Deformable tip for stent delivery and methods of use

• US 10,258,491 B2
• Filed: 01/30/2017
• Issued: 04/16/2019
• Est. Priority Date: 02/02/2016
• Status: Active Grant

• Current Assignee: Inspired Industry, LLC, InspireMD, Ltd.
• Original Assignee: InspireMD, Ltd.
• Inventors: Bar, Eli, Hazan, Dror
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US15/419,437
• Publication Number:
  US 20170216066A1
• Time in Patent Office: 806 Days
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A stent-delivery assembly that includes a catheter; an expandable stent that is movable, relative to the catheter, from a first position to a second position; and a guidewire assembly extending through a longitudinal passage of the catheter and a longitudinal passage of the stent, the guidewire assembly being movable, relative to the catheter, from a third position to a fourth position. While the expandable stent is in the first position and while the guidewire assembly is in the third position, the stent-delivery assembly has an a-traumatic shape. While the expandable stent is in the second position and while the guidewire assembly is in the fourth position, the guidewire assembly is capable of passing through the stent to allow for retrieval of the stent-delivery assembly. Methods of use and manufacture are also included.

Claims

1. A stent-delivery assembly comprising:

a catheter configured to deliver a stent at a distal end thereof and having a first longitudinal passage at the distal end and a catheter inner diameter;

an expandable stent movable, relative to the catheter, from a first position to a second position, the expandable stent having a second longitudinal passage and a stent inner diameter; and

a guidewire assembly extending through the first longitudinal passage and through the second longitudinal passage, the assembly movable, relative to the distal end of the catheter, from a third position to a fourth position, the guidewire assembly comprising;

an inner lumen having an exterior surface; and

a radially adjustable tip concentrically disposed about the exterior surface of the inner lumen and comprising;

a first end that is tapered towards the inner lumen and that is coupled to the inner lumen;

an opposing second end; and

a radially adjustable middle portion;

wherein when the stent is in the first position, the stent is concentrically disposed within the first longitudinal passage and has a first stent inner diameter;

wherein when the stent is in the second position, the stent is spaced longitudinally from the first longitudinal passage of the catheter and has a second stent inner diameter that is greater than the first stent inner diameter;

wherein when the guidewire assembly is in the third position, the inner lumen is under tension, the opposing second end extends within the first longitudinal passage and the second longitudinal passage, and a portion of the radially adjustable middle portion of the tip has a first tip outer diameter that is greater than or equal to the catheter inner diameter; and

wherein when the guidewire assembly is in the fourth position, the opposing second end of the tip is spaced longitudinally from the first longitudinal passage of the catheter and the adjustable middle portion of the tip has a second tip outer diameter that is less than the first tip outer diameter and less than the second stent inner diameter.

2. The stent-delivery assembly of claim 1,

wherein when the guidewire assembly is in the third position, the expandable stent is in the first position;

and

wherein when the guidewire assembly is in the fourth position, the expandable stent is in the second position.

3. The stent-delivery assembly of claim 1, wherein the tip comprises an elastic tip that is configured to accommodate a predetermined amount of a fluid.

4. The stent-delivery assembly of claim 3,

wherein when the guidewire assembly is in the third position, the stent compresses the tip so that the predetermined amount of fluid expands a portion of the radially adjustable middle portion such that the first tip outer diameter is greater than the catheter inner diameter;

and

wherein when the guidewire assembly is in the fourth position, the tip is in a neutral state that is not radially constrained, permitting a predetermined amount of fluid to extend along a length of the tip and the second tip outer diameter to become less than the first tip outer diameter and less than the stent second inner diameter.

5. The stent-delivery assembly of claim 3, wherein the predetermined amount of fluid comprises at least one of a liquid and a gas.

6. The stent-delivery assembly of claim 3, wherein the opposing second end of the tip is coupled to the inner lumen.

7. The stent-delivery assembly of claim 6, wherein the opposing second end of the tip is tapered towards the inner lumen.

8. The stent-delivery assembly of claim 3, wherein compression of one portion of the radially adjustable middle portion results in another portion of the radially adjustable middle portion expanding to the first tip outer diameter.

9. The stent-delivery assembly of claim 1, wherein the stent-delivery assembly is configured to be inserted in a vessel when the stent is in the first position and when the guidewire assembly is in the third position.

10. The stent-delivery assembly of claim 1, wherein the opposing second end of the tip moves relative to the inner lumen.

11. The stent-delivery assembly of claim 10,

wherein the tip is a substantially cylindrical tip;

and

wherein the radially adjustable middle portion has circumferentially-spaced, longitudinally-extending slots that define longitudinally extending leg portions.

12. The stent-delivery assembly of claim 11, wherein the compression of the tip in the longitudinal direction results in the leg portions extending in a radial direction to the first tip outer diameter.

13. The stent-delivery assembly of claim 10, wherein the tip has a first length when the guidewire assembly is in the third position and a second length that is greater than the first length when the guidewire assembly is in the fourth position.

14. The stent-delivery assembly of claim 10,

wherein the tip is a substantially cylindrical tip;

and

wherein the radially adjustable middle portion comprises a braided material.

15. The stent-delivery assembly of claim 1, wherein each of the first end and the opposing second end forms an a-traumatic shape.