U.S. patent number RE47,514 [Application Number 15/437,102] was granted by the patent office on 2019-07-16 for balloon delivery apparatus and method for using and manufacturing the same.
This patent grant is currently assigned to Svelte Medical Systems, Inc.. The grantee listed for this patent is Svelte Medical Systems, Inc.. Invention is credited to Fernando DiCaprio.
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United States Patent |
RE47,514 |
DiCaprio |
July 16, 2019 |
Balloon delivery apparatus and method for using and manufacturing
the same
Abstract
A balloon delivery catheter apparatus including a catheter
tubing defining a lumen therethrough, a balloon disposed near a
distal end of the catheter tubing and moving between deflated and
inflated states, and a core wire having a proximal end attached to
the catheter tubing inside the lumen and extending distally away
and substantially co-axially with the catheter tubing through the
balloon to a distal free end. Proximal and distal balloon control
bands are concentrically arranged around respective proximal and
distal end portions of the balloon. A coil disposed around the core
wire has a proximal end attached to at least one of the distal end
portion of the balloon and the distal balloon control band.
Inventors: |
DiCaprio; Fernando (St. Paul,
MN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Svelte Medical Systems, Inc. |
New Providence |
NJ |
US |
|
|
Assignee: |
Svelte Medical Systems, Inc.
(New Providence, NJ)
|
Family
ID: |
42781870 |
Appl.
No.: |
15/437,102 |
Filed: |
February 20, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
PCT/US2010/028581 |
Mar 25, 2010 |
|
|
|
|
61163103 |
Mar 25, 2009 |
|
|
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Reissue of: |
13224037 |
Sep 1, 2011 |
8968348 |
Mar 3, 2015 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
25/104 (20130101); A61M 25/1027 (20130101); A61M
25/1034 (20130101); A61F 2/958 (20130101); A61F
2/958 (20130101); A61M 25/1027 (20130101); A61M
25/104 (20130101); A61M 2025/0186 (20130101); A61M
2025/1079 (20130101); Y10T 29/49826 (20150115); Y10T
29/4987 (20150115); A61M 2025/1093 (20130101); A61F
2002/9583 (20130101); A61M 2025/1093 (20130101); A61M
25/0102 (20130101); A61M 2025/0186 (20130101); A61M
2025/1079 (20130101); A61M 25/0102 (20130101) |
Current International
Class: |
A61M
29/02 (20060101); A61M 25/10 (20130101); A61M
25/01 (20060101); A61F 2/958 (20130101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
US. Patent and Trademark Office Non-Final Office Action dated Dec.
18, 2012, relating to U.S. Appl. No. 13/224,037. cited by applicant
.
International Search Report for Application PCT/US2010/028581 dated
Jun. 2, 2010. cited by applicant .
U.S. Patent and Trademark Office Non-Final Office Action dated Jan.
17, 2013, relating to U.S. Appl. No. 12/969,189. cited by applicant
.
European Search Report for Application No. 10756822 dated Nov. 2,
2012. cited by applicant.
|
Primary Examiner: Dawson; Glenn K
Attorney, Agent or Firm: Honigman LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This U.S. patent application under 35 U.S.C. .sctn.111(a) is a
continuation of, and claims priority under 35 U.S.C. .sctn.120 and
.sctn.365(c) from, PCT Patent Application PCT/US2010/28581, having
an international filing date of Mar. 25, 2010, which claims
priority under 35 U.S.C. .sctn.119(e) to U.S. Provisional
Application 61/163,103, filed on Mar. 25, 2009. The disclosures of
these prior applications are considered part of the disclosure of
this application and are hereby incorporated by reference in their
entireties.
Claims
What is claimed is:
1. A balloon delivery catheter apparatus comprising: a catheter
tubing defining a lumen therethrough; a balloon disposed near a
distal end of the catheter tubing and moving between deflated and
inflated states; a core wire having a proximal end attached to the
catheter tubing inside the lumen and extending distally away and
substantially co-axially with the catheter tubing through the
balloon to a distal free end; proximal and distal balloon control
bands concentrically arranged around respective proximal and distal
end portions of the balloon, each balloon control band comprising
an elastic material that expands during inflation of the balloon
and contracts upon deflation of the balloon, the balloon control
bands impeding expansion of the proximal and distal end portions of
the balloon and assisting deflation of the balloon after balloon
inflation; a coil disposed around the core wire, the coil having a
proximal end attached to at least one of the distal end portion of
the balloon and the distal balloon control band; .[.and.]. a
balloon support tube co-axially disposed over the core wire and
within the balloon, wherein the balloon support tube prevents
compression of the balloon below a threshold diameter; and a laser
activated low density polyethylene bonding portion abutting and
interposed between the coil and each of the distal end portion of
the balloon and the distal balloon control band, the laser
activated low density polyethylene bonding the coil and one or more
of the balloon and the distal balloon control band, the laser
activated low density polyethylene bonding portion having a first
state before laser activation and a second state after activation,
wherein the laser activated low density polyethylene bonding
portion is unbonded to the coil in the first state and the laser
activated low density polyethylene bonding portion is bonded to the
coil and extending into spaces defined by the coil in the second
state; wherein the control bands each have a diametric
cross-section larger than the balloon in its uninflated state and
an unexpanded stent received over the balloon to impede axial
movement of the unexpanded stent off of the balloon.
2. The balloon delivery catheter apparatus of claim 1, wherein the
proximal and distal balloon control bands are secured to the
respective proximal and distal end portions of the balloon.
3. The balloon delivery catheter apparatus of claim 1, wherein the
proximal end portion of the balloon and the proximal balloon
control band are both attached to the catheter tubing.
4. The balloon delivery catheter apparatus of claim 3, wherein the
proximal balloon control band is attached at least partially to the
balloon and at least partially to the catheter tubing.
5. The balloon delivery catheter apparatus of claim 1, wherein the
distal balloon control band is attached at least partially to the
balloon and at least partially to the core wire.
6. The balloon delivery catheter apparatus of claim 1, wherein each
balloon control band has a non-uniform cross-sectional thickness
along an axial direction of the balloon control band.
7. The balloon delivery catheter apparatus of claim 6, wherein each
balloon control band has first and second end portions, the first
end portion having a larger diametric cross-section than the second
end portion, the first end portion of each balloon control band
disposed adjacent to a received stent on the balloon.
8. The balloon delivery catheter apparatus of claim 1, wherein the
balloon and the balloon control bands are coaxially disposed about
the core wire.
9. The balloon delivery catheter apparatus of claim 1, wherein the
coil extends beyond the distal end portion of the balloon.
10. The balloon delivery catheter apparatus of claim 1, wherein the
balloon control bands restrict expansion of at least the end
portions of the balloon to a threshold diameter.
11. The balloon delivery catheter apparatus of claim 1, further
comprising a handle received by a proximal end of the catheter
tubing, the handle comprising: a handle base defining a handle
lumen therethrough; a collet received at least partially in the
handle lumen at a distal end portion of the handle base, the collet
defining a collet lumen therethrough; and a handle head releasably
connected to the distal end portion of the handle base over the
collet, the handle head defining an aperture axially aligned with
the collet lumen and sized to receive the proximal end of the
catheter tubing therethrough and at least partially in the collet
lumen; wherein the handle lumen is in fluid communication with the
lumen of the received catheter tubing; and wherein movement of the
handle head toward the handle base causes constriction of the
collet about the received catheter tubing.
12. The balloon delivery catheter apparatus of claim 11, wherein
the collet comprises: a substantially tubular section having an
outer diameter less than or equal to a diameter of the handle
lumen; and a chuck attached to the substantially tubular section
and having an outer diameter larger than the .Iadd.diameter of the
.Iaddend.handle lumen, the chuck defining a chamfered surface
arranged to engage an opposing chamfered surface of the handle
base; wherein movement of the handle head toward the handle base
causes movement of the collet toward the handle base and the
chamfered surface of the handle base to exert a substantially
radially inward force on the opposing chamfered surface of the
chuck.
13. The balloon delivery catheter apparatus of claim 11, wherein
the handle head is threadably received by the distal end portion of
the handle base.
14. The balloon delivery catheter apparatus of claim 11, wherein
the handle further comprises a valve member disposed on a proximal
end portion of the handle base.
15. The balloon delivery catheter apparatus of claim 11, wherein
the handle further comprises a strain relief disposed on at least
one of the handle base and the handle head.
16. A balloon delivery catheter apparatus comprising: a catheter
tubing defining a lumen therethrough; a balloon disposed near a
distal end of the catheter tubing and moving between deflated and
inflated states.Iadd., the balloon having proximal and distal end
portions.Iaddend.; a core wire having a proximal end attached near
the distal end of the catheter tubing inside the lumen and
extending distally away and substantially co-axially with the
catheter tubing through the balloon to a distal free end; a coil
disposed around the core wire, the coil having a proximal end
attached to .[.at least one of.]. the distal end portion of the
balloon .[.and the distal balloon control band.].; a balloon
support tube co-axially disposed over the core wire and within the
balloon; and a laser activated low density polyethylene bonding
portion abutting and interposed between the coil and the distal end
portion of the balloon, the laser activated low density
polyethylene bonding portion having a first state before laser
activation and a second state after activation, wherein the laser
activated low density polyethylene bonding portion is unbonded to
the coil in the first state and the laser activated low density
polyethylene bonding portion is bonded to the coil and extending
into spaces defined by the coil in the second state; wherein the
balloon support tube prevents compression of the balloon below a
threshold diameter.
17. The balloon delivery catheter apparatus of claim 16, wherein
the balloon support tube prevents compression of a received stent
over the balloon to a diameter less than a threshold un-deployed
stent diameter.
18. The balloon delivery catheter apparatus of claim 16, wherein
the balloon support tube has an axial length less than or equal to
an axial length of the balloon.
19. The balloon delivery catheter apparatus of claim 16, wherein
the balloon support tube is attached to the core wire so that a
proximal end of the balloon support tube is approximately
concentric with a proximal end of the balloon, and a distal end of
the balloon support tube is approximately concentric with a distal
end of the balloon.
20. The balloon delivery catheter apparatus of claim 16, wherein
the balloon support tube comprises a polyamide material.
21. The balloon delivery catheter apparatus of claim 16, further
comprising proximal and distal marker bands disposed on the core
wire near respective proximal and distal ends of the balloon, the
balloon disposed over the marker bands.
22. The balloon delivery catheter apparatus of claim 16, further
comprising a handle received by a proximal end of the catheter
tubing, the handle comprising: a handle base defining a handle
lumen therethrough; a collet received at least partially in the
handle lumen at a distal end portion of the handle base, the collet
defining a collet lumen therethrough; and a handle head releasably
connected to the distal end portion of the handle base over the
collet, the handle head defining an aperture axially aligned with
the collet lumen and sized to receive the proximal end of the
catheter tubing therethrough and at least partially in the collet
lumen; wherein the handle lumen is in fluid communication with the
lumen of the received catheter tubing; and wherein movement of the
handle head toward the handle base causes constriction of the
collet about the received catheter tubing.
23. The balloon delivery catheter apparatus of claim 22, wherein
the collet comprises: a substantially tubular section having an
outer diameter less than or equal to a diameter of the handle
lumen; and a chuck attached to the substantially tubular section
and having an outer diameter larger than the .Iadd.diameter of the
.Iaddend.handle lumen, the chuck defining a chamfered surface
arranged to engage an opposing chamfered surface of the handle
base; wherein movement of the handle head toward the handle base
causes movement of the collet toward the handle base and the
chamfered surface of the handle base to exert a substantially
radially inward force on the opposing chamfered surface of the
chuck.
24. The balloon delivery catheter apparatus of claim 22, wherein
the handle head is threadably received by the distal end portion of
the handle base.
25. The balloon delivery catheter apparatus of claim 22, wherein
the handle further comprises a valve member disposed on a proximal
end portion of the handle base.
26. The balloon delivery catheter apparatus of claim 22, wherein
the handle further comprises a strain relief disposed on at least
one of the handle base and the handle head.
27. A balloon delivery catheter apparatus comprising: a catheter
tubing defining a lumen therethrough; a balloon disposed near a
distal end of the catheter tubing and moving between deflated and
inflated states; a core wire having a proximal end attached near
the distal end of the catheter tubing inside the lumen and
extending distally away and substantially co-axially with the
catheter tubing through the balloon to a distal free end; proximal
and distal balloon control bands concentrically arranged around
respective proximal and distal end portions of the balloon, each
balloon control band comprising an elastic material that expands
during inflation of the balloon and contracts upon deflation of the
balloon, the balloon control bands impeding expansion of the
proximal and distal end portions of the balloon and assisting
deflation of the balloon after balloon inflation; a coil disposed
around the core wire, the coil having a proximal end attached to at
least one of the distal end portion of the balloon and the distal
balloon control band; proximal and distal marker bands disposed on
the core wire near respective proximal and distal ends of the
balloon, the balloon disposed over the marker bands; a laser
activated low density polyethylene bonding portion abutting and
interposed between the coil and each of the distal end portion of
the balloon and the distal balloon control band, the laser
activated low density polyethylene bonding the coil and one or more
of the balloon and the distal balloon control band, the laser
activated low density polyethylene bonding portion having a first
state before laser activation and a second state after activation,
wherein the laser activated low density polyethylene bonding
portion is unbonded to the coil in the first state and the laser
activated low density polyethylene bonding portion is bonded to the
coil and extending into spaces defined by the coil in the second
state; and a balloon support tube co-axially disposed over the core
wire and the marker bands and within the balloon; wherein the
balloon control bands each have a diametric cross-section larger
than the balloon in its uninflated state and an unexpanded stent
received over the balloon to impede axial movement of the
unexpanded stent off of the balloon; and wherein the balloon
support tube impedes axial movement of the marker bands along the
core wire and prevents compression of the balloon below a threshold
diameter.
28. The balloon delivery catheter apparatus of claim 27, wherein
the proximal and distal balloon control bands are secured to the
respective proximal and distal end portions of the balloon.
29. The balloon delivery catheter apparatus of claim 27, wherein
the proximal end portion of the balloon and the proximal balloon
control band are both attached to the catheter tubing.
30. The balloon delivery catheter apparatus of claim 27, wherein
each balloon control band has a non-uniform cross-sectional
thickness along an axial direction of the balloon control band.
31. The balloon delivery catheter apparatus of claim 30, wherein
each balloon control band has first and second end portions, the
first end portion having a larger diametric cross-section than the
second end portion, the first end portion of each balloon control
band disposed adjacent to a received stent on the balloon.
32. The balloon delivery catheter apparatus of claim 27, wherein
the balloon and the balloon control bands are coaxially disposed
about the core wire.
33. The balloon delivery catheter apparatus of claim 27, wherein
the balloon control bands restrict expansion of at least the end
portions of the balloon to a threshold diameter.
34. The balloon delivery catheter apparatus of claim 27, wherein
the balloon support tube prevents compression of a received stent
over the balloon to a diameter less than a threshold un-deployed
stent diameter.
35. The balloon delivery catheter apparatus of claim 27, wherein
the balloon support tube has an axial length less than or equal to
an axial length of the balloon.
36. The balloon delivery catheter apparatus of claim 27, wherein
the balloon support tube is attached to the core wire so that a
proximal end of the balloon support tube is approximately
concentric with a proximal end of the balloon, and a distal end of
the balloon support tube is approximately concentric with a distal
end of the balloon.
37. The balloon delivery catheter apparatus of claim 27, wherein
the balloon support tube comprises a polyamide material.
38. The balloon delivery catheter apparatus of claim 27, wherein
the balloon support tube prevents an inner surface of the balloon
from contacting an outer radial surface of each of the marker
bands.
39. The balloon delivery catheter apparatus of claim 27, wherein
the coil extends beyond the distal end portion of the balloon.
40. The balloon delivery catheter apparatus of claim 27, further
comprising a handle received by a proximal end of the catheter
tubing, the handle comprising: a handle base defining a handle
lumen therethrough; a collet received at least partially in the
handle lumen at a distal end portion of the handle base, the collet
defining a collet lumen therethrough; and a handle head releasably
connected to the distal end portion of the handle base over the
collet, the handle head defining an aperture axially aligned with
the collet lumen and sized to receive the proximal end of the
catheter tubing therethrough and at least partially in the collet
lumen; wherein the handle lumen is in fluid communication with the
lumen of the received catheter tubing; and wherein movement of the
handle head toward the handle base causes constriction of the
collet about the received catheter tubing.
41. The balloon delivery catheter apparatus of claim 40, wherein
the collet comprises: a substantially tubular section having an
outer diameter less than or equal to a diameter of the handle
lumen; and a chuck attached to the substantially tubular section
and having an outer diameter larger than the .Iadd.diameter of the
.Iaddend.handle lumen, the chuck defining a chamfered surface
arranged to engage an opposing chamfered surface of the handle
base; wherein movement of the handle head toward the handle base
causes movement of the collet toward the handle base and the
chamfered surface of the handle base to exert a substantially
radially inward force on the opposing chamfered surface of the
chuck.
42. The balloon delivery catheter apparatus of claim 40, wherein
the handle head is threadably received by the distal end portion of
the handle base.
43. The balloon delivery catheter apparatus of claim 40, wherein
the handle further comprises a valve member disposed on a proximal
end portion of the handle base.
44. The balloon delivery catheter apparatus of claim 40, wherein
the handle further comprises a strain relief disposed on at least
one of the handle base and the handle head.
45. A method of manufacturing a medical device, the method
comprising: disposing a proximal end of a core wire near a distal
end of a catheter tubing inside a lumen defined by the catheter
tubing; disposing a balloon near the distal end of a catheter
tubing and over the core wire, the balloon being movable between
deflated and inflated states, the core wire extending distally away
and substantially co-axially with the catheter tubing through the
balloon to a distal free end; disposing proximal and distal balloon
control bands concentrically around respective proximal and distal
end portions of the balloon, each balloon control band comprising
an elastic material that expands during inflation of the balloon
and contracts upon deflation of the balloon, the balloon control
bands impeding expansion of the proximal and distal end portions of
the balloon and assisting deflation of the balloon after balloon
inflation; attaching a proximal end of a coil to at least one of
the distal end portion of the balloon and the distal balloon
control band, the coil extending around the core wire; bonding the
coil to each of the distal end portion of the balloon.[.,.].
.Iadd.and .Iaddend.the distal control band.[., and the balloon.].
using a laser activated low density polyethylene bonding portion,
the laser activated low density polyethylene bonding portion
existing in a first state where the bonding portion is unbonded to
the coil and a second state where the bonding portion is bonded to
the coil and extending into spaces defined by the coil; laser
activating the bonding portion from the first state to the second
state, thereby reshaping the bonding portion such that the bonding
portion is interposed between the coil and each of the distal end
portion of the balloon and the distal control band; and co-axially
disposing a balloon support tube over the core wire and within the
balloon; wherein the balloon support tube prevents compression of
the balloon below a threshold diameter; and wherein the balloon
control bands each have a diametric cross-section larger than the
balloon in its uninflated state and an unexpanded stent received
over the balloon to impede axial movement of the unexpanded stent
off of the balloon.
46. The method of claim 45, further comprising at least partially
securing the proximal and distal balloon control bands to the
respective proximal and distal end portions of the balloon.
47. The method of claim 45, further comprising affixing the
proximal end portion of the balloon and the proximal balloon
control band both to the catheter tubing.
48. The method of claim 45, further comprising shaping the balloon
control bands to have a non-uniform cross-sectional thickness along
an axial direction of the balloon control band.
49. The method of claim 45, wherein each balloon control band has
first and second end portions, the first end portion having a
larger diametric cross-section than the second end portion, the
method further comprising arranging the first end portion of each
balloon control band adjacent to a received stent on the
balloon.
50. The method of claim 45, further comprising extending the core
wire beyond the distal end portion of the balloon.
51. The method of claim 45, further comprising coaxially disposing
the balloon and the balloon control bands about the core wire.
52. The method of claim 45, wherein the balloon control bands
restrict expansion of at least the end portions of the balloon to a
threshold diameter.
53. A method of manufacturing a medical device, the method
comprising: disposing a proximal end of a core wire near a distal
end of a catheter tubing inside a lumen defined by the catheter
tubing; disposing a balloon near .[.a.]. .Iadd.the .Iaddend.distal
end of .[.a.]. .Iadd.the .Iaddend.catheter tubing, the balloon
being movable between deflated and inflated states, .Iadd.the
balloon having proximal and distal end portions, .Iaddend.the core
wire extending distally away and substantially co-axially with the
catheter tubing through the balloon to a distal free end; attaching
a proximal end of a coil to at least one of the distal end portion
of the balloon and a distal balloon control band, the coil
extending around the core wire; bonding the coil to each of the
distal end portion of the balloon.[.,.]. .Iadd.and .Iaddend.the
distal control band.[., and the balloon.]. using a laser activated
low density polyethylene bonding portion, the laser activated low
density polyethylene bonding portion existing in a first state
where the bonding portion is unbonded to the coil and a second
state where the bonding portion is bonded to the coil and extending
into spaces defined by the coil; laser activating the bonding
portion from the first state to the second state, thereby reshaping
the bonding portion such that the bonding portion is interposed
between the coil and each of the distal end portion of the balloon
and the distal control band; and co-axially disposing a balloon
support tube over the core wire and within the balloon; wherein the
balloon support tube prevents compression of the balloon below a
threshold diameter.
54. The method of claim 53, further comprising coining a length of
material to form the core wire.
55. The method of claim 53, wherein the balloon support tube
prevents compression of a received stent over the balloon to a
diameter less than a threshold un-deployed stent diameter.
56. The method of claim 53, further comprising sizing the balloon
support tube to have an axial length less than or equal to an axial
length of the balloon.
57. The method of claim 53, further comprising affixing the balloon
support tube to the core wire so that a proximal end of the balloon
support tube is approximately concentric with a proximal end of the
balloon, and a distal end of the balloon support tube is
approximately concentric with a distal end of the balloon.
58. The method of claim 53, wherein the balloon support tube
comprises a polyamide material.
59. The method of claim 53, further comprising: disposing proximal
and distal marker bands on the core wire near respective proximal
and distal ends of the balloon, the balloon disposed over the
marker bands; and co-axially disposing the balloon support tube
over the core wire and the marker bands and within the balloon;
wherein the balloon support tube impedes axial movement of the
marker bands along the core wire.
60. The method of claim 59, wherein the balloon support tube
prevents an inner surface of the balloon from contacting an outer
radial surface of each of the marker bands.
61. A method of manufacturing a medical device, the method
comprising: disposing a proximal end of a core wire near a distal
end of a catheter tubing inside a lumen defined by the catheter
tubing; disposing a balloon near the distal end of .[.a.].
.Iadd.the .Iaddend.catheter tubing and over the core wire, the
balloon being movable between deflated and inflated states, the
core wire extending distally away and substantially co-axially with
the catheter tubing through the balloon to a distal free end;
disposing proximal and distal marker bands on the core wire near
respective proximal and distal ends of the balloon, the balloon
disposed over the marker bands; and co-axially disposing a balloon
support tube over the core wire and the marker bands and within the
balloon; disposing proximal and distal balloon control bands
concentrically around respective proximal and distal end portions
of the balloon, each balloon control band comprising an elastic
material that expands during inflation of the balloon and contracts
upon deflation of the balloon, the balloon control bands impeding
expansion of the proximal and distal end portions of the balloon
and assisting deflation of the balloon after balloon inflation;
attaching a proximal end of a coil to at least one of the distal
end portion of the balloon and the distal balloon control band, the
coil extending around the core wire; bonding the coil to each of
the distal end portion of the balloon.[.,.]. .Iadd.and .Iaddend.the
distal control band.[., and the balloon.]. using a laser activated
low density polyethylene bonding portion, the laser activated low
density polyethylene bonding portion existing in a first state
where the bonding portion is unbonded to the coil and a second
state where the bonding portion is bonded to the coil and extending
into spaces defined by the coil; and laser activating the bonding
portion from the first state to the second state, thereby reshaping
the bonding portion such that the bonding portion is interposed
between the coil and each of the distal end portion of the balloon
and the distal control band; wherein the balloon support tube
prevents compression of the balloon below a threshold diameter and
impedes axial movement of the marker bands along the core wire; and
wherein the balloon control bands each have a diametric
cross-section larger than the balloon in its uninflated state and
an unexpanded stent received over the balloon to impede axial
movement of the unexpanded stent off of the balloon.
62. The method of claim 61, further comprising attaching a proximal
end of the coil to at least one of the distal end portion of the
balloon and the distal balloon control band.
63. The method of claim 61, further comprising securing the
proximal and distal balloon control bands to the respective
proximal and distal end portions of the balloon.
64. The method of claim 61, further comprising affixing the
proximal end portion of the balloon and the proximal balloon
control band both to the catheter tubing.
65. The method of claim 61, further comprising shaping the balloon
control bands to have a non-uniform cross-sectional thickness along
an axial direction of the balloon control band.
66. The method of claim 65, wherein each balloon control band has
first and second end portions, the first end portion having a
larger diametric cross-section than the second end portion, the
method further comprising arranging the first end portion of each
balloon control band adjacent to a received stent on the
balloon.
67. The method of claim 61, further comprising extending the core
wire beyond the distal end portion of the balloon.
68. The method of claim 61, further comprising coaxially disposing
the balloon and the balloon control bands about the core wire.
69. The method of claim 61, wherein the balloon control bands
restrict expansion of at least the end portions of the balloon to a
threshold diameter.
70. The method of claim 61, wherein the balloon support tube
prevents compression of a received stent over the balloon to a
diameter less than a threshold un-deployed stent diameter.
71. The method of claim 61, further comprising sizing the balloon
support tube to have an axial length less than or equal to an axial
length of the balloon.
72. The method of claim 61, further comprising affixing the balloon
support tube to the core wire so that a proximal end of the balloon
support tube is approximately concentric with a proximal end of the
balloon, and a distal end of the balloon support tube is
approximately concentric with a distal end of the balloon.
73. The method of claim 61, wherein the balloon support tube
comprises a polyamide material.
74. The method of claim 61, wherein the balloon support tube
prevents an inner surface of the balloon from contacting an outer
radial surface of each of the marker bands.
75. A method of treating vascular stenosis, the method comprising:
inserting into a vessel of a patient a portion of a balloon
delivery catheter apparatus, the balloon delivery catheter
apparatus comprising: a catheter tubing defining a lumen
therethrough; a balloon disposed near a distal end of the catheter
tubing and moving between deflated and inflated states; a core wire
having a proximal end attached near the distal end of the catheter
tubing inside the lumen and extending distally away and
substantially co-axially with the catheter tubing through the
balloon to a distal free end; proximal and distal balloon control
bands concentrically arranged around respective proximal and distal
end portions of the balloon, each balloon control band comprising
an elastic material that expands during inflation of the balloon
and contracts upon deflation of the balloon, the balloon control
bands impeding expansion of the proximal and distal end portions of
the balloon and assisting deflation of the balloon after balloon
inflation; a coil disposed around the core wire, the coil having a
proximal end attached to at least one of the distal end portion of
the balloon and the distal balloon control band; a laser activated
low density polyethylene bonding portion abutting and interposed
between the coil and each of the distal end portion of the balloon
and the distal balloon control band, the laser activated low
density polyethylene bonding the coil and one or more of the
balloon and the distal balloon control band, the laser activated
low density polyethylene bonding portion having a first state
before laser activation and a second state after activation,
wherein in the first state the bonding portion is unbonded to the
coil and in the second state the bonding portion is bonded to the
coil and extending into spaces defined by the coil; proximal and
distal marker bands disposed on the core wire near respective
proximal and distal ends of the balloon, the balloon disposed over
the marker bands; and a balloon support tube co-axially disposed
over the core wire and the marker bands and within the balloon;
wherein the balloon control bands each have a diametric
cross-section larger than the balloon in its uninflated state and
an unexpanded stent received over the balloon to impede axial
movement of the unexpanded stent off of the balloon; and wherein
the balloon support tube impedes axial movement of the marker bands
along the core wire and prevents compression of the balloon below a
threshold diameter; advancing the balloon across the vascular
stenosis; inflating the balloon to compress the vascular stenosis;
deflating the balloon; and removing the balloon delivery catheter
apparatus from the patient.
Description
TECHNICAL FIELD
This disclosure relates to balloon catheter delivery apparatuses
and methods for using and manufacturing the same.
BACKGROUND
Balloon deliver apparatuses, or angioplasty balloons, are useful
for treating maladies in patients that involve the patients'
vasculature. For example, angioplasty balloon dilation is sometimes
used for the treatment of stenosis, wherein a small balloon is
disposed at the location of the stenosis and inflated to expand the
stenosis in a vessel lumen and improve the vessel's patency.
Angioplasty balloons are also useful for deploying stents in a
patient's vasculature that maintain the vessel's locally expanded
state or patency and prevent restenosis. It is noted that coronary
stenting is believed to reduce restenosis rates in patients when
compared with conventional balloon dilation. Amer. J. Cardio. 2002,
90, 1187-1192.
In either balloon angioplasty or stenting procedures, angioplasty
balloons are typically used to expand a stenosis in a patient's
vasculature. In procedures including the deployment of a stent, the
angioplasty balloon may also expand and deploy the stent within the
patient's vasculature. These procedures are traditionally preceded
by the placement of a guidewire through the stenosis, which is
followed by angioplasty balloon dilation at the stenosis with a
balloon angioplasty catheter that has been advanced over the
guidewire. The balloon angioplasty catheter is then withdrawn from
the patient and a stent delivery system that includes the stent is
advanced over the guidewire, and the stent is then deployed at the
site of the dilated stenosis.
Conventional stenting procedures include the following steps:
1. Place coronary guidewire into wire introducer;
2. Load guidewire into guiding catheter;
3. Advance guidewire across lesion;
4. Remove wire introducer;
5. Load predilatation balloon angioplasty catheter onto
guidewire;
6. Advance balloon catheter into guiding catheter;
7. Cross lesion with predilatation balloon;
8. Dilate lesion with balloon;
9. Angiography;
10. Remove predilatation balloon catheter;
11. Load stent delivery system (SDS) onto guidewire;
12. Advance SDS into guiding catheter;
13. Cross lesion with SDS;
14. Deploy stent at high pressure;
15. Angiography; and
16. Remove delivery system.
Because of the complexity of the procedure, conventional stenting
often involves lengthy procedural times, prolonged exposure to
radiation, lengthy administration of contrast agents, and great
expense. J. Amer. Col. Cardio. 1999, 34, 1910-1915. Furthermore,
the balloon predilation followed by stent placement often leads to
major vascular trauma in a patient.
SUMMARY
The disclosure provides an apparatus and methods that improve the
treatment of stenosis in a patient when compared with conventional
stenting treatments. The apparatus and the methods of using the
apparatus reduce vascular trauma in a patient, reduce procedural
time, reduce a patient's exposure to radiation, reduce the
administration of a contrast agent, and reduce costs using direct
stenting procedures.
The disclosed apparatus and methods may concern direct stenting
procedures for treating stenosis. Direct stenting using the
apparatus and/or methods may generally involve the following
steps:
1. Placing a peel away introducer over distal end of stent delivery
system;
2. Loading a stent delivery system into a guiding catheter and
removing the peel away introducer;
3. Advancing the stent delivery system across lesion;
4. Dilating a balloon of the delivery system and deploying the
stent at high pressure;
5. Angiography; and
6. Removing the delivery system.
Thus, direct stenting using the apparatus and/or methods offers
fewer steps than conventional stenting; and consequently,
procedural times are often reduced by 20-30%, the patient's
radiation exposure (e.g., Fluoroscopy Time) is reduced by 20-30%,
and the procedural cost is often reduced by 22-35%. Some
implementations may provide some patients with a reduced incidence
of restenosis and/or a reduced MACE rate. It is also noted that the
omission of the predilation step in direct stenting is believed to
reduce vessel wall damage and distal embolization compared with
conventional stenting. See e.g., J. Amer. Coll. Cardio. 2008, 51,
1060-1065.
One aspect of the disclosure provides a balloon delivery catheter
that includes a catheter tubing having a balloon near the distal
end of the catheter tubing. The balloon includes a distal end, a
proximal end, and an intermediate segment. The balloon is nested
between a distal balloon control band and a proximal balloon
control band. A core wire extends throughout a portion of the
catheter and includes a proximal portion and a distal portion in
which the distal portion of the core wire includes a coiled section
that extends beyond the distal end of the balloon. In some
implementations, the balloon delivery catheter further includes a
stent disposed around the balloon such that when the balloon is
inflated the inflated balloon expands the stent so that a radius of
the stent is increased. In some examples, the catheter includes a
distal balloon control band having a portion (e.g., the proximal
end of the distal control band) that has a larger profile (e.g., a
larger diametric cross section) than that of the unexpanded stent,
so that when the balloon and stent are advanced to a stenosis site,
the distal balloon control band pushes through the stenosis leaving
a channel having a size sufficient for the stent. Moreover, the
larger profile distal balloon control band may prevent any of the
stent edges from catching on previously deployed stents thereby
improving stent crossing in a patient's vasculature. In
conventional catheter systems, the balloon material distal to the
stent can be compressed as it is advanced into the stenosis and the
distal edge of the stent can catch or engage a narrowed vessel wall
or occlusion as it passes through the stenosis. These problems are
advantageously avoided using the disclosed catheter, which includes
a stent and a distal balloon control band having a larger profile
than the stent, because the stent does not have and does not
develop any exposed edges during its advancement into the stenosis.
Consequently, the stent does not typically catch on the narrowed
vessel walls or occlusion causing the stenosis.
The details of one or more implementations of the disclosure are
set forth in the accompanying drawings and the description below.
Other aspects, features, and advantages will be apparent from the
description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
FIG. 1 is a side view of a balloon catheter delivery apparatus, in
which the distal shaft portion is shown in partial
longitudinal-sectional view for illustrative purposes.
FIG. 2 is a longitudinal-sectional view of a distal shaft portion
of the balloon catheter delivery apparatus of FIG. 1.
FIG. 3 is an enlarged view of a portion of the distal shaft portion
indicated by line 3 of FIG. 2.
FIG. 4 is an enlarged view of a portion of the distal shaft portion
indicated by line 4 of FIG. 2.
FIG. 5 is an enlarged view of a portion of the distal shaft portion
indicated by line 5 of FIG. 2.
FIG. 6 is an enlarged view of a portion of the distal shaft portion
indicated by line 6 of FIG. 2.
FIG. 7 is an enlarged view of a portion of the distal shaft portion
indicated by line 7 of FIG. 2.
FIG. 8 is a longitudinal-sectional view of an exemplary handle
portion of the balloon catheter delivery apparatus, wherein the
handle portion includes an optional stop cock.
FIG. 9 is an enlarged view of a portion of the handle portion
indicated by line 10 of FIG. 8.
FIG. 10 is a perspective view of an exemplary handle portion and a
proximal shaft portion of the balloon catheter apparatus of FIG.
1.
FIG. 11 is a longitudinal-sectional view of a distal shaft portion
of the balloon catheter apparatus in an undeployed state.
FIG. 12 is a cross-sectional illustration of the distal shaft taken
at about line 12 of FIG. 11 and viewed in a proximal direction in
accordance with an example embodiment of the invention.
FIG. 13 is a plot of distal output (in degrees) as a function of
proximal input (in degrees) for an exemplary balloon catheter
delivery apparatus.
FIG. 14 is a plot of back-out force as a function of track position
in an S-curve track, demonstrating that the apparatus is highly
maneuverable in a patient's vasculature.
Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
The present disclosure relates generally to a balloon catheter
delivery apparatus that is useful for treating stenosis in a
patient.
I. Definitions
As used herein, the terms "catheter" or "catheter tubing" are used
interchangeably and refer to a tube that sized and shaped to be
inserted into a body cavity, duct, or vessel. Some catheters are
formed of a distal portion and a proximal portion wherein the
proximal portion is a hypotube, and the distal portion is a distal
flexible tube. Catheters may have diameters of from about 0.3 mm to
about 2.4 mm and lengths of from about 70 cm to about 170 cm.
As used herein, the terms "catheter hypotube" or "hypotube" are
used interchangeably and refer to a small metallic tube that often
forms the proximal portion of a catheter. Hypotubes are generally
sized and shaped to be inserted into a body cavity, duct, or
vessel. For example, may have outer diameters of from about 0.3 mm
to about 2.4 mm, and lengths of from about 50 cm to about 140 cm
(e.g., from about 70 cm to about 120 cm). Metallic hypotubes may be
treated (e.g., coated, polished, sterilized, any combination
thereof, or the like) to improve its utility as a portion of a
catheter.
As used herein, a "distal flexible tube" is a component of a
catheter located distal to a proximal portion. In some examples,
the distal flexible tube has a greater flexibility than the
proximal portion of the catheter. In some implementations, the
distal flexible tube is formed from a polymer such as silicone
rubber. In other implementations, the distal flexible tube has a
diameter of from about 0.3 mm to about 2.4 mm, and a length of from
about 0.5 cm to about 20 cm (e.g., from about 1 cm to about 10
cm).
As used herein, the terms "core wire" and "guide wire" are used
interchangeably and refer to a small wire that extends from a
distal tip of a catheter hypotube. In many instances, the distal
tip of the core wire has a curved or rounded surface to inhibit its
tendency to pierce or dissect a blood vessel.
As used herein, the term "balloon" and "balloon member" are used
interchangeably and refer to a flexible inflatable container
capable of increasing its volume upon inflation with a fluid and
decreasing its volume upon deflation.
As used herein, "stainless steel" refers to any steel alloy with a
minimum of about 10.5% chromium content by mass. It is noted that
stainless steel may be coated or otherwise treated to enhance one
or more of its physical properties. For instance, stainless steel
may be coated with a polymer such as PTFE to reduce its coefficient
of friction or improve is chemical resistance.
As used herein, "PTFE" and "polytetrafluoroethylene" are used
interchangeably and refer to a synthetic fluoropolymer of
tetrafluoroethylene. One such polymer is known by the DuPont brand
name Teflon.
As used herein, "silicone rubber" refers to any rubber-like
material composed of silicone, carbon, hydrogen, or oxygen. In
several instances, silocone rubber comprises a Si--O--Si polymer
backbone. Exemplary silicone rubbers include polymethylsiloxane,
polyethylsiloxane, polypropylsiloxane, any combination thereof, or
the like.
As used herein, "depth marker", "optical marker", and "marker" are
used interchangeably and refer to optically visible marks that
identify a given length or desired location on the catheter
hypotube or the core wire. Some optical markers are observable in
X-Ray scans of the catheter hypotube or core wire on which they are
located. Other markers are optically observable by the human eye
under visible light conditions. Optical markers may include painted
markers or structural markers that attach to the catheter hypotube
or the core wire (e.g., bands, notches, blocks, or the like).
As used herein, "affix" and "affixed" refer to the attachment of
one object to another. Affixing includes bonding, welding,
crimping, or otherwise adhering or attaching one object to another
object.
II. Apparatus
The apparatus and methods offer several advantages over traditional
balloon angioplasty and conventional stenting, for example, by
providing a balloon delivery catheter that includes a catheter
tubing having a balloon near the distal end of the catheter tubing.
The balloon includes a distal end, a proximal end, and an
intermediate segment. The balloon can be nested between a distal
balloon control band and a proximal balloon control band. The
catheter may include core wire extending throughout a portion of
the catheter and including a proximal portion and a distal portion
in which the distal portion of the core wire includes a coiled
section that extends beyond the distal end of the balloon. The
catheter may reduce vasculature trauma experienced by a patient
when compared with conventional balloon angioplasty or conventional
stenting, because the proximal and distal balloon control bands
restrict longitudinal overexpansion of the balloon during
inflation. This restriction in overexpansion of the balloon
affected by the balloon control bands may reduce the trauma to the
patient's vasculature and reduce the incidence of restenosis.
Referring to FIGS. 13 and 14, the balloon delivery catheter may
provide improved control and flexibility, which provides improved
maneuverability through a patient's vasculature. FIG. 13
demonstrates that the disclosed apparatus can provide excellent
rotational responsiveness to a user's input rotation, and FIG. 14
demonstrates that the disclosed apparatus has excellent flexibility
and can be withdrawn from bends around a series of alternating
curves without the need of excessive force.
In some implementations, the balloon delivery catheter optionally
includes a stent disposed around a balloon such that when the
balloon is inflated, the inflated balloon expands the stent so that
a radius of the stent increases. In some examples, the distal
balloon control band includes at least a portion that has a greater
profile, i.e., diametric cross section DC.sub.A, than the
unexpanded stent disposed about the balloon. These implementations
may reduce the likelihood that the stent snags on a vessel wall or
other occlusion at the stenosis site, because the larger profile
distal control band pushes through the stenosis before the stent
and creates a channel of suitable size for accepting the stent.
Moreover, these implementations may reduce the likelihood that the
leading edge of the stent snags on a vessel wall, a previously
deployed stent, or other occlusion in the patient's vasculature,
because the larger profile distal balloon control band reduces or
altogether eliminates any exposed leading edges on the stent that
could catch on previously deployed stents or vessel wall in a
patient's vasculature. In addition, the constriction applied at the
ends of the balloon by the balloon control bands retract the
balloon to a minimum diameter so that the apparatus does not snag
the stent upon withdrawal of the apparatus from the patient.
A balloon delivery catheter apparatus may include an all-in-one
stent delivery system comprising a fixed guide wire and a catheter
including an elongate flexible hypotube having distal and proximal
shaft portions and an inflatable balloon to which a stent may
optionally be affixed thereto. The balloon may be in fluid
communication with the lumen of the flexible hypotube. In some
examples, the proximal end of the core wire is affixed to the
distal end of the proximal shaft portion of the catheter hypotube
and the distal tip of the core wire extends beyond the balloon. The
balloon has a proximal end attached to the distal section of the
hypotube and a distal end attached to the core wire at a location
proximal to the distal tip of the wire. The apparatus may include
balloon control bands that assist in stent deployment and/or vessel
expansion by constricting dilation of the balloon at its proximal
and distal ends, thereby encouraging the balloon midsection beneath
the stent (if a stent is affixed to the balloon) to inflate and
deploy at the middle before the ends expand. In embodiments
comprising the optional stent, the balloon control bands restrict
the overexpansion of the balloon and the stent affixed thereto at
their respective ends--an event that often causes trauma to vessel
walls. This restriction in overexpansion of the balloon caused by
balloon control bands may reduce the incidence of restenosis in the
patient. In addition, the constriction applied at the ends of the
balloon by the balloon control bands retract the balloon to a
minimum diameter so that the apparatus does not snag the stent upon
removal from the patient. In various examples, the profile of the
apparatus may be minimized not only by the balloon control bands,
but also by the various connections within the apparatus, many of
the components being directly bonded to one another, for example,
but not limited to, laser welding.
FIG. 1 provides a part side view, part longitudinal-sectional
illustrative view of a balloon catheter delivery apparatus 10,
which may also be referred to as a stent-on-a-wire (SOAW) delivery
catheter. The delivery apparatus 10 may be sterilized by an
ethylene oxide gas, radiation treatment (e.g., treatment with
e-beam or gamma radiation), sterilizing solution, any combination
thereof, or other sterilizing medium or procedure compatible with
the materials used in the balloon catheter delivery apparatus.
Although the foregoing description discloses a balloon catheter
delivery apparatus 10 that may be used for placing a stent S at,
for example, a stenosis V.sub.S of a vessel V in, for example, a
patient, (e.g., a human), other uses are possible. Accordingly, in
some implementations, the delivery apparatus 10 may be utilized to
treat, for example, ischemic heart disease. Further, the delivery
apparatus 10 may also find utility as an angioplasty catheter that
does not include a stent S or the stent S may be removably affixed
to the balloon catheter delivery apparatus 10.
The delivery apparatus 10 may be used for placing an angioplasty
balloon catheter through a stenosis V.sub.S. The structure of
delivery apparatus 10 may enhance, for example, the pushability of
an angioplasty catheter that is utilized for dilating a stenosis
V.sub.S.
A distal shaft portion 16 of the delivery apparatus 10 is shown in
a slightly expanded or inflated state in the examples shown in
FIGS. 1-7. The examples shown in FIGS. 11 and 12 illustrate the
distal shaft portion 16 of the delivery apparatus 10 prior to
inflation.
As seen in FIG. 1, an axis A-A extends through the delivery
apparatus 10 from a proximal end 10a to a distal end 10b. The
delivery apparatus 10 may optionally include a handle 12 having a
proximal end 12a and a distal end 12b. The delivery apparatus 10
may also include a catheter hypotube that comprises a proximal
shaft section 14 having a proximal end 14a and a distal end 14b.
The catheter hypotube also comprises a proximal distal shaft
portion 16 having a proximal end 16a and a distal end 16b.
The handle 12, the proximal shaft portion 14, and/or all or part of
the distal shaft portion 16 may form a lumen or passage allowing
for inflation of a balloon 28 of the delivery apparatus 10. The
proximal end 14a of the proximal shaft portion 14 may be fixedly or
removably connected to the distal end 12b of the handle 12. In some
examples, the distal end 12b of the handle 12 is approximately 145
centimeters from the distal end 10b of the delivery apparatus 10.
Moreover, the distal end 14b of the proximal shaft portion 14 may
be fixedly or removably connected proximate to the proximal end 16a
of the distal shaft portion 16. In some examples, the distal end
14b of the proximal shaft portion 14 is disposed within the distal
shaft portion 16 proximate to the proximal end 16a of the distal
shaft portion 16 (see e.g., FIG. 4). Alternatively, the proximal
end 16a of the distal shaft portion 16 may be disposed within the
distal end 14b of the proximal shaft portion 14. Other ways of
connecting the handle 12, the proximal shaft portion 14 and the
distal shaft portion 16 are possible as well.
In some implementations, the delivery apparatus 10 functions in a
manner that permits the stent, S, to be removably attached to the
distal shaft portion 16. Further, the distal shaft portion 16 may
retain the stent S and later deploy the stent S at, for example, a
stenosis V.sub.S of a vessel V of a human body. Upon deployment of
the stent S, the delivery apparatus 10 may be said to no longer
include or retain the stent S.
The handle 12 and the proximal shaft portion 14 may function in a
manner that permits communication of a fluid F from a fluid source
F.sub.S to the distal shaft portion 16. In some examples, the
handle 12 functions in a manner that permits or denies movement of
the fluid F into or out of the distal shaft portion 16 by way of
the proximal shaft portion 14. The fluid F may be pressurized to
between about 8 and about 16 atmospheres.
Referring to FIGS. 1 and 2, in some implementations, the distal
shaft portion 16 includes an axial core wire 18, a capped distal
tip member 20, a coil member 22, a distal balloon control band 24,
a distal bonding portion 26, a balloon 28, a distal marker band 30,
a proximal marker band 32, a proximal balloon control band 36, a
distal shaft mounting portion 38 and a proximal shaft mounting
portion 40.
Referring now to FIGS. 3 and 4, the core wire 18 may include a
radial outer surface 42, a first, axial distal end segment 44 and a
distal end surface 48 (see e.g., FIG. 3) and a second, axial
proximal end segment 46 and a distal end surface 52 (see e.g., FIG.
4). As shown in FIGS. 1 and 2, in some examples, the distal end
segment 44 of the core wire 18 may extend beyond the distal end of
the balloon control band 24.
The radial outer surface 42 may define the core wire 18 to include
a substantially circular cross-section having an outer diameter D1.
The radial outer surface 42 is not limited, however, to defining
the core wire 18 to include a substantially circular cross section
and the core wire 18 may include any desirable cross-sectional
shape, such as, for example, a square, rectangular, hexagonal
cross-section or the like. In addition, the shape of the core wire
18 may not be uniform. For example, a portion of the core wire 18
within the capped distal tip member 58 may be substantially
circular, while a portion of the core wire 18 that lies within the
coil member 22 may be rectangular. The core wire 18 may taper as it
extends axially from the proximal end 10a to the distal end 10b.
The core wire 18 may also be coined. The tapering and coining of
the core wire 18 may permit the core wire 18 to be flexible and/or
shapeable.
As seen in FIGS. 2 and 3, the first axial, distal, end segment 44
of the core wire 18 may define, in part, a distal end 10b of the
delivery apparatus 10. The first, axial distal end segment 44 may
terminate in a rounded, substantially dome-shaped distal end
surface 48. As seen in FIGS. 2 and 4, the second axial, proximal,
end segment 46 of the core wire 18 may be located axially away from
the distal end 10b of the delivery apparatus 10 at any desirable
axial distance/length. The second axial proximal end segment 46 may
terminate in a proximal end surface 52. The proximal end surface 52
may be connected directly to an inner wall 184 of the proximal
shaft portion 14 by any suitable method, such as, but not limited
to, laser welding.
Referring to FIG. 3, in some implementations, the capped distal tip
member 20 defines, in part, the distal end 10b of the delivery
apparatus 10. For example, the capped distal tip member 20 may be
formed from or an integral part of the core wire 18, or,
alternatively, the capped distal tip member 20 may be formed as a
separate component, as illustrated, from that of the core wire
18.
The capped distal tip member 20 may define a cup-shaped body 58
having a substantially U-shaped longitudinal section. The
cup-shaped body 58 may include a distal, dome-shaped outer axial
surface 60 and a proximal, recessed axial surface 62 that
corresponds to and may be axially disposed adjacent the rounded,
substantially dome-shaped axial/distal end surface 48 of the core
wire 18. In some examples, the recessed axial surface 62 is
heat-bonded with the axial/distal end surface 48 of the core wire
18. In additional examples, the distal portion of the core wire 18
is melted, with a laser welder or by other suitable means, to form
the integral capped distal tip member 20.
The proximal, recessed axial surface 62 of the capped distal tip
member 20 may extend axially toward the proximal end 10a of the
delivery apparatus 10 to define a substantially annular (in
cross-section) axial proximal end surface 64 around the radial
outer surface 42 of the core wire 18. The substantially annular
axial proximal end surface 64 may extend to an outer radial side
surface 66 that extends to the distal, dome-shaped outer axial
surface 60. The connection of the substantially annular, axial end
surface 64 and the outer radial side surface 66 may define a
diameter D2 of the capped distal tip member 20. In some examples,
the diameter D2 may be greater than the diameter D1 of core wire
18.
The coil member 22 may be composed of, but is not limited to, a
platinum-iridium (Pt/Ir) material in whole or in part. As shown in
FIG. 3, the coil member 22 may generally define an inner surface 23
and an outer surface 25. In some examples, the inner surface 23
defines a passage 27 with a diameter that is approximately the same
as, but slightly greater than the diameter D1 of core wire 18, to
permit the core wire 18 to extend through the passage 27 so that
the coil member 22 may be arranged concentrically relative to the
core wire 18. Moreover, the coil member 22 may be radiopaque.
The outer surface 25 of the coil member 22 may define the coil
member 22 to have an outer diameter substantially equal to or less
than the diameter D2 of the capped distal tip member 20. The outer
diameter D2 of the coil member 22 may be approximately, but is not
limited to, 0.012 inches. In some examples, the coil member 22 has
any desirable axial length, for instance, but not limited to,
approximately 22 millimeters. As shown in FIG. 5, in some
implementations, the proximal portion of the coil member 22 may be
stretched to create a series of spaces 22a between individual
coils.
Referring back to FIGS. 2 and 3, the coil member 22 may be disposed
substantially adjacent to either of or both of the radial outer
surface 42 of the core wire 18 and the substantially circular,
axial end surface 64 of the capped distal tip member 20. The coil
member 22 may be fixedly connected or joined to one or more of the
radial outer surface 42 and the substantially annular, axial end
surface 64. The coil member 22 may be connected or joined to either
or both surfaces 42, 64 via any suitable methodology such as, for
example, a laser-welding operation. In some examples, the outer
surface 25 of the coil member 22 is heat-bonded with an inner
surface 130 of the distal balloon control band 24, shown in FIG. 5.
The inner surface 130 of the distal balloon control band 24 may
extend into the spaces 22a (not shown).
The cup-shaped body 58 of the capped distal tip member 20 may help
to functionally prevent the coil member 22 from axially moving
and/or radially separating (i.e., uncoiling) along the core wire
18. Further, the geometry of the rounded, dome-shape surface 60 of
the capped distal tip 20 may functionally provide the delivery
apparatus 10 with a radiused, atraumatic tip.
Referring to FIG. 5, the distal bonding portion 26 may include, but
is not limited to, a substantially cylindrical body, sleeve or tube
68 having an inner radial surface 70 and an outer radial surface
72. The outer radial surface 72 may define a diameter D3. The inner
radial surface 70 may define a diameter that may be approximately
the same as, but slightly greater than diameter D2 (see e.g., FIG.
3).
The distal bonding portion 26 may include a low-density
polyethylene (LDPE) material or the like. In some examples, the
distal bonding portion 26 is utilized to bond the coil member 22
with one or more of the balloon 28 and the distal balloon control
band 24, which may prevent twisting of the balloon 28 on the core
wire 18. Bonding between other components, such as the coil member
22 and the distal balloon control band 24 and the distal bonding
portion 26 or other reshaping of the bonding portion 26 may be
activated by, for example, treatment of the bonding portion 26 with
a laser. The distal bonding portion 26 may extend into the spaces
22a. In some examples, the coil member 22 is stretched to permit
the distal bonding portion 26 to extend into the spaces 22a.
The substantially cylindrical tube 68 may be concentrically
arranged relative to the core wire 18 and the coil member 22 such
that one or more of the core wire 18 and the coil member 22 extends
through a passage 74 defined by the inner radial surface 70 of the
substantially cylindrical tube 68 of the distal bonding portion 26.
The inner radial surface 70 may be disposed adjacent to the outer
radial surface 25 of the coil member 22.
Referring to FIG. 6, one or more of the distal shaft mounting
portion 38 and the proximal shaft mounting portion 40 may include,
but are not limited to, a polymeric material such as a polyamide
material. A proximal end of the distal shaft mounting portion 38
may be heat-bonded to a distal end of the proximal shaft mounting
portion 40. Although the distal and proximal shaft mounting
portions 38, 40 may include a polymeric material in some
embodiments, the durometer (i.e., the hardness/softness) of the
polymeric material may not necessarily be the same between or
within the shaft mounting portions 38, 40. For instance, the
hardness/softness of the proximal shaft portion 14, proximal shaft
mounting portion 40, and the distal shaft mounting portion 38 can
each be selected such that the proximal shaft portion 14 is more
rigid than the proximal shaft mounting portion 40 and the distal
shaft mounting portion 38, and the proximal shaft mounting portion
40 is more flexible than the proximal shaft portion 14, but less
flexible than the distal shaft mounting portion 38. In this
configuration, the proximal shaft portion 14 provides rigidity to
the apparatus and the proximal shaft mounting portion 40 and the
distal shaft mounting portion 38 provide sufficient flexibility to
navigate coronary or other vessel anatomy as the distal shaft
portion 16 is positioned for deployment.
Figures illustrating the proximal shaft portion 14, the proximal
shaft mounting portion 40, the distal shaft mounting portion 38 and
the distal shaft portion 16 are not drawn to scale and are merely a
convenient representation of those components. The relative lengths
of these components can vary as necessary to provide an apparatus
that can be used to navigate coronary or other vessel anatomy. For
instance, the relative lengths of proximal shaft mounting portion
40 and the distal shaft mounting portion 38 can be approximately 15
centimeters and 35 centimeters, respectively.
As illustrated in FIG. 6, the distal shaft mounting portion 38 may
include, but is not limited to, a substantially cylindrical body,
sleeve or tube 76 having an inner radial surface 78 and an outer
radial surface 80, an axial distal end surface 82 and an axial
proximal end surface 84. A passage 90 that may be defined by the
inner radial surface 78 may have an inner diameter D6 that extends
axially through the distal shaft mounting portion 38 from the axial
proximal end surface 84 to the axial distal end surface 82. The
distal shaft mounting portion 38 may be concentrically arranged
relative to the core wire 18 such that the core wire 18 axially
extends through the passage 90.
In some implementations, a proximal portion of the proximal balloon
control band 36 is bonded to the outer radial surface 80 of a
distal end of the distal shaft mounting portion 38, by any suitable
method, such as by laser welding. The area of the outer radial
surface covered by the proximal portion of the proximal balloon
control band 36, i.e., area 86, may extend part or all of the way
over the outer radial surface 80 of distal shaft mounting portion
38. The distal portion of proximal balloon control band 36 may
extend radially around the proximal portion of balloon 28. The
distal portion of the proximal balloon control band 36 may be made
of a material that will stretch as axial chamber 174 as defined by
balloon 28 is inflated and snap back or relax into its initial
position when axial chamber 174 as defined by balloon 28 is
deflated, thereby helping to collapse the balloon 28 and minimize
the profile of the apparatus following balloon 28 deflation. In
some examples, a proximal bonding portion may secure the proximal
balloon control band 36 to the distal end of the distal shaft
mounting portion 38 (not shown).
Referring to FIGS. 2 and 5-7, the balloon 28 may include, but is
not limited to, for example, a nylon material. The balloon 28 may
include a distal segment 106 (see e.g., FIG. 5), an intermediate
segment 108 (see e.g., FIG. 7) and a proximal segment 110 (see
e.g., FIG. 6) collectively defining an inner surface 112 and an
outer surface 114 of the balloon 28.
Referring to FIG. 5, in some implementations, a portion 116 of the
inner surface 112 of the distal segment 106 of the balloon 28 may
be arranged adjacent to a portion 118 of the outer radial surface
72 of the distal bonding portion 26. Similarly, referring to FIG.
6, in some implementations, a portion 120 of the inner surface 112
of the proximal segment 110 of the balloon 28 may be arranged
adjacent to the outer radial surface 80 of the distal shaft
mounting portion 38. The inner surface 112 of the portion 120 of
the balloon 28 may be bonded to the distal end of distal shaft
mounting portion 38, by, for instance, but not limited to laser
welding, thereby minimizing the profile of apparatus 10.
With further reference to FIG. 5, the distal balloon control band
24 may include a distal segment 124, an intermediate segment 126
and a proximal segment 128 that collectively define an inner
surface 130 and an outer surface 132 of the distal balloon control
band 24. In some examples, the outer surface 132 of distal balloon
control band 24 generally defines the distal balloon control band
24 to form a conical outer surface tapering in the distal
direction.
The distal segment 124 of the distal balloon control band 24 may be
arranged concentrically with respect to the core wire 18 and the
coil member 22. The inner surface 130 may define the distal balloon
control band 24 to include a passage 134 that permits one or more
of the core wire 18, the coil member 22, the distal bonding portion
26, and the balloon 28 to axially extend through the distal control
band 24.
The passage 134 may include a constant or a non-constant diameter
(e.g., creating a tapering, widening, constricting, and/or
expanding passage 134) for one or more of the segments 124, 126,
and 128. For instance, the passage 134 may decrease in diameter, as
shown in FIG. 5, as the distal balloon control band 24 extends from
the proximal end 10a toward the distal end 10b of the delivery
apparatus 10.
In some examples, one or more of the core wire 18, the coil member
22 and the distal bonding portion 26 axially extend through the
passage 134 proximate to one or more of the distal segment 124 and
the intermediate segment 126 of the distal balloon control band 24.
The inner surface 130 of the distal segment 124 of the distal
balloon control band 24 may be disposed substantially adjacent and
attached to one or more of the outer surface 25 of the coil member
22 and a portion 136 of the outer surface 72 of the distal bonding
portion 26.
The intermediate segment 126 of the distal balloon control band 24
may be arranged concentrically with respect to one or more of the
core wire 18, the coil member 22, the distal bonding portion 26 and
a portion of the distal segment 106 of the balloon 28. The inner
surface 130 of the intermediate segment 126 of the distal balloon
control band 24 may be disposed adjacent to a portion 138 of the
outer surface 114 of the distal segment 106 of the balloon 28. The
portion 138 can be referred to as a distal step portion or a distal
tubular portion of the balloon 28.
The proximal segment 128 of the distal balloon control band 24 may
be arranged concentrically with respect to one or more of the core
wire 18, a portion of the axial length of the coil member 22, and a
portion of the distal segment 106 of the balloon 28. The inner
surface 130 of the proximal segment 128 of the distal balloon
control band 24 may be disposed adjacent to a portion 140 of the
outer surface 114 of the distal segment 106 of the balloon 28. The
portion 140 may be referred to as a distal ramp portion or distal
conical portion of the balloon 28. The distal conical portion 140
may be connected to the distal tubular portion 138 of the balloon
28.
Referring to FIG. 6, the proximal balloon control band 36 may
include a distal segment 144, an intermediate segment 146 and a
proximal segment 148 collectively defining an inner surface 150 and
an outer surface 152. The outer surface 152 of the proximal balloon
control band 36 may define the proximal balloon control band to
include a proximal outer conical portion, tapering in the proximal
direction.
The distal segment 144 of the proximal balloon control band 36 may
be arranged concentrically with respect to one or more of the core
wire 18 and a portion 154 of the balloon 28. A portion 156 of the
inner surface 150 of the proximal balloon control band 36 may be
disposed substantially adjacent and attached to a portion 158 of
the outer surface 114 of the proximal segment 110 of balloon 28.
The portion 158 can be referred to as a proximal ramp portion or
the proximal conical portion of the balloon 28.
An intermediate segment 146 of the proximal balloon control band 36
may be arranged concentrically with respect to one or more of the
core wire 18, the distal shaft mounting portion 38 and the proximal
segment 110 of the balloon 28. A portion 160 of the inner surface
150 of the proximal balloon control band 36 may be disposed
adjacent a portion 162 of the outer surface 114 of the proximal
segment 110 of the balloon 28. The portion 162 can be referred to
as a proximal tubular portion of the balloon 28. The proximal
conical portion 158 of the balloon 28 may be connected to the
proximal tubular portion 162 of the balloon 28.
The proximal segment 148 of the proximal balloon control band 36
may be arranged concentrically with respect to one or more of the
core wire 18, a portion 120 of the balloon 28, and a portion 170 of
the distal shaft mounting portion 38. A portion 164 of the inner
surface 150 of the proximal segment 148 of the proximal balloon
control band 36 may be disposed substantially adjacent to the
portion 170 of the outer radial surface 80 of the distal shaft
mounting portion 38.
The proximal balloon control band 36 may define an axial passage
171 that permits one or more of the core wire 18, the proximal
segment 110 of the balloon 28, and the distal shaft mounting
portion 38 to axially extend therethrough. Further, the passage 171
may include a constant or non-constant diameter for one or more
segments 144, 146, 148 of the proximal balloon control band 36
and/or may increase in diameter as the proximal balloon control
band 36 extends from the proximal end 10a toward the distal end 10b
of the delivery apparatus 10.
The proximal control bands 36 and distal balloon control bands 24
may apply pressure to the proximal segments 110 and the distal
segment 106 of the balloon 28. When fluid F moves into the balloon
28, causing dilation of the balloon 28, the pressure applied by the
proximal and distal balloon control bands 36, 24 at the proximal
and distal segments 110, 106 of the balloon 28 encourages inflation
at the intermediate segment 108 of the balloon 28 first relative to
the ends. This improves uniform stent deployment by promoting
uncrimping of the stent S at its middle rather than at the distal
and proximal ends of the stent S, thereby minimizing over expansion
at the ends of the stent S and/or preventing vessel tissue trauma
distal and/or proximal to the deployed stent S and area of
stenosis. In addition, the pressure applied by the proximal and
distal balloon control bands 36, 24 to the proximal and distal
segments 110, 106 of the balloon 28 may assist with balloon
deflation after stent deployment. As the fluid F is removed from
the apparatus 10, the pressure applied by the balloon control bands
36, 24 assists in collapsing the proximal and distal balloon
segments 110, 106. This minimizes the profile of the balloon 28 so
that it can be removed from the vessel V without snagging the
vessel wall or the deployed stent S.
FIG. 7 depicts an exemplary intermediate segment 108 of the balloon
28 and a portion of the stent S. In some implementations, the stent
S defines an inner radial surface S.sub.RI and an outer radial
surface S.sub.RO. The inner radial surface S.sub.RI of stent S may
be disposed/stowed substantially adjacent to the outer surface 114
of the balloon 28 before/during the axial carrying/delivery of the
stent S within the vessel V. In some examples, the inner radial
surface S.sub.RI of the stent S is crimped onto the outer surface
114 of the balloon 28.
The intermediate segment 108 of the balloon 28 may also be referred
to as an intermediate tubular portion of the balloon 28. The outer
surface 114 of the intermediate tubular portion 108, taken together
with the outer surface S.sub.RO of stent S may have a generally
constant diameter D7. The intermediate tubular portion 108 may be
arranged between and connect the distal and proximal conical
portions of the balloon 28.
The balloon 28 may be expanded from a retracted orientation as
shown in the figures to an expanded/inflated orientation (not
shown). The expansion/inflation of the balloon 28 may be caused by
the received fluid F (see e.g., FIG. 1), which may be moved into an
axial chamber 174 of the balloon 28 as defined by its inner surface
112. In some examples, the fluid F is prevented from leaking into
the vessel V by a seal between the distal and proximal balloon
member segments 106, 110 and the distal and proximal balloon
control bands 24, 36 and/or the distal bonding portion 26 and the
shaft mounting portion 38. Movement of the fluid F into the axial
chamber 174 may be permitted by the handle 12 and the proximal
shaft portion 14.
When the balloon 28 is expanded/inflated, the outer surface 114 of
the balloon 28 imparts a radially, outwardly directed force to the
inner radial surface S.sub.RI of the stent 5, such that the outer
diameter D7 of the stent S is increased to a diameter that is
greater than the diameter D7 at insertion of the apparatus 10 and
the stent S is said to be moved to a deployed orientation.
Deployment of the stent S may ultimately result in the outer radial
surface S.sub.RO of the stent S imparting a radially outwardly
directed force to the stenosis V.sub.S of the vessel V.
Upon placing the stent S adjacent to and against the stenosis
V.sub.S of the vessel V, the fluid F may be removed from the axial
chamber 174 of the balloon 28 such that the outer surface 114 of
the balloon 28 is retracted radially away from the stent S and
stenosis V.sub.S of the vessel V. When the balloon 28 is moved from
the expanded/inflated orientation back to the
retracted/non-inflated orientation, the inner radial surface
S.sub.RI of the stent S may remain in place adjacent to and against
the stenosis V.sub.S of the vessel V and be no longer in contact
with any portion of the delivery apparatus 10. The distal balloon
control band 24 and the proximal balloon control band 36 may
include an elastic and/or rigid materials that assist in the
forcing of the fluid F out of the balloon 28, such that the balloon
28 may be collapsed/retracted to its non-inflated orientation.
Referring now to FIGS. 2 and 6, the second axial/proximal end 84 of
the distal shaft mounting portion 38 may be disposed adjacent to
and connected/joined to a first axial/distal end 176 of the
proximal shaft mounting portion 40. As shown in FIG. 6, the core
wire 18 may extend toward the proximal end 10a of the delivery
apparatus 10, through the passage 90 of the distal shaft mounting
portion 38 and into a passage 178 that may be defined a first inner
radial surface 180 of the proximal shaft mounting portion 40. The
passage 178 may define an inner diameter that is approximately
equal to the diameter D6.
Referring to FIG. 2 and the expanded view in FIG. 4, the core wire
18 may extend further toward the proximal end 10a of the delivery
apparatus 10 and through the passage 178 such that the second,
axial proximal end segment 46 of the core wire 18 may be disposed
within or proximate to a passage 182 of the distal end 14b of the
proximal shaft portion 14. The length of passage 182 containing the
core wire 18, i.e., the passage 202, may be any suitable distance,
allowing for improved attachment and reduced kinking (where
proximal shaft portion 14 comprises a catheter) of the proximal
shaft portion 14 near the site of attachment to the distal shaft
portion 16. In some embodiments, the passage 182 may be defined by
an inner surface 184 of the proximal shaft portion 14.
One or more of the second axial end segment 46 of the core wire 18
and an axial/proximal end surface 186 of the proximal shaft
mounting portion 40 permits the distal shaft portion 16 to be
connected to the proximal shaft portion 14. In some examples, one
or more of the axial/proximal end surface 186 of the proximal shaft
mounting portion 40 may be disposed adjacent and connected/joined
to a first axial/distal end surface 188 of the proximal shaft
portion 14.
A second inner radial surface 190 of the proximal shaft mounting
portion 40 may define an inner diameter, D8. In some examples, an
outer radial surface 192 of the proximal shaft portion 14 may
include a diameter that is approximately the same as but less than
the diameter D8. The second inner radial surface 190 of the
proximal shaft mounting portion 40 may be disposed adjacent to and
connected/joined to the outer radial surface 192 of the proximal
shaft portion 14.
Referring to FIG. 4, a portion of the core wire 18 near the
proximal end 52 can be connected to the inner surface 184 of the
proximal shaft portion 14, by any suitable method, such as, for
example, laser welding.
FIG. 8 depicts an exemplary arrangement of the handle 12, the
proximal shaft portion 14 and the proximal end 16a of the distal
shaft portion 16. In some implementations, the proximal shaft
portion 14 is ultra-violet (UV) adhesive-bonded to the handle
12.
As seen in FIGS. 8-10, the handle 12 may include a docking torque
apparatus 206, which may include a base portion 208, a collet
portion 210, and a head portion 212. The base portion 208 and the
head portion 212 may include an acrylonitrile butadiene styrene
(ABS) material. The collet portion 210 may include a brass
material. In some examples, where the handle comprises two pieces,
the collet portion 210 and the cylindrical socket portion 224 are
integral, i.e., combined to form a unitary piece.
Referring to FIG. 9, the base portion 208 may include a first
axial/distal end 214, a second axial/distal end 216, a first
axial/proximal end 218 and a second axial/proximal end 220. The
base portion 208 may include a substantially cylindrical sleeve
portion 222 and a substantially cylindrical socket portion 224. The
substantially cylindrical sleeve portion 222 may be integrally
formed with the substantially cylindrical socket portion 224.
The substantially cylindrical sleeve portion 222 may extend axially
from the first axial/proximal end 218 to the second axial/distal
end 216. The substantially cylindrical socket portion 224 may
extend axially from the second axial/distal end 216 to the first
axial/distal end 214.
The base portion 208 may include an inner radial surface 226 that
may define an axial passage 228 with an internal diameter D9. The
collet portion 210 may include a substantially tubular sleeve
portion 230 connected to a chuck portion 232. The substantially
tubular sleeve portion 230 may define the collet portion 210 to
include a first proximal end surface 234 connected to a first outer
radial surface 236 that is connected to a second proximal end
surface 238 of the chuck portion 232. The second proximal end
surface 238 of the chuck portion 232 may be connected to a second
outer radial surface 240 of the chuck portion 232 that is connected
to a distal end surface 242 of the chuck portion 232. The
substantially tubular sleeve portion 230 and the chuck portion 232
may define an inner radial surface 244 that defines an axial
passage 246 that extends axially from the first proximal end
surface 234 to the distal end surface 242.
The first outer radial surface 236 of the collet portion 210 may
include a diameter approximately equal to but less than the
diameter D9 of the axial passage 228 of the base portion 208. The
axial passage 246 of the collet portion 210 may include an inner
diameter that may be approximately equal to but slightly greater
than the outer diameter D8 of the proximal shaft portion 14.
The head portion 212 may include a U-shaped cross-section having a
first inner radial surface 248, a second inner radial surface 250,
an axial/proximal surface 252 and an axial/distal surface 254. The
first inner radial surface 248 may include a diameter D10 that may
be approximately similar to, but slightly greater than, an outer
diameter of the substantially cylindrical socket portion 224 of the
base portion 208. The second inner radial surface 250 may define
the head portion 212 to include a passage 256 that is approximately
the same as, but slightly greater than, the outer diameter D8 of
the proximal shaft portion 14.
The substantially tubular sleeve portion 230 of the collet portion
210 may be axially disposed within the axial passage 228 of the
substantially cylindrical socket portion 224 such that the second
proximal end surface 238 of the chuck portion 232 may be arranged
substantially adjacent/proximate/opposingly facing a
chamfered/conical surface 258 of the first axial/distal end 214 of
the substantially cylindrical socket portion 224.
The first inner radial surface 248 of the head portion 212 may
include a threaded surface 260 that connectably interfaces with a
correspondingly-threaded surface 262 formed on an outer radial
surface 264 of the substantially cylindrical socket portion 224.
The threaded connected of the head portion 212 and the
substantially cylindrical socket portion 224 of the base portion
208 permits the head portion 212 to be axially movable according to
the direction of arrows, X (i.e., axially toward the distal end
10b), X' (axially toward the proximal end 10a), relative one or
more of the base portion 208, collet portion 210 and the proximal
end 14a of the proximal shaft portion 14.
As seen in FIG. 9, the proximal shaft portion 14 may be axially
inserted through the passage 256 of the head portion 212 and into
the axial passage 246 of the collet portion 210. As such, upon
axially moving the head portion 212 according to the direction of
the arrow, X', an axial/proximal surface 266 of the head portion
212 may come into contact with the distal end surface 242 of the
chuck portion 232 such that the second proximal end surface 238 of
the chuck portion 232 may come into contact with the
chamfered/conical surface 258 of the first axial/distal end 214 of
the substantially cylindrical socket portion 224.
As the second proximal end surface 238 comes into contact with the
chamfered/conical surface 258, the axial passage 246 of the collet
portion 210 at least proximate to the chuck portion 232 may be
radially reduced such that the inner radial surface 244, at least
proximate to the chuck portion 232, may engage, grip, /or "bite
into" a portion 267 of the outer radial surface 192 proximate to at
least the proximal end 14a of the proximal shaft portion 14. The
engagement of the chuck portion 232 and the proximal end 14a of the
proximal shaft portion 14 may provide a frictional,
axially-selective connection of the handle 12 and the proximal
shaft portion 14.
Referring to FIGS. 8-10, the handle 12 may also include a handle
body 268, an optional stopcock 270, and a strain relief member 272.
The handle body 268 may axially extend from the proximal end 10a
toward the distal end 10b of the delivery apparatus 10 to define a
nose portion 274 that is press-fitted to the strain relief member
272. The strain relief member 272 may be axially connected to one
or more of the first axial/proximal end 218 and the second
axial/proximal end 220 of the base portion 208.
The optional stopcock 270 may be inserted through a radial passage
276 formed in the handle body 268. In some examples, the optional
stopcock 270 may be press-fitted to the handle body 268 such that
the stopcock 270 may be rotatably connected to the handle body 268
(e.g., to permit the stopcock 270 to be able to turn 90.degree. in
a "quarter-turn" orientation relative to the handle body 268 and
within the radial passage 276). The optionally integrated stopcock
may effectuate a time savings because the user will not have to
assemble the stopcock as an additional part with the delivery
apparatus 10.
The stopcock 270 may include an axially-alignable passage 278.
Rotation of the stopcock 270 permit the stopcock to act as a valve
member to permit or deny movement of the fluid, F, through the
handle body 268.
The stopcock 270 may be rotatably-connected to the handle body 268
such that the axial passage 278 of the stopcock 270 may be axially
aligned with an axial passage 280 extending through the handle body
268 and an axial passage 282 extending through the strain relief
member 272. Accordingly, as seen in FIG. 8, the axial passage 278
may be axially aligned with the axial passages 280, 282 of the
handle body 268 and the strain relief member 272. The fluid F may
be provided through the axial passages 228, 246, 256, 278, 280, 282
of the handle 12, through the axial passages 182, 202 of the
proximal shaft portion 14 and through the axial passages 90, 178
(see, e.g., FIGS. 4 and 6) of the distal shaft portion 12 and into
the axial chamber 174 of the balloon 28. The passages 90, 178, 182,
202, 228, 246, 256, 278, 280 and 282 may be in fluid communication
with one another and axial chamber 174 in order to permit the fluid
F to be moved into the balloon 28 in order to permit the balloon 28
to be moved to an inflated orientation and deploy the stent S.
In some implementations, the handle body 268 does not include the
stopcock 270. A valve may be located upstream of the handle body
268 to control flow into the axial passage 280 of the handle body
268.
Referring to FIGS. 1 and 10, the proximal shaft portion 14 may
include a stainless steel material and the outer radial surface 192
of the proximal shaft portion may be coated with a
polytetrafluoroethylene (PTFE) material. The outer radial surface
192 may include a proximal depth marker 284 and a distal depth
marker 286 formed on outer radial surface 192 of the proximal shaft
portion 14. The proximal depth marker 284 may be arranged on the
outer radial surface 192 approximately 100 centimeters from the
distal end 10b of the delivery apparatus 10. The distal depth
marker 286 may be arranged on the outer radial surface 192
approximately 90 centimeters from the distal end 10b of the
delivery apparatus 10.
Referring to FIGS. 2, 5 and 7, the proximal marker band 32 and the
distal marker band 34 may be formed on the radial outer surface 42
of the core wire 18. The proximal marker band 32 permits a user to
gauge the approximate axial location of where the proximal segment
110 and intermediate segment 108 of the balloon 28 are joined
together. The distal marker band 34 permits the user to know of an
approximate axial location of where the distal segment 106 and
intermediate segment 108 of the balloon 28 are joined together. As
such, by knowing the location of the segments 106-110 of the
balloon 28, the user may also know the approximate axial location
of the stent S as well.
Each of the proximal and distal marker bands 32, 34 may include an
inner radial surface 288 and an outer radial surface 290. The inner
radial surface 288 may be connectively swaged to the radial outer
surface 42 of the core wire 18. The proximal and distal marker
bands 32, 34 may include any desirable material, such as, for
example, a platinum-iridium material.
Referring to FIGS. 1 and 2, one or more protective tubular members
292 may be arranged coaxially relative to the core wire 18 and the
proximal and distal marker bands 32, 34.
The protective tubular member 292 may include an inner radial
surface 294 and an outer radial surface 296. The outer radial
surface 296 may define an outer diameter D11. The inner radial
surface 294 may be arranged adjacent to the outer radial surface
290 of the proximal and distal marker bands 30, 32. The protective
tubular member 292 may include any desirable material, such as a
polymer. An example of a polymer material includes, without
limitation, a polyamide material.
The protective tubular member 292 may prevent the inner surface 112
of the balloon 28 from contacting the outer radial surface 290 of
the proximal and distal marker bands 32, 34. By preventing the
inner surface 112 of the balloon 28 from contacting the outer
radial surface 290 of the proximal and distal marker bands 32, 34,
any axial shifting of the proximal and distal marker bands 32, 34
relative the core wire 18 may be reduced/eliminated as the delivery
apparatus 10 is being inserted into the vessel, V. In addition, the
protective tubular member 292 may prevent the stent from being
compressed to a diameter so small that it cannot be properly
deployed.
In some implementations, the distal shaft portion 16 of the
delivery apparatus 10 may be coated with a friction-reducing
material that may assist a user in the inserting or removing the
delivery apparatus 10. The coating may include a hydrophillic
coating, which may include a polymer-based material. Not every
element 18-40 of the distal shaft portion 16 may be coated with the
friction-reducing material. For example, the balloon 28 may not be
coated with the friction-reducing material. Further, although the
stent S may not necessarily be considered to be part of the
delivery apparatus 10, the stent S may also not be coated with the
friction-reducing material.
A protective polytetrafluoroethylene (PTFE) tubular sheath (not
shown) may be arranged about the outer radial surface S.sub.RO of
the stent S or the catheter tubing. The sheath may be provided with
the delivery apparatus 10 if, for example, the stent S is arranged
relative to the delivery apparatus in a "pre-mounted"
configuration. Accordingly, prior to utilizing the delivery
apparatus 10, a user may remove the sheath in order to expose the
stent S.
In some implementations, the axial core wire 18 may include a
stainless steel material. Moreover, the distal balloon control band
24 may include a polyurethane material and the handle body 268 may
include a polycarbonate (PC) material. The stopcock 270 may include
an acetal material. The strain relief member 272 may include a
thermoplastic polyether material, a polybutylene material, a
terphthalate material, a polyether glycol material or the like.
One or more of the structures of the shaft portions 18-40, may
include a material that lends itself to having a non-rigid,
shapeable quality. Further, one or more of the structures 18-40 may
include a material that lends itself to having similar or
dissimilar durometers (i.e., softness/hardness ratings). Further,
although the distal shaft portion 16 is described to include
structures identified at 18-40, the distal shaft portion 16 is not
limited to the number of, type or geometry of structure identified
at 18-40 and that the invention may be practiced with any desirable
number of, type or geometry of structure.
The balloon 28 may be folded upon itself one or more times.
Accordingly, although the balloon 28 is illustrated in FIGS. 1, 2,
5, 6, and 7 to include one, non-folded layer, the illustration of
the balloon 28 in the figures does not limit the disclosed
structure or function of the invention. Various balloon folding,
combinable with this disclosure, can be found in U.S. Pat. No.
6,071,285 and U.S. Pat. No. 6,120,533, which are hereby
incorporated by reference in their entireties.
Referring to FIGS. 11 and 12, the distal shaft portion 16 is shown
prior to inflation. FIGS. 11 and 12 also illustrate a "folded
balloon" in which the balloon is folded upon itself. Although, for
simplicity, the balloon is shown as being folded on itself three
times, the balloon can be folded in any manner.
In some implementations, the balloon delivery apparatus includes a
catheter comprising a proximal hypotube portion, a distal flexible
tube portion, and a lumen disposed longitudinally through the
proximal hypotube portion and distal flexible tube portion. The
balloon delivery apparatus also includes a balloon having a
proximal end that is affixed to a distal shaft mounting portion of
the proximal hypotube portion and a distal end that is affixed to a
core wire at a location proximal to the distal tip of the core
wire. The balloon can be coaxial with the core wire and in fluid
communication with the lumen of the proximal hypotube portion and
the distal flexible tube portion. The balloon delivery apparatus
includes a plurality of balloon control bands, wherein at least one
balloon control band is located at the proximal end of the balloon
and at least one balloon control band is located at the distal end
of the balloon. The balloon control bands may restrict the
balloon's longitudinal expansion upon inflation.
In some examples, the proximal hypotube portion comprises a first
material and the distal flexible tube section comprises a second
material. For example, the proximal hypotube portion comprises a
metal. In additional examples, the proximal hypotube portion
comprises stainless steel. And in some instances, the stainless
steel is coated with PTFE. The proximal hypotube section may
further include a plurality of optical markers (e.g., depth
markers). The distal flexible tube portion may comprise a polymer
material, which may comprise a silicone rubber material.
In some implementations, the distal tip of the core wire further
comprises a prolate spherical or hemispherical cap. The core wire
further comprises a coiled section wherein the coiled section is
located proximal to the distal tip. The core wire may include a
plurality of depth markers, wherein at least one depth marker is
located approximately concentrically with the proximal end of the
balloon and at least one depth marker is located approximately
concentrically with the distal end of the balloon. Optionally, the
core wire includes at least one protective tubular member having a
length approximately equal to the length of the balloon, wherein
the protective tubular member is coaxial with the core wire and the
balloon. For example, the protective tubular member can be disposed
between the depth marker located approximately concentrically with
the proximal end of the balloon and the depth marker can be located
approximately concentrically with the distal end of the balloon. In
some examples, the balloon control bands comprise an elastomer
material that elastically expands upon inflation of the
balloon.
In some implementations, the balloon is a non-compliant balloon
comprising a polymer material. For instance, the balloon comprises
a polyamide polymer material.
In some examples, the apparatus includes a handle affixed to the
proximal hypotube portion. The handle may include an inflation
control that controls the inflation of the balloon.
In some implementations, the balloon delivery catheter apparatus
includes a catheter comprising a proximal hypotube, a distal
flexible tube, and a lumen that extends longitudinally throughout
both tubes. The balloon delivery catheter apparatus also includes a
balloon near the distal end of the proximal hypotube that fluidly
communicates with the lumen. The balloon includes a distal end, a
proximal end, and an intermediate segment. A core wire extending
throughout at least a portion of the catheter lumen and beyond the
distal end of the balloon includes a proximal end, a distal tip,
and a coiled member. The coiled member can be disposed between the
proximal end and the distal tip. A proximal balloon control band
may be concentrically arranged around the proximal end of the
balloon, and a distal balloon control band may be concentrically
arranged about the distal end of the balloon. The distal and
proximal balloon control bands may restrict inflation of the
balloon at the proximal and distal ends of the balloon. The distal
and proximal balloon control bands may comprise an elastomer
material that elastically expands during inflation of the balloon
and contracts upon deflation.
In some examples, a bonding element coaxially mounted about the
coiled member of the core wire secures the distal end of the
balloon to the coil member.
A portion of the distal balloon control band may be affixed to the
distal end of the balloon. The proximal end of the balloon can be
affixed to the distal end the proximal hypotube, and the proximal
balloon control band can be affixed to the proximal hypotube. Or,
the proximal balloon control band can be affixed to the proximal
end of the balloon. In additional examples, the proximal end of the
core wire is affixed to the distal end of the proximal
hypotube.
In some examples, a plurality of depth markers are affixed to the
catheter (e.g., affixed to the proximal hypotube). Moreover, at
least one depth marker may be approximately concentric with the
proximal end of the balloon and at least one depth marker may be
approximately concentric with the distal end of the balloon.
A protective tubing member, having a proximal end and a distal end,
may be affixed to the core wire so that the proximal end of the
member is approximately concentric with the proximal end of the
balloon, and the distal end of the member is approximately
concentric with the distal end of the balloon.
In some implementations, the distal tip comprises a round surface
comprising a hemisphere or prolate hemisphere. The balloon may
comprise a polyamide polymer material (e.g., a polyamide material
(e.g., Nylon)).
The proximal hypotube may comprise a first material and the distal
flexible tube may comprise a second material. For example, the
proximal hypotube may comprise stainless steel. In some instances,
the stainless steel is substantially coated with a polymer material
comprising PTFE. Moreover, the distal flexible tube may comprise a
polymer material comprising silicone rubber.
Upon inflation, the balloon may adopt a geometry having two inward
facing cones and a cylindrical segment located between said
cones.
In some implementations, a handle may be connected to and in fluid
communication with the lumen of the proximal hypotube. The handle
may include a docking torque apparatus having a base portion, a
collet portion disposed within a passage of the base portion 208,
and a head portion movably connected to the base portion. The head
portion may be selectively engagable with the collet portion. The
proximal shaft section of the hypotube may be disposable through
one or more of the head portion, the collet portion, or the base
portion. In some examples, the handle includes a strain relief
member connected to the handle body and/or the base portion.
A method of treating vascular stenosis in a patient may include
providing a balloon delivery apparatus that includes a handle
having a handle body, a catheter having a hypotube section, a
distal shaft section, and a lumen extending longitudinally
throughout both sections. The hypotube section may be connected to
the handle body, and the handle body may be in fluid communication
with the lumen. The balloon delivery apparatus includes a balloon
having a distal segment, an intermediate segment, and a proximal
segment, each of which is defined by an inner surface and an outer
surface. The proximal segment of the balloon may be affixed to the
distal end of the hypotube section and in fluid communication with
the lumen of the hypotube section. The balloon delivery apparatus
includes a distal balloon control band having an inner surface, an
outer surface, and a proximal end surface and a proximal balloon
control band having an inner surface, an outer surface and a distal
end surface. The inner surface of the distal balloon control band
is adjacent to the outer surface of the distal segment of the
balloon. The inner surface of the proximal balloon control band is
adjacent to the outer surface of the proximal segment of the
balloon member. A core wire extends through a portion of the distal
shaft section and entirely through the balloon. The handle slidably
engages the hypotube section of the catheter, and rotational
movement of the handle longitudinally advances or retracts the core
wire, the hypotubes section, the distal shaft section, or any
combination thereof. Several methods further comprise inserting the
balloon into a blood vessel of a patient. And some methods comprise
advancing the balloon sufficiently into the vessel such that a
portion of the intermediate segment of the balloon is approximately
concentric with the stenosis. Some methods further comprise
inflating the balloon such that the stenosis is at least partially
alleviated. And, some methods further comprise deflating the
balloon member and removing the balloon from the patient.
A number of implementations have been described. Nevertheless, it
will be understood that various modifications may be made without
departing from the spirit and scope of the disclosure. Accordingly,
other implementations are within the scope of the following
claims.
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