U.S. patent application number 11/206702 was filed with the patent office on 2005-12-22 for methods, systems, and devices for providing embolic protection.
Invention is credited to Edmiston, Daryl R., Johnson, Steven W., Linder, Richard J..
Application Number | 20050283185 11/206702 |
Document ID | / |
Family ID | 27539153 |
Filed Date | 2005-12-22 |
United States Patent
Application |
20050283185 |
Kind Code |
A1 |
Linder, Richard J. ; et
al. |
December 22, 2005 |
Methods, systems, and devices for providing embolic protection
Abstract
A filter device is adapted to function as a guidewire, an
exchange guidewire, and provide embolic protection during a
procedure. The filter device includes a filter assembly that is
either integral with or coupled to a guide member. The filter
assembly includes a plurality of struts that expand outwardly to
deploy a filter that collects or captures material flowing along
the blood vessel within which the filter device is deployed. The
plurality of struts are constrained by a restraining member or
mechanism that prevents the plurality of struts from expanding or
extending outwardly to deploy the filter. Cooperating with the
restraining member or mechanism is an actuating assembly that is
adapted to release the restraining member or mechanism and enable
the filter to be deployed from the guide member. A capture catheter
that cooperates with the filter device and substantially surrounds
the filter during removal of the filter device.
Inventors: |
Linder, Richard J.; (Sandy,
UT) ; Edmiston, Daryl R.; (Sandy, UT) ;
Johnson, Steven W.; (West Jordan, UT) |
Correspondence
Address: |
CROMPTON, SEAGER & TUFTE, LLC
1221 NICOLLET AVENUE
SUITE 800
MINNEAPOLIS
MN
55403-2420
US
|
Family ID: |
27539153 |
Appl. No.: |
11/206702 |
Filed: |
August 18, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11206702 |
Aug 18, 2005 |
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10186304 |
Jun 28, 2002 |
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6962598 |
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60302417 |
Jul 2, 2001 |
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60345333 |
Nov 9, 2001 |
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60347500 |
Jan 11, 2002 |
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60341092 |
Dec 12, 2001 |
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Current U.S.
Class: |
606/200 |
Current CPC
Class: |
A61F 2230/008 20130101;
A61F 2230/0006 20130101; A61F 2/011 20200501; A61F 2/01 20130101;
A61F 2002/018 20130101 |
Class at
Publication: |
606/200 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A filter device comprising: (a) a guide member comprising a
distal end, a proximal end, and a lumen extending from the distal
end to the proximal end, (b) a plurality of struts coupled to said
guide member, at least one of said plurality of struts being biased
to extend outwardly; (c) a filter coupled to at least two of said
plurality of struts, said filter being adapted to filter material
from a blood stream; and (d) means for preventing said plurality of
struts extending outwardly until said filter is to be deployed into
a blood vessel.
2. A filter device as recited in claim 1, wherein each strut of
said plurality of struts is adapted to extend outwardly away from a
longitudinal axis of said lumen.
3. A filter device as recited in claim 1, wherein each strut of
said plurality of struts comprises a proximal portion separated
from a distal portion by an intermediate portion, wherein a
cross-sectional dimension of said distal portion is larger than a
cross-sectional dimension of said intermediate portion.
4. A filter device as recited in claim 1, wherein each strut of
said plurality of struts comprises a proximal portion separated
from a distal portion by an intermediate portion, wherein a length
of each strut is varied to control a biasing force of each
strut.
5. A filter device as recited in claim 1, wherein each strut of
said plurality of struts comprises a proximal portion separated
from a distal portion by an intermediate portion, wherein a
curvature of each strut is varied to control a biasing force of
each strut.
6. A filter device as recited in claim 1, wherein said means for
filtering comprises a filter, said filter comprising a plurality of
pores.
7. A filter device as recited in claim 1, wherein said guide member
comprises an atraumatic tip.
8. A filter device as recited in claim 1, wherein at least one of
said plurality of struts is biased toward a longitudinal axis of
said lumen.
9. A filter device as recited in claim 1, wherein at least one of
said plurality of struts comprises an atraumatic tip coil.
10. A filter device as recited in claim 1, further comprising at
least one radiopaque marker.
11. A filter device as recited in claim 1, wherein a portion of
said guide member is made radiopaque.
12. A filter device comprising: (a) a guide member comprising a
distal end, a proximal end, and a lumen extending from the distal
end to the proximal end; (b) a strut assembly coupled to said
distal end of said guide member, said strut assembly comprising a
plurality of struts, at least one of said plurality of struts being
biased to extend outwardly away from a longitudinal axis of said
lumen of said guide member; (c) a filter coupled to at least one of
said plurality of struts, said filter being adapted to filter
material from fluid flowing in a fluid stream within which said
filter is disposed; and (d) a restraining member surrounding at
least one of said plurality of struts and said distal end of said
guide member, said restraining member being adapted to prevent said
plurality of struts extending outwardly and subsequently release
said plurality of struts when said filter is to be deployed into
the fluid stream.
13. A filter device as recited in claim 12, wherein each strut of
said plurality of struts has at least one portion that has a
cross-sectional dimension larger than at least one another portion
thereof.
14. A filter device as recited in claim 12, wherein a length of
each strut of said plurality of struts is varied to control a
biasing force of each strut.
15. A filter device as recited in claim 12, wherein a curvature of
each strut of said plurality of struts is varied to control a
biasing force of each strut.
16. A filter device as recited in claim 12, wherein said filter
comprises a plurality of pores, at least two of said plurality of
pores being differently configured one from another.
17. A filter device as recited in claim 16, wherein each of said
plurality of pores is sized in the range from about 50 microns to
about 200 microns.
18. A filter device as recited in claim 12, wherein said
restraining member is adapted to be moved in a proximal direction
to enable said plurality of struts to extend outwardly.
19. A filter device as recited in claim 18, further comprising an
actuating member coupled to said restraining member and extending
substantially to said proximal end of said guide member, said
actuating member being adapted to move in the proximal direction to
move said restraining member in the proximal direction.
20. A filter device as recited in claim 12, wherein said
restraining member is attached to each of said plurality of struts,
said restraining member comprising at least one preferential
separation region.
21. A filter device as recited in claim 20, further comprising at
least one actuating member cooperating with said at least one
preferential separation region, said at least one actuating member
adapted to cause said restraining member to preferentially separate
at said at least one preferential separation region.
22. A filter device as recited in claim 20, wherein said
preferential separation region dissolves based upon a chemical
reaction between said restraining member and said fluid.
23. A filter device as recited in claim 20, wherein said
preferential separation region separates under the influence of at
least one of heat, ultrasonic energy, or radio frequency
energy.
24. A filter device as recited in claim 12, wherein said
restraining member comprises a plurality of hoops, each of said
plurality of hoops being adapted to receive a securing member.
25. A filter device as recited in claim 12, wherein said
restraining member comprises a first portion and a second portion,
said first and second portions being maintained substantially
together by stitching a securing member through said restraining
member substantially at said first portion and said second
portion.
26. A filter device as recited in claim 12, wherein said
restraining member comprises a first side and a second side, each
side comprises a plurality of extensions.
27. A filter device as recited in claim 26, wherein one or more
extensions of said plurality of extensions on said first end are
offset from one or more extensions of said plurality of extensions
on said second end.
28. A filter device as recited in claim 27, wherein each of said
plurality of extensions are folded to form one or more channels
through which a securing member is disposed to cause said
restraining member to prevent said plurality of struts extending
outwardly.
29. A filter device as recited in claim 12, wherein said
restraining member comprises at least one tubular member coupled to
at least one of said plurality of struts, said at least one tubular
member being adapted to receive a securing member.
30. A filter device as recited in claim 12, wherein said
restraining member comprises at least one flap coupled to said
filter, said at least one flap being adapted to surround said
plurality of struts and prevent said plurality of struts from
extending outwardly.
31. A filter device for percutaneous insertion into a blood vessel
during a procedure, the filter device comprising: (a) a guide
member comprising a distal end, a proximal end, and a lumen
extending from said distal end to said proximal end, said guide
member being configured to act as an exchange guidewire; (b) a
filter assembly coupled to said guide member, said filter assembly
comprising a filter adapted to filter material from a blood stream
and a plurality of struts; and (c) means for preventing said
plurality of struts from extending outwardly to allow said filter
to deploy into the blood stream in the blood vessel.
32. A filter device as recited in claim 31, wherein each of said
plurality of struts is biased to open said filter.
33. A filter device as recited in claim 31, wherein said filter
comprises an open proximal end and a closed distal end, said
proximal end being adapted to conform to an inner surface of the
blood vessel.
34. A filter device as recited in claim 31, wherein said filter
opens in response to a force applied by the blood flowing through
the blood vessel.
35. A filter device as recited in claim 31, wherein said filter is
fabricated from at least one of a woven mesh material, a braided
material, or a film material.
36. A filter device as recited in claim 31, wherein said filter
comprises a material comprising a plurality of pores.
37. A filter device as recited in claim 36, wherein each of said
plurality of pores is sized in the range from about 50 microns to
about 200 microns.
38. A filter device as recited in claim 36, wherein a major axis
and a minor axis of each of said plurality of pores is sized in the
range from about 50 microns to about 200 microns.
39. A filter device as recited in claim 31, further comprising
means for radiopacity coupled to at least one of said guide member,
said filtering, said plurality of struts, and said means for
preventing.
40. A filter device as recited in claim 39, wherein said means for
radiopacity comprises at least one of (i) a plurality of markers
fabricated from a radiopaque material (ii) a plurality of markers
coated with a radiopaque material and (iii) a plurality of markers
doped with a radiopaque material
41. A filter device as recited in claim 31, wherein said guide
member comprises a flexible, atraumatic tip coupled to said filter
assembly.
42. A filter device as recited in claim 41, wherein said tip
extends through said filter.
43. A filter device as recited in claim 31, wherein said filter
assembly is integral with said guide member.
44. A filter device as recited in claim 31, wherein said filter
assembly is a separate assembly coupled to said guide member.
45. A filter device comprising: (a) a guide member comprising a
distal end, a proximal end, and a lumen extending from the distal
end to the proximal end; (b) a filter assembly coupled to said
guide member, said filter assembly comprising: (i) a filter
comprising a proximal end with an opening formed therein; and (ii)
a plurality of struts coupled to said proximal end of said filter,
each of said plurality,of struts being biased to open said opening;
and (c) an actuating assembly coupled to said guide member and said
filter assembly, said actuating assembly comprising: (i) a
restraining member cooperating with said plurality of struts, said
restraining member applying a restraining force to the plurality of
struts to prevent the plurality of struts from extending outwardly;
(ii) an actuating member coupled to said restraining member and
extending toward said proximal end of said guide member; and (iii)
an actuating element coupled to a proximal end of said actuating
member, said actuating element being adapted to move in a proximal
direction to release the restraining force to enable said plurality
of struts to extend outwardly.
46. The filter device as recited in claim 45, wherein said
actuating member is disposed in said lumen of said guide
member.
47. The filter device as recited in claim 45, wherein said
actuating member is partially disposed in said lumen of said guide
member.
48. The filter device as recited in claim 45, wherein said proximal
end of said filter, when deployed, is constrained against the
vessel wall.
49. The filter device as recited in claim 45, wherein said guide
member further comprises at least one radiopaque marker.
50. The filter device as recited in claim 45, wherein at least one
of said plurality of struts is biased to extend inwardly to a
center of said lumen.
51. The filter device as recited in claim 45, wherein disposed upon
a distal end of the at least one of said plurality of struts is a
coiled tip.
52. The filter device as recited in claim 51, wherein said coiled
tip extends through said filter.
53. The filter device as recited in claim 51, wherein said coiled
tip is coupled to said filter.
54. The filter device as recited in claim 51, wherein said coiled
tip extends through an aperture in said filter.
55. The filter device as recited in claim 45, wherein said
restraining member further comprises at least one preferential
separation region.
56. The filter device as recited in claim 55, further comprising at
least one actuating member cooperating with said at least one
preferential separation region, said at least one actuating member
adapted to cause said restraining member to preferentially separate
at said at least one preferential separation region.
57. The filter device as recited in claim 45, wherein said
restraining member comprises a plurality of apertures adapted to
receive said actuating member.
58. The filter device as recited in claim 57, wherein said
restraining member comprises a first end and a second end, each of
said first end and said second end comprising one or more of said
plurality of apertures.
59. The filter device as recited in claim 58, wherein said
apertures in said first end and second end alternately receive said
actuating member to maintain said restraining member in a closed
position to prevent said plurality of struts from extending
outwardly.
60. The filter device as recited in claim 58, wherein said
actuating member is adapted to be removed from said plurality of
apertures to allow said plurality of struts to extend
outwardly.
61. The filter device as recited in claim 58, wherein said
actuating member is stitched through said restraining member.
62. The filter device as recited in claim 45, wherein said
restraining member comprises a plurality of channels.
63. The filter device as recited in claim 62, wherein one or more
channels of said plurality of channels on said first end are offset
from one or more channels of said plurality of channels on said
second end.
64. The filter device as recited in claim 62, wherein each of said
plurality of channels is adapted to receive said actuating member
so that said sleeve prevents said plurality of struts extending
outwardly.
65. The filter device as recited in claim 45, where said plurality
of struts are integrally coupled to said guide member.
66. The filter device as recited in claim 45, wherein said
plurality of struts are separate members that are coupled to a
distal end of said guide member.
67. The filter device as recited in claim 66, wherein said
restraining member comprises at least one tubular member coupled to
at least one of said plurality of struts, said at least one tubular
member being adapted to receive said actuating member.
68. A filter device as recited in claim 66, wherein said
restraining member comprises at least one flap coupled to said
filter, said at least one flap being adapted to surround said
plurality of struts and prevent said plurality of struts from
extending outwardly.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims priority to U.S. Provisional
Patent Application Ser. No. 60/302,417, filed Jul. 2, 2001, U.S.
Provisional Patent Application Ser. No. 60/345,333, filed Nov. 9,
2001, U.S. Provisional Patent Application Ser. No. 60/347,500,
filed Jan. 11, 2002 and U.S. Provisional Patent Application Ser.
No. 60/341,092, filed Dec. 12, 2001, the disclosures of which are
herein incorporated by this reference.
[0002] Additionally, this patent application incorporates by
reference the disclosure of co-pending patent applications entitled
"Methods, Systems, and Devices for Providing Embolic Protection and
Removing Embolic Material," U.S. patent application Ser. No.
______, "Methods, Systems, and Devices for Deploying an Embolic
Protection Filter," U.S. patent application Ser. No. ______, and
"Methods, Systems, and Devices for Deploying a Filter from a Filter
Device," U.S. patent application Ser. No. ______.
BACKGROUND OF THE INVENTION
[0003] 1. The Field of the Invention
[0004] The present invention relates generally to the field of
percutaneous medical filters, and more specifically, to vascular
filter devices that are configured for percutaneous insertion into
a blood vessel of a patient.
[0005] 2. The Relevant Technology
[0006] Human blood vessels often become occluded or blocked by
plaque, thrombi, other deposits, or material that reduce the blood
carrying capacity of the vessel. Should the blockage occur at a
critical place in the circulatory system, serious and permanent
injury, and even death, can occur. To prevent this, some form of
medical intervention is usually performed when significant
occlusion is detected.
[0007] Several procedures are now used to open these stenosed or
occluded blood vessels in a patient caused by the deposit of plaque
or other material on the walls of the blood vessels. Angioplasty,
for example, is a widely known procedure wherein an inflatable
balloon is introduced into the occluded region. The balloon is
inflated, dilating the occlusion, and thereby increasing the
intraluminal diameter.
[0008] Another procedure is atherectomy. During atherectomy, a
catheter is inserted into a narrowed artery to remove the matter
occluding or narrowing the artery, i.e., fatty material. The
catheter includes a rotating blade or cutter disposed in the tip
thereof. Also located at the tip-are an aperture and a balloon
disposed on the opposite side of the catheter tip from the
aperture. As the tip is placed in close proximity to the fatty
material, the balloon is inflated to force the aperture into
contact with the fatty material. When the blade is rotated,
portions of the fatty material are shaved off and retained within
the interior lumen of the catheter. This process is repeated until
a sufficient amount of fatty material is removed and substantially
normal blood flow is resumed.
[0009] In another procedure, stenosis within arteries and other
blood vessels is treated by permanently or temporarily introducing
a stent into the stenosed region to open the lumen of the vessel.
The stent typically comprises a substantially cylindrical tube or
mesh sleeve made from such materials as stainless steel or nitinol.
The design of the material permits the diameter of the stent to be
radially expanded, while still providing sufficient rigidity such
that the stent maintains its shape once it has been enlarged to a
desired size.
[0010] Unfortunately, such percutaneous interventional procedures,
i.e., angioplasty, atherectomy, and stenting, often dislodge
material from the vessel walls. This dislodged material can enter
the bloodstream, and may be large enough to occlude smaller
downstream vessels, potentially blocking blood flow to tissue. The
resulting ischemia poses a serious threat to the health or life of
a patient if the blockage occurs in critical tissue, such as the
heart, lungs, kidneys, or brain, resulting in a stroke or
infraction.
[0011] In general, existing devices and technology have a number of
disadvantages including high profile, difficulty using multiple
parts and components that result in an involved procedure,
manufacturing complexity, and complex operation of the device or
system.
BRIEF SUMMARY OF THE INVENTION
[0012] Embodiments of the present invention provide systems,
methods, and devices for overcoming the above-referenced problems.
More specifically, embodiments of the present invention include
filter devices that have small, low, or no profiles, few parts and
components, and are simple to manufacture and use. Consequently,
embodiments of the present invention are able to be easily inserted
into a patient, be steerable through the tortuous anatomy of a
patient, provide filtering capabilities, have a sufficiently low
profile to provide exchange capability so other medical devices can
be advanced along the filter device, and be capable of removing the
captured material without allowing such material to escape during
filter retrieval.
[0013] According to one aspect of one embodiment of present
invention, an illustrative embodiment of the present invention
includes a vascular filter device. This device includes a guide
member, such as a guidewire or hypo-tube having a lumen that
extends from a distal end toward a proximal end thereof. Disposed
within the lumen are one or more actuating members and a filter
assembly. The one or more actuating members are coupled to an
actuating mechanism at the proximal end of the guide member and are
configured to deploy the filter assembly during a procedure, such
as through movement of one or more actuating members.
[0014] The filter assembly includes a filter and a plurality of
radially spaced-apart struts connected to a peripheral edge of a
proximal end of the filter. The struts expand outwardly upon being
deployed from the lumen of the guide member to place the peripheral
edge of the proximal end of the filter adjacent to the wall of the
vessel.
[0015] The filter includes a plurality of pores or holes that are
so sized to capture material that may become detached during the
procedure. The proximal end of the filter is configured to be
constrained against the blood vessel within which the filter is
disposed, while the distal end, in one embodiment, is configured to
"float" within the blood flowing through the blood vessel and
change shape to collect material and maintain the flow of blood
through the vessel.
[0016] In one embodiment of the present invention, the filter
device includes a number of radiopaque bands and/or markers affixed
to a variety of positions on the device. These radiopaque bands
and/or markers are one example of means for radiopacity, with
various other means for radiopacity being known to those skilled in
the art.
[0017] During use of the filter device of the present invention,
blood flow will cause the filter to assume a parachute-like
configuration such that material is collected within the interior
of the filter. To remove the filter and the material, in one
embodiment, the actuating member is moved in the proximal direction
so that the proximal end of the filter cooperates with the distal
end of the lumen through the guide member. Upon positioning the
proximal end of the filter, a capture catheter is moved or advanced
along the guide member until the catheter substantially encloses
the filter. Following positioning of the capture catheter, the
catheter and guide member are removed from the patient.
[0018] According to another embodiment of the present invention, a
guide member includes a plurality of struts disposed at the distal
end of the guide member. In one configuration, the distal end of
the guide member is divided into a plurality of struts, at least
two of which are biased to move outwardly. In another
configuration, a strut assembly is coupled to the distal end of the
guide member, with the strut assembly including one or more struts
attached to the filter, while formed at a distal end of a third
strut is a coil tip. This third strut is optionally biased toward
the center of the lumen of the guide member. Before the filter is
deployed, the filter is folded about the distal end of the guide
member, folded about one or more of the plurality of struts, and/or
is positioned within the lumen of the guide member.
[0019] To maintain the struts in the closed position, i.e., not
extending outwardly from the remaining body of the guide member, a
retaining member or mechanism cooperates with the guide member
and/or struts and applies a restraining force to one or more of the
struts. By moving the guide member relative to the restraining
member, or vice versa, the distal ends of two or more of the biased
struts are allowed to move outwardly to deploy the filter, i.e.,
the restraining force is released.
[0020] In another configuration, the restraining member or
mechanism surrounds a tip of the guide member, including the struts
and a part of the guide member. This restraining member or
mechanism can be attached to the struts and is configured to apply
a restraining force to the one or more struts. In one
configuration, the restraining member or mechanism is configured to
separate into a number of different sections to allow the distal
ends of two or more of the biased struts to move outwardly to
deploy the filter. In another embodiment, the restraining member or
mechanism includes two or more actuating members that are attached
to a location just proximal to the proximal end of each strut. The
two or more actuating members extend to the distal end of the guide
member, pass through apertures in the distal end of the restraining
member or mechanism, and terminate within the lumen of the guide
member after passing through holes formed in the guide member
proximal to the proximal end of each strut.
[0021] To actuate the filter device, an actuating assembly at the
proximal end of the guide member draws the actuating members in the
proximal direction. Since one end of the actuating member is
located at the proximal end of the restraining member or mechanism,
whether forming part of the restraining member or mechanism,
attached to the restraining member or mechanism, or attached to the
guide member, pulling the actuating member in the proximal
direction causes the actuating member to preferentially separate
the restraining member or mechanism, thereby releasing the
strut.
[0022] In another configuration, the restraining member or
mechanism includes a plurality of apertures formed therein. The
restraining member or mechanism has a first portion and a second
portion with one or more of the plurality of apertures formed
therein. The restraining member or mechanism further includes a
securing member that passes through one or more of the plurality
apertures to cause the first portion to be releasably connected to
the second portion. The securing member passes through an aperture
in the guide member and/or a strut assembly to pass into the end of
the guide member and extend toward the proximal end. Upon moving
the securing member in a proximal direction using one of a variety
of different actuating mechanisms, a distal end of the securing
member is removed from the apertures and the first and second both
portions of the restraining member or mechanism. In this manner,
the force applied to the struts to maintain a closed configuration,
where the struts are retained or prevented from extending
outwardly, is released from the struts, enabling them to deploy the
filter.
[0023] In still another configuration, the restraining member or
mechanism includes a securing member that is "sewn" through
portions of the restraining member. In a similar manner to the
configuration discussed above, the securing member can be removed
from cooperating with the restraining member or mechanism to allow
the struts to extend outwardly and deploy the filter.
[0024] In still another configuration, the restraining member or
mechanism includes a plurality of channels. These channels are
formed on both first and second ends of the filter in an offset
configuration. The securing member can pass through one or more of
the channels formed in the first side and the second side to
maintain the first side in cooperative engagement with the second
side. In this manner, the restraining member or mechanism applies a
restraining force to the one or more struts and prevents them from
extending outwardly. Upon moving the securing member in a proximal
direction, a distal end of the securing member is removed from
within the channels formed in the first side and second side,
thereby releasing the restraining force applied by the restraining
member or mechanism against the one or more struts.
[0025] In still another configuration, the restraining member or
mechanism has the form of a sleeve that is adapted with one or more
hoops formed therein. The wire forms a channel by maintaining a
first set of hoops and second set of hoops in engagement using a
securing member. By removing the securing member from engaging
within one or more of the hoops, the first side and second side of
the restraining member or mechanism can disengage with one another
and release the restraining force that was applied to the one or
more struts. In this manner, the struts are able to deploy the
filter.
[0026] In yet another configuration, the restraining member or
mechanism is combined with the one or more struts of the filter
device. In such a configuration, two or more of the struts include
tubular members adapted to receive a securing member. As the struts
are brought towards each other, the lumens of the tubular members
become aligned so that the securing member can pass therethrough to
prevent the struts from extending outwardly or otherwise maintain
the struts together or in close proximity one to another.
[0027] In still another configuration, the restraining member or
mechanism is combined with the filter of the filter device. In this
configuration, the filter includes at least one flap that is
adapted to extend through the gap disposed between two struts. The
flap(s) can be wrapped around the struts and secured to prevent the
struts from extending outwardly.
[0028] These and other objects and features of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] To further clarify the above and other advantages and
features of the present invention, a more particular description of
the invention will be rendered by reference to specific embodiments
thereof which are illustrated in the appended drawings. It is
appreciated that these drawings depict only typical embodiments of
the invention and are therefore not to be considered limiting of
its scope. The invention will be described and explained with
additional specificity and detail through the use of the
accompanying drawings in which:
[0030] FIG. 1 illustrates an exemplary filter device according to
one embodiment of the present invention.
[0031] FIG. 2 illustrates an exploded perspective view of an
exemplary tip of the filter device of FIG. 1.
[0032] FIG. 3 illustrates a cross-sectional side view of the
exemplary tip of the filter device of FIG. 2.
[0033] FIGS. 4A-41 illustrates various cross-sectional side views
of different exemplary configurations or embodiments of the tip of
the filter device of FIG. 2.
[0034] FIG. 5 illustrates a cross-sectional side view of the tip of
the filter device of FIG. 2 with exemplary actuating member and
filter assembly in a closed position.
[0035] FIG. 6a illustrates a cross-sectional side view of the tip
of the filter device of FIG. 2 with exemplary actuating member and
filter assembly in an actuated position.
[0036] FIG. 6b illustrates one or more pores of the filter of the
filter device of the present invention.
[0037] FIG. 7 illustrates a cross-sectional side view of the tip of
the filter device of FIG. 2 with exemplary actuating member and
filter assembly in an actuated position and a portion of the filter
filled with material.
[0038] FIG. 8 illustrates a cross-sectional side view of the tip of
the filter device of FIG. 2 with exemplary actuating member and
filter assembly in a retracted position.
[0039] FIG. 9 illustrates a cross-sectional side view of an
exemplary actuating assembly of the filter device of FIG. 2.
[0040] FIG. 10 illustrates a perspective view of one exemplary
capture catheter adapted for use with the filter device of the
present invention.
[0041] FIG. 11 illustrates a cross-sectional side view of the
actuating member and filter assembly in a retracted position with
the capture catheter in position surrounding the filter of the
filter device of FIG. 2.
[0042] FIG. 12 illustrates a flow diagram of an exemplary method
for using the filter device of FIG. 2.
[0043] FIG. 13 illustrates a portion of the vasculature of an
individual within which the filter device of FIG. 2 can be
inserted.
[0044] FIG. 14 illustrates a lesion formed in the interior carotid
artery of the individual of FIG. 13.
[0045] FIG. 15 illustrates one embodiment of the filter device of
FIG. 2 deployed in the interior carotid artery distal of the lesion
of FIG. 14.
[0046] FIG. 16 illustrates one embodiment of the filter device of
FIG. 2 deployed in the interior carotid artery distal of the lesion
of FIG. 14 and a pre-dilation balloon.
[0047] FIG. 17 illustrates one embodiment of the filter device of
FIG. 2 deployed in the interior carotid artery distal of the lesion
of FIG. 14 and a stent located about the lesion.
[0048] FIG. 18 illustrates a partial cross-sectional side view of
another embodiment of the filter device of the present
invention.
[0049] FIG. 19 illustrates a cross-sectional side view of another
exemplary actuating assembly of the filter device according to the
present invention.
[0050] FIG. 20 illustrates a partial cross-sectional view of yet
another embodiment of the filter device of the present
invention.
[0051] FIG. 21 illustrates a side view of a tip of the filter
device of FIG. 20.
[0052] FIG. 22 illustrates a side view of the embodiment of FIG. 20
with the filter deployed.
[0053] FIG. 23 illustrates a side view of yet another embodiment of
a filter device with a restraining member coupled to the filter
device according to another aspect of the present invention.
[0054] FIG. 24 illustrates a side view of the embodiment of FIG. 23
with the filter deployed.
[0055] FIG. 25 illustrates a cross-sectional side view of another
exemplary actuating assembly of the filter device according to the
present invention.
[0056] FIG. 26 illustrates a perspective view of another embodiment
of a filter device with a restraining member coupled to the filter
device according to another aspect of the present invention.
[0057] FIG. 27 illustrates a perspective view of the restraining
member of FIG. 26 before becoming coupled to the filter device
according to another aspect of the present invention.
[0058] FIG. 28 illustrates a perspective view of the restraining
member of FIG. 26 before becoming coupled to the filter device
according to another aspect of the present invention.
[0059] FIG. 29 illustrates a perspective view of another
restraining member of the filter device according to another aspect
of the present invention.
[0060] FIG. 30 illustrates a perspective view of another embodiment
of a filter device with a restraining member coupled to the filter
device according to another aspect of the present invention.
[0061] FIG. 31 illustrates a perspective view of the restraining
member of FIG. 30 before becoming coupled to the filter device
according to another aspect of the present invention.
[0062] FIG. 32 illustrates a side view of the restraining member of
FIG. 30 before becoming coupled to the filter device according to
another aspect of the present invention.
[0063] FIG. 33 illustrates a side view of the restraining member
FIG. 30 part way through restraining the filter device according to
another aspect of the present invention.
[0064] FIG. 34 illustrates a side view of the restraining member
FIG. 30 as it restrains the filter device according to another
aspect of the present invention.
[0065] FIG. 35 illustrates a perspective view of another embodiment
of a filter device with a restraining member coupled to the filter
device according to another aspect of the present invention.
[0066] FIG. 36 illustrates a perspective view of another embodiment
of a filter device with a restraining member coupled to the filter
device according to another aspect of the present invention.
[0067] FIG. 37 illustrates a side view of the restraining member of
FIG. 36 before becoming coupled to the filter device according to
another aspect of the present invention.
[0068] FIG. 38 illustrates a side view of the restraining member of
FIG. 36 before becoming coupled to the filter device according to
another aspect of the present invention.
[0069] FIG. 39 illustrates perspective view of the restraining
member FIG. 36 as it restrains the filter device according to
another aspect of the present invention.
[0070] FIG. 40 illustrates a perspective side view of another
embodiment of a filter device with a restraining member coupled to
the filter device according to another aspect of the present
invention.
[0071] FIG. 41 illustrates a perspective side view of the
restraining member FIG. 40 as it restrains the filter device
according to another aspect of the present invention.
[0072] FIG. 42 illustrates a side view of another embodiment of a
filter device according to another aspect of the present
invention.
[0073] FIG. 43 illustrates a side view of yet another embodiment of
a filter device according to another aspect of the present
invention.
[0074] FIG. 44 illustrates a perspective view of another embodiment
of a capture catheter used with the filter device of the present
invention.
[0075] FIG. 45 illustrates a perspective view of yet another
embodiment of a capture catheter used with the filter device of the
present invention.
[0076] FIG. 46 illustrates a perspective view of still another
embodiment of a capture catheter used with the filter device of the
present invention.
[0077] FIG. 47 illustrates a side view of the capture catheter of
FIG. 46 as it begins to capture the filter device of the present
invention.
[0078] FIG. 48 illustrates a side view of the capture catheter of
FIG. 46 as it captures the filter device of the present
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0079] The present invention generally relates to percutaneous
filter devices, systems, and methods of using the same. Embodiments
of the present invention can be utilized in association with
devices, systems, and methods for inserting a filter device, such
as but not limited to a vascular filter device, within any blood
vessel of a patient.
[0080] One or more of the embodiments of the filter devices of the
present invention meet criteria for both guidewires and filter
devices. For instance, it is preferable that a guidewire is
steerable. Consequently, embodiments of the filter device of the
present invention can be insertable within any blood vessel of a
patient, such as but not limited to, coronary artery, carotid
arteries, renal arteries, bypass grafts, superficial femoral
artery, the arteries of the upper and lower extremities, or
cerebral vasculature, and manipulated and steered by a physician to
traverse the tortuous anatomy of the patient to a lesion or
occlusion.
[0081] To assist the physician with the above-recited endeavor, one
or more embodiments of the filter device include a shapeable, soft,
distal tip. In addition, the filter device is capable of
translating rotational movement or force applied to the, proximal
end thereof substantially equally to the distal end. In other
words, with the filter device positioned within a vessel of the
patient, as a physician rotates the proximal end of the filter
device, the distal end of the filter device rotates substantially
simultaneously with the movement of the proximal end. This is
typically defined as having a one-to-one torqueability.
[0082] Further, the filter device of the present invention is kink
resistant and is capable of receiving a variety of different
coatings to improve lubricity, have anti-thrombogenic properties,
and/or reduce platelet aggregation. These coatings can include, but
are not limited to, a hydrophilic coating, a heparinized coating,
Teflon, silicone, or other coating known to those skilled in the
art in light of the teaching contained herein.
[0083] With respect to the filter of the filter device of the
present invention, in one embodiment, the filter is configured to
capture material of a variety of sizes and enable removal of the
captured material. Therefore, filter pore sizes and shapes can be
selected based upon the size of material to be captured. The
material can include but is not limited to, particulates, thrombi,
any atherosclerosis or plaque material dislodged during a
procedure, or other foreign material that may be introduced in to
the vasculature of the patient.
[0084] Referring now to FIG. 1, depicted is one embodiment of a
vascular filter device, designated by reference number 10, of the
present invention. As illustrated, filter device 10 includes a
guide member 12 having a distal end 14 and a proximal end 16.
Extending between distal end 14 and proximal end 16 of guide member
12 is a lumen 18 within which is disposed an actuating member 40
and a filter assembly 42. Distal end 14 of guide member 12 includes
a tip 15 that is configured for percutaneous insertion into a blood
vessel of a patient, while proximal end 16 is configured with or
couples to an actuating assembly 20.
[0085] In this configuration, filter device 10 is capable of being
insertable into any blood vessel of a patient or body and function
as a guidewire or exchange wire for other medical components or
devices, such as but not limited to catheters, stents, balloons,
atherectomy devices, or other components or devices that can be
exchanged using a guidewire. Further, filter device 10 can be used
to filter particulates, as will be described in more detail
hereinafter, thereby acting or providing embolic protection during
a procedure.
[0086] Illustratively, the term "guide member" can refer to a
member that is completely solid, such as a guidewire, a member that
partially includes a lumen therein, or a member that includes a
lumen extending from a proximal end to a distal end thereof, such
as a hypo-tube. Consequently, the term "guide member" can include
or encompass a guidewire or a hypo-tube that is configured to
perform the functions described herein.
[0087] Guide member 12 can be fabricated from a variety of
materials. For example, guide member 12 can be fabricated from
Nitinol, steel, metals, metal alloys, composites, plastic, polymer,
synthetic materials, or combinations thereof. Further, guide member
12 can be covered with a variety of different coatings, such as but
not limited to, coatings to improve lubricity or having
anti-thrombogenic properties, reduce platelet aggregation,
hydrophilic coatings, a heparinized coating, Teflon, silicone, or
combinations thereof.
[0088] Illustratively, guide member 12 can have an outside diameter
of between about 0.010 inches to about 0.035 inches, between about
0.014 inches to about 0.018 inches, or between about 0.010 inches
to about 0.018 inches. In one configuration, the outside diameter
of guide member 12 is about 0.014 inches. Similarly, the diameter
of lumen 18 can range from about 0.004 inches to about 0.029 inches
or between about 0.008 inches to about 0.014 inches. In one
configuration, the diameter of lumen 18 is about 0.008 inches.
[0089] As illustrated in FIGS. 2 and 3, the exemplary distal end 14
of guide member 12 has a step configuration, with a step portion 22
of guide member 12 having a smaller diameter than other portions of
guide member 12. For ease of explanation, actuating member 40 and
filter assembly 42 have been excluded from FIGS. 2 and 3.
[0090] The step portion 22 can have a variety of different
configurations so long as it is adapted to couple with other
portions of filter device 10. For instance, step portion 22 can
include multiple steps instead of a single step as illustrated in
FIG. 2. Consequently, distal end 14 of guide member 12 could
include a first step portion having a first outer diameter smaller
than the outer diameter of the remaining portion of guide member 12
toward proximal end 16 thereof. Further, distal end 14 of guide
member 12 could include a second step portion having a smaller
outer diameter than the first outer diameter of the first
portion.
[0091] Attached to step portion 22 of guide member 12 is a sheath
24. Sheath 24 has a lumen 30 that extends between a distal end 26
and a proximal end 28 thereof. A portion of distal end 26 is
substantially co-planar with distal end 14 of guide member 12 when
sheath 24 is connected to guide member 12. Stated another way, a
portion of distal end 14 of guide member 12 and distal end 26 of
sheath 24 are contained within a plane that is substantially
perpendicular to the longitudinal axis of lumen 18 of guide member
12 when sheath 24 is coupled, connected, or attached to guide
member 12. Although this is the case in one embodiment of the
present invention, one skilled in the art can identify various
other configurations where this need not be the case. For instance,
in an alternate configuration, distal ends 14 and 26 are not
co-planar. In another configuration, portions of distal ends 14 and
26 are co-planar. In still another configuration, at least one of
distal ends 14 and 26 is angularly orientated relative to the
longitudinal axis of lumen 18 or lumen 30.
[0092] As illustrated in FIG. 3, distal end 26 of sheath 24, either
alone or in combination with distal end 14 of guide member 12 is
atraumatic. In this manner, as filter device 10 is inserted within
a blood vessel filter device 10 is able to slide along the interior
surface of the blood vessel and is prevented from catching upon
protrusions, i.e., lesions, occlusions, stenosis, or the like,
during a procedure. One skilled in the art can identify a variety
of different configurations of distal ends 14 and/or 26 to perform
such a desired function. For instance, the curvature of distal end
14 of guide member 12 can be varied as long as the curvature allows
filter device 10 to slide along the interior surface of the blood
vessel without catching upon protrusions; the curvature can be
based upon distal end 14 of guide member 12 and/or the distal end
of sheath 24.
[0093] Proximal end 28 of sheath 24 is configured to cooperate with
a proximal end of step portion 22. Proximal end 28 of sheath 24 and
the proximal end of step portion 22 are substantially parallel one
to another upon coupling, connecting, or attaching sheath 24 to
step portion 22. In another configuration, the proximal end of step
portion 22 can include one or more raised portions within which one
or more complementary recesses formed in proximal end 28 mate, or
vice versa. In still another configuration, sheath 24 has a stepped
configuration that allows matting with a complementary configured
stepped proximal end of step portion 22, such as when step portion
includes multiple steps. Various other configurations are
applicable to allow sheath 24 and the remainder of guide member 12
to couple, connect, or be attached one to another.
[0094] According to another aspect of one embodiment of the present
invention, sheath 24 has an outside diameter substantially the same
as the outer diameter of guide member 12, while the diameter of
lumen 30 is substantially the same as the outer diameter of step
portion 22. Consequently, when sheath 24 is coupled to guide member
12 at step portion 22, guide member 12 has substantially the same
outer diameter along its length. In other configurations, sheath 24
has a smaller or larger diameter than guide member 12.
[0095] As illustrated, sheath 24 is configured to friction fit to
step portion 22. Consequently, the inner diameter of sheath 24 is
configured to securely mount to step portion 22 upon slidable
engagement of sheath 24 and step portion 22. In other
configurations, sheath 24 can be affixed to step portion 22 with an
adhesive, such as but not limited to, any medical grade adhesive,
UV curable adhesive, or other adhesive that cause sheath 24 to
securely connect to step portion 22. In still another
configuration, sheath 24 can be press fit, soldered, mechanical
attached, or coupled to guide member 12 using any other mechanism
that causes sheath 24 to be securely connected to step portion 22.
In still other configurations, sheath 24 and step portion 22 have a
key configuration where sheath 24 includes at least one key and
step portion 22 includes at least one key way to receive the at
least one key, or vice versa.
[0096] In general, sheath 24 can be fabricated from a variety of
different materials and have a variety of different configurations.
For example, sheath 24 can be fabricated from steel, titanium,
platinum, metals, metal alloys, composites, plastics, polymers,
synthetic materials, or combinations thereof. Further, sheath 24
can include means for radiopacity. Additionally, sheath 24 can be
fabricated from (i) a radiopaque substance, (ii) a non-radiopaque
substance and coated with a radiopaque substance, or (iii) a
non-radiopaque substance doped with a radiopaque substance. The
radiopaque substances can include, but not limited to, barium
sulphate, bismuth subcarbonate, titanium dioxide, combinations
thereof, or other radiopaque substances. In still another
configuration, sheath 24 can include one or more markers that have
radiopaque characteristics. These markers can be fabricated from a
radiopaque material, whether the material is radiopaque, a
non-radiopaque material coated with a radiopaque material, or a
non-radiopaque materials doped with a radiopaque material.
Consequently, sheath 24 can include means for radiopacity, whether
such means results from the materials forming sheath 24 or from
attaching, coupling, or connecting markers, bands, or other
indicators having radiopaque properties or characteristics.
[0097] Disposed over sheath 24 and optionally a portion of guide
member 12 is cover 32. Cover 32 is configured to seal and secure
sheath 24 to guide member 12. Consequently, cover 32 acts as a
means for securing sheath 24 to guide member 12. In one embodiment,
cover 32 is a thin walled plastic heat shrink tubing or silicon
tubing. In other configurations, interference fit or compression
fit plastics, polymers, synthetic materials, or silicon can be used
that need not be heat shrunk. In general, cover 32 can be a medical
grade synthetic material.
[0098] According to another aspect of the present invention, distal
end 14 of guide member 12, distal end 26 of sheath 24, and/or the
distal end of cover 32 can be configured, collectively, to form a
bullet nose or have a curved profile. This can be in addition to or
alternatively from only distal end 14 of guide member 12 and/or
distal end 26 of sheath 24 being curved or being atraumatic.
[0099] Collectively, distal end 14 of guide member 12, sheath 24,
and cover 32 form tip 15 of filter device 10. Although this is one
configuration, one skilled in the art can appreciate that tip 15
can be formed solely from or any combination of guide member 12,
sheath 24, and cover 32.
[0100] To provide flexibility to tip 15 of filter device 10,
embodiments of the present invention may include one or more
grooves 34 that extend entirely or partially through one or more of
distal end 14 of guide member 12, sheath 24, and cover 32, as
illustrated in FIGS. 4A-41. The flexibility of tip 15 allows a
physician or clinician to shape the tip and enable the guide member
to be steered during a procedure. Consequently, the tip may
maintain a level of resiliency so that a curvature defined by the
physician or clinician is maintained during movement of the guide
member through the tortuous anatomy of a patient.
[0101] The term "groove" includes one or more cuts or slits that
partially or completely extend through a portion of filter device
10, optionally including the sleeve and the securing member.
Further, the term "groove" includes one or more cuts or slits that
partially or completely surrounds a portion of filter device 10,
whether or not such one or more cuts or slits extend completely or
partially through one or more of the guide member, the sleeve, or
the securing member.
[0102] Each groove 34 can have a variety of different
configurations, such as but not limited to straight, helical,
geometric, or combinations thereof. For instance, a single groove
34 can extend around all or a portion of tip 15 and optionally
extend into the remainder of filter device 10. Further, any number
of grooves 34 can be included in tip 15 of filter device 10
depending upon the degree of flexibility needed for a procedure.
For example, the more grooves 34 included in tip 15 of filter
device 10, the greater the flexibility. Similarly, the depth of
each groove 34 can vary depending upon the flexibility desired. For
instance, the deeper grooves 34 the greater the flexibility of tip
15 of filter device 10. Similarly, difference in the configuration
of each groove 34 can affect the flexibility of tip 15 of filter
device 10. For instance, the steeper the sides of grooves 34, the
less flexibility of tip 15.
[0103] As illustrated in FIGS. 4A-41, grooves 34 can be disposed
along the longitudinal length of tip 15 of filter device 10
equally, gradually, continuously, periodically, or combinations
thereof. For instance, as shown in FIG. 4A, tip 15 includes a
single helical groove 34 that has an equal pitch along the length
of tip 15, while FIG. 4B depicts a single helical groove 34 that
has a gradually increasing pitch along the length of tip 15.
Although not shown, it can be understood that tip 15 can include a
single helical groove 34 that has a gradually decreasing pitch
along the length of tip 15 from the proximal end to the distal end
thereof.
[0104] As shown in FIG. 4C, tip 15 can have a plurality of
individual grooves 34 disposed along the length of tip 15. It can
be understood that each groove 34 need not encircle tip 15 of guide
member 12; rather, each groove 34 can partially encircle tip 15 of
guide member 12, as depicted illustratively in FIG. 4D.
[0105] FIG. 4E depicts a configuration of tip 15 where groupings of
grooves 34, whether straight, helical, or geometric, are disposed
at different portions of tip 15.
[0106] FIG. 4F depicts a configuration where grooves 34 are large
and have shallow sides, i.e., the angle between the axis of the
groove that passes through the apex of the groove and the side of
the groove is large. In the alternative, each groove 34 can be
small and have steep sides, i.e., the angle between the axis of the
groove that passes through the apex of the groove and the side of
the groove is small.
[0107] FIG. 4G illustrates a configuration of tip 15 of filter
device 10 where the pitch between adjacent grooves is increasing
from the proximal end to the distal end of tip 15 and the depth of
each groove 34 varies, i.e., each groove 34 need not extend the
entire depth of tip 15 of filter device 10.
[0108] FIG. 4H illustrates a configuration of tip 15 of filter
device 10 wherein grooves 34 are straight and extend into lumen 18,
while FIG. 4I illustrates a configuration where grooves 34 are
helical and extend from the exterior of tip 15 to lumen 18.
[0109] The above described configurations of the grooves with tip
15 of filter device 10 are only illustrative and should not be
considered as limiting the applicability of other configurations as
known by one skilled in the art in light of the teaching contained
herein. For instance, grooves 34 can pass through securing member
32, sleeve 24, and terminate in guide member 12, can pass through
sleeve 24 and terminate in guide member 12, be contained solely in
guide member 12, combinations thereof, or the like.
[0110] Generally, grooves 34 can be formed in tip 15 of filter
device 10 using a variety of different techniques, such as but not
limited to, micro-machining, grinding, etching, laser cutting,
abrasive water jet, electrical discharge machine, or the like.
Further, grooves 34 can have a pitch of between about 0.015 inches
to about 0.100 inches, from about 0.020 inches to about 0.060
inches, or from about 0.025 inches to about 0.050 inches.
[0111] Referring now to FIG. 5, depicted is a partial
cross-sectional view of a lumen 18 of guide member 12. Disposed
within lumen 18 of guide member 12 are an actuating member 40 and a
filter assembly 42. Actuating member 40 forms part of actuating
assembly 20 and is adapted to deploy and partially or completely
retract filter assembly 42. Additionally, actuating member 40
provides structural support to filter device 10 and assists with
preventing kinking of filter device 10.
[0112] The actuating member 40 extends toward a proximal end 16 of
filter device 10.
[0113] As illustrated, the distal end of actuating member 40
includes a head 44. Head 44 has a generally cylindrical form and is
configured to create a seal between actuating member 40 and the
interior walls of lumen 18. In other embodiments of the present
invention, the remainder of actuating member 40 is configured to
create a seal between actuating member 40 and the interior walls of
lumen 18. Alternatively, actuating member 40 and head 44 are not
configured to create a seal with the interior walls of lumen 18,
rather a separate seal, such as but not limited to, one or more
O-rings, quad-rings, V-rings, gaskets, combinations thereof or
other structure capable of creating a seals is mounted to head 44
to create a seal between the interior wall of lumen 18 and head
44.
[0114] The head 44 of actuating member 40 cooperates or engages
with filter assembly 42 and forces filter assembly 42 from the
distal end of lumen 18 as actuating member 40 is moved during a
procedure. By so doing, a filter 50 of filter assembly 42 is
deployed to collect material. Further, head 44 can be moved within
lumen 18 by actuating member 40 to retrieve filter assembly 42,
thereby aiding with removal of the collected material subsequent to
a procedure or to allow for repositioning of filter 50 of filter
assembly 42. The head 44 and actuating member 40 can have various
other configurations so long as actuating member 40 is capable of
deploying and retrieving filter assembly 42. For instance, in
another configuration, actuating member 40 can be devoid of head 44
and be formed from a plurality of wires, strands, or members that
are braided together, connected to, or formed as part of filter
assembly 42.
[0115] Actuating member 40 and head 44 can be fabricated from a
variety of different materials, such as but not limited to,
stainless steel, tungsten, titanium, platinum, Nitinol, other
metals, alloys thereof, composites, plastics, polymers, synthetic
materials, or combinations thereof.
[0116] Referring now to FIG. 6a and 6b, depicted is filter assembly
42 in a deployed position following movement of actuating member 40
in the distal direction. As illustrated, filter assembly 42
includes filter 50 and a plurality of radially spaced-apart struts
52 extending from filter 50 to head 44 of actuating member 40.
Filter 50 has a distal end 54 separated from a proximal end 58 by
an intermediate portion 56. A peripheral edge of proximal end 58 is
secured to struts 52 to form an opening 60 that allows material to
flow into filter 50, while distal end 54 is closed to prevent
material from escaping or exiting from filter 50.
[0117] Although in one configuration filter is hemispherical, it
can be understood that filter 50 can be a variety of
configurations, such as but not limited to, hemispherical, conical,
cylindrical, combinations thereof, or any other configuration that
allows for material to be collected therein, while the opening of
the filter substantially extends to the peripheral surface of the
blood vessel within which the filter is disposed. More generally,
filter 50 can have any configuration so long as proximal end 58 has
an opening that allows material to flow into filter 50 and distal
end 54 is closed to prevent material from escaping or exiting from
filter 50.
[0118] Intermediate portion 56 and distal end 54 are free to float
in the blood flow or stream within the blood vessel, while proximal
end 58 is in a fixed relationship with actuating member 40 through
struts 52. By allowing intermediate portion 56 and distal end 54 of
filter 50 to float, as filter collects material, such as
illustrated in FIG. 7, the material creates drag on filter 50 so
that the shape of filter 50 changes, while maintaining
substantially the same volume as when deployed. Consequently, blood
can continue to flow through portions of intermediate portion 56 as
distal end 54 continues to fill with material, as indicated by
arrows A and B in FIG. 7. In this manner, material can be collected
as blood flow is maintained through filter 50.
[0119] Filter 50 can be fabricated from a variety of different
materials, such as but not limited to, a woven or braided plastic
or metallic mesh, a perforated polymer film, a Nitinol mesh,
combinations thereof, or other material that is capable of
capturing material within flowing blood, while allowing the blood
to flow through the pores or apertures thereof Generally, filter 50
can be fabricated from a variety of materials so long as filter 50
is capable of being packed within lumen 18, floating in the blood
flow or stream passing through the blood vessel within which it is
inserted, and is bio-compatible.
[0120] Filter 50 can have a variety of differently sized pores 51
ranging from about 50 microns to about 200 microns, from about 60
microns to about 180 microns, or from about 75 microns to about 150
microns. For instance, as illustrated in FIG. 6b, pores 51 can have
a variety of different configurations, such as but not limited to
circular, oval, polygonal, combinations thereof or other
configurations known to one skilled in the art in light of the
teaching contained herein. In one configuration, therefore, filter
50 can includes pores that are differently sized and configured.
Consequently, a major or minor axis of each pore can have a variety
of different sizes ranging from about 50 microns to about 200
microns, from about 60 microns to about 180 microns, or from about
75 microns to about 150 microns. Generally, the pore size can vary
as needed, so long as the pores are sized so that the pores do not
compromise blood flow through the filter, i.e., prevent blood
flowing through the filter, and collect material that could
potentially occlude smaller downstream vessels, potentially
blocking blood flow to tissue or result in stroke or
infarction.
[0121] In addition to the above, filter 50 can be coated with a
hydrophilic coating, a heparinized coating, Teflon, silicone,
combinations thereof, or various other coatings as know or desired
by one skilled in the art in light of the teaching contained
herein.
[0122] Referring again to FIG. 6a, connecting filter 50 to head 44,
and optionally directly to actuating member 40, are struts 52. As
illustrated, the distal ends of struts 52 are connected at radially
spaced-apart locations about the peripheral edge of proximal end 58
of filter 50. The struts 52 attach to filter 50 on the exterior of
filter 50, on the interior of filter 50, along the edge of filter
50, through filter 50, or combinations of one or more of the above.
The struts 52 can be attached to filter 50 and/or actuating member
40 by medical grade adhesives, such as but not limited to, ultra
violet curable adhesives, acrylics, cyanoacrylates, solvent
bonding, radio frequency or ultrasonic bonding, or some other
manner to securely connect the distal end of one or more struts 52
to filter 50. Alternatively, struts 52 can be thermally bonded to
filter 50 and/or actuating member 40, such as when struts 52 are
fabricated from a material allowing such thermal bonding. In
another configuration, struts 52 are woven into filter 50 or are
distally formed with hooks or loops that are can be used to attach
struts 52 to filter 50. In still another configuration, struts 52
can be lengthened strands of filter 50 that extend from filter 50
to actuating member 40. In still another configuration, struts 52
are extensions or strands of actuating member 40, such as when
actuating member 40 is a braided wire, a slit tube, or other member
that is capable of performing the functions described herein with
respect to actuating member 40. In still another configuration,
struts 52 are extensions of filter 50 that extend to head 44 and
connect thereto.
[0123] As illustrated, each strut 52 is formed from Nitinol,
stainless steel, metals, alloys, composites, plastics, polymers,
synthetic materials, combinations thereof, or other materials that
allow struts to perform one or more of the functions described
herein. Each strut 52 can have a generally curved distal portion 62
and may be biased to extend radially outward when filter 52 is to
be deployed. In this manner, distal portion 62 is in close
proximity to the wall of the blood vessel within which filter
device 10 is inserted when deployed. The struts 52 extend the edge
of proximal end 58 of filter 50 into contact with the wall of the
blood vessel. By so doing, the proximal end 58 of filter 50 can
contact a substantial portion of the wall of the blood vessel and
accommodate for variations in the profile of the wall.
[0124] Although, reference is made to the edge of proximal end 58
contacting the blood vessel, other configurations of the present
invention locate the edge of proximal end 58 adjacent to, in close
proximity to, juxtaposed, or contiguous with the wall of the blood
vessel. This can be the case, so long as material can be captured
through opening 60 and material is not captured between the outer
surface of filter 50 and the wall of the blood vessel within which
filter device 10 is inserted.
[0125] Referring now to FIG. 8, depicted is filter 50 in the
captured or retrieved position. When actuating member 40 is moved
in the proximal direction, opening 60 of filter 50 is drawn toward
distal end 14 of guide member 12. As actuating member 40 is moved
in the proximal direction, the interior wall of lumen 18 forces
struts 52 inwardly. Simultaneously, distal end 62 of each strut 52
moves inwardly to close opening 60. This simultaneous motion
prevents material trapped within the interior of filter 50 from
escaping. Opening 60 can alternatively be substantially completely
closed following the initial movement of actuator member 40 in the
proximal direction. In still another configuration, opening 60 can
be partially closed as actuator member 40 is moved in the proximal
direction and gradually becomes substantially completely closed
upon a substantial portion of struts 52 being retracted into lumen
18 of filter device 10. In still another configuration, opening 60
can be substantially completely closed upon a portion of struts 52
being retracted into lumen 18 of filter device 10.
[0126] To move actuating member 40 in the proximal direction and/or
distal direction filter device 10 includes an actuating assembly
20. The actuating assembly 20 can be integrated with guide member
12 and/or separate therefrom. With reference to FIG. 9, depicted in
an illustrative configuration of actuating assembly 20.
[0127] Referring now to FIG. 9, depicted is an exemplary embodiment
of an actuating assembly 20 that can be used to manipulate
actuating member 40. Through operating actuating assembly 20,
filter assembly 42 (FIG. 5) can be deployed and retrieved.
[0128] As illustrated, actuating assembly 20 includes an actuating
element 70 and actuator member 40. Actuating element 70 includes a
distal end 74 that is configured to cooperate with guide member 12,
while a proximal end 76 of actuating element 70 is attached to
proximal end 16 of guide member 12. The distal end 74 has a step
configuration and includes indentations 78 that are configured to
cooperate with complementary protrusions 80 formed in guide member
12. As actuating element 70 is moved in the distal direction,
indentations 78 and protrusions 80 mate to position actuating
element 70 in a desired location relative to proximal end 16 of
guide member 12, thereby positioning filter assembly 42 in a
selected position, such as in the retracted position illustrated in
FIG. 9.
[0129] As actuating element 70 is continually moved in the distal
direction, distal end 74 meets a wall 82 formed in guide member 12
that prevents further movement in the distal direction. Through
this configuration, actuating element 70 is prevented from
excessive longitudinal displacement in the distal direction. This
stopping of the longitudinal displacement of actuating element 70
indicates that filter assembly 42 is deployed.
[0130] Although reference is made to one manner to indicate the
particular location filter assembly 42, one skilled in the art can
identify a variety of different manners. For instance, a plurality
of indentations and/or protrusions can be included within actuating
element 70 and guide member 12 to control the distance which
actuating element 70 and consequently filter assembly 42 is moved.
In another configuration, a wall formed in actuating element 70
mates with the distal end of guide member 12 to prevent excessive
longitudinal displacement in the distal direction. In still another
configuration, a combination of walls in actuating element 70 and
guide member 12 can be used. In still another configuration, distal
end 76 of actuating element 70 is tapered and cooperates with a
taper formed in proximal end 16 of guide member 12. The
complementary tapers control the longitudinal displacement of
actuating element 70 relative to proximal end 16 of guide member
12. In still other configurations, a combination of indentations,
protrusions, walls, or tapers can be used. Various other manners
are known to control the distance traveled by actuator element 70
while indicating the position of filter assembly 42.
[0131] To remove filter device 10 from within the patient,
embodiments of the present invention provide a capture catheter 90,
as shown in FIG. 10. Capture catheter 90 is adapted to enclose
filter 50 to prevent filter from tearing or catching on stents,
grafts, other implants, guide members, catheters, sheaths, or other
protrusions that may be encountered as filter 50 is removed from
the patient.
[0132] As illustrated in FIG. 10, capture catheter 90 has a
generally elongate form having a lumen 92 extending from a distal
end 94 to a proximal end 96 thereof. Disposed at distal end 94 is
at least one radiopaque marker or band 100 that aids a physician or
clinician in placing capture catheter 90 in the desired location
relative to filter 50, as illustrated in FIG. 11. Through viewing
the insertion of capture catheter 90 through a fluoroscope, a
physician or clinician can place distal end 94 to surround filter
50.
[0133] The lumen 92 of capture catheter 90 is adapted to receive
filter 50 and substantially completely enclose filter 50. The
inside diameter of lumen 92 is configured to engage with struts 52
when they are in the open configuration, i.e., filter 50 is in the
deployed position, and push struts 52 radially together to close
opening 60. Through this configuration, opening 60 is closed before
distal end 94 of capture catheter 90 contacts filter 50 and the
engagement of capture catheter 90 with filter 50 does not cause
embolic material to escape from within filter 50.
[0134] As capture catheter 90 is advanced over filter 50, it is
compressed into lumen 92 of capture catheter 90. To limit the
amount of compression of the embolic material within filter 50, a
section of lumen 92 which or that optionally has greater elasticity
than the remainder of capture catheter 90, the border of this
section being represented by dotted lines in FIG. 10. By so doing,
this portion of capture catheter 90 can expand around filter 50 and
any captured embolic material.
[0135] Capture catheter 90 can have various configurations and be
fabricated from a variety of different materials. For example,
capture catheter 90 can be fabricated from metals, alloys,
plastics, polymers, synthetic materials, composite's, or other
medical grade materials. Further, capture catheter 90 can be kink
resistant, biocompatible, radiopaque, in whole or in part, and
capable of being exchanged over guide member 12. Additionally, the
elasticity of capture catheter 90 can be constant along its length,
variable along its length, constant along a portion and variable
along another portion of capture catheter 90, or combinations
thereof.
[0136] As illustrated in FIG. 10, disposed at proximal end 96 of
capture catheter 90 is a locking mechanism 98. The locking
mechanism 98 engages with the proximal end of guide member 12 to
securely capture guide member 12 when distal end 94 partially or
completely surrounds filter 50 (FIG. 11). In one configuration,
locking mechanism 98 is an annular clamp that can be rotated to
clamp a proximal end of guide member 12. In another configuration,
locking mechanism 98 can be a rotating hemostatis valve through
which is disposed the proximal end of guide member 12. In still
another configuration, locking mechanism 98 can be a locking
jaw-set, such as a mechanical collett. Each of these locking
mechanisms can be configured in a variety of different manners and
fabricated from a variety of different materials as known to those
skilled in the art. For instance, the locking mechanism can be
fabricated from plastics, polymers, metals, synthetic materials,
alloys, or various other materials.
[0137] According to another aspect of the present invention, filter
device 10 is generally used with a fluoroscope that enables a
physician to view the insertion of filter device 10 through the
tortuous anatomy of a patient. To enable filter device 10 to be
visible to the physician, filter device 10 includes radiopaque
bands, markers, or other means for radiopacity that provide
reference points for the physician. With reference to FIG. 7,
various locations are illustrated as being radiopaque by reference
letter R. As shown, tip 15 of filter device 10 is radiopaque. More
specifically, the most distal portion of distal end 14 is
radiopaque so that the physician knows the location of tip 15 of
filter device 10.
[0138] The distal end of actuating member 40 is radiopaque so that
the physician knows whether filter assembly 42 is in the stored,
deployed, or retrieved position, while distal end 54 of filter 50
includes a radiopaque marker that defines the most distal portion
of filter device 10. Similarly, capture catheter 90 can include
radiopaque bands, other markers, or means for radiopacity to define
the distal end thereof.
[0139] In addition to the distal ends of guide member 12, capture
catheter 90, actuating member 40, and filter 50, embodiments of the
present invention include radiopaque markers or other means for
radiopacity at the junction of struts 52 and proximal end 58 of
filter 50. In this manner, a physician can view the location of
opening 60 during the procedure and verify that opening 60 is
closed before the physician retrieves filter device 10 when the
procedure is completed.
[0140] Although reference is made to placing radiopaque bands or
markers at various locations on the components of filter device 10,
one skilled in the art can identify various other locations where
radiopaque bands, markers, or other means for radiopacity are
appropriate. Further, embodiments of the present invention need not
include all discussed radiopaque bands or markers, but rather can
include one or more of the described radiopaque bands or markers as
desired.
[0141] Following hereinafter is a discussion of an illustrative
manner by which a filter device of one embodiment of present
invention is inserted into a carotid artery. Although reference is
made to the present invention being inserted into a carotid artery,
it can be understood by one skilled in the art that different
methods can by used to insert the filter device of the present
invention into any blood vessel within a patient.
[0142] With reference to FIGS. 12-17, initially, a small needle is
used to gain femoral access, as represented by block 110. This
small hole is subsequently dilated until the hole is large enough
to allow the insertion of an introducer of appropriate size as
known to one skilled in the art.
[0143] With reference to FIG. 13, it can be understood by one
skilled in the art, that a variety of different access sites can be
used. For example, the right subclavian artery 210, left subclavian
artery 206, right brachial artery 218, left brachial artery 215,
right femoral artery 225, left femoral artery 220, right radial
artery and left radial arteries 227, 228, or any other artery as
known by one skilled in the art can be used to enter a patient's
arterial circulation. Alternatively, as known by one skilled in the
art, any other blood vessel selectable by the physician can be
chosen as an access site.
[0144] Referring now to FIGS. 12-17, following insertion of the
introducer, a guidewire 230 is inserted into the femoral access
site and steered, under fluoroscopy, to the desired location in the
arterial system, just proximal to the lesion to be treated, as
represented by block 112. In this illustrative example, the
following discussion relates to stenting of a lesion in the
internal carotid artery, as referenced by arrow D in FIG. 12 and
illustrated in FIG. 13.
[0145] Guidewire 230 and guide catheter 232 are advanced together
incrementally until the distal tip of guidewire 230 is placed
proximal to the lesion, as represented by block 114 and shown in
FIG. 12. Upon placing guide catheter 232, guidewire 230 is removed
and filter device 10 is advanced through guide catheter 232, as
represented by block 116 and illustrated in FIG. 14.
[0146] The filter device 10 is carefully advanced through the
lesion to a point distal to the lesion and subsequently acts as an
exchange guidewire with a filter attached. Alternatively, filter
device 10 can function as guide member 230 so that a physician need
not exchange filter device 10 for guidewire 230. In such a
configuration, the steps of placing the filter device and accessing
the lesion can be performed simultaneously. This particular
configuration is useful because it limited the number of exchanges
performed by the physician and consequently accelerates the
performance of the procedure.
[0147] Once in position, moving actuating member 40 distally
actuates filter device 10 and deploys filter 50, as represented by
block 118 and shown in dotted lines in FIG. 15. In this manner,
filter assembly 42 is deployed from lumen 18 of guide member 12 and
struts 52 expand to secure proximal end 58 of filter against the
wall of the vessel, as shown in FIG. 6a. Alternatively, when struts
52 are formed from the same material as filter 50, the flow of
blood through the vessel causes proximal end 58 to become secured
against the wall of the vessel. Consequently, in either case, the
blood flowing through the lesion subsequently flows through filter
50.
[0148] Next, a stent is placed over the lesson, as represented by
block 120. This may be preceded by advancing a pre-dilation balloon
234, such as a relatively long, high-pressure balloon, over filter
device 10, shown in dotted lines, until balloon 234 is within the
lesion. Next, balloon 234 is inflated to dilate the lesion, as
illustrated in FIG. 16, and then deflated and removed from the
patient. Then a stent delivery system is advanced over guide member
12 until a stent 236, shown in dotted lines in FIG. 17, is within
the lesion. The stent delivery system deploys stent 236, which then
expands to fit the interior of the lesion within the artery. Once
"stent 236 is thus deployed, the stent delivery system is then
removed.
[0149] To secure stent 236 in place, a post-dilation balloon,
having a similar configuration to the pre-dilation balloon, is
advanced over filter device 10 until the balloon is within stent
236. Subsequently, the post-dilation balloon is inflated to a
pressure and held at the desired pressure for a period selected by
the physician. The maintenance of the balloon at such a pressure
for this period causes stent 236 to be imbedded into the inner wall
of the vessel. Following imbedding stent 236 into the inner wall of
the vessel, the balloon is deflated and removed.
[0150] To complete the procedure, the devices within the patient
and punctured vessel and tissue are closed. With respect to filter
device 10, locking mechanism 20 is activated to cause actuating
member 40 to move in the proximal direction. The actuating member
40 draws struts 52 within lumen 18 of guide member 12, thereby
causing proximal end 58 of filter 50 to be retained within lumen
18, as illustrated in FIG. 8 and represented by block 122 in FIG.
12. In another configuration, activating actuating member 40 causes
proximal end 58 of filter 50 to contact distal end 26 of guide
member 12, while remaining external from lumen 18. In either case,
the material captured within filter 50 are enclosed and prevented
from escaping during removal of filter device 10. By locating
proximal end 58 of filter 50 within lumen 18 or in contact distal
end 26 of guide member 12, filter device 10 securely encloses the
material with a sufficiently low force to prevent escape of any
material but not cause material to be extruded through the holes of
filter 50.
[0151] Once filter 50 is in the retracted position, capture
catheter 70 is advanced over guide member 12 until the capture
catheter encloses filter device 10, as illustrated in FIG. 11. This
capture catheter is optionally locked in place with respect to
guide member 12 and the filter system, including filter device 10.
Subsequently, the capture catheter 70 and the filter device 10 are
removed from the patient, as represented by block 124. To complete
the procedure, all remaining devices are removed from the patient
and the vessel puncture is closed.
[0152] The previously described embodiment of a filter device of
the present invention is only one illustrative embodiment of the
filter device. The following discussion provides various other
configurations of various alternate embodiments of the filter
device, including the guide member, the capture catheter and
various elements of components. The following embodiments can be
used in a similar manner to filter device 10 in performing the
above-discussed method to insert the filter device into a carotid
artery or some other body lumen. Further, the applicability of the
features and functions discussed with respect to the previously
discussed embodiment of the present invention are applicable to the
to the following embodiments.
[0153] Referring now to FIG. 18 is another configuration or
embodiment of the filter assembly and actuating assembly. As
depicted in FIG. 18, a filter device 310 includes a guide member
312 having a distal end 314 and a lumen 318 extending from distal
end 314 toward a proximal end (not shown). In this particular
configuration, a sheath and cover are excluded from guide member
312. In another configuration, however, a sheath and cover can be
included in a similar manner to guide member 12.
[0154] Disposed within lumen 318 are a filter assembly 342 and an
actuator 340, with associated head 344. The filter assembly 342
includes a filter 350, which can be similar to other filters
described herein, and a plurality of struts 352 extending from
filter 350 to actuator 340 or head 344. Each strut 152 includes a
distal portion 362, a proximal portion 366, and an intermediate
portion 364 disposed between distal portion 362 and proximal
portion 366. The struts 352 attach to filter 350 on the exterior of
filter 350, on the interior of filter 350, along the edge of filter
350, through filter 350, or combinations of one or more of the
proceeding. To provide additional surface area to connect each
strut 352 to filter 30, each strut 352 can be configured so that
distal portion 362 has a cross-sectional dimension larger than
intermediate portion 364. Stated another way, distal portion 362
can have a larger surface area than intermediate portion 364. The
large cross-sectional area provided by the cross-sectional
dimension of distal portion 312 provides large area for bonding
each strut 352 to filter 350. In this configuration, a strong bond
is created between each strut 352 and filter 350.
[0155] Similarly, each strut 352 can be configured so that proximal
portion 366 has a cross-sectional dimension larger than
intermediate portion 364, while optionally having a similar,
larger, or smaller cross-sectional dimension than distal portion
362. By having a large cross-sectional dimension and hence large
surface area, each strut 352 can be securely connected to actuating
member 340 or head 342 which can be similar to other actuating
members and heads described herein.
[0156] By varying the cross-sectional dimensions of distal portion
362, intermediate portion 364, and/or proximal portion 366, the
degree of bias exerted by each strut 352 to move distal portion 362
toward the wall of a blood vessel can be varied. The biasing force
can also be changed through optionally varying the length of each
strut 352 and/or changing the curvature of each strut 352.
[0157] Although reference is made herein to each strut 352 having
the above-referenced configurations, one skilled in the art can
appreciate that one or more of struts 352 can be configured as
described above. Further, each strut 352 can optionally be
configured differently so that each strut 352 can have similar or
dissimilar biasing forces compared to others struts 352 of the same
filter device. Through varying the biasing forces, the filter
device can be used for a variety of different procedures or blood
vessel configurations.
[0158] Struts 352 can be formed from Nitinol, stainless steel,
metals, alloys, composites, plastics, polymers, synthetic
materials, or combinations thereof. Each strut 352 can have a
generally curved distal portion 362, proximal portion 366, and/or
intermediate portion 364.
[0159] Referring now to FIG. 19, illustrated is an alternate
embodiment of actuator assembly, designated by reference number
420. This particular embodiment of actuator 420 is capable of
deploying and retrieving a filter assembly with use of a clamp
assembly 472.
[0160] As illustrated, actuating assembly 420 includes an actuating
element 470, and an actuating member 440, each of which can be
similar to other actuating elements and actuating members described
herein. Actuating element 470 includes a distal end 474 that is
configured to cooperate with guide member 412, which can be similar
to the other guide members described herein, while a proximal end
476 of actuating element 470 is attached to proximal end of
actuating member 440. The distal end 474 has a step configuration
and includes protrusions 478 that are configured to cooperate with
complementary indentations 480 formed in guide member 412. As
actuating element 470 is moved in the distal direction, such as by
a physician, clinician, or a device operated by the physician,
clinician, or technician, protrusions 478 and indentations 480 mate
to position actuating element 470 in a desired location relative to
proximal end 416 of guide member 412, thereby positioning filter
assembly 442 in a selected position, such as in the retracted
position illustrated in FIG. 8.
[0161] As actuating element 470 is continually moved in the distal
direction, distal end 474 meets a wall 482 formed in guide member
412 that prevents further movement in the distal direction. Through
this configuration, actuating element 470 is prevented from
excessive longitudinal displacement in the distal direction. This
stopping of the longitudinal displacement of actuating element 470
indicates that filter assembly 442 is deployed.
[0162] As illustrated, actuator element 470 engages with clamp
assembly 472. The clamp assembly 472 includes two annular clamp
sets 484 and 486. Clamp set 484 couples to actuator element 470,
while clamp set 486 couples to guide member 412. In this
illustrative embodiment, clamp set 484 is capable of being
translated along the longitudinal axis of the filter device, while
clamp set 486 is fixed. Clamp set 484 can be connected to a
threaded screw, hydraulic rams, pneumatic rams, slide systems,
linear actuators, combinations thereof, or the like that enables
clamp set 484 to move in the proximal and distal directions. For
instance, in one embodiment a threaded screw is rotatably attached
to clamp set 486, with clamp set 484 mounted thereto. Upon rotating
the threaded screw, clamp set 484 advances along the threaded screw
in either the proximal or distal direction to open or retract the
filter assembly (not shown) of the filter device.
[0163] Generally, clamp assembly 472 can include a variety of
different clamp sets, whether annular or opposed clamping jaws or
clamp set, or the like as known to one skilled in the art. Further,
clamp assembly 472 can use pneumatics, hydraulics, electricity,
combinations thereof, or the like to move actuator element 470
and/or guide member 412.
[0164] Referring now to FIG. 20, another illustrative embodiment of
the present invention is depicted. As shown, a guide member 512,
which can be similar to the other guide member described herein,
has a distal end 514, a proximal end 516, and a lumen 518 extending
from distal end 514 to proximal end 516. A tip 515 of guide member
512 includes a plurality of struts 522, such as three or more
struts. Each strut 522 can be biased such that a distal end thereof
is biased to move outwardly from the longitudinal axis of guide
member 512.
[0165] At least one strut, designated by reference numeral 524, is
biased toward the longitudinal axis of guide member 512, as shown
in FIG. 21. Disposed upon strut portion 524, as more clearly seen
in FIG. 20, is a coil tip 526 that is commonly used with
guidewires. This coil tip 526, either alone or in combination with
strut 524, may be configured to allow a physician or clinician to
shape the same before insertion into a body lumen. In this manner,
the physician or clinician is able to configure the tip with an
appropriately shaped J that enables guide member 512 to be guided
through the tortuous anatomy of a patient. The coil tip 526 can be
platinum, platinum alloys, radiopaque materials, metals, alloys,
plastic, polymer, synthetic material, combinations thereof, or
other materials that provide an appropriate radiopaque signature,
while capable of being shaped, whether alone or in combination with
strut 524, by a physician or clinician.
[0166] Attached to the distal ends of two or more of struts 522 is
a filter 550. As shown, filter 550 is disposed within lumen 518 of
guide member 512. In alternate embodiments, filter 550 can surround
guide member 512 or partially surround and partially be contained
within lumen 518. Filter 550 can have a variety of different
configuration such as those described with respect to the other
filters described herein.
[0167] Filter 550 can be attached to guide member 512 via a variety
of different techniques and methods as known to one skilled in the
art. For instance, filter 550 can be attached through adhesives,
solvent bonding, thermal bonding, mechanical connections, or some
other manner that is capable of securely connecting filter 550 to
one or more of struts 522. In another configuration, a distal end
of two or more struts 522 can include respective holes (not shown)
through which strands of filter 550 can be passed and attached to
strut 522 to connect filter 550 to struts 522. Alternately, the
strands can be tied in a knot or folded back upon filter 550 and
woven into or affixed to filter 550.
[0168] To maintain struts 522 in the closed position, i.e., not
extending outwardly from guide member 512, a catheter 540 surrounds
guide member 512. The catheter can extend completely or partially
from the distal end to the proximal end of guide member 512.
Illustratively, the catheter can surround substantially only struts
522. The catheter 540 acts as a restraining member or mechanism
that applies a force against the struts to prevent the struts from
extending outwardly. Catheter 540 can have a lumen (not shown) that
has an inside diameter that is sufficiently similar to the outside
diameter of guide member 512 that struts 522 are restrained from
extending outwardly. Through moving guide member 512 with respect
to catheter 540, or vice versa, the distal ends of two or more of
struts 522 are allowed to move outwardly to deploy filter 550, as
illustrated in FIG. 21 that depicts guide member 512 having two
struts 522. Retracting filter 550 and catheter 540 can be performed
in a similar manner to that described with respect to the other
filter devices discussed herein, such as but not limited to using a
capture catheter.
[0169] As mentioned above, the catheter can extend completely or
partially the length of the guide member. In another configuration,
the catheter can be replaced with a sleeve, a band, or other
structure that partially extends toward the proximal end of the
guide member from the distal end. These sleeves, bands, or other
structures can be radiopaque or include one or more radiopaque
markers. Furthermore, these sleeves, bands, or other structures can
be slidable relative to the guide member using an actuating member
that is disposed on the exterior of the guide member, within the
lumen of the guide member, or partially within the lumen and
partially on the exterior of the guide member. The actuator member
can be any of the actuator members described herein.
[0170] According to an alternate configuration of the present
invention, a filter device 610 includes a guide member 612 with a
plurality of struts 622 disposed at a distal end 614 thereof. These
struts 622 can be maintained in the closed position using a sleeve
660, as illustrated in FIG. 22. The sleeve 660 acts as a
restraining member or mechanism that applies a force against the
struts to prevent the struts from extending outwardly.
[0171] Sleeve 660 surrounds struts 622, and a filter 650, which can
be similar to other filters described herein, when filter 650 is
located on an exterior surface of guide member 612. Disposed within
sleeve 660 or between sleeve 660 and guide member 612 and/or filter
650 are one or more actuating members or actuating members 654.
These actuating members 654 are attached to guide member 612 at a
location just proximal to the proximal end of each struts 622,
identified by letter E, extend distally to the distal end of sleeve
660, and subsequently extend proximally on the outside of sleeve
660 to terminate at an actuating element 670 of an actuating
assembly 620 (FIG. 25) via one or more holes 656 and lumen 618.
Since one end of each actuating member 654 is located at the
proximal end of sleeve 660, whether forming part of sleeve 660,
attached to sleeve 660, attached to guide member 612, or
combinations thereof, pulling actuating member 654 in the proximal
direction by actuating element 670 of actuating assembly 620 (FIG.
25) causes actuating member 654 to preferentially separate sleeve
660 into one or more portions, thereby releasing struts 622, as
illustrated in FIG. 24.
[0172] Stated another way, and with reference to FIG. 25, one or
more of actuating members 654 can cooperate with an actuating
assembly 620 and connect to actuating element 670, such as through
soldering, adhesives, or other forms of attachment. The actuating
element 670 can be moved in the proximal direction until a stop
member 672 formed in a proximal end 616 of actuating element 670
engages with a stop member 674 in guide member 612. During the
movement from a distal end 676 of actuating element 670 cooperating
with a surface 678 of guide member 612 to stop member 672 engaging
with stop member 674, actuating member 654 moves in a proximal
direction to preferentially separate sleeve 660.
[0173] Sleeve 660 can be formed from a variety of different
materials, so long as the material is sufficiently strong to secure
struts 522, while being configured to preferentially separate under
the action of actuating member or actuating member 654. For
example, sleeve 660 can be fabricated from heat shrink synthetic
material, including but not limited to, low-density polyethylene
(LDPE), polyethylene terphthalate (PET), Polytetrafluoroethylene
(PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE),
polyurethane (PU) or silicone tubing.
[0174] Actuating members 654 can be formed from a variety of
different materials, so long as the material used is sufficiently
strong to allow an actuating mechanism, such as those actuating
mechanisms disclosed herein, to move actuating members or actuating
member 654 proximally without breaking the same. For example,
actuating members 654 can be fabricated from plastics, polymers,
metals, composites, alloys, synthetic materials, or combinations
thereof
[0175] Instead of using actuating members 654, embodiments of the
present invention can employ various other manners to
preferentially separate sleeve 660. For example, sleeve 660 can
have dissolvable chemical bonds which dissolve due to a chemical
reaction with the fluid in the vessel within which the filter
device is disposed, bonds that are broken through applying
resistive heating, ultrasonic or radio frequency energy,
preferential regions or zones where the material has a weaker
strength than other regions or zones of the sleeve, or combinations
thereof.
[0176] Following is a discussion of other methods, devices, and
systems for restraining or constraining one or more struts attached
to or integrally formed as part of a guide member. The embodiments
provide methods, devices, and systems for, applying a restraining
force to one or more struts and subsequently releasing the same to
allow the struts to expand outwardly.
[0177] Referring now to FIG. 26, depicted is a perspective view of
one embodiment of a restraining member or mechanism. The
restraining member or mechanism, is in the form of a sleeve 760 and
associated securing member 762, the combination of which is adapted
to surround one or more struts 752 of a guide member 712 and apply
a restraining force against struts 752 to maintain struts 752 in a
closed configuration. The sleeve 760 includes a first side 764 and
a second side 766 with first and second sides 764, 766 being
separated by an intermediate portion 768. The sleeve 760 surrounds
guide member 712 in such a manner that intermediate portion 768
surrounds guide member 712 so that portions of intermediate portion
768 contacts with, are juxtaposed to, are contiguous with, or are
adjacent one to another. The securing member 762 passes through
such portions of intermediate portion 768 to secure sleeve 760 upon
guide member 712. To further aid with applying a restraining force
against struts 752, first side 764 and second side 766 are folded
to attach to respective portions of outside surface of sleeve
760.
[0178] The process of forming the restraining member or mechanism
of FIG. 26 is illustrated in FIGS. 27 and 28. With reference first
to FIG. 27, which depicts sleeve 760 in an open position before
securing member 762 is coupled thereto, sleeve 760 can be directly
formed on guide member 712 or can be formed on a separate tubular
member and subsequently attached or coupled to guide member 712.
Sleeve 760 is illustrated as having a generally polygonal
configuration, however, one skilled in the art can appreciate that
sleeve 760 can have various other configuration so long as it is
capable of performing the functions described herein. In this
exemplary configuration, sleeve 760 is coupled directly to a guide
member 712. The first side 764 and second side 766 of sleeve 760
are wrapped around at least a portion of guide member 760, until a
portion of intermediate portion 768 is in close proximity another
portion of intermediate portion 768. Alternatively, a first side
764 can be contacting, juxtaposed, contiguous, or adjacent to
second side 766.
[0179] When the portions of intermediate portion 768 are in close
proximity, securing member 762, or alternatively some other
actuating member, is stitched through both sleeve 760 to couple the
portions of intermediate portion 768, as shown in FIG. 28. Once
securing member 762 is drawn straight, first end 764 and second end
766 are folded to attach to respective outside surfaces of sleeve
760, as shown in FIG. 25.
[0180] In an alternate configuration, as illustrated in FIG. 29,
sleeve 760 can include a plurality of apertures 780 on portions of
intermediate portion 768 that receive securing member 762 thereby
allowing securing member 762 to be passed through apertures 780
rather than stitched through sleeve 760. In another embodiment,
first end 764 of sleeve 760 can be coupled to second end 764 of
sleeve 760 without attaching first end 764 or second end 766 to the
outside surface of sleeve 760. Depending upon the particular
configuration, a portion of first end 764 can overlap a portion of
second end 766, or vice versa. Alternatively, first end 764 and
second end 766 contact each other but do not overlap. Similarly,
first end 764 and second end 766 can be adjacent to one another,
adjoining one another, contiguous to one another, or juxtaposed to
one another.
[0181] To operate the restraining member or mechanism described in
reference to FIGS. 26-29, a proximal end (not shown) of securing
member 762 extends to a proximal end (not shown) of guide member
712, either within or without a lumen of the guide member 712.
Disposed upon the end of securing member 762 is an actuating
member, such as actuating member 20, which allows a physician or
clinician to move securing member 762 longitudinally to remove
securing member 762 from being disposed through at least a portion
of sleeve 760. By so doing, the restraining force applied by sleeve
760 is released, struts 752 extend outwardly, and the filter (not
shown) is deployed.
[0182] Sleeve 760 can be formed from a variety of different
materials, so long as the material is sufficiently strong to
restrain one or more struts 752. For example, sleeve 760 can be
fabricated from various types of polymer or silicone films, such as
but not limited to, heat shrink plastic, polymer, low-density
polyethylene (LDPE), polyethylene terphthalate (PET),
Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene
(FEP), polyethylene (PE), polyurethane (PU), or silicone
tubing.
[0183] Securing member 762 can be formed from a variety of
different materials, so long as the material used is sufficiently
strong to allow the actuating mechanisms disclosed herein to move
securing member 762 proximally without breaking securing member
762. For example, securing member 762 can be fabricated from
plastics, polymers, metals, composites, alloys, synthetic
materials, combinations thereof, or other material that is capable
of performing the function of being disposed through sleeve 760 and
capable of being withdrawn therefrom.
[0184] Referring now to FIGS. 30-34, illustrated is another
alternate configuration of a restraining member or mechanism. This
particular configuration utilizes a hinged configuration with a
securing member acting as the pin to maintain the hinged portions
of a sleeve in a closed configuration to constrain or restrain a
portion of the guide member.
[0185] As shown in FIG. 30, a sleeve 860 includes a plurality of
channels 864a-864f that are adapted to receive a securing member
862. Both a first side 866 and a second side 868 of sleeve 860 are
formed with some of channels 864a-864f, i.e., channels 864a, 864c,
and 864e on first side 866 and channels 864b, 864d, and 864f on
second side 868. Through passing securing member 862 through
channels 864a-864f in sequential order, so that securing member 862
passes through a channel on first side 866 and subsequently a
channel on second side 868, first side 866 is coupled to second
side 868 and sleeve 860 applies a restraining force against the
struts (not shown) of a guide member.
[0186] The process of forming the restraining member or mechanism
of FIG. 30 is illustrated in FIGS. 31-34. With reference first to
FIG. 31, which depicts sleeve 860 in an open position before
securing member 862 is coupled thereto, sleeve 860 includes a
number of extensions or tongues 870a-870n. These extensions
870a-870n are configured to surround a tubular member or tube, such
as but not limited to, a guide member 812, and form channels
864a-864f within which securing member 862 is located, as will be
described hereinafter.
[0187] To attach sleeve 860 to guide member 812, sleeve 860 is
positioned over the desired portion of guide member 860. The
securing member 862 is placed in close proximity to guide member
860, as shown in FIGS. 31 and 32. The ends of the extensions
870a-870n are inserted between guide member 860 and securing member
862, as shown in FIG. 33. Alternatively, extensions 870a-870n can
be partially wrapped around guide member 812 and securing member
862 placed into contact with these partially wrapped extensions
870a-870n.
[0188] After the extensions 870a-870n are pulled tightly around
guide member 812 and securing member 862, an end of each extension
870a-870n is folded over securing member 862 to attach to the outer
surface of sleeve 860, as shown in FIGS. 30 and 34. In this manner,
channels 862a-862n are formed and sleeve 860 is configured with
securing member 862 to releasably restrain the struts (not shown)
of guide member 812.
[0189] Releasing the restraining force applied by sleeve 860, alone
or in combination with securing member 862, is achieved through
moving or pulling securing member 862 longitudinally with respect
to guide member 812. The securing member 862 is withdrawn from
channels 864a-864f to allow the biasing force of the struts (not
shown) to extend the struts outwardly to deploy the filter (not
shown). The longitudinal motion of securing member 862 can be
initiated through a variety of different mechanisms as described
herein, such as but not limited to actuating assembly 20, or
otherwise known to one skilled in the art in light of the teaching
contained herein.
[0190] Referring now to FIG. 35, depicted is another embodiment of
a restraining member or mechanism of the present invention. The
restraining member 960 includes a number of hoops 964a-96n that are
adapted to receive a securing member 962. In a similar manner to
that described with respect to other embodiments of the restraining
member or mechanism, securing member 962 is disposed within hoops
964a-964n so that restraining member 960 applies a retaining force
against the struts of a guide member 912. The securing member 962
can be removed from hoops 964a-964n to thereby allow the struts to
extend outwardly to deploy the filter (not shown). The restraining
member 960 may be made from metallic wires, polymer fibers, or
other materials that can be manipulated to form hoops through which
a securing member is disposed and which can expand outwardly either
under the influence of one or more struts or due to a biasing force
applied by the configuration and/or material of the restraining
member.
[0191] The restraining member 960 can be attached to guide member
912 and/or one or more of the struts associated therewith through
various attachment mechanisms. For instance, restraining member 960
can be attached to guide member and/or one or more of the struts
through adhesives, mechanical fasteners, securing loops, or other
manner that securely attaches restraining member 960 to the guide
member and/or one or more of the struts. Alternatively, restraining
member 960 may be attached to securing member 962 and be removed
when securing member 962 is moved in a proximal direction.
[0192] Referring now to FIGS. 36-39, depicted is another embodiment
of a restraining member or mechanism of the present invention.
Instead of a separate restraining member or mechanism that is
connected to a guide member, the filter media itself is adapted to
function both as a filter and as a restraining member or
mechanism.
[0193] As illustrated, a guide member 1010 includes a plurality of
struts 1052 that are adapted to extend outwardly to deploy a filter
1050 that is disposed within a lumen 1018 of guide member 1010. The
filter 1050 includes two flaps 1060 and 1062 that extend between a
gap 1064 between two struts 1052. These flaps 1060 and 1062 are
adapted to be pulled around struts 1052 to compress them and secure
filter 1050 within lumen 1018, as illustrated in FIG. 37. These
flaps 1060 and 1062 can be integral with filter 1050, two separate
members that are bonded or otherwise connected to filter 1050, or a
single member that has an intermediate portion bonded or otherwise
connected to filter 1050, with the ends of the member forming flaps
1060 and 1062.
[0194] When flaps 1060 and 1062 have been positioned to securely
retain struts 1052, they are then stitched together at a location
1066 identified in FIG. 38 with an actuating member 1070. This
actuating member 1070 extends the length of the filter device to
cooperate with an actuating assembly, such as but not limited to an
actuating assembly described herein and those others known to one
skilled in the art in light of the teaching contained herein.
[0195] Following the coupling of flaps 1060 and 1062 using
actuating member 1070, flaps 1060 and 1062 are folded back around
the bundled struts 1052 and filter 1050, and then attached to
filter 1050, struts 1052, or other portion of guide member 1012, as
illustrated in FIG. 39. When actuating member 1070 is moved in a
proximal direction, flaps 1060 and 1062 are released and filter
1050 is deployed as struts 1052 extend outwardly.
[0196] Although reference is made to two flaps 1060 and 1062, one
skilled in the art can appreciate that the filter can includes one
or more flaps. For instance, one flap can be wrapped around struts
1052 and an end of the flap sewn or otherwise releasable connected
to filter 1050.
[0197] Referring now to FIG. 40, depicted is another embodiment of
a restraining member or mechanism of the present invention. This
particular configuration is depicted as part of a filter assembly
1142 that can be coupled to or attached to a distal end of a guide
member. The filter assembly 1142 can includes a strut assembly 1144
and a filter (not shown) coupled to strut assembly 1144. The strut
assembly 1144 has an elongated proximal end 1146 and a distal end
1148 having a plurality of struts 1152. The length of elongated
proximal end 1146 can vary based upon the particular configuration
of the guide member. For instance, proximal end 1146 can have any
length greater than 1 centimeter.
[0198] As mentioned above, disposed at distal end 1148 are struts
1152. Each strut 1152 includes a tubular member 1154 adapted to
receive a securing member 1162. Adjacent tubular members 1154 on
adjacent struts 1152 are staggered such that when struts 1152 are
brought together securing member 1162 can be disposed through
tubular members 1154 to restrain struts 1152 and prevent them from
extending outwardly, as illustrated in FIG. 41.
[0199] The securing member 1162 can extend through a lumen 1164 of
strut assembly 1144 into a lumen 1118 of guide member 1112 to
terminate at an actuating assembly (not shown) at a proximal end
1116 of guide member 1112. Alternatively, securing member 1162 can
extend through lumen 1164 to exit through an aperture 1166,
depicted in dotted lines, in strut assembly 1144 before terminating
at an actuating assembly (not shown) at a proximal end of guide
member 1112. In still another configuration, securing member 1162
can pass into lumen 1164 through aperture 1166, depicted in dotted
lines, in strut assembly 1144 before terminating at an actuating
assembly (not shown) at a proximal end of guide member 1112.
[0200] Each tubular member 1154 coupled to struts 1152 can be
fabricated from a metal, a plastic, polymer, a polymer, a synthetic
materials, whether or not the material is the same as that forming
guide member 1112. In one embodiment, each tubular member 1154 is a
polymer tube, such as a polyimide or polyurethane tube that is
fixed to respective struts 1152 with adhesive. In another
configuration, each tubular member 1154 is a metallic cut tube that
may be attached to respective struts 1152 with and adhesive or
solder. In still another configuration, each strut 1152 includes an
aperture through which securing member 1162 passes to restrain
struts 1152 and prevents the same from extending outwardly.
[0201] Referring now to FIG. 42 is another configuration or
embodiment of a device according to another aspect of the present
invention. As depicted in FIG. 42, a filter device 1210 includes a
guide member 1212 having a distal end 1214 and a lumen 1218
extending from distal end 1214 toward a proximal end (not shown).
In this particular configuration, and for ease of explanation,
filter device 1210 is devoid of a restraining member or mechanism,
however, in other configurations, filter device 1210 can include a
restraining member or mechanism.
[0202] Disposed at distal end 1214 are a plurality of struts 1252,
coupled to which is a filter 1250. Although reference is made
herein to struts 1252 being integrally formed with guide member
1212, it can be appreciated that struts 1252 can be part of a strut
assembly that is attached to proximal end 1214 of guide member
1212. For instance, the struts assembly can have a proximal end
that terminates substantially with a proximal end of the guide
member or at a location distal to the proximal end of the guide
member, whether such location is close to the distal end of the
guide member or the proximal end of the guide member.
[0203] Each strut 1252 includes a distal portion 1262, a proximal
portion 1266, and an intermediate portion 1264 disposed between
distal portion 1262 and proximal portion 1266. The struts 1252
attach to filter 1250 on the exterior of filter 1250, on the
interior of filter 1250, along the edge of filter 1250, through
filter 1250, or combinations of one or more of the proceeding. To
provide additional surface area to connect each strut 1252 to
filter 1250, each strut 1252 can be configured so that distal
portion 1262 has a cross-sectional dimension larger than
intermediate portion 1264. Stated another way, distal portion 1262
can have a larger surface area than intermediate portion 1264. The
large cross-sectional area provided by the cross-sectional
dimension of distal portion 1212 provides large area for bonding
each strut 1252 to filter 1250. In this configuration, a strong
bond is created between each strut 1252 and filter 1250.
[0204] Similarly, each strut 1252 can be configured so that
proximal portion 1266 has a cross-sectional dimension larger than
intermediate portion 1264, while optionally having a similar,
larger, or smaller cross-sectional dimension than distal portion
1262. By having a large cross-sectional dimension and hence large
surface area, each strut 1252 can apply a greater biasing force to
extend strut 1252 outwardly to deploy filter 1250.
[0205] By varying the cross-sectional dimensions of distal portion
1262, intermediate portion 1264, and/or proximal portion 1266, the
degree of bias exerted by each strut 1252 to move distal portion
1262 toward the wall of a blood vessel can be varied. The biasing
force can also be changed through optionally varying the length of
each strut 1252 and/or changing the curvature of each strut
1252.
[0206] Although reference is made herein to each strut 1252 having
the above-referenced configurations, one skilled in the art can
appreciate that one or more of struts 1252 can be configured as
described above. Further, each strut 1252 can optionally be
configured differently so that each strut 1252 can have similar or
dissimilar biasing forces compared to others struts 1252 of the
same filter device. Through varying the biasing forces, the filter
device can be used for a variety of different procedures or blood
vessel configurations.
[0207] Struts 1252 can be formed from Nitinol, stainless steel,
metals, alloys, composites, plastics, polymers, synthetic
materials, or combinations thereof. Each strut 1252 can have a
generally curved distal portion 1262, proximal portion 1266, and/or
intermediate portion 1264.
[0208] Disposed with lumen 1218 at distal end 1214 is a core 1260
forming part of an atraumatic tip 1262. Surrounding at least a
portion of core 1260 is a coil 1264 that provides flexibility and
radiopaque properties to atraumatic tip 1262. The core 1260 passes
through an aperture 1266 in a distal end of filter 1250.
Alternatively, core 1260 passes through one or more pores formed in
filter 1250.
[0209] To secure filter 1250 to atraumatic tip 1262, a securing
coil 1270 surrounds a portion of coil 1264 and the distal end of
filter 1250. Although this is one manner to connect filter 1250 to
atraumatic tip 1262, one skilled in the art can identify various
other manners to connect filter 1250 to atraumatic tip 1262. For
instance, the distal end of filter 1250 can be bonded to atraumatic
tip 1262 using adhesives, mechanical fasteners, crimping, seals,
friction fit, press fit, or other manners to connect filter 1250 to
atraumatic tip 1262. In another configuration, filter 1250 is not
connected to atraumatic tip 1262 but can slide along a portion of
atraumatic tip 1262.
[0210] Referring now to FIG. 43, another illustrative embodiment of
the present invention is depicted. The majority of the features
previously discussed with respect to other embodiments of the
present invention apply to this exemplary embodiment.
[0211] A filter assembly 1342 comprises a filter 1350 and a spring
member 1364. Filter 1350 includes a plurality of struts 1352. These
struts 1352 are lengthened strands of filter 1350. These struts
1352 connect filter 1350 to actuating member 1340 and are unbiased.
Alternatively, struts 1352 can be biased to open filter 1350.
[0212] Disposed at proximal end 1358 of filter 1350, is biased
spring member 1364. Biased spring member 1364 has a coil-type
configuration and includes a proximal end 1368 that extends into
lumen 1318 of guide member 1312 to be attached to actuating member
1340, such as similar to actuating member 40 discussed herein,
and/or a head 1344. Spring member 1364 is biased to an opened
position where spring member 1364 forms opening 1360. During
deployment of filter assembly 1342, the flow of blood through the
blood vessel applies a force to filter 1350. This force enables
filter 1350 to be withdrawn from lumen 1318 and become deployed
into the form described herein. Since spring member 1364 is biased
to open, spring member 1364 draws the outer peripheral edge of
filter 1350 at proximal end 1358 toward the inner wall of the blood
vessel.
[0213] To retract filter 1350, actuating member 1340 is moved in
the proximal direction, causing proximal end 1358 of filter 1350 to
be drawn proximally. This causes proximal end 1358 to be drawn
toward lumen 1318 and become closed, thereby enabling filter 1350
to be removed through the procedure discussed herein, such as
through use of a capture catheter.
[0214] Various configurations of capture catheter are known to
those skilled in the art in light of the teaching contained herein.
The capture catheters described herein can be used with any of the
embodiments of the filter device or guide member described
herein.
[0215] As illustrated in FIG. 44 an alternate embodiment of a
capture catheter, designated by reference number 1390 is
illustrated. As shown, capture catheter 1390 includes a distal
portion 1392 and a positioning member 1394 connected or attached to
distal portion 1392. The distal portion 1392 includes a lumen 1400
extending from a distal end 1396 to terminate at an aperture 1402
at a proximal end 1398 thereof. The distal end 1396 optionally
includes a radiopaque marker or band 1408, while lumen 1400 is
configured to receive a filter assembly of a filter device in a
similar manner to lumen 92 of capture catheter 90. Alternatively,
lumen 1400 can include a stop member 1404, depicted in dotted
lines, with a hole 1406 therethrough. The stop member 1404 allows
guide member 1412 to pass through hole 1406, but prevents a filter
assembly disposed at a distal end of guide member 1412 to pass
through hole 1406 once capture catheter 1390 has received the
filter assembly within lumen 1400. One skilled in the art can
identify various other configurations of stop member. For instance,
hole 1406 can be disposed in stop member 1404 at any location.
[0216] To move capture catheter 1390 along guide member 1412 of the
filter device, capture catheter 1390 includes positioning member
1394. This positioning member 1394 has sufficient stiffness that
application of a force at a proximal end 1416 can be transferred to
longitudinal motion of distal portion 1392 of capture catheter
1390. In one configuration, positioning member 1394 is a solid
member, while in another configuration positioning member 1394 is
hollow or has at least a portion thereof hollow. The positioning
member 1394 can be fabricated from a polymer, a plastic, polymer, a
synthetic material, a metal, an alloy, combinations thereof, or
other material that can be used for medical devices and has the
needed stiffness.
[0217] As illustrated in FIG. 45 an alternate embodiment of a
capture catheter, designated by reference number 1420 is
illustrated. As shown, capture catheter 1420 includes a distal end
1422 and a lumen 1424 extending from distal end 1422 to terminate
at an aperture 1426 at a location proximal to distal end 1422.
Lumen 1424 is configured to receive a filter assembly of a filter
device in a similar manner to lumen 92 of capture catheter 90,
while aperture 1426 is adapted to receive guide member 1412 and
prevent passage of filter assembly of the filter device. In this
configuration, the length of lumen 1424 is configured to prevent
capture catheter 1420 from being advanced further over the filter
device or filter assembly of the filter device than is required.
Alternatively, lumen 1424 can include a stop member similar to stop
member 1404 discussed herein. Furthermore, capture catheter 1420
can optionally include one or more radiopaque markers disposed at
and/or between a distal end and a proximal end thereof.
[0218] Referring now to FIG. 46, depicted is another embodiment of
a capture catheter in accordance with another aspect of the present
invention. As illustrated, capture catheter 1490 is adapted to
cooperate with a filter device 1510. The illustrative filter device
1510 includes a filter assembly 1542 coupled to a distal end 1514
of guide member 1512. The filter assembly 1542 includes a plurality
of struts 1552 and a filter 1550 connected to one or more of the
plurality of struts 1552. As shown, filter assembly 1542 is a
separate component that is attached, connected, or coupled to guide
member 1512. In an alternate configuration, however, filter
assembly 1542 can be integrally formed with guide member 1512, such
that each of the plurality of struts 1552 is formed from a portion
of guide member 1512. Also forming part of filter assembly 1542 is
an atraumatic tip 1560. This atraumatic tip 1560 can be disposed
through filter 1550 of filter assembly 1542. Alternatively,
atraumatic tip 1560 can pass around filter 1550, as depicted in
dotted lines, and be configured from one of the plurality of struts
1552 that elongated.
[0219] Returning to capture catheter 1490, the capture catheter
1490 includes a distal portion 1492 and a proximal portion 1494
that communicates with the distal portion 1492. The proximal
portion 1494 is stiffer than the distal portion 1492 and can have a
similar configuration to the other capture catheters described
herein. For instance, proximal portion 1494 can be capture catheter
90, can have a similar configuration to distal portion 1392 of
capture catheter 1390, or can be capture catheter 1420. The distal
portion 1492 is flexible and tapers from proximal to proximal
portion 1494 to a distal end 1498 of capture catheter 1490.
[0220] Disposed at distal end 1498 is a lumen 1500 that receives
guide member 1512 of filter device 1510. Lumen 1500 can be formed
from a separate tubular member that is connected, attached, or
coupled to the distal end of capture catheter 1490. Alternatively,
lumen 1500 can be formed from the distal portion 1492 of capture
catheter 1490. The lumen 1500 is adapted to slidably receive guide
member 1512 of filter device 1510, but prevent passage of filter
assembly 1542. Stated another way, filter assembly 1542 has an
outer diameter greater than the inner diameter of lumen 1500.
Consequently, as capture catheter 1490 is moved in a distal
direction, distal end 1498 engages with either a proximal end of
filter assembly 1542 or one or more of the extending struts 1552.
As capture catheter 1490 continues to be advanced, distal portion
1492, due to its flexibility, begins to invert, as depicted in FIG.
47. As capture catheter 1490 is continued to be advanced, struts
1552 and filter 1550 are completely enclosed within capture
catheter 1490, as shown in FIG. 48.
[0221] Embodiments of the present invention and the various
components or elements thereof can be used interchangeably so that
features and functions of one exemplary embodiment of a filter
device can be used with other embodiments of the filter device.
Illustratively, the restraining members or mechanisms of the
described embodiments of the present invention can be used with
multiple different configurations of the filter device. Further,
exemplary capture catheters can be used interchangeably such that
any capture catheter can be used with any of the described filter
devices and such other that may be known to those skilled in the
art in light of the teaching contained herein. Additionally,
methods of using one embodiment of the present invention can be
used with other embodiments of the present invention. Therefore,
embodiments of the present invention provide filter devices that
have small, low, or no profiles, few parts and components, are
simple to manufacture and use, are able to be easily inserted into
a patient, be steerable through the tortuous anatomy of a patient,
provide filtering capabilities, provide exchange capability so
other medical devices can be advanced over or along the filter
device, and be capable of removing captured material without
allowing such material to escape during filter retrieval.
[0222] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *