Medical devices having MRI compatible metal alloys

• US 9,327,057 B1
• Filed: 01/17/2014
• Issued: 05/03/2016
• Est. Priority Date: 12/02/2008
• Status: Active Grant

• Current Assignee: University of Central Florida Research Foundation Inc. (State University System of Florida)
• Original Assignee: University of Central Florida Research Foundation Inc. (State University System of Florida)
• Inventors: Vaidyanathan, Rajan
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/158,444
• Time in Patent Office: 837 Days
• Field of Search: 607/116, 623/1.15
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads

Abstract

An MRI compatible medical device includes a non-magnetic metal alloy portion having a bulk portion including a first and a second metal. A surface of the metal alloy portion includes an integral MRI heating resistant surface structure having a thickness ≧3 nanometers. The non-magnetic metal alloy portion is structurally different from the bulk portion and includes a lamellar nanostructure or microstructure. The MRI heating resistant surface structure can include (i) a matrix phase including the first and second metal having nanometer or micron scale particles, precipitates and/or inclusions that differ in chemical composition and physical characteristics of the matrix phase and are discontinuously distributed therein; (ii) a level of crystallinity at least 5% less than the bulk portion; and/or (iii) metal atoms different from the first and second metal having a concentration profile evidencing diffusion into the metal alloy portion.

Claims

1. An MRI compatible implantable medical device, comprising:

at least one non-magnetic metal alloy portion, wherein said non-magnetic metal alloy portion comprises;

a bulk portion including a first and at least a second metal different from said first metal;

wherein a surface of said non-magnetic metal alloy portion includes an integral MRI heating resistant surface structure having a thickness >

3 nanometers, and

wherein said surface is structurally different from said bulk portion and comprises a lamellar nanostructure or microstructure.

2. The MRI compatible implantable medical device of claim 1, wherein said lamellar nanostructure or microstructure is continuous.

3. The MRI compatible implantable medical device of claim 1, wherein said lamellar nanostructure or microstructure is discontinuous.

4. The MRI compatible implantable medical device of claim 1, wherein said lamellar nanostructure or microstructure extends into both said MRI heating resistant surface structure and said bulk portion.

5. The MRI compatible implantable medical device of claim 1, wherein said MRI heating resistant surface structure is compositionally different from said bulk portion and further comprises at least one of:

(i) a matrix phase comprising said first and said second metal having a plurality of nanometer scale to micron scale particles, precipitates and/or inclusions therein constituting a volume fraction >

3%, wherein said particles, precipitates or inclusions differ in chemical composition and physical characteristics from said matrix phase and are discontinuously distributed therein;

(ii) a level of crystallinity that is at least 5% less as compared to a level of crystallinity in said bulk portion of said non-magnetic metal alloy portion; and

(iii) one or more metal atoms different from said first and second metal having a concentration profile evidencing diffusion which varies as a function of distance into said non-magnetic metal alloy portion.

6. The MRI compatible implantable medical device of claim 5, wherein said MRI heating resistant surface structure comprises said (iii) one or more metal atoms different from said first and second metal having a concentration profile evidencing diffusion which varies as a function of distance into said non-magnetic metal alloy portion.

7. The MRI compatible implantable medical device of claim 6, wherein one or more different metal atoms from said first and second metal is in a concentration of at least 0.1 atomic % for increasing MRI visibility of said non-magnetic metal alloy portion.

8. The MRI compatible implantable medical device of claim 7, wherein said metal atoms different from said first and second metal comprise Au, Pt, Pd or Ag.

9. The MRI compatible implantable medical device of claim 1, further comprising a battery, wherein said non-magnetic metal alloy portion is in leads that are coupled to said battery for carrying current from said battery.

10. The MRI compatible implantable medical device of claim 9, wherein said leads comprise cardiac leads for a cardiac device or neuro-stimulator leads for a neuro-stimulator device.

11. The MRI compatible implantable medical device of claim 5, wherein said MRI heating resistant surface structure includes said (i) matrix phase comprising said first and said second metal having a plurality of nanometer scale to micron scale particles, precipitates and/or inclusions therein constituting a volume fraction >

3%, wherein said particles, precipitates or inclusions differ in chemical composition and physical characteristics from said matrix phase and are discontinuously distributed therein.

12. The MRI compatible implantable medical device of claim 5, wherein said MRI heating resistant surface structure includes said (ii) level of crystallinity that is at least 5% less as compared to a level of crystallinity in said bulk portion of said non-magnetic metal alloy portion.

13. The MRI compatible implantable medical device of claim 1, wherein said integral MRI heating resistant surface structure provides an increase of at least 10% in a magnitude of its impedance in a frequency range of an RF field of 42.56 MHz per Tesla as compared to said bulk portion for reduced heating of said surface from current induced by said RF field.