Micro-fabricated catheter devices formed with hybrid materials

• US 9,067,332 B2
• Filed: 04/02/2010
• Issued: 06/30/2015
• 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): SCHMIDT, EMILY LOUISE
• Application Number:
  US12/753,831
• Publication Number:
  US 20100256605A1
• Time in Patent Office: 1,915 Days
• Field of Search: 604/523, 604/525, 604/528, 604/529, 604/530
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/09091 where a sheath surrounds the coil at the distal part
• 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 25/0009 Making of catheters or other medical or surgical tubes
• 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 25/0097 characterised by the hub connectors A61M39/10
• 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 catheter device is disclosed including an elongated outer member having a plurality of resultant beams of substantially identical thickness along a length of the outer member, where each resultant beam from among the plurality of resultant beams is formed between two simultaneously cut fenestrations on substantially opposite sides of the outer member, the outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end, where the outer member is formed from two or more different stock materials.

Claims

1. A catheter device comprising:

an elongated outer member having a proximal end and a distal end connected together by an intermediate joint a proximal portion extending between said proximal end and said intermediate joint and having a midpoint, and a distal portion located between said intermediate joint and said distal end, a plurality of fenestrations located in said distal portion extending from said distal end to a midpoint of said distal portion, said plurality of fenestrations defining a plurality of resultant beams and a plurality of rings located in said distal portion along a length of said elongated outer member, said plurality of tings extending about a portion of the circumference of said elongated outer member such that said plurality of tings extend within a plane that is perpendicular to a longitudinal axis of said elongated outer member, said plurality of resultant beams extending parallel to the longitudinal axis between said plurality of rings, said elongated outer member having an outer surface and an interior surface extending from said proximal end to said distal end, wherein said proximal end of said elongated outer member is formed from a first stock material, said distal end of said elongated outer member is formed from a second stock material, and said first stock material and said second stock material are different materials; and

an outer elastomer laminate layer completely filling said plurality of fenestrations located in said elongated outer member such that said plurality of resultant beams and said plurality of rings are completely encapsulated within said outer elastomer laminate layer, said filled fenestrations forming a first lumen at least partially extending along an axis of said elongated outer member from said proximal end to said distal end of said elongated outer member,

wherein said distal portion of said elongated outer member has a curved shape relative to said distal end, said distal portion has a first plurality of fenestrations and a second plurality of fenestrations and said curved shape of said distal portion of said elongated outer member relative to said distal end is held by bending said elongated outer member such that said first plurality of fenestrations are smaller than said second plurality of fenestrations prior to filling said fenestrations with said outer elastomer laminate layer such that said second plurality of fenestrations are filled with said outer elastomer laminate layer to be larger than said first plurality of fenestrations.

2. The catheter device of claim 1 further comprising a torqueable hub connected to said proximal end and having a barrel-shaped body with a plurality of longitudinal groves formed therein, and further forming an axial interior space within which a syringe can be inserted.

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

4. The catheter device of claim 3, wherein said stainless steel is used at said proximal end.

5. The catheter device of claim 3, wherein a second stock material of said two or more different stock materials is nitinol.

6. The catheter device of claim 5, wherein said distal portion of said elongated outer member comprises nitinol.

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

8. The catheter device of claim 1, wherein said outer elastomer laminate layer extends beyond said distal end to form a hollow distal tip having a second lumen therein.

9. The catheter device of claim 8, wherein said hollow distal tip includes a wire holding a shape for said hollow distal tip.

10. The catheter device of claim 8, wherein said hollow distal tip includes a radiopaque marker.

11. The catheter device of claim 8, wherein said second lumen is in fluid communication with said first lumen.

12. The catheter device of claim 1, wherein said second plurality of fenestrations passing through said outer surface and said interior surface.

13. The catheter device of claim 1, wherein said elongated outer member includes a second plurality of fenestrations located in said proximal portion of said outer member said second plurality of fenestrations passing through said outer surface and said interior surface.

14. The catheter device of claim 13, wherein said outer elastomer laminate layer fills said second plurality of fenestrations located in said proximal portion of said elongated outer member.

15. The catheter device of claim 1, wherein said elongated outer member has an outer diameter of said distal end that is larger than an outer diameter of said proximal end.

16. The catheter device of claim 1, wherein said a first lumen is fluid impermeable.

17. The catheter device of claim 1, wherein said plurality of fenestrations located in said distal portion extend from said distal end to said intermediate joint.

18. The catheter device of claim 1, said plurality of fenestrations are located in said proximal portion and extend from said distal end to a midpoint of said proximal portion.

19. The catheter device of claim 1, said plurality of fenestrations not extending to the proximal end.

20. The catheter device of claim 1, said plurality of fenestrations not extending to the midpoint in the proximal portion.

21. The catheter device of claim 1, said plurality of fenestrations not extending to the intermediate joint.