Apparatus, systems and methods for medical device expansion

Patent metadata

Field	Value
Publication number	US-2016008152-A1
Application number	US-201514860402-A
Country	US
Kind code	A1
Filing date	Sep 21, 2015
Priority date	Jun 6, 2012
Publication date	Jan 14, 2016
Grant date	—

Abstract

A method for manufacturing a medical device. The method can include forming a medical device from a tube having a first diameter; uniformly expanding the medical device from the first diameter to a second diameter at which the medical device can be left within a body vessel, the medical device being expanded from the first diameter to the second diameter while being continuously positioned on an expander; and heat setting the expanded medical device at the second diameter while the medical device is positioned on the expander.

First claim

What is claimed is:

1 . A method of manufacturing a medical device, the method comprising:
forming a medical device from a tube having a first diameter; uniformly expanding the medical device from the first diameter to a second diameter at which the medical device can be left within a body vessel, the medical device being expanded from the first diameter to the second diameter while being continuously positioned on an expander; and heat setting the expanded medical device at the second diameter while the medical device is positioned on the expander.

2 . The method of claim 1 , wherein heat setting the expanded medical device comprises maintaining the expanded medical device at the second diameter on the expander for a predetermined period of time while the expander is maintained at a predetermined heat-setting temperature.

3 . The method of claim 2 , wherein the expander is positioned within a thermal chamber that maintains the expander at the predetermined heat-setting temperature during the steps of uniformly expanding the medical device and heat setting the expanded medical device.

4 . The method of claim 1 , wherein the medical device is comprised of a shape-memory material.

5 . The method of claim 1 , wherein the medical device is physically separated from the expander when the medical device is positioned on the expander.

6 . The method of claim 1 , further comprising:
preheating the medical device within a thermal chamber before uniformly expanding the medical device; and maintaining heat on the medical device within the thermal chamber during radial expansion of the medical device.

7 . A method of manufacturing a medical device, the method comprising:
forming a medical device from a tube having a first diameter; supporting the medical device on an expander, the medical device being supported by and spaced apart from an outer surface of the expander; uniformly expanding the medical device from the first diameter to a second diameter at which the medical device can be left within a body vessel, the medical device being expanded from the first diameter to the second diameter while being continuously positioned on the expander and separated from the outer surface of the expander; and heat setting the expanded medical device at the second diameter while the medical device is positioned on the expander.

8 . The method of claim 7 , wherein supporting the medical device on the expander comprises supporting the medical device on segmented portions of the expander.

9 . The method of claim 7 , further comprising positioning segmented portions of the expander on an expansion mechanism before uniformly expanding the medical device.

10 . The method of claim 7 , further comprising positioning longitudinal elements between the medical device and the expander, the longitudinal elements supporting the medical device.

11 . The method of claim 7 , wherein supporting the medical device on the expander comprises supporting the medical device on a volute expander.

12 . The method of claim 11 , wherein uniformly expanding the medical device further comprises unrolling the expander from a first diameter with a first end and a second end of the expander having a first angular separation to a second diameter with the first end and the second end having a second angular separation.

13 . The method of claim of claim 12 , wherein the first angular separation is a negative angular separation.

14 . The method of claim 12 , wherein the second angular separation is a positive angular separation.

15 . The method of claim 7 , further comprising aligning a plurality of longitudinal structures disposed between the medical device and the expander within a plurality of transport guides formed on a surface of the expander.

16 . The method of claim 15 , wherein aligning the plurality of longitudinal structures comprises aligning an internally positioned alignment mechanism with a lumen of the expander.

17 . The method of claim 15 , wherein aligning the plurality of longitudinal structures comprises aligning a pair of clamp arms with an advancement guide configured to rotationally align with the expander.

18 . A method of manufacturing a medical device, the method comprising:
positioning a medical device on a transport assembly having a plurality of transport mechanisms, the transport mechanisms being arranged generally parallel to a central longitudinal axis; positioning a portion of the transport assembly on an expander so that the medical device becomes positioned radially over the expander; radially expanding the medical device with the expander while the medical device is positioned on the transport assembly; and heat setting the expanded medical device while the medical device is positioned on the expander, the acts of radially expanding the medical device and heat setting the expanded medical device being performed while the medical device is positioned in a heated thermal chamber.

19 . The method of claim 18 , wherein positioning the portion of the transport assembly on the expander comprises:
positioning ends of the transport mechanisms of the transport assembly in transport guides formed on the expander; and moving the transport assembly longitudinally with respect to the expander so that the transport mechanisms slide along the transport guides until the medical device is positioned radially over the expander.

20 . The method of claim 19 , wherein positioning the portion of the transport assembly on the expander further comprises:
inserting an axial guide into a guide opening extending longitudinally through the expander, the transport assembly being attached to the axial guide so as to move therewith, and wherein the steps of positioning the ends of the transport mechanisms in the transport guides and moving the transport assembly longitudinally are accomplished by moving the axial guide along the guide opening.

21 . The method of claim 18 , wherein radially expanding the medical device with the expander comprises moving the medical device relative to the expander from a first position on a first portion of the expander to a second position on a second portion of the expander, the first and second portions of the expander respectively having first and second cross sectional areas, the second cross sectional area being greater than the first cross sectional area, the medical device being radially expanded as the medical device moves from the first position to the second position.

Assignees

• Abbott Cardiovascular Systems

Inventors

• Green Michael Lee

Classifications

• B29L2023/007

  Medical tubes other than catheters (catheters B29L2031/7542) · CPC title

• B29C71/02

  Thermal after-treatment {(B29C71/0063 and B29C71/0072 take precedence)} · CPC title

• B29C55/24

  radial · CPC title

• A61F2/91

  made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes · CPC title

• A61F2/86

  Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure · CPC title