Devices and methods for intrahepatic shunts
The invention provides methods and devices for treating liver cirrhosis or portal hypertension by creating an intrahepatic shunt, or new passage, from a portal vein of a patient to a hepatic vein using a device with intravascular imaging capabilities and pressure sensing capabilities or positioning mechanisms. The integration of intravascular imaging aids in the precise placement of the shunt and pressure measurement may verify successful shunt creation. An apparatus may include a catheter with an extended body for insertion into a hepatic vein of a patient, an intravascular imaging device and a needle exit port on the distal portion of the extended body, and a needle disposed within a lumen in the catheter and configured to be pushed out of the exit port and extend away from a side of the extended body, in which the needle includes a pressure sensor.
1. An apparatus for creating an intrahepatic portosystemic shunt, the apparatus comprising:
a catheter with an extended body configured for insertion down a jugular vein into a hepatic vein of a patient;
an intravascular imaging device on a distal portion of the extended body;
a needle exit port on the distal portion of the extended body, the needle exit port comprising an opening; and
a needle comprising an extended portion and a distal portion constructed of a shape-memory metal, whereupon being in a lumen of the catheter, the distal portion of the needle is configured to maintain the shape of the catheter, and whereupon extending out of the opening of the needle exit port and away from a side of the extended body, the distal portion of the needle is configured to assume a curved shape, wherein the curved shape comprises (i) an angle between 55 degrees and 79 degrees measured between a distal tip of the distal portion and the extended portion of the needle and (ii) a lateral reach between 1 cm and 2.5 cm, wherein the lateral reach is a distance from the extended portion of the needle to the distal tip in a direction perpendicular to a longitudinal axis of the extended portion of the needle; and
a pressure sensor disposed on the distal portion of the needle.
2. The apparatus of claim 1 , wherein the pressure sensor is disposed on the distal portion of the needle a distance from the distal tip, wherein the distance is less than 50% of the lateral reach.
3. The apparatus of claim 2 , wherein the needle comprises a shape memory metal that assumes a curved shape as the needle exits the nonadjustable needle exit port.
4. The apparatus of claim 3 , wherein the needle comprises a lumen extending therethrough, the lumen dimensioned to receive a guidewire.
5. The apparatus of claim 3 , wherein the intravascular imaging device comprises an ultrasound transducer.
6. The apparatus of claim 5 , wherein the needle is dimensioned to extend from the non-adjustable needle exit port away from the side of the catheter body through tissue and into a portal vein.
7. The apparatus of claim 6 , wherein the distal tip is a sharp tip configured to pierce through the tissue between the hepatic vein and the portal vein thereby creating a portosystemic shunt.
8. The apparatus of claim 7 , wherein the ultrasound transducer is operable to produce an image of the portal vein when within the hepatic vein.
9. The apparatus of claim 8 , wherein a proximal end of the catheter is attached to an imaging system comprising a processor and a display, and wherein the image produced by the ultrasound transducer is viewable on the display.
10. The apparatus of claim 1 , further comprising a positioning mechanism operable to bias a portion of the extended body towards a side of the hepatic vein.
11. The apparatus of claim 10 , wherein the positioning mechanism comprises a first balloon and a second balloon disposed in parallel to one another along a length of the extended body.
12. The apparatus of claim 1 , wherein the needle comprises a lumen for delivering a treatment agent to tissue.
13. The apparatus of claim 1 , wherein the angle is at least 65 degrees.
14. The apparatus of claim 1 , wherein the distal tip is a beveled tip.
15. The apparatus of claim 14 , wherein the beveled tip defines the angle with the extended body, and the angle is at least 65 degrees.
16. An apparatus for creating an intrahepatic portosystemic shunt, the apparatus comprising:
a catheter with an extended body configured for insertion down a jugular vein into a hepatic vein of a patient, a distal portion of the extended body having a first side and a second side opposing the first side;
an intravascular imaging device on the distal portion of the extended body;
a needle exit port on the first side of the distal portion of the extended body;
a needle disposed within a lumen in the catheter and configured to be pushed out of the exit port and extend away from the first side of the distal portion of the extended body; and
a first balloon and a second balloon disposed on the second side of the distal portion of the extended body and in parallel to one another along a length of the extended body and partially spaced apart from one another along a circumference of the extended body, wherein inflation of the first balloon and the second balloon biases a portion of the extended body towards a side of the hepatic vein.
17. The apparatus of claim 16 , wherein the needle comprises a distal tip, wherein the distal tip has a lateral reach of at least 1 cm, wherein the lateral reach is a perpendicular distance from the extended body to the distal tip.
18. The apparatus of claim 17 , wherein the needle comprises a shape memory material that assumes a curved shape as the needle exits the exit port.
19. The apparatus of claim 18 , further comprising a pressure sensor disposed on the needle a distance from a distal tip of the needle, wherein the distance is less than 50% of the lateral reach.
20. The apparatus of claim 16 , wherein the intravascular imaging device comprises an ultrasound transducer operable to produce an image of a portal vein when within the hepatic vein.