Guidewire having occlusive device and repeatably crimpable proximal end

• US 7,169,161 B2
• Filed: 11/06/2001
• Issued: 01/30/2007
• Est. Priority Date: 11/06/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Jenson, Mark L., Le, Hieu V., Bonnette, Michael J., Thor, Eric J., Kravic, Rick C.
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): Mendoza; Michael G.
• Application Number:
  US10/012,891
• Publication Number:
  US 20030088262A1
• Time in Patent Office: 1,911 Days
• Field of Search: 606191-200, 606/159, 606/108, 606/168, 606/166, 600/585, 604 9601-103
• US Class Current: 606/191
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 Valves

Abstract

A tubular guidewire assembly having a distal occlusive device and an extended crimpable section proximate a proximal end that is adapted to connect to a gas inflation/evacuation system. The extended crimpable section can be selectively sealed at one of a plurality of separate locations to form an airtight seal of the tubular guidewire assembly. Each time a deflation of the occlusive device is desired in order to reestablish blood flow to a vessel downstream of the occlusive device, the extended crimpable section preferably is cut distal to the location of the last seal to quickly deflate the occlusive device.

Claims

1. A tubular guidewire assembly comprising:

a guidewire member having a distal end and a proximal end;

the guidewire member comprising an extended crimpable section proximate the proximal end and a main body portion distal of the extended crimpable section;

a lumen extending through the extended crimpable section and through the main body portion from the proximal end of the guidewire member and continuing to the distal end of the guidewire member;

an occlusive balloon proximate the distal end, the occlusive balloon being fluidly connected to the lumen so as to enable inflation and deflation of the occlusive balloon through the lumen upon respectively introducing and withdrawing fluid from the proximal end of the lumen;

the extended crimpable section being adapted to be selectively sealed with a permanent crimp at each of a plurality of separate locations to form successive airtight seals of the lumen to maintain the occlusive balloon inflated when it is in an inflated state, the extended crimpable section being dimensioned so as to be no larger in any outer diameter after being crimped than the largest outer diameter of any other portion of the tubular guidewire assembly; and

,

the extended crimpable section being quickly and reliably severable distal to each crimp to reopen the lumen to thereby provide for withdrawing fluid from the proximal end of the lumen and thereby deflate the occlusive balloon.

2. The tubular guidewire assembly of claim 1 wherein the guidewire assembly has an effective length of at least 40 cm and an outer diameter of the main body portion less than 0.060 inch, and wherein the extended crimpable section has an effective length of at least 1 cm and an outer diameter smaller than that of the main body portion and less than 0.050 inch.

3. The tubular guidewire assembly of claim 1 wherein the guidewire assembly has an effective length of at least 100 cm and an outer diameter of the main body portion less than 0.018 inch, and wherein the extended crimpable section has an effective length of at least 5 cm and an outer diameter smaller than that of the main body portion and less than 0.012 inch.

4. The tubular guidewire assembly of claim 1 wherein the extended crimpable section is dimensioned such that the largest outer diameter of the extended crimpable section after crimping is no greater than the largest outer diameter of the main body portion, and wherein the largest outer diameter of the extended crimpable section after crimping is less than a minimum inner diameter of a lumen of an intravascular device sized to be passed over the main body portion and tracked along the guidewire member to a treatment location.

5. The tubular guidewire assembly of claim 1 wherein the extended crimpable section has a length sufficient to permit a plurality of crimps and a plurality of corresponding cuts therealong and has an outer diameter that is smaller than the outer diameter of the main body portion of the guidewire member.

6. The tubular guidewire assembly of claim 1 wherein the main body portion is formed of a stainless steel hypotube.

7. The tubular guidewire assembly of claim 1 wherein the main body portion comprises a stainless steel hypotube and the extended crimpable section is collinearly attached to the proximal end of the stainless steel hypotube and is formed of a stainless steel hypotube having an outer diameter smaller than the outer diameter of the stainless steel hypotube of the main body portion.

8. The tubular guidewire assembly of claim 6 wherein the guidewire member further includes a distal portion formed of a Ni—

Ti alloy.

9. The tubular guidewire assembly of claim 8 wherein the distal portion includes a tapered portion.

10. The tubular guidewire assembly of claim 9 wherein the tapered portion has an outer diameter that ranges from 0.014 inch to 0.0075 inch.

11. The tubular guidewire assembly of claim 8 wherein the distal portion includes a platinum markerband proximal to the occlusive balloon.

12. The tubular guidewire assembly of claim 8 further comprising a flexible coil tip attached to the distal portion distal to the occlusive balloon.

13. The tubular guidewire assembly of claim 1 wherein the occlusive balloon is capable of repeated inflation and deflation during a vascular procedure in between which the proximal end of the extended crimpable section is free of mechanical connections and obstructions thereby enabling the guidewire member to function as a conventional exchange guidewire with the largest outer diameter of the extended crimpable section being no larger than the outer diameter of the main body portion, regardless of whether the extended crimpable section is crimped or not crimped, so that an intravascular catheter can be passed over the extended crimpable section and the main body portion without interference.

14. The tubular guidewire assembly of claim 1 wherein the lumen has an inner diameter of at least 0.002 inch such that passive deflation of the occlusive balloon can be accomplished in less than one minute after crimping and subsequently severing a portion of the extended crimpable section.

15. The tubular guidewire assembly of claim 1 wherein the extended crimpable section is formed of a material and is dimensioned such that the extended crimpable section has sufficient strength in terms of high tensile and kink resistance to permit catheter devices to repeatedly pass over the extended crimpable section yet, when severed, the extended crimpable section does not penetrate a standard surgical glove when gripped within less than one inch of a proximate end of the extended crimpable section.

16. The tubular guidewire assembly of claim 1 wherein the occlusive balloon has been preinflated to prestretch it so that expansion of the occlusive balloon in use is relatively linear with pressure.

17. The tubular guidewire assembly of claim 1 wherein the extended crimpable section further comprises a plurality of scores which extend only partway through the wall of the extended crimpable section and weaken the extended crimpable section at a plurality of locations along the extended crimpable section to aid in severing the extended crimpable section at the scored locations.

18. The tubular guidewire assembly of claim 1 wherein the entire guidewire member is formed of a continuous stainless steel tube having a wire wrapped therearound except for along the extended crimpable section.

19. The tubular guidewire assembly of claim 1 wherein the guidewire member comprises a braided polyimide hypotube having a tapered core rod positioned therein.

20. The tubular guidewire assembly of claim 19 wherein at least a proximal portion of the tapered core rod is tubular having a lumen defined therein and extending proximate a proximal end of the braided polyimide hypotube to define the extended crimpable section.

21. The tubular guidewire assembly of claim 1 further comprising a pair of coils positioned along a distal portion of the guidewire member that are longitudinally spaced apart and adjacent to at least one hole in the guidewire member that provides fluid access between the lumen and the occlusive balloon, with at least a portion of the occlusive balloon being bonded to at least a portion of each of the pair of coils.

22. The tubular guidewire assembly of claim 1 wherein the extended crimpable section further comprises a plurality of weakened sections at a plurality of locations along the extended crimpable section to aid in severing the extended crimpable section at the locations of the weakened sections, there being no leakage of fluid at any weakened section unless the extended crimpable section has been severed at a weakened section.

23. A tubular guidewire assembly comprising:

a guidewire member having a proximal end and a distal end and including a main body portion with a lumen extending therethrough and an extended crimpable section with a lumen extending therethrough, the extended crimpable section being joined to the main body portion and extending from the main body portion to the proximal end of the guidewire member, the lumens of the main body portion and the extended crimpable section being in fluid communication with each other;

an occlusive balloon proximate the distal end of the guidewire member, the occlusive balloon being in fluid communication with the lumen of the main body portion and thereby in fluid communication with the lumen of the extended crimpable section so as to enable inflation of the occlusive balloon upon introduction of fluid into the lumens at the proximal end of the guidewire member and deflation of the occlusive balloon upon withdrawal of fluid from the lumens at the proximal end of the guidewire member;

the extended crimpable section being of sufficient length to enable the lumen therethrough to be repeatably selectively sealed airtight by flattening the extended crimpable section with successive permanent crimps at separate locations along its length to maintain the occlusive balloon inflated whenever it is in its inflated state; and

,

the extended crimpable section being structured so that it can be quickly and reliably severed distal to each successive permanent crimp to reopen its lumen and thereby provide for rapid deflation of the occlusive balloon.