Devices and methods for removing obstructive material from an intravascular site

• US 10,653,434 B1
• Filed: 11/14/2019
• Issued: 05/19/2020
• Est. Priority Date: 05/01/2018
• Status: Active Grant

• Current Assignee: Incept LLC
• Original Assignee: Imperative Care, Inc.
• Inventors: Yang, Yi, Khosravi, Farhad, Jansen, Lex Philip, Krone, Ryan Taylor, Ray, Miranda, Stone, Carolyn, Ngo, Tiffany Tran
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US16/683,718
• Publication Number:
  US 20200138460A1
• Time in Patent Office: 187 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A system for removing embolic material from an intravascular site is disclosed. The system includes an elongate, flexible tubular body, having a proximal end, a distal end, and a tubular side wall defining at least one lumen extending axially there through; an axial restraint carried by the side wall and exposed to the lumen; a rotatable core wire extendable through the lumen, the core wire having a distal end; a limit carried by the core wire, the limit having a bearing surface for rotatably engaging the restraint; and an agitator tip on the distal end of the core wire. The limit and the restraint are engageable to permit rotation of the core wire but limit distal advance of the tip relative to the tubular body.

Claims

1. A system for removing embolic material from an intravascular site, comprising:

an elongate, flexible tubular body, having a proximal end, a distal end, and a tubular side wall defining at least one lumen extending axially there through;

an axial restraint carried by the side wall and exposed to the lumen;

a rotatable core wire extendable through the lumen, the core wire having a proximal end and a distal end;

a limit carried by the core wire, the limit having a bearing surface for rotatably engaging the restraint; and

an agitator tip on the distal end of the core wire;

wherein the limit and the restraint are engageable to permit rotation of the core wire but limit distal advance of the tip relative to the tubular body; and

wherein the core wire is tapered from a larger diameter at a proximal point to a smaller diameter at the limit that is no more than about 30% of the larger diameter.

2. A system as in claim 1, wherein the axial restraint comprises a proximally facing bearing surface.

3. A system as in claim 2, wherein the axial restraint comprises a radially inwardly extending projection.

4. A system as in claim 3, wherein the axial restraint comprises an annular flange.

5. A system as in claim 1, wherein the limit comprises a distally facing bearing surface.

6. A system as in claim 5, wherein the limit comprises a radially outwardly extending projection.

7. A system as in claim 6, wherein the radially outwardly extending projection comprises a spoke which supports a slider configured for sliding contact with an inside surface of the tubular side wall.

8. A system as in claim 7, comprising three spokes each supporting a slider.

9. A system as in claim 8, comprising a flow path defined between each adjacent pair of spokes and in communication with the lumen.

10. A system as in claim 9, comprising three flow paths and the sum of the cross sectional areas of the three flow paths is at least about 75% of the cross sectional area of the lumen within 1 cm proximally of the restraint.

11. A system as in claim 10, wherein the sum of the cross sectional areas of the three flow paths is at least about 90% of the cross sectional area of the lumen within 1 cm proximally of the restraint.

12. A system as in claim 6, wherein the limit comprises an annular ring.

13. A system as in claim 1, wherein the limit comprises an annular ring spaced radially outwardly apart from the core wire.

14. A system as in claim 13, further comprising at least two spokes extending between the core wire and the ring.

15. A system as in claim 14, comprising three spokes extending between the core wire and the ring.

16. A system as in claim 1, wherein the core wire is tapered to a smaller diameter at the limit that is no more than about 18% of the larger diameter.

17. A system as in claim 16, wherein the core wire is tapered from a diameter of about 0.025 inches at a proximal point to a diameter that is no more than about 0.005 inches at the limit.

18. A system as in claim 1, further comprising a spring carried by the core wire and extending proximally from the tip for a length within the range of from about 5 cm to about 60 cm.

19. A system as in claim 18, wherein the spring extends proximally from the tip for a length within the range of from about 20 cm to about 40 cm.

20. A system as in claim 1, wherein the agitator tip comprises a helical thread.

21. A system as in claim 20, wherein the helical thread has a major diameter that is no more than about 90% of the inside diameter of the lumen, leaving an annular flow path between the tip and the inner surface of the side wall.

22. A system as in claim 20, wherein the helical thread has a blunt outer edge.

23. A system as in claim 1, wherein the limit is positioned within about the distal most 50% of the tubular body length.

24. A system as in claim 23, wherein the limit is positioned within about the distal most 25% of the tubular body length.

25. A system as in claim 24, wherein the bearing surface decouples distal advance of the agitator tip beyond the tubular body in response to positioning the tubular body within tortuous vasculature.

26. A system as in claim 1, wherein the core wire is removably positionable within the tubular body.