MULTI-LUMEN BALLOON CATHETERS SUITABLE FOR BALLOON OCCLUSION CHOLANGIOGRAPHY AND SPHINCTER OF ODDI DILATION AND RELATED METHODS OF USE

Multi-lumen catheters with first and second expandable members are configured so that one expandable member dilates the Sphincter of Oddi and the second anchors within the biliary duct distal to the Common Bile Duct/Cystic Duct junction or within the cystic duct. The multi-lumen catheters include a primary lumen sized and configured for delivering a flushing agent to remove gallstones together or separately with a dye to complete a Cholangiogram and also include at least one lumen in fluid communication with the first and second expandable members.

FIELD OF THE INVENTION

The present invention relates to surgical devices suitable for gastroenterology.

BACKGROUND

Choledocholithiasis is the presence of stones within the common bile duct. Bile stasis, bactibilia, chemical imbalances, increased bilirubin excretion, pH imbalances, and the formation of sludge are some of the factors which lead to the formation of these stones [1]. The incidence of choledocholithiasis has risen substantially in the last 3 decades and its management creates logistical and therapeutic challenges for surgeons [2-4]. It is noted that several publications and patent documents are cited in the background and specification of this patent application by footnote or journal reference. Each of these citations is incorporated herein by reference in their entirety as though set forth in full.

Choledocholithiasis can be managed safely by either open or laparoscopic cholecystectomy (LC) with pre-/post-operative endoscopic retrograde cholangiopancreatography (ERCP) or open or LC with intraoperative open common bile duct exploration (CBDE) or laparoscopic common bile duct exploration (LCBDE) [5-8]. LC with pre-/post-operative ERCP is a multistep process, while LC+LCBDE, for example, has the advantage of being a one-step, one-anesthetic process [9-11]. Despite this advantage, ERCP before or after cholecystectomy has firmly supplanted both CBDE and LCBDE nationwide [12]. This trend has persisted despite multiple reports of the efficacy and safety of LCBDE, specifically, and the associated decrease in hospital costs and length of stay [13-14].

One of the most significant factors contributing to the shift from LCBDE and to ERCP is believed to be the associated learning curve of the techniques involved in LCBDE, and in particular those involved in common duct clearance and the real/perceived logical hurdles at the time of laparoscopic cholecystectomy and the myriad device and technique options. Addressing those challenges may allow for broader adoption of LCBDE and be a benefit to patients.

SUMMARY

Embodiments of the present invention provide a treatment system that can be used with a single intrabody insertion of a single multi-lumen catheter and is configured to drive adoption of LCBDE by allowing for an efficient and relatively simple-to-implement intervention.

Embodiments of the present invention are directed to a multi-lumen catheter that includes longitudinally spaced apart first and second expandable members. The first expandable member is sized and configured for dilating the Sphincter of Oddi and the second expandable member is sized and configured for anchoring the catheter anywhere in the biliary tree to create different size seals such as within the biliary duct distal to the Common Bile Duct/Cystic Duct junction or within the cystic duct. The multi-lumen catheter has a lumen configured for delivering a fluid for flushing to remove gallstones, together or separately with a dye, to complete a Cholangiogram.

Embodiments of the present invention are directed to related methods of treatment using the multi-lumen catheter.

Embodiments of the present invention are directed to a multi-lumen catheter that includes: a catheter body having opposing proximal and distal end portions; a first expandable member on the distal end portion; a second expandable member on the distal end portion, longitudinally spaced apart from the first expandable member; and a primary lumen that extends longitudinally and that is open at opposing proximal and distal ends thereof. The distal end of the primary lumen resides distally of the first and second expandable members. The multi-lumen catheter also includes at least one additional lumen in fluid communication with the first and second expandable members to controllably inflate and deflate the first and second expandable members.

The second expandable member can be distal of the first expandable member and can have a longitudinally extending length that is less than a length of the first expandable member.

The first expandable member can have/be formed of/a material with a first durometer. The second expandable member can have/be formed of/a material with a second durometer. The first durometer can be greater than the second durometer whereby the first expandable member can be configured to have less flexibility than the second expandable member thereby providing a non-compliant body suitable for dilating a sphincter or other target tissue.

The first expandable member can have a fully inflated state defining an outer diameter. The second expandable member can have a fully inflated state defining an outer diameter. The outer diameter of the first expandable member can be less than the outer diameter of the second expandable member in respective fully inflated states.

A length of the first expandable member can be 2-4 times greater than a length of the second expandable member.

The first expandable member can be closely spaced apart from the second expandable member by a longitudinal distance that can be in a range of 0.5 mm-20 mm.

The multi-lumen catheter can also include valves upstream of the first and second expandable members in fluid communication with the at least one additional lumen. The first and second expandable members can be independently/separately inflatable and deflatable.

The catheter body can be sized and configured for placement through a transductal opening in a biliary tree and the distal end portion can be sized and configured to distally terminate and be able to slidably extend into and retract from a duodenum of a patient.

The primary lumen can be coupled to a syringe comprising liquid and can be configured to allow liquid to pass through the distal end of the primary lumen into a duct of a patient.

The primary lumen can be configured to allow a medical device to be deployed through the primary lumen into the duct of the patient.

The deployable medical device can be an interventional wire.

The deployable medical device is a stone retrieval basket

The liquid can include saline.

The liquid can include a contrast agent.

The liquid can include a mixture of saline and a contrast agent.

The multi-lumen catheter can further include a plurality of longitudinally spaced apart radiopaque markings that can be positioned along the distal end portion of the catheter body thereby allowing visual indication of a location of one or both of the first and second expandable members in a medical image.

The first expandable member can have an elongate shape and can be made of a semi-rigid material. The second expandable member can have a spherical shape when inflated and can be formed of a material with increased flexibility relative to the first expandable member.

The first expandable member can be configured to expand to a diameter sufficient to dilate a target sphincter.

The diameter can be in a range of 1 to 20 mm.

The diameter can be in a range of 4 to 10 mm.

The multi-lumen catheter can further include a rotational inflation device coupled to a first lumen, the first lumen being provided by the at least one additional lumen. The first lumen can be in fluid communication with the first and/or second expandable member, typically the elongate first expandable member.

The second expandable member can be sufficiently compliant to expand to conform to and seal against surrounding tissue in apposition to walls of a duct in a biliary tree that it inhabits.

The second expandable member can be sized and configured to inflate to occlude a duct to facilitate pressurization and flushing of a distal portion of the duct.

The duct can be a biliary duct distal to a Common Bile Duct.

The duct can be a biliary duct distal to a Cystic Duct junction.

The duct can be a biliary duct within the cystic duct.

Other embodiments are directed to a method for using the multi-lumen catheter with the first and second expandable members. The methods include: a) advancing the multi-lumen catheter over a previously placed guidewire through a formed or natural orifice in a body of a patient toward a duodenum; b) at least partially inflating the first expandable member when the first expandable member is past a sphincter and in the duodenum; c) at least partially deflating and pulling back the first expandable member to traverse the sphincter; d) inflating the first expandable member to stretch the sphincter while the first expandable member straddles the sphincter; then e) deflating the first expandable member and pulling the multi-lumen catheter and guidewire together back in a proximal direction; then f) inflating the second expandable member to form a barrier in a duct; and g) discharging liquid from the multi-lumen catheter to flush debris in a distal direction out of a duct of a biliary tree.

The previously placed guidewire can be placed in a location that is provided from a transabdominal access site with a treatment path that enters into the biliary tree and distally terminates in the duodenum.

The inflation of the second expandable member to form the barrier in the duct can be within the biliary tree, and wherein the first expandable member can be at least partially deflated and reside outside the biliary tree or in the biliary tree when the second expandable member forms the barrier in the duct.

The discharged liquid can include saline.

The discharged liquid can include a contrast agent.

The discharged liquid can include a mixture of saline and a contrast agent(s).

The method can further include obtaining an X-ray of the biliary tree with the multi-lumen catheter in the patient after or during the discharging of the liquid.

The method can include deploying a medical device from a distal end of the multi-lumen catheter to dislodge or capture debris in a distal portion of the duct.

Yet other embodiments are directed to a biliary treatment system. The system include: a multi-lumen catheter comprising first and second expandable members on a distal end portion thereof. The multi-lumen catheter has a primary lumen and at least one additional lumen residing adjacent thereto and extending longitudinally. The distal end portion includes radiopaque markers. The system also includes a syringe with liquid coupled to the multi-lumen catheter and in fluid communication with the first and/or second expandable members and configured to inflate and deflate the first and/or second expandable members. The system also includes a Touhy-Borst connector coupled to the multi-lumen catheter and in communication with the primary lumen.

The syringe can be in fluid communication with only the second expandable member. The biliary treatment system can also include a rotational inflation device in fluid communication with the first expandable member to controllably inflate and deflate the first expandable member.

The biliary treatment system can also include a guidewire configured to be slidably received in the primary lumen.

The second expandable member can be distal of the first expandable member and can have a longitudinally extending length that is less than a length of the first expandable member.

The first expandable member can have/be formed of/a material with a first durometer. The second expandable member can have/be formed of/a material with a second durometer. The first durometer can be greater than the second durometer whereby the first expandable member is configured to have less flexibility than the second expandable member thereby providing a non-compliant body suitable for dilating a cystic duct and/or a sphincter.

The first expandable member can have a fully inflated state defining an outer diameter. The second expandable member can have a fully inflated state defining an outer diameter. The outer diameter of the second expandable member can be at least 50% greater than the outer diameter of the second first expandable member in respective fully inflated, operational, states.

A length of the first expandable member can be 2-4 times greater than a length of the second expandable member.

The first expandable member can be closely spaced apart from the second expandable member by a longitudinal distance that can be in a range of 0.5-20 mm.

The biliary treatment system can further include valves upstream of the first and second expandable members in fluid communication with the at least one additional lumen. The first and second expandable members can be independently/separately inflatable and deflatable.

The first expandable member can have an elongate shape and can be made of a semi-rigid material. The second expandable member can have a spherical shape when inflated and can be formed of a material with increased flexibility relative to the first expandable member.

The biliary treatment system can further include a medical device that is sized and configured to slidably deploy from a distal end of the multi-lumen catheter.

The first expandable member can be configured to dilate in a region of interest, such as a sphincter or cystic duct, in response to inflation pressure in a range of 1 atm to 10 atm to expand to an inflated state. The second expandable member can be configured to seal against walls of a duct in an inflated state having a larger outer diameter in response to inflation pressure that is lower than the inflation pressure applied to the first expandable member to inflate to one or more of its inflated operational inflated diameters and while the first expandable member is in at least a partially deflated state.

Still other aspects of the present invention are directed to a method for using the multi-lumen catheter with the first and second expandable members. The method includes: a) advancing the multi-lumen catheter over a previously placed guidewire through a formed or natural orifice in a body of a patient toward a duodenum; b) inflating the second expandable member to form a barrier in a duct in a biliary tree downstream of a cystic duct to thereby anchor the first inflatable member in the cystic duct; and c) inflating the first expandable member in the cystic duct to dilate the cystic duct.

The method can also include deflating the first and second expandable members, separately or concurrently, then withdrawing the catheter from the cystic duct, then inserting a choledochoscope into the dilated cystic duct to perform a medical procedure to thereby remove a stone or stones from the biliary tree.

DETAILED DESCRIPTION

The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. The abbreviation “FIG.” may be used interchangeably with “Fig.” and the word “Figure” in the specification and figures. It will be appreciated that although discussed with respect to a certain embodiment, features or operation of one embodiment can apply to others.

In the drawings, the thickness of lines, layers, features, components and/or regions may be exaggerated for clarity and broken lines (such as those shown in circuit of flow diagrams) illustrate optional features or operations, unless specified otherwise. In addition, the sequence of operations (or steps) is not limited to the order presented in the claims unless specifically indicated otherwise.

It will be understood that when a feature, such as a layer, region or substrate, is referred to as being “on” another feature or element, it can be directly on the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly on” another feature or element, there are no intervening elements present. It will also be understood that, when a feature or element is referred to as being “connected” or “coupled” to another feature or element, it can be directly connected to the other element or intervening elements may be present. In contrast, when a feature or element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Although described or shown with respect to one embodiment, the features so described or shown can apply to other embodiments. The term “about” means that the noted number can vary by +/−20%.

Referring toFIGS.1A,2A-2Can example multi-lumen catheter10is shown. The multi-lumen catheter10has a catheter body15with a primary lumen18that is open from a proximal end portion15pthrough a tip15tat the distal end portion15d. The distal end portion15dcomprises a first expandable member20and a second expandable member30. The expandable members20,30can be interchangeably referred to as “inflatable members” which can be inflated to expand the expandable members20,30using a fluid source such as a gas and/or a liquid.

As will be discussed further below, the multi-lumen catheter10can include a catheter body15with a proximal end portion15pthat comprises a plurality of connectors40,50,60. Some or all of the connectors40,50,60can cooperate with fluid sources that together form a treatment system100.

The catheter10can have a longitudinally extending length that is in a range of 50-80 cm. The catheter body15can have an outer diameter that is in a range of 4FR to 6FR. The catheter10can be suitable for human and veterinarian medical uses.

The catheter10can include one more radiopaque markers200on the distal end portion15dof the catheter body15. As shown, one of the one or more radiopaque markers200can reside at a distal end20dof the first expandable member20. As shown, one of the one or more radiopaque markers200can reside at a proximal end20pof the first expandable member20. One or more of the one or more radiopaque markers200can extend adjacent the second expandable member30, shown as closer to a distal end30dthereof than a proximal end thereof.

FIG.1Billustrates the first expandable member20residing closer to the distal end portion15dof the catheter body15than the second expandable member30. This embodiment will result in a modification of the workflow/method steps described below with respect toFIGS.3-13and may be less efficient in certain uses relative to the embodiment shown inFIG.1A.

FIG.2Adepicts connectors and fluid source components that are commercially available and can be attached to the multi-lumen catheter10. As shown, the treatment system100includes a pressurized fluid source140, shown as a syringe140s, for selectively inflating/deflating the second inflatable member30(which can be a round compliant balloon). As also shown, the treatment system100also includes a Touhy-Borst Connector155that can be in communication with the primary lumen18. The system100can also include a rotational inflation device148in fluid communication with the first inflatable member20for inflation/deflation thereof (e.g., a non-compliant elongate balloon). The treatment system100also includes a fluid source150, shown as a contrast/saline flush injection syringe150s, in fluid communication with the primary lumen18.

The treatment system100can also include a guidewire35, which can be for catheter guidance which may be configured with a floppy tip. However, other configurations of guidewires may be used. The guidewire35that has an outer diameter in a range of about 0.018-0.038 inches, more typically about 0.38 inches. The guidewire35can be slidably received through the primary lumen18and the connector155.

Each connector40,50,60can be attached to a valve40v,50v,60v, for selectively allowing fluid in or out of the lumen associated therewith. Extension conduits141,149,151,161can also be used to form part of flow paths of the treatment system100, some of which can be longer than others.

The multi-lumen catheter10can be configured for dilating the Sphincter of Oddi with the first expandable member20and anchoring a distal end portion of the catheter10in position with the second expandable member30at any location in the biliary tree such as within the biliary duct distal to the Common Bile Duct/Cystic Duct junction or within the cystic duct. The second expandable member30is configured to expand sufficiently and to different outer diameters to seal to tissue at those different locations. As shown inFIGS.1A,2A, the second expandable member30can be distal of the first expandable member20. In other embodiments, as shown inFIG.1B, the second expandable member30can be proximal of the first expandable member20, e.g., the positions of the first and expandable members20,30shown inFIG.1Acan be reversed.

The multi-lumen catheter10is configured to deliver a flushing agent(s) and/or one or more interventional devices (e.g., wire-based stone retrieval devices) to remove gallstones. The flushing agent(s) can be delivered via a lumen such as the primary lumen18together with a dye or the dye can be delivered separately to complete a Cholangiogram.

The primary lumen18may be configured as a central lumen18. The primary lumen18has an open proximal end18pcoupled to connector50that branches to connector155, adjacent the proximal end15pof the catheter body15. The multi-lumen catheter10can have at least one additional lumen21, referred to as a second lumen21. The second lumen21can extend longitudinally and can reside adjacent the primary lumen18, in fluid communication with and configured to accommodate and deploy one or more of the expandable members20,30attached to the distal end portion15dof the catheter10.

While the same lumen can be used to inflate/deflate each of the first and second inflatable members20,30, in other embodiments the multi-lumen catheter10can have dedicated separate lumens21,31(FIG.2C) for each inflatable member20,30. Thus, the multi-lumen catheter10can include a possible third lumen31, which can longitudinally extend adjacent to the primary lumen18and/or the second lumen21. The second lumen21can be in fluid communication and accommodate and deploy the first expandable member20and the third lumen31can be in fluid communication and accommodate and deploy the second expandable member30.

The primary lumen18can slidably receive or accept a guidewire35to allow the multi-lumen catheter10to be advanceable thereover to a desired intrabody position. In use, the guidewire35can be placed in position in the body and the multi-lumen catheter10can then be advanced into place along the guidewire35.

The primary lumen18, or an additional lumen, can also be attached to a fluid source150, such as a liquid filled syringe150s, to allow liquid to pass through the distal end18dof that lumen18(or the additional lumen) for deployment in the duct. The liquid can include a flushing agent comprising saline in order to flush the location of gallstones and other natural products. The flushing agent can comprise a contrast agent in order to opacify the biliary tree during diagnostic cholangiography.

In some embodiments, the primary or central lumen18can be attached to a liquid filled syringe150sand can also be configured to allow one or more other low-profile medical devices250(FIGS.18,19) to pass through the distal end18dof the lumen18at the tip15tof the catheter body15for deployment in the duct. The devices250,250′ can be inserted through the primary lumen18and can include, but are not limited to, an interventional wire, electrical or ultrasonic probe, a probe for laser lithotripsy, and/or a stone retrieval basket.

As discussed above, the second and third lumens21,31(or lumina) can each be in fluid communication with and deploy a respective expandable member20,30. The second lumen21can be used to deploy the first expandable member20. The first expandable member20can sometimes referred to as the “first”, “semi-flexible”, “elongated”, “non-compliant” or “semi-compliant” balloon. Sometimes terms are combined such as an “elongated, non-compliant expandable member.” It is attached to the distal end portion15dof the catheter body15in fluid communication with the second lumen21. In some embodiments, this first expandable member20has an elongate shape and is made from semi-flexible material. The first expandable member20can be non-compliant in order to move the tissue and fully inflate. The terms “semi-flexible” and “non-compliant” means that the first expandable member20has sufficient structural rigidity to be able to force a restriction in the sphincter to open when exposed to forces of the surrounding tissue. The first expandable member20can be elongate/elongated and be configured to expand using high pressure fluid to a target, controllable, outer diameter, such as to 6 mm, 8 mm, 10 mm, and the like. The first expandable member20can be in fluid communication with a high-pressure rotational inflation source148(FIG.2A). The high-pressure inflation source148can provide inflation pressures of at least about 1 atm, such as inflation pressures in a range of about 1 atm to about 10 atm to inflate the first expandable member20. In some embodiments, this first expandable member20is not limited to a semi-flexible material or an elongated shape. As will be appreciated by those of skill in the art, the first expandable member20can alternatively be configured as a semi-compliant (mid-pressure) balloon rather than a non-compliant (high-pressure) balloon in some particular embodiments.

The third lumen31can be configured to deploy the second expandable member30. This second expandable member30is sometimes referred to as the “second”, “flexible”, “round”, or “compliant” balloon. Sometimes termed are combined. It can be attached to the distal end portion15dof the catheter body15at the end of the third lumen31. This second expandable member30can have a spherical shape (a round, 2-dimensional shape) and can be made from flexible material and/or a material that has a greater flexibility than the first expandable member20. The second expandable or inflatable member30can be sufficiently compliant to open and conform to and/or seal against, the surrounding tissue and fully inflate in apposition to the walls of the duct that it inhabits. The second expandable member30can be inflated to a larger outer diameter than the first expandable member20.

The second expandable member30can be inflated to a maximal outer diameter that is greater in size than a maximal outer diameter of the first expandable member30such maximal outer diameter can be generated using lower inflation pressures relative to the first expandable member20, typically 40% or less inflation pressure. The lower pressures can be in a range of about 5 mmHg to about 200 mmHg, in some embodiments. The second expandable member30can be inflated/deflated using a syringe140s(FIG.2A) comprising fluid. The second expandable member30can be configured to inflate to a 6 mm-20 mm outer diameter, with 20 mm defining a maximal outer diameter, in some embodiments. The second expandable member30can inflate by volume rather than by pressure. The second expandable member30can (elastically) stretch by 100-800%, in some embodiments. In some embodiments, this second expandable member30is not limited to a flexible material or a spherical shape.

The first expandable member20can have a wall thickness that is greater than a wall thickness of the second expandable member30. The first expandable member20can be formed of a material of high durometer such as, for example, medical grade polyurethane of high durometer. The first expandable member20can be formed of medical grade polyester, silicone or nylon. The second expandable member30can be formed of a lower durometer medical grade material such as polyurethane of lower durometer than the first expandable member20to have greater compliance and/or greater expandability at a lower inflation pressure(s) relative to the first expandable member20. Other medical grade materials may be used.

Both the second and third lumen21,31, where used, can be attached to the same or a different fluid source, such as a fluid filled syringe(s) to allow fluid, gas and/or liquid, to move through the lumen into the respective expandable member20,30, to inflate and to reverse the flow to back out through the lumen back into the syringe to deflate the corresponding expandable member. In another embodiment, the second and third adjacent lumen21,31can be attached at the proximal end to the same or a different rotational inflation device, such as rotational device140shown inFIG.2A, to controllably inflate and deflate the respective expandable members,20,30.

As discussed above, the first expandable member20can be dilated to a specific diameter to dilate the Sphincter of Oddi, such as a diameter in a range from 1 to 20 mm or in a range from 4 to 10 mm, in some embodiments. The desired/target diameter for the inflation can vary depending on a particular patient.

In some embodiments, one or more additional lumens are attached to the catheter10. These additional lumens can include but are not limited to having, closed or open distal ends, expandable members at distal ends, the ability to connect syringes or rotational inflation devices at proximal ends, the ability to accommodate flushing agents and contrast agents and/or low-profile devices250other useful characteristics.

The first and second expandable members20,30can be controllably, separately (independently) inflated and deflated at different times during a treatment procedure.

FIG.2Billustrates that the first expandable member20has a length L1, the second expandable member30has a length L2and the first and second expandable members20,30are spaced apart a longitudinal length L3. As shown, L1>L2and L1>L3. In some embodiments, L1is in a range of 4-20 mm, more typically in a range of 4-10 mm, such as about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm. In some particular embodiments, L2can be in a range of 0.5 mm-10 mm, such as about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm and about 10 mm.

When each is in a fully inflated state, the second expandable member30can have an increased outer diameter relative to the first expandable member20. In some embodiments, the second expandable member30can expand to an outer diameter in a range of 10 mm-2 cm when fully inflated, while the first expandable member20can expand to an outer diameter that is 10%-400% less than the second expandable member30, measured when each are in a fully inflated state. The desired outer diameter of each of the expandable members20,30can vary depending on the target anatomy of a particular patient.

In some embodiments, the first expandable member20expands by 2-4× less than the second expandable member30, with both in fully inflated operational states.

In some embodiments, the outer diameter of the second expandable member30can be at least 1.1×-10× greater, typically at least 50% greater, than the outer diameter of the first expandable member20in respective fully inflated states. For example, in some embodiments, the first expandable member20can be expanded to have an 8 mm outer diameter and the second expandable member30can be expanded to have an outer diameter of 10 mm to 2 cm.

The first expandable member20can have a length L1that is 2×-4× the length of the second expandable member30.

As shown inFIG.2B, L2<L3. In some embodiments, L2>L3. In some embodiments L2=L3. In some embodiments, L3can be in a range of 0.5 mm-2 cm, more typically 1 mm-15 mm, such as in a range of 1-7 mm, such as about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm and about 7 mm. The spacing L3between the first and second expandable members20,30can be important for manufacturability and/or proper anchoring and functionality.

Turning now toFIGS.3-13, example actions for performing a therapeutic/interventional treatment with respect to a biliary tree are described. As is well known to those of skill in the art, the biliary tree is a system of vessels that directs these secretions from the liver, gallbladder and pancreas through a series of ducts into the duodenum. The exit hole into the duodenum is called the papilla of Vater.

FIG.3depicts step1—Initial wire access into the CBD via ureteral stent.

FIG.5depicts step3—Catheter10inserted fully into the duodenum.

FIG.7depicts step5—Noncompliant balloon20pulled back to access location and angle of the sphincter S.

FIG.8depicts step6—Noncompliant balloon20deflated and then pulled back to straddle the sphincter S.

FIG.9depicts step7—Noncompliant balloon20inflated to dilate the sphincter S—correct placement indicated by the “waist” (W) separating first and second larger segments20a,20bin the balloon as it comes up to profile.

FIG.10depicts step8—Noncompliant balloon20fully inflated to dilate the sphincter S—left in position for a period of time such as several minutes, such as 2-10 minutes.

FIG.11depicts step9—Noncompliant balloon20deflated and then pulled back into the CBD/Cystic duct.

FIG.12depicts step10—The distal compliant balloon30is inflated to fill the lumen of the CBD and facilitate high pressure/volume flushing of the stones through the dilated sphincter.

FIG.13depicts step11—High pressure, high volume flushing of the stones through the dilated sphincter S after guidewire35removed.

FIG.14depicts a fluoroscopic image demonstrating step5—Multi-lumen catheter's second balloon (compliant balloon)30is inflated and pulled back to access location and angle of the sphincter.

FIG.15depicts a fluoroscopic image demonstrating step7—Multi-lumen catheter's first balloon (non-compliant balloon)20inflated to dilate the sphincter—correct placement indicated by the “waist” in the balloon as it comes up to profile (arrowhead).

FIG.16depicts an X-ray image of step10—The distal second balloon30(compliant balloon) (arrowhead) is inflated to fill the lumen of the Common Bile Duct and facilitate high pressure/volume flushing of the stones through the dilated sphincter.

FIG.17depicts step11—high pressure/volume flushing of the stones and contrast through the dilated sphincter (arrow) after guidewire35removed. Contrast fills the duodenum (arrowhead).

FIG.18schematically illustrates an interventional (low-profile) device250can be extended out the distal end15dof the catheter body15via primary lumen18to retrieve/disintegrate the stones. The interventional device250can be provided as a wire, electrical probe, laser, ultrasound probe, or basket, by way of example.

FIG.19illustrates that the interventional device can comprise a nitinol basket250′. As is well known to those of skill in the art, advancing and retracting a switch on the basket handpiece opens and closes the baskets distally. The basket250′ can be thread through the Tuohy-Borst connector155and through the working channel/primary lumen18immediately after a filling defect is noted on intraoperative cholangiogram without any additional alterations to the setup. Nitinol baskets are available as tipped or non-tipped. The tipped baskets may be more easily visualized with fluoroscopy but may damage choledochoscopes.

Fluoroscopic images can indicate if a filling defect is present in the distal CBD without the passage of contrast into the duodenum. The second expandable member30can be inflated to seal the CBD. This allows for a cholangiogram to be performed through the balloon and prevents debris from being flushed proximally into the hepatic ducts. For discussions of treatments/devices, and approaches, see: Bosley M E, Zamora I J, Neff L P. Choledocholithiasis—A New Clinical Pathway.Journal of Translational Gastroenterology and Hepatology.2021; 6:35: the contents of which are hereby incorporated by reference as if recited in full herein.

The back aperture of the Tuohy-Borst connector155(FIG.2A) can be closed when performing a cholangiogram and then subsequently opened to accept a (0.035 inch) guidewire35as needed. In order to successfully thread the wire into the system, the catheter10can be backed out of the Tuohy-Borst connector155. The connector155can also be closed-down on the wire once it is in position. This configuration can facilitate a “step-up approach” to dilation of the cystic duct with the non-compliant balloon to create sufficient cystic duct luminal diameter for introduction of other devices such as endoscopes, laparoscopic common bile duct exploration and balloon sphincteroplasty with the next step immediately available to the operator using the same platform. Maximizing the likelihood for success for endoscopic or catheter-based interventions such as balloon sphincteroplasty not only includes a system through which to perform the procedure, but also consideration of operating room ergonomics.

When performing the procedure, one or more monitors in the operating room(s) can be configured to display both the fluoroscopy and laparoscopy images simultaneously. While seemingly a minor point, optimization of the OR (operating room) layout can allow for more favorable working conditions and efficiency. Successful management of the wire and catheters can optionally be facilitated by a team of three people. It can be helpful to have one person maintain forward tension on the catheter10while the primary surgeon manages the flushing and catheter manipulation, and a third person manages the wires and equipment on a back table.

Turning now toFIGS.20A-20D, example actions for performing an alternative workflow for a therapeutic/interventional treatment with respect to a biliary tree are described.FIG.20Adepicts an incision site I, similar to that shown with respect toFIG.3, for use in a ductotomy procedure to remove one or more stones (Stones) in the biliary tree without requiring dilation of a sphincter.

FIG.20Bdepicts that the catheter10can be inserted via the incision site I through the cystic duct (CD) over a previously placed guidewire35so that the second expandable member30resides in the primary biliary channel where it is then inflated to anchor the catheter in position while the first expandable member20remains in the CD.

FIG.20Cdepicts the second expandable member30remains expanded in the primary biliary channel with the first expandable member20is then inflated in the CD to dilate the CD (FIG.20D) in preparation for insertion of a choledochoscope or other medical device.

FIG.20Dillustrates that the catheter10can be removed with the CD having been dilated downstream of the incision site I for passage of the choledochoscope.

Embodiments of the invention will be described further below by way of the following non-limiting Examples.

Examples

Procedure

During an example procedure, the primary or central lumen of the catheter10is advanced over a guidewire35previously placed through a transductal opening in the biliary tree and distally terminating at any length along its path into the duodenum. The first expandable member20is inflated and pulled back to access location and angle of a sphincter. In other embodiments, any expandable member can access location and angle of a sphincter S. Next, the first expandable member20is deflated and pulled back to traverse the sphincter. Once the first expandable member20is across the sphincter, it is inflated to stretch sphincter. In some embodiments, the first expandable member20is left in place for several minutes. This is done so the tissue briefly maintains a preferred shape and form. Once stretching of the tissue is complete, the first expandable member20is deflated and the catheter10is pulled back proximally within the biliary tree. The second expandable member30is inflated in the biliary tree after removing the guidewire35. While the second expandable member30remains inflated, the biliary tree is flushed through the primary or central lumen18with saline and/or contrast. The first expandable member20can remain at least partially, typically totally deflated so as to reside at a common profile with adjacent segments of the catheter body when the second expandable member30is inflated and sealed against local tissue. The first expandable member20can be upstream of the second expandable member and can be in the biliary tree or outside the biliary tree, even potentially outside a cut of the cystic duct. In some embodiments, one or more low-profile medical devices pass through the primary lumen18, such as an interventional wire or a stone retrieval basket.

Methods

The catheter10(FIGS.1A,2A) allows for a cholangiogram to be performed through the lumen of the catheter for the identification of common bile duct stones and delineation of the biliary tree anatomy. The advantage of this system is that the distal tip of the catheter has a round (spherical) balloon30which can be inflated to seal and then pressurize the bile duct distally when performing the cholangiogram and for flushing stones forward into the duodenum before or after dilation of the Sphincter of Oddi. If pressurized flushing is unsuccessful, the distal balloon can be deflated and the elongated proximal balloon20can be advanced to straddle the sphincter. Once the second balloon is in position, it can be inflated to dilate the sphincter which should then facilitate subsequent attempts for forward flushing of the retained stones. For example, after dilation, the smaller balloon30can once again be utilized to seal the duct and flush stones forward into the duodenum. All of these steps can be performed sequentially without the need for device exchanges.

The distal balloon can also be inflated just inside the common bile duct to anchor the catheter at the junction of the cystic duct and common bile duct. This will facilitate positioning and effective inflation of the non-compliant balloon to dilate the cystic duct to enlarge its diameter and permit insertion of other devices such as endoscopes.

The device shown inFIG.1Awas tested in a model in which peanuts were inserted into the common bile duct to act as common bile duct stones. Clearance of the duct was attempted with the novel device and was successful.

Results

Initially fluoroscopy demonstrated the “stones” (peanuts) in the common bile duct of the animal. The common bile duct was sealed with the distal balloon and a subsequent cholangiogram performed with pressurized flushing. The sphincter was dilated by the more proximal elongated balloon. After dilation the proximal balloon was deflated and the catheter withdrawn. The distal balloon re-created a seal for final cholangiogram/power flushing. The “stones” were noted to have advanced forward into the duodenum (FIG.17).

CONCLUSIONS

The balloon occlusion cholangiography and sphincteroplasty catheter is a novel device that allows for performing a cholangiogram, dilation of the sphincter, and pressurized flushing of the CBD without requiring any instrument changes and with a single intrabody insertion to place the multi-lumen catheter. It has been determined to be successful in clearance of common bile duct stones in an animal model and may prove to be helpful in an operative setting. The multi-lumen catheter can provide a double biliary balloon dilator for laparoscopic common bile duct exploration (lap CBDE).

Choledocholithiasis can be managed safely by either laparoscopic cholecystectomy (LC) with pre-/post-operative endoscopic retrograde cholangiopancreatography (ERCP) or LC with intraoperative laparoscopic common bile duct exploration (LCBDE). LC+LCBDE has the advantage of being a one-step, one-anesthetic process. This technique has decreased in utilization over the past decade in the United States.

The multi-lumen catheter10(such as shown inFIG.1A) allows for a cholangiogram to be performed through the lumen of the catheter for the identification of common bile duct stones. The advantage of this system is that the distal tip of the catheter has a (round) balloon30which can be inflated to seal and then pressurize the bile duct distally when performing the cholangiogram and attempting to flush stones forward. If pressurized flushing is unsuccessful, the distal balloon can be deflated and the elongated proximal balloon can be advanced to straddle the sphincter. Once the second balloon20is in position, it can be inflated to dilate the sphincter which then should allow for forward flushing of the retained stones. After dilation, the smaller proximal balloon can once again be utilized to seal the duct and flush stones forward into the duodenum. All of these steps can be performed sequentially without the need for any device exchange. This prototype device was tested in a pig animal model in which peanuts were inserted into the common bile duct to act as common bile duct stones. Clearance of the duct was attempted with the novel device.

Thus, the foregoing is illustrative of the present invention and is not to be construed as limiting thereof. More particularly, the workflow steps may be carried out in a different manner, in a different order and/or with other workflow steps or may omit some or replace some workflow steps with other steps. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention.

Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. In the claims, means-plus-function clauses, where used, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Therefore, it is to be understood that the foregoing is illustrative of the present invention and is not to be construed as limited to the specific embodiments disclosed, and that modifications to the disclosed embodiments, as well as other embodiments, are intended to be included within the scope of the appended claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.

REFERENCES (INCORPORATED BY REFERENCE AS IF RECITED IN FULL HEREIN)