Granted Patent B2

US 12,426,922 · App. 17/734,179 · Granted Sep 30, 2025

Inventors: Elad Sapir (Kefar Vitkin, IL); Francesco Maisano (Milan, IT); Eyal Teichman (Hod-Hasharon, IL)

Assignee: TRANSSEPTAL SOLUTIONS LTD.

A61B17/3478A61B2017/00247A61B2017/22071A61B2090/065A61B2090/0807

Abstract

Claims (44)

1. Apparatus for puncturing a fossa ovalis, the apparatus comprising:

a catheter, which (a) has a distal portion that is shaped so as to define a catheter distal end opening at a distal end of the catheter, and first and second lateral openings, and (b) is shaped so as to define a central catheter lumen open through the catheter distal end opening, wherein an angle between (i) a first line running between the first and the second lateral openings and (ii) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees; and

a flexible longitudinal member, which:

passes (a) from a proximal portion of the catheter to the distal portion of the catheter, (b) out of the first lateral opening, and (c) into the second lateral opening, so as to form a loop outside the catheter, and

is configured to assume a deployment configuration in which a distal-most portion of the loop is curved and is distal to the catheter distal end opening,

wherein a wall of the catheter is shaped so as to define first and second longitudinally-running channels in the wall, and

wherein the flexible longitudinal member passes (a) from the proximal portion of the catheter to the distal portion of the catheter via the first longitudinally-running channel, (b) out of the first longitudinally-running channel via the first lateral opening, (c) into the second longitudinally-running channel via the second lateral opening, and (d) from the distal portion of the catheter to the proximal portion of the catheter via the second longitudinally-running channel, so as to form the loop outside the catheter.

2. The apparatus according to claim 1 , wherein the angle between the first and the second lines is between 60 and 120 degrees.

3. The apparatus according to claim 2 , wherein the angle between the first and the second lines is between 80 and 100 degrees.

4. The apparatus according to claim 1 , wherein the first and the second lateral openings are at a same distance from the distal end of the catheter, such that the angle between the first and the second lines equals 90 degrees.

5. The apparatus according to claim 1 , wherein the first and the second lateral openings are disposed at a distance that is 1-5 cm from the distal end of the catheter.

6. The apparatus according to claim 1 , wherein the first and the second lateral openings are disposed at a distance that is no more than 1 cm from the distal end of the catheter.

7. The apparatus according to claim 1 , wherein a distance of the first lateral opening from the distal end of the catheter differs by less than 1 cm from a distance of the second lateral opening from the distal end of the catheter.

8. The apparatus according to claim 1 , wherein the first and the second lateral openings are separated from one another by an angle of 170-190 degrees measured along a circumference of the catheter.

9. The apparatus according to claim 1 , wherein the apparatus is configured to form exactly one loop that passes out of the distal portion of the catheter.

10. The apparatus according to claim 1 , wherein the flexible longitudinal member comprises a wire.

11. The apparatus according to claim 1 , wherein an internal diameter of the central catheter lumen is greater than respective internal diameters of the first and the second longitudinal-running channels in the wall.

12. The apparatus according to claim 1 ,

wherein the flexible longitudinal member is configured such that, when in the deployment configuration, in an absence of any force applied to the deployed portion of the flexible longitudinal member by an element that is not part of the apparatus, a deployment angle of the flexible longitudinal member is between 10 and 80 degrees, and

wherein the deployment angle is between (a) a vector that is (i) tangent to the flexible longitudinal member at an exit point of the flexible longitudinal member from the catheter, and (ii) directed away from the catheter, and (b) a distally-directed vector that is parallel to the central longitudinal axis of the catheter at the exit point.

13. The apparatus according to claim 12 , wherein the deployment angle is between 30 and 60 degrees.

14. The apparatus according to claim 1 , further comprising a needle, which is shaped to be slidably disposed within the central catheter lumen, and is configured to puncture a hole through the fossa ovalis by being advanced out of the catheter distal end opening and through the fossa ovalis.

15. The apparatus according to claim 14 , wherein the apparatus further comprises a dilator, which (a) is slidably disposed within the central catheter lumen, and (b) comprises:

a dilator body, which is shaped so as to define a dilator lumen; and

a dilator tip, which is (i) disposed at a distal end of the dilator, (ii) shaped so as to define a dilator-tip distal end opening through which the dilator lumen is open, and (iii) configured to dilate the hole in the fossa ovalis punctured by the needle.

16. The apparatus according to claim 15 , wherein the needle is shaped to be slidably disposed within the dilator lumen, and is configured to puncture the hole in the fossa ovalis by being advanced out of the dilator-tip distal end opening and through the fossa ovalis.

17. The apparatus according to claim 14 ,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a helical distal portion, and

wherein the apparatus further comprises a fluid-impermeable cover surrounding the helical distal portion of the needle.

18. The apparatus according to claim 14 ,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a distal portion that is more flexible than the proximal portion, and

wherein the apparatus further comprises a fluid-impermeable cover surrounding the distal portion of the needle.

19. The apparatus according to claim 14 ,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a distal portion comprising a wall that is shaped to define a plurality of openings that pass completely therethrough, and

wherein the apparatus further comprises a fluid-impermeable cover surrounding the distal portion of the needle.

20. The apparatus according to claim 14 ,

wherein the needle is hollow, and comprises (a) a proximal portion, and (b) a distal portion comprising an elastomeric tube having an outer surface, an inner surface, and an interior portion between the outer and inner surfaces that is selected from the group consisting of: a braided metal interior, and a coiled metal interior.

21. The apparatus according to claim 14 ,

wherein the needle is hollow, and comprises:

a proximal portion having an outer diameter between 0.7 and 3 mm, a length between 650 and 1200 mm, and a wall thickness between 0.1 and 0.3 mm; and

a distal portion at least partially made of nitinol, the distal portion having an outer diameter between 0.5 and 1.5 mm and a length between 30 and 200 mm.

22. The apparatus according to claim 14 , wherein the needle is electrically conductive, and wherein the apparatus further comprises:

one or more conductors; and

a controller, which is coupled to the needle by the one or more conductors, and which is configured to drive the needle to apply energy capable of creating the hole through the fossa ovalis.

Assignments (2)

Continuity (10)

References Cited (193)