Cutting wire assembly with coating for use with a catheter

• US 9,622,771 B2
• Filed: 02/27/2016
• Issued: 04/18/2017
• Est. Priority Date: 10/06/2010
• Status: Expired due to Fees

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: Schur, Israel, McGuckin, Jr., James F., Bressler, James Erich
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US15/055,547
• Publication Number:
  US 20160175002A1
• Time in Patent Office: 416 Days
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member

Abstract

A device for treating a lesion in a body lumen to enlarge a passageway in the body lumen having at least one cutting member and a tracking member. The at least one cutting member has a cutting surface and a separate material associated therewith. The cutting member and tracking member are connected at a distal portion and insertable into the body lumen as a unit, the cutting member configured for movement in a direction transverse to a longitudinal axis of the tracking member to widen a gap between the cutting member and tracking member at least at a distal region and to apply the separate material to an interior of the lesion.

Claims

1. A device for treating a lesion in a body lumen to enlarge a passageway in the body lumen, the device comprising at least one cutting member and a tracking member, the at least one cutting member having a proximal portion, a distal portion, a cutting surface, a second surface facing the tracking member and a separate material associated with the cutting member, the tracking member having a proximal portion and distal portion, the at least one cutting member and tracking member being connected at a distal portion and insertable into the body lumen as a unit, the at least one cutting member configured for movement in a direction transverse to a longitudinal axis of the tracking member to widen a gap between the at least one cutting member and tracking member at least at a distal region and to apply the separate material to an interior of the lesion, wherein the cutting surface is formed only at a distal region of the cutting member, and the separate material is associated with the cutting surface, the second surface and surfaces connecting the cutting surface and second surface.

2. The device of claim 1, wherein a proximal end of the at least one cutting member extends outside the body lumen.

3. The device of claim 1, wherein the separate material is only associated with the distal region of the cutting member having the cutting surface.

4. The device of claim 1, wherein the tracking member includes a proximal and distal marker band, the distal marker band positioned where the at least one cutting member and tracking member are connected.

5. The device claim 1, wherein the at least one cutting member includes a plurality of cutting members, the plurality of cutting members are connected at a distal portion to the tracking member and inserted as a unit through a lumen of the catheter, and a proximal end of the cutting members extends outside the body lumen.

6. The device of claim 1, in combination with a catheter having a lumen and an expandable portion, wherein the cutting surface is configured to treat the lesion to enlarge the passageway in the body lumen when moved by the expandable portion of the catheter to widen the gap between the at least one cutting member and tracking member.

7. The device claim 1, wherein the at least one cutting member has a first exposed portion of a first configuration and a second exposed portion of a second configuration, the second portion including a cutting surface and the first portion being atraumatic, wherein the separate material is placed on the second portion and not on the first portion.

8. The device of claim 1, wherein the at least one cutting member has a first height in a first portion and a second height in a second portion, wherein the second height is less than the first height.

9. The device of any of claim 1, wherein the tracking member has a coil at a distal tip, and further comprising shrink wrap over a connection region of the tracking and at least one cutting member.

10. The device of any of claim 1, wherein the at least one cutting member is a wire and the tracking member is a wire.

11. The device of claim 1, wherein the separate material is a thrombolytic agent.

12. The device of claim 1, wherein the separate material is an anti-coagulant.

13. The device of claim 1, wherein the separate material is a material applied to an external region of the cutting member.

14. The device of claim 1, wherein the separate material is embedded in the cutting member and leaches into the lesion.

15. A device for treating a lesion in a body lumen to enlarge a passageway in the body lumen, the device comprising at least one cutting member and a tracking member, the at least one cutting member having a proximal portion, a distal portion, a cutting surface and a separate material associated therewith, the tracking member having a proximal portion and distal portion, the at least one cutting member and tracking member being connected at a distal portion and insertable into the body lumen as a unit, the at least one cutting member configured for movement in a direction transverse to a longitudinal axis of the tracking member to widen a gap between the at least one cutting member and tracking member at least at a distal region and to apply the separate material to an interior of the lesion, wherein the at least one cutting member is substantially circular in cross-section in a proximal region and substantially triangular in cross-section in a distal region, wherein the substantially triangular cross section has a first cutting surface, a second surface opposite the cutting surface and facing the tracking member and surfaces between the first and second surfaces, wherein the separate material is associated with the first cutting surface, the second surface and the surfaces between the first and second surfaces.

16. A method of treating a lesion in a body lumen, the method comprising:

inserting a tracking member and at least one cutting member having a separate material associated therewith through a first lumen of a first catheter and into the body lumen, the at least one cutting member has a first cutting surface, a second surface opposite the cutting surface and facing the tracking member and surfaces between the cutting surface and second surface, wherein the separate material is associated with the first cutting surface, the second surface and the surfaces between the cutting surface and second surface;

withdrawing the first catheter from the body lumen;

inserting the first catheter over a proximal end of the tracking member from outside the body lumen so the tracking member extends through the first lumen of the first catheter and the at least one cutting member does not extend through the first lumen; and

moving the at least one cutting member away from the tracking member into cutting contact with the lesion to enlarge a passageway in the body lumen and apply the separate material to an interior of the lesion.

17. The method of claim 16, wherein the step of moving the at least one cutting member away from the tracking member includes expanding an expandable balloon of the first catheter, the step of expanding the balloon causes the at least one cutting member to be moved radially with respect to the first catheter and a gap between the at least one cutting member and tracking member to widen.

18. The method of claim 16, wherein the at least one cutting member and tracking member are attached at a distal end for insertion as a unit through the lumen of the first catheter.