Personalized coronary stent methods

• US 10,568,697 B2
• Filed: 12/31/2017
• Issued: 02/25/2020
• Est. Priority Date: 07/17/2017
• Status: Active Grant

• Current Assignee: International Business Machines Corporation
• Original Assignee: International Business Machines Corporation
• Inventors: Baldauf, Julia S., Beurle, Darcy J., Downton, Matthew, Halupka, Kerry J., Moore, Stephen M., Schieber, Christine
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/859,558
• Publication Number:
  US 20190015159A1
• Time in Patent Office: 786 Days
• CPC Class Codes: A61B 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

A method including generating a 3-D model of an unstenosed geometry of a blood vessel responsive to a 3-D model of an actual geometry of the blood vessel, establishing a parametric description of a stent that is expanded from a collapsed configuration to a final configuration that apposes the unstenosed geometry, developing a design for the stent by varying parameters of the parametric description responsive to a design heuristic that includes risk of stent strut breakage during a plastic deformation between the collapsed configuration and the final configuration, embodying the stent according to the design for the stent, inserting the stent into a blood vessel in its collapsed configuration, maneuvering the stent through the blood vessel to a stenosis, and expanding the stent to its final configuration.

Claims

1. A method for making a personalized coronary stent, the method comprising:

generating a three-dimensional (3-D) model of an unstenosed geometry of a blood vessel responsive to a 3-D model of an actual geometry of the blood vessel;

establishing a parametric description of a stent that can be expanded from a collapsed configuration to a final configuration that apposes the unstenosed geometry, wherein the parametric description includes parameters that characterize struts of the stent;

developing a design for the stent by varying parameters of the parametric description responsive to a design heuristic that includes risk of stent strut breakage during a plastic deformation between the collapsed configuration and the final configuration; and

embodying the stent, by 3-D printing the stent in the final configuration around an expandable and collapsible mandrel with bridges of the stent in registry with pillars of the mandrel, according to the design for the stent.

2. The method of claim 1 further comprising:

establishing a geometry of the mandrel for supporting the stent in the collapsed configuration; and

embodying the mandrel according to the geometry of the mandrel.

3. The method of claim 2 wherein establishing the geometry of the mandrel includes establishing the pillars protruding from a membrane of the mandrel, wherein at least one of the pillars extends to a different radius than at least one other of the pillars.

4. The method of claim 2 wherein establishing the geometry of the mandrel includes configuring the pillars of the mandrel to support bridges of the stent in the collapsed configuration.

5. The method of claim 4 wherein establishing the geometry of the mandrel includes configuring the pillars of the mandrel to also support bridges of the stent in the final configuration, when the mandrel is expanded to a stretched geometry.

6. The method of claim 2 wherein embodying the mandrel includes 3-D printing the mandrel.

7. The method of claim 1, further comprising:

establishing a geometry of a sleeve for facilitating crimping of the stent from the final configuration to the collapsed configuration; and

embodying the sleeve according to the geometry of the sleeve.

9. The method of claim 7 wherein establishing the geometry of the sleeve includes configuring the pillars of the sleeve to uniformly radially compress bridges of the stent from its final configuration to its collapsed configuration.

10. The method of claim 9 wherein embodying the sleeve includes 3-D printing the sleeve around the stent.

8. A method for making a personalized coronary stent, the method comprising:

generating a three-dimensional (3-D) model of an unstenosed geometry of a blood vessel responsive to a 3-D model of an actual geometry of the blood vessel;

establishing a parametric description of a stent that can be expanded from a collapsed configuration to a final configuration that apposes the unstenosed geometry, wherein the parametric description includes parameters that characterize struts of the stent;

developing a design for the stent by varying parameters of the parametric description responsive to a design heuristic that includes risk of stent strut breakage during a plastic deformation between the collapsed configuration and the final configuration;

embodying the stent, by 3-D printing the stent in the final configuration around a mandrel with bridges of the stent in registry with pillars of the mandrel, according to the design for the stent;

establishing a geometry of a sleeve for facilitating crimping of the stent from the final configuration to the collapsed configuration, wherein the geometry of the sleeve includes a generally cylindrical body and pillars protruding inwardly from the body; and

embodying the sleeve around the stent according to the geometry of the sleeve.

11. The method of claim 8 further comprising:

crimping the stent onto the mandrel, using the sleeve to distribute a uniform radial force onto asymmetric bridges of the stent.

12. A method for using a personalized coronary stent, the method comprising:

inserting into a blood vessel a stent that has an asymmetric collapsed configuration;

maneuvering the stent through the blood vessel to a stenosis at a given location of the blood vessel;

expanding the stent from the collapsed configuration to an asymmetric final configuration that corresponds to an asymmetric unstenosed geometry of the given location within the blood vessel; and

during inserting and maneuvering the stent, supporting the stent on a mandrel that has asymmetric pillars for supporting the collapsed configuration of the stent at bridges of the stent, wherein expanding the stent includes inflating a balloon inside the mandrel.