Infusion guidewire having fixed core wire and flexible radiopaque marker

• US 6,027,461 A
• Filed: 10/11/1995
• Issued: 02/22/2000
• Est. Priority Date: 10/11/1995
• Status: Expired due to Fees

• Current Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Walker, Blair D., Evans, Scott M.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/541,147
• Time in Patent Office: 1,595 Days
• Field of Search: 600/585, 600/433, 600/434, 604/280, 604/281, 604/282
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09091 where a sheath surrounds the coil at the distal part
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An infusion guidewire that can be used either as a guidewire or an infusion catheter having an integral, tapered core wire within an infusion lumen formed of the aligned lumens of the conduit of a proximal connector housing, a proximal inner sheath in a proximal guidewire portion and a distal coil wire in a distal guidewire portion. The core wire proximal end is attached to the connector housing, and the core wire distal end is connected to the distal end of the distal wire coil. An outer sheath is attached to the connector housing and formed over the proximal inner sheath and the distal wire coil. A plurality of infusion side holes are formed in a distal infusion segment of the outer sheath in fluid communication with the infusion lumen. At the junction of the proximal inner sheath and the distal wire coil, a radiopaque wire coil of a material having a higher radiopacity than the distal wire coil is formed into a plurality of radiopaque wire coil turns of substantially the same pitch, inner lumen diameter and outer diameter as the distal wire coil. The radiopaque wire coil turns are wound into spacings between adjacent turns of the proximal wire coil such that the wire coils and the inner coil lumens are substantially co-axially aligned and maintained in alignment by the inner and outer sheathes.

Claims

1. A flexible elongated medical infusion guidewire having guidewire proximal and distal portions enclosing an infusion lumen and extending between proximal and distal guidewire ends, the guidewire adapted to be introduced through a selected path in a patient'"'"'s body to a site in a blood vessel or body cavity for infusing a drug or agent through the infusion lumen and into the blood vessel or body cavity, the infusion guidewire further comprising:

an elongated, tubular outer sheath of substantially constant outer diameter having an outer sheath lumen formed therein extending between said guidewire proximal and distal ends, said outer sheath having a plurality of infusion ports formed through the outer sheath side wall and distributed along an infusate length of said guidewire distal portion;

a flexible, elongated, tubular, proximal inner sheath having an inner sheath lumen formed therein and having an inner sheath lumen diameter and an inner sheath lumen length, said inner sheath disposed within said outer sheath lumen and extending from said guidewire proximal end and distally through said guidewire proximal portion to a distal inner sheath end, said inner sheath lumen defining said infusion lumen through said guidewire proximal portion;

an elongated, helically wound, distal wire coil having a distal wire coil lumen formed therein and having a distal wire coil inner diameter and distal wire coil length, said distal wire coil disposed within said outer sheath lumen and extending from a distal wire coil distal end at said guidewire distal end and proximally through said guidewire distal portion and terminating at a distal wire coil proximal end thereof at a junction with said distal inner sheath end, said distal wire coil lumen axially aligned with said inner sheath lumen at said junction by said tubular outer sheath and defining said infusion lumen through said guidewire distal portion, said distal wire coil having spaced apart wire coil turns defining an elongated helical spacing along said infusate length of said guidewire distal portion;

an elongated stiffening core wire having a proximal core wire end and a distal core wire end positioned within said infusion lumen to extend therein from said guidewire proximal end to said guidewire distal end, said core wire having a proximal core wire section with a proximal core wire diameter smaller than said inner sheath lumen diameter in said guidewire proximal portion, a distal core wire section with a distal core wire diameter smaller than said proximal core wire diameter in said guidewire distal portion and an intermediate core wire section having a tapered core wire diameter that decreases from said proximal core wire diameter to said distal core wire diameter;

means for attaching said distal core wire end to said distal wire coil end; and

a hub formed at the guidewire proximal end for infusing fluids into said infusion lumen and for coupling said proximal core wire end to said proximal ends of said outer and inner tubular sheaths and disposed within said infusion lumen for minimally obstructing said infusion lumen through the length of said infusion lumen,

whereby fluids infused into said hub under pressure flow through said infusion lumen alongside said core wire, through the elongated helical spacing between the wire coil turns, and through the plurality of infusion ports to infuse the fluid into the blood vessel or body cavity exterior of said outer sheath distal portion along said infusate length thereof.

2. The infusion guidewire of claim 1 further comprising:

radiopaque means disposed in coaxial alignment with said inner tubular sheath and said distal wire coil within said outer sheath lumen.

3. The infusion guidewire of claim 2 wherein:

said radiopaque means comprises a radiopaque wire coil formed of a radiopaque material having a plurality of spaced apart radiopagque wire coil turns and a radiopaque coil lumen formed therein, said plurality of radiopaque wire coil turns intertwined in the helical spacing between a like plurality of adjacent distal wire coil turns and maintained in coaxial alignment therewith such that said distal coil lumen and said radiopaque coil lumen are substantially co-axially aligned with said infusion lumen.

4. The infusion guidewire of claim 2 wherein:

said means for attaching said distal core wire end to said distal wire coil distal end is at least partially within said outer sheath and comprises a closed end, ball braze.

5. The infusion guidewire of claim 4 wherein said hub further comprises:

a hub member having an outer surface adapted to be engaged to advance and rotate said infusion guidewire through a blood vessel and a conduit therein for transmission of infusion fluids to said infusion lumen and for receiving said proximal core wire end;

core wire fixation means formed in said conduit for fixing said proximal core wire end from rotation in said conduit and in said infusion lumen during advancement and rotation of said infusion guidewire.

6. The infusion guidewire of claim 5 wherein:

said core wire is formed with a bent shape in one plane at said proximal core wire end of a size to prevent said bent shape of said core wire from being advanced distally through said conduit and said aligned infusion lumen; and

said core wire fixation means further comprises a pair of planar side walls extending from said conduit within said hub member to form a cavity for receiving said bent shape of said core wire and for restraining rotation thereof, whereby rotational motion imparted on said hub member is imparted to said core wire and through said core wire to said means for attaching said distal core wire end to said distal wire coil distal end within said outer sheath.

7. The infusion guidewire of claim 1 wherein:

said means for attaching said distal core wire end to said distal wire coil distal end within said outer sheath comprises a closed end, ball braze.

8. The infusion guidewire of claim 7 wherein said hub further comprises:

a hub member having an outer surface adapted to be engaged to advance and rotate said infusion guidewire through a blood vessel and a conduit therein for transmission of infusion fluids to said infusion lumen and for receiving said proximal core wire end;

core wire fixation means formed in said conduit for fixing said proximal core wire end from rotation in said conduit and said infusion lumen during advancement and rotation of said infusion guidewire.

9. The infusion guidewire of claim 8 wherein:

said core wire is formed with a bent shape in one plane at said proximal core wire end of a size to prevent said bent shape of said core wire from being advanced distally through said conduit and said aligned infusion lumen; and

said core wire fixation means further comprises a pair of planar side walls extending from said conduit within said hub member to form a cavity for receiving said bent shape of said core wire and for restraining rotation thereof, whereby rotational motion imparted on said hub member is imparted to said core wire and through said core wire to said means for attaching said distal core wire end to said distal end of said distal wire coil within said outer sheath.

10. The infusion guidewire of claim 1 wherein said hub further comprises:

a hub member having an outer surface adapted to be engaged to advance and rotate said infusion guidewire through a blood vessel and a conduit therein for transmission of infusion fluids to said infusion lumen and for receiving said proximal core wire end;

core wire fixation means formed in said conduit for fixing said proximal core wire end from rotation in said conduit and said infusion lumen during advancement and rotation of said infusion guidewire.

11. The infusion guidewire of claim 10 wherein:

said core wire is formed with a bent shape in one plane at said proximal core wire end of a size to prevent said bent shape of said core wire from being advanced distally through said conduit and said aligned infusion lumen; and

said core wire fixation means further comprises a pair of planar side walls extending from said conduit within said hub member to form a cavity for receiving said bent shape of said core wire and for restraining rotation thereof, whereby rotational motion imparted on said hub member is imparted to said core wire and through said core wire to said means for attaching said distal core wire end to said distal wire coil distal end within said outer sheath.

14. A flexible elongated medical infusion guidewire having guidewire proximal and distal portions enclosing an infusion lumen and extending between proximal and distal guidewire ends, the guidewire adapted to be introduced through a selected path in a patient'"'"'s body to a site in a blood vessel or body cavity for infusing a drug or agent through the infusion lumen and into the blood vessel or body cavity, the infusion guidewire further comprising:

an elongated, tubular outer sheath of substantially constant outer diameter having an outer sheath lumen formed therein extending between said guidewire proximal and distal ends, said outer sheath having at least one infusion port formed through the outer sheath side wall in an infusate length of said guidewire distal portion;

an elongated, tubular, proximal inner sheath having an inner sheath lumen formed therein and having an inner sheath lumen diameter and an inner sheath lumen length, said inner sheath disposed within said outer sheath lumen and extending from said guidewire proximal end and distally through said guidewire proximal portion to a distal inner sheath end, said inner sheath lumen defining said infusion lumen through said guidewire proximal portion;

a flexible, elongated, helically wound, distal wire coil having a distal wire coil lumen formed therein and having a distal wire coil inner diameter and distal wire coil length, said distal wire coil disposed within said outer sheath lumen and extending from a distal wire coil distal end at said guidewire distal end and proximally through said guidewire distal portion and terminating at a distal wire coil proximal end thereof at a junction with said distal inner sheath end, said distal wire coil lumen axially aligned with said inner sheath lumen at said junction by said tubular outer sheath, said distal wire coil having spaced apart wire coil turns defining an elongated helical spacing along said infusate length of said guidewire distal portion;

a radiopaque wire coil formed of a radiopaque material having a plurality of spaced apart radiopaque wire coil turns and a radiopaque coil lumen formed therein, said plurality of radiopaque wire coil turns intertwined in the helical spacing between a like plurality of adjacent distal wire coil turns and maintained in coaxial alignment therewith such that said distal coil lumen and said radiopaque coil lumen are substantially co-axially aligned with and define said infusion lumen through said guidewire distal portion;

an elongated stiffening core wire having a proximal core wire end and a distal core wire end positioned within said infusion lumen to extend therein from said guidewire proximal end to said guidewire distal end;

means for attaching said distal core wire end to said distal wire coil distal end; and

a hub formed at the guidewire proximal end for infusing fluids into said infusion lumen and for coupling said proximal core wire end to said proximal ends of said outer and inner tubular sheaths and disposed within said infusion lumen for minimally obstructing said infusion lumen through the length of said infusion lumen,

whereby fluids infused into said hub under pressure flow through said infusion lumen alongside said core wire, through the elongated helical spacing between the wire coil turns, and through the plurality of infusion ports to infuse the fluid into the blood vessel or body cavity exterior of said outer sheath distal portion along said infusate length thereof.

12. The infusion guidewire of claim 14 wherein said distal and radiopaque wire coils are wound in wire coil turns having substantially the same outer coil diameter and inner coil diameter.

13. The infusion guidewire of claim 12 wherein said outer sheath lumen contacts and aligns the outer diameters of said distal and radiopaque wire coils and applies compressive force thereto.

15. The infusion guidewire of claim 14 wherein said radiopaque wire coil extends from said junction and said distal wire coil proximal end through a proximal section of said distal wire coil and terminates proximally to said distal coil wire distal end.