Micro-fabricated guidewire devices having elastomeric compositions

• US 9,072,873 B2
• Filed: 04/02/2010
• Issued: 07/07/2015
• 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): HINDENBURG, MAX F
• Assistant Examiner(s): Pani, John
• Application Number:
  US12/753,849
• Publication Number:
  US 20100256527A1
• Time in Patent Office: 1,922 Days
• Field of Search: 600/585
• 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 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; an outer elastomer laminate layer in contact with at least a portion of said outer surface; and an inner member disposed within a substantial portion of said lumen, and embodiments thereof.

Claims

1. A guidewire device comprising:

a micro-fabricated elongated outer member made of a first material and having a plurality of fenestrations forming resultant beams, the micro-fabricated elongated outer member having an outer surface and an interior surface extending from a proximal end to a distal end including a centerpoint therebetween, the plurality of fenestrations extending from the outer surface through the interior surface, the resultant beams being perpendicular to a longitudinal axis of the micro-fabricated elongated outer member, the resultant beams including an outer surface, an interior surface, a proximal surface, and a distal surface;

a second material monolithically interspersed around the resultant beams of the micro-fabricated elongated outer member and forming an outer elastomer laminate layer that defines an outside dimension of said guidewire, the second material defining a first lumen, and the second material having a modulus value in the range of 10 to 500 MPa, the second material abutting the outer surface, the proximal surface, and the distal surface of the resultant beams; and

an inner member disposed within the first lumen;

wherein the first material and second material are polymers, and the first material and second material have a ratio of elastic moduli between 7.4 and 370.

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

3. The guidewire device of claim 1, wherein the inner member is a hypotube.

4. The guidewire device of claim 1, wherein each resultant beam among the plurality of resultant beams is formed between adjacent rings among a plurality of rings.

5. The guidewire device of claim 1, wherein the micro-fabricated elongated outer member is formed from polyetheretherketone.

6. The guidewire device of claim 1, wherein the second material is polyether block amide.

7. The guidewire device of claim 1, wherein the outer elastomer laminate layer extends beyond the distal end to form a hollow distal tip.

8. The guidewire device of claim 7, wherein the hollow distal tip includes a wire holding a shape for the hollow distal tip.

9. The guidewire device of claim 7, wherein the hollow distal tip includes a radiopaque marker.

10. The guidewire device of claim 1, wherein the plurality of fenestrations is disposed in a portion extending from a distalmost end of the device to a proximalmost end of the device.

11. The guidewire device of claim 1, further comprising a hub attached to a proximalmost end of the micro-fabricated elongated outer member, wherein the plurality of fenestrations extends from a distalmost end of the device to the hub.

12. The guidewire device of claim 1, wherein the first material and second material have a ratio of elastic moduli of 308.

18. The guidewire device of claim 1, wherein a first fenestration of the plurality of fenestrations is longitudinally offset and rotationally offset about a longitudinal axis of the micro-fabricated elongated outer member from a longitudinally adjacent second fenestration of the plurality of fenestrations.

19. The guidewire device of claim 18, wherein the first fenestration of the plurality of fenestrations is longitudinally offset from the longitudinally adjacent second fenestration of the plurality of fenestrations by a first distance and a third fenestration of the plurality of fenestrations is longitudinally offset from an longitudinally adjacent fourth fenestration of the plurality of fenestrations by a second distance and wherein the first distance is smaller than the second distance.

13. A guidewire device comprising:

a micro-fabricated elongated outer member made of a first material and having a plurality of fenestrations forming resultant beams, each resultant beam among the plurality of resultant beams formed between adjacent rings among a plurality of rings, the resultant beams being perpendicular to a longitudinal axis of the micro-fabricated elongated outer member, the resultant beams including an outer beam surface, an interior beam surface, a proximal beam surface, and a distal beam surface, the micro-fabricated elongated outer member having an outer surface and an interior surface, the plurality of fenestrations extending from the outer surface through the interior surface;

a second material monolithically interspersed around the resultant beams of the micro-fabricated elongated outer member and forming an outer elastomer laminate layer that at least partially defines an outside dimension of the guidewire, the second material defining an interior lumen extending along an axis of the micro-fabricated elongated outer member, the second material having a modulus value in the range of 10 to 500 MPa, the second material abutting the outer beam surface, the proximal beam surface, and the distal beam surface of the resultant beams; and

an inner member disposed within the interior lumen, the inner member having a higher modulus of elasticity than the micro-fabricated elongated outer member;

wherein the first material and second material have a ratio of elastic moduli between 7.4 and 370, and the first and second materials are polymers.

14. The guidewire device of claim 13, wherein the micro-fabricated elongated outer member is formed from a polymer.

15. The guidewire device of claim 13, wherein the second material is polyether block amide.

16. A guidewire device comprising:

a micro-fabricated elongated outer member made of a first material and having a plurality of fenestrations forming resultant beams, the outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end, the plurality of fenestrations extending from the outer surface through the interior surface, the resultant beams being perpendicular to a longitudinal axis of the micro-fabricated elongated outer member, the resultant beams including an outer beam surface, an interior beam surface, a proximal beam surface, and a distal beam surface;

a second material monolithically interspersed around the resultant beams of the micro-fabricated elongated outer member and forming an outer elastomer laminate layer over the micro-fabricated elongated outer member, the second material defining an interior lumen within the micro-fabricated elongated outer member, the second material having a modulus value in the range of 10 to 500 MPa, the material abutting the outer beam surface, the proximal beam surface, and the distal beam surface of the resultant beams; and

an inner member disposed within a substantial portion of the interior lumen;

wherein the first material and second material have a ratio of elastic moduli between 7.4 and 370 and the first and second materials are polymers.

17. A guidewire device comprising:

a micro-fabricated elongated outer member made of a first material and having a plurality of fenestrations forming resultant beams, each resultant beam among the plurality of resultant beams formed between adjacent rings among a plurality of rings, the resultant beams being perpendicular to a longitudinal axis of the micro-fabricated elongated outer member, the resultant beams including an outer beam surface, an interior beam surface, a proximal beam surface, and a distal beam surface, the micro-fabricated elongated outer member having an outer surface and an interior surface, the plurality of fenestrations extending from the outer surface through the interior surface;

a second material monolithically interspersed around the resultant beams of the micro-fabricated elongated outer member and forming an outer elastomer laminate layer covering at least a portion of the resultant beams, the second material having a modulus value in the range of 10 to 500 MPa, the second material abutting the outer beam surface, the proximal beam surface, and the distal beam surface of the resultant beams; and

a hub attached to a proximalmost end of the micro-fabricated elongated outer member, wherein the plurality of fenestrations extends from a distalmost end of the device to the hub;

wherein the first material and second material have a ratio of elastic moduli between 7.4 and 370, and the first and second materials are polymers.