Shape-set textile structure based mechanical thrombectomy systems

• US 9,179,931 B2
• Filed: 08/28/2013
• Issued: 11/10/2015
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Insera Therapeutics, Inc.
• Original Assignee: Insera Therapeutics, Inc.
• Inventors: Janardhan, Vallabh, Janardhan, Vikram
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US14/012,161
• Publication Number:
  US 20140277081A1
• Time in Patent Office: 804 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D04C 3/48 Auxiliary devices
• CPC Class Codes: D10B 2401/046 Shape recovering or form memory
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A biomedical shape-set textile structure based mechanical thrombectomy systems and methods are described. In one of the embodiments, the mechanical thrombectomy device can be customized to the length of the clot in each patient. In one of the embodiments, the mechanical thrombectomy device because of the textile structure has a very low overall profile or thickness that is less than 0.0125 inches (0.317 mm) and therefore can be deployed within microcatheters with inner lumen diameter as small as 0.014 inches (0.355 mm).

Claims

1. A thrombectomy device comprising:

an elongate support structure comprising a plurality of shape-memory and radiopaque wires woven to form a textile fabric having a collapsed state and an expanded state, the elongate support structure comprising;

a plurality of self-expanding generally spherical bulbs in the expanded state comprising;

a first bulb;

a second bulb distal to the first bulb, the first bulb and the second bulb having a first diameter;

a third bulb distal to the second bulb;

a fourth bulb distal to the third bulb, the third bulb and the fourth bulb having a second diameter smaller than the first diameter;

a fifth bulb distal to the fourth bulb;

a sixth bulb distal to the fifth bulb;

a seventh bulb distal to the sixth bulb, the fifth bulb, the sixth bulb, and the seventh bulb having a third diameter smaller than the second diameter;

an eighth bulb distal to the seventh bulb;

a ninth bulb distal to the eighth bulb; and

a tenth bulb distal to the ninth bulb, the eighth bulb, the ninth bulb, and the tenth bulb having a fourth diameter smaller than the third diameter,

necks longitudinally between and radially inward of the self-expanding bulbs, and

a distal neck distal to and radially inward of a distal-most bulb of the self-expanding bulbs, the distal neck comprising a coated distal end;

a delivery system comprising a hypotube comprising two longitudinally interspersed and circumferentially staggered cut patterns, the cut patterns each comprising a plurality of rows each comprising two longitudinally-spaced kerfs angled with respect to a longitudinal axis of the hypotube and comprising rounded edges, wherein a longitudinally-spacing of the kerfs varies along the hypotube; and

a bonding zone where the delivery system is coupled to the elongate support structure, the bonding zone comprising a radiopaque marker band.

2. The device of claim 1, wherein an outer diameter of the elongate support structure in the collapsed state is less than about 0.0125 inches.

3. The device of claim 1, wherein an outer diameter of the elongate support structure in the collapsed state is in a range of about 0.1-0.9 mm.

4. The device of claim 1, wherein the first diameter is about 4.5 mm, the second diameter is about 4 mm, the third diameter is about 3.5 mm, and the fourth diameter is about 3 mm.

5. A thrombectomy device comprising:

an elongate support structure comprising a plurality of wires woven to form a textile fabric having a collapsed state and an expanded state, the elongate support structure comprising a plurality of longitudinally-spaced self-expanding bulbs in the expanded state, wherein the plurality of bulbs comprises five to ten bulbs, and wherein at least two of the plurality of bulbs have different outer diameters in the expanded state; and

a delivery system comprising a hypotube comprising a plurality of longitudinally interspersed cut patterns each comprising a plurality of rows of longitudinally-spaced kerfs.

6. The device of claim 5, wherein the plurality of bulbs comprises ten bulbs.

7. The device of claim 5, wherein at least two of the plurality of bulbs have different shapes in the expanded state.

8. The device of claim 5, wherein at least one of the plurality of bulbs has a spherical shape in the expanded state.

9. The device of claim 5, wherein at least one of the plurality of bulbs has a oblong shape in the expanded state.

10. The device of claim 5, wherein longitudinal spacing between the plurality of bulbs is constant.

11. The device of claim 5, wherein the plurality of wires comprises shape memory and radiopaque wires.

12. The device of claim 11, wherein the radiopaque wires are clustered to enhance visibility under x-ray.

13. The device of claim 5, wherein an outer diameter of the elongate support structure in the collapsed state is less than about 0.0125 inches.

14. The device of claim 5, wherein each of the rows is angled with respect to a longitudinal axis of the hypotube.

15. The device of claim 5, wherein the kerfs comprise rounded edges.

16. The device of claim 5, wherein the plurality of bulbs comprises five bulbs.

17. The device of claim 5, wherein the plurality of bulbs comprises six bulbs.

18. The device of claim 5, wherein the outer diameters of the plurality of bulbs are tapered from a largest outer diameter of the proximal-most bulb to a smallest outer diameter of a distal-most bulb.

19. The device of claim 5, wherein the plurality of wires comprises a first plurality of wires comprising shape-memory material and a second plurality of wires comprising radiopaque material.

20. The device of claim 19, wherein at least some of the second plurality of wires are grouped to form a radiopaque band under fluoroscopy.