Systems and methods for delivery retrievable stents

• US 10,390,982 B1
• Filed: 11/13/2018
• Issued: 08/27/2019
• Est. Priority Date: 11/13/2018
• Status: Active Grant

• Current Assignee: ICAD Endovascular LLC
• Original Assignee: ICAD Endovascular LLC
• Inventors: Raychev, Radoslav I., Benjamin, Joshua A., Stoppenhagen, Eric P.
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US16/189,596
• Time in Patent Office: 287 Days
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Systems and method for delivering and deploying an expandable stent to treat Intracranial atherosclerotic disease (ICAD) involving large and medium-sized blood vessels. The disclosed systems include a catheter, a shaft comprising a distal end disposed within the catheter, an expandable stent comprising a proximal end and a distal end, wherein the shaft is coupled to the expandable stent and the shaft is disposed within the expandable stent, and a plurality of struts, wherein a first end of each strut is coupled to the shaft and a second end of each strut is coupled to the expandable stent. Longitudinal movement of the shaft relative to the expandable stent extends the plurality of struts radially outward and expands the expandable stent, similar to umbrella. The plurality of struts provides radial force to the expandable stent in an expanded configuration to the vessel walls of the patient.

Claims

1. A stent delivery system for delivery and deploying an expandable stent comprising:

a catheter;

a shaft comprising a distal end, disposed within the catheter;

an expandable stent comprising a proximal end and a distal end, wherein the shaft is attached directly to the expandable stent and the shaft is disposed within the expandable stent; and

a plurality of struts disposed within the expandable stent, wherein a first end of each strut is coupled to the shaft and a second end of each strut is coupled to the expandable stent,

wherein longitudinal movement of the shaft relative to the expandable stent pulls the distal end of the expandable stent and the proximal end of the expandable stent toward one another, extends the plurality of struts radially outward, and expands the expandable stent, and

wherein the plurality of struts provide an adjustable outward radial force to an outer surface of the expandable stent.

2. The stent delivery system of claim 1, wherein the distal end of the shaft is coupled to the distal end of the expandable stent.

3. The stent delivery system of claim 1, wherein a distally oriented force applied to the shaft extends the plurality of struts radially outward, expanding the expandable stent.

4. The stent delivery system of claim 1, wherein a proximally oriented force applied to the expandable stent extends the plurality of struts radially outward, expanding the expandable stent to an expanded configuration.

5. The stent delivery system of claim 1, wherein the struts are disposed at the distal end of the expandable stent and the struts are disposed at a proximal end of the expandable stent to an expanded configuration.

6. The stent delivery system of claim 1, wherein the plurality of struts are disposed longitudinally along the expandable stent and the plurality of struts are radially aligned with each other, and wherein in an expanded configuration, radial alignment of the plurality of struts creates a plurality of channels that extend a length of the expandable stent.

7. The stent delivery system of claim 1, wherein the plurality of struts comprise subsets of struts, wherein a first subset of struts are coupled to a predetermined position of the shaft and are radially spaced apart from each other and a second subset of struts are coupled to a predetermined position of the shaft distal to the first subset of struts and are radially spaced apart from each other, and wherein the first subset of struts and the second subset of struts are radially aligned.

8. The stent delivery system of claim 1, wherein the expandable stent in an expanded configuration provides a radial force that ranges between 0.00590 and 0.0090 Newtons/mm.

9. The stent delivery system of claim 1, wherein in a collapsed configuration, the plurality of struts is oriented in a distal direction.

10. The stent delivery system of claim 1, wherein in an expanded configuration, the plurality of struts is oriented in a proximal direction.

11. The stent delivery system of claim 1, wherein the shaft comprises a locking mechanism, wherein the locking mechanism is configured to lock the position of the proximal end of the expandable stent relative to the distal end of the expandable stent.

12. The stent delivery system of claim 1, wherein the expandable stent comprises a porosity that ranges from 10 to 35 percent.

13. The stent delivery system of claim 1, wherein the expandable stent comprises a porosity that ranges from 15 to 30 percent.

14. The stent delivery system of claim 1, wherein the expandable stent comprises a cover.

15. The stent delivery system of claim 1, wherein the expandable stent comprises a proximal portion, a central portion, and a distal portion, wherein the central portion comprises a plurality a helical wires that rotate around the shaft.

16. An expandable stent system comprising:

a shaft comprising a distal end;

an expandable stent comprising a proximal end and a distal end, wherein the shaft is attached directly to the expandable stent and the shaft is disposed within the expandable stent; and

a plurality of struts disposed within the expandable stent, wherein a first end of each strut is coupled to the shaft and a second end of each strut is coupled to the expandable stent,

wherein the plurality of struts extends radially outward and expands the expandable stent to an expanded configuration, and

wherein the plurality of struts radially outward movement is configured to provide an adjustable outward radial force to an outer surface of the expandable stent.

17. The expandable stent system of claim 16, wherein longitudinal movement of the shaft relative to the expandable stent extends the plurality of struts radially outward.

18. The expandable stent system of claim 16, wherein the expandable stent in an expanded configuration provides a radial force that ranges between 0.00590 and 0.0090 Newtons/mm.

19. A method for deploying a retrievable expandable stent comprising:

inserting a catheter into a vasculature of a patient, wherein an expandable stent system is disposed within the catheter, the expandable stent system comprising;

a shaft comprising a distal end;

an expandable stent comprising a proximal end and a distal end, wherein the shaft is attached directly to the expandable stent and the shaft is disposed within the expandable stent; and

a plurality of struts disposed within the expandable stent, wherein a first end of each strut is coupled to the shaft and a second end of each strut is coupled to the expandable stent,

advancing the catheter to a target location within the patient;

deploying the expandable stent outside a distal end of the catheter; and

selectively controlling an outward radial force and size of the expandable stent to expand the expandable stent against vessel walls, wherein longitudinal movement of the shaft relative to the expandable stent extends the plurality of struts radially outward and expands the expandable stent.

20. The method of claim 19, wherein the expandable stent is deployed in an expanded configuration against the vessel walls for up to 30 minutes before collapsing the expandable stent to a collapsed configuration.

21. The method of claim 19, wherein deploying the expandable stent comprises deploying the expandable stent into an intracranial target location to treat the patient for intracranial atherosclerotic disease (ICAD).

22. The method of claim 21, wherein advancing the catheter to the target location comprises advancing the catheter through a femoral artery, aorta, and carotid artery of the patient to the intracranial target location.

23. The method of claim 21, wherein controlling the outward radial force and size of the expandable stent comprises expanding the expandable stent to come in contact with plaque disposed on the vessel walls, and adjusting the outward radial force to crush or crack the plaque with the expandable stent.

24. The method of claim 23, further comprising maintaining the outward radial force while allowing blood flow through the expandable stent.

25. The method of claim 19, wherein deploying the expandable stent comprises deploying the expandable stent in a blood vessel having a diameter between 1.5 millimeters (mm) and 7 mm.

26. The method of claim 25, wherein selectively controlling the outward radial force comprises selectively applying between 0.00590 and 0.0090 Newtons/mm of outward radial force.

27. The method of claim 19, wherein selectively controlling the outward radial force and size of the expandable stent comprises:

moving the distal end of the expandable stent and the proximal end of the expandable stent toward one another; and

engaging a locking mechanism to prevent movement of the distal end of the expandable stent and the proximal end of the expandable stent relative to one another.

28. The method of claim 19, further comprising using the plurality of struts to provide an inward radial force to the expandable stent to collapse the expandable stent for removal through the catheter.