Granted Patent B2

US 12,402,835 · App. 18/390,711 · Granted Sep 2, 2025

Inventors: Nasser Rafiee (Andover, MA); Biwei MacDonald (Andover, MA); Morgan House (Andover, MA); Koosha Rafiee (Andover, MA); Mai Le Diep (Andover, MA)

Assignee: Transmural Systems LLC

A61B5/6859A61B5/283A61B18/1492A61B2017/0003A61B2018/00279A61B2018/00369A61B2018/00601A61B2018/00839A61M25/0074

Abstract

Claims (28)

1. A method of performing a medical procedure, comprising:

providing a medical device, the medical device including:

an elongate tether having a proximal end configured to be anchored to a proximal anchor point outside of a patient's anatomy and a distal end having a tissue anchor disposed thereon to penetrate through myocardial tissue to permit tension to be applied to and maintained along the elongate tether when the proximal end of the elongate tether is anchored to the proximal anchor point and the tissue anchor is anchored into myocardial tissue;

a first tubular catheter surrounding the elongate tether and being slidably displaceable along and with respect to the elongate tether when the elongate tether is under tension, the first tubular catheter having a proximal end, a distal end, and a cutter; and

a second tubular catheter surrounding the first tubular catheter and being slidably displaceable along and with respect to the first tubular catheter, the second tubular catheter having a proximal end and a distal end;

directing the medical device to a target location inside a patient's left ventricle proximate a native tissue obstruction in a left ventricular outflow tract of the patient;

placing the distal end of the second tubular catheter in a first location located proximally with respect to the tissue obstruction;

placing the distal end of the first tubular catheter in a second location located distally with respect to the tissue obstruction;

penetrating the myocardial tissue with the tissue anchor to secure the distal end of the elongate tether in place with respect to the myocardium;

orienting the cutter of the first tubular catheter toward the native tissue obstruction; and

reciprocating the first tubular catheter along the elongate tether to cause the cutter to cut into the native tissue.

2. The method of claim 1 , wherein the first tubular catheter includes a distally-facing flush port configured to direct a pressurized fluid over the cutter of the first tubular catheter, and wherein the method further includes directing the pressurized fluid out of the distally-facing flush port over the cutter while reciprocating the first tubular catheter.

3. The method of claim 1 , wherein the cutter includes an electrode operably coupled to electrical circuitry that is configured to determine a state of the anatomical tissue.

4. The method of claim 1 , wherein the cutter includes an ultrasonically-driven cutter.

5. The method of claim 1 , wherein the cutter is operably coupled to electrical circuitry, wherein the electrical circuitry is configured to correlate a voltage drop or a current drop of the cutter with a state selected from the group consisting of (i) a state of tissue being cut by the electrode, (ii) a state of fouling of the electrode.

6. The method of claim 2 , wherein the pressurized fluid is a dielectric fluid.

7. The method of claim 6 , wherein the dielectric fluid includes a dextrose solution.

8. The method device of claim 1 , wherein the medical device further includes an actuator assembly coupled to a proximal region of the elongate tether, a proximal region of the first tubular catheter, and a proximal region of the second tubular catheter.

9. The method device of claim 8 , wherein the medical device further includes a third tubular catheter surrounding the second tubular catheter and being slidably displaceable along and with respect to the second tubular catheter, the third tubular catheter having a proximal end and a distal end, and further wherein a proximal end of the third tubular catheter is coupled to the actuator assembly.

10. The method of claim 9 , wherein the actuator assembly further includes a first actuator operably coupled to a proximal end of the first tubular catheter, and wherein the first actuator is configured to advance and retract the first tubular catheter proximally and distally over the elongate tether when the elongate tether is under tension.

11. The method of claim 10 , wherein the actuator assembly further includes a second actuator operably coupled to a proximal end of the second tubular catheter, wherein the second actuator is configured to advance and retract the second tubular catheter proximally and distally over the first tubular catheter, and further wherein the distal end of the second tubular catheter is capable of being retracted proximally past the distal end of the first tubular catheter.

12. The method of claim 11 , wherein the actuator assembly further includes a third actuator operably coupled to a proximal end of the third tubular catheter, wherein the third actuator is configured to advance and retract the third tubular catheter proximally and distally over the second tubular catheter, and further wherein the distal end of the third tubular catheter is capable of being retracted proximally past the distal end of the first tubular catheter and the distal end of the second tubular catheter.

13. The method of claim 1 , wherein each of the first tubular catheter and second tubular catheter to permit an operator to determine relative axial and rotational location of each of the first tubular catheter and second tubular catheter relative to each other and surrounding anatomy.

14. The method of claim 1 , further comprising conforming a shape of the first tubular catheter to match that of the native tissue obstruction such that the first tubular catheter is in at least substantially continuous contact with the native tissue obstruction along a length of the tissue obstruction.

15. The method of claim 1 , wherein the first tubular catheter is reciprocated along the elongate tether to cut an incision into the obstruction to enlarge an effective cross-sectional area of the left ventricular outflow tract of the patient.

16. The method of claim 1 , wherein the first tubular catheter is reciprocated along the elongate tether to cut an incision into the obstruction until the cutting element traverses a straight path between the distal end of the second tubular catheter and the tissue anchor.

17. The method of claim 1 , wherein the cutter is formed at least in part from radiopaque material.

18. The method of claim 1 , wherein the cutter includes a diamond coated wire.

Assignments (1)

Continuity (6)

References Cited (117)