Micro-fabricated guidewire devices having varying diameters

• US 10,363,389 B2
• Filed: 04/02/2010
• Issued: 07/30/2019
• 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): Abouelela, May A
• Application Number:
  US12/753,858
• Publication Number:
  US 20100256528A1
• Time in Patent Office: 3,406 Days
• Field of Search: 600585, 600434, 60416413
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 an elongated outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end, wherein an outer diameter of said distal end is larger than an outer diameter of said proximal end; and an inner member disposed within a portion of said lumen, and embodiments thereof.

Claims

1. A guidewire device comprising:

an elongated outer member including

a proximal portion,

a distal portion having an outer surface, an interior surface, and a plurality of radially extending resultant rings and longitudinally extending resultant beams formed between fenestrations on opposing sides of said elongated outer member, the fenestrations having a depth extending between the outer surface and interior surface,

wherein an outer diameter of said distal portion of the elongated outer member is larger than an outer diameter of said proximal portion of the elongated outer member and a length of the distal portion is up to 20% of a full length of the guidewire device;

a monolithic elastomeric filling material fully encapsulating said distal portion, including encapsulating the outer surface of the distal portion, and the same monolithic elastomeric filling material completely filling said fenestrations, including filling the depths of the fenestrations, to thereby establish fluid integrity in the elongated outer member; and

an inner member disposed within at least a portion of said lumen.

2. The guidewire device of claim 1 wherein at least a portion of said proximal portion of said guidewire device is a hypotube.

3. The guidewire device of claim 1 further comprising a torquer that is fixed to the guidewire device and that includes a barrel-shaped body with a plurality of longitudinal grooves formed therein, and further forms an axial interior space within which a syringe can be inserted.

4. The guidewire device of claim 1, wherein said outer diameter of a proximal end of said proximal portion of said guidewire device is about 0.030 inches (0.076 centimeters).

5. The guidewire device of claim 1, wherein said outer diameter of a distal end of said distal portion of said guidewire device is about 0.039 inches (0.099 centimeters).

6. The guidewire device of claim 1, wherein said outer diameter of a proximal end of said proximal portion of said guidewire device is about 0.030 inches (0.076 centimeters), and said outer diameter of a distal end of said distal portion of said guidewire device is about 0.039 inches (0.099 centimeters).

7. The guidewire device of claim 1, wherein said lumen has an inner diameter of about 0.024 inches (0.061 centimeters).

8. The guidewire device of claim 1, wherein said inner member extends from a distal end of the elongated outer member to a proximal end of the elongated outer member, said inner member decreasing in diameter from a proximal end of the inner member to a distal end of the inner member.

9. The guidewire device of claim 1, wherein the length of the distal portion is between 18% and 20% of an entire length of the elongated outer member.

10. The guidewire device of claim 1, wherein the length of the distal portion is 20% of an entire length of the elongated outer member.

11. The guidewire device of claim 1, wherein said lumen has a constant diameter from a proximal end to a distal end of the lumen.

12. A guidewire device comprising:

a proximal portion;

a distal portion;

a micro-fabricated elongated outer member extending from the proximal portion to the distal portion, at least a portion of the micro-fabricated elongated outer member having a plurality of resultant beams formed between fenestrations on opposing sides of said elongated outer member, and the micro-fabricated elongated outer member defining a lumen,

wherein an outer diameter of said micro-fabricated elongated outer member at said proximal portion of said guidewire device is less than an outer diameter of said micro-fabricated elongated outer member at said distal portion of said guidewire device;

a monolithic elastomeric filling material fully encapsulating said plurality of resultant beams and completely filling said fenestrations,

wherein an amount of monolithic elastomeric filling material within the plurality of fenestrations of the elongated outer member is varied so as to form outer curve fenestrations and inner curve fenestrations, wherein the outer curve fenestrations are filled with a greater amount of elastomeric filling than the inner curve fenestrations so that the outer curve fenestrations are expanded longitudinally and the inner curve fenestrations are contracted longitudinally, thereby forming a shape holding tip at the distal portion of the elongated outer member; and

an inner member disposed within at least a portion of said lumen wherein the inner member has a constant diameter along a full length of the inner member.

13. The device of claim 12, further comprising a proximal end of said proximal portion of said guidewire device, wherein said micro-fabricated elongated outer member extends to said proximal end of said proximal portion of said guidewire device.

14. The device of claim 12, wherein said resultant beams are oriented perpendicular to a longitudinal axis of said lumen.

15. The device of claim 12, wherein said lumen is continuous from said proximal portion to said distal portion of said guidewire device.

16. A guidewire device comprising:

a proximal portion;

a distal portion;

a length;

a micro-fabricated elongated outer member extending along said length of said guidewire device, at least a portion of the micro-fabricated elongated outer member having a plurality of radially extending resultant rings and longitudinally extending resultant beams formed between fenestrations on opposing sides of said elongated outer member, said resultant rings having an inner surface, an outer surface, and two longitudinal surfaces, said resultant beams having an inner surface, and outer surface, and two lateral surfaces, and said micro-fabricated elongated outer member having an outer surface and an interior surface defining a lumen extending from said proximal portion to said distal portion,

wherein an outer diameter of said micro-fabricated elongated outer member at said proximal portion of said guidewire device is less than an outer diameter of said micro-fabricated elongated outer member at said distal portion of said guidewire device, the outer diameter of said micro-fabricated elongated outer member at a proximal end having a constant diameter, and a diameter of the lumen increasing at the distal portion of the guidewire device;

a monolithic elastomeric filling material fully encapsulating said plurality of resultant rings and beams and completely filling said fenestrations between said resultant rings and beams such that the same monolithic elastomeric filling material abuts said inner surface, said outer surface, and both of said two longitudinal surfaces of said resultant rings, and abuts said inner surface, said outer surface, and both of said two laterals surfaces of said resultant beams; and

an inner member disposed within a portion of said lumen, wherein the inner member has a constant diameter along a full length of the inner member.