Variable flexibility catheter support frame

• US 10,617,847 B2
• Filed: 01/23/2019
• Issued: 04/14/2020
• Est. Priority Date: 11/04/2014
• Status: Active Grant

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: OrbusNeich Medical Pte Ltd
• Inventors: Cottone, Robert J., Juman, Mohamad Ike
• Primary Examiner(s): Mendez, Manuel A
• Assistant Examiner(s): Fredrickson, Courtney B
• Application Number:
  US16/255,141
• Publication Number:
  US 20190160259A1
• Time in Patent Office: 447 Days
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers

Abstract

A guide catheter extension, including a push member having a lumen, a proximal end and a distal end; a tube frame defining a lumen therein, a longitudinal axis, and a proximal segment and a distal segment, wherein the tube frame comprises a plurality of cut patterns therein; and a tongue element extending from the proximal segment of the tube frame, wherein the tongue element is coupled to the push member.

Claims

1. A guide catheter extension, comprising:

a push member having a proximal region and a distal region; and

a tube frame defining;

a longitudinal axis;

a lumen therethrough having a diameter sufficient to receive an interventional cardiology device therethrough;

a proximal opening of the lumen that is substantially perpendicular to the longitudinal axis; and

a tongue element extending from a proximal segment of the tube frame, wherein the tongue element is directly coupled to the distal region of the push member,

wherein the tongue element extends distal to the proximal opening of the lumen, wherein the tube frame includes cuts adjacent to a distal region of the tongue element, wherein the cuts create spaces between sides of the tongue element and the tube frame;

and wherein the tube frame comprises a plurality of cut patterns therein.

2. The guide catheter extension of claim 1, wherein the tube frame has an average stiffness between approximately 0.03 N/mm and approximately 0.10 N/mm along a substantial length thereof.

3. The guide catheter extension of claim 2, wherein the tube frame is pushable through a curve having a radius of approximately 2.5 mm without kinking.

4. The guide catheter extension of claim 3, wherein the tube frame has a wall thickness between approximately 0.0254 mm and approximately 0.254 mm.

5. The guide catheter extension of claim 1, wherein the plurality of cut patterns comprises a plurality of interrupted spiral-cut patterns.

6. The guide catheter extension of claim 5, wherein the plurality of interrupted spiral-cut patterns extends along a length of the tube frame having an average stiffness between 0.002-0.004 N/mm.

7. The guide catheter extension of claim 1, wherein the push member comprises a lumen.

8. The guide catheter extension of claim 1, wherein the plurality of cut patterns comprises a continuous spiral-cut pattern.

9. The guide catheter extension of claim 8, wherein the continuous spiral-cut pattern extends along a length of the tube frame having an average stiffness between 0.001-0.003 N/mm.

10. The guide catheter extension of claim 1, wherein the plurality of cut patterns comprises a plurality of rings coupled together by a plurality of struts.

11. The guide catheter extension of claim 10, wherein the plurality of struts are axially aligned.

12. The guide catheter extension of claim 10, wherein the plurality of struts are angularly offset from one another at an angle ranging from about 5 degrees and to about 180 degrees.

13. The guide catheter extension of claim 12, wherein the struts form a helical pattern.

14. The guide catheter extension of claim 10, wherein the plurality of rings extends along a length of the tube frame having an average stiffness between 0.005-0.016 N/mm.

15. The guide catheter extension of claim 10, further comprising an outer polymer jacket covering at least a portion of the plurality of rings, wherein the outer polymer jacket is not fused to any portion of the plurality of rings.

16. The guide catheter of claim 1, wherein the plurality of cut patterns comprises at least two cut patterns selected from the group consisting of continuous spirals, interrupted spirals, interconnected rings and zones or combinations thereof.

17. The guide catheter extension of claim 1, further comprising a polymer liner disposed within the lumen.

18. The guide catheter extension of claim 17, wherein the polymer liner comprises at least two polymer layers, wherein each polymer layer has a different glass transition temperature and wherein the polymer layer adjacent to the inner wall of the tube frame has a lower glass transition temperature (melt temperature) than the polymer layer adjacent to the lumen.

19. The guide catheter extension of claim 1, wherein the cuts are substantially parallel to the distal region of the tongue element, and wherein the cuts are substantially parallel to the longitudinal axis of the tube frame.

20. The guide catheter extension of claim 1, further comprising a polymer flare circumscribing the proximal opening of the lumen, and wherein the flare has a greater diameter than an outer diameter of the tube frame.

21. The guide catheter extension of claim 1, wherein a longitudinal axis of a distal segment of the tongue element is not parallel to the longitudinal axis of the tube frame.

22. The guide catheter extension of claim 21, wherein the tongue element extends through an opening defined by the flare.

23. A guide catheter extension, comprising:

a push member having a proximal end and a distal end;

a tube frame directly coupled by a tongue element to the distal end of the push member, the tube frame defining;

a longitudinal axis;

a lumen having a diameter sufficient to receive an interventional vascular device therethrough; and

a proximal opening of the lumen that is substantially perpendicular to the longitudinal axis; and

wherein the tongue element extends from a proximal segment of the tube frame and is coupled to the push member, wherein the tongue element extends distal to the proximal opening of the lumen, wherein the tube frame includes cuts adjacent to a distal region of the tongue element, and wherein the cuts create spaces between sides of the tongue element and the tube frame.

24. The guide catheter extension of claim 23, wherein the tongue element is a unitary component of the tube frame.

25. The guide catheter extension of claim 23, wherein the cuts are substantially parallel to the distal region of the tongue element, and wherein the cuts are substantially parallel to the longitudinal axis of the tube frame.

26. The guide catheter extension of claim 25, further comprising a keyhole in the tube frame adjacent to each of the cuts.

27. The guide catheter extension of claim 23, wherein the push member further comprises a lumen.

28. The guide catheter extension of claim 23, wherein a longitudinal axis of a distal segment of the tongue element is not parallel to the longitudinal axis of the tube frame.

29. The guide catheter extension of claim 23, further comprising a polymer liner disposed within the lumen of the tube frame.

30. The guide catheter extension of claim 23, further comprising a polymer flare circumscribing the proximal opening of the lumen, and wherein the flare has a greater diameter than an outer diameter of the tube frame.

31. The guide catheter extension of claim 30, wherein the tongue element extends through an opening defined by the flare.

32. The guide catheter extension of claim 23, wherein the tube frame has an average stiffness between approximately 0.03 N/mm and approximately 0.10 N/mm along a substantial length thereof, and wherein the tube frame has a wall thickness between approximately 0.0254 mm and approximately 0.254 mm.

33. The guide catheter extension of claim 23, wherein the tube frame is pushable through a curve having a radius of approximately 2.5 mm without kinking.

34. The guide catheter extension of claim 23, wherein the push member comprises a lumen.

35. The guide catheter extension of claim 23, further comprising a polymer liner disposed within the lumen.

36. A guide catheter extension, comprising:

a push member having a lumen, a proximal end and a distal end;

a nitinol tube frame coupled to the distal end of the push member, the tube frame defining a longitudinal axis, a lumen having a diameter sufficient to receive an interventional vascular device therethrough, and a proximal opening of the lumen that is substantially perpendicular to the longitudinal axis, wherein the tube frame comprises a plurality of cut patterns therein;

a polymer liner disposed within the lumen of the tube frame;

a plurality of protrusions extending from a proximal region of the tube frame;

a polymer flare coupled about the plurality of protrusions and circumscribing a proximal opening of the lumen, wherein the flare has a greater diameter than an outer diameter of the tube frame;

a tongue element unitary with and extending from a proximal segment of the tube frame, wherein the tongue element is coupled to the push member, and wherein the tongue element extends distal to the proximal opening of the lumen, wherein the tube frame includes cuts adjacent to a distal region of the tongue element, and wherein the cuts create spaces between sides of the tongue element and the tube frame;

an outer polymer jacket covering a least a portion of the tube frame; and

a polymer tip coupled to a distal region of the tube frame.