TRANSCATHETER DEVICE FOR TREATING TRICUSPID VALVE REGURGITATION
A transcatheter device for treating the tricuspid valve regurgitation. The transcatheter device comprises a main shaft, a proximal portion, a distal tail, and a spacer body mounted on the main shaft and located between the proximal portion and the distal tail. This transcatheter device could be used for treating tricuspid valve regurgitation in a patient's heart. All or part of the transcatheter device is supported by the main shaft. The spacer body is mounted on the shaft, which travels through the spacer body. Also disclosed are a coaptation assembly that comprises the transcatheter device, and a method of treating tricuspid valve regurgitation using the transcatheter device.
1 . A method of treating tricuspid valve regurgitation in a patient's heart, comprising:
having a transcatheter device comprising (i)-(iv) below;
(i) a main shaft;
(ii) a proximal portion comprising a proximal segment of the main shaft and an intravascular anchor;
(iii) a distal tail comprising a distal portion of the main shaft;
(iv) a spacer body mounted on the main shaft and located between the proximal segment of the main shaft and the distal tail;
inserting the transcatheter device into a femoral vein;
advancing the transcatheter device through an inferior vena cava;
advancing the transcatheter device through a right atrium of the heart;
advancing the transcatheter device across a tricuspid valve and into a right ventricle of the heart;
advancing the transcatheter device towards a pulmonary artery;
advancing the distal tail into the pulmonary artery for a distance of at least 10 cm into the pulmonary artery;
positioning the spacer body between leaflets of the tricuspid valve;
lodging the intravascular anchor within the inferior vena cava.
2 . The method of claim 1 , further comprising positioning the spacer body to abut against a supraventricular crest of the heart.
3 . The method of claim 2 , wherein the abutting against the supraventricular crest occurs at a location within the distal half of the spacer body.
4 . The method of claim 2 , wherein the tricuspid valve has a tricuspid annulus and there is an annular plane defined for the tricuspid annulus;
wherein the annular plane is along an x-axis of the tricuspid annulus and orthogonal to a Y-axis of the tricuspid annulus;
wherein the spacer body is positioned at an oblique angle relative to the annular plane.
5 . The method of claim 2 , wherein the main shaft comprises a lumen, and the method further comprises:
inserting a guidewire into the femoral vein;
advancing the guidewire through the inferior vena cava;
advancing the guidewire through the right atrium;
advancing the guidewire to traverse the tricuspid valve and into the right ventricle;
introducing the guidewire into the lumen of the shaft;
advancing the transcatheter device over the guidewire.
6 . The method of claim 1 , wherein the distal tail is advanced past a first branching point of the pulmonary artery.
7 . The method of claim 6 , wherein the distal tail is advanced past a second branching point of the pulmonary artery.
8 . The method of claim 7 , wherein the distal tail of the transcatheter device is advanced past a third branching point of the pulmonary artery.
9 . The method of claim 1 , wherein the distal tail of the transcatheter device is advanced a least 15 cm into the pulmonary artery.
10 . The method of claim 1 , wherein the spacer body has an opening through which blood flows through the spacer body.
11 . The method of claim 1 , wherein the pulmonary artery is a left-side pulmonary artery.
12 . A transcatheter device comprising:
a main shaft;
a proximal portion comprising a proximal segment of the main shaft and an intravascular anchor;
a distal tail comprising a distal portion of the main shaft, wherein the distal tail has a length in the range of 10-40 cm long;
a spacer body mounted on the main shaft and located between the proximal segment of the main shaft and the distal tail.
13 . The transcatheter device of claim 12 , wherein the spacer body has a non-linear shape.
14 . The transcatheter device of claim 12 , wherein the distal tail comprises a bend.
15 . The transcatheter device of claim 12 , wherein the distal tail comprises a proximal segment and a distal segment, wherein the distal segment has a thinner diameter than the proximal segment.
16 . The transcatheter device of claim 12 , wherein the spacer body has a length in the range of range of 4-13 cm.
17 . The transcatheter device of claim 12 , wherein the intravascular anchor is a spiral coil.
18 . The transcatheter device of claim 17 , wherein the intravascular anchor is has at least two spirals.
19 . A coaptation assembly comprising:
a transcatheter device of claim 12 , wherein the main shaft comprises a lumen;
a guidewire traveling through the lumen of the main shaft;
a moveable delivery sheath that covers the spacer body and intravascular anchor;
a deployment catheter for intravascular deployment of the transcatheter device.
20 . The transcatheter device assembly of claim 19 , further comprising an entry opening on the main shaft at a location between the intravascular anchor and the spacer body and an exit opening on the main shaft at a tip of the distal tail;
wherein the lumen of the main shaft extends from the entry opening to the exit opening;
wherein the guidewire travels through the lumen from the entry opening to the exit opening.