port may be opened, unstopped, unglued, etc. Once the shunt has been deflated, it may be removed with an endoscopic tool, such as a grasper, a snare, a loop, to grasp the shunt and withdraw it from the body. Alternatively, the deflated shunt may be allowed to exit the body via a natural process, such as peristalsis. Further, if the shunt is bioabsorbable or resorbable, it may be left in place as long as desired, while it is dissolved, absorbed, or otherwise eliminated from the body.

In an alternate method for inflatable shunts that incorporate inflation/deflation ports to which inflation or deflation elements may be attached and detached, rather than compromising the integrity of the inflatable shunt to deflate it, a deflation element may be attached to one or more of the ports and the inflation material may be withdrawn from the shunt, e.g, via suction. The deflated shunt may then be removed from the body in any of the ways previously described.

In a further alternate method, inflatable shunts that are filled with activatable inflation materials may be deflated by deactivating the inflation material. For example, in cases where an activatable inflation material (e.g., one that includes nanotubes) is activated via illumination by light with specific properties (e.g., wavelength, intensity, duration, power, etc.) and deactivated via light with properties that may be the same or different from the light that activates the material, the inflation material may be withdrawn from the inflatable shunt once it is deactivated. The deflated shunt may then be removed from the body in any of the ways previously described.