U.S. patent application number 10/285843 was filed with the patent office on 2003-03-20 for expansible shearing catheters for thrombus and occlusive material removal.
This patent application is currently assigned to Bacchus Vascular, Inc.. Invention is credited to Demarais, Denise M., Evans, Michael A., Eversull, Christian S., Leeflang, Stephen A..
Application Number | 20030055445 10/285843 |
Document ID | / |
Family ID | 27393213 |
Filed Date | 2003-03-20 |
United States Patent
Application |
20030055445 |
Kind Code |
A1 |
Evans, Michael A. ; et
al. |
March 20, 2003 |
Expansible shearing catheters for thrombus and occlusive material
removal
Abstract
Devices, methods, kits, and methods remove obstructive material
from the vasculature and other body lumens. Expansible baskets may
be used as cooperating radially expansible shearing members.
Helically oriented struts of each basket may wind in a uniform
circumferential direction. The struts can be independently
flexible, allowing the shearing members to flex axially together.
The inner basket may be rotatably driven and may use an axial pump
extending proximally from the shearing members and/or a distal
penetrator for advancing into an occlusion which inhibits guidewire
access. The struts may slide substantially continuously across each
other, and may be sufficiently aggressive for highly effective
thrombectomy. A rotationally static and axially flexible outer
basket may provide a safe, limited atherectomy treatment.
Inventors: |
Evans, Michael A.; (Palo
Alto, CA) ; Demarais, Denise M.; (San Jose, CA)
; Leeflang, Stephen A.; (Stanford, CA) ; Eversull,
Christian S.; (Pal Alto, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
Bacchus Vascular, Inc.
3110 Coronado Avenue
Santa Clara
CA
95054
|
Family ID: |
27393213 |
Appl. No.: |
10/285843 |
Filed: |
October 31, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10285843 |
Oct 31, 2002 |
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09820301 |
Mar 27, 2001 |
|
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60193539 |
Mar 31, 2000 |
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60260170 |
Jan 4, 2001 |
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Current U.S.
Class: |
606/159 |
Current CPC
Class: |
A61B 17/320758 20130101;
A61B 17/221 20130101; A61B 17/320725 20130101; A61B 2017/00685
20130101; A61B 2017/22094 20130101; A61B 2017/2212 20130101; A61B
17/320783 20130101; A61B 2090/08021 20160201 |
Class at
Publication: |
606/159 |
International
Class: |
A61D 001/02 |
Claims
What is claimed is:
1. A method for removing obstructive material from a blood vessel
of a patient, the method comprising: introducing a distal portion
of a catheter into the blood vessel; positioning the distal portion
of the catheter adjacent the obstructive material from outside the
patient by manipulating a flexible body of the catheter; radially
expanding inner and outer shearing members of the catheter within
the blood vessel; and rotating the inner shearing member within the
outer shearing member to shear the occlusive material
therebetween.
2. A method of removing a total occlusion from the vessel of a
patient, the method comprising: providing a positioning cage
catheter system having a proximal end, a distal end and a lumen
therethrough; introducing said catheter system into a vessel of a
patient and advancing it to the site of the occlusion to be
treated; radially expanding a positioning cage of the catheter
system within the vessel to position a lumen of the catheter
system; advancing an occlusion penetrator of the catheter system
within the positioned lumen and into the occlusion along a luminal
length of the occlusion; manipulating the catheter system to
advance a guidewire or guide catheter distally of the
occlusion.
3. A method of removing a total occlusion from the vessel of a
patient comprising the following steps: providing a positioning
cage catheter device having a proximal end, a distal end and a
lumen therethrough; introducing said positioning cage catheter
device into a vessel of a patient and advancing it to the site of
the occlusion to be treated; further advancing said positioning
cage catheter device to engage the occlusion to be treated such
that a pilot hole is formed at a given point along the length of
the occlusion to be treated; advancing a guidewire device through
the position cage catheter device lumen; manipulating the
positioning cage catheter device and said guidewire device such
that the guidewire can be advanced through the pilot hole of the
occlusion and positioned past the distal portion of the occlusion
to be treated.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a division of, and claims the benefit of
priority from U.S. Ser. No. 09/820,301 (Attorney Docket No.
19744P-001010US), which claims the benefit of priority from
Provisional Application No. 60/193,539 filed Mar. 31, 2000
(Attorney Docket No. 19744P-001000US), and from Provisional
Application No. 60/260,170 filed Jan. 4, 2001 (Attorney Docket No.
19744P-001200), the full disclosures of which are incorporated
herein by reference.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED
RESEARCH OR DEVELOPMENT
[0002] Not Applicable
REFERENCE TO A "SEQUENCE LISTING," A TABLE, OR A COMPUTER PROGRAM
LISTING APPENDIX SUBMITTED ON A COMPACT DISK.
[0003] Not Applicable
BACKGROUND OF THE INVENTION
[0004] 1. Field of the Invention
[0005] The present invention relates generally to medical devices
and methods. In one embodiment, the present invention relates to
devices and methods for disrupting, collecting, and removing
thrombus and/or other occlusive material from blood vessels and
other body lumens. In other embodiments, the present invention
relates to devices and methods for placement of guidewires, often
for subsequent removal of unwanted tissue, thrombus, atheroma,
fluid, polyps, cysts or other obstructive matter from natural and
artificial body lumens such as blood vessels, grafts, implanted
stenosed stents, ureters, bile ducts or fallopian tubes.
[0006] Thrombosis and atherosclerosis are common ailments which
occur in humans and which result from the deposition of thrombus
and clot on the walls of blood vessels. When hardened, such
deposits are commonly referred to as plaque. Such deposits are most
common in the peripheral blood vessels that feed the limbs of the
human body and the coronary arteries which feed the heart. Stasis,
incompetent valves, and trauma in the venous circulation cause
thrombosis, particularly occurring as a deep vein thrombosis in the
peripheral vasculature. When such deposits build-up in localized
regions of the blood vessel, they can restrict blood flow and cause
a serious health risk.
[0007] In addition to forming in the natural vasculature,
thrombosis is a serious problem in "artificial" blood vessels,
particularly in peripheral femoral-popliteal and coronary bypass
grafts and dialysis access grafts and fistulas. The creation of
such artificial blood vessels generally involves anastomotic
attachment at at least one, and usually at at least two, locations
in the vasculature. Such sites of an anastomotic attachment are
particularly susceptible to thrombus formation due to narrowing
caused by intimal hyperplasia, and thrombus formation at these
sites is a frequent cause of failure of the implanted graft or
fistula. The arteriovenous grafts and fistulas which are used for
dialysis access are significantly compromised by thrombosis at the
sites of anastomotic attachment and elsewhere. Thrombosis often
occurs to such an extent that the graft needs to be replaced within
a few years or, in the worst cases, a few months.
[0008] A variety of methods have been developed for treating
thrombosis and atherosclerosis in the coronary and peripheral
vasculature as well as in implanted grafts and fistulas. Such
techniques include surgical procedures, such as coronary artery
bypass grafting, and minimally invasive procedures, such as
angioplasty, atherectomy, transmyocardial revasculaturization, and
the like. In many of the surgical clinical approaches to removing
unwanted material, the treatment site is accessed directly through
a surgical incision. Of particular interest of the present
invention, a variety of techniques generally described as
"thrombectomy" have been developed. Thrombectomy generally refers
to procedures for the removal of relatively soft thrombus and clot
from the vasculature. Removal is usually achieved by mechanically
disrupting the clot, optionally with the introduction of
thrombolytic agents. The disrupted thrombus or clot is then
withdrawn through a catheter, typically with a vacuum or mechanical
transport device.
[0009] Thrombectomy generally differs from angioplasty and
atherectomy in the type of occlusive material which is being
treated and in the desire to avoid damage to the blood vessel wall.
The material removed in most thrombectomy procedures is relatively
soft, such as the clot formed in deep vein thrombosis, and is
usually not hardened plaque of the type treated by angioplasty in
the coronary vasculature. Moreover, it is usually an objective of
thrombectomy procedures to have minimum or no deleterious
interaction with the blood vessel wall. Ideally, the clot will be
disrupted and pulled away from the blood vessel wall with no
harmful effect on the wall itself.
[0010] While successful thrombectomy procedures have been achieved,
most have required comprise between complete removal of the
thrombosis and minimum injury to the blood vessel wall. While more
aggressive thrombectomy procedures employing rotating blades can be
very effective at thrombus removal, they can present a significant
risk of injury to the blood vessel wall. Alternatively, those which
rely primarily on vacuum extraction together with minimum
disruption of the thrombus, often fail to achieve sufficient
thrombus removal.
[0011] In work related to the present invention, an expansible
macerator for safely breaking up or disrupting thrombus and other
occlusive materials has been proposed. U.S. patent application Ser.
No. 09/454,517 filed on Dec. 6, 1999 and entitled "Systems and
Methods for Clot Disruption and Retrieval," describes a catheter
having an expansible positioning cage and a helical macerator
positioned within the cage. The macerator can be separated from the
surrounding cage so as to maintain separation between the macerator
and a surrounding wall of the body lumen. This caged macerator
represents a significant advancement in the art, as it allows
disruption of soft clot while inhibiting trauma to blood vessels of
varying diameters. However, as with all advances, still further
improvements would be desirable. In particular, it may be
beneficial to provide more aggressive and more rapid removal of
clot material. It would also be helpful to allow the physician to
selectively and controllably remove plaque or other more solid
occlusive material during a thrombectomy, preferably using the
thrombectomy catheter. It may also be beneficial to more uniformly
urge the severed debris toward an aspiration port of the
thrombectomy catheter. Finally, it may also be beneficial to find
additional beneficial uses for similar and/or related catheter
structures.
[0012] As mentioned, atherectomy has been proposed for treatment of
the hardened plaque of atherosclerosis. Atherectomy may also remove
occlusive tissues proliferating from the vessel wall. While a
variety of atherectomy structures and devices have been proposed,
and although a variety of atherectomy structures have been made
commercially available on the market, the efficacy and use of
atherectomy has remained somewhat limited, particularly when
compared to alternative treatments for stenotic disease.
[0013] Many of the vascular catheter devices recently developed for
fragmentation and removal of plaque and/or thrombus, and for other
intraluminal and intravascular procedures, are inserted
percutaneously through a puncture in the skin. For example, a
catheter device may be inserted into a blood vessel at some
distance away from the intended treatment site, and can then be
advanced through the vessel lumen until the selected location is
reached. In most instances this approach is performed "over the
wire," a technique in which the physician first places a guidewire
device into the vessel lumen, so that the larger treatment catheter
device can be tracked over the guidewire. In many cases the vessel
to be treated is effectively blocked by an occlusive lesion
(sometimes referred to as a "total occlusion," the occlusive lesion
usually comprising, thrombus, soft plaque, and/or calcified plaque)
so that advancing a guidewire to and/or beyond the lesion is
challenging and/or impossible.
[0014] Several techniques and devices can assist in problematic
intraluminal procedures, including guided or steerable guidewires
and catheters, blunt-ended catheters, and the like. Once a
guidewire or guiding catheter is placed, various techniques can be
employed to fragment the unwanted plaque or tissue from blood
vessels, including rotating abrasion structures or impellers,
cutters, high pressure fluid infusion to create a Venturi effect,
and the like. Other devices such as atherectomy cutters may also be
employed. These known catheters and techniques for accessing and
treating luminal lesions have had varying degrees of success.
Unfortunately, total occlusions can impede access to the treatment
site, making it challenging and/or impossible to place a guide
structure for most of these subsequent treatments.
[0015] In light of the above, it would be beneficial to provide
improved devices, systems, methods, methods for manufacture, and
kits for removing occlusive material from the vasculature and other
body lumens. It would be particularly desirable to provide improved
techniques for advancing a guidewire or guide catheter, positioning
a treatment catheter across the blocking occlusion, isolating the
treatment site, and further treating the occlusion while minimizing
or eliminating any distal emboli. An improved procedure would also
benefit from having a device that can rapidly aspirate the
occlusive material from the body lumen. Optionally, these improved
devices and methods might be used to treat a total occlusion as the
treatment device is being advanced through the occlusion,
facilitating placement of a wire across the occlusion so that
further treatment can be easily commenced. Device and methods which
allow creation of a channel through a total occlusion for placement
of a guidewire would also be advantageous, as would improved
debulking of stenotic tissues.
[0016] Some or all of these objectives may be met by the device and
methods of the present invention.
[0017] 2. Description of the Background Art
[0018] As mentioned above, systems and methods for clot disruption
and removal related to the present invention are described in U.S.
patent application Ser. No. 09/454,517. A related mechanical pump
for removal of fragmented matter and methods was described in U.S.
patent application Ser. No. 09/590915, filed on Jun. 9, 2000. A
further related method and system for reinfusing filtered body
aspirates is described in U.S. Provisional Patent No. 60/174,108,
filed on Dec. 31, 1999.
[0019] A cutting stent with a flexible tissue extractor is
described in U.S. Pat. No. 6,036,708. A compressible/expandable
atherectomy cutter is described in U.S. Pat. No. 5,224,945. Unitary
removal of plaque is described in U.S. Pat. No. 5,665,098. A method
for performing a partial atherectomy is described in U.S. Pat. No.
5,282,484, while an atherectomy device having a helical blade and a
blade guide is described in U.S. Pat. No. 5,569,277. A catheter
arthrotome is described in U.S. Pat. No. 5,178,625. A surgical
apparatus for transurethral resection is described in U.S. Pat. No.
3,320,957. A vessel deposit sharing apparatus is described in U.S.
Pat. No. 5,527,326.
[0020] A coiled stent with locking ends is described in U.S. Pat.
No. 5,725,549. A medical instrument with a slotted memory metal
tube is described in U.S. Pat. No. 5,885,258. A method for
manufacturing a tubular medical device is described in U.S. Pat.
No. 6,027,863. The following U.S. Pat. Nos. may also be relevant:
6,010,449; 5,968,064; 5,741,270; 5,766,191; 5,569,275; 5,501,694;
5,795,322; 5,904,968; 5,224,945; 5,312,425; 5,330,484; and
6,022,336.
[0021] All of the above references, and any and all other
references cited in this application, are incorporated herein by
reference in their entirety for all purposes.
BRIEF SUMMARY OF THE INVENTION
[0022] The present invention provides improved devices, methods,
kits, methods for fabrication, and the like, for removing thrombus
and/or other obstructive material from the vasculature and other
body lumens. The invention generally makes use of cooperating
radially expansible shearing members, each shearing members often
being in the form of an expansible basket. The exemplary baskets
comprise helically oriented struts, with the struts of each
shearing member extending with a uniform circumferential direction.
The struts will often be independently flexible between proximal
and distal portions of the shearing members, which can allow the
shearing the members to flex axially to follow axially curving body
lumens. The inner basket may be rotatably driven within the outer
basket, and may optionally be coupled to an axial pump extending
proximally from the shearing members. The outer basket may be
coupled to a catheter body to avoid excessive tissue trauma to the
body lumen, and the helical struts of the shearing members can by
helically counterwound, so that the inner struts may slide
substantially continuously across the outer struts. The inner and
outer baskets may both radially expand selectively, independently
and/or with a single actuator. The resulting shearing action is
sufficiently aggressive for highly effective thrombectomy, while
use of a rotationally static and axially flexible outer basket may
provide a safe, limited, and controllable atherectomy
treatment.
[0023] Improved methods and apparatus are also provided for
treating total occlusions in natural and artificial lumens of the
body such as the vasculature (including the coronary, peripheral,
neurovascular circulation, grafts, and implanted stents). In
particular, the present invention provides methods and devices for
positioning a catheter or guidewire at the proximal side of a total
occlusion and crossing that occlusion with a guidewire, and often
with another catheter to enable further treatment. The present
invention further provides a treatment device that enables crossing
of the lesion, and optionally isolating the treatment site (for
purposes of embolic protection or for infusing a therapeutic agent
to assist in debulking the occlusion), flushing debris, treatment
of the occlusion, and maceration and removal of the debris. These
techniques may include flushing the vessel or treatment site with
fluid (saline, for example) or pharmacologic agents to assist in
breaking up the clot or tissue into a particle size that can then
be aspirated through a lumen of a treatment device, or of a
secondary catheter coupled with a source of vacuum/suction. Due to
this fragmentation process, it may also be desirable to occlude or
filter the lumen of the vessel proximally and/or distally of the
treatment site to inhibit clot, plaque or tissue from embolizing
and creating complications for the patient such as stroke,
myocardial infarction, limb thrombosis, or limb ischemia,
optionally using a non-integral embolic protection device, one or
more balloons or expandable structures mounted to the treatment
catheter, guidewire, a proximal sheath over the treatment catheter,
or the like.
[0024] In a first aspect, the invention provides a vascular
obstruction removal catheter comprising a flexible tubular body
having a proximal end and a distal end. An outer shearing member is
attached near the distal end, the outer member having a perforate
inner surface. An inner shearing member is rotatably disposed
within the outer member, the inner member having a proximal
portion, a distal portion, and a circumferential series of struts
extending therebetween. The struts can flex to slide across the
inner surface of the outer shearing member when the inner shearing
member rotates.
[0025] Optionally, the inner member may rotate about an axis, and
the inner and outer shearing bodies may be sufficiently flexible to
deflect the axis laterally when the outer shearing member is
expanded to engage a surrounding vessel and the inner member
rotates therein. The struts may uniformly coil helically in a first
circumferential orientation so that rotation of the inner shearing
member toward the first circumferential orientation consistently
urges sheared occlusive material proximally. The inner shearing
member may comprise tube material, the struts being separated by
cut surfaces between adjacent tube material portions. The outer
shearing member may comprise outer tube material having a proximal
outer portion, a distal outer portion and a circumferential series
of outer struts extending helically therebetween, with the struts
being separated by cut outer surfaces between outer adjacent tube
material portions. The struts may be affixed together at the
proximal portion and at the distal portion, and may flex
independently therebetween.
[0026] The struts may be helically oriented with a local pitch of
the struts varying axially along the struts. The local pitch can
increase toward the proximal and distal portions sufficiently to
inhibit excessive separation between adjacent struts when the outer
shearing member flexes axially. The struts may have protrusions
which inhibit sliding of obstructive material axially between
cooperating edges of the inner and outer shearing bodies. At least
one expansion actuator may extend proximally from the shearing
members so that the inner and outer shearing members can be
radially expanded in situ. Axial translation of an expansion
actuator may selectively radially expand the inner and outer
shearing members concurrently.
[0027] A distally oriented occlusion penetrator may be disposed
adjacent the distal end of the shearing members. The occlusion
penetrator may comprise one or more end cutters that rotate with
the inner shearing member and are exposed distally of the outer
shearing member to help advance the shearing members distally
through occlusive material and within a body lumen. Alternative
occlusion penetrators include a shaft extendable distally of the
shearing members, the shaft axially oscillating through occlusive
material without penetrating through a vessel wall. An
intravascular ultrasound sensor can be used to measure vascular
obstructions for removal and/or identify partial or total occlusion
that may impede access to the target region.
[0028] It may also be desirable to attach a porous or non-porous
coverings or coatings to at least one shearing member, particularly
to the outer shearing member. Such a covering or coating may extend
between the struts of a shearing member or positioning cage when
the shearing member or positioning cage expands, and can be made
from PTFE woven material, filter material (metallic or polymeric),
braid material (metallic or polymeric), mesh, polymeric coatings,
and the like. The coatings can be applied to the outer basket
through a dipping process. Alternatively, the coverings may be
applied to the outer basket using cyanoacrylate or other adhesives,
thread or suturing, welding or bonding, or the like. Such coatings
may be disposed along a distal and/or proximal region of the
expandable perforate shearing member or positioning cage, and may
inhibit embolization of fragmented occlusive material, constrain a
treatment fluid or fluid stream, and the like.
[0029] In another aspect, the invention provides a vascular
obstruction removal catheter comprising a flexible tubular body
having a proximal end and a distal end. A flexible drive shaft is
rotatably disposed within the tubular body. An outer shearing
member attached near the distal end of the tubular body has a
circumferential series of independently flexible outer struts with
inner surfaces. An inner shearing member is rotationally driven by
the drive shaft within the outer member, the inner member having a
circumferential series of independently flexible inner struts, the
inner struts having outer surfaces which slide across the inner
surfaces of the outer struts when the inner shearing member
rotates, at least one member of the group comprising the inner
struts and the outer struts being helically oriented.
[0030] Optionally, the inner and outer shearing members can each
have proximal portions and distal portions, the struts of each
shearing member affixed together at the proximal and distal
portions and extending independently therebetween so that the
shearing members flex axially primarily along the struts. A
proximal housing may be coupled to the tubular body, the housing
having a motor drivingly engaging the drive shaft. The drive shaft
may engage the distal portion of the inner shearing member and be
axially translatable relative to the outer tubular member from
adjacent the proximal housing. An axial bearing surfaces of the
outer and inner shearing members can cooperate to effect concurrent
radial expansion of the inner and outer shearing members when the
drive shave translates axially.
[0031] In another aspect, the invention also provides a method for
forming a vascular obstruction removal catheter. The method
comprises providing a first tube having a proximal end and a distal
end with a central region therebetween, the tube comprising a tube
material. The central region of the first tube is cut axially so as
to define a circumferential series of independent deformable
struts, the struts comprising the tube material. The first cage can
be positioned coaxially with a second resiliently deformable cage,
and a drive can be attached for rotating at least one of the cages
within a blood vessel for shearing of obstructive material between
the cages.
[0032] In another aspect, the invention comprises a method for
removing obstructive material from a blood vessel of a patient. The
method comprises introducing a distal portion of a catheter into
the blood vessel. The distal portion of the catheter is positioned
adjacent the obstructive material from outside the patient by
manipulating a flexible body of the catheter. Inner and outer
shearing members of the catheter are radially expanded within the
blood vessel, the inner shearing member is rotated within the outer
shearing member to shear the occlusive material therebetween.
[0033] In yet another aspect, the invention provides a component
for use in a catheter device for removal of obstructive material
from the lumen of a body conduit. The component comprises first and
second end portions having a longitudinal axis there between. A
middle portion has one or more struts around the circumference of
said longitudinal axis and extending between (but not along) said
first end portion and said second end portion. Said middle portion
and said end portions are formed from a continuous tube.
[0034] The struts may comprise a helix about said longitudinal
axis. Alternatively, the struts may be formed in a straight
configuration along said longitudinal axis and between said first
and second end portions. The struts may have a width and a
thickness, wherein said width is greater than said thickness. The
width of the struts may vary along the length of the struts, and
may form at least one serration or pocket. The thickness of the
struts may be varied along the length of said strut, optionally so
as to form a cutting edge. A cross section of the middle portion
may be greater than cross sections of said end first and second end
portions. The struts may be formed by laser cutting, by
photoetching, by EDM, or by water jet abrasion. The first and
second end portions can be formed in a zigzag configuration, and
may have a longitudinal length that is less than that of the length
of said middle portion. The component can comprise a shape memory
alloy (such as a nickel titanium alloy, Elgiloy.RTM., or the like),
stainless steel, a formable polymer, a composite material, or the
like.
[0035] In yet another aspect, the invention may comprise a
component for use in a catheter device for removal of obstructive
material from the lumen of a body conduit. The component comprises
first and second end portions having a first cross sectional
diameter and a longitudinal axis therebetween. A middle portion
extends between but does not include the end portions, and has at
least one second cross sectional diameter and a plurality of struts
forming a helix around the circumference of said longitudinal axis.
The middle portion and said end portions are formed from a
continuous tube.
[0036] In some embodiments, the struts are axially connected to the
adjacent strut by an expandable connector element, with the
expandable connector element optionally having a serpentine
configuration, defining a zigzag, or the like.
[0037] In yet another aspect, the invention provides a device for
treating a total occlusion in a vessel having a vessel wall. The
device comprises a catheter body having a proximal end, a distal
end and a lumen. A radially expansible positioning cage is disposed
near the distal end of the catheter body. A shaft is disposed in
the catheter body lumen, the shaft advanceable into the total
occlusion without penetrating through the vessel wall when the
positioning cage is radially expanded.
[0038] Optionally, the shaft may comprises a dottering member
extendable beyond the catheter body distal end. The dottering
member by cycle axially and/or rotationally to facilitate advancing
the dottering member into the total occlusion, the dottering member
making a "pilot hole" into the occlusive material without
penetrating through the vessel wall. A mechanical pump may be
received within the catheter body lumen, and/or a macerator may
extend at least partially along the length of said lumen,
particularly adjacent the distal end. Distally exposed rotating
cutters may be particularly beneficial for advancing the catheter
into the total occlusion.
[0039] In another method aspect, the invention provides a method of
removing a total occlusion from the vessel of a patient. The method
comprises introducing a positioning cage catheter system into a
vessel of a patient and advancing the catheter system to the site
of the occlusion to be treated. A positioning cage of the catheter
system is radially expanded within the vessel to position a lumen
of the catheter system. An occlusion penetrator of the catheter
system is advanced within the positioned lumen and into the
occlusion along a luminal length of the occlusion. The catheter
system is manipulated to advance a guidewire or guide catheter
distally of the occlusion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 is a perspective view of inclusive material removal
catheter having a rotationally driven inner basket which cooperates
with a outer basket to shear occlusive material therebetween.
[0041] FIG. 2 is a perspective view of the distal portion of the
catheter of FIG. 1.
[0042] FIG. 3A-3C is a perspective view showing the inner and outer
baskets of the catheter of FIG. 1. 3B and 3C show how the outer
basket may have a coating or covering for embolic capture.
[0043] FIG. 4 is a perspective view of an outer basket or shearing
member of the catheter of FIG. 1.
[0044] FIG. 5 is a perspective view of a tube cut so as to form the
inner or outer basket of the catheter of FIG. 1.
[0045] FIG. 6 illustrates a flat pattern of the basket of FIG. 5,
showing variable pitch of the helical struts.
[0046] FIG. 7 is a perspective view of an alternative basket having
protrusions and/or circumferential indentations to inhibit axial
sliding of occlusive material during shearing.
[0047] FIG. 8 is a perspective view of yet another alternative
basket having circumferential proximal and/or distal web members
between struts to inhibit severing of valves and other structures
disposed axially of the shearing baskets.
[0048] FIG. 9 is a cross-sectional view of the connection between
the proximal end of the shearing baskets and the distal end of the
catheter body.
[0049] FIG. 10 is a simplified cross-sectional view of the proximal
end of the shearing baskets and the distal end of the catheter.
[0050] FIG. 11 is a cross-sectional view showing attachment of the
inner shearing basket to a drive shaft.
[0051] FIG. 12 is a perspective view of a proximal housing of the
catheter of FIG. 1.
[0052] FIG. 13 is a perspective view of the housing of FIG. 12 with
a portion of the cover removed to show the drive system and other
internal components.
[0053] FIGS. 14-17 schematically illustrate the use of the
occlusive material removal catheter of FIG. 1.
[0054] FIGS. 18A and 18B illustrate alternative embodiments of the
positioning cage catheter device of the present invention.
[0055] FIGS. 18C-18F illustrate radially expandable positioning and
shearing structures having an occlusive material penetrator in the
form of a distally exposed morcellator for forming a passage
through a total occlusion.
[0056] FIG. 19 illustrates the positioning cage catheter device of
the present invention being used to initiate the crossing of a
total occlusion.
[0057] FIG. 20 illustrates an alternative embodiment of the present
invention wherein a positioning cage and a treatment device are
formed integrally and placed over a guidewire.
[0058] FIG. 21 illustrates details of the distal end of the
integral positioning cage and treatment device of FIG. 20.
[0059] FIGS. 22, 23, and 24A-24B illustrates steps in methods for
use of the system of FIG. 20 for accessing a treatment site of an
occlusion which is challenging and/or impossible to traverse with a
standard guidewire.
[0060] FIG. 25A-25C illustrates method of treating luminal
occlusions in which a treatment region of the lumen is at least
partially isolated.
[0061] FIG. 26 illustrates an alternative embodiment of the present
invention wherein a drive shaft is advanced to gain access through
the total occlusion.
DETAILED DESCRIPTION OF THE INVENTION
[0062] Referring now to FIG. 1, a vascular obstruction removal
catheter 10 generally includes an elongate flexible catheter body
12 having a proximal end 14 and a distal end 16. Cooperating inner
and outer shearing baskets 18, 20 define shearing means 19, and are
disposed near distal end 16 of catheter body 12, while a proximal
housing 22 is disposed near proximal end 14 of the catheter body.
More specifically, outer basket 20 will typically be affixed at
distal end 16 of catheter body 12, while a drive shaft drivingly
couples inner basket 18 to a drive motor of proximal housing
22.
[0063] The inner and outer baskets 18, 20 of shearing means 19 are
illustrated with some of the adjacent structures in FIG. 2, and in
a simplified format (without some of the adjacent structures) in
FIG. 3A. Outer basket 20 is shown without inner basket 18 in FIG.
4.
[0064] Each of the baskets 18, 20 includes a proximal portion 24, a
distal portion 26, and an intermediate portion 28. Intermediate
portion 28 includes a circumferential series of helical struts 30.
Struts 30 are affixed together at proximal portion 24 and distal
portion 26, but generally extend independently therebetween. This
allows struts 30 to flex individually, and allows the overall axis
of each basket 18, 20 (as well as shearing means 19) to deflect
laterally so as to accommodate axial curvature of the
vasculature.
[0065] Baskets 18, 20 will generally be radially expansible in situ
from a low profile configuration to a larger profile configuration.
Baskets 18, 20 will often comprise a resilient or superelastic
material, and may be biased to expand radially when released from a
radially constraining sheath. As helically wound baskets exhibit
radial expansion which is coupled with a decrease in axial length,
manipulation of the axial lengths of the baskets may also be used
to induce or control the radial expansion, so that baskets 18, 20
may expand resiliently when released from an axial elongation
restraint.
[0066] The baskets may also be biased toward a profile which is
smaller than a fully radially expanded configuration, so that
radially and/or axial restraints are used to actively expand the
diameter of shearing means 19. In other words, by decreasing the
length of baskets 18, 20, struts 30 may be pushed radially
outwardly. In the exemplary embodiment, inner and outer baskets 18,
20 will expand radially when an axial actuator 34 of proximal
housing 22 (see FIG. 1) is actuated from outside the patient body,
as will be described hereinbelow. Hence, struts 30 may optionally
be biased toward the radially expanded configuration, a low-profile
configuration, or some configuration therebetween. Advantageously,
the profile of shearing means 19 can be selected from a plurality
and/or continuous range of expanded sizes, and can be varied during
treatment.
[0067] Outer basket 20 may be rotationally coupled to catheter body
12. Thus, movement of the outer basket within the vasculature can
be substantially limited to, for example, axial positioning and
advancement of the shearing means for treatment, thereby inhibiting
excessive trauma to the surrounding vessel wall. Optionally,
additional manipulation of catheter body 12 may be used to abraid
the vessel wall with direct engagement between the outer basket and
the endothelium.
[0068] Struts 30 of outer basket 20 have continuous inner surfaces
36 between proximal portion 24 and distal portion 26. Similarly,
struts 30 of inner basket 18 may have continuous outer surfaces 38
between the proximal and distal portions. By rotationally driving
inner basket 18 within outer basket 20 using drive shaft 32, outer
surfaces 38 slide across inner surfaces 36 so as to shear occlusive
material within the vasculature therebetween. In some cases, direct
engagement between the inner basket and the surrounding tissues
between the struts of the outer basket may also provide some
shearing and/or abrasion of occlusive mater.
[0069] The drive shaft may be axially coupled to both the inner and
outer baskets at distal portions 26. This allows concurrent and
coordinated radial expansion of the inner and outer baskets so as
to maintain sufficient proximity between the inner surface 36 and
the outer surface 38 to provide the desired shearing effect. In the
exemplary embodiment, drive shaft 32 comprises a tube having a
guide wire lumen 40 and an outer helical pumping element 42. As
described in detail in U.S. patent application Ser. No. 09/590,915,
previously incorporated herein by reference, rotation of such a
helical pumping element within an aspiration lumen 44 of catheter
body 12 can draw and/or pump severed fragments of occlusive
material, debris, and fluid proximally into and/or through the
catheter body. This actively pumped aspiration may draw fluid
proximally from within proximal portions 24 of baskets 18, 20,
and/or radially inwardly and then proximally through one or more
aspiration windows 46 about catheter body 12.
[0070] In some embodiments, at least one of the inner and outer
baskets 18, 20 may have struts 30 which extend, at least in part,
substantially axially. Preferably, at least one of the baskets will
have struts 30, which wind primarily toward a first circumferential
orientation 50 as the struts proceed distally, as can be understood
with reference to FIG. 4. Such a consistent winding direction can
be used to consistently urge sheared materials proximally, as can
be understood with reference to the arrows illustrated in FIG. 3A.
As inner and outer surfaces 36, 38 slide against each other,
material which is severed between these cooperating surfaces can be
urged proximally when the inner basket is rotated relative to the
outer basket in the proper direction.
[0071] FIGS. 3B and 3C illustrate a catheter having a shearing
means similar to that of FIG. 3A, and also having an expansible
distal covering 31 (FIG. 3B) or an expansible proximal covering 33
(FIG. 3C). Coverings 31, 33 comprise a porous or non-porous
coverings or coatings carried on (and expansible with) the outer
shearing member along some (but typically not all) of the
expansible portion of baskets 18, 20. Coatings 31, 33 may inhibit
embolization of fragmented occlusive material, constrian a
treatment fluid or fluid stream, inhibit injury to the venous
valves and the like. Coverings 31, 33 extend between adjacent
struts of a shearing member or positioning cage and accommodate
radial expansion of the shearing member or positioning cage, the
covering optionally being made from a PTFE woven material, filter
material (metallic or polymeric), braid material (metallic or
polymeric), mesh, polymeric coatings, and the like. The coatings
may be applied to the outer basket through a dipping, filament
winding or braiding process, or the like. Alternatively, the
coverings may be applied to the outer basket using cyanoacrylate or
other adhesives, thread or suturing, welding or bonding, or the
like.
[0072] Referring now to FIGS. 5 and 6, an alternative basket
structure is illustrated in a perspective view and as a flat
pattern, respectively. The flat pattern of FIG. 6 graphically
illustrates the configuration of the struts 30 as if basket 50 were
cut along one side and unrolled. Such flat patterns are useful for
fabrication and understanding the strut configuration.
[0073] As is clearly seen in FIGS. 5 and 6, a local helical wind
angle defined between struts 30 and an axis 52 of basket 50 can
vary along the axis. Preferably, a helical angle 54 along a central
portion of struts 30 is significantly greater than a helical angle
56 near proximal and distal portions 24, 26. In other words, a
pitch of struts 30 may vary locally along the axis of basket 50,
with the pitch generally being greater adjacent the proximal and
distal portions 24, 26. In the exemplary embodiment illustrated in
FIGS. 5 and 6, the pitch varies according to a sinusoidal function
in which the period in the central 1/3 of the axial strut length is
1/2 the period on the proximal and distal thirds. Advantageously,
such enhanced central helical winding angles help to avoid
circumferential distortion of struts 30 when axis 52 is deflected
laterally, so that uneven separation between the struts during
axial bending is inhibited.
[0074] Referring now to FIG. 7, at least one of inner and outer
baskets 18, 20 may include struts 30 having one or more
circumferential protrusions 62. Struts 30 of basket 60 can define
pockets which effectively capture occlusive material against the
struts of the cooperating basket. This can help avoid excessively
axial sliding of material for which shearing is desired, as the
material will be caught at a pocket or protrusion between the
cooperating shearing struts. This can be understood by imagining a
pencil which is to be sheared between the cooperating surfaces of a
pair of scissors. The pencil may slide along straight cooperating
shearing surfaces. Such sliding may be inhibited by forming a
protrusion and/or pocket to capture the pencil along an edge of one
or both shearing members.
[0075] A still further alternative basket 70 is illustrated in FIG.
8. In this embodiment, one or more circumferential members 72
extend between adjacent struts 30 adjacent proximal and/or distal
portions 24, 26. Circumferential member 72 can allow some expansion
at the ends, and can help inhibit entraining structures which are
disposed axially of the shearing baskets. For example,
circumferential member 72 may help avoid severing valves within
blood vessels. A variety of alternative circumferential members
might be used, including expandable and/or elastomeric webs,
braided meshes, or the like.
[0076] The shearing baskets may be formed of a metal, optionally
comprising a superelastic metal, such as Nitinol.RTM.,
Elgiloy.RTM., or the like. Alternative basket materials may include
stainless steel or other high strength metals, and the baskets may
comprise a polymer in some embodiments. Optionally, struts 30 may
comprise wire with wire struts often being affixed at the proximal
and distal portions 24, 26. In the exemplary embodiment, the
shearing baskets are formed from a continuous material extending
along proximal portion 24, along struts 30, and along distal
portion 26. The struts may have a circumferential width in a range
from about 0.004" to about 0.100", preferably having a width from
about 0.006" to about 0.025". The radial thickness of the struts
will typically be in a range from about 0.001" to 0.050",
preferably being in a range from about 0.003" to about 0.025". The
baskets may be formed by selectively cutting a tube so as to define
the struts, often by use of photoetch processing, laser cutting,
water jet abrasion, or EDM techniques.
[0077] Referring now to FIGS. 9-11, coupling of drive shaft 32 and
catheter body 12 to inner and outer shearing baskets 18, 20 can be
understood. Adjacent proximal end 24, catheter 12 is axially and
rotationally affixed to outer basket 20, as illustrated in FIGS. 9
and 10. Drive shaft 32 rotates within aspiration lumen 44 of
catheter body 12, and the drive shaft may have a helical pumping
member 42. Pumping member 42 acts as an Archimedes screw, urging
fluid and debris within proximal portion 24 of inner basket 18
proximally, and/or entraining fluid radially through aspiration
windows 46.
[0078] Inner cutter 18 is rotationally affixed to drive shaft 32
adjacent portion 26, as illustrated in FIG. 11. Inner basket 18 is
rotatable within proximal portion 24 of outer basket 20, and axial
movement of the inner basket within the outer basket is limited by
proximal cooperating thrust bearing surfaces 80, as seen in FIGS. 9
and 10. Similarly, distal portion 26 of outer basket 20 is axially
coupled to drive shaft 32 and inner basket 18 by distal thrust
bearing surfaces 82, as illustrated in FIG. 11. A nose cone 84
presents an atraumatic distal tip adjacent the distal port of
guidewire lumen 40.
[0079] As can now be understood with reference to FIGS. 9-11,
rotation of drive shaft 40 results in rotation of inner basket 18
within outer basket 20. Translating drive shaft 40 proximally
within catheter 12 can result in radial expansion of the shearing
baskets, as the cooperating distal thrust bearing surfaces 82
decrease the overall length of the shearing baskets. Separate
thrust bearing surfaces might be coupled to independently axially
movable structures so as to effect independent radial expansion of
the baskets
[0080] The structure and use of proximal housing 22 can be more
clearly understood with reference to FIGS. 12 and 13. Housing 22
contains a motor drivingly engaging drive shaft 32 within catheter
body 12. The motor may be actuated by a drive actuator 88, with the
drive actuator optionally effecting shearing motion of the inner
basket and urging the sheared debris proximally when the actuator
is moved in a first direction. When drive actuator is moved in a
second direction, drive shaft 32 may rotate in an alternative
direction, which may help free a jammed inner cutting member, or
the like. An aspiration port 90 may be coupled to a vacuum source,
such as a lockable syringe, a vacuum pump, or the like. A vacuum
actuator 92 may provide momentary aspiration. Linear actuation of
the drive shaft 32 may be provided by a linear actuator 34 (See
FIG. 1)coupled to the drive shaft using thrust bearings and axially
slidable engagement of drive splines, or the like.
[0081] Referring now to FIGS. 14-17, catheter 10 will generally be
introduced into a blood vessel B over a guidewire GW using a
conventional percutaneous or cut-down technique. Optionally, a
portion of the blood vessel encompassing the target occlusive
material may be isolated from surrounding blood flow. Such
isolation may be provided by using a balloon guidewire and/or a
sheath disposed around catheter body 12, with the sheath having an
expandable member such as an annular balloon. Hence, isolation may
be provided proximally and/or distally of an occlusive material O
within a blood vessel wall W. Inner and outer baskets 18, 20 may be
inserted and positioned adjacent the targeted occlusive material O
while the baskets are in a low profile configuration, optionally
using a remote imaging modality such as fluoroscopy, ultrasound, or
the like.
[0082] As illustrated in FIG. 15, once catheter 10 has been
appropriately positioned, drive shaft 32 may be translated
proximally relative to catheter body 12 so as to radially expand
inner and outer baskets 18, 20. Where the inner and outer baskets
are biased to expand resiliently, drive shaft 32 may be released to
allow the baskets to expand. Where the baskets are biased to a
configuration smaller than the desired deployed configuration, the
drive shaft may be urged proximally relative to catheter body 12 so
as to overcome the resilience of the basket structures.
Advantageously, the overall size of the cooperating shearing
members may be selected by selectively axially positioning the
drive shaft relative to the surrounding catheter body. This helps
provide accurate control over the depth of material sheared from
wall W.
[0083] Once the positioned catheter is properly expanded to the
desired size, rotation of the inner basket 18 is initiated by
actuation of drive actuator 88 of the proximal housing 22. This
results in both shearing of occlusive material O from wall W, and
in urging of the severed debris in a proximal direction (effected
both by the crossing angle of the struts 30 and pumping of the
helical member of drive shaft 32. An aspiration pressure
differential may also be applied via proximal housing 22 as
described above so as to avoid release of debris within the blood
vessel.
[0084] As illustrated in FIG. 16, catheter 10 may advanced distally
over guidewire GW within the vessel wall W during rotation of inner
basket 18. Outer basket 20 slides distally against the vessel wall
substantially without rotating, thereby providing an incremental
and controlled shearing action which can follow axial bends of the
natural or artificial blood vessel B. The amount of occlusive
material O removed form vessel wall W at a particular location may
depend on the expanded size of the cooperating shearing baskets at
that location, on the speed of rotation of the inner basket, on the
speed of axial translation of the shearing means, and on the total
time and number of rotations of the inner basket at that
location.
[0085] For relative soft occlusive material O, such as clot
material, the proximal shearing action of the struts may, at least
in part, draw the occlusive material proximally from along the
vessel wall into the interior of the baskets, as can be understood
with reference to FIG. 17. Similarly, rotation of the helical
struts 30 of inner basket 18 may help draw catheter 10 distally
within blood vessel B.
[0086] As can be understood with reference to FIG. 17, serrated
circumferential surfaces 94 may improve shearing efficiency by
limiting sliding of occlusive material O. Regardless, as the strut
of inner basket 18 rotates relative to the struts of outer basket
20, occlusive material O protruding into an interior of the baskets
from wall W is both severed and/or urged proximally.
[0087] A variety of adaptations and modifications on the structures
and methods described herein may be provided. For example, a kit
may include some or all of the components of catheter 10 together
with instructions for their use according to one or more of the
methods described herein. Proximal end or distal portions 24, 26 of
the inner and/or outer baskets may comprise a serpentine
circumferential member, thereby allowing that portion to be
expanded radially during assembly of catheter 10. It may be
advantageous to at least slightly bias struts 30 radially outwardly
so as to facilitate initial axial compression of the baskets. While
the present invention has been described with reference to removal
of clot, plaque, hyperplasia, or other occlusive material of a
blood vessel, the structures and methods of the present invention
may find applications for removing occlusive material from a wide
variety of alternative body structures and lumens, including the
fallopian tubes, genitourinary tract (for example, for treatment of
benign prostatic hyperplasia, and the like), gastrointestinal
tract, and the like.
[0088] A positioning cage catheter 120 which is particularly
beneficial for treatment of blood vessels having a total occlusion
(when it is difficult or impossible to access the entire treatment
site with a standard guidewire) is illustrated in FIGS. 18A and
18B. Many of known intraluminal therapies require that (or are
facilitated when) the lumen has a significant open cross section,
without an excessively tortuous luminal path, to allow the guide
structure to be placed across the occlusion.
[0089] It should be noted that the term total occlusion may refer
to any substance or anatomic morphology that acts to severely
occlude a body conduit such that it is difficult to pass a wire
from proximal end of the occlusion to the distal end. Depending on
the type of material occluding the body conduit (soft plaque,
calcified plaque, thrombus, fibrin, clot, intimal hyperplasia,
in-stent restenosis, fatty tissue etc.) some occlusions may be more
severe than others but all are included in the scope of the present
invention when there may be some difficulty passing a guidewire
therethrough.
[0090] Cage 110 may be formed of multiple straight wires or struts
111, or multiple curved wires or struts 112 formed into a helix as
depicted in FIG. 18B. It is noted that a double wire (not shown)
may also be employed to form the cage structure. These cage
structures are fixedly attached to a catheter body 113, having a
distal tip 114 accommodating passage of a guidewire through lumen
115.
[0091] In an exemplary embodiment, catheter system 120 comprises a
positioning cage such as described one of those described above, or
such as those in related U.S. patent application Ser. No.
09/388,294, incorporated herein by reference. A guidewire such as
the described in U.S. patent application Ser. No. 09/491,401
(vibrating guidewire) or U.S. patent application Ser. No.
09/005,217 incorporated herein by reference, or in some cases such
as those readily available from various manufacturers (TERUMO,
CORP./BOSTON SCIENTIFIC, Natick, Mass., GUIDANT, CORP.,
Indianapolis, Ind., or PERCUSURGE, Sunnyvale, Calif.) may be used
within catheter system 120, as will be understood from the
following description. Optionally, the positioning cage and the
treatment catheter may be employed as an integral unit to both
place the guidewire, and to perform the subsequent treatment. In
such embodiments a device such as those described in U.S. patent
application Ser. Nos. 09/491,401 and 09/388,294 previously
incorporated herein by reference, may be employed.
[0092] In use, the total occlusion access devices of the present
invention may be inserted into a body conduit and advanced to the
proximal side of the occlusion, either over a guidewire, or by just
advancing the positioning cage to the treatment site, depending on
the body lumen to be treated. Once at the treatment site, the
positioning cage can be pushed against the occlusion. As will be
described below, a guidewire or dottering device may be advanced
from the cage through a lumen coaxial with the cage (and hence,
substantially coaxial with the body lumen when the cage is expanded
therein ) to penetrate and/or pierce the occlusion. The combination
action of the positioning cage asserting forces against the vessel
wall and the occlusive material (optionally by rotating the cage or
expanding the against the vessel wall), and the guidewire or
dottering device probing against the occlusion, may work to tunnel
the devices through the occlusion to the distalmost portion and
beyond. The positioning cage may help to center the action of the
dottering member and inhibit perforations through the vessel wall
or other vessel wall damage.
[0093] The positioning cage may be part of a treatment catheter and
therefore, once the guidewire is in place, the treatment catheter
may be advanced to initiate removal of the occlusion. Depending on
the occlusion to be treated, a distal protection device, such as a
balloon fixed to a guidewire, a filter affixed to a guidewire, or
the like, may be employed distal of the occlusion and expanded to
minimize any embolization of clot or other material. In addition,
an occlusion balloon or filter may be deployed proximal of the
occlusion to isolate the lesion and allow the treatment device (or
a separate structure) to infuse saline, contrast, pharmacologic
agents such as tPA, ReoPro, IIB3A inhibitors and the like, or
chemical ablation agents or acid solutions such as those described
in PCT Application No. PCT/US99/15918 (WO 00/03651). The occlusive
debris can be removed by activating the shearing, macerating, and
aspirating function of the device of the present invention as
described above, and in U.S. patent application Ser. No. 09/388,294
and U.S. Provisional Patent Application No. 60/154,752.
[0094] Referring now to FIGS. 18C-F, the structure of an exemplary
positioning cage catheter system 120a adjacent distal tip 114 is
illustrated in more detail. Catheter system 120a includes inner and
outer shearing members in the form of baskets 18, 20, as described
above, and can also include some or all of the catheter structures
described above for selectively expanding the inner and/or outer
baskets, for irrigating and/or aspirating fluids, for urging fluids
and severed fragments proximally within the outer sheath, for
isolating the body lumen proximally and/or distally of the shearing
members, and the like.
[0095] To facilitate advancement of catheter system 120a distally
for treatment of a total occlusion, a total occlusion penetrator is
provided adjacent tip 114. In the embodiment of FIGS. 18C-F, the
penetrator is in the form of a distally exposed morcellator 122.
Morcellator 122 comprises a circumferential series of helical
cutters which may be rotationally coupled to inner shearing member
18 or may rotate independently of the shearing member. The cutters
of morcellator 122 may extend distally of the distal portion of the
outer shearing member 20 and/or distally of the inner tubular body
which defines the guidewire lumen 115 sufficiently to allow the
rotating cutters to advance into the occlusive material of a total
occlusion when the morcellator rotates. Expansion of the shearing
member can maintain separation between the advancing morcellator
and the vascular walls, so that the expanded shearing member acts
as a positioning cage. As described above, use of a morcellator in
the form of one or more helical structures within a lumen (the
lumen here defined by the distal portion of outer shearing member
20) can act as a pump or Archimedes screw to urge the occlusive
material proximally.
[0096] In use (as illustrated in FIG. 19), the positioning catheter
120 is inserted into a vessel BV and advanced to the treatment site
just proximal of total occlusion TO. Cage 110 may actually engage
the occlusion TO and begin loosening the plaque or other material
making up the occlusion. Furthermore cage may be manually rotated
to further engage the occlusion. Once at the treatment site,
guidewire GW may be optionally advanced out of the distal tip of
the positioning catheter to contact and help fragment the occlusion
TO, the guidewire optionally being adapted for use as an occlusion
penetrator, as will be described below. As described above
regarding FIGS. 18C-E, a morcellator 122 may also be used as an
occlusive material penetrator by rotating the distally exposed
morcellator and advancing the catheter system to engage the
rotating morcellator against the total occlusion TO. Catheter 120,
guidewire GW, and/or morcellator 122 may be used in combination or
in an alternating motions or cycles to create a pilot hole through
the occlusion TO such that the guidewire GW may be placed through
the occlusion and advanced distally therebeyond.
[0097] An alternative positioning cage catheter system is
schematically depicted in FIG. 20. Treatment catheter 130 comprises
a proximal end having a handle 131 with an actuator knob 132 and a
Y connection 133 to allow infusion and/or aspiration. A catheter
shaft 113 extends distally from handle 131 toward a distal working
end 134. FIG. 21 depicts the distal working end of treatment
catheter 130, showing a positioning cage 110 attached at its
proximal end to catheter shaft 113, and on its distal end to distal
tip 114. Distal working end 134 further comprises a drive shaft 141
with an optional coiled mechanical pump 141' and a macerator 142
coiled therearound. A more detailed description of treatment
catheter 130 may be found in related case U.S. patent application
Ser. No. 09/388,294 as previously incorporated by reference.
[0098] In use, as illustrated in FIG. 22, treatment catheter 130 is
inserted into the lumen of a vessel BV and advanced to the proximal
portion of the treatment site. At this point the lesion can either
be crossed mechanically (as described above regarding FIG. 19)
and/or saline or other therapeutic agents may be infused
(optionally via guidewire lumen 115, as shown in FIGS. 18) to
assist in dissolving, softening, and/or fragmenting the occlusive
material. In some embodiments, such agent flow from the catheter
system alone may be sufficient to allow a standard guidewire to be
advanced through the occlusion. The remaining components of the
catheter system may then be advanced over the guidewire and remove
some or all of the occlusive material, as described above.
[0099] A standard or modified guidewire may be used to help form a
pilot hole or passage for placement of a guide structure. In the
exemplary embodiment, a dottering tool or dottering guidewire 151
can be centered within the lumen of the blood vessel BV by
expanding cage 110. The centered dottering tool 151 may then be
used as an occlusive material penetrator by advancing the dottering
tool in a linear translating and/or cycling motion to begin
formation of a pilot hole or pathway through the total occlusion.
Although dottering guidewire 151 may have a structure similar to a
standard guidewire, the dottering tool will optionally have a more
rigid construction than a standard guidewire adjacent the distal
end, and the distal portion of the dottering tool may also be able
to assume a straight configuration with sufficient axial column
strength for advancement of an atraumatic tip distally from the
guidewire lumen of the catheter system and into the occlusive
material. Once dottering tool 151 has formed a passage 153 through
the total occlusion, other devices (such as standard guidewires, a
balloon guidewire or other distal protection devices to inhibit
embolisms and/or release of therapeutic agents distally of the
total occlusion, and the like) may be advanced through the passage,
or the dottering wire may be used as a guide structure.
[0100] Referring now to FIGS. 22 and 23, centering cage or basket
110 can provide centering of guidewire lumen 115. Centering of this
coaxial lumen can help protect the vessel wall from mechanical
injury imposed by dottering device 151. Dottering device 151 may be
cycled axially mechanically or using an axial drive motor, and may
also be rotated manually or by drive motor. The centered guidewire
lumen, which should be substantially coaxial with the vessel, may
also be used for infusion of any of a variety of fluids. It may be
advantageous to locally deliver (via guidewire lumen 115 or via
some other infusion pathway) a thrombolytic agent having an
enzymatic action with breads down fibrin clot matrix (such as
Alteplase, tPA, Activase, Tenecteplase, TNK, and TNKase from
Genentech, Inc.; Anistrpelase a-SK, and Eminase from Roberts
Pharmaceuticals; Reteplase, r-PA, and Retavase from Centocor, Inc.;
Streptokinase, SK, and Streptase from AstraZeneca, Inc.; and/or
Abbokinase, from Abbott, Inc. In some embodiments, a GP IIb/IIIa
inhibitor, which inhibits the fibrogen binding site of platelet
membrane, may be locally delivered. Suitable GP IIb/IIIa inhibitors
may include Abciximab and ReoPro from Centocor, Inc.; Tirofiban and
Aggrastat from Merck, Inc.; Eptifibatide and Integrelin from Cor
Therapeutics, Inc.; Bitistatin, Kistrin, and Aspirin. Still further
active agents might be used, including anti-thrombin agents and
agents directed toward prevention of restenosis (to inhibit
coagulation and/or decreasing smooth muscle proliferation and
migration), such as Heparin, LMW, enoxaparine or Lovenox,
dalteparin or Fragmin, ardeparin or Normoflo, Hirudin, Argatroban,
PPACK, radioactive agents, nitrate, HA 1077, calcium antagonists,
angiotensin converting enzyme inhibitor, anti-inflammatory agents,
steroidal agents, anti-mitotic agents, HMG CoA reductase
inhibitors, colchicine, angiopeptin, cytoclasin B, and the like.
Gene therapy agents might also be locally delivered to inhibit
restenosis and/or promote angiogenesis, with suitable agents
optionally being delivered via plasmid vectors or by viral vectors,
and suitable agents including genes relating to VEGF, C-myb, FGF,
transforming growth factor b. endothelial growth factor,
protooncogenes such as C-myc, C-myg, CDC-2, PCNA, and the like.
Local delivery of chemotherapeutic agents (which are used to treat
malignancies) may be employed, such as adriamycin or Doxorubicin.
Imaging Media such as contrast media, radioactively labeled agents,
or the like may be locally delivered, as might other agents such as
plasminogen addative as an adjunct to thrombolytic therapy,
immunosuppressive agents, Corazo'n material, lytics, saline, or the
like.
[0101] As seen in FIG. 23, positioning cage 110 and dottering
device 151 may be advanced simultaneously or in alternating partial
steps into and through the total occlusion. Alternatively,
dottering device 151 may be advanced through the total occlusion
while the expanded positioning cage remains at a fixed location.
Regardless, some penetrator structure of the catheter system will
preferably advance until a passage 153 is formed through the total
occlusion. Once an opening, propagation plane, or pathway has been
formed through the occlusion TO, a guide structure may be passed
distally along passage 153 beyond the total occlusion.
[0102] In addition to use of cage 110 to protect the vessel wall W
from harm by positioning of the penetrator, the cage may be
advanced against the proximal portion of the occlusion TO as shown
in FIG. 24A (in which cage 110 is shown in a partially expanded
configuration 110a) and then expanded (to a more fully expanded
configuration 110b) to assist in propagating a passage, plane, or
pathway through the occlusion, as shown in FIG. 24B. In other
words, expansion of cage 110 may open up or propagate a cleavage
plane to facilitate passing a guidewire or dottering device 51
using a wedge effect. This wedge effect may, of course, be combined
with axial cycling of dottering device 51, rotation and advancement
of a cutter, occlusive material agent dissolution, and any of the
other mechanisms described herein. Similarly, the various occlusion
treatment methods and structures described herein will generally be
compatible for use in combination.
[0103] FIGS. 25A-25B illustrate further steps in treatment of the
occlusion (TO) once a guidewire has been passed distally. As
illustrated, a distal protection member 155 is inserted over the
guidewire (or is attached to the guidewire itself) through passage
153 and expanded distally of the occlusion. Distal protection
member 155 inhibits distal flow beyond the occlusion and can help
decrease or prevent embolization of material downstream of the
treatment site. Distal member 155 may comprise an annular balloon
fixed on a catheter or guidewire, a radially expandable filter, or
any of a wide variety of flow and/or embolization inhibiting
intraluminal structures. Optionally, an intravascular ultrasound
(IVUS) sensor 157 may be carried by at least one of the components
of the catheter system, optionally in a component which will
traverse the occlusion such as the guidewire or dottering device
151 (or other penetrator), a shaft axially coupled to distal
protection member 155, or the like. Alternatively, IVUS
capabilities may be incorporated in one or more of the other
catheter system components, or may be provided by a dedicated
structure that can be advanced through a lumen of the catheter
system or independent thereof. Such IVUS capabilities may be useful
for planning an occlusion therapy, for monitoring progress of the
therapy, and/or for verifying the effectiveness of the therapy.
[0104] Once flow distal of the occlusive material OM is inhibited,
treatment of the lesion can continue using any of a wide variety of
modalities of treatment such as atherectomy, endarterectomy,
infusion of occlusive material removal flow or active agents, and
the like. Alternatively, as shown in FIG. 25B, a proximal occluding
member 159 may also be inflated or expanded to isolate the
treatment site. Proximal occluding member may again comprise a
balloon or embolic filter carried on the outer surface of shaft 113
or on an outer sheath 161, with occlusion and fluid isolation
allowing the infusion of various treatment modalities such as
saline, contrast, pharmacologic agents such as tPA, ReoPro, IIB3A
inhibitors and the like, or chemical ablation agents or acid
solutions such as those listed above regarding FIGS. 22 and 23,
and/or those described in PCT Application No. PCT/US99/15918
(Publication No. WO 00/03651). In the case of any acidic compounds,
it is beneficial to fully contain the compounds infused within the
treatment site, and to expeditiously remove and aspirate the
dissolved material.
[0105] In FIGS. 25B and C, the treatment catheter 130, and
specifically the mechanical pump (141 and 141') is used to remove
some or all remaining occlusive material OM, including thrombus,
plaque, fibrin, clot and the like, while still protecting the
vessel wall. Fluid may optionally be circulated by, for example,
infusion via lumen 115 while aspirating via a lumen 163 of shaft
113, the aspiration often being assisted by rotation of the
Archimedes screw pump 141' within the aspiration lumen as described
above. A vacuum source may be applied to the aspiration lumen via
the proximal housing or only a proximal pump may be included, and
some embodiments of the occlusion removal and access catheters
described herein may not include an integral mechanical pump
disposed in a distal lumen of the catheter system. The catheter is
then removed and the vessel may then be further treated with a
liner, stent, coated stent, stent-graft, or the like, as is taught
by the prior art and is known to those skilled in the art.
[0106] The use of the occlusive material removing catheter system
embodiment of FIGS. 18C-E can be understood with reference to FIG.
26. Once again, a positioning cage 110 is located on the distal
portion of a treatment catheter 120a. Treatment catheter 120a may
include an axially moveable driveshaft 165, the cutters 122 may be
axially affixed in a distally exposed configuration, or a distal
cover may be removed in situ from cutters 122 of the morcellator.
Regardless, the driveshaft 165 can be advanced into the occlusion
TO while the driveshaft and (and the cutters carried thereon)
rotate to create the desired pilot hole, propagation plane or
passage for a guidewire or other guide device. Alternatively, the
inner or outer cage may be translated distally and/or in tension to
distally expose a morcellator that drills similarly into and/or
through the total occlusion TO. Hence, a variety of related
embodiments will be clear to those of skill in the art in light of
the disclosure herein. For example, rather than a morcellator
formed of helical cutters extending distally from within a lumen,
the penetrator may comprise a blunt disection tool distally
extending from a fixed outer or rotating inner cage, a cutter in
the form of a spinning burr or screw extending distally from a
rotating inner cage, or the like.
[0107] It should be noted that any of the method steps or devices
used in one method description may be interchanged with method
steps of another description and still be in the scope of the
present invention. For example, the isolation balloon or distal
protection device may be used in conjunction with the positioning
cage catheter 120, and well as through and in conjunction with
treatment catheter 130. Furthermore, the terms pilot hole and
propagation plane are used to refer to any path that is created
through a occlusion (TO), either through the center of the vessel
lumen, or to one side or the other around the circumference of the
vessel lumen.
[0108] While the exemplary embodiments have been described in some
detail, by way of example and for clarity of understanding, a
variety of adaptations, changes, and modifications will be obvious
to those of skill in the art. Hence, the scope of the present
invention is limited solely by the appended claims.
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