U.S. patent application number 16/526952 was filed with the patent office on 2019-11-21 for unitary body systems and devices and methods to use the same for retroperfusion.
This patent application is currently assigned to CVDevices, LLC. The applicant listed for this patent is CVDevices, LLC. Invention is credited to Hyo Won Choi, Ghassan S. Kassab.
Application Number | 20190351127 16/526952 |
Document ID | / |
Family ID | 52432584 |
Filed Date | 2019-11-21 |
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United States Patent
Application |
20190351127 |
Kind Code |
A1 |
Kassab; Ghassan S. ; et
al. |
November 21, 2019 |
UNITARY BODY SYSTEMS AND DEVICES AND METHODS TO USE THE SAME FOR
RETROPERFUSION
Abstract
Unitary body systems and devices and methods to use the same for
retroperfusion. In an exemplary device embodiment of the present
disclosure, the device comprises a unitary body having a wall and a
lumen defined therethrough, a first portion terminating at a first
end and configured for at least partial placement within a
mammalian artery, a first valve positioned at or near an end of the
first portion opposite the first end, a second portion terminating
at a second end and configured for at least partial placement
within a mammalian vein, and a second valve positioned at or near
an end of the second portion opposite the second end.
Inventors: |
Kassab; Ghassan S.; (La
Jolla, CA) ; Choi; Hyo Won; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CVDevices, LLC |
San Diego |
CA |
US |
|
|
Assignee: |
CVDevices, LLC
San Diego
CA
|
Family ID: |
52432584 |
Appl. No.: |
16/526952 |
Filed: |
July 30, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14908597 |
Jan 29, 2016 |
10363354 |
|
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PCT/US14/49270 |
Jul 31, 2014 |
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16526952 |
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61917018 |
Dec 17, 2013 |
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61866280 |
Aug 15, 2013 |
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61860395 |
Jul 31, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2475 20130101;
A61F 2/06 20130101; A61M 29/02 20130101; A61M 25/09 20130101; A61M
39/24 20130101; A61M 1/3655 20130101; A61M 1/3613 20140204 |
International
Class: |
A61M 1/36 20060101
A61M001/36; A61M 29/02 20060101 A61M029/02; A61M 39/24 20060101
A61M039/24; A61M 25/09 20060101 A61M025/09 |
Claims
1. A perfusion device, comprising: a first elongated portion
terminating at a first end of the device and configured for at
least partial placement within a mammalian artery; a second
elongated portion terminating at an opposite second end of the
device and configured for at least partial placement within a
mammalian vein; and a first valve and a second valve, each
positioned away from the first end and the second end; wherein, in
use, the device is configured to permit a flow of blood from the
artery, through the device, and into the vein.
2. The device of claim 1, wherein the first valve is positioned at
or near an end of the first portion opposite the first end, and
wherein the second valve is positioned at or near and end of the
second portion opposite the second end.
3. The device of claim 1, wherein the first portion is relatively
shorter than the second portion.
4. The device of claim 1, wherein the first portion and the second
portion have a similar or equal length.
5. The device of claim 1, wherein the first valve is a first
one-way valve, and wherein the second valve is a second one-way
valve.
6. The device of claim 1, further comprising: a segment between the
first one-way valve and the second one-way valve.
7. The device of claim 1, wherein the first valve is sized and
shaped to receive at least part of a first guidewire therethrough,
and wherein the second valve is sized and shaped to receive at
least part of a second guidewire therethrough.
8. The device of claim 1, further comprising: a balloon positioned
within or coupled to the second portion, wherein, in use, the
balloon is used to ensure retrograde flow of blood.
9. The device of claim 1, further comprising: a balloon positioned
within or coupled to the second portion, wherein, in use, the
balloon is used to hold/anchor a portion of the device in place
within a patient's vasculature.
10. The device of claim 1, further comprising: a flarable tip
defined at or coupled to the second end of the device.
11. The device of claim 1, wherein at least one of the first
portion and the second portion is tapered.
12. The device of claim 1, wherein when the device comprises a
segment between the first one-way valve and the second one
way-valve, the device is configured so that a first angle ranging
from above 0.degree. to 180.degree. can be formed relative to the
first portion and the segment and/or a second angle ranging from
above 0.degree. to 180.degree. can be formed relative to the second
portion and the segment.
13. A method, comprising the steps of: positioning a first portion
of a perfusion device within an artery, wherein a first guidewire
is positioned through part of the first portion of the device into
the artery, and positioning a second portion of a perfusion device
within an vein, wherein a second guidewire is positioned through
part of the second portion of the device into the vein; and
removing the first guidewire from the first part of the device and
removing the second guidewire from the second part of the
device.
14. The method of claim 13, wherein the device is as claimed in
claim 1, wherein the part of the first portion is the first one-way
valve, and wherein the part of the second portion is the second
one-way valve.
15. The method of claim 14, wherein blood can flow from the artery,
through the perfusion device, and into the vein.
16. The method of claim 14, further comprising the step of: bending
the perfusion device to form a desired angle within the device.
17. A method, comprising the step of positioning the device of
claim 1 within a mammalian patient so that the first portion is
positioned within an artery and so that the second portion is
positioned within a vein.
18. The method of claim 17, wherein the positioning step is
performed by positioning a first portion of a perfusion device
within the artery, wherein a first guidewire is positioned through
part of the first portion of the device into the artery, and
positioning a second portion of a perfusion device within the vein,
wherein a second guidewire is positioned through part of the second
portion of the device into the vein.
19. The method of claim 18, wherein the positioning step is further
performed by advancing a first dilator over the first guidewire
before positioning the first portion of the perfusion device into
the artery and by advancing a second dilator over the second
guidewire before positioning the second portion of the perfusion
device into the vein.
20. A method, comprising one or more of the steps of, in any order:
(a) implanting a retroperfusion device into a patient so that a
first part of the device is in communication with an artery and
that a second part of the device is in communication with a vein
and so that blood can flow from the artery, through the device, and
into the vein; (b) bending the device so that one or more desired
angles and/or bends are present along at least part of the device,
so to obtain a desired pressure drop through the device; (c)
configuring one or more lengths and/or one or more diameters of the
device and/or of parts of the device based upon use within the
patient, a height of the patient, a blood pressure of the patient,
and/or a flow of blood through the artery and/or the vein of the
patient; and (d) selecting a suitable device from a plurality of
available devices, the suitable device selected based upon the one
or more lengths and/or the one or more diameters of the device
and/or of parts of the device based upon use within the patient,
the height of the patient, the blood pressure of the patient,
and/or the flow of blood through the artery and/or the vein of the
patient.
Description
PRIORITY
[0001] The present application is related to, claims the priority
benefit of, and is a U.S. continuation patent application of, U.S.
patent application Ser. No. 14/908,597, filed Jan. 29, 2016 and
issued as U.S. Pat. No. 10,363,354 on Jul. 30, 2019, which related
to, claims the priority benefit of, and is U.S. 35 U.S.C. 371
national stage patent application of, International Patent
Application Serial No. PCT/US14/49270, filed Jul. 31, 2014, which
is related to, and claims the priority benefit of, U.S. Provisional
Patent Application Ser. No. 61/860,395, filed Jul. 31, 2013, U.S.
Provisional Patent Application Ser. No. 61/866,280, filed Aug. 15,
2013, and U.S. Provisional Patent Application Ser. No. 61/917,018,
filed Dec. 17, 2013. The contents of each of these applications are
hereby incorporated by reference in their entirety into this
disclosure.
INCORPORATION BY REFERENCE
[0002] The contents of the following patent applications are hereby
incorporated by reference in their entirety into this disclosure:
(a) U.S. patent application Ser. No. 13/705,101, filed Dec. 4,
2012, (b) U.S. patent application Ser. No. 13/965,548, filed Aug.
13, 2013, and (c) U.S. patent application Ser. No. 14/093,300,
filed Nov. 29, 2013.
BACKGROUND
[0003] Peripheral arterial disease involves inadequate blood supply
to the peripheral limbs due to arterial damage, defect, or
blockage. In view of the same, devices, systems, and methods of
using the same to facilitate adequate blood supply to the
peripheral limbs would be well appreciated in the marketplace.
BRIEF SUMMARY
[0004] The present disclosure includes disclosure of various
perfusion and/or retroperfusion devices and systems and methods of
using the same, configured for use in connection with various
coronary, peripheral, and other retroperfusion methods/procedures
and/or to treat various conditions of ischemia and/or to
facilitate/promote local venous arterialization.
[0005] In at least one embodiment of a perfusion device of the
present disclosure, the perfusion device comprises a unitary body
having a wall and a lumen defined therethrough, a first portion
terminating at a first end and configured for at least partial
placement within a mammalian artery, and a second portion
terminating at a second end and configured for at least partial
placement within a mammalian vein. In another embodiment, the first
portion is relatively shorter than the second portion. In yet
another embodiment, the first portion has a first length, wherein
the second portion has a second length, and wherein the first
length is less than the second length. In an additional embodiment,
the device further comprises a first one-way valve positioned at or
near an end of the first portion opposite the first end. In yet an
additional embodiment, the device further comprises a second
one-way valve positioned at or near an end of the second portion
opposite the second end.
[0006] In at least one embodiment of a perfusion device of the
present disclosure, the device further comprises an optional
segment between the first one-way valve and the second one-way
valve. In an additional embodiment, the first one-way valve and the
second one-way valve are each sized and shaped to be immediately
adjacent to one another. In yet an additional embodiment, the
one-way valve is sized and shaped to receive at least part of a
first guidewire therethrough. In another embodiment, the second
one-way valve is sized and shaped to receive at least part of a
second guidewire therethrough.
[0007] In at least one embodiment of a perfusion device of the
present disclosure, and when in use, at least part of the first
portion could be positioned within a subclavian artery or axiallary
artery, and wherein at least part of the second portion could be
positioned within a subclavian vein or an axillary vein for use
and/or treatment at or near the heart. In another embodiment, in
use at least part of the first portion could be positioned within
an iliac artery, and wherein at least part of the second portion
could be positioned within a saphenous vein or a femoral vein. In
yet another embodiment, the entire body is flexible or one or more
portions of the body is/are flexible. In an additional embodiment,
the body is able to deform easily without collapsing so that the
lumen remains open to allow blood to flow from the first end,
through the body, and out of the second end when in use.
[0008] In at least one embodiment of a perfusion device of the
present disclosure, the body comprises a coil-reinforced wall
having one or more coils. In an additional embodiment, the one or
more coils are used in connection with an impermeable coating. In
yet an additional embodiment, the device further comprises a
balloon positioned within or coupled to the second portion. In
another embodiment, the device further comprises a balloon tube
having a balloon port, the balloon tube coupled to the balloon. In
at least one embodiment of a perfusion device of the present
disclosure, introduction of a gas and/or a liquid into the balloon
port can be used to inflate the balloon, and removal of the gas
and/or the liquid via the balloon port can be used to deflate the
balloon. In an additional embodiment, the balloon is used to ensure
retrograde flow of blood. In yet an additional embodiment, at least
a portion of the device is sized and shaped to fit within a
splittable introducer sheath.
[0009] In at least one embodiment of a perfusion device of the
present disclosure, the device further comprises a flarable tip
defined at or coupled to the second end of the device. In another
embodiment, the flarable tip is configured to shift from a first
configuration to a second configuration and back to the first
configuration. In yet another embodiment, the first configuration
is generally tapered or unflared, and wherein the second
configuration is generally flared. In an additional embodiment, the
first configuration is not expanded, and wherein the second
configuration is expanded. In at least one embodiment of a
perfusion device of the present disclosure, the first configuration
exists under typical venous blood pressure, and wherein the second
configuration exists due to a relatively higher arterial blood
pressure. In an additional embodiment, the flarable tip is
generally configured so that the second end distends to a luminal
perimeter of a portion of a vein having the second end positioned
therein so that blood flow therethrough is retrograde. In yet an
additional embodiment, the flarable tip comprises a membrane
reinforced by a plurality of struts. In another embodiment, the
membrane comprises a material selected from the group consisting of
polytetrafluoroethylene, mammalian tissue, and/or one or more other
biologically-compatible thin or relatively thin materials. In yet
another embodiment, the struts comprise a material selected from
the group consisting of nitinol, stainless steel, and/or one or
more other biologically-compatible rigid compositions.
[0010] In at least one embodiment of a perfusion device of the
present disclosure, the second portion comprises a first tapered
portion. In another embodiment, the first tapered portion comprises
part of the second portion. In yet another embodiment, the first
tapered portion comprises all or substantially all of second
portion. In an additional embodiment, the second portion is sized
and shaped to conform to dimensions of the mammalian vein. In yet
an additional embodiment, the device is configured so that the
second portion is sized and shaped to facilitate implantation
within the mammalian vein. In at least one embodiment of a
perfusion device of the present disclosure, the device is
configured so that the second portion is sized and shaped to reduce
a risk of rupture of the mammalian vein. In an additional
embodiment, the tapered portion tapers distally from a first
diameter to a second diameter, wherein the first diameter is
greater than the second diameter. In yet an additional embodiment,
the second portion comprises a second tapered portion. In another
embodiment, the second portion comprises one or more additional
tapered portions. In yet another embodiment, the first tapered
portion is the only tapered portion.
[0011] In at least one embodiment of a perfusion device of the
present disclosure, a degree, number, and length of tapered
portions can be selected to regulate the degree of pressure drop
along the device in order to reduce the transmission of arterial
pressure to the venous system and to generally avoid
over-pressurization of the venous system. In another embodiment, a
blood pressure is decreased during blood flow through the device.
In yet another embodiment, the decrease in blood pressure is
facilitated at the first tapered portion. In at least one
embodiment of a perfusion device of the present disclosure, when
the first portion is immediately adjacent to the second portion,
the first portion meets the second portion at a central junction.
In another embodiment, part of the first portion adjacent to the
central junction is flexible. In yet another embodiment, part of
the second portion adjacent to the central junction is flexible. In
an additional embodiment, the first portion is configured to bend
at a first amount, the first amount having a range of above
0.degree. to 180.degree.. In yet an additional embodiment, the
second portion is configured to bend at a second amount, the second
amount having a range of above 0.degree. to 180.degree.. In at
least one embodiment of a perfusion device of the present
disclosure, the device is configured so that a first angle ranging
from above 0.degree. to 180.degree. can be formed within the first
portion and/or a second angle ranging from above 0.degree. to
180.degree. can be formed within the second portion. In an
additional embodiment, when the device comprises a segment between
the first one-way valve and the second one way-valve, the device is
configured so that a first angle ranging from above 0.degree. to
180.degree. can be formed relative to the first portion and the
segment and/or a second angle ranging from above 0.degree. to
180.degree. can be formed relative to the second portion and the
segment. In yet an additional embodiment, the bend at the first
amount corresponds to the first angle in various embodiments and
wherein the bend at the second amount corresponds to the second
angle in various embodiments.
[0012] In at least one embodiment of a perfusion device of the
present disclosure, a pressure drop along the device can vary
depending upon the bend at the first amount, the first angle, the
bend at the second amount, and/or the second angle. In another
embodiment, the pressure drop can be regulated up to at least 32%
due to an extent of the first amount, the first angle, the bend at
the second amount, and/or the second angle. In yet another
embodiment, the pressure drop is a function of a device length, a
device diameter, a flow friction factor, and a relative flow
condition between two vessels which are connected by the device. In
at least one embodiment of a retroperfusion system of the present
disclosure, the system comprises an exemplary retroperfusion device
of the present disclosure, and at least one other item, such as,
for example, one or more of a first guide wire, a second guide
wire, a splittable introducer sheath, and/or a data wire.
[0013] The various device and systems referenced herein may be
configured for use in connection with various coronary, peripheral,
and other retroperfusion methods/procedures and/or to treat various
conditions of ischemia and/or to facilitate/promote local venous
arterialization, depending on device and/or system configuration.
In at least one embodiment of a method of the present disclosure,
the method comprises, one or more of the steps of, in any order,
(a) implanting an exemplary retroperfusion device of the present
disclosure into a patient so that a first part of the device is in
communication with an artery and that a second part of the device
is in communication with a vein and so that blood can flow from the
artery, through the device, and into the vein; (b) bending the
device so that one or more desired angles and/or bends are present
along at least part of the device, so to obtain a desired pressure
drop through the device; (c) configuring one or more lengths and/or
one or more diameters of the device and/or of parts of the device
based upon use within the patient, a height of the patient, a blood
pressure of the patient, and/or a flow of blood through the artery
and/or the vein of the patient; and/or (d) selecting a suitable
device from a plurality of available devices, the suitable device
selected based upon the one or more lengths and/or the one or more
diameters of the device and/or of parts of the device based upon
use within the patient, the height of the patient, the blood
pressure of the patient, and/or the flow of blood through the
artery and/or the vein of the patient. In at least one method, the
method comprises the steps of positioning a first portion of a
perfusion device within an artery, wherein a first guidewire is
positioned through part of the first portion of the device into the
artery, and positioning a second portion of a perfusion device
within an vein, wherein a second guidewire is positioned through
part of the second portion of the device into the vein, and
removing the first guidewire from the first part of the device and
removing the second guidewire from the second part of the device.
In another embodiment, the part of the first portion is the first
one-way valve, and the part of the second portion is the second
one-way valve. In various embodiments, blood can flow from the
artery, through the perfusion device, and into the vein. In another
method, the method further comprises the step of bending the
perfusion device to form a desired angle within the device. In an
exemplary method embodiment, the method comprises the step of
positioning a device of the present disclosure within a mammalian
patient so that the first portion is positioned within an artery
and so that the second portion is positioned within a vein. In
another embodiment, the positioning step is performed by
positioning a first portion of a perfusion device within the
artery, wherein a first guidewire is positioned through part of the
first portion of the device into the artery, and positioning a
second portion of a perfusion device within the vein, wherein a
second guidewire is positioned through part of the second portion
of the device into the vein. In another embodiment, the positioning
step is further performed by advancing a first dilator over the
first guidewire before positioning the first portion of the
perfusion device into the artery and by advancing a second dilator
over the second guidewire before positioning the second portion of
the perfusion device into the vein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The disclosed embodiments and other features, advantages,
and disclosures contained herein, and the matter of attaining them,
will become apparent and the present disclosure will be better
understood by reference to the following description of various
exemplary embodiments of the present disclosure taken in
conjunction with the accompanying drawings, wherein:
[0015] FIG. 1 shows a side view of a catheter for placement within
an arterial vessel and that may be used to deliver retroperfusion
therapy, according to at least one embodiment of the present
disclosure;
[0016] FIG. 2A shows a side view of the catheter of FIG. 1 in a
collapsed position, according to at least one embodiment of the
present disclosure;
[0017] FIG. 2B shows a side view of the catheter of FIG. 1 in an
extended position, according to at least one embodiment of the
present disclosure;
[0018] FIG. 3 shows a side view of an autoretroperfusion system
positioned to deliver retroperfusion therapy to a heart, according
to at least one embodiment of the present disclosure;
[0019] FIGS. 4A and 4B show perspective views of the distal end of
a venous catheter used in the autoretroperfusion system of FIG. 3,
according to at least one embodiment of the present disclosure;
[0020] FIG. 5 shows the components of an autoretroperfusion system
that can be used to deliver retroperfusion therapy to ischemic
tissue, according to at least one embodiment of the present
disclosure;
[0021] FIG. 6 shows a view of the base and diaphragmatic surface of
a heart with the distal ends of two components of the
autoretroperfusion system of FIG. 5 positioned therein such that
the autoretroperfusion system can deliver simultaneous selective
autoretroperfusion therapy thereto, according to at least one
embodiment of the present disclosure;
[0022] FIG. 7 shows a flow chart of a method for delivering
autoretroperfusion therapy, according to at least one embodiment of
the present disclosure;
[0023] FIG. 8A shows a side view of the catheter of FIG. 1 in a
collapsed position within an introducer, according to at least one
embodiment of the present disclosure;
[0024] FIG. 8B, shows a side view of the catheter of FIG. 1 being
introduced via an introducer into an arterial vessel, according to
at least one embodiment of the present disclosure;
[0025] FIGS. 8C and 8D show side views of the introducer of FIG. 8A
being removed from an arterial vessel, thereby deploying the
projection cannula of the catheter of FIG. 1, according to at least
one embodiment of the present disclosure;
[0026] FIG. 8E shows a side view of the catheter of FIG. 1 anchored
within an arterial vessel through the use of an expandable balloon,
according to at least one embodiment of the present disclosure;
[0027] FIG. 9 shows a schematic view of the autoretroperfusion
system of FIG. 5 as applied to a heart, according to at least one
embodiment of the present disclosure;
[0028] FIG. 10 shows a schematic view of the autoretroperfusion
system of FIG. 5 as applied to a heart, according to at least one
embodiment of the present disclosure;
[0029] FIG. 11 shows a schematic view of a step of the method of
FIG. 7 as the method is applied to a heart, according to at least
one embodiment of the present disclosure;
[0030] FIG. 12 shows a flow chart of a method for delivering
simultaneously selective autoretroperfusion therapy, according to
at least one embodiment of the present disclosure;
[0031] FIG. 13 shows a schematic view of a step of the method of
FIG. 12 as the method is applied to a heart, according to at least
one embodiment of the present disclosure;
[0032] FIG. 14 shows a schematic view of a step of the method of
FIG. 12 as the method is applied to a heart, according to at least
one embodiment of the present disclosure;
[0033] FIG. 15 shows an exemplary retroperfusion system, according
to at least one embodiment of the present disclosure;
[0034] FIG. 16 shows a portion of an exemplary retroperfusion
system, according to at least one embodiment of the present
disclosure; and
[0035] FIG. 17 shows a block diagram of components of an exemplary
retroperfusion system coupled to a blood supply, according to at
least one embodiment of the present disclosure;
[0036] FIG. 18 shows a schematic of the retroperfusion system
showing the arterial and retroperfusion catheters, according to a
study in connection with the present disclosure;
[0037] FIG. 19 shows a diagram of steps of an exemplary method of
organ perfusion, according to at least one embodiment of the
present disclosure;
[0038] FIG. 20 shows a block diagram of a regional hypothermia
system and kit used in connection with an exemplary device or
system of the present disclosure;
[0039] FIG. 21 shows an intravenous arterialization catheter,
according to an exemplary embodiment of the present disclosure;
[0040] FIG. 22 shows a biodegradable intravenous arterialization
catheter, according to an exemplary embodiment of the present
disclosure;
[0041] FIG. 23A shows steps of a method of using an intravenous
arterialization catheter, according to an exemplary embodiment of
the present disclosure;
[0042] FIG. 23B shows an embodiment of a catheter positioned within
a vein and connected to a graft in communication with an artery,
according to an exemplary embodiment of the present disclosure;
[0043] FIG. 23C shows steps of another method of using an
intravenous arterialization catheter, according to an exemplary
embodiment of the present disclosure;
[0044] FIG. 24A shows an intravenous arterialization catheter,
according to an exemplary embodiment of the present disclosure;
[0045] FIG. 24B shows an embodiment of a catheter positioned
subcutaneously and into a vein and connected to a graft in
communication with an artery, according to an exemplary embodiment
of the present disclosure;
[0046] FIG. 25 shows an intravenous arterialization catheter,
according to an exemplary embodiment of the present disclosure;
and
[0047] FIGS. 26A and 26B show embodiments of catheters positioned
into a human and animal vein, respectively, according to exemplary
embodiments of the present disclosure.
[0048] FIG. 27A shows a retroperfusion device, according to an
exemplary embodiment of the present disclosure;
[0049] FIG. 27B shows a portion of a retroperfusion device
according to an exemplary embodiment of the present disclosure;
[0050] FIG. 27C shows part of a retroperfusion device, according to
an exemplary embodiment of the present disclosure;
[0051] FIG. 28 shows a retroperfusion device positioned at least
partially within a mammalian vasculature, according to an exemplary
embodiment of the present disclosure;
[0052] FIG. 29 shows a retroperfusion device, according to an
exemplary embodiment of the present disclosure;
[0053] FIG. 30 shows a retroperfusion device positioned at least
partially within a mammalian vasculature, according to an exemplary
embodiment of the present disclosure;
[0054] FIGS. 31A and 31B show a portion of a retroperfusion device
having a flarable tip, according to an exemplary embodiment of the
present disclosure;
[0055] FIG. 32 shows a retroperfusion device with a tapered
portion, according to an exemplary embodiment of the present
disclosure;
[0056] FIG. 33 shows several curvature profiles tied to
mathematical functions, according to exemplary embodiments of the
present disclosure;
[0057] FIG. 34 shows various device configurations based upon
sigmoidal functions, according to exemplary embodiments of the
present disclosure;
[0058] FIG. 35 shows in vivo wave forms obtained from a femoral
artery;
[0059] FIG. 36 shows a pulsatile inlet velocity profile, according
to an exemplary embodiment of the present disclosure;
[0060] FIG. 37 shows a device having an extreme curvature
(180.degree. bend), according to an exemplary embodiment of the
present disclosure;
[0061] FIG. 38 shows a depiction of a relative pressure drop as
compared to a relative pressure drop in view of device curvature
angles, according to an exemplary embodiment of the present
disclosure;
[0062] and
[0063] FIG. 39 shows a device positioned within a mammalian artery
and vein, according to an exemplary embodiment of the present
disclosure.
DETAILED DESCRIPTION
[0064] The embodiments discussed herein include devices, systems,
and methods useful for providing selective autoretroperfusion to
the venous system. In addition, and with various embodiments of
devices and systems of the present disclosure, said devices and/or
systems can also be used to achieve a controlled arterialization of
the venous system. For the purposes of promoting an understanding
of the principles of the present disclosure, reference will now be
made to the embodiments illustrated in the drawings, and specific
language will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of this disclosure is
thereby intended.
[0065] The devices, systems and methods disclosed herein can be
used to safely and selectively arterialize venous vessels in order
to decrease the stress thereon and prevent rupture of the same.
Accordingly, through the use of the devices, systems and methods
disclosed herein, long-term autoretroperfusion of oxygenated blood
through the coronary venous system can be achieved, thereby
providing a continuous supply of oxygen-rich blood to an ischemic
area of a tissue or organ. While the devices, systems and methods
disclosed herein are described in connection with a heart, it will
be understood that such devices, systems and methods are not
limited in their application solely to the heart and the same may
be used in connection with any ischemic tissue and/or organ in need
of an oxygen-rich blood supply.
[0066] Selective auto-retroperfusion (SARP) can be indicated for
both chronic and acute applications, and exemplary catheters 10
and/or systems 100 of the present disclosure (and as referenced in
further detail herein) can be used in connection therewith.
References to "acute" for SARP applications are used generally to
indicate the amount of time that an exemplary catheter 10 and/or
system 100 of the present disclosure may be in use on a given
patient. In at least one embodiment, catheter 10 and/or system 100,
or portions thereof, will be sterile and intended for disposal
after a single use. In at least one embodiment of a system 100
useful in connection with an acute indication, use of system 100
could be limited to less than 24 hrs.
[0067] Now referring to FIG. 1, a side view of a catheter 10 is
shown. The catheter 10 is configured to be placed within an
arterial vessel and comprises a flexible, elongated tube having a
proximal end 12, a distal end 14 and at least one lumen 15
extending between the proximal end 12 and the distal end 14. The
dimensions of the catheter 10 may vary depending on the particulars
of a specific patient or with respect to the artery to be
cannulated. For example and without limitation, where the catheter
10 is used to in a system for autoretroperfusion of the coronary
sinus, the catheter 10 may comprise a diameter of about 2.7
millimeters to about 4 millimeters (about 8 Fr to about 12 Fr).
Furthermore, the at least one lumen 15 of the catheter 10 comprises
a sufficient diameter such that blood can flow therethrough. In
addition, the catheter 10 may be comprised of any appropriate
material, including without limitation, polyurethane or silicone
rubber. Furthermore, the catheter 10 may be coated with heparin or
any other suitable anti-coagulant such that the catheter 10 may be
placed within a vessel for an extended period of time without
inhibiting blood flow due to coagulation. The distal end 14 of the
catheter 10 is configured to allow arterial blood to flow
therethrough and into the at least one lumen 15 of the catheter 10.
Similarly, the proximal end 12 of the catheter 10 is configured to
allow blood within the at least one lumen 15 to flow out of the
catheter 10. Accordingly, when the catheter 10 is positioned within
an arterial vessel, the oxygenated blood is allowed to flow into
the catheter 10 through the distal end 14 of the catheter 10,
through the at least one lumen 15, and out of the catheter 10
through the proximal end 12 of the catheter 10. In this manner,
placement of the catheter 10 within a vessel does not inhibit the
flow of blood through the vessel or significantly affect the
pressure of the blood flow within the vessel.
[0068] As shown in FIG. 1, the catheter 10 further comprises a
projection cannula 16 that extends from the proximal end 12 of the
catheter 10 and forms a Y-shaped configuration therewith. The
projection cannula 16 comprises a flexible tube of material that is
appropriate for insertion within a vessel and placement within an
opening in a vessel wall. Furthermore, the projection cannula 16
comprises at least one lumen 18, a proximal end 20, and a distal
end 22. The distal end 22 of the projection cannula 16 is coupled
with the body of the catheter 10 and configured to allow the lumen
18 of the projection cannula 16 to communicate with at least one of
the at least one lumens 15 of the catheter 10. Accordingly, when
blood flows through the at least one lumen of the catheter 10, a
portion of the blood flow enters the lumen 18 of the projection
cannula 16 through the distal end 22 thereof and flows out through
the proximal end 20 of the projection cannula 16. In this manner,
the catheter 10 is capable of bifurcating the flow of blood through
the vessel in which it is inserted and routing some of that blood
flow out of the vessel and to another location. This bifurcation
can be exploited to modify the pressure of the blood flowing
through the projection cannula 16 and/or through the proximal end
12 of the catheter 10 by manipulating the dimensions of the
projection cannula 16 and the body of the catheter 10. For example,
and without limitation, if the diameter of the projection cannula
16 is less than the diameter of the at least one lumen 15 of the
catheter 10, the majority of the blood will flow through the
proximal end 12 of the catheter 10 and the pressure of the
remaining blood that flows through the smaller projection cannula
16 will necessarily be reduced. Predictably, the smaller the
diameter of the lumen 18 of the projection cannula 16, the greater
the pressure drop that can be achieved in the blood flowing through
the lumen 18 of the projection cannula 16. Accordingly, with
respect to the catheter's 10 application to autoretroperfusion
therapies, the projection cannula 16 can be used to re-route blood
flow from an artery to a vein while simultaneously achieving the
necessary pressure drop in the re-routed blood between the arterial
system and unarterialized venous system. Moreover, the catheter 10
is capable of maintaining substantially normal blood flow through
the artery in which it is housed as the arterial blood not
re-routed through the projection cannula 16 is allowed to flow
through the open proximal end 12 of the catheter 10 and back into
the artery in the normal antegrade fashion.
[0069] Due to the configuration of the projection cannula 16 and
the material of which it is comprised, the projection cannula 16 is
capable of hingedly moving relative to the body of the catheter 10
between a collapsed position and an extended position. Now
referring to FIGS. 2A and 2B, the projection cannula 16 is shown in
the collapsed position (FIG. 2A) and in the extended position (FIG.
2B). When the projection cannula 16 is in the collapsed position,
the projection cannula 16 is positioned substantially parallel with
the body of the catheter 10. Alternatively, when the projection
cannula 16 is in the extended position, the projection cannula 16
is positioned such that the projection cannula 16 forms an angle
.theta. with the proximal end 12 of the catheter 10. The value of
angle .theta. may be selected depending on the desired application
of the catheter 10. For example, in at least one embodiment, the
angle .theta. may comprise any value ranging between about
15.degree. and about 90.degree.. In another example, the angle
.theta. may comprise about 45.degree. when the projection cannula
16 is in the extended position. The projection cannula 16 is biased
such that, when it is not subject to a downward force, the
projection cannula 16 rests in the expanded position. Conversely,
when a downward force is applied to the projection cannula 16 by
way of an introducer or otherwise, the projection cannula 16 moves
into and remains in the collapsed position until the downward force
is removed. In this manner, the projection cannula 16 may be
introduced into a vessel in the collapsed position through the use
of an introducer or shaft and thereafter move into the expanded
position when the catheter 10 is properly positioned within the
vessel and the introducer or shaft is removed.
[0070] Optionally, as shown in FIG. 1, the catheter 10 may further
comprise an expandable balloon 58 coupled with an intermediary
portion of the external surface of the catheter 10 such that the
expandable balloon 58 encases the catheter 10 and the distal end 22
of the projection cannula 18. The expandable balloon 58 may be any
expandable balloon 58 that is appropriate for insertion within a
vessel and may comprise any material suitable for this function,
including without limitation, polyethylene, latex,
polyestherurethane, polyurethane, sylastic, silicone rubber, or
combinations thereof. In operation, the expandable balloon 58 can
be used to anchor the catheter 10 in a desired position within a
vessel wall and prevent leakage from the opening in the vessel wall
through which the projection cannula 16 traverses. The expandable
balloon 58 is capable of being controlled by a clinician such that
it can inflate and/or deflate to the proper size. The sizing of the
expandable balloon 58 will differ between patients and
applications. The expandable balloon 58 may be in fluid
communication with a balloon inflation port 62 through a secondary
lumen 60 within the lumen 18 of the projection cannula 16.
Alternatively, the expandable balloon 58 may be in fluid
communication with the balloon inflation port 62 through a tube or
other means that is positioned within the lumen 18 of the
projection cannula 16 as shown in FIG. 1. The balloon port 62 may
be positioned subcutaneously or otherwise such that a clinician can
easily access the balloon port 62 when the catheter 10 is
positioned within a vessel. In this manner the balloon port 62 can
be accessed by a clinician, subcutaneously, percutaneously or
otherwise, and used to inflate or deflate the expandable balloon 58
with no or minimal invasion to the patient.
[0071] Now referring to FIG. 3, an autoretroperfusion system 100 is
shown positioned to allow arterial blood to irrigate the coronary
sinus of a heart 101. With respect to the heart 101, the
autoretroperfusion system 100 may be used for treatment of
myocardial infarctions by injecting arterial blood into the
coronary sinus in synchronism with the patient's heartbeat.
Furthermore, the autoretroperfusion system 100 is capable of
controlling the pressure of the arterial blood flow as it enters
the venous vessel such that when the arterial blood flow is first
introduced into the venous system, the pressure of the re-routed
arterial blood flow is reduced to protect the thinner venous
vessels. In this manner, the venous system is allowed to gradually
arterialize. Further, after the selected venous vessel has
sufficiently arterialized, the autoretroperfusion system 100 is
capable of reducing or ceasing its influence on the pressure of the
re-routed arterial blood flow such that the standard arterial blood
flow pressure is thereafter allowed to flow into the arterialized
venous vessel.
[0072] Autoretroperfusion system 100 comprises the catheter 10, a
second catheter 150, and a connector 170. The catheter 10 is for
placement within an arterial vessel and is configured as previously
described in connection with FIGS. 1-2B. The second catheter 150 is
configured for placement within the venous system. The connector
170 is configured to form an anastomosis between the catheter 10
and the second catheter 150 and further functions to monitor
various data points on the blood flow flowing therethrough. In
addition, in at least one embodiment, the connector 170 is capable
of controlling the pressure of arterial blood flowing therethrough.
The second catheter 150 is configured for placement within a venous
vessel wall 114 and comprises a flexible tube having a proximal end
152, a distal end 154 and at least one lumen 156 extending between
the proximal end 152 and the distal end 154. Both the proximal end
152 and the distal end 154 of the second catheter 150 are open and
in communication with the at least one lumen 156 of the second
catheter 150, thereby allowing blood to flow into the at least one
lumen 156 through the proximal end 152 and out of the distal end
154 back into the venous vessel 114. The second catheter 150 may be
any catheter known in the art that is capable of intravascular
insertion and advancement through the venous system and may
comprise any appropriate material, including without limitation,
polyurethane or silicone rubber. In at least one embodiment, the
second catheter 150 is configured to receive a guidewire 510 (see
FIGS. 4A and 4B) through the at least one lumen 156 to facilitate
the intravascular delivery of the distal end 154 of the second
catheter 150 into the desired location of the venous vessel 114.
Furthermore, similar to the catheter 10, the second catheter 150
may be coated with heparin or any other suitable anti-coagulant
prior to insertion in order to facilitate the extended placement of
the second catheter 150 within the venous vessel 114. Accordingly,
the autoretroperfusion system 100 may be used to deliver chronic
retroperfusion treatment to an ischemic area of a body.
[0073] FIGS. 4A and 4B show side views of the distal end 154 of the
second catheter 150 positioned within the venous vessel wall 114.
As shown in FIG. 4A, the distal end 154 of the second catheter 150
may further comprise an expandable balloon 158 coupled with the
external surface of the second catheter 150. In operation, the
expandable balloon 158 can be used to anchor the distal end 154 of
the second catheter 150 in the desired location within the venous
vessel wall 114. The expandable balloon 158 may be any expandable
balloon that is appropriate for insertion within a vessel and can
be formed of any material suitable for this function, including
without limitation, polyethylene, latex, polyestherurethane,
polyurethane, sylastic, silicone rubber, or combinations
thereof.
[0074] The expandable balloon 158 is capable of being controlled by
a clinician such that it can inflate and/or deflate to the proper
size. The sizing of the expandable balloon 158 will differ between
patients and applications and it is often important to determine
the proper sizing of the expandable balloon 158 to ensure the
distal end 154 of the second catheter 150 is securely anchored
within the desired location of the vessel wall 114. The accurate
size of the expandable balloon 158 can be determined through any
technique known in the art, including without limitation, by
measuring the compliance of the expandable balloon 158 ex vivo or
in vivo. In addition, the distal end 154 of the second catheter 150
may further comprise a plurality of electrodes that are capable of
accurately measuring the cross-sectional area of the vessel of
interest as is known in the art. For example, the plurality of
electrodes may comprise a combination of excitation and detection
electrodes as described in detail in the currently pending U.S.
patent application Ser. No. 11/891,981 entitled System and Method
for Measuring Cross-Sectional Areas and Pressure Gradients in
Luminal Organs, and filed on Aug. 14, 2007, which is hereby
incorporated by reference in its entirety. In at least one
embodiment, such electrodes may comprise impedence and conductance
electrodes and may be used in connection with ports for the suction
of fluid from the vessel and/or the infusion of fluid therein. The
expandable balloon 158 may be in fluid communication with a
secondary lumen 160 disposed within the at least one lumen 156 of
the second catheter 150. In this example, the secondary lumen 160
is coupled with a balloon port 162 that extends from the proximal
end 152 of the second catheter 150 (see FIG. 3). Accordingly, when
the autoretroperfusion system 100 is positioned within a patient,
the balloon port 162 can be easily accessed by a clinician,
subcutaneously, percutaneously or otherwise, and used to inflate or
deflate the expandable balloon 158 with no or minimal invasion to
the patient.
[0075] As shown in FIGS. 4A and 4B, the distal end 154 of the
second catheter 150 may further comprise at least one sensor 166
coupled therewith. In at least one embodiment, the at least one
sensor 166 is disposed on the distal end 154 of the second catheter
150 distally of the expandable balloon 158; however, it will be
understood that the at least one sensor 166 may be disposed in any
location on the distal end 154 of the second catheter 150. The at
least one sensor 166 may be used for monitoring purposes and, for
example, may be capable of periodically or continuously monitoring
the pressure of the blood flow flowing through the at least one
lumen 156 of the first catheter 150 or the venous vessel 14 in
which the second catheter 150 is inserted. Additionally, one of the
at least one sensors 166 may be used to monitor the pH or the
concentrations of carbon dioxide, lactate, or cardiac enzymes
within the blood. Furthermore, the at least one sensor 166 is
capable of wirelessly communicating the information it has gathered
to a remote module through the use of telemetry technology, the
internet, or other wireless means, such that the information can be
easily accessed by a clinician on a real-time basis or
otherwise.
[0076] Now referring back to FIG. 3, the autoretroperfusion system
100 further comprises a connector 170. The connector 170 comprises
any connector or quick connector known in the medical arts that is
capable of forming an anastomosis between an artery and a vein such
that oxygenated blood from the arterial system can flow into the
venous system. For example, the connector 170 may comprise an
annular connector that is capable of coupling with the proximal end
20 of the projection cannula 16 of the catheter 10 and with the
proximal end 152 of the second catheter 150 such that arterial
blood can flow continuously from the at least one lumen 15 of the
catheter 10 to the at least one lumen 156 of the second catheter
150. The connector 170 may be formed of any suitable material known
in the art including, but not limited to, silicon rubber,
poly(tetrafluoroethene), and/or polyurethane. The connector 170 of
the autoretroperfusion system 100 may comprise a pressure/flow
regulator unit that is capable of measuring the flow rate of the
blood moving therethrough, the pressure of the blood moving
therethrough, and/or other data regarding the blood flowing through
the anastomosis. The connector 170 may also be capable of
transmitting such gathered data to a remote module 180 through a
lead placed intravascularly or, in the alternative, through
telemetry or another wireless means. The remote module 180 may
comprise any device capable of receiving the data collected by the
connector 170 and displaying the same. For example, and without
limitation, the remote module 180 may comprise any display device
known in the art or a computer, a microprocessor, hand-held
computing device or other processing means.
[0077] Additionally, the connector 170 may further comprise a means
for regulating the blood flow through the anastomosis. One of the
main challenges of successfully delivering retroperfusion therapies
is that the arterial blood pressure must be reduced prior to being
introduced into a vein due to the thinner and more fragile anatomy
of venous walls. Indeed, subjecting a non-arterialized venous
vessel to the high pressures of arterial blood flow typically
results in rupture of the venous vessel. Accordingly, with
retroperfusion therapies, it is critical to ensure that the
pressure of the arterial blood flow is at least initially
controlled such that the venous vessel can arterialize prior to
being subjected to the unregulated pressure of the arterial blood
flow. In at least one embodiment the connector 170 may comprise an
external compression device to facilitate the control of the flow
rate of the blood moving through the anastomosis. Alternatively,
other means that are known in the art may be employed to regulate
the blood flow and pressure of the blood flowing through the
anastomosis formed by the connector 170. In at least one
embodiment, the means for regulating the blood flow through the
anastomosis formed by the connector 170 is capable of regulating
the pressure and/or flow velocity of the blood flowing through the
anastomosis. For example, the means for regulating blood flow can
be adjusted to ensure that about a 50 mg Hg pressure drop occurs in
the blood flow between the arterial vessel and the venous
vessel.
[0078] The connector 170 is capable of not only transmitting data
to the remote module 180, but also receiving commands from the
remote module 180 and adjusting the means for regulating blood flow
pursuant to such commands. Accordingly, when the autoretroperfusion
system 100 is positioned within a patient for retroperfusion
therapy, a clinician can use the remote module 180 to view the
blood flow data collected by the connector 170 and non-invasively
adjust the connector 170 to achieve the desired pressure and/or
flow through the anastomosis. Such remote control of the connector
170 is particularly useful as a clinician may incrementally
decrease the connector's 170 regulation of the blood flow without
surgical intervention during the venous arterialization process
and/or after the venous vessel arterializes. Further, where the
remote module 180 comprises a computer or other processing means,
the remote module 180 is also capable of being programmed to
automatically analyze the data received from the connector 170 and,
based on the results thereof, suggest how to adjust the means of
regulating the blood flow of the connector 170 and/or automatically
adjust the means of regulating the blood flow of the connector 170
to achieve the optimal result. For example, and without limitation,
when the autoretroperfusion system 100 is implanted into a patient
and the anastomosis is first performed, the remote module 180 can
automatically adjust the means for regulating the blood flow of the
connector 170 based on the initial blood flow data received by the
remote module 180. In this manner, the desired pressure drop
between the arterial system and the venous system is immediately
achieved and the risk of venous rupture is significantly
reduced.
[0079] Alternatively, where the connector 170 of the
autoretroperfusion system 100 does not comprise a means for
regulating blood flow, the gradual arterialization of the venous
vessel can be achieved through other techniques known in the art.
For example, in at least one embodiment, the autoretroperfusion
system 100 further comprises a coil designed to at least partially
occlude the vein of interest. In this manner, the pressure is
allowed to build in front of the portion of the vein at least
partially occluded by the coil and the vein gradually arterializes.
In this at least one embodiment, the coil may comprise a metallic
memory coil (made of nitinol, stainless steel or other acceptable
materials that are radioopaque) and is covered with
polytetrafluorethylene, polyethylene terephthalate, polyurethane or
any other protective covering available in the medical arts.
Additionally, gradual arterialization can be performed by the
second catheter 150. In this embodiment of autoretroperfusion
system 100, the at least one lumen 156 of the second catheter 150
is designed to provide an optimal stenosis geometry to facilitate
the desired pressure drop as the arterial blood flows therethrough
and into the venous system. For example, and without limitation,
the at least one lumen 156 may further comprise an internal balloon
or resorbable stenosis as disclosed in International Patent
Application No. PCT/US2006/029223, entitled "Devices and Methods
for Controlling Blood Perfusion Pressure Using a Retrograde
Cannula," filed Jul. 28, 2006, which is hereby incorporated by
reference herein.
[0080] In at least one embodiment, the stenosis comprises an
internal expandable balloon (not shown) positioned within the lumen
156 of the second catheter 150. In this at least one embodiment,
the internal expandable balloon can be used to provide a pressure
drop between the arterial and venous systems as is required to
achieve the gradual arterialization of the target vein. The
internal expandable balloon and the external expandable balloon 158
of the second catheter 150 may positioned concentrically or,
alternatively, the internal expandable balloon and the expandable
balloon 158 may be coupled with distinct portions of the second
catheter 150. The internal expandable balloon may comprise any
material suitable in the medical arts, including, without
limitation, polyethylene, latex, polyestherurethane, polyurethane,
sylastic, silicone rubber, or combinations thereof. Further, the
internal expandable balloon may be in fluid communication with a
tertiary lumen (not shown) disposed within the at least one lumen
156 of the second catheter 150. In this embodiment, the tertiary
lumen is also in fluid communication with an internal balloon port
that extends from the proximal end 152 of the second catheter 150.
Accordingly, the internal balloon port can be easily accessed by a
clinician, subcutaneously, percutaneously or otherwise, and the
internal balloon port can be used to inflate or deflate the
internal expandable balloon with minimal or no discomfort to the
patient when the system 100 is in operation. Alternatively, the
internal expandable balloon may be in fluid communication with the
at least one lumen 156 of the second catheter 150. In this example,
the arterial blood flow through the at least one lumen 156
functions to inflate and deflate the internal expandable balloon in
conjunction with the systolic and diastolic components of a
heartbeat.
[0081] The internal expandable balloon may be sized to a specific
configuration in order to achieve the desired stenosis. In one
embodiment, the size of the desired stenosis may be obtained by
measuring the pressure at the tip of the distal end 156 of the
second catheter 150 with the at least one sensor 166 while the
internal expandable balloon is being inflated. Once the desired
intermediate pressure is obtained, the internal expandable balloon
volume may then be finalized and the vein is thereafter allowed to
arterialize at the modified pressure for a defined period of time.
At the end of the defined period (typically about 2-3 weeks), the
internal expandable balloon may be removed from the at least one
lumen 156 of the second catheter 150. Insertion and/or removal of
the internal expandable balloon from the system 100 may be achieved
through the internal balloon port and the related tertiary lumen of
the second catheter 150. For example, if the internal expandable
balloon is no longer necessary to control the pressure on the
venous system because the arterialization of the vein is
substantially complete, the internal expandable balloon can be
deflated through use of internal balloon port and withdrawn from
the system 100 through the tertiary lumen and the internal balloon
port.
[0082] Other embodiments of the system 100 may comprise other
suitable means for providing a stenosis within the at least one
lumen 156 of the second catheter 150 such that a pressure drop is
achieved in blood flowing therethrough. For example, while a
stenosis can be imposed by inflation of the internal expandable
balloon, it may also be imposed through positioning a resorbable
material within the at least one lumen 156 of the second catheter
150. The resorbable stenosis may be comprised of a variety of
materials including, for example and without limitation, magnesium
alloy and polyols such as mannitol, sorbitol and maltitol. The
degradation rate of the resulting resorbable stenosis will be
dependent, at least in part, upon on what type of material(s) is
selected to make-up the resorbable stenosis and the same may be
manipulated to achieve the desired effect.
[0083] In addition to the aforementioned components of the
autoretroperfusion system 100, the autoretroperfusion system 100
may further include a first graft 185 and a second graft 190 as
shown in FIG. 3. In this embodiment, the first graft 185 is coupled
with the proximal end 20 of the projection cannula 16 (that extends
through the exterior arterial wall 116) and the connector 170.
Further, the second graft 190 is coupled with the proximal end 152
of the second catheter 150 (positioned within the venous vessel
wall 114) and the connector 170. Accordingly, in this at least one
embodiment, the second graft 190 is capable of traversing the
venous vessel wall 114 in such a manner that the anastomosis is
sealed and no blood flow is allowed to leak from the anastomosed
vein 114. In this manner, the first and second grafts 185, 190
facilitate the formation of an elongated anastomosis between the
venous and arterial vessels 114, 116 and thereby relieve any
pressure that may be applied to the two vessels 114, 116 due to the
anastomosis formed therebetween. For example and without
limitation, in at least one embodiment the combined length of the
grafts 185, 190 and the connector 170 is about 6 centimeters.
However, it will be understood that the grafts 185, 190 may
comprise any length(s) so long as the dimensions allow for an
anastomosis to form between the applicable vessels and a fully
developed blood flow is achieved from the artery to the venous
vessel of interest.
[0084] Alternatively, the autoretroperfusion system 100 may only
comprise the second graft 190 in addition to the catheter 10, the
second catheter 150 and the connector 170. In this embodiment, the
connector 170 is coupled with the proximal end 20 of the projection
cannula 16 and the second graft 190. Furthermore, the second graft
190 is further coupled with the proximal end 152 of the second
catheter 150 such that the second graft 190 traverses an opening
within the venous vessel wall 114 (see FIG. 5). The grafts 185, 190
may comprise any biocompatible, non-resorbable material having the
necessary strength to support the surrounding tissue and withstand
the pressure asserted by the blood flow therethrough. Furthermore,
the grafts 185, 190 must exhibit the necessary flexibility to form
an anastomosis between the vein and the artery within which the
catheter 10 and the second catheter 150 are respectively housed.
For example, and without limitation, the grafts 185, 190 may
comprise any conventional implant including synthetic and natural
prosthesis, grafts, and the like. The grafts 185, 190 may also
comprise a variety of suitable materials, including those
conventionally used in anastomosis procedures, including, without
limitation, natural and synthetic materials such as heterologous
tissue, homologous tissue, polymeric materials, Dacron,
fluoropolymers, and polyurethanes. For example, and without
limitation, the first and second grafts 185, 190 may comprise a
material such as GORE-TEX (polytetraflouroethylene). The grafts
185, 190 may be coated with heparin or any other suitable
anti-coagulant. Accordingly, the first graft 185 and the second
graft 190 may be placed within a vessel or have blood flow
therethrough for an extended period of time without inhibiting
blood flow due to coagulation.
[0085] In at least one embodiment of the autoretroperfusion system
100, the components of the system 100 are available in a package.
Here, the package may also contain at least one sterile syringe
containing the fluid to be injected into the balloon port 62 to
inflate the expandable balloon 58 of the catheter 10 and/or the
balloon port 162 to inflate the expandable balloon 158 of the
second catheter 150. Furthermore, the package may also contain
devices to facilitate delivery of the autoretroperfusion system 100
such as venous and arterial access devices, a delivery catheter, a
guidewire and/or mandrel, an introducer to maintain the catheter 10
in the collapsed position during delivery and, in those embodiments
where a coil is used to arterialize the vein of interest, a pusher
bar as is known in the art. The guidewire used to facilitate the
delivery of the autoretroperfusion system 100 into a vessel by
providing support to the components thereof. The guidewire may
comprise any guidewire known in the art. Furthermore, the distal
end of the guidewire may comprise a plurality of impedance
electrodes that are capable of taking measurements of the size the
vessel in which the guidewire is inserted through the use of
impedance technology. Additionally, in at least one embodiment, the
impedance electrodes may be further capable of communicating such
measurements to the remote module 180 through telemetry or other
wireless means in a manner similar to the at least one sensor 166
of the distal end 154 of the second catheter 150. In at least one
embodiment, the distal end of the guidewire may comprise two
tetrapolar sets of impedance electrodes disposed on its distal-most
tip.
[0086] Based on the information gathered by the impedance
electrodes, a clinician can obtain accurate measurements of a
selective region of a vessel. In this manner, the expandable
balloon 158 coupled with the distal end 154 of the second catheter
150 may be properly sized and the amount of fluid or gas needed to
inflate the expandable balloon 158 can be determined prior to
introducing the second catheter 150 into the vein of interest. For
example, a clinician can use the plurality of impedance electrodes
on the guidewire to obtain measurements of the size and shape of
the sub-branches of the coronary sinus. Now referring to FIG. 5,
components of a simultaneous selective autoretroperfusion system
300 are shown. The simultaneous selective autoretroperfusion system
300 (the "SSA system 300") are configured identically to the
autoretroperfusion system 100 except that the SSA system 300
further comprises a third catheter 350 and a Y connector 320, both
configured for placement within the venous vessel wall 114.
Specifically, the SSA system 300 comprises the catheter 10, the
second catheter 150, the third catheter 350, the connector 170, and
the Y connector 320. It will be understood that the SSA system 300
can also further comprise the first graft 185 and/or the second
graft 190, and the remote module 180 as described in connection
with autoretroperfusion system 100. The third catheter 350 is
configured for placement within the venous vessel wall 114 adjacent
to the second catheter 150. The third catheter 350 is configured
identically to the second catheter 150 and comprises a flexible
tube having a proximal end 352, a distal end 354 and at least one
lumen 356 extending between the proximal end 352 and the distal end
354. Both the proximal end 352 and the distal end 354 of the third
catheter 350 are open and in communication with the at least one
lumen 356 of the third catheter 350, thereby allowing blood to flow
into the at least one lumen 356 through the proximal end 352 and
out of the distal end 354 back into the venous vessel 114. The
third catheter 350 may be any catheter known in the art that is
capable of intravascular insertion and advancement through the
venous system. The third catheter 350 may comprise any appropriate
material, including without limitation, polyurethane or silicone
rubber. In at least one embodiment, the third catheter 350 is
configured to receive a guidewire 310 (see FIGS. 5 and 6) through
the at least one lumen 356 in order to facilitate the intravascular
delivery of the distal end 354 of the third catheter 350 into the
desired location of the venous vessel 114. Furthermore, the third
catheter 350 is coated with heparin or any other suitable
anti-coagulant prior to insertion in order to facilitate the
extended placement of the third catheter 350 within the venous
vessel 114.
[0087] As shown in FIG. 5, the distal end 354 of the third catheter
350 further comprises an expandable balloon 358 coupled with the
external surface of the third catheter 350. In operation, the
expandable balloon 358 can be used to anchor the distal end 354 of
the third catheter 350 in the desired location within the venous
vessel wall 114. The expandable balloon 358 may be any expandable
balloon that is appropriate for insertion within a vessel and can
be formed of any material suitable for this function, including
without limitation, polyethylene, latex, polyestherurethane,
polyurethane, sylastic, silicone rubber, or combinations thereof.
Similar to the expandable balloon 158 of the second catheter 150,
the expandable balloon 358 is capable of being controlled by a
clinician such that it can inflate and/or deflate to the proper
size. The appropriate size of the expandable balloon 358 can be
determined through any technique known in the art, including
without limitation, by measuring the compliance of the expandable
balloon 358 ex vivo or in vivo. Furthermore, when the guidewire 310
is used to facilitate the delivery of the distal end 354 of the
third catheter 350 into the desired location within the venous
vessel wall 114, the electrodes on the distal end of the guidewire
310 may be used to accurately measure the cross-sectional area of
the venous vessel 114 such that the expandable balloon 358 can be
precisely sized prior to insertion into the vein 114. In this at
least one embodiment, the expandable balloon 358 is in fluid
communication with a secondary lumen 360 disposed within the at
least one lumen 356 of the third catheter 350. In this example, the
secondary lumen 360 is coupled with a balloon port 362 that extends
from the proximal end 352 of the third catheter 350. Accordingly,
when the SSA system 300 is positioned within a patient, the balloon
port 362 can be easily accessed by a clinician, subcutaneously,
percutaneously or otherwise, and used to inflate or deflate the
expandable balloon 358 with no or minimal invasion to the
patient.
[0088] Similar to the second catheter 150, the distal end 354 of
the third catheter 350 may further comprise at least one sensor 366
coupled therewith. The at least one sensor 366 may be configured
identically to the at least one sensor 166 of the second catheter
150 and, accordingly, the at least one sensor 366 may be used to
monitor the pressure of blood flow through the at least one lumen
356 of the third catheter 350 or the venous vessel 114 or to
monitor the pH or the concentrations of carbon dioxide, lactate, or
cardiac enzymes within the blood. Furthermore, the at least one
sensor 366 is capable of communicating the data it gathers to the
remote module 180 through the use of a wireless technology such
that a clinician can easily access the gathered information on a
real-time basis or otherwise. In at least one embodiment, the at
least one sensor 366 is disposed on the distal end 354 of the third
catheter 350 distally of the expandable balloon 358; however, it
will be understood that the at least one sensor 366 may be disposed
in any location on the distal end 354 of the third catheter 350.
The Y connector 320 of the SSA system 300 comprises flexible
material and has a proximal end 322, a distal end 324 and at least
one lumen 326 extending between the proximal and distal ends 322,
324. The proximal end 322 of the Y connector 322 is open and
configured to be securely coupled with the graft 190. The distal
end 324 of the Y connector 322 comprises two open ends which extend
from the body of the Y connector 322 in a substantially Y-shaped
configuration. The two open ends of the distal end 324 of the Y
connector 322 thereby divide the at least one lumen 326 into two
separate channels and thus the blood flowing through the at least
one lumen 326 is yet again bifurcated. The proximal end 152 of the
second catheter 150 is coupled with one of the two open ends of the
distal end 324 of the Y connector 322, thereby receiving a portion
of the blood flow that flows through the at least one lumen 326 of
the Y-connector. Similarly, the proximal end 352 of the third
catheter 350 is coupled with the other open end of the distal end
324 of the Y connector 322 and, thus, the third catheter receives a
portion of the blood flow that flows through the at least one lumen
326 of the Y-connector. In this manner, the SSA system 300 can be
used to simultaneously retroperfuse more than one ischemic area of
the body.
[0089] In application, the second catheter 150 and the third
catheter 350 are positioned adjacent to each other within the
venous vessel wall 114 as shown in FIG. 5. Furthermore, the distal
ends 154, 354 of the second and third catheters 150, 350,
respectively, may be placed within different veins such that the
arterial blood is delivered to selective portions of ischemic
tissue. For example, as shown in FIG. 6, in at least one embodiment
the SSA system 300 can be applied to a heart 314 to provide an
arterial blood supply to two separate coronary veins, or
sub-branches, simultaneously. In this at least one embodiment, the
distal ends 154, 354 of the second and third catheters 150, 350 are
both advanced through the coronary sinus 370. As the diameter of
the coronary sinus 370 ranges from about 10 to about 20
millimeters, cannulating the coronary sinus 370 with both the
second and third catheters 150, 350 does not occlude the normal
antegrade flow of the blood therethrough. Upon reaching the veins
or sub-branches of interest, the distal ends 154, 354 of the second
and third catheters 150, 350 are each independently positioned
within the veins of interest. In the example shown in FIG. 6, the
second catheter 150 is positioned within the interventricular vein
374 and the distal end 354 of the third catheter 350 is positioned
within the middle cardiac vein 376. As with autoretroperfusion
system 100, the expandable balloons 158, 358 are inflated through
balloon ports 162, 362, respectively (shown in FIG. 5), such that
the distal ends 154, 354 of the second and third catheters 150, 350
are securely anchored in the desired location within the veins of
interest. In this manner, the SSA system 300 can deliver controlled
arterial blood flow to, and thus arterialize, two areas of the
heart 314 simultaneously.
[0090] In at least one embodiment of the SSA system 300, the
components of the system 300 are available in a package. Here, the
package may also contain sterile syringes with the fluids to be
injected into the balloon ports 162, 362 to inflate the expandable
balloons 158, 358, respectively. Furthermore, the package may also
contain devices to facilitate delivery of the SSA system 300 such
as arterial and venous access devices, a delivery catheter, at
least two guidewires (configured as described in connection with
the delivery of autoretroperfusion system 100), an introducer to
maintain the catheter 10 in the collapsed position during delivery
and, in those embodiments where a coil is used to arterialize the
vein of interest, a pusher bar as is known in the art. Now
referring to FIG. 7, a flow chart of a method 400 for performing
automatic retroperfusion using the system 100 is shown. While the
method 400 is described herein in connection with treating a heart
through catheterization of the coronary sinus, it will be
understood that the method 400 may be used to perform
autoretroperfusion on any organ or tissue in need of retroperfusion
treatment and/or other areas near the coronary sinus, such as the
great cardiac vein, for example. Method 400, and the embodiments
thereof, can be performed under local anesthesia and do not require
any arterial sutures. Further, once implanted, the system 100 can
deliver chronic treatment to the patient as the system 100 is
capable of remaining within a patient's vascular system for an
extended period of time. In this manner, the system 100 and method
400 can be used to treat no-option patients and greatly enhance
their quality of life. As shown in FIG. 7, in one approach to the
method 400, at step 402 an artery 502 of interest is percutaneously
punctured under local anesthesia with a conventional artery access
device or as otherwise known in the art. For example and without
limitation, in at least one embodiment, an 18 gauge needle is
inserted into the femoral or subclavian artery. At step 404, the
catheter 10 housed in a collapsed position within an introducer 504
(see FIG. 8A) is inserted into the artery 502 of interest. After
the distal end 14 of the catheter 10 is positioned in the desired
location within the artery 502, the introducer 504 is proximally
withdrawn from the artery 502 as shown in FIG. 8B, leaving the
catheter 10 positioned therein.
[0091] In at least one embodiment, the projection cannula 16 is
configured such that when the introducer 504 is withdrawn in a
proximal direction, the proximal end 12 of the catheter 10 is
released from the introducer 504 before the proximal end 20 of the
projection cannula 16 is released from the introducer 504. In this
manner, the proximal end 12 of the catheter 10 is delivered within
the interior of the arterial wall 502, while the projection cannula
16 remains housed within the interior of the introducer 504 as
shown in FIG. 8C. Furthermore, because the introducer 504 no longer
applies downward pressure to the projection cannula 16 relative to
the proximal end 12 of the catheter 10, the projection cannula 16
is allowed to shift from the collapsed position to the expanded
position and therefore extends in a direction that is not parallel
with the artery 502 or the body of the catheter 10. In this manner,
as shown in FIGS. 8C and 8D, the proximal end 20 of the projection
cannula 16 is directed through the opening formed in the arterial
wall 502 by the introducer 504. Accordingly, when the catheter 10
is positioned within the artery 502, the antegrade blood arterial
blood flow is allowed to continue through the artery 502 through
the proximal end 12 of the catheter 10, while only a portion of the
arterial blood is rerouted through the projection cannula 16 and
into the veins 506 of interest. In this manner, the normal blood
flow through the artery 502 is not inhibited by operation of the
autoretroperfusion system 100. Furthermore, in addition to
bifurcating the blood flowing through the artery 502, the
projection cannula 16 traversing the arterial wall 502 further
functions to anchor the catheter 10 in the desired position within
the artery 502.
[0092] In the embodiment where the catheter 10 further comprises
the expandable balloon 58 (see FIG. 1), step 404 may further
comprise inflating the expandable balloon 58 to the desired size by
injecting fluid into the balloon port 62. In this manner, the
expandable balloon 58 functions to further anchor the catheter 10
in the desired location within the artery 502 and seal the opening
in the artery 502 through which the projection cannula 16 projects
(see FIG. 8E). At step 406, a vein 506 of interest is
percutaneously punctured under local anesthesia with a conventional
venous access device or as otherwise known in the art. For example
and without limitation, in at least one embodiment, an 18 gauge
needle is inserted into the femoral or subclavian vein. At step
408, a delivery catheter 508 is inserted into and advanced through
the vein 506 to catheterize the coronary sinus ostium. A guidewire
510 is then inserted at step 410 into the delivery catheter 510 and
advanced into the lumen of the vein 506 through the distal end of
the delivery catheter 510. Furthermore, the guidewire 510 is
advanced into the region of interest by use of x-ray (i.e.
fluoroscopy), direct vision, transesophageal echocardiogram, or
other suitable means or visualization techniques.
[0093] FIGS. 9 and 10 show schematic views of the method 400 as
applied to a heart 500. Specifically, in this at least one
embodiment, at steps 402 and 404 the artery 502, which in FIG. 9
comprises the subclavian artery, is punctured and the catheter 10
is inserted and positioned therein. Further, at step 406 the vein
506, which in FIG. 9 comprises the subclavian vein, is punctured
and at step 408 the delivery catheter 508 is advanced through the
superior vena cava 518 and into the coronary ostium of the coronary
sinus 520. As shown in FIG. 10, at step 410, the guidewire 510 is
advanced through the coronary sinus 520 and into the vein of
interest, which, in this at least one embodiment, comprises the
posterior vein 522 of the heart 500.
[0094] Now referring back to FIG. 7, the guidewire 510 inserted
into the vein 506 at step 410 may further comprise a plurality of
impedance electrodes as previously described herein. In this
approach, the guidewire 510 may be used at optional step 411 to
determine the size of the vessel of interest through use of the
plurality of impedance electrodes disposed thereon. In this manner,
a clinician can use the measurements generated by the impedance
electrodes to select a properly sized expandable balloon 158 for
use in connection with the second catheter 150. By using a
precisely sized expandable balloon 158 and inflation volume, the
clinician can ensure that the distal end 154 of the second catheter
150 is securely anchored within the vessel of interest without
imposing an undue force on the venous vessel walls. After the
guidewire 510 has been advanced into the vessel of interest at step
410 and, optionally, the dimensions of the vessel of interest have
been measured at step 411, the method 400 advances to step 412. At
step 412, the distal end 154 of the second catheter 150 is inserted
into the delivery catheter 508 over the guidewire 510. Accordingly,
the guidewire 510 is slidably received by the at least one lumen
156 of the second catheter 150. The distal end 154 of the second
catheter 150 is then advanced over the guidewire 510 to the region
of interest and the expandable balloon 158 of the second catheter
150 is inflated to anchor the distal end 154 within the targeted
vessel. FIG. 11 shows a schematic view of the method 400, as
applied to the heart 500, after step 412 has been completed. It
will be understood that at any point after the distal end 154 of
the second catheter 150 is positioned and anchored within the
desired location in the targeted vessel, the delivery catheter 508
and the guidewire 510 may be withdrawn from the vein of interest.
After the distal end 154 of the second catheter 150 is secured
within the targeted vessel, at step 414 the anastomosis between the
vein 506 and the artery 502 is formed. Specifically, in at least
one approach, the proximal end 20 of the projection cannula 16 of
the catheter 10 is coupled with the proximal end 152 of the second
catheter 150 by way of the connector 170. In the at least one
embodiment of the system 100 comprising the first graft 185 and the
second graft 190, the connector 170 may be coupled with the
catheter 10 and the second catheter 150 via the first graft 185 and
the second graft 190 to form an elongated anastomosis.
Alternatively, in yet another approach, the connector 185 may be
coupled with the catheter 10 via the proximal end 20 of the
projection cannula 16 and the second catheter 150 via only the
second graft 190. It will be understood that any combination of the
catheter 10, the second catheter 150 and the first and second
grafts 185, 190 may be used in connection with the connector 170 to
form the desired anastomosis between the vein 506 and the artery
502.
[0095] After the anastomosis is formed and the arterial blood is
allowed to flow through the anastomosis and thereby through the
connector 170, at step 416 the connector 170 measures the flow
rate, pressure and any other desired data of the arterial blood
flow. The connector 170 transmits the collected data to the remote
module 180 either through intravascularly placed leads or
wirelessly, through telemetry or other means. In this manner, a
clinician may easily view the blood flow data on the remote module
180 and assess the degree of pressure drop that will be required to
preserve and gradually arterialize the vein 506. At step 418, the
pressure of the arterial blood flow through the system 100 is
modified to transmit the desired pressure to the venous system. In
this step 418 the pressure modification can be achieved through a
clinician modifying the means of regulating the blood flow of the
connector 170 through remote means or, in at least one embodiment
of the system 100, inflating the internal expandable balloon of the
second catheter 150 using the internal balloon port in order to
partially occlude the flow of arterial blood through the at least
one lumen 156 of the second catheter 150. Furthermore, in at least
one alternative embodiment of the system 100, a clinician may
deliver a resorbable stenosis configured to achieve the necessary
pressure drop into the at least one lumen 156 of the second
catheter 150 through means known in the art. Alternatively, as
previously described in connection with autoretroperfusion system
100, the remote module 180 may further comprise a computer or other
processing means capable of being programmed to automatically
analyze the data received from the connector 170 and, based on such
data, determine the proper degree of adjustment required in the
blood pressure flowing through the anastomosis. In this embodiment,
at step 418, the remote module 180 automatically adjusts the means
of regulating the blood flow of the connector 170 to achieve the
optimal pressure drop. In this manner, the desired pressure drop
between the arterial system and the venous system is immediately
achieved and the risk of venous rupture is significantly reduced.
In step 420 the method 400 allows the arterial blood having a
modified pressure to irrigate the vein 506 for a period of time
such that the vein 506 properly arterializes. For example, and
without limitation, the patient's venous system may be subjected to
the reduced arterial pressure for about fourteen days to allow the
vein 506 to adapt to the elevated blood pressure flowing
therethrough.
[0096] After arterialization of the vein 506 is achieved, at step
422 the patient may optionally undergo a coronary venous bypass
graft surgery and the components of the autoretroperfusion system
100 may be removed. However, as previously discussed, even with a
properly arterialized vein 506, many patients that require
retroperfusion therapy may still not be candidates for a coronary
vein bypass graft surgery. In the event that the patient is unable
to tolerate such a procedure, after the vein 506 has arterialized
at step 420, the method 400 can progress directly to step 424. At
step 424, the pressure modification of the arterial blood flowing
through the second catheter 150 is ceased. Accordingly,
pre-arterialized veins 506 are subjected to the full arterial
pressure of the blood flowing through the anastomosis and second
catheter 150. In at least one embodiment, a clinician can cease the
pressure modification by adjusting the controller 170.
Alternatively, in the at least one embodiment where the controller
170 can be automatically adjusted by the remote module 180, the
remote module 180 can automatically adjust the controller 170 after
the veins 506 have pre-arterialized. Further, where the pressure
drop is achieved through the use of an internal expandable balloon
positioned within the at least one lumen 156 of the second
catheter, the clinician may deflate the internal expandable balloon
through the internal balloon port and thereafter withdraw the
deflated internal expandable balloon through the tertiary lumen of
the second catheter and the internal balloon port. In yet another
embodiment where a resorbable stenosis is used to achieve the
pressure drop in the arterial blood as it flows through the second
catheter 150, the resorbable stenosis can be configured to dissolve
after the desired period of time, thereby gradually decreasing the
influence the resorbable stenosis has on the pressure of the blood
flowing through the at least one lumen 156 of the second catheter
over a period of time. Accordingly, the autoretroperfusion system
100 can remain chronically implanted within the patient to deliver
oxygen-rich blood to a targeted area of tissue over an extended
period of time.
[0097] Now referring to FIG. 12, a flow chart of a method 600 for
performing simultaneous selective retroperfusion using the SSA
system 300 is shown. While the method 600 is described herein in
connection with treating a heart 500 through catheterization of the
coronary sinus 520, it will be understood that the method 600 may
be used to perform autoretroperfusion on any organ or tissue in
need of retroperfusion treatment. The reference numerals used to
identify the steps of method 600 that are included in the
description of method 400 designate like steps between the two
methods 400, 600. As such, like steps between the two methods 400,
600 will not be discussed in detail with respect to the method 600
and it will be understood that such description can be obtained
through the description of the method 400. Method 600, and the
embodiments thereof, can be performed under local anesthesia and
does not require arterial sutures. Further, once implanted, the SSA
system 300 can deliver simultaneous chronic treatment to multiple
ischemic locations as the system 300 is capable of remaining within
a patient's vascular system for an extended period of time and
selectively retroperfusion more than one sub-branch of a vein 506.
The method 600 progresses through steps 402 through 410 as
previously described in connection with the method 400. After the
guidewire 510 is advanced through the coronary sinus 520 and into
the first vein of interest, a second guidewire 610 is inserted at
step 602 into the delivery catheter 508 adjacent to the guidewire
510, and advanced into the lumen of the vein 506 through the distal
end of the delivery catheter 510. The second guidewire 610 is then
advanced into a second region of interest by use of x-ray (i.e.
fluoroscopy), direct vision, transesophageal echocardiogram, or
other suitable means or visualization techniques. The second
guidewire 610 is configured similar to the guidewire 510 and is
capable of functioning the in the same manner.
[0098] FIG. 13 shows a schematic view of the method 600 as applied
to a heart 500. Specifically, in this at least one embodiment, FIG.
13 shows the method 600 at step 602 wherein the guidewire 510 is
inserted a first vein of interest, which comprises the posterior
vein 522 of the heart 500, and the second guidewire 610 is inserted
into a second vein of interest, which comprises the
interventricular vein 622 of the heart 500. Now referring back to
FIG. 12, the guidewire 610 inserted into the second vein of
interest in step 602 may further comprise a plurality of impedance
electrodes as previously described with respect to the guidewire
510. In this embodiment, the guidewire 610 may be used at optional
step 603 to determine the size of the second vessel of interest
through use of the plurality of impedance electrodes disposed
thereon. In this manner, a clinician can use the measurements
generated by the impedance electrodes to select a properly sized
expandable balloon 358 for use in connection with the third
catheter 350. By using a precisely sized expandable balloon 358 and
inflation volume, a clinician can ensure that the distal end 354 of
the third catheter 350 is securely anchored within the second
vessel of interest without imposing an undue force on the venous
vessel walls. After the guidewire 610 has been advanced into the
second vessel of interest at step 602 and, optionally, the
dimensions of the second vessel of interest have been measured at
step 603, the method 600 advances to step 412 wherein the second
catheter 150 is inserted over the guidewire 510 as described in
connection with method 400. At step 604, the distal end 354 of the
third catheter 350 is inserted into the delivery catheter 508 over
the second guidewire 610. Accordingly, the second guidewire 610 is
slidably received by the at least one lumen 356 of the third
catheter 350. The distal end 354 of the third catheter 350 is then
advanced over the second guidewire 610 to the second region of
interest and the expandable balloon 358 of the third catheter 350
is inflated to anchor the distal end 354 within the targeted
vessel. FIG. 14 shows a schematic view of the method 600 at step
604 as applied to the heart 500. It will be understood that at any
point after the distal ends 154, 354 of the second and third
catheters 150, 350 are positioned and anchored in the desired
locations within the targeted vessels, the delivery catheter 508
and the guidewires 510, 610 may be withdrawn from the vein 506.
[0099] After both the distal end 154 of the second catheter 150 and
the distal end 354 of the third catheter 350 are secured within the
targeted vessels, the method 600 proceeds to step 414 where the
anastomosis is formed between the vein 506 and the artery 502 as
described in connection with method 400. Thereafter, the method 600
advances through steps 416 through 424 as described in connection
with the method 400. Furthermore, at step 418, it will be
recognized that a clinician can independently adjust the pressure
drop through the second and third catheters 150, 350 in the event
that an internal expandable balloon is used in either or both
catheters 150, 350 or resorbable stenosis are employed within the
at least one lumens 156, 356 of the second and third catheters 150,
350. Alternatively, in the at least one embodiment where the
controller 170 comprises a means for regulating the blood flow
through the anastomosis, the pressure of the arterial blood flowing
through both the second and third catheters 150, 350 may be
substantially the same. As described herein, the method 600 may be
used to simultaneously and immediately treat two different ischemic
areas of a tissue through the use of one minimally to non-invasive
procedure. Furthermore, the method 600 can provide no-option
patients with a viable treatment option that is not associated with
contraindications for congestive heart failure, diabetes, or drug
treatment.
[0100] An additional embodiment of a perfusion system 100 of the
present disclosure is shown in FIG. 15. As shown in FIG. 15, system
100 comprises a first catheter 1000 having a distal end 1002, a
proximal end 1004, and defining a lumen 1006 therethrough, wherein
at least a portion of first catheter 1000 is configured for
insertion into a body of a patient, such as into a patient's heart
or a patient's vein, for example. First catheter 1000, after
insertion into a patient's vein or heart, for example, is capable
of providing arterial blood (which is relatively rich in oxygen and
other nutrients) thereto by way of transfer of arterial blood from,
for example, a patient's artery, as described below, into a
proximal catheter opening 1008, through lumen 1006, and out of
distal catheter opening 1010. In such a fashion, for example, a
system 100 can be referred to as an autoretroperfusion system 100,
noting that no outside pumps are necessary (as the patient's own
heart serves as the pump), and due to the retrograde nature of the
perfusion with respect to such a use. Exemplary uses, as provided
in detail herein, are to provide arterial blood, using system 100,
to a patient's femoral vein, internal jugular vein, subclavian
vein, and/or brachial cephalic vein. In an exemplary embodiment,
first catheter 1000 may be tapered toward distal end 1002 to
facilitate insertion into a patient. In at least one embodiment of
system 100, and as shown in FIGS. 15 and 16, system 100 comprises a
coupler 1012 having an outlet port 1013 and one or more additional
ports to facilitate connection outside of the patient's body. For
example, and as shown in FIGS. 15 and 16, coupler 1012 comprises an
inflation port 1014, whereby fluid and/or gas introduced into
inflation port 1014 can be used to inflate an expandable balloon
1016 positioned along first catheter 1000 at or near the distal end
1004 of first catheter 1000. As shown in the figures, and in at
least one embodiment, an inflation tube 1018 may be coupled to
inflation port 1014 at a distal end 1020 of inflation tube 1018,
whereby inflation tube 1018 may also have an optional flow
regulator 1022 positioned relative thereto to regulate the flow
and/or pressure of fluid and/or gas in and out of a lumen 1024 of
inflation tube 1018 to inflate and deflate expandable balloon 1016.
Inflation tube 1018 may further comprise a proximal connector 1026
configured to receive fluid and/or gas from a fluid/gas source (not
shown), whereby proximal connector 1026 can be positioned at or
near a proximal end 1028 of inflation tube 1018, for example.
Inflation of expandable balloon 1016, for example, can be used to
anchor first catheter 1000 to a desired position within a luminal
organ of a patient. An exemplary coupler 1012 of the present
disclosure further comprises an arterial blood port 1030 configured
to receive arterial/oxygenated blood from, for example, an arterial
blood tube 1032 coupled thereto at or near a distal end 1034 of
arterial blood tube 1032. As shown in FIGS. 15 and 16, a blood flow
regulator 1036 may be positioned relative to arterial blood tube
1032 and operate to regulate the flow and/or pressure of
arterial/oxygenated blood flow therethrough. In at least one
embodiment, blood flow regulator 1036 comprises a rotatable dial
capable of rotation to apply and/or remove pressure to/from
arterial blood tube 1032 to regulate the flow and/or pressure of
blood through a lumen 1038 of arterial blood tube 1032 and/or to
adjust pressure therein based upon identified blood pressure
measurements. Such a blood flow regulator 1036, for example, can be
used to control blood pressure to limit injury to the patient's
luminal organs (such as the patient's venous system and/or
myocardium) and/or to minimize potential edema with respect to the
same luminal organs. Arterial blood tube 1032 may further comprise
a proximal connector 1040 configured to receive arterial/oxygenated
blood from a blood supply, whereby proximal connector can be
positioned at or near a proximal end 1040 of arterial blood tube
1032, for example. A coupler catheter 1042, as shown in the
component block diagram of system 100 shown in FIG. 17, may be used
to couple arterial blood tube 1032 to a blood supply 1044, which,
as described herein, could be a patient's own artery using the
patient's heart as a pump, or could be an external supply that
provides blood to arterial blood tube 1032, which may then be used
in connection with an apparatus to remove blood from the patient as
well.
[0101] Furthermore, and in at least one embodiment, an exemplary
coupler 1012 of the present disclosure further comprises a
medicament port 1046 configured to receive a medicament, saline,
and/or the like, so that the same can enter the patient by way of
first catheter 1000. Medicament port 1046, as shown in FIGS. 15 and
16, may receive a medicament tube 1048 defining a lumen 1050
therethrough, whereby a distal end 1052 of medicament tube 1048 can
couple to medicament port 1046 so that a medicament, saline, and/or
the like can be introduced from a medicament source (not shown)
coupled to medicament tube 1052 at or near a proximal end 1054 of
medicament tube 1048. Exemplary medicaments may include, but are
not limited to, fibrinolitic drugs, cardiotonic drugs, antirrhytmic
drugs, scavengers, cells or angiogenic growth factors, for example,
through the coronary vein or another luminal organ. In at least one
embodiment, and as shown in FIGS. 15 and 16, medicament tube 1048
can be branched, whereby a second proximal end 1056 of medicament
tube 1048 can receive a medicament and control the flow of
medicament therethrough, for example, by way of a medicament
regulator 1058 positioned relative to medicament tube 1048, for
example. Furthermore, one or more of proximal end 1054 and second
proximal end 1056 may be configured to receive a wire therein, such
as, for example, a 0.035'' guidewire and/or a 0.014'' pressure
wire. As generally referenced herein, any blood, air, fluid,
medicament, wire, etc. that enters coupler 1012 by way of inflation
port 1014, arterial blood port 1030, and/or medicament port 1046
and eventually enters a lumen of first catheter 1000 will enter one
or more of said ports of coupler 1012 and exit outlet port 1013 at
the time of entry into first catheter 1000. FIG. 17, as referenced
above, is a block diagram of various components of an exemplary
system 100 of the present disclosure. As shown therein, an
exemplary embodiment of a system 100 of the present disclosure
comprises a first catheter 1000, a coupler 1012, an arterial blood
tube 1032 with a blood flow regulator 1036, and a coupler catheter
1042 configured to for connection to a blood supply 1044, wherein
the blood supply may or may not be considered as part of a formal
system 100. In addition, an exemplary system 100 may comprise an
inflation tube 1018 with a flow regulator 1022, whereby an end of
inflation tube 1018 is configured for connection to a gas/liquid
source 1060. Various embodiments of systems 100 of the present
disclosure may have more or less components than shown in FIG. 17,
and exemplary embodiments of systems 100 of the present disclosure
may be configured to engage various embodiments of catheters 10 as
referenced herein.
[0102] In use, for example, first catheter 1000 of system 100 may
be positioned within a luminal organ of a patient within the
patient's venous system. Inflation of expandable balloon 1016 to
secure first catheter 1000 can not only provide oxygenated arterial
blood to the patient's venous system, but can also continue to
allow coronary venous return to continue due to the selective
autoretroperfusion nature of an exemplary embodiment of system 100
and use thereof and due to the redundancy of the patient's venous
system. In the event that an increased pressure, edema, or other
undesired condition may occur at or near the site of inflated
expandable balloon 1016, a user of system 100 could, if desired,
temporarily deflate expandable balloon 1016 to allow the increased
pressure and or edema to alleviate itself. For example, system 100
could be used for a relatively long period of time (an hour, by way
of example), and expandable balloon 1016 could be deflated for a
relatively short period of time (seconds, for example), to
alleviate a high pressure or edema occurrence, and then expandable
balloon 1016 could be re-inflated to again secure first catheter
1000 at a desired location within the patient. The type of patients
for whom the device will be utilized in the acute application may
fall into various categories, including, but not limited to, S-T
segment Elevated Myocardial Infarction (STEMI) patients,
cardiogenic shock patients, and high risk Percutaneous Coronary
Intervention (PCI) patients (such as those undergoing PCI of the
left main coronary artery). STEMI is the traditional "emergent"
patient who presents with classic heart attack symptoms, and when
diagnosed in a hospital emergency room for example, the patient
would traditionally be immediately moved to a Cath Lab to receive
PCI to open an occluded coronary artery and restore blood flow to
the myocardium. These patients are hemodynamically unstable and
need support for the left ventricle.
[0103] In such a use, for example, an exemplary system 100 of the
present disclosure could be used to, for example: (i) provide
cardiac support to a patient who does not have immediate access to
the Cath Lab and PCI. These patients may present in rural or
community hospitals that do not have Cath Labs. They will need some
type of temporary support while being transferred to an appropriate
facility. These patients might also present at a hospital with a
Cath Lab, but the Cath Lab is either understaffed to treat the
patient, or does not have an available room to treat. In these
cases, the system 100 of the present disclosure operates as a
bridge to provide support until definitive treatment (primary PCI)
is available; and/or (ii) provide cardiac support before, during,
and after primary PCI. Many patients enter the Cath Lab in an
unstable condition, and the insertion of balloons and stents adds
to hemodynamic instability. An exemplary system 100 can provide
cardiac support and improve hemodynamics such that the physician
can operate in a more stable/controlled environment. It is also
believed that by reperfusing ischemic myocardium before/during/and
after primary PCI, one may reduce the amount of myocardium that is
damaged by the ischemic event. This is clinically referred to as a
"reduction in infarct size." Initial animal studies (as referenced
in further detail herein) have suggested that the use of SARP in
support of STEMI patients could cause a reduction in infarct size,
which would have a significant impact on the outcomes for the
patient in both the near and long term. Reduction in infarct size
would slow the progression of any subsequent heart failure and
reduce long term hospitalization and costs for this group of
patients.
[0104] Cardiogenic shock is marked by a significant lowering of
blood pressure and cardiac output that if not reversed, will
ultimately lead to multisystem organ failure and death. Cardiogenic
shock patients have a mortality exceeding 60%. In many cases,
cardiogenic shock patients are too unstable to undergo surgery or
PCI. Pharmacologics are used to increase pressure and cardiac
output. Intra Aortic Balloon Pumps (IABP) and other LVAD type
products are also employed to improve hemodynamics in an attempt to
reverse the downward cycle of cardiogenic shock patients Exemplary
embodiments of systems 100 of the present disclosure could be used
in much the same fashion. High Risk PCI is typically defined as
patients who have disease of the left main coronary artery, are
diabetic, have multivessel disease, are above 75 years of age, have
a prior history of MI, have renal insufficiency, etc. These are
very sick patients, who are considered at high risk of adverse
events before, during, and after undergoing PCI. Mortality rates
and Major Adverse Cardiac Event (MACE) rates are much higher in
this patient population. IABP's are commonly used in this patient
population. In this population, systems 100 of the present
disclosure may be used to provide cardiac support for a high risk
PCI patient who is, at the time of the procedure, found to be
hemodynamically unstable. It is evident to the operator that
cardiac support is and will be needed during the procedure, and an
exemplary system 100 of the present disclosure would be deployed
from the outset. The patient's hemodynamics improve and the
operator feels more comfortable working in the coronary system.
IABP use is common in these patients.
[0105] Systems 100 of the present disclosure may also be used in
this high risk population when it is anticipated that cardiac
support may be needed during the procedure. In this case, an
exemplary system 100 is deployed prior to the case, in order to
provide support when and if it is needed. The patient is
hemodynamically stable at the outset, and remains so throughout.
IABP's are currently used in this fashion. This is commonly
referred to as prophylactic use of cardiac support.
[0106] Acute Applications:
[0107] In this setting, exemplary systems 100 of the present
disclosure will be used for cardiac support and to protect
myocardium for a period of time that will generally be less than 24
hours. The clinical condition that precipitated the need for SARP
will have typically been resolved in that 24 hour period, and the
system 100 would be removed. However, use of systems 100 of the
present disclosure are not limited to a 24 hour period, as in some
cases, IABPs and other short term cardiac support devices are left
in for periods exceeding 24 hours. Typically, the longest period of
time that a short term device might be left in place is 4-6 days,
at which point the clinician would begin to consider longer term
implanted Left Ventricular Assist Devices (LVADs), which can
support a patient for an extended period of time (weeks), and are
often used as a bridge to heart transplant.
[0108] Clinical conditions that would require the acute application
of an exemplary system 100 of the present disclosure include, but
are not limited to: (i) Emergent treatment of STEMI and/or other
Acute Myocardial Infarction (AMI) patients; (ii) Cardiogenic shock;
(iii) High Risk PCI; (iv) Failed or aborted PCI where severe
hemodynamic instability presents after initiation of the procedure.
These patients are often transferred to immediate cardiac surgery,
and require cardiac support while waiting for the surgical
intervention; and/or (v) Weaning from a cardiopulmonary bypass
machine in cardiac surgery. Some cardiac surgery patients have
difficulty returning to normal cardiac condition when the
cardiopulmonary bypass machine is turned off and the heart is
restarted after successful revascularization in cardiac surgery.
Exemplary systems 100 of the present disclosure could be used to
support the heart until normal cardiac parameters return. Insertion
could occur in the surgical suite, and the device would be left in
place while the patient was transferred to a Cardiac Critical Care
Unit (CCU). These exemplary clinical conditions cover the majority
of potential applications for an acute embodiment of a system 100
of the present disclosure. Currently, more than 95% of all IABP and
other short term support devices are used for these applications.
In such applications, the goal of using an exemplary system 100 of
the present disclosure is to deliver arterial (oxygenated) blood to
the myocardium, in a retrograde manner using the venous system, in
order to create hemodynamic stability for the patient and to
protect and preserve myocardial tissue until the clinical event
resolves or primary intervention (PCI or CABG) and
revascularization can occur.
[0109] Chronic Applications:
[0110] In this setting it is intended that an exemplary embodiment
of a system 100 of the present disclosure be implanted for 2 weeks
or longer, for example, noting that ultimate implantation may be
somewhat shorter in duration. Initial animal studies suggest that
within 2 weeks, arterialization of the venous system is achieved,
such that the venous system can become the conduit for a constant
flow of arterial blood at arterial pressure. A clinical condition
where the chronic application of a system 100 would be utilized is
often referred to as "no option" patients, that is, patients for
which there are no options available through which their clinical
condition can be resolved. More specifically, these are patients
with diffuse coronary artery disease (CAD) or refractory angina,
where PCI and/or Coronary Artery Bypass Graft Surgery (CABG) is not
an option. Patients that are diabetic, or have other
co-morbidities, and are not candidates for interventions, would be
candidates for a chronic application of a system 100 of the present
disclosure. As previously referenced herein, the chronic
application will generally require 10-14 days of retroperfusion in
order to allow arterialization of the venous system. In certain
instances, retroperfusion could be required for a longer period
(such as 2-3 weeks, for example), or a lesser period, such as less
than 10 days, for example. These patients, dependent upon their
complete clinical situation, may be hospitalized for that period,
or they may reside outside of the hospital. When residing outside
of the hospital, the device utilized may be a catheter 10
embodiment with a branched implantable portion, such as shown in
FIG. 1, for example. The catheter 10, including method of pressure
regulation, would be implanted in the patient.
[0111] For those chronic patients, who must remain in the hospital
for one of the aforementioned time periods, an acute embodiment of
a system 100, for example, may be applicable. In such an
embodiment, for example, system 100 may be percutaneously inserted
and utilized during that time frame. Once arterialization occurs, a
more permanent conduit may be constructed percutaneously or
surgically to provide the permanent arterial blood source. When
using an exemplary system 100 of the present disclosure, standard
guide catheters can be used by the clinician to locate the coronary
sinus and/or the great cardiac vein, for example. An 0.035''
guidewire can be inserted to further establish access to the
coronary sinus or the great cardiac vein. An exemplary system 100
can then be inserted over the 0.035'' guidewire and advanced to the
coronary sinus or the great cardiac vein, for example, via one of
the ports as referenced herein. The distal end 1004 of the first
catheter 1000 is intended to be located at the left main vein. The
operator may advance the tip (distal end 1014) of first catheter
1000 to other vein sites dependent on clinical need. A balloon
1016, which in at least one embodiment may be located approximately
2 cm back from the distal end 1004, would then be inflated to
secure the position of first catheter 1000 within the coronary
sinus or the great cardiac vein, for example, allowing for the
distal end 1004 of first catheter 1000 to locate at the left main
vein. The inflated balloon 1016 will also work to ensure that
arterial blood will flow in the retrograde fashion. Once the distal
balloon 1016 is inflated, the 0.035'' guidewire can be exchanged
for an 0.014'' pressure measurement wire, which will be used to
measure the pressure at the distal end 1004 of first catheter 1000,
to ensure that the portions of system 100 are not over pressurizing
the vein, and to tell the operator how much pressure change will be
required from the external pressure regulator. The proximal end of
the pressure wire will be connected to its appropriate monitor.
[0112] When the catheter is located in the coronary sinus or the
great cardiac vein, for example, the operator can now make the
external (outside the body) connection to the arterial blood supply
1044. This is typically, but not limited to, the femoral or radial
arteries. The physician will have previously inserted a standard
procedural sheath into the arterial source in order to gain access
to the source. This arterial sheath can also be used to provide
access for catheters, guidewires, balloons, stents, or other
devices that might be utilized while treating the patient. That
arterial sheath will have a connector which can connect to the
arterial supply cannula (with regulator) on the acute device (an
embodiment of system 100). Once the connection is established and
flow commences, the pressure wire will indicate the distal pressure
measurement and the regulator can be adjusted to the proper setting
(not to exceed 60 mmhg, for example). Monitoring of the distal
pressure will be on-going throughout the period of time that the
device is in-vivo. The regulator allows the operator to provide the
correct distal pressures and to adjust those pressures, dependent
on changes in the patient's pressure. With the pressure set and
monitored, the patient is now receiving oxygenated blood to the
myocardium in a retrograde fashion thru the coronary venous system.
Such an operation (namely to retrogradly provide oxygenated blood)
can be used to save a significant amount of ischemic tissue at the
level of the border zone. In at least one embodiment, such a system
100 is used to perfuse the left anterior descending vein to supply
oxygenated blood to the LAD artery occluded territory. Depending
upon patient need and circumstance, the acute device (an embodiment
of system 100) will be removed typically within the first 24 hours
of insertion. The physician will make that determination. The
insertion site will be closed per hospital protocol.
Validation of Methodology
[0113] As referenced in detail herein, coronary artery disease
(CAD) is the number one cause of morbidity and mortality in the
U.S. and worldwide. Even today, with percutaneous transluminal
coronary angioplasty (PTCA) and coronary artery bypass grafting
(CABG), optimal and timely treatment is still not available for all
patients. Bridge therapies to complement existing gold standards of
reperfusion therapy would be of significant value to a large number
of patients. Because the coronary venous system rarely develops
atherosclerosis, the use of the venous system for delivery of
oxygenated blood has been well explored. Synchronized retrograde
perfusion (SRP) and pressure-controlled intermittent coronary sinus
occlusion (PICSO) are two retroperfusion methods for acute
treatment of myocardial ischemia through the coronary venous
system. PICSO and SRP have been used in conjunction with a
balloon-tipped catheter positioned just beyond the orifice of the
coronary sinus connected to a pneumatic pump, and either passively
redirect coronary sinus blood (PICSO) or actively pump arterial
blood during diastole (SRP) to the ischemic myocardium. These
techniques have been shown to decrease ischemic changes, infarct
size, myocardial hemorrhage, and no-reflow phenomenon, and improve
left ventricular (LV) function when coronary blood flow is
reinstituted after an acute occlusion. Wide application of these
techniques, however, has been limited by concerns over their safety
and complexity, and in particular, the need for repeated occlusion
of the coronary sinus with a balloon. High pressure (SRP and PICSO)
and flow (SRP) can cause damage to the coronary sinus with
thrombosis and chronic myocardial edema.
[0114] We have validated in animal studies both the acute and
chronic application of the methodologies referenced herein. In a
recent acute study, we showed that preservation of the contractile
function of the ischemic myocardium can be accomplished with
selective autoretroperfusion (SARP) without the use of an external
pump during acute LAD artery ligation. The hypothesis that SARP can
preserve myocardial function at regulated pressures without
hemorrhage of vessels or damage of myocytes was verified. In
connection with this animal work, a bolus of Heparin was given
before instrumentation and was then supplemented as needed to keep
an activated clotting time (ACT) over 200 seconds. The right
femoral artery was cannulated with a 7Fr catheter and connected to
a pressure transducer (TSD104A--Biopac Systems, Inc) for monitoring
of arterial pressure. Before the sternotomy, the right carotid
artery was cannulated with a 10Fr polyethylene catheter through a
ventrolateral incision on the neck to reach the brachiocephalic
artery to supply the LAD vein during retroperfusion. The catheter
had a roller clamp that was used to control the arterial pressure
transmitted to the LAD vein. The right jugular vein was cannulated
with an 8Fr catheter for administration of drugs and fluids.
Lidocaine hydrochloride was infused at a rate of 60 .mu.g/kg/min
before opening the chest and during the rest of the procedure.
Magnesium sulfate (10 mg/min IV) along with lidocain was also used
to treat extrasystole in the case of the control group. A
vasopressor (Levophed.RTM., Norepinephrine Bitartrate Injection,
Minneapolis, Minn., 2-6 .mu.g/min IV) was used during the
procedure, and was adjusted accordingly to maintain a constant
arterial blood pressure (70.0.+-.8.9 mmHg, mean) in both the
experimental and the control groups. Finally, heparin and
nitroglycerine were diluted in 60 mL of 0.9% sodium chloride and
infused using a syringe pump at a rate of 1 ml/min. The chest was
opened through a midsternal thoracotomy, and an incision was made
in the pericardium with the creation of a sling to support the
heart with pericardial stay sutures.
[0115] A pair of piezoelectric ultrasonic crystals (2 mm in
diameter on 34 gauge copper wire--Sonometrics Corporation) were
implanted through small stab incisions in the anterior wall of the
LV (area at risk) distal to the planned site (below first diagonal
branch in the SARP group, and second diagonal branch in the control
group) of LAD artery ligation, for assessment of regional
myocardial function through measurement of midwall segment length
changes. An additional pair of crystals was also implanted in the
anterior wall of the LV within the normal perfusion bed (control
area) of the proximal portion of the LAD artery. FIG. 18 shows a
schematic of the retroperfusion system showing the arterial and
retroperfusion catheters. Each pair of crystals were positioned in
the midmyocardium (about 7 mm from the epicardium) approximately
10-15 mm apart and oriented parallel to the minor axis of the
heart. The acoustical signal of the crystals was verified by an
oscilloscope. In the SARP group (ligation+retroperfusion) the LAD
artery was dissected free from the surrounding tissue distal to the
first diagonal branch for subsequent ligation. A 2.5 mm flow probe
was placed around the LAD artery and connected to a flow meter
(T403--Transonic Systems, Inc). The LAD vein was also dissected
close to the junction with the great cardiac vein, and the proximal
portion ligated with 2-0 silk suture in order to prevent runoff to
the coronary sinus. The LAD vein was then cannulated below the
ligation with a 10Fr cannula that was attached to the
brachiocephalic catheter through one of two four-way stopcocks. A
flow probe was placed between the stopcocks for measurement of
coronary venous flow. Venous pressure was recorded through the
pressure monitoring line from the retroperfusion cannula (as shown
in FIG. 18). Retroperfusion was initiated immediately after
ligation of the LAD artery and was maintained for a period of 3
hours. Arterial blood samples were taken at baseline and at the end
of the first, second and third hours of ligation+retroperfusion for
monitoring of pH, hematocrit, electrolytes, activated clotting
time, and cardiac troponin I. Coronary venous SARP may be an
effective method of protecting the myocardium during acute ischemia
before definitive treatment is established as referenced herein
regarding various catheter 10 and system 100 embodiments of the
present disclosure. SARP may not only offer protection to the
ischemic myocardium through retrograde perfusion of oxygenated
blood but may also serve as a route for administration of
thrombolytics, antiarrhythmics, and cell and gene therapy to the
jeopardized myocardium before PTCA or CABG can be implemented in
patients eligible for these procedures.
[0116] In addition to the foregoing, various devices and systems of
the present disclosure can be used to perform methods for
retroperfusion of various bodily organs to treat many different
types of conditions. As referenced above, providing blood from one
bodily vessel to another bodily vessel can be performed using
devices and systems of the present disclosure, but in accordance
with the following, said devices and systems can also be used to
perform the following novel methods and procedures.
[0117] As generally referenced above, the concept of using veins to
deliver oxygenated nutrient-filled blood (arterial blood) is
predicated on the fact that despite any extent of the coronary
arterial disease, the corresponding venous counterpart is
atherosclerosis-free. An additional fact is that the upper body
arterial system has much less predilection for atherosclerosis than
the lower body. As such, the present disclosure identifies that the
upper body can generally serve as the source of arterial blood to
the venous systems of organs with arterial disease, and that
devices and systems of the present disclosure can also be used in
that regard. An additional characteristic of the venous system
necessary to facilitate SARP (as referenced herein) is the
existence of a redundancy of the venous system (namely multiple
veins per artery as well as interconnections between venous
vessels) to ensure proper venous drainage when portion of the
system is used for SARP.
[0118] In view of the foregoing, a number of embodiments for
retroperfusion of various organs or bodily regions that identify
arterial blood donor and organ (venous system) are identified with
the present disclosure, including, but not limited to, the
following:
[0119] (i). Peripheral vessels. Embodiments of devices and systems
of the present disclosure can be used to provide oxygenated blood
from the femoral artery, the internal femoral artery, or the iliac
artery, for example, to the distal saphenous vein or to deep muscle
veins for arterialization in diabetic patients (a diffuse disease)
to treat, for example a leg pre-amputation or a necrotic or
gangrenous foot ulcer. This venous system has valves (typically
larger than 1-1.5 mm in diameter) which can be overcome (inverted)
through catheterization (namely the insertion of guidewire and SARP
catheter, with guidewire dimensions down to 0.35 mm for 0.014''
standard guidewire) to facilitate said peripheral vessel
treatment.
[0120] (ii). Kidney-Renal Vein. Embodiments of devices and systems
of the present disclosure can also be used to facilitate
arterialization of the renal vein, which can be partial (polar
vein) or total (left or right main veins) by way of the femoral or
iliac arteries (if disease free), or from the axillary, brachial,
or subclavian arteries of the upper body, if desired. Said
procedure could be performed to, for example, treat acute or
chronic renal ischemia due to diffuse atherosclerosis, severe
intima hyperplasia, and to treat the kidney in connection with
various collagen-vascular diseases.
[0121] (iii). Intestine (Bowel). A number of arterial sources, such
as the femoral, iliac, axiallary, brachial, subclavian, or
epigastric arteries, can be used with devices and systems of the
present disclosure to facilitate regional arterialization following
vein anastomosis (at the vein arch) to treat mesenteric arterial
ischemia. In at least one embodiment, said arterialization is
performed to treat an acute embolic or thrombotic mesenteric artery
occlusion in patients with a severe bowel ischemia.
[0122] (iv). Spine. The first of the two main divisions of the
spinal system, namely the intracranial veins, includes the cortical
veins, the dural sinuses, the cavernous sinuses, and the ophthalmic
veins. The second main division, namely the vertebral venous system
(VVS), includes the vertebral venous plexuses which course along
the entire length of the spine. The intracranial veins richly
anastomose with the VVS in the suboccipital region, and caudally,
the cerebrospinal venous system (CSVS) freely communicates with the
sacral and pelvic veins and the prostatic venous plexus. The CSVS
constitutes a unique, large-capacity, valve-less venous network in
which flow is bidirectional. The CSVS plays important roles in the
regulation of intracranial pressure with changes in posture, and in
venous outflow from the brain. In addition, the CSVS provides a
direct vascular route for the spread of a tumor, an infection, or
an emboli among its different components in either direction.
Various embodiments of devices and systems of the present
disclosure can be used to provide oxygenated blood from the
external carotid artery, the brachial artery, or the axiallary
artery, directly to the jugular vein to treat any number of
potential spinal injuries or conditions, including spinal cord
ischemia.
[0123] (v). Penis. Various embodiments of devices and systems of
the present disclosure can also be used to provide arterial blood
from the epigastric artery to the penile dorsal vein to the
cavernous system of the penis to treat erectile dysfunction.
[0124] The foregoing examples of organ-specific perfusion protocols
are not intended to be exhaustive, but merely exemplary of various
novel uses of perfusion devices and systems of the present
disclosure. Accordingly, the present disclosure includes various
methods for treating organ-related diseases, various methods of
providing arterial (oxygenated) blood to veins at or near various
organs, and various methods of potentially arterializing veins at
or near various bodily organs using devices and systems of the
present disclosure. For example, and as shown in FIG. 19, an
exemplary method of organ perfusion of the present disclosure is
provided. Method 1900, in at least one embodiment, comprises the
steps of positioning at least a portion of a device into a
patient's artery (an exemplary artery positioning step 1902),
positioning at least a portion of the same or a different device
into a patient's vein at or near a target organ (an exemplary vein
positioning step 1904), and facilitating operation of the
positioned portions to allow blood to flow from the artery to the
vein to treat a condition or disease of the target organ (an
exemplary operation step 1906). By way of example, an exemplary
artery positioning step 1902 could be performed by positioning at
least part of a first catheter 10 having a cannula 16 within an
artery of a patient, the first catheter 10 configured to permit
arterial blood to flow therethrough and further configured to
permit a portion of the arterial blood to flow through the cannula
16, and an exemplary vein positioning step 1904 could be performed
by positioning at least part of a second catheter 150 within a vein
of the patient at or near a target organ, the second catheter 150
configured to receive some or all of the portion of the arterial
blood. In such an embodiment, which may be referred to as a chronic
treatment using catheter 10 and catheter 150, an exemplary
operation step 1906 involves connecting the cannula 16 of the first
catheter 10 to a portion of the second catheter 150 so that some or
all of the portion of the arterial blood flowing through the
cannula 16 is provided into the vein to treat a condition or
disease of the target organ. Further, and by way of another
example, an exemplary artery positioning step 1902 could be
performed by positioning at least a portion of an arterial tube
1032 of a perfusion system 100 within an artery of a patient, the
arterial tube 1032 configured to permit arterial blood to flow
therethrough, and an exemplary vein positioning step 1904 could be
performed by positioning at least a portion of a first catheter
1000 of the perfusion system 100 into a vein of the patient at or
near a target organ, the first catheter 1000 configured to receive
some or all of the arterial blood from the arterial tube 1032. In
such an embodiment, which may be referred to as an acute treatment
using system 100 of the present disclosure, an exemplary operation
step 1906 involves operating a first flow regulator 1036 of the
perfusion system 100 so that some or all of the arterial blood
flowing through the arterial tube 1032 is provided into the vein to
treat a condition or disease of the target organ.
[0125] In addition to the foregoing, and in various embodiments of
devices (such as catheters 10 and/or cannulas 16), systems 100,
and/or SSA systems 300, for example, of the present disclosure,
such catheters 10, cannulas 16, and/or systems 100 may optionally
comprise a regional hypothermia system 4000 configured in
accordance with the following. Various regional hypothermia systems
4000 of the present disclosure, as shown in component block diagram
of FIG. 20 and as referenced in further detail herein, are
configured for use to cool (reduce the temperature of) blood and/or
other fluids within the body for targeted delivery to a location
within the body. Such cooling can be from, for example, at or about
0.5.degree. C. to as much as 10.degree. C. cooler, for example,
than the native temperature of blood within the mammalian body. In
some embodiments, localized blood cooling of greater than
10.degree. C. may be desired and accomplished using one or more
regional hypothermia systems 4000 of the present disclosure. In
various embodiments, regional hypothermia systems 4000 are
configured for use within a mammalian body even at tissues that are
relatively difficult to reach due to, for example, potential
occlusion of one or more coronary and/or cerebral arteries. Such
regional hypothermia systems 4000 of the present disclosure may be
useful in connection with the reduction of perfusion injuries by
cooling the region of risk, whether it be at, near, or in the heart
and/or brain, may be critical to reduce reperfusion injury and to
decrease infarct size, for example, prior to opening an artery in
the heart or brain. Retroperfusion, as referenced generally herein,
provides an ideal mechanism to deliver blood at a target location,
and the use of a regional hypothermia system 4000 of the present
disclosure in connection with one or more catheters 10, cannulas
16, systems 100, and/or SSA systems 300 of the present disclosure
can effectively deliver blood at a desired/targeted temperature by
way of delivery through open veins, for example, to the region at
risk, such as a heart or brain. In general, such catheters 10,
cannulas 16, systems 100, and/or SSA systems 300, in connection
with the use of one or more regional hypothermia systems 4000 of
the present disclosure, can allow perfusion/retroperfusion of
oxygenated blood, control blood perfusion pressure within a vessel,
condition a blood vessel to operate under higher blood pressure
(such as arterialization of a vein), increase flow of oxygenated
blood to ischemic myocardium, and/or decrease the acute ischemic
area during a myocardial infarct event, all at a relatively colder
temperature than would otherwise be allowed without the use of a
regional hypothermia system.
[0126] In at least one embodiment of a regional hypothermia system
4000 of the present disclosure, and as shown in FIG. 20, regional
hypothermia system 4000 comprises a heat exchanger 4002 coupled to
one or more components of catheters 10, cannulas 16, systems 100,
and/or SSA systems 300 of the present disclosure, such as, for
example, catheter 10, cannula 16, second catheter 150, connector
170, first graft 185, second graft 190, Y connector 320, third
catheter 350, first catheter 1000, arterial blood tube 1032,
coupler catheter 1042, and/or other components referenced herein.
Heat exchanger 4002, in various embodiments, is configured to
reduce the temperature of blood passing through one or more
components of catheters 10, cannulas 16, systems 100, and/or SSA
systems 300, so that the blood that is ultimately delivered to the
targeted area of interest, such as being at, near, or in the heart
and/or brain, is at a lower temperature than normal (or without the
use of a regional hypothermia system 4000). For example, and in at
least one embodiment, regional hypothermia system 4000 is used to
reduce the temperature of blood delivered at, near, or in the heart
and/or brain by or about 3.degree. C. to 4.degree. C. via the
general blood circuit created using various catheters 10, cannulas
16, systems 100, and/or SSA systems 300. Heat exchanger 4002, as
referenced herein, can utilize one or more cooling products 4004,
such as perfluorocarbon, liquid carbon dioxide, helium, another
cooled gas, and/or another refrigerant or refrigeration mechanism
known in the art, that facilitates the cooling of blood, and
ultimately tissues at or near the cooled blood, through components
of catheters 10, cannulas 16, systems 100, and/or SSA systems 300
of the present disclosure. Furthermore, one or more temperature
sensors 4006 can be coupled to various components of catheters 10,
cannulas 16, systems 100, and/or SSA systems 300 of the present
disclosure, catheter 10, cannula 16, second catheter 150, connector
170, first graft 185, second graft 190, Y connector 320, third
catheter 350, first catheter 1000, arterial blood tube 1032,
coupler catheter 1042, and/or other components referenced herein,
so that blood and/or tissue temperature(s) (including temperatures
at, near, or in the heart and/or brain, depending on the type of
catheters 10, cannulas 16, systems 100, and/or SSA systems 300
used) can be detected by temperature sensors 4006 and transmitted
(via wire or wirelessly) to a remote module 270 and/or another data
acquisition and processing system/mechanism so that a user of
regional hypothermia system 4000 can regulate localized temperature
(at, near, or in the heart or brain, for example), as desired. A
generic device 4008 is shown in FIG. 20 as being operably coupled
to an exemplary regional hypothermia system 4000 of the present
disclosure, whereby generic device 4008 may comprise one or more
catheters 10, cannulas 16, systems 100, SSA systems 300, other
devices and/or systems of the present disclosure, and/or individual
components thereof. An exemplary kit 4010 of the present
disclosure, as shown in the figures, comprises an exemplary
regional hypothermia system 4000 operably coupled to an exemplary
generic device 4008 of the present disclosure.
[0127] Further, and in various embodiments, heat exchanger 4004 can
be at the level of an arterial-venous connector, a double-lumen
catheter, and/or another component of one or more catheters 10,
cannulas 16, systems 100, and/or SSA systems 300 of the present
disclosure. For the heart, this can be particularly important for
patients with a door-to-balloon time of greater than two hours, for
patients with ST segment elevation myocardial infarction (STEMI)
that are at high risk for reperfusion injury, and/or patients with
hemodynamics instability. There are several advantages to using a
regional hypothermia system 400 of the present disclosure,
including but not limited to rapid percutaneous insertion and rapid
cooling of the myocardial area before opening the culprit artery to
avoid the cascade of inflammatory reactions responsible for
reperfusion injury. As referenced generally above, various regional
hypothermia systems 4000 of the present disclosure are configured
and operable to introduce mild hypothermia to reduce cardiac
infarct size and general severity of the same. Such systems 4000,
in connection with various catheters 10, cannulas 16, systems 100,
and/or SSA systems 300 of the present disclosure, can treat chronic
and acute heart failure, as needed, and generally reduce the
severity of an injury and/or reduce inflammation as referenced
herein, by way of regionally reducing blood temperature.
[0128] The disclosure of the present application also relates to a
potential goal of translating the efficacy of a currently invasive
open surgery that requires destruction of vein valves and induces
edema due to the transmission of arterial blood pressure to the
veins to a mini-surgical/percutaneous procedure that is much less
invasive, takes less time and does not require removal of valves
and damps the pressure to the veins to reduce the edema. In lower
extremities with total or near complete obstruction of arterial
blood flow, the perfusion of the limb in a retrograde manner
through the venous system with arterial blood using various devices
of the present disclosure will provide adequate oxygen and nutrient
supply/demand matching to salvage limb function. Accordingly, the
present disclosure includes methods of using venous circulation as
an alternative method of limb salvage to deliver arterial blood in
a retrograde manner to the ischemic extremity through a novel
retroperfusion devices that will transform a lengthy surgical
procedure into a simpler surgical/percutaneous hybrid procedure. In
the absence of substantial forward native arterial pressure in the
capillaries, arterial blood fed into the venous system at higher
pressure than the native venous pressure will stimulate the
development of significant collateral network between the native
arteries and newly arterialized veins to supply nutritive flow and
adequate oxygenation to the ischemic tissue and thus salvage the
limb (to avoid amputation).
[0129] An exemplary catheter for facilitating intravenous
arterialization of the present disclosure is shown in FIG. 21.
Catheter 3100, as shown in FIG. 21, is configured as a hybrid
endovascular catheter and comprises an elongated body 3102 having a
proximal end 3104 and a distal end 3106. A balloon 3108 (which may
be any number of inflatable members used in the catheter arts), in
at least one embodiment, is positioned along elongated body 3102
and may be located closer to distal end 3106 than proximal end
3104. Balloon 3108, in various embodiments, may either be
expandable (inflatable) as desired, using a gas and/or a liquid for
example, or may be inflated automatically using a gas and/or a
liquid, the latter referred to herein as being "autoexpandable." As
shown in FIG. 21, exemplary catheters 3100 of the present
disclosure have a plurality of apertures 3110 defined through
elongated body 3102 at or near distal end 3106. Apertures 3110 are
configured to allow fluid, such as oxygenated arterial blood, to
flow from within a catheter lumen 3112 defined along a longitudinal
length of elongated body 3102 out of apertures 3110 and into a
luminal organ of interest, such as to an ischemic venous blood
vessel. Apertures 3110, in certain other embodiments, may extend
either an entire, substantial, or partial length of catheter 3110,
and the number, concentration, and/or size of apertures 3110 can
vary, as can the dimensions (such as internal diameter or
cross-sectional area of catheter 3100) so to control the pressure
by way of a pressure drop so that oxygenated arterial blood flowing
through catheter 3100 and out of apertures 3110 is at a pressure or
pressure range that the venous system can handle. Accordingly,
various catheter 3100 features (such as length and diameter) can be
tested to ensure proper pressure/flow relationships for the types
of resistances that will be experienced in-vivo.
[0130] To facilitate proper guidance and positioning within a
luminal organ of interest, various catheter 3100 embodiments of the
present disclosure are configured to receive a guidewire 3114
therein (such as within lumen 3112 of catheter 3100), whereby
guidewire 3114 could be positioned within catheter 3100 between a
proximal opening 3116 (also referred to as a "lateral entrance")
and a distal opening 3118 of catheter 3100 as shown in FIG. 21, for
example. In addition, and in at least one embodiment of a catheter
3100 of the present disclosure, the proximal end 3104 of catheter
3100 is configured to attach to a graft 3120 (which may also be
referred to herein as a "prosthesis"), with said connection by way
of an optional connector 3122 (also referred to herein as a "quick
connector") in some embodiments. In embodiments using one or more
connectors 3122, proximal end 3104 of catheter 3100 may be
configured with a "female" end or using a connector 3122 with a
male or female end, and graft 3120 may be configured with a "male"
end or using a connector 3122 with a male or female end. In other
embodiments, opposing gender connections may appear on said
components. As referenced herein, a general system 3150, as
identified in FIG. 21, may comprise an exemplary catheter 3100 of
the present disclosure and one or more additional elements, such
as, for example, an exemplary graft 312, and exemplary guidewire
3114, and/or an exemplary dilator 3402, as shown in FIG. 24B and
referenced in further detail herein.
[0131] Graft 3120, as shown in FIG. 21, can be used to effectively
anastomose an artery of interest to a vein of interest. For
example, and as shown in FIG. 23B, a proximal end 3124 of graft
3120 can be positioned within an artery 3220 (such as a femoral
artery, as shown in FIG. 23B), and a distal end 3126 of graft 3120
can be positioned within a vein 3222 (such as a saphenous vein,
also shown in FIG. 23B) so that oxygenated blood from artery 3220
can flow through a lumen 3128 of graft 3120 and into catheter 3100
coupled thereto, either directly or via the use of a connector
3122. Desired dimensions of graft 3120 would be such that the risk
of lumen 3128 closing off (via thrombosis) would be reduced or
eliminated. As shown in FIG. 3B, graft 3120 would be positioned
within artery 3220 at a location proximal to an area of artery 3220
having diffuse disease (such as atherosclerotic plaques 3224 as
shown in the figure), so that the user placing graft 3120 has a
level of confidence that sufficient oxygenated arterial blood flow
will exist at that location of artery 3220. If properly placed and
connected, blood can flow from artery 3220, through graft 3120,
into lumen 3112 of catheter 3100, and out of apertures 3110 so to
introduce oxygenated blood to the peripheral/collateral veins 3206
at or near the distal end 3106 of catheter 3100 within vein 3222.
In various embodiments of catheters 3100 of the present disclosure,
shown in FIG. 21 or otherwise and/or as referenced herein,
catheters 3100 may comprise one or more biologically compatible
materials, such as polyurethane and/or other synthetic polymers.
Grafts 3120 and/or catheters 3100 of the present disclosure may
comprise the same or different materials, such as
polytetrafluoroethylene ("PTFE"), polyethylene terephthalate (such
as Dacron.RTM.), and/or other synthetic polymers. In addition, at
least one embodiment of a catheter 3100 of the present disclosure
is at least partially coated with an anticoagulant and/or an
antithrombotic material, such as heparin, for example. An exemplary
catheter 3100 and an exemplary graft 3120 of the present disclosure
may couple to one another by way of their inherent coupling
characteristics and/or using one or more connectors 3122 for
anastomosis of graft 3120. The use of graft 3120 with catheter
3100, in at least one embodiment, allows for a controlled flow of
oxygenated blood from an artery into a venous area of interest.
Arterialization of a vein, as generally referenced herein, should
preferably occur in a controlled or gradual fashion, as a rapid
increase in blood flow and pressure to a vein can cause significant
swelling, localized blood accumulation, and potential venous
rupture. Graft 3120, in various embodiments, can be sutured to the
artery and/or vein so to prevent unintended or undesired migration
so to stabilize the same. Furthermore, the dimensions of graft 3120
(length, inner diameter or cross-sectional area, etc.) can be
varied so to provide an initial controlled measure (flow or
pressure) of blood therethrough upon implantation. By controlling
the dimensions of graft 3120 and/or catheter 3100, as referenced
above, side effects such as edema can be controlled/minimized by
reducing the pressure of blood flowing into the vein or veins of
interest. Implantation of graft 3120, as referenced in further
detail herein, can be performed percutaneously.
[0132] An additional catheter 3100 embodiment of the present
disclosure is shown in FIG. 2. As shown in FIG. 22, catheter 3100
is configured to fit within an external shaft 3200, with external
shaft 3200 being split at its proximal end 3202. Catheter 3100, in
such an embodiment, also defines a plurality of apertures 3110
within elongated body 3102 so that fluid can flow through a lumen
3112 of elongated body 3102 and out of apertures 3110. Exemplary
catheters 3100 of the present disclosure, such as shown in FIG. 22,
are partially or completely biodegradable and/or bioabsorbable.
Various polymers, such as poly(lactic-co-glycolic acid) ("PLGA"),
may be used within various catheter 3100 components, such as nodes
3204 shown in FIG. 22. Nodes 3204, as shown therein, would be
located on the external wall of catheter 3100 (such as on elongated
body 3102) for segmental occlusion at different levels of a luminal
organ, such as the saphein vein. Exemplary nodes 3204 can resorb at
different times, such as in one or more days, weeks, or months, and
differing resorption rates can allow oxygenated blood to be
introduced into other areas of the vein proximal to the initial
introduction over time to facilitate gradual arterialization of the
vein proximal to the initial introduction location. External shaft
3200, in various embodiments, is used/configured to cover apertures
3110, so that if it is desired to arterialize different locations
within the vein, external shaft 3200 can be retracted so that
additional apertures 3110 proximal to the originally exposed
aperture(s) 3100 are exposed to irrigate oxygenated blood to the
additional targeted vein area(s). External shaft 3200, in various
embodiments, is used/configured to cover nodes 3204, whereby
retraction of external shaft 3200 to expose nodes 3204 to blood
flow would start/facilitate the process of resorption of nodes
3204. An exemplary biodegradable and/or bioabsorbable catheter
3100, such as shown in FIG. 22, may have additional features such
as those shown in FIG. 21 or as otherwise shown or described
herein, such as, for example, a connector 3122.
[0133] Exemplary catheters 3100 of the present disclosure may be
used in accordance with the following methods, as depicted in step
format in FIG. 23A with mammalian body placement shown in FIG. 23B.
In an exemplary method 3300 of the present disclosure, a small
incision is made at the level of the peripheral artery source, such
as the iliac, femoral, or popliteal artery (an exemplary arterial
incision step 3302), and the proximal end 3124 of graft 3120 is
positioned into the artery and the distal end 3126 of graft 3120 is
positioned into the vein of interest, such as the saphenous vein,
to anastomose the same (an exemplary graft anastomosis step 3304).
Method 3300, in at least one embodiment, further comprises one or
more of the steps of puncturing the vein of interest (such as the
saphenous vein, for example) (an exemplary venous puncture step
3306), introducing at least part of a guidewire 3114 into the vein
through the puncture aperture (an exemplary guidewire insertion
step 3308), and the distal advancement (progression) of guidewire
3114 to a location at or near the portion of the vein of interest
(such as, for example, the malleolus saphenous vein segment), while
avoiding any venous valves along the way if possible (an exemplary
guidewire advancement step 3310). Various methods 3300 of the
present disclosure further comprise the steps of advancing
(progressing) catheter 3100 over guidewire 3114 so that the distal
end 3106 of guidewire 3100 is located within the vein at the region
of interest (an exemplary catheter advancement step 3312), and
connecting catheter 3100 (at, for example, the proximal end 3104 of
catheter 3100) to the graft 3120 (at, for example, the distal end
3126 of graft 3120), either directly or using connector 3122,
releasing the oxygenated arterial blood and allowing it to flow
from the artery into lumen 3112 of catheter 3100 and out of
apertures 3110 (an exemplary catheter-graft connection step 3314).
Such a mini-surgical procedure, namely the performance of
catheter-graft step 3314, will create a graft anastomosis with an
artery, such as the femoral artery. This would complete the
procedure to allow arterial oxygenated blood to flow from the
artery to the vein via graft 3120 and catheter 3100 to various
extremities, including the lower extremities. Steps 3310 and/or
3312, or other method 3300 steps of the present disclosure, may be
performed using fluoroscopy, intravascular ultrasound ("IVUS"), a
surface ultrasound, or other scanning methods so that the user of
guidewire 3114 and/or catheter 3100 is aware of the locations of
portions of said devices within the patient's vasculature. To avoid
or reduce retrograde flow and/or to secure a portion of catheter
3100 within the vein of interest, an exemplary method 3300 of the
present disclosure may further comprise the step of inflating
balloon 3108 (by way of manually or automatically operating an
inflation source operably coupled to balloon 3108) (an exemplary
balloon inflation step 3316). Balloon 3108, which in at least one
embodiment may be positioned approximately 1-2 cm from the distal
end 3106 of catheter 3100, will be inflated to ensure selective
retroperfusion of the region of interest (minimize edema) and to
prevent antegrade flow of the blood once retroperfusion is
established. Steps of methods 3300, as referenced above, may be
performed in a different order than described above. For example,
step 3304 may be performed after steps 3310 and 3312.
[0134] Over time, such as after two to four weeks for example after
use of catheter 3100 within the patient, the venous vessels in the
area at or distal to the distal end 3106 of catheter 3100 will
arterialize, and over a period of approximately four to six weeks,
the native arterial system will form collaterals with the newly
arterialized venous vessels to revascularize the limb, such as the
leg or portions thereof, such as the foot. After arterialization
has been achieved, catheter 3100 can be removed from the patient
(an exemplary catheter removal step 3318). However, and prior to
catheter 3100 removal, catheter removal step 3318 may further
comprise the additional step of connecting the vein to the artery
so to provide oxygenated blood to the distal arterialized venous
area. Such a step may also include the step of occluding the vein
by way of a tying and/or clipping the proximal portion of the vein.
In general, removal of catheter 3100 would discontinue the supply
of oxygenated blood to the venous region of interest, and
connecting the artery to the vein would allow oxygenated blood to
continue to flow through the vein. The tying and/or clipping of the
vein proximal to the region of interest, using a tie and/or a
cutting tool, for example, would eliminate undesired retrograde
blood flow through the vein. The above-referenced exemplary methods
3300, or other methods whereby some of all of an exemplary catheter
3100 of the present disclosure is positioned within a patient's
vasculature, would allow the patient to resume or pursue certain
mobility, such as walking and sitting if catheter 3100 is
positioned within the patient's leg. In such embodiments, catheter
3100 may comprise malleable and non-collapsible
biologically-compatible material(s) so to improve overall comfort.
However, certain patient's either may not wish to have the majority
or all of catheter 3100 positioned within their vasculature, or the
treating physician/interventionalist may determine that using
catheter 3100 in a different fashion, or a different catheter 3100
embodiment, may be preferred.
[0135] Accordingly, at least one additional method 3300 of the
present disclosure is depicted in step format in FIG. 23C and
described as follows. In at least one additional method 3300 of the
present disclosure, method 3300 comprises the steps of implanting
catheter 3300 within the patient through a subcutaneous tunnel 3400
parallel or substantially parallel to the length of the vein of
interest (such as the saphenous vein), reaching the desired area of
interest (such as the malleolus saphein vein segment) (an exemplary
catheter implantation step 3350), and making an incision in the
skin and isolating the distal end 3106 of catheter 3100 at the
level of the malleolus saphein vein segment, for example (an
exemplary skin incision step 3352). Step 3350 may be performed via
skin puncture as well, using an optional guidewire 3114 and/or an
optional dilator 3402, as shown in FIG. 24B if desired. Dilator
3402, in at least one embodiment, comprises an elongated body
having a cross-section larger than a cross-section of catheter
3100, so that when dilator 3402 is advanced subcutaneously,
catheter 3100 can be positioned within the subcutaneous tunnel
created using dilator 3402. In at least another embodiment, and as
shown in FIG. 24B, dilator comprises a dilator lumen 3404 defined
therethrough along a longitudinal length of dilator 3402,
terminating at or near one end with a distal dilator aperture 3406,
whereby a guidewire 3114 can be positioned within dilator lumen
3404, and/or whereby device 3100 can be positioned within dilator
lumen 3404. In view of the same, catheter implantation step 3350
may be performed in various manners. For example, catheter
implantation step 3350 can be performed by creating a subcutaneous
tunnel using dilator 3402, and advancing at least a portion of
catheter 3100 within the subcutaneous tunnel. In another
embodiment, catheter implantation step 3350 may be performed by
introducing and subcutaneously advancing guidewire 3114 into the
mammalian patient and advancing at least a portion of catheter 3100
over guidewire 3114. In yet an additional embodiment, catheter
implantation step 3350 can be performed by introducing and
subcutaneously advancing a guidewire into the mammalian patient,
advancing a dilator over the guidewire to create a subcutaneous
tunnel, and advancing at least a portion of the catheter within the
dilator. In another embodiment, catheter implantation step 3350 can
be performed by introducing and subcutaneously advancing a dilator
having a dilator lumen defined therein and a guidewire positioned
within the guidewire lumen into the mammalian patient to create a
subcutaneous tunnel, removing the dilator, and advancing at least a
portion of the catheter within over the guidewire. In yet another
embodiment, catheter implantation step 3350 can be performed by
introducing and subcutaneously advancing a dilator having a dilator
lumen defined therein and a guidewire positioned within the
guidewire lumen into the mammalian patient to create a subcutaneous
tunnel, removing the dilator, and advancing at least a portion of
the catheter within over the guidewire.
[0136] Exemplary methods 3300 may further comprise the steps of
puncturing the vein of interest (such as the saphenous vein) via
traditional venous puncture or incision so to form a venous
entrance 3408 (an exemplary venous puncture step 3306), and
introducing the distal end 3106 of catheter 3100 into the vein of
interest (such as the distal malleolus saphenous vein segment) (an
exemplary catheter introduction step 3354). Various methods 3300
further comprise the steps of implanting an exemplary graft 3120
(such as by performing arterial incision step 3302) so that the
proximal end 3124 of graft 3120 is positioned into the artery and
the distal end 3126 of graft 3120 is available to be connected to
catheter 3100 at, for example, the proximal end 3104 of catheter
3100, and connecting catheter 3100 (at, for example, the proximal
end 3104 of catheter 3100) to the graft 3120 (at, for example, the
distal end 3126 of graft 3120), either directly or using connector
3122, releasing the oxygenated arterial blood and allowing it to
flow from the artery into lumen 3112 of catheter 3100 and out of
apertures 3110 (an exemplary catheter-graft connection step 3314).
Over time, such as after two to four weeks for example, the venous
vessels in the area at or distal to the distal end 3106 of catheter
3100 will become fully arterialized, and over a period of
approximately four to six weeks, the native arterial system will
form collaterals with the newly arterialized venous vessels to
revascularize the limb, such as the leg. After arterialization has
been achieved, catheter 3100, or remaining non-biodegradable
portions thereof, can be removed from the patient (an exemplary
catheter removal step 3318). If the entire catheter 3100 is
biodegradable or bioresorbable, catheter removal step 3318 may not
be required. The term "collaterals", as referenced herein, refers
generally to the phenomenon that occurs during and after initial
arterialization. Arteries and veins tend to run generally parallel
to one another, with the veins forming a general drainage system
that allows blood to flow back to the heart. By performing one or
more methods 3300 as referenced herein, oxygenated blood flows to a
vein, for which the increased blood pressure and increased overall
blood nutrients facilitates arterializations. Arteries generally do
not collateralize with veins, as veins generally have nothing to
offer with respect to oxygenated blood or other blood nutrients.
Arties having oxygen-deficient or nutrient-deficient blood flowing
therethrough will want to connect with arteries having oxygen
and/or nutrient rich blood flowing therethrough, but that process
is generally limited naturally as arteries would need to be
adjacent to one another to facilitate the collateralization
process. As arteries and veins overlap one another, various methods
3300 of the present disclosure effectively turn portions of veins
into arteries, and the newly-formed arteries can then collateralize
with other adjacent arteries and potentially adjacent veins.
Various additional methods 3300 of the present disclosure may
further comprise the step of moving catheter 3100 to another
location within the vein of interest, or moving catheter 3100 to
another vein of interest, so to facilitate arterialization of a
second region within the patient's venous vasculature (an exemplary
second region arterialization step 3375, such as shown in FIGS. 23A
and 23C). For example, catheter-graft connection step 3314, as
referenced above, may be performed at a first location, and, after
a desired amount of time has elapsed, catheter 3100 can be moved to
a second location within the patient's body, allowing for
additional localized arterialization to take place via step
3375.
[0137] FIG. 24A shows selected components of an exemplary catheter
3100 of the present disclosure useful in connection with method
3300 as depicted in FIG. 23C and referenced above. As shown in FIG.
24A, exemplary catheter 3100 comprises an elongated body 3102, an
autoexpandable balloon 3108 and a plurality of apertures 3110 at or
near distal end 3106 of elongated body 3102, and a quick connector
3122 at proximal end 3104 of elongated body to connect graft 3120
to elongated body 3102 of catheter 3100. FIG. 24B shows placement
of an exemplary catheter 3100 of the present disclosure in
connection with one or more above-referenced methods 3300 whereby
catheter 3100 is positioned subcutaneously through a subcutaneous
tunnel 3400. As shown therein, the distal end 3106 of catheter 3100
is positioned through a venous entrance 3408 so that arterial
(oxygenated) blood can flow through graft 3120, through lumen 3112
of catheter 3100, and out of apertures 3110 into vein 3222 so to
arterialize peripheral/collateral veins 3206. FIG. 25 shows an
exemplary catheter 3100 of the present disclosure with certain
identified components. As shown therein, catheter 3100 comprises an
elongated body 3102 having a proximal end 3104 and a distal end
3106, a balloon 3108 positioned at or near distal end 3106, and a
graft 3120 coupled to catheter 3100 at or near proximal end 3104 of
catheter 3100. FIGS. 26A and 26B show embodiments of catheters 3100
of the present disclosure positioned within a veins 3222 of a
mammalian circulatory system. As shown therein (human leg in FIG.
26A, animal leg in FIG. 26B), catheter 3100 is positioned within
the great saphenous vein (vein 3222), distal to the femoral vein
3600, while an anastomosis 3602 is present between graft 3120 and
the femoral artery 3220. Balloon 3108 is shown in its inflated
stated, potentially to anchor catheter 3100 within vein 3222 and to
prevent retrograde flow of arterial blood through the great
saphenous vein 3222 proximal to balloon 3108.
[0138] In addition, the use of a graft 3120 and a catheter 3100 of
the present disclosure can not only control pressure and flow of
blood therethrough to a vein of interest, catheter 3100 can be used
in a way to preserve (not destroy) any valves present in the vein
where catheter 3100 is implanted. For example, advancement of a
guidewire 3114 through lumen 3112 of catheter 3100 and out of
distal opening 3118, as shown in FIG. 21, can facilitate
advancement of catheter 3100 within the vein of interest, allowing
any valves passed by catheter 3100 to resume operation upon
withdrawal or bioabsorption of catheter 3100. In addition to the
foregoing, catheter 3100 and/or graft 3120 can be implanted
percutaneously, which may be a preferred implantation method for
high risk or otherwise compromised patient conditions. For example,
graft 3120 can be inserted percutaneously by puncture of the
targeted arterial site (identified using echodoppler, angiography,
or another scanning method), and catheter 3100 can be inserted
percutaneously into the vein (such as the saphein vein, identified
using echodoppler, angiography, or another scanning method).
Furthermore, connecting catheter 3100 and graft 3120 using a quick
connector 3122 percutaneously can also facilitate the movement of
catheter 3100 to a second location within the patient or removal
out of the patient altogether. As generally referenced above,
exemplary methods 3300 of the present disclosure, and potentially
other uses of exemplary catheters 3100 of the present disclosure,
have a number of advantages over current invasive surgical
procedures. For example, certain traditional surgical procedures
not only take several hours to perform, but also are invasive open
surgeries where most, if not all, branches off of the vein of
interest are ligated, and certain other surgeries actually remove
the vein of interest itself, reverse it, and reconnect it, creating
additional potential complications. Uses of catheters 3100 of the
present disclosure are far less invasive, do not require
complicated open surgical procedures, and can be used to treat
inoperable lower limbs via gradual and selective
retroperfusion/revascularization. Furthermore, and as referenced
above, destruction of venous valves is avoided using catheters 3100
of the present disclosure, while certain surgical procedures either
intentionally or intentionally destroy or reduce the functionality
of said valves. In addition to the foregoing, various methods 3300
of the present disclosure may be used to direct blood to and
arterialize other areas of the mammalian body, not just the
peripheral venous system of a patient's leg or foot. For example,
other areas of a patient, such as the patient's hands, arms, torso,
and other areas, may be targeted as locations to receive
arterialized blood using one or more catheters 3100 of the present
disclosure.
[0139] The present disclosure also includes disclosure of various
perfusion and/or retroperfusion devices and systems and methods of
using the same, configured for use in connection with various
coronary, peripheral, and other retroperfusion methods/procedures
and/or to treat various ischemic conditions. Various devices and
systems of the present disclosure are configured to facilitate
blood flow in a retrograde direction, from a patient's artery to
the patient's vein, so that a supply of oxygenated blood can reach
parts of the patient's body that can benefit from that blood.
Various devices and systems of the present disclosure can also be
used to generally facilitate arterialization of a venous vessel
over time at or by way of a gradual increase in pressure, so that
the arterialized vessel can ultimately withstand full or
substantially full blood pressures that otherwise exist within a
patient's arterial system. Furthermore, various devices and systems
of the present disclosure can be used to generally regulate blood
pressures therethrough.
[0140] An exemplary perfusion/retroperfusion device of the present
disclosure is shown in FIG. 27A. As shown therein, device 100
comprises a unitary body 4100 having a wall 4102, a first portion
4104 terminating at a first end 4106 and configured for at least
partial placement within a mammalian artery 4200 (as shown in FIG.
28), and a second portion 4108 terminating at a second end 4110 and
configured for at least partial placement within a mammalian vein
4202 (also as shown in FIG. 28). As shown in FIG. 27A, device 100
has a lumen 4112 defined therethrough inside of wall 4102. Devices
100, as referenced herein, may also generally be referred to as
"catheters" or "catheter devices" given that they have some sort of
lumen defined therethrough. At least one advantage of unitary body
4100 over other retroperfusion devices 100 known in the art is that
unitary body 4100 is a single continuous component, and does not
comprises at least two components that must be coupled to one
another. Such a unitary body 4100 therefore eliminates all risk of
the two or more components becoming disconnected while in use. In
at least one embodiment, and as shown in FIG. 27A, first portion
4104 of device 100 is relatively shorter than second portion 4108
of device 100. Phrased differently, and as shown in the figure,
first portion 4104 has a first length (L.sub.1), and second portion
4108 has a second length (L.sub.2), whereby L.sub.1 is less than
L.sub.2. For example, and in certain device 100 embodiments,
L.sub.1 can range from or about 5-10 cm, while L.sub.2 can range
from or about 50-70 cm. Other embodiments, such as devices 100
where L.sub.1 is under 5 cm or over 10 cm, and/or where L.sub.2 is
under 50 cm or over 70 cm, are also within the scope of the present
disclosure. Such a configuration is indicative of the potential
need to deliver the source of oxygenated blood to a peripheral area
of a patient, such as to the patient's feet, and access to a
suitable artery 4200 may be significantly away from that ultimate
delivery location. The ability to deliver oxygenated blood to a
peripheral area of a patient, such as to a patient's foot, may
ultimately facilitate being able to prevent potential foot
amputation. As such, a relatively longer second portion 4108 would
allow blood to travel within device 100 a relatively longer
distance in the second portion 4108 as compared to the first
portion 4104. As such a longer portion would not be required within
the patient's artery 4200, first portion 4104 can be somewhat
shorter than second portion 4108, and in at least certain device
100 embodiments, it may be desirable to have a shorter first
portion 4104.
[0141] An exemplary device 100 of the present disclosure, as shown
in FIG. 27A, has a first one-way valve 4114 and a second one-way
valve 4116. A segment 4118 may exist between first one-way valve
4114 and second one-way valve 4116, or first one-way valve 4114 and
second one-way valve 4116 may be sized and shaped to be immediately
adjacent to one another. First one-way valve 4114 is sized and
shaped to receive at least part of a first guidewire 4204 (as shown
in FIG. 28) therethrough, and second one-way valve 4116 is sized
and shaped to receive at least part of a second guidewire 4206
(also shown in FIG. 28) therethrough. As shown in FIG. 27A, first
one-way valve 4114 may be positioned at or near an end of first
portion 4104 opposite first end 4106, and second one-way valve 4116
may be positioned at or near an end of second portion 4108 opposite
second end 4110. Various retroperfusion devices 100 of the present
disclosure can be used in connection with various coronary,
peripheral, and other retroperfusion methods and/or to treat
various conditions as referenced in the various patent applications
incorporated herein by reference. For example, at least part of
first portion 4104 of device 100 could be positioned within a
subclavian or axiallary artery (exemplary arteries 4200), and at
least part of second portion 4108 of device 100 could be positioned
within a subclavian or an axillary vein (exemplary veins 4202) for
use and/or treatment at or near the heart (such as, for example,
coronary retroperfusion). Peripheral uses, for example, may include
positioning at least part of first portion 4104 of device within an
iliac artery (an exemplary artery 4200) and positioning at least
part of a second portion 4108 of device 100 within a saphenous vein
(an exemplary vein 4202), as shown in FIG. 28, for example. Various
arteries 4200, such as the femoral artery, the iliac artery, and in
potentially more extreme instances/circumstances, the aorta itself,
can be used as potential sources of oxygenated blood for retrograde
delivery to a patient's venous system.
[0142] Furthermore, various devices 100 of the present disclosure
have a flexible body 4100/wall 4102, which is able to deform easily
without collapsing (so that lumen 4112 remains open to allow blood
to flow from first end 4106, through body 4100, and out of second
end 4110). The entire body 4100, or portions thereof, can be
flexible. Such an embodiment of body 4102 may comprise a
coil-reinforced wall, whereby one or more coils 4150, as shown in
FIG. 27B, are used in connection with an impermeable coating 4152.
Use of an exemplary device 100 of the present disclosure may
include the following steps/tasks. An exemplary device 100 is shown
in FIG. 28 positioned in part within an artery 4200 and in part
within a vein 4202 in a patient's arm. A second guidewire 4206 may
be inserted into device 100 through one-way valve 4116 so to
position at least part of the second portion 4108 within vein 4202.
A first guidewire 4204 may be inserted into device 100 through
one-way valve 4114 so to position at least part of the first
portion 4104 within artery 4200. Upon positioning device 100 or
portions thereof as desired, first guidewire 4204 and second
guidewire 4206 can be removed, and one-way valves 4114, 4116
prevent blood from leaking out of device 100. An optional dilator
3402, as referenced in detail herein, can be used to facilitate a
transition between the first guidewire 4204 and/or the second
guidewire 4206 and the artery 4200 and/or vein 4202 of interest, so
that the artery 4200 and/or vein 4202 is gradually expanded to
receive portions of device 100 after use of dilator 3402. For
example, one or more dilators 3402 may be advanced over first
guidewire 4204 and/or second guidewire 4206 into artery 4200 and/or
vein 4202, noting that dilators 3402 would have a larger outer
perimeter than the guidewires 4204, 4206, and then portions of
device 100 could be positioned into artery 4200 and/or vein 4202
over dilator(s) 3402. When such a device 100 is properly
positioned, blood can flow from artery 4200 into device 100 and
into vein 4202. As shown in FIG. 28, device 100 does not need to
enter an artery 4200 and an adjacent vein 4202 within the same
plane, and that such an angle (at or near 90.degree. relative to
artery 4200 and vein 4202) may not be preferred due to potential
fluid shear with said angles. FIGS. 27A and 27C show exemplary
angle A.sub.1 and an exemplary angle A.sub.2, whereby A.sub.1 and
A.sub.2, as shown therein, are each greater than 90.degree., and
said angles are also greater than 90.degree. as shown in FIG. 28.
Should angles A.sub.1 and/or A.sub.2 approach 90.degree. (implying
a device bend approaching 90.degree.), be 90.degree. (implying a
device bend of 90.degree.), or be less than 90.degree. (implying a
device bend of greater than 90.degree.), blood flow would become
disturbed given the sharp turn which would result in energy losses,
which is generally not preferred. A larger angle A.sub.1 also
allows first portion 4104 of device 100 to be positioned in artery
4200 relatively higher up, for example, than second portion 4108
positioned within vein 4202, in at least one exemplary use, such as
shown in FIG. 28. General deformability/flexibility of at least
part of device 100 would allow a user not only to more easily
position the various areas of device 100 within a patient's
vasculature, but also would allow for desired angles (such as angle
A.sub.1 and/or A.sub.2) to be achieved upon device 100
implantation. For example, device 100 could have a general s-shape
when being positioned or ultimately positioned within a patient,
such as shown in FIGS. 27A and 28.
[0143] FIG. 29 shows an additional embodiment of a device 100 of
the present disclosure. As shown therein, device 100 comprises a
balloon 4300 positioned within or coupled to second portion 4108 of
device 100, with balloon 4300 in communication with a balloon
inflation tube 4302 having a balloon port 4304. Introduction of a
gas and/or a liquid into balloon port 4304 can be used to inflate
balloon 4300, and removal of gas and/or a liquid via balloon port
4304 can be used to deflate balloon 4300. Balloon 4300, in at least
one embodiment, is useful to hold/anchor a portion of device 100 in
place within a patient's vasculature. Balloon 4300 may also, or
alternatively, be used to ensure that blood flowing through device
100 flows in a retrograde direction, and that blood flowing
therethrough flows at a desirable rate, which may be less than a
full rate which would occur should no balloon 4300 be present. For
example, inflation and/or deflation of balloon 4300 could be used
to control blood flow through that portion of device 100, so that a
desired flow rate, volume, and/or pressure of blood flows through
device 100 to vein 4202, which can be determined using a
pressure/flow guidewire, for example. As such, devices 100 can
effectively regulate blood pressures through device 100 and the
amount (rate, volume, and/or pressure) of blood into vein 4202. In
at least one embodiment, general dimensions (diameter(s) and/or
length(s) of various regions of device 100) may be specified so
that blood flow therethrough is at a desired rate, consistent with
the general teachings of Pouiselle's law. Balloon 4300 can also be
used to prevent the backflow of blood from vein 4202 into device
100. The entirety of device 100 does not need to be deformable, but
in at least some embodiments, portions of first portion 4104 and/or
second portion 4108 are deformable as referenced herein. FIG. 30
shows an embodiment of a device 100 of the present disclosure
partially positioned within vein 4202, with such placement
facilitated using a splittable introducer sheath 4400. Splittable
introducer sheath 4400 can be positioned within an opening of vein
4202, and a portion of device 100 (such as second portion 4108) can
be positioned inside of splittable introducer sheath, with such
placement being facilitated using a second guide wire 4206, such as
shown in FIG. 28. In at least one method (or step(s) of a method),
splitttable introducer sheath 4400 can be positioned within an
opening of an artery 4200 and/or a vein 4202 (noting that two
splittable introducer sheaths can be used, one in artery 4200 and
one in vein 4202, or only one splittable introducer sheath can be
used in either artery 4200 or vein 4202), and using guidewire 4204
or 4206, a portion of device 100 can be advanced into artery 4200
and/or vein 4202. Guidewire 4206, for example, can be advance
through various vein 4202 valves (such as in the middle/center of
each valve), so that said valves remain functional after ultimate
removal of guidewire 4206 (so not to destroy said valves). After
placement of the portion of device 100 therein, splittable
introducer sheath 4400 can be split so that it can be removed from
vein 4202 while the portion of device 100 remains within vein. One
or more optional sutures 4402, as shown in FIG. 30, can be used to
secure device 100 to the patient's skin 4404, and/or one or more
bandages 4406 can be used to cover the skin 4404 to potentially
facilitate healing and/or maintain a relatively clean location.
After a period of time, such as 4-6 weeks to allow vein 4202 to
generally and locally arterialize due to the higher pressure of
blood flowing therethrough from device 100, device 100 can be
removed from the patient. Should it be desired to have device 100
positioned subcutaneously, instead of being exposed from the
patient, an incision and/or other type of puncture can be made
through skin 4404 to position the device subcutaneously.
Procedurally, and in at least one method, second portion 4108 would
be first positioned within vein 4202 prior to positioning first
portion 4104 into artery 4200. In such a method, blood from artery
4200 would be routed through device 100 to vein 4202. However,
should first portion 4104 be positioned into artery 4200 before
second portion 4108 is positioned within vein 4202, blood from
artery 4200 may exit device 100 outside of vein 4202, which would
not be preferable.
[0144] In addition to the foregoing, at least one exemplary device
100 of the present disclosure may comprise a pressure controlling
element 4408, such as shown in FIG. 30. Pressure controlling
element 4408 would allow a user to control/regulate the general
blood pressure through at least part of device 100, and may be
positioned at various regions along device. Pressure controlling
element 4408, in at least one embodiment, may be positioned at or
near segment 4118, which, in various embodiments and/or uses, may
be exposed outside of a patient when device 100 is implanted and in
use. Pressure controlling element 4408, in at least one embodiment,
is adjustable by a user of device 100 and/or a person positioning
or otherwise maintaining device 100. For example, pressure
controlling element 4408 may comprise an occluder (to partially
occlude lumen 4112 at a location within device 100), a
pressure/flow wire (operable to detect blood pressure within lumen
4112), or another device useful to obtain blood pressure/flow data
and/or adjust a local dimension of device 100 as desired. There are
several ways pressure can be controlled/regulated to avoid
over-pressurization of veins, including the foregoing as well as,
for example, use of an external constrictor (another exemplary
pressure controlling element 4408), an internal stenosis that
resorbs over time (poly(lactic-co-glycolic acid) (PLGA), another
exemplary pressure controlling element 4408), and/or by design, to
reduce the dimension of the arterial portion (first portion 4104)
of device 100. As noted above, and based on Pouseulle's law,
diameter and length can be selected of the arterial portion (first
portion 4104) to obtain the desired pressure drop, which will, in
at least one embodiment, involve a reduction of the diameter of
(first portion 4104) of the catheter, which is desirable as it
would imply a lower profile device 100 in the patient's arterial
system. As shown in FIG. 30, an exemplary system 4450 of the
present disclosure includes an exemplary device 100 of the present
disclosure and at least one other item, such as, for example, one
or more of a first guide wire 4204, a second guide wire 4206, a
splittable introducer sheath 4400, and/or a data wire 4460.
[0145] An additional embodiment of a portion of an exemplary device
100 of the present disclosure is shown in FIGS. 31A and 31B. As
shown in FIG. 31A, part of a second portion 4108 (of unitary body
4100) of an exemplary device 100 is shown therein, wherein distal
end 4110 comprises, defines, and/or is coupled to a flarable tip
4500. Flarable tip 4500, as shown in FIG. 31A, can be coupled to
second end 4110 of second portion 4108, or can be part of or
defined at second end 4110. Flarable tip 4500, as shown in FIG. 31B
and in various embodiments, is configured to shift from a first
configuration 4502, which is generally tapered or unflared, to a
second configuration 4504, which is generally flared, and back
again. Phrased differently, flarable tip 4500, in various
embodiments, is configured to shift from a first configuration
4502, which is not expanded, to a second configuration 4504, which
is generally expanded, and back again. Said configurations, as
referenced above, occur based upon pressures of fluid flowing
therethrough when device 100 is positioned within a luminal organ
having a fluid therein, as described in further detail below. For
example, and as shown on the left side of FIG. 31B, if device 100
was positioned wholly within a vein 4202 and not susceptible to
arterial blood pressures, flarable tip 4500 would be in a first
configuration 4502 or relatively close to a first configuration
4502, as flarable tip 4500, configured consistent with the present
disclosure, would not shift to a second configuration 4504 because
venous blood pressure (P.sub.1 in FIG. 31B) would not be high
enough to cause flarable tip 4500 to shift to a second
configuration 4504. However, for example and as shown on the right
side of FIG. 31B, when device 100 is positioned within a
vasculature as generally referenced herein (wherein a first portion
4104 of device 100 is positioned within an artery 4200 and a second
portion 4108 of device 100 is positioned within a vein 4202),
flarable tip 4500 would be in or shift to a second configuration
4504 or relatively close to a second configuration 4504, as
flarable tip 4500, configured consistent with the present
disclosure, would flare or generally expand due to higher arterial
blood pressure (P.sub.2 in FIG. 31B) as compared to the relatively
lower venous blood pressure (P.sub.1 in FIG. 31B). Flarable tip
4500, as referenced herein, is generally configured so that the
second end 4110 of the second portion 4108 of device 100 distends
to the size (luminal perimeter) of the portion of vein 4202 having
second end 4110 positioned therein so that blood flow therethrough
is retrograde. In such a configuration, flarable tip 4500 serves as
a flow direction regulator. In at least one embodiment, and as
shown in FIG. 31B, an exemplary flarable tip 4500 may comprise a
membrane 4510 of one or more thin or relatively thin materials,
such as polytetrafluoroethylene (PTFE), mammalian tissue, and/or
one or more other biologically-compatible thin or relatively thin
materials, reinforced by a number of struts 4512 (also referred to
as structural fibers), which may comprise nitinol, stainless steel,
and/or one or more other biologically-compatible rigid
compositions, so that a general axial integrity of flarable tip
4500 exists whereby flarable tip 4500 does not crumple or fold over
during insertion into vein 4202 when it is in its first
configuration 4502. As noted above, second configuration 4504 of
flarable tip 4500 can be induced by pressure, such as when device
100 is connected to arterial pressure as generally referenced
herein, since membrane 4510 can be distended open. The converse
occurs when the pressure is disconnected (the flarable tip 4500
collapses) for removal. Flarable tip 4500 deployment, as referenced
herein, can also flare open (shift to second configuration 4504)
based upon a memory aspect of one or more component materials, such
as nitinol, whereby struts 4512 have a general memory that permits
struts 4512 to flare open due to some sort of engagement or general
touching of struts 4512 in one or more particular fashions.
[0146] An additional embodiment of a device 100 of the present
disclosure is shown in FIG. 32. As shown in FIG. 32, device 100
comprises a number of components as shown in FIG. 27A as well as
flarable tip 4500 as shown in FIGS. 31A and 31B. In addition, and
in at least this embodiment, device 100 further comprises a tapered
portion 4600, which comprises a portion of second portion 4108 (as
shown in FIG. 32), or even all or substantially all of second
portion 4108, extending from second one-way valve 4116 to flarable
tip 4500, for example. As venous cross-sectional areas generally
decrease toward the more peripheral areas of the body, such a
device 100 embodiment may not only be easier to position within a
patient, but also may provide more comfort to the patient upon
implantation. In addition, a narrower or tapered second portion
4108 would reduce the risk of venous rupture during and after
implantation, as such a device 100 would better conform to the
patient's actual vein, such as a peripheral vein in a patient's
leg. As shown in FIG. 32, tapered portion 4600 tapers distally from
a first diameter (identified as D1 in the figure) to a second
diameter (identified as D2 in the figure), whereby the first
diameter is greater than the second diameter. Furthermore, one or
more device embodiments of the present disclosure may have more
than one tapered portion 4600 within second portion 4108 of device
100. The degree, number, and length of tapered portions 4600 can be
selected to regulate the degree of pressure drop along the device
100 in order to reduce the transmission of arterial pressure to the
venous system and to generally avoid over-pressurization of the
venous system. For example, if the arterial pressure into the first
portion 4104 (the arterial portion of device 100) may be between 80
and 100 mmHg, it may be desirable to reduce this pressure, such as
to between 40 and 60 mmHg, in the patient's venous system through a
40 mmHg (or other comparable) pressure drop along device 100. Such
a determination of pressure drop can be implemented through a
computational fluid dynamic simulation.
[0147] As referenced above, the present disclosure includes a novel
approach for the reperfusion of a diseased peripheral artery, where
an exemplary device 100 of the present disclosure can be used to
connect a vein 4202 and an artery 4200 that run alongside one
another. In this approach, the diseased vein 4202 is bypassed and
`retro-perfused` through the adjacent artery 4200 with arterial
blood flow through a simple, flexible tube-type device 100. The
diseased vein 4202 is not only provided with oxygen-rich blood
immediately but, as referenced herein, may also be arterialized
chronically (such as over a period of several weeks, for example).
The pressure level and flow rate in the peripheral vein are usually
much lower than in the artery 4200 at the corresponding level
(e.g., femoral vein vs. femoral artery). As the vein 4202 is
perfused by the blood flow from the artery 4200 through the device
100, the venous pressure may change depending on the relative flow
conditions between the vein 4202 and the artery 4200. One factor,
which may be a relatively important one, for the arterialization is
how much the vein 4202 is pressurized by the arterial blood flow.
Too much pressure would cause damage, while too little pressure
would not have the desired effect. Hence, the right amount of
pressure increased (such as approximately the average of arterial
and venous pressure; i.e., .about.40-60 mmHg as previously
referenced herein) would be necessary. Device 100 embodiments of
the present disclosure can regulate the pressure through the degree
of articulation (bending) of said device 100. The pressure drop or
energy loss in a circular pipe occurs to various degrees depending
on the geometry of the device and the inlet and outlet boundary
conditions. The geometric change is the primary determinant of
pressure drop (e.g., sudden expansion or contraction of the lumen
area). For an isodiametric circular tube, such as device 100
embodiments of the present disclosure, a simple but effective way
of manipulating the pressure drop along the unitary body 4100 is to
make a local curvature in the unitary body 4100 as referenced above
and as shown in FIGS. 27A and 27C for example (with respect to the
localized device 100 bending corresponding to angles A.sub.1 and
A.sub.2).
[0148] The present disclosure also includes a determination of the
relation between the degree of local bend in the device 100 and the
pressure drop along the device 100 in connection with the local
bend. To demonstrate the same, a sigmoidal function was adopted to
model the local curvature of a circular tube since a wide range of
profiles can be systematically generated by varying two arguments
of the function according to the situations where the device is
deployed. The adopted sigmoidal function has two primary arguments
(A and B in Equation 1) that can be changed in the profile as
follows:
f ( x ) = A ( 1 + e - Bx ) [ 1 ] ##EQU00001##
[0149] where A and B are varied depending on the vein and artery
size, the distance between two vessels alongside one another, and
degree of local bending of the device. For the present testing, the
diameter (D) and the distance between the inlet and outlet of the
device (L) was assumed to be 4 and 60 mm, respectively, such as
shown in the exemplary devices shown in FIG. 34. FIG. 33 shows that
given the vein and artery dimension (i.e., A is determined by the
vein and artery diameter and distance between two vessels
alongside), a variety of local curvature profiles of the device are
generated by changing the argument B. As the B value increases, the
profile becomes steeper which may lead to the larger pressure drop
across the device. FIG. 34 depicts the actual device configurations
constructed from the sigmoidal function with various arguments
(i.e., B varies from 0.25 to 0.75).
[0150] The ability of the device to adjust the pressure change
along the device with various local geometric changes subject to in
vivo flow conditions (such as shown in FIG. 35) was then
determined. The temporal velocity profile at the device inlet (as
shown in FIG. 36) was specified by digitizing in vivo flow wave
form shown in FIG. 35 for flow modeling purposes. The flow field
was then obtained by solving the Navier-Stoke Equation as
follows:
Continuity : .gradient. V .fwdarw. = 0 [ 2 ] Momentum : .rho.
.differential. V .fwdarw. .differential. t + .rho. ( V .fwdarw.
.gradient. ) V .fwdarw. = - .gradient. p + .gradient. ( .mu. (
.gradient. V .fwdarw. + ( .gradient. V .fwdarw. ) T ) ) [ 3 ]
##EQU00002##
[0151] where {right arrow over (V)}, p, .mu., and r are pressure,
dynamic viscosity of blood, and blood density, respectively. Blood
was assumed as an incompressible and Newtonian viscous fluid with a
constant density of 1060 kg/m.sup.3 and a constant dynamic
viscosity of 0.0035 kg/m-s.
[0152] Regarding pressure regulation, the pressure drop across the
device is a function of the device configuration modeled by the
local curvature prof