PORTAL VEIN ACCESS DEVICE AND METHOD FOR FACILITATING PORTAL VENOUS ENTRY FOR CREATION OF A PERCUTANEOUS TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT

Abstract

The invention features is an embodiment of methods and devices that comprise a multilumen portal vein access device, comprising at least a lumen for passage of a needle or needle-tipped guide wire that is used for piercing the liver from a hepatic vein position to a branch of the portal vein through the substance of the liver, and at least one other lumen that is use for passage of a guide wire, said other lumen and guide wire serving the function of preserving the position of the portal vein access device within the hepatic vein, thereby facilitating multiple attempts at puncturing the portal vein without the need to select the hepatic vein with separate maneuvers between needle advancement attempts.

Claims

1. A portal vein access device comprising a tube with a proximal or hub end and a distal or tip end, said device containing a plurality of lumens essentially parallel to its long axis, said lumens being non-concentric, in which a first lumen accommodates a curved needle when passed from proximal to distal within said first lumen, said first lumen having a proximal end at the hub end of the portal vein access device and a distal end, said first lumen distal end occurring at a needle exit port, and also having at least one second lumen, said second lumen accommodating a guide wire through its entire length.

2. A portal vein access device of claim 1 with a first lumen needle exit port that deflects the path of the exiting needle or needle-tipped guide wire at least 5 degrees off of the long axis of said portal vein access device.

3. A portal vein access device comprising a tube with a proximal or hub end and a distal or tip end, said device containing a plurality of lumens essentially parallel to its long axis, said lumens being non-concentric, in which a first lumen accommodates a curved needle when passed from proximal to distal within said first lumen, said first lumen having a proximal end at the hub end of the portal vein access device and a distal end, said first lumen distal end occurring at a needle exit port, and also having at least one second lumen, said second lumen accommodating a guide wire through its entire length, and said second lumen having an elongated tip that it extends between 5 and 30 cm beyond the said needle exit port of said first lumen.

4. A portal vein access device of claim 3 with a first lumen needle exit port that deflects the path of the exiting needle or needle-tipped guide wire at least 5 degrees off of the long axis of said portal vein access device.

5. A method for performing a percutaneous transjugular intrahepatic portosystemic shunt procedure, using fluoroscopic or other medical imaging guidance, that includes preserving access of a guide wire to a hepatic vein during maneuvers of a needle used to access the portal vein, consisting of the following steps, not necessarily in order: access of the jugular vein using a first needle and a first guide wire; placement of a vascular access sheath into the jugular vein; placement of a multilumen portal vein access device comprising at least a first lumen for guide wire and catheter placement and at least a second lumen for second curved needle placement therethrough, said multilumen portal vein access device advanced over said guidewire and through said vascular access sheath; placement of a catheter over said guide wire through a first lumen of said multilumen portal vein access device to traverse the heart and selectively entering one of the following veins: left hepatic vein, middle hepatic vein, right hepatic vein, common hepatic vein; advancement of said guide wire and catheter distally into said vein; advancement of said portal vein access device over said guide wire and said catheter into said vein such that said portal vein access device needle exit port resides at least 3 cm caudal to the confluence of said vein with the inferior vena cava; introduction of said second, curved needle into said second lumen of said portal vein access device so that it passes through said second lumen to, but not out of, said needle exit port; adjustment of position of said portal vein access device in said vein so that advancement of said second, curved needle out of said needle exit port is anatomically likely to enter a portal vein branch; advancement of said second, curved needle through said second lumen into said liver parenchyma and into a portal vein or portal vein branch; advancement of a second guide wire through said second, curved needle into the portal vein; removal of said portal vein access device and said first guide wire; dilation of the parenchymal tract using an angioplasty balloon or dilator introduced over said second guide wire; deployment of a tube conduit in the portal-vein-to-hepatic vein liver parenchymal tract over said second guide wire; removal of said tube conduit stent or stent-graft introducer, said second guide wire, and said large-bore vascular access sheath.

6. A method of performing percutaneous transjugular intrahepatic portosystemic shunt procedures of claim 5, in which said tube conduit stent or stent-graft is dilated using a balloon catheter or dilator after deployment in said portal-vein-to-hepatic vein liver parenchymal tract.

7. A method of performing percutaneous transjugular intrahepatic portosystemic shunt procedures of claim 5 that includes preserving access to said hepatic vein during retraction of the portal vein access device prior to needle advancement through the hepatic parenchyma by use of an elongated tip of said portal vein access device that extends distally between 5 cm and 30 cm beyond the needle exit port.

8. A method of performing percutaneous transjugular intrahepatic portosystemic shunt procedures of claim 5 that includes preserving access to a hepatic vein during retraction of the portal vein access device prior to needle advancement through the hepatic parenchyma by use of a guide wire that extends beyond the tip of said portal vein access device, to a distance in the vein between5 cm and 30 cm beyond the needle exit port.

9. A method of performing percutaneous transjugular intrahepatic portosystemic shunt procedures of claim 5 that includes preserving access to a hepatic vein during retraction of the portal vein access device prior to needle advancement through the hepatic parenchyma by use of an expansile element on the portal vein access device located distally enough to be within the hepatic vein during retraction maneuvers of the portal vein access device during attempts at portal vein access.

10. A method of performing percutaneous transjugular intrahepatic portosystemic shunt procedures of claim 9 where said expansile element is an angioplasty balloon.

11. A method of performing percutaneous transjugular intrahepatic portosystemic shunt procedures of claim 9 where said expansile element is Malecot tip.

12. A method of performing percutaneous transjugular intrahepatic portosystemic shunt procedures of claim 9 where said expansile element is an anchoring device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0047] FIG. 1 is an illustration one exemplary embodiment of the invention, which comprises a portal vein access apparatus, as seen here in longitudinal cut-away section.

[0048] FIG. 2 is an illustration of another exemplary embodiment of the invention, comprising a portal vein access apparatus, also seen in longitudinal cut-away section

[0049] FIG. 3 is an illustration of an exemplary embodiment of the invention, comprising a portal vein access apparatus, in longitudinal cut-away view.

[0050] FIG. 4 is an illustration of a cross-section of the proximal section of the embodiment seen in FIG. 2.

[0051] FIG. 5 is a schematic of the anatomy of the liver, portal veins, hepatic veins, vena cava, and right atrium.

DETAILED DESCRIPTION OF THE DRAWINGS

[0052] Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures. The singular forms a, an, and the include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a solvent includes reference to one or more of such solvents, and reference to the dispersant includes reference to one or more of such dispersants.

[0053] According to one embodiment of the device, as shown in FIG. 1, the portal vein access device 101 comprises a sheath with multiple lumens, in FIG. 1 two lumens are shown by way of example, one lumen 10 which accommodates a needle or needle-sheath combination 12, said needle which has a cap or handle at its hub end 15, said lumen 10 with an entry port 16 at the hub end 14 and a needle exit port 17 at its distal end, in this embodiment. The second lumen 11 accommodates a guide wire 13 with an entry port 18 at the hub end of the apparatus and a guide wire exit port 19 at the tip end.

[0054] According to another embodiment of the invention, as shown in FIG. 2, the portal vein access device 101 comprises a sheath with multiple lumens, in FIG. 2 two lumens are shown by way of example, but the shaft between the needle exit port 17 and the guide wire exit port 19 of the portal vein access device 101 is elongated, and in this embodiment comprises an extended single-lumen component 20 at the distal end at the guide wire exit port 19. In this embodiment, the extended tip is of similar outer diameter to the sheath proximal to needle or needle-tip guide wire exit port, so the portal vein access device is of nearly uniform outer diameter throughout its length.

[0055] According to another embodiment of the invention, as shown in FIG. 3, the portal vein access device 101 comprises a sheath with multiple lumens, in FIG. 2 two lumens are shown by way of example, but the shaft between the needle exit port 17 and the guide wire exit port 19 of the portal vein access device 101 is elongated, and in this embodiment comprises and extended single-lumen component 20 at the tip end near the guide wire exit port 19. In this embodiment, the outer diameter of the portal vein access device is not uniform throughout its length, but rather it tapers distal to the exit port of the needle or needle-tipped guide wire, so that the distal segment without the needle or needle-tipped guide wire lumen is of narrower outer diameter than the proximal segment that includes the needle or needle-tipped guide wire lumen.

[0056] FIG. 4 is an example of an embodiment of the multi-lumen portal vein access device 101 showing a proximal segment of the apparatus in cross-section, which comprises in this example two lumens, one that accommodates the portal vein access needle or needle-cannula 10 and a second lumen 11 that accommodates a guide wire.

[0057] FIG. 5 is a schematic in coronal section of the liver 25, right hepatic vein 26, superior vena cava 23, right atrium 24, right portal vein 27, inferior vena cava 22, superior mesenteric vein 28, splenic vein 21, and coronary vein varix 20.

INCORPORATION BY REFERENCE

[0058] References and citations to other documents, such as patents, patent applications, provisional patent applications, patent publications, journals, books, papers, web content, that have been made throughout this disclosure are hereby incorporated herein by reference in their entirety for all purposes.

Equivalents

[0059] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.