U.S. patent application number 12/578473 was filed with the patent office on 2010-04-15 for inventory sparing catheter system.
Invention is credited to Mark C. Bates, Peter J. D'Aquanni, Jason Andrew Habeger, Kent C.B. Stalker, John D. Whitfield.
Application Number | 20100094257 12/578473 |
Document ID | / |
Family ID | 41562145 |
Filed Date | 2010-04-15 |
United States Patent
Application |
20100094257 |
Kind Code |
A1 |
Stalker; Kent C.B. ; et
al. |
April 15, 2010 |
INVENTORY SPARING CATHETER SYSTEM
Abstract
Some embodiments relate to a catheter system having a changeable
or adjustable working length. The catheter system can comprise a
proximal end, a distal end, and a first axial lumen configured to
receive a guidewire formed through at least a portion of the
catheter body. A first opening can be formed through a portion of
the catheter body and be in communication with the first lumen. The
sheath can be rotatable, axially movable, or otherwise changeable
from at least a first position to a second position, wherein the
sheath can substantially cover the first opening in the catheter
body in the first position, and can substantially expose the first
opening in the catheter body in the second position.
Inventors: |
Stalker; Kent C.B.; (San
Marcos, CA) ; Whitfield; John D.; (Temecula, CA)
; Bates; Mark C.; (Encinitas, CA) ; D'Aquanni;
Peter J.; (Murrieta, CA) ; Habeger; Jason Andrew;
(Carlsbad, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET, FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
41562145 |
Appl. No.: |
12/578473 |
Filed: |
October 13, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61104678 |
Oct 10, 2008 |
|
|
|
Current U.S.
Class: |
604/524 ;
604/528 |
Current CPC
Class: |
A61F 2/958 20130101;
A61M 2025/107 20130101; A61M 25/0041 20130101; A61M 25/10 20130101;
A61M 2025/0681 20130101; A61M 25/104 20130101; A61M 2025/0063
20130101; A61M 2025/0183 20130101; A61M 25/01 20130101; A61M
2025/0008 20130101; A61M 2025/0175 20130101 |
Class at
Publication: |
604/524 ;
604/528 |
International
Class: |
A61M 25/09 20060101
A61M025/09; A61M 25/00 20060101 A61M025/00 |
Claims
1. A catheter system comprising: a catheter body comprising a
proximal end, a distal end, and a first lumen formed axially
through at least a portion of the catheter body, the first lumen
being configured to receive a guidewire; a first opening formed
through at least a portion of the catheter body, the first opening
being in communication with the first lumen; and a sheath supported
by the catheter body, the sheath being slidable relative to the
catheter body; wherein: the sheath is movable between at least a
first position and a second position; in the first position, the
first opening is substantially covered by the sheath; in the second
position, the first opening is substantially uncovered; and when
the sheath is in the second position, the catheter system is
configured to direct a guidewire being advanced through the first
lumen to pass through the first opening.
2. The catheter system of claim 1, wherein the first opening is
formed through a side wall of the catheter body.
3. The catheter system of claim 1, wherein the sheath is rotatable
relative to the catheter body.
4. The catheter system of claim 1, wherein the sheath is axially
movable relative to the catheter body.
5. The catheter system of claim 1, further comprising a second
opening formed in the sheath.
6. The catheter system of claim 5, wherein the second opening
formed in the sheath is approximately aligned with the first
opening formed in the catheter body when the sheath is in the
second position.
7. The catheter system of claim 1, wherein the catheter body
further comprises a second lumen formed axially through at least a
portion of the catheter body configured to communicate with an
expandable balloon supported at a distal end of the catheter
body.
8. The catheter system of claim 1, wherein the catheter body
comprises a lumen configured to receive a mandrel to increase the
stiffness of the catheter body adjacent to the first opening.
9. The catheter system of claim 1, further comprising a mandrel
that is extendable through at least a portion of the catheter
adjacent to the first opening to increase the stiffness of the
catheter body adjacent to the first opening.
10. The catheter system of claim 1, further comprising a mandrel
that is advanceable through at least a portion of the first lumen,
the mandrel being configured to direct a guidewire in the first
lumen to pass through the first opening.
11. The catheter system of claim 10, wherein the mandrel comprises
an angled surface at a distal end thereof.
12. The catheter system of claim 1, further comprising a slider
mechanism configured to selectively position the sheath in one of a
plurality of axial or radial positions relative to the catheter
body.
13. The catheter system of claim 1, further comprising at least one
of detents, depressions, and protrusions to selectively bias the
sheath in one of a plurality of axial or radial positions relative
to the catheter body.
14. The catheter system of claim 1, wherein: the catheter body
defines an inflection point adjacent to the first opening, the
inflection point being the approximate point wherein the catheter
body defines a bend having an angle; the catheter body is movable
between at least a first configuration and a second configuration;
and the angle is greater in the first configuration than in the
second configuration.
15. The catheter system of claim 14, wherein the angle is
substantially greater in the first configuration than in the second
configuration.
16. The catheter system of claim 14, wherein the angle in the first
configuration is approximately 30 degrees.
17. The catheter system of claim 14, wherein the angle in the first
configuration is from approximately 5 degrees to approximately 30
degrees.
18. The catheter system of claim 14, wherein the angle in the
second configuration is from approximately 0 degrees to
approximately 5 degrees.
19. The catheter system of claim 14, wherein the catheter body is
biased toward the first configuration.
20. The catheter system of claim 14, comprising a mandrel supported
within the catheter body, the mandrel configured to bias the
catheter body toward the first configuration.
21. The catheter system of claim 14, wherein the catheter body is
heat set in the first configuration.
22.-38. (canceled)
39. A catheter system comprising: a catheter body comprising a
proximal end, a distal end, and a first lumen formed axially
through at least a portion of the catheter body, the first lumen
being configured to receive a guidewire; and a first opening formed
through at least a portion of the catheter body, the first opening
being in communication with the first lumen; wherein: the catheter
body defines an inflection point adjacent to the first opening, the
inflection point being the approximate location wherein the
catheter body defines a bend having an angle; the catheter body is
movable between at least a first configuration and a second
configuration; and the angle is greater in the first configuration
than in the second configuration.
40. The catheter system of claim 39, wherein the angle is
substantially greater in the first configuration than in the second
configuration.
41. The catheter system of claim 39, wherein the angle in the first
configuration is approximately 30 degrees.
42. The catheter system of claim 39, wherein the angle in the first
configuration is from approximately 10 degrees to approximately 30
degrees.
43. The catheter system of claim 39, wherein the angle in the
second configuration is approximately 0 degrees.
44. The catheter system of claim 39, wherein the angle in the
second configuration is from approximately 0 degrees to
approximately 5 degrees.
45. The catheter system of claim 39, wherein the catheter body is
biased toward the first configuration.
46. The catheter system of claim 39, comprising a mandrel supported
within the catheter body, the mandrel configured to bias the
catheter body toward the first configuration.
47. The catheter system of claim 39, wherein the catheter body is
heat set in the first configuration.
48. The catheter system of claim 39, further comprising a sheath
supported by the catheter body, the sheath being movable between at
least a first position and a second position such that the sheath
substantially covers the first opening in the first position and
substantially exposes the first opening in the second position.
49. The catheter system of claim 48, wherein the catheter system is
configured such that moving the sheath from the first to the second
position moves the catheter body from the first to the second
configuration.
50. The catheter system of claim 48, further comprising a housing
supported about a proximal portion of the catheter body, the
housing being in communication with the sheath and being configured
to move the sheath between the first and second positions.
51. The catheter system of claim 50, wherein the housing comprises
a release mechanism configured to selectively secure the sheath in
the first or second position.
52. The catheter system of claim 51, wherein the release mechanism
comprises a spring member.
53. The catheter system of claim 39, wherein the catheter body
further comprises a second lumen formed axially through at least a
portion of the catheter body configured to communicate with an
expandable balloon supported at a distal end of the catheter
body.
54. The catheter system of claim 39, further comprising a mandrel
that is extendable through at least a portion of the catheter
adjacent to the first opening to increase the stiffness of the
catheter body adjacent to the first opening.
55. The catheter system of claim 54, wherein the mandrel extends
through at least a portion of an inflation lumen of the catheter
body.
56. The catheter system of claim 39, further comprising detents,
depressions, or protrusions configured to selectively bias the
sheath in one of a plurality of positions relative to the catheter
body.
57.-77. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/104,678, filed Oct. 10, 2008, the entirety of
which is hereby incorporated by reference as if fully set forth
herein.
BACKGROUND OF THE DISCLOSURE
[0002] 1. Field of the Invention
[0003] The present disclosure relates to percutaneous catheters,
more particularly, to percutaneous catheters having a changeable
working length.
[0004] 2. Description of the Related Art
[0005] One of the differences with the use of peripheral
percutaneous transluminal angioplasty (PTA) catheters compared to
percutaneous transluminal coronary angioplasty catheters (PTCA) is
the ubiquitous need for different working lengths for PTA
catheters. Coronary catheters are designed to traverse a fixed
distance between the access point (common femoral, brachial or
radial artery) and the heart (or sometimes the brain) to treat
lesions. Thus, a single standard PTCA catheter length of 135 cm
satisfies almost all the distances needed to treat these lesions
irrespective of the patient height and habitus, while at the same
time not having too much redundant catheter outside the body. In
difference, the target lesions for PTA vary in location and
distance from the access site so a single catheter length, if too
short, will not reach all the lesions and, if too long, will leave
a long unwieldy segment outside the body that is difficult to keep
in the sterile field.
[0006] For example, PTA catheters may be used to treat lesions very
close to the access site with an ipsilateral iliac approach where
the distance from the sheath in the common femoral artery to the
lesion may be only 5 to 20 cm. Compare this to the patients with
lesions in the great vessels like the subclavian artery where the
target treatment sites are frequently over 100 cm remote from the
femoral access site.
[0007] A problem arises when using too long of a catheter in the
short distances because the length requires guide wires two times
the catheter length, and these often extend below the patient's
feet while on the interventional table, and the devices become
clumsier and can take two people to load and unload the catheter on
the wire. This also creates an increased risk for catheter
contamination as the proximal end of the catheter can flip up and
hit an unsterile monitor or even reach the floor. In these
instances the entire system must be discarded and the procedure
begins all over again. Hence, there is a preference for shorter
catheters when the target lesion is close to the access site, and
for longer catheters when treating more distal lesions that cannot
be reached by shorter catheters. Shorter catheters are simpler in
the close proximity cases and require less labor and time under
fluoroscopy (i.e. radiation exposure).
[0008] This need for different length catheters creates a burden on
the end user in the hospital catheter lab to stock large amounts of
inventory due to all the combinations of lengths and sizes.
Catheters may be chosen by guide wire size (e.g., 0.014'', 0.018'',
or 0.035''), balloon pressures/compliance (i.e. high pressure
non-compliant, or low pressure compliant), over a range of balloon
diameters and balloon lengths, and by whether the systems are
balloon only or balloons with stents mounted on them. In the domain
of PTA, the inventory is doubled by the need for 2 or more working
lengths. This leads to thousands of units being stocked and
accounted for in the hospital catheter lab, for example up to 3
wire sizes.times.2 pressure types.times.10 diameters.times.8
balloon lengths.times.2 catheter lengths, plus having multiples of
each size available. Layered on top of this, the catheterization
laboratory may need multiple product types from multiple suppliers
since different products are needed for different lesions.
[0009] Recent changes in Joint Commission on the Accreditation of
Healthcare Organizations (JCAHO) guidelines make it more difficult
for hospitals to maintain inventory and protect products from
contamination. Many hospitals have shifted to closed inventory
management systems with limited space. In a typical hospital, about
60 percent of the total supply cost is driven by three clinical
service areas: surgery, cardiology and pharmacy (source: 2004 VHA
Supply Cost Benchmarking Database; VHA, Inc.). Forty percent of
supply costs can be attributed to implants, stents, and other
devices (source: Serb, Chris; Strategic Savings;
Hospitalconnect.com; Apr. 16, 2004). Add to this that many
hospitals are pushing companies to provide products on consignment,
then additional costs are also funneled back to the companies that
manufacture the product.
SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS
[0010] Some embodiments of this disclosure relate to a catheter
system having a catheter body comprising a proximal end, a distal
end, and a first lumen formed through at least a portion of the
catheter body. The first lumen can be configured to receive a
guidewire. In some embodiments, a first opening can be formed
through at least a portion of the catheter body. The first opening
can be in communication with the first lumen. In some embodiments,
the catheter system can have a sheath (also referred to herein as
an outer sheath) supported by the catheter body, the sheath having
a second opening formed through an outer wall of the sheath. The
sheath can be configured to be movable between at least a first
position and a second position. In some embodiments, in the second
position, at least a portion of the second opening of the sheath is
approximately aligned with the first opening of the catheter body,
and, in the first position, no portion of the second opening of the
sheath is aligned with the first opening of the catheter body.
[0011] Some embodiments of this disclosure relate to a catheter
system comprising a catheter body having a proximal end, a distal
end, and a first lumen formed through at least a portion of the
catheter body, the first lumen being configured to receive a
guidewire. A first opening can be formed through at least a portion
of the catheter body, the first opening being in communication with
the first lumen. Additionally, a sheath can be supported by the
catheter body. The sheath can have a second opening formed through
an outer wall of the sheath. In some embodiments, the sheath can be
movable between at least a first position and a second position.
The catheter system can be configured such that at least a portion
of the second opening of the sheath is adjacent to the first
opening of the catheter body when the sheath is in the first
position and such that no portion of the second opening of the
sheath is adjacent to the first opening of the catheter body when
the sheath is in the second position.
[0012] Some embodiments of this disclosure relate to a catheter
system comprising a catheter body having a proximal end, a distal
end, and a first lumen formed axially through at least a portion of
the catheter body, the first lumen being configured to receive a
guidewire. The catheter system can have a first opening formed
through at least a portion of the catheter body, the first opening
being in communication with the first lumen. The catheter body can
be biased to be angled at an acute angle adjacent to the first
opening when the catheter body is in a relaxed configuration.
[0013] Some embodiments of this disclosure relate to a catheter
system comprising a catheter body having a proximal end, a distal
end, and a first lumen formed through at least a portion of the
catheter body. The first lumen can be configured to receive a
guidewire. A diverter can be positioned at any of a plurality of
positions along the length of the catheter body. In some
embodiments, the catheter body can be substantially sealed along
the length thereof such that the first lumen is substantially
sealed along the length thereof. The diverter can be configured
such that at least a portion of the diverter passes through the
catheter body such that an opening formed in the diverter
communicates with the first lumen, whereby a guidewire that is
advanced through the first lumen can be advanced through the
opening formed in the diverter.
[0014] Some embodiments of this disclosure relate to a catheter
system comprising a catheter body having a proximal end, a distal
end, and a first lumen formed axially through at least a portion of
the catheter body, the first lumen being configured to receive a
guidewire. A first opening can be formed through at least a portion
of the catheter body, the first opening being in communication with
the first lumen. The catheter system can also have a sheath
supported by the catheter body, the sheath being slidable relative
to the catheter body. The sheath can be movable between at least a
first position and a second position. In the first position, the
first opening can be substantially covered by the sheath. In the
second position, the first opening can be substantially uncovered.
Further, when the sheath is in the second position, the catheter
system can be configured to direct a guidewire being advanced
through the first lumen to pass through the first opening. In some
embodiments, the catheter body can define an inflection point
adjacent to the first opening, the inflection point being the
approximate point wherein the catheter body defines a bend, a
curve, an angle, or other suitable change in the orientation of the
catheter body. The catheter body can be movable between at least a
first configuration and a second configuration, wherein an angle at
the inflection point is greater in the first configuration than in
the second configuration.
[0015] Some embodiments of this disclosure relate to a catheter
system comprising a catheter body having a proximal end, a distal
end, and a first lumen formed axially through at least a portion of
the catheter body, the first lumen being configured to receive a
guidewire. A first opening can be formed through at least a portion
of the catheter body, the first opening being in communication with
the first lumen. The catheter system can further comprise a sheath
supported by the catheter body, the sheath having a second opening
formed through an outer wall thereof. In some embodiments, the
sheath can be movable between at least a first position and a
second position such that, in the second position, at least a
portion of the second opening of the sheath can be approximately
aligned with the first opening of the catheter body, and, in the
first position, no portion of the second opening of the sheath is
aligned with the first opening of the catheter body.
[0016] Some embodiments of this disclosure relate to a catheter
system comprising a catheter body having a proximal end, a distal
end, and a first lumen formed axially through at least a portion of
the catheter body, the first lumen being configured to receive a
guidewire, and a first opening formed through at least a portion of
the catheter body, the first opening being in communication with
the first lumen. In some embodiments, the catheter body can define
an inflection point adjacent to the first opening, the inflection
point being the approximate location wherein the catheter body
defines a bend having an angle. Further, the catheter body can be
movable between at least a first configuration and a second
configuration, and the angle can be greater in the first
configuration than in the second configuration.
[0017] Some embodiments of this disclosure relate to a catheter
system comprising a catheter body comprising a proximal end, a
distal end, and a first lumen axially formed through at least a
portion of the catheter body, the first lumen being configured to
receive a guidewire, and a diverter that can be positioned at any
of a plurality of positions along the length of the catheter body.
In some embodiments, the diverter can be configured such that at
least a portion of the diverter passes through the catheter body
into the first lumen such that an opening formed in the diverter
communicates with the first lumen, whereby a guidewire that can be
advanced through the first lumen can be advanced through the
opening formed in the diverter.
[0018] Some embodiments of this disclosure relate to a method of
using a catheter, comprising advancing a catheter body over a
guidewire positioned within a bodily vessel so that the guidewire
passes at least partially through a first lumen formed axially
through at least a portion of the catheter body and through a first
opening of the catheter body, moving a sheath positioned about the
catheter body from a first position to a second position, and
diverting the guidewire so that, when the sheath is in the second
position, the guidewire passes through the first opening formed in
the catheter body as the catheter is advanced over the guidewire.
In some embodiments, the sheath can substantially cover the first
opening when the sheath is in a first position. In some
embodiments, at least a portion of the first opening can be
uncovered when the sheath is in the second position.
[0019] Some embodiments of this disclosure relate to a method of
using a catheter, comprising advancing a distal portion of a
catheter body over a guidewire positioned within a bodily vessel so
that the guidewire passes through a lumen formed axially in the
catheter body, diverting the guidewire through a side-wall opening
formed in the catheter body, and advancing the distal portion of
the catheter into an introducer sheath positioned in a patient's
body to a treatment site while maintaining a proximal portion of
the catheter body at least up the side-wall opening proximal of the
introducer sheath. The side-wall opening can be in communication
with the lumen.
[0020] Some embodiments of this disclosure relate to a method of
using a catheter, comprising advancing a catheter body into a
patient's vasculature, the catheter body comprising a proximal end,
a distal end, a first lumen configured to receive a guidewire
formed axially through at least a portion of the catheter body, and
a bend at an inflection point adjacent to the first opening. The
catheter body can be movable between at least a first configuration
and a second configuration, and the angle of the bend can be
greater in the first configuration than in the second
configuration. The method can further comprise moving the catheter
body from the first configuration to the second configuration to
reduce the angle of the bend, and advancing the catheter body over
a guidewire positioned within a bodily vessel so that the guidewire
passes through the first lumen and past the first opening of the
catheter body.
[0021] Some embodiments of this disclosure relate to a method of
using a catheter, comprising advancing the catheter over a
guidewire positioned within a bodily vessel so that the guidewire
passes through a first lumen formed in a catheter body. The method
can also comprise moving a sheath positioned about the catheter
body from a first position (wherein the sheath can substantially
cover a first opening formed in the catheter body) to a second
position (wherein at least a portion of the first opening is not
covered by the sheath). The first opening formed in the catheter
body can be in communication with the first lumen formed in the
catheter body. The method can also comprise diverting the guidewire
so that, when the sheath is in the second position, the guidewire
advances through the first opening formed in the catheter body as
the catheter is advanced over the guidewire.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The foregoing summary, as well as the following detailed
description of the preferred embodiments of the present invention,
will be better understood when read in conjunction with the
appended drawings, in which:
[0023] FIG. 1A is a perspective view of an embodiment of a catheter
system.
[0024] FIG. 1B is a side view of the embodiment of the catheter
system illustrated in FIG. 1A.
[0025] FIG. 1C is a section view of the embodiment of the catheter
system shown in FIG. 1A, taken through line 1C-1C in FIG. 1B.
[0026] FIG. 2 is a side view of another embodiment of a catheter
system, showing the catheter system in a longer inserted length
configuration.
[0027] FIG. 3 is a side view of the embodiment of a catheter system
shown in FIG. 2, showing the catheter system in a shorter inserted
length configuration.
[0028] FIG. 4 is a side view of another embodiment of a catheter
system, showing the catheter system in a shorter inserted length
configuration.
[0029] FIG. 5 is a side view of the embodiment of the catheter
system shown in FIG. 4, showing the catheter system in a longer
inserted length configuration.
[0030] FIG. 6 is a perspective view of another embodiment of a
catheter system.
[0031] FIG. 7 is a perspective view of the embodiment of the slider
mechanism shown in FIG. 6.
[0032] FIG. 8 is a side view of the embodiment of the slider
mechanism shown in FIG. 6.
[0033] FIG. 9 is an end view of the embodiment of the slider
mechanism shown in FIG. 6.
[0034] FIG. 10 is a side view of another embodiment of a catheter
system.
[0035] FIG. 11 is a top view of an embodiment of the mandrel shown
in FIG. 10.
[0036] FIG. 12 is a side view of an embodiment of the mandrel shown
in FIG. 10.
[0037] FIG. 13A is an enlarged section view of a portion of the
embodiment of the catheter system shown in FIG. 10, defined by
curve 13A-13A shown in FIG. 10.
[0038] FIG. 13B is an enlarged section view of a portion of the
embodiment of the catheter system shown in FIG. 10, defined by line
13B-13B shown in FIG. 13A.
[0039] FIG. 13C is an enlarged section view of a portion of another
embodiment of a catheter system, defined by line 13C-13C shown in
FIG. 13A.
[0040] FIG. 14A is a side view of another embodiment of a catheter
system, showing the catheter system in an extended
configuration.
[0041] FIG. 14B is a side view of the embodiment of the catheter
system shown in FIG. 14A, showing the catheter system in a shorter
inserted length configuration.
[0042] FIG. 15A is a section view of the embodiment of the catheter
system shown in FIG. 14A, taken through line 15A-15A in FIG.
14B.
[0043] FIG. 15B is a section view of the embodiment of the catheter
system shown in FIG. 14A, taken through line 15B-15B in FIG.
14B.
[0044] FIG. 16A is a side view of another embodiment of a catheter
system, showing the catheter system in a first configuration.
[0045] FIG. 16B is a side view of the embodiment of a catheter
system shown in FIG. 16A, showing the catheter system in a second
configuration.
[0046] FIG. 16C is an enlarged section view of the embodiment of
the catheter system shown in FIG. 16A, taken through line 16C-16C
in FIG. 16A.
[0047] FIG. 16D is an enlarged section view of the embodiment of
the catheter system shown in FIG. 16A, taken through line 16D-16D
in FIG. 16B.
[0048] FIG. 17A is a side view of another embodiment of a catheter
system, showing the catheter system in a first configuration.
[0049] FIG. 17B is a side view of the embodiment of a catheter
system shown in FIG. 17A, showing the catheter system in a second
configuration.
[0050] FIG. 17C is an enlarged section view of the embodiment of
the catheter system shown in FIG. 17A, taken through line 17C-17C
in FIG. 17B.
[0051] FIG. 18A is a side view of another embodiment of a catheter
system, showing the catheter system in an extended
configuration.
[0052] FIG. 18B is a side view of the embodiment of the catheter
system shown in FIG. 18A, showing the catheter system in a shorter
inserted length configuration.
[0053] FIG. 18C is a side view of an embodiment of a mandrel that
can be used with the embodiment of the catheter system shown in
FIGS. 18A and 18B.
[0054] FIG. 19 is a perspective view of another embodiment of a
catheter system.
[0055] FIG. 20 is a perspective view of the embodiment of a
catheter system shown in FIG. 19, with a portion of the housing
removed for clarity.
[0056] FIG. 21 is an exploded view of the embodiment of a catheter
system shown in FIG. 19.
[0057] FIG. 22 is a perspective view of another embodiment of a
catheter system.
[0058] FIG. 23 is a perspective view of the embodiment of a
catheter system shown in FIG. 22, with a portion of the housing
removed for clarity.
[0059] FIG. 24 is a top view of the embodiment of a catheter system
shown in FIG. 22
DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS
[0060] The embodiments of the present disclosure reduce catheter
inventory by providing balloon catheter or any other suitable
catheter having an adjustable length. Having the capability to
adjust the working length of the catheter can reduce the number of
inventoried catheters significantly, in some cases in half. Some
embodiments can utilize a notch or opening in the catheter shaft or
body at a position where it would be advantageous to permit a
guidewire to exit. In some embodiments, the notch location can be
the same as in a shorter catheter length, in most cases
approximately 80-85 cm proximal of the tip of the catheter. The
opening can also be located close enough to the proximal end of the
catheter such that it does not enter the introducer sheath (or the
body). For example, the catheter can be configured such that the
opening will be covered if it is to be inserted into the guide
catheter or introducer sheath, i.e., if an extended working length
is needed for lesion access.
[0061] Additionally, with conventional apparatuses, the inflation
lumen can be approximately 1-2 feet behind where the physician is
standing (near the sheath), causing him/her to have to move back
and forth to operate the inflation lumen. To solve this dilemma, as
will be described in greater detail, in some embodiments, the
catheter can have a movable inflation port that can be movable to
accommodate the physician's position.
[0062] In some embodiments, a catheter can be provided that can
have a catheter body having a guidewire lumen and an inflation
lumen axially formed therein. An inflatable balloon can be
supported on a distal portion of the catheter body. The catheter
can be configured such that the working length (e.g., the length of
the catheter to be positioned inside a patient during use) of the
catheter body can be increased or decreased depending on the
individual patient need.
[0063] FIG. 1A is a perspective view of an embodiment of a catheter
system 20. FIG. 1B is a side view of the embodiment of the catheter
system 20 illustrated in FIG. 1A. FIG. 1C is a section view of the
embodiment of the catheter system 20 shown in FIG. 1A, taken
through line 1C-1C in FIG. 1B. In some embodiments, the catheter
system 20 can comprise features, components, configurations, or
other details found in conventional catheter systems, in addition
or in the alternative to features, components, configurations, or
other details described herein.
[0064] With reference to FIGS. 1A-1C, the catheter system 20 can
comprise a catheter body 22 having an inflation lumen 24 and a
guidewire lumen 26. At least a portion of, or the entire length of,
the guide wire lumen 26 can be configured to slidingly receive a
guidewire 28 (omitted from FIG. 1A for clarity). The guidewire 28
can exit the lumen 26 at the distal end of the catheter body 22
through an opening (not illustrated) in communication with the
guidewire lumen 26.
[0065] An interface mechanism 32 can be positioned on the catheter
body 22 to surround at least a portion of the outside surface of
the catheter body 22. In some embodiments, the interface mechanism
32 can be configured to be slidingly positionable along the length
of the catheter body 22. The interface mechanism 32 can also be
configured to be completely removable from the catheter body 22.
For example, the interface mechanism 32 and/or the catheter body 22
can have detents, clamps, or other features to selectively secure
the interface mechanism 32 at a desired position along the length
of the catheter body 22.
[0066] The guidewire lumen 26 can be configured to be at least
substantially sealed along a substantial portion of its length
other than at the opening accessed by the interface mechanism 32.
In some embodiments, the interface mechanism 32 comprises a lever
arm or blade 34 that is configured to create an opening or provide
access to a preexisting opening in the lumen wall between the
guidewire lumen 26 and an outside surface 22a of the catheter body
22. The lever arm or blade 34 can provide a passageway 36 to the
guidewire lumen 26 at any of a variety of longitudinal positions on
the catheter body 22.
[0067] In some embodiments, the lever or blade 34 creates an
opening by pressing down on the lumen wall to open a slit 36, as
illustrated in FIG. 1C. The blade 34 can also be used to open a
portion of a slit created in the lumen wall between the outside
surface 22a of the catheter body 22 and the guidewire lumen 26.
FIG. 1C depicts a catheter cross-section that comprises a preformed
opening or slit 38 allowing access to the guidewire lumen 26 at a
multitude of locations along the length of the catheter body 22. In
some embodiments, as depicted in FIGS. 1A and 1B, the lever arm or
blade 34 is configured to extend into an opening or slit 38 in the
lumen wall and to divert the guidewire 28 out of the lumen 26. In
some embodiments, the lever or blade 34 extends into the opening or
slit 38 to divert the guidewire 28 out of the lumen 26.
[0068] In some embodiments, the catheter system 20 can be
configured to permit the location of the passageway 36 to be moved
as the interface mechanism 32 is moved along the catheter body 22,
while sealing the other portions of the catheter body 22 so that
the guidewire lumen remains substantially sealed along its length.
In some embodiments, the opening or slit 38 can be formed in the
catheter body 22 adjacent to the guidewire lumen 26. The opening or
slit 38 can be configured so that the blade 34 can create the
opening along any desired portion of the catheter body, even with
the guidewire 28 occupying the opening 36. The opening or slit 38
can be self-sealing such that it is biased to form a closed seal
along the length of the catheter body 22 adjacent to the lumen
26.
[0069] The sealed passageway 36 can be configured to receive the
guidewire 28 and provide a sealed conduit for the guidewire 28 to
the guidewire lumen 26. In this arrangement, the interface
mechanism 32 can be moved along the length of the catheter body 22
to provide the adjustment of the position of the opening 36. In
this arrangement, the working length of the catheter system 20 can
be changed by moving the interface mechanism 32 along the length of
the catheter body 22.
[0070] In some embodiments, the interface mechanism 32 can define a
hinge member 40 and a latching mechanism 42. The hinge member 40
and latching mechanism 42 shown most clearly in FIG. 1A can be
configured such that a user can open a cover portion 44 of the
interface mechanism 32 so that the interface mechanism 32 can be
removed from or assembled with the catheter body 22.
[0071] FIG. 2 is a side view of another embodiment of a catheter
system 50, showing the catheter system 50 in a longer inserted
length configuration. FIG. 3 is a side view of the embodiment of a
catheter system 50 shown in FIG. 2, showing the catheter system 50
in a shorter inserted length configuration. In some embodiments,
the catheter system 50 can have a catheter body 52, a sliding mount
54, an inflation lumen fitting 56, and a guidewire exchange port
58. An inflation balloon 62 can be supported by the catheter body
52. As illustrated, the sliding mount 54 can be slidably
positionable on the catheter body 52 so that the position of the
inflation lumen fitting 56 (which can have a luer fitting on the
end thereof) can be adjustable. For example, in the longer inserted
length configuration shown in FIG. 2, the inflation lumen fitting
56 can be positioned farther away from the guidewire exchange port
58 as compared to the shorter inserted length configuration of the
catheter system 50 shown in FIG. 3. In some embodiments, a user can
shorten the distance between the inflation lumen fitting 56 by
sliding the inflation lumen fitting 56 along the catheter body 52
toward a guidewire exchange port 58 through which a guidewire 60
can pass to enter into or exit from the guidewire lumen formed in
the catheter body 52. In some embodiments, the guidewire exchange
port 58 can be in a fixed position along the catheter body 52. In
some embodiments, the position of the guidewire exchange port 58
can be adjustable.
[0072] In some embodiments, the sliding mount 54 can be moved
toward the distal end 52a of the catheter body 52 (e.g., closer to
the guidewire exchange port 58) to shorten the working portion of
the catheter body 52. The shorter inserted length configuration is
illustrated in FIG. 3. In this configuration, the user then can
work with a shorter catheter and guidewire working length, with the
inflation port 56 being close to the guidewire port 58. This
innovation enables the physician not to have to move down the
operating table to actuate an inflation device coupled with the
inflation lumen of the catheter system 50.
[0073] In some embodiments, the sliding mount 54 can be pulled back
toward the proximal end 52b of the catheter body 52 to lengthen the
working length or portion of the catheter body 52. This
configuration is illustrated in FIG. 2.
[0074] In some embodiments, all or a portion of the catheter body
52 can be stiffened with a stiffening mandrel, braids, wires,
coils, a stiff or rigid material, or otherwise to enable the
catheter body 52 to be pushed without buckling or inadvertently
bending during use of the catheter system 50. In some embodiments,
the distance between the location of the guidewire port 58 and a
coupling 64 (discussed further below) can be between approximately
40 cm and approximately 80 cm. In some embodiments, the distance
between the location of the guidewire port 58 and the distal end of
the catheter 52a can be approximately 60 cm or greater.
[0075] In the illustrated embodiment, the guidewire 60 can pass
through the guidewire lumen and exit the catheter body 52 at the
distal end 52a thereof. Additionally, in some embodiments, an
inflation balloon 62 can be supported by the catheter body 52 near
the distal end 52a of the catheter body 52. As such, the catheter
system 50 can be configured for an angioplasty treatment, for stent
delivery or other treatment for which a balloon is useful.
[0076] In some embodiments, the catheter system 50 can have an
inflation lumen coupling 64 that can provide a coupling between the
inflation lumen fitting or port 56 and the remaining portion of the
catheter body 52. A length of tubing 66 can provide a flexible
conduit between the inflation port 56 and the coupling 64.
[0077] FIG. 4 is a side view of another embodiment of a catheter
system 80, showing the catheter system 80 in a shorter inserted
length configuration. FIG. 5 is a side view of the embodiment of
the catheter system 80 shown in FIG. 4, showing the catheter system
80 in a longer inserted length configuration. As illustrated in
FIGS. 4 and 5, the catheter system 80 can have a catheter body 82,
an inflation balloon 84, and a quick connect coupling 86. The
catheter body 82 can include an inflation lumen and a guidewire
lumen. As illustrated in FIG. 4, the quick connect coupling 86 can
be used to connect a short extension 88 to the catheter body 82.
The short extension 88 can have an inflation lumen port 92 and an
exit port 94 for the guidewire lumen. A long extension 90 shown in
FIG. 5 can have an inflation lumen port 92 and an exit port 94 for
the guidewire lumen. The catheter system 80 can be configured such
that the short extension 88 and the long extension 90 can be
interchangeably joined to the quick connect coupling 86.
[0078] By attaching the long extension 90 to the catheter body 82
with the quick connect coupling 86, a user can extend the working
length of the catheter body 82 so that the length of the catheter
body 82 is increased. In some embodiments, the length of the
catheter body 82 can be approximately 100 cm or more. In some
embodiments, the long extension 90 can be approximately 55 cm or
greater in length, or between 50 cm or less and approximately 75 cm
or more. In some embodiments, the catheter body 82 can be
approximately 80 cm in length from the distal end of the catheter
body 82 to the quick connect coupling 86.
[0079] In some embodiments, the quick connect coupling 86 can be
configured to be insertable into a vessel within a body. In some
embodiments, the quick connect coupling 86 can be configured to be
pliable and also have indexing features so that the inflation lumen
and guidewire lumen in the extension portion 88, 90 can be aligned
with the inflation lumen and guidewire lumen in the catheter body
82 when the quick connect coupling is joined. The quick connect
coupling can be sufficiently short to not create a long, stiffened
section in the catheter body 82. The quick connect coupling 86 can
be formed from one or more pliable materials. In some embodiments,
the quick connect coupling 86 can be a snap fit connector or
similar connector that can have indexing features to maintain the
alignment of the lumens in the catheter body 82. In some
embodiments, the quick connect coupling 86 can be a twist or
threaded connector having indexing features to ensure the alignment
of the guidewire and inflation lumens in the catheter body 82.
[0080] FIG. 6 is a perspective view of another embodiment of a
catheter system 100 having a catheter body 102, an inflation
balloon 104, and a slider mechanism 106 (also referred to herein as
a diverter). FIGS. 7-9 are a perspective view, a side view, and an
end view, respectively, of the embodiment of the slider mechanism
106 shown in FIG. 6. The slider mechanism 106 can be configured to
divert the guidewire 114 outside of a guidewire lumen 110. A
typical over-the-wire inflation luer of the kind commonly found in
the art can be attached to the proximal end 102a of the catheter
body 102.
[0081] With reference to FIG. 6, a lengthwise slit 108 can be
formed in the catheter body 102 between the outer surface of the
catheter body 102 and the guidewire lumen 110, but not into the
inflation lumen 112. The slit 108 can extend along the entire
length of the catheter body 102, or along only a portion of the
length of the catheter body 102. In some embodiments, the catheter
body 102 can be configured such that the slit 108 is substantially
self-sealing. Some embodiments of the slider mechanism 106 can have
a first portion 106a sized and configured to be gripped by a user's
hands or fingers, and a second portion 106b configured to be
supported within a lumen of the catheter body 102. For example, in
some embodiments, the slider mechanism 106 can be supported by the
catheter system 100 such that the first portion 106a of the slider
mechanism 106 can be located external to the catheter body 102 and
guidewire lumen 110 while second portion 106b of the slider
mechanism 106 can be slidably received within the guidewire lumen
110.
[0082] In some embodiments, the second portion 106b of the slider
mechanism 106 can have a cross-sectional shape that is similar to
the cross-sectional shape of the guidewire lumen 110. In some
embodiments, the second portion 106b can have a tubular shape or
have one or more curved surfaces. In some embodiments, the second
portion 106b can have a flat bottom surface, such as the bottom
surface 106c shown in FIG. 106b, to abut against a similarly shaped
surface in the guidewire lumen 110. The flat bottom surface 106c
can be configured to stabilize the slider mechanism 106 with
respect to the catheter body 102 to inhibit movement of or rotation
of the slider mechanism 106 relative to the catheter body 102 about
a longitudinal axis of the catheter body 102. In some embodiments,
the second portion 106b of the slider mechanism 106 can have a
tubular or C-shaped cross-sectional shape. The first portion 106a
of the slider mechanism 106 can be sized and shaped so that a user
can easily grasp and manipulate the slider mechanism 106.
[0083] With reference to FIGS. 6-9, a guidewire 114 can be
assembled with the catheter system 100 by advancing the guidewire
114 through the distal end 102b of the catheter body 102 and
feeding the guidewire 114 through the guidewire lumen 110. Once the
guidewire 114 reaches the slider mechanism 106, as mentioned, the
slider mechanism 106 can divert the guidewire 114 outside of the
guidewire lumen 110. The slider 106 can be distally or proximally
advanced or translated until the desired position of the slider
mechanism 106 is reached. After the guidewire 114 has been advanced
through the catheter body 102 and the slider mechanism 106, a
typical over-the-wire inflation luer fitting can be coupled with
the proximal end 102a of the catheter body 102. In this
arrangement, the guidewire 114 can remain within the guidewire
lumen 110 of the portion of the catheter body 102 that can be
inserted into the patient, and the working length of the catheter
body 102 can be adjusted by sliding the slider 106 toward or away
from the distal end of the catheter.
[0084] FIG. 10 is a side view of another embodiment of a catheter
system 150. FIG. 11 is a top view of an embodiment of the mandrel
162 shown in FIG. 10. FIG. 12 is a side view of an embodiment of
the mandrel 162 shown in FIG. 10. FIG. 13A is an enlarged section
view of a portion of the embodiment of the catheter system 150
shown in FIG. 10, defined by curve 13A-13A shown in FIG. 10. FIG.
13B is an enlarged section view of a portion of the embodiment of
the catheter system 150 shown in FIG. 10, defined by line 13B-13B
shown in FIG. 13A.
[0085] With reference to FIGS. 10-13B, the catheter system 150 can
comprise a catheter body 152 having an inflation balloon 154, an
inflation port 156 in communication with an inflation lumen 157,
and a guidewire lumen 159 for receiving a guidewire 158. In some
embodiments, the catheter body 152 can have some or all of the same
features of any typical over the wire type catheter wherein the
guidewire 158 can be advanced through the entire length of the
catheter body 152 and exit through the proximal end 152a of the
catheter body 152 when the mandrel 162 is not positioned in the
guidewire lumen 159.
[0086] In the illustrated arrangement, the guidewire 158 can be
advanced through a portion of the catheter body 152 so that the
guidewire 158 exits through an opening 160 (also referred to herein
as a port or notch) formed in the catheter body 152. In some
embodiments, more than one opening 160 can be formed in the
catheter body 152 or any other catheter body disclosed herein at
any of a range of positions along the catheter body so that the
guidewire 158 can exit the catheter body 152 at any of a wide range
of locations. The mandrel 162 can be inserted into the catheter
body 152 through the proximal end 152a of the catheter body and can
be configured to help guide or deflect the guidewire 158 through
the opening 160 if so desired. In some embodiments, the mandrel 162
can have a curved distal end 162a to divert the guidewire 158
through the opening 160 when oriented properly. In some
embodiments, with reference to the mandrel 162 shown in FIG. 13A,
the distal end portion 162a of the mandrel 162 can be beveled or
slanted to divert the guidewire 158 from the guidewire lumen
159.
[0087] In some embodiments, the mandrel 162 and/or catheter body
152 can be indexed or keyed such as at the proximal end or along
any portion of the length of the catheter body 152 to ensure the
desired orientation of the mandrel 162 within the guidewire lumen
159 so that the guidewire 158 can exit smoothly. For example, with
reference to FIG. 13B, the mandrel 162 and/or the guidewire lumen
159 through which the mandrel 162 is advanced can be keyed,
indexed, or otherwise configured such that the beveled or angled
end portion 162a of the mandrel 162 is biased to be in an optimal
rotational orientation with respect to the opening 160. The end
portion 162a can be angled by bending the end portion 162a of the
mandrel 162. In some embodiments, an optimal rotational orientation
with respect to the opening 160 can be one in which the end portion
162a of the mandrel 162 smoothly diverts the guidewire out of the
opening 160 when the mandrel 162 has been advanced into the desired
axial position within the guidewire lumen.
[0088] As illustrated in FIG. 13B, the guidewire lumen 159 can
define a recess or channel 161 therein which can receive the end
portion 162a therein or otherwise be configured to prevent the
inadvertent rotation of the mandrel 162. In this configuration, the
rotational or radial orientation of the mandrel 162 can be
controlled. The channel 161 can be formed along all of or a portion
of the length of the guidewire lumen 159.
[0089] Additionally, with reference to FIG. 13C, the guidewire
lumen 159 can define a recess or channel 161 therein which can
receive a ridge or protrusion 163 of the mandrel 162 therein or
otherwise be configured to prevent the inadvertent rotation of the
mandrel 162. The embodiment of the mandrel 162 illustrated in FIG.
13C can have a beveled or angled end portion (not illustrated)
configured to divert a guidewire 158 through the opening 160 in the
catheter body 152. In this configuration, the rotational or radial
orientation of the mandrel 162 can be controlled. The channel 161
illustrated in FIG. 13C can be formed along all of or a portion of
the length of the guidewire lumen 159.
[0090] In some embodiments, a handle 164 can be supported at the
proximal end 162b of any embodiments of the mandrel 162 or other
mandrels disclosed herein to assist the user in manipulation or
removal of the mandrel. The handle 164 supported at the proximal
end 162b of the mandrel 162 can also be keyed such that, when the
handle is coupled with a feature on the proximal end 152a of the
catheter 152, the mandrel's slanted or curved distal end 162a can
be oriented to divert the guidewire 158 through the opening
160.
[0091] In some embodiments, the opening 160 can be positioned
approximately 80 cm from the distal end 152b of the catheter body
152. In some embodiments, the opening 160 can be positioned at any
desired or suitable location along the length of the catheter body
152. As mentioned above, when the mandrel 162 is removed from the
guidewire lumen, the guidewire 158 can continue through the entire
length of the catheter body 152 so that the entire length of the
catheter body 152 can comprise a working length. In some
embodiments, a cover or plug (not illustrated) can be positioned
over the opening 160 to substantially cover the opening 160 when
substantially the entire length of the catheter body 152 is desired
to be inserted into the patient.
[0092] In some embodiments, the catheter body 152 can be
strengthened or supported in the region of or adjacent to the
opening 160 to prevent the catheter body 152 from buckling or
kinking at or adjacent to the opening 160 due to the interruption
of the outer surface of the catheter or the decrease in the
cross-sectional area at the opening 160. In some embodiments, a
solid mandrel or support can be inserted in the adjacent balloon
inflation lumen or another lumen formed in the catheter body 152 to
strengthen the catheter body 152 in the region of the opening 160.
The mandrel or support can extend past the location of the opening
160, and can be removably or non-removably secured at the proximal
end of the catheter using adhesive, welds, fasteners, or by any
other suitable means. The mandrel can be tapered at the distal end
or modified to reduce its stiffness to prevent the end of the wire
from accidently perforating the lumen and exiting the catheter
shaft.
[0093] In some embodiments (not illustrated), a removable clip can
also be positioned on the outside of the catheter body 152 around
or adjacent to the opening 160 to help the user locate the opening
160 and also assist in diverting the guidewire 158 out of the
opening 160 when a shorter catheter length is desired. An interface
mechanism, such as the sliding interface mechanism 32 described
above, can also be attached to the catheter body 152 to permit the
location of the inlet to the inflation lumen to be brought closer
to the opening 160.
[0094] FIGS. 14A and 14B are side views of another embodiment of a
catheter system 170, showing an embodiment of a slideable assembly
172 incorporating an outer cover or sheath 174 that can be used to
cover an opening 176 (also referred to herein as a port or notch)
formed in the catheter body 178 when the longer length of the
catheter is being used. Some embodiments of the catheter system 170
can have one or any combination of the same features, components,
configurations, or details of any other catheter system embodiments
disclosed herein. FIG. 14A shows the catheter system 170 in a
longer inserted length configuration wherein the slideable assembly
172 has been axially advanced away from the proximal end 178a of
the catheter body 178 such that the catheter system 170 is in an
extended position. FIG. 14B shows the catheter system 170 in a
shorter inserted length configuration wherein the slideable
assembly 172 has been axially retracted to be positioned closer to
the proximal end 178a of the catheter body 178 such that the
catheter system 170 is in a shorter inserted length configuration.
With reference to FIGS. 14A and 14B, the working length (i.e., the
length that is designed to be insertable into the introducer
sheath, or patient) of the catheter system 170 in the first or
longer inserted length configuration (represented by D1 in FIG.
14A) is significantly greater than the working length of the
catheter system 170 in the second or shorter inserted length
configuration (represented by D2 in FIG. 14B).
[0095] In some embodiments of the catheter system 170 or any of the
catheter system embodiments disclosed herein, the working length of
the catheter system 170 in the first or longer inserted length
configuration (represented by D1 in FIG. 14A) can be from 125 cm or
less to approximately 150 cm or more, or from approximately 130 cm
to approximately 140 cm, or from approximately 133 cm to
approximately 137 cm, or to or from any values within these ranges.
In some embodiments of the catheter system 170 or any of the
catheter system embodiments disclosed herein, the working length of
the catheter system 170 in the second or shorter inserted length
configuration (represented by D2 in FIG. 14B) can be from 65 cm or
less to approximately 100 cm or more, or from approximately 70 cm
to approximately 90 cm, or from approximately 75 cm to
approximately 85 cm, or to or from any values within these
ranges.
[0096] In the extended position as shown in FIG. 14A, the sheath
174 of the slideable assembly 172 has been extended in the
direction represented by arrow A1 in FIG. 14A so that the sheath
174 substantially covers the opening 176. In this position, the
sheath 174 or any sheath of any other embodiment of the catheter
system disclosed herein can provide additional structural support
to the catheter body 178 at or adjacent to the position of the
opening 176. Additionally, in some embodiments, the sheath 174 or
any sheath of any other embodiment of the catheter system disclosed
herein can be configured to provide a relatively fluid tight seal
around the outside surface of the catheter body (such as, without
limitation, catheter body 178). In some embodiments, with the
sheath 174 or any other sheath herein positioned so as to cover the
opening in the catheter body, the guidewire lumen can be used to
inject fluids into the patient's vasculature.
[0097] In the shorter inserted length configuration, as illustrated
in FIG. 14B, the sheath 174 of the slideable assembly 172 can be
retracted in the direction represented by arrow A2 in FIG. 14B so
that the sheath 174 does not cover the opening 176. In this
position, a guidewire can pass through the opening 176. In some
embodiments, the catheter system 170 can be configured such that a
mandrel or other suitable device or feature can selectively divert
a guidewire through the opening or opening 176.
[0098] In some embodiments, the slideable assembly 172 can be
incorporated into any of the other catheters or catheter systems
described herein or known in the field, including but not limited
to the catheter system 150 or any other catheter system described
herein. Further, in some embodiments, the catheter system 170 can
have any of the components, features, or other details of any of
the catheter systems disclosed herein or any other catheter systems
known in the field.
[0099] In this arrangement, when the slideable assembly 172 has
been advanced to cover the opening 176, as shown in FIG. 14A, the
opening 176 can be substantially covered to prevent guidewires and
other devices advanced through the proximal or distal end of the
catheter lumen from inadvertently exiting the opening 176. When a
shorter version of the catheter body 178 is preferred (or a shorter
working length), the slideable assembly 172 can be retracted
proximally (i.e., in the direction represented by arrow A2 in FIG.
14B) and an optional diverter rod (such as without limitation the
mandrel 162 shown in FIG. 10 and described above) can be positioned
in the guidewire lumen to divert the guidewire out of the opening
176. Then the catheter can be loaded onto the guide wire and
advanced until the guide wire exits the opening 176. At this point,
the guidewire and catheter 170 can be manipulated separately. As
mentioned, when the longer version of the catheter system 170 is
needed (e.g., a longer working length), the slideable assembly 172
can be extended distally to cover the opening 176 and the diverter
rod can be removed. Then the catheter can be loaded onto the guide
wire and advanced until the guide wire passes through the proximal
end 178a of the catheter body 178.
[0100] In some embodiments, the opening 176 or any other port or
notch herein can be positioned relative to the distal end of the
catheter body 178 to ensure that a sufficient length of the
catheter body 178 is provided distal of the opening 176.
Positioning the opening 176 as described can ensure that the
opening 176 remains outside of, i.e., proximal of, the introducer
sheath when a guidewire is advanced through the opening 176. These
features minimize the chance for tissue within the vasculature
getting trapped between a guidewire and the body of the catheter
170 or the opening 176, which could lead to injury to the
patient.
[0101] FIGS. 15A and 15B are section views of two embodiments of
the catheter system shown in FIGS. 14A and 14B, taken through line
15A-15A in FIG. 14B. In some embodiments, as with any of the other
embodiments of the catheters disclosed herein, the catheter body
178 can have a lumen 180 configured to removably or non-removably
receive a stiffening mandrel or support 182 therein. The lumen 180
can be disposed parallel to the guidewire lumen 184. The stiffening
mandrel 182 can be sized and configured to increase the strength
and/or stiffness of the catheter body 178 adjacent to the opening
176. Alternatively, with reference to FIG. 15B, the catheter system
170 can be configured such that the stiffening mandrel or support
182 can be received within all or a portion of the inflation lumen
186 that can be formed in the catheter body 178. In any of the
embodiments disclosed herein, the stiffening mandrel 182 can have a
solid cross-section, a hollow cross-section, or any combination
thereof.
[0102] FIGS. 16A and 16B show another embodiment of a catheter
system 200 that has a first or longer inserted length configuration
and a second or shorter inserted length configuration,
respectively. Some embodiments of the catheter system 200 can have
one or any combination of the same features, components,
configurations, or details of any other catheter system embodiments
disclosed herein. The catheter system 200 can have a slideable
assembly 202 incorporating an outer cover or sheath 204 that can be
used to cover a notch or opening 206 formed in the catheter body
208 when the longer length of the catheter is being used. In some
embodiments, the sheath 204 or, more particularly, the catheter
body 208 can comprise more than one opening that can be
independently exposed to provide the medical practitioner with a
range of different working lengths of the catheter system 200. The
catheter system 200 or any other catheter system herein can be
configured such that the space between the sheath 204 and the
catheter body 208 is substantially sealed or tight to prevent or
inhibit any blood flow or other leakage between the sheath 204 and
the catheter body 208.
[0103] FIG. 16A shows the catheter system 200 in a longer inserted
length configuration wherein the slideable assembly 202 has been
axially retracted toward the proximal end 208a of the catheter body
208 such that the catheter system 200 is in an extended position.
FIG. 16B shows the catheter system 200 in a shorter inserted length
configuration wherein the slideable assembly 202 has been axially
advanced away from the proximal end 208a of the catheter body 208
such that the catheter system 200 is in a shorter inserted length
configuration. In the retracted position as shown in FIG. 16A, the
outer cover 206 of the slideable assembly 202 has been retracted in
the direction represented by arrow A3 in FIG. 16A so that the notch
or opening 210 (also referred to as a second opening) in the outer
cover 206 is not aligned with the notch or opening 206 formed in
the catheter body 208. In this position, where the openings 206,
210 are not aligned and the opening 206 is not exposed, the outer
cover 206 can provide structural support to the catheter body 208
at or adjacent to the position of the opening 206.
[0104] In the axially advanced position, as illustrated in FIG.
16B, the sheath 204 of the slideable assembly 202 can be advanced
in the direction represented by arrow A4 in FIG. 16B so that the
opening 210 is aligned with and provides access through the sheath
204 to the opening 206. In this position, a guidewire can pass
through the substantially aligned openings 206, 210.
Advantageously, a portion of the sheath 204 adjacent to the opening
210 can provide some additional structural support at the axial
position of the opening 206. In some embodiments, the catheter
system 200 can be configured such that a mandrel or other suitable
device or feature can selectively divert a guidewire through the
opening 206 and 210. In some embodiments, instead of being axially
movable, the sheath 204 of the slideable assembly 202 can be
rotatable to align the openings 206, 210 or misalign the openings
206, 210.
[0105] In some embodiments, the slideable assembly 202 can be
incorporated into any of the other catheters or catheter systems
described herein or known in the field, including but not limited
to the catheter system 150 or 170. Further, in some embodiments,
the catheter system 200 can have any of the components, features,
or other details of any of the catheter systems disclosed herein or
any other catheter systems known in the field.
[0106] In this arrangement, when the slideable assembly 202 has
been retracted to cover the opening 206, as shown in FIG. 16A, the
opening 206 can be substantially covered to prevent guidewires and
other devices advanced through the proximal or distal end of the
catheter lumen from inadvertently exiting the opening 206. When a
shorter working length version of the catheter body 208 is
preferred, the slideable assembly 202 can be advanced distally
(i.e., in the direction represented by arrow A4 in FIG. 16B). In
some techniques, a diverter rod (such as without limitation the
mandrel 162 shown in FIG. 10 and described above) can be positioned
in the guidewire lumen to divert the guidewire out of the opening
206. Then the catheter can be loaded onto the guide wire and
advanced proximally from a distal end port of the catheter body 208
until the guide wire exits the opening 206. At this point, the
guidewire and catheter system 200 can be manipulated separately. As
mentioned, when the longer version of the catheter system 200 is
needed, the slideable assembly 202 can be extended distally to
cover the opening 206 and the diverter rod can be removed. Then the
catheter can be loaded onto the guide wire and advanced until the
guide wire passes through the proximal end 208a of the catheter
body 208.
[0107] In any of the embodiments disclosed herein, one or more of
the components of the catheter system (for example, without
limitation, the catheter system 200) can be indexed or otherwise
configured to maintain the desired radial orientation, axial
position, or otherwise of the components of the catheter system.
For example, in some embodiments wherein the sheath 204 can be
configured to be axially movable with respect to the catheter body
208, the sheath 204, catheter body 208, and/or other components of
the catheter system 200 can have channels, depressions,
protrusions, tabs, or other indexing or keying features to prevent
the opening 210 formed in the sheath 204 from becoming radially
misaligned with respect to the opening 206 formed in the catheter
body 208.
[0108] For example, an inside surface of the sheath 204 can define
a channel 212 longitudinally formed therein along at least a
portion of the length of the sheath 204, and an outer surface of
the catheter body 208 can have a protrusion or tab 214 formed
thereon configured to engage with the channel 212 formed in the
sheath 204. In an alternative embodiment (not illustrated), the tab
(such as the tab 214) can be disposed on the sheath 204 and the
channel (such as channel 212) can be disposed on the catheter body
208. In these configurations, to align the respective openings 206,
210, the medical practitioner need only be concerned with the axial
positioning of the openings 206, 210 and may align these components
merely by changing the axial position of the sheath 204 with
respect to the catheter body 208.
[0109] In any of the embodiments disclosed herein, although not
required, one or more of the components of the catheter system (for
example, without limitation, the catheter system 200 described
above) can have depressions or detents or other biasing or
indicating features formed therein. The depressions, detents, or
other biasing or indicating features can be configured to
selectively bias the relative components such as the sheath 204 and
the catheter body 208 in one of two or more desired positions
relative to one another.
[0110] FIG. 16D is an enlarged section view of the embodiment of
the catheter system 200 shown in FIG. 16A, taken through line
16D-16D in FIG. 16B. The section view defined by FIG. 16D is taken
through the inflation lumen 216 of the catheter body 204. With
reference to FIG. 16D, an inside surface of the sheath 204 can
define one or more depressions or detents 236 formed therein at
various locations on the inside surface of the sheath 204, and an
outer surface of the catheter body 208 can have a rounded or
otherwise shaped protrusion or tab 238 formed thereon configured to
selectively engage with one of the depression or depressions 236
formed in the sheath 204. In an alternative embodiment (not
illustrated), the tab or protrusion 238 can be disposed on the
sheath 204 and the depression or depressions 236 can be disposed on
the catheter body 208. The depressions and protrusions, or other
similar features can be located at a variety of predetermined
radial or longitudinal locations, depending on whether the sheath
204 is axially movable, radially movable, or movable in both the
axial and radial directions with respect to the catheter body
208.
[0111] In this arrangement, the depressions or other biasing or
indicating features formed in the sheath 204 and/or catheter body
208 can provide the user (which may be a medical practitioner) with
a physical indication, e.g., a tactile feedback, of the relative
positioning of the sheath 204 and the catheter body 208. The
tactile feedback provided to the user that can indicate the
relative positioning of the outer sleeve and the catheter body can
be achieved not only by indicating features formed in the outer
sleeve or catheter body, but also by configuring a proximal handle
of any embodiments of the catheter systems disclosed herein to
incorporate a spring that forces a button into one of two or more
slots. For example, a first slot could be configured for a distal
sleeve position (i.e., a long catheter configuration) and a second
slot could be configured for a proximal sleeve position (i.e., a
short catheter configuration).
[0112] In some embodiments, one depression 236 can be formed in the
sheath 204 at one position associated with the first or longer
inserted length configuration of the catheter system 200, while
another depression 236 can be formed in the sheath 204 at a second
position associated with the second or shorter inserted length
configuration of the catheter system 200. A protrusion or tab 238
formed in the catheter body 208 can be configured to engage with
each one of the two or more depressions 236 that can be formed in
the sheath 204 so that the medical practitioner can feel when the
sheath 204 has been positioned in the desired axial or radial
position relative to the catheter body 208. Additionally, these
features can be configured to bias the sheath 204 to remain in the
selected axial or radial position with respect to the catheter body
208.
[0113] In any of the embodiments disclosed herein, the opening 206
or any other notch or port disclosed herein can be positioned
relative to the distal end of the catheter body 208 to ensure that
a sufficient length of the catheter body 208 is provided distal of
the opening 206. In some embodiments, positioning the opening 206
as described can ensure that the opening 206 does not enter the
introducer sheath or the patient's vasculature when a guidewire is
advanced through the opening or opening 206, thus preventing
potential injury to the patient from the guidewire.
[0114] FIG. 17A is a side view of another embodiment of a catheter
system 220, showing the catheter system 220 in a first
configuration. FIG. 17B is a side view of the embodiment of a
catheter system 220 shown in FIG. 17A, showing the catheter system
220 in a second configuration. FIG. 17C is an enlarged section view
of the embodiment of the catheter system 220 shown in FIG. 17A,
taken through line 17C-17C in FIG. 17B. The section view defined by
FIG. 17C is taken through the inflation lumen 240 of the catheter
body 224. In some embodiments, the catheter system 220 can have any
of the features, components, or details of any of the other
catheter systems disclosed herein, such as catheter system 200, in
addition to or the alternative to, any of the features described
below or illustrated in the figures.
[0115] In some embodiments, such as illustrated in FIGS. 17A-17C,
the sheath 224 can be configured to be radially or rotationally
movable with respect to the catheter body 228 to align the openings
226, 230. For example, the rotatable assembly 222 can be rotated to
rotate the sheath 224 and, hence, the opening 230 formed in the
sheath 224. Additionally, the sheath 224, catheter body 228, and/or
other components of the catheter system 220 can have channels,
depressions, protrusions, tabs, or other indexing or keying
features to prevent the opening 230 formed in the sheath 224 from
becoming axially misaligned with respect to the opening 226 formed
in the catheter body 228. For example, with reference to FIG. 17C,
an inside surface of the sheath 224 can define a channel 232
partially or fully circumferentially formed therein, and an outer
surface of the catheter body 228 can have a protrusion or tab 234
formed thereon configured to engage with the channel 232 formed in
the sheath 224.
[0116] Similar to the catheter system 200, in some embodiments, the
catheter system 210 can have depressions or detents or other
biasing or indicating features formed therein. The depressions,
detents, or other biasing or indicating features can be configured
to selectively bias the relative components such as the sheath 224
and the catheter body 228 in one of two or more desired positions
relative to one another. In some embodiments, the channel 232 can
have protrusions, tabs, stops, or other similar features to limit
the degree of rotation of the sheath 224 relative to the catheter
body 228, or to assist with aligning the openings 226, 230.
[0117] In an alternative embodiment (not illustrated), the tab 234
can be disposed on the sheath 224 and the channel 232 can be
disposed on the catheter body 228. In this configuration, to align
the respective openings 226, 230, the medical practitioner need
only be concerned with the radial or rotational positioning of the
openings 226, 230 and can align the openings 226, 230 by changing
the radial position of the sheath 224 with respect to the catheter
body 228. The radial position of the sheath 224 with respect to the
catheter body 228 and, hence, the radial position of the opening
230 with respect to the opening 226, can be adjusted by rotating
the sheath 224 about a longitudinal axis of the catheter body
208.
[0118] FIGS. 18A and 18B are side views of another embodiment of a
catheter system 260, showing an embodiment of a slideable assembly
262 incorporating an outer cover or sheath 264 that can be used to
cover an opening 266 (also referred to herein as a port or notch)
formed in the catheter body 268 when the longer length of the
catheter is being used. Some embodiments of the catheter system 260
can have one or any combination of the same features, components,
configurations, or details of any other catheter system embodiments
disclosed herein. FIG. 18A shows the catheter system 260 in a
longer inserted length configuration wherein the slideable assembly
262 has been axially advanced away from the proximal end 268a of
the catheter body 268 such that the catheter system 260 is in an
extended position. FIG. 18B shows the catheter system 260 in a
shorter inserted length configuration wherein the slideable
assembly 262 has been axially retracted to be positioned closer to
the proximal end 268a of the catheter body 268 such that the
catheter system 260 is in a shorter inserted length configuration.
Some embodiments of the catheter system 300 can have one or any
combination of the same features, components, configurations, or
details of any other catheter system embodiments disclosed
herein.
[0119] In the extended position as shown in FIG. 18A, the sheath
264 of the slideable assembly 262 has been extended in the
direction represented by arrow A5 in FIG. 18A so that the sheath
264 substantially covers the opening 266. In this position, the
sheath 264 or any sheath of any other embodiment of the catheter
system disclosed herein can provide additional structural support
to the catheter body 268 at or adjacent to the position of the
opening 266. Additionally, in some embodiments, the sheath 264 or
any sheath of any other embodiment of the catheter system disclosed
herein can be configured to provide a relatively fluid tight seal
around the outside surface of the catheter body (such as, without
limitation, catheter body 268). In some embodiments, with the
sheath 264 positioned so as to cover the opening 266 in the
catheter body, the guidewire lumen can be used to inject fluids
into the patient's vasculature.
[0120] In the shorter inserted length configuration, as illustrated
in FIG. 18B, the sheath 264 of the slideable assembly 262 can be
retracted in the direction represented by arrow A6 in FIG. 18B so
that the sheath 264 does not cover the opening 266. In this
position, a guidewire can pass through the opening 266. As will be
described, the catheter system 300 can be configured such that,
when the catheter system 270 is in the shorter inserted length
configuration such as shown in FIG. 18B, a mandrel or other
diverting device is not required to divert a guidewire through the
opening or opening 266. Rather, the angulation of the catheter body
268 adjacent to the opening 266 can bias a guidewire toward the
opening 266 without the use of a mandrel or diverter.
[0121] In this arrangement, when the slideable assembly 262 has
been advanced to cover the opening 266, as shown in FIG. 18A, the
opening 266 can be substantially covered to prevent guidewires and
other devices advanced through the proximal or distal end of the
catheter lumen from inadvertently exiting the opening 266. When a
shorter version or working length of the catheter body 268 is
preferred, the slideable assembly 262 can be retracted proximally
(i.e., in the direction represented by arrow A6 in FIG. 18B). The
catheter system 260 can be configured such that, in the shorter
inserted length configuration as illustrated in FIG. 18B, the
catheter body 268 is configured to bend or curve upwardly (for
example, without limitation, such that the catheter bends in a
direction that is away from the opening 266) in the portion of the
catheter body 268 adjacent to the opening 266. In some embodiments,
the catheter body 268 can bend or curve about an inflection point.
The inflection point can be adjacent to a center point or an end
point of the opening 266.
[0122] In some embodiments, the catheter body 268 can be
substantially linear (in a relaxed state) along the lengths of the
catheter body 268 proximal to and distal of the opening 266. In
this configuration, as the catheter system 260 is being advanced
over a guidewire 270, due to the curvature of the catheter body 268
adjacent to the opening 266, the guidewire can be directed out of
the opening 266 without the use of a mandrel or diverter positioned
within the proximal portion of the guidewire lumen.
[0123] The catheter body 268 can be configured to be biased to
curve upwardly adjacent to the opening 266 in any of a number of
different ways. In some embodiments, a preformed, shaped mandrel,
such as, without limitation, the shaped mandrel 272 shown in FIG.
18C, can be embedded or otherwise positioned within the catheter
body 268 so as to bias the catheter body 268 to curve upwardly
adjacent to the opening 266. As illustrated in FIG. 18C, the shaped
mandrel 272 can have a curve or angle 274 configured to coincide
with the location of the opening 266 formed in the catheter body
268 when the mandrel 270 has been positioned within the catheter
body 268.
[0124] In some embodiments, the catheter body 268 can be configured
such that, when the catheter is in the shorter inserted length
configuration, as shown in FIG. 18B, the angle of curvature of the
catheter body 268 at or adjacent to the opening 266 (represented by
angle X as shown in FIG. 18B) can be approximately 30 degrees
relative to the proximal portion of the catheter body 268. In some
embodiments, the angle of curvature of the catheter body 268 at or
adjacent to the opening 266 can be from approximately 5 degrees or
less to approximately 30 degrees or more, or from approximately 30
degrees to approximately 50 degrees relative to the proximal
portion of the catheter body 268. Additionally, in some
embodiments, the desired angle of curvature of the catheter body
268 at or adjacent to the opening 266 can be selected based on the
size of the opening 266 formed in the catheter body 268, the size
of the guidewire to be advanced through the opening 266, and/or the
smallest bend radius that can be substantially straightened by
advancing the sheath 264 thereover. Therefore, in some embodiments,
the angle of the catheter body 268 in the first position can be
greater than the angle of the catheter body 268 in the second
position. The angle of the catheter body 268 in the first position
can be substantially greater than the angle of the catheter body
268 in the second position.
[0125] In some embodiments, the opening 266 can be configured such
so that the angle required to divert a guidewire out of the
guidewire lumen can be minimized. For example, without limitation,
a proximal portion of the opening 266 can be angled or beveled so
that a guidewire exiting the opening 266 when the catheter body 268
is in an angled (i.e., first configuration), the guidewire will not
be obstructed from exiting the opening 266 by the sidewall of the
catheter body 268.
[0126] As discussed in greater detail below, in some embodiments, a
removable mandrel (not illustrated) can move the catheter body 268
between the first and second configurations. The mandrel can have a
predetermined angle at an inflection point that can correspond with
the inflection point of the catheter body.
[0127] Accordingly, in some embodiments, the shaped mandrel can be
positioned within an inflation lumen of the catheter body 268,
imbedded within the wall of the catheter body, or positioned within
a separate lumen configured to receive the shaped mandrel. The
shaped mandrel can be formed from Nitinol heat set in the angled
shape, or from stainless steel or any other suitable material. In
some embodiments, the catheter body 268 can be formed or heat set
to have the desired angle adjacent to the opening 266 so that an
angled or shaped mandrel is not required.
[0128] The catheter body 268 can be configured such that, when the
longer inserted length configuration of the catheter body 268 is
desired, such as is illustrated in FIG. 18A, the slideable assembly
262 can be extended distally in the direction A5 so that the sheath
264 covers the opening 266. In some embodiments, though not
required, the sheath 264 can be configured to overcome the angled
or curved bias of the catheter body 268 to substantially straighten
the catheter body 268 as the sheath 264 is being advanced over the
opening 266 in the catheter body 268. Additionally, in some
embodiments, a mandrel can be advanced through a lumen in the
catheter body, such as the inflation lumen, to substantially
straighten the catheter body 268 adjacent to the opening 266, when
the longer inserted length configuration is desired. However, in
some embodiments, the catheter system 260 can be configured such
that the catheter body 268 remains at least partially curved or
angled adjacent to the opening 266 in the longer inserted length
configuration. Then the catheter can be loaded onto the guide wire
and advanced until the guide wire passes through the proximal end
268a of the catheter body 268. In some embodiments, a user can move
the catheter body 268 with his or her hands to change the catheter
body 268 from an angled configuration to an approximately straight
configuration. The catheter body 268 can be configured to be biased
to remain in either the angled or the straight configuration.
[0129] In some embodiments, the opening 266 or any other port or
notch herein can be positioned relative to the distal end of the
catheter body 268 to ensure that a sufficient length of the
catheter body 268 is provided distal of the opening 266.
Positioning the opening 266 as described can ensure that the
opening 266 remains outside of (i.e., proximal of) the introducer
sheath when a guidewire is advanced through the opening 266, and
throughout a procedure in some cases. These features minimize the
chance for tissue within the vasculature getting trapped between a
guidewire and the body of the catheter 260 or the opening 266,
which could lead to injury to the patient.
[0130] FIG. 19 is a perspective view of another embodiment of a
catheter system 300. Some embodiments of the catheter system 300
can have one or any combination of the same features, components,
configurations, or details of any other catheter system embodiments
disclosed herein. As illustrated FIG. 19, the catheter system can
have a catheter body 302 having an inflation port 304 in
communication with an inflation lumen, and a guidewire lumen for
receiving a guidewire. In some embodiments, the catheter body 302
can be curved or angled, such as with the embodiment of the
catheter body 268 described above, or in some embodiments, the
catheter body 302 can be can be straight, as described above. A
slider mechanism 306 having a housing 308 and a release mechanism
310 can be supported by the catheter body 302. The housing 308 can
have a first cover 308a and a second cover 308b that can be held
together about the catheter body 302 using adhesive, snap fit
features, press fit features, sonic welds, or other suitable
components or features.
[0131] FIG. 20 is a perspective view of the embodiment of a
catheter system 300, with the second cover 308b removed for
clarity. FIG. 21 is an exploded view of the catheter system 300.
With reference to FIGS. 19-21, the slider mechanism 306 can have a
tip member 314 that can project from the distal end portion of the
housing 308. The tip member 314 can provide additional support to
the catheter body 302 to substantially prevent the catheter body
302 from kinking or collapsing at a position that is distal of the
housing 308. The tip member 314 can be strain relief device of any
suitable configuration. Additionally, the slider mechanism 306 or
the tip member 314 can support an outer sheath 316, which can
project distally from the end of the tip member 314. With reference
to FIG. 20, in some embodiments, the tip member 314 can be radially
and axially supported within the housing 308 such that the tip
member 314 and the outer sheath are substantially prevented from
translating in an axial direction relative to the housing 308. In
some embodiments, the housing 308 and/or tip member 314 can have
annular protrusions, annular channels, tabs, depressions, or other
features to substantially prevent the tip member 314 and the outer
sheath from translating in the axial direction relative to the
housing 308. In this arrangement, the tip member 314 and the outer
sheath 316 can move with the housing 308 and other components of
the slider mechanism 306 when the slider mechanism 306 is moved
between at least a first and a second position.
[0132] The outer sheath 316 can be configured to extend over an
outside surface of the portion of the catheter body 302 that
extends distally beyond the housing 308. Similar to other
embodiments of catheter systems disclosed herein, the outer sheath
316 can be configured to translate axially between at least a first
and a second position so as to selectively expose or cover an
opening (not illustrated) in the catheter body 302 through which a
guidewire (not illustrated) can be advanced. For example, when
slider mechanism is translated to the first position such that the
catheter system 300 is in a first or longer inserted length
configuration, the sheath 316 can cover the opening in the catheter
body 302. In this configuration, a guidewire can be advanced
proximally past the opening in the catheter body 302 and continue
through the guidewire lumen to the proximal end of the catheter
body 302. Alternatively, when slider mechanism is translated to the
second position such that the catheter system 300 is in a second or
shorter inserted length configuration, the sheath 316 can expose
the opening in the catheter body 302 so that a guidewire can be
advanced through the opening in the catheter body so as to exit the
catheter body 302 through the opening.
[0133] As will be described, the slider mechanism 306 can be moved
from a first position, as illustrated in FIG. 20 wherein the slider
mechanism 306 is in a forward position relative to the catheter
body 302, to a second position (not illustrated) wherein the slider
mechanism 306 is in a rearward position relative to the catheter
body 302. In some embodiments, the slider mechanism 306 can be
configured to engage with at least two channels 320, 322 formed in
the catheter body 302. The slider mechanism 306 is in the first or
forward position when engaged with channel 320 (as illustrated in
FIG. 20), and is in the second or rearward position when engaged
with channel 322. With reference to FIG. 21, the release mechanism
310 that is supported within the housing 308 can be configured to
selectively engage with the channels 320, 322. A spring member 324,
which can be a cantilevered spring member, can bias a tab or other
protrusion (not illustrated) supported by the release mechanism 310
in the direction defined by arrow A7 shown in FIG. 20 to
selectively engage with the channels 320, 322.
[0134] A portion of the release mechanism 310 can project through
an opening 330 in the housing 308 so that a user can depress the
release mechanism 310 against the bias of the spring member 324, so
that the housing 308 and the sheath 316 can be translated axially
between at least the first and second positions. In this
arrangement, a user can depress the release mechanism 310 in the
direction defined by arrow A8 in FIG. 20 to allow the housing 308
to slide or translate axially relative to the catheter body 302.
Channels, protrusions, or other features, such as the channels 334
formed on the inside of the housing 306 can be configured to engage
with or receive the catheter body 302 to provide increased support
to the housing 308 as the housing 308 is translated relative to the
catheter body 302. Additionally, in some embodiments, a stop or tab
336 can be formed on the catheter body 302 to prevent the
over-translation of the housing 308 relative to the catheter body
302.
[0135] In some embodiments, openings 338 can be formed in the
housing 308 to allow a user to view the position of the housing 308
relative to the catheter body 302, or to view other aspects of the
catheter body 302. Further, in some embodiments, the catheter
system 300 can support a mandrel 340 having a handle portion 342.
The mandrel 340 can be advanceable within a lumen formed in the
catheter body 302, such as an inflation lumen or separate lumen
configured to receive the mandrel 340. The mandrel 340 can have any
of the same features or shapes of any of the other mandrels
disclosed herein.
[0136] FIG. 22 is a perspective view of another embodiment of a
catheter system 400. Some embodiments of the catheter system 400
can have one or any combination of the same features, components,
configurations, or details of any other catheter system embodiments
disclosed herein. As illustrated FIG. 22, the catheter system can
have a catheter body 402 having an inflation port 404 in
communication with an inflation lumen, and a guidewire lumen for
receiving a guidewire. In some embodiments, the catheter body 402
can be curved or angled, such as with the embodiment of the
catheter body 268 described above, or in some embodiments, the
catheter body 402 can be can be straight, as described above. A
slider mechanism 406 can be supported within a housing 408. The
slider mechanism can have a release mechanism 410 configured to
selective secure the slider mechanism 406 in the axial direction in
one of two or more predetermined positions. The housing 408 can
have a first cover 408a and a second cover 408b that can be held
together about the catheter body 402 using adhesive, snap fit
features, press fit features, sonic welds, or other suitable
components or features.
[0137] FIGS. 23 and 24 are a perspective view and a top view,
respectively, of the embodiment of a catheter system 400, with the
second cover 408b removed for clarity. With reference to FIGS.
22-23, the slider mechanism 406 can have a tip member or strain
relief device (not illustrated) that can be similar to the tip
member 314 described above that can project from the distal end
portion of the housing 408. The tip member can provide additional
support to the catheter body 402 to substantially prevent the
catheter body 402 from kinking or collapsing at a position that is
distal of the housing 408. Additionally, the slider mechanism 406
can support an outer sheath 416, which can project distally from
the end of the tip member. In some embodiments, the tip member can
be radially and axially supported within the housing 408 such that
the tip member and the outer sheath are substantially prevented
from translating in an axial direction relative to the housing 408.
In some embodiments, the housing 408 and/or tip member can have
annular protrusions, annular channels, tabs, depressions, or other
features to substantially prevent the tip member and the outer
sheath from translating in the axial direction relative to the
housing 408. In this arrangement, the tip member and the outer
sheath 416 can move with the housing 408 and other components of
the slider mechanism 406 when the slider mechanism 406 is moved
between at least a first and a second position.
[0138] The outer sheath 416 can be configured to extend over an
outside surface of the portion of the catheter body 402 that
extends distally beyond the housing 408. Similar to other
embodiments of catheter systems disclosed herein, the outer sheath
416 can be configured to translate axially between at least a first
and a second position so as to selectively expose or cover an
opening (not illustrated) in the catheter body 402 through which a
guidewire (not illustrated) can be advanced. For example, when
slider mechanism is translated to the first position such that the
catheter system 400 is in a first or longer inserted length
configuration, the sheath 416 can cover the opening in the catheter
body 402. In this configuration, a guidewire can be advanced
proximally past the opening in the catheter body 402 and continue
through the guidewire lumen to the proximal end of the catheter
body 402. Alternatively, when slider mechanism is translated to the
second position such that the catheter system 400 is in a second or
shorter inserted length configuration, the sheath 416 can expose
the opening in the catheter body 402 so that a guidewire can be
advanced through the opening in the catheter body so as to exit the
catheter body 402 through the opening.
[0139] As will be described, the slider mechanism 406 can be moved
from a first position, as illustrated in FIG. 23 wherein the slider
mechanism 406 is in a forward position relative to the catheter
body 402, to a second position (not illustrated) wherein the slider
mechanism 406 is in a rearward position relative to the catheter
body 402. In some embodiments, the slider mechanism 406 can be
configured to engage with at least two channels 420, 422 formed in
the housing 408. The slider mechanism 406 is in the first or
forward position when engaged with channel 420 (as illustrated in
FIG. 23), and is in the second or rearward position when engaged
with channel 422. With reference to FIG. 21, the release mechanism
410 can have one or more opposing tabs 411 that can selectively
engage with the channels 420, 422. The channels 420, 422 can be
formed in radially opposing positions in the housing 408. A spring
member 424, which can be a cantilevered spring member, can bias
each of the opposing tabs 411 supported by the release mechanism
410 in the direction defined by arrows A9 shown in FIG. 20 to
selectively engage with the channels 420, 422.
[0140] As illustrated, the tabs 411 can engage with the channels
420, 422 and extend through the housing 408 so that a user can
depress the release mechanism 410 against the bias of the spring
member 424 by squeezing the tabs 411 together in the direction
defined by arrows A10 shown in FIG. 23, so that the slider
mechanism 406 and the sheath 416 can be translated axially between
at least the first and second positions. Channels, protrusions, or
other features, such as the protrusions 434 formed on the inside of
the housing 406 can be configured to engage with or receive the
slider mechanism 406 to provide increased support to the slider
mechanism 406 as the slider mechanism 406 is translated relative to
the catheter body 402.
[0141] In some embodiments, openings (not illustrated) can be
formed in the housing 408 to allow a user to view the position of
the housing 408 relative to the catheter body 402, or to view other
aspects of the catheter body 402. Further, in some embodiments, the
catheter system 400 can support a mandrel 440 having a handle
portion 442. The mandrel 440 can be advanceable within a lumen
formed in the catheter body 402, such as an inflation lumen or
separate lumen configured to receive the mandrel 440. The mandrel
440 can have any of the same features or shapes of any of the other
mandrels disclosed herein.
[0142] Although the inventions have been disclosed in the context
of a certain preferred embodiments and examples, it will be
understood by those skilled in the art that the present inventions
extend beyond the specifically disclosed embodiments to other
alternative embodiments and/or uses of the inventions and obvious
modifications and equivalents thereof. In addition, while a number
of variations of the inventions have been shown and described in
detail, other modifications, which are within the scope of the
inventions, will be readily apparent to those of skill in the art
based upon this disclosure. It can be also contemplated that
various combinations or subcombinations of the specific features
and aspects of the embodiments may be made and still fall within
the scope of the inventions. Accordingly, it should be understood
that various features and aspects of the disclosed embodiments can
be combined with or substituted for one another in order to form
varying modes of the disclosed inventions. Thus, it can be intended
that the scope of the present inventions herein disclosed should
not be limited by the particular disclosed embodiments described
above.
* * * * *