Implantable expandable medical devices having regions of differential mechanical properties and methods of making same

Patent metadata

Field	Value
Publication number	US-11045338-B2
Application number	US-201715397334-A
Country	US
Kind code	B2
Filing date	Jan 3, 2017
Priority date	Nov 25, 2002
Publication date	Jun 29, 2021
Grant date	Jun 29, 2021

Abstract

An implantable expandable medical device in which selected regions of the device are in a martensite phase and selected regions are in an austenite phase. The martensitic regions exhibit pseudoplastic behavior in vivo and may be deformed without recovery under in vivo body conditions. In contrast the austenitic regions exhibit superelastic behavior in vivo and will recover their pre-programmed configuration upon deformation or release of an applied strain.

First claim

What is claimed is:

1. An implantable medical device made of a biocompatible metal alloy, comprising:
a plurality of circumferential ring members made of the biocompatible metal alloy and having a first chemical stoichiometry, the plurality of circumferential ring members comprising a plurality of strut members that are in an austenite phase in vivo, wherein the austenite phase of the plurality of strut members accommodates radial self-expansion of the circumferential ring members under in vivo conditions;
a plurality of interconnecting members made of the biocompatible metal alloy and having a second chemical stoichiometry and interconnecting adjacent circumferentially expansible ring members, the plurality of interconnecting members comprising a second plurality of strut members that are in the martensite phase in vivo, wherein the martensite phase of the second plurality of strut members accommodates substantially non-recoverable longitudinal expansion of the implantable medical device under in vivo conditions;
wherein the medical device can be loaded to at least 8% strain with a loading plateau of at least 600 MPa and is fully recoverable by unloading to 0% strain with an unloading plateau of at least 300 MPa.

2. The implantable medical device of claim 1 wherein the plurality of interconnecting members have a substantially non-recoverable deformation of less than 1% upon application of a deforming load.

3. The implantable medical device of claim 1 wherein the plurality of interconnecting members have a longitudinal elastic recoil less than 20% when the device is flexed along a longitudinal axis.

4. The implantable medical device according to claim 1 , wherein the biocompatible metal alloy is a nickel-titanium alloy.

5. The implantable medical device of claim 4 wherein second chemical stoichiometry comprises a greater composition of titanium relative to the first chemical stoichiometry.

6. The implantable medical device of claim 4 wherein second chemical stoichiometry comprises a lesser composition of nickel relative to the first chemical stoichiometry.

7. The implantable medical device of claim 1 wherein the medical device is loaded to an 8% strain with a loading plateau at about 200 MPa and a peak loading at about 400-600 MPa and while unloading the biocompatible metal alloy, there remains a residual strain in of about 7% strain in the biocompatible metal alloy.

8. The implantable medical device according to claim 1 , wherein the plurality of circumferential ring members are sufficiently austenitic under in vivo conditions to allow at least about 90% recovery of an unstrained configuration of the device.

9. The implantable medical device according to claim 1 , wherein the plurality of interconnecting members further have a higher transition temperature than the remainder of the implantable medical device.

10. An implantable medical device made of a biocompatible metal alloy comprising:
a plurality of first members made of the biocompatible metal alloy and having a first chemical stoichiometry that are in an austenitic phase in vivo, wherein the plurality of first members are sufficiently austenitic to permit self-deformation under in vivo conditions; and
a plurality of second members made of the biocompatible metal alloy and having a second chemical stoichiometry interconnecting the plurality of first members, the plurality of second members are martensitic in vivo sufficient to permit substantially non-recoverable deformation of the plurality of second members under in vivo conditions;
wherein the medical device can be loaded to at least 8% strain with a loading plateau of at least 600 MPa and is fully recoverable by unloading to 0% strain with an unloading plateau of at least 300 MPa.

11. The implantable medical device of claim 10 wherein the plurality of second members have a substantially non-recoverable deformation of less than 1% upon application of a deforming load.

12. The implantable medical device of claim 10 wherein the plurality of second members have an elastic recoil less than 20% when the medical device is flexed along a longitudinal axis of the medical device.

13. The implantable medical device according to claim 10 , wherein the biocompatible metal alloy is a nickel-titanium alloy.

14. The implantable medical device of claim 13 wherein second chemical stoichiometry comprises a greater composition of titanium relative to the first chemical stoichiometry.

15. The implantable medical device of claim 13 wherein second chemical stoichiometry comprises a lesser composition of nickel relative to the first chemical stoichiometry.

16. The implantable medical device according to claim 10 , wherein the plurality of first members are sufficiently austenitic under in vivo conditions to allow at least about 90% recovery of an unstrained configuration of the device.

17. The implantable medical device according to claim 10 , wherein the plurality of second members further have a higher transition temperature than the remainder of the implantable medical device.

18. The implantable medical device of claim 10 wherein the medical device is loaded to an 8% strain with a loading plateau at about 200 MPa and a peak loading at about 400-600 MPa and while unloading the biocompatible metal alloy, there remains a residual strain in of about 7% strain in the biocompatible metal alloy.

Assignees

• Vactronix Scientific Llc
• Vactronix Scient

Inventors

• Boyle Christopher T
• Banas Christopher E
• Marton Denes

Classifications

• A61F2/91

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

• A61F2250/0042

  differing in shape-memory transition temperatures, e.g. in martensitic transition temperature, in austenitic transition temperature · CPC title

• A61F2/915 Primary

  with bands having a meander structure, adjacent bands being connected to each other · CPC title

• A61F2210/0023

  operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title