Granted Patent B2

US 12,268,828 · App. 15/748,658 · Granted Apr 8, 2025

Inventors: Avraham Shekalim (Nesher, IL); Noam Peleg (Gan Ner, IL)

Assignee: CARDIOSERT LTD.

A61M25/09041A61M2025/09083A61M2025/09116A61M2025/0915

Abstract

Claims (33)

1. A double guidewire comprising:

a) a first guidewire comprising an elongated flexible shaft and having a distal portion that terminates in a distal tip, said distal portion of said first guidewire comprising a deflectable helical coil, said first guidewire being a hollow guidewire having a central lumen extending along a length of said first guidewire;

b) a second guidewire comprising an elongated flexible shaft and having a distal portion that terminates in a distal tip, said distal portion of said second guidewire comprising a deflectable helical coil, said second guidewire being deployed within said central lumen of said first guidewire, wherein the distal tips of the first guidewire and the second guidewire are distinct; and

c) an adjuster mechanism mechanically linked to a proximal portion of at least said second guidewire, said adjuster mechanism being operable to displace said second guidewire longitudinally relative to said first guidewire between at least:

i) a first state in which said distal tip of said second guidewire is adjacent to said distal tip of said first guidewire,

ii) a second state in which at least part of said distal portion of said second guidewire is advanced beyond the distal tip of said first guidewire; and

iii) a third state in which said distal tip of said second guidewire is withdrawn proximally along said central lumen of said first guidewire so as to leave empty a part of said central lumen of said first guidewire along at least part of said distal portion of said first guidewire;

wherein a region of said distal portion of each of said first and said second guidewires is preshaped to impart a lateral deflection from a longitudinal axis of the elongated flexible shaft of said first and said second guidewires, respectively,

wherein, advancing said second guidewire proximally along said central lumen of said first guidewire, from said third state to said first state, results in a reduction of a lateral deflection of said double guidewire, and results in at least partial overlap of the deflected portions of the first and second guidewires.

2. The double guidewire of claim 1 , wherein an external surface of said distal portion of said first guidewire is coated with a hydrophilic coating, and wherein an external surface of said distal portion of said second guidewire is not coated with said hydrophilic coating.

3. The double guidewire of claim 1 , wherein said first guidewire further comprises a metal strip extending along an inner surface of said helical coil of said distal portion of said first guidewire and permanently attached to said helical coil of said distal portion of said first guidewire at a plurality of spaced-apart locations along said helical coil of said distal portion of said first guidewire.

4. The double guidewire of claim 1 , wherein said second guidewire further comprises a tapered metal core extending within said helical coil of said distal portion of said second guidewire and permanently attached to said helical coil of said distal portion of said second guidewire at said distal tip of said second guidewire.

5. The double guidewire of claim 1 , wherein an outer diameter of said first guidewire is no greater than 0.014 inch (0.36 mm).

6. The double guidewire of claim 1 , wherein an outer diameter of said first guidewire is no greater than 0.038 inch (0.97 mm).

7. The double guidewire of claim 1 , further comprising a handle located at a proximal end of said double guidewire, wherein said adjuster mechanism is integrated with said handle.

8. The double guidewire of claim 1 , wherein said distal tip of said second guidewire is curved and deflected and displaced longitudinally when it protrudes beyond the distal tip of the first guidewire.

9. A method of performing a surgical procedure on a patient comprising the steps of:

a) providing a double guidewire comprising:

a) a first guidewire comprising an elongated flexible shaft and having a distal portion that terminates in a distal tip, the distal portion of the first guidewire comprising a deflectable helical coil, the first guidewire being a hollow guidewire having a central lumen extending along a length of the first guidewire;

b) a second guidewire comprising an elongated flexible shaft and having a distal portion that terminates in a distal tip, the distal portion of the second guidewire comprising a deflectable helical coil, the second guidewire being deployed within the central lumen of the first guidewire, wherein the distal tips of the first guidewire and the second guidewire are distinct; and

c) an adjuster mechanism mechanically linked to a proximal portion of at least the second guidewire, the adjuster mechanism being operable to displace the second guidewire longitudinally relative to the first guidewire between at least:

i) a first state in which the distal tip of the second guidewire is adjacent to the distal tip of the first guidewire,

ii) a second state in which at least part of the distal portion of the second guidewire is advanced beyond the distal tip of the first guidewire; and

iii) a third state in which said distal tip of said second guidewire is withdrawn proximally along said central lumen of said first guidewire so as to leave empty a part of said central lumen of said first guidewire along at least part of said distal portion of said first guidewire;

 wherein a region of the distal portion of each of said first and said second guidewires is preshaped to impart a lateral deflection from a longitudinal axis of the elongated flexible shaft of each of said first and said second guidewires, respectively, and wherein a region of the distal portion adjacent to the distal tip of each of the first and second guidewires having a lateral deflection, a deflected portion of the first guidewire having a first length;

b) introducing the double guidewire into a bodily lumen of the patient and navigating the double guidewire within the bodily lumen to reach a target location; and

c) selectively displacing the second guidewire relative to the first guidewire, via the adjuster mechanism, so as to locate the deflected portion of the first guidewire and a second deflected portion of the second guidewire longitudinally relative to each other, thereby imparting to the double guidewire a lateral deflection extending for a second length, the second length being greater than the first length, to facilitate navigation of the double guidewire within the bodily lumen.

10. The method of claim 9 , further comprising selectively displacing the second guidewire relative to the first guidewire so that the distal portion of the second guidewire extends beyond the distal tip of the first guidewire.

11. The method of claim 9 , further comprising advancing along the double guidewire an “014-compatible” over-the-wire device selected from the group consisting of: an angioplasty balloon and an expandable stent.

12. The method of claim 9 , further comprising rotating at least the first guidewire about its longitudinal axis.

13. The method of claim 9 , wherein the bodily lumen comprises a blood vessel.

14. The method of claim 9 , wherein the displacement of the second guidewire within the first guidewire generates an additional region of deflection.

15. The method of claim 9 , wherein the displacement of the second guidewire adjusts an overall extent, angle and geometry of the curvature of a distal tip portion of the double guidewire.

Assignments (3)

Continuity (2)

References Cited (78)