High-torque guidewires and methods for making and using them

• US 10,220,189 B2
• Filed: 01/20/2016
• Issued: 03/05/2019
• Est. Priority Date: 01/20/2015
• Status: Active Grant

• Current Assignee: Selfex Devices, Inc.
• Original Assignee: Selfex Devices, Inc.
• Inventors: Gupta, Vikas
• Primary Examiner(s): McCrosky, David J
• Application Number:
  US15/002,381
• Publication Number:
  US 20160206860A1
• Time in Patent Office: 1,140 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/320012 Brushes
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: B21F 45/008 of medical instruments, e.g. stents, corneal rings medical science A61

Abstract

High torque guidewires and methods for making and using them are provided. A guidewire may include an inner core wire movable relative to an outer jacket. The outer jacket includes proximal and distal ends, a lumen extending there between, thereby defining a longitudinal axis, and one or more helical slots adjacent the distal end. The core wire includes a proximal portion, a distal portion slidably received in the outer jacket lumen and terminating in a curved distal tip that extends from the outer jacket distal end, and one or more pins on the distal portion, each pin slidably received in a respective helical slot in the outer jacket such that axial movement of the core wire relative to the outer jacket causes the pin to slide within the helical slot and rotate the distal tip relative to the outer jacket distal end.

Claims

1. A guidewire, comprising:

an outer jacket comprising a proximal end, a distal end sized for introduction into a patient'"'"'s body, a lumen extending between the proximal and distal ends, thereby defining a longitudinal axis, and one or more helical slots extending along an axial length of the outer jacket adjacent the distal end; and

an inner core wire comprising a proximal portion extending through the lumen to the outer jacket proximal end, a distal portion slidably received in the outer jacket lumen and terminating in a curved distal tip that extends from the outer jacket distal end, and one or more pins on the distal portion, each pin slidably received in a respective helical slot in the outer jacket such that axial movement of the core wire proximal portion relative to the outer jacket proximal end causes the pin to slide within the helical slot and rotate the distal tip relative to the outer jacket distal end while limiting movement of the distal tip between a proximal-most position and a distal-most position defined by the axial length.

2. The guidewire of claim 1, wherein the outer jacket includes two helical slots offset from one another around a circumference of the outer jacket, and the core wire includes two corresponding pins.

3. The guidewire of claim 2, wherein the pins extend from opposite sides of the core wire distal portion such that pins define a transverse axis substantially perpendicular to the longitudinal axis.

4. The guidewire of claim 2, the core wire further comprising a hole extending through the distal portion and a pin member inserted through the hole, the ends of the pin member defining the two pins.

5. The guidewire of claim 1, wherein the outer jacket has a maximum outer diameter between the proximal and distal ends that is between about 0.010 inch to 0.050 inch (0.25-1.25 mm).

6. The guidewire of claim 1, wherein the outer jacket has a substantially uniform outer diameter between the proximal and distal ends that is between about 0.010 inch to 0.050 inch (0.25-1.25 mm).

7. The guidewire of claim 1, wherein the core wire comprises a tubular intermediate portion carrying the one or more pins and wherein the core wire distal portion extends distally from the intermediate portion, the core wire distal portion comprising a central wire and one or more coiled wires surrounding the central wire extending from the intermediate portion to the distal tip.

8. The guidewire of claim 1, wherein the distal portion is biased to a curvilinear shape.

9. The guidewire of claim 1, wherein the distal portion is biased to a curved shape that extends transversely from the longitudinal axis and then curving to cross the longitudinal axis before the distal tip.

10. The guidewire of claim 1, wherein the distal portion of the core wire has an outer diameter between about 0.004 inch to 0.045 inch (0.1-0.9 mm).

11. The guidewire of claim 1, wherein a length of the core wire distal portion between the outer jacket distal end and the distal tip is between about five and one hundred centimeters (5-100 cm).

12. The guidewire of claim 1, wherein the core wire comprises a central wire and one or more helical wires wrapped around the central wire and defining the proximal and distal portions.

13. The guidewire of claim 12, wherein the one or more pins are attached to the outer surface of the one or more helical wires.

14. The guidewire of claim 12, wherein the one or more pins comprise a pin member inserted through a hole formed through the core wire.

15. The guidewire of claim 1, wherein the outer jacket comprises a plastic sleeve extending between the outer jacket proximal and distal ends, and wherein the one or more helical slots extend through a wall of the plastic sleeve.

16. The guidewire of claim 1, wherein the outer jacket comprises a distal tubular portion having the one or more helical slots extending through a wall of the distal tubular portion, and a proximal tubular portion coupled to and extending proximally from the distal tubular portion, the distal tubular portion having a shorter length than a length of the proximal tubular portion.

17. The guidewire of claim 1, wherein the one or more helical slots define a take-off angle relative to the longitudinal axis that is between about five and seventy five degrees (5-75°

).

18. The guidewire of claim 1, wherein the one or more helical slots comprise a first helical slot extending around a circumference of the outer jacket at least one turn.

19. The guidewire of claim 1, wherein the one or more helical slots comprise a first helical slot extending around a circumference of the outer jacket between about one and four turns.

20. The guidewire of claim 1, wherein the axial length is set to limit a number of turns that the distal tip rotates when the distal tip moves between the proximal-most position and the distal-most position.

21. A guidewire, comprising:

an outer jacket comprising a proximal portion, a distal portion sized for introduction into a patient'"'"'s body and terminating at a distal end, a lumen extending there between, and a helical slot extending from an opening at the outer jacket distal end proximally and helically around and along an axial length of the outer jacket distal portion;

an inner core wire comprising a proximal portion extending through the lumen to the outer jacket proximal portion and a distal portion terminating in a curved distal tip, the core wire received in the lumen such that an intermediate portion of the core wire is aligned with the helical slot and the curved distal tip extends from the outer jacket distal end; and

a pin attached to the core wire intermediate portion through the helical slot such that the pin is slidable along the helical slot when the core wire is directed axially relative to the outer jacket to rotate the core wire distal tip while limiting movement of the distal tip between a proximal-most position and a distal-most position defined by the axial length.

22. The guidewire of claim 21, wherein the core wire comprises a hole through the core wire intermediate portion and wherein the pin is attached to the core wire by inserting the pin into the hole.

23. The guidewire of claim 21, wherein:

the core wire distal portion comprises one or more helical wires wrapped around a central wire;

the core wire intermediate portion comprises a tubular body comprising a first end coupled to a first end of the core wire distal portion; and

the core wire proximal portion comprises an elongate member coupled to a second end of the tubular body.

24. The guidewire of claim 23, wherein the first end of the core wire distal portion is coupled to the first end of the tubular body by inserting the first end of the core wire distal portion into the first end of the tubular body.

25. The guidewire of claim 23, wherein the first end of the core wire proximal portion is coupled to the second end of the tubular body by inserting the first end of the core wire proximal portion into the second end of the tubular body.

26. The guidewire of claim 21, further comprising a plug inserted into the opening to limit movement of the pin within the helical slot.

27. The guidewire of claim 21, further comprising material received in the opening to limit movement of the pin within the helical slot.