U.S. patent application number 10/085149 was filed with the patent office on 2002-09-05 for embolic protection filter delivery sheath.
This patent application is currently assigned to SciMed Life Systems, Inc.. Invention is credited to Cassell, Robert L., Deyette, Thomas JR., Forsberg, Andrew, Hart, Colin P., Lowe, Brian J..
Application Number | 20020123755 10/085149 |
Document ID | / |
Family ID | 26772355 |
Filed Date | 2002-09-05 |
United States Patent
Application |
20020123755 |
Kind Code |
A1 |
Lowe, Brian J. ; et
al. |
September 5, 2002 |
Embolic protection filter delivery sheath
Abstract
Embolic protection sheath and method of using the same. In some
embodiments, the present invention includes an elongate shaft, an
embolic protection filter coupled to the shaft, and a sheath
disposed over at least a portion of the shaft.
Inventors: |
Lowe, Brian J.; (Zimmerman,
MN) ; Cassell, Robert L.; (Otsego, MN) ;
Forsberg, Andrew; (Minneapolis, MN) ; Hart, Colin
P.; (Queensbury, NY) ; Deyette, Thomas JR.;
(Hudson Falls, NY) |
Correspondence
Address: |
Glenn M. Seager
CROMPTON, SEAGER & TUFTE, LLC
Suite 895
331 Second Avenue South
Minneapolis
MN
55401-2246
US
|
Assignee: |
SciMed Life Systems, Inc.
|
Family ID: |
26772355 |
Appl. No.: |
10/085149 |
Filed: |
February 27, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60272544 |
Mar 1, 2001 |
|
|
|
Current U.S.
Class: |
606/108 ;
606/200 |
Current CPC
Class: |
A61F 2230/0006 20130101;
A61F 2230/0067 20130101; A61M 25/0668 20130101; A61F 2230/005
20130101; A61F 2/97 20130101; A61F 2/011 20200501; A61F 2002/018
20130101; A61F 2/0108 20200501 |
Class at
Publication: |
606/108 ;
606/200 |
International
Class: |
A61F 011/00 |
Claims
What is claimed is:
1. An apparatus for delivering an intravascular filter, comprising
an elongate sheath having a proximal end, a distal end, and a lumen
extending therethrough; an elongate shaft having a proximal end and
a distal end, the shaft adapted for being disposed within the lumen
of the sheath; a filter coupled to the shaft; a manifold coupled to
the proximal end of the sheath; and a cutting blade coupled to the
manifold.
2. The apparatus in accordance with claim 1, wherein the sheath has
a flared distal end.
3. The apparatus in accordance with claim 1, wherein the manifold
includes a hypodermic tube having a lumen configured for having the
shaft disposed therein.
4. The apparatus in accordance with claim 1, wherein a collet for
securing the shaft is coupled to the manifold.
5. The apparatus in accordance with claim 1, wherein the manifold
further comprises a luer fitting.
6. The apparatus in accordance with claim 1, wherein the blade
includes a distally disposed cutting edge.
7. An apparatus for delivering an intravascular filter, comprising
an elongate sheath having a proximal end, a distal end, a
longitudinal axis, and a lumen extending therethrough; wherein the
sheath includes a slit along at least a portion of the longitudinal
axis of the sheath; an elongate shaft having a proximal end and a
distal end, the shaft adapted for being disposed within the lumen
of the sheath; a filter coupled to the distal end of the shaft; a
manifold coupled to the proximal end of the sheath; and a pull tab
attached to the proximal end of the sheath, the pull tab releasably
coupled to the manifold.
8. The apparatus in accordance with claim 7, wherein the sheath has
a flared distal end.
9. The apparatus in accordance with claim 7, wherein the manifold
includes a hypodermic tube having a lumen configured for having the
shaft disposed therein.
10. The apparatus in accordance with claim 7, wherein a collet for
securing the shaft is coupled to the manifold.
11. The apparatus in accordance with claim 7, wherein the manifold
further comprises a luer fitting.
12. The apparatus in accordance with claim 7, further comprising a
cutting blade coupled to the manifold.
13. The apparatus in accordance with claim 12, wherein the blade
includes a distally disposed cutting edge.
14. An apparatus for delivering an intravascular filter, comprising
an elongate sheath having a proximal end, a distal end, a
longitudinal axis, and a lumen extending therethrough; an elongate
shaft having a proximal end and a distal end, the shaft adapted for
being disposed within the lumen of the sheath; a filter coupled to
the distal end of the shaft; a manifold coupled to the proximal end
of the sheath; a pull tab attached to the proximal end of the
sheath, the pull tab releasably coupled to the manifold; and means
for longitudinally opening the sheath.
15. The apparatus in accordance with claim 14, wherein means for
longitudinally opening the sheath includes a slit along at least a
portion of the longitudinal axis of the sheath.
16. The apparatus in accordance with claim 14, wherein means for
longitudinally opening the sheath includes a cutting blade coupled
to the manifold.
17. A method of delivering an intravascular filtering device,
comprising the steps of: providing a delivery catheter assembly
including an outer sheath having a proximal end, a distal end, a
longitudinal axis, and a lumen extending therethrough; an elongate
shaft having a proximal end and a distal end; a filter coupled to
the shaft; advancing the delivery catheter through a blood vessel
to an area of interest; and splitting the sheath along at least a
portion of the longitudinal axis thereof removal the sheath at
least in part from the vessel.
18. The method in accordance with claim 17, wherein the filter is
configured to shift between a first generally collapsed
configuration and a second generally expanded configuration, and
wherein the step of removing the sheath from the blood vessel
shifts the filter from the first configuration to the second
configuration.
19. The method in accordance with claim 17, wherein the step of
splitting the sheath along at least a portion of the longitudinal
axis thereof occurs after advancing the delivery catheter through
the blood vessel.
20. A method of delivering an intravascular filtering device,
comprising the steps of: providing a delivery catheter assembly
including an outer sheath having a proximal end, a distal end, a
longitudinal axis, and a lumen extending therethrough; an elongate
shaft having a proximal end and a distal end; a filter coupled to
the distal end of the shaft; a manifold coupled to the distal end
of the sheath; a pull tab attached to the proximal end of the
sheath, the pull tab releasably coupled to the manifold; and a
cutting blade coupled to the manifold; advancing the delivery
catheter through a blood vessel to an area of interest; fixing the
position of the shaft relative to the manifold; and actuating the
pull tab so as to split the sheath along at least a portion of the
longitudinal axis thereof.
21. The method in accordance with claim 20, wherein the filter is
configured to shift between a first generally collapsed
configuration and a second generally expanded configuration, and
wherein the step of actuating the pull tab so as to remove the
sheath from the blood vessel shifts the filter from the first
configuration to the second configuration.
22. The method in accordance with claim 20, wherein sheath includes
a longitudinal slit disposed along at least a portion of the
longitudinal axis of the sheath, and wherein the step of actuating
the pull tab so as to split the sheath along at least a portion of
the longitudinal axis thereof includes longitudinally splitting the
sheath along the longitudinal axis proximate the slit.
23. The method in accordance with claim 20, wherein the step of
actuating the pull tab so as to split the sheath along at least a
portion of the longitudinal axis thereof using the pull to pull the
sheath across the cutting blade.
24. The method in accordance with claim 20, wherein the manifold
includes a collet, and wherein the step of fixing the position of
the shaft relative to the manifold includes securing the shaft to
the manifold with the collet.
25. The method in accordance with claim 20, further comprising the
step of releasing the shaft relative to the manifold.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority to
co-pending provisional U.S. Patent Application Serial No.
60/272,544, filed Mar. 1, 2001 entitled DISTAL PROTECTION FILTER
DELIVERY SHATH, the entire disclosure of which is herein
incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention pertains generally to the field of
embolic distal protection. More particularly, the invention
pertains to embolic and distal protection filters.
BACKGROUND OF THE INVENTION
[0003] Embolic protection filters can be used to collect debris
dislodged when performing a procedure in a vessel. For example, an
embolic protection filter can be placed distally of a lesion in a
coronary artery when performing angioplasty. The embolic protection
filter is first placed distally of the lesion. An angioplasty
catheter can then be advanced to the lesion. The lesion is then
dilated. Debris dislodged by the dilation of the lesion can be
captured by a filter. After dilatation of the lesion, the
angioplasty catheter is removed as well as the filter containing
the debris.
SUMMARY OF THE INVENTION
[0004] The present invention pertains to an embolic protection
filter delivery sheath assembly. The present invention include an
elongate sheath, an elongate shaft (e.g., a guidewire or filter
wire) adapted for being disposed with in the sheath, a filter
coupled to the shaft, and a manifold coupled to the sheath. In some
embodiments, the manifold including a sheath cutting blade. The
sheath cutting blade can be used to split the sheath
longitudinally, so that the sheath can be peeled away from the
filter wire. In some embodiments, the sheath may include a slit
that can allow the sheath to be spit whether the cutting blade is
present or absent.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 is a cross-sectional view of an embodiment of an
embolic protection filter delivery sheath assembly in accordance
with the present invention.
DETAILED DESCRIPTION
[0006] The following description should be read with reference to
the drawings wherein like reference numerals indicate like elements
throughout the several views. The detailed description and drawings
illustrate example embodiments of the claimed invention.
[0007] FIG. 1 is a cross-sectional view of an embolic protection
filter delivery sheath assembly 10 in accordance with the present
invention. Assembly 10 includes a tubular sheath 12 having a
generally cylindrical larger diameter portion 14 and a proximal end
16. Sheath 12 may also include an opening 18 through a side wall
near proximal end 16. An elongate shaft or wire 20 having an
embolic protection filter coupled thereto can be slidably disposed
within sheath 12.
[0008] It can be appreciated that sheath 12 is generally tubular
and may comprise a number of different medical devices such as a
catheter (e.g., a guide, diagnostic, or therapeutic catheter).
Sheath 12 may be comprised of a polymer. For example, sheath 12 may
be comprised of polyethylene (PE), polypropylene (PP),
polyvinylchloride (PVC), polyether block amide (PEBA), or other
suitable materials. Alternatively, sheath 12 may be comprised of a
metal, metal alloy, or metal-polymer composite. In general, sheath
12 is comprised of materials having an appropriate amount of
flexibility, torquability, and pushability to allow sheath 12 to be
advanced through a blood vessel or other body lumen.
[0009] Wire 20 may comprise a guidewire, filter wire, or other
suitable device. Wire 20 is generally metallic and may be comprised
of, for example, stainless steel, nickel-titanium alloy, or other
suitable materials. In embodiments where wire 20 is a guidewire,
wire 20 may includes a distal tip 24, for example including a coil
or spring. In some embodiments, a stop 26 is disposed on wire 20
proximally of filter 22.
[0010] Filter 22 may be comprised of a polyurethane sheet disposed
over a filter frame. The polyurethane sheet has at least one
opening that may be, for example, formed by known laser techniques.
The holes or openings are sized to allow blood flow therethrough
but restrict flow of debris or emboli floating in the body lumen or
cavity. In some embodiments, the filter frame may include one or
more struts 25 extending between filter 22 and wire 20.
[0011] Filter 22 is adapted to shift between a first generally
closed collapsed configuration and a second generally expanded
configuration for collecting debris in a body lumen. In some
embodiments, filter 22 is biased to be in the expanded
configuration. Thus, filter 22 can be at least partially collapsed
within sheath 12 and may "self-expand" when sheath 12 is withdrawn
from filter 22.
[0012] Embolic protection filter delivery sheath assembly 10
includes a manifold housing 28 located at proximal end 16 of sheath
12. Manifold housing 28 is available to the clinician for
manipulating or otherwise actuating or holding assembly 10. It can
be appreciated that modifications to the general shape or material
composition of manifold housing 28 can be substituted without
departing from the spirit of the invention.
[0013] A hypotube 29 can be affixed to and/or disposed within
manifold housing 28 (and/or within a lumen defined by housing 28).
Hypotube 29 may serve as a conduit for wire 20 to pass through or
otherwise separate from sheath 12. Separation of sheath 12 and wire
20 may be important because sheath 12 may need to be moved relative
to wire 20. Moving sheath 12 in the proximal direction relative to
wire 20 may allow filter 22 to shift from the collapsed
configuration to the expanded configuration.
[0014] A blade 30 can be affixed to or within housing 28. Blade 30
may include a distally disposed cutting edge 32. Blade 30 is
configured to cut or otherwise split sheath 12. In some
embodiments, sheath 12 can be cut by pulling sheath 12 across blade
30 and/or cutting edge 32.
[0015] A proximal portion of sheath 12 is disposed within an
opening 34 defined by manifold housing 28. Opening 34 may define a
position where sheath 12 and wire 20 are separated by manifold
housing 28. A opening 34, sheath 12 may curve or bend laterally
(i.e., away from the longitudinal axis along the majority of the
length of sheath 12). Wire 20 generally continues in the direction
of the longitudinal axis. A portion of filter wire 20 can extend
longitudinally through hypotube 29 and can be held in place
relative to manifold 28 (and, thus, sheath 12) by a collet 36
threadably connected to housing 28. Housing 28 also includes a lure
fitting 38 for prepping sheath 10.
[0016] A pull tab 40 is releasably connected to housing 28. Distal
end 16 of sheath 12 is connected to pull tab 40 by adhesive or
another method. Pull tab 40 and sheath 12 are connected at or near
the portion of sheath 14 that curves laterally away from the
longitudinal axis. Pull tab 40 may, for example, comprise a thumb
ring, finger ring, or other graspable surface that can be pulled
away from manifold housing 28. Because sheath 12 is connected to
pull tab 40, pull tab 40 may be used to move sheath 12. Sheath 12
may be split, cut, opened, etc. by using pull tab 40 to pull sheath
12 across blade 30. In embodiments where sheath 12 includes a slit,
actuating pull tab 40 may allow sheath 12 to become spit along the
slit.
[0017] Embolic protection filter delivery sheath 10 can be used in
conjunction with filter 22 to provide embolic protection from
embolism during procedures performed in a patient's vasculature.
For example, filter 22 can be delivered distally of a coronary
lesion using assembly 10. Prior to delivery, filter 22 is
positioned in sheath 12 as shown. Collet 36 is tightened to fix the
position of filter 22 relative to manifold 28 (and sheath 12).
Saline is introduced through lure fitting 38 and hypotube 29 to
flush air from sheath 12 and distal larger diameter portion 14.
When filter 22 is positioned as shown in FIG. 1, sheath 12 and
filter 22 can be advanced through a blood vessel or body lumen to a
location distal of the lesion to be treated.
[0018] Once sheath 10 and filter 22 are advanced distally of the
lesion, sheath 12 is "peeled away", generally moved proximally,
and/or removed from the blood vessel to deploy filter 22. In some
embodiments, sheath 12 is completed removed from assembly 10 (and,
thus, the blood vessel). When sheath 12 is removed, an angioplasty
catheter (or any other suitable guide, diagnostic, or therapeutic
catheter) can be advanced over filter wire 20 to the lesion. The
lesion may then be dilated by the angioplasty catheter. The
angioplasty catheter and filter assembly 10 may then removed.
[0019] To remove sheath 10 from filter wire 20 and filter 22, pull
tab 40 is pulled from manifold 28 generally in the direction of
arrow A. This will draw sheath 12 proximally as shown by arrows B.
As sheath 12 moves in the direction of arrows B, sheath 12 is
sliced longitudinally by cutting edge 32 of blade 30. Thus, an
elongate slit will extend from side opening 18 and distal larger
diameter portion 14 will move proximally until it becomes disposed
proximate manifold 28. In some embodiments, collet 36 is loosened
and manifold 28 and larger diameter portion 14 may be removed
proximally from filter wire 20. Alternatively, pull tab 40 may be
actuated until the entire length of sheath 12 is sliced open and
can be removed from assembly 10 and/or the blood vessel.
[0020] It can be appreciated that a slit can be preformed in sheath
12 such that blade 32 would not be necessary. Alternately, a narrow
longitudinal region of sheath 12 could be thinned to peel away
sheath 12 from wire 20 without the need of blade 30.
[0021] By peeling or otherwise removing sheath 12 at least in part
away from wire 20 rather than removing it entirely over the
proximal end wire 20, a shorter filter wire 20 can be used. Thus,
if sheath 12 is split along a sufficient amount of its length, wire
20 can be short enough to enable single operator removal of sheath
12.
[0022] It should be understood that this disclosure is, in many
respects, only illustrative. Changes may be made in details,
particularly in matters of shape, size, and arrangement of steps
without exceeding the scope of the invention. The invention's scope
is, of course, defined in the language in which the appended claims
are expressed.
* * * * *