INFUSION FLOW GUIDEWIRE SYSTEM

• US 20140094835A1
• Filed: 12/09/2013
• Published: 04/03/2014
• Est. Priority Date: 09/28/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Ball, Douglas J., Thor, Eric J., Teschendorf, John L., Le, Hieu V., Riles, John, Bonnette, Michael J.
• Granted Patent: US 9,585,686 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 and a system including an infusion flow guidewire. The minimal cross section flexible infusion flow guidewire includes a nitinol hypotube, a flexible tip having a closed distal end, a coil, a core wire and at least one distally located rearwardly directed 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 in the system for grasping members of the invention for rotational torqueing and for longitudinal actuation along and within the vasculature.

Claims

1. An infusion flow guidewire comprising:

a flexible hypotube having a lumen, a proximal end, a distal end, and a drawn hypotube section located at the distal end, wherein the drawn hypotube section has a diameter less than a diameter of the flexible hypotube;

a reinforcement collar having a lumen, a proximal end, and a distal end, wherein a region of the drawn hypotube section of the flexible hypotube extends through the lumen of the reinforcement collar;

at least one proximally directed jet orifice comprising a hole in the reinforcement collar and an aligned hole in the drawn hypotube section of the flexible hypotube which allows fluid communication from the lumen of the drawn hypotube section of the flexible hypotube;

a flexible coil attached to and extending distally from the reinforcement collar, wherein a portion of the drawn hypotube section of the flexible hypotube which extends distally from the reinforcement collar lies within a lumen of the flexible coil;

a core wire secured within the lumen at the distal end of the flexible hypotube and extending distally therefrom, wherein the core wire has a proximal end located distally from the reinforcement collar, the core wire coaxially aligned within the lumen of the flexible coil and having a proximally located round section, a distally located flat section and a tapered transition section therebetween, a distal end of the core wire terminating in a weld to the distal end of the flexible coil; and

,

wherein the flexible coil located distally from the drawn hypotube section of the flexible hypotube and the core wire located distally from the drawn hypotube section of the flexible hypotube and the weld therebetween together define a flexible tip.

4. The infusion flow guidewire of claim 1, wherein the reinforcement collar is secured to the drawn hypotube section of the flexible hypotube by at least one laser weld.

5. The infusion flow guidewire of claim 4, wherein the at least one laser weld is one of two laser welds securing the reinforcement collar to the drawn hypotube section and the two laser welds are located near the distal end and near the proximal end of the reinforcement collar.

6. The infusion flow guidewire of claim 1, wherein the hole in reinforcement collar and the hole in the drawn hypotube section of the flexible hypotube are formed by electrical discharge machining.

10. The infusion flow guidewire of claim 1, wherein the core wire is secured to an inner wall surface of the lumen of the drawn hypotube section of the flexible hypotube.

11. The infusion flow guidewire of claim 1, wherein the core wire is secured to an inner wall surface of the lumen of the drawn hypotube section of the flexible hypotube by at least one laser swage.

12. The infusion flow guidewire of claim 1, wherein the flexible tip is more flexible than the drawn hypotube section of the flexible hypotube.

17. The infusion flow guidewire of claim 1, wherein the flexible hypotube has a proximal extension of stainless steel tubing.

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38. An infusion flow guidewire system comprising:

a flexible infusion flow guidewire including

a flexible tip section, and

an elongated flexible hypotube for delivering a pressurized liquid to a thrombus in a vessel or artery, said elongated flexible hypotube having a proximal end, a distal end, and at least one jet orifice near said distal end for expelling said pressurized liquid therefrom;

a torque handle having a lumen, a distal end and a proximal end, said torque handle being connected to said elongated flexible hypotube; and

a torque coupling assembly having a proximal end and a distal end, said torque coupling assembly being connected to a high pressure, tubular, liquid supply line on said proximal end thereof and to said elongated flexible hypotube on said distal end thereof, wherein said elongated flexible hypotube extends from said torque coupling assembly to said proximal end of said torque handle, passing through said lumen of said torque handle and extends externally from said distal end of said torque handle to said flexible tip section.

39. The infusion flow guidewire system of claim 38, wherein said flexible infusion flow guidewire further includes:

an elongated flexible delivery sheath surrounding said elongated flexible hypotube and extending internally from within said lumen of said torque handle towards said flexible tip section of the flexible infusion flow guidewire, said elongated flexible delivery sheath being fixed near the proximal end of said torque handle.

40. The infusion flow guidewire system of claim 38, wherein said elongated flexible hypotube further includes

a drawn-down section extending in a distal direction;

and

a cylindrical reinforcement collar surrounding and fixed to a portion of said drawn-down section of said elongated flexible hypotube,

wherein the at least one proximally directed jet orifice comprises a hole in said drawn-down section and an aligned hole in said cylindrical reinforcement collar, said jet orifice configured to expel said pressurized fluid in a rearward direction.

41. The infusion flow guidewire system of claim 40, wherein said cylindrical reinforcement collar is fixed to said portion of said drawn-down section of said elongated flexible hypotube by a plurality of laser welds.

42. The infusion flow guidewire system of claim 40, wherein a flexible core wire is fixed within a distal portion of said drawn-down section of said elongated flexible hypotube and extends from said distal end thereof a predetermined distance terminating at a weld at a distal end of said flexible tip section of said a flexible infusion flow guidewire.

43. The infusion flow guidewire system of claim 42, wherein said flexible core wire is cylindrically shaped for a major portion thereof and substantially flat the remainder thereof terminating in said weld.

45. The infusion flow guidewire system of claim 42, wherein an elongated flexible coil surrounds a substantial portion of said drawn-down section of said elongated flexible hypotube and surrounds said extended portion of said flexible core wire and terminates in said weld.

46. The infusion flow guidewire system of claim 45, wherein said elongated flexible coil is attached to said drawn-down section of said elongated flexible hypotube by soldering, welding or otherwise suitably attached.

48. The infusion flow guidewire system of claim 45, wherein said cylindrical reinforcement collar has a proximal end and a distal end and wherein said elongated flexible coil has a proximal end and a distal end, said proximal end of said elongated flexible coil being adjacent to said distal end of said reinforcement collar and said distal end of said elongated flexible coil terminating in said weld.

49. The infusion flow guidewire system of claim 39, wherein said elongated flexible hypotube and said elongated flexible delivery sheath, either separately or together, are secured within said lumen of said torque handle such that they can be rotated or longitudinally moved in a distal or a proximal direction.

50. The infusion flow guidewire system of claim 38, wherein said torque handle further includes

a substantially tubular torque body with a proximal end, a distal end, a central bore, and external threads at said proximal end thereof;

a collet having a distal end, a proximal end with flexible jaws, and a tubular member extending distally from said proximal end, wherein said collect is inserted into said central bore at said proximal end of said tubular torque body; and

,

a nut having internal threads therein for cooperating with said external threads of said tubular torque body to cause, when said nut and tubular body are twisted relative to each other, a horizontal movement between said tubular torque body and said nut resulting in the clamping or releasing of said elongated flexible hypotube between said flexible jaws of said collet.

51. The infusion flow guidewire system of claim 50, wherein said tubular torque body further includes:

a strain relief tube partially inserted and fixed within said distal end of said tubular torque body and extending externally a short distance beyond said distal end of said tubular torque body.

52. The infusion flow guidewire system of claim 38, wherein said torque coupling assembly further includes:

a stationary knob having a central bore therethrough, wherein the stationary knob is located at a proximal end of the torque coupling assembly;

a first internally threaded insert partially fixed within said central bore of said stationary knob;

a rotatable knob having a central bore, wherein the rotatable knob is located at a distal end of the torque coupling assembly;

a second internally threaded insert embedded in said central bore of said rotatable knob,

an elongated tubular member having an external thread along its entire length, said elongated tubular member having a proximal end and a distal end, said external threads adjacent said proximal end of said elongated tubular member engaging said internal threads of said first internally threaded insert and said external threads adjacent said distal end of said elongated tubular member engaging said internal threads of said second internally threaded insert, said elongated tubular member having a central bore therein which opens at said distal end of said elongated tubular member and terminates in a proximal direction at a surface wall within said central bore of said elongated tubular member, said elongated tubular member having a tubular flange extending from said proximal end thereof, said elongated tubular member having a smaller central bore therein which begins from said surface wall within said central bore of said elongated tubular member and extends through said tubular flange;

an elongated compression tube being inserted within said central bore of said elongated tubular member, said elongated compression tube having a proximal end, a distal end, and a central bore therethrough with a diameter slightly greater than the outer diameter of said elongated flexible hypotube passing therethrough, a partial bore being defined between said distal end of said elongated tubular member and an internal surface of said first internally threaded insert,

a tubular collet sandwiched between an internal surface of said central bore of said first internally threaded insert and an external surface at said distal end of said elongated compression tube, and said tubular collet having a plurality of flexible jaws and a plurality of arcuate surfaces interfacing an annual tapered surface at said distal end of said elongated compression tube.

53. The infusion flow guidewire system of claim 52, wherein said elongated compression tube has an annular recess at said proximal end thereof and a compressible O-ring inserted therein and interfacing said surface wall within said central bore of said elongated tubular member.

54. The infusion flow guidewire system of claim 52, wherein said first internally threaded insert has at least one threaded hole in a peripheral wall and an externally threaded set screw engaging said at least one threaded hole.

58. The infusion flow guidewire system of claim 38, wherein said pressurized liquid is delivered to said elongated flexible hypotube at a pressure exceeding 0.25 kpsi at a flow rate of 5 cc/min.

60. The infusion flow guidewire system of claim 50, wherein said elongated flexible delivery sheath is secured within said tubular torque member remote from said flexible jaws of said collet and near said distal end of said collet by an adhesive.

61. The infusion flow guidewire system of claim 39, wherein said torque handle includes means for simultaneously or individually rotating or longitudinally moving said elongated flexible hypotube and said elongated flexible delivery sheath.

62. The infusion flow guidewire system of claim 38, wherein said torque coupling assembly includes means for rotationally or longitudinally moving said elongated flexible hypotube.

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63. An infusion flow guidewire system comprising:

a flexible infusion flow guidewire including

a flexible hypotube having a lumen, a proximal end, a distal end, and a drawn hypotube section located at the distal end, wherein the drawn hypotube section has a diameter less than a diameter of the flexible hypotube,

a reinforcement collar having a lumen, a proximal end, and a distal end, wherein a region of the drawn hypotube section of the flexible hypotube extends through the lumen of the reinforcement collar,

at least one proximally directed jet orifice comprising a hole in the reinforcement collar and an aligned hole in the drawn hypotube section of the flexible hypotube which allows fluid communication from the lumen of the drawn hypotube section of the flexible hypotube,

a flexible coil attached to and extending distally from the reinforcement collar, wherein a portion of the drawn hypotube section of the flexible hypotube which extends distally from the reinforcement collar lies within a lumen of the flexible coil, and

a core wire secured within the lumen at the distal end of the flexible hypotube and extending distally therefrom, wherein the core wire has a proximal end located distally from the reinforcement collar, the core wire coaxially aligned within the lumen of the flexible coil and having a proximally located round section, a distally located flat section and a tapered transition section therebetween, a distal end of the core wire terminating in a weld to the distal end of the flexible coil,

wherein the flexible coil located distally from the drawn hypotube section of the flexible hypotube and the core wire located distally from the drawn hypotube section of the flexible hypotube and the weld therebetween together define a flexible tip;

a torque handle having a lumen, a distal end and a proximal end, said torque handle being connected to said flexible hypotube; and

a torque coupling assembly having a proximal end and a distal end, said torque coupling assembly being connected to a high pressure, tubular, liquid supply line on said proximal end thereof and to said flexible hypotube on said distal end thereof, wherein said flexible hypotube extends from said torque coupling assembly to said proximal end of said torque handle, passing through said lumen of said torque handle and extends externally from said distal end of said torque handle to said flexible tip.

64. The infusion flow guidewire system of claim 63, wherein said flexible infusion flow guidewire further includes:

an elongated flexible delivery sheath surrounding said flexible hypotube and extending internally from within said lumen of said torque handle towards said flexible tip of the flexible infusion flow guidewire, said elongated flexible delivery sheath being fixed near the proximal end of said torque handle.