GUIDEWIRE DEVICES HAVING SHAPEABLE TIPS AND BYPASS CUTS

• US 20180015261A1
• Filed: 05/26/2017
• Published: 01/18/2018
• Est. Priority Date: 07/18/2016
• Status: Active Grant

• Current Assignee: Scientia Vascular, LLC
• Original Assignee: Scientia Vascular, LLC
• Inventors: Lippert, John A., Snyder, Edward J.
• Granted Patent: US 11,207,502 B2
• Time in Patent Office: Days
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/09075 having a core without a coil possibly combined with a sheath
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09091 where a sheath surrounds the coil at the distal part
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 2025/0915 having features for changing the stiffness
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section extends into the tube structure. The tube structure includes a plurality of bypass cuts formed tangentially within the tube structure to increase the flexibility of the tube structure and to reduce the tendency of resilient forces from the tube structure to disrupt a shaped distal tip of the guidewire device.

Claims

1. A guidewire device having a shapeable tip, the guidewire device comprising:

a core having a proximal section and a distal section, the distal section having a smaller diameter than the proximal section; and

a tube structure coupled to the core such that the distal section of the core passes into the tube structure,

wherein the tube structure includes a cut pattern which forms a plurality of axially extending beams coupling a plurality of circumferentially extending rings,

wherein at least a portion of the cut pattern includes a one-beam section having a one-beam cut pattern which forms a single beam between each adjacent ring within the one-beam section, and

wherein a distal tip of the guidewire device is configured to be manually shapeable.

2. The guidewire device of claim 1, wherein the distal section of the core tapers from the proximal section of the core.

3. The guidewire device of claim 1, further comprising a coil disposed within the tube structure so as to be positioned between an outer surface of the distal section of the core and an inner surface of the tube structure.

4. The guidewire device of claim 3, wherein the coil is configured in size and shape to pack the space between the outer surface of the distal section of the core and the inner surface of the tube such that a curvature of the tube structure is aligned with a curvature of the distal section of the core when the tube structure or distal section are curved.

5. The guidewire device of claim 3, wherein the coil is formed at least in part from a radiopaque material.

6. The guidewire device of claim 1, wherein the core is formed from stainless steel.

7. The guidewire device of claim 1, wherein the tube structure is formed from a superelastic material.

8. The guidewire device of claim 7, wherein the tube structure is formed from nitinol.

9. The guidewire device of claim 1, wherein at least a portion of the cut pattern includes a single-sided one-beam cut pattern wherein a plurality of successive beams are disposed on a single side of the tube structure with respect to a longitudinal axis of the guidewire device.

10. The guidewire device of claim 1, wherein the cut pattern includes a two-beam cut pattern disposed proximal of the one-beam cut pattern.

11. The guidewire device of claim 10, wherein the two-beam cut pattern includes a depth-symmetric two-beam cut pattern and a depth-offset two-beam cut pattern, wherein the depth-symmetric two-beam cut pattern is disposed proximal of the depth-offset two-beam cut pattern.

12. The guidewire device of claim 1, wherein the one-beam cut pattern includes a rotational offset such that successive beams or sets of beams along a length of the tube structure are circumferentially rotated with respect to a preceding beam or set of beams.

13. The guidewire device of claim 12, wherein the rotational offset forms a helical arrangement of beams along a length of the tube structure.

14. The guidewire device of claim 1, wherein the one-beam cut pattern is arranged with cuts of increasing depth toward a distal end of the tube structure.

15. The guidewire device of claim 1, wherein the one-beam cut pattern is arranged such that spacing between successive cuts decreases toward a distal end of the tube structure.

16. A guidewire device having a shapeable tip, the guidewire device comprising:

a core having a proximal section and a distal section, the distal section having a smaller diameter than the proximal section; and

a tube structure coupled to the core such that the distal section of the core passes into the tube structure, a distal section of the tube structure defining a distal tip of the guidewire device,

wherein the tube structure includes a plurality of bypass cuts extending transversely into the tube structure, each bypass cut forming a single beam defined by a remaining section of tube material,

wherein the plurality of bypass cuts form rings disposed between the bypass cuts and connected by the beams, and

wherein the distal section of the core is formed from a shapeable material and is configured to have a stiffness such that when the distal tip is bent into a shaped configuration, the distal section of the core is able to withstand deformation caused by an elastic recovery force of the tube structure.

17. The guidewire device of claim 16, wherein the plurality of bypass cuts are arranged with cuts of increasing depth toward a distal end of the tube structure.

18. The guidewire device of claim 17, wherein the plurality of bypass cuts are arranged such that spacing between successive cuts decreases toward a distal end of the tube structure.

19. The guidewire device of claim 16, further comprising a radiopaque coil disposed within the tube structure so as to be positioned between an outer surface of the distal section of the core and an inner surface of the tube structure.

20. A guidewire device having a shapeable tip, the guidewire device comprising:

a core having a proximal section and a distal section, the core tapering from the proximal section to the distal section and the distal section having a smaller diameter than the proximal section;

a tube structure coupled to the core such that the distal section of the core passes into the tube structure,

wherein the tube structure includes a cut pattern which forms a plurality of axially extending beams coupling a plurality of circumferentially extending rings,

wherein the cut pattern includes a depth-symmetric two-beam section, a depth-offset two-beam section, and a one-beam cut pattern, the depth-symmetric two-beam section being disposed proximal of the depth-offset two-beam section, and the depth-offset tow-beam section being disposed proximal of the one-beam section, and

a coil disposed within the tube structure so as to be positioned between an outer surface of the distal section of the core and an inner surface of the tube structure;

wherein a distal tip of the guidewire device is configured to be manually shapeable and wherein a distal section of the core coinciding with the distal tip has a stiffness such that the distal section of the core is able to withstand deformation caused by an elastic recovery force of the tube structure.