Method and catheter for creating an interatrial aperture
A catheter device with a cutting structure or means on the distal portion is disclosed, along with a medical procedure for using the device. The catheter is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue.
1. A medical device, comprising:
a catheter, the catheter comprising:
a catheter shaft, the catheter shaft having a central lumen,
a distal catheter lumen,
a shaped blade around the distal catheter lumen, the blade adapted to cut an area of tissue to create an aperture in a tissue,
a tissue articulator, the tissue articulator having a first position and a second position, being configured to move with respect to the shaped blade, and being adapted to hold the tissue against the shaped blade for cutting while in the second position,
an actuator connected to the tissue articulator, the actuator having a first position and a second position, wherein when the actuator is in the second position the tissue articulator holds the tissue against the shaped blade.
2. The medical device of claim 1 further comprising a sheath adapted to protect tissue from the shaped blade before the shaped blade is deployed.
3. The medical device of claim 1 , wherein the shaped blade is selected from the group consisting of a circular blade, a square blade, a triangular blade, or a polygonal blade.
4. The medical device of claim 1 wherein the tissue articulator comprises a tissue removal device.
5. The medical device of claim 4 , wherein the tissue removal device comprising a hook, a balloon, or an expandable basket.
6. The medical device of claim 4 , wherein the tissue removal device comprises a proximal portion and a distal portion, the actuator configured to move one or both portions with respect to the other, and the proximal and distal portions being adapted to hold the tissue securely between them when actuated.
7. The medical device of claim 6 , wherein the proximal and distal portions are moveable with respect to the shaped blade, and are adapted to withdraw the cut tissue securely into the shaped blade.
8. The medical device of claim 1 , wherein the distal catheter lumen is larger than the central catheter lumen.
9. The medical device of claim 1 , further comprising multiple blades on the exterior of the catheter shaft, the blades being arranged apart from each other circumferentially around the catheter shaft and extending outward from the catheter shaft.
10. The medical device of claim 9 wherein each blade is attached to the catheter shaft by at least one pin and is adapted to expand away from the catheter shaft when actuated.
11. The medical device of claim 9 wherein at least one of the multiple blades are actuated by moving a second actuator.
12. The medical device of claim 1 further comprising a first radiopaque marker on the distal end of the catheter.
13. The medical device of claim 12 further comprising a sheath, the sheath comprising a second radiopaque marker on the distal end of the sheath, wherein the first and second radiopaque markers are different and are configured to identify when the catheter has exited the sheath.
14. The medical device of claim 1 further comprising a suction opening configured to apply suction to the tissue in the approximate area of the cutting blade, the suction configured to assist in cutting the tissue or to remove the cut tissue portion.
15. The medical device of claim 1 wherein the tissue articulator is a tapered cone having a proximal face, the proximal face being adapted to retain a tissue, and further being adapted to fit within the distal lumen of the catheter shaft.
16. The medical device of claim 1 further comprising a tenting device adapted to tent a target tissue into the distal lumen of the catheter such that a larger portion of the target tissue may be cut by the cutting device.
17. A method of treating congestive heart failure comprising the steps of:
inserting a catheter into the right atrium of the heart, the catheter comprising:
a shaft,
a distal catheter lumen,
a shaped cutting blade arranged around the distal catheter lumen,
a tissue articulator, the tissue articulator having a first position and a second position,
an actuator connected to the tissue articulator
crossing the interatrial septum,
actuating the actuator to move the tissue articulator into a second position that holds the tissue against the shaped cutting blade,
cutting an aperture in the interatrial septum between the right atrium and the left atrium,
removing a cut tissue from the right atrium.
18. The method of claim 17 further comprising a step of attaching a tissue removal device to the interatrial septum.
19. The method of claim 17 further comprising a step of pulling the attached tissue into a lumen at a distal end of the catheter shaft.
20. The method of claim 17 further comprising a step of expanding the cutting device to a diameter greater than the diameter of the catheter.