Shape-set textile structure based mechanical thrombectomy systems

• US 9,750,524 B2
• Filed: 10/29/2015
• Issued: 09/05/2017
• 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:
  US14/926,636
• Publication Number:
  US 20160045211A1
• Time in Patent Office: 677 Days
• 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:

a plurality of wires woven to form a textile structure having a collapsed configuration and an expanded configuration, the textile structure comprising five to ten self-expanding bulbs in the expanded configuration, at least three of the five to ten self-expanding bulbs having different outer diameters in the expanded configuration, a proximal end bulb of the five to ten self-expanding bulbs larger than at least one middle bulb of the five to ten self-expanding bulbs in the expanded configuration, wherein the plurality of wires comprises shape memory wires and radiopaque wires, and wherein the radiopaque wires are circumferentially clustered to enhance visibility under x-ray; and

a delivery system proximal to the textile structure.

2. The device of claim 1, wherein at least one of the self-expanding bulbs has a spherical shape in the expanded configuration.

3. The device of claim 1, wherein the textile structure comprises five said self-expanding bulbs.

4. The device of claim 1, wherein the textile structure comprises six said self-expanding bulbs.

5. The device of claim 1, wherein the textile structure comprises ten said self-expanding bulbs.

6. The device of claim 1, wherein the delivery system comprises a multi-filament hybrid.

7. The device of claim 1, wherein the delivery system comprises a hypotube.

8. The device of claim 1, wherein the delivery system comprises a multi-filament hybrid, wherein the textile structure comprises six said self-expanding bulbs, wherein at least one of the self-expanding bulbs has a spherical shape in the expanded configuration.

9. The device of claim 1, wherein the delivery system comprises a multi-filament hybrid, wherein the textile structure comprises six said self-expanding bulbs, wherein each of the self-expanding bulbs has a spherical shape in the expanded configuration, and wherein the delivery system is coupled to the textile structure using solder comprising radiopaque material.

10. A thrombectomy device comprising:

a plurality of wires woven to form a textile structure having a collapsed configuration and an expanded configuration, the textile structure comprising;

five to ten self-expanding bulbs in the expanded configuration, the five to ten self-expanding bulbs in the expanded configuration comprising three or more sizes in series and a proximal end bulb of the five to ten self-expanding bulbs larger than at least one middle bulb of the five to ten self-expanding bulbs in the expanded configuration, and

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

a delivery system having a distal end overlay bonded to the distal neck.

11. The device of claim 10, wherein the textile structure comprises six said self-expanding bulbs.

12. The device of claim 10, wherein the textile structure comprises ten said self-expanding bulbs.

13. The device of claim 10, wherein the delivery system comprises a multi-filament hybrid.

14. The device of claim 10, wherein the delivery system comprises a multi-filament hybrid, wherein the textile structure comprises six said self-expanding bulbs, wherein at least one of the self-expanding bulbs has a spherical shape in the expanded configuration, and wherein the plurality of wires comprises shape memory wires and radiopaque wires.

15. A thrombectomy device comprising:

a plurality of wires woven to form a textile structure having a collapsed configuration and an expanded configuration, the textile structure comprising five to ten self-expanding bulbs in the expanded configuration, the five to ten self-expanding bulbs in the expanded configuration comprising three or more sizes in series and a proximal end bulb of the five to ten self-expanding bulbs larger than at least one middle bulb of the five to ten self-expanding bulbs in the expanded configuration;

a delivery system proximal to the textile structure; and

a bonding zone where the delivery system is coupled to the textile structure, the bonding zone comprising solder, the solder comprising radiopaque material.

16. The device of claim 15, wherein the textile structure comprises six said self-expanding bulbs.

17. The device of claim 15, wherein the textile structure comprises ten said self-expanding bulbs.

18. The device of claim 15, wherein the delivery system comprises a multi-filament hybrid.

19. The device of claim 15, wherein the delivery system comprises a multi-filament hybrid, wherein the textile structure comprises six said self-expanding bulbs, wherein at least one of the self-expanding bulbs has a spherical shape in the expanded configuration, and wherein the plurality of wires comprises shape memory wires and radiopaque wires.