Intravascular device and method of manufacture and use

• US 6,622,367 B1
• Filed: 11/04/1999
• Issued: 09/23/2003
• Est. Priority Date: 02/03/1998
• Status: Expired due to Fees

• Current Assignee: Salient Interventional Systems Incorporated
• Original Assignee: Salient Interventional Systems Incorporated
• Inventors: Lewis, B. Douglas, Bolduc, Lee R., Laroya, Gilbert S.
• Primary Examiner(s): Vidovich, Gregory M.
• Assistant Examiner(s): Cozart, Jermie E.
• Application Number:
  US09/434,390
• Time in Patent Office: 1,419 Days
• Field of Search: 294/47, 294/58, 295/272, 294/695, 294/23, 128/898, 604/8, 604/9
• US Class Current: 29/447
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: Y10T 29/49863 : with prestressing of part
• CPC Class Codes: Y10T 29/49865 : by temperature differential [e.g., shrink fit]
• CPC Class Codes: Y10T 29/49885 : with coating before or during assembling
• CPC Class Codes: Y10T 29/49906 : Metal deforming with nonmetallic bonding

Abstract

An intravascular device and method of constructing an intravascular device. The device has a proximal portion which is stiffer than a distal portion. The device of the present invention may also be advanced through small vessels without the aid of a guidewire although a guidewire may be used when necessary. The device may be manufactured in a number of different ways and a preferred method is to use an expanded PTFE liner at the distal portion and an etched PTFE liner along the proximal portion. The device also has a number of different jacket sections, preferably at least four, with increasing durometer towards the proximal end and a braided section with varying pic along the length.

Claims

1. A method of forming an intravascular device, comprising the steps of:

mounting an expanded PTFE liner over a first mandrel portion and an etched PTFE liner over a second mandrel portion;

placing a reinforcing layer over the expanded and etched PTFE liners after the mounting step; and

applying a jacket layer over the reinforcing layer.

2. The method of claim 1, further comprising the steps of:

covering the jacket layer, the reinforcing layer and the expanded PTFE liner with a shrink tube;

fusing the jacket layer to the expanded PTFE liner to form an integrated structure; and

removing the shrink tube after the fusing step.

3. The method of claim 1, wherein:

the applying step is carried out by positioning a tube of material over the reinforcing layer.

4. The method of claim 1, wherein:

the applying step is carried out with the jacket layer having a first jacket section and a second jacket section, the first jacket section being positioned over the expanded PTFE liner and the second jacket section being positioned over the etched PTFE liner, the first jacket section having a durometer which is at least 30 D less than the second jacket section.

5. The method of claim 4, wherein:

the applying step is carried out with the first jacket section having a durometer which is at least 40 D less than the second jacket section.

6. The method of claim 1, wherein:

the mounting step is carried out with the expanded PTFE liner having a porosity of 8-10 microns.

7. The method of claim 1, wherein:

the mounting step is carried out with the first and second mandrel portions being part of the same mandrel.

8. The method of claim 1, further comprising the step of:

inverting an end of the expanded PTFE liner at a distal end.

9. The method of claim 8, wherein:

the inverting step is carried out to form an inverted portion of the expanded PTFE liner which extends longitudinally at least 0.5 mm from a distal end of the reinforcing layer.

10. A method of forming an intravascular device, comprising the steps of:

providing a first mandrel portion and an expanded PTFE liner, the expanded PTFE liner being mounted on the first mandrel portion;

positioning a reinforcing layer over the expanded PTFE liner;

applying a jacket layer over the reinforcing layer; and

positioning an etched PTFE liner over a second mandrel portion;

the positioning step being carried out with the reinforcing layer being wound over the etched PTFE liner; and

the applying step is carried out with the jacket layer being positioned over the reinforcing layer and the etched PTFE liner after the positioning step.

11. The method of claim 10, further comprising the steps of:

covering the jacket layer, the reinforcing layer and the expanded PTFE liner with a shrink tube;

fusing the jacket layer to the expanded PTFE liner to form an integrated structure; and

structure; and

removing the shrink tube after the fusing step.

12. The method of claim 10, wherein:

the applying step is carried out by positioning a tube of material over the reinforcing layer.

13. The method of claim 10, wherein:

the positioning step is carried out with the expanded PTFE liner having a porosity of 8-10 microns.

14. The method of claim 13, wherein:

the positioning step is carried out with the first and second mandrel portions being part of the same mandrel.

15. The method of claim 10, further comprising the step of:

inverting an end of the expanded PTFE liner at a distal end.

16. The method of claim 15, wherein:

the inverting step is carried out to form an inverted portion of the expanded PTFE liner which extends longitudinally at least 0.5 mm from a distal end of the reinforcing layer.

17. A method of forming an intravascular device, comprising the steps of:

providing a first mandrel portion and an expanded PTFE liner, the expanded PTFE liner being mounted on the fist mandrel portion;

positioning a reinforcing layer over the expanded PTFE liner;

applying a jacket layer over the reinforcing layer; and

inverting an end of the expanded PTFE liner at a distal end.

18. The method of claim 17, further comprising the steps of:

positioning an etched PTFE liner over a second mandrel portion; and

the positioning step is carried out with the reinforcing layer being wound over the etched PTFE liner; and

the applying step is carried out with the jacket layer being positioned over the reinforcing layer and the etched PTFE liner after the positioning step.

19. The method of claim 18, wherein:

the applying step is carried out with the jacket layer having a first jacket section and a second jacket section, the first jacket section being positioned over the expanded PTFE liner and the second jacket section being positioned over the etched PTFE liner, the first jacket section having a durometer which is at least 30 D less than the second jacket section.

20. The method of claim 19, wherein:

the applying step is carried out with the first jacket section having a durometer which is at least 40 D less than the second jacket section.