U.S. patent application number 10/498035 was filed with the patent office on 2005-10-13 for methods and devices for percutaneous and surgical interventions.
Invention is credited to Hofmann, Lawrence.
Application Number | 20050228402 10/498035 |
Document ID | / |
Family ID | 27613505 |
Filed Date | 2005-10-13 |
United States Patent
Application |
20050228402 |
Kind Code |
A1 |
Hofmann, Lawrence |
October 13, 2005 |
Methods and devices for percutaneous and surgical interventions
Abstract
Methods and devices for performing percutaneous and surgical
interventions. The devices comprising a tubular portion and
retractable mechanism at the distal end of the tubular portion. The
retractable mechanism prevents the device from pulling out of an
anatomical structure during complex interventions, for example,
when switching from an antegrade to a retrograde approach within a
blood vessel, enables the use of a single sheath when declotting AV
hemodialysis fistulas and can provide occlusion of blood flow
during interventions and means of removal of debris or clot from
the blood vessel.
Inventors: |
Hofmann, Lawrence; (Severna
Park, MD) |
Correspondence
Address: |
EDWARDS & ANGELL, LLP
P.O. BOX 55874
BOSTON
MA
02205
US
|
Family ID: |
27613505 |
Appl. No.: |
10/498035 |
Filed: |
June 7, 2004 |
PCT Filed: |
January 24, 2003 |
PCT NO: |
PCT/US03/02186 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60351516 |
Jan 24, 2002 |
|
|
|
Current U.S.
Class: |
606/108 |
Current CPC
Class: |
A61M 39/06 20130101;
A61B 2217/005 20130101; A61M 25/0017 20130101; A61B 2017/22069
20130101; A61B 17/22 20130101; A61B 2017/3488 20130101 |
Class at
Publication: |
606/108 |
International
Class: |
A61F 011/00 |
Claims
1. A device for use during vascular percutaneous interventions,
comprising: a tubular portion, having a proximal end and a distal
end, and a lumen extending from the proximal end to the distal end;
and a retractable mechanism near the distal end of the tubular
portion, the mechanism providing an increased cross section of the
tubular portion when deployed and no increase or substantially no
increase in cross section of the tubular portion when retracted;
whereby the tubular portion is introduced into a vessel using
either an antegrade or a retrograde approach and whereby the
tubular portion can be repositioned within the vessel from an
antegrade to a retrograde approach and from a retrograde to an
antegrade approach without losing vascular access.
2. The device of claim 1, wherein the device is a vascular
sheath.
3. The device of claim 1, wherein the device is a guide
catheter.
4. The device of claim 1, further comprising a hemostatic valve
near the proximal end of the tubular portion.
5. The device of claim 4, wherein the hemostatic valve is
removable.
6. The device of claim 1, further comprising a silicone pinch valve
near the proximal end of the tubular portion.
7. The device of claim 4, further comprising a silicone pinch valve
positioned between the hemostatic valve and the distal end of the
tubular portion.
8. The device of claim 1, wherein the distal end of the tubular
portion is beveled or sharpened to assist in puncturing the
vessel.
9. The device of claim 1, further comprising a side-arm extending
from near the proximal end of the sheath.
10. The device of claim 1, wherein the tubular portion has an outer
diameter no greater than 45 mm.
11. The device of claim 10, wherein the tubular portion has an
outer diameter ranging from about 1 mm to about 70 mm.
12. The device of claim 11, wherein the tubular portion has an
outer diameter ranging from about 1 mm to about 8 mm.
13. The device of claim 1, wherein the tubular portion has a length
ranging from about 5 cm to about 135 cm.
14. The device of claim 1, wherein the lumen has a diameter of at
least about 1 mm.
15. The device of claim 14, wherein the lumen has a diameter
ranging from about 70 mm to about 1 mm.
16. The device of claim 15, wherein the lumen has a diameter
ranging from about 1 mm to about 8 mm.
17. The device of claim 1, wherein the retractable mechanism
comprises at least one inflatable balloon.
18. The device of claim 17, further comprising at least one balloon
inflation port near the proximal end of the tubular portion for
inflation of the at least one balloon.
19. The device of claim 18, further comprising at least one
inflation channel connecting the at least one balloon to the at
least one balloon inflation port.
20. The device of claim 19, wherein the at least one inflation
channel is located in the walls of the tubular portion.
21. The device of claim 20, wherein the walls of the tubular
portion are hollow and the at least one inflation channel comprises
the hollow of the walls of the tubular portion.
22. The device of claim 19, further comprising at least one
aperture in the walls of the tubular portion, wherein the at least
one aperture connects the at least one inflation channel to the at
least one balloon.
23. The device of claim 17, wherein the mechanism comprises a
single inflatable balloon and wherein the balloon, when inflated,
is circular or oval in shape.
24. The device of claim 23, wherein the balloon, when inflated, has
a cross-sectional diameter of no greater than 70 mm.
25. The device of claim 24, wherein the balloon, when inflated, has
a cross-sectional diameter ranging from about 2 mm to about 70
mm.
26. The device of claim 25, wherein the balloon, when inflated, has
a cross-sectional diameter ranging from about 3 mm to about 20
mm.
27. The device of claim 23, wherein the balloon, when inflated, has
a length of no greater than three-quarters the length of the
tubular portion.
28. The device of claim 23, wherein the balloon, when inflated, has
a length ranging from about 1 mm to about 150 mm.
29. The device of claim 17, wherein the mechanism comprises a
plurality inflatable balloons and wherein the balloons, when
inflated, form a circular or oval shape.
30. The device of claim 17, wherein the mechanism comprises one or
more inflatable balloons that, when inflated, form a funnel
shape.
31. (canceled)
32. The device of claim 30, wherein the largest width of the funnel
shaped balloon, when inflated, is no greater than 70 mm.
33. The device of claim 30, wherein the largest width of the funnel
shaped balloon, when inflated, ranges from about 2 mm to about 60
mm.
34. The device of claim 30, wherein the largest width of the funnel
shaped balloon, when inflated, ranges from about 2 mm to about 20
mm.
35. The device of claim 17, wherein the one or more balloons, when
inflated, are flush with the distal end of the tubular portion.
36. The device of claim 17, wherein the one or more balloons, when
inflated, protrude in front of the distal end of the tubular
portion forming a funnel.
37. The device of claim 17 wherein the one or more balloons is
inflatable to various sizes.
38. The device of claim 1, wherein the retractable mechanism
comprises at least one retractable extension.
39. The device of claim 38, wherein the at retractable mechanism
comprises two or more arm-like extensions.
40. The device of claim 38, wherein the retractable mechanism
comprises one or more extensions forming a funnel-like shape.
41. The device of claim 40, further comprising biodegradable
material connecting the extensions together to form the funnel-like
shape.
42. The device of claim 36, wherein the retractable mechanism
comprises one or more extensions forming a circular shape.
43. The device of claim 42, further comprising biodegradable
material connecting the extensions together to form the circular
shape.
44. The device of claim 38, wherein the at least one retractable
extension is housed within the tubular portion when retracted.
45. The device of claim 38, wherein the at least one retractable
extension is folded back against the side surfaces of the tubular
portion when retracted.
46. The device of claim 38, wherein the at least one retractable
extension is deployable and retractable to various sizes.
47. A medical device kit, comprising one or more of the devices of
claim 1.
48. The kit of claim 47, wherein the one or more devices are
packaged in sterile condition.
49. A method for performing a vascular percutaneous intervention
comprising utilizing the device of claim 1.
50. A method for performing a vascular percutaneous intervention
comprising the steps of: (a) providing a device comprising: a
tubular portion, having a proximal end and a distal end, and a
lumen extending from the proximal end to the distal end; a
retractable mechanism near the distal end of the tubular portion,
the mechanism providing an increased cross section of the tubular
portion when deployed and substantially no increase in cross
section of the tubular portion when retracted; (b) inserting the
tubular portion of the device into a blood vessel distal end first
with the retractable mechanism retracted; (c) deploying the
retractable mechanism to a size larger than the opening through
which the tubular portion entered the blood vessel; (d) performing
the vascular percutaneous intervention; (e) retracting the
retractable mechanism; and (f) removing the device from the blood
vessel.
51. The method of claim 50, wherein the device is inserted using a
retrograde approach, wherein the retractable mechanism is deployed
to a size larger than the opening through which the tubular portion
entered the blood vessel, and wherein the method further comprises
the step of, after (d), repositioning the device to an antegrade
approach, wherein the deployed retractable mechanism prevents the
tubular portion from exiting the blood vessel.
52. The method of claim 50, wherein the retractable mechanism
comprises at least one inflatable balloon.
53. The method of claim 50, wherein the retractable mechanism
comprises at least one retractable extension.
54. The method of claim 50, wherein the device is in the form of a
guide catheter.
55. A method of repositioning a device within a blood vessel
between a retrograde approach and an antegrade approach and
vice-versa, comprising utilizing the device claim 1.
56. A method of repositioning a device within a blood vessel
between a retrograde approach and an antegrade approach and
vice-versa, comprising: (a) providing a device comprising: a
tubular portion, having a proximal end and a distal end, and a
lumen extending from the proximal end to the distal end; a
retractable mechanism near the distal end of the tubular portion,
the mechanism providing an increased cross section of the tubular
portion when deployed and substantially no increase in cross
section of the tubular portion when retracted; (b) inserting the
tubular portion of the device into a blood vessel in one direction
distal end first with the mechanism retracted; (c) deploying the
mechanism to a size larger than the opening through which the
tubular portion entered the blood vessel; (d) pulling the device
back out of the blood vessel, while maintaining vascular access;
(e) pushing the device back into the blood vessel in the opposite
direction whereby the deployed mechanism prevents the device from
losing vascular assess.
57. A method for aspirating blood clots, emboli and other materials
from a blood vessel comprising the steps of: (a) providing a device
comprising: a tubular portion, having a proximal end and a distal
end, and a lumen extending from the proximal end to the distal end;
a retractable mechanism near the distal end of the tubular portion,
the mechanism providing an increased cross section of the tubular
portion when deployed and substantially no increase in cross
section of the tubular portion when retracted; (b) inserting the
tubular portion of the device into the blood vessel distal end
first facing towards the material to be aspirated with the
retractable mechanism retracted; (c) deploying the retractable
mechanism to a size that occludes the blood vessel; (d) removing
blood clots, emboli and other materials from the blood vessel; (e)
retracting the retractable mechanism; and (f) removing the device
from the blood vessel.
58. The method of claim 57, wherein the step of (d) removing blood
clots, emboli and other materials from the blood vessel comprises
aspirating the blood clots, emboli and other materials from the
blood vessel through the tubular portion
59. The method of claim 57, wherein the step of (d) removing blood
clots, emboli and other materials from the blood vessel comprises
pulling the blood clots, emboli and other materials from the blood
vessel through the tubular porting using another balloon
catheter.
60. The method of claim 57, further comprising the steps of, after
(d) removing the blood clot, emboli and other materials from the
blood vessel; partially retracting the retractable mechanism to a
size smaller than the blood vessel but larger than the opening
through which the tubular portion entered the blood vessel; pulling
the device back out of the blood vessel, while maintaining vascular
access, whereby the deployed mechanism prevents the device from
losing vascular assess; pushing the device back into the blood
vessel in the opposite direction; deploying the retractable
mechanism to a size that occludes the blood vessel; and aspirating
blood clots, emboli and other materials from the opposite direction
of the blood vessel.
61. The method of claim 49, wherein the device is a guide
catheter.
62. The method of claim 49, wherein the device is a vascular
sheath.
63. A method for performing a vascular percutaneous intervention
comprising the steps of: (a) providing a first device comprising: a
tubular portion, having a proximal end and a distal end, and a
lumen extending from the proximal end to the distal end; a
retractable mechanism near the distal end of the tubular portion,
the mechanism providing an increased cross section of the tubular
portion when deployed and substantially no increase in cross
section of the tubular portion when retracted; (b) inserting the
tubular portion of the first device into a donor blood vessel
distal end first with the retractable mechanism retracted; (c)
deploying the retractable mechanism to a size larger than the
opening through which the tubular portion entered the blood vessel;
(d) connecting the first device to a recipient blood vessel; and
(e) transferring materials from the donor blood vessel, through the
tubular portion of the first device, and into the recipient blood
vessel.
64. The method of claim 63 wherein the step of (d) connecting the
first device to a recipient blood vessel comprises the step of
connecting the first device to a tube and inserting the tube into
the recipient blood vessel.
65. The method of claims 63 wherein the first device further
comprises a side arm and the step of (d) connecting the first
device to a recipient blood vessel comprises the step of inserting
the side arm the recipient vessel.
66. The method of claim 63 further comprising the step of providing
a second device comprising a tubular portion, having a proximal end
and a distal end, and a lumen extending from the proximal end to
the distal end and wherein the step of (d) connecting the first
device to a recipient blood vessel comprises the step of inserting
the second device into recipient vessel and connecting the first
device to the second device.
67. The method of claim 63, further comprising the step of
interposing a pump between the first device and the recipient blood
vessel, wherein the pump assists in aspirating materials from the
donor blood vessel and into the recipient blood vessel, or
visa-versa.
68. The method of claim any one of claim 64 wherein the tube
further includes a retractable mechanism, the mechanism providing
an increased cross section of the tube when deployed and
substantially no increase in cross section of the tube
retracted.
69. The method of claim 63, wherein the step of (c) deploying the
retractable mechanism to a size larger than the opening through
which the tubular portion entered the blood vessel comprises
deploying the mechanism to a size that occludes the blood vessel
and stops the blood flow through the blood vessel.
70. The method of claim 69, further comprising the steps of: (f)
optionally stopping the transfer of materials from the donor blood
vessel into the recipient blood vessel; (g) optionally aspirating
emboli, debris and other materials out of the recipient blood
vessel through the tubular portion; (h) at least partially
retracting the retractable mechanism to re-establish blood flow
through the donor blood vessel; (i) deploying the retractable
mechanism to a size larger than the opening through which the
tubular portion entered the blood vessel and optionally to a size
that stops blood flow through the donor blood vessel; and (j)
reestablishing the transfer of materials from the donor blood
vessel into the recipient blood vessel if the transfer has been
stopped.
71. The method of claim 66, wherein the first and/or second device
is a guide catheter.
Description
[0001] The present invention generally relates to methods and
devices for performing percutaneous and surgical interventions.
More particularly, the present invention provides improved vascular
sheaths and guide catheters and methods of use.
BACKGROUND OF THE INVENTION
[0002] Vascular sheaths and guide catheters are used routinely in
interventional radiology and interventional cardiology. The sheath
serves as a conduit from the skin surface to the artery to allow
passages of catheters, guide wires, stents, angioplasty balloons
and similar instruments through the subcutaneous track without
damaging the surrounding tissues or the blood vessel itself. The
sheath is generally composed of four main components. The first is
the tubular portion, which is the conduit from the skin surface
into the blood vessel. The second portion is a hemostatic valve on
the skin surface portion of the sheath. The third component is a
sidearm tubing with a stopcock that allows the sheath to be flushed
or aspirated with fluid. The fourth component is a tapered dilator
that passes through the tubular portion of the sheath to allow a
non-traumatic introduction of the sheath into the blood vessel.
Once the sheath is introduced into the blood vessel, the dilator is
then removed to allow passages of catheters. These sheaths are used
in over 99 percent of all vascular cases. The vascular sheaths are
generally used by first puncturing the blood vessel with a needle,
followed by insertion of a guide wire. A dilator, having mounted in
the vascular sheath, is then advanced into the blood vessel over
the guide wire. The dilator is removed, leaving the distal end of
the vascular sheath inside the blood vessel.
[0003] While these current vascular sheaths and methods are
generally suitable, they have many drawbacks.
[0004] The designs of current vascular sheaths do not adequately
maintain the sheaths steadily in the blood vessel. For example the
sheaths can be easily pulled out of the blood vessel during
manipulations of catheters and other devices within the lumen of
the sheath.
[0005] Further, when using vascular sheaths to perform surgery on
carotid artery stenosis, emboli may form during the course of the
procedure. These emboli can flow into the cerebral vasculature,
leading to ischemic stroke. Current sheaths do not adequately
prevent the flow of emboli into the cerebral vasculature.
[0006] Still further, during a number of vascular procedures, it
would be advantageous to reposition the sheath from a retrograde
position (against the blood flow) to an antegrade position (with
the blood flow) or visa-versa. For example, when placing a stent in
a vessel, performing an angioplasty or performing a thrombectomy, a
vascular sheath is inserted to the treatment location using a
retrograde common femoral arterial approach. However, during such
procedures, it is often discovered that there are a plurality of
treatment locations. For example, in performing an angioplasty
procedure on an obstructed vessel, it is not uncommon to find that
the vessel is obstructed at more than one location. For example,
one location may be located upstream from the insertion point of
the vascular sheath and another location may be located downstream
from the insertion point of the vascular sheath. Thus, it would be
very desirable to be able to position the vascular sheath in a
retrograde position to treat the first location, followed by
repositioning of the vascular sheath in an antegrade position to
treat the second location. This is extremely difficult to do with
the current sheath technology. These sheaths pull out of the vessel
when the operator tries to redirect the sheath, and the operator
loses vascular access. Thus, with current sheath designs, the first
location is first treated by making an incision to provide
retrograde access to the first obstructed location. After the first
location is treated, the sheath is removed and the puncture in the
vessel must be allowed to heal prior to treatment of the second
obstructed location. It can take as long as a week for the puncture
in the vessel to heal. The patient must then return for a second
procedure to treat the second obstructed location, which requires a
second incision.
[0007] Additionally, current methods for Fogarty balloon
thrombectomy require a surgical incision of the blood vessel and
clamping of the blood vessel distal to the incision (for an iliac
artery thrombectomy). The balloon is passed to the superior most
aspect of the clot, inflated and pulled inferiorly, dragging the
clot to the arteriotomy site and out of the blood vessel. If the
same aforementioned procedure were performed percutaneous with
current sheath technology, the size mis-match between the blood
vessel and the sheath would cause the clot to flow past the sheath
and into the distal blood vessels.
[0008] Thus, any improvements in vascular sheaths would be
desirable.
SUMMARY OF THE INVENTION
[0009] The present invention provides improved devices for
performing percutaneous and surgical interventions, particularly
vascular sheaths and guide catheters, and methods of use thereof.
More particularly, the present invention provides a device that may
be manipulated within an anatomical structure while eliminating the
possibility of the device losing access to the anatomical structure
during such manipulation.
[0010] For example, in one embodiment, the device comprises a
vascular sheath or a guide catheter that may be inserted and
repositioned within a blood vessel while eliminating the
possibility of losing vascular access during such manipulation. In
one embodiment, the vascular sheath or guide catheter may be
repositioned from a retrograde to an antegrade position in a blood
vessel, and vice versa, while eliminating the possibility of losing
vascular access during such manipulation.
[0011] The devices of the present invention can be used during all
types of percutaneous interventions and surgical interventions
including, for example, vascular percutaneous interventions such as
thrombectomies, carotid stenting, hemodialysis AV fistula
declotting, superficial femoral artery interventions, pelvic
vasculature stenting, and biliary interventions and kidney stone
extraction.
[0012] In an exemplary embodiment, the device includes a tubular
portion having a proximal end and a distal end. During use, at
least a portion of the device is inserted into an anatomical
structure distal end first. Located near the distal end of the
tubular portion is a mechanism that prevents the device from losing
access to the anatomical structure during manipulation of the
device. At least one lumen further extends along the length of the
tubular portion from the proximal end to the distal end. The lumen
is designed so that materials can be removed from and added to the
anatomical structure through the lumen. For example, emboli, blood
clots and other materials can be evacuated from a blood vessel
using an aspiration technique or by pulling clot or other material
out through the sheath by means of a Fogarty balloon, and agents,
such as medicaments, anticoagulants and contrast media may be
injected into the blood vessel. In embodiments wherein the device
is a vascular sheath, the lumen is sized so that various
instruments may be inserted through the sheath to the treatment
site. In embodiments wherein the device is a guide catheter, the
lumen is also sized so that various instruments may be inserted
through the sheath to the treatment site.
[0013] In some embodiments, for example, wherein the device is a
vascular sheath, a hemostatic valve is located at the proximal end
of the tubular portion. In some embodiments, the hemostatic valve
is removable. A side arm in fluid communication with the lumen can
further be located near the proximal end of the tubular portion to
allow emboli, blood clots and other materials to be evacuated from
the blood vessel through the tubular portion and to allow agents,
such as medicaments, anticoagulants and contrast media to be
injected into the blood vessel through the tubular portion. In some
embodiments, a tapered dilator further passes from the distal end
to the proximal end through the tubular portion. In devices used
for balloon thrombectomy, a silicon pinch valve would further be
included near the proximal end of the tubular portion.
[0014] The mechanism that prevents the device from losing access to
the anatomical structure during manipulation of the device can
vary.
[0015] In one embodiment, the mechanism is an inflatable balloon
located at or near the distal end of the tubular portion. The
inflatable balloon can be designed to inflate to a variety of
shapes and sizes. For example, in one embodiment, the inflatable
balloon inflates to an overall round or oval shape and is situated
coaxial with the tubular portion. In another embodiment, the
inflatable balloon inflates to a funnel-like shape coaxial with the
tubular portion, wherein the smaller cross-section of the
funnel-like shaped balloon is towards the proximal end of the
tubular portion and the larger cross-section of the funnel-like
shaped balloon is towards the distal end of the tubular portion. In
yet another embodiment, a plurality of inflatable balloons are
positioned to inflate about the outer circumference of the tubular
portion.
[0016] In embodiments wherein the mechanism is in the form of one
or more inflatable balloons, one or more inflation ports are
further located near the proximal end of the tubular portion for
inflation of the one or more balloons. The one or more inflation
ports are in communication with the one or more balloons via, for
example, one or more inflation channels extending from the
inflation port(s) to the balloon(s) through the wall of the tubular
portion.
[0017] In another embodiment, the mechanism comprises one or more
retractable extensions near the distal end of the tubular portion.
For example, two or more retractable arm-like extensions may be
located near the distal end of the tubular portion. These
retractable extensions are remotely deployed and retracted by a
user of the device with a deployment/retraction mechanism located
near the proximal end of the device. During insertion of the device
into the anatomical structure, these extensions would be retracted
(e.g. housed within the tubular portion or folded back against the
side surfaces of the tubular portion) such that the cross section
of the tubular portion is not significantly increased during
insertion of the device. As used herein, no "significant" increase
in the cross-section of the tubular portion means that the
mechanism does not overdilate the arteriotomy (the incision in the
anatomical structure through which the device is inserted). Upon
insertion of the device into the anatomical structure to the
desired site, the extensions could then be deployed.
[0018] The device of the present invention provides a number of
advantages over prior devices. For example, by forming the device
with a mechanism, such as a balloon or one or more extensions, at
the distal end of the tubular portion, the mechanism prevents the
device from pulling out of a anatomical structure during complex
interventions, for example, when switching from a retrograde to an
antegrade approach within a blood vessel (i.e. from a position
pointing towards the head to a position pointing towards the feet)
and vice versa.
[0019] Use of balloon or extension mechanisms further enables the
use of a single device when declotting AV hemodialysis
fistulas.
[0020] The device of the present invention also serves as a
protection device during any number of procedures. For example,
during use of the device in a blood vessel, the mechanism on the
distal end of the device can be deployed to provide occlusion of
antegrade blood flow during interventions and protect against
embolization. For example, during the placement of an internal
carotid artery stent, using current vascular sheaths, the antegrade
blood flow can cause embolic material to propagate into the
intracerebral circulation, thereby causing a stroke. By inflating
the one or more balloons in the carotid artery in accordance with
the present invention, or, for example, by deploying one or more
extensions that occlude the blood vessel, antegrade flow can be
prevented. Retrograde flow would be provided from the contralateral
carotid artery. Similarly, during percutaneous coronary
interventions in either native vessels or bypass grafts, inflation
of the balloon serves as a protection device, preventing distal
emboli from propagating forward. In addition, during a suction
thrombectomy, if a clot has lodged in a blood vessel, antegrade
flow will apply a pressure head to keep the clot lodged in its
position. By occluding the lumen with the balloon or extension
mechanisms on the sheath, back-bleeding causes the clot to
propagate towards the vascular sheath, and the clot can be
aspirated through the vascular sheath or pulled through the
vascular sheath using a Fogarty balloon. Still further, the balloon
or extension mechanisms can also prevent blood flow from passing
through the blood vessel, which is advantageous during thrombectomy
to prevent embolic material from propagating downstream.
[0021] During each of these procedures, after occlusion of the
vessel, the embolic material, clot or other materials in the blood
vessel could then be aspirated through the vascular sheath or
pulled through the vascular sheath using a Fogarty balloon.
[0022] Alternatively, during each of these procedures, after
occlusion of the vessel, a continuous flow reversal could be
created. For example, a continuous flow reversal could be created
by forming a circuit from the blood vessel, through the distal end
of the tubular portion, through the tubular portion, and into a
target vessel. This would require vascular access to the target
vessel. Such continuous flow reversal would be useful, for example,
in performing a procedure wherein materials, for example emboli,
blood clots, or blood, are transferred from a donor blood vessel
into a recipient blood vessel. For example, the device could be
used to occlude a donor vessel and prevent emboli, blood clots and
other materials from propagating into the coronary vasculature,
followed by transfer of the emboli, blood clots and other materials
to a recipient blood vessel wherein the danger of having the
materials propagate into the coronary vasculature is eliminated. In
this embodiment, the vascular sheath would be inserted in the donor
blood vessel and, a continuous flow reversal could be created by
forming a circuit between the "donor" vessel housing the embolic
material to a "recipient" vessel elsewhere in the body. The
circuit, thus, would extend from the distal portion of the tubular
portion, through the tubular portion, and into a recipient vessel.
Vascular access to the recipient vessel could be provided, for
example, by a tube, a guide catheter or a vascular sheath. Thus,
for example, a vascular sheath in accordance with the present
invention could be inserted in the donor vessel, and the side-arm
of the vascular sheath could be connected to the recipient vessel,
for example, via tubing or via a second vascular sheath or a guide
catheter. In some embodiments, a pumping mechanism is interposed in
the circuit between the donor and recipient vessels to assist in
reversing the blood flow.
[0023] Preferably, during the continuous flow reversal procedure,
the balloon or extensions could be retracted or partially retracted
at any point in the procedure to allow reperfusion of blood flow
through the blood vessel.
[0024] Continuous flow reversal could also be useful in a procedure
wherein blood is transferred from one patient to another, or from
one site in a patient to another site in the same patient either
during cardiac bypass surgery or during carotid artery surgery. In
such procedures, the device of the present invention, for example,
in the form of a vascular sheath or guide catheter, would be
inserted into a donor vessel. The device of the present invention
would then be connected to a recipient vessel via, for example, a
tube, conventional guide catheter, conventional vascular sheath, or
second device in accordance with the present invention. The device
of the present invention would be particularly helpful on
preventing the loss of vascular access during the blood transfer
procedure.
[0025] Methods in accordance with the present invention comprise
making a small incision in the upper thigh or other insertion site
to provide access to the target location. The device of the present
invention is then inserted into the anatomical structure. For
example, when the anatomical structure is a blood vessel, a needle
is introduced through the incision into the blood vessel. A guide
wire is then inserted through the needle into the blood vessel
using a retrograde approach. The device is then inserted over the
guide wire and is passed into the blood vessel to a desired depth
using a retrograde approach. In embodiments wherein the device is
guide catheter, a vascular sheath is typically first inserted and
the guide catheter is inserted through the vascular sheath. In
embodiments wherein the device is a vascular sheath, the vascular
sheath with dilator in the central lumen is inserted over the guide
wire and is passed into the blood vessel to a desired depth using a
retrograde approach. The guide wire and dilator are removed and the
vascular sheath remains positioned in the blood vessel. Once the
device is positioned within the anatomical structure, the mechanism
is then activated, e.g. by inflating the balloon(s) at the distal
end of the tubular portion through the inflation port or deployment
of the extension(s). If a procedure requiring the blood vessel to
be occluded is being performed, the one or more balloons are
inflated until the vessel is completely occluded. Further, the one
or more extensions can be designed such that the vessel can be
completely occluded by the extensions, by, for example, forming the
one or more extensions to extend outwards from the tubular portion
in a circle arrangement or a funnel-like arrangement.
[0026] To aspirate emboli, blood clots and other materials from a
blood vessel, an aspiration device is connected to the device, for
example, an aspiration device may be connected to the vascular
sheath through the side-arm, and the material(s) aspirated from the
blood vessel, through the tubular portion and out of the device. If
agents are to be injected into the anatomical structure, e.g. a
blood vessel, a syringe or similar injection mechanism is connected
to the device, for example, to the side-arm of a vascular sheath,
and the agent is injected through the device into the anatomical
structure. In embodiments wherein the device is a vascular sheath,
various devices such as, for example, catheters, guide wires,
stents, angioplasty balloons and similar instruments can also be
inserted through the tubular portion for various procedures.
[0027] If the surgeon wishes to reposition the device to an
antegrade position so that the surgeon can, for example, perform a
thrombectomy on the other side of the puncture site into the blood
vessel, the surgeon inflates or deflates the balloon(s) such that
the cross-section of the tubular portion plus balloon(s) is smaller
than the diameter of the blood vessel and larger than the
arteriotomy (the incision in the blood vessel through which the
device was inserted) and simply pulls the device back towards the
insertion point. The device is then pulled outwards through the
incision, but not completely out of the incision. Then, the device
is manipulated and pushed back into the blood vessel in an
antegrade position. The device can, likewise, be repositioned from
an antegrade to a retrograde position. In the embodiment where the
mechanism comprises one or more extensions, the surgeon, likewise,
deploys the extension(s) such that the cross-section of the tubular
portion of the device plus extension(s) is smaller than the
diameter of the blood vessel and larger than the arteriotomy (the
incision in the blood vessel through which the vascular sheath was
inserted) and simply pulls the device back towards the insertion
point. The device is then pulled outwards through the incision, but
not completely out of the incision. Then, the device is manipulated
and pushed back into the blood vessel in an antegrade position,
possibly over a guide wire with the dilator in the central lumen of
the device. The sheath can, likewise, be repositioned from an
antegrade to a retrograde position. In the above procedures, the
balloon(s) or extension(s) prevent the device from being completely
withdrawn from the blood vessel, so that the operator can
manipulate the device without the concern of losing vascular
access.
[0028] Methods of the invention also include use of the device to
provide occlusion of antegrade blood flow during interventions and
protect against embolization.
[0029] For example, in one embodiment, the device is inserted into
the blood vessel and the mechanism (i.e. balloon(s) or
extension(s)) is deployed until the vessel is occluded and
antegrade blood flow is prevented. An internal carotid artery,
coronary artery, or renal artery stent can then be placed within
the vessel. By preventing antegrade blood flow, the mechanism will
prevent embolic material from propagating into the intracerebral
circulation.
[0030] In another embodiment, during percutaneous coronary
interventions in either native vessels or bypass grafts, deployment
of the mechanism (i.e. balloon(s) or extension(s)) to occlude the
vessel functions to prevent distal emboli from propagating
forward.
[0031] In another embodiment, during a suction thrombectomy, the
mechanism (i.e. balloon(s) or extension(s)) is deployed to occlude
the vessel, thereby causing back-bleeding. The back-bleeding will
then cause any clots lodged in the blood vessel to propagate
towards the device. The clot can then be removed by aspirating it
through the device or pulling it through the device using a Fogarty
balloon.
[0032] In yet another embodiment, the mechanism (i.e. balloon(s) or
extension(s)) can be deployed during a thrombectomy to prevent
blood flow from passing through the blood vessel and around the
device, which, in turn, prevents embolic material from propagating
downstream.
[0033] In yet another embodiment, the device of the present
invention could be used to create continuous flow reversal. For
example, the device of the present invention is inserted in a
target blood vessel and is also connected to a recipient blood
vessel, such that materials could be transferred from the target
blood vessel into the recipient blood vessel. In this embodiment,
vascular access to the recipient vessel would be required. For
example, the device of the present invention could be connected to
tubing, to a conventional guide catheter, to a conventional
vascular sheath, or to a second device in accordance with the
present invention, which, in turn is inserted in the recipient
blood vessel. The continuous flow reversal could then be used to
transfer materials, such as clots and embolic materials, from a
target vessel where there is a risk that the materials will
propagate to the coronary or cerebral vasculature to a recipient
vessel wherein this risk is eliminated. The continuous flow
reversal could also be used to simply transfer blood from a target
vessel to a recipient vessel, for example, in performing a blood
transfer from one patient to another.
[0034] During the continuous flow reversal, the mechanism may be
deployed to occlude the vessel, for example, if there is a risk
that clots and embolic material may propagate to the cerebral
vasculature. Alternatively, the mechanism may be deployed not to
occlude the vessel, but, rather, to maintain vascular access if,
for example, there is minimal risk that clots and embolic material
may propagate to the cerebral vasculature. If the mechanism is
deployed to occlude the vessel, the method of continuous flow
reversal may further include reperfusion of blood. For example, if
reestablishment of the flow of blood to the heart is desired for a
period of time during the procedure, the mechanism may be retracted
during the procedure so that the vessel is no longer occluded and
blood flow is reestablished. After perfusion of the blood is
reestablished for a desired period of time, the mechanism may again
be deployed to occlude the vessel. In some embodiments, during
reperfusion, the circuit between the target blood vessel and
recipient blood vessel can be blocked so that reperfusion is
carried out while transfer of materials from the donor to recipient
blood vessel is stopped. Then, after perfusion of the blood is
reestablished for a desired period of time, the circuit may then be
opened to continue transfer of materials from the donor to
recipient blood vessel. During this time, the vessel may remain not
occluded or may again be occluded by redeployment of the
mechanism.
[0035] Other aspects and embodiments of the invention are discussed
infra.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] FIG. 1 shows a side view of a device for performing
percutaneous and surgical interventions with a deflated balloon
mechanism in accordance with one embodiment of the present
invention.
[0037] FIG. 2 shows a side view of the device shown in FIG. 1,
having an inflated circular shaped balloon in accordance with one
embodiment of the present invention.
[0038] FIG. 3 shows a side view of the device shown in FIG. 1,
having an inflated cone or funnel shaped balloon in accordance with
another embodiment of the present invention.
[0039] FIG. 4 shows a side view of a device for performing
percutaneous and surgical interventions having a catheter hub at
its proximal end and a deflated balloon mechanism in accordance
with one embodiment of the present invention.
[0040] FIG. 5 shows a side view of the device in FIG. 4, having an
inflated cone or funnel shaped balloon in accordance with one
embodiment of the present invention.
[0041] FIG. 6 shows a side view of a device for performing
percutaneous and surgical interventions having a catheter hub at
its proximal end and an inflated balloon mechanism flush with the
distal end of the tubular portion in accordance with one embodiment
of the present invention.
[0042] FIG. 7 shows a front view of a device for performing
percutaneous and surgical interventions having an inflated balloon
and a single balloon inflation aperture in accordance with one
embodiment of the present invention.
[0043] FIG. 8 shows a front view of a device for performing
percutaneous and surgical interventions having an inflated balloon
and an open circular strip for balloon inflation in accordance with
another embodiment of the present invention.
[0044] FIG. 9 shows a side view of the device of FIG. 7 showing a
single balloon inflation channel and aperture.
[0045] FIG. 10 shows a side view of a device for performing
percutaneous and surgical interventions having an inflated balloon,
a single balloon inflation channel and a plurality of balloon
inflation apertures.
[0046] FIG. 11 shows a shows a side view of a device for performing
percutaneous and surgical interventions having an inflated balloon,
a plurality of balloon inflation channels and a plurality of
balloon inflation apertures.
[0047] FIG. 12 shows a shows a side view of a device for performing
percutaneous and surgical interventions having a plurality of
inflatable balloons near the distal end of the tubular portion.
[0048] FIG. 13 shows a shows a side view of a device for performing
percutaneous and surgical interventions having a plurality of
inflatable balloons near the distal end of the tubular portion and
a single balloon inflation channel that splits to provide inflation
to each of the balloons.
[0049] FIG. 14 shows a shows a side view of a device for performing
percutaneous and surgical interventions having a plurality of
inflatable balloons near the distal end of the tubular portion and
a single balloon inflation channel that extends to a ring that
provides inflation to each of the balloons.
[0050] FIG. 15 shows a side view of a device for performing
percutaneous and surgical interventions having a plurality of
deployable extensions extending from the distal end of the device
in accordance with one embodiment of the present invention.
[0051] FIG. 16 shows a side view of the distal end of a device for
performing percutaneous and surgical interventions having a
plurality of extensions extending in a funnel-like shape from the
distal end of the device in accordance with one embodiment of the
present invention.
[0052] FIG. 17 shows a side view of the distal end of a device for
performing percutaneous and surgical interventions having a
plurality of extensions, with a material connecting the extensions
together, extending in a funnel-like shape from the distal end of
the device in accordance with another embodiment of the present
invention.
[0053] FIG. 18 shows a side view of the distal end of a device for
performing percutaneous and surgical interventions having a
plurality of extensions extending in a circular-like shape from the
distal end of the device in accordance with one embodiment of the
present invention.
[0054] FIG. 19a-b show a shows a side view of a device for
performing percutaneous and surgical interventions having a tapered
distal end into which one or more mechanisms are retracted (19a)
and deployed (19b) in accordance with one embodiment of the present
invention.
[0055] FIG. 20a-b show a side view of a device for performing
percutaneous and surgical interventions having a tapered section
along its length end into which one or more mechanisms are
retracted (20a) and deployed (20b) in accordance with one
embodiment of the present invention.
[0056] FIG. 21 shows a side view of the device shown in FIG. 1,
having an inflated U-like shaped balloon in accordance with one
embodiment of the present invention.
[0057] FIG. 22 shows an exploded view of a silicone pinch valve
assembly.
DETAILED DESCRIPTION OF THE INVENTION
[0058] The present invention provides methods and devices for
performing percutaneous and surgical interventions. The device
includes a mechanism near its distal end that prevents the device
from pulling out of an anatomical structure, for example, a blood
vessel during complex interventions.
[0059] In one preferred embodiment, the device is designed for
performing a variety of vascular percutaneous interventions. For
example, in one preferred embodiment, the device is in the form of
a vascular sheath or a guide catheter and the mechanism near its
distal end prevents the vascular sheath of guide catheter from
pulling out of a blood vessel, for example, when switching from a
retrograde to an antegrade approach and vice versa. The mechanism
also allows the operator to use a single sheath when declotting AV
hemodialysis fistulas. Further, the mechanism can serve as a lumen
occluder while allowing large interventional devices to be passed
through the sheath. This property, an embolic protection device, is
particularly helpful during thrombectomy and vascular
interventions.
[0060] Referring now to the various figures of the drawing, wherein
like reference characters refer to like parts, there is shown
various views of a device for performing percutaneous and surgical
interventions 1, in accordance with the invention. The device is
shown in the Figures and will be described below with particular
reference to vascular sheaths. However, it is to be understood that
the device is not limited to vascular sheaths and may include any
type of devices for use in performing percutaneous and surgical
interventions. For example, the device may also be in the form of a
guide catheter. Devices for performing percutaneous and surgical
interventions, including vascular sheaths and guide catheters, are
well-known and, thus, although described and shown with reference
to a preferred embodiment, the general features (e.g. size, shape,
materials) of the a device for performing percutaneous and surgical
interventions 1 may be in accordance with conventional devices for
performing percutaneous and surgical interventions.
[0061] As shown in FIGS. 1-3, one embodiment of the vascular sheath
1 includes a tubular portion 2 having a proximal end 4 and a distal
end 6. A lumen 3 extends from the proximal end 4 to the distal end
6 of the tubular portion 2. A hemostatic valve 8 is located at the
proximal end 4 of the tubular portion 2 to prevent leakage of blood
out of the sheath. A side-arm 14 in fluid communication with the
lumen 3 may also be located near the proximal end 4 of the tubular
portion 2.
[0062] Guide catheters are similar in general structure to vascular
sheaths but typically do not include a hemostatic valve or a side
arm. Further, guide catheters are not typically used in with a
dilator. Generally, guide catheters are used in combination with
vascular sheaths and are inserted through the lumen of a vascular
sheath. Guide catheters are predominantly used in coronary
interventions and can have a variety of shapes. Guide catheters are
well known and, thus, the general features (e.g. size, shape,
materials) of the vascular sheath 1 in the form of a guide catheter
may be in accordance with conventional guide catheters. However, in
some embodiments of the present invention, it may be desirable to
provide a guide catheter having a hemostatic valve, side arm,
and/or dilator and any combination of these additional
elements.
[0063] As shown in the Figures, the tubular portion 2 of a device
for performing percutaneous and surgical interventions has a
generally cylindrical outer surface 18 and a longitudinal axis 20.
The dimensions of the tubular portion 2 are not particularly
limited and can vary depending on the ultimate use of the device.
For example, when the device is a vascular sheath, in general, the
tubular portion is sized such that it properly fits inside a
desired blood vessel and provides access from the point of
insertion to the area being treated. Further, when the vascular
sheath is used as a conduit from the skin surface to the blood
vessel to allow passages of catheters, guide wires, and instruments
through vascular sheath 1, the tubular portion 2 is sized to allow
these various instruments to be passed through the lumen 3.
[0064] Various instruments that are typically passed through the
lumen 3 of the tubular portion 2 of a vascular sheath have a
maximum diameter ranging from about 0.5 mm to about 10 mm and,
thus, when the device is a vascular sheath used for passing various
instruments through the tubular portion 2, the lumen 3 has a
diameter of at least about 0.5 mm and, preferably, between about
1.35 mm and about 11 mm.
[0065] The outer diameter of the tubular portion 2 is not
particularly limited and may be in accordance with tubular portions
of conventional device for performing percutaneous and surgical
interventions. Generally, the outer diameter of the tubular portion
2 of the device is limited only by the size of the anatomical
structure that it is to be inserted in. The size of the tubular
portion 2 of the device may also be limited based on the desired
size of the incision through which the device is inserted and which
must subsequently be sealed. For example, when the device is a
vascular sheath, because the vascular sheath can be used on any
blood vessels, the outer diameter can vary depending on the
targeted blood vessel. In general, the tubular portion 2 preferably
has an outer diameter that is smaller than the inner diameter of
the blood vessel. The largest blood vessel(s) of the human body is
the aorta, which has a diameter ranging from about 20 mm to about
70 mm. Thus, the largest outer diameter of the tubular portion 2 is
preferably no greater than about 70 mm, preferably, no greater than
about 10 mm, and more preferably, no greater than about 4.5 mm. The
smallest blood vessel(s) of the human body are the coronary
arteries, infrapopliteal arteries and intra-cranial arteries, which
have a diameter ranging from about 1 mm to about 5 mm. Thus, for
use on these small blood vessels, the outer diameter of the tubular
portion 2 is preferably no greater than about 5 mm, more
preferably, no greater than about 3 mm and, more preferably, no
greater than about 1 mm. In general practice, it is preferable that
the outer diameter of the tubular portion 2 is no greater than
about 80% of the inner diameter of the blood vessel, more
preferably, no greater than about 20%. However, while it is
preferred that the outer diameter of the tubular portion 2 is no
greater than the diameter of the blood vessel into which it is
inserted, this is not necessary and, in some cases, the outer
diameter of the tubular portion 2 is greater than the diameter of
the blood vessel into which it is inserted.
[0066] In some embodiments, the diameter of the tubular portion 2
narrows at or near the distal end 6 along the mechanism that
prevents the device from pulling out of the anatomical structure.
Preferably, in this embodiment, the diameter of the tubular portion
2 at the distal end 6 along the mechanism that prevents the device
from pulling out of the anatomical structure narrows such that the
total diameter of the tubular portion 2 plus the mechanism in its
non-deployed state is equal to or no greater than the greatest
diameter of the tubular portion along the remainder of its length.
This would ensure that when the device is placed into the
anatomical structure, the mechanism would not overdilate the
arteriotomy. Thus, for example, in one embodiment, wherein the
mechanism is one or more balloons 10, the tubular portion 2 along
the one or more deflated balloons 10 narrows such that the one or
more balloons 10 can be deflated and compressed about the tubular
portion 3 to form a total diameter of the tubular portion 2 plus
deflated balloon(s) 10 that is equal to or no greater than the
greatest diameter of the tubular portion 2 along the remainder of
its length. Further, when the mechanism is one or more extensions
11, the extensions 11 can be retracted within the tubular portion 2
or can extend along the sides of the tubular portion 2 along the
narrowed portion such that the total diameter of the tubular
portion 2 plus retracted extensions 11 is equal to or no greater
than the greatest diameter of the tubular portion 2 along the
remainder of its length Thus, for example, if the mechanism is
located at the distal end 6 of the tubular portion 2, the tubular
portion 2 may taper toward the distal end as shown in FIG. 19a-b.
If the mechanism is located somewhere between the proximal end 4
and the distal end 6 of the tubular portion 2, the tubular portion
2 may narrow at the location of the mechanism, for example, in an
hour-glass-like shape as shown in FIG. 20a-b.
[0067] The length of the tubular portion 2 is not particularly
limited and may be in accordance with tubular portions of
conventional devices for performing percutaneous and surgical
interventions. Generally, the lengths of the tubular portions may
vary depending on the use of the device, the insertion point of the
tubular portion and the distance to the target area in the
anatomical structure. Further, when the device is used as a conduit
through which other interventional devices may be passed, it is
often desirable to form the tubular portion 2 so that it is long
enough to fully accommodate the longest interventional device that
will be inserted. For example, in one embodiment the device is a
vascular sheath 1 designed for use in a variety of cardiac
procedures, including procedures within the coronary arteries. The
vascular sheath 1, when used during cardiac procedures, can be
inserted through a blood vessel in the upper thigh or,
alternatively, can be inserted through a blood vessel in the arm.
For example, in one preferred embodiment, the vascular sheath 1 is
inserted by anesthetizing an area the patient's upper thigh and
inserting the vascular sheath 1 through a blood vessel in the upper
thigh and towards the heart. As such, the vascular sheath 1
preferably has a length ranging from about 5 cm to about 100 cm,
more preferably, from about 5 cm to about 30 cm. The longest
interventional devices typically have a length that ranges from
about 30 cm to about 135 cm and, thus, such lengths of tubular
portions 2 will accommodate a variety of interventional devices. Of
course, the length of the vascular sheath 2 may vary depending on
the point of insertion, the distance from the point of insertion to
the target site and the types of interventional devices that will
be used in each procedure.
[0068] In some embodiments, as shown in FIG. 2, the tubular portion
2 includes indicia 24 along its length to indicate the depth of
insertion of the tubular portion 2.
[0069] Materials for fabricating the tubular portion 2 of the
devices for performing percutaneous and surgical interventions are
well-known and include, by way of example TEFLON, polyethylenes,
polyamide elastomers, polyurethanes, nylons including polyamide
homopolymers and polyamide copolymers. Because the tubular portion
2 enters the body and anatomical structures, the materials used in
fabricating the tubular portion 2 are biocompatible. Preferably,
the tubular portion 2 is somewhat flexible along its length to
allow bending and maneuvering of the tubular portion 2 as it passes
within an anatomical structure, such as a blood vessel. In
addition, the tubular portion 2 preferably is sufficiently stiff to
resist kinking, which could damage interventional devices and
stents passed through the lumen 3 of the tubular portion 2.
Preferably, at least the distal end 6 of the tubular portion has
adequate rigidity to allow puncture and entry through the wall of
an anatomical structure. The tubular portion 2 may be designed with
a rigid distal end 6 and flexibility along its length by, for
example, fabricating the distal end 6 of the tubular portion 2 of a
material more rigid than the material used to form the length of
the tubular portion 2. Such materials may be readily determined by
one of skill in the art. Alternatively, the entire tubular portion
2, including the distal end 6, may be fabricated of the same
somewhat flexible material and the walls of the tubular portion 2
may be formed thicker at the distal end 6 or, for example, the
walls of the distal end 6 may be reinforced. In some embodiments,
the distal end 6 is pointed or beveled to enhance puncturing
ability of the tubular portion 2.
[0070] A silicone pinch valve 40, shown in FIG. 22, may further be
included in some embodiments of the present invention. As shown,
the silicone pinch valve 40 is preferably located near the proximal
end 4 of the tubular portion 2, preferably at the proximal end 4 of
the tubular portion 2. In some embodiments, the silicone pinch
valve 40 replaces the hemostatic valve 8 at the proximal end 4 of
the tubular portion 2. Thus, the vascular sheath 1 may include a
removable hemostatic valve 8 that can be removed and replaced with
the silicone pinch valve 40 if desired. The silicone pinch valve 40
could be removably mountable on the tubular portion 2 using, for
example, mating threaded portions on the silicone pinch valve 40
and the tubular portion 2. The silicone pinch valve 40 may also be
designed to snap onto and off of the end of the tubular portion 2.
The silicone pinch valve 40 assists in controlling backbleeding
while the vascular sheath 1 is inserted and during manipulation of
the vascular sheath 1. The silicone pinch valve 40 preferably
includes a cap 42, preferably fabricated of a plastic, that
functions, like a side arm, allowing aspiration and injection of
materials through the tubular portion 2. In some embodiments, the
plastic cap 42 could be replaced with a side arm. The silicone
pinch valve 40 may also include a Rutner adapter 44 and a silicone
septum 46, which function as a hemostatic valve. The Rutner adapter
44 is preferably rigid and fits into the soft silicone pinch valve
40. The silicone septum 46 fits on the end of the Rutner adapter
44. In some embodiments, a central hole (not shown) is located in
the silicone septum 46 through which small catheters may be
introduced. In embodiments where a large device is introduced
through the tubular portion or clot removed from a blood vessel,
the silicone septum is preferably opened or removed to provide a
large aperature that is at least as large as the diameter of the
Rutner adapter 44 and lumen 3.
[0071] In some embodiments, the silicone pinch valve 40 is
positioned between the hemostatic valve 8 and the tubular portion
2. In this embodiment, the hemostatic valve 8 may be directly
connected to the silicone pinch valve 40 or, for example,
indirectly connected to the silicone pinch valve 40. For example,
the silicone pinch valve 40 could be located interposed with
portions of tubular portion 2 on either side and the hemostatic
valve 8 at the proximal end. The hemostatic valve 8 may or may not
be removable or could be of the configuration of the Rutner adapter
44 and silicone septum 46.
[0072] Located near the distal end 4 of the tubular portion 2 is a
mechanism that prevents the device 1 from pulling out of an
anatomical structure during complex interventions. Of course, the
location of the mechanism is not particularly limited and may also
be located elsewhere along the length of the tubular portion 2. For
example, in one embodiment, the device is a vascular sheath or a
guide catheter and the mechanism prevents the vascular sheath or
guide catheter from pulling out of a blood vessel when switching
from an antegrade to a retrograde approach and vice versa.
[0073] In one embodiment, as shown in FIGS. 1-5, the mechanism is
in the form of an inflatable balloon 10 located at the distal end 6
of the tubular portion 2. The inflated balloon 10 is preferably
coaxial with the longitudinal axis 20 of the tubular portion 2. The
balloon 10 can be fabricated of any expandable or non-expandable
materials that are biocompatible. Preferably, the balloon 10 is
fabricated of a material that expands away from the tubular portion
2 when inflated such that the distal end 6 of the tubular portion 2
becomes larger in cross section on account of the inflated balloon
10. Preferably, the balloon 10 is fabricated of a material that
compresses about the tubular portion 2 when deflated such that the
balloon 10, when deflated, does not significantly increase the
diameter of the distal end 6 of the tubular portion 2 when the
sheath is inserted and withdrawn. When used herein, "does not
significantly increase the diameter of the tubular portion" means
that, when the device is placed into the anatomical structure, the
mechanism would not overdilate the arteriotomy.
[0074] Suitable materials for use in forming the balloon 10 are
well known in the art and include, by way of example, PET,
polyurethane, polyolefin, polyvinylchloride, any materials used to
form angioplasty type balloons, and materials used in forming
balloons used in the Swan Ganz catheter or the Fogarty balloon
catheter.
[0075] As shown, the balloon 10 is preferably attached directly to
the distal end 6 of the tubular portion 2. Of course, the balloon
10 may also be located elsewhere along the length of the tubular
portion 2. Preferably, the balloon 10 is compressed about the
diameter of the tubular portion 2 for insertion and withdrawal of
the vascular sheath 1 into and out of the body.
[0076] Preferably, the balloon 10 is inflatable to different sizes
to enable use of the vascular sheath 1 in various procedures. For
example, when the vascular sheath 1 is used in a procedure
requiring repositioning the vascular sheath from a retrograde to an
antegrade position in a blood vessel, and vice versa, the balloon
10 is inflated so that it is smaller than the inner diameter of the
blood vessel and larger than the arteriotomy through which the
vascular sheath 1 entered the blood vessel. By sizing the balloon
10 larger than the arteriotomy through which the vascular sheath 1
entered the blood vessel, the tubular portion 2 is prevented from
completely exiting from the blood vessel during manipulation from a
retrograde to an antegrade position, and vice versa. The vascular
sheath 1 can also be used to aspirate blood clots, emboli and other
materials from the blood vessel. When used in this way, the balloon
10 is inflated until it obstructs the blood vessel. In such a
procedure, the vascular sheath 1 is inserted into the blood vessel
with the distal end 6 of the tubular portion 2 facing towards the
material to be aspirated. If the material, for example, a blood
clot, has lodged in the blood vessel, antegrade flow will apply a
pressure head to keep this clot lodged in its position. The balloon
10 is then inflated until it occludes the blood vessel, thereby
blocking blood flow through the blood vessel. Back-bleeding will
then cause the blood clot to propagate towards the vascular sheath
1. An aspiration device connected to the side arm 14 of vascular
sheath 1 can then be used to aspirate the blood clot out of the
blood vessel through the lumen 3. Thus, the vascular sheath 1 could
be inserted into the blood vessel in a retrograde position, the
balloon inflated to occlude the blood vessel and blood clots,
emboli and other materials could be aspirated from one side of the
blood vessel, followed by partial deflation of the balloon 10,
repositioning of the vascular sheath 1 to an antegrade position,
re-inflation of the balloon 10 to occlude the blood vessel, and
aspiration of and blood clots, emboli and other materials on the
other side of the blood vessel.
[0077] When the vascular sheath is used to aspirate materials out
of the blood vessel, it is preferable to form the vascular sheath 1
and balloon 10 in a manner that will prevent the emboli, blood
clots and other materials from being lodged between the balloon 10
and the distal end 6 of the tubular portion 2. For example, in one
embodiment, the vascular sheath 1 and balloon 10 are formed so that
the balloon 10 is flush with the distal end 6 of the tubular
portion 2, as shown in FIGS. 3 and 5. In another embodiment, the
vascular sheath 1 and balloon 10 are formed so that the balloon 10
extends beyond the distal end 6 of the tubular portion 2. In yet
another embodiment, the vascular sheath 1 and balloon 10 are formed
so that the balloon 10 extends behind the distal end 6 of the
tubular portion 2. In one embodiment, as shown in FIG. 6, the
balloon 10 is in the form of a round or oval shaped balloon that,
when inflated, expands flush with the distal end 6 of the tubular
portion 10. In another embodiment, as shown in FIGS. 3 and 5, the
balloon 10 is funnel-like or cone-like in shape, wherein the large
end of the funnel or cone is at the distal end 6 of the tubular
portion 2 and inflates perpendicular and flush with the distal end
6 of the tubular portion 2. The funnel can also protrude out in
front of distal end 6, to create a true "funnel" appearance of the
balloon and distal tip. Still further, the funnel can also extend
so that it is behind the front of distal end 6. In another
embodiment, the balloon 10 is U-like in shape, as shown in FIGS.
21a-c. The U-shaped balloon 10 can protrude out in front of the
distal end 6 of the tubular portion 2, as shown on FIG. 21a, can
extend behind the distal end 6 of the tubular portion 2, as shown
on FIG. 21b or can extend flush with the distal end 6 of the
tubular portion 2, as shown on FIG. 21c. These embodiments will
provide complete aspiration of the emboli, blood clots and other
materials from the blood vessel.
[0078] When the vascular sheath 1 is used to insert a stent or
perform angioplasty, the balloon 10 is also preferably inflated
until it obstructs the vessel. A wire (not shown) is used to cross
through the obstruction. Then the stent (not shown) is deployed or
angioplasty performed, thus opening the blood vessel. During the
manipulation of the wire and stent, it is possible to withdraw
blood, blood clots, and debris by aspiration through side arm 14.
Alternatively, the aspiration can take place after the stent has
been deployed. This would be determined by the location of the
sheath relative to the lesion (i.e. upstream vs. downstream).
[0079] The size of the balloon 10 is not particularly limited. For
example, when the device is used within a blood vessel, the
inflated cross section of the balloon 10, as measured perpendicular
to the length of the tubular portion, can range from its deflated
size to as large as, or larger than, the inner diameter of the
blood vessel. When used on other anatomical structures, the
inflated cross section of the balloon 10 may vary and is limited
only by the size of the anatomical structure and the particular
requirements of the procedure. Preferably, so that the device can
be used for various procedures requiring various inflation sizes,
the balloon 10 is inflatable to any size in between its deflated
size and its maximum inflated size by simply controlling the amount
of air or material injected into the balloon 10. The length of the
balloon, as measured parallel to the length of the tubular portion
2 is not limited and, for example, when the device is used in blood
vessels, is preferably no greater than three quarters the length of
the tubular portion 2, more preferably, between about 1 mm and
about 150 mm, more preferably, between about 3 mm and about 40
mm.
[0080] Inflation of the balloon 10 is accomplished through an
inflation port 12. In a preferred embodiment, as shown in FIGS.
7-10, the wall of the tubular portion, which extends from the inner
diameter of the tubular portion to the outer diameter of the
tubular portion, has embedded inside one or more inflation channels
22 that connect the inflation port 12 to the balloon 10. In a
preferred embodiment, the balloon 10 is mounted over a portion of
the distal end 6 of the tubular portion 2. The one or more channels
22 extend from the balloon inflation port 12 to a point on the
tubular portion 2 covered by the balloon 10. One or more apertures
30 are located along the length of the tubular portion 2 covered by
the balloon 10 such that air or other material inserted through
inflation port 12 passes through the one or more channel 22,
through the one or more apertures 30 and into the balloon 10.
[0081] In one embodiment, as shown in FIGS. 9 and 10, a single
tubular inflation channel 22 connects the inflation port 12 to the
balloon. In this embodiment, one or more apertures 30 may be
located in the tubular portion 2 covered by the balloon 10 in the
pathway of the inflation channel 22. In another embodiment, as
shown in FIG. 8, the wall of the tubular portion 2 can be hollow
along its circumference between the inner diameter and the outer
diameter of the tubular portion 2, and the channel 22 comprises the
hollow portion. As shown in FIG. 11, one or more apertures 30 may
be located along the circumference of the tubular portion 2 in the
portion covered by the balloon 10. Alternatively, an open circular
strip 32 may be formed along the circumference of the tubular
portion 2 covered by the balloon 10 for conveying the air or other
balloon inflation materials from the channel 22 into the balloon
10.
[0082] In another embodiment, as shown in FIG. 12, the mechanism
that prevents the device from pulling out of an anatomical
structure during complex interventions, e.g. when switching from an
antegrade to a retrograde approach in a blood vessel and vice
versa, comprises a plurality of balloons 10a located near the
distal end 6 of the tubular portion 2. The plurality of balloons
10a are preferably located about the outer circumference of the
tubular portion 2. The fabrication and design of the plurality of
balloons 10a are similar to the fabrication and design of the
single balloon 10 described above. For example, the materials used
on fabricating the plurality of balloons 10a are the same as those
used in fabricating the single balloon 10. The balloons 10a are
preferably compressed to the diameter of the tubular portion 2 for
insertion and withdrawal of the vascular sheath 1. Further, the
balloons 10a are preferably inflatable to different sizes to enable
use of the device in various procedures. For example, when the
device is used in a blood vessel, the balloons 10a are preferably
inflatable to a size wherein the cross section of the tubular
portion 2 plus balloons 10a is larger than the arteriotomy and to a
size wherein the balloons 10a obstruct the blood vessel.
[0083] The balloons 10a can also come in a variety of shapes. For
example, each of the balloons 10a may inflate to a circular or oval
shape. In another embodiment, the plurality of balloons 10a may
inflate such that the plurality of balloons 10a together form a
ring about the distal end 6 of the tubular portion 2. In some
embodiments, the ring inflates flush with the distal end 6 of the
tubular portion 2. In another embodiment, the plurality of balloons
10a inflate such that, when inflated, the plurality of balloons 10a
together form a funnel-like shape. In some embodiments, the
funnel-like shape may inflate flush with the distal end 6 of the
tubular portion 2. In other embodiments, the funnel can also
protrude out in front of distal end 6, to create a true "funnel"
appearance of the balloon and distal end of the tubular
portion.
[0084] For the plurality of balloons 10a, there may be a single
inflation port 12 in fluid communication with all of the balloons
10a or multiple inflation ports 12a in fluid communication each of
the balloons 10a. One or more inflation channels 22a embedded
inside the tubular portion 2 preferably connect the inflation
port(s) 12a to the balloons 10a. In one embodiment, a single
inflation channel 22 extends from an inflation port 22 and splits
to extend to each of the balloons 10a, as shown in FIG. 13.
Alternatively, the single inflation channel 22 can extend towards
the balloons 10a and extend within the circumference of the tubular
portion 2 to each balloon 10a as shown in FIG. 14. In another
embodiment, a plurality of inflation ports 12a and inflation
channels 22a can be formed in the tubular portion 2, for example,
each extending to a separate balloon 10a.
[0085] In another embodiment, as shown in FIGS. 15-18, the
mechanism that prevents the device from pulling out of an
anatomical structure is in the form of one or more extensions 11
near the distal end 6 of the tubular portion 2. For example, two or
more arm-like extensions 11 can be located near the distal end 6 of
the tubular portion 2, as shown in FIG. 15. In another embodiment,
one or more extensions 11 forming a funnel-like shape are located
near the distal end 6 of the tubular portion 2, as shown in FIGS.
16 and 17. For example, as shown in FIG. 16, a plurality of
extensions 11 may deploy to connect together and form a funnel
shape. In another embodiment, a plurality of extensions 11 may
deploy with a material 52 connecting the extensions 11 together,
like an umbrella, to form a funnel shape, as shown in FIG. 17. Any
type of biocompatible material may be used to connect the
extensions. In yet another embodiment, one or more extensions 11
forming a circular shape are located near the distal end 6 of the
tubular portion 2, as shown in FIG. 18. As with the funnel shape,
the plurality of extensions 11 may deploy to connect together and
form a circular shape or, for example, the plurality of extensions
11 may deploy with a material 52 connecting the extensions 11
together to form a circular shape.
[0086] These extensions 11 are preferably retractable to allow for
retraction and deployment of the extensions 11 during use of the
device. A deployment/retraction mechanism (not shown) is preferably
located near the proximal end of the device so that a user of the
device can remotely retract and deploy the extensions 11 during
use. Preferably, the extensions 11 would be deployable by the user
of the device such that, during insertion and withdrawal of the
device into and out of the anatomical structure, the extensions 11
would be in their retracted state and the cross section of the
tubular portion 2 as the device is inserted and withdrawn is not
increased or not significantly increased by the extensions. For
example, the extensions could be housed within the tubular portion
2 or, for example, folded back against the side surfaces of the
tubular portion 2 during insertion of the device into the
anatomical structure. Upon insertion of the device into the
anatomical structure to the desired site, the extensions 11 could
them be deployed by the user using the deployment/retraction
mechanism. Prior to withdrawal of the device from the anatomical
structure, the extensions 11 would be returned to their retracted
state using the deployment/retraction mechanism.
[0087] In some embodiments, the extensions 11 are deployable to
different sizes to enable use of the devices in various procedures.
For example, when the device is a vascular sheath used in a
procedure requiring repositioning the vascular sheath from a
retrograde to an antegrade position, and vice versa, the extensions
11 are deployed so that the cross section of the tubular portion 2
plus extensions 11 is smaller than the inner diameter of the blood
vessel and larger than the arteriotomy through which the vascular
sheath 1 entered the blood vessel. By sizing the extensions 11 so
that the cross section of the tubular portion 2 plus extensions 11
is larger than the arteriotomy through which the vascular sheath 1
entered the blood vessel, the tubular portion 2 is prevented from
completely exiting from the blood vessel during manipulation from a
retrograde to an antegrade position and vice versa.
[0088] In some embodiments, the vascular sheath 1 is used to
aspirate blood clots, emboli and other materials from the blood
vessel. When used in this way, the extensions 11 are designed such
that when fully deployed, the blood vessel is obstructed. In such a
procedure, the vascular sheath 1 is inserted into the blood vessel
with the distal end 6 of the tubular portion 2 facing towards the
material to be aspirated. If the material, for example, a blood
clot, has lodged in the blood vessel, antegrade flow will apply a
pressure head to keep this clot lodged in its position. The
extensions 11 are then deployed until they occlude the blood
vessel, thereby blocking blood flow through the blood vessel.
Back-bleeding will then cause the blood clot to propagate towards
the vascular sheath 1. An aspiration device connected to the side
arm 14 of vascular sheath 1 can then be used to aspirate the blood
clot out of the blood vessel through the lumen 3, or alternatively,
a catheter can be placed through the vascular sheath 1 and
hemostatic valve 8 to the location of the obstruction and the
material could be aspirated through the catheter. Thus, the
vascular sheath 1 could be inserted into the blood vessel in a
retrograde position, the extensions 11 deployed to occlude the
blood vessel and blood clots, emboli and other materials could be
aspirated from one side of the blood vessel, followed by partial
deployment of the extensions 11, repositioning of the vascular
sheath 1 to an antegrade position, re-deployment of the extensions
11 to occlude the blood vessel, and aspiration of and blood clots,
emboli and other materials on the other side of the blood
vessel.
[0089] When the vascular sheath 1 is used to insert a stent or
perform angioplasty, the extensions 11 are also preferably deployed
until they obstruct the vessel. A wire is used to cross through the
obstruction. Then the stent is deployed or angioplasty performed,
thus opening the blood vessel. During the manipulation of the wire
and stent it is possible to withdraw blood, blood clots, and debris
by aspiration through side arm 14. Alternatively, the aspiration
can take place after the stent has been deployed or using a Fogarty
balloon to pull debris out through the sheath. This would be
determined by the location of the sheath relative to the lesion
(i.e. upstream vs. downstream).
[0090] The size of the extensions 11 is not particularly limited.
For example, when the device is used within a blood vessel, the
deployed cross section of the extensions 11, as measured
perpendicular to the length of the tubular portion, can range from
just larger than the incision through which the tubular portion 2
was inserted into the blood vessel to as large as the inner
diameter of the blood vessel. When used on other anatomical
structures, the deployed cross section of the extensions 11 may
vary and is limited only by the size of the anatomical structure
and the particular requirements of the procedure. Preferably, so
that the device can be used for various procedures requiring
various deployment sizes, the extensions 11 are deployable to any
size in between its retracted size and its maximum deployed size by
simply controlling the amount of deployment and retraction of the
extensions 11.
[0091] A side-arm 14 in fluid communication with the lumen 3 may
also be located near the proximal end 4 of the tubular portion 2.
The general features of the side-arm 14 are not particularly
limited and may be in accordance with side-arms of conventional
vascular sheaths.
[0092] The side-arm 14 can be used to allow air, emboli, blood
clots and other materials to be evacuated from the anatomical
structure through the tubular portion 2 and to allow agents, such
as medicaments, anticoagulants and contrast media to be injected
into the tubular portion 2 if desired. A stopcock 28 or similar
mechanism is preferably attached to the end of the side arm 22 to
selectively provide a seal.
[0093] When the side-arm 14 is used to aspirate emboli, blood clots
and other materials from the anatomical structure, the side-arm 14
and stopcock 28 preferably has an inner diameter at least as large
as the lumen 3 of the tubular portion 2 so that materials aspirated
through the tubular portion 2 fit through the side-arm 14 and do
not become lodged at the opening of the side-arm 14.
[0094] In some embodiments, the device of the present invention
could be inserted in a target blood vessel or anatomical structure,
and also connected to a recipient blood vessel or anatomical
structure. For example, the device may be inserted into a blood
vessel and also connected to another blood vessel, usually a vein,
by either a surgical cutdown or using a percutaneous technique.
This embodiment would effectively create an arterial venous
shunt/circuit. For example, in one embodiment the tubular portion
of the device is inserted in the target anatomical structure and
the side-arm 14 is connected to a recipient anatomical structure,
thereby creating a continuous flow reversal circuit from the target
anatomical structure, through the distal end of the tubular
portion, through the tubular portion, through the side arm, and
into a target anatomical structure.
[0095] Such a continuous flow reversal circuit would require access
to the recipient anatomical structure. For example, in some
embodiments, the side arm 14 could be directly inserted in the
recipient anatomical structure. In other embodiments, the side arm
14 or another portion of the device could be connected to tubing
that is inserted in the recipient anatomical structure. In other
embodiments, the device of the present invention is connected to a
recipient anatomical structure via a conventional guide catheter or
conventional vascular sheath. In other embodiments, the side arm 14
or another portion of the device of the present invention is
connected to a second device in accordance with the present
invention such that the tubular portion of the first device is
inserted in the target anatomical structure and the tubular portion
of the second device is inserted into the recipient anatomical
structure. The first and second devices are connected to each
other, for example, via the side arms 14 of each device or, for
example, via the hemostatic valves 8 of each device through tubing
connecting the two hemostatic valves 8 together.
[0096] Such continuous flow reversal would be useful, for example,
in performing a procedure wherein materials, for example emboli,
blood clots, or blood, are transferred from a donor blood vessel
into a recipient blood vessel. The device of the present invention
could be used to occlude a donor vessel and prevent emboli, blood
clots and other materials from propagating into the cerebral or
cornary vasculature. The emboli, blood clots and other materials
could then be transferred to a recipient blood vessel wherein the
danger of having the materials propagate into the cerebral or
coronary vasculature is eliminated. In addition to occluding the
donor vessel, the mechanism would prevent the device from being
pulled from the donor vessel during the transfer. In this
embodiment, the device would be inserted in the donor blood vessel
and, a continuous flow reversal could be created by forming a
circuit between the "donor" vessel housing the embolic material to
a "recipient" vessel elsewhere in the body. Vascular access to the
recipient vessel would then be provided, for example, via the side
arm 14, a tube, a guide catheter, a vascular sheath or another
device in accordance with the present invention. In some
embodiments, a pumping mechanism is interposed in the circuit
between the donor and recipient vessels to assist in reversing the
blood flow.
[0097] Preferably, during the continuous flow reversal procedure,
the balloon (s) 10 or extensions 11 could be retracted or partially
retracted at any point in the procedure to allow reperfusion of
blood flow through the blood vessel. Then, if desired, the transfer
of materials from the donor to recipient blood vessel could be
reestablished at any point simply by again deploying the balloon(s)
10 or extensions 11 to occlude the vessel.
[0098] The continuous flow reversal described above could also be
useful in a procedure wherein blood is transferred from one patient
to another or from one site to another in the same patient as in
cardiac bypass surgery. In such procedures, the device of the
present invention, for example, in the form of a vascular sheath or
guide catheter, would be inserted into a donor patient's vessel.
The device of the present invention would then be connected to a
recipient patient's vessel via, for example, a tube, conventional
guide catheter, conventional vascular sheath, or second device in
accordance with the present invention. The device of the present
invention would be particularly helpful on preventing the loss of
vascular access during the blood transfer procedure.
[0099] While continuous flow reversal is described, in particular,
wherein the mechanism (e.g. balloon(s) 10 or extensions 11) are
deployed to occlude the vessel, thereby preventing the flow of
emboli, blood clots and other materials through the donor vessel,
the mechanism could be retracted or partially deployed so as to not
occlude the vessel wherein the danger of emboli, blood clots and
other materials flowing through the donor anatomical structure is
minimal. For example, in some embodiments, the mechanism is only
partially deployed so as to prevent the device from losing access
to the anatomical structure.
[0100] The hemostatic valve 8 is located at the proximal end 4 of
the tubular portion 2, as shown in the Figures. The general
features of the hemostatic valve 8 are not particularly limited and
may be in accordance with hemostatic valves of conventional
vascular sheaths.
[0101] The hemostatic valve 8 prevents leakage of blood and
materials out of the anatomical structure through the device. In
some embodiments, the hemostatic valve 8 can also be used to remove
materials aspirated out of the anatomical structure. Preferably,
when used to remove materials aspirated out of the anatomical
structure, the hemostatic valve 8 is removably mounted on the
proximal end 4 of the tubular portion 2 to facilitate removal of
materials out of the proximal end 4 of the tubular portion 2. Thus,
the hemostatic valve 8 could be removed after insertion and
positioning of the device and inflation of the balloon 10 or
deployment of extensions 11 and materials aspirated directly out of
the proximal end 4 of the tubular portion 2. While the hemostatic
valve 8 may be permanently mounted on the proximal end 4 of the
tubular portion 2 and materials can be aspirated and removed
through the hemostatic valve 8, it is generally easier to remove
these materials through the proximal end 4 of the tubular portion 2
after removal of the hemostatic valve 8.
[0102] The hemostatic valve 8 can be removably or permanently
mounted on the proximal end 4 of the tubular portion 2 with any
conventional means such as, for example, using various adhesives,
forming the tubular portion 2 and hemostatic valve 8 with threaded
portions so that the hemostatic valve could be screwed on and off
of the tubular portion 2, and by forming the hemostatic valve 8 to
permanently or removably snap onto the tubular portion 2.
[0103] In one embodiment, rather than a single mechanism at or near
the distal end 6 of the tubular portion 2, the device may further
include a second mechanism at or near the proximal end 4 of the
tubular portion 2. In this embodiment, both the proximal end 4 and
the distal end 6 would be inserted into the anatomical structure.
For example, the device may be inserted distal end 6 first into a
blood vessel, followed by insertion of the proximal end 4 into the
blood vessel. A portion of the device between the two mechanisms
would include one or more balloon inflation ports 12, in the
embodiment where the mechanism for preventing the device from
pulling out of the anatomical structure comprises one or more
balloons 10. In embodiments where the mechanism for preventing the
device from pulling out of the anatomical structure comprises one
or more extensions 11, one or more deployment/retraction mechanisms
are located along the portion of the device between the two
mechanisms. The inflation port(s) 12 or deployment/retraction
mechanism(s) would remain external to the blood vessel during use
such that the mechanism for preventing the device from pulling out
of the anatomical structure (balloons 10 or extensions 11) could be
inflated/deployed and deflated/retracted at any point during the
procedure. This type of an embodiment would be particularly
suitable for use as a shunt. A typical procedure using such a
device would include carotid endarectomy where the device would be
inserted proximal and distal to the lesion to be operated on. The
balloons 10 would be inflated to obstruct flow through the native
vessel and flow through the shunt, around the lesion to be operated
on and back into the native vessel, distal to the aformentioned
lesion.
[0104] The use of the device of the present invention can be
further understood from the following discussion and with reference
to FIGS. 1-19. The following discussion relates to a device in the
form of a vascular sheath used in connection with a blood vessel.
However, it is to be understood that other types of devices for
performing percutaneous and surgical interventions (e.g. guide
catheters) may be used in a similar manner on various anatomical
structures of the body.
[0105] The vascular sheath is generally used by the following
procedure: the vascular sheath is prepared with the mechanism not
deployed, i.e. the balloon 10 empty and preferably compressed about
the tubular portion 2 or the extensions 11 retracted. An incision
is made to provide access to the target site. For example, an
incision may be made in the patient's upper thigh and a needle
passed through the incision into the common femoral artery. A wire
is passed through the needle into the artery and the needle
removed, leaving the wire in place. The vascular sheath with
dilator is inserted, distal end 6 first, over the wire into the
blood vessel in the upper thigh. The dilator is then removed,
leaving the sheath in place, inside the blood vessel. The vascular
sheath is then directed to the target location. Preferably, the
vascular sheath is inserted into the blood vessel in a retrograde
position towards the patient's head. Indicia 24 can be used to
determine the depth of insertion of the vascular sheath. The
balloon 10, balloons 10a, or extensions 11 can then be inflated or
deployed.
[0106] More specifically, techniques currently used for the
insertion of small angiographic catheters is preferably utilized to
insert the vascular sheath 1 (e.g. the Seldinger technique). See
the Journal of The American Medical Association, Jan. 31, 1977,
Volume 237.
[0107] If the surgeon wishes to aspirate blood clots, emboli or
other materials out of the blood vessel, the balloon(s) 10, 10a or
extensions are then inflated or deployed until the vessel is
occluded. The vessel is known to be occluded when contrast injected
through side-arm 14 into tubular portion 2 into the blood vessel is
stagnant. An aspiration device can then be connected stopcock 28 on
the side-arm 14 and the blood clots, emboli or other materials can
be aspirated out of the blood vessel through the side-arm 14. In
another embodiment, the blood clots, emboli or other materials can
be removed through the hemostatic valve 8 by using a Fogarty
balloon to pull the blood clots out of the blood vessel, into the
sheath and out to the hemostatic valve 8. In another embodiment,
the hemostatic valve 8 is removably mounted on the tubular portion
2. Thus, the hemostatic valve 8 is first removed from the proximal
end 4 of the tubular portion 2 and the aspiration device is then
attached to the proximal end of the tubular portion 2, so that the
blood clots, emboli or other materials can be removed through the
tubular portion 2 out the proximal end 4 or blood clots, emboli and
other material pulled out of the vessel through the sheath by means
of a Fogarty balloon. In another embodiment, the hemostatic valve 8
is removably mounted on the tubular portion 2. Thus, the hemostatic
valve 8 is first removed from the proximal end 4 of the tubular
portion 2. Then, a Fogarty balloon is used to pull clot out of the
blood vessel through the tubular portion 2 out the proximal end 4
and the silicon pinch valve 40 is used to occlude the sheath once
the Fogarty balloon has been removed and allow the user to
re-attach the hemostatic valve 8 or silicone septum 46.
[0108] If the surgeon wishes to inject agents, such as medicaments,
anticoagulants and contrast media, into the blood vessel through
the vascular sheath, the surgeon simply opens stopcock 28 and
inserts a syringe or similar injection mechanism into the entrance
of the side-arm 14 and injects the agent.
[0109] When using the vascular sheath to implant a stent in the
blood vessel, the device functions as an embolic protection device.
The balloon(s) 10, 10a or extensions 11 are typically
inflated/deployed to occlude the blood vessel. A wire is passed
through the lumen 3 of tubular portion 2 and across the narrowed or
occluded blood vessel. The stent is mounted on an angioplasty
balloon and is then advanced over the wire through the lumen 3 of
the tubular portion 2 and positioned at the narrowed or occluded
portion of the blood vessel. The location can be confirmed by
injecting contrast medial through stopcock 28 of side-arm 14 into
lumen 3 of the tubular portion 2 into the blood vessel. The stent
is deployed by either using an inflation device to inflate the
angioplasty balloon or by unsheathing a self-expanding stent. The
surgeon can aspirate through stopcock 28 of side-arm 14 during this
process in order to prevent distal emboli if the vascular sheath is
upstream from the occlusion. Additionally, a tubing circuit can be
created between connected stopcock 28 on the side-arm 14 and
another vascular sheath placed in a recipient blood vessel, usually
a vein. A pump would be interposed in this circuit to aspirate the
blood clots, emboli or other materials, during the procedure, out
of the target blood vessel through the side-arm 14, through the
tubing, and then into the recipient blood vessel.(already stated
above) Moreover, if it is necessary during the procedure to
re-establish blood flow, as may be the case during a prolonged
coronary intervention, the vessel segment can have the debris
cleared via aspiration, the balloon can be deflated to allow
reperfusion, and then the balloon can be re-inflated to allow
continuance of the procedure. Alternatively, if the vascular sheath
is downstream from the lesion, the surgeon can wait until the stent
is deployed to aspirate any embolic material that has been trapped
by balloon(s) 10, 10a or extensions 11.
[0110] If the surgeon wishes to reposition the vascular sheath from
a retrograde to an antegrade position and vice versa, the surgeon
simply inflates or partially deflates the balloon 10 or deploys or
partially withdraws the extensions 11 until the tubular portion
plus balloon(s) 10, 10a or extensions 11 are sized smaller than the
inner diameter of the blood vessel but larger than the opening
through which the vascular sheath entered the blood vessel. As
such, the balloon(s) 10, 10a or extensions are sized to enable
manipulation of the vascular sheath 1 within the blood vessel while
preventing loss of vascular access. The surgeon then pulls the
vascular sheath back towards the opening through which the vascular
sheath entered the blood vessel, then upwards and partially out of
the opening if necessary, and back into the blood vessel in the
opposite position. Often the dilator and a guidwire will be placed
through the vascular sheath and into the blood vessel to permit the
safe re-advancement of the sheath well into the artery. Because the
tubular portion 2 plus inflated balloon(s) 10, 10a or extensions 11
are larger than the opening through which the vascular sheath
entered the blood vessel, they prevent the vascular sheath 1 from
exiting the blood vessel and, thus, allow the surgeon to access
antegrade and retrograde positions in the blood vessel in a single
procedure through a single incision.
[0111] If the surgeon wished to use the device of the present
invention for the treatment of hemodialysis access grafts, only one
sheath would be required, as compared to the two sheaths that are
currently used in conventional methods. Using the device of the
present invention, the surgeon would introduce the sheath with the
dilator in place into the graft using Seldinger technique towards
the venous anastomosis. The balloon(s) 10, 10a or extensions 11 on
the tubular portion 2 could be used to angioplasty any narrowing of
the graft or blood vessels, and also could used to push any clots
out of the graft, into the arm vein. The surgeon then pulls the
vascular sheath back towards the opening through which the vascular
sheath entered the blood vessel, then upwards and partially out of
the opening if necessary, and back into the blood vessel in the
opposite position, towards the arterial anastomosis. The vascular
sheath could then be used for access towards the arterial limb.
Additionally, the vascular sheath with dilator could be advanced
over the wire to the arterial anastomosis. The balloon(s) 10, 10a
would be inflated or the extensions 11 deployed and the vascular
sheath pulled back towards the opening through which the vascular
sheath entered the blood vessel, then upwards and partially out of
the opening if necessary, and back into the blood vessel in the
opposite position, towards the venous anastomosis. The balloon(s)
10, 10a will then be re-inflated to the diameter of the graft or
the extensions re-deployed to the diameter of the graft and the
vascular sheath used to push any clots out of the graft and into
the vein.
[0112] If the surgeon wishes to transfer materials from a target or
donor anatomical structure to a recipient anatomical structure, the
device of the present invention could be used to create continuous
flow reversal. For example, the device of the present invention
could be used to transfer materials, such as blood, clots and
embolic materials, from one blood vessel in a patient to another
vessel in a patient. For example, the continuous flow reversal
could be used to transfer materials, such as clots and embolic
materials, from a target vessel where there is a risk that the
materials will propagate to the cerebral or coronary vasculature to
a recipient vessel wherein this risk is eliminated. Alternatively,
the device of the present invention could be used to transfer blood
and other materials from a donor patient's blood vessel to a
recipient patient's blood vessel.
[0113] In this embodiment, the method would further involve
providing access to the recipient anatomical structure. For
example, the device of the present invention could be connected to
tubing, to a conventional guide catheter, to a conventional
vascular sheath, or to a second device in accordance with the
present invention, which, in turn is inserted in the recipient
anatomical structure. Still further, in some embodiments, the side
arm 14 of the device could be directly inserted in the recipient
anatomical structure.
[0114] During the continuous flow reversal, the mechanism may be
deployed to occlude the vessel, for example, if there is a risk
that clots and embolic material may propagate to the cerebral
vasculature. Alternatively, the mechanism may be deployed not to
occlude the vessel, but, rather, to maintain vascular access if,
for example, there is minimal risk that clots and embolic material
may propagate to the cerebral vasculature. If the mechanism is
deployed to occlude the vessel, the method of continuous flow
reversal may further include reperfusion of blood. For example, if
reestablishment of the flow of blood to the heart is desired for a
period of time during the procedure, the mechanism may be retracted
during the procedure so that the vessel is no longer occluded and
blood flow is reestablished. After perfusion of the blood is
reestablished for a desired period of time, the mechanism may again
be deployed to occlude the vessel. In some embodiments, during
reperfusion, the circuit between the target blood vessel and
recipient blood vessel can be blocked so that reperfusion is
carried out while transfer of materials from the donor to recipient
blood vessel is stopped. Then, after perfusion of the blood is
reestablished for a desired period of time, the circuit may then be
opened to continue transfer of materials from the donor to
recipient blood vessel. During this time, the vessel may remain not
occluded or may again be occluded by redeployment of the
mechanism.
[0115] Upon completion of the procedure, the balloon(s) 10, 10a is
deflated or the extensions 11 withdrawn and the vascular sheath 1
removed from the blood vessel.
[0116] It will be appreciated that the vascular sheath 1 is usable
for any type of surgical procedure wherein a vascular sheath is
needed to provide communication of medical devices with a patient's
blood vessel, body organ, or body cavity.
[0117] The present invention also includes kits that comprise one
or more device of the invention, preferably packaged in sterile
condition. Kits of the invention also may include various sized
tubular portions 2, balloons 10, 10a, extensions 11, side-arms 14,
hemostatic valves 8, needles, dilators, etc. for use with the
device, preferably packaged in sterile condition, and/or written
instructions for use of the device and other components of the
kit.
[0118] All documents mentioned herein are incorporated by reference
herein in their entirety.
[0119] The foregoing description of the invention is merely
illustrative thereof, and it is understood that variations and
modifications can be effected without departing from the scope or
spirit of the invention as set forth in the following claims.
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