Catheter balloon systems and methods

• US 20050102019A1
• Filed: 11/10/2004
• Published: 05/12/2005
• Est. Priority Date: 11/12/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Advanced Stent Technologies Inc. (Boston Scientific Corporation)
• Inventors: Yadin, Amnon
• Granted Patent: US 7,344,557 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/1059 : having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1068 : having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Apparatus and method are provided for treatment of a bifurcation of a body lumen. The apparatus includes an elongated catheter body having a proximal end and a distal end. A balloon is associated with the distal end of the balloon catheter. The balloon includes a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation. The branch vessel balloon includes an accordion configuration capable of being expanded from an unexpanded collapsed accordion configuration to an expanded accordion configuration extending into the branch vessel.

Claims

1. A catheter assembly for use in bifurcated vessels, comprising:

an elongated catheter body having a proximal end and a distal end; and

a balloon associated with the distal end of the catheter, the balloon including a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation,

wherein the branch vessel balloon includes an accordion configuration capable of being expanded from an unexpanded collapsed accordion configuration to an expanded configuration extending into the branch vessel.

2. A catheter assembly for use in bifurcated vessels as claimed in claim 1, wherein the branch vessel balloon includes accordion folds and the folds are substantially collapsed against each other in the unexpanded configuration and separated from each other in the expanded configuration.

3. A catheter assembly for use in bifurcated vessels as claimed in claim 1, further comprising a bifurcated stent, wherein the bifurcated stent is disposed on the balloon.

4. A catheter assembly for use in bifurcated vessels as claimed in claim 1, further comprising a bifurcated stent having a main vessel portion and an extendible branch vessel portion, wherein the branch vessel balloon is disposed substantially adjacent the extendible branch portion, whereby upon expansion the branch vessel balloon expands the extendible branch vessel portion of the stent into the branch vessel.

5. A catheter assembly for use in bifurcated vessels as claimed in claim 1, wherein the catheter includes an inflation lumen and the balloon has an interior in fluid communication with the inflation lumen.

6. A catheter assembly for use in bifurcated vessels as claimed in claim 5, wherein the inflation lumen comprises two inflation lumens, a first inflation lumen in fluid communication with an interior of the branch vessel balloon and a second inflation lumen in fluid communication with an interior of the main vessel balloon.

7. A catheter assembly for use in bifurcated vessels as claimed in claim 1, wherein the branch and main vessel balloons comprise a unitary balloon.

8. A catheter assembly for use in bifurcated vessels as claimed in claim 1, wherein the branch vessel balloon is separate from the main vessel balloon.

9. A catheter assembly for use in bifurcated vessels as claimed in claim 1, further comprising a side sheath associated with the elongated catheter body, wherein at least a portion of the side sheath extends along the distal end of the catheter body and adjacent the branch vessel balloon.

10. A catheter assembly for use in bifurcated vessels as claimed in claim 9, wherein the branch vessel balloon is disposed on the side sheath.

11. A catheter assembly for use in bifurcated vessels as claimed in claim 9, wherein the side sheath is disposable in the branch vessel and the main vessel balloon is disposable in the main vessel during placement of the catheter assembly in a bifurcated vessel.

12. A catheter assembly for use in bifurcated vessels as claimed in claim 1, wherein the branch vessel balloon is oriented to expand in a direction substantially perpendicular to a longitudinal axis of the main vessel balloon.

13. A catheter assembly for use in bifurcated vessels as claimed in claim 1, wherein the branch vessel balloon comprises a herniation on the main vessel balloon.

14. A catheter assembly for use in bifurcated vessels as claimed in claim 1, further comprising a side sheath and wherein one end of the branch vessel balloon is slidably affixed to the side sheath.

15. A catheter assembly for use in bifurcated vessels as claimed in claim 1, further comprising a side sheath and wherein the branch vessel balloon is located on the side sheath and oriented to expand in a direction substantially parallel to a longitudinal axis of the side sheath.

16. A catheter assembly for use in bifurcated vessels as claimed in claim 2, wherein the profile of the accordion folds is substantially hexagonal or rounded when viewed perpendicularly to the direction of inflation.

17. A catheter assembly for use in bifurcated vessels as claimed in claim 2, wherein the profile of the accordion folds is substantially round, elliptical, square, hexagonal or octagonal when viewed along the direction of inflation.

18. A catheter assembly for use in bifurcated vessels as claimed in claim 1, wherein the branch vessel balloon comprises a plurality of fluidly connected cells connected in series, the series defining an axis of primary inflation.

19. A catheter assembly for use in bifurcated vessels as claimed in claim 18, wherein the successive cells have a different size from the preceding cell in the series.

20. A catheter assembly for use in bifurcated vessels as claimed in claim 18, wherein the cells are adapted to merge into a substantially tubular structure when fully expanded.

21. A catheter assembly for use in bifurcated vessels, comprising:

an elongated catheter body having a proximal end and a distal end; and

a balloon associated with the distal end of the balloon catheter, the balloon including a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation,

wherein the branch vessel balloon comprises a plurality of fluidly connected cells connected in series, the series defining an axis of primary inflation; and

wherein when the branch vessel balloon is expanded, expansion along the axis of primary inflation is greater than expansion in a radial direction, which is substantially perpendicular to the axis of primary inflation.

22. The catheter assembly of claim 21, wherein successive cells have a different size from the preceding cell in the series.

23. The catheter assembly of claim 21, wherein the cells are adapted to merge into a substantially tubular structure when fully expanded.

24. A method of treating a bifurcation of a body lumen, the bifurcation including a main vessel and a branch vessel, the method comprising:

introducing a balloon and stent assembly into the main vessel, the balloon having at least one accordion configuration, wherein the accordion configuration comprises a plurality of accordion folds;

positioning the assembly at the bifurcation; and

inflating the balloon to expand the stent in the main vessel.

25. The method of claim 24, wherein the step of inflating includes expanding a portion of the stent outwardly toward the branch vessel.

26. The method of claim 25, wherein the accordion configuration expands the portion of the stent outwardly toward the branch vessel.

27. The method of claim 24, wherein the body lumen is a blood vessel.