Torqueable kink-resistant guidewire

• US 8,157,766 B2
• Filed: 02/10/2009
• Issued: 04/17/2012
• Est. Priority Date: 09/01/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Bonnette, Michael J., Prather, Richard R., Thor, Eric J.
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/368,578
• Publication Number:
  US 20090143729A1
• Time in Patent Office: 1,162 Days
• Field of Search: 604/96.01, 604 9901- 9904, 604/103.09, 604/103.1, 600/585, 606/192, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

An occlusive guidewire system having an ergonomic handheld control mechanism and torqueable kink-resistant guidewire having a distally located inflatable balloon. The present invention provides convenient structure and overall mechanism for operation of a torqueable kink-resistant guidewire, including evacuation and inflation control of an occlusive balloon, and sealing and severing of a crimpable inflation tube which is in communication with an occlusive balloon. The torqueable kink-resistant guidewire includes a centrally located shaft which imparts robustness to the torqueable kink-resistant guidewire. An inflation lumen aligns within the torqueable kink-resistant guidewire for inflation of the balloon.

Claims

1. A guidewire comprising:

(a) a shaft extending from a proximal end thereof to a distal tip thereof;

(b) a crimpable inflation tube interconnected in series with the proximal end of the shaft and defining a tube lumen section therethrough, the crimpable inflation tube having a proximal portion of sufficient length to enable the tube lumen section to be repeatedly sealed airtight by crimping said proximal portion separately at each of a plurality of successive locations therealong and to be repeatedly reopened thereafter by severing said proximal portion just distal to each such location where so crimped to reopen the tube lumen section;

(c) a polymer jacket formed around a predetermined length of the shaft and at least a distal portion of the crimpable inflation tube;

the polymer jacket defining within itself an inflation lumen section in communication with the tube lumen section of the crimpable inflation tube; and

(d) a balloon secured about the polymer jacket proximal to the distal tip of the shaft, the balloon having proximal and distal shoulders fixed to and sealed against the polymer jacket on opposite sides of an inflation port defined in the polymer jacket, with the inflation lumen section and the inflation port of the polymer jacket and the tube lumen section of the crimpable inflation tube forming an inflation lumen of the guidewire through which the balloon is capable of being inflated and deflated from a proximal end of the crimpable inflation tube.

2. The guidewire of claim 1 wherein the shaft is made of a super-elastic material.

3. The guidewire of claim 2 wherein the super-elastic material includes nitinol.

4. The guidewire of claim 1 wherein the predetermined length of the shaft is the entirety of the shaft.

5. The guidewire of claim 1 wherein the shaft and the polymer jacket therearound has a tapered section extending distally from approximate the proximal shoulder of the balloon.

6. The guidewire of claim 1 wherein the distal tip of the shaft is angled in a fixed position relative to a centerline of the shaft.

7. The guidewire of claim 1 wherein the distal tip of the shaft has an inner core of nitinol and an outer cover made of at least one of a polymer and a coil, and is thus shapeable relative to a centerline of the shaft.

8. The guidewire of claim 1 wherein the distal tip of the shaft is one of a pre-shaped polymer tip, a shapeable polymer tip, a pre-shaped coil tip and a shapeable coil tip.

9. The guidewire of claim 1 wherein at least one radiopaque marker is located around the polymer jacket approximate the balloon.

10. The guidewire of claim 1 wherein the polymer jacket is coated with a hydrophilic material.

11. The guidewire of claim 1 wherein the polymer of the jacket is loaded with a radiopaque material, the radiopaque material being at least one of tungsten and barium sulfate.

12. The guidewire of claim 1 further including a spiral cut tube for joining the distal portion of the crimpable inflation tube to the proximal end of the shaft.

13. The guidewire of claim 12 the spiral cut tube is coiled about and thereby joins the distal portion of the crimpable inflation tube and the proximal end of the shaft.

14. The guidewire of claim 12 wherein the spiral cut tube defines a continuous spiral space along the length thereof into which the polymer flows as the polymer jacket is formed around the junction of the crimpable inflation tube and the shaft.

15. The guidewire of claim 12 wherein the spiral cut tube is made of stainless steel.

16. The guidewire of claim 1 wherein the balloon is made from at least one of silicone, Pebax and polyurethane.

17. The guidewire of claim 1 wherein the proximal and distal shoulders of the balloon are heat-bonded to the polymer jacket to achieve a minimal profile of the balloon thereupon.

18. A guidewire comprising:

(a) a shaft extending from a proximal end thereof to a distal tip thereof, the shaft defining an inflation lumen section therein;

(b) a crimpable inflation tube interconnected in series with the proximal end of the shaft and defining a tube lumen section therethrough that is in communication with the inflation lumen section of the shaft, the crimpable inflation tube having a proximal portion of sufficient length to enable the tube lumen section to be repeatedly sealed airtight by crimping said proximal portion separately at each of a plurality of successive locations therealong and to be repeatedly reopened thereafter by severing said proximal portion just distal to each such location where so crimped to reopen the tube lumen section;

(c) a polymer jacket formed around a predetermined length of the shaft and at least a distal portion of the crimpable inflation tube; and

(d) a balloon secured about the polymer jacket proximal to the distal tip of the shaft, the balloon having proximal and distal ends sealingly secured to the polymer jacket on opposite sides of an inflation port defined in both the polymer jacket and the shaft through respective sidewalls thereof, with the tube lumen section of the crimpable inflation tube, the inflation lumen section of the shaft and the inflation port defined in both the polymer jacket and the shaft through the respective sidewalls thereof collectively forming an inflation lumen of the guidewire through which the balloon is capable of being inflated and deflated from a proximal end of the crimpable inflation tube.

19. The guidewire of claim 18 wherein the shaft is made of a super-elastic material.

20. The guidewire of claim 19 wherein the super-elastic material includes nitinol.

21. The guidewire of claim 18 wherein the predetermined length of the shaft is the entirety of the shaft.

22. The guidewire of claim 18 wherein the shaft and the polymer jacket therearound has a tapered section extending distally from approximate the proximal shoulder of the balloon.

23. The guidewire of claim 18 wherein the distal tip of the shaft is angled in a fixed position relative to a centerline of the shaft.

24. The guidewire of claim 18 wherein the distal tip of the shaft has an inner core of nitinol and an outer cover made of at least one of a polymer and a coil, and is thus shapeable relative to a centerline of the shaft.

25. The guidewire of claim 18 wherein the distal tip of the shaft is one of a pre-shaped polymer tip, a shapeable polymer tip, a pre-shaped coil tip and a shapeable coil tip.

26. The guidewire of claim 18 wherein at least one radiopaque marker is located around the polymer jacket approximate the balloon.

27. The guidewire of claim 18 wherein the polymer jacket is coated with a hydrophilic material.

28. The guidewire of claim 18 wherein the polymer of the jacket is loaded with a radiopaque material, the radiopaque material being at least one of tungsten and barium sulfate.

29. The guidewire of claim 18 further including a spiral cut tube for joining the distal portion of the crimpable inflation tube to the proximal end of the shaft.

30. The guidewire of claim 29 wherein the spiral cut tube defines a continuous spiral space along the length thereof into which the polymer flows as the polymer jacket is formed around the junction of the crimpable inflation tube and the shaft.

31. The guidewire of claim 29 wherein the spiral cut tube is made of stainless steel.

32. The guidewire of claim 18 wherein the balloon is made from at least one of silicone, Pebax and polyurethane.

33. The guidewire of claim 18 wherein the proximal and distal ends of the balloon are heat-bonded to the polymer jacket to achieve a minimal profile of the balloon thereupon.