Multi-functional wire guide assembly and method of using same

• US 9,211,390 B2
• Filed: 11/16/2012
• Issued: 12/15/2015
• Est. Priority Date: 11/30/2011
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Conklin, Hannah, Elsesser, James, Hecht, Nathan William, Alley, Richard
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): Lee, Brandy S
• Application Number:
  US13/679,063
• Publication Number:
  US 20130138052A1
• Time in Patent Office: 1,124 Days
• Field of Search: 604/164.13, 604/265, 604/528, 600/585, 600/434
• US Class Current: 1/1
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2025/0915 having features for changing the stiffness
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires

Abstract

A multi-functional wire guide assembly includes an elongate tubular housing having a length and defining a lumen extending from an open proximal end of the elongate tubular housing to an open distal end of the elongate tubular housing. A first mandril is positioned within the lumen, extends a majority of the length of the elongate tubular housing, and has a fixed position relative to the elongate tubular housing. A second mandril is positioned within the lumen, has a length greater than the length of the elongate tubular housing, and is axially movable relative to the elongate tubular housing. The multi-functional wire guide assembly has a first configuration in which a distal tip of the second mandril is proximally spaced from a distal segment of the elongate tubular housing and a second configuration in which the distal tip of the second mandril is axially aligned with the distal segment.

Claims

1. A multi-functional wire guide assembly, comprising:

an elongate tubular housing having a length and defining a lumen extending from an open proximal end of the elongate tubular housing to an open distal end of the elongate tubular housing;

a first mandril positioned within the lumen, extending a majority of the length of the elongate tubular housing, having a portion of an outer surface attached to an inner surface of the elongate tubular housing at an attachment joint, and having a fixed position relative to the elongate tubular housing, and a segment of the attachment joint being remote from a distal end of the first mandril and being remote from the distal end of the elongate tubular housing; and

a second mandril positioned within the lumen, having a length greater than the length of the elongate tubular housing, and axially movable relative to the elongate tubular housing;

wherein the multi-functional wire guide assembly has a first configuration in which a distal tip of the second mandril is proximally spaced from a distal segment of the elongate tubular housing and a second configuration in which the distal tip of the second mandril is axially aligned with the distal segment; and

wherein the first mandril and the second mandril are exposed to fluid passing through the lumen.

2. The multi-functional wire guide assembly of claim 1, wherein the first mandril is less stiff than the second mandril.

3. The multi-functional wire guide assembly of claim 2, wherein the first mandril includes nitinol.

4. The multi-functional wire guide assembly of claim 2, wherein the second mandril includes stainless steel.

5. The multi-functional wire guide assembly of claim 2, wherein at least one of an outer surface of the first mandril, an outer surface of the second mandril, and an inner surface of the elongate tubular housing includes a lubricious coating.

6. The multi-functional wire guide assembly of claim 5, wherein the elongate tubular housing includes a braided sheath.

7. The multi-functional wire guide assembly of claim 5, wherein each of the first mandril and the second mandril has a semi-circular cross section.

8. The multi-functional wire guide assembly of claim 5, further including an injection port attached at the open proximal end of the elongate tubular housing, wherein the injection port is fluidly connected to the open distal end.

9. The multi-functional wire guide assembly of claim 1, wherein the multi-functional wire guide assembly has a third configuration in which the distal tip of the second mandril is distally spaced from the distal segment and outside the lumen.

10. A method of performing a percutaneous vascular procedure using a multi-functional wire guide assembly, wherein the multi-functional wire guide assembly includes an elongate tubular housing having a length and defining a lumen extending from an open proximal end of the elongate tubular housing to an open distal end of the elongate tubular housing, a first mandril positioned within the lumen, extending a majority of the length of the elongate tubular housing, having a portion of an outer surface attached to an inner surface of the elongate tubular housing at an attachment joint, and having a fixed position relative to the elongate tubular housing, and a segment of the attachment joint being remote from a distal end of the first mandril and being remote from the distal end of the elongate tubular housing, and a second mandril positioned within the lumen, having a length greater than the length of the elongate tubular housing, and axially movable relative to the elongate tubular housing, the method comprising steps of:

moving the multi-functional wire guide assembly into a first configuration to provide a first tip load;

advancing the multi-functional wire guide assembly through a vessel of a patient at the first tip load;

moving the multi-functional wire guide assembly into a second configuration to provide a second tip load that is different than the first tip load;

further advancing the multi-functional wire guide assembly through the vessel of the patient at the second tip load; and

moving a fluid through the open distal end of the elongate tubular housing;

exposing the first mandril and the second mandril to the fluid moving through the lumen of the elongate tubular member;

wherein the steps of moving the multi-functional wire guide assembly include moving the second mandril relative to the first mandril, which has the portion of the outer surface between opposite ends attached to the inner surface of the elongate tubular housing.

11. The method of claim 10, wherein the first moving step includes decreasing a stiffness of the multi-functional wire guide assembly at a distal segment of the elongate tubular housing by proximally retracting the second mandril such that a distal tip of the second mandril is proximally spaced from the distal segment.

12. The method of claim 11, wherein the second moving step includes increasing the stiffness at the distal segment by distally advancing the second mandril such that the distal tip of the second mandril is axially aligned with the distal segment.

13. The method of claim 10, further including reducing friction during the steps of moving the multi-functional wire guide assembly with a lubricious coating on at least one of an outer surface of the first mandril, an outer surface of the second mandril, and an inner surface of the elongate tubular.

14. The method of claim 10, further including:

advancing the multi-functional wire guide assembly toward a lesion; and

crossing the lesion, at least in part, by advancing a distal tip of the second mandril through the open distal end of the elongate tubular housing and into contact with the lesion.

15. The method of claim 10, wherein the step of moving a fluid includes injecting a liquid into the vessel of the patient through an injection port attached at the open proximal end of the elongate tubular housing, through the lumen, and through the open distal end.