WO2025074196A1

WO2025074196A1 - Devices and methods for transjugular intrahepatic portosystemic shunt procedures

Info

Publication number: WO2025074196A1
Application number: PCT/IB2024/059286
Authority: WO
Inventors: Amanda CENTAZZO-COLELLA; Patrick Ryan; Michael DALLIMORE; Amanda Hartley; Luke KEAVENEY; Pat MCHUGH
Original assignee: Baylis Medical Technologies Inc; Baylis Medical Technologies Usa Inc
Current assignee: Baylis Medical Technologies Inc; Baylis Medical Technologies Usa Inc
Priority date: 2023-10-02
Filing date: 2024-09-24
Publication date: 2025-04-10
Anticipated expiration: 2026-04-02

Abstract

A method and system are disclosed for performing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The present invention provides a medical device assembly comprising a plurality of devices, arranged in a telescoping arrangement, including a puncture device and a plurality of elongate members, where several devices are configured to perform multiple steps of a TIPS procedure that are typically done by a single device. Various steps of the procedure can be performed while maintaining the configuration of the medical device assembly within a patient's body.

Description

DEVICES AND METHODS FOR TRANSJUGULAR INTRAHEPATIC

PORTOSYSTEMIC SHUNT PROCEDURES

TECHNICAL FIELD

[0001] The disclosure relates to medical devices, and more particularly to improved methods and devices for performing a Transjugular Intrahepatic Portosystemic Shunt or Direct Intrahepatic Portosystemic Shunt procedure.

BACKGROUND OF THE ART

[0002] For patients suffering from portal hypertension, a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure may be performed. In this procedure, a shunt is created from the hepatic to the portal vein, which allows flow to bypass the liver and alleviates the portal pressure. Creation of the shunt is done percutaneously and uses dedicated TIPS kits, catheters, and wires.

[0003] Current puncture kits for use in a TIPS procedure require a number of exchanges, i.e., inserting multiple devices within a patient, removing one device, inserting another device, and sometimes inserting and removing the same device multiple times. The ability to use the same device for multiple steps can reduce the number of exchanges, thereby reducing procedure time and decreasing procedural complexity.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] In order that the invention may be readily understood, embodiments of the invention are illustrated by way of examples in the accompanying drawings, in which:

[0005] FIGS. 1A and IB are illustrations of the anatomy of a liver and surrounding blood vessels; [0006] FIGS. 2A and 2B are illustrations of a telescoping assembly for use during a TIPS procedure comprising a plurality of elongate devices, in accordance with an embodiment of the present invention;

[0007] FIG. 3A is an illustration of a steerable sheath in accordance with an embodiment of the present invention;

[0008] FIG. 3B is an illustration of a dilator in accordance with an embodiment of the present invention;

[0009] FIG. 3 C is an illustration of a catheter comprising radiopaque marker bands in accordance with an embodiment of the present invention;

[0010] FIG. 3D is an illustration of catheter and needle hubs in accordance with an embodiment of the present invention;

[0011] FIG. 3E is an illustration of a catheter hub and spacer in accordance with an embodiment of the present invention;

[0012] FIG. 4 is a flow diagram showing a method of performing a TIPS procedure using a telescoping assembly in accordance with an embodiment of the present invention;

[0013] FIGS. 5 A to 5F disclose a method of facilitating a TIPS procedure in accordance with an embodiment of the present invention;

[0014] FIG. 6 is a flow diagram showing a method of performing a TIPS procedure using a telescoping assembly in accordance with an alternative embodiment of the present invention;

[0015] FIG. 7 is a flow diagram showing a method of performing a TIPS procedure using a telescoping assembly in accordance with a further alternative embodiment of the present invention; [0016] FIGS. 8 A and 8B are illustrations of a curved RF wire and sleeve in accordance with an alternative embodiment of the present invention;

[0017] FIG. 9 is an illustration of the proximal end of a sleeve and catheter hub in accordance with an embodiment of the present invention;

[0018] FIGS. 10A and 10B are illustrations of an angled catheter and RF wire in accordance with a further alternative embodiment of the present invention;

[0019] FIG. 11 is a flow diagram showing a method of performing a TIPS procedure in accordance with a further alternative embodiment of the present invention; and

[0020] FIGS. 12A to 12F disclose a method of facilitating a TIPS procedure in accordance with alternative embodiment of the present invention.

[0021] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead being placed upon generally illustrating the various concepts discussed herein.

DETAILED DESCRIPTION

[0022] In one broad aspect, embodiments of the present invention comprise a method of performing a trans-jugular intrahepatic portosystemic shunt (TIPS) procedure using a medical device assembly including a plurality of devices positioned within a patient’s body comprising at least one puncture device and one or more elongate members, the method comprising the steps of: puncturing through a liver to create a tract between a hepatic vein and a portal vein; dilating the tract; and measuring at least one pressure in at least one of the hepatic vein and the portal vein; where at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, and measuring.

[0023] As a feature of this aspect, the at least one of the plurality of devices is a dilator, and the dilator is used to for the steps of dilating the tract and measuring the at least one pressure. [0024] As a feature of this aspect, the method further comprises a step of confirming portal vein access and the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and confirming.

[0025] As a feature of this aspect, the at least one of the plurality of devices is a needle, and the needle is used for the steps of puncturing through the liver and confirming portal vein access.

[0026] As a feature of this aspect, the at least one of the plurality of devices is a catheter, and the catheter is used for the steps of measuring at least one pressure and confirming portal vein access.

[0027] As a feature of this aspect, the method of claim 1 further comprises a step of injecting fluid to visualize at least one of: a portion of the hepatic vein, a portion of the portal vein, and a portion of the tract, and the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and injecting.

[0028] As a feature of this aspect, the at least one of the plurality of devices is a steerable sheath, and the steerable sheath is used for the steps of measuring at least one pressure and injecting fluid.

[0029] As a feature of this aspect, the at least one of the plurality of devices is a dilator, and the dilator is used for the steps of dilating the tract and injecting fluid.

[0030] As a feature of this aspect, the at least one of the plurality of devices is a dilator and the dilator is used for the steps of measuring at least one pressure and injecting fluid.

[0031] As a feature of this aspect, the at least one of the plurality of devices is a catheter and the catheter is used for the steps of measuring at least one pressure and injecting fluid. [0032] As a feature of this aspect, the method further comprises a step of confirming portal vein access, the at least one of the plurality of devices is a catheter, and the catheter is used for the steps of confirming portal vein access and injecting fluid.

[0033] As a feature of this aspect, the method further comprises a step of determining a length of the tract, and the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and determining the length of the tract.

[0034] As a feature of this aspect, the at least one of the plurality of devices is a catheter, and the catheter is used for the steps of determining the length of the tract and measuring at least one pressure.

[0035] As a feature of this aspect, the method further comprises a step of injecting fluid to visualize at least one of: a portion of the hepatic vein, a portion of the portal vein, and a portion of the tract, and the at least one of the plurality of devices is a catheter, and the catheter is used for the steps of determining the length of the tract and injecting fluid.

[0036] As a feature of this aspect, the method further comprises a step of confirming portal vein access, and the at least one of the plurality of devices is a catheter, and the catheter is used for the steps of determining the length of the tract and confirming portal vein access.

[0037] As a feature of this aspect, the method further comprises a step of tracking into the portal vein and the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and tracking into the portal vein.

[0038] As a feature of this aspect, the at least one of the plurality of devices is the puncture device, and the puncture devices comprises a radio frequency (RF) wire, and the RF wire is used for the steps of puncturing through the liver and tracking into the portal vein. [0039] As a feature of this aspect, the RF wire comprises a flexible distal end.

[0040] As a feature of this aspect, the RF wire is received within a sleeve and a distal portion of the RF wire is configured to have a straight orientation while constrained by the sleeve and a curved orientation while outside of the sleeve, and the step of puncturing comprises advancing the RF wire substantially concurrently with the sleeve, whereby the distal portion of the RF wire retains the straight orientation and the step of tracking comprises advancing a distal portion of the RF wire outside of the sleeve, whereby the distal portion of the RF wire adopts the curved orientation.

[0041] As a feature of this aspect, the method of claim 1 further comprising a step of aiming the medical device assembly from a first blood vessel to a second blood vessel, and the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and aiming.

[0042] As a feature of this aspect, the at least one of the plurality of devices is a steerable sheath, and the steerable sheath is used for the steps of aiming the medical device assembly and measuring the at least one pressure.

[0043] As a feature of this aspect, the first blood vessel is an inferior vena cava and the second blood vessel is the hepatic vein.

[0044] As a feature of this aspect, the first blood vessel is the hepatic vein, and the second blood vessel is the portal vein.

[0045] In a further broad aspect, embodiments of the present invention comprise a kit for performing a trans-jugular intrahepatic portosystemic shunt (TIPS) procedure, the kit including a plurality of devices comprising: a puncture device for creating a tract, through tissue, between a first blood vessel and a second blood vessel; and at least one elongate device; where at least one of the plurality of devices is configured to perform at least two functions selected from the group consisting of: aiming the plurality of devices, creating the tract, dilating the tract, confirming portal vein access, manipulating fluid in at least one of the first and second blood vessels, and measuring a length of the tract; and where the at least two functions can be performed while the number of the plurality of devices positioned within a patient’s body remains constant.

[0046] As a feature of this aspect, the at least one of the plurality of devices is a dilator, and the dilator is configured to dilate the tract and manipulate fluid.

[0047] As a feature of this aspect, the puncture device is a needle, and the needle is configured to create the tract and confirm portal vein access.

[0048] As a feature of this aspect, the at least one of the plurality of devices is a catheter, and the catheter is configured to manipulate fluid and confirm portal vein access.

[0049] As a feature of this aspect, the at least one of the plurality of devices is a catheter, and the catheter is configured to measure the length of the tract and manipulate fluid.

[0050] As a feature of this aspect, the at least one of the plurality of devices is a catheter, and the catheter is configured to measure the length of the tract and confirm portal vein access.

[0051] As a feature of this aspect, the puncture device a radio frequency (RF) wire, and the RF wire is configured to create the tract and track into the portal vein.

[0052] As a feature of this aspect, the RF wire comprises a flexible distal end.

[0053] As a feature of this aspect, the RF wire is received within a sleeve and a distal portion of the RF wire is configured to have a straight orientation while constrained by the sleeve and a curved orientation while outside of the sleeve and the RF wire is configured to create the tract while in the straight orientation and the RF wire is configured to track into the portal vein in the curved orientation. [0054] As a feature of this aspect, the at least one of the plurality of devices is a steerable sheath, the steerable sheath is configured to aim the plurality of devices and manipulate fluid.

[0055] As a feature of this aspect, the number of devices positioned within the patient’s body remains constant while the at least one of the plurality of devices is used to perform the at least two steps.

[0056] As a feature of this aspect, the plurality of devices remains positioned within the patient’s body while the at least one of the plurality of devices is used to perform the at least two steps.

[0057] As a feature of this aspect, while the at least one of the plurality of devices is used to perform the at least two of the steps, the medical device assembly configuration is maintained.

[0058] For explanatory purposes, the systems and methods disclosed herein are generally described with reference to a transjugular intrahepatic shunt (TIPS) procedure, where a tract is created from the hepatic vein to the portal vein. As would be apparent to one skilled in the art, the systems and methods described herein are also applicable to a direct intrahepatic shunt (DIPS) procedure. Certain aspects of this disclosure are also applicable to other medical procedures as well beyond TIPS and DIPS.

[0059] With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of certain embodiments of the present invention only. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. [0060] Referring to FIG. 1A, a diagram of a liver 10 and adjoining structures is shown. For a TIPS procedure, a tract is created through the liver 10, from the hepatic vein 12 to the portal vein 14. The devices used for the procedure are delivered to the hepatic vein 12 through the inferior vena cava (IVC) 16. FIG. IB shows a stent 18 in place extending from the hepatic vein 12 to the portal vein 14, after a TIPS procedure is complete.

[0061] Referring to FIGS. 2A to 2B, according to one embodiment of the present invention, a medical device assembly 1000 for performing at least part of a TIPS procedure is provided that includes a plurality of devices including a puncture device and one or more elongate members.

[0062] In one embodiment, the medical device assembly 1000 comprises a steerable sheath 100, a dilator 200, a catheter 300, and a puncture device 400. In one embodiment, puncture device 400 uses mechanical energy to create a puncture through the liver 10, for example a needle, a stylet, or stiff wire.

[0063] In another embodiment, puncture device 400 comprises a radio frequency (RF) wire 401 that delivers RF energy to create a puncture through the liver, for example, the Baylis PowerWire®, disclosed in US Patent 11,234,761 which is hereby incorporated by reference. The proximal end of the RF wire 401 may be connected to an energy delivery device, for example a generator (not shown).

[0064] In one specific example, puncture device 400 is a needle 400 made of stainless steel and has an outside diameter of approximately 0.035”. In another example, the needle 400 defines a lumen with an inner diameter of 0.035”, to accommodate a wire guide 500, for example an 0.035” wire guide. Wire guide 500 may also be referred to as “guidewire”.

[0065] In one specific example, the medical device assembly 1000 comprises a sheath 100 such as a 10 French (Fr) steerable sheath, a dilator 200 such as a 10 Fr flexible dilator, a catheter 300 such as a 6 Fr catheter, and a puncture device 400 such as a needle 400 with an outside diameter of approximately 0.035”. In one example, sheath 100 is of the type disclosed in US 9,498,602 B2, granted Nov. 22, 2016, to Oscor Inc.

[0066] In another embodiment, medical device assembly 1000 may comprise two sheaths including a first introducer sheath such as a fixed lOFr sheath, and a second, smaller sheath with steering capabilities, such a s 7 Fr steerable sheath. The steerable guiding sheath being received with the introducer sheath for parts of the TIPS procedure.

[0067] In some embodiments, catheter 300 is configured to traverse into the splenic vein to assess and./or treat varices caused by portal hypertension or some other branch of the portal venous system such as, but not limited to, the superior or inferior mesenteric vein. For example, the catheter may have an additional length, such that the catheter is capable of extending out of the sheath distal end approximately 17 cm. The catheter may be advanced through the TIPS tract and further into the splenic vein or other vessel within the hepatic portal system to treat the varices.

[0068] In such examples, the medical device assembly 1000 includes a sheath 100, a dilator 200 received within the sheath 100, a catheter 300 received within the dilator 200, and a puncture device 400 received within the catheter 300, each component being received in a telescoping arrangement relative to the others. FIG. 2A shows medical device assembly 1000 with four devices in a telescoped arrangement and FIG. 2B shows each device separate and removed from the others. Medical device assembly 1000 may also be referred to as “telescoping assembly”. In some embodiments, one or more devices may define tapered distal ends.

[0069] For descriptive purposes, any of the sheath, dilator, or catheter may be referred to as a “device” or “elongate device”, for example, the same modifications and relationships between the sheath and dilator may apply between the dilator and catheter, where applicable. Devices may also be referred to as either an “inner device” or an “outer device”. For example, when describing the sheath and the dilator, the dilator may be positioned within the sheath, such that the sheath is referred to as the outer device and the dilator is referred to as the inner device.

[0070] In some embodiments, each device of telescoping assembly 1000 is separate and fully removable from all other devices. In other words, the devices may be assembled in any combination at any one time. If more space is needed within a lumen of one device, for example the sheath, then one or more devices, for example the dilator and catheter, can be removed to create space in the sheath lumen. Further, each device may be “backloadable”, i.e., an inner device, may be removable from an outer device without having to remove a different inner device. For example, the dilator 200 may be removable from the sheath 100 without first having to remove the catheter 300.

[0071] Having each device fully removeable from the assembly could offer advantages. For example, if a problem occurs with any one device, it could be exchanged for a new device. This exchange could be made at any point during a TIPS procedure.

[0072] Typically, a TIPS procedure requires numerous devices for different steps. For example, aspirating may be performed with a first catheter at one step, and a second catheter (sizing catheter) is required at a later step to measure the tract length to select an appropriately sized stent. The first catheter is removed, and the sizing catheter is introduced. Each exchange of devices requires additional time and complexity, increasing procedural risks.

[0073] The present inventors have conceived of novel and inventive devices, assemblies, and methods for reducing the number of exchanges by performing multiple steps in the procedure using fewer devices, thereby speeding up procedure time. In other words, modifying a single device to perform two (or more) steps that are usually performed using two devices. In some embodiments, individual devices have modifications to enable to them perform multiple functions during TIPS procedure.

[0074] Referring to FIG 3 A, in one embodiment, steerable sheath 100 comprises a handle 102 at the proximal end having an actuator 104 that is configured to deflect the distal end 106 in a curved configuration. Deflecting the distal end 106 of the steerable sheath allows a physician to “aim” the steerable sheath, such that the sheath 100 and/or medical device assembly 1000 can point to a second location. For example, during a TIPS procedure, while the assembly is in the JVC 16, the steerable sheath 100 can aim towards the hepatic vein 12 so that a wire guide 500 can be advanced into the hepatic vein 12. At a later step of the procedure, with the sheath 100 distal end located in the hepatic vein 12, the steerable sheath 100 can aim towards to the portal vein 14 for the puncture step. For descriptive purposes, “aiming” of the sheath 100/assembly 1000 may also be referred to as “steering”.

[0075] Sheath 100 further comprises a flush port 108 fluidically connected to one or more valves 110 to connect an external fluid manipulation device. A fluid manipulation device may be a device that injects or withdraws fluids from within a blood vessel, or a device that is capable of measuring a pressure within the device lumen. In one example, fluid manipulation device is a syringe and the fluid being injected is contrast fluid. In other examples, fluid manipulation device is a power injector or pressure injection machine. In another example, fluid manipulation device is a pressure transducer. Pressure transducer measures a pressure within a device lumen, thereby also measuring the pressure within a blood vessel. For descriptive purposes, the term “manipulating fluids” includes, but is not limited to interacting with fluids within a blood vessel, for example, aspirating, injecting fluids into a blood vessel such as contrast fluid and measuring a pressure in a blood vessel by measuring a pressure in the device lumen.

[0076] In one embodiment, shown in FIG. 3B, dilator 200 comprises a dilator hub 202 on the proximal end. Dilator hub 202 may comprise one or more valves (or hemostatic valves) for receiving an inner device, for example, catheter 300, and for connecting to an external valve 204, for example a stopcock or a two-way valve that connects to a fluid manipulation device. External valve 204 forms part of a flush port. Dilator 200 further defines a tapered distal end for dilating a tract, for example the tract through the liver 10, between the hepatic vein 12 and the portal vein 14. In other embodiments, the sheath 100 and/or catheter 300 may also define a tapered distal end (see appending A figures) which may also be used to dilate the tract.

[0077] Referring to FIGS. 3C to 3E, in one embodiment, catheter 300 comprises a visual indicator that is visible under one or more imaging modalities, for example fluoroscopy. In one example, the visual indicator comprises a plurality of markers located on the outer surface or embedded within the inner and outer walls of the catheter. Markers may be radiopaque maker bands, radiopaque ink, or any other known marking that may show up under one more imaging modalities. In one example, catheter 300 comprises a plurality of radiopaque marker bands 302. Radiopaque marker bands 302 may be used to measure the tract length between the hepatic vein 12 and portal vein 14, to select an appropriately sized stent for the TIPS procedure. In other embodiments, any one of the sheath 100, dilator 200, or puncture device 400 may comprise a visual indicator to measure the tract length.

[0078] In other embodiments, one or more devices may comprise graduated markings, such that one device can be advanced over another device to measure the length of the tract through the liver, i.e., the tract from the hepatic vein 12 to the portal vein 14. In one embodiment, catheter 300 comprises graduated markings. To measure the tract length, sheath 100 distal end and catheter 300 distal end are aligned and located in the portal vein 14. Sheath 100 is then retracted until the sheath distal end is located in the hepatic vein 12, while catheter 300 remains stationary. The distance the sheath 100 is retracted can be measured by the graduated markings, thus providing a length of the tract. Alternatively, the devices may be used to measure the tract where both device distal ends are aligned and positioned in the hepatic vein, and the inner device is advanced to the portal vein while the outer device is held stationary.

[0079] In one embodiment, catheter 300 extends from the dilator approximately 7 cm in length. In another embodiment, catheter 300’ (not shown) is configured to reach the splenic vein or other vessels of the hepatic portal system and has a length of approximately 17 cm extending from the dilator end, in other words it is longer than a catheter required to perform only the TIPS procedure. Catheter 300’ may be referred to as a “long catheter”.

[0080] In one embodiment, catheter 300 comprises a catheter hub 304 at the proximal end which may be connected a fluid manipulation device, such that contrast can be injected, or a pressure measurement could be taken at the catheter distal end. In one embodiment, the catheter is configured such that the fluid manipulation device can inject contrast fluid or measure a pressure while the puncture device 400 or wire guide 500 is within the catheter lumen. In other words, the inner device does not need to be removed from the catheter in order to inject contrast or measure a pressure using the catheter. Similarly, in some embodiments, dilator 200 is configured to manipulate fluids while a smaller device, for example catheter 300, is within the dilator 200 primary lumen.

[0081] In some embodiments, two fluid manipulation devices may be connected to two devices simultaneously, such that contrast fluid may be injected into two locations without having to reposition the devices, or two different pressures may be measured without having to reposition the two devices. For example, with the distal end of the sheath 100 located in the hepatic vein 12, and the distal end of catheter 300 located in the portal vein 14, contrast fluid may be injected to both veins through two devices, or pressure could be measured at the two locations using two devices.

[0082] In other embodiments, one or more devices may comprise pressure sensors to measure pressures within blood vessels. Pressure sensors may be wireless or may be connected to wires running the length of the device to the proximal end. Pressure sensors may be located on the device outer wall or between the inner and outer walls. In other embodiments, one device may comprise more than one pressure sensor, for example located a linear distance from each other to measure two pressures, for example one in the portal vein and one in the hepatic vein.

[0083] Any or all devices may comprise locking features on the proximal ends such that they may be secured together to be moved as a single device. For example, the proximal end of the catheter 300 may comprise locking features known in the art, for example a Tuohy Borst adapter or similar mechanism, which may be used to secure the puncture device to the catheter. Once secured, the catheter 300 and puncture device 400 can be advanced simultaneously, as if they were a single device.

[0084] In one embodiment, medical device assembly 1000 comprises a catheter hub 304 and needle hub 306. Catheter hub 304 and needle hub 306 may be a luer-lock connection, or other commonly known mechanism, to lock the needle 400 to the catheter 300, thereby forming a needle-catheter assembly that can be advanced or retracted as a single device.

[0085] In one embodiment, catheter 300 comprises a spacer 308 located on the proximal end, proximal to catheter hub 304. Spacer 308 is configured to prevent the needle 400 from advancing past a certain distance while the spacer 308 is in place. For example, spacer 308 may prevent the distal end of needle 400 from advancing out of the catheter 300 distal end, to prevent the needle from damaging tissue. During a TIPS procedure, the spacer may be in place for the steps prior to the puncture step. At the puncture step, the spacer 308 is removed and the needle 400 is advanced such that the needle distal tip 402 protrudes out of the catheter 300 distal end.

[0086] In another embodiment, catheter 300 may be a steerable catheter (not shown) comprising similar features to the steerable sheath 100 described herein. In one example, steerable catheter comprises a handle on its proximal end connected to an elongate member or shaft. Handle further comprises an actuator and a valve configured to receive a smaller device, for example a wire guide 500 or puncture device 400. Manipulating actuator 307 will cause tension in a pull wire (not shown) running the length of the shaft, causing the distal end of the shaft to deflect, thereby allowing steerable catheter to be aimed within a blood vessel.

[0087] In some embodiments, steerable sheath 100 and steerable catheter 301 may be used together during a TIPS procedure. For example, steerable sheath 100 may be used to aim the assembly in the hepatic vein 12 for the puncture, and the steerable catheter 301 may be used to aim the assembly to track into the portal vein 14 after the puncture.

[0088] In one embodiment, needle 400 comprises inner and outer walls defining a lumen, with an outer diameter and inner diameter. Needle 400 further comprises a sharp distal tip. In one embodiment lumen inner diameter is at least 0.035” such that lumen is configured to accommodate a 0.035” guidewire. In another embodiment, the outer diameter of needle 400 may be approximately 0.035”, and lumen is configured to accommodate a 0.014” guidewire, in other words inner diameter is at least 0.014”. In another embodiment, needle 400 is solid and does not define an inner lumen. In some embodiments, the sharp distal tip may define a bevel.

[0089] In one embodiment, needle 400 comprises a connection feature on the proximal end, for example a luer-lock, (not shown) to enable a fluid manipulation device to be attached for fluid manipulation capabilities through the lumen, for example aspiration or injecting fluids.

[0090] In summary, in some embodiments, the sheath 100 is configured to aim the assembly using a steering feature and configured to manipulate fluids (manipulate fluids includes injecting a fluid into a blood vessel and measuring a pressure in the device lumen/blood vessel). The dilator 200 is configured to dilate the tract between the hepatic vein 12 and the portal vein 14 and configured to manipulate fluids. Catheter 300 is configured to manipulate fluids, measure the tract length, dilate the tract, and track into the portal vein. The puncture device 400 is configured to puncture through the liver 10 tissue and, in some embodiments, is also configured to manipulate fluids. In another embodiment, puncture device 400 is configured to puncture through the liver 10 using RF energy and track into the portal vein 14, described in more detail below.

[0091] Further, the devices are configured to perform various functions while telescoped inside each other. In other words, one or more of the functions listed herein can be performed using an outer device without having to first remove an inner device. In one example, catheter 300 may be used to manipulate fluids through its primary lumen without having the remove puncture device 400 or wire guide 500. In another example, dilator 200 may be used to manipulate fluids without having to remove catheter 300. In another example, sheath 100 may be used to manipulate fluids without having to remove catheter.

[0092] As a general example, four devices (sheath, dilator, catheter, and puncture device) are introduced at the start of the procedure. The devices are introduced into the various blood vessels, pressures measurements are taken, the puncture is made through the liver creating the tract, pressures are measured again, contrast is injected before and/or after the puncture. All of these steps can be performed at least once while the same four devices remain in the patient’s body, i.e., a device does not need to be removed. In other words, the configuration of the assembly is maintained during various steps. The number of devices within the patient’s body does not change. In other words, the number of devices remains constant. The steps of aiming, measuring pressure, puncturing, dilating the tract (initially), and confirming portal vein access, are all performed with the same four-device assembly configuration. This will be described further in the method steps below.

Method 1 (0,035” Inner Diameter hollow needle)

[0093] FIG. 4 discloses a method of performing a TIPS procedure using a telescoping assembly 1000 in accordance with one embodiment of the present invention. The method may be better understood by referring to FIGS. 5 A to 5F, which illustrate the devices in use during the procedure.

[0094] This method uses a telescoping assembly 1000 that includes hollow, 0.035” inner diameter needle 400, lOFr steerable sheath 100, lOFr dilator 200 with fluid manipulation capabilities, 6Fr catheter 300 with fluid manipulation capabilities, and a 0.035” wire guide 500. [0095] Method 4000 begins at step 4002, where the devices are introduced into the patient and delivered to the hepatic vein. Using micro-puncture access techniques known by those skilled in the art, an 0.035” wire guide is introduced into the inferior vena cava (IVC) via the jugular vein. The wire guide is advanced down the IVC towards the hepatic vein.

[0096] The telescoping assembly, including the sheath, dilator, catheter, and needle are introduced over the wire guide and positioned near the hepatic vein. Using steering features on the steerable sheath, the assembly is aimed towards the hepatic vein, so that the wire guide can be advanced into the hepatic vein. Once the wire guide has advanced, the assembly can also be advanced into the hepatic vein, as shown in FIG. 5A. Once the assembly is in the hepatic vein, the 0.035” wire guide is removed.

[0097] At step 4004, the puncture is made to create a tract from the hepatic vein, through the liver, to the portal vein. With all devices aligned at the distal end (i.e., distal tips of each device are aligned longitudinally), such that the needle tip is not exposed (i.e., not protruding out of the assembly), the steerable sheath can be used to aim the assembly towards portal vein.

[0098] In order to perform the puncture, the needle is advanced so that the distal end of the needle extends, or protrudes, distally out of the assembly. The needle is also secured to the catheter at the proximal end, creating a needle-catheter assembly, such that the needle and catheter can be advanced as a single device. In other words, the needle and catheter are advanced or retracted simultaneously. The puncture is then performed with the needle-catheter assembly.

[0099] The needle-catheter assembly is mechanically forced/pushed through the hepatic vein wall, through the liver, into the portal vein, and possibly past the portal vein, as shown in FIG.5B. If the needle has gone through the portal vein, the distal end of the needle and/or catheter must be retracted back into the portal vein to continue with the procedure. Confirming that the distal end of the needle in the portal vein may be referred to as “confirming access” to the portal vein or “confirming portal vein access”. Portal vein access may be confirmed with any elongate device that comprises a hollow lumen with aspiration capabilities, for example the catheter 300. Alternatively, other methods of confirming access include: 1) viewing the device tip on ultrasound (IVUS/ICE) with an echogenic tip, 2) injecting contrast, 3) advance a wire down the needle lumen to see if it tracks into the portal vein.

[00100] At step 4006, to confirm access to the portal vein, the physician aspirates through the needle while also retracting the needle proximally. A syringe with contrast agent may be attached to the proximal end of the needle, and the needle is retracted proximally while the syringe is also pulled back, creating suction. The needle is retracted until blood is observed in the syringe, which confirms the distal end of the needle is in the portal vein.

[00101] A flexible wire guide is then inserted through the needle and advanced further into the portal vein, also referred to as “tracking” into the portal vein. Tracking into the portal vein means that the wire guide is advanced far enough such that the wire guide will not leave the portal vein as other steps of the procedure are performed, for example as other devices are removed and inserted over the wire guide. To track sufficiently, the wire guide may be advanced approximately 5 centimeters into the portal vein. Once the wire guide has tracked into the portal vein, the needle is uncoupled from the catheter and is removed from the assembly. FIG. 5C shows the assembly with the wire guide in the portal vein. The distal end of the catheter remains in the portal vein.

[00102] At step 4008, with the guidewire acting as a rail, the dilator and sheath are advanced into portal vein to dilate the tract made by the needle, shown in FIG. 5D. The sheath and dilator are then retracted proximally back into hepatic vein, such that the distal ends of the sheath and dilator are located in the hepatic vein.

[00103] At step 4010, a splenogram and/or venogram may be made to visualize one or more blood vessels around the liver and/or the tract. Contrast fluid may be injected through the dilator to visualize the confluence of the IVC and HV. Contrast fluid may also be injected through the catheter to visualize the portal vein and gastrointestinal varices using the splenogram/venogram. Once contrast fluid is injected, the tract length is measured by observing and counting a series of radiopaque marker bands located on the catheter. Contrast fluid is represented by the arrows in FIG. 5E.

[00104] Before moving to the next step, using the long catheter described herein, the physician has the option of cannulating the splenic vein or other deeper veins in the portal system, to visualize or treating varices.

[00105] At step 4012, the portosystemic (or “portacaval”) gradient is determined by measuring the pressure in the hepatic vein and the portal vein. A pressure measurement device, for example a pressure transducer is connected to the proximal end of each of the dilator and catheter. The pressure in the portal vein is measured using the catheter and the pressure in the hepatic vein is measured using the dilator.

[00106] At step 4014, the sheath and dilator are advanced to portal vein to dilate the tract further in preparation for stent deployment. The catheter and dilator are then removed from the assembly so that the stent can be delivered.

[00107] At step 4016 the stent is delivered and deployed. A stent, for example a Viatorr® stent is delivered across the tract. The sheath is retracted, exposing the stent, and the stent is expanded by pulling the ripcord and removing the stent catheter. Contrast fluid may be injected through the sheath to visualize the location of the stent junction in the vein.

[00108] The stent is then dilated by introducing a balloon and inflating the balloon across the stent’s length. After the stent is dilated, the balloon is removed, and the catheter is reintroduced so the pressure may be measured and a venogram may be made.

[00109] At step 4018, systemic/atrial pressure (hepatic vein pressure) is measured through the sheath and the portal pressure is measured through the catheter, shown in FIG. 5F. A final venogram is also performed by injecting contrast through the catheter. If the portosystemic gradient is within a predetermined threshold, the procedure is complete, and the devices are removed from the patient.

[00110] A visualization step may happen between steps 4002 and 4004 using known techniques, before the puncture. In one embodiment, intravascular ultrasound (IVUS) may be performed after femoral access has been established, using an IVUS catheter. In another embodiment, CO2 may be injected through the catheter.

[00111] In method 4000, the needle is configured to perform the puncture through the liver to create the tract from the hepatic vein to the portal vein, and the needle is configured to aspirate and/or inject fluids in order to confirm portal vein access. Also in this method, the catheter is configured to measure the pressure in the portal vein, to inject contrast fluid into the portal vein, and to determine the tract length using a visual indicator. The dilator is configured to dilate the tract, to measure the pressure in the hepatic vein, and to inject contrast fluid in the hepatic vein. The sheath is configured to aim the assembly, to measure the pressure in the hepatic vein, and to inject contrast fluid into the hepatic vein.

[00112] Steps 4002 to 4006 occur with all four devices remaining in the patient’s body. Steps 4008 to 4014 occur with the sheath, dilator, and catheter remaining in the patient’s body.

Method 2 (Smaller. 0,035” outer diameter needle)

[00113] FIG. 6 discloses a method of performing a TIPS procedure using a telescoping assembly 1000 in accordance with one embodiment of the present invention. The method may be better understood by referring to FIGS. 5 A to 5F, which illustrate the devices in use during the procedure. Certain aspects of this method are substantially the same as the method 4000. [00114] This method uses a telescoping assembly 1000 that includes hollow, 0.035” outer diameter needle 400, lOFr steerable sheath 100, lOFr dilator 200 with fluid manipulation capabilities, 6Fr catheter 300 with fluid manipulation capabilities, and a 0.035” wire guide 500. (i.e., a smaller needle than in method 4000, not capable of supporting an 0.035” wire guide.)

[00115] Method 6000 begins at step 6002, where the devices are introduced into the patient and delivered to the hepatic vein. Using micro-puncture access techniques known by those skilled in the art, an 0.035” wire guide is introduced into the inferior vena cava via the jugular vein.

[00116] Next the telescoping assembly, including the sheath, dilator, and catheter, are introduced and positioned near the hepatic vein. Using steering features on the steerable sheath, the assembly aimed towards the hepatic vein, so that the wire guide can be advanced into the hepatic vein. Once the wire guide has advanced into the hepatic vein, the assembly can then be advanced into the hepatic vein, as shown in FIG. 5A. The 0.035” wire guide is removed, and the needle is introduced into the assembly.

[00117] At step 6004, the puncture is performed to create a tract from the hepatic vein, through the liver, to the portal vein. With all devices aligned at the distal end (i.e., distal tips of each device are aligned longitudinally), and with the needle tip is not exposed (i.e., not protruding out of the assembly), the steerable sheath can be used to aim the assembly towards portal vein.

[00118] The needle is then advanced for the puncture so that the distal end of the needle extends, or protrudes, distally out of the assembly. The needle is also secured to the catheter at the proximal end, creating a needle-catheter assembly, such that the needle and catheter can be advanced as a single device.

[00119] The puncture is then performed with the needle-catheter assembly. The needle-catheter assembly is mechanically forced/pushed through the hepatic vein wall, through the liver, into the portal vein, and possibly past/through the portal vein, as shown in FIG. 5B. If the needle has gone through the portal vein, the distal end of the needled is retracted into the portal vein.

[00120] At step 6006, to confirm access to the portal vein, the physician aspirates through the needle while also retracting the needle proximally. A syringe with contrast agent may be attached to the proximal end of the needle, and the needle is retracted proximally while the syringe is also pulled back, creating suction. The needle is retracted until blood is observed in the syringe, which confirms the distal end of the needle is in the portal vein.

[00121] The needle is then removed, and a flexible wire guide is then inserted through the catheter and advanced further into the portal vein. The wire guide tracks into the portal vein far enough so that access is not lost throughout the procedure, approximately 5 centimeters, shown in FIG. 5C.

[00122] Another option for tracking into the portal vein involves inserting a 0.014” wire guide through the needle lumen after portal vein access is confirmed. The 0.014” wire guide can be advanced deeper into the portal vein to ensure access is not lost. Next the needle can be removed, and the catheter can be advanced over the 0.014” wire guide deeper into the portal vein. Once the catheter is advanced far enough, the 0.014” can be removed and a 0.035” wire guide can be inserted through the catheter to act as a rail for the remainder of the procedure.

[00123] Steps 6008 to 6018 are substantially the same as steps 4008 to 4018.

[00124] In method 6000, the needle is configured to perform the puncture through the liver to create the tract from the hepatic vein to the portal vein, and the needle is configured to aspirate in order to confirm portal vein access. Also in this method, the catheter is configured to measure pressure in the portal vein, to inject contrast fluid into the portal vein, and to determine the tract length using a visual indicator. The dilator is configured to dilate the tract, to measure pressure in the hepatic vein, and to inject contrast fluid in the hepatic vein. The sheath is configured to aim the assembly, to measure pressure in the hepatic vein, and to inject contrast fluid into the hepatic vein.

Method 3 (Solid needle)

[00125] FIG. 7 discloses a method of performing a TIPS procedure using a telescoping assembly 1000 in accordance with one embodiment of the present invention. The method may be better understood by referring to FIGS. 5 A to 5F, which illustrate the devices in use during the procedure. Certain aspects of this method are substantially the same as method 4000.

[00126] This method uses a telescoping assembly 1000 that includes solid needle 400’, lOFr steerable sheath 100, lOFr dilator 200 with aspiration capabilities, 6Fr catheter 300 with aspiration, and a 0.035” wire guide 500.

[00127] Method 7000 begins at step 7002, where the devices are introduced into the patient and delivered to the hepatic vein. Using micro-puncture access techniques known by those skilled in the art, an 0.035” wire guide is introduced into the inferior vena cava via the jugular vein. Next the telescoping assembly, including the sheath, dilator, and catheter, are introduced and, using steering features on the steerable sheath, the assembly is advanced to the hepatic vein, as shown in FIG. 5A. Once the assembly is in the hepatic vein, the 0.035” wire guide is removed, and the solid needle is introduced into the assembly.

[00128] At step 7004, the puncture is made to create a tract from the hepatic vein, through the liver, to the portal vein. With all devices aligned at the distal end (i.e., distal tips of each device are aligned longitudinally), and with the needle tip is not exposed (i.e., not protruding out of the assembly), the steerable sheath can be used to aim the assembly towards portal vein.

[00129] The needle is then advanced for the puncture so that the distal end of the needle extends, or protrudes, distally out of the assembly. The needle is also secured to the catheter at the proximal end and the puncture is performed with the needle-catheter assembly. The needle-catheter assembly is mechanically forced/pushed through the hepatic vein wall, through the liver, into the portal vein, and possibly past/through the portal vein, as shown in FIG.5B.

[00130] At step 7006, to confirm access to the portal vein, the solid needle is removed and the physician aspirates through the catheter while also retracting the catheter proximally. A syringe with contrast agent may be attached to the proximal end of the catheter, and the catheter is retracted proximally while the syringe is also pulled back, creating suction. The catheter is retracted until blood is observed in the syringe, which confirms the distal end of the catheter is in the portal vein.

[00131] A flexible wire guide is then inserted through the catheter and advanced further into the portal vein. The wire guide is advanced far enough so that access is not lost throughout the procedure, approximately 5 centimeters into the portal vein, shown in FIG. 5C. The wire guide remains in the portal vein throughout the procedure and does not dislodge as other devices are exchanged and moved along the wire guide.

[00132] Steps 7008 to 7018 are substantially the same as steps 4008 to 4018.

[00133] In method 7000, the catheter is configured to confirm portal vein access, to measure pressure in the portal vein, to inject contrast fluid into the portal vein, and to determine the tract length using a visual indicator. The dilator is configured to dilate the tract, to measure pressure in the hepatic vein, and to inject contrast fluid in the hepatic vein. The sheath is configured to steer the assembly, to measure pressure in the hepatic vein, and to inject contrast fluid into the hepatic vein.

TIPS Procedure Using “Trackable” RF Wire

[00134] In addition to a mechanical needle, as described herein, puncture device 400 may be an RF wire 401. In one example, RF wire 401 may be similar to the Baylis PowerWire® disclosed in US Patent 11,234,761. A method of performing a TIPS procedure using an RF wire is disclosed in US Patent 11,324,548, which is hereby incorporated by reference. While this type of wire may be used for the puncture, in some cases this wire may not be flexible enough at the distal end to track into the portal vein after the puncture, and thus may need to be exchanged for a mechanical 0.035” guidewire. The mechanical guidewire then tracks into the portal vein.

[00135] One embodiment of the RF wire disclosed in US 11,234,761 has a relatively rigid distal end that, in some instances, may be incapable of tracking into the portal vein. In some cases, the portal vein diameter is relatively small (average of 10mm, but can also be as small as approximately 4-5mm in diameter), the rigid (5 mm) distal end of the RF wire may not be able to turn from the parenchyma tract into the portal vein in some cases. The parenchyma tract and portal vein may also be at approximately 90-degree angles in some cases.

[00136] To use an RF wire for a TIPS procedure, the distal end of the RF wire must be relatively short and rigid. It must be rigid enough for the puncture and short enough so that the wire can curve/turn into the portal vein. For example, an RF wire with 5 mm rigid distal end may not curve into the portal vein which may only be 5 mm in diameter. Existing mechanical guidewires have a rigid distal end of 1-1.5mm long. These wires are flexible enough to make the turn from the tract to the portal vein.

[00137] As disclosed in US 11,234,761, the Baylis PowerWire® has a core wire, first insulation layer, second insulation layer, marker band, heat shield, and active electrode tip, which is formed from the core wire onto a support structure, for example a tantalum puck. Marker band is approximately 2 mm in length, heath shield is approximately 2.5 mm, and the electrode tip is approximately 0.5 mm long, creating a 5.0 mm rigid distal region. Further, the RF Wire has an inner PTFE layer, an FEP heat shrink layer, and an outer PTFE layer.

[00138] The present inventors have come up with novel solutions to allow an RF wire to track into the portal vein during a TIPS procedure. A first solution involves an RF wire 401 comprising a flexible distal end. To make a portion of the distal end flexible, the dimensions of the rigid features at the distal tip can be modified and still retain the thermal protection properties necessary to safely use an RF wire to puncture through the liver. To maintain the thermal protection properties, the RF wire requires a heat shield and insulation.

[00139] According to one embodiment of the present invention, RF wire 401 comprises several modifications to reduce the overall length of the rigid distal region. A first modification is to remove the 2.0 mm marker band and reduce the length of the heat shield. Heat shield is in the range of 1.0 to 1.5 mm long. The distal tip (energy delivery component) is approximately 0.5 mm. Thus, the total length of the rigid distal region is approximately 2.0 mm, which would enable the RF wire 401 to track into the portal vein after the puncture is performed.

[00140] According to one embodiment, a second modification, which may be used in combination with the first modification, is to reduce the outer diameter of the core wire at the distal end. In one embodiment, the distal region of the core wire defines a reduced diameter region, a tapered region, and a larger diameter proximal region. In specific example, reduced diameter region is located at the distal end of core wire and has an outer diameter of 0.005”, and longitudinal length of approximately 1.5 mm. Larger diameter proximal region begins approximately 15 cm from the distal end and has an outer diameter of 0.018”. The tapered region has a varying outer diameter and extends from the proximal end of the reduced diameter region to the larger diameter proximal region.

[00141] In another embodiment, core wire comprises a reduced diameter region, which is larger than the distal end of tapered region. In one specific example, reduced diameter region has an outer diameter of 0.010” (10 thou) and a longitudinal length of approximately 1.5 mm. In both embodiments, the heat shield surrounds the reduced diameter region. [00142] In some embodiments, the wire may also comprise a coil covering a portion of the reduced diameter region and/or tapered region of the core wire. The coil may add to the overall diameter to maintain compatibility with the catheter, while also maintaining flexibility.

[00143] In another embodiment, a third modification, which may be used in combination with the first and/or the second modification is removing some of the FEP layer of insulation. Removing some or all of the middle FEP layer increases flexibility of the wire, while allowing the measured leakage current to remain below the allowable leakage current.

[00144] Any of all of the first, second, or third modifications described herein ensure that the RF wire 401 is flexible enough to curve to turn from the parenchyma tract into the portal vein 14, in other words track into the portal vein. The RF wire 401 comprises a flexible distal end having a rigid distal region of approximately 2.0 mm.

[00145] A second solution to enable the RF wire to track into the portal vein is described with reference to to FIGS. 8 A, 8B, and 9, in which RF wire 401’ comprises a pre-curved distal end 402’ and the assembly further comprises a sleeve 600 with a rigid distal region 602. In one embodiment, sleeve 600 is an elongate member flexible enough to traverse a patient’s vascular, including into vessels necessary for a TIPS procedure, and also configured to deflect the pre-curved distal end 402’ end of RF wire 401 ’ into a straight configuration. In one embodiment, sleeve 600 has a uniform stiffness throughout its body. In another embodiment, the rigid distal region 602 may be stiffer than other parts of the sleeve body.

[00146] While RF wire 401’ is received within the sleeve and protrudes a certain distance, for example 5 mm out of the sleeve distal end, the RF wire-sleeve assembly has a substantially straight configuration/orientation, as shown in FIG. 10A. When RF wire 401’ is advanced distally out of the sleeve 600 RF wire 401’ adopts a curved configuration/orientation, shown in FIG. 8B. (Alternatively, sleeve 600 may be retracted). RF wire 401 ’ and sleeve 600 may be in a coupled or an uncoupled state. In a coupled state, RF wire 401 ’ and sleeve 600 may be advanced or retracted as a single device. In an uncoupled state, RF wire 401’ and sleeve 600 may move longitudinally with respect to one another.

[00147] In some embodiments, sleeve 600 comprises one or more locking features to secure the sleeve to the catheter 300 and/or RF wire 401 ’. Referring to FIG. 9, in one embodiment, sleeve 600 comprises a sleeve hub 604. Sleeve hub 604 may comprise a luer-connector, or similar mechanism, configured to couple catheter hub 304 with sleeve 600, thereby allowing the catheter 300 and sleeve 600 to move as a single device.

[00148] In one embodiment, sleeve 600 may comprise a second locking feature to couple RF wire 401 ’ and sleeve 600. The second locking feature may comprise a pushbutton 606, or other mechanism, to couple and uncouple RF wire 401’ and sleeve 600.

[00149] In some embodiments, catheter 300 is floppy at least at the distal end, and as sleeve 600 is retracted, both the RF wire 401’ and the catheter 300 adopt a curved configuration. In other embodiments, sleeve 600 and catheter 300 may be coupled together and RF wire 401 ’ is advanced (or sleeve-catheter is retracted) such that RF wire 401’ wire adopts a curved configuration.

[00150] During a TIPS procedure, RF wire 401 ’ and sleeve 600 may be secured together such that they can be advanced as a singe device, and advanced in a substantially straight orientation for the puncture. After the puncture step, the RF wire 401 ’ and sleeve 600 can be uncoupled, such that the RF wire 401’ advances out of the sleeve 600. With the distal end of the sleeve located inside the portal vein, RF wire 401’ may track into the portal vein by adopting a curved orientation.

[00151] In a further embodiment shown in FIGS. 10A and 10B, RF wire 401 has a substantially straight configuration and angled catheter 300” has a curved distal end 326”. The curved distal end 326” of angled catheter 300” is flexible such that when the RF wire 401 is received within and/or extends out of the angled catheter 300”, both devices have a substantially straight configuration as shown in FIG.10A. When the angled catheter 300” advances further over RF wire 401 (or if RF wire 401 is retracted), angled catheter 300” adopts a curved configuration at the distal end, as shown in FIG. 10B.

[00152] In such a configuration, for a TIPS procedure, the two devices can be secured together (described herein) with the RF wire 401 slightly protruding out of the distal end of angled catheter 300”. The puncture through the liver can be performed in a straight configuration. When the RF wire 401 has entered the portal vein 14, the angled catheter 300” is advanced such that it tracks into the portal vein 14.

[00153] In other embodiments, steerable catheter 301, described herein, may be used to track into the portal vein 14. After a puncture is made, steerable catheter is advanced into the portal vein 14. The puncture device may be removed, and a steering mechanism on the steerable catheter 301, for example actuator 307, may be used to deflect the distal end of the catheter, such that it tracks into the portal vein 14. At which point, wire guide 500 may be advanced further into the portal vein 14.

Method 4 (RF Wire)

[00154] FIG. 11 discloses a method of performing a TIPS procedure using a telescoping assembly 1000 in accordance with one embodiment of the present invention. The method may be better understood by referring to FIGS. 12A tol2F, which illustrate the devices in use during the procedure. Certain aspects of this method are substantially similar to aspects of method 4000.

[00155] Method 1100 uses a telescoping assembly 1000 that includes an RF wire 401/401’ as the puncture device 400, lOFr steerable sheath 100, lOFr dilator 200, and a 6Fr catheter 300, both dilator 200 and catheter 300 have fluid manipulation capabilities.

[00156] The method begins at step 1102, where the devices are introduced into the patient and delivered to the hepatic vein. Using micro-puncture access techniques known by those skilled in the art, an 0.035” wire guide or the 0.035” RF wire 401 is introduced into the inferior vena cava via the jugular vein. Next the telescoping assembly, including the sheath, dilator, and catheter, are introduced and, using steering features on the steerable sheath, the assembly is advanced to the hepatic vein, as shown in FIG. 12 A. (FIG. 12A shows guide wire 500, but in some examples, RF wire 401 may be used) Once the assembly is in the hepatic vein, if the 0.035” wire guide was used, it can be removed and the RF wire is introduced into the assembly.

[00157] At step 1104, the puncture is made to create a tract from the hepatic vein, through the liver, to the portal vein. The steerable sheath can be used to aim the assembly towards portal vein. Using RF energy, the RF wire punctures and advances through the hepatic vein wall, through the liver, and into the portal vein, shown in FIG. 12B. If a precurved RF wire is used, the puncture is performed with at least the sleeve and RF-wire, such that the RF-wire has a substantially straight configuration. (NOTE: sleeve and catheter not shown in FIG. 12B)

[00158] At step 1106, the RF wire then tracks into the portal vein and then may be used as a rail for the remaining steps in the procedure. In one embodiment, the RF wire has a flexible distal end such that it tracks into the portal vein. In another embodiment, the sleeve is used to straighten a pre-curved RF wire for the puncture, and then the RF wire is advanced out of the sleeve and adopts a curved configuration for the tracking. Both embodiments described herein above. (Alternatively, if the RF wire is not configured to track, the RF is removed and an 0.035” wire guide is inserted)

[00159] The RF wire tracks far enough into the portal vein such that access is not lost throughout the procedure, approximately 5 centimeters into the portal vein. The RF wire remains in the portal vein throughout the whole procedure and does not dislodge as other devices are exchanged and moved along the RF wire. In other words, the RF wire acts as a rail throughout the procedure. [00160] To confirm access to the portal vein, the catheter is advanced over the RF wire and into the portal vein and the physician aspirates through the catheter to confirm portal vein access, shown in FIG. 12C. Aspiration may be done through the catheter while RF wire 401 is within catheter 300.

[00161] Steps 1108 to 1118 are substantially the same as steps 4008 to 4018, and the RF wire is used as a rail and not of the 0.035” wire guide. (Note, refer to FIGS. 12D to 12F)

[00162] In method 1100, the RF wire is configured to perform the puncture through the liver, and to track into the portal vein. Also in this method, the catheter is configured to confirm portal vein access, to measure pressure in the portal vein, to inject contrast fluid into the portal vein, and to determine the tract length using a visual indicator. The dilator is configured to dilate the tract, to measure pressure in the hepatic vein, and to inject contrast fluid in the hepatic vein. The sheath is configured to steer the assembly, measure pressure in the hepatic vein, and inject contrast fluid into the hepatic vein.

[00163] The embodiment(s) of the invention described above are intended to be exemplary only. The scope of the invention is therefore intended to be limited solely by the scope of the appended claims.

[00164] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub combination.

[00165] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation, or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

CLAIMS:

1. A method of performing a transjugular intrahepatic portosystemic shunt procedure using a medical device assembly including a plurality of devices positioned within a patient’s body comprising at least one puncture device and one or more elongate members, the method comprising the steps of: puncturing through a liver to create a tract between a hepatic vein and a portal vein; dilating the tract; and measuring at least one pressure in at least one of the hepatic vein and the portal vein; wherein at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, and measuring.

2. The method of claim 1, wherein the at least one of the plurality of devices is a dilator, and wherein the dilator is used to for the steps of dilating the tract and measuring the at least one pressure.

3. The method of claim 1 further comprising a step of confirming portal vein access and wherein the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and confirming.

4. The method of claim 3, wherein the at least one of the plurality of devices is a needle, and wherein the needle is used for the steps of puncturing through the liver and confirming portal vein access.

5. The method of claim 3, wherein the at least one of the plurality of devices is a catheter, and wherein the catheter is used for the steps of measuring at least one pressure and confirming portal vein access.

6. The method of claim 1 further comprising a step of injecting fluid to visualize at least one of: a portion of the hepatic vein, a portion of the portal vein, and a portion of the tract, and wherein the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and injecting.

7. The method of claim 6, wherein the at least one of the plurality of devices is a steerable sheath, and wherein the steerable sheath is used for the steps of measuring at least one pressure and injecting fluid.

8. The method of claim 6, wherein the at least one of the plurality of devices is a dilator, and wherein the dilator is used for the steps of dilating the tract and injecting fluid.

9. The method of claim 6, wherein the at least one of the plurality of devices is a dilator and wherein the dilator is used for the steps of measuring at least one pressure and injecting fluid.

10. The method of claim 6, wherein the at least one of the plurality of devices is a catheter and wherein the catheter is used for the steps of measuring at least one pressure and injecting fluid.

11. The method of claim 6 further comprising a step of confirming portal vein access, wherein the at least one of the plurality of devices is a catheter, and the catheter is used for the steps of confirming portal vein access and injecting fluid.

12. The method of claim 1 further comprising a step of determining a length of the tract, and wherein the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and determining the length of the tract.

13. The method of claim 12, wherein the at least one of the plurality of devices is a catheter, and wherein the catheter is used for the steps of determining the length of the tract and measuring at least one pressure.

14. The method of claim 12 further comprising a step of injecting fluid to visualize at least one of: a portion of the hepatic vein, a portion of the portal vein, and a portion of the tract, and the at least one of the plurality of devices is a catheter, and wherein the catheter is used for the steps of determining the length of the tract and injecting fluid.

15. The method of claim 12 further comprising a step of confirming portal vein access, and the at least one of the plurality of devices is a catheter, wherein the catheter is used for the steps of determining the length of the tract and confirming portal vein access.

16. The method of claim 1 further comprising a step of tracking into the portal vein and wherein the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and tracking into the portal vein.

17. The method of claim 16, wherein the at least one of the plurality of devices is the puncture device, and wherein the puncture devices comprises a radio frequency (RF) wire, and the RF wire is used for the steps of puncturing through the liver and tracking into the portal vein.

18. The method of claim 17, wherein the RF wire comprises a flexible distal end.

19. The method of claim 17, wherein the RF wire is received within a sleeve and wherein a distal portion of the RF wire is configured to have a straight orientation while constrained by the sleeve and a curved orientation while outside of the sleeve, and wherein the step of puncturing comprises advancing the RF wire substantially concurrently with the sleeve, whereby the distal portion of the RF wire retains the straight orientation and wherein the step of tracking comprises advancing a distal portion of the RF wire outside of the sleeve, whereby the distal portion of the RF wire adopts the curved orientation.

20. The method of claim 1 further comprising a step of aiming the medical device assembly from a first blood vessel to a second blood vessel, and wherein the at least one of the plurality of devices is used to perform at least two of the steps of puncturing, dilating, measuring, and aiming.

21. The method of claim 20, wherein the at least one of the plurality of devices is a steerable sheath, wherein the steerable sheath is used for the steps of aiming the medical device assembly and measuring the at least one pressure.

22. The method of claim 21 wherein the first blood vessel is an inferior vena cava and the second blood vessel is the hepatic vein.

23. The method of claim 21 wherein the first blood vessel is the hepatic vein and the second blood vessel is the portal vein.

24. A kit for performing a transjugular intrahepatic portosystemic shunt procedure, the kit including a plurality of devices comprising: a puncture device for creating a tract, through tissue, between a first blood vessel and a second blood vessel; and at least one elongate device; wherein at least one of the plurality of devices is configured to perform at least two functions selected from the group consisting of: aiming the plurality of devices, creating the tract, dilating the tract, confirming portal vein access, manipulating fluid in at least one of the first and second blood vessels, and measuring a length of the tract; and wherein the at least two functions can be performed while a number of the plurality of devices positioned within a patient’s body remains constant.

25. The kit of claim 24, wherein the at least one of the plurality of devices is a dilator, and wherein the dilator is configured to dilate the tract and manipulate fluid.

26. The kit of claim 24, wherein the puncture device is a needle, and wherein the needle is configured to create the tract and confirm portal vein access.

27. The kit of claim 24, wherein the at least one of the plurality of devices is a catheter, and wherein the catheter is configured to manipulate fluid and confirm portal vein access.

28. The kit of claim 24, wherein the at least one of the plurality of devices is a catheter, and wherein the catheter is configured to measure the length of the tract and manipulate fluid.

29. The kit of claim 24, wherein the at least one of the plurality of devices is a catheter, and wherein the catheter is configured to measure the length of the tract and confirm portal vein access.

30. The kit of claim 24, wherein the puncture device a radio frequency (RF) wire, and the RF wire is configured to create the tract and track into a portal vein.

31. The kit of claim 30, wherein the RF wire comprises a flexible distal end.

32. The kit of claim 30, wherein the RF wire is received within a sleeve and wherein a distal portion of the RF wire is configured to have a straight orientation while constrained by the sleeve and a curved orientation while outside of the sleeve and wherein the RF wire is configured to create the tract while in the straight orientation and wherein the RF wire is configured to track into the portal vein in the curved orientation.

33. The kit of claim 24, wherein the at least one of the plurality of devices is a steerable sheath, wherein the steerable sheath is configured to aim the plurality of devices and manipulate fluid.

34. The method of claim 1, wherein the number of devices positioned within the patient’s body remains constant while the at least one of the plurality of devices is used to perform the at least two steps.

35. The method of claim 1, wherein the plurality of devices remain positioned within the patient’s body while the at least one of the plurality of devices is used to perform the at least two steps.

36. The method of claim 1, wherein while the at least one of the plurality of devices is used to perform the at least two steps, a configuration of the medical device assembly is maintained.