Granted Patent B2

US 12,440,648 · App. 17/680,975 · Granted Oct 14, 2025

Inventor: Yaron Keidar (Kiryat Ono, IL)

Assignee: Edwards Lifesciences Innovation (Israel) Ltd.

A61M25/0147A61M29/00A61M2025/015

Abstract

Claims (66)

1. An apparatus comprising:

a steerable catheter, the steerable catheter comprising:

a flexible tube:

having a proximal portion and a distal portion, at least the distal portion being percutaneously advanceable into a subject, and

comprising a circumferential wall that defines an elongate lumen between the proximal portion and the distal portion;

a pull-wire, extending, in association with the wall, from the proximal portion to the distal portion; and

a pull-ring:

at the distal portion of the tube, coupled to the wall such that the pull-ring circumscribes the lumen,

coupled to the pull-wire, such that pulling on the pull-wire bends the distal portion of the tube,

having (i) a first state in which the pull-ring is elliptical and has a first eccentricity, and (ii) a second state in which the pull-ring is elliptical and has a second eccentricity that is smaller than the first eccentricity,

biased toward assuming the first state, and

elastically deformable toward the second state; and

an article axially slidable through the distal portion of the tube such that passage of the article past the pull-ring elastically deforms the pull-ring into the second state.

2. The apparatus according to claim 1 , wherein:

the pull-ring, in at least the first state, defines a major axis and a minor axis, and

the pull-ring is shaped to define a tension spring at each intersection of the major axis with the pull-ring.

3. The apparatus according to claim 1 , wherein:

the pull-ring is disposed at an axial site at the distal portion of the tube,

the tube has an outer surface, and

in the first state, the outer surface of the tube at the axial site is circular in transverse cross-section.

4. The apparatus according to claim 1 , wherein:

the pull-ring is disposed at an axial site at the distal portion of the tube,

the tube has an outer surface, and

in the second state, the outer surface of the tube at the axial site is non-circular elliptical in transverse cross-section.

5. The apparatus according to claim 1 , wherein:

the tube is a first flexible tube, and defines, at the distal portion, a distal opening out of the lumen, and

the article is a second flexible tube, advanceable distally through the lumen, past the pull-ring, and out of the distal opening, the second tube dimensioned such that advancement of the second tube through the lumen past the pull-ring elastically deforms the pull-ring toward the second state.

6. The apparatus according to claim 1 , wherein:

the pull-wire is a first pull-wire, and

the apparatus further comprises a second pull-wire:

extending, in association with the wall, from the proximal portion to the distal portion,

axially slidable with respect to the wall at least at the proximal portion, and

coupled to the pull-ring opposite the first pull-wire.

7. The apparatus according to claim 1 , wherein the tube, at the proximal portion, is circular in transverse cross-section.

8. The apparatus according to claim 1 , wherein the pull-ring, in the second state, is circular.

9. The apparatus according to claim 1 , wherein:

the pull-ring has (i) an inner surface that faces radially inward toward the lumen, and (ii) an outer surface that faces radially outward from the lumen, and

the pull-wire is attached to the outer surface of the pull-ring.

10. The apparatus according to claim 1 , wherein:

the tube defines, at the distal portion, a distal opening out of the lumen,

the article is a transseptal dilator, shaped to define:

a shaft, extending through the lumen;

a head; and

a neck, connecting the shaft to the head, and disposed within the pull-ring, the head extending distally away from the pull-ring and out of the distal opening, and

the dilator is dimensioned such that axial movement of the head through the pull-ring elastically deforms the pull-ring toward the second state.

11. The apparatus according to claim 10 , wherein the pull-ring is disposed at an axial site at the distal portion of the tube, and the neck fits snugly within the lumen at the axial site.

12. The apparatus according to claim 10 , wherein the dilator is dimensioned such that the pull-ring resists axial movement of the neck away from the pull-ring.

13. The apparatus according to claim 10 , wherein the neck is noncircular in transverse cross-section.

14. The apparatus according to claim 13 , wherein the neck is noncircular elliptical in transverse cross-section.

15. The apparatus according to claim 10 , wherein the head is conical.

16. The apparatus according to claim 15 , wherein:

the head has a widest part, and tapers away from the widest part and from the neck, and

in at least one longitudinal cross-section, a narrowest portion of the neck is narrower than the widest part of the head.

17. The apparatus according to claim 1 , wherein:

the pull-ring, in at least the first state, defines a major axis and a minor axis, and

the pull-wire is attached to the pull-ring at a circumferential position on the pull-ring that is within 10 degrees of the minor axis.

18. The apparatus according to claim 17 , wherein the circumferential position is on the minor axis, and the pull-wire is attached to the pull-ring at the circumferential position that is on the minor axis.

19. A method, comprising:

transluminally advancing a distal portion of a flexible tube into a body chamber of a subject, wherein:

the tube includes a circumferential wall that defines an elongate lumen from a proximal portion of the tube to the distal portion,

the distal portion is shaped to define a distal opening out of the lumen, and

at the distal portion, an elliptical pull-ring is coupled to the wall such that the pull-ring circumscribes the lumen, the pull-ring being in a first state in which the pull-ring has a first eccentricity; and

while the distal portion is disposed in the body chamber, advancing an article through the lumen such that a distal end of the article passes the pull-ring and elastically deforms the pull-ring into a second state in which the pull-ring has a second eccentricity that is smaller than the first eccentricity.

20. The method according to claim 19 , wherein:

advancing the distal portion of the flexible tube comprises advancing the distal portion of the flexible tube while the distal portion is circular in transverse cross-section, and

advancing the article through the lumen comprises advancing the article through the lumen such that the distal end of the article passes the pull-ring and elastically deforms the distal portion of the flexible tube to become noncircular elliptical in transverse cross-section.

Assignments (4)

Continuity (3)

References Cited (400)