Micro-fabricated guidewire devices formed with hybrid materials

• US 9,950,137 B2
• Filed: 04/02/2010
• Issued: 04/24/2018
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: Scientia Vascular, LLC
• Original Assignee: Scientia Vascular, LLC
• Inventors: Lippert, John, Snyder, Edward J.
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US12/753,836
• Publication Number:
  US 20100256602A1
• Time in Patent Office: 2,944 Days
• Field of Search: 600585
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 25/0013 Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: B26D 5/20 with interrelated action between the cutting member and work feed
• CPC Class Codes: B26F 1/0053 by machining, e.g. cutting, grinding, projections on the tube wall
• CPC Class Codes: B26F 1/0061 whereby the tube moves axially or radially B26F1/0038, B26F1/0046, B26F1/0053 take precedence

Abstract

A guidewire device comprising: a micro-fabricated elongated outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end, wherein said outer member is formed from two or more stock materials; and an inner member disposed within a portion of said lumen, and embodiments thereof.

Claims

1. A guidewire device comprising:

a tubular micro-fabricated elongated outer member having a proximal end, a distal end, and an intermediate portion located between said proximal end and said distal end, said tubular micro-fabricated elongated outer member having a plurality of resultant beams defined by a plurality of fenestrations formed in said intermediate portion, each resultant beam having an outer surface, an inner surface, a proximal surface, and a distal surface, wherein said tubular micro-fabricated elongated outer member is formed from two or more different stock materials;

an outer elastomer laminate layer contacting the outer surfaces of the resultant beams and filling said plurality of fenestrations located in said intermediate portion of said tubular micro-fabricated elongated outer member such that said outer elastomer laminate layer, as a single integrated piece of material, encapsulates said tubular micro-fabricated elongated outer member, the outer elastomer laminate layer covering the outer surface, the inner surface, the proximal surface, and the distal surface of each resultant beam, said plurality of filled fenestrations defining a first lumen, the outer elastomer laminate layer varying in durometer along its length; and

an inner member disposed within a portion of said first lumen.

2. The guidewire device of claim 1, wherein said inner member is a monofilament wire core.

3. The guidewire device of claim 1, further comprising a hypotube coupled to said proximal end of said tubular micro-fabricated elongated outer member.

4. The guidewire device of claim 1, wherein a first stock material of said two or more different stock materials is stainless steel.

5. The guidewire device of claim 4, wherein said stainless steel is used at said proximal end.

6. The guidewire device of claim 1, wherein a second stock material of said two or more different stock materials is nitinol.

7. The guidewire device of claim 6, wherein said nitinol is used at said distal end.

8. The guidewire device of claim 1, wherein said outer elastomer laminate layer comprises a flexible material.

9. The guidewire device of claim 1, wherein said tubular micro-fabricated elongated outer member further comprises a second plurality of fenestrations located in a distal portion of said tubular micro-fabricated elongated outer member, said distal portion being located between said intermediate portion and said distal end, said second plurality of fenestrations defining a plurality of resultant beams located in said distal portion.

10. The guidewire device of claim 1, wherein said tubular micro-fabricated elongated outer member further comprises a second plurality of fenestrations located in a proximal portion of said tubular micro-fabricated elongated outer member, a distal portion being located between said intermediate portion and said proximal end, said second plurality of fenestrations defining a plurality of resultant beams located in said distal portion.

11. The guidewire device of claim 1, wherein said tubular micro-fabricated elongated outer member has an outer diameter of said distal end that is larger than an outer diameter of said proximal end.

15. The guidewire device of claim 9, wherein said outer elastomer laminate layer fills said second plurality of fenestrations.

17. The guidewire device of claim 1, wherein the outer elastomer laminate layer has a first durometer in a proximal portion and a second durometer in a distal portion, the first durometer and the second durometer being different.

18. The guidewire device of claim 17, wherein the outer elastomer laminate layer has a third durometer in an intermediate portion, the first durometer, the second durometer, and the third durometer being different.

19. The guidewire device of claim 18, wherein the first durometer is higher than the second durometer, and wherein the second durometer is higher than the third durometer.

12. A guidewire device comprising:

a tubular micro-fabricated elongated outer member having a proximal end, a distal end, and an intermediate portion located between said proximal end and said distal end, said tubular micro-fabricated elongated outer member having an outer surface and an interior surface, the tubular micro-fabricated elongated outer member having a plurality of resultant beams defined by a plurality of fenestrations formed in said intermediate portion, each resultant beam having an outer surface, an inner surface, a proximal surface, and a distal surface, said plurality of fenestrations passing through said outer surface and said interior surface, said plurality of fenestrations having a convex outer surface, wherein said micro-fabricated elongated outer member is formed from two or more different stock materials;

an outer elastomer laminate layer located radially outside of and contacting the outer surfaces of the resultant beams and filling said plurality of fenestrations located in said intermediate portion of said tubular micro-fabricated elongated outer member such that said outer elastomer laminate layer, as a single integrated piece of material, encapsulates said tubular micro-fabricated elongated outer member, the outer elastomer laminate layer covering the outer surface, the inner surface, the proximal surface, and the distal surface of each resultant beam, said plurality of filled fenestrations defining a first lumen, said first lumen extending from said proximal end to said distal end, the outer elastomer laminate layer varying in durometer along its length; and

an inner member disposed within a portion of said first lumen.

13. The guidewire device of claim 12, wherein said inner member is a monofilament wire core.

14. The guidewire device of claim 12, wherein said tubular micro-fabricated elongated outer member further comprises a second plurality of fenestrations located in a proximal portion of said tubular micro-fabricated elongated outer member, said proximal portion being located between said intermediate portion and said proximal end.

16. The guidewire device of claim 14, wherein said tubular micro-fabricated elongated outer member further comprises a third plurality of fenestrations located in a distal portion of said tubular micro-fabricated elongated outer member, said distal portion of said being located between said intermediate portion and said distal end, wherein said outer elastomer laminate layer fills said third plurality of fenestrations.

20. A guidewire device comprising:

a tubular micro-fabricated elongated outer member having a proximal portion adjacent a proximal end, a distal portion adjacent a distal end, and an intermediate portion located between said proximal end and said distal end, said tubular micro-fabricated elongated outer member having a plurality of resultant beams defined by a plurality of fenestrations formed in said intermediate portion, each resultant beam having an outer surface, an inner surface, a proximal surface, and a distal surface, wherein said tubular micro-fabricated elongated outer member is formed from stainless steel and nitinol, wherein said tubular micro-fabricated elongated outer member has an outer diameter at said distal portion that is larger than an outer diameter at said proximal portion; and

an outer elastomer laminate layer contacting the outer surfaces of the resultant beams and filling said plurality of fenestrations located in said intermediate portion of said tubular micro-fabricated elongated outer member such that said outer elastomer laminate layer, as a single integrated piece of material, encapsulates said tubular micro-fabricated elongated outer member, the outer elastomer laminate layer covering the outer surface, the inner surface, the proximal surface, and the distal surface of each resultant beam, said plurality of filled fenestrations defining a first lumen, the outer elastomer laminate layer varying in durometer along its length.