DUAL TAPER STENT PROTECTOR

• US 20090018634A1
• Filed: 07/10/2007
• Published: 01/15/2009
• Est. Priority Date: 07/10/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: State, Matt
• Granted Patent: US 9,216,101 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A dual taper stent protector having a first stent covering region configured to cover a stent without substantially engaging the stent, a second covering region, and an engagement region for engaging a product mandrel removably disposed within a catheter shaft, and first and second tapered regions connecting the first stent covering region and the second stent covering region and the second covering region and the engagement region respectively, and to methods of making and using the same.

Claims

1. A catheter assembly comprising:

at least one catheter shaft having a distal end and a proximal end, a distal tip disposed at the distal end and a longitudinal axis;

a stent disposed about the distal end of the catheter;

a product mandrel, the product mandrel removably disposed within the catheter shaft, and exposed at the distal end of the catheter shaft and distal of the distal tip;

a stent protector having an inner surface and an outer surface and having a proximal end and a distal end, the stent protector having a first stent covering region having a first inner diameter defined by the inner surface and disposed about the stent without substantially engaging the stent, a second covering region having a second inner diameter defined by the inner surface which is less than the first inner diameter located distal of the stent covering region disposed about the catheter distal tip, a first connecting region connecting the first stent covering region and the second covering region, an engagement region having a third inner diameter defined by the inner surface which is less than the second inner diameter, the engagement region engaging the product mandrel, and a second connecting region connecting the second covering region and the engagement region

2. The catheter assembly of claim 1 wherein the first connecting region has an inner diameter that tapers between the first stent covering region and the second covering region and the second connecting region and an inner diameter than tapers between the second covering region and the engagement region.

3. The catheter assembly of claim 2 wherein the outer diameter of the first connecting region tapers between the first stent covering region and the second covering region and the outer diameter of the second connecting region tapers between the second covering region and the engagement region.

4. The catheter assembly of claim 1 wherein said second covering region of said stent protector substantially engages said catheter distal tip.

5. The catheter assembly of claim 1 wherein second covering region, the first tapered region, the engagement region and the second tapered region are located distally of said stent covering region in that order, and the proximal end of the stent proctor is non-tapered.

6. The catheter assembly of claim 5 wherein said stent protector comprises a flange at said proximal end of said stent protector.

7. The catheter assembly of claim 1 wherein the proximal end of the stent protector comprises at least one tapered region.

8. The catheter assembly of claim 1 further comprising an expandable balloon member having a body region, a distal waist region, a distal cone region, a proximal waist region, a proximal cone region, and a longitudinal axis, and wherein said proximal end of said stent protector has a third tapered region and a third covering region, the third covering region substantially engages said proximal waist region of said balloon.

9. The catheter assembly of claim 8 wherein said stent protector further comprises perforations from said proximal end to said distal end of said stent protector for facilitating removal of said stent protector from said catheter assembly.

10. The catheter assembly of claim 1 wherein said stent comprises a drug eluting coating.

11. The catheter assembly of claim 1 wherein said catheter distal tip comprises a lubricious coating.

12. A protector for a medical device comprising a distal end and a proximal end, the distal end of the protector comprising:

a first covering region, the first covering region having a first diameter configured so as to cover a medical device without substantial frictional contact;

a second covering region having a second diameter which is less than the first diameter;

a first connecting region connecting said first covering region and said second covering region;

an engagement region having a third diameter, the third diameter is less than the second diameter, the engagement region configured to engage a tubular portion of a catheter assembly, the engagement region located distally from the stent covering region; and

a second connecting region connecting said second covering region and said engagement region.

13. The protector of claim 12 used in combination with a stent, a balloon or both.

14. The protector of claim 12 used in combination with a stent and the first covering region is a stent covering region.

15. The protector of claim 12 wherein said second covering region covers a catheter distal tip.

16. The protector of claim 12 wherein said first connecting region tapers between said first covering region and said second covering region of said protector.

17. The protector of claim 12 wherein said second connecting region tapers between said second covering region and said engagement region of said protector.

18. The protector of claim 12 wherein said second covering region is configured to engage a tubular portion of a catheter assembly having a second diameter which is larger than said first diameter.

19. A method of making the protector of claim 12 comprising forming said protector in an injection mold.

20. A method of making the protector of claim 12 by disposing said protector about a catheter assembly and crimping said protector onto said catheter assembly with heat and pressure.