Temporary vascular scaffold and scoring device

• US 9,277,935 B2
• Filed: 11/15/2013
• Issued: 03/08/2016
• Est. Priority Date: 08/13/2009
• Status: Active Grant

• Current Assignee: Nfinium Vascular Technologies, LLC
• Original Assignee: Quadra Endovascular, Inc.
• Inventors: Fulton, Richard Eustis III
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US14/080,917
• Publication Number:
  US 20140142598A1
• Time in Patent Office: 844 Days
• Field of Search: 623 111- 118, 623/1.22, 623/1.42, 606/108, 606/159, 606/198, 606/200
• US Class Current: 1/1
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/32096 for slowly cutting through tissue, e.g. stent like temporary implants having sharp edges
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Devices and methods for treating a target site in a body lumen are provided. A medical device includes a stent-like structure including a plurality of scoring and non-scoring filaments interwoven with one another. Generally, the stent-like structure will have more non-scoring filaments than scoring filaments to provide greater structural support and to focus the scoring forces on only a few select areas. The stent-like structure is expanded within the target site to score the target site and to provide temporary structural support while the target site is infused with a therapeutic agent. Such therapeutic agent infusion occurs with the use of a drug eluting or drug coated balloon disposed within the stent-like structure or by occluding the target site and introducing a drug into the occluded target site to sit for a period of time.

Claims

1. A medical device for treating a target site in a body lumen, the medical device comprising:

a stent-like structure comprising a plurality of scoring filaments and a plurality of scoring filaments and a plurality of non-scoring filaments interwoven with one another such that the plurality of scoring filaments cross over and under the plurality of non-scoring filaments, each scoring filament and non-scoring filament extending continuously over a full length of the stent-like structure,

wherein the stent-like structure comprises more non-scoring filaments crossing over and under scoring filaments than scoring filaments cross over and under non-scoring filaments,

wherein each scoring filament has a shape providing a scoring element,

wherein the plurality of non-scoring filaments are configured to radially support the body lumen after the stent-like structure has been expanded therein, and

wherein the shape of each scoring filament provides a plurality of notches, each notch receiving an individual non-scoring filament as the non-scoring filament crosses over the scoring filament.

2. The medical device of claim 1, wherein the stent-like structure comprises a tubular mesh braid.

3. The medical device of claim 1, wherein the stent-like structure has an expanded configuration and a collapsed configuration, and wherein the stent-like structure in the expanded configuration is collapsible into the collapsed configuration.

4. The medical device of claim 3, wherein the stent-like structure in the expandable configuration is collapsible into the collapsed configuration by axially shortening the stent-like structure.

5. The medical device of claim 1, wherein one or more of the plurality of scoring filaments or the plurality of non-scoring filaments are non-axial.

6. The medical device of claim 5, wherein one or more of the plurality of scoring filaments or the plurality of non-scoring filaments are helically wound over a longitudinal axis of the stent-like structure.

7. The medical device of claim 6, wherein one or more of the plurality of scoring filaments or the plurality of non-scoring filaments are helically wound in the same direction.

8. The medical device of claim 5, wherein the plurality of scoring filaments are helically wound over a longitudinal axis of the stent-like structure.

9. The medical device of claim 8, wherein the plurality of scoring filaments are helically wound in the same direction.

10. The medical device of claim 1, wherein a cross-section of each scoring filament has one or more of a pointed, triangular, or rectangular shape.

11. The medical device of claim 1, wherein a cross-section of each non-scoring filament has one or more of a flat, rounded, rectangular, or cylindrical shape.

12. The medical device of claim 1, further comprising an expandable element, wherein the stent-like structure is disposed over the expandable element, and wherein the expandable element is expandable to urge the stent-like structure radially outward against an inner wall of the body lumen.

13. The medical device of claim 12, wherein the expandable element comprises an inflatable balloon.

14. The medical device of claim 12, wherein the expandable element is independently collapsible from the stent-like structure.

15. The medical device of claim 12, wherein the expandable element comprises an outer surface coated with a therapeutic agent or substance.

16. The medical device of claim 12, wherein the expandable element comprises one or more pores for releasing a therapeutic agent or substance.

17. The medical device of claim 12, further comprising a catheter shaft, wherein the expandable element is disposed over the catheter shaft.

18. The medical device of claim 17, further comprising an expandable proximal occluder disposed over the catheter shaft proximal of the expandable element and the stent-like structure.

19. The medical device of claim 17, further comprising an expandable distal occluder.

20. The medical device of claim 19, wherein the distal occluder is advancable through an inner lumen of the catheter shaft to be positioned distal of the expandable element and the stent-like structure.

21. The medical device of claim 19, wherein the distal occluder is non-inflatable.

22. The medical device of claim 1, wherein the full length of the stent-like structure extends from a proximal end of the stent-like structure to a distal end of the stent-like structure.

23. The medical device of claim 1, wherein the full length of an individual scoring filament extends from a proximal end of the stent-like structure to a distal end of the stent-like structure.

24. A medical device for treating a target site in a body lumen, the medical device comprising:

a stent-like structure comprising a plurality of scoring filaments and a plurality of non-scoring filaments interwoven with one another, each scoring filament and non-scoring filament extending continuously over a full length of the stent-like structure,

wherein each scoring filament has a shape providing a scoring element, and

wherein the shape of each scoring filament provides a plurality of notches, each notch defined by an indentation in the scoring element, and each individual non-scoring filament being received in and slidable over a corresponding individual notch as the stent-like structure expands or contracts.

25. The medical device of claim 24, wherein the stent-like structure comprises a tubular mesh braid.

26. The medical device of claim 24, wherein the plurality of non-scoring filaments are configured to radially support the body lumen after the stent-like structure has been expanded therein.

27. The medical device of claim 24, wherein the stent-like structure has an expanded configuration and a collapsed configuration, and wherein the stent-like structure in the expanded configuration is collapsible into the collapsed configuration.

28. The medical device of claim 27, wherein the stent-like structure in the expandable configuration is collapsible into the collapsed configuration by axially shortening the stent-like structure.

29. The medical device of claim 24, wherein one or more of the plurality of scoring filaments or the plurality of non-scoring filaments are non-axial.

30. The medical device of claim 29, wherein one or more of the plurality of scoring filaments or the plurality of non-scoring filaments are helically wound over a longitudinal axis of the stent-like structure.

31. The medical device of claim 30, wherein one or more of the plurality of scoring filaments or the plurality of non-scoring filaments are helically wound in the same direction.

32. The medical device of claim 24, wherein a cross-section of each scoring filament has one or more of a pointed, triangular, or rectangular shape.

33. The medical device of claim 24, wherein a cross-section of each non-scoring filament has one or more of a flat, rounded, rectangular, or cylindrical shape.

34. The medical device of claim 24, further comprising an expandable element, wherein the stent-like structure is disposed over the expandable element, and wherein the expandable element is expandable to urge the stent-like structure radially outward against an inner wall of the body lumen.

35. The medical device of claim 24, wherein the plurality of scoring filaments and the plurality of non-scoring filaments are interwoven with one another such that the plurality of scoring filaments cross over and under the plurality of non-scoring filaments.