Infusion flow guidewire system

• US 8,608,703 B2
• Filed: 10/30/2007
• Issued: 12/17/2013
• Est. Priority Date: 06/12/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Riles, John C., Ball, Douglas J., Bonnette, Michael J., Thor, Eric J., Teschendorf, John L., Le, Hieu V.
• Primary Examiner(s): Price, Nathan R
• Application Number:
  US11/980,164
• Publication Number:
  US 20080312671A1
• Time in Patent Office: 2,240 Days
• Field of Search: 604/158, 604/164.02, 604/164.07, 604/164.11, 604/164.13, 60416501-16504, 604/167.01, 604/170.01, 604/170.02, 604/523, 604/524, 606/159
• US Class Current: 604/167.06
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22049 Means for locking the guide wire in the catheter
• CPC Class Codes: A61M 2025/09083 having a coil around a core

Abstract

An infusion flow guidewire system and method of use. The infusion flow guidewire system includes a delivery sheath and an infusion flow guidewire. The minimal cross section flexible infusion flow guidewire includes a flexible tip having a closed distal end, a coil, a core wire and at least one distally located jet orifice for infusion of fibrinolytics and for introduction of high pressure fluids for maceration and rearwardly directed flow of thrombus debris located in tortuous small sized vessels. Apparatus, some of which is removably attachable, is provided for grasping members of the invention for rotational torqueing and for longitudinal actuation along and within the vasculature.

Claims

1. An infusion flow guidewire system comprising:

a. an infusion flow guidewire having a proximal end, a distal end, at least one jet orifice, and a flexible tip at the distal end, wherein the flexible tip has a closed distal end and further comprises a coil and core wire;

b. a delivery sheath having a proximally located torque handle, wherein the infusion flow guidewire is capable of passing through the delivery sheath; and

c. a coupling assembly removeably attachable to the proximal end of the infusion flow guidewire to facilitate connection of the proximal end of the infusion flow guidewire to a pressurized fluid supply and to facilitate manipulation of the infusion flow guidewire,

wherein the torque handle of the delivery sheath includes proximal and distal ends and further includes;

i. a torque body having a bore and external threads;

ii. a collet for insertion into the bore of the torque body;

iii. a collet nut for compressing the collet when tightened on the external threads; and

iv. a strain relief having a passage carrying the proximal end of the delivery sheath, wherein the assembled torque handle provides coaxial accommodation of the delivery sheath and frictional engagement of the infusion flow guidewire when tightened, and wherein the infusion flow guidewire passes through the proximal and distal ends of the torque handle.

2. The infusion flow guidewire system of claim 1, wherein the delivery sheath has an outer diameter of 0.035 inch.

3. The infusion flow guidewire system of claim 1, wherein the delivery sheath has an inner diameter of 0.017 inch.

4. The infusion flow guidewire system of claim 1, wherein the delivery sheath is formed of polyimide.

5. The infusion flow guidewire system of claim 1, wherein the delivery sheath is formed of braided polyimide.

6. An infusion flow guidewire system comprising:

a. an infusion flow guidewire having a proximal end, a distal end, at least one jet orifice, and a flexible tip at the distal end, wherein the flexible tip has a closed distal end and further comprises a coil and core wire;

b. a delivery sheath having a proximally located torque handle, wherein the infusion flow guidewire is capable of passing through the delivery sheath; and

c. a coupling assembly removeably attachable to the proximal end of the infusion flow guidewire to facilitate connection of the proximal end of the infusion flow guidewire to a pressurized fluid supply and to facilitate manipulation of the infusion flow guidewire,

wherein the coupling assembly includes;

i. a generally stationary proximal knob and a rotatable distal knob, the proximal knob providing removable connection to a distal end of the pressurized fluid supply and the proximal knob providing removable attachment to the proximal end of the infusion flow guidewire;

ii. a threaded insert;

iii. a threaded body having an outside surface and a bore defining an inner diameter, the outside surface of the threaded body interacting with the threaded insert;

iv. an O-ring having a diameter that is less than the inner diameter of the threaded body;

v. a compression fixture; and

vi. a tube collet,

wherein rotatably tightening the rotatable distal knob relative to the generally stationary proximal knob causes the threaded insert, the threaded body and the compression fixture to interact to compress the O-ring to seal about the proximal end of the infusion flow guidewire.

7. The infusion flow guidewire system of claim 6, wherein the delivery sheath has an outer diameter of 0.035 inch.

8. The infusion flow guidewire system of claim 6, wherein the delivery sheath has an inner diameter of 0.017 inch.

9. The infusion flow guidewire system of claim 6, wherein the delivery sheath is formed of polyimide.

10. The infusion flow guidewire system of claim 6, wherein the delivery sheath is formed of braided polyimide.

11. An infusion flow guidewire system comprising:

a. an infusion flow guidewire having a proximal end, a distal end, at least one jet orifice, and a flexible tip at the distal end, wherein the flexible tip has a closed distal end and further comprises a coil and core wire;

b. a delivery sheath having a proximally located torque handle, wherein the infusion flow guidewire is capable of passing through the delivery sheath; and

c. a coupling assembly removeably attachable to the proximal end of the infusion flow guidewire to facilitate connection of the proximal end of the infusion flow guidewire to a pressurized fluid supply and to facilitate manipulation of the infusion flow guidewire,

wherein the torque handle of the delivery sheath includes proximal and distal ends and further includes;

i. a torque body having a bore and external threads;

ii. a collet for insertion into the bore of the torque body; and

iii. a collet nut for compressing the collet when tightened on the external threads,

wherein the assembled torque handle provides coaxial accommodation of the delivery sheath and frictional engagement of the infusion flow guidewire when tightened, and wherein the infusion flow guidewire passes through the proximal and distal ends of the torque handle.

12. The infusion flow guidewire system of claim 11, wherein the delivery sheath has an outer diameter of 0.035 inch.

13. The infusion flow guidewire system of claim 11, wherein the delivery sheath has an inner diameter of 0.017 inch.

14. The infusion flow guidewire system of claim 11, wherein the delivery sheath is formed of polyimide.

15. The infusion flow guidewire system of claim 11, wherein the delivery sheath is formed of braided polyimide.

16. A method of removing thrombus from vasculature, comprising:

providing an infusion flow guidewire system comprising;

a. an infusion flow guidewire having a proximal end, a distal end, at least one jet orifice, and a flexible tip at the distal end, wherein the flexible tip has a closed distal end and further comprises a coil and core wire;

b. a delivery sheath having a distal end and a proximally located torque handle, wherein the infusion flow guidewire is capable of passing through the delivery sheath; and

c. a coupling assembly removeably attachable to the proximal end of the infusion flow guidewire to facilitate connection of the proximal end of the infusion flow guidewire to a pressurized fluid supply and to facilitate manipulation of the infusion flow guidewire,

wherein the torque handle of the delivery sheath includes proximal and distal ends and further includes;

i. a torque body having a bore and external threads;

ii. a collet for insertion into the bore of the torque body; and

iii. a collet nut for compressing the collet when tightened on the external threads,

wherein the assembled torque handle provides coaxial accommodation of the delivery sheath and frictional engagement of the infusion flow guidewire when tightened, and wherein the infusion flow guidewire passes through the proximal and distal ends of the torque handle;

maneuvering the delivery sheath through the vasculature to position the distal end of the delivery sheath near a thrombus to be removed;

inserting the distal end of the infusion flow guidewire into the proximal end of the delivery sheath;

connecting the proximal end of the infusion flow guidewire to the pressurized fluid source; and

positioning the at least one jet orifice of the infusion flow guidewire in the thrombus to be removed and expelling fluid from the at least one jet orifice to act upon the thrombus to remove thrombus by action of fluid expelled from the at least one jet orifice.

17. The method of claim 16, wherein inserting the infusion flow guidewire into the delivery sheath precedes maneuvering the delivery sheath through the vasculature to position the distal end of the delivery sheath near the thrombus to be removed.

18. The method of claim 16, wherein inserting the infusion flow guidewire into the delivery sheath follows maneuvering the delivery sheath through the vasculature to position the distal end of the delivery sheath near the thrombus to be removed.

19. The method of claim 16, further comprising:

removing the delivery sheath while leaving the infusion flow guidewire in the vasculature; and

installing another device over the infusion flow guidewire.

20. The method of claim 19, wherein the another device is a stent.

21. The method of claim 19, wherein the another device is an aspiration catheter.

22. The method of claim 16, wherein connecting the proximal end of the infusion flow guidewire to the pressurized fluid source precedes inserting the distal end of the infusion flow guidewire into the proximal end of the delivery sheath.

23. The method of claim 16, wherein the pressurized fluid source is a high pressure source.

24. The method of claim 23, wherein the high pressure fluid source is capable of a pressure of up to about 20 kpsi.

25. The method of claim 23, wherein the high pressure fluid source is applied in pulses.

26. The method of claim 16, wherein positioning the at least one jet orifice of the infusion flow guidewire in the thrombus to be removed and expelling fluid from the at least one jet orifice to act upon the thrombus to remove thrombus by action of fluid expelled from the at least one jet orifice is accompanied by at least one additional actuation motion of the infusion flow guidewire.

27. The method of claim 26, wherein the at least one accompanying additional actuation motion is selected from the group consisting of to and fro motion and rotary motion.

28. The method of claim 16, wherein the expelled fluid includes fibrinolytic agents.