BIFURCATED BALLOON STENT

• US 20110077730A1
• Filed: 09/30/2009
• Published: 03/31/2011
• Est. Priority Date: 09/30/2009
• Status: Abandoned Application

• Current Assignee: Cardiology Specialists of Florida PLLC
• Original Assignee: Cardiology Specialists of Florida PLLC
• Inventors: Fenster, Michael S.
• Application Number:
  US12/570,151
• Publication Number:
  US 20110077730A1
• Time in Patent Office: Days
• US Class Current: 623/1.3
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A bifurcated stent assembly having a main branch balloon incorporating a sheath associated with the outer wall of the balloon, the sheath having a frangible or separable portion which allows for a guide wire to be passed through the sheath and to be separated from the sheath and the balloon when desired. When the balloon is expanded, the top and bottom edges of the sheath which are associated with the balloon are forced away from each other and cause the frangible or separable portion to separate, allowing the guide wire to be separated from the sheath and the balloon.

Claims

1. A bifurcated stent assembly, comprising:

a) a main branch stent unit comprising

i) a main branch tubular stent,

ii) a main branch expandable member at least partially disposed within said stent material and having

a) an outer wall,

b) an inner wall,

c) a proximal end,

d) a distal end,

e) an expandable portion disposed between said proximal and said distal ends, and

f) a sheath associated with said outer wall of said expandable portion and being sized to allow a guide wire to pass therethrough, said sheath comprising

(1) an inner surface and an outer surface,

(2) a proximal opening,

(3) a distal opening,

(4) a top portion associated with said outer wall of said expandable member,

(5) a bottom portion generally parallel to and proximate to said top portion and associated with said outer wall of said expandable member, and,

(6) a frangible portion disposed between said proximal and distal openings and between said top and bottom portions, said frangible portion having a closed first configuration having a generally tubular shape when said main branch expandable member is in an uninflated configuration and an open second configuration when said main branch expandable member is in an inflated configuration whereby said frangible portion is separated and said top and bottom portions are separated so as to define a sheath edge opening therethrough, allowing a guide wire which is disposed within said sheath to be removable from said sheath via said sheath edge opening; and

,

b) a side branch stent unit comprising

i) a side branch tubular stent,

ii) a side branch expandable member at least partially disposed within said stent material and having

a) a proximal end,

b) a distal end, and,

c) an expandable portion disposed between said proximal and said distal ends.

2. The bifurcated stent assembly of claim 1, further comprising a main branch guide wire.

3. The bifurcated stent assembly of claim 1, further comprising a side branch guide wire.

4. The bifurcated stent assembly of claim 1, wherein said frangible portion comprises a top portion and a bottom portion joined together and having a series of perforations extending at least partially through said sheath wall outer surface.

5. The bifurcated stent assembly of claim 1, wherein said frangible portion comprises a top portion and a bottom portion joined together and having a reduced wall thickness.

6. The bifurcated stent assembly of claim 1, wherein said frangible portion comprises a top portion having a generally zigzag edge and a bottom portion having a generally zigzag edge which mates with and is proximate to said top portion edge.

7. The bifurcated stent assembly of claim 1, wherein said sheath top portion has a generally straight edge and said sheath bottom portion has a generally straight edge, said top portion edge and said bottom portion edge overlapping to define a frangible portion whereby said top portion edge and said bottom portion edge can separate and not overlap when said sheath is in said second open configuration.

8. The bifurcated stent assembly of claim 1, wherein said sheath top portion has an edge including at least one protruding portion alternating with at least one recessed portion and said sheath bottom portion has an edge including at least one protruding portion alternating with at least one recessed portion such that said top portion edge mates with and is proximate to said bottom portion edge, whereby when in said closed first configuration said sheath and said top and bottom portion edges form a generally tubular configuration and whereby when in said open second configuration said top portion edge and said bottom portion edge protruding and recessed portions separate.

9. The bifurcated stent assembly of claim 1, wherein said sheath comprises a plurality of loops of material, each loop having a top end and a bottom end associated with said outer wall of said main branch expandable member.

10. The sheath of claim 9, whereby each loop has a thickness and a portion of reduced thickness, said reduced thickness portion being capable of separating.

11. The bifurcated stent assembly of claim 1, wherein said sheath comprises a plurality of hooks of material having a degree of flexion, each hook having a base end associated with and extending generally orthogonally from said outer wall of said main branch expandable member.

12. The sheath of claim 11, whereby said plurality of hooks are disposed such that said bases of said hooks are alternately above and below an imaginary line parallel to an axis of said main branch expandable member such that a guide wire passing through said plurality of hooks can be removed from said sheath when said sheath is in said open second configuration.

13. A bifurcated stent assembly kit, comprising:

c) a main branch guide wire;

d) a side branch guide wire;

e) at least one guide catheter; and

,

f) a stent assembly comprising

i) a main branch stent unit comprising

a) a main branch tubular stent,

b) a main branch expandable member at least partially disposed within said stent material and having

(1) an outer wall,

(2) an inner wall,

(3) a proximal end,

(4) a distal end,

(5) an expandable portion disposed between said proximal and said distal ends, and

(6) a sheath associated with said outer wall of said expandable portion and being sized to allow a guide wire to pass therethrough, said sheath comprising

 

(a) an inner surface and an outer surface,

 

(b) a proximal opening,

 

(c) a distal opening,

 

(d) a top portion associated with said outer wall of said expandable member,

 

(e) a bottom portion generally parallel to and proximate to said top portion and associated with said outer wall of said expandable member, and,

 

(f) a frangible portion disposed between said proximal and distal openings and between said top and bottom portions, said frangible portion having a closed first configuration having a generally tubular shape when said main branch expandable member is in an uninflated configuration and an open second configuration when said main branch expandable member is in an inflated configuration whereby said frangible portion is separated and said top and bottom portions are separated so as to define a sheath edge opening therethrough, allowing a guide wire which is disposed within said sheath to be removable from said sheath via said sheath edge opening; and

,

ii) a side branch stent unit comprising

a) a side branch tubular stent,

b) a side branch expandable member at least partially disposed within said stent material and having

(1) a proximal end,

(2) a distal end, and,

(3) an expandable portion disposed between said proximal and said distal ends.

14. A balloon for a stent delivery system allowing for separation of a guide wire associated with said balloon from said balloon, comprising:

a) an expandable member having

i) an outer wall,

ii) an inner wall,

iii) a proximal end, and

iv) a distal end; and

,

b) a sheath associated with said outer wall of said expandable member, said sheath comprising

i) an inner surface and an outer surface,

ii) a proximal opening,

iii) a distal opening,

iv) a top portion associated with said outer wall of said expandable member,

v) a bottom portion generally parallel to and proximate to said top portion and associated with said outer wall of said expandable member, and

vi) a frangible portion disposed between said proximal and distal openings and between said top and bottom portions, said frangible portion having a closed first configuration having a generally tubular shape when said expandable member is in an uninflated configuration and an open second configuration when said expandable member is in an inflated configuration whereby said frangible portion is separated and said top and bottom portions are separated so as to define a sheath edge opening therethrough,

whereby a wire which is disposed at least partially within said sheath may be from said sheath via said sheath edge opening when said expandable member is in said second inflated configuration.

15. A method for treating a bifurcated vessel having a main branch and a side branch, comprising:

a) providing a stent assembly comprising

iii) a main branch stent unit comprising

a) a main branch tubular stent,

b) a main branch expandable member at least partially disposed within said stent material and having

(1) an outer wall,

(2) an inner wall,

(3) a proximal end,

(4) a distal end,

(5) an expandable portion disposed between said proximal and said distal ends, and

(6) a sheath associated with said outer wall of said expandable portion and being sized to allow a guide wire to pass therethrough, said sheath comprising

 

(a) an inner surface and an outer surface,

 

(b) a proximal opening,

 

(c) a distal opening,

 

(d) a top portion associated with said outer wall of said expandable member,

 

(e) a bottom portion generally parallel to and proximate to said top portion and associated with said outer wall of said expandable member, and,

 

(f) a frangible portion disposed between said proximal and distal openings and between said top and bottom portions, said frangible portion having a closed first configuration having a generally tubular shape when said main branch expandable member is in an uninflated configuration and an open second configuration when said main branch expandable member is in an inflated configuration whereby said frangible portion is separated and said top and bottom portions are separated so as to define a sheath edge opening therethrough, allowing a guide wire which is disposed within said sheath to be removable from said sheath via said sheath edge opening; and

,

iv) a side branch stent unit comprising

a) a side branch tubular stent,

b) a side branch expandable member at least partially disposed within said stent material and having

(1) a proximal end,

(2) a distal end, and,

(3) an expandable portion disposed between said proximal and said distal ends;

g) inserting the branch stent in said branch vessel;

h) inserting said main vessel balloon in said main vessel;

i) inflating said main vessel balloon;

j) pulling back on said branch vessel stent until resistance is felt;

k) deploying said branch vessel stent;

l) removing said branch vessel stent balloon;

m) inflating said main vessel balloon;

n) removing said branch vessel stent;

o) inserting said stent assembly over both said main vessel guide wire and said branch vessel guide wire;

p) inserting said stent assembly of step j) into said main vessel;

q) advancing and deploying said stent assembly in said main vessel;

r) advancing said branch vessel balloon over said branch vessel guide wire; and

,

s) inflating said main vessel balloon and said branch vessel balloon.

16. A method for treating a bifurcated vessel having a main branch and a side branch, comprising:

b) providing a stent assembly comprising

i) a main branch stent unit comprising

a) a main branch tubular stent,

b) a main branch expandable member at least partially disposed within said stent material and having

(1) an outer wall,

(2) an inner wall,

(3) a proximal end,

(4) a distal end,

(5) an expandable portion disposed between said proximal and said distal ends, and

(6) a sheath associated with said outer wall of said expandable portion and being sized to allow a guide wire to pass therethrough, said sheath comprising

 

(a) an inner surface and an outer surface,

 

(b) a proximal opening,

 

(c) a distal opening,

 

(d) a top portion associated with said outer wall of said expandable member,

 

(e) a bottom portion generally parallel to and proximate to said top portion and associated with said outer wall of said expandable member, and,

 

(f) a frangible portion disposed between said proximal and distal openings and between said top and bottom portions, said frangible portion having a closed first configuration having a generally tubular shape when said main branch expandable member is in an uninflated configuration and an open second configuration when said main branch expandable member is in an inflated configuration whereby said frangible portion is separated and said top and bottom portions are separated so as to define a sheath edge opening therethrough, allowing a guide wire which is disposed within said sheath to be removable from said sheath via said sheath edge opening; and

,

ii) a side branch stent unit comprising

a) a side branch tubular stent,

b) a side branch expandable member at least partially disposed within said stent material and having

(1) a proximal end,

(2) a distal end, and,

(3) an expandable portion disposed between said proximal and said distal ends;

a) providing a main branch guide wire and a side branch guide wire;

b) inserting said main branch stent over said main branch guide wire and said side branch guide wire;

c) inserting said stent assembly into a main branch lumen and advancing said stent assembly to a site for implantation;

d) inflating said main branch expandable member and expanding said main branch stent;

e) advancing said side branch stent unit over said side branch guide wire into a side branch lumen;

f) inflating said main branch expandable member;

g) pulling on said side branch guide wire until resistance is felt;

h) inflating said side branch expandable member and expanding said side branch stent;

i) deflating said main branch expandable member;

j) retracting at least partially said side branch expandable member;

k) inflating said main branch expandable member and said side branch expandable member,

whereby initial expansion of said main branch expandable member causes said frangible portion of said sheath to come apart such that said side branch guide wire can be released from said sheath.