Constraining structure with non-linear axial struts

• US 10,524,825 B2
• Filed: 11/09/2015
• Issued: 01/07/2020
• Est. Priority Date: 02/08/2012
• Status: Active Grant

• Current Assignee: Trireme Medical Incorporated
• Original Assignee: Trireme Medical Incorporated
• Inventors: Feld, Tanhum, Konstantino, Eitan
• Primary Examiner(s): Schwiker, Katherine H
• Application Number:
  US14/936,458
• Publication Number:
  US 20160058991A1
• Time in Patent Office: 1,520 Days
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/50 Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body locating otherwise A61B5/06; locating by radiation A61B6/00; removing calculi A61B17/22; from the eyes A61F9/00709
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A constraining structure for use with a balloon catheter can include multiple longitudinal struts and multiple, sinusoidal shaped radial rings. The constraining structure can expand to form a pattern of channels including substantially square windows. The constraining structure can modify, restrict, and control a shape and/or size of the balloon when inflated. Inflating the balloon catheter within the constraining structure can provide nonuniform pressure on a vessel wall adjacent the balloon.

Claims

1. A balloon catheter, comprising:

a shaft having a proximal end and a distal end;

an inflatable balloon mounted on the distal end of the shaft and having a proximal end and a distal end;

a constraining structure mounted over the inflatable balloon, the constraining structure being radially expandable and having a proximal end and a distal end fixedly attached to the proximal and distal ends of the inflatable balloon respectively to prevent the constraining structure from disengaging from the inflatable balloon;

wherein the balloon catheter has a collapsed state and an expanded state, such that in the collapsed state the constraining structure has a collapsed diameter and is closed on the inflatable balloon, and in the expanded state the constraining structure has an expanded diameter that is larger than the collapsed diameter and smaller than an inflated diameter of the inflatable balloon such that the inflatable balloon protrudes radially outward through a plurality of openings in the constraining structure,

wherein the constraining structure is configured to prevent the inflatable balloon from lengthening during inflation of the inflatable balloon;

wherein the constraining structure is configured to shorten when expanded by the inflatable balloon.

2. The balloon catheter of claim 1, wherein the constraining structure comprises:

a plurality of radial rings that are expandable and spaced apart along a length of the constraining structure, the plurality of radial rings comprising a proximal end radial ring and a distal end radial ring and at least one radial ring therebetween; and

a plurality of longitudinal struts spaced along a circumference of the constraining structure.

3. The balloon catheter of claim 2, wherein the plurality of longitudinal struts comprising a first longitudinal strut and a second longitudinal strut, wherein a first end of the first longitudinal strut is attached to the distal end of the constraining structure and a second end of the first longitudinal strut attached to the proximal end radial ring, a first end of the second longitudinal strut attached to the proximal end of the constraining structure and a second end of the second longitudinal strut attached to the distal end radial ring.

4. The balloon catheter of claim 3, wherein the constraining structure is configured such that the first longitudinal strut moves in a first axial direction and the second longitudinal strut moves in a second axial direction during expansion of the constraining structure, the second axial direction being opposite the first axial direction.

5. The balloon catheter of claim 3, wherein the second end of the first longitudinal strut is attached to a peak of the proximal end radial ring extending toward the distal end of the constraining structure and the second end of the second longitudinal strut is attached to a peak of the distal end radial ring extending towards the proximal end of the constraining structure.

6. The balloon catheter of claim 2, wherein each of the plurality of radial rings comprises one or more sine waves.

7. The balloon catheter of claim 6, wherein the number of the plurality of longitudinal struts is twice the number of sine waves in one of the plurality of radial rings.

8. The balloon catheter of claim 2, wherein each of the plurality of longitudinal struts is a waved strut comprises a waved shape.

9. The balloon catheter of claim 2, wherein the proximal and distal ends of the constraining structure are not directly connected by any one of the plurality of longitudinal struts.

10. The balloon catheter of claim 2, wherein only half of the plurality of longitudinal struts are connected to the proximal end of the constraining structure and only the other half of the plurality of longitudinal struts are connected to the distal end of the constraining structure.

11. The balloon catheter of claim 2, wherein, the plurality of openings in the constraining structure are a plurality of open spaces positioned between the plurality of radial rings and the plurality of longitudinal struts such that in the expanded state, the inflatable balloon forms a plurality of pillows protruding through the plurality of open spaces.

12. The balloon catheter of claim 1, wherein the constraining structure comprises an elastic polymer.

13. The balloon catheter of claim 1, wherein the constraining structure is biased to the collapsed state.

14. The balloon catheter of claim 1, wherein during inflation of the inflatable balloon, the proximal and distal ends of the constraining structure are configured to apply compressive forces on the inflatable balloon to prevent the lengthening of the inflatable balloon.

15. The balloon catheter of claim 1, wherein the expanded diameter of the constraining structure is between 0.1 mm to 0.5 mm less than an unconstrained inflated diameter of the inflatable balloon.