U.S. patent application number 12/271401 was filed with the patent office on 2009-03-12 for inflatable occlusion devices, methods, and systems.
Invention is credited to Brian C. Case, Jacob A. Flagle, Ram H. Paul.
Application Number | 20090069838 12/271401 |
Document ID | / |
Family ID | 36095919 |
Filed Date | 2009-03-12 |
United States Patent
Application |
20090069838 |
Kind Code |
A1 |
Paul; Ram H. ; et
al. |
March 12, 2009 |
INFLATABLE OCCLUSION DEVICES, METHODS, AND SYSTEMS
Abstract
Described are devices, methods and systems useful for achieving
occlusion of vascular vessels. Percutaneous procedures can be used
to occlude and obliterate the greater saphenous vein, for example
in the treatment of varicose vein condition caused by venous
reflux. Certain embodiments encompass the deployment and filling of
an inflatable occlusion device via a percutaneous procedure, so as
to occlude or obliterate a portion of a vascular vessel.
Inventors: |
Paul; Ram H.; (Bloomington,
IN) ; Flagle; Jacob A.; (Indianapolis, IN) ;
Case; Brian C.; (Bloomington, IN) |
Correspondence
Address: |
WOODARD, EMHARDT, MORIARTY, MCNETT & HENRY LLP
111 MONUMENT CIRCLE, SUITE 3700
INDIANAPOLIS
IN
46204-5137
US
|
Family ID: |
36095919 |
Appl. No.: |
12/271401 |
Filed: |
November 14, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11294998 |
Dec 6, 2005 |
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12271401 |
|
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60633543 |
Dec 6, 2004 |
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Current U.S.
Class: |
606/195 |
Current CPC
Class: |
A61B 17/1219 20130101;
A61B 2017/1205 20130101; A61B 17/12109 20130101; A61B 17/12136
20130101; A61L 29/005 20130101 |
Class at
Publication: |
606/195 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1. A medical product comprising an occlusion balloon including a
remodelable material.
2. The medical product of claim 1, wherein the remodelable material
comprises an extracellular matrix material.
3. The medical product of claim 2, wherein the extracellular matrix
material comprises submucosa, renal capsule membrane, dermal
collagen, dura mater, pericardium, serosa, peritoneum, or basement
membrane.
4. The medical product of claim 3, wherein the submucosa comprises
mammalian submucosa.
5. The medical product of claim 4, wherein mammalian submucosa
comprises porcine, bovine, or ovine submucosa material.
6. The medical product of claim 5, wherein porcine submucosa
comprises adult porcine submucosa.
7. The medical product of claim 1, wherein the balloon comprises a
single wall.
8. The medical product of claim 7, wherein the balloon has a length
of at least about 20 cm.
9. The medical product of claim 7, wherein the balloon has a length
of at least about 40 cm.
10. An inflatable occlusion device for occluding a vascular vessel
of a human, comprising: a balloon having a proximal end and a
distal end, wherein the balloon has a length of at least about 10
cm, and wherein the balloon is configured for percutaneous delivery
into the vascular vessel so as to cause occlusion of the vascular
vessel.
11. The inflatable occlusion device of claim 10, wherein the
balloon includes a balloon wall formed from a remodelable
extracellular matrix sheet material harvested from a biological
tissue source, the remodelable extracellular matrix sheet material
being effective to promote ingrowth of tissue of the patient into
the remodelable extracellular matrix sheet material.
12. The inflatable occlusion device of claim 10 further comprising
a delivery device having a lumen, wherein the balloon is removably
positioned in the delivery device lumen and deployable from the
lumen to the vascular vessel for causing occlusion of the
vessel.
13. The inflatable occlusion device of claim 12 further comprising
a wire guide positioned in the delivery device lumen.
14. The inflatable occlusion device of claim 13, wherein the
balloon is received over the wire guide.
15. The inflatable occlusion device of claim 14, wherein the
balloon has an opening in a wall of the balloon through which the
wire guide extends.
16. The inflatable occlusion device of claim 10, wherein the
balloon includes a double walled balloon.
17. The inflatable occlusion device of claim 10, further comprising
a fill material for filling the balloon.
18. The inflatable occlusion device of claim 17, wherein the fill
material comprises, collagen, chitosan, oxidized regenerated
cellulose, calcium alginate, alginate, or any suitable combination
thereof.
19. The inflatable occlusion device of claim 17, wherein the fill
material comprises a remodelable extracellular matrix fill material
effective to promote ingrowth of tissue of the patient into the
remodelable extracellular matrix fill material.
20. The inflatable occlusion device of claim 19, wherein the
remodelable extracellular matrix fill material comprises a
particulate remodelable extracellular matrix.
21. A medical product, comprising: an inflatable occlusion device
deployable within the vasculature of a patient; and a fill material
for filling the inflatable occlusion device, the fill material
comprising a remodelable extracellular matrix material.
22. The medical product of claim 21, wherein the remodelable
extracellular matrix material comprises fluidized material.
Description
STATEMENT OF RELATED APPLICATIONS
[0001] This application is a divisional of application Ser. No.
11/294,998, filed Dec. 6, 2005, which claims the benefit of
priority of U.S. Provisional Patent Application Ser. No. 60/633,543
filed Dec. 6, 2004, each of which is incorporated by reference
herein in its entirety.
BACKGROUND
[0002] The present invention resides generally in the field of
devices and methods useful for the occlusion of vascular vessels,
and in a particular aspect relates to the occlusion of the greater
or lessor saphenous vein to treat complications, such as varicose
vein condition, resultant of venous reflux.
[0003] As further background, vascular vessels are comprised of
tissue and are the conduit for circulating blood through a
mammalian body. A vascular vessel that carries blood from the heart
is known as an artery. A vascular vessel that returns blood to the
heart is known as a vein. There are three types of veins in a
human: deep veins, which are located deep in the body close to the
bones, superficial veins, which are located close to the skin, and
perforating veins, which are smaller veins that connect the deep
veins to the superficial veins.
[0004] To assist blood flow, venous vascular vessels contain venous
valves. Each venous valve is located inside the vein and typically
includes at least two valve leaflets, which are disposed annularly
along the inside wall of the vein. These leaflets open to permit
blood flow toward the heart and close, upon a change in pressure,
such as a transition from systole to diastole, to restrict the back
flow of blood. When blood flows towards the heart, the venous
pressure forces the valve leaflets to move apart in a downstream
flexing motion, thereby creating an open path for blood flow. The
leaflets normally flex together when moving in the upstream
direction; therefore, they return to a closed position to restrict
or prevent blood flow in the upstream, or retrograde, direction
after the venous pressure is relieved. The leaflets, when
functioning properly, extend radially inward toward one another
such that the leaflet tips, or cusps contact each other when the
valve is closed.
[0005] On occasion, and for a variety of reasons, such as
congenital valve or vein weakness, disease in the vein, obesity,
pregnancy, and/or an occupation requiring long periods of standing,
one or more valves in a vein will allow deleterious retrograde flow
to occur. When a valve allows such retrograde flow, blood will
collect, or pool in vessels beneath the valve. This pooling of
blood causes an increase in the venous pressure below the valve.
Venous valves that allow such deleterious retrograde flow are known
as incompetent or inadequate venous valves. The condition resulting
from such incompetent venous valves is known as venous valve
insufficiency.
[0006] In the condition of venous valve insufficiency, the venous
valve leaflets do not function properly. Incompetent venous valves
can cause the veins to bulge, can cause swelling in the patient's
lower extremities, and can result in varicose veins and/or chronic
venous insufficiency. If left untreated, venous valve insufficiency
can cause venous stasis ulcers of the skin and subcutaneous
tissue.
[0007] A common method of treatment for venous valve insufficiency
is the placement of an elastic stocking around the patient's leg to
apply external pressure to the vein, forcing the walls radially
inward to force the leaflets into apposition. Although sometimes
successful, the tight stocking is quite uncomfortable, especially
in warm weather, because the stocking must be constantly worn to
keep the leaflets in apposition. The elastic stocking also affects
the patient's physical appearance, thereby potentially having an
adverse psychological affect. This physical and/or psychological
discomfort can lead to the patient removing the stocking, thereby
inhibiting treatment.
[0008] Surgical methods for treatment of venous valve insufficiency
have also been developed. A vein with incompetent venous valves can
be surgically constricted to bring incompetent leaflets into closer
proximity in hopes of restoring natural valve function. Methods for
surgical constriction of an incompetent vein include implanting a
frame around the outside of the vessel, placing a constricting
suture around the vessel (e.g., valvuloplasty), or other types of
treatment to the outside of the vessel to induce vessel
contraction. Other surgical venous valve insufficiency treatment
methods include bypassing or replacing damaged venous valves with
autologous sections of veins containing competent valves.
[0009] Another surgical method includes vein stripping and
ligation. In this procedure, the femoral vein and other major
venous tributaries are disconnected from the greater saphenous vein
(GSV) and tied off. Next, the GSV is removed from the leg by
advancing a wire through the vein, tying the wire to a saphenous
vein end, and then pulling the wire, and vein, out through an
incision in the upper calf or ankle. Unfortunately, the above
surgeries require at least one incision and have several
undesirable side effects and risks, such as a long patient recovery
time, the potential for scarring, and numerous other risks inherent
with surgery, such as those associated with the administration of
anesthesia.
[0010] Recently, various implantable prosthetic devices and
minimally invasive methods for implantation of these devices have
been suggested to treat venous valve insufficiency. Such prosthetic
devices can be inserted intravascularly, for example from an
implantation catheter. Prosthetic devices can function as a
replacement venous valve, or enhance venous valve function by
bringing incompetent valve leaflets into closer proximity. In one
procedure, venous valve function can be enhanced by clipping the
valve leaflets together with a clip made from a biocompatible
material, such as a metal, polymer, or fabric. In other procedures,
venous valve leaflets can be attached using a plastic or metal
staple.
[0011] Recently, a number of methods have been suggested to treat
varicose veins and venous valve leaflets with energy sources, such
as radiofrequency (RF) energy. In one such method, valve leaflets
can be fastened together with electrodes delivering RF energy. In
another such method, a catheter having an electrode tip can be used
to apply RF energy to cause localized heating and corresponding
shrinkage of venous tissue. After treatment of one venous section
is complete, the catheter can be repositioned to treat a different
venous section.
[0012] Methods for treatment of varicose veins have also been
developed involving various forms of sclerotherapy. Generally,
sclerotherapy involves the delivery of sclerosing agents to the
lumen of a vein, which induce the vein to collapse and the venous
walls to fuse, thereby closing the vein.
[0013] In view of this background, the need remains for improved
and alternative techniques, devices and systems for affecting the
venous system to treat venous conditions. The present invention is
addressed to these needs.
SUMMARY OF INVENTION
[0014] Accordingly, in one aspect, the present invention provides a
method for treating a refluxing vascular vessel. The method
includes accessing the vascular vessel, inserting an inflatable
occlusion device into the vascular vessel, and inflating the
occlusion device so as to occlude the vascular vessel and prevent
reflux therethrough.
[0015] In one aspect, the present invention includes a medical
product comprising an occlusion balloon that includes a remodelable
material.
[0016] In another aspect, the present invention provides a method
for occluding a portion of the vasculature that includes providing
percutaneous access to the vasculature and delivering an inflatable
occlusion device to a site within the vasculature. The method also
includes inflating the inflatable occlusion device with fill
material. In certain aspects, the occlusion device is at least
about 10 centimeters in length.
[0017] In yet another aspect, the invention provides a method for
treating a venous dysfunction in a leg of a patient that includes
providing access to a venous vessel and delivering a remodelable
balloon within the venous vessel. The method continues by inflating
the balloon with fill material.
[0018] In another aspect, the invention provides an inflatable
occlusion device for occluding a vascular vessel or similar bodily
vessel that includes a balloon having a length of at least about 10
centimeters, wherein the balloon is configured for percutaneous
delivery into the vascular or similar bodily vessel so as to cause
occlusion of the vessel. In certain aspects, the balloon can
include remodelable materials, e.g. extracellular matrix (ECM)
materials, such as mammalian small intestine submucosa. The
remodelable material can be incorporated so as to provide a
structural wall of the balloon.
[0019] The invention also provides a medical product or system for
vascular occlusion that includes a kit enclosed in sterile
packaging. In certain aspects, the kit includes an inflatable
occlusion device having a length of at least about 10 centimeters
and a cannulated device configured for delivery of the inflatable
occlusion device into a vascular vessel.
[0020] In yet another aspect, the invention provides a method that
includes inflating a balloon with a remodelable fill material.
Advantageous such fill materials include, for example, remodelable
collagenous foams and fluidized remodelable ECM materials.
[0021] In still yet another aspect, the invention provides an
occlusion method that includes periodic loading or filling of an
inflatable occlusion device located in a vascular vessel. The
periodic loading can be conducted so as to combat recanalaization
of the vascular vessel around or through the occlusion device. In
addition, the fill material can be a remodelable material and the
periodic loading can serve to replenish the device and facilitate
tissue ingrowth across the diameter of the vessel so as to stably
occlude the vessel.
[0022] In another aspect, the invention provides a method for
occluding a vascular vessel that includes providing an opening in
the vessel and positioning an inflatable occlusion device having a
proximal end and a distal end, such that the distal end is located
at a point within the vessel and the proximal end is located at a
point exterior to the vessel opening. The method also includes
passing fill material into the inflatable occlusion device.
[0023] The present invention provides improved methods, systems and
devices for occluding venous and other vascular or bodily vessels.
Additional embodiments as well as features and advantages of the
invention will be apparent from the further descriptions
herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 depicts a human leg showing certain venous structures
therein.
[0025] FIG. 2 depicts a human leg showing certain venous structures
therein.
[0026] FIG. 3 depicts a human leg showing certain venous structures
therein.
[0027] FIG. 4 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0028] FIG. 5 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0029] FIG. 6 depicts an illustrative deployment embodiment of the
invention occurring in that portion of the human leg occurring
generally between points 13 and 14 in FIG. 1.
[0030] FIG. 7 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0031] FIG. 8 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0032] FIG. 9 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0033] FIG. 10 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0034] FIG. 11 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0035] FIG. 12 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0036] FIG. 13 depicts an illustrative balloon-loading embodiment
of the present invention.
[0037] FIG. 14 depicts an illustrative deployment embodiment of the
invention in that portion of the human leg occurring generally
between points 13 and 14 in FIG. 1.
[0038] FIG. 15 depicts an illustrative balloon-loading embodiment
of the present invention.
[0039] FIG. 16 depicts an illustrative balloon-loading embodiment
of the present invention.
[0040] FIG. 17 depicts an illustrative balloon-loading embodiment
of the present invention.
[0041] FIG. 18 depicts an illustrative balloon-loading embodiment
of the present invention.
[0042] FIG. 19 depicts an illustrative balloon inflated in a
vascular vessel according to an embodiment of the present
invention.
[0043] FIG. 20 depicts an illustrative deployment method of the
present invention.
[0044] FIG. 21 depicts an illustrative deployment method of the
present invention.
[0045] FIG. 22 depicts an illustrative balloon inflated in a
vascular vessel according to an embodiment of the present
invention.
DETAILED DESCRIPTION
[0046] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to certain
embodiments thereof and specific language will be used to describe
the same. It will nevertheless be understood that no limitation of
the scope of the invention is thereby intended, such alterations,
further modifications and further applications of the principles of
the invention as described herein being contemplated as would
normally occur to one skilled in the art to which the invention
relates.
[0047] As disclosed above, certain embodiments of the present
invention provide methods, devices and systems for achieving
occlusion of a vascular vessel, such as a saphenous vein. Certain
methods of the invention can be performed, for instance, in order
to treat venous reflux through the greater saphenous vein (GSV)
such as that involved in the varicose vein condition.
[0048] With reference now more particularly to the figures, shown
in FIG. 1 is a diagram of a human leg 200 showing certain venous
structures therein. In particular, shown is human leg 200 having
GSV 10 and femoral vein 11 which adjoin at the sapheno-femoral
junction 12. In accordance with certain aspects of the present
invention, the GSV 10 is occluded in a region constituting
substantially all of the passage between a point 13 occurring near
the medial side of the knee to a point 14 occurring prior to the
sapheno-femoral junction 12, as illustrated by the shaded area in
FIG. 2. Desirably, such occlusion is effective to prevent reflux of
venous blood from the sapheno-femoral junction 12 in a direction
down toward the medial side of the knee (e.g. at point 13). Such
occlusion is effective to treat varicosities that commonly occur in
lower portions of the leg, e.g. portions occurring below the
knee.
[0049] With reference now to FIG. 3, in certain forms of the
invention, occlusion of the passage of the GSV occurring between
points 13 and 14 is achieved by an elongate inflatable occlusion
device 15 that extends from point 13 to point 14, and that may
include an end portion 16 that traverses the wall of the GSV 10.
This may be achieved by deploying an inflatable occlusion device
15, such as a single or double walled balloon, during a
percutaneous procedure, e.g. as described hereinbelow.
Additionally, the occlusion device can comprise a remodelable
material inflated with remodelable fill material, such that the
patient's tissue remodels the device and fill material to enhance
occlusion of the GSV.
[0050] With reference now to FIG. 4, shown is an enlarged view of
that portion of the human leg occurring generally between points 13
and 14 of FIG. 1. In an illustrative deployment procedure,
percutaneous access to the GSV 10 can be achieved at point 13 using
the Seldinger or any other suitable technique. For instance, an
access needle (not shown) can be passed through the skin to access
the GSV 10, and a wire guide 20 can be passed through the access
needle and into the vein 10. Prior to deployment of an inflatable
occlusion device (not shown), wire guide 20 can be used for any
number of conventional procedures including catheterization and
imaging procedures in order to locate the sapheno-femoral junction
12. After any such preliminary procedures that are performed, the
wire guide 20 can be used in a deployment procedure for an
inflatable occlusion device.
[0051] Specifically, referring still to the illustrative embodiment
shown in FIG. 4, a deployment sheath 24 can be placed at a suitable
location in the GSV 10 using a flexible guide catheter 22, or,
alternatively, a suitable dilator or dilator tip mounted on the
guide catheter. In placing or inserting the sheath 24 in the GSV,
the guide catheter 22 can be first received over the wire guide 20,
then pushed into the GSV 10, where it follows along the wire guide
20 to a location within the GSV 10. Next, the sheath 24 can be
received over the guide catheter 22, pushed into the GSV 10, and
follow the guide catheter 22 to a suitable location in proximity to
point 14. Alternatively, the sheath 24 and guide catheter 22 can be
placed within the GSV 10, with the guide catheter 22 leading the
sheath 24, and both can be pushed along the wire guide 20 until the
sheath 24 is in a suitable location. Still alternatively, a
steerable catheter can be used in conjunction with a sheath,
thereby negating the need for a wire guide.
[0052] With reference now to FIG. 5, shown is a deployment sheath
24 received within the GSV 10 from point 13 to point 14. The guide
catheter 22 and wire guide 20 have been removed from the GSV 10,
leaving the sheath 24 in place with an empty lumen for slidably
receiving an inflatable or expandable occlusion device.
[0053] Turning now to FIG. 6, shown is the delivery of an
inflatable occlusion device 28 extending between points 13 and 14
in the GSV 10. In one embodiment, a single walled occlusion device
28, such as a single walled balloon, can be delivered into the GSV
10 by placing the distal end of a flexible pusher 26 inside the
balloon, such that the pusher 26 contacts the distal end of the
balloon 29. Next, the pusher 26 and balloon 28 can be tracked
through the sheath 24 until the distal end of the balloon 29 is
located at point 14, while the proximal end of the balloon 27
remains external to the patient's leg 200. In an alternative
embodiment, as shown in FIG. 10, the proximal end of the balloon 27
can be located within the GSV 10 proximate to point 13 during
delivery.
[0054] Turning now to FIGS. 7 through 10, an illustrative
deployment procedure continues by removing the deployment sheath 24
while maintaining the balloon 28 in place with, for example, the
pusher 26, as shown in FIG. 7. After the sheath 24 is removed, the
pusher 26 can be removed leaving the distal end of the balloon 29
proximate to point 14 while its proximal end 27 remains external to
the patient's leg 200. Next, as illustrated in FIG. 8, the
occlusion device 28 may be inflated from its proximal end 27 by
flowing fill material 30 into the occlusion device 28 using any
suitable method known in the art, such as a needle and syringe 35,
or other device for delivering a fill material, e.g. under
pressure. Other such suitable fill methods include flowing fill
material 30 into the occluder 28 with a pusher 26 having a lumen
for receiving fill material, by use of a catheter, and/or, with
multiple syringe penetrations into the occlusion device 28 along
the patient's leg 200 between points 13 and 14. Fill material 30 is
added to the occluder until the occluder substantially eliminates
blood reflux from the iliac and femoral veins into the lower
saphenous vein (LSV). The amount of reflux can be determined using
any suitable method in the art, such as sonographic and/or
ultrasonic imaging.
[0055] After the expandable occluder 28 is filled with an adequate
amount of fill material 30, the proximal end of the occluder 27 can
be trimmed, if necessary, closed, and optionally anchored. As shown
in FIGS. 9 and 10, the proximal end of the occluder 27 can be
located, by trimming if necessary, to a number of suitable
locations, such as a location within the GSV 10, as shown in FIG.
10, a location external to the GSV, such as within a dermal layer
of the leg 200 (FIG. 9), or to a location above the leg's 200
epidermal layer (not shown). The proximal end 27 of the device can
be closed using any suitable closing device or technique, such as
any suitable combination of sutures, staples, clamps, clips,
elastic cuffs, fusion bonding, or by tying the proximal end of the
device into one or more knots. Alternatively, the proximal end can
be closed, for example, by incorporating a suitable valve into the
proximal end of the occluder, such as a flapper valve or a duck
bill valve. For more information on valves suitable for use in the
present invention, reference can be made, for example, to U.S. Pat.
Nos. 5,222,970, 5,779,672, 6,312,405, and/or 6,736,793.
[0056] Additionally, the occlusion device 28 can be anchored if
necessary or desirable. In one embodiment, the proximal end 27 of
the device can be secured to a suitable portion of the patient to
assist in anchoring the device 28 in the GSV. Suitable anchoring
locations include the GSV, a portion of the leg surrounding the
access site, or a portion of a muscular or dermal layer within the
leg. Any suitable securing means can be used to anchor the proximal
end 27 of the balloon, such as any combination of sutures, clamps,
clips, staples, or energy-based fusion, or the like. Further, any
number of anchoring devices, such as barbs, clips, sutures, or the
like can be placed along one or multiple locations of the device's
28 wall or body to assist in securing the balloon 28 within the
GSV.
[0057] Turning now to a discussion of alternative deployment
methods involving the use of a sheath with an external wire port,
reference can be made to FIGS. 11 through 13. In an illustrative
embodiment as shown in FIG. 11, a sheath 40 having an external wire
port 42 can be located in the GSV 10 between points 13 and 14. In
locating the sheath 40, percutaneous access to the GSV 10 can be
achieved at point 13 and a wire guide 20 can be placed within the
GSV 10 as shown in FIG. 11. After the wire guide 20 is placed, the
sheath 40 with external wire guide port 42 can be received over the
wire guide 20 and pushed to point 14 within the GSV 10.
[0058] In an alternative embodiment, as shown in FIG. 12, the
sheath 40 with external wire guide port 42 can have a compliant tip
44 that provides for easy tracking of the sheath through a
patient's skin, tissue, and vasculature, while also readily opening
to provide egress to an object traveling through the sheath's 40
lumen.
[0059] Turning now to FIG. 13, shown is one method for deploying an
occlusion device 28 down a sheath having an unobstructed lumen,
such as any one of the sheaths depicted in FIGS. 5, 11, and 12. As
shown in FIG. 13, the balloon can first be packed within a
cartridge 46 having a sufficient cross-sectional shape and diameter
to pass through the lumen of the sheath 24. Thereafter, the
occluder 28 and cartridge 46 can be pushed to the distal end of the
sheath 24 using a pusher 26 or similar device. Once at the distal
end of the sheath 24, the occluder 28 can be deployed by holding
the occluder 28 and pusher 26 stationary, with the pusher in
contact with the occluder, while the sheath 28 and cartridge 46 are
retracted. Any suitable device or method may be used to cause the
cartridge 46 to retract with the sheath 24, such as placing a taper
or mounting a stop on the distal end of the sheath 24.
[0060] Any suitable alternative method for deploying an occlusion
device through a sheath with a substantially unobstructed lumen is
considered as being within embodiments of the present invention.
One such alternative method includes packing an occlusion device,
or balloon, into the lumen of the sheath and pushing the balloon
through the sheath using a pusher in contact with the proximal end
of the occlusion device. Once the balloon is at the distal end of
the sheath, the sheath can be retracted while holding the pusher
stationary, thereby deploying the balloon. Still alternatively, in
an illustrative embodiment, the balloon may be folded in a
controlled pattern to reduce its cross-sectional diameter and/or
increase its compliance and ability to be pushed through a sheath.
The folded balloon may then be pushed through a suitable sheath or
catheter and deployed into the GSV.
[0061] Turning now to a discussion of other alternative deployment
methods of the invention, reference can be made to FIGS. 14 through
18 which demonstrate various over-the-wire deployment embodiments.
In the illustrative embodiment shown in FIG. 14, the distal end of
sheath 24 having a compliant tip 44 is located at point 14 within
the GSV 10 by tracking the sheath over a previously located wire
guide 20.
[0062] Once the sheath 24 is located between points 13 and 14, a
number of alternative over the wire balloon deployment methods can
be used to deploy an inflatable occlusion device in the GSV 10
while leaving the wire guide disposed within the lumen of the
sheath 24. For example, turning to FIG. 15, an embodiment is shown
where the balloon 28 is wrapped in a cylindrical candy cane fashion
to form a lumen for receiving the wire guide 20. Once the lumen is
formed, the balloon can be fed along the wire guide 20 with a
pusher 26 and deployed within the GSV. Alternatively, as shown in
FIG. 16, the occlusion device 28 can be wrapped in candy cane
fashion around a thin walled tube or cannula 50. The balloon and
cannula can then be pushed over the wire guide 20 until the balloon
reaches the deployment site. Once at the deployment site, the
sheath 24 can be retracted while the balloon 28 and cannula 50 are
held in place with the pusher 26. During sheath 24 retraction, the
pusher 26 and/or cannula 50 can be used to support and/or position
the balloon 28 at a suitable location within the GSV.
[0063] FIG. 17 depicts an alternative over-the-wire deployment
method, wherein a hole 48 can be placed in the distal end 29 of a
balloon 28 for slidably receiving the wire guide 20. After the
balloon 28 is received over the wire guide 20, it can be tracked to
a deployment site using a pusher 26 disposed within the distal end
29 of the balloon 28. Once the balloon 28 is at the deployment
site, the wire guide 20 can be removed from its distal end 29, and
the hole 48 can be closed with any suitable closing device, such as
an elastic cuff, suture, or the like. Alternatively, fill material
having a diameter larger than the hole 48 can be used to inflate
the balloon, thereby sealing the hole 48 upon inflation. Still
alternatively, any other suitable device or means for receiving a
wire guide can be placed at the distal end of the balloon 29, such
as, for example, a flapper valve or duck bill valve. For more
information on valves suitable for use in the present invention,
reference can be made, for example, to U.S. Pat. Nos. 5,222,970,
5,779,672, 6,312,405, and/or 6,736,793.
[0064] Turning now to FIG. 18, a cross-section taken along the
vertical centerline of an illustrative over the wire deployment
embodiment is shown. In the depicted embodiment, a double-walled
balloon 28 having an outside diameter (OD) and an inside diameter
(ID) is mounted on a cannula 50, such that the balloon's 28 inside
diameter is in contact with the exterior portion of the cannula 50.
The cannula 50 and balloon 28 are then threaded onto the wire guide
20 and are pushed, through the sheath 24, to a deployment site
using one or more pushers 25, 26. Once at the deployment site, the
balloon 28 can be deployed by retracting the sheath 24 and
optionally using the pushers 25, 26 to position the balloon off of
the cannula 50. If necessary, a gripping device (not shown) can be
passed through the sheath 24 to hold the cannula 50 while the
balloon 28 is deployed from the sheath 24.
[0065] Although certain procedures have been described above for
the delivery of occlusion devices, it will be understood that other
modes of delivery of occlusion devices are also contemplated in
embodiments of the present invention. In the context of occluding
the greater saphenous vein, such techniques can be conducted with
the percutaneous access site provided either at the knee level or
near the groin in the area of the sapheno-femoral junction, or any
appropriate location in between or otherwise. Further, it is
contemplated within certain embodiments of the invention that
cut-down or other surgical procedures could be used in providing
access to vascular vessels for delivery of vascular occlusion
devices.
[0066] Turning now to a discussion of certain embodiments of
inflatable occlusion devices of the invention, reference can be
made to illustrative embodiments displayed in FIGS. 19 through 21.
FIG. 19 shows an embodiment where a vascular occlusion device 60
having a single wall is inflated in a vascular vessel 80 using fill
material 95. The inflatable occlusion device 60 has an occlusion
body 65, a proximal end 62, and a distal end 64. Device 60 has a
length "L" sufficient to occlude the length of the passage for
which occlusion or ablation is desired. In accordance with certain
embodiments of the invention, the device 60 will have a length
sufficient and will be positioned so as to traverse at least one
vessel 82, 84 that branches from the vessel to be occluded, for
instance a perforator or communicator vein branching from a larger
vein to be occluded such as a saphenous vein, e.g. the GSV. In the
context of GSV occlusion procedures as described above, length "L"
will be sufficient to traverse the greater saphenous vein from
position 13 to position 14, desirably having sufficient excess
length to exit the percutaneous access site for filling, closure,
and/or anchoring procedures. These same considerations may be
applied to the other inflatable vascular occlusion devices
described herein.
[0067] Turning now to FIG. 20, a cross-section taken along the
vertical centerline of an over the wire deployment embodiment with
a partially deployed inflatable occlusion device 70 in a vascular
vessel 80 is shown. The inflatable occlusion device 70 in FIG. 20
is a double walled balloon having an OD and an ID. The balloon 70
is shown in a partially deployed state with elastic cuffs 72
positioned within the balloon's ID to ensure closure of the ID
after deployment. As the wire guide 78 and cannula 76 are retracted
from the balloon's 70 ID, the elastic cuffs 72 collapse as they
fall off the cannula 76, thereby ensuring the ID of the balloon
closes. Additionally, the balloon 70 can be inflated with fill
material 95 using a syringe and needle 90 while the wire guide 78,
cannula 76, and sheath 74 are retracted, so as to give the double
walled balloon some form and support during the retraction
process.
[0068] Turning now to FIG. 21, in an alternative embodiment, a
cross-section taken along the vertical centerline of a fully
deployed occlusion device having a double wall 100 is shown. As
depicted in FIG. 21, a cannula 110 can be tracked over the ID of
the balloon 100 and positioned within the balloon's OD at its
distal end 104. Locating the cannula 110 at the balloon's distal
end 104 promotes closure of the balloon ID during inflation.
Additionally, in FIG. 21, the proximal end of the balloon 102 is
located outside the patient's body 210 where it can receive
suitable fill material 95 to inflate the balloon 100, so as to
occlude the vascular vessel 80. After the balloon 100 is filled,
the proximal end 102 can be trimmed, closed, and secured at a
suitable location, as discussed above, if desirable.
[0069] Turning now to FIG. 22, in an illustrative embodiment, a
deployed and fully inflated double walled balloon 120 is shown. The
balloon in FIG. 22 can be deployed and filled using any suitable
deployment and filling method, as discussed above. The balloon 120
depicted in FIG. 22 has an ID 127 that is capable of closing by
itself, so as to prevent blood reflux through the ID 127 of the
balloon 120. The self-closing functionality can be achieved in a
number of ways, such as by constructing the balloon 120 such that
its ID 127 closes upon inflation of the balloon 120 with fill
material 95. Alternatively, the ID 127 of the balloon 120, or the
entire balloon can be constructed with an elastic-type material,
such that the balloon ID 127 closes before, after, or during
balloon 120 deployment. Additionally, as depicted in FIG. 22, the
proximal end of the balloon 122 comprises ports 130, 131, which can
be used to fill the balloon 120 with fill material 95. The fill
ports 130, 131 can have a self-sealing means, such as a one way
valve, or alternatively, can be sealed with any suitable closure
device, such as a clamp, clip, staple, and/or suture, or the
like.
[0070] Turning now to a discussion of alternative balloon filling
methods, in one embodiment, a balloon can be filled or loaded on
more than one occasion to combat the occurrence of patency in the
occluded vessel. For example, in one embodiment, the balloon can be
filled with fill material during placement of the balloon in the
GSV. Then, during follow up patient visits, more fill material can
be added to the balloon, if needed, using a suitable filling
method, such as injecting the balloon with fill material using a
syringe and needle.
[0071] In an alternative embodiment, additional fill material can
be stored in a reservoir in communication with the balloon. The
fill material can then be transferred from the reservoir to the
balloon, as needed, using any suitable transfer method, such as a
pressure differential. The reservoir can be located in any suitable
location, extracutaneous or intracutaneous, as desired. In one
embodiment, for example, the reservoir can be a silicone bulb
secured in an extracutaneous location that is capable of receiving
additional fill material via a syringe or, alternatively, a fill
port.
[0072] Turning now to a discussion of suitable balloon materials,
the material used in the formation of illustrative vascular
occlusion devices of the invention can be any material suitable for
occluding a vascular vessel of interest. In this regard, the
occlusion material may be a synthetic material such as a polymeric
material, or a naturally-derived material, such as an extracellular
matrix (ECM) material. Illustrative synthetic materials may include
biodegradable or non-biodegradable materials. These include, for
example, synthetic biocompatible polymers such as cellulose
acetate, cellulose nitrate, silicone, polyethylene teraphthalate,
polyurethane, polyamide, polyester, polyorthoester, polyanhydride,
polyether sulfone, polycarbonate, polypropylene, high molecular
weight polyethylene, polytetrafluoroethylene, or mixtures or
copolymers thereof, polylactic acid, polyglycolic acid or
copolymers thereof, a polyanhydride, polycaprolactone,
polyhydroxy-butyrate valerate, polyhydroxyalkanoate, or another
biodegradable polymer.
[0073] Reconstituted or naturally-derived collagenous materials can
also be used as occlusion materials in certain embodiments of the
present invention. Such materials that are at least bioresorbable
will provide advantage in the present invention, with materials
that are bioremodelable (remodelable) and promote cellular invasion
and ingrowth providing particular advantage. Bioremodelable
materials may be used in this context to promote cellular growth
within the lumen of the occluded vessel. This helps to guard
against re-establishment of patency of the vessel through biologic
processes after the occlusion procedure is completed.
[0074] Collagenous ECM materials can be used in the formation of
illustrative occlusion devices of the invention, including
bioremodelable ECM materials. These can be delivered to the vessel
in a lyophilized or otherwise dried or hydrated state. For example,
suitable collagenous materials include ECM material such as
submucosa, renal capsule membrane, dermal collagen, dura mater,
pericardium, serosa, peritoneum or basement membrane layers,
including liver basement membrane. Suitable submucosa materials for
these purposes include, for instance, intestinal submucosa
including small intestinal submucosa, stomach submucosa, urinary
bladder submucosa, and uterine submucosa. The preferred occlusion
devices of the invention will include submucosa, such as submucosa
derived from a warm-blooded vertebrate. Mammalian submucosa
materials are preferred. In particular, submucosa materials derived
from animals raised for meat or other product production, e.g.
pigs, cattle or sheep, will be advantageous. Porcine submucosa
provides a particularly preferred material for use in the present
invention, especially porcine small intestine submucosa, more
especially porcine small intestine submucosa retaining
substantially its native cross-linking.
[0075] The submucosa or other ECM material can be derived from any
suitable organ or other biological structure, including for example
submucosa derived from the alimentary, respiratory, intestinal,
urinary or genital tracts of warm-blooded vertebrates.
Additionally, suitable balloon materials can be obtained by
isolating tubular or pouch form ECM materials, such as, for
example, small stomachs, urinary bladders, vascular vessels,
ureters, and/or suitable portions of the gastrointestinal (GI)
tract. Submucosa useful in the present invention can be obtained by
harvesting such tissue sources and delaminating the submucosa from
smooth muscle layers, mucosal layers, and/or other layers occurring
in the tissue source. For additional information as to submucosa
useful in the present invention, and its isolation and treatment,
reference can be made, for example, to U.S. Pat. Nos. 4,902,508,
5,554,389, 5,993,844, 6,206,931, and 6,099,567.
[0076] As prepared and used, the submucosa material and any other
ECM material used, may optionally retain growth factors or other
bioactive components native to the source tissue. For example, the
submucosa or other ECM material may include one or more growth
factors such as basic fibroblast growth factor (FGF-2),
transforming growth factor beta (TGF-beta), epidermal growth factor
(EGF), and/or platelet derived growth factor (PDGF). As well,
submucosa or other ECM material used in embodiments of the
invention may include other biological materials such as heparin,
heparin sulfate, hyaluronic acid, fibronectin and the like. Thus,
generally speaking, the submucosa or other ECM material may include
a bioactive component that induces, directly or indirectly, a
cellular response such as a change in cell morphology,
proliferation, growth, protein or gene expression.
[0077] Further, in addition or as an alternative to the inclusion
of such native bioactive components, non-native bioactive
components such as those synthetically produced by recombinant
technology or other methods, may be incorporated into the submucosa
tissue. These non-native bioactive components may be
naturally-derived or recombinantly produced proteins that
correspond to those natively occurring in the ECM material tissue,
but perhaps of a different species (e.g. human proteins applied to
collagenous ECMs from other animals, such as pigs). The non-native
bioactive components may also be drug substances. Illustrative drug
substances that may be incorporated into and/or onto the occlusion
devices include, for example, antibiotics, thrombus-promoting
substances such as blood clotting factors, e.g. thrombin,
fibrinogen, and the like. These substances may be applied to the
occlusion device as a premanufactured step, immediately prior to
the procedure (e.g. by soaking the material in a solution
containing a suitable antibiotic such as cefazolin), or during or
after deployment of the occlusion device in the patient.
[0078] Submucosa or other ECM tissue used in embodiments of the
invention is preferably highly purified, for example, as described
in U.S. Pat. No. 6,206,931 to Cook et al. Thus, preferred ECM
material will exhibit an endotoxin level of less than about 12
endotoxin units (EU) per gram, more preferably less than about 5 EU
per gram, and most preferably less than about 1 EU per gram. As
additional preferences, the submucosa or other ECM material may
have a bioburden of less than about 1 colony forming units (CFU)
per gram, more preferably less than about 0.5 CFU per gram. Fungus
levels are desirably similarly low, for example less than about 1
CFU per gram, more preferably less than about 0.5 CFU per gram.
Nucleic acid levels are preferably less than about 5 .mu.g/mg, more
preferably less than about 2 .mu.g/mg, and virus levels are
preferably less than about 50 plaque forming units (PFU) per gram,
more preferably less than about 5 PFU per gram. The ECM material
used in the invention is preferably disinfected with an oxidizing
agent, particularly a peracid, such as peracetic acid. These and
additional properties of submucosa or other ECM tissue taught in
U.S. Pat. No. 6,206,931 may be characteristic of the submucosa
tissue used in the present invention.
[0079] Additionally, other suitable occlusion balloon materials
include, substantially non-antigenic elastic materials, latex, and
silicone. For more information on suitable balloon materials that
can be used in the present invention, reference can be made, for
example, to U.S. Pat. Nos. 4,819,637, 5,222,970, 5,304,123,
5,411,475, 5,779,672, and/or 5,830,228.
[0080] The remodelable ECM or other material may include one or
more radiopaque and/or ecogenic markers or a radiopaque coating or
impregnation to assist in visualization of the material during a
non-invasive procedure. For example, radiopaque substances
containing tantalum, barium, iodine, or bismuth, e.g. in powder
form, can be coated upon or incorporated within the ECM or other
remodelable material, such that, for example, the location of the
balloon's distal end is detectable.
[0081] Turning now to a discussion of inventive fill materials, the
occlusion device can be filled with any material conducive to
achieving chronic occlusion of a vascular vessel of interest. In
this regard, the fill material may be a solid, liquid, gel, foam or
gas, such as blood, polymer, contrast medium, a remodelable or
bioabsorbable material, saline, a non-bioabsorbable material,
collagen rods or particulates, a collagenous or gelatinous foam,
air, chitosan, gelatin, oxidized regenerated cellulose, calcium
alginate, alginate, thrombin-fibrin enhanced materials, fibrin
glues, or any suitable combination thereof.
[0082] In one embodiment, the fill material can comprise a
comminuted, fluidized, and/or gelatinous remodelable material. For
example, a remodelable gel can be formed from fluidized
compositions, as illustrated in U.S. Pat. Nos. 5,275,826,
5,516,533, 6,206,931, and/or International Publication No.
WO2005020847 (Cook Biotech Incorporated) published Mar. 10, 2005,
which are each hereby incorporated by reference in their entirety.
In this regard, solutions or suspensions of ECM can be prepared by
comminuting and/or digesting ECM with a protease (e.g. trypsin or
pepsin), for a period of time sufficient to solubilize the ECM and
form substantially a homogenous solution. The ECM starting material
is desirably comminuted by tearing, cutting, grinding, shearing or
the like. Grinding the ECM in a frozen or freeze-dried state is
advantageous, although good results can be obtained as well by
subjecting a suspension of pieces of the submucosa to treatment in
a high speed blender and dewatering, if necessary, by centrifuging
and decanting excess waste. The comminuted ECM can be dried, for
example freeze dried, to form a powder. Thereafter, if desired, the
powder can be hydrated, that is, combined with water or buffered
saline and optionally other pharmaceutically acceptable excipients,
to form a fluid composition, e.g. having a viscosity of about 2 to
about 300,000 cps at 25.degree. C. The higher viscosity
compositions can have a gel or paste consistency. This gelatinous
composition can be used as fill material in an inventive
remodelable balloon of the invention.
[0083] Additionally, such gelatinous or flowable materials can
include solubilized and/or particulate ECM components, and in
preferred forms include ECM gels having suspended therein ECM
particles, for example having an average particle size of about 50
microns to about 500 microns, more preferably about 100 microns to
about 400 microns. The ECM particulate can be added in any suitable
amount relative to the solubilized ECM components, with preferred
ECM particulate to ECM solubilized component weight ratios (based
on dry solids) being about 0.1:1 to about 200:1, more preferably in
the range of 1:1 to about 100:1. The inclusion of such ECM
particulates in the ultimate gel can serve to provide additional
material that can function to provide bioactivity to the gel (e.g.
itself including FGF-2 and/or other growth factors or bioactive
substances as discussed herein) and/or serve as scaffolding
material for tissue ingrowth.
[0084] Alternatively, the fill material can comprise a suitable
solidifying polymer, such as HEMA. Upon addition of a catalyst to
HEMA at a certain temperature, HEMA will gradually change from a
liquid form to either a gelatinous or solid form over approximately
twenty minutes. This change in form is desirable in a fill material
because the material can easily flow into the occlusion device,
eliminating void space between the device and the vessel wall, and
then solidify, thereby enhancing the occlusion ability of the
balloon. For more information on HEMA and other fill materials
useful in the present invention, reference can be made, for
example, to U.S. Pat. Nos. 4,819,637, 5,222,970, 5,304,123,
5,411,475, and/or 5,830,228, each of which is hereby incorporated
herein in its entirety.
[0085] Additionally, the fill material, including, e.g. remodelable
ECM fill materials, can include one or more radiopaque and/or
ecogenic markers or a radiopaque coating or impregnation to assist
in visualization of the material during a non-invasive procedure.
For example, radiopaque substances containing tantalum, barium,
iodine, or bismuth, e.g. in powder form, can be coated upon or
incorporated within a fill material, such that, for example, the
location of the fill material within a patient's body can be
detected.
[0086] Occlusion devices of the invention will generally be of
sufficient dimension to achieve occlusion of the desired stretch of
vascular vessel, either alone or in combination with other similar
or differing devices. In certain embodiments, the occlusion device
will have a length of at least about 10 cm, and in many situations
at least about 20 cm. Indeed, for preferred occlusion procedures
involving a significant stretch of an artery or vein, occlusion
devices having lengths greater than 30 cm will be used.
Illustratively, in the occlusion of the GSV in human adolescents or
adults, occlusion devices having lengths of at least about 40 cm or
50 cm can be used.
[0087] While discussions above focus upon occluding the GSV via
access at the knee level, the GSV may also be accessed at a lower
level, e.g. near the ankle. During such access, any or all of the
GSV occurring between the ankle and the sapheno-femoral junction
may be subjected to occlusion. Other veins in the leg(s) that may
be involved in the varicose vein condition may also be occluded,
alternatively or in addition to the GSV. For example, the lesser
saphenous vein, or varicose veins themselves, may be occluded and
obliterated in accordance with certain embodiments of the
invention. Further, other bodily lumens, veins, or arteries, either
in the leg(s) or elsewhere in the body, may be occluded within
embodiments of the present invention by obtaining access at any
suitable location, e.g. the jugular vein.
[0088] Percutaneously conducted occlusion procedures of the
invention will typically be performed under local anesthesia, such
as at the point of access. In addition, after completion of the
procedure, it may be beneficial to use graduated compression
stockings in the occluded area, for example for a week or more.
Compression of the occluded area may serve to facilitate permanent
closure of the occluded vessel, for example when applied during a
remodeling period during which tissue ingrowth into the occluded
lumen occurs.
[0089] Sheaths, dilators, wire guides and needles used in the
present invention can all be conventional marketed products or
modifications thereof. For example, sheaths can be formed from PTFE
(e.g. Teflon) or polyamide (e.g. Nylon) material, or a combination
of materials such as an assembly including an inner layer of PTFE,
a flat wire coil over the PTFE for kink resistance, and a polyamide
(Nylon) outer layer to provide integrity to the overall structure
and a smooth surface (e.g. as in the Flexor sheath, Cook, Inc.).
Dilators can be made from conventional dilator/catheter type
materials such as polyethylene, polyamide, polyurethane or vinyl,
or any combination of these materials. Fittings provided for
sheath/dilator assemblies can be conventional elements such as luer
locks, and the dilator can have a fitting allowing it to be locked
to the sheath during insertion and manipulation. Catheters can be
made from conventional materials such as polyethylene, polyamide,
PTFE, polyurethane, and other materials.
[0090] Delivery sheaths used in certain embodiments of the
invention will have a lumen diameter sized to allow for the
introduction of a suitable inflatable occlusion device to occlude
the artery or vein of interest. Illustratively, the inner diameter
(I.D.) of the final delivery sheath can range from about 6 to 8
French up to about 40 French.
[0091] As is conventional, the distal ends of the catheters,
sheaths, dilators, wires, inflatable occlusion devices or other
components used in percutaneous procedures can include markers that
can be X-ray, sonographically, or otherwise non-invasively
visualized to identify their location during the procedure.
Metallic bands of stainless steel, tantalum, platinum, gold, or
other suitable materials, which include a dimple pattern, can serve
to purpose for both ultrasound and X-ray identification.
[0092] Certain embodiments of the invention can also include
medical kits, such as an inventive remodelable balloon and a sheath
with a compliant tip, sealed within sterile medical packaging. The
final, packaged product is provided in sterile condition. This may
be achieved, for example, by gamma, e-beam or other irradiation
techniques, ethylene oxide gas, or any other suitable sterilization
technique, and the materials and other properties of the medical
packaging will be selected accordingly. The prosthesis device may
be packaged wet or after it is dried.
[0093] All publications cited herein are hereby incorporated by
reference in their entirety as if each had been individually
incorporated by reference and fully set forth.
[0094] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the invention are desired to be
protected.
* * * * *