U.S. patent application number 11/923411 was filed with the patent office on 2009-01-15 for infusion treatment agents, catheters, filter devices, and occlusion devices, and use thereof.
This patent application is currently assigned to Abbott Cardiovascular Systems Inc.. Invention is credited to Gabriel Asongwe, Hongzhi Bai, Nianjiong Joan Bei, Mark J. Bly, Gregory Waimong Chan, Jessica G. Chiu, Mina Chow, Robert C. Esselstein, Douglas Gesswein, Thomas R. Hatten, Stephen G. Schaible, Yan Shen, Srinivasan Sridharan, William E. Webler.
Application Number | 20090018498 11/923411 |
Document ID | / |
Family ID | 32995884 |
Filed Date | 2009-01-15 |
United States Patent
Application |
20090018498 |
Kind Code |
A1 |
Chiu; Jessica G. ; et
al. |
January 15, 2009 |
INFUSION TREATMENT AGENTS, CATHETERS, FILTER DEVICES, AND OCCLUSION
DEVICES, AND USE THEREOF
Abstract
Embodiments include an infusion-occlusion system having a
delivery catheter, a guide catheter adapted to receive the delivery
catheter, and a guidewire with an occlusion device adapted to be
received within the guide catheter. The guide catheter of the
catheter kit may be provided with an occlusion device at the distal
end of the guide catheter. The delivery catheter may have an
accessory lumen, coaxial or co-linear lumen, a supporting mandrel,
or an occlusion device at its distal end. Moreover, according to
some embodiments, occlusion devices may be a single material or a
composite balloon having an inner liner and an outer layer of
different materials, a high compliance low pressure balloon, or a
filter device that restricts particles from passing through but
does not restrict fluid, such as blood. An inflation device with a
large volume and low volume syringe can be used to inflate the
balloon.
Inventors: |
Chiu; Jessica G.; (Belmont,
CA) ; Chan; Gregory Waimong; (Mountain View, CA)
; Asongwe; Gabriel; (San Jose, CA) ; Esselstein;
Robert C.; (Fallbrook, CA) ; Gesswein; Douglas;
(Temecula, CA) ; Sridharan; Srinivasan; (Morgan
Hill, CA) ; Bei; Nianjiong Joan; (Foster City,
CA) ; Webler; William E.; (Escondido, CA) ;
Schaible; Stephen G.; (Anaheim, CA) ; Chow; Mina;
(Campbell, CA) ; Shen; Yan; (Sunnyvale, CA)
; Bai; Hongzhi; (Menlo Park, CA) ; Bly; Mark
J.; (Saint Paul, MN) ; Hatten; Thomas R.; (Los
Altos, CA) |
Correspondence
Address: |
BLAKELY SOKOLOFF TAYLOR & ZAFMAN LLP
1279 OAKMEAD PARKWAY
SUNNYVALE
CA
94085-4040
US
|
Assignee: |
Abbott Cardiovascular Systems
Inc.
|
Family ID: |
32995884 |
Appl. No.: |
11/923411 |
Filed: |
October 24, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
10800323 |
Mar 11, 2004 |
|
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|
11923411 |
|
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|
10387048 |
Mar 12, 2003 |
7250041 |
|
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10800323 |
|
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60467402 |
May 1, 2003 |
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Current U.S.
Class: |
604/97.02 |
Current CPC
Class: |
A61M 2025/1052 20130101;
A61M 25/1002 20130101; A61M 25/10 20130101 |
Class at
Publication: |
604/97.02 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1. An apparatus to inflate a low volume balloon to occlude a blood
vessel, the balloon coupled to a distal end of a cannula having an
inflation lumen extending from the balloon to a proximal end of the
cannula and through a proximal exit in the cannula, the apparatus
comprising: a large volume syringe comprising an elongated hollow
body having a proximal end, a distal end, an opening in the distal
end to couple to the proximal exit of the cannula, and a first
plunger longitudinally slidable within the body and having a first
shaft with a first piston disposed on the first shaft distal end,
the piston and shaft having an elongated hollow inner diameter; a
second plunger longitudinally slidable within the inner diameter
and having a second shaft with a second piston disposed on the
second shaft distal end; wherein the inner diameter and second
plunger define a low volume syringe having a volume relatively
substantially less than a volume of the large volume syringe.
2. The apparatus of claim 1 further comprising a first lock
mechanism to releasably secure the first plunger to lock the first
piston at least one location along the hollow body, a second lock
mechanism to releasably secure the second plunger to lock the
second piston at least one location along the hollow inner
diameter, and at least one latch mechanism to unlatch the second
lock mechanism from the hollow inner diameter to move the second
piston towards the proximal end of the hollow body to evacuate a
selected volume of fluid from the balloon into the low volume
syringe.
3. The apparatus of claim 1 wherein the second lock mechanism
includes an adjustment mechanism to adjust the position of the
second piston to at least one location along the hollow inner
diameter; and wherein the adjustment mechanism includes a threaded
cavity coupled to a knob exterior to the large volume syringe and a
bolt portion threadably engaging the cavity and coupled to the
second plunger such that the second piston may be adjusted to at
least one location along the hollow inner diameter by rotating the
knob.
4. The apparatus of claim 3 wherein rotation of the knob from a
first position to a balloon volume position delivers a selected
volume of fluid to the balloon, and rotation of the knob from the
balloon volume position back to the first position evacuates a
selected volume fluid from the balloon into the low volume syringe.
Description
[0001] This application is a Divisional application of copending
application Ser. No. 10/800,323, which is a Continuation-in-Part of
co-pending application Ser. No. 60/467,402, filed May 1, 2003,
entitled "Multiple Occlusion Device"; and is a Continuation-in-Part
of copending application Ser. No. 10/387,048, filed Mar. 12, 2003,
entitled "Multiple Occlusion Device"; and claims the priority
benefit thereof.
BACKGROUND
[0002] Local treatment with a substance such as a drug at a
particular internal site of a patient, as opposed to systemic
treatment, has become increasingly important.
[0003] Such local access is useful not only for substance delivery
but for other treatments, such as myocardial revascularization, as
well. Myocardial revascularization forms "holes" in ischemic
ventricular tissue to increase blood flow to the treated area.
[0004] For example, to achieve local treatment of tissue,
physicians can use catheters and occlusion devices. Specifically,
cardiovascular guide catheters are generally percutaneous devices
that the physician advances through a vasculature of a patient to a
treatment region and are uses to guide other catheters or devices
to the region. Delivery catheters generally deliver a treatment
agent to a treatment region in a patient's vasculature and
typically are inserted through another catheter (e.g., a guide
catheter). Additionally, occlusion devices, such as balloons, may
connect to a delivery catheter to occlude a treatment region in the
vasculature. Guidewires are generally devices that guide through
the vasculature to a treatment region and typically can be inserted
through another catheter (e.g., an introducer).
SUMMARY
[0005] In various embodiments, there is disclosed an
infusion-occlusion system for infusing a treatment agent to a
treatment region of an artery or vein (including a blood vessel of
the human heart) that includes a delivery catheter, a guide
catheter adapted to receive the delivery catheter, a pressure
increasing device adapted to be connected to the delivery catheter,
a pressure-sensing device adapted to be connected to the delivery
catheter, an inflation device adapted to be connected to the
delivery catheter, and a guidewire with an occlusion device adapted
to be received within the guide catheter. In another embodiment,
the guide catheter of the catheter kit is provided with an
occlusion device at the distal end of the guide catheter. In
another embodiment, the delivery catheter of the catheter kit is
provided with an occlusion device at the distal end of the delivery
catheter.
[0006] Examples of occlusion devices include balloons of a material
and dimension to have an outer diameter that inflated to selected
diameters when the balloon is inflated with a selected inflation
pressure or volume of gas or fluid. The balloon may be inflated by
an inflation device having a high volume, low pressure syringe for
initially inflating the balloon to a controlled low pressure
initial diameter and having a low volume syringe for further
inflating the balloon with a controlled volume increment(s) to
produce controlled diameter increase(s) up the an occlusion
diameter. Moreover, an occlusion device may be a composite balloon
having an inner liner and an outer layer of different materials, a
high compliance low pressure balloon, or a filter device that
restricts particles from passing through but does not restrict
fluid, such as blood. Also, according to some embodiments,
occlusion devices may include various types of balloons, such as a
high compliance low pressure balloons having a thermoplastic blend
copolymer material with a polyether block amide resin moiety or a
polyetheramide moiety. Likewise, according to some embodiments,
occlusion devices may include various types of high-compliance
low-tension balloons, such as a composite or multi-layer expanded
PolyTetraFlouroEthylene (ePTFE) balloon having an inner liner.
[0007] For instance, according to some embodiments, a catheter,
such as a guide catheter, may include a coronary sinus access guide
with a collection cage or filter device, to filter unwanted
particles or material from blood. Also, a delivery catheter may be
a catheter that has a support mandrel extending therethrough or may
have lumen or tubes in a coaxial or co-linear orientation with the
longitudinal axis of the catheter.
[0008] In another embodiment, there is disclosed a method of
providing treatment in a vessel of a patient that includes placing
a guide catheter in the vessel of the patient, feeding a delivery
catheter through the guide catheter, where the delivery catheter is
provided with an occlusion device at its distal end, feeding at
least one guidewire with an occlusion device through the guide
catheter or the delivery catheter, deploying the occlusion
device(s) of the guidewire(s), deploying the occlusion device at
the delivery end of the delivery catheter, administering a
treatment agent through the delivery catheter, disengaging all the
occlusion devices, and removing the guidewire(s), the delivery
catheter, and the guide catheter from the vessel of the patient. In
another embodiment, the method further provides for aspirating the
vessel of the patient before disengaging all of the occlusion
devices. Also described is are methods including occluding a blood
vessel, infusing treatment agent, such as progenitor cells (such as
progenitor cells derived from bone marrow), to treat a treatment
region of the blood vessel for a first time period, then allowing
blood or treatment agent perfusion or flow to the treatment region
for a second period of time, and repeating infusing and perfusion
as necessary to accomplish sufficient treatment.
[0009] Specific examples of apparatus to allow for blood or
treatment agent perfusion or flow to the treatment region include
occlusion balloons that can be deflated and inflated to selected
outer diameter, catheters having perfusion lumen that bypass and
exit holes in the catheter on either end of the occlusion device,
and catheters having guidewire lumen with exit holes through the
catheter proximal to the occlusion device and an exit port at the
distal end of the catheter. Additional features, embodiments, and
benefits will be evident in view of the figures and detailed
description presented herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 schematically illustrates a cross-section of the
heart showing blood flow throughout the heart.
[0011] FIG. 2 schematically illustrates a vertical cross-section of
the heart.
[0012] FIG. 3A illustrates a catheter system having a guide
catheter, delivery catheter, guide wires, and multiple occlusion
devices.
[0013] FIG. 3B shows a sectional side view of FIG. 3A through line
C-C' of FIG. 3A.
[0014] FIG. 4 schematically illustrates the placement of the
catheters of FIGS. 3A and 3B in the coronary sinus.
[0015] FIG. 5 schematically illustrates a guide catheter.
[0016] FIG. 6 shows a sectional view of FIG. 5 through line C-C' of
FIG. 5.
[0017] FIG. 7 is a side view of a cannula and a filter device in a
sheath.
[0018] FIG. 8 is a view of FIG. 7 from perspective "A".
[0019] FIG. 9 is a side view of a distal end of a cannula including
a filter device having a distal portion with a second diameter that
is approximately the inner diameter of a blood vessel at a
treatment region.
[0020] FIG. 10 is a view of FIG. 9 from perspective "B".
[0021] FIG. 11 is a side section view of a filter device with a
distal portion having a first diameter and balloons coupled to the
filter device or the cannula.
[0022] FIG. 12 is a side-section view of a filter device with a
distal portion having a second diameter, wherein the filter device
is attached to inflated balloons which are attached to a
cannula.
[0023] FIG. 13 is a side section view of a filter device with a
distal portion having a third diameter, where the filter device is
attached to deflated balloons which are attached to a cannula.
[0024] FIG. 14 is a side sectional view of a filter device having a
distal portion attached to tendons which pivot at pivot point and
extend through a cannula.
[0025] FIG. 15 is a side section view of a filter device with a
distal portion having a second diameter, wherein the filter device
is attached to tendons which extend through a cannula.
[0026] FIG. 16 is a side section view of a filter device with a
distal portion having a third diameter and tendons attached to the
distal portion and extending through a cannula.
[0027] FIG. 17 is a front cross sectional view of the filter device
of FIG. 9 showing a proximal portion of the filter device axially
attached to an exterior surface of a cannula and lumens extending
through the cannula.
[0028] FIG. 18 is a front cross sectional view of a filter device
having a proximal portion axially attached to an exterior surface
of a cannula, wherein the filter device has a helical spring
shape.
[0029] FIG. 19 is a flow diagram of a process for using a filter
device to restrain and aspirate particles.
[0030] FIG. 20 illustrates a guide catheter with an occlusion
device.
[0031] FIG. 21 illustrates a telescoping guide catheter system.
[0032] FIG. 22 illustrates a balloon catheter tip with a
guidewire.
[0033] FIG. 23 illustrates a balloon catheter tip proximal end.
[0034] FIG. 24 shows a section view of FIG. 23 through Line
D-D'.
[0035] FIG. 25 schematically illustrates a delivery catheter
system.
[0036] FIG. 26 schematically illustrates a side elevational view of
a delivery catheter.
[0037] FIG. 27 schematically illustrates a side view of the distal
portion of the delivery catheter of FIG. 26.
[0038] FIG. 28 schematically illustrates transverse cross-sections
of the delivery catheter of FIG. 26 taken along the line 9-9.
[0039] FIG. 29 schematically illustrates transverse cross-sections
of the delivery catheter of FIG. 26 taken along the line 9-9.
[0040] FIG. 30 schematically illustrates a catheter system.
[0041] FIG. 31 schematically illustrates a sectional view of a
catheter with a self inflating balloon.
[0042] FIG. 32 schematically illustrates the placement of a
catheter in the coronary sinus.
[0043] FIG. 33 schematically illustrates the diaphragmatic surface
of the heart.
[0044] FIG. 34 schematically illustrates the sternocostal surface
of the heart.
[0045] FIG. 35 schematically illustrates a partial cross-sectional
perspective view of a catheter within the coronary sinus.
[0046] FIG. 36 illustrates a tapered balloon catheter tip.
[0047] FIG. 37 illustrates a balloon catheter tip with a
guidewire.
[0048] FIG. 38 illustrates a balloon catheter tip with a
guidewire.
[0049] FIG. 39 schematically illustrates a catheter within a
vein.
[0050] FIG. 40 illustrates a guidewire tip with an occlusion
device.
[0051] FIG. 41 illustrates a guidewire with an occlusion
device.
[0052] FIG. 42 illustrates the guidewire of FIG. 41 with the
occlusion device open.
[0053] FIG. 42B, is a front view of FIG. 42A from perspective
"A".
[0054] FIG. 42C, is a side of the occlusion device of FIG. 42A
showing the occlusion device overlapping leaflets.
[0055] FIG. 43 illustrates a guidewire with an occlusion
device.
[0056] FIG. 44 is a cross-sectional view of a cannula and a
balloon.
[0057] FIG. 45 is a cross-section view of a cannula and a lined
ePTFE balloon.
[0058] FIG. 46 is a flow diagram of a process for forming a lined
ePTFE balloon.
[0059] FIG. 47 is an elevated cut-away view of layers of ePTFE
windings.
[0060] FIG. 48 is a cross section view of a cannula and a
balloon.
[0061] FIG. 49A is a cross sectional view of a cannula and a
balloon inflated to occlude a blood vessel.
[0062] FIG. 49B may be a cross sectional view of FIG. 49A from
perspective "A", according to an embodiment.
[0063] FIG. 50 is a cross sectional view of a cannula and a
postinflated deflated balloon.
[0064] FIG. 51 is a cross sectional view of FIG. 48 from
perspective "A".
[0065] FIG. 52 is a cross sectional view of FIG. 49A from
perspective "A".
[0066] FIG. 53 is a cross sectional view of FIG. 50 from
perspective "A".
[0067] FIG. 54 is a flow diagram of a process for using a balloon
to occlude a blood vessel or vein.
[0068] FIG. 55 illustrates a balloon outside diameter growth
rate.
[0069] FIG. 56 illustrates a graph of blood vessel pressure over
time.
[0070] FIG. 57 illustrates a cross-sectional view of a centrifugal
pump.
[0071] FIG. 58 schematically illustrates a pressure increasing
device.
[0072] FIG. 59 schematically illustrates a pressure increasing
device.
[0073] FIG. 60 schematically illustrates a pressure transferring
device.
[0074] FIG. 61 schematically illustrates a pressure-maintaining or
dampening device.
[0075] FIG. 62 schematically illustrates a pressure-maintaining or
dampening device with inlet and outlet.
[0076] FIG. 63 is a flow diagram of a method of treating a patient,
in accordance with an embodiment.
[0077] FIG. 64A is a cross sectional view of a cannula and a
balloon.
[0078] FIG. 64B is a cross-sectional view the apparatus of FIG. 64A
from perspective "A".
[0079] FIG. 65A shows the balloon and cannula of FIG. 64A, with the
balloon inflated to a second inflation volume.
[0080] FIG. 65B is a cross-sectional view the apparatus of FIG. 65A
from perspective "A".
[0081] FIG. 66A shows the cannula and balloon of FIG. 65A, with the
balloon inflated to a third inflation volume.
[0082] FIG. 66B is a cross-sectional view the apparatus of FIG. 66A
from perspective "A".
[0083] FIG. 67A shows the cannula and balloon of FIG. 66A, with the
balloon inflated to a selected fourth inflation volume.
[0084] FIG. 67B is a cross-sectional view the apparatus of FIG. 67A
from perspective "A".
[0085] FIG. 68 is a graph showing the relationship between the
outer diameter of a balloon and the volume of inflation contrast
fluid injected into the balloon.
[0086] FIG. 69A is a side perspective view of a cannula having a
balloon attached to its distal end and an infusion lumen and
accessory lumen running through the cannula.
[0087] FIG. 69B is a cross section view of the first section of
FIG. 69A from perspective "A".
[0088] FIG. 69C is a cross sectional view of the second section of
FIG. 69A from perspective "B".
[0089] FIG. 69D is a cross sectional view of the balloon section of
FIG. 69A from perspective "C".
[0090] FIG. 69E is a cross sectional view of the third section of
FIG. 69A from perspective "D".
[0091] FIG. 69F is a cross section view of the fourth section of
FIG. 69A from perspective "E".
[0092] FIG. 70 is a cross sectional view of the balloon section of
FIG. 69A from perspective "C", with the balloon inflated to a
second volume that is less than that shown in FIG. 69D.
[0093] FIG. 71A is a cross-sectional view of a cannula and a
balloon, where the cannula includes coaxially aligned lumens.
[0094] FIG. 71B is a cross-sectional view of the apparatus of FIG.
71A from perspective "A".
[0095] FIG. 72A is a cross-sectional view of a cannula and a
balloon, where the cannula includes coaxially and co-linearly
aligned lumens.
[0096] FIG. 72B is a cross-sectional view of the apparatus of FIG.
72A from perspective "B".
[0097] FIG. 73 is a cross-sectional view of a cannula and a
balloon, where the cannula has coaxially and co-linearly aligned
lumens.
[0098] FIG. 74 is a cross-sectional view of the apparatus of FIG.
71A from perspective "C" before forming tack joints between the
guidwire tube and the infusion tube.
[0099] FIG. 74B is the structure of FIG. 74A after forming tack
joints between the guidwire tube and the infusion tube.
[0100] FIG. 75A is a cross sectional view of an apparatus to
inflate a low volume balloon to occlude a blood vessel.
[0101] FIG. 75B is a cross-sectional view of the apparatus of FIG.
75A from perspective "A".
[0102] FIG. 76 shows the latch mechanisms of FIG. 75A in an
unlatched position.
[0103] FIG. 77 shows the latch mechanisms of FIG. 76 relatched.
[0104] FIG. 78 shows FIG. 77 after the inflation volume adjustment
knob has been rotated or turned to retain fluid.
[0105] FIG. 79 shows FIG. 78 after the inflation volume adjustment
knob has been rotated or turned to inflate the balloon with a
selected inflation volume fluid.
[0106] FIG. 80 shows FIG. 79 after unlatching inner the plunger
lock to deflate the balloon.
[0107] FIG. 81 shows an alternate embodiment of an apparatus to
perform the functions of FIG. 75A-80.
[0108] FIG. 82 is a flow diagram of a process for treating a
treatment region of a blood vessel with one or more treatment
agents or progenitor cells.
[0109] FIG. 83 is a cross-sectional view of an occlusion balloon
attached to a cannula having holes through an exterior surface of
the cannula proximate to the balloon, where the holes extend to a
lumen in the cannula having an exit distal to the balloon.
[0110] FIG. 84 is a cross-sectional view of FIG. 83 from
perspective "A".
[0111] FIG. 85 is a cross-sectional view of the apparatus shown in
FIG. 83 advanced to a treatment region of a blood vessel.
[0112] FIG. 86 is a cross-sectional view of a cannula having a
balloon attached to its distal end and a bypass lumen extending
from a hole distal to the balloon to a hole proximal to the
balloon.
[0113] FIG. 87 shows the apparatus of FIG. 86 where the infusion
lumen extends to a location distal to balloon 8810.
[0114] FIG. 88 is a cross-sectional view of a cannula having a
balloon attached to its distal end, and infusion lumen to provide
treatment agent to a location distal to the balloon, and a bypass
lumen to allow for perfusion of liquid from the location distal to
the balloon to the location proximal to the balloon.
[0115] FIG. 89 is a cross-sectional view of a cannula having two
balloons attached to its distal end, and infusion lumen exiting the
cannula between the balloons, and a bypass lumen to allow perfusion
between a location proximal to both balloons and a location distal
to both balloons.
DETAILED DESCRIPTION
[0116] Referring first to FIG. 1, a cross-sectional view of a heart
is shown to illustrate blood flow throughout the heart.
Deoxygenated blood returning from the body comes into heart 100
from either superior vena cava 126 or inferior vena cava 116 and
collects in right atrium 122. Right atrium 122 contracts to pump
the blood through tricuspid valve 118 where it flows into right
ventricle 114. Right ventricle 114 contracts to send the blood
through pulmonary valve 120 into pulmonary artery 124 where it goes
into the lungs (not shown). The oxygenated blood returning from the
lungs flows through pulmonary veins 102 where it flows into left
atrium 101. Left atrium 101 contracts sending the blood through
bicuspid or mitral valve 104 and into left ventricle 108. When left
ventricle 108 contracts, the blood is sent through aortic valve 106
and into aorta 128. Left ventricle 108 and right ventricle 114 are
separated by ventricular septum 110.
[0117] Referring to FIG. 2, a more detailed vertical cross-section
of heart 100 is shown. Blood first collects in right atrium 122
from superior vena cava 126 or other veins. Right atrium 122 also
includes right auricle 142. When right atrium 122 contracts, blood
is sent through tricuspid valve 118 and into right ventricle 114.
Tricuspid valve 118 is made up of three cusps: posterior cusp 176,
septal cusp 178, and anterior cusp 180 (shown retracted). Right
ventricle 114 has a number of muscles that contract to send blood
out of right ventricle 114. Some of the muscles in right ventricle
114 include right anterior papillary muscle 174 (shown cut), and
right posterior papillary muscle 172. Other parts of the anatomy of
right ventricle 114 includes conus arteriosis 156, supra
ventricular crest 152, and moderator band 160 and septal band 162
of septal marginal trabacula 164. The blood outflow to the
pulmonary trunk is marked by arrow 154. Pulmonary trunk is shown as
138. The blood returning from the lungs returns by left pulmonary
veins 134 and right pulmonary veins 136 where it collects in left
atrium 101. Left atrium 101 also includes left auricle 138. When
left atrium 101 contracts, blood is sent through mitral valve 104
which is made up of posterior cusp 132 and anterior cusp 130. Blood
flows through mitral valve 104 and into left ventricle 108. Muscles
in the left ventricle include left posterior papillary muscle 170,
left anterior papillary muscle 168. Septum 110 separates left
ventricle 108 from right ventricle 114. Septum 110 includes the
muscular part of intraventricular septum 186, interventricular part
of the membranous septum 182, and the atrial ventricular part of
membranous septum 184. When left ventricle 108 contracts, blood is
sent through aortic valve 106 which includes left semi-lunar cusp
146, posterior semi-lunar (non-coronary) cusp 148, and right
semi-lunar cusp 150. Most of the blood flows through aortic valve
106 and into ascending aorta 128, although some of the blood is
diverted into the openings of coronary arteries 140.
[0118] Referring now to FIG. 3A, a catheter system having a guide
catheter, a delivery catheter, guidewires and multiple occlusion
system is illustrated. In various embodiments, system 300 includes
guide catheter 302 having proximal portion 305 and distal portion
306. System 300 includes guide catheter 302 having lumen 304, for
allowing system 300 to be fed and maneuvered over a guidewire, such
as guidewire 320 or guidewire 330. In various embodiments, lumen
304 extends the length of guide catheter 302 from proximal portion
305 to distal portion 306. Representatively, in a procedure, a
guidewire 320 or 330 may be initially placed through a treatment
region in a physiological lumen (e.g., a blood vessel) After
placement, guide catheter 302 is advanced on and over the guidewire
to or through a treatment region in an over the wire (OTW) fashion.
In another embodiment, system 300 may be a rapid transfer type
catheter assembly and only a portion of system 300 (e.g., a distal
portion) is advanced over the guidewire (also see FIG. 37).
Guidewire 320 or guidewire 330 may be retracted or removed once
system 300 is placed at a treatment region.
[0119] System 300 includes guide catheter 302 having a lumen 304.
Guide catheter 302 includes distal portion 306 having occlusion
balloon 308 about distal portion 306. Delivery catheter 310 is
shown disposed through lumen 304 of guide catheter 302. Delivery
catheter 310 has distal end 312. Balloon 314 attaches at distal end
312. Notch 316 is located at distal end 312 and guidewire opening
318 opens into lumen 313 of delivery catheter 310 and is provided
distally adjacent notch 316. Guidewire 320 is disposed through
notch 316 and lumen 313 within delivery catheter 310 and out
guidewire opening 318 of delivery catheter 310. Guidewire 320
includes distal end 322 and occlusion device 324. Occlusion device
324 may be an occlusion balloon attached to the exterior surface of
guidewire 320 at or adjacent distal end 322 by adhesive, heat
bonding, laser bonding, or shrink wrap bonding. Also shown disposed
through guide catheter lumen 304 is guidewire 330. Guidewire 330
includes distal end 332 and occlusion device 334. Also note that
occlusion device 334 may be an occlusion balloon attached to the
exterior surface of guidewire 330 at or adjacent distal end 332 by
adhesive, heat bonding, laser bonding, or shrink-wrap bonding. In
this embodiment, guidwire 330 is shown disposed through guide
catheter 302 (e.g., from a proximal end to a distal end of the
guide catheter) but is not engaged by delivery catheter 310.
[0120] Proximal portion 305 of system 300 may reside outside the
body of a patient while the remainder of system 300 is
percutaneously introduced into patient's vasculature through a
blood vessel. As shown in FIG. 3A, proximal portion 305 of system
300 includes hub 351. Hub 351 includes guidewire 320, guidewire
330, and treatment agent delivery lumen 319. In various
embodiments, relative to the materials for the various cannulas
described herein, a housing of hub 351 is a hard or rigid polymer
material, e.g., a polycarbonate or acrylonitrile bubadiene styrene
(ABS). A distal end of hub 351 has an opening to accommodate a
proximal end of guide catheter 302. Hub 351 also has guidewire
track 391, guidewire track 392, and a number of cavities at least
partially through hub 351 (extending in a distal to proximal
direction) to accommodate guidewire 320, guidewire 330, and
treatment agent delivery lumen 319. Treatment agent delivery lumen
319 may be used to infuse a treatment agent including liquids,
drugs, infusion pellets, suspended cells, stem cells, microspheres,
peptides, growth factors, or various other appropriate liquids,
materials, and therapeutic agents (mixed with blood or not) to be
delivered locally or to a treatment region in a blood vessel. Also,
delivering a treatment agent may include performing an
infusate-uptake-enhancing procedure such as of electroporation,
ultrasonic excitation, or photodynamic therapy. A proximal portion
of hub 351 flares to create a spacing between guidewire 320 and
guidewire 330, and treatment agent delivery lumen 319 (i.e., a
distal end of hub 351 has width W1 sufficient to accommodate a
proximal end of guide catheter 302 and a proximal end of hub 351
has width W2 that is greater than width W1). Hub 351 also includes
medial section 390 which may have various appropriate lengths such
as between a fraction of an inch and 10 inches to allow hub 351 to
function appropriately. Moreover, guide catheter 302, delivery
catheter 310, or hub 351 may include additional lumen, tubes, or
cannula to inflate or expand occlusion devices, balloons, or to
provide pressure measurements or pressure relief.
[0121] For example, in various embodiments, hub 351 may have at
least the following functions: guidewire movement and control,
guide catheter movement and control, delivery catheter movement and
control, occlusion device expansion and retraction, balloon
inflation and deflation, treatment agent delivery, and aspiration
of fluid or particles from a treatment region of a blood vessel.
With reference to FIG. 3A, in this embodiment, hub 351 also
includes strain relief 370 catheter holder 373 (e.g., such as for
holding a delivery catheter disposed through lumen 304), treatment
agent delivery port 323, guidewire port 398, and guidewire port
399. A proximal end of guide catheter 302 terminates inside hub 351
near a distal end of hub 351. Guidewire 320, guidewire 330, and
treatment agent delivery lumen 319 extend proximally beyond a
proximal end of guide catheter 302 and may be secured in respective
cavities through hub 351.
[0122] FIG. 3A also shows a distal portion of hub 351 including
strained relief 370. Strained relief 370 may be an elastic tubular
component that may act to reduce stress and inhibit shaft (e.g., of
guide catheter 302) kinking for/or during the transition, movement,
or control of a guidewire, such as guidewire 320 or guidewire 330,
a catheter, such as guide catheter 302 or delivery catheter 320, or
other functions identified above for hub 351.
[0123] FIG. 3B shows a sectional side view of FIG. 3A through line
C-C' of FIG. 3A. FIG. 3B shows guidewire 320 and guidewire 330
disposed within lumen 304 of guide catheter 302. FIG. 3B also shows
delivery catheter 310 disposed through guide catheter 302, wherein
treatment agent delivery lumen 319 is disposed within delivery
catheter 310.
[0124] According to various embodiments, the components of system
300, such as guide catheter 302, delivery catheter 310, balloon
308, balloon 314, occlusion devices 324 and 334, hub 351, strained
relief 370, catheter holder 373, medial section 390, and other
cannula or tubes surrounding lumens may be made of a material
including materials described herein for such components, as well
as materials described herein for balloons. For example, the
components of system 300 may include a polycarbonate or
acrylonitrile bubadiene styrene (ABS); a biocompatible polymer such
as a polyether block amide resin; a biocompatible polymer blend of
polyurethane and silicone a polymer having a structure of a regular
linear chain of rigid polyamide segments interspaced with flexible
polyether segments, a styrenic block copolymer (SBC), or a blend of
SBC's; a thermoplastic blend copolymer material having one of a
polyether block amide resin moiety and a polyetheramide moiety; a
styrene isoprene styrene (SIS), a styrene butadiene styrene (SBS),
a styrene ethylene butylene styrene (SEBS), a polyetherurethane, an
ethyl propylene, a ethylene vinyl acetate (EVA), an ethylene
methacrylic acid, an ethylene methyl acrylate, and an ethylene
methyl acrylate acrylic acid; a material from a material family of
one of styrenic block copolymers and polyurethanes; a nylon
material; a melt processible polymer; or a low durometer material.
It is also contemplated that other components of system, apparatus,
or devices described herein, such as other catheters, cannulas,
balloons, filter devices, occlusion devices, tubes (e.g., such as
lumen 989, lumen surrounding material, lumen sleeves, lumen cannula
or lumen tubes, such as described below with respect to infusion
lumen 9520 or accessory lumen 9530 of FIGS. 69A-F), syringes,
pressure increasing devices, pressure transfer devices, pressure
maintaining devices, or pumps described below made of a material
including materials described above.
[0125] In use, system 300 may be referred to as a "rapid transfer
type system" designed to have the distal end of guide catheter 302
advanced percutaneously to a desired first location in a blood
vessel where balloon 308 may be inflated to occlude the blood
vessel or to fix the distal end of guide catheter 302 at the first
location. Note that balloon 308 may be inflated later on in the use
of system 300, such as after delivery catheter 310 is advanced as
described below. Next, guidewire 320 may be advanced percutaneously
to a desired second location in the same or a different blood
vessel so that the distal end 312 of delivery catheter 310 can be
advanced or tracked over guidewire 320 by feeding lumen 131 over
guidewire 320. Then, balloon 314 may be inflated to occlude the
blood vessel or to fix the distal end of delivery catheter 310 at
or adjacent to the second location. It is also contemplated that
guidewire 330 may be advanced through a blood vessel and to a third
location. Occlusion devices 324 or 334 may be expanded to occlude
blood vessels, such as at those locations, to define a distal end
of a treatment region or treatment area. The treatment agent
infuses into the blood vessel from treatment agent delivery lumen
319 of delivery lumen 310 (e.g., where the region of interest,
treatment agent, and infusion of treatment agent from the delivery
catheter are in accordance with corresponding descriptions
herein).
[0126] For instance, in one example, guide catheter 302 may be fed
and maneuvered as described above into blood vessels of a person's
heart. More particularly, FIG. 4 schematically illustrates the
placement of the catheters of FIGS. 3A and 3B in the coronary
sinus, such as coronary sinus 3286 of FIGS. 32-33. As shown in FIG.
4, delivery catheter 310 may be fed through lumen 304 of guide
catheter 302 and into middle cardiac vein 406, such as by being fed
through lumen 304 before or after guide catheter 302 is placed
through a treatment region in an OTW fashion, or is placed through
a treatment region in a rapid transfer type fashion. Guidewire 320
may also be fed through guide catheter 302 through guidewire
opening 318 of delivery catheter 310 and into middle cardiac vein
406 distal to distal end 312 of delivery catheter 310. Guidewire
330 may be fed through lumen 304 and into small cardiac vein 492.
Next, occlusion device 324, occlusion device 334, and balloon 314
may be engaged to occlude small cardiac vein 492, and respectively
occlude a portion of middle cardiac vein 406 between balloon 314
and occlusion device 334. Next, balloon 308 may be engaged. A
treatment agent may be fed through treatment agent delivery cannula
319 distal to balloon 314 and proximal to occlusion device 324.
Occlusion device 334 is engaged, and balloon 308 is engaged to
prevent the treatment agent from reaching the right atrium through
shunts or anastimoses. Following the conclusion of the
administration of the treatment agent, occlusion device 324,
occlusion device 334, and balloon 314 may be disengaged, and
guidewire 320, delivery catheter 310, and guidewire 330 are removed
from lumen 304 of guide catheter 302. Then, coronary sinus 486 may
be aspirated (e.g., see hole 988 of FIG. 9 and accompanying text)
and then balloon 308 disengaged and guide catheter 302 removed from
the coronary sinus.
[0127] Embodiments also include system 300 having a filter device
instead of balloon 308. For instance, the system and process
described above for FIGS. 3A, 3B and 4 may also apply to a system
and process having filter device 720, instead of and at the
location of balloon 308, to restrain and aspirate particles shown
and described below for FIGS. 7-19.
[0128] Referring now to FIG. 5, a guide catheter is illustrated.
FIG. 5 shows guide catheter 502 which may or may not be or be part
of system 300, such as if guide catheter 502 is part of guide
catheter 302, as shown and described with respect to FIG. 3. In
particular, guide catheter 502 has proximal end 504 and distal end
506, which may be or be part of proximal end 305 or distal end 306,
as shown and described with respect to FIG. 3. Lumen 508 is shown
in FIG. 5 extending through guide catheter 502 from guide catheter
opening 514 at proximal end 504 to distal end 506. Guide catheter
502 also has balloon 510 attached around the exterior surface of
catheter 502 at or adjacent distal end 506. Lumen 508 or balloon
510 may correspond to lumen 304 or balloon 308, as shown and
described with respect to FIG. 3. FIG. 5 also includes balloon
inflation cannula 512 within guide catheter 502 from proximal end
504 to opening 513 within balloon 510.
[0129] FIG. 6 shows a sectional view of FIG. 5 through line C-C' of
FIG. 6. As shown in FIG. 6, balloon inflation cannula 512 is
disposed within guide catheter 502 such as by being disposed
through guide catheter opening 514 and extended into a portion of
balloon 510, such as to provide opening 513 to inflate balloon
510.
[0130] In various embodiments, proximal end 504 includes guide
catheter opening 514 and balloon inflation cannula 512. Also valve
device 516, with selector mechanism 518. Guide catheter 502 may
have an opening extending from lumen 508 at distal end 506 to guide
catheter opening 514 at proximal end 504. Thus, in embodiments
implementing valve device 516, selector mechanism 518 may be
disengaged to allow the opening extending from lumen 508 to guide
catheter opening 514 to remain open. Alternatively selector
mechanism 518 may be engaged, such as by turning, to cause valve
device 516 to close the opening between lumen 508 and guide
catheter opening 514 at valve device 516 and instead direct any
fluid flowing through the opening and toward guide catheter opening
514 through nozzle 520 and out of valve device 516. In some
embodiments, the fluid flows such as into collecting reservoir 524,
which in some embodiments connected to nozzle 520 such as by a hose
connected to nozzle 520. Thus, selector mechanism 518 is engaged,
for example, to aspirate fluid such as blood or particles such
(e.g., see hole 988 of FIG. 9 and accompanying text), form a
treatment region of a blood vessel through lumen 508, and out of
nozzle 520. This could be used, for example, to aspirate a vessel
distal to balloon 510, before deflating balloon 510 so that fluid
will be removed from the vessel.
[0131] According to various embodiments, guide catheter 502 may be
an appropriate length for reaching a treatment region of a subject
during a medical procedure, such as by having a length of between
three inches and five feet. Also, guide catheter 502, balloon 510,
and balloon inflation cannula 512 may be formed of materials
similar to those for forming components of system 300. Moreover,
balloon inflation cannula 512 may include one or more of a
synthetic or natural latex or rubber, such as a polymer material; a
polyetheramide; a plasticiser free thermoplastic elastomer; a
thermoplastic blend; a block copolymer of polyether and polyester
(e.g., such as a polyester sold under the trademark Hytrel.RTM. of
DUPONT COMPANY); a biocompatible polymer such as a polyether block
amide resin (e.g., for instance, PEBAX.RTM. of ATOCHEM
CORPORATION); a polycarbonate or acrylonitrile bubadiene styrene
(ABS); a biocompatible polymer such as a polyether block amide
resin; a styrene isoprene styrene (SIS), a styrene butadiene
styrene (SBS), a styrene ethylene butylene styrene (SEBS), a
polyetherurethane, an ethyl propylene, an ethylene vinyl acetate
(EVA), an ethylene methacrylic acid, an ethylene methyl acrylate,
an ethylene methyl acrylate acrylic acid, a material from a
material family of one of styrenic block copolymers and
polyurethanes, a melt processible polymer, a low durometer
material, and nylon. Likewise, balloon 510 may be attached to guide
catheter 502 by processes described herein for attaching a balloon
to a catheter, including by laser, adhesive, shrink tube bonding,
and heat bonding.
[0132] In other embodiments, proximal end 504 of guide catheter 502
is provided with flap 519 instead of valve device 516. Flap 519 is,
for example, a material similar to a material for inflation cannula
512 (e.g., such as materials described above with respect to
components of system 300, or a synthetic or natural latex or
rubber, or other materials that can block fluid flow). Flap 519 has
a suitable dimensions to block off and occlude lumen 508, such as
to prohibit blood or treatment agent from flowing past flap 519.
Thus, flap 519 serves to close guide catheter opening 514 when
there are no devices disposed in or through guide catheter 502 such
as a device or cannula holding flap 519 open. For instance, flap
519 may be attached to the inside of catheter 502 along lumen 508,
at one or more locations, by one or more of a hinge, a pin, an
anchor, laser bonding, adhesive bonding, and heat bonding. Thus,
when the device, catheter, or cannula (not shown) is inserted into
guide catheter opening 514, the device or cannula pushes flap 519
opens with some degree of force, such as by forcing flap 519 from
close position CL to open position OP, as shown in FIGS. 5 and 6.
For instance, a device, catheter, or cannula inserted into guide
catheter opening 514 in direction 583 can push flap 519 from close
position CL to open position OP, as shown in FIGS. 5 and 6, and
allow lumen 508 to define an opening extending from guide catheter
opening 514 to distal opening 594. After the device or cannula is
removed from guide catheter opening 514 or pushing flap 519 open,
flap 519 has a property that causes it to resist or occlude a flow
of any liquid or particles flowing from lumen 508 towards guide
catheter opening 514. Hence, after the device or cannula is removed
from pushing flap 519 open, flap 519 has a property or is mounted
to close, such as by causing flap 519 to move from open position OP
to close position CL, and to be biased in closed position CL with
sufficient force to stop or occlude a flow of any liquid or
particles flowing from lumen 508 towards guide catheter opening 514
Thus, when closed, flap 519 prevents fluid originating from opening
594 from flowing through lumen 508 within guide catheter 502 and
flowing out guide catheter opening 514.
[0133] In other embodiments, proximal end 504 of guide catheter 502
includes sealing cap 530 adapted to seal guide catheter opening 514
instead of valve device 516 or flap 519. Sealing cap 530 serves to
seal guide catheter opening 514 such as by having threads that
engage other threads at the proximal end of guide catheter 502, or
by having a recess for engaging a lip at the proximal end of guide
catheter 502. Thus sealing cap 530 may be used to seal off proximal
end of guide catheter 502 when attached thereto, and may be removed
from proximal end of guide catheter 502 such as to aspirate a
treatment region of a vessel as described above with respect to
valve device 516. More particularly, cap 530 may be attached to
guide catheter 502 unit til such time as it is desired to aspirate
a vessel distal to balloon 510 (e.g., such as after the balloon is
inflated and before deflating the balloon). At that time, cap 530
can be removed, and liquid from the vessel can flow from lumen 508
through guide catheter 502 out guide catheter opening 514 and into
collection receptacle 532.
[0134] Furthermore, according to some embodiments, catheters, such
as a guide catheter, include a filter device capable of filtering
certain particles from passing through the catheter but not
restricting fluid flow. For instance, a coronary sinus access guide
or catheter may have a collection cage or filter device to filter
unwanted particles or material from blood. For example, FIG. 7 is a
side view of a cannula and a filter device in a sheath. As shown in
FIG. 7, apparatus 700 includes cannula 710, such as a cannula
having a dimension suitable for percutaneous advancement through a
blood vessel, includes proximal section 712 and distal end 714.
FIG. 7 also shows filter device 720 having proximal portion 722
axially coupled or connected to an exterior surface of cannula 710
at or adjacent distal end 714. For instance, an inner diameter of
proximal portion 722 may be attached to an exterior surface of
cannula 710 by laser bonding, adhesive bonding, heat bonding, or
other bonding techniques at an appropriate location adjacent to
distal end 714 to filter unwanted particles or material from blood
flowing in direction 784 in a treatment region, such as treatment
region 996.
[0135] Filter device 720 also has distal portion 724 having a first
diameter D1 under a first set of conditions. For example, a first
set of conditions may include filter device 720 being restrained
(e.g., to less than an inner diameter of a blood vessel into which
it will be placed) by sheath 790, or restricted by a retraction or
contraction pressure, such as a pressure resulting from a deflated
balloon, tendon, or self-contracting filter device.
[0136] Thus, as shown in FIG. 7, diameter D1 is smaller than and
restrained by diameter of the sheath DS, and is larger than
diameter of the cannula DC, forming first angle A1 between
generally conical-shaped inner surface 737 and the surface of
cannula 710. For example, according to some embodiments, first
angle A1 shown in FIG. 7 may be an angle between 0.degree. and
20.degree., such as an angle of 2.degree., 3.degree., 4.degree.,
5.degree., 6.degree., or 10.degree.. As a result distal portion 724
may have a first diameter between 1 mm and 14 mm, such as by having
an outer diameter corresponding to French size 5F, 6F, 7F, 8F, 9F,
10F, 12F, 15F, 18F, 24F, and 30F.
[0137] FIG. 8 is a view of FIG. 7 from perspective "A". FIG. 8
shows conical shape inner surface 737 at filter device 720
including proximal portion 722 having a diameter approximately
equal to diameter of cannula DC and distal portion 724 having first
diameter D1. FIG. 8 also shows sheath 790 having diameter of sheath
DS, such as a diameter of sheath sufficient to restrict or contain
the diameter of distal portion 724 to first diameter D1. Note that
although in FIGS. 7 and 8, cannula 710, proximal portion 722,
distal portion 724, and sheath 790 are shown having side sections
through line A-A' that are approximately circular, various other
closed shapes are contemplated such as an oval, a square, a
triangle, a trapezoid, an ellipse, or a combination thereof.
[0138] Moreover, sheath 790 may be retracted in a proximal
direction (e.g., direction 784) so that sheath end 794 is pulled
back beyond distal portion 724 allowing first diameter D1 to expand
beyond a diameter of the sheath DS. Similarly, according to some
embodiments, pull wire 792 (e.g., such as a wire disposed within
sheath 790 extending from distal end 714 to a proximate end of
sheath 790 external to the body of a subject) may be pulled or
removed, such as by being pulled in direction 784, to form a seam
in sheath 790 (e.g., such as where pull wire 792 was before
removal) so that sheath 790 may be entirely or partially removed
from encasing cannula 710 or filter device 720. More particularly,
filter device 720 may have a property such that first diameter D1
of distal portion 724 can be transformed, enlarged, or expanded to
a second diameter under a second set of conditions. Consequently,
first diameter D1 can be transformed to become a second diameter,
such as in response to expansion pressures 730 and 732 applied to
generally conical-shaped inner surface 737.
[0139] In various embodiments, distal portion 724 has a different
second diameter under a second set of conditions, where the second
diameter approximates an inner diameter of a blood vessel. For
example, FIG. 9 is a side view of a distal end of a cannula
including a filter device having a distal portion with a second
diameter that is approximately the inner diameter of a blood vessel
at a treatment region. Specifically, FIG. 9 shows cannula 710
percutaneously advanced through blood vessel 990, and sheath 790
retracted so that sheath end 794 is retracted beyond proximal
portion 722 allowing filter device 720 to expand in directions 786
and 788 so that distal portion 724 has different second diameter D2
under the second set of conditions (e.g., retraction of sheath 790)
that is at least equivalent to inner diameter of blood vessel DV at
treatment region 996.
[0140] Note that treatment region 996 may be a treatment region
proximate to where distal portion 724 contacts blood vessel 990,
and optionally included the region contained in blood vessel 990
distal to filter device 720 and containing distal end 714. For
example, second diameter D2 may be a diameter approximately equal
to the diameter of a blood vessel at a region or point of interest,
a diameter slightly less than that of a blood vessel at a point or
treatment region, or a diameter slightly greater than that of a
diameter of a blood vessel at a point or treatment region. More
particularly, second diameter D2 may be greater than the diameter
of blood vessel 990 at a point or treatment region, such as by
being in a range of between 0% and 25% larger, such as by being 3%
larger, 5% larger, 10% larger, or 15% larger in diameter.
[0141] Specifically, filter device 720 may have a property such
that first diameter D1 can be transformed to become second diameter
D2 in response to expansion pressures having a total of between
approximately two atmospheres in pressure and six atmospheres in
pressure applied to generally conical-shaped inner surface 737
(e.g., such as caused by pressures 730 and 732) to cause surface
737 to expand to second generally conical-shaped inner surface 937.
According to some embodiments, expansion pressures 730 and 732 may
be the result of, applied by, or caused by, a fluid flow in
direction 784. For example, expansion pressures 730 and 732 may be
applied by a flow of blood 986 in direction 784 having a pressure
greater than 2.0 millimeters of Mercury (mmHg) in pressure to cause
distal portion 724 to expand in directions 786 and 788.
[0142] Also, according to some embodiments, filter device 720
includes self-expanding materials (e.g., such as shape memory
alloys, including for example, Nickel-Titanium) or other materials
that have shape memory where the memorized shape is the expanded
shape. To modify the shape (e.g., to restrict the shape) a sheath
may be placed over filter device 720. Removing the restriction will
allow the shape memory material to return to its memorized shape
(e.g., an expanded shape). Specifically, for example, filter device
720 may include a self-expanding frame portion to provide the
second set of conditions under which distal portion 724 has second
diameter D2.
[0143] Furthermore, according to some embodiments, filter device
720 may have a property, such as including a material, such that
under the second condition (e.g., the condition described above
wherein second diameter D2 approximates an inner diameter of a
blood vessel) filter device 720 will restrain from flowing through
filter device 720 plurality of particles 980 having a particle size
greater than an average particle size of blood cells 982. More
specifically, for example, as shown in FIG. 9, filter device 720
may restrain particles 980 (e.g., such as infusion pellets,
suspended cells, stem cells, or microspheres) in fluid 986 flowing
in direction 784, from flowing through filter device 720. Thus,
particles having a particle size approximately that of an average
particle size of blood cells, such as blood cells 982, contained in
fluid 986 flowing in direction 784, may travel through filter
device 720 without being restrained (e.g., such as if unrestrained
blood cell 983 originated in treatment region 996). For example, a
typical red blood cell has a size of approximately 7 micrometers in
diameter, and a typical white blood cell has a size of between
approximately 7 and 15 micrometers in diameter.
[0144] Consequently, according to some embodiments, filter device
720 may include a material, such as material 930 having or pierced
by a plurality of openings, such as openings 931 and 932, having a
dimension suitable to allow a fluid, such as blood, to pass
therethrough. More particularly, openings 931 and 932 may have a
dimension suitable to allow a fluid including blood cells 982 to
flow through the openings and having a dimension suitable to
restrain particles 980 having a particle size greater than an
average particle size of blood cells. For example, openings 931 and
932 may have a diameter of between 10 micrometers and 100
micrometers in diameter. Thus, openings 931 and 932 may act like a
trap, a sieve, or a strainer of particles to restrain particles
980. Moreover, according to some embodiments, particles, materials,
and matter restrained by filter device 720 may be restrained such
as by causing the particles, material, or matter to bond to or be
coupled to filter device 720, to rest against filter device 720, or
to be restrained within the area of blood vessel 990 distal to
filter device 720, such as the area including distal end 714. It is
contemplated that material 930 may include various suitable
materials such as natural or synthetic material, plastic, stainless
steel, PEBAX.RTM. 91 (a biocompatible polymer such as a polyether
block amide resin, sold under the trademark PEBAX.RTM. of ATOCHEM
CORPORATION, PUTEAUX, FRANCE), embolic protection material, or
various other appropriate filtration materials.
[0145] Material 930 may be connected or attached to a frame
portion, such as by laser bonding, adhesive bonding, thermal
bonding, mechanical restriction (e.g., such as if material 930 is
woven or sewn through structure or portions of the frame, such as a
structure having space between pieces of the structure or holes in
the frame), or various other appropriate attachment methods.
[0146] For example, filter device 720 may include a frame portion
defined by proximal portion 722 and distal portion 724. According
to some embodiments, an inner diameter of the frame portion may be
attached to an outer surface of cannula 710, at proximal portion
722 such as by laser bonding, adhesive bonding, thermal bonding,
mechanical bonding (e.g., such as is described above for attaching
material 930 to the frame portion), or various other techniques of
bonding sufficient to preclude all or a portion of the inner
diameter of filter device 720 from becoming separated from the
outer surface of cannula 710. For example, a sufficient attachment
would preclude a portion or all of an inner diameter of filter
device 720 from becoming detached from the outer surface of cannula
710 during expansion or retraction of distal portion 724, a first
set of conditions, a second set of conditions, during restriction
of a fluid flowing through filter device 720, or during aspiration
of particles from treatment region 996, such as is described herein
(e.g., see hole 988 of FIG. 9 and accompanying text).
[0147] It is contemplated that the frame portion may include one or
more of a leaflet-shaped support, a helical-shaped support, a
cone-shaped support, a spar-shaped support, a basket-shaped
support, a ring-shaped support (e.g., to allow material 930 to form
a "parachute" shape), or a combination thereof. More specifically,
a frame portion may have a plurality of extending supports
extending from proximal portion 722 to distal portion 724, such as
a spar, a rod, a shaft, a dowel, a pull, a spine; and a plurality
of cross supports disposed between the plurality of extending
supports, such as a rib, a cross-link, and a cross-wrap wrapped
around, over, or under the extending support. In addition, it is
contemplated that filter device 720 or the frame portion of filter
device 720 may include one or more of tubing, wires, ribs, ribbons,
forged materials, extruded materials, cast materials, and deposited
materials. For example, FIG. 9 shows filter device 720 having
longitudinally disposed, circumferentially spaced elements,
including elements 920, 921, and 922. Moreover, filter device 720
may include ribs or cross supports, such as ribs 924 and 926.
[0148] Likewise, filter device 720 may include a material stretched
on a frame portion to form a generally conical-shaped inner
surface. For example, FIG. 10 is a view of FIG. 9 from perspective
B. FIG. 10 shows proximal portion 722 having diameter of proximal
portion DP and material 930 stretched to form generally
conical-shaped inner surface 937 between proximal portion 722 and
distal portion 724 having second diameter D2. Thus, frame portion
720 may have material 930 on, over or under longitudinally disposed
elements or spars spaced and defining a conical shape extending
from proximal portion 722 to distal portion 724, such as is shown
by conical shape 937 of FIGS. 9 and 10 or conical shape 737 shown
in FIGS. 7 and 8. FIG. 10 also shows blood vessel 990 having
diameter of vessel DV which is slightly less than second diameter
D2. Thus, in various embodiments, it is contemplated that second
diameter D2 approximates an inner diameter of a coronary sinus of a
subject at a treatment region, such as by having a diameter of
between 6.5 millimeters and 11 millimeters. Also, material 930 may
be stretched on a frame portion, such as a frame including elements
920, 921, and 922 or ribs 924 and 926 to form generally
conical-shaped inner surface 737 under a first set of conditions
and generally conical-shaped inner surface 937 under a different
second set of conditions.
[0149] In addition, FIG. 9 shows generally conical-shaped inner
surface 937 forming second angle A2 between generally
conical-shaped inner surface 937 and the surface of cannula 710.
According to some embodiments, second angle A2 may be an angle
between 5.degree. and 85.degree., such as an angle of 10.degree.,
20.degree., 25.degree., 30.degree., 35.degree., 40.degree.,
45.degree., 50.degree., 55.degree., 60.degree., and 65.degree..
Consequently, distal portion 724 may have second diameter D2 in a
range between three mm and 15 mm, such as, an outer diameter
corresponding to French size 9F, 12F, 15F, 18F, 24F, 28F, 30F, 32F,
and 34F.
[0150] Furthermore, according to some embodiments, distal portion
724 may have various cross sectional aspects or shape.
Specifically, although distal portion 724 is shown in FIGS. 7 and 9
having a w-shaped profile, distal portion 724 may have various
appropriate shaped profiles, such as an m-shape, a flat shape, a
c-shape, an s-shape, or a shape including one or more of the
previously mentioned shapes. Likewise, elements 920, 921, and 922,
as well as ribs 924 and 926 may also have various appropriate
shapes, such as those described above with respect to distal
portion 724. Also, it is contemplated that a self-expanding or
self-contracting frame may include frame structure, portions,
elements, or ribs having a metallurgy with a memory, an elastic
material, nitinol (NiTi), a shaped memory alloy (e.g., such as a
memory alloy that when formed to a shape remembers or returns to
that shape if not restrained or damaged). For example, a
self-expanding or self-extracting frame may be a metal frame with a
helical-spring shape, or a shape including ribs with a memory, that
flexes when constrained.
[0151] Once particles are restrained, such as with the filter
devices restraining particles, material, and matter, according to
various embodiments, filter device 720 may include a property to
allow aspiration of the particles, material, and matter being
restrained. Specifically, cannula 710 may include one or more
holes, such as hole 988 through the exterior surface of cannula
710, as shown in FIG. 9, to allow aspiration of restrained
particles, such as particle 980. Thus, hole 988 may be used to
aspirate or draw unwanted material, such as infusion pellets,
suspended cells, stem cells, or microspheres out of the treatment
zone or treatment region, such as via evacuation or suction to pull
the unwanted material through hole 988 and into cannula 710. For
example, aspiration of restrained particles is contemplated to
include aspiration of fluid 986, and blood cells 982, such as via a
suction or vacuum provided at hole 988 provided via a cannula
including lumen 989 extending from hole 988 through cannula 710 to
proximal section 712. According to some embodiments lumen 989 may
include a surrounding material, sleeve, cannula or lumen, such as
described below with respect to infusion lumen 9520 or accessory
lumen 9530 of FIGS. 69A-F. Hole 988 may be located between 0.2 mm
and 10 cm from the end of distal end 714.
[0152] Distal portion 724 may be expanded from first diameter D1
(FIGS. 7 & 8) to second diameter D2 (FIGS. 9 & 10) as a
result of filter device 720 being self-expanding, expansion
pressure from fluid flow in direction 784, or various other
appropriate systems or devices, such as for applying pressures 730
and 732. For example, FIG. 11 is a side section view of a filter
device with a distal portion having a first diameter and balloons
attached to the filter device or the cannula. FIG. 11 shows
balloons 1132 and 1134 attached to filter device 720 at attachment
locations 1139, and attached to cannula 710, such as at attachment
locations 1129, such that inflation of balloons 1132 and 1134
(e.g., such as inflation via cannulas as described below in FIGS.
17 and 18) transforms distal portion 724 of filter device 720 from
first diameter D1 to a second diameter. According to some
embodiments, the balloons may be attached to the filter device or
cannula at attachments locations 1129 or 1139, such as by an
adhesive, heat bonding, laser bonding, welding, or stitching.
[0153] Thus, for example, balloons 1132 and 1134 may be inflated
with sufficient pressure to cause an expansion pressure as
described with respect to FIGS. 7 and 9 (e.g., such as pressure
similar to those described above for pressure 730 and 732) applied
to generally conical-shaped inner surface 1137 (e.g., such as
similar to conical shape 737 described above).
[0154] Consequently, balloons 1132 and 1134 may be inflated to have
a volume greater than that shown in FIG. 11 to transform distal
portion 724 from first diameter D10 to a larger second diameter.
For example, FIG. 12 is a side-section view of a filter device with
a distal portion having a second diameter, wherein the filter
device is attached to inflated balloons, which are attached to a
cannula. FIG. 12 shows inflated balloons 1142 and 1144 attached to
filter device 720 and cannula 710 (e.g., such as described above
with respect to balloons 1130 and 1131) for transforming distal
portion 724 of filter device 720 from first diameter D10 to second
diameter D20. For instance, in various embodiments, inflated
balloons 1142 and 1144 may be balloons 1132 and 1134 respectively,
after inflation to become balloons 1142 and 1144. Note that
according to some embodiments, diameter D10 may be a diameter
similar to those described above with respect to first diameter D1,
and second diameter D20 may be a diameter similar to those
described above with respect to second diameter D2.
[0155] Also, according to some embodiments, filter device 720 may
include anchors proximate to distal portion 724 for engaging
tissue, to anchor filter device 720, or cannula 710 to an inner
diameter of a blood vessel. For instance, FIG. 11 shows a filter
device with a distal portion having anchors capable of engaging
tissue of a blood vessel. As shown in FIG. 11, anchors 1122 and
1124 proximate to distal portion 724, where anchors 1122 and 1124
include a protruding barb capable of engaging tissue of a blood
vessel, such as by piercing the inner diameter tissue to a
sufficient depth to engage a sufficient amount of the tissue of
blood vessel 990 to prohibit and anchor from being removed from its
engagement of blood vessel 990, such as by the flow of liquid or
blood in direction 784 toward filter device 720. Moreover, anchors
1122 and 1124 may be attached to elements or ribs of a frame of
filter device 720 such as element 922 and rib 926 of FIG. 9. Thus,
anchors 1122 and 1124 may be extended in directions 786 and 788 as
shown in FIG. 11, to engage tissue of blood vessel as shown in FIG.
12. Consequently, anchors 1122 and 1124 may be disengaged from
tissue of blood vessel 990 such as by retraction of distal end 724
or by moving filter device 720 in direction 985. Hence, anchors
1122 and 1124 may be disengaged from tissue, such as by retracting
or contracting distal portion 724 to move anchors 1122 and 1124 in
directions 1186 and 1188 as shown in FIG. 12.
[0156] For instance, filter device 720 may have a property such
that second diameter 1120 can be transformed to become or constrict
to approximately first diameter D10 in response to a retraction or
contraction pressure such as shown by pressures 1140 and 1141 of
FIG. 12. According to some embodiments, sufficient retraction
pressure may be in the range of between approximately two
atmospheres in pressure and 35 atmospheres in pressure applied to
generally conical-shaped inner surface 1138. More particularly, as
shown in FIG. 12, balloons 1142 and 1144 attached to filter device
720 and cannula 710 may be deflated (e.g., such as via lumens as
described below with respect to FIGS. 17 and 18) to transform
distal portion 724 of filter device 720 from second diameter D20
approximately to first diameter D10. For example, FIG. 13 is a side
section view of a filter device with a distal portion having a
third diameter, where the filter device is attached to deflated
balloons which are attached to a cannula. FIG. 13 shows deflated
balloons 1152 and 1154 attached to filter device 720 (e.g., as
described above with respect to attachment at attachment locations
1139) and attached to cannula 710 (e.g., such as described above
with respect to attachment at attachment locations 1129) such that
distal portion 724 is transformed to third diameter D30. For
instance, in various embodiments, deflated balloons 1152 and 1154
may be balloons 1132 and 1134 respectively, after inflation and
deflation (e.g., such as after inflation of balloons 1132 and 1134
to become balloons 1142 and 1144, and deflation of balloons 1142
and 1144 to become balloons 1152 and 1154).
[0157] Therefore, for example, inflated balloons 1142 and 1144 may
be deflated to cause pressures 1140 and 1141 sufficient to create a
retraction pressure as described above, applied to generally
conical-shaped inner surface 1138, thereby retracting distal
portion 724 to directions 1186 and 1188 from second diameter 1120
to third diameter D30 as shown in FIG. 13, which may be a diameter
in a range of between 100 percent and 130 percent of D10.
[0158] FIG. 14 is a side view of a distal portion of a cannula
including a filter device having a distal portion attached to
tendons which pivot at a pivot point and extend through a cannula.
As shown in FIG. 14, filter device 720 includes tendons 1430 and
1440 which extend from proximal section 712 of cannula 710 to pivot
points 1432 and 1442 and then are attached to distal portion 724,
such as via attachment at attachment locations 1439. Note that
attachment at attachment locations 1439 may be an attachment
achieved such as is described with respect to attachment at
attachment locations 1139 and 1129. Tendons 1430 and 1440 may
extend from proximal section 712 of cannula 710 to pivot points
1432 and 1442, such as via lumens as described below in FIGS. 17
and 18. Thus, tendons 1430 and 440 may be actuated such as by
releasing tension or extending the tendons in direction 985 to
transform distal portion 724 from first diameter D11 to a second
diameter (e.g., such as a result of an expansion pressure similar
to those described above with respect to FIGS. 7-13 and pressures
730 and 732 applied to generally conical inner surface 1437). It is
contemplated that generally conical inner surface 1437 may be
similar to conical shape 737 as described above. It is also to be
appreciated that tendons 1430 and 1440 may extend through proximal
section 712 such as to exit a proximal portion of cannula 710
exterior to the body of a subject so that tendons 1430 and 1440 may
be locked in a locking position. More particularly, tendons 1430
and 1440 may extend through a tendon port similar to port 398 above
(see FIG. 3 and accompanying text) and be locked in a locking
position, such as by a locking mechanism disposed within a proximal
portion of cannula 710, a tendon port, or external to the tendon
port. Hence, tendons 1430 and 1440 may be retained in their locking
position until it is desired to actuate them as described above.
Moreover, after actuation of tendons 1430 and 1440 as described
above, the tendons may be manipulated, or retracted as described
below and returned to a locking position, such as their original
locking position before actuation.
[0159] Moreover, tendons 1430 and 1440 may be of various suitable
materials such as natural or synthetic fiber, plastic, stainless
steel or various other appropriate metals. Likewise, pivot points
1432 and 1442 may be hard points such as a point where the tendon
exits cannula 710 or a lumen as described below with respect to
FIGS. 17 and 18. Moreover pivot point 1432 and 1442 may contain
various appropriate pivot structures such as a curved surface, a
hard point, an exit hole of an inflation lumen, an exit of a lumen
such as lumens described below in FIGS. 17 and 18, or an aspiration
hole such as hole 988 (see FIG. 9 and accompanying text), or a
small wheel.
[0160] For example, FIG. 15 is a side section view of a filter
device with a distal portion having a second diameter, wherein the
filter device is attached to tendons which extend through a
cannula. FIG. 15 shows actuated or released tendons 1450 and 1460
attached or coupled to distal portion 724 and cannula 710 (e.g.,
such as described below in FIGS. 17 and 18) for transforming distal
portion 724 from first diameter D11 to second diameter D21. Note
that according to some embodiments, diameter D11 may be a diameter
similar to those described above with respect to first diameter D1
(see FIG. 7 and accompanying text), and second diameter D21 may be
a diameter similar to those described above with respect to second
diameter D2.
[0161] Actuated or released tendons 1450 and 1460 may be
manipulated, such as by retracting or pulling tendons 1450 and 1460
in direction 784 to move distal portion 724 in directions 1186 and
1188 to transform second diameter D21 into a third diameter, such
as a diameter approximately equal to first diameter D11. For
example, FIG. 16 is a side section view of a filter device with a
distal portion having a third diameter and tendons attached to the
distal portion and extending through a cannula. As shown in FIG.
16, reactuated or pulled tendons 1470 and 1480 are attached to
distal portion 724, pivot at pivot points 1432 and 1442, and extend
through cannula 710, such that distal portion 724 is transformed to
third diameter D31. It is contemplated that third diameter D31 may
be a diameter similar to those described above with respect to
third diameter D30.
[0162] Suitable actuation or manipulation tension for tendons 1430
and 1440 includes a range of tension between for example, zero
pounds and five pounds such as a suitable tension for causing or
countering an expansion pressure (e.g., such as caused by pressures
730 and 732) and or retraction pressure (e.g., such as described by
pressures 1140 and 1141) as described above.
[0163] According to some embodiments, distal portion 724 may also
be retracted from the second diameter to approximately the first
diameter by various other appropriate designs or systems including
a self contracting filter device, such as using materials similar
to the self expanding filter device described above, but having an
opposite transformation principle. Likewise, distal portion 724 may
be retracted by a sheath such as sheath 790. Specifically, as shown
in FIG. 9, sheath 790 may be moved in direction 985, to retract and
cover over filter device 720 such as where the force of sheath
moving in a distal direction causes retraction of distal portion
724. Specifically, sheath 790 may be moved in direction 985 of FIG.
9 until the configuration of FIG. 7 is accomplished (e.g., with
sheath 790 over distal portion 724 of filter device 720).
[0164] Besides the above descriptions of retracting the second
diameter of distal portion 724, it is contemplated that filter
device 720 can be removed from blood vessel 990 without retraction
of the second diameter. For example, distal portion 724 may have a
property such that it can be retracted in direction 784 along blood
vessel 990 without damaging or breaching blood vessel 990.
Specifically, distal portion 724 may have atraumatic tips (e.g.,
such as by having properties at second diameter D2 as shown in FIG.
9, or atraumatic tips instead of anchors 1122 and 1124 at positions
shown in FIG. 12) such that filter device 720 can be retracted in
direction 784 while having second diameter D2 or second diameter
D20 under a second set of conditions. The tension on distal portion
724 is such that second diameter D20 may fluctuate (constrain or
expand) as filter device 720 moves through one or more blood
vessels.
[0165] Note that FIG. 14 also shows third angle A3 formed between
tendon 1430 extending through lumen 710 and a point at which tendon
1430 is attached or coupled to distal portion 724. For example,
according to some embodiments, third angle A3 shown in FIG. 14 may
be an angle between 10.degree. and 210.degree., such as an angle of
45.degree., 60.degree., 70.degree., 80.degree., 90.degree.,
100.degree., 120.degree., and 125.degree..
[0166] According to some embodiments it is possible to mix
technologies described above with respect to restraining distal
portion 724 by a retraction or contraction pressure, expanding
distal portion 724 by an expansion pressure, or retracting distal
portion 724 by a retraction or contraction pressure. For example,
it is possible for filter device 720 and cannula 710 to include a
self expanding filter device, or balloon expanded filter device,
restrained by tendons, wherein the distal portion of filter device
720 may be expanded to a second diameter by self expansion or
inflation of the balloons as described above, and then retracted to
a third diameter by deflation of the balloons or manipulation of
the tendons as described above. Likewise, it is possible for filter
device 720 and cannula 710 to include a self expanding filter
device, or balloon expanded filter device, restrained by a sheath,
wherein the distal portion of filter device 720 may be expanded to
a second diameter by self expansion or inflation of the balloons as
described above, and then retracted to a third diameter by
deflation of the balloons or manipulation of tendons attached to
the distal portion, as described above.
[0167] FIG. 17 is a front cross sectional view of the filter device
of FIG. 9 showing a proximal portion of the filter device axially
attached to an exterior surface of a cannula and lumens extending
through the cannula. As shown in FIG. 17, filter device 720 has
distal portion 724 and proximal portion 722 attached to an exterior
surface of cannula 710. For example, in embodiments, FIG. 17 may be
a front cross sectional view of a filter device and cannula from
perspective "A" of FIG. 12 or 15. FIG. 17 also shows lumens 1712,
1714, 1716, and 1718 extending within cannula 710, such as to
extend from proximal section 712 of cannula 710 to a point distal
to proximal portion 722 of filter 720 (See FIGS. 7, 9, and 11-16,
and accompanying text). In addition, lumen 1740 is shown extending
along inner surface of cannula 1722 from proximal section 712 of
cannula 710 to a point distal to proximal portion 722 of filter
720. It is to be appreciated that lumens 1712, 1714, 1716, 1718, or
1740 may exit cannula 710 through exit holes or openings in the
proximal end, distal end, or exterior of cannula 710, similar to
how inflation lumen 9540 extends from proximal end 9504 to balloon
9510 and exits an inflation opening within balloon 9510, as
described below with respect to balloon inflation lumen 9540 of
FIGS. 69A-F. For example, lumens 1712, 1714, 1716, 1718, or 1740
may be lumens sufficient for passing inflation gas or fluid
through, such as for inflating and deflating balloons 1132, 1134,
1142, or 1144 as described above (see FIGS. 11-13 and accompanying
text). Also, lumens 1712, 1714, 1716, 1718, or 1740 may have a
pivot point as any hole or opening where a lumen exits cannula 710,
such as by having pivot point 1432 or 1442 at an opening where the
lumen exits the exterior surface of cannula 710. Likewise, lumens
1712, 1714, 1716, 1718, or 1740 may be lumens sufficient for
extending, actuating, releasing, extending, manipulating, or
pulling tendons 1430, 1440, 1450, or 1460 therethrough (see FIGS.
14-16 and accompanying text). Specifically, lumen 1712 is shown in
FIG. 17 with tendon 1730 extended therethrough (e.g., tendon 1730
may be a tendon such as tendon 1430, 1450, or 1470).
[0168] Furthermore, lumens described herein, such as lumen 1712 and
lumen 1714 may provide for aspiration of particles, material, and
matter as described above with respect to hole 988 (e.g., see FIG.
9 and accompanying text). Moreover, lumens 1712, 1714, 1716, 1718,
or 1740 may be include a surrounding material, sleeve, cannula or
lumen, such as described below with respect to infusion lumen 9520
or accessory lumen 9530 of FIGS. 69A-F
[0169] In addition, according to some embodiments, any or all of
lumens 1712, 1714, 1716, 1718, or 1740 may be used to inflate or
deflate a balloon (e.g., such as balloons 1132, 1134, 1142, or 1144
as described above with respect to FIGS. 11-13 and accompanying
text) as well as have a tendon extending therethrough (e.g., such
as for actuating, releasing, extending, manipulating, or pulling
tendons 1430, 1440, 1450, or 1460 therethrough as described above
with respect to FIGS. 14-16 and accompanying text). Specifically,
for example, lumen 1712 may be used for inflating and deflating
balloons as described herein, as well as for having a tendon for
actuation or manipulation as described herein, extending
therethrough.
[0170] Note that it is contemplated that balloons described herein
will be inflated and deflated using fluids, including fluids
described herein as a treatment agent. Likewise, it is also
contemplated that lumens described herein, such as lumen 1712 and
1714, may provide the capability to inflate or deflate occlusion
devices and balloons, to contain tendons, to contain guide wires,
to provide for delivery of treatment agent, to provide for
aspiration of treatment agent or particles, or to provide for
pressure release, such as by providing those capabilities for
filter 720, devices other than filter 720, or at various regions of
interest other than treatment region 996. Thus, balloons 1132,
1134, 1140, 1141, 1152, and 1154 (See FIGS. 11-13, and accompanying
text), as well as lumens 1712, 1714, 1716, 1718, and 1740 may
contain and provide sufficient pressure of a fluid, including a
treatment agent, to inflate and deflate balloons as described
herein.
[0171] Although FIG. 17 shows four lumens extending through cannula
710, according to some embodiments, any number of lumens may be
associated with cannula 710, filter device 720 other devices, or
regions of interest as described herein. Constraints on the number
of lumens that may be associated with cannula 710, include the
number lumen or cannula necessary for a particular purpose and the
overall size (e.g, inner or outer diameter) of a system for
delivery of a treatment agent to a treatment region. For example,
in an embodiment where filter device 720 has a helical spring
shape, three lumen may be associated with cannula 710 to restrain,
actuate, manipulate, or extend distal portion 724 of the filter
device. More particularly, FIG. 18 is a front cross sectional view
of a filter device having a proximal portion axially attached to an
exterior surface of a cannula, wherein the filter device has a
helical spring shape. FIG. 18 shows filter device 720 having
proximal portion 722 axially attached to an exterior surface of
cannula 710, wherein filter device 720 includes helical spring
shape 1820. Helical spring shape 1820 may provide filter device 720
with a self-expanding frame, a self-contracting frame, or a frame
portion (e.g., such as for having material stretched on the frame)
as described herein. FIG. 18 also shows lumens 1812, 1814, and 1818
extending along the outer surface of cannula 710 from proximal
section 712 of cannula 710 to a point distal to proximal portion
722 of filter 720. Lumens 1812, 1814, or 1818 may be a lumen such
as is described above with respect to lumen 1712.
[0172] The various configurations of filter device 720 and lumen
710 described herein can be used to restrain and aspirate
particles, material, and matter as described above for a variety of
catheters, including guide catheters, delivery catheters, guide
wires, and other cannula. For example, FIG. 19 is a flow diagram of
a process for using a filter device to restrain and aspirate
particles. At block 1910 a cannula, such as cannula 710, is
advanced percutaneously through a blood vessel, such as blood
vessel 990, wherein the cannula includes an exterior surface at or
adjacent a distal end of the cannula axially coupled or connected
to a proximal portion of a filter device, such as filter device
720. It is contemplated that the cannula may be advanced via a
retrograde advancement, such as by being pushed up or down a blood
vessel (e.g., such as a blood vein or artery) against or with a
flow of blood. Specifically, the cannula may be advanced, such as
from one blood vessel into a smaller blood vessel to provide
retrograde infusion treatment, to a treatment region such as a
region in a coronary sinus of a subject.
[0173] At block 1920, the distal diameter of a filter device, such
as first diameter D1, is transformed or enlarged to a different
second diameter, such as second diameter D2, that is approximately
equivalent to an inner diameter of a blood vessel at a treatment
region, such as diameter of vessel DV of blood vessel 990 at
treatment region 996. For example, first diameter D1 may be
expanded in directions 786 and 788 to second diameter D2 until
second diameter D2 approximates an inner diameter of a coronary
sinus of a subject at a treatment region. Moreover, it is
contemplated that second diameter D2 may be expanded sufficiently
to make a pressure wave form in the blood vessel or coronary sinus
become ventricularized.
[0174] At block 1930 particles, material, or matter may be
restrained from flowing through the filter device, such as by
restraining a plurality of particles having a particle science
greater than an average particle size of blood cells contained in
blood flowing through the filter device. Thus, after block 1920, it
is contemplated that a liquid including a drug, treatment agent,
infusion pellets, suspended cells, stem cells, microspheres, or
other drugs or treatment agent mentioned herein may be delivered or
infused through a lumen extending from proximal section 712 of
cannula 710 to treatment region 996 (e.g., to treat vessel 990 at
treatment region 996). During or after delivery of the liquid,
particles, material, or matter, such as described above, as well as
stem cells, microspheres, metal, particles from devices, pieces of
tissue, or other drugs or treatment agents mentioned herein may be
restrained by the filter device, such as is described above with
respect to filter device 720.
[0175] For instance, in various embodiments, at block 1935 a
treatment agent mentioned herein is infused to a treatment region
of a blood vessel, such with respect to FIGS. 3, 63, 69A-70, and
82. Specifically, a treatment tagent may be infused to a treatment
region via a delivery catheter disposed through a lumen extending
from proximal section 712 to distal end 714 of cannula 710, and
extending to a region of a blood vessel.
[0176] At block 1940 the restrained particles are aspirated. For
example, a plurality of particles being restrained, such as
particles 980, can be aspirated proximate to the exterior surface
of cannula 710, such as is described above with respect to hole 988
proximate to distal end 714 or lumen 1712 (e.g., see FIG. 9 and
accompanying text). It is contemplated that aspirating may occur
during delivery of liquid or after delivery of liquid as described
above at block 1930.
[0177] At block 1950 the distal diameter of the filter device is
contracted. For example, second diameter D2 may be contracted or
retracted to a diameter that is approximately that of first
diameter D1 (e.g., such as third diameter D30, or D31 as described
above) in response to a retraction pressure (e.g., such as pressure
1140 and 1141, or 1451 and 1461).
[0178] At block 1960 the cannula and attached filter device are
retracted, such as by retracting or withdrawing the cannula back
out of vessel 990 and out of the subject. For example, as noted
above, it is contemplated that cannula 710 and filter device 720
may be retracted without modifying distal portion 724 of filter
device 720 (e.g., to leave distal portion 724 at second diameter
D2), or may be retracted or removed from the subject after
transforming or contracting second diameter D2 to become
approximately the first diameter (e.g., block 1950).
[0179] Note that according to some embodiments, the process for
using filter device 720 to restrain and aspirate particles shown
and described above for FIG. 19 may also apply for an apparatus
similar to apparatus 700 as shown in FIGS. 7-18, but having an
occlusion device or balloon attached to cannula 710 instead of and
at the location of filter device 720. Specifically, the process for
using filter device 720 of FIG. 19 may have an occlusion device or
balloon, instead of filter device 720, enlarged at block 1920 and
restraining particles and fluid at block 1930, by occluding the
blood vessel, such as is shown and described with respect to
balloon 308 of FIGS. 3A, 3B, and 4. It can be appreciated that the
other blocks of FIG. 19 also apply to a process having an occlusion
device or balloon in place of filter device 720.
[0180] Referring now to FIG. 20, there is illustrated a guide
catheter. Guide catheter 2000 has distal end 2002 and proximal end
(not shown). Adjacent distal end 2002 is occlusion device 2006.
Occlusion device 2006 may be provided with self-expanding frame
2010, and material 2012 stretched between frame structure or
portions. Frame 2010 may be made of an elastic material or a
superelastic material, for example, nitinol or NiTi, wherein NiTi
or a material described above with respect to forming the frame
portion of filter device 720. For example, guide catheter 2000 may
be a guide catheter as described herein, such as cannula 710
described for FIG. 7 above, and frame 2010 may be a framed portion
such as described above with respect to filter 720 described for
FIG. 7. Moreover, in various embodiments, material 2012 may act as
an occlusion device, such as by having no holes through it, or
having a property such that fluid does not flow through it. For
example, material 2012 may include one or more of a synthetic or
natural latex or rubber, such as a polymer material; a
polyetheramide; a plasticiser free thermoplastic elastomer; a
thermoplastic blend; a block copolymer of polyether and polyester
(e.g., such as a polyester sold under the trademark Hytrel.RTM. of
DUPONT COMPANY); a biocompatible polymer such as a polyether block
amide resin (e.g., for instance, PEBAX.RTM. of ATOCHEM
CORPORATION); a polycarbonate or acrylonitrile bubadiene styrene
(ABS); a biocompatible polymer such as a polyether block amide
resin; a styrene isoprene styrene (SIS), a styrene butadiene
styrene (SBS), a styrene ethylene butylene styrene (SEBS), a
polyetherurethane, an ethyl propylene, an ethylene vinyl acetate
(EVA), an ethylene methacrylic acid, an ethylene methyl acrylate,
an ethylene methyl acrylate acrylic acid, a material from a
material family of one of styrenic block copolymers and
polyurethanes, a melt processible polymer, a low durometer
material, nylon, and other materials that can block fluid flow.
[0181] Sheath 2004, for example, a retractable or a tear-away
sheath, such as sheath 790, is shown pulled away from occlusion
device 2006 in direction of arrow 2014. When guide catheter 2000 is
deployed into a vessel (e.g., such as is described above with
respect to deployment of cannula 710 for FIG. 7, and including a
blood vessel of a subject or fluid flow 2020 occurs in direction of
arrow 2014.
[0182] Distal end 2005 of sheath may be covering occlusion device
2006. After distal end 2002 of catheter is located in a preferred
location, sheath 2004 may be moved in a proximal direction (e.g., a
direction of arrow 2014) to uncover occlusion device 2006.
Thereafter, self-expanding frame 2010 forces open device 2006 in
direction of arrows 2018 so that occlusion device 2006 occupies
substantially the entire vessel. Any fluid flowing through vessel
in direction of arrows 2020 must then pass through material 2012,
or be trapped by material 2012.
[0183] In another embodiment, if guide catheter is placed in a
vessel with fluid flow in the direction of arrow 2022, then
occlusion device 2006 may be turned around so that opening 2024 of
occlusion device 2006 faces into the direction of fluid flow (e.g.,
see arrow 2022). Therefore, frame 2010 and fluid flow 2020 or 2022
serve to force occlusion device 2006 against the interior walls of
a vessel (not shown). Aspiration side-hole 2016 may be provided
adjacent distal end 2002 in guide catheter 2000 such as at a
location and to function as is described above with respect to hole
988 for FIG. 9 (e.g., distal to a proximal end of occlusion device
2006). Thus, aspiration side-hole 2016 may be used to aspirate
fluid or particles from a vessel distal to device 2006.
[0184] Referring now to FIG. 21, there is illustrated a telescoping
guide catheter system. Telescoping guide catheter system includes
outer guide catheter 2100 having proximal end (not shown) and
distal end 2101. Outer guide catheter 2100 has an inner diameter
adapted to contain inner guide catheter 2102, for example, the
outside diameter of inner guide catheter 2102 is smaller than the
inside diameter of outer guide catheter 2100, so that outer guide
catheter 2100 and inner guide catheter 2102 may be slidingly
engaged. Inner guide catheter 2102 has proximal end (not shown) and
distal end 2103. Outer guide catheter 2100 is provided with
occlusion device 2104 at distal end 2101, and inner guide catheter
2102 is provided with occlusion device 2112 at distal end 2103.
[0185] As illustrated, occlusion device 2104 includes frame 2106,
for example, an elastic frame, and material 2108 stretched between
structure or portions of frame 2106. For example, frame 2106 may
have a similar structure, functionality, and material as that
described above for frame 2010 of FIG. 20. Likewise, material 2108
may have a similar structure, functionality, and material as that
described above for material 2012 of FIG. 20. There may also be
provided a sheath (not shown) to cover occlusion device 2104 until
such time as it is to be deployed, and the same or a different
sheath may be used for device recovery. Catheter 2102 may also
include aspiration side-hole 2110 at distal end 2101, which may be
used to aspirate fluid or particles distal to occlusion device
2104, such as at a location and to function as is described above
with respect to hole 988 for FIG. 9. In FIG. 21, occlusion device
2112 is shown as balloon 2112, which may be any type of balloon or
occlusion device such as occlusion device 2006, or may be filter
device such as filter device 720.
[0186] Inner guide catheter 2102 has first curve 2114, and outer
guide catheter 2100 has second curve 2116. For example, according
to some embodiments, first curve 2114 may be an angle between
10.degree. and 125.degree., such as an angle of 10.degree.,
20.degree., 30.degree., 45.degree., 60.degree., 80.degree.,
90.degree., 100.degree., 120.degree., and 125.degree.. Also,
according to some embodiments, second curve 2116 may be an angle
between 10.degree. and 90.degree., such as an angle of 10.degree.,
15.degree., 20.degree., 25.degree., 35.degree., 45.degree.,
60.degree., 70.degree., 80.degree., and 90.degree.. By sliding
inner guide catheter 2102 back and forth in direction of arrows
2118 within outer guide catheter 2100, and rotating outer guide
catheter 2100 or inner guide catheter 2102, distal end 2103 may be
steered and tracked through a vessel network.
[0187] Note that according to some embodiments proximate end 712 of
FIG. 7, a proximate end of guide catheter 2000, or a proximate end
of guide catheter 2100 may be attached to or extend to a guide
catheter proximate portion, such as a proximate portion similar to
proximate portion 305 of FIG. 3, and having the necessary holders,
tracks, cannulas, lumens, and ports to provide for the
functionality of cannula 710 of FIG. 7, guide catheter 2000, or
guide catheter 2100, or any other guide catheter as described
herein.
[0188] Referring now to FIGS. 22 and 23, there is illustrated the
distal end and proximal end of a balloon catheter. Balloon catheter
2200 may be a delivery or infusion catheter having distal end 2202
and proximal end 2203. Adjacent distal end 2202 of catheter is
first balloon 2204. First balloon inflation cannula 2206 has a
lumen there through and distal end including first opening 2208
within first balloon 2204 to inflate or deflate first balloon 2204.
There is also provided second balloon 2250, with second balloon
2250 distal to first balloon 2204. First balloon 2204 or second
balloon 2250 may be made of various appropriate natural rubber,
polymer, lined ePTFE, thermoplastic blend, copolymer materials,
having various appropriate dimensions, and being attached to
balloon catheter 220 by various procedures (e.g., such as laser
bonding, adhesive bonding, or heat bonding) as described
herein.
[0189] First balloon 2204 may be a distance from second balloon
2250 sufficient to block a proximal and a distal end of a treatment
region, such as a region for delivering a treatment agent. For
example, distance D defining a region for delivering a treatment
agent between first balloon 2204 and second balloon 2250 may be a
distance in the range between one centimeter and 20 centimeters,
such as a distance of 10 centimeters.
[0190] Moreover, according to some embodiments, first balloon 2204
or second balloon 2250 may have a maximum inflated outer diameter
of between two millimeters and 15 millimeters, such as by having an
outer diameter during inflation of 10 millimeters. Furthermore,
according to some embodiments, first balloon 2204 or second balloon
2250 may employ a wedge or conical tapered shape, such as a shape
having a tapered outer diameter towards distance D of four
millimeters and an increasing diameter to a maximum diameter away
from distance D of 10 millimeters. Thus it is possible to select
balloons having a tapered profile to promote better sealing of a
treatment region in a vessel as well as better centering of the
balloons upon inflation. Likewise, the size and shape of first
balloon 2204 and second balloon 2250 may be selected to provide a
treatment region that may be pressurized, such as by a pressurized
infusion of treatment agent as described herein, while preventing
the flow of infused treatment agents out of the treatment region.
For example, second balloon 2250 can be selected to prevent the
flow of treatment agents out of a treatment region, such as defined
within a blood vessel along distance D, while first balloon 2204
can be selected to prevent the backflow of infused treatment agents
out of the treatment region and towards proximal end 2203. Next,
the size, shape, and material of first balloon 2204 and second
balloon 2250 may be selected to establish a desired pressure
gradient within a vessel at the location of proximate to or between
first balloon 2204 and second balloon 2250. More particularly,
size, shape, material, and inflation pressure of first balloon 2204
and second balloon 2250 may be selected such that a treatment
region as defined by distance D within a vessel may be pressurized,
such as with a treatment agent, to a pressure between one and 30
atmospheres (e.g., such as to a pressure of between six and eight
atmospheres).
[0191] First balloon 2204 and second balloon 2250 may be the same
shape, size, or material, or first balloon 2204 may have a
different shape, size, or material than second balloon 2250. Second
balloon inflation cannula 2256 has a lumen there through and
includes distal end and second opening 2258 within second balloon
2250 to inflate or deflate second balloon 2250. In another
embodiment, first balloon inflation lumen 2206 and second balloon
inflation cannula 2256 are the same lumen, with two openings 2208
and 2258, while in another embodiment (as illustrated), first
balloon inflation lumen 2206 is different than and not connected to
second balloon inflation cannula 2256.
[0192] Pressure-sensing cannula 2210 has distal end and pressure
sensing opening 2212, which enables pressure-sensing, such as via a
pressure sensing device with respect to fitting 2548, or other
measurements or parameters to be taken in a region of a vessel
between first balloon 2204 and second balloon 2250, or where ever
distal end 2202 is placed. Delivery cannula 2214 has distal end and
delivery opening 2216 which enables a fluid or treatment agent path
from proximal end 2203 of balloon catheter 2200 to opening 2216
between first balloon 2204 and second balloon 2250.
[0193] In various embodiments, balloon catheter 2200 has a tapered
tip. Tapered tip of catheter 2200 may enable easier tracking of
distal end 2202 of catheter through a blood vessel. In various
embodiments, distal end 2202 may have tapered cut 2222, which may
be curved to have the profile shown in FIG. 22. Other
configurations of distal ends 2202 are envisioned which would ease
tracking through a blood vessel. For example, tapered cut 2222 may
be at angle "A" with respect to the longitudinal axis of catheter
2200, where angel "A" may be an angle between 10.degree. and
90.degree., such as an angle of 10.degree., 15.degree., 20.degree.,
25.degree., 35.degree., 45.degree., 60.degree., 70.degree.,
80.degree., and 90.degree.. Also, tapered cut 2222 may have or form
a tapered shape with respect to the longitudinal axis of catheter
2200, where the tapered shaped may include one or more of a convex,
a concave, and a three dimensionally shaped cut. Thus, tapered cut
2222 can have angle "A" and a tapered shape sufficient to allow
balloon catheter 2200 to be fed through a vessel such as is
described above with respect to feeding guide catheter 302 through
a vessel; or to be fed through another catheter such as guide
catheter 302 or 502, such as is described above with respect to
delivery catheter 310 being fed through guide catheter 302. Balloon
catheter 2200 may have an outer diameter or outer dimension to fit
within a guide catheter such as guide catheter 302 or guide
catheter 502. For example, balloon catheter 2200 may have an outer
diameter of between 5 French and 6 French and be capable of fitting
within a guide catheter having an outer diameter of between 8
French and 9 French.
[0194] Balloon catheter 2200 may have one or more radio-opaque
markers applied to its outer diameter, such as by adhesive, laser
bonding, or heat bonding, or may include a filler such as barium
sulfate added to the polymeric material used to form balloon
catheter 2200 near distal end 2202 to track the position of distal
end 2202. According to some embodiments, such markers or filler may
have various widths such as a width between one millimeter and two
centimeters, and may extend around a portion of or completely
around the circumference of balloon catheter 2200.
[0195] For example, catheter 2200 may also include marker 2230, for
example, a radio-opaque marker, which may serve to ease
visualization of distal end 2202 of catheter 2200 with a diagnostic
visualization system. There may also be provided a second marker
(not shown) adjacent second balloon 2250, so that first marker 2230
and second marker (not shown) may be used to locate first balloon
2204 and second balloon 2250, respectively.
[0196] Catheter 2200 may also include guidewire cannula 2242 to
extend from proximal end 2203 through catheter 2200 to guidewire
opening 2243. Guidewire cannula 2242 has distal end and guidewire
opening 2243, adjacent distal end 2202 of catheter 2200. Guidewire
cannula 2242 has dimensions to receive guidewire 2244. Guidewire
2244 is illustrated, where guidewire 2244 has distal end 2246 and
occlusion device 2248 attached to guidewire 2244 adjacent guidewire
distal end 2246. Occlusion device 2248 may be attached to guidewire
2244 by various appropriate methods including laser bonding,
adhesive bonding, thermal bonding and other bonding processes for
attaching an occlusion device, such as a balloon, to a guidewire or
catheter. In addition, balloon catheter 2200 and guide catheter
1002 may have a length such as is described above with respect to
the length of guide catheter 302.
[0197] FIG. 23 also shows first balloon inflation cannula 2206
attached to first balloon inflation port 2290, such as via adhesive
bonding, heat bonding, threaded bonding or various other
appropriate bonding processes for attaching first balloon inflation
port 2290 sufficiently so that an appropriate volume and pressure
of liquid may pass therethrough to inflate first balloon 2204.
Likewise, second balloon inflation cannula 2256 is attached to
second balloon inflation port, such as is described above with
respect to first balloon inflation port 2290. Pressure sensing
cannula 2210 is attached to pressure sensing port 2294 similar to
methods described above for attaching port 2290 to cannula 2206,
and sufficiently to allow a volume in pressure of fluid to float
through pressure sensing port 2294, such as to a pressure sensing
device attached to pressure sensing port 2294, such as is described
herein with respect to a pressure sensing device with respect to
fitting 2548. Next, delivery cannula 2214 is attached to delivery
port 2296, such as is described above with respect to attachment of
port 2290 to cannula 2206, and sufficiently for delivery of a
volume and pressure of a liquid or treatment agent and to a
treatment region, to provide a treatment or treatment region as
described herein. Finally, guidewire cannula 2242 is attached to
guidewire port 2298, similarly to the attachment described above
for attaching port 2290 to cannula 2206, and sufficiently so that
guidewire 2244 can extend through guidewire port 2298 and can be
manipulated, controlled, and used to place guidewire distal end
2246 or occlusion device 2248 at a desired region within a vessel
as described herein.
[0198] FIG. 24 shows a section view of FIG. 23 through line D-D'.
As shown in FIG. 24, first balloon inflation cannula 2206, second
balloon inflation cannula 2256, pressure sensing cannula 2210,
delivery cannula 2214, and guidewire cannula 2242 are shown
disposed through balloon catheter 2200 such as from proximal end
2203 to distal end 2202. Furthermore, guidewire 2244 is shown fed
through or disposed through guidewire cannula 2242, such as is
described above. In another embodiment, guidewire and guidewire
lumen (not shown) are in a monorail or OTW configuration. It is
also contemplated that the guidewire and guidewire lumen (not
shown) can te in a rapid-transfuser type configuration, such as
illustrated in FIGS. 3 and 37, and described in accompanying
text.
[0199] FIG. 25 illustrates a catheter system. Catheter system 2500
includes delivery catheter 2520 having flexible shaft 2522, distal
end 2524, proximal end 2526, with a delivery lumen extending
therebetween. For instance, delivery catheter 2520 or any delivery
catheter may have a distal end has an outer diameter less than
about 10 mm, seven mm, five mm or three mm. In addition, according
to some embodiments, delivery catheter 2520 or any delivery
catheter may have a flexible shaft made of a bio-compatible
polymer, a bio-compatible polymer having a durometer hardness of
about 30 to about 100 shore D, a bio-compatible polymer having a
durometer hardness of about 50 to about 70 shore D, a polyether
block amide resin, or a flexible shaft that is radiopaque. Soft tip
2530 is bonded to distal end 2524 of shaft 2522. The delivery lumen
extends from fitting 2532 at proximal end 2526 through shaft 2522
and through soft tip 2530 to outlet port 2592 in soft tip 2530.
Note that a delivery lumen may have cross-sectional area suitable
for advancing into a cardiovascular system of a patient and to
deliver a treatment agent to a treatment region in a blood vessel
of the patient. Suitable cross-sectional areas include at least
about 0.95 mm.sup.2, 2 mm.sup.2, 3 mm.sup.2, 5 mm.sup.2, or 10
mm.sup.2. One or more side holes in communication with the delivery
lumen may also be provided near distal end 2524 of shaft 2522.
Pressure increasing device 2560 is shown attached to fitting
2532.
[0200] Catheter 2520 is provided with balloon 2547 on distal end
2524 of catheter 2520, which balloon 2547 is adapted to occlude the
coronary sinus or another vessel when inflated. An inflation lumen
extends through shaft 2522 and is in communication with the
interior of balloon 2547 through opening 2537. Specifically, the
inflation lumen, or any other inflation lumen may be a balloon
inflation lumen within a flexible tube or cannula shaft (e.g., such
as a lumen having a surrounding material, sleeve, cannula or lumen,
such as described below with respect to infusion lumen 9520 or
accessory lumen 9530 of FIGS. 69A-F). Near proximal end 2526, the
inflation lumen is connected to inflation extension tube 2538
attached to shaft 2522 having fitting 2540 at its proximal end
shown attached to inflation device 2564. Optionally, pressure
release valve 2541 may be connected to inflation extension tube
2538 to prevent over inflation of balloon 2547. Extension tube 2538
may have a surrounding material, sleeve, cannula or lumen, such as
described below with respect to infusion lumen 9520 or accessory
lumen 9530 of FIGS. 69A-F.
[0201] A pressure lumen is also provided in shaft 2522 which opens
at pressure port 2544 on side-wall of shaft 2522 near distal end
2524, or in soft tip 2530 as illustrated. The pressure lumen is
connected to extension tube 2546 attached to shaft 2522 near
proximal end 2526. Extension tube 2546 has fitting 2548 at its
proximal end shown connected to pressure measuring device 2562.
Extension tube 2546 may have a surrounding material, sleeve,
cannula or lumen, such as described below with respect to infusion
lumen 9520 or accessory lumen 9530 of FIGS. 69A-F.
[0202] Pressure increasing device 2560 is shown connected by
connection 2572 to controller 2570. Pressure measuring device 2562
is shown connected to controller 2570 by connection 2574. Inflation
device 2564 is shown connected to controller 2570 by connection
2576.
[0203] In various embodiments, distal end 2524 of catheter 2520 is
inserted into a vessel, for example, the coronary sinus. Once
distal end 2524 of catheter 2520 is in place, balloon 2547 may be
inflated by inflation device 2564. Pressure measuring device 2562
measures pressure distal to balloon 2547 through pressure port 2544
on side-wall of shaft 2522. Once the pressure waveform in the
vessel has become ventricularized, for example, blood beating
against balloon 2547 in a similar rhythm to a heartbeat, inflation
of balloon 2547 is stopped by controller 2570. At this point,
pressure increasing device 2560 begins to force a liquid through
catheter 2520 to soft tip 2530 to outlet port 2592. Liquid is
forced into the vessel distal to balloon 2547. Pressure measuring
device 2562 measures pressure distal of balloon while liquid is
being forced by pressure increasing device 2560. Controller 2570
controls pressure increasing device 2560 to regulate fluid flow and
pressure, by the information provided by pressure measuring device
2562. After a sufficient period of time, controller 2570 stops the
delivery of liquid by pressure increasing device 2560, then
deflates balloon 2547 with inflation device 2564, and catheter 2520
may then be removed from the vessel. It is worth explaining that
although references are made herein to a pressure lumen and a
pressure-sensing device (e.g., such as is describe above with
respect to FIG. 25), it is considered that a pressure lumen., can
be used for measuring other parameters including flow, oxygen
saturation, pH, or temperature. Similarly, a pressure-sensing
device., can be exchanged with another device to measure one of the
parameters above. Moreover, although system 2500 describes a
catheter with three lumens, it is envisioned that a cannula or
catheter (e.g., such as is describe above with respect to FIG. 25),
may have four or more lumens. Specifically, a cannula or catheter
as described herein, may include a balloon inflation lumen, a
delivery lumen, and two parameter measurement lumens (e.g., such as
one lumen to measure pressure and another lumen to measure
temperature).
[0204] Delivery catheter 2620 is shown in FIGS. 26, 27, 28 and 29.
Delivery catheter 2620 includes flexible shaft 2622 having distal
end 2624, proximal end 2626 and delivery lumen 2628 extending
therebetween. In various embodiments, shaft 2622 is at least about
50 cm long, and in another embodiment, at least about 60 cm long,
between proximal end 2626 and distal end 2624, so that distal end
2624 may be positioned in the coronary sinus or another vessel (as
seen in FIGS. 33 and 34) with proximal end 2626 extending out of
the patient through a puncture in a peripheral vein, such as a
femoral vein. Shaft 2622 is made of a material such that it is
sufficiently flexible to navigate this path without difficulty. In
various embodiments, shaft 2622 is made of a biocompatible polymer
such as a polyether block amide resin, for example, PEBAX.degree.,
a registered trademark of Atochem, with a durometer in a range of
about 50 to about 72 Shore D. In another embodiment, a portion,
including the entire portion, of shaft 2622 is radiopaque to permit
fluoroscopic observation thereof to facilitate positioning.
Radiopaque markers may be applied to the shaft near distal end
2624, or a filler such as barium sulfate may be added to the
polymeric material used to form shaft 2622.
[0205] To allow percutaneous introduction of delivery catheter 2620
in a peripheral vein, in various embodiments, shaft 2622 will have
an outer diameter ("OD") of no more than about 5.0 mm from distal
end 2624 to at least about 30 cm proximal thereto, and in another
embodiment, to at least about 50 cm proximal thereto.
[0206] In some embodiments, delivery cathters described herein
(e.g., such as balloon catheter 2200, delivery catheter 2520, or
delivery catheter 2620) may be adapted for introduction through a
commercially-available 9 French or 10 French introducer sheath or a
suitably sized guide catheter, or by feeding over a guidewire, or
for introduction by surgical cut-down into a comparably-sized blood
vessel (e.g., such as an artery of vein, including a peripheral
vein). Additionally, the delivery catheters described herein may be
adapted to be introduced through guide catheters (e.g., such as
catheter 302, 502, 2000, or 2100) to be delivered to a location of
a blood vessel from which the distal end of the delivery catheter
(e.g., such as distal end 2524 or 2624) may be advanced to a
treatment region of a blood vessel to be treated by infusing a
treatment agent (e.g., such as by infusion through system 2500, as
described above).
[0207] In various embodiments, a guide catheter (e.g., such as a
guide catheter to be used with a delivery catheters described
herein) is adapted to be fed into a femoral vein, then to an
external iliac vein, then to a common iliac vein, to inferior vena
cava 116), then into right atrium 122, and into coronary sinus 3286
(see FIG. 32), and can then be fed further into venus system on
exterior of heart (see FIGS. 33 and 34). In another embodiment,
guide catheter is adapted to be fed into an external jugular vein
or an internal jugular vein, into superior vena cava 126, and then
into right atrium 122 and into coronary sinus 3286, where guide
catheter may stay in coronary sinus 3286 (see FIG. 32), or be fed
further into the venus system on exterior of the heart (see FIGS.
33 and 34).
[0208] In various embodiments, a suitable guide catheter is
described in a co-pending patent application Ser. No. 10/293,535,
filed on Nov. 12, 2002. Co-pending patent application Ser. No.
10/293,535, filed on Nov. 12, 2002 is herein incorporated by
reference in its entirety. The guide catheter disclosed in the
co-pending patent application may be inserted into a blood vessel,
such as a femoral vein. Note that that guide catheter has a first
convex curved portion, a concave curved portion distal to the first
convex curved portion, and a second convex curved portion distal to
the concave curve portion. Suitable guide catheters may also
include an occlusion balloon at a distal end (e.g., such as
catheter 302, 502, and 2100 having balloons 308, 510, and 2112,
respectively). Other suitable guide catheters include the Viking
Opima Line.TM. (a trademark of Guidant Corporation), the ACS
Viking.TM. line of guide catheters (a trademark of Guidant
Corporation), and the ACS RAD Curve.TM. line of guide catheters (a
trademark of Guidant Corporation). Appropriate guide catheters also
include EasyTrak.RTM. guiding catheters, Rapido.TM. guiding
catheters, and telescoping guide catheters, for example, CS-MP REF
7300 and CS-IC 90 REF 666776-101.
[0209] Referring again to FIGS. 26-29, soft tip 2630 (of for
example, PEBAX.RTM. with a durometer of 20 to 30 Shore D) is bonded
to distal end 2624 of shaft 2622 to reduce the risk of trauma to
the coronary sinus or other vessels. Delivery lumen 2628 extends
from fitting 2632 at proximal end 2626 through shaft 2622 and
through soft tip 2630 to outlet port 2692 in the distal end of soft
tip 2630. Side holes 2634 in communication with delivery lumen 2628
may also be provided near distal end 2624 of shaft 2622 as shown in
FIG. 27. In various embodiments, delivery lumen 2628 preferably has
a cross-sectional area no less than about 4 mm at any point between
proximal end 2626 and outlet port 2692 to facilitate delivery of
treatment agent at sufficient flow rates while keeping the pressure
at which the treatment agent is delivered low enough to avoid
excessive hemolysis if there is a blood component of the treatment
agent, as described more fully below. In various embodiments, the
inner diameter (ID) of delivery lumen 2628 is at least about 2.8
mm, and height H1 is at least about 1.8 mm.
[0210] Catheter 2620 is provided with balloon 2647 on distal end
2624 of catheter 2620 which is adapted to occlude the coronary
sinus or another vessel (see FIGS. 33 and 34) when inflated. In
various embodiments, balloon 2647 includes a biocompatible polymer
such as a polyether block amide resin, for example, PEBAX.RTM. (a
registered trademark of ATOCHEM CORPORATION, PUTEAUX, FRANCE). In
another embodiment, balloon 2647 is a biocompatible polymer blend
of polyurethane and silicone, for example PurSil.TM. (a trademark
of THE POLYMER TECHNOLOGY GROUP, BERKELEY, CALIFORNIA). In various
embodiments, balloon 2647 has an inflated diameter range of about
four mm to about nine mm, an uninflated diameter of about three mm,
and a working length of about six mm. For instance, a balloon as
described above with respect to balloons 308, 510, and 2112, may be
inflated as described below with respect to balloons 8810 and 9510,
or by an inflation device such as apparatus 9700 or 9800 of FIG.
75A-81.
[0211] In various embodiments, balloon 2647 may be located at least
about 15 mm from distal end 2624 of shaft 2622 so that, during
positioning, if balloon 2647 is pulled out of the coronary sinus,
there is sufficient length of shaft 2622 distal to the balloon that
will remain in the coronary sinus to eliminate the need to relocate
distal end 2624 in the coronary sinus.
[0212] In various embodiments, balloon 2647 is formed by dipping a
mandrel in liquefied polymer and curing as needed. Balloon 2647 may
be attached to shaft 2622 by, for example, heat welding or an
adhesive.
[0213] Inflation lumen 2636 extends through shaft 2622 and is in
communication with the interior of balloon 2647 through opening
2637. Near proximal end 2626, inflation lumen 2636 is connected to
inflation extension tube 2638 attached to shaft 2622 having fitting
2640 at its proximal end for attachment to an inflation fluid
delivery device. In various embodiments, inflation lumen 2636 is
configured to allow delivery of inflation fluid or gas at a
sufficient rate to fully inflate balloon 2647 in about two seconds.
In another embodiment, inflation lumen 2636 has a height H2 of
about 0.5-0.9 mm and a width W of about 0.9-1.3 mm. Inflation lumen
2636 may alternatively be a coaxial lumen around shaft 2622,
enclosed by a separate tubular member (not shown). Extension tube
2638 may have a surrounding material, sleeve, cannula or lumen,
such as described below with respect to infusion lumen 9520 or
accessory lumen 9530 of FIGS. 69A-F.
[0214] Optionally, pressure relief valve 2641 may be connected to
inflation extension tube 2638 to prevent overinflation of balloon
2647, which might damage the tissue of the coronary sinus or
another vessel. Pressure relief valve 2641 is configured to open
and relieve fluid pressure from inflation lumen 2636 when balloon
2647 exceeds the maximum desired inflated pressure or diameter,
e.g., about 9 mm. This may be accomplished by pre-inflating balloon
2647 to the maximum inflated diameter without pressure relief valve
2641 mounted to the delivery catheter, thereby plastically
deforming balloon 2647 to its fully inflated size. Balloon 2647 is
then collapsed onto the shaft by applying a vacuum to inflation
lumen 2636, and pressure relief valve 2641 is mounted to inflation
extension tube 2638. In use, when delivery catheter 2620 is
positioned in the coronary sinus, inflation of balloon 2647 to the
desired inflated size will require relatively low pressure, e.g.
less than about 0.5-2.0 psi. However, once the maximum inflated
size is reached, the pressure will increase significantly, causing
pressure relief valve 2641 to open, thus preventing overinflation
of balloon 2647. A suitable pressure relief valve 2641 is available
from, for example, Smart Products, Inc. of San Jose, Calif., under
the name "Luer Check Valve."
[0215] In another embodiment, balloon 2647 may be self-inflating,
wherein the treatment agent itself acts as the inflation fluid for
balloon 2647, eliminating the need for a separate inflation lumen
2636 in shaft 2622. In this embodiment, delivery lumen 2628
communicates with the interior of balloon 2647 in such a way that
balloon 2647 will inflate fully to occlude the coronary sinus only
during delivery of treatment agent. For example, a fluid path
between delivery lumen 2628 and balloon 2647 may be provided such
that all or a major portion of the treatment agent delivered
through delivery lumen 2628 first enters the balloon to cause
balloon 2647 to inflate, before treatment agent flows into the
coronary sinus through outlet holes in shaft 2622 distal to balloon
2647, or through outlet holes in the balloon itself. One way to
accomplish this is by a reduction in the diameter of the lumen
distal to balloon 2647 such that a sufficient head pressure is
established to inflate balloon 2647 and administer a treatment
agent from shaft 2622.
[0216] Pressure lumen 2642 may also be provided in shaft 2622 which
opens at pressure port 2644 on side-wall of shaft 2622 near distal
end 2624, or in soft tip 2630 as illustrated. Pressure lumen 2642
is connected to extension tube 2646 attached (e.g., via adhesive)
to shaft 2622 near proximal end 2626 and includes fitting 2648 at
its proximal end suitable for connection to pressure monitoring
equipment. In this way, pressure in the coronary sinus distal to
balloon 2647 may be monitored during treatment agent delivery to
ensure that pressure within the coronary sinus is maintained at a
safe level. Extension tube 2646 may have a surrounding material,
sleeve, cannula or lumen, such as described below with respect to
infusion lumen 9520 or accessory lumen 9530 of FIGS. 69A-F.
[0217] Pressure relief valve (e.g., not shown, but such as relief
valve 2641) connected to inflation extension tube 2638, may also be
connected to delivery lumen 2628 to ensure that treatment agent
pressure does not exceed a predetermined level, avoiding hemolysis
in the blood component of the fluid or protecting the coronary
sinus from excessive infusion pressure. In various embodiments,
pressure in the range of about zero to about five mmHg could be
measure at port 2644.
[0218] As shown in FIG. 29, distal portion of shaft 2622 may
include delivery lumen 2628, inflation lumen 2636, pressure lumen
2642, and guidewire lumen 2691. Guidewire lumen 2691 is adapted to
receive a guidewire, where the guidewire may be used for navigating
through the vasculature or the guidewire may be provided with a
balloon on a distal end of the guidewire.
[0219] As shown in FIG. 27, distal portion of shaft 2622 may
include first bend 2650 and second bend 2652, which facilitate the
placement of distal end 2624 in the coronary sinus. In various
embodiments, second bend 2652 may be distance L2 of between about
three mm and 10 mm in distance from distal end of soft tip 2630,
and first bend 2650 may be a distance L.sub.1 of between 20 mm and
40 mm in distance proximal to second bend 2652. First and second
bends 2650, 2652 may subtend various angles depending upon patient
anatomy and surgeon preference. In various embodiments
configuration, first bend 2650 subtends an angle A of between about
20.degree. and about 70.degree. relative to the longitudinal axis
of proximal portion 2654 of shaft 2622. In another embodiment,
second bend 2652 may subtend an angle B of about 30.degree. to
about 40.degree. relative to mid-portion 2656 of shaft 2622.
[0220] A liquid containing a treatment agent or drug, e.g., a
caroporide solution, may be introduced into proximal end 2626 of
catheter 2620, which extends outside of the patient, under
sufficient pressure so that the fluid containing the treatment
agent can be forced to pass through the coronary sinus, through the
capillary beds (not shown) in the patient's myocardium, and
optionally through coronary arteries (not shown) and ostia
associated with the respective coronary arteries (not shown) into
the ascending aorta (not shown).
[0221] In various embodiments, balloon 2647 on the distal extremity
of catheter 2620 is inflated to occlude the coronary sinus or
another vessel to prevent fluid loss into the right atrium. A
liquid containing a treatment agent such as adenosine is directed
through catheter 2620 into the coronary sinus or another vessel and
the pressure and volumetric flow rate of the treatment agent within
the coronary sinus or another vessel are maintained sufficiently
high (e.g. at least 100 ml/min at about 40 mm Hg) so that the
treatment agent will pass through the coronary veins, and reaching
the capillary beds, and optionally on to the coronary arteries (not
shown) and out the ostia (not shown).
[0222] Treatment agent is delivered through delivery catheter 2620
at a flow rate sufficient to maintain desired treatment by periodic
or continual infusions. However, treatment solution pressure within
the coronary sinus or another vessel should be less than about 50
mm Hg to avoid tissue damage. In various embodiments, the treatment
agent is a mixture of blood and a treatment agent such as an
antioxidant, in various embodiments at a ratio or four parts blood
to one part antioxidant solution (by volume). This antioxidant
solution may be mixed into oxygenated blood.
[0223] The treatment agent may be directed to fitting 2632 on
proximal end of delivery catheter 2620, and delivered to the
coronary sinus, or another vessel, in various embodiments at a flow
rate of at least about 100 ml/min. and in another embodiment, at
about 200 ml/min. If treatment agent includes a blood component,
the pressure required to pump the treatment agent through the lumen
of the delivery catheter ("pump pressure") should not exceed 300
mmHg to avoid excessive hemolysis of the blood component. Treatment
agent flow through delivery catheter 2620 is maintained on a
periodic basis, e.g., about every 15-30 seconds for 2-4 minutes, so
long as the heart is to remain under treatment.
[0224] Referring now to FIG. 30, another embodiment of a catheter
system is illustrated. Catheter system 3000 includes delivery
catheter 3020 (for example, delivery catheter 2620, 3122, 3201,
3510, 3920, or any other catheter or cannula.). Delivery catheter
3020 includes proximal ends 3026 (for example, 2626) and distal end
3024 (for example, 2624, 3112, 3260). Delivery catheter 3020
includes a delivery lumen (not shown) (for example, 2628, or any
other delivery lumen, tube or cannula as described herein).
Delivery lumen connects outlet port 3092 (for example, 2692, 3162,
3154, 2628, 3228, 3992, or any other treatment agent delivery or
infusion opening, exit, or port.) on distal end 3024 of catheter
and has fitting 3032 (for example, 2632) on proximal end 3026 of
catheter. Fitting 3032 may be connected to a pressure increasing
device 3050 (for example, 5600, 5700, or 5800) by device outlet
3004 (for example, 5604, 5718, or 5818). Intermediate to device
outlet 3004 and fitting 3032 there may be located one or more (in
series) of pressure-transferring device, pressure-maintaining, or
pressure-dampening device 3052 (for example, 5900, 6000, 6100).
[0225] On distal end 3024 of catheter is located balloon 3047 (for
example balloon 8810, 9510, filter device 710, or any other
balloon, occlusion device, or filter device as described herein)
with inflation lumen (not shown) (for example, 2636, 3936, or any
other inflation lumen, tube or cannula.), where inflation lumen has
opening 3037 (for example, 2637, 3172), which serves to inflate or
deflate balloon 3047. Inflation lumen is through catheter 3020 from
opening 3037 (for example, 2637, 3172) to inflation extension tube
3038 (for example, 2638), which has fitting 3040 (for example,
2640) at the proximal end of inflation extension tube 3038. There
is also optionally provided pressure relief valve 3041 (for
example, 2641) adjacent to fitting 3040. Inflation device 3070 (for
example, apparatus 9700, 9800 of FIGS. 75A-81 or any other balloon
or occlusion device inflation device.) may be connected to fitting
3040. Extension tube 3038 may have a surrounding material, sleeve,
cannula or lumen, such as described below with respect to infusion
lumen 9520 or accessory lumen 9530 of FIGS. 69A-F.
[0226] Delivery catheter 3020 may also have a pressure lumen (not
shown) (for example, 2642, 3142, 3220, accessory lumen 9530, or any
other lumen, tube, or cannula capable of measuring pressure or
inserting a pressure sensing device through.), where pressure lumen
has pressure port 3044 (for example, 2644, 3136, 3228, 3944) at
distal end of pressure lumen. Pressure lumen extends from pressure
port 3044 to extension tube 3046 (for example, 2646). Extension
tube 3046 has fitting 3048 (for example, 2648) at proximal end of
extension tube 3046. Pressure-sensing device 3060 may be connected
to fitting 3048. Extension tube 3046 may have a surrounding
material, sleeve, cannula or lumen, such as described below with
respect to infusion lumen 9520 or accessory lumen 9530 of FIGS.
69A-F.
[0227] In various embodiments, system 3000 has controller 3080,
such as a controller (e.g., including an automatic, computer, or
machine controller) adapted to control a pressure increasing
device, a pressure-sensing device, or an inflation device as
described herein. More particularly, pressure-sensing device 3060
may be connected to pressure measurement connection 3008 (for
example, 5708 or 5808 of FIGS. 57 and 58) of pressure increasing
device 3050 by pressure measurement connection 3062. Optionally,
there may be provided system controller 3080, for example, a
computer or mini-computer, which is connected to pressure
increasing device 3050, pressure-sensing device 3060, or inflation
device 3070. For example, system controller 3080 may access a
memory including instructions (e.g., such as machine readable
instructions) to control a pressure increasing device, a
pressure-sensing device, an inflation device, in infusion device,
or any device or apparatus. Specifically, controller 3080 may be
used to control inflation or deflation of a balloon to various
outer diameters (e.g., see FIGS. 55 and 68 herein, which
illustrates a balloon outside diameter growth rate) by inflating a
balloon with a selected inflation pressure or volume.
[0228] Moreover, system controller 3080 may be used to control an
amount of treatment agent infused, a period of time during which
treatment agent is infused, a period of time during which an
occlusion device occludes a blood vessel (e.g., such as first
period of time 9670, or a period of time that filter device 720
(e.g., see FIGS. 7-19 and accompanying text) is expanded within the
blood vessel), or a period of time during which blood or treatment
agent is allowed to perfuse or flow through a treatment region in a
blood vessel (e.g., such as second period of time 9680). Similarly,
system controller 3080 may be used to control a treatment process
for infusion of a treatment agent into an artery or vein of a
patient using devices, apparatus, methods, or processes described
herein (e.g., such as according to the process described with
respect to FIG. 3, 19, 54, 55, 63, or 82).
[0229] A suitable self-inflating balloon configuration is
illustrated in FIG. 31. FIG. 31 illustrates the structure and
operation of self inflating balloon 3147 and flow tip 3148 of
catheter 3120. Pear shaped balloon 3147 tapers gradually from its
widest diameter to form distal circular cuff 3168, and tapers more
quickly from its widest diameter to form proximal circular cuff
3170. Proximal cuff 3170 coaxially receives catheter body 3122 and
is attached thereto to form a fluid tight seal between cuff 3170
and catheter body 3122. Distal cuff 3168 coaxially receives and
attaches to flow tip 3148.
[0230] Plurality of radial holes 3172 extend through body of
catheter 3122 from within infusion lumen 3128, proximal of flow tip
base plug 3152, into interior space 3174 enclosed by balloon 3147.
Thus the flow of treatment agent through catheter 3120 shown by
arrows 3190 exits infusion lumen 3128 through holes 3172, enters
balloon interior 3174, flows into flow channels 3158 and exits each
flow channel 3158 through its side exits 3162, or distal exits
3154. The aggregate cross sectional area of holes 3172 filling
balloon interior 3174 exceeds the aggregate cross sectional area of
flow channels 3158 draining balloon interior 3174, providing a
positive pressure within balloon interior 3174 to keep balloon 3147
inflated while the treatment agent flows through catheter 3120.
[0231] Pressure monitoring lumen 3142 extends through one of open
channels 3158 via extension tube 3175. Extension tube 3175 may have
a surrounding material, sleeve, cannula or lumen, such as described
below with respect to infusion lumen 9520 or accessory lumen 9530
of FIGS. 69A-F. Extension tube 3175 extends from flow tip body
3150, where pressure monitoring lumen 3142 exits flow tip body
3150, through one of flow channels 3158, and terminates proximally
adjacent flow channel distal exit (not shown), to form pressure
lumen distal opening 3136. The pressure monitoring equipment (not
shown) is thus in pressure communication with the inside of the
coronary sinus or another vessel in which pressure lumen distal
opening 3136 is located. Because the pressure lumen distal opening
3136 is recessed into the flow channel 3158, there is less chance
of it becoming occluded by the wall of the coronary sinus, or
another vessel.
[0232] Also note that stylet well 3176 can coaxially sink into base
plug 3152 of flow tip 3148 for receiving a stylet (not shown), and
providing additional reinforcement at distal end 3156 of catheter
body 3122 where the stylet (not shown) impacts base plug 3152 of
flow tip 3148.
[0233] FIG. 32 depicts catheter 3201 positioned within heart 100.
Catheter 3201 may be inserted percutaneously through a blood
vessel, such as an artery or vein. Specifically, catheter 3201 can
be advanced through a percutaneous venus entry, such as through a
femoral vein, and tip 3212 is guided through right atrium 122 into
coronary sinus 3286. Blood drains into right atrium 122 via
superior vena cava 126 and interior vena cava 116, and from
coronary sinus 3286 via coronary sinus ostium 3288. Moreover, blood
drains from the myocardium to coronary sinus 3286 via great cardiac
vein 3290 and small cardiac vein 3292.
[0234] Tip 3212 having port 3214 is inserted into coronary sinus
3286 to a depth from about zero to about four inches (zero to about
10.2 cm) from coronary sinus ostium 3288. Optionally, markers 3218
may be provided on catheter 3201 and optionally spaced about two
inches apart along catheter 3201; in various embodiments, markers
3218 are radiopaque.
[0235] Referring now to FIG. 33, which illustrates diaphragmatic
surface of heart 3300. Coronary sinus 3286 is shown feeding into
right atrium. Great cardiac (anterior interventricular) vein 3290,
oblique vein of left atrium 3310, and posterior vein of left
ventricle 3304 feed into coronary sinus 3286. Also, middle cardiac
(posterior interventricular) vein 3306, and small cardiac vein 3308
feed into coronary sinus 3286. All the veins are provided with
arrows to show direction of ordinary blood flow into coronary sinus
3286 and into right atrium.
[0236] Referring now to FIG. 34, sternocostal surface of heart 3301
is shown. Great cardiac (anterior interventricular) vein 3290 is
shown, as are anterior cardiac veins of right ventricle 3314, and
small cardiac vein 3308.
[0237] Left coronary artery 3320 and right coronary artery 3322
feed out of aorta 3350. Branching off of left coronary artery 3320
are circumflex branch of left coronary artery 3324, and anterior
interventricular branch (left anterior descending) of left coronary
artery 3344, and interventricular septal branches 3326. Feeding off
of right coronary artery 3322 are atrial branch of right coronary
artery 3330, and right marginal branch of right coronary artery
3328.
[0238] Referring again to FIG. 33, right coronary artery 3322 is
shown. Feeding off of right coronary artery 3322 are right marginal
branch 3338, and interventricular septal branches 3342. Other
branches from left coronary artery (3320 in FIG. 34) are circumflex
branch of left coronary artery 3324, and posterior left ventricular
branch 3340. Also shown in FIG. 33 are sinuatrial nodal branch
3332, and sinuatrial node 3334.
[0239] FIG. 35 illustrates distal end 3560 of catheter 3510 within
coronary sinus 3286. Catheter 3510 has tip 3514 at distal end 3560,
and plurality of lumen outlets 3528 proximal to tip 3514. Balloon
3522 is shown occluding coronary sinus 3286 and coronary sinus
ostium 3288 adjacent to right atrium wall 3556. Balloon 3522 on
catheter 3510 may also be used to occlude other veins distal to
coronary sinus 3286, for example, great cardiac vein 3290, anterior
cardiac vein of right ventricle 3314, and small cardiac vein 3308
(shown in FIGS. 33 and 34). In this embodiment, a self-inflating
balloon is shown with infusion lumen 3518 through which a treatment
agent flows and inflates balloon 3522 then flows out of lumen
outlets 3528. Pressure-sensing lumen 3520 is also provided. In
another embodiment, a third lumen was provided (not shown) to
inflate balloon 3522 when balloon 3522 is not self-inflating. There
is also provided guidewire 3570, having distal end 3576. Guidewire
3570 is fed through guidewire lumen 3572, which guidewire lumen
3572 has distal opening 3574 at tip 3514.
[0240] Referring now to FIG. 36 is a staggered tip of a balloon
catheter. Balloon catheter 3600 has distal end 3602 and proximal
end (not shown). Adjacent distal end 3602 of catheter is balloon
3604. Balloon inflation lumen 3606 has distal end and opening 3608
within balloon 3604 to inflate or deflate balloon 3604.
Pressure-sensing lumen 3610 has distal end and opening 3612 which
enables pressure-sensing lumen 3610 to sense pressure or other
measurements or parameters wherever distal end 3602 of catheter is
placed. Delivery lumen 3614 has distal end and opening 3616 which
enables a fluid path from proximal end (not shown) of catheter to
distal end 3602 of catheter.
[0241] Staggered tip of catheter 3600 may enable easier tracking of
distal end 3602 of catheter through a blood vessel. In various
embodiments, pressure-sensing lumen 3610 or catheter body 3620
adjacent pressure-sensing lumen 3610 have tapered cut 3622 which
may be curved. According to some embodiments, tapered cut 3622, may
have an angle and a tapered shape, such as is described above with
respect to tapered cut 2222 of FIG. 22. In various embodiments,
distance L.sub.1 marked with reference numeral 3624 is the distance
between distal end 3612 of pressure-sensing lumen 3610 and distal
end 3616 of delivery lumen 3614. In various embodiments, L.sub.1
3624 may be between about 0.5 millimeters and five millimeters.
[0242] In another embodiment, catheter 3600 is illustrated.
Catheter has balloon inflation lumen 3606, balloon 3604, delivery
lumen 3610 having opening 3612, and pressure-sensing lumen 3614
having opening 3616. Catheter 3600 has a staggered tip where
opening 3612 of delivery lumen 3610 is distance L.sub.1 3624 from
opening 3616 of pressure-sensing lumen 3614. In addition, catheter
body 3620 adjacent opening 3612 of delivery lumen 3610 may have a
tapered or curved shape 3622.
[0243] In another embodiment, catheter 3600 may include marker
3630, for example a radio-opaque marker, which may serve to ease
visualization of distal end 3602 of catheter 3600 with a diagnostic
or visualization system.
[0244] Referring now to FIG. 37, is a staggered tip of a balloon
catheter. Balloon catheter 3700 has distal end 3702 and proximal
end (not shown). Adjacent distal end 3702 of catheter is balloon
3704. Balloon inflation lumen 3706 has distal end and opening 3708
within balloon 3704 to inflate or deflate balloon 3704.
Pressure-sensing lumen 3710 has distal end and opening 3712 which
enables pressure-sensing lumen 3710 to sense pressure or other
measurements or parameters wherever distal end 3702 of catheter is
placed. Delivery lumen 3714 has distal end and opening 3716 which
enables a fluid path from proximal end (not shown) of catheter to
distal end 3702 of catheter. Staggered tip of catheter 3700 may
enable easier tracking of distal end 3702 of catheter through a
blood vessel. In various embodiments, pressure-sensing lumen 3710
or catheter body 3720 adjacent pressure-sensing lumen 3710 have
tapered cut 3722 which may be curved. According to some
embodiments, tapered cut 3722, may have an angle and a tapered
shape, such as is described above with respect to tapered cut 2222
of FIG. 22. There is also provided an indentation 3740 proximal to
distal end 3702, with guidewire lumen 3742 distal to indentation
3740. Indentation 3740 and guidewire lumen 3742 are adapted to
receive guidewire 3744. Guidewire 3744 has proximal end (not shown)
and distal end 3746. Guidewire 3744 may be provided with balloon
3748 adjacent distal end 3746. In use, catheter 3700 may be tracked
over the guidewire through by feeding distal end 3702 of catheter
over guidewire 3744 by way of lumen 3742. This "over the wire"
(OTW) is also known as monorail.
[0245] Referring now to FIG. 38, the staggered tip of a balloon
catheter. Balloon catheter 3800 has distal end 3802 and proximal
end (not shown). Adjacent distal end 3802 of catheter is balloon
3804. Balloon inflation lumen 3806 has distal end and opening 3808
within balloon 3804 to inflate or deflate balloon 3804.
Pressure-sensing lumen 3810 has distal end and opening 3812 which
enables pressure-sensing lumen 3810 to sense pressure or other
measurements or parameters wherever distal end 3802 of catheter is
placed. Delivery lumen 3814 has distal end and opening 3816 which
enables a fluid path from proximal end (not shown) of catheter to
distal end 3802 of catheter.
[0246] Staggered tip of catheter 3800 may enable easier tracking of
distal end 3802 of catheter through a blood vessel. In various
embodiments, pressure-sensing lumen 3810 or catheter body 3820
adjacent pressure-sensing lumen have tapered cut 3822 which may be
curved. According to some embodiments, tapered cut 3822, may have
an angle and a tapered shape, such as is described above with
respect to tapered cut 2222 of FIG. 22. In various embodiments,
distance L.sub.1 marked with reference numeral 3824 is the distance
between distal end 3812 of pressure-sensing lumen 3810 and distal
end 3816 of delivery lumen 3814. In various embodiments, L.sub.1
3824 may be between about 0.5 mm and about five mm.
[0247] Catheter 3800 may also include marker 3830, for example, a
radio-opaque marker, which may serve to ease visualization of
distal end 3802 of catheter 3800 with a diagnostic visualization
system.
[0248] Catheter 3800 may also include guidewire lumen 3842 through
catheter 3800. Guidewire lumen 3842 has distal end and opening 3843
adjacent distal end 3802 of catheter. Guidewire lumen 3842 is
adapted to receive a guidewire. Guidewire 3844 is illustrated,
where guidewire 3844 has distal end 3846 and balloon 3848 adjacent
distal end 3846.
[0249] Referring now to FIG. 39, which shows catheter 3920 within
blood vessel 3910 (e.g., such as a vein or artery). Catheter 3920
includes balloon 3947 on distal end 3924 of catheter 3920. Also, on
distal end 3924 is outlet port 3992 to deliver a treatment agent
into blood vessel 3910. Pressure port 3944 is on distal end 3924 to
measure a pressure in blood vessel 3910. Balloon 3947 is inflated
by outlet ports of inflation lumen 3936. Blood vessel 3910 is
divided into two portions, first portion 3914 is distal to balloon
3947, and second portion 3912 is proximal to balloon 3947. Balloon
3947 serves to seal against inner wall of blood vessel 3910, and
provide a pressure separation between first portion 3914 and second
portion 3912. In various embodiments, treatment agent flowing
through outlet port 3992 serves to increase the size of first
portion 3914 due to the high pressure exerted by treatment agent on
blood vessel walls in first portion 3914. This causes first portion
3914 to have a larger diameter than second portion 3912, and a
frusto-conical shape taper is created between first portion 3914
and second portion 3912. In this embodiment, balloon 3947 is
tapered to accommodate the frusto-conical shape of the taper
between first portion 3914 and second portion 3912.
[0250] In various embodiments, balloon 3947 may be tapered by
having distal end 3949 of balloon have a thinner wall thickness
than proximal end 3951 of balloon 3947, so that fluid or gas
inserted into balloon 3947 through outlet port of inflation lumen
3936 serves to make the distal end 3949 of balloon larger than
proximal end 3951 of balloon 3947. In another embodiment, balloon
3947 may have uniform wall thickness of proximal end 3951 and
distal end 3949, but the balloon is molded or formed in a tapered
shape, or otherwise formed so that balloon 3947 will assume a
tapered shape when inflated.
[0251] In various embodiments, a pressure-sensing device may be
connected to pressure port 3944 via an attachment to fitting 3648
at proximal end of extension tube 2646 of catheter 2620 (shown in
FIGS. 26-29). In various embodiments, pressure-sensing device may
be attached to proximal end of pressure lumen 2642 (shown in FIG.
28-29). In another embodiment, a pressure-sensing device may be fed
through pressure lumen 2642 adjacent to pressure port 2644 on
side-wall of shaft 2622 near distal end 2624 of catheter 2620
(shown in FIGS. 26-29). In various embodiments, pressure-sensing
device is disposable. In another embodiment, pressure-sensing
device is a disposable piezo-electric pressure sensor, for example,
a piezoelectric pressure sensor manufactured by Utah Medical
Products, Inc., which is attached to fitting 2648 (shown in FIG.
26).
[0252] In various embodiments, an inflation device may be connected
to inflation lumen 3936 via attachment to fitting 2640 at proximal
end of inflation extension tube 2638 attached to shaft 2622 and
inflation lumen 2636 extending through catheter 2620. In various
embodiments, the inflation device is a syringe. In another
embodiment, the inflation device is a pump, for example, a
centrifugal pump, a gear pump, or a reciprocating pump. In another
embodiment, balloon 2647 is inflated with carbon dioxide, saline,
or contrast medium by the inflation device.
[0253] Referring now to FIG. 40, is illustrated guidewire 4000.
Guidewire 4000 has distal end 4002. At distal end 4002 is balloon
4004. Balloon 4004 may be inflated or deflated by balloon inflation
lumen 4006 though guidewire 4000. Balloon inflation lumen 4006 has
distal end and opening 4008 within balloon 4004. There may be
provided one or more markers 4010 to aid visualization, for example
under fluoroscopy, at distal end 4002 of guidewire. Spring 4012 is
provided about guidewire at distal end 4002 to improve tracking of
distal end 4002 through curves. In various embodiments, spring 4012
imparts a natural curve to distal end 4002. Tip 4014 is provided to
minimize damage to vessels as tip 4014 travels through vessels. Tip
4014 has diameter L.sub.1 4016. In various embodiments, L.sub.1 is
between about 0.005 inches and 0.025 inches.
[0254] Referring now to FIG. 41, guidewire 4100 has proximal end
4101 and distal end 4102. For ease of illustration, break 4103 is
provided. Guidewire has sheath 4106 (e.g., such as sheath 790 as
shown and described with respect to FIGS. 7-9) about guidewire from
proximal end 4101 to distal end 4102. FIG. 41 shows sheath 4106
enclosing occlusion device 4108. Distal end 4102 also includes
floppy tip 4104. FIG. 42A illustrates the guidewire of FIG. 41 with
the occlusion device open. As shown in FIG. 42A, sheath 4106 has
been laterally moved in the direction of arrows 4110 to uncover
occlusion device 4108. Distal end 4102 of guidewire is within
vessel 4112. Vessel 4112 has fluid flow in the direction of arrow
4113. When sheath 4106 is moved, to uncover occlusion device 4108,
fluid flow within vessel 4112 forces open occlusion device 4108 in
the direction of arrows 4109. Occlusion device 4108 then occludes
vessel 4112 (e.g., such as by since occlusion device being forced
against vessel wall by fluid flow within vessel 4112). Suitable
materials for occlusion device 4108 may include one or more of a
synthetic or natural latex or rubber, such as a polymer material; a
polyetheramide; a plasticiser free thermoplastic elastomer; a
thermoplastic blend; a block copolymer of polyether and polyester
(e.g., such as a polyester sold under the trademark Hytrel.RTM. of
DUPONT COMPANY); a biocompatible polymer such as a polyether block
amide resin (e.g., for instance, PEBAX.RTM. of ATOCHEM
CORPORATION); a polycarbonate or acrylonitrile bubadiene styrene
(ABS); a biocompatible polymer such as a polyether block amide
resin; a styrene isoprene styrene (SIS), a styrene butadiene
styrene (SBS), a styrene ethylene butylene styrene (SEBS), a
polyetherurethane, an ethyl propylene, an ethylene vinyl acetate
(EVA), an ethylene methacrylic acid, an ethylene methyl acrylate,
an ethylene methyl acrylate acrylic acid, a material from a
material family of one of styrenic block copolymers and
polyurethanes, a melt processible polymer, urethane, polyurethane,
polyethylene, polypropylene, polybutylene, copolymers of ethylene,
propylene, butylene, a low durometer material, nylon, and other
materials that can block fluid flow.
[0255] FIG. 42B, is a front view of FIG. 42A from perspective "A".
FIG. 42B shows an embodiment of occlusion device 4108 having
overlapping leaflets. First leaflet 4120 is shown overlapping
second leaflet 4122 from the front. FIG. 42C, is a side of the
occlusion device of FIG. 42A showing the occlusion device
overlapping leaflets. FIG. 42C shows occlusion device 4108 with
second leaflet 4120 overlapping first leaflet 4122 from the back.
In another embodiment, occlusion device 4208 is a single member,
without leaflets. For instance, occlusion device 4108 may be a
single member with fold lines to prevent crimping of occlusion
device 4108 when retracted by sheath 4106 (e.g., such as if filter
device 720 were a solid member or material).
[0256] In use, distal end 4102 of guidewire 4100 is fed into vessel
4112. Once distal end 4102 of guidewire has been located in the
correct position, sheath 4106 may be pulled back in the direction
of arrows 4110 to expose occlusion device 4108. Fluid flow in the
direction of arrow 4113, within vessel 4112, forces open occlusion
device 4108 in the direction of arrows 4109 to occlude vessel 4112.
At the end of the procedure, sheath 4106 may be advanced in the
direction of arrows 4111 to recover or disengage occlusion device
4108 and force it closed. At that point, distal end 4102 may be
removed from vessel 4112. In another embodiment, before removing
distal end 4102, sheath 4106 may be removed, and a second sheath
(not shown) may be fed over proximal end 4101 of guidewire to
recover occlusion device 4108. Second sheath may have a larger
diameter to trap fluid, particles, or foreign objects which were
caught in occlusion device 4108. In this embodiment, second sheath
(not shown) is fed in direction of arrows 4111 until occlusion
device 4108 has been closed and then distal end 4102 may be removed
from vessel 4112.
[0257] In various embodiments, occlusion device 4108 may be
provided with leaflets or fold lines to ease deployment and
recapture of occlusion device. For instance, in various
embodiments, occlusion device 4108 may be opened (such as after
sheath 4106 has been pulled back) by rotation of guidewire 4100 to
cause occlusion device 4108 to rotate in direction 4182 to open
occlude vessel 4112 (see FIGS. 42A-42C). Specifically, rotation of
occlusion device 4108 in direction 4182 causes leaflets of the
device (e.g., including first and second leaflets 4120 and 4122) to
open. Similarly, occlusion device 4108 may be closed, such as for
removal, by rotation of guidewire 4100 to cause occlusion device
4108 to rotate in direction 4184 to recover or disengage occlusion
device 4108 by forcing it closed (see FIGS. 42B-42C). Thus,
rotation of occlusion device 4108 in direction 4184 causes leaflets
of the device (e.g., including first and second leaflets 4120 and
4122) to close or form a smaller outer diameter than shown in FIG.
42A.
[0258] Referring now to FIG. 43, guidewire 4300 is illustrated
having a proximal section 4301 and distal end 4302. Occlusion
device 4304 is provided adjacent distal end 4302. Occlusion device
4304 has a frame 4306, and basket 4308 stretched between the
structure of frame 4306. For instance, frame 4306 is shown having
distal frame 4362 and proximal frame 4364 to support basket 4308,
such as where basket 4308 forms a scoup, cone, "parachute", or net
shape between distal frame 4362 and proximal frame 4364 by being
on, over, between, or attached to distal frame 4362 and proximal
frame 4364. Suitable materials for basket 4308 include urethane,
polyurethane, polyethylene, polypropylene, polybutylene, copolymers
of ethylene, propylene, or butylene, latex, elastomers, PEBAX.RTM.,
nylon and other materials that can block fluid flow. Also, suitable
materials for frame 4306 include an elastic material, nitinol
(NiTi), or self-expanding materials (e.g., such as shape memory
alloys, including for example, Nickel-Titanium) or other materials
that have shape memory where the memorized shape is the expanded
shape. To modify the shape (e.g., to restrict the shape) a sheath
may be placed over occlusion device 4304. Removing the restriction
will allow the shape memory material to return to its memorized
shape (e.g., an expanded shape) without being damaged. In the case
shown by FIG. 43, sheath 4310 is provided over guidewire 4300 to be
place over or restrain occlusion device 4304 (e.g., sheath 4310 may
be a material or function as described above for sheath 790 or 4106
as described above with respect to FIGS. 7-9, and 41
respectively).
[0259] According to some embodiments, basket 4308 may be connected
or attached to a frame 4306, such as by laser bonding, adhesive
bonding, thermal bonding, mechanical restriction (e.g., such as if
material basket 4308 is woven or sewn through structure of the
frame, such as structure including gaps between the structure or
holes in the frame), and or various other appropriate attachment
methods as described herein. Likewise, an inner diameter of the
frame 4306, such as in inner diameter of proximal frame 4364, may
be attached to an outer surface of guidewire 4300, such as by laser
bonding, adhesive bonding, thermal bonding, mechanical bonding.
[0260] In use, distal end 4302 is placed within vessel 4312, with
sheath 4310 covering occlusion device 4304. When distal end 4302 is
located in an appropriate location, sheath 4310 is pulled back, and
frame 4306, which includes an elastic or expanding material to
apply an expaning force to occlusion device 4304, forces open
occlusion device 4304 stretching basket 4308 across vessel 4312 to
occlude fluid flow. In addition, fluid flow in the direction of
arrow 4314 forces open occlusion device 4304 and acts to press
basket 4308 against the walls of vessel 4312, by also applying a
force on the inside surfaces of basket 4308 which creates an
expaning force to occlusion device 4304.
[0261] According to some embodiments, occlusion devices may include
various types of balloons made of various materials and according
to various manufacturing techniques. For example, in various
embodiments, devices 720, 2006, 2104, 4108, 4304 as described
herein; balloons 308, 314, 510, 2112, 2204, 2250, 2547, 2647, 3047,
3147, 3522, 3604, 3704, 3804, 3947, 4004, 4420, 4520, 4820, 8810,
9510 as described herein; or any other catheter, cannula, tube,
sheath, balloon or occlusion device., may be made from or include a
polymer material, such as a synthetic or natural latex or rubber.
Moreover, the polymer material may be a polyether block amide
resin, a polyetheramide, or a plasticiser free thermoplastic
elastomer, for example, PEBAX.RTM., a registered trademark of
Atochem. Similarly, balloons or occlusion devices described herein
may be made from or include a blend of different types of
PEBAX.RTM.. In various embodiments, balloons or occlusion devices
described herein may be made from or include a styrenic block
copolymer (SBC), or a blend of SBC's. Suitable SBC's include SBC's
sold under the tradename Kraton Polymers.RTM. a registered
trademark of Shell Oil Company, SBC's sold under the tradename
Vector.RTM. a registered trademark of Dexco Polymers, and SBC's
sold under the tradename Europrene.RTM. a registered trademark of
Polymeri Europa.
[0262] In fact, in some embodiments, balloons mentioned above, or
other balloons or occlusion device., may include various types of a
high-compliance or low-tension balloons, such as a composite or
multi-layer expanded PolyTetraFlouroEthylene (ePTFE) balloon having
an inner liner. For example, FIG. 44 is a cross-sectional view of a
cannula and a balloon. As shown in FIG. 44, cannula 4410 (e.g.,
such as a cannula having a dimension suitable for percutaneous
advancement through a blood vessel, such as advancement in
direction 4586 through blood vessel 4490) includes proximal end
4412, distal end 4414, and exterior surface 4416. FIG. 44 also
shows balloon 4420 (e.g., such as balloon mentioned above, or
another balloon or occlusion device.) axially connected to exterior
surface 4416 of cannula 4410, at or adjacent distal end 4414. Also
shown are diameter of cannula DC, pre-inflation diameter of balloon
DM, inflated diameter of balloon D2, post-inflation deflated
diameter of balloon DP, and diameter of vessel DV.
[0263] According to some embodiments, balloon 4420 may have a
property such that when inflated balloon 4420 will expand in size
to an outer diameter sufficient for occlusion of a blood vessel at
an inflation pressure (or at an inflation volume with respect to
balloon 8810 or apparatus 9700 or 9800 of FIGS. 75A-81) and less
than sufficient to cause an axial force on an inner diameter of the
blood vessel. For instance, FIG. 44 shows balloon 4420 inflated to
outer diameter D2 sufficient for occlusion of blood vessel 4490 at
inflation pressure PR, which is a pressure less than sufficient to
cause an axial force, such as a force in directions 4487, on inner
diameter 4492 of blood vessel 4490.
[0264] More particularly, balloon 4420 may include a property such
that when inflated to volume V1, balloon 4420 will expand in size
to outer diameter D2 that is approximately inner diameter DV of
blood vessel 4490 at inflation pressure PR, which is a pressure
less than sufficient to exert an axial strain on blood vessel 4490
in directions 4487. Thus, balloon 4420 may be a high-compliance
balloon that expands radially and longitudinally upon inflation and
forms a plurality of radial outer diameters during inflation to an
outer diameter sufficient to occlude the blood vessel at an
inflation pressure that does not appreciably expand the blood
vessel radially (e.g., such as by occluding the blood vessel at a
location while the inner diameter of the blood vessel at the
location stays within five percent its pre-occlusion inner
diameter). Furthermore, balloon 4420 may be a low-tension balloon,
such as a balloon that expands radially and longitudinally upon
inflation and forms a plurality of radial outer diameters during
inflation and deflation, but does not form wings. For example,
balloon 4420 may have a balloon pre-inflated outer diameter DM
between three mm and five mm at an inflation pressure of between
zero atmospheres and one atmosphere in pressure, and a balloon
inflated outer diameter D2 between five mm and nine mm at an
inflation pressure between six atmospheres and eight atmospheres in
pressure. In addition, according to some embodiments, pressure PR
may be a pressure sufficient to cause balloon 4520 to occlude the
blood vessel without radially expanding the blood vessel.
[0265] In addition, balloon may have a property to cause
post-inflation deflated outer diameter DP of balloon 4420 to
retract to within 20% of pre-inflated outer diameter DM of balloon
4420. It is also contemplated that balloon 4420 may include one or
more of the following characteristics: effective modulus of less
than 1.5 MPa (e.g., such as during insertion into a blood vessel,
use as an occlusion device, and removal from the blood vessel), and
elongation of less than 500% at breaking, a tension set of less
than 30%, a tension strength of at least 200 MPa, and an inflation
range of pressure between zero and six atmospheres in pressure. In
various embodiments, balloon 4420 may have a tension set of less
than 30% in residual strength after elongation to 300%, such as by
having a tension set of 20%, 15%, 10%, or 5%. Specifically,
according to various embodiments, balloon 4420 may have a property
to withstand an inflation pressure of between six and eight
atmospheres of pressure and retract to within 20% of balloon 4420's
initial pre-inflation dimension, upon removal of inflation
pressure.
[0266] It is also contemplated that balloon 4420 may have a wall
thickness that varies with respect to the axis of cannula 4410, so
that when balloon 4420 is inflated, it has a tapered profile. For
instance, according to various embodiments, balloon 4420 has a
first wall thickness at first axial distance 4432 from distal end
4414 of the cannula and a different second wall thickness at
different second axial distance 4434 from distal end 4414 of
cannula 4410. Thus, when balloon 4420 is inflated, it will expand
to a first outer diameter at distance 4432 and a different second
outer diameter at distance 4434.
[0267] Similarly, it is contemplated that balloon 4420 may have a
pre-inflated outer diameter that varies along the axis of cannula
4410 so that when balloon 4420 is inflated, it has a tapered
profile. In various embodiments, when deflated, balloon 4420 has a
first pre-inflated outer diameter at distance 4432 and a second
pre-inflated outer diameter at distance 4434. Thus, when inflated,
balloon 4420 will expand in size to a first outer diameter at
distance 4432 and a different second outer diameter at distance
4434. An illustration of a balloon having a tapered profile is
shown in FIG. 39.
[0268] In accordance with embodiments, balloon 4420 may be formed
by various appropriate processes. For example, balloon 4420 may be
formed by injection molding a material, extruding a material,
solvent casting a material, or dip coating a material to form a
balloon. Moreover, it is contemplating that extruding may include
extruding a material such that balloon 4420 has a deflated outer
diameter in a range of between 0.5 mm and five mm in diameter. For
instance, material may be extruded such that balloon 4420 has a
deflated outer diameter of 1.5 mm, and a thickness sufficient to
reach an inflated outer diameter of nine mm at less than six
atmospheres of inflation pressure.
[0269] Furthermore, in embodiments, balloon 4420 may include one or
more of a silicone rubber; a polyurethane such as Pursil.TM., or
another biocompatible silicone polyether urethane; Pebax.TM. such
as polyether-block co-polyamide polymer, polyether-block anide;
diene polymers and their copolymers; isoprenes; neoprenes; diene;
styrene; butadienes; styreneisoprene-styrene block co-polymers;
styrene-butadiene-styrene co-polymers; partially or fully
crosslinked versions of these same polymers, such as a Kraton.TM.
(e.g., such as Kraton.TM. 1161K, which is a
styrene-isoprene-styrene tri-block co-polymer with 85% isoprene and
15% styrene), any styrene-isoprene-styrene tri-block co-polymer
with up to 100% isoprene and up to 50% styrene; unsaturated dienes,
their co-polymers and partially or fully crosslinked versions of
these same; and an aliphatic polymethane with polydimethyl siloxane
backbone. Note that for bondability of such polymers, one or more
functional groups may be chemically added to the polymer structure.
In particular, balloon 4420 may include one or more of a silicone
rubber, a Kraton.TM., and a styrene-isoprene-styrene tri-block
co-polymer treated with one or more of the following additives:
thiuram disulfide derivatives (R'R''N-(C=5)-S-S-(C=5)-NR''R''),
mercaptobenzothiazoles, amino-mercaptobenzothrazole (e.g, such as
to vulcanized a silicone rubber), sulfides, and azides. Therefore,
for example, balloon 4420 may include any of the materials listed
above, and may be treated with an additive such as by treating
balloon outer diameter 4428 with one or more of the additives
mentioned above.
[0270] Finally, in accordance with embodiments, outer diameter 4428
of balloon 4420 may be bonded to an inner diameter of a plurality
of fused layers of ePTFE. For example, FIG. 45 is a cross-section
view of a cannula and a lined ePTFE balloon. FIG. 45 shows balloon
4520 having a plurality of fused layers of ePTFE 4510 with inner
diameter 4538 of the ePTFE layers bonded to outer diameter 4428 of
balloon liner 4420. According to some embodiments, balloon liner
4420 described below as a liner for balloon 4520 may be balloon
4420 described above for FIG. 44, or any of balloons 308, 314, 510,
2112, 2204, 2250, 2547, 2647, 3047, 3147, 3522, 3604, 3704, 3804,
3947, 4004, 4520, 4820, 8810, 9510, 9110, 9210, 9310, 9910,
9920.
[0271] According to some embodiments, balloon 4520 may have a
property such that when inflated balloon 4520 will expand in size
to an outer diameter sufficient for occlusion of a blood vessel at
an inflation pressure (or at an inflation volume with respect to
balloon 8810 or apparatus 9700 or 9800 of FIGS. 75A-81) and less
than sufficient to cause an axial force on an inner diameter of the
blood vessel. For instance, FIG. 45 shows balloon 4520 inflated to
outer diameter D2 sufficient for occlusion of blood vessel 4490 at
inflation pressure PR, which is a pressure less than sufficient to
cause an axial force, such as a force in directions 4487, on inner
diameter 4492 of blood vessel 4490. Note that according to some
embodiments, a pressure less than sufficient to cause an axial
force, includes a pressure less than sufficient to cause an axial
force of more than 25 percent of the radial pressure caused by a
balloon on the inner diameter of a blood vessel.
[0272] More particularly, balloon 4520 may include a property such
that when inflated to volume V2, balloon 4520 will expand in size
to outer diameter D2 that is approximately inner diameter DV of
blood vessel 4490 at inflation pressure PR, which is a pressure
less than sufficient to exert an axial strain on blood vessel 4490
in directions 4487. Thus, balloon 4520 may be a high-compliance or
low-tension balloon, such as a balloon that expands radially and
longitudinally upon inflation or forms a plurality of radial outer
diameters during inflation and deflation, but does not form wings.
In addition, according to some embodiments, pressure PR may be a
pressure sufficient to cause balloon 4520 to occlude the blood
vessel without radially expanding the blood vessel.
[0273] In addition, in accordance with embodiments, fused layers of
ePTFE 4510 may include one or more layers of ePTFE windings. For
example, fused layers of ePTFE 4510 may include one or more layers
of ePTFE windings wound over each other in concentric, overlaying,
intersecting, or criss-cross patterns, wound according to a
process, such as is described below with respect to FIG. 46.
Specifically, an ePTFE winding may be one or more strips or ribbons
of ePTFE material greater in length than in width, where the width
of the material is less than or equal to the distance between
proximal coupling 4422 and distal coupling 4424 as shown in FIG.
45. Thus, windings of ePTFE material may be supplied from spools,
such as spools for storing or supplying ribbon, cloth material, or
tape. Also, it is contemplated that fused layers of ePTFE 4510, or
windings of ePTFE material may be porous or may include a property
such that the layers or windings of ePTFE do not stretch or have a
limited ability to stretch axially, or with respect to the width of
the fused layers of ePTFE or ePTFE windings. Thus, during inflation
or deflation, balloon 4520 may include a property such that fused
layers of ePTFE 4510 expand and contract radially but have no
substantial expansion or contraction axially. Note that according
to some embodiments, no substantial expansion or contraction
axially, includes not expanding or contracting axially in length by
a distance of more than 5 percent of the outer diameter distance of
the layers. For example, fused layers of ePTFE 4510 may expand and
retract in directions 4489 but have no substantial expansion
axially in directions 4487 as shown in FIG. 45. Moreover, for the
embodiment shown in FIG. 45, it is contemplated that balloon liner
4420 may expand and contract axially in directions 4487 as well as
radially in directions 4489.
[0274] Thus, according to some embodiments, balloon 4520 may have a
property to cause balloon 4520 to have a post-inflation deflated
outer diameter that retracts to within 20% of a pre-inflated outer
diameter of balloon 4520. Specifically, balloon liner 4420 may
cause balloon 4520 to retract when deflated to a post-inflated
deflated outer diameter DP that is approximately 440% greater than
the pre-inflated outer diameter DM of balloon 4520. Moreover,
balloon 4520 may include a property such that during inflation
outer radial surface 4528 of balloon 4520 is parallel to the axis
of cannula 4410, and surface 4528 expands radially in directions
4489 but has no substantial expansion axially in directions 4487,
or along a direction parallel to the axis of cannula 4410.
[0275] Similarly to balloon 4420 of FIG. 44, fused layers of ePTFE
4510 may include a property such that during inflation and
deflation, fused layers of ePTFE 4510 form a plurality of radial
outer diameters, such as diameters DM, D2, and DP, but do not form
wings. Also, balloon 4420 or balloon 4520 may include a property
such that inflated outer diameter D2 approximates an inner diameter
of a coronary sinus of a subject at a treatment region and may be
sufficient in diameter to make a pressure waveform of fluid in a
coronary sinus or blood vessel become ventricularized.
Specifically, balloon 4420 or balloon 4520 may have an outer
diameter D2 sufficient to make pressure waveform 4486 of fluid 4480
in blood vessel 4490 become ventricularized. It is also
contemplated that diameter D2 may be a diameter sufficient to
expand an inner diameter of a blood vessel without damaging or
bursting the blood vessel. In other embodiments, inflated outer
diameter D2 of balloon 4420 or balloon 4520 may expand inner
diameter DV of blood vessel 4490 sufficient to increase the
permeability of a wall of blood vessel 4490 to a treatment or
biological agent infused into the blood vessel proximate or
super-adjacent to the balloon (e.g., such as a treatment agent
described herein, infused at treatment region 4496).
[0276] In embodiments, balloon 4520 may have a pre-inflated outer
diameter between three mm and five mm at a pressure of between zero
and one atmosphere (e.g., such as approximately zero atmospheres),
and a balloon inflated outer diameter D2 between seven mm and
eleven mm inflation pressure PR, of between six and eight
atmospheres. Embodiments of balloon 4520 also include a balloon
having inflated outer diameter D2 in a range of between five mm and
nine mm in diameter at a pressure of less than six atmospheres.
[0277] Likewise, according to some embodiments, balloon 4420, or
balloon 4520 may have an outside diameter growth rate such as that
shown in FIG. 55. Specifically, for an inflation pressure between
two and six atmospheres, balloon 4420 or balloon 4520 may include a
property such that the balloon will inflate to increase in outer
diameter by at least 15% in diameter as compared to a prior outer
diameter, for each one atmosphere increase in inflation pressure.
Notably, the semi-linear relationship between outer diameter and
inflation pressure as shown in FIG. 55 for balloon 4420 or balloon
4520 allows a balloon to be calibrated to determine an amount or
volume of liquid, such as volumes V1 or V2, for providing a desired
inflation pressure, such as pressure PR. Thus, once a calibration
curve of inflation volume versus inflation pressure for a balloon
for various inflation volumes of liquid is created, it is possible
to select a desired inflation pressure and determine the amount or
volume of liquid required to provide that desired pressure. Then,
the balloon may be inserted into a subject, such as via
percutaneous insertion as described herein, and filled with the
predetermined volume of fluid to provide the desired inflation
pressure. Therefore, the various configurations of balloon 4420 or
balloon 4520 described herein can be used to occlude a blood
vessel, such as an artery or vein in the human heart as is
described herein. Furthermore, according to some embodiments,
cannula 4410 of FIGS. 44 and 45 may be a guide catheter, a delivery
catheter, or a guidewire, such as described herein.
[0278] In addition, according to some embodiments, various
appropriate processes may be used to form a lined ePTFE balloon or
an ePTFE composite balloon, such as balloon 4520. For example, FIG.
46 is a flow diagram of a process for forming a lined ePTFE
balloon. At block 4610, a balloon liner is formed, such as by
forming balloon 4420 as described above.
[0279] At block 4620, layers of ePTFE are wound onto a large
mandrel, such as by wrapping ePTFE windings, as described above,
around a mandrel having a diameter in a range of between 10 mm and
12 mm in diameter. According to some embodiments, the diameter of
the large mandrel may be selected to be a diameter that is in a
range between one mm and two mm larger than the desired diameter of
the lined ePTFE balloon when inflated. Specifically, for example, a
10 mm diameter large mandrel may be used when forming a lined ePTFE
balloon, such as balloon 4520, to have an inflated diameter D2 of 9
mm. Likewise, a mandrel of 11 mm may be used to produce a lined
ePTFE balloon having an inflated diameter of 12 mm.
[0280] In addition, according to some embodiments, the layers of
ePTFE may be formed by ePTFE windings, strips, or ribbons, such as
those described above for fused layers of ePTFE 4510. For instance,
windings of ePTFE material may be wound onto a large mandrel to
form multiple layers of ePTFE that overlay, intersect, are
concentric with, or criss-cross other windings or layers of ePTFE
in various patterns and at various angles. Thus, fused layers of
ePTFE 4510 may include one layer of ePTFE windings wound over
another layer of ePTFE windings such that the one layer of windings
forms an "X" pattern, a "W" pattern, a "S" pattern, or a
criss-cross pattern. For example, FIG. 47 is an elevated cut-away
view of layers of ePTFE windings. As shown in FIG. 47, first ePTFE
windings 4710 and 4712 are wound over second ePTFE windings 4720
and 4722, such that first ePTFE windings 4710 and 4712 are at an
angle, as shown by angle N of between 30.degree. and 120.degree.
with respect to second ePTFE windings 4720 and 4722. Specifically,
in FIG. 47, angle N is 90.degree.. However, it is contemplated that
angle N may be various other angles between 30.degree. and
120.degree. such as, an angle of 35.degree., an angle of
45.degree., an angle of 60.degree., an angle of 90.degree., or an
angle of 115.degree..
[0281] Besides winding ePTFE windings in various patterns to form
ePTFE layers, various numbers of ePTFE layers may be wound or
formed as necessary to ensure that there are enough layers to
ensure that the ePTFE layers or windings do not come apart or
separate (e.g., such as during inflation and deflation), but not so
many ePTFE windings or layers that expansion is inhibited beyond a
desired inflation diameter of expansion. For instance, when forming
plurality of fused ePTFE layers 4510, a sufficient number of ePTFE
layers may be wound or formed such that when balloon 4520 is
completed, fused ePTFE layers 4510 do not separate when ePTFE
balloon 4520 is inflated to inflation pressure PR of between 6 and
8 atmospheres in pressure. More particularly, as shown in FIG. 47,
a first ePTFE layer having first ePTFE windings 4710 and 4712 may
be formed over a second ePTFE layer having second ePTFE windings
4720 and 4722 to form balloon 4520 such that when balloon 4520 is
inflated first ePTFE windings 4710 and 4712 do not separate from
second ePTFE windings 4720 and 4722. Moreover, according to some
embodiments, sufficient ePTFE layers and windings may be provided
so that ePTFE layers or windings do not separate along seams, such
as seam 4730 between first ePTFE windings 4710 and 4712. Although
FIG. 47 shows only two ePTFE layers, it is contemplated that fused
ePTFE layers 4510 may include more than two layers, such as by
including three layers, four layers, five layers, six layers, seven
layers, or 10 layers. Thus, for instance, block 4620 may include
windings between two and six ePTFE layers in a single direction in
a "bandage" wrapped style so that seams between ePTFE windings in a
single layer are bonded or super-adjacent to each other.
[0282] At block 4630, layers or windings of ePTFE, such as from
block 4620, are fused together, such as by heating the layers or
windings wound onto the large mandrel. For instance, layers of
ePTFE wound onto a large mandrel may be heated at a temperature
between 350.degree. C. and 400.degree. C. for a duration of greater
than 10 minutes and less than 60 minutes, as necessary to sinter
the plurality of ePTFE layers or windings. Thus, plurality of fused
ePTFE windings 4510 may include windings such as first windings
4710 and 4712 wound over second windings 4720 and 4722 onto a large
mandrel and heated to a temperature of approximately 380.degree. C.
for a duration of between 20 and 30 minutes so as to fuse first
windings 4710 and 4712 to each other and to second windings 4720
and 4722. After fusing, fused ePTFE layers may be removed from the
large mandrel.
[0283] At block 4640, the fused layers of ePTFE are stretched onto
a small mandrel. For instance, a small mandrel may be placed within
an inner diameter of the fused ePTFE layers and the fused ePTFE
layers may then be stretch apart along the axis of the small
mandrel sufficiently so that the ePTFE layers are stretched onto,
touch, or conform to the small mandrel. Thus, a distal end and a
proximate end of the fused ePTFE layers may be gripped or connected
to and stretched apart in opposite directions until the fused
layers of ePTFE are stretched sufficiently as described above.
After the fused layers are sufficiently stretched, they may be
stabilized by heating. For example, the layers may be stabilized
over a set temperature and time, such as by heating to a
temperature of 380.degree. C. for a duration of between 30 seconds
and two minutes in duration (e.g., such as for approximately one
minute). Moreover, according to some embodiments, the outer
diameter of the small mandrel may be selected to be a diameter in a
range of between two mm and three mm larger than the desired
deflated diameter of a lined ePTFE balloon before inflation. For
example, the small mandrel may have an outer diameter between two
and three mm larger than deflated diameter DM of balloon 4520.
[0284] At block 4650, the stretched fused layers of ePTFE are
compacted axially, such as by being compacted in directions
opposite of directions 4487. For instance, fused layers of ePTFE
stretched onto a small mandrel may then have their outer diameter
wrapped with a TEFLON.TM. tape, a "plumbers" tape, or may be
constrained with a steel tube. Then the wrapped or constrained
layers of ePTFE may be compacted axially so that the wrapping or
constraining of their outer diameter controls expansion of the
outer diameter during compacting. For instance, according to some
embodiments, compacting includes sufficiently compacting axially
inwards (e.g., such as in directions opposite of directions 4487) a
distal end and a proximate end of the stretched fused layers of
ePTFE, such that during inflation of the lined ePTFE balloon (e.g.,
such as during inflation of balloon 4520 to inflation pressure PR),
the compacted stretched fused layers of ePTFE (e.g., such as fused
ePTFE layers 4510) may not expand axially (e.g., such as by being
incapable of expanding in directions 4487). Moreover, according to
some embodiments compacting may include sufficiently compacting
axially inwards a distal end and a proximate end of the compacted
stretched fuses of ePTFE such that during inflation of the lined
ePTFE balloon (e.g., such as described above) the compacted
stretched fused layers of ePTFE (e.g., such as fused ePTFE layers
4510) may expand axially (e.g., such as in directions 4487) by a
selected percentage of an axial size of the compacted stretched
fused layers of ePTFE, during inflation of the lined ePTFE balloon.
Hence, more particularly, the stretched fused layers of ePTFE may
be compacted sufficiently at block 4650 so that during inflation of
balloon 4520, fused ePTFE layers 4510 may expand axially in
directions 4487 by a selected percentage of the length of the
compacted stretched fused layers of ePTFE along the longitudinal
axis of the small mandrel.
[0285] Furthermore, according to some embodiments, compacting may
include compacting sufficiently to reduce the porosity of the
windings or layers of ePTFE. After compacting, it is contemplated
that the compacted stretched fused layers of ePTFE be stabilized
over a set temperature and time, such as is described above for
stabilizing the fused stretched layers of ePTFE with respect to
block 4640. After stabilizing the TEFLON.TM. tape, "plumbers" tape,
or tube may be removed from the ePTFE layers and the ePTFE layers
may be removed from the small mandrel.
[0286] Moreover, it is contemplated that the large mandrel or small
mandrel associated with blocks 4620 and 4640 may be tapered so that
the lined ePTFE balloon formed has a tapered profile, such that
when inflated, the balloon with expand in size to a first outer
diameter at a first position and a different second outer diameter
at a different second position. Thus, the large mandrel and the
small mandrel may be selected to have a tapered profile so that
ePTFE layers have a tapered profile and form lined ePTFE balloon
4520 that when inflated will expand in size to a first outer
diameter at first axial distance 4432 from distal end 4414 of the
cannula and will expand in size to a different second outer
diameter at different second axial distance 4434 from distal end
4414 of the cannula, such as to provide a tapered profile similar
to that shown in FIG. 39.
[0287] At block 4660, the layers of ePTFE may be bonded to a
balloon liner to form a lined ePTFE balloon, such as balloon 4520.
It can be appreciated that an inner diameter of the compacted
stretched fused layers of ePTFE may be chemically modified before
bonding to a balloon liner. Specifically, inner diameter 4538 of
ePTFE layers 4510 may be modified with a plasma polymerization of
acrylic acid or a chemical etch of sodium naphthalene before being
bonded to balloon 4420. Moreover, it is considered that bonding may
include vulcanizing an inner diameter of the compacted stretched
fused layers of ePTFE to a liner having an outer diameter of
silicone rubber material. Also, according to some embodiments,
bonding may include hydrogen bonding an inner diameter of the
compacted stretched fused layers of ePTFE with a balloon liner
having an outer diameter of polyurethane material.
[0288] Likewise, in embodiments, bonding may include bonding an
inner diameter of the compacted stretched fused layers of ePTFE
with a balloon liner having an outer diameter of material such as
materials described above for forming balloon 4420 or treated of
modified with additives, such as additives described above with
respect to balloon 4420. Specifically, chemical modifications to an
outer diameter of a balloon liner, such as balloon 4420, are
considered before bonding the balloon liner to the compacted
stretched fused layers of ePTFE.
[0289] According to various embodiments, the bonding at block 4660
may include inserting a balloon liner, such as balloon 4420, into
the inner diameter of the compacted stretched fused layers of
ePTFE, such as into inner diameter 4538 of fused layers of ePTFE
4510. Then, the outer diameter of the compacted stretched fused
layers of ePTFE, such as outer diameter 4528 may be constrained
with, for example, a TEFLON.TM. tape, a "plumbers" tape, or a steel
tube. Next, the balloon liner, such as balloon 4420, may be
inflated to cause an outer diameter of the balloon liner, such as
outer diameter 4428, to contact or bond to the inner diameter of
the constrained compacted stretched fused layers of ePTFE, such as
inner diameter 4538. For example, the balloon liner may be inflated
to an inflation pressure of between 10 and 50 psi, such as to
approximately 30 psi. Next, it is contemplated that the constrained
compacted stretched fused layers of ePTFE, such as layers of ePTFE
4510, may be heated sufficiently to bond the outer diameter of the
balloon liner, such as outer diameter 4428, to the inner diameter
of the compacted stretched fused layers of ePTFE, such as inner
diameter 4538. For example, the layers of ePTFE may be heated such
as described with respect to stabilizing the layers of ePTFE with
respect to block 4640.
[0290] After bonding the liner to the layers of ePTFE, the
constraining tape or steel tube can be removed and the resulting
lined ePTFE balloon can be attached to a cannula. For example, at
block 4670, lined ePTFE balloon 4520 may be attached to cannula
4410 such as by methods for attaching occlusion devices to a
cannula as described herein. Specifically, proximal end 4422 or
distal end 4424 of balloon 4420 or balloon 4520 may be attached to
cannula 4410 using one of an adhesive, a crimping bond, a laser
bond, and a heat bond, such as to bond proximal end 4422 or distal
end 4422 to surface 4416 of cannula 4410. Moreover, it is
contemplated that such bonding may include ultraviolet (UV) light
adhesive or UV thermal bonding. Finally, it is considered, that
cannula 4410 may be a cannula described herein, such as including a
guide catheter, delivery catheter, or guidewire.
[0291] Also, in embodiments, occlusion or filter devices 720, 2006,
2104, 4108, 4304 as described herein; balloons 308, 314, 510, 2112,
2204, 2250, 2547, 2647, 3047, 3147, 3522, 3604, 3704, 3804, 3947,
4004, 4420, 4520, 4820, 8810, 9510, 9110, 9210, 9310, 9910, 9920 as
described herein; and any other catheter, cannula, tube, sheath,
balloon or occlusion device, may be formed of material including a
polymer material, such as a polyurethane-silicone blend (e.g., for
example, PurSil.TM.), a homopolymer of an olefin, or a co-polymer
of an olefin and one or more other material(s). In various
embodiments, a filter device, catheter, cannula, tube, sheath, or
balloon or occlusion device., may have a coating applied to its
inside or outside surface, such as, for example, a hydrophilic
coating.
[0292] Additionally, in various embodiments, a filter device,
catheter, cannula, tube, sheath, balloon or occlusion device., may
be made of or include a material that minimizes allergic reactions
or provides improved control of expansion outer diameter during
inflation and deflation. For instance, such a balloon can be used
in a vessel having a diameter range of about four mm to about nine
mm diameter. Moreover, such a filter device, balloon, or occlusion
device may be designed or formed to have a larger distal outer
diameter and a smaller proximal outer diameter when inflated (e.g.,
be thicker distally in outer diameter when inflated and thinner
proximally). Specifically, such a filter device, balloon, or
occlusion device may have a conical shape.
[0293] In various embodiments, a balloon as mentioned herein may be
placed in a blood vessel, such as the coronary sinus or a cardiac
vein. For example, a balloon can be advanced to a location in the
great cardiac vein, a branch of the great cardiac vein, the middle
cardiac vein, the small cardiac vein, or a coronary artery. Thus,
the coronary sinus or the cardiac vein may be elastic in nature, so
the balloon may prevent vessel hematomas or occlusion of adjacent
coronary artery by functioning as a sealer, and not a dilator. In
various embodiments, the balloon is very compliant, achieving
occlusion at low pressure for a range of vessel sizes. For example,
a diameter of the coronary sinus may range from about 6.5 mm to
about 11 mm, a diameter of the great cardiac vein may range from
about 4.0 mm to about 7.5 mm, and the diameter of a branch of the
great cardiac vein may range from about 2.5 mm to about 5.0 mm.
[0294] It is also considered that a balloon may be placed in a
blood vessel, such as the coronary sinus or a cardiac vein. For
example, a balloon described herein may be advanced to a location
in the great cardiac vein, a branch of the great cardiac vein, the
middle cardiac vein, or the small cardiac vein, or a coronary
artery to occlude the vessel before the infusion or retro-infusion
of a fluid or treatment agent. In this embodiment, the balloon is
able to extend if the vessel is enlarged during the infusion or
retro-infusion and maintain occlusion of the vessel.
[0295] In some embodiments, a balloon may be made from or include
material such as a polyether block amide, a polyetheramide, and
mixtures thereof. Similarly, a balloon may be made from or include
a polymer having a structure of a regular linear chain of rigid
polyamide segments interspaced with flexible polyether segments. In
an embodiment, a balloon may be made from or include a polymer or a
mixture of two or more of the polymers having the tradename
PEBAX.RTM. (a registered trademark of ATOCHEM), for example Pebax
63D and 55D, or for example one or more PEBAX.RTM. polymers having
a Shore D hardness less than 70D. In an embodiment, a balloon as
described herein, such as for occluding a blood vessel may be made
from or include a polymer or a mixture of two or more of the
polymers represented by the formula:
##STR00001##
[0296] (Where PA represents a polyamide segment, and PEth
represents a polyether segment, and "n" represents an integer of at
least one.)
[0297] In an embodiment, a balloon to be inflated to a selected
inflation pressure or volume may occlude a blood vessel at a
pressure of about 0.5 to about five atmospheres. In another
embodiment, a balloon may achieve a growth rate greater than about
40% while maintaining a pressure below four atmospheres or even
below one atmosphere. Here, the balloon pressure is kept low
despite an increase in diameter because of the elasticity of the
balloon material. In an embodiment, the balloon may have an
expanded outer diameter between about 1.5 millimeters (mm) and
about 18 mm when inflated. Moreover, the balloon may have a double
wall thickness between about 0.0003 and about 0.0038 inches or a
minimum hoop strength of at least about 23,000 pounds per square
inch (psi). In another embodiment, the balloon may be either heat
bonded, laser bonded, shrink tube or wrap bonded, or attached with
an adhesive to a catheter, cannula, port, lumen, or tube as
described herein.
[0298] In some embodiments, a balloon or occlusion device, may be a
high compliance low pressure balloon. For example, FIG. 48 is a
cross section view of a cannula and a high compliance low pressure
balloon. As shown in FIG. 48, cannula 4810 (e.g., such as a cannula
having a dimension suitable for percutaneous advancement through a
blood vessel, such as advancement in direction 4885 through blood
vessel 4890), includes proximal end 4812, distal end 4814, and
exterior surface 4816. FIG. 48 also shows balloon 4820 axially
connected to exterior surface 4816 of cannula 4810, at or adjacent
distal end 4814. FIG. 48 shows cannula 4810 having diameter of
cannula DC, and balloon 4820 having minimal wing diameter DM, and
balloon outer first diameter D1. Blood vessel 4890 is shown having
diameter of vessel DV and fluid 4880 (e.g., such as blood or
treatment agent). Balloon 4820 may be a balloon, occlusion device,
or filter device such as described herein.
[0299] Furthermore, according to some embodiments, balloon 4820 may
include material or matter having a polymer moiety represented by
the formula
##STR00002##
[0300] wherein PA represents a polyamide moiety, and PEth
represents a polyether moiety, and "n" represents an integer of at
least one. In addition, according to some embodiments, balloon 4820
may include a thermoplastic blend copolymer material having one of
a polyether block amide resin moiety and a polyetheramide moiety.
In addition, according to some embodiments, balloon 4820 may be
restricted or restrained from expansion or inflation, such as by a
sheath (e.g., such as sheath 790 described above for FIGS. 7-10),
to have first diameter D1.
[0301] According to some embodiments, balloon 4820 may have a
property such that balloon 4820 will inflate, such as in directions
4886 and 4888 as a result of pressures 4830 and 4832 increasing
balloon first volume V1, to an inflated balloon outer second
diameter that will occlude a blood vessel. For example, FIG. 49A is
a cross sectional view of a cannula and a balloon inflated to
occlude a blood vessel. As shown in FIG. 49A, balloon 4820 is
inflated to second diameter D2 that will occlude blood vessel 4990,
such as by substantially preventing fluid 4980 from flowing in
blood vessel 4890 past balloon 4820 in direction 4985. Likewise,
FIG. 49A shows balloon 4820 inflated to have volume V2, and exert
pressure PR on an inner diameter of blood vessel 4890.
[0302] Consequently, according to some embodiments, balloon 4820
may include a property such that balloon 4820 can achieve a
volumetric expansion (e.g., such as by expanding from first volume
V1 to second volume V2) of greater than about 40% during inflation.
Specifically, balloon 4820 may have a property such that it may
inflate according to the growth rate chart of FIG. 55. Moreover,
balloon 4820 may be able to expand or inflate to an inflated outer
diameter, such as second diameter D2, between 1.5 millimeters and
18 millimeters in diameter. Likewise, according to some
embodiments, balloon 4820 may be inflated to second diameter D2 to
occlude blood vessel 4890 at a predetermined pressure, such as
pressure PR, of between 0.5 atmospheres and 5.0 atmospheres of
pressure. More particularly, balloon 4820 may include a property
such that it will inflate to a predetermined pressure, such as
pressure PR, sufficient to make a pressure waveform in a blood
vessel become ventricularized. For example, balloon 4820 may
inflate to a predetermined pressure to make a pressure waveform of
blood or fluid, such as fluid 4980, traveling in direction 4985
become ventricularized. Thus, balloon 4820 may be inflated to a
predetermined volume, such as second volume V2, or a predetermined
inflated outer diameter, such as second diameter D2.
[0303] Furthermore, balloon 4820 may have deflated a double wall
thickness between 0.0003 and 0.0038 inches in thickness. For
example, FIG. 49B may be a cross sectional view of FIG. 49A from
perspective "A", according to an embodiment. FIG. 49B shows single
wall thickness T of balloon 4820, wherein T is 1/2 of the double
wall thickness. Moreover, according to some embodiments, balloon
4820 may have a minimum hoop strength of at least about 23,000 psi
strength. Also, balloon 4820 may include a property such that the
balloon will have a durometer hardness of between 50 Shore D and 70
Shore D. Next, balloon 4820 may be axially connected to an exterior
surface of a cannula, such as cannula 4810, wherein the cannula may
be a guide cannula, a delivery cannula, or a guide wire as
described herein.
[0304] FIG. 49B also shows cannula 4810 having lumens 4912, 4914,
and 4940. Lumen 4912 may be a lumen such as lumen 1712 described
above for FIG. 17. Lumen 4914 may be a lumen such as lumen 1812
described above for FIG. 18. Lumen 4940 may be a lumen such as
lumen 1740 described above for FIG. 17. It is also considered any
of that lumens 4912, 4914, and 4940 may be similar to a guidewire
lumen, accessory lumen or pressure lumen as described herein.
[0305] According to some embodiments, balloon 4820 may include a
property such that the balloon will deflate, such as in directions
4986 and 4988 as a result of pressures 4930 and 4932 to reduce
second volume V2, to a post-inflated deflated balloon outer third
diameter. For example, FIG. 50 is a cross sectional view of a
cannula and a postinflated deflated balloon. As shown in FIG. 50,
balloon 4820 is postinflated deflated to third volume V3 and third
diameter D3. Specifically, balloon 4820 may be deflated to third
diameter D3 that will allow balloon 4820 to be withdrawn from a
blood vessel, such as withdrawn in direction 4985 from blood vessel
4890. Consequently, postinflated deflated volume of balloon 4820,
such as third volume V3 may be approximately equal to preinflated
volume of balloon 4820, such as volume V1.
[0306] Furthermore, according to some embodiments, balloon 4820 may
include a property such that it has at least three wings before
being inflated and after being deflated. For example, FIG. 51 may
be a cross sectional view of FIG. 48 from perspective "A",
according to an embodiment. FIG. 51 shows balloon 4820 having wings
4852, 4854, and 4856 before balloon 4820 being inflated. Moreover,
each wing has a wing length defined by the length of a line
extending within the wing along a medial axis of a cross-section of
the wing. For example, FIG. 51 shows wing 4852 having wing length
one WL1 defined by the length of a line extending within wing 4852
along a median access of a cross section of wing 4852, such as
shown by wing length one WL1 in FIG. 51.
[0307] In addition, balloon 4820 includes a property such that the
wings of balloon 4820 are subsumed into the outer diameter of
balloon 4820 when inflated. For example, FIG. 52 may be a cross
sectional view of FIG. 49A from perspective "A", according to an
embodiment. FIG. 52 shows balloon 4820 having outer balloon
diameter 5228 when inflated, and second diameter D2 which is
approximately equivalent to that of or at least equivalent to that
of an inner diameter of a blood vessel at a treatment region. Thus,
second diameter D2 may be approximately equivalent to or at least
equivalent to diameter of vessel DV of blood vessel 4890. Moreover,
according to some embodiments, second diameter D2 may be a diameter
sufficient to occlude a blood vessel, such as blood vessel
4890.
[0308] Further, balloon 4820 may include a property such that the
balloon will have at least three wings before being inflated and
after being deflated, wherein a pre-inflated wing length for each
wing is approximately equal to a post-inflated deflated wing length
for each wing. For example, FIG. 53 may be a cross sectional view
of FIG. 50 from perspective "A", according to an embodiment. FIG.
53 shows postinflated deflated wing length two WL2 of wing length
4852 being a wing length that is approximately equal to preinflated
wing length one WL1. Thus, although balloon 4820 is shown before
inflation in FIG. 49A and after being inflated and deflated in FIG.
53, the wing length of wing 4852 before inflation is approximately
equal to that for wing 4852 after being inflated and deflated.
[0309] However, according to some embodiments, balloon 4820 may
include a property such that an outer diameter point farthest away
from the access of cannula 4810 for each wing is approximately 30%
greater for the postinflated deflated wing than it is for the
preinflated wing. For example, FIG. 51 shows wing 4852 having outer
diameter point one P1 defined by a point of wing 4852 radially
farthest away from axis of the cannula AC, and wing diameter one
DW1 defined by a length of a straight line extending from axis of
cannula AC, radially out to the outer diameter point one P1.
Similarly, FIG. 53 shows wing 4852 after being inflated and
deflated having outer diameter point two P2 defined by a point of
the wing radially farthest away from axis of the cannula AC, and a
wing diameter two DW2 defined by a length of a straight line
extending from axis of the cannula AC, radially out to outer
diameter point two P2. Thus, according to some embodiments,
preinflated wing diameter DW1 for wing 4852 is approximately 30%
less than postinflated deflated wing diameter DW2 of wing 4852.
Hence, although the wing length for a postinflated deflated wing is
approximately equal to that of a preinflated wing, the wing
diameter for a postinflated deflated wing may be greater than that
for a preinflated wing, such as in a range between 10% and 50%
greater in wing diameter.
[0310] Therefore, the various configurations of balloon 4820 and
lumen 4810 described herein can be used to occlude a blood vessel,
such as by using a high compliance low pressure balloon for balloon
4820, as described above. For example, FIG. 54 is a flow diagram of
a process for using a balloon (e.g., such as any balloon or
occlusion device described herein, including embodiments of balloon
4820 described with respect to FIGS. 48-53 and views thereof) to
occlude a blood vessel (e.g., such as a process that may be used
with system controller 3080, or a treatment process for infusion of
a treatment agent into an artery or vein of a patient using
devices, apparatus, methods, or processes described herein (e.g.,
such as according to the process described with respect to FIG. 3,
19, 54, 55, 63, or 82). At block 5410 a cannula, such as cannula
4810, is advanced percutaneously through a blood vessel, such as
blood vessel 4890, wherein a balloon, such as balloon 4820, is
axially connected to an exterior surface of the cannula at or
adjacent the distal end of the cannula. It is contemplated that the
cannula may be advanced via a retrograde advancement, such as by
being pushed up a blood vessel with or against a flow of blood,
such as from one vessel into a smaller vessel to provide retrograde
infusion treatment. Specifically, the cannula may be advanced to a
treatment region such as a region in a coronary sinus or vein of a
subject (e.g., such as treatment region 4996).
[0311] At block 5420, the balloon is inflated to between 0.5
atmospheres and 5.0 atmospheres of pressure. For example, balloon
4820 may be inflated so that first diameter D1 is increased to
second diameter D2, as described above. Also, according to some
embodiments, balloon 4820 may be inflated by inflating to an
expansion pressure of between two atmospheres in pressure and six
atmospheres in pressure applied to an inner diameter of a blood
vessel, such as diameter of vessel DV, at a treatment region such
as region 4996. Moreover, according to some embodiments, balloon
4820 may be inflated to a predetermined volume (e.g., such as
volume V2), a predetermined second diameter in a range between four
millimeters and 17 millimeters in diameter (e.g., such as second
diameter D2), or a predetermined pressure of between 0.5
atmospheres and six atmospheres in pressure (e.g., such as pressure
PR).
[0312] At block 5430 the blood vessel is occluded. Specifically,
balloon 4820 may be inflated to expand first diameter D1 to second
diameter D2 until second diameter D2 approximates an inner diameter
of a coronary sinus or a coronary blood vessel of a subject at a
treatment region or until second diameter D2 is sufficient to make
a pressure waveform of fluid in the coronary sinus or coronary vein
become ventricularized, such as is described herein.
[0313] At block 5435 a treatment agent is delivered, such as to a
treatment region. For example, a treatment agent may include
infusion pellets, suspended cells, stem cells, microspheres, blood
cells, drugs, or various other appropriate liquids and materials as
described herein. Likewise, it is contemplated that such treatment
agents may be delivered to treatment region 4996, such as by being
delivered as part of or as all of liquid 4980. Note that it is
contemplated that balloon 4820 may be inflated or deflated using
fluids, including fluids described herein as a treatment agent.
[0314] At block 5440 the option of aspirating a treatment region is
provided. For example, treatment region 4996 may be aspirated such
as by a hole in distal end 4814 of cannula 4810 or via a hole
through exterior surface 4816 of cannula 4810 at distal end 4814.
Specifically, for instance, liquid 4980 may be aspirated as
described above with respect to hole 988 for FIG. 9. Thus, as shown
in FIG. 49, liquid 4980 in treatment region 4996 may optionally be
aspirated. It is contemplated that liquid 4980 may include a drug,
treatment agent, infusion pellets, suspended cells, stem cells,
microspheres, or various other appropriate liquids or materials as
mentioned herein.
[0315] At block 5450 balloon 4820 is deflated, such as described
herein. For example, balloon 4820 may be deflated to a post
inflation deflation volume, such as third volume V3, approximately
equal to a preinflated volume, such as first volume V1, of balloon
4820.
[0316] At block 5460 cannula 4810 may be retracted, such as to
withdraw balloon 4820 back out of vessel 4890 and out of the
subject.
[0317] FIG. 55, illustrates a balloon outside diameter growth rate,
such as for an occlusion or filter device (e.g., including devices
720, 2006, 2104, 4108, 4304 as described herein), a balloon (e.g.,
such as balloons 308, 314, 510, 2112, 2204, 2250, 2547, 2647, 3047,
3147, 3522, 3604, 3704, 3804, 3947, 4004, 4420, 4520, 4820, 8810,
9510, 9110, 9210, 9310, 9910, 9920 as described herein), or other
balloons or occlusion devices.). For instance, FIG. 55 may show the
outside diameter growth rate 5510 for an eight mm balloon starting
with the uninflated outside diameter, and growing to the balloon's
inflated outer diameter, where the growth rate is plotted as a
function of inflation pressure 5520. FIG. 55 shows a balloon with a
growth rate or elasticity of about 25% at a pressure of about two
atmospheres. In another embodiment, a balloon may have a growth
rate or elasticity of about 40% at a pressure of about 3.5
atmospheres.
[0318] In various embodiments, balloon outer diameter sizing (e.g.,
such as to occlude a blood vessel with a balloon.) is controlled by
monitoring factors including venous pressure waveform changes
distal to the balloon. For instance, inflation of the balloon may
be continued until a waveform becomes ventricularized.
[0319] FIG. 56 illustrates a graph showing pressure distal to a
balloon 6510 in a blood vessel as a function of time 6520 (e.g.,
such as the pressure at treatment region 996 to be infused with a
treatment agent, where the treatment region may be distal to, or
proximal to a balloon occluding a blood vessel.). It is to be
appreciated that the process related to FIG. 56 may be a process
that may be used with a system controller (e.g., such as a system
controller that may access a memory including machine readable
instructions, such as system controller 3080), or a treatment
process for infusion of a treatment agent into an artery or vein of
a patient using devices, apparatus, methods, or processes described
herein (e.g., such as according to the process described with
respect to FIG. 3, 19, 54, 55, 63, or 82). Reference numeral 6501
illustrates time t1 during which a catheters or cannula is advance
percutaneously so that a distal end of the catheter or cannula can
be located in the coronary sinus or another vessel.
[0320] Reference numeral 5602 corresponds to time t2 during which a
balloon, such is inflated to occlude the coronary sinus or another
blood vessel. The coronary sinus or other blood vessel may be
occluded, for example by inflating an occluding balloon or device
until the coronary sinus or other blood vessel has a pressure
waveform that becomes ventricularized.
[0321] Reference numeral 5603, corresponding to time t3 during
which a treatment agent, such as described herein, is infused or
introduced into the blood vessel and increases the pressure in the
vessel to a relatively higher pressure distal to the balloons (or
at treatment region 996).
[0322] At the conclusion of the infusion period, t3, time t4
referred to by reference numeral 5604, is a period of time where
the pressure distal to the balloon is a lower pressure following
infusion, even though the coronary sinus or other vessel is still
occluded by a balloons or occlusion device.
[0323] Reference numeral 5605, refers to time t5, during which the
occluding balloon or device is deflated, and the catheter or
cannula may be removed so that the perfusion (e.g., such as
according to the process described with respect to FIG. 82) or flow
of blood or treatment agent can resume in the coronary sinus or
another vessel.
[0324] In various embodiments, the plot illustrated in FIG. 56
allows for an efficient treatment agent or drug infusion from a
vein or artery to tissue to be treated with the possibility of
"hands-off" operation. In various embodiments, when the pressure
waveform changes to a "ventricularized" waveform of venous
pressure, a balloon-sizing indicator notifies the operator or
control system to stop balloon inflation. After balloon inflation
has been stopped, a pressure sensor can measure the infusion
pressure needed for an effective therapeutic dosage of a liquid
containing a treatment agent. Infusion of a treatment agent can be
accomplished with auto-infusion with a controller (e.g., such as
controller 3080), or by an operator manually (e.g., such as by
apparatus 9700 or 9800 of FIGS. 75A-81).
[0325] Suitable treatment agents to be used with catheters or
cannula include a liquid carrying one or more treatment agents. In
another embodiment, a treatment agent or liquid includes one or
more drugs or treatment agents, such as is used to prevent
reperfusion injury. For instance, according to some embodiments, a
treatment agent may be or include a liquid having one or more
antibodies, for example, the antibodies against CD 11/18,
P-selectin, L-selectin, ICAM, or VCAM. In another embodiment, the
liquid includes IGF-I, estrogen, or GIK solution. In another
embodiment, the liquid includes drugs like adenosine or its
isoforms, Na/H exchangers, or Na/K exchangers. In another
embodiment, the liquid can include cells, for example,
cardiomyocites or multi-potent or ologo-potent cells like stem
cells or progenitor cells. Also, the liquid may include angiogenic
cells, or other types of structural cells like skeletal or smooth
muscle cells. In another embodiment the liquid includes biological
agents or genes, for example, VEGF, FGF, or HGF. In another
embodiment, liquid includes one or more of the following: Calpain
I, insulin, adenosine, antioxidants, glutathione peroxidase,
vitamin E (alpha tocopherol), Na+-H+ exchange inhibitors,
caroporide (HOE 642), agents that open K.sub.ATP channels, nitric
oxide (NO), endothelin receptor antagonists, tetrahydrobiopterin,
statins, sevoflurane, propofol, pinacidil, morphine, verapamil, and
blends or mixtures thereof.
[0326] In an embodiment, a pressure increasing device may be
attached to fitting 2632 at proximal end 2626 of catheter 2620
(e.g., see FIGS. 26-29, and fitting 3032 at proximal end 3026 of
catheter 3020 of FIG. 30) to deliver a liquid that is or includes a
treatment agent., through delivery lumen and to a blood vessel,
such as at treatment region 996 (e.g., such as via a catheter,
cannula, or deliver lumen as described herein). In various
embodiments, the pressure increasing device is a syringe. In
embodiments, the pressure increasing device may be a pump (which
may or may not include one or more syringes). For example, the
pressure increasing device can be a centrifugal pump, a
reciprocating pump, or a gear pump. In various embodiments, the
pump is able to achieve a low flow rate at a high pressure. One
suitable pump is illustrated in FIG. 57. Centrifugal pump 5700
includes inlet 5702 and outlet 5704 so that the fluid flows as
marked by arrow 5706. Pump 5700 has pump housing 5708 to contain
fluid and rotor 5710 which has impeller 5712 attached. In various
embodiments, impeller 5712 rotates to create a centrifugal force to
force fluid from inlet 5702 to outlet 5704 as shown by arrow 5706.
Pump 5700 also includes stator 5714 which has winding 5716
attached. In various embodiments, rotor 5710 is removably connected
to stator 5714, and there is no direct mechanical connection
between stator 5714 and rotor 5710. In various embodiments, rotor
5710 and impeller 5712 are driven by a magnetic force generated by
winding 5716. In various embodiments, rotor 5710 and pump housing
5708 are disposable, while stator 5714 and winding 5716 are not
disposable. In another embodiment, the fluid flows through inlet
5702 to outlet 5704, which fluid path is sterilized, while stator
5714 and winding 5716 are not sterilized. It is considered that a
suitable pump can be a disposable infusion pump or a
magnetically-levitated centrifugal pump with a disposable rotor
chamber.
[0327] In another embodiment, a suitable pressure increasing device
is illustrated in FIG. 58. Pump 5800 includes handle 5820 with
batteries 5809, and activator button 5810. Connected to handle 5820
is body 5830 of pump 5800. Body 5830 includes pressure measurement
connection 5808, micro-controller 5805, and motor driver chip 5812.
Pump 5800 also includes attachment 5832 with motor 5804, motor
coupler 5803, where coupler 5803 is connected to lead screw 5802.
Lead screw 5802 is fed into non-rotating threaded coupling 5824, so
that when motor 5804 is activated, rotational force and motion from
motor 5804 is transferred through coupler 5803 to lead screw 5802
to advance or retract non-rotating threaded coupling 5824,
depending on the direction of rotation. Non-rotating threaded
coupling 5824 is attached to plunger 5801, so that when
non-rotating threaded coupling 5824 moves, plunger 5801 also moves.
Plunger 5801 can move distally to make reservoir 5814 smaller, or
proximally to make reservoir 5814 larger. At the distal end of
reservoir 5814 is nozzle 5816 attached to outlet 5818.
[0328] In operation, user (not shown) may activate pump 5800 by
pressing button 5810. Pressing button 5810 causes micro-controller
5805 to activate, which in turn activates motor driver chip 5812
which sends a current from batteries 5809 to motor 5804. This
causes motor 5804 to rotate, sending a rotational motion and force
through coupler 5803 to lead screw 5802. Rotating lead screw 5802
causes non-rotating threaded coupling and plunger 5801 to advance
or retract, depending on the rotation of motor 5804 and lead screw
5802. Advancing plunger 5801 causes an increase in pressure and a
decrease in volume in reservoir 5814 causing fluid or gas stored in
reservoir 5814 to be forced through nozzle 5816 and into outlet
5818. In various embodiments, to maintain a suitable pressure,
pressure feedback from the patient may be received into pump 5800
through pressure measurement connection 5808, which pressure
information is fed to micro-controller 5805, which activates motor
driver chip 5812, to activate motor 5804 to increase pressure, or
to deactivate motor 5804 to allow pressure to drop, or to reverse
the direction of motor 5804 to decrease pressure.
[0329] Another suitable pressure increasing device is illustrated
in FIG. 59. Pump 5900 includes handle 5920 having batteries 5909,
and activation button 5910. Handle 5920 is connected to body 5930,
which includes pressure measurement connection 5908, motor driver
chip 5912, and micro-controller 5905. Connected to body 5930 is
attachment 5932 with motor 5904, coupler 5903, and lead screw 5902.
Lead screw 5902 feeds into non-rotating threaded coupling 5924,
which is attached to syringe or abutted against head 5940. Syringe
5922 is located in a suitably shaped opening, the distal end of
handle 5932, and includes syringe head 5940, plunger 5901,
reservoir 5914, and nozzle 5916. Nozzle 5916 feeds into outlet
5918. In another embodiment, syringe 5922 may be disposable and
thrown away after each treatment. In another embodiment, syringe
5922 may be removed and cleaned or sterilized before the next
treatment. In some embodiments, the pump, such as pump 5900 may
have multiple syringes with different treatment agents.
[0330] In operation, pump 5900 may be activated by a user (not
shown) by button 5910, which activates micro-controller 5905, which
activates motor driver chip 5912, which in turn activates motor
5904, by sending a current from batteries 5909 to motor 5904. Motor
5904 rotates coupler 5903, which rotates lead screw 5902 to advance
or retract non-rotating threaded coupling 5924, which serves to
advance or retract syringe head 5940, respectively. If syringe head
5940 is advanced, plunger 5901 is also advanced towards the distal
end of handle 5932 which serves to increase the pressure and
decrease the volume of reservoir 5914, which forces fluid or gas
stored in reservoir 5914 through nozzle 5916 and into outlet 5918.
If syringe head 5940 is pulled towards proximal end of handle 5932,
then the pressure in reservoir 5914 is lowered, and the volume in
reservoir 5914 is increased, and fluid may be pulled from outlet
5918 through nozzle 5916 and into reservoir 5914. In various
embodiments, a pressure measurement from the patient may be
delivered into pump 5900 through pressure measurement connection
5908, which information is fed to micro-controller 5905 then into
motor driver chip 5912 which is used to control motor 5904 to
advance or retract syringe head 5940 to raise or lower pressure in
reservoir 5914, respectively.
[0331] Referring now to FIG. 60, there is illustrated a suitable
pressure transferring device. Pressure transferring device 6000
includes fluid inlet 6002, and fluid outlet 6004. Plunger 6006 is
located in device 6000, which plunger 6006 serves to separate inlet
reservoir 6008 from outlet reservoir 6010. As a fluid is pumped
into inlet 6002, fluid enters inlet reservoir 6008 and exerts a
force upon plunger 6006. This forces plunger 6006 distally, which
increases the pressure and lowers the volume of outlet reservoir
6010, which forces the fluid in outlet reservoir 6010 into outlet
6004. Conversely, when a fluid is forced into outlet 6004 and into
outlet reservoir 6010, it exerts a force on plunger 6006, and
forces plunger 6006 proximally, which increases the pressure and
lowers the volume of inlet reservoir 6008 and forces the fluid in
inlet reservoir 6008 into inlet 6002. Device 6000 serves to
equalize the pressures in inlet 6002 and inlet reservoir 6008, with
the pressures in outlet 6004 and outlet reservoir 6010. Device 6000
may be used immediately before a catheter, so that a relatively
expensive treatment agent can be placed in outlet reservoir 6010
and outlet 6004, while a relatively inexpensive liquid, for example
a saline solution or water, can be placed in inlet reservoir 6008
and inlet 6002, with a pump (not shown) or other pressure
increasing device connected to inlet 6002.
[0332] Referring now to FIG. 61, is a pressure-maintaining or
dampening device 6100. Device 6100 has inlet 6102 and outlet 6104.
Inside device 6100 is plunger 6106 which serves to seal fluid into
pressure reservoir 6112. As fluid flows from inlet 6102 into
pressure reservoir 6112, the fluid exerts a force on plunger 6106
which compresses spring 6108, until the force exerted by spring
6108 equals the force exerted by the fluid in pressure reservoir
6112 on plunger 6106. When the fluid stops flowing from inlet 6102
into pressure reservoir 6112, there will be a fluid flow provided
to outlet 6104 as plunger 6106 is forced down by compressed spring
6108, decreasing the size of fluid reservoir 6112. This downward
movement of plunger 6106 continues until pressure in pressure
reservoir 6112 equals downward pressure exerted by spring 6108. In
another embodiment, spring adjusting device 6110 may be provided to
adjust the tension of spring 6108, so that more or less force is
required to compress spring 6108.
[0333] Referring now to FIG. 62, is a pressure-maintaining or
dampening device 6200, with inlet 6202 and outlet 6204. As fluid
flows through inlet 6202 and into pressure reservoir 6212, the
fluid causes reservoir 6212 to force walls 6208 of device 6200
outwards until the inward force exerted by walls 6208 equals the
outward force exerted by fluid in pressure reservoir 6212. When the
fluid flow through inlet 6202 stops, fluid flow to outlet 6204
continues until force exerted by walls 6208 equals force exerted by
fluid in pressure reservoir 6212. Walls 6208 may be made of a
flexible material, for example rubber. Materials and thickness of
walls 6208 may be adjusted so that an appropriate pressure may be
maintained within fluid reservoir 6212.
[0334] Referring now to FIG. 63, is a flow diagram of a process or
method of treating a patient, in accordance with an embodiment.
First, a vein is accessed 6302 by a catheter, for example, the
exterior femoral vein, the interior femoral vein, carotid, jugular,
brachial, subclavian, or saphalic vein is accessed by distal end of
a guide catheter. Coronary sinus 6304 is accessed with a guide
catheter through either the inferior vena cava or superior vena
cava. Venogram 6306 is performed through the guide catheter to
visualize coronary sinus or great cardiac vein. Deployment of
guidewire and retroinfusion balloon catheter 6308 into the coronary
sinus through the guide catheter. Venogram 6310 to visualize distal
venus anatomy. Navigation of infusion catheter over guidewire 6312
to a target location. Measurement of baseline parameters 6314, for
example, pressure, flow, oxygen saturation, pH, or temperature at
the target location. Inflate balloon 6316 to occlude coronary sinus
or other vessel where balloon catheter has been placed, for example
the target location. Perform blush score 6318, an optional step to
determine blush pressure. Set infusion parameters 6320, for
example, absolute pressure, differential pressure, blush pressure,
dosage, or flow rate. Start infusion 6322. Optional measuring of
infusion parameters and feedback to a controller. Stop infusion
6324 when set parameters are satisfied. Hold balloon inflated 6326
for a period of time to allow uptake or saturation. Deflate balloon
6328. Remove catheter, guide catheter or guidewire, from vessel
6330.
[0335] Note that it is contemplated that the process described
above with respect to FIG. 63, any or all of the pressure
increasing devices, pumps, pressure transfer devices, or pressure
maintaining devices described herein may be controlled manually,
automatically, or by a machine, such as by system controller 3080,
or according to a treatment process for infusion of a treatment
agent into an artery or vein of a patient using devices, apparatus,
methods, or processes described herein (e.g., such as according to
the process described with respect to FIG. 3, 19, 54, 55, or
82).
[0336] In another embodiment, a catheter may be used to locally
administer a treatment or therapeutic agent. Copending U.S.
Application having Ser. No. 10/246,249 filed on Sep. 18, 2002
discloses suitable treatment agents and suitable methods of
administering the treatment agents. Copending U.S. Application
having Ser. No. 10/246,249 filed on Sep. 18, 2002 is herein
incorporated by reference in its entirety. U.S. Pat. No. 6,346,098,
issued to Yock et al., discloses a suitable method of locally
administering a treatment agent. U.S. Pat. No. 6,346,098, issued to
Yock et al., is herein incorporated by reference in its
entirety.
[0337] Note that all embodiments of devices, apparatus, methods, or
processes described herein are contemplated to include treatment
including by one or more balloons, occlusion devices, or filter
devices (e.g., such as balloon 2647, 3147, 3522, 3947, 2547, 3047,
3604, 3704, 3804, 4004, 308, 2204, 2250, 2112, 314, 510, 4420,
4520, 4620, 4820, 8810, 9510, 9110, 9210, 9310, 9910, 9920, or
other balloons or occlusion devices.) that may have an outer
diameter that is volume controlled (e.g., see balloon 8810) or
pressure controlled (e.g., see balloons 4520, 4620, and 4820) to
expand to, occlude, or filter fluid in a blood vessel (e.g., such
as an artery or vein of a human being). For example, an outer
diameter may be volume controlled by controlling the amount of
inflation volume of a gas (e.g., such as air, carbon dioxide, or a
gas having a fluoroscopy contrast agent) or a liquid (e.g., such as
water, saline solution, or a fluid having a fluoroscopy contrast
agent) used to inflate the occlusion device. Specifically, an
inflation volume may be incrementally increased by a selected
volume amount over a range of total inflation volume to cause the
outer diameter of an occlusion balloon to incrementally increase by
a predictable amount for each incremental increase in volume. Thus,
equal or unequal incremental increases in inflation volume can be
used to cause equal or unequal increases in occlusion device outer
diameter, over a desired total diameter range.
[0338] For instance, according to some embodiments, additional
inflation fluid volume does not increase pressure because the high
compliance balloon grows in outer diameter. Furthermore, according
to some embodiments, when the outer diameter reaches a constraint,
such as the inner diameter of a blood vessel as described herein,
the balloon has a property, dimension, or is configured such that
additional inflation fluid volume does not increase pressure or
force in a direction perpendicular to the outer diameter (e.g.,
such as in a direction towards the inner diameter of the blood
vessel), because the high compliance balloon grows in an axial
direction within the blood vessel. It is also contemplated that
when the outer diameter of the balloon reaches a constraint,
additional inflation fluid volume will increase pressure or force
in a direction perpendicular to the outer diameter of the balloon,
but not appreciably. Specifically, in accordance with an
embodiment, additional inflation fluid volume will increase
pressure or force in a direction perpendicular to the outer
diameter of the balloon by a non appreciable amount, such as by
between zero and 10 percent increase in pressure (e.g., where the
pressure in a direction perpendicular to the outer diameter of the
balloon may be equal to the inflation pressure within the
balloon).
[0339] For example, FIG. 64A is a cross sectional view of a cannula
and a balloon. FIG. 64A shows apparatus 8800 having cannula 8802
with a dimension suitable for percutaneous advancement through a
blood vessel (e.g., such as blood vessel 990 mentioned herein) and
having a cannula proximal end (not shown, but such as proximal end
9504 shown and described with respect to FIGS. 69A-F) and distal
end 8806. FIG. 64B is a cross-sectional view of apparatus 8800 of
FIG. 64A from perspective "A". Cannula 8802 may be a cannula
similar to cannula 710 or any other catheter or cannula. FIGS. 64A
and B also show cannula 8802 having diameter CRD such as a diameter
for a guide catheter, delivery catheter, or guidewire catheter as
described herein. Balloon 8810 is axially attached to exterior
surface 8808 at or adjacent distal end 8806 of cannula 8802 at
proximal attachment 8809 and distal attachment 8811. Balloon 8810
may be a balloon such as a balloon or occlusion device as described
herein.
[0340] According to some embodiments, balloon 8810 may have a
property such that when inflated to a plurality of selected
increasing inflation volumes, balloon 8810 forms a plurality of
predictably increasing radial outer diameters, and has an inflation
pressure that increases by less than five percent in pressure while
being inflated to the plurality of selected increasing inflation
volumes.
[0341] Moreover, balloon 8810 may be is adapted to inflate to an
outer diameter in a range of about 2 mm to about 20 mm, such as to
occlude a blood vessel having an inner diameter in a range of
between 1.5 mm and 19.5 mm. Specifically, balloon 8810 may selected
or inflated by a sufficient inflation volume or pressure to inflate
to an outer diameter approximately 0.5 mm greater than the inner
diameter of the blood vessel it is to occlude. Thus, balloon 8810
may inflate to an outer diameter of about 2 mm to occlude a blood
vessel having an inner diameter of about 1.5 mm, and may inflate to
an outer diameter of about 20 mm to occlude a blood vessel having
an inner diameter of about 19.5 mm.
[0342] Also shown in FIGS. 64A and B, balloon 8810 has first
diameter BRD1, first length BRL1, first inflation volume BRV1 and
first inflation pressure BRP1. According to some embodiments first
length BRL1 may be a selected preinflated length greater than two
millimeters in length, such as a length of between two millimeters
and 30 millimeters, (e.g., including first length BRL1 equal to
three millimeters, between five and six millimeters, between eight
and 10 millimeters, between five and 10 millimeters, or greater
than 30 millimeters in length). In addition, first diameter BRD1
may be a preinflated outer diameter of between 0.25 inches and 0.65
inches in diameter (e.g., such as first diameter BRD1 of 0.44
inches) that inflates to expand to an outer diameter of 18
millimeter when inflated without bursting or permanently deforming.
Next, balloon 8810 may have a preinflated single wall thickness of
between 0.001 inches and 0.02 inches in thickness (e.g., such as a
wall thickness of 0.003 inches) at a preinflation pressure below
one atmosphere in pressure, such as a preinflation pressure of zero
atmosphere.
[0343] FIG. 65A shows the balloon and cannula of FIG. 64A, with the
balloon inflated to a second inflation volume. FIG. 65B is a
cross-sectional view of apparatus 8800 of FIG. 65A from perspective
"A". FIGS. 65A and B show balloon 8810 inflated to second inflation
volume BRV2, second inflation pressure BRP2, second length BRL2,
and second diameter BRD2. For example, second inflation volume BRV2
may be one of a plurality of selected increasing inflation volumes
to cause balloon 8810 to form a second predictably increasing
radial outer diameter, second diameter BRD2, and to have a second
inflation pressure, BRP2 that may or may not be less than five
percent greater than first inflation pressure BRP1.
[0344] FIG. 66A shows the cannula and balloon of FIG. 65A, with the
balloon inflated to a third inflation volume. FIG. 66B is a
cross-sectional view of apparatus 8800 of FIG. 66A from perspective
"A". Balloon 8810 is inflated to third inflation volume BRV3, third
inflation pressure BRP3, third length BRL3, and third diameter
BRD3. For example, FIGS. 66A and B show balloon 8810 inflated to a
selected increasing third inflation volume BRV3 to form predictably
increasing radial outer diameter third diameter BRD3 and having
third inflation pressure BRP3 that may increase by less than five
percent in pressure as compared to second inflation pressure
BRP2.
[0345] Thus, according to some embodiments, balloon 8810 may be
inflated with a plurality of selected increasing inflation volumes
increasing from zero to 2.0 cubic centimeters. In some cases,
balloon 8810 may be inflated with a plurality of selected
increasing inflation volumes that including increasing inflation
volume from 0.05 cubic centimeters to 0.2 cubic centimeters by
steps of additional controlled volumes in increments of between
0.005 cubic centimeters in volume and 0.05 cubic centimeters in
volume (e.g., such as 0.01 cubic centimeters in volume), to form a
plurality of predictably increasing outer diameters that increase
to an outer diameter between 1.25 millimeters and 18 millimeters in
diameter, by steps of between 0.2 millimeters and 0.4 millimeters
increase in diameter. For instance, balloon 8810 may be inflated by
selected increasing inflation volumes to cause the outer diameter
to increase to a plurality of predictably increasing outer
diameters that are equally spaced increments in diameter between
0.2 millimeters and 0.4 millimeters, such as to increase outer
diameter by 0.25 millimeters for each selected increasing inflation
volume until balloon 8810 is inflated to an outer diameter
sufficient to occlude a blood vessel. It is also considered that
balloon 8810 may be inflated with an inflation pressure of between
0.5 atmospheres and six atmospheres in pressure, such as to reach a
sufficient outer diameter to occlude a blood vessel. Additionally,
FIGS. 66A and B show balloon 8810 having third diameter BRD3 which
may or may not be sufficient to occlude blood vessel 990 at
treatment region 996.
[0346] FIG. 67A shows the cannula and balloon of FIG. 66A, with the
balloon inflated to a selected fourth inflation volume. FIG. 67B is
a cross-sectional view of apparatus 8800 of FIG. 67A from
perspective "A". Here, balloon 8810 is inflated to fourth inflation
volume BRV4, fourth inflation pressure BRP4, fourth length BRL4,
and fourth diameter BRD4. For example, FIGS. 67A and B show balloon
8810 inflated to a selected increasing fourth inflation volume BRV4
to form a predictably increasing fourth outer diameter BRD4 and to
have a fourth inflation pressure BRP4 that may be greater than
first inflation pressure BRP1, second inflation pressure BRP2, or
third inflation pressure BRP3 by less than five percent in
pressure. Thus, balloon 8810 may be inflated to fourth inflation
volume BRV4 sufficient to cause fourth inflation pressure BRP4 to
allow balloon 8810 to occlude blood vessel 990 at treatment region
996, such as to occlude a flow or volume of fluid such as blood or
treatment agent from passing through blood vessel 990 past balloon
8810 in directions 8860. According to some embodiments, fourth
inflation volume BRV4 may be a total inflation volume of gas or
fluid up to 2.0 cubic centimeters, such as a volume of between 0.03
cubic centimeters and 0.4 cubic centimeters (e.g., where inflation
volume, such as fourth inflation volume BRV4 may be a total
inflation volume of gas or fluid within balloon 8810, and does not
include any gas or fluid within cannula 8802, or within a lumen, a
tube, an inflation lumen, a catheter, a shaft, or other structure
related to inflating balloon 8810 extending within cannula 8802 or
within balloon 8810).
[0347] In addition, fourth inflation pressure BRP4 may be an
inflation pressure of between one atmosphere and six atmosphere in
pressure, such as a pressure between three atmosphere and four
atmosphere, or between four atmosphere and five atmosphere in
pressure. Note, fourth inflation pressure BRP4 may be within five
percent of any of inflation pressures BRP1 through BRP3, thus any
of inflation pressures BRP1 through BRP3 may also be between one
atmosphere and six atmosphere in pressure, or may in fact be equal
to fourth inflation pressure BRP4. Further, according to some
embodiments, BRP3 or BRP4 may be a pressure sufficient to occlude
the blood vessel without radially expanding the blood vessel
appreciable, such as by expanding the blood vessel by less than
five or ten percent in outer diameter.
[0348] Also, according to some embodiments, balloon 8810 may
include a property such that when inflated to a first inflation
volume (e.g., such as third inflation volume BRV3) balloon 8810 has
a first inflated axial length (e.g., such as third length BRL3) and
an outer diameter (e.g., such as third diameter BRD3) of the
balloon exerts a first inflation pressure (e.g., such as third
inflation pressure BRP3) on an inner diameter of a blood vessel
(e.g., such as blood vessel 990) sufficient to occlude the blood
vessel at a treatment region (e.g., such as treatment region 996).
Moreover, when inflated to a second greater inflation volume (e.g.,
such as fourth inflation volume BRV4) balloon 8810 has a second
inflated axial length (e.g., such as fourth length BRL4) that is
sufficiently greater than the first inflated axial length (e.g.,
such as third length BRL3) to allow the outer diameter of the
balloon (e.g., fourth diameter BRD4) of the balloon to exert a
second inflation pressure (e.g., such as fourth inflation pressure
BRP4) on the inner diameter of the blood vessel (e.g., such as
blood vessel 990) that is less than appreciable, such as by being
less than five percent greater than the first inflated pressure
(e.g., such as third inflation pressure BRP3). Specifically, as
shown in FIGS. 67A and B, when balloon 8810 is inflated to fourth
inflation volume BRV4, instead of growing to fifth inflation
diameter BRD5, balloon 8810 is constrained by the inner diameter of
blood vessel 990 and only grows to fourth diameter BRD4 (e.g.,
where fourth diameter BRD4 is a diameter that may be within five or
10 percent of third diameter BRD3). Hence, for balloon 8810 to
retain fourth inflation pressure BRP4 equal to or within five
percent of third inflation pressure BRP3, instead of balloon 8810
growing in diameter to fifth diameter BRD5, the balloon grows
axially in length to fourth length BRL4, which is greater than
third length BRL3, and which is greater than first length BRL1 by
BRLI1 plus BRLI2.
[0349] To design a balloon that limits fourth inflation pressure
BRP4 as described above consideration or selection of the following
may be made: a deflated length of the balloon, a target inflated
outer diameter of the balloon, the diameter and characteristics of
the cannula, deflated balloon diameter, balloon wall thickness,
type of inflation gas or liquid, type of balloon material,
diameters of the plurality of predictably increasing radial balloon
outer diameters, volumes of the plurality of selected increasing
balloon inflation volumes, inner diameter of the blood vessel at
the treatment region, blood or fluid flow pressure in the blood
vessel proximate to the balloon, inflation pressure of the balloon
during occlusion, actual outer diameter of the balloon in the blood
vessel during occlusion, and other appropriate considerations such
as those described herein.
[0350] For instance, first length BRL1 may be selected between
eight and 10 millimeters in length for a balloon to have a final
radial outer diameter of 3.25 millimeters (e.g., such as if fourth
diameter BRD4 were equal to 3.25 millimeters). Similarly, a first
length BRL1 of between five and six millimeters may be selected for
a balloon to have a final radial outer diameter of 4.25 millimeters
(e.g., such as a fourth diameter BRD4 of 4.25 millimeters). Also,
in an embodiment, balloon 8810 may have a preinflated outer
diameter (e.g., such as first diameter BRD1) of between one
millimeter and three millimeters in diameter, and inflated outer
diameter (e.g., such as fourth diameter BRD4) of between four
millimeters and seven millimeters at an inflation pressure (e.g.,
such as fourth inflation pressure BRP4) of between three atmosphere
and four atmosphere in pressure, while having an inflated axial
length that increases with increasing inflation volume (e.g., such
as third length BRL3 increasing to fourth length BRL4 with third
inflation volume BRV3 increasing to fourth inflation volume BRV4)
to allow the balloon to occlude a blood vessel (e.g., such as blood
vessel 990) while the balloon inflated outer diameter (e.g., such
as fourth diameter BRD4) maintains an inflation pressure (e.g.,
such as fourth inflation pressure BRP4) of between three atmosphere
and four atmosphere pressure on an inner diameter of the blood
vessel (e.g., such as on an inner diameter of blood vessel 990 at
treatment region 996).
[0351] Furthermore, balloon 8810 may be designed to inflate by
select increasing inflation volumes to a total inflation volume
which is greater than, or oversized as compared to, an inner
diameter of a blood vessel, such as by being greater than an inner
diameter of a blood vessel by a selected diameter. Specifically,
referring to FIGS. 67A and B, it is possible to inflate balloon
8810 to a plurality of selected increasing inflation volumes up to
third volume BRV3 and then to increase the inflation volume to
fourth volume BRV4 to target fifth diameter BRD5 which is greater
than the inner diameter of blood vessel 990 by oversized diameters
8870 plus 8872. For example, oversized diameters 8870 plus 8872 may
add to be a diameter distance in a range of between 0.1 millimeters
and one millimeter in diameter distance, such as by totaling to be
0.25 millimeters in diameter.
[0352] Examples of balloon 8810 contemplated include a balloon
having an inflated outer diameter (e.g., such as fourth diameter
BRD4) of between 1.25 millimeters and 12 millimeters in diameter
(e.g., such as if fourth diameter BRD4 were between four
millimeters and seven millimeters in diameter), and an inflated
length that increases in inflated length by a total length of up to
15 millimeters (e.g., such as by increasing by a total increased
length of BRLI1 plus BRLI2). Specifically, in accordance with
embodiments, balloon 8810 may having an inflated length that
increases in inflated length by a total length that is inversely
proportional to the preinflated length of the balloon. For
instance, as shown in FIGS. 64A-67B, balloon 8810 may increase by a
total increased length of BRLI1 plus BRLI2 of 0.5 mm for a balloon
preinflated first length, BRL1 of eight mm (e.g., here, BRL4 is 8.5
mm), and increase by a total increased length of BRLI1 plus BRLI2
of 0.25 mm for a balloon preinflated first length, BRL1 of 10 mm
(e.g., here, BRL4 is 10.25 mm) It is also contemplated that
examples of balloon 8810 may have a wall thickness that decreases
by between 10 percent and 75 percent in thickness, at an inflation
pressure (e.g., such as fourth inflation pressure BRP4) of between
three atmosphere and four atmosphere in pressure.
[0353] In a second example balloon 8810 may have first diameter
BRD1 of 1.3 millimeters at first inflation pressure BRP1 below one
atmosphere in pressure, and fourth diameter BRD4 between four
millimeters and seven millimeters at fourth inflation pressure BRP4
of between three atmosphere and four atmosphere in pressure.
Specifically, in this case, balloon 8810 may have an inner diameter
of 0.044 inches and a wall thickness of 0.003 inches when deflated,
such as when at first inflation volume BRV1.
[0354] In another instance, balloon 8810 may have first diameter
BRD1 of 1.3 millimeters and be designed to expand to fifth diameter
BRD5 of 14 millimeters when inflated to fourth inflation pressure
BRP4 of between one and six atmosphere in pressure, without balloon
8810 bursting or permanently deforming. In other words, balloon
8810 may expand to several times its original diameter under low
pressure (e.g., such as fourth inflation pressure BRP4 of less than
six atmosphere in pressure) and then return to its original low
profile dimension upon inflation volume release (e.g., such as by
returning to first diameter BRD1 upon reducing inflation volume
from fourth inflation volume BRV4 to first inflation volume BRV1).
Thus, balloon 8810 may return to almost its original size upon or
after deflation. For example, after inflation, balloon 8810 may
return to an outer diameter that is within 10 percent of its
preinflated diameter (e.g., such as within 10 percent of first
diameter BRD1), an axial length within 10 percent of its
preinflated axial length (e.g., such as within 10 percent of first
length BRL1), and a wall thickness of within five percent of its
preinflated wall thickness. Additionally, according to some
embodiments, balloon 8810 may include a property such that during
deflation it forms a plurality of decreasing radial outer
diameters, such as by forming radial outer diameters third diameter
BRD3, second diameter BRD2, and first diameter BRD1 during
deflation from fourth inflation volume BRV4 back down to first
inflation volume BRV1.
[0355] Furthermore, according to some embodiments, balloon 8810 may
be made of or include a balloon material having one or more of a
block copolymer of polyether and polyester (e.g., such as a
polyester sold under the trademark Hytrel.RTM. of DUPONT COMPANY),
a biocompatible polymer such as a polyether block amide resin
(e.g., for instance, PEBAX.RTM. of ATOCHEM CORPORATION), a styrene
isoprene styrene (SIS), styrene butadiene styrene (SBS), styrene
ethylene butylene styrene (SEBS), polyetherurethane, ethyl
propylene, ethylene vinyl acetate (EVA), ethylene methacrylic acid,
ethylene methyl acrylate, and ethylene methyl acrylate acrylic
acid. It is also contemplated that balloon 8810 may include a
material from a material family of one of styrenic block copolymers
and polyurethanes; or a melt processible polymer. Balloon 8810 may
also include a low durometer material, such as a material to allow
the walls or outer diameter of balloon 8810 to gently occlude a
blood vessel during infusion of therapeutic agents such as stem
cells, genes, adenovirus, progenitor cells, and other treatment
agents as described herein.
[0356] It is to be appreciated that balloon 8810 may be formed by
melt extruding a material, such as balloon material described
above, into a tube to form a balloon, and then bonding the balloon
or tube to a cannula, such as a catheter or cannula 8802. For
example, a balloon or tube as described above can be bonded by
laser, heat, shrink tube, or adhesive bonding to a catheter or
cannula. Specifically, according to some embodiments, a tube or
balloon may be shrink tube bonded to cannula 8802 such as at
proximal attachment 8809 and distal attachment 8811 so that
exterior surface of balloon 8810 forms symmetrical shapes with
respect to an axis of cannula 8802 when balloon 8810 is inflated
over a range of inflation volumes. For example, shrink tube bonding
may be used to bond balloon 8810 to cannula 8802 so that when the
balloon is inflated from first inflation volume BRV1 to fourth
inflation volume BRV4, balloon 8810 forms a plurality of
symmetrical shapes, such as first shape 8820, second shape 8822,
third shape 8824, and fourth shape 8826 during inflation. More
particularly, such shrink tube bonding may include an even or
straight perpendicular radial bond of a balloon or balloon tube to
a cannula with respect to an axis of the cannula to effect a
symmetrical inflation of the balloon over a range of selected
inflation volumes as mentioned herein. Hence, cannula 8802 may
function as one or more of a guide catheter, a delivery catheter,
and a guidewire catheter; while balloon 8810 may inflate to expand
in size to an outer diameter in a range of between one millimeter
and 15 millimeters in diameter, such as to occlude a blood vessel
injuring treatment infusion to a treatment region of the blood
vessel.
[0357] According to some embodiments, a balloon high compliance
balloon, such as balloon 8810, may be heat bonded, laser bonded,
shrink tube bonded, or attached with an adhesive to a cannula, such
as cannula 8802 (e.g., or cannula 9502 as shown in FIGS. 69A-70 and
described in accompanying text, or a catheter as describe herein).
Specifically, a balloon (e.g., such as any balloon, occlusion
device or filter device as described herein) may be shrink tube
bonded to a cannula so that the balloon exterior surface inflates
to symmetrical shape with respect to an axis of the cannula. For
instance, shrink tube bonding may provide and even and straight
bond of a balloon tube to a cannula with respect to an axis of the
cannula to effect such symmetrical inflation of the balloon over a
range of inflation volumes as mentioned herein.
[0358] Hence, a balloon may have a balloon outer diameter growth
rate that changes in correlation to a percentage change in the
inflation volume of gas or fluid (e.g., such as fluoroscopy
contrast media) within the balloon. For instance, it is possible to
design a high compliance balloon formed of a material and by a
process as described herein, having a length of between two
millimeters and 20 millimeters, and a double wall thickness between
about 0.0003 inches and about 0.0038 inches, such that an outer
diameter of the balloon can inflate from one millimeter when
deflated to 18 millimeters when inflated without bursting or
permanently deforming.
[0359] Specifically, a high compliance balloon formed of PEBAX 63D
can be designed to have a deflated outer diameter and length to
achieve a growth rate greater than about 40% while maintaining an
inflation pressure that increases by less than five percent. For
instance, FIG. 68 is a graph showing the relationship between the
outer diameter of a balloon and the volume of inflation contrast
fluid injected into the balloon. Here, FIG. 68 plots outer diameter
of the balloon 8881 versus volume of inflation contrast fluid
injected into the balloon 8882 for a 4.0 millimeter outer diameter
by 10 millimeter long balloon of PEBAX 63D operating at an
inflation pressure below four atmospheres.
[0360] Note that although FIGS. 64A-68 show and the related
discussion describes inflating balloon 8810 with selected inflation
volumes to occlude a blood vessel, it can be appreciated that a
balloon (e.g., including balloon 8810) may be designed by a process
or of the materials described herein and may have a dimension,
characteristic, deflated outer diameter, or deflated length, such
that the outer diameter of the balloon may be inflation pressure
controlled. More particularly, a balloon may be designed by a
process or of the materials described herein to have an outer
diameter that can be controlled by controlling the amount of
inflation pressure of a gas (e.g., such as air, carbon dioxide, or
a gas having a fluoroscopy contrast agent) or a liquid (e.g., such
as water, saline solution, or a fluid having a fluoroscopy contrast
agent) used to inflate the balloon. Again, such a balloon may be
used as an occlusion device.
[0361] Hence, a balloon (e.g., such as balloon 8810) can be used
with a cannula or catheter (e.g., such as cannula 8802) that has a
dimension suitable for percutaneous advancement through a blood
vessel to infuse a treatment agent (e.g., such as biological
agents) into a treatment region, such as arterial vessels or venous
vessels. For example, FIG. 69A is a side perspective view of a
cannula having a balloon attached to its distal end and an infusion
lumen and accessory lumen running through the cannula. FIG. 69A
shows apparatus 9500 having cannula 9502 with proximal end 9504 and
distal end 9506. Cannula 9502 may be a cannula or catheter such as
a cannula similar to cannula 710 or any of the various other guide,
delivery, or guidewire catheters or cannulas described herein. For
instance, cannula 9502 may be include materials as described above
for catheter 302 or 512, such as may one or more of a synthetic or
natural latex or rubber, such as a polymer material; a
polyetheramide; a plasticiser free thermoplastic elastomer; a
thermoplastic blend; a block copolymer of polyether and polyester;
a biocompatible polymer such as a polyether block amide resin; a
polycarbonate or acrylonitrile bubadiene styrene (ABS); a
biocompatible polymer such as a polyether block amide resin; a
styrene isoprene styrene (SIS), a styrene butadiene styrene (SBS),
a styrene ethylene butylene styrene (SEBS), a polyetherurethane, an
ethyl propylene, an ethylene vinyl acetate (EVA), an ethylene
methacrylic acid, an ethylene methyl acrylate, an ethylene methyl
acrylate acrylic acid, a material from a material family of one of
styrenic block copolymers and polyurethanes, a melt processible
polymer, a low durometer material, and nylon.
[0362] Balloon 9510 is axially connected to exterior surface 9508
of cannula 9502 at proximal coupling 9509 and distal coupling 9511,
at or adjacent distal end 9506. Balloon 9510 may be a balloon,
occlusion device, or filter device such as balloon 2647, 3147,
3522, 3947, 2547, 3047, 3604, 3704, 3804, 4004, 308, 2204, 2250,
2112, 314, 4520, 4620, 4820, 8810, or other balloons or occlusion
devices. For example, balloon 9510 may be a balloon including a
property such that when inflated to a selected inflation volume the
balloon will expand in size to an outer diameter sufficient to
occlude a blood vessel as described herein. In one example, balloon
9510 may be a high-compliance balloon made of a low durometer
material or it may function similarly to balloon 8810 as described
herein.
[0363] In addition, cannula 9502 may have infusion lumen 9520
extending from proximal end 9504 to distal end 9506 and exiting
infusion opening 9522 distal to balloon 9510. Furthermore, cannula
9502 may also include accessory lumen 9530 extending from proximal
end 9504 to distal end 9506 and exiting accessory opening 9532
distal to balloon 9510.
[0364] Thus, according to some embodiments, infusion lumen 9520 or
accessory lumen 9530 may be adapted to have a guidewire, such as
guidewire 9533 disposed therethrough to guide cannula 9502 through
a blood vessel (e.g., such as blood vessel 990) to a treatment
region (e.g., such as treatment region 996). For instance, infusion
lumen 9520 or accessory lumen 9530 may be adapted to have a
guidewire disposed therethrough to guide cannula 9502 to a location
in a blood vessel with respect to delivery catheter 310 as shown
and described with respect to FIG. 3, cannula 720 as shown and
described with respect to FIGS. 7-19, or cannula 9902-9904 as shown
and described with respect to FIGS. 86-89. More particularly
cannula 9502 may have a dimension or profile compatible with or
suitable to be received within, or be slidably disposed within a
guide catheter (e.g., such as a guide catheter or cannula as
described herein, including guide catheter 302) having an outer
diameter in a range of between 5 French and 9 French. It is also
contemplated that cannula 9502 may have a dimension suitable for
percutaneous advancement through a blood vessel such as blood
vessel 990.
[0365] FIG. 69B is a cross section view of first section 9556 of
apparatus 9500 of FIG. 69A from perspective "A". FIG. 69B shows
cannula 9502 having outer diameter COD1 less than 0.09 inches. It
is also contemplated that cannula 9502 may include a shaft having
an outer diameter which is less than 0.06 inches in diameter. FIG.
69B also shows accessory lumen 9530 having inner diameter ALID1 and
infusion lumen 9520 having inner diameter ILID1. According to some
embodiments inner diameter ALID1 may be less than inner diameter
ILID1. In addition, it is contemplated that infusion lumen 9520 may
have inner diameter ILID1 greater than 0.01 inches in diameter.
[0366] Also, accessory lumen 9530 may have an inner diameter that
is greater than between 0.01 inches and 0.5 inches in diameter,
such as an inner diameter capable of accommodating a guidewire
having a diameter of at least 0.01 inches. Furthermore, lumen 9530
may be used to infuse a treatment agent to a treatment region, or
to aspirate fluids from a treatment region (e.g., see hole 988 of
FIG. 9 and accompanying text).
[0367] It is also contemplated that accessory lumen 9530 may have a
dimension suitable to allow for several usages including continuous
guidewire access during an infusion process to maintain the
location of cannula 9502, to monitor pressure distal to balloon
9510, to allow for accessibility of other accessories to a location
distal to balloon 9510. For example, accessory lumen 9530 may allow
for accessibility of a flow and pressure wire to measure distal
flow and pressure, or other types of sensor wires to make
measurements in a location of a blood vessel distal to balloon
9510. Specifically, accessory lumen 9530 may have a dimension
suitable to allow a device to be connected to a proximal end of the
accessory lumen, such as at proximal access lumen port 9554, or for
a device to be disposed through accessory lumen 9530 to measure one
of chronic renal failure (CRF), electrocardiogram (EKG), oxygen
level, pressure, flow, blood sampling, or temperature, such as at
treatment region 996. Moreover, it is contemplated that accessory
lumen 9530 may be used to measure or to receive a device to measure
various other physiological parameters, such as at treatment region
996 distal to balloon 9510.
[0368] According to some embodiments infusion lumen 9520 or
accessory lumen 9530 may each include a surrounding material,
sleeve, cannula or lumen, such as by being constructed with
composite tube. For example, the composite tube may include a braid
or coil reinforced polyamide or polymer tube. Thus, infusion lumen
9520 or accessory lumen 9530 may include a reinforced tube, to
prevent catheter or lumen (e.g., such as lumen 9502) kinking. Note,
that composite accessory or infusion lumen such as described above
with respect to balloon section 9511, third section 9558 and fourth
section 9559 also help maintain lumen roundness.
[0369] Infusion lumen 9520 or accessory lumen 9530 may be adapted
to receive a guidewire or have a guidewire disposed therein and
exiting a proximal opening at proximal end 9506 (e.g., such as
opening 9532 or opening 9522), so that cannula 9502 can be used in
an over-the-wire fashion, or have the guidewire removed therefrom.
It is also considered that infusion lumen 9520 or accessory lumen
9530 may have a proximal opening, such as port 9554 or 9552 located
proximal to balloon 9510 and within 35 centimeters of the distal
end of cannula 9502 such that cannula 9502 can be used in rapid
exchange fashion.
[0370] FIG. 69C is a cross sectional view of second section 9557 of
apparatus 9500 of FIG. 69A from perspective "B". FIG. 69C shows
second section 9557 of cannula 9502 having width CW1 between 0.03
inches and 0.05 inches, such as a width of 0.04 inches. FIG. 69C
also shows cannula 9502 having height CHI between 0.04 inches and
0.06 inches, such as a height of 0.055 inches.
[0371] FIG. 69D is a cross sectional view of balloon section 9511
of FIG. 69A from perspective "C". FIG. 69D shows balloon 9510
including a property such that when inflated to inflation volume
BIV1, such as a selected inflation volume, the balloon will expand
in size to outer diameter BOD1 sufficient to occlude a blood
vessel. For example, balloon 9510 may include a property such that
the balloon has inflation pressure BPI1 of less than five
atmospheres in pressure at inflation volume BIV1.
[0372] Moreover, according to some embodiments balloon 9510 may
have a property such that when inflated to a plurality of
increasing inflation volumes, the balloon forms a plurality of
increasing radial outer diameters, and has an inflation pressure
that increases by less than five percent in pressure over the range
of the increasing inflation volumes. For example, FIG. 70 is a
cross sectional view of the balloon section of FIG. 69A from
perspective "C", with the balloon inflated to a second volume that
is less than that shown in FIG. 69D. FIG. 70 shows balloon section
9511 after balloon 9510 inflated with inflation volume BIV2 which
is less than volume BIV1 to form radial outer diameter BOD2 which
is less than BOD1. Thus, although the inflation volume of balloon
9510 can be increased from inflation volume BIV2 to BIV1, the
inflation pressure of balloon 9510 may increase from pressure BPI2
to pressure BPI1, where pressure BPI1 is less than 105% of BPI2 in
pressure. For example, balloon 9510 may be a balloon that expands
in size to an outer diameter, such as diameter BOD1, in a range of
between one millimeter and 15 millimeters in diameter, controlled
by volume injection, such as to inject volumes BIV2 and BIV1 of a
gas or a fluid.
[0373] Cannula 9502 may further include balloon inflation lumen
9540 extending from proximal end 9504 to balloon 9510 and exiting
and inflation opening (not shown) within balloon 9510. Balloon
inflation lumen 9540 and the inflation opening may have a diameter
sufficient to inflate and deflate balloon 9510 as described herein,
such as by having a diameter of between 0.01 inches and 0.02 inches
in diameter. Also, infusion lumen 9520 may have an inner diameter
that is at least 0.015 inches in diameter. In addition, balloon
inflation lumen 9540 may be connected to an inflation device or
syringe to inflate balloon 9510 as described herein.
[0374] It is also to be appreciated that cannula 9502 may include
additional cannula or lumen extending through cannula 9502, such as
from proximal end 9504 to distal end 9506, or otherwise as
described herein. Moreover, according to some embodiments, each of
infusion lumen 9520, accessory lumen 9530, inflation lumen 9540, or
other lumen described herein may include or have its own sleeving,
cannula, or other surrounding material or structure having a
dimension to fit within the surrounding cannula in which the lumen
is disposed or extending through. For example, each of infusion
lumen 9520, accessory lumen 9530, and inflation lumen 9540 may
include an independent sleeve of material extending through cannula
9502 (e.g., such as by fitting within cannula 9502 and restricted
to the dimension of cannula 9502 as described herein) and function
with that sleeving.
[0375] In addition, as shown in FIG. 69A, accessory lumen 9530 may
extend first length LL1, infusion lumen 9520 may extend second
length LL2 and inflation lumen may extend third length LL3 in
distance beyond or out of proximal end 9504, where at least one of
the first length LL1, second length LL2, or third length LL3 is a
different distance in length than at least one of the others. Also,
it is to be appreciated that accessory lumen 9530 being of a
dimension suitable to infuse a first volume of treatment agent to a
treatment region (e.g., such as treatment region 996) and to ask
for a second volume of blood and treatment agent from the treatment
region. Similarly balloon inflation lumen 9540 may have a dimension
suitable to inflate balloon 9510 with a volume of (e.g., such as
volume BIV1) a gas or liquid to an inflation pressure (such as
inflation pressure BPI1) of less than 6 atmospheres and maintain
the inflation volume or inflation pressure for at least 4
minutes.
[0376] As shown in FIG. 69A cannula 9502 may have luer adaptor 9550
at or attached to proximal end 9504. Thus, accessory lumen 9530,
infusion lumen 9520, or inflation lumen 9540 may extend through
luer adaptor 9550 or be attached to luer adaptor 9550 at proximal
end 9504. It is also considered that luer adaptor 9550 may include
proximal end of access lumen 9534, proximal end of inflation lumen
9544, or proximal end of infusion lumen 9524. Correspondingly,
proximal end of access lumen 9534 may end with proximal access
lumen port 9554, proximal end of inflation lumen 9544 may end with
balloon inflation port 9553. Luer adaptor 9550 may include a port,
such as proximal access lumen, port 9554 to connect to a hemastatic
valve. Furthermore, proximal end of inflation lumen 9524 may end
with proximal infusion port 9552, such as a port having a spring
loaded pressure seal. Also, balloon inflation port 9553 may be a
port to have an inflation device or syringe attached thereto as
described herein. Some embodiments of inflation device or syringes
contemplated for use with apparatus 9500 are discussed herein with
respect to apparatus 9700 and 9800 of FIGS. 75A-81. For instance,
an inflation device or syringe attached to balloon inflation port
9553 may include a label on its surface such as to identify a
purpose or information related to the device or syringe.
[0377] According to some embodiments luer adaptor may have a
dimension suitable to allow a first volume of treatment agent to be
infused to a treatment region, to allow a second volume of blood
and treatment agent to be aspirated from the treatment region
(e.g., see hole 988 of FIG. 9 and accompanying text), and to allow
a volume of a gas or fluid to inflate balloon 9510 to a pressure,
such as BPI1, of less than six atmospheres, and to maintain the
inflation volume (e.g., such as BVI1) for at least four
minutes.
[0378] FIG. 69E is a cross sectional view of third section 9558 of
FIG. 69A from perspective "D". FIG. 69E shows third section 9558 of
cannula 9502 having second width CW2 of between 0.035 inches and
0.055 inches, such as having a width of 0.048 inches. FIG. 69E also
shows cannula 9502 having a second height CH2 of between 0.05 and
0.065 inches, such as a height of 0.057 inches. For instance,
according to some embodiments, third section 9558 may be a section
that extends from a proximal end of balloon 9510 to a distal end of
balloon 9510, such as a balloon shaft. More particularly, third
section 9558 may include balloon section 9511, and may have a
profile that is taller or wider than second section 9557, such as a
profile shown in FIG. 69E resulting from third section 9558
including balloon 9510.
[0379] FIG. 69F is a cross section view of fourth section 9559 of
FIG. 69A from perspective "E". FIG. 69F shows fourth section 9559
having third width CW3 of between 0.03 inches and 0.045 inches,
such as having a width of 0.037 inches. FIG. 69F also shows fourth
section 9559 having third height CH3 of between 0.05 inches and
0.065 inches such as having a height of 0.057 inches. According to
some embodiments, balloon inflation lumen 9540 does not extend into
either third section 9558 or fourth section 9559.
[0380] For example, the distal end of cannula 9502 may have a soft
tip having a plurality of compliant tubes, lumen, sub-cannula with
extended portions extending past the distal end of the cannula,
where the extended portions are bound together by a compliant
material wrap. Specifically, for example, as shown in fourth
section 9559 of FIGS. 69A and 69F, infusion lumen 9520 or accessory
lumen 9530 may be joined to or joined by a soft tube made with a
polymer material that is bondable to the infusion or accessory
lumen tube. Moreover, the polymer may have a lower hardness
Durometer than either the tube of infusion lumen 9520 or the tube
of accessory lumen 9530. In addition, the soft section described
above may be further wrapped with another soft jacket wrapping over
the soft tubes to form the tip of cannula 9502. It is contemplated
that all the joining and wrapping described above may be performed
with laser bonding, heat melting, or adhesive gluing.
[0381] Also, according to some embodiments, cannula 9502 may have
support mandrel 9560 disposed within the cannula and exiting or
ending at proximal end 9504 and extending proximal to, within the
length of, or distal to balloon 9510. Specifically, mandrel 9560
may extend to balloon 9510 such as shown by balloon section 9511
and may or may not extend past balloon 9510, such as shown by third
cross section 958. Thus, mandrel 9560 may extend through third
section 9558 to support apparatus 9500 through the third section,
where exterior surface 9508 or cannula 9502 may not exist through
the third section. It is also contemplated that support mandrel
9560 may have a partial length, such as beginning at proximal end
9504 or beginning distal to proximal end 9504 and extending to the
midpoint between proximal end 9504 and distal end 9506, a point
along first section 9556, or a point along second section 9557. In
addition, as a marker band, shrink wrap, infused material, extruded
material, laser-bonded material, heat-bonded material, or other
material or wrap may be used to couple, attach, or connect mandrel
9560, accessory lumen 9530, or infusion lumen 9520 within balloon
section 9511. For example, as described below, a radio-opaque
marker band, material infused from third section 9558, or material
that is included in third section 9558 may extend through a portion
or all of balloon section 9511 to connected together or be a part
of inflation lumen 9540, accessory lumen 9530, infusion lumen 9520,
or support mandrel 9560.
[0382] It is also considered that where materials described above
with respect to third section 9558 extend into balloon section
9511, materials included in or used to form fourth section 9559 may
also exist or form components of the structure within balloon
section 9511 or third section 9558 as described herein.
[0383] Moreover, according to some embodiments, mandrel 9560 may
have various cross-sectional shapes, such as a circle, oval,
square, rectangle, or other polygon or curved cross-sectional shape
as mandrel 9560 extends through cannula 9502. For example, mandrel
9560 may have outer diameter MOD1 which is constant, or which
reduces with extension of the mandrel from proximal end 9504 toward
distal end 9506. For example, mandrel 9560 may have a constant
outer diameter MOD1 of less than 0.017 inches in diameter.
Alternately, mandrel 9560 may have proximal outer diameter MOD1
that begins with less than 0.017 inches at proximal end 9504 and
steps down to a plurality of lesser outer diameters that end with a
distal diameter of the MOD2 between 0.012 inches and 0.003 inches
in diameter such as shown in FIG. 70.
[0384] In addition, it is contemplated that support mandrel 9560
may be anchored or attached to a proximal adaptor such as luer
adaptor 9550, cannula 9502 at proximal end 9504, as well as cannula
9502 within the length of balloon 9510, such as where the balloon
is connected to the exterior surface of the cannula. It is also
contemplated that support mandrel 9510 may only be attached at one
or none of the locations identified above.
[0385] Support mandrel 9560 may be used to add stiffness to or
reinforce catheter 9520, such as to prevent the catheter from
kinking. Support mandrel 9560 may include one or more of titanium,
nickel-titanium (NiTi), stainless steel, a plastic, a polymer, a
polyether block amide resin having a durometer hardness of about 50
to about 70 shore D, a polyimide, a polyethylene, or other suitable
materials or metals, such as those having a sufficient stiffness to
pre-vent the cannula from kinking. For example, support mandrel
9560 may extend from proximal end 9504 to a location distal to
proximal coupling 9517 to prevent or reduce the possibility of
cannula 9502 from kinking when the cannula is not supported by a
guidewire, such as is a guidewire used during insertion of cannula
9502 is removed from accessory lumen 9530 and accessory lumen 9530
is used to monitor parameters at a treatment region.
[0386] Note that material coupling infusion lumen 9520, accessory
lumen 9530, mandrel 9560, or inflation lumen 9540 in balloon
section 9511 may also be coupled to or may include cannula 9502,
such as in embodiments where cannula 9502 extends through balloon
section 9511. It may be appreciated that one or more marker bands,
polymer sheaths, on other materials may be mounted around all
tubes, mandrel, lumens, or cannula running through balloon 9510, or
can be mounted over single components thereof. Thus, if a marker
band is mounted over a single component, a polymer sheath may be
added to bundle together more than one of the components identified
above, such as within the length of balloon 9510. Specifically, a
polymer sheath may bundle together cannula 9502, inflation lumen
9540, mandrel 9560, or accessory lumen 9530 at a point along the
length of balloon 9510 (e.g., such as where balloon 9510 is coupled
coupled to exterior surface 9508). According to an embodiment,
balloon inflation lumen 9540 may extend through exterior surface
9508 and to balloon 9510, and marker band 9570 may be attached to
cannula 9502 at the location that balloon inflation lumen 9540
exits to balloon 9510 at an inflation opening. Thus, placement of
marker band 9570 may assist in bonding of balloon inflation lumen
9540 to cannula 9502, may create a more resilient bond, and may
protect the inflation opening.
[0387] According to some embodiments, apparatus 9500 may include at
least one radio-opaque marker band. For example, FIGS. 69A, 69D,
and 70 show radio-opaque marker band 9570 around the exterior of
accessory lumen 9530, infusion lumen 9520, and mandrel 9560 at
midpoint 9516 of balloon 9510. Moreover, as described above, marker
band 9570 may encircle a portion of balloon section 9511 that
includes material infused there from or also included in third
section 9558. In addition, it is to be appreciated that marker band
9570 may be around the exterior of cannula 9502 (e.g., if cannula
9502 extends through balloon section 9511), accessory lumen 9530,
or infusion lumen 9520 at midpoint 9516 of the balloon, proximal
end 9517 of the balloon or distal end 9518 of the balloon (e.g.,
proximal end 9517 and distal end 9518 may correspond to the
"shoulder" where the balloon is coupled to the exterior surface of
the cannula). Note that more than one marker band may be used such
as at more than one of the locations identified above.
[0388] According to some embodiments, lengths, diameters,
materials, and other characteristics of cannula 9502, infusion
lumen 9520, accessory lumen 9530, inflation lumen 9540, mandrel
9560, balloon 9510, or other components mentioned with respect to
FIGS. 69A-F and 70 may be selected so that apparatus 9500 may
assist in or be used for treatment agent or cell infusion to treat
acute myocardia infraction (AMI) or other forms of loss of heart
function due to heart muscle damage.
[0389] Another example of a cannula or catheter that has a
dimension suitable for percutaneous advancement through a blood
vessel to infuse a treatment agent (e.g., such as biological
agents) into a treatment region, such as arterial vessels or venous
vessels is a cannula having coaxial or co-linear lumen extending
therethrough. For example, FIG. 71A is a cross-sectional view of a
cannula and a balloon, where the cannula includes coaxially aligned
lumens. As shown in FIG. 71A, apparatus 9100 has cannula 9102
having proximal end 9104 and distal end 9106 and balloon 9110
axially coupled to the exterior surface of the cannula at or
adjacent distal end 9106, where balloon 9110 includes a property
such that when inflated, the balloon may expand in size to an outer
diameter sufficient to occlude a blood vessel. FIG. 71B is a
cross-sectional view of apparatus 9100 of FIG. 71A from perspective
"A". Cannula 9102 includes guidewire tube 9132 extending from
proximal end 9104 to distal end 9106 and existing guidewire opening
9133. Guidewire tube 9132 is part of or includes guidewire lumen
9130.
[0390] Infusion tube 9122 is disposed around guidewire tube 9132
and extends from proximal end 9104 to distal end 9106 and exist
infusion opening 9123. Also shown, infusion tube 9122 includes
infusion lumen 9120. FIGS. 71A and B also show inflation lumen 9140
defined between infusion tube 9122 and cannula 9102. According to
some embodiments, guidewire tube 9132, infusion tube 9122, and
inflation lumen 9140 are coaxially aligned with an axis of cannula
9102 (e.g., such as shown in FIGS. 71A and B).
[0391] It is to be appreciated that inflation lumen 9140 extends to
balloon 9110 and has a dimension suitable to inflate balloon 9110.
Similarly, infusion tube 9122 has an outer diameter sufficient to
infuse a treatment agent, such as treatment agents described
herein, to a treatment region distal to balloon 9110. Next,
guidewire tube 9132 has a sufficient outer diameter and be adapted
to have a guidewire disposed therethrough to guide cannula 9102
through a blood vessel to a treatment region, such with respect to
guiding cannula or catheters (e.g., such as cannula 9502) to a
treatment region of a blood vessel.
[0392] As shown in FIG. 71B, cannula 9102 may have an exterior
surface that forms a circular cross-section with respect to
perspective "A" where balloon 9110 is axially coupled to the
exterior surface of cannula 9102. Sealing on a round shaft allows
for a more concentric balloon outer diameter profiles, such as
elastomeric balloon inflation profiles. A concentrically inflated
balloon profile puts can put an even stress or inflation pressure
on the balloon wall to seal around or occlude a blood vessel more
reliably and evenly. Similarly, it is contemplated that infusion
tube 9122 may be coupled or attached to the exterior surface of
guidewire tube 9132 at a location or along locations distal to
balloon 9110, such as adjacent to or at the distal end of cannula
9102.
[0393] FIG. 72A is a cross-sectional view of a cannula and a
balloon, where the cannula includes coaxially and co-linearly
aligned lumens. As shown in FIG. 72A, apparatus 9200 has cannula
9202 having proximal end 9204 and distal end 9206 and balloon 9210
axially coupled to the exterior surface of the cannula at or
adjacent distal end 9206, where balloon 9210 includes a property
such that when inflated, the balloon may expand in size to an outer
diameter sufficient to occlude a blood vessel. FIG. 72B is a
cross-sectional view of apparatus 9200 of FIG. 72A from perspective
"B". Cannula 9202 includes guidewire tube 9232 extending from
proximal end 9204 to distal end 9206 and existing guidewire opening
9233. Guidewire tube 9232 is part of or includes guidewire lumen
9230.
[0394] FIGS. 72A and B also show infusion lumen 9220 defined
between guidewire tube 9232 and cannula 9202. According to some
embodiments, guidewire tube 9232 and infusion lumen 9220 are
coaxially aligned with an axis of cannula 9202, such as shown in
FIGS. 72A and B. Inflation tube 9240 is shown extending from
proximal end 9204 to balloon 9210 and is co-linearly aligned with
an axis of cannula 9202. It is contemplated that inflation tube
9240 may be attached or coupled to cannula 9202 such as by
adhesive, heat bonding, or laser bonding. Thus, guidewire lumen
9330, guidewire tube 9332, and inflation lumen 9340 may be
co-linearly aligned with an axis of cannula 9302.
[0395] It is to be appreciated that inflation tube 9240 extends to
balloon 9210 and has a dimension suitable to inflate balloon 9210.
Similarly, infusion lumen 9220 has an outer diameter sufficient to
infuse a treatment agent, such as treatment agents described
herein, to a treatment region distal to balloon 9210. Next,
guidewire tube 9232 has a sufficient outer diameter and be adapted
to have a guidewire disposed therethrough to guide cannula 9202
through a blood vessel to a treatment region, such with respect to
guiding cannula or catheters to a treatment region of a blood
vessel.
[0396] It is also contemplated that cannula 9202 may have an
exterior surface that forms a circular cross-section with respect
to perspective "A" where balloon 9210 is axially coupled to the
exterior surface of cannula 9202. Similarly, it is contemplated
that infusion tube 9222 may be coupled or attached to the exterior
surface of guidewire tube 9232 at a location or along locations
distal to balloon 9210, such as adjacent to or at the distal end of
cannula 9202.
[0397] FIG. 73 is a cross-sectional view of a cannula and a
balloon, where the cannula has coaxially and co-linearly aligned
lumens. FIG. 73 shows apparatus 9300 having cannula 9302. Cannula
9302 includes guidewire tube 9332 forming guidewire lumen 9330 is
coaxially aligned with infusion lumen 9320. FIG. 73 also shows
inflation lumen 9340 formed within cannula 9302, and balloon 9310
axially coupled to the exterior surface of cannula 9302. Balloon
9310 may be a part of or correspond to a balloon such as described
above with respect to balloon 9110. Similarly, infusion lumen 9320,
guidewire tube 9332, guidewire lumen 9330, and cannula 9301 may
have an outer diameter, dimension, or character to function
similarly to their counterparts described above with respect to
FIGS. 71A and B.
[0398] Moreover, according to some embodiments, none, any, or all
of guidewire tube 9132, infusion tube 9122, inflation lumen 9140,
guidewire tube 9232, infusion lumen 9220, inflation tube 9240,
guidewire tube 9332, infusion lumen 9320, or inflation lumen 9340
may include or have its own sleeving, cannula, or other surrounding
material or structure having a dimension to fit within the
surrounding cannula in which the lumen is disposed or extending
through, such with respect to lumen 9520 at FIGS. 69A-F.
[0399] Additionally, because of it's structure, apparatus 9100,
9200, and 9300 may track better in tortuous vasculature than
cannula or catheters that do not have lumen coaxially or
co-linearly located. In addition, a coaxial or co-linearly
constructed catheters can be easier to fabricate. For instance,
various processes may be used to form apparatus 9100, 9200, or 9300
of FIGS. 71A-73. For example, one or more materials may be
melt-extruded to form a multilumen extruded cannula having a
plurality of coaxially aligned tubes with respect to an axis of the
cannula, where each coaxially aligned tube has an exterior surface
with a circular cross-sectional shape with respect to the axis of
the cannula. Then, a balloon may be axially sealed to the circular
cross-sectional exterior surface of the cannula where the balloon
includes a property such that when inflated, the balloon with
expand in size to an outer diameter sufficient to occlude a blood
vessel (e.g., such as described above with respect to balloon
9110).
[0400] A process for forming apparatus 9100, 9200, or 9300 of FIGS.
71A-73, as described above may also include melt-extruding at least
one material to form a number of tubes where some of the tubes may
be inserted into other tubes to form a multi-tube cannula having a
number of coaxially aligned tubes or co-linearly aligned tubes with
respect to an axis of the cannula, where each of the tubes has a
circular cross-sectional shape with respect to an axis of the
cannula. Then, a balloon (e.g., as described for balloon 9110) may
be axially sealed to the circular cross-sectional exterior surface
of the cannula.
[0401] Next, a process for forming apparatuses 9100, 9200, or 9300
of FIGS. 71A-73, as described above might include placing a mandrel
having a crescent-shaped cross-section within an infusion tube,
placing an inflation tube on a support mandrel next to the infusion
tube, wrapping the infusion tube and the inflation tube in a jacket
material, inserting the jacket material into a shrink tube, and
heating the shrink tube sufficiently to melt a portion of the
infusion tube and the inflation tube material so that those
materials are redistributed to form a cannula having the infusion
tube and inflation tube coaxially aligned with respect to an axis
of the cannula.
[0402] It is also considered that a process for forming apparatus
9100, 9200, or 9300 of FIGS. 71A-73, as described above might
include placing a round support mandrel within a portion of a
guidewire tube and placing the guidewire tube within an infusion
tube so the guidewire tube is coaxially aligned with the infusion
tube. Note that it can be appreciated the guidewire tube and
infusion tube may each have a circular cross-section with respect
to an axis of the infusion tube. Next, two crescent-shaped mandrel
may be placed between the guidewire tube and the infusion tube at
or along a location where the support mandrel is within the
guidewire tube. The two crescent-shaped mandrel may be located at
opposing axial locations to form a construction. The construction
described above then may be inserted into a shrink tube and heated
(e.g., such as by thermal heat or laser energy) sufficiently to
melt the infusion tube to a portion of the guidewire tube, to form
one or more tack joints where the crescent mandrels do not support
the infusion tube, and thus the infusion tube bonds to the
guidewire tube.
[0403] For example, FIG. 74A is a cross-sectional view of the
apparatus of FIG. 71A from perspective "C" before forming tack
joints between the guidwire tube and the infusion tube. FIG. 74A
shows the structure of apparatus 9100 having guidewire opening 9133
within guidewire tube 9132 and infusion tube 9122 around infusion
opening 9123 and guidewire tube 9132. FIG. 74B is the structure of
FIG. 74A after forming tack joints between the guidwire tube and
the infusion tube. For instance, FIG. 74B is the structure shown of
apparatus 9100 after tack joints 9470 and 9472 are formed such as
by heat or laser energy as described above with respect to forming
apparatus 9100, 9200, and 9300 of FIGS. 71A-73. Thus, after tack
joints 9470 and 9472 are formed, FIG. 74B shows infusion openings
9423 formed between attached infusion tube sections 9420 and 9422,
and guidewire tube 9132. Note that the structures and processes
described above with respect to FIGS. 74A and B, such as forming
tack joints, may also be applied to apparatus 9200 and 9300 of
FIGS. 72A-73. Furthermore, the structure and processes described
above with respect to FIGS. 72A-73 may also be applied to apparatus
9100 of FIGS. 71A and B.
[0404] Some embodiments of inflation device or syringes
contemplated for use with apparatus, cannula, and catheters,
described herein (e.g., including apparatus 9100, 9200, 9300, 9500
of FIGS. 69A-74) for inflating or deflating balloons described
herein (e.g., such as balloon 8810 and 9510 of FIGS. 64A-70) may
include one or more inflation syringes. For example, FIG. 75A is a
cross sectional view of an apparatus to inflate a low volume
balloon to occlude a blood vessel. For example, apparatus 9700, as
will be shown and described below in FIGS. 75A-80 may be used to
inflate a balloon coupled to a distal end of a cannula having an
inflation lumen extending from the balloon through a cannula and
out a proximal exit in the cannula where the lumen will be coupled
to apparatus 9700. FIG. 75A shows apparatus 9700 having large
volume syringe 9720 and low volume syringe 9750 within an elongated
hollow inner diameter of the plunger of large volume syringe 9720.
FIG. 75B is a cross-sectional view of the apparatus of FIG. 75A
from perspective "A".
[0405] Large volume syringe 9720 is shown having barrel 9702 which
forms an elongated hollow body proximal end 9704, and distal end
9706. Barrel 9702 of apparatus 9700 is shown cut away in the travel
region of the outer plunger 9703. Outer plunger 9703 incorporates
one or more seals on piston 9707, which do not allow fluid/air flow
between the outer diameter (OD) of the outer plunger 9703 and the
inner diameter (ID) of barrel 9702 in the area where they form a
seal. The lumen/ID of the barrel 9702 is in communication with the
output extension tube 9714 and pressure gage 9705, such that as
outer plunger 9703 is translated distally, fluid may be expelled
out of the extension tube 9714 and the pressure applied to the
fluid may be measured. The distal end of extension tube 9714 is
terminated in a male Luer Lock connector 9716. Thus, large volume
syringe 9720 has an opening in the distal end to couple to a
proximal exit of a cannula, such as by coupling male Luer Lock
connector 9716 to a lumen in a cannula. More particularly,
embodiments of apparatus 9700 and 9800 may attach to delivery
catheter 2620 or catheter system 3000, such as by coupling male
Luer Lock connector 9716 to fitting 2640 as shown in FIGS. 26-29 or
fitting 3040 as shown in FIG. 30.
[0406] The position of the outer plunger 9703 in the barrel 9702
may be locked into position or unlocked to move freely by actuating
outer plunger lock 9708. Outer plunger lock 9708 is on the proximal
end of the barrel 9702 and can have many configurations. The
simplest configuration is a pressure/force engagement of the
proximal portion of plunger 9703 with sufficient force and material
coefficient of friction to hold plunger 9703 in place when the lock
9708 is engaged. For example, the basic mechanism can be the
similar to lock/unlock mechanisms for use on balloon inflation
devices, indeflators and syringes.
[0407] According to some embodiments, outer plunger 9703 is
longitudinally slidable within barrel 9702 and has a first shaft
with first piston 9707 disposed on the first shaft distal end. In
accordance with embodiments, first piston 9707 and the shaft have
elongated hollow inner diameter 9740 with inner plunger 9709
longitudinally slidable within the inner diameter. Inner plunger
9740 has a second shaft with second piston 9710 disposed on the
second shaft distal end. Therefore, the inner diameter and second
plunger define low volume syringe 9750 having a volume relatively
substantially less than a volume of large volume syringe 9720.
[0408] For example, low volume syringe 9750 is may communicate with
the draw volume of internal volume of large volume syringe 9720 in
barrel 9702 distal to plunger 9707. For example, outer plunger 9703
is a hollow construction in which inner plunger 9709 resides. Inner
plunger 9709 may contain seals 9710 which perform the same function
for the inner plunger 9709 and the ID of the outer plunger 9703 as
seals 9707 do for the outer plunger 9703 and the ID of the barrel
9702. In its most distal travel position, the distal end of the
inner plunger 9709 aligns with or is very close to the distal end
of the outer plunger 9703. If the distal position of the inner
plunger 9709 is too far proximal of the distal end of the outer
plunger 9703, then it is possible that air could get trapped in the
ID of the outer plunger 9703 that is distal to the distal end of
the inner plunger 9709. As previously explained, trapped air is not
desirable and should be avoided in these applications. In one
design, the ID of the barrel 9702 is designed such that it can
accommodate a significant protrusion of the inner plunger 9709
distal to the distal end of the outer plunger 9703 and distal to
the seals 9710.
[0409] Also, apparatus 9700 may include one or more lock mechanisms
to lock the plunger of each syringe so that a user can selects
whether the plunger is free or constrained to move in response to
the rotation of its threads or a lock can be used to engage the
plunger surface(s) with sufficient friction to prevent accidental
plunger motion (in this case the threads aren't really needed to
provide the mechanical advantage to more easily produce high
pressures, since the pressures are to be low), the plunger handle
configuration modified to make accidental motion less likely (i.e.
from a "T" shape to a more round shape). As shown in FIG. 75A, low
volume syringe 9750 may have its own associated translation and
locking control. Specifically, large volume syringe 9720 may use
outer plunger lock 9708 to releasably secure plunger 9703 to lock
piston 9707 at various locations along barrel 9702.
Correspondingly, low volume syringe 9750 may use inner plunger lock
9711 to releasably secure plunger 9709 to lock piston 9710 at
various locations along inner diameter 9740. Thus, inner plunger
lock 9711 is on the proximal end of the outer plunger 9703 and
allows the locking and unlocking of the inner plunger 9709 position
relative to the outer plunger 9703. Inner plunger lock 9711 may
have a mechanism similar to that of the outer plunger lock
9708.
[0410] The maximum proximal travel position of the inner plunger is
constrained to limit the amount of fluid that may be drawn into the
ID of outer plunger 9703 (or alternatively or in addition to limit
the minimum protrusion of the distal end of the inner plunger 9709
into the ID of barrel 9702). Many mechanisms are commonly used to
accomplish this, the most common utilize OD or cross-section
changes of the plunger 9709 (or the ID of the outer plunger 9703)
to interfere with portions of the device that it must translate
through, such as the lock 9711. (A similar method may be used to
constrain the proximal travel of the outer plunger 9703.) The
limiting of plunger 9703 or 9709 travel sets the fluid displacement
allowed for that plunger. In a design for a compliant balloon, the
displacement set for inner plunger 9709 is the maximum incremental
injection that can be safely injected into the catheter to
incrementally inflate the balloon or less. This is an important
safety feature.
[0411] In addition, according to some embodiments, the proximal end
of the outer plunger 9703 may contain a mechanism to allow the
selection of different proximal travels of inner plunger 9709 and,
thus allow a single inflation/deflation device to safely operate
catheters with different inflation or deflation volumes.
Alternately or in addition, the previously mentioned proximal
travel limit (used to initially limit the inflation of a compliant
balloon) may be removed (a distal limit may be added) and the inner
plunger 9709 may subsequently be used to more rapidly inflate and
deflate the balloon. Alternately or in addition, the proximal end
of the outer plunger 9703 may contain a mechanism to control the
translation of inner plunger. Such mechanisms can be incorporated
as a part of the lock 9711 mechanism.
[0412] It can be appreciated that the translation control on the
second plunger or other components of the device (i.e. the first
plunger) may contain an indicator or marks that show the expected
size of the balloon or the expected sizes of various balloon
catheters or their expected deflation volumes. The translation
control on the second plunger may contain a selection mechanism
that limits the plunger translation to a safe maximum injection
volume for the selected catheter.
[0413] More particularly, according to an embodiment, large volume
syringe 9720 may have large drawing volume, such as between 10
cubic centimeters (cc) in volume and 30 cubic centimeters in
volume; and low volume syringe 9750 may have substantially smaller
drawing volume, such as between 0.2 cubic centimeters in volume and
three cubic centimeters in volume to inject additional controlled
volumes in increments of between 0.005 cubic centimeters in volume
and 0.05 cubic centimeters in volume.
[0414] For example, in order to allow a balloon (e.g., such as a
low pressure, high compliance, or low tension occlusion balloon
with respect to balloons 4420, 8810, or 9510) to be conveniently
and quickly deflated and then accurately re-inflated, apparatus
9700 may include latch mechanisms 9760 and 9762 to unlatch inner
plunger lock 9711 from inner diameter 9740 so that piston 9710 can
be moved towards proximal end 9704. Thus, when unlatched, piston
9710 may be moved towards proximal end 9704 of inner diameter 9740
to evacuate a selected volume of fluid from the balloon and into
low volume syringe 9750. Furthermore, latch mechanisms 9760 and
9762 may be configured to latch inner plunge lock 9711 back to
inner diameter 9740 so that piston 9710 can be moved towards distal
end 9706 to return or deliver a selected volume of fluid to the
balloon. More particularly, latching or re-latching inner plunger
lock 9711 to inner diameter 9740 may return the same volume of
fluid evacuated from a balloon and into low volume syringe 9750, as
described above, when piston 9710 is moved towards the proximal end
of hollow inner diameter 9740 and returned to its original
position. Latch mechanisms 9760 and 9762 will be described further
below with respect to FIGS. 76-80.
[0415] Inner plunger lock 9711 may also include an adjustment
mechanism to adjust the position of piston 9710 to various
locations along hollow inner diameter 9740. For example, inner
plunger lock 9710 may include threaded cavity 9770 coupled to knob
9730 which is exterior to hollow inner diameter 9740. Thus, bolt
9772 may threadably engage threaded cavity 9770 and be coupled to
plunger 9709 so that knob 9730 may be rotated to adjust a position
of piston 9710 to various locations along inner diameter 9740. More
particularly, knob 9730 may include indicia disposed about the knob
to indicate a selected volume of fluid to be communicated to or
from the balloon corresponding to the marked position on the knob,
such that knob 9730 may be rotated to various marked positions to
inflate the balloon with various selected volumes of an inflation
gas or liquid. For instance, knob 9730 may be rotated from a first
position to a balloon volume position to deliver a selected volume
of fluid to the balloon. On the other hand, knob 9730 may be
rotated from the balloon volume position back to the first position
to evacuate the same selected volume of fluid from the balloon and
into apparatus 9700.
[0416] It can be appreciated that piston 9710 or 9707 may each
include one or more sealing members adapted to create a fluid seal
between the piston and the elongated hollow in which the piston is
slidably disposed (e.g., such as by including one or more elastic
O-rings).
[0417] FIGS. 76-80 show latch mechanisms 9760 and 9762, and knob
9730 adjusted to various positions, such as positions they may be
adjusted to during use of inner plunger lock mechanism 9711 or
apparatus 9700. For instance, FIGS. 76-80 show what effect latching
and unlatching mechanisms 9760 and 9762, or rotating knob 9730 to
various positions have on the position of piston 9710. FIG. 76
shows the latch mechanisms of FIG. 75A in an unlatched position.
FIG. 76 shows latch mechanisms 9760 and 9762 in an unlatched
position to unlatch inner plunger lock 9711 from hollow inner
diameter 9740. Latch mechanisms 9760 and 9762 may include retaining
structure on their proximal and distal ends so that an unlatched
position, such as shown in FIG. 76 cannot be exceeded and inner
plunger lock 9711 cannot be separated from inner diameter 9740.
FIG. 76 also shows gap 9780 between inner plunger lock 9711 and
inner diameter 9740. Latch mechanisms 9760 and 9762 may be used to
provide an unlatched position, such as shown in FIG. 76, so that
low volume syringe 9750 may be filled with liquid or bubbles my be
removed therefrom.
[0418] FIG. 77 shows the latch mechanisms of FIG. 76 relatched.
FIG. 77 shows FIG. 76 after latch mechanisms 9760 and 9762 are used
to reattach or latch inner plunger lock 9711 to inner diameter
9740. The latch positions shown in FIGS. 76 and 77 may be used to
remove bubbles or air from low volume syringe 9750, such as by
alternating between the latch positions shown in FIGS. 76 and 77
for latch mechanisms 9760 and 9762 to remove bubbles or air from
low volume syringe 9750. After bubble/air removal, the latch
position of latch mechanisms 9760 and 9762 may be returned to the
latched position as shown in FIG. 77.
[0419] FIG. 78 shows FIG. 77 after the inflation volume adjustment
knob has been rotated or turned to retain fluid. FIG. 78 shows FIG.
77 after knob 9730 has been rotated or turned, such as to draw in
or retain a maximum amount of fluid within low volume syringe 9750.
As shown in FIG. 78, bolt portion 9772 is in a most proximal
position, as to where bolt portion 9772 is in a most distal portion
in FIG. 77. The travel of bolt portion 9772 may be limited such
that the maximum fluid volume that may be retained (and then
expelled into the balloon) is limited to an amount that limits the
maximum outer diameter to which the balloon may be inflated. Thus,
a limit to the travel of bolt portion 9772 may be selected (e.g.,
such as a safety feature) to prevent over-inflation/bursting of the
balloon or over-stretching of the blood vessel to be occluded.
[0420] FIG. 79 shows FIG. 78 after the inflation volume adjustment
knob has been rotated or turned to inflate the balloon with a
selected inflation volume fluid. FIG. 79 shows knob 9730 turned or
rotated to inflate a balloon, such as to occlude a blood vessel.
Note that FIG. 79 shows bolt portion 9772 between a minimum and
maximum distal position along threaded cavity 9770, such as when
knob 9730 is being rotated to various rotational positions as
indicated by markings to provide selected volumes of fluid to the
balloon.
[0421] FIG. 80 shows FIG. 79 after unlatching inner the plunger
lock to deflate the balloon. FIG. 80 shows FIG. 79 after unlatching
inner plunger lock 9711 from inner diameter 9740. For example,
latch mechanisms 9760 and 9762 are in an unlatched position and
allow for gap 9780. Thus, the configuration shown in FIG. 80 may be
used after the balloon is inflated with a proper volume to occlude
a blood vessel and it is desired to deflate the balloon to allow
blood to perfuse back into a treatment region of the blood vessel,
such as treatment region 996 of blood vessel 990. More
particularly, after a blood vessel is sufficiently occluded and
treatment agent is infused through a treatment region for a
sufficient period of time, inner plunger lock 9711 may be unlatched
from inner diameter 9740 so that plunger 10 may be pulled to a
distal position to deflate the occluding balloon to allow blood to
reflow through the portion of the blood vessel previously
occluded.
[0422] After the position shown in FIG. 80, it is then possible to
re-latch inner plunger lock 9711 to inner diameter 9740, such as by
pushing knob 9730 forward to return apparatus 9700 to the position
that is shown in FIG. 79. Thus, it is possible to alternate between
the positions shown in FIG. 79 and FIG. 80 in order to inflate a
balloon to a sufficient volume to occlude a blood vessel is
described herein, then deflate the balloon sufficiently to allow
blood flow through the blood vessel, and then re-inflate the
balloon to the same volume of inflation fluid that the balloon was
inflated with before deflation.
[0423] Thus, the apparatus and steps shown and described with
respect to FIGS. 75A-80 provide a safe and predictable device and
process for inflating, deflating, and re-inflating and a high
compliance, low pressure, or low tension balloons for occlusion of
a blood vessel. For instance, latch mechanisms 9760 and 9762 allow
apparatus 9700 to be used to safely more rapidly inflate and
deflate a low volume balloon after an initial inflation.
[0424] FIG. 81 shows an alternate embodiment of an apparatus to
perform the functions of FIGS. 75A-80. As shown in FIG. 81,
apparatus 9800 has low pressure indeflator 9882 which may be a
large volume syringe having a functionality similar to that
described above with respect to large volume syringe 9720. FIG. 81
also shows controlled volume indeflator 9881, which may have a
functionality similar to that described above with respect to low
volume syringe 9750. Indeflator 9881 and 9882 are coupled to
three-way stop cock 9883 which is in turn coupled to extension line
9884 and rotating male luer 9885. In turn, luer 9885 is coupled to
occlusion/infusion catheter 9889. And balloon 9880 is coupled to
catheter 9889. Thus, apparatus 9800 may provide a balloon inflation
and deflation functionality similar to that described above with
respect to apparatus 9700. Thus, in accordance with embodiments a
balloon may be inflated by apparatus 9700 or 9800 having large
volume syringe 9720 or low pressure indeflator 9882 which may be a
high volume, low pressure syringe for initially inflating the
balloon to a controlled or selected low pressure initial diameter.
Then, the balloon may be further inflated by low volume syringe
9750 or controlled volume indeflator 9881 of apparatus 9700 or
9800, which may be a low volume syringe for further inflating the
balloon with controlled volume increments (e.g., such as selected
low volume increments of inflation fluid) to produce controlled
diameter increase(s) up the an occlusion diameter.
[0425] It can be appreciated that apparatus 9700 or 9800 may be low
pressure inflation/deflation device that requires only one operator
and the normal stopcock connections, and still provide the ability
to effectively evacuate the air, to inflate the balloon to its
nominal out diameter (OD), to subsequently control the injected
inflation volumes (for a compliant balloon) or the subsequent
withdrawn volumes (to allow subsequent rapid balloon deflations and
inflations) to the desired degree of precision, to lock the
injected inflation volumes (so the device may be set aside) and
unlock the injected inflation volumes (so the balloon may be
deflated).
[0426] For example large volume syringe 9720 provides a large
volume capacity to allow a vacuum/low pressure to be drawn on a
device via normal Luer connected components that may leak a little
air under dry/low pressure (relative to air pressure) conditions
and to allow for any relatively low pressure/higher volume initial
filling steps, while subsequently providing for very
controlled/adjustable small volume injections and withdrawals. As
such, large volume syringe 9720 can be used to remove air from a
catheter and balloon, and subsequently inflate the balloon with
contrast to a low pressure (to its beginning/initial OD or desired
OD). Then, low volume syringe 9750 can be used to inflate the
balloon (e.g., such as a balloon as described herein, including
balloons 4420, 8810, and 9510) with additional controlled small
volumes of contrast to be adjustably injected to bring the
compliant balloon controllably up to the desired OD in steps to
occlude a vessel or to withdraw/inject a controlled small volume of
contrast to subsequently rapidly and safely deflate and re-inflate
the balloon.
[0427] Apparatus 9700 or 9800 may be designed to effectively remove
the air in a balloon and its inflation lumen so that only a small
residual volume of air remains (air which will be replaced with the
inflation fluid) to allow the balloon's OD to be effectively
controlled by the volume of the injected fluid. One inflation fluid
used is contrast. Contrast allows the balloon and its location to
be very easily imaged by conventional fluoroscopy. As the OD of a
compliant balloon is stepped up or a relatively non-compliant
balloon is inflated to a low pressure, contrast may be injected
proximal of the balloon into the vessel (normally via the guiding
catheter) to assess whether the desired occlusion has been obtained
or not.
[0428] It is also contemplated that apparatus 9700 or 9800 may be
designed to have a relatively large drawing volume (usually in the
10-30 cc range) compared to the volume of air leaked, to maintain a
sufficiently low pressure for effective air removal. Thus, using
apparatus 9700 or 9800, it is possible to first inflate a compliant
balloon to its nominal OD (its lowest OD) at a specified low
pressure and then inject additional controlled volumes to produce
the larger OD's. For instance, a balloon may be inflated with
controlled volumes with increments on the order of 0.005 to 0.05 cc
(or smaller) with a maximum total on the order of about 0.5 cc (or
less) to control the balloon OD effectively.
[0429] Next a process for percutaneous advancing one or more
cannula or catheters through a blood vessel to treat or infuse a
treatment agent (e.g., such as biological agents) into a treatment
region, such as arterial vessels or venous vessels is
described.
[0430] For example, FIG. 82 is a flow diagram of a process for
treating a treatment region of a blood vessel with one or more
treatment agents or progenitor cells. At block 9610, a treatment
region of a blood vessel is identified. For example, a treatment
region may be similar to treatment region 996 of blood vessel 990;
or may be a treatment zone of a blood vessel, a coronary vein, a
coronary artery, or an infarct artery may be identified such as by
releasing a marker into the blood vessel and marking ischemic
signal at a location or region. Also, a treatment region includes
those described above with respect to block 9610 as well as a
location of a blood vessel, such as blood vessel 990, proximal to a
treatment zone, such as a zone to be treated with a treatment agent
(e.g., which may include progenitor cells).
[0431] Moreover, if sufficient ischemic signal does not exist
before treatment of a blood vessel, it is possible to precondition
a treatment region to allow for marking as described above. For
example, at block 9620 ischemic preconditioning of a treatment
region can be performed, such as by occluding a treatment region
(e.g., such as treatment region 996 or a treatment region in the
myocardium) for a period of time between 30 minutes and 180 minutes
before releasing the marker fluid into the blood vessel. More
particularly, a balloon or occlusion device may be inflated to
block the blood vessel just above a targeted location of the vessel
with respect to the direction of blood flow for a sufficient period
of time to increase the ischemic signal from that location
sufficiently for the marker to mark.
[0432] At block 9630 a cannula may be percutaneously advanced
through a blood vessel. It is contemplated that the cannula may be
a guide catheter, delivery catheter, guidewire, or other catheter
or cannula (e.g., such as cannula 8802 or 9502). For example, the
cannula may have a proximal end, a distal end, and a surface at or
adjacent a distal end axially coupled to a balloon. For example, at
block 9638, the cannula to be advanced through a blood vessel may
include a lumen adapted to have a guidewire disposed therethrough
so that a distal end of a guidewire (e.g., which may or may not
have an occlusion balloon or balloon that may be inflated to an
outer diameter greater than the inner diameter of the blood vessel
at the location, such as to fix the guidewire distal end) may be
advanced percutaneously through a blood vessel to or beyond a
treatment region so that the cannula may be advanced over the
guidewire, such as by inserting and sliding the guidewire lumen
over the guidewire to advance the distal end of the cannula through
the blood vessel and to the treatment region.
[0433] Specifically, a cannula such as 8802 or 9502 may be advanced
through a blood vessel such as 990 and may have a balloon such as
balloon 8810 or 9510 axially coupled to the cannulous exterior
surface at or adjacent the distal end of the cannula. In one
example, the cannula may have an outer diameter of less than 0.09
inches and include a lumen extending from the proximal end to the
distal end of the cannula, where the lumen has an inner diameter
greater than 0.010 inches.
[0434] At block 9640 it is determined whether the tip of the
cannula or the balloon has been advanced to the treatment region.
If at block 9640 the cannula or balloon is not at a treatment
region, the process returns to block 9630 or the cannula or balloon
may be advanced further. On the other hand, if at block 9640 the
cannula or balloon is at a treatment region, the process continues
to block 9650.
[0435] At block 9650 the balloon is inflated to occlude the blood
vessel. For example, a balloon such as a balloon described above
with respect to block 9630 may be inflated from a first diameter
(e.g., such as first diameter BRD1 as described above) to a
different second diameter (e.g., such as fourth diameter BRD4 as
described above) that is at least equivalent to an inner diameter
of a blood vessel to occlude the blood vessel at a treatment region
(e.g., such as a treatment region as described above with respect
to block 9610) for a first period of time. For example the balloon
may be inflated by controlling a volume of a gas or a fluid
injected into the balloon, such as to inflate the balloon to a
plurality of increasing inflation volumes to form a plurality of
increasing radial outer diameters. Moreover, it is contemplated
that the increasing inflation volumes may be increased to a volume
corresponding to a radial outer diameter of the balloon which is
greater than the radial inner diameter of the blood vessel at a
treatment region.
[0436] Furthermore, according to some embodiments, as described
with respect to balloon 8810, the balloon may have a property such
that when inflated to such a volume, the balloon has an inflation
pressure that increases by less than five percent in pressure than
the inflation pressure at one or more of the previous inflation
volumes. For example, the balloon may be a high compliance balloon
that increases in inflated axial length sufficiently to cause the
balloon inflated outer diameter to maintain an inflation pressure
that is within five percent of the previous pressure on the inner
diameter of the blood vessel while the inflation volume is
increased.
[0437] At block 9660 treatment agents are infused to the treatment
region. For example, a treatment agent or a plurality of progenitor
cells (e.g., such as progenitor cells suspended in a liquid) may be
infused through a lumen extending from a proximal end to a distal
end of the cannula and exit in outlet portal at the distal end of
the cannula (e.g., such as by being infused through lumen 9520 and
exiting outlet port 9522 distal to balloon 8810 or 9510 as
described above). According to some embodiments the progenitor
cells may be bone marrow derived progenitor cells such as those
produced by: (1) harvesting bone marrow, (2) selecting stem cells
from bone marrow, or (3) deriving cells from bone marrow aspirates.
It is also contemplated that the progenitor cells may be blood
derived progenitor cells, such as those produced by: (1) collecting
venous blood, (2) purifying mononuclear cells, or (3) ex-vivo
culturing of mononuclear cells. It is to be appreciated that the
treatment region being treated may be in the blood vessel of the
same person from which the progenitor cells are derived (e.g., the
progenitor cells may be reinfused into the infarct artery of the
person from which the bone marrow or blood derived progenitor cells
are taken).
[0438] In addition, it is contemplated that block 9660 may include
infusion and a therapeutic agent having one or more of
cardiomyocytes, stem cells, progenitor cell, skeletal myocytes,
smooth muscle cells, and endothelial cells, and growth factors such
as IGF-I, HGF, VEGF, NGF, FGF, TGF-beta, and their isoforms.
[0439] In addition, infusing at block 9660 may include infusing
treatment agent or progenitor cells at a low pressure and distal to
the occluding balloon such that a flow of blood through the
treatment region is precluded and does not wash the treatment agent
away from the treatment region. For example, the occluding balloon
may completely preclude blood flow through the treatment region,
such as treatment region 996. Thus, an occluding balloon or device
may block off blood flow from treatment region 996 to increase
treatment agent residence time in treatment region 996, such as a
capillary bed. Without such blood flow, the treatment agent
residence time in the blood vessel allows for more treatment agent
(e.g., such as stem cells) to adhere to the vessel wall and
eventually migrate into target muscle, such as heart muscle. Also,
infusing may include infusing a volume of between one milliliter
and 10 milliliters of treatment agent or progenitor cells, such as
by infusing a volume of between three milliliters and four
milliliters of a progenitor cell suspension (e.g., such as 3.3
milliliters of progenitor cell suspension).
[0440] At block 9670 it is determined whether the first period of
time has expired. According to some embodiments the first period of
time may be a period of time between two minutes and five minutes,
such as a period of three minutes in time. If at block 9670 the
first period of time has not expired, more time is allowed to
elapse, and additional treatment agent or progenitor cells may be
infused. Also, if the first period of time has not expired, other
processes or measurements may be performed, such as those described
herein or desired during an infusion treatment. Specifically,
measurement or procedures such as those described above with
respect to accessory lumen 9530 may be performed during the first
period of time.
[0441] In accordance with embodiments, one way to balance the
benefit of having a long treatment agent or progenitor cell
residence time at the treatment region with the risk of inducing
ischemic damage to the target muscle during occlusion of the blood
vessel is to provide for blood perfusion around or through the
occluding device so that blood can still pass through the treatment
region in a controlled amount or during a controlled time period
during treatment of the treatment region.
[0442] For instance, If at block 9670 the first period of time has
expired, the process continues to block 9675. At block 9675, liquid
(e.g., such as blood or a treatment agent) is allowed to perfuse
from a location in the blood vessel proximal to the balloon to the
treatment region (or vice versa depending on the direction of blood
flow). In other words, at block 9675, a liquid, such as blood or
treatment agent, may be allowed to perfuse between a location in
the blood vessel proximal to the balloon and the treatment region,
such as by allowing the liquid to flow from a location proximal to
the balloon to a location distal to the balloon, or vice versa. For
example, the balloon may be deflated sufficiently to allow the
blood vessel (such as blood vessel 990 at treatment region 996) to
be open to a flow of fluid, such as blood. Thus, the balloon may be
deflated (e.g., such with respect to balloon 8810 or 9510) to allow
a reflow of blood through the treatment region, such as to minimize
extensive ischemia. According to some embodiments, at block 9675
the balloon may be configured to be and may be sufficiently
deflated to be subsequently reinflated after a second period of
time. Moreover, at block 9675 the balloon may be deflated
sufficiently to be retracted from the blood vessel, such as by
being withdrawn by the cannula.
[0443] Alternatively or in addition to allowing perfusion at block
9675 by deflating the balloon, a liquid (e.g., such as blood or
treatment agent) may be allowed to perfuse between a location in
the blood vessel proximal to the balloon and the treatment region
via a lumen extending through the cannula. For example, the cannula
may include a lumen extending from a location proximal to the
balloon to a location distal to the balloon and a proximal hole
through the exterior surface of the cannula and to the lumen at a
location proximal to the balloon as well as a hole through the
exterior surface of the cannula and to the lumen at a location
distal to the balloon. Thus, a lumen for perfusing liquid such as
is described herein with respect to apparatus 9910, 9920, 9930, or
9940 may be used at block 9675.
[0444] Likewise, instead of or in addition to deflating the
balloon, perfusion of a liquid (e.g., such as blood or treatment
agent) at block 9675 may including retracting or pulling back a
guidewire disposed through a guidewire lumen extending past at
least one hole in the exterior of the cannula and to the guidewire
lumen proximal to the balloon to allow liquid to perfuse between a
location in the blood vessel proximal to the balloon and to a
location distal to the balloon via a guidewire lumen opening in the
distal end of the cannula. Specifically, for example, the cannula
may include a guidewire lumen extending from a proximal end to a
distal end of the cannula and exiting in opening in the cannula
distal to the balloon, so that a distal end of a guidewire disposed
through the guidewire lumen can be retracted to a location proximal
to at least one hole through the exterior of the cannula and to the
guidewire lumen, where the at least one hole is located proximal to
the balloon. Furthermore, disembodiment also allows the distal end
of the guidewire to be advanced to a location distal to the at
least one hole through the exterior of the cannula to prohibit or
reduce liquid perfusion between a location in the blood vessel
proximal to the balloon and the treatment region, such as by
blocking perfusion of the liquid between the blood vessel and the
lumen. Specifically, the embodiment described above may be
performed by an apparatus such as apparatus 9600 as described
herein.
[0445] The ability to retract the distal end of the guidewire to
allow perfusion and advance the distal end of the guidewire to
reduce or prohibit perfusion is important since such an embodiment
may provide a simple process for performing block 9675 as well as
repeating blocks 9650 through 9685 one or more times. As with
apparatus 9600, it is also worth noting that the plurality of holes
through the cannula exterior described above can include various
numbers and size and shape holes to allow the movement of the
distal end of the guidewire to control an amount of liquid
perfusion between a location of the blood vessel proximal to the
balloon and the treatment region.
[0446] At block 9680 it is determined whether a second period of
time, during which the liquid is allowed to perfuse, has expired.
If at block 9680 the second period of time has not expired, further
time may be allowed to elapse while the liquid is allowed to
perfuse. For instance, the deflated occluding, the balloon may be
further deflated, the balloon may be inflated to a diameter that
does not occlude the blood vessel or other processes or
measurements may be performed. For example, measurements or
procedures, such as those described above with respect to accessory
lumen 9530, may be performed during the second period of time.
Similarly, during block 9680, perfusion may be allowed to continue
as described above with respect to apparatus 9910, 9920, 9930,
9940, or 9600. According to some embodiments the second period of
time may be a period of between two minutes and five minutes in
time, such as a period of three minutes in time. Moreover, it is
contemplated that the second period of time may be shorter than,
equal to, or greater than the first period of time.
[0447] If at block 9680 the second period of time has expired, the
process proceeds to block 9685. At block 9685 it is determined
whether treatment is complete. For example, according to some
embodiments treatment may include repetition of blocks 9650 through
9685 to infuse treatment agent or progenitor cells a number of
times to the treatment region. Specifically, blocks 9650 through
9685 may be repeated 2, 3, 4, 5, 6, or more times to infuse
treatment agent or progenitor cells at the treatment region. In one
case, treatment region may be occluded (e.g., such as by inflating
the balloon for a first period of time) (such as for three minutes)
during which treatment agent or progenitor cells are infused to the
treatment region, then blood or treatment agent may be allowed to
perfuse into the treatment region (e.g., such as by deflating the
balloon for a second period of time) (such as for three minutes).
Thus, this occlusion/treatment and perfusion may be performed a
total of three repetitions to infuse a total of 10 milliliters of
progenitor cell suspension via three infusions of 3.3 milliliters
each.
[0448] If at block 9685 treatment is completed the process may
continue to block 9690. At block 9690 the occluding balloon may be
deflated and the cannula may be retracted from the blood vessel,
such as by withdrawing the deflated balloon using the cannula.
[0449] Note that it is contemplated that the process described
above with respect to FIG. 82 may be controlled manually,
automatically, or by a machine, such as by system controller 3080,
or according to a treatment process for infusion of a treatment
agent into an artery or vein of a patient using devices, apparatus,
methods, or processes described herein (e.g., such as according to
the process described with respect to FIG. 3, 19, 54, 55 or
63).
[0450] Now, specifically addressing three types of apparatus for
allowing blood or treatment agent to perfuse between a location in
the blood vessel proximal and distal to an occluding balloon, such
as is described above with respect to block 9675. First, as
mentioned at block 9675, the occluding balloon may be deflated
sufficiently to allow the blood vessel (such as blood vessel 990 at
treatment region 996) to be open to a flow of fluid, such as
blood.
[0451] Second or in addition to allowing perfusion at block 9675 by
deflating the balloon, blood or treatment agent may be allowed to
perfuse between a location in the blood vessel proximal and distal
to an occluding balloon by retracting or pulling back a guidewire
disposed through a guidewire lumen extending past at least one hole
in the exterior of the cannula proximal to the balloon to allow
perfusion to a location distal to the balloon via a guidewire lumen
opening in the distal end of the cannula.
[0452] Thus, according to some embodiments, liquid, blood, or
treatment agent perfusion between the treatment region and a
location proximal to the balloon, or from a location on one side of
an occlusion device to a location on the other side of an occlusion
device as described herein, may be achieved by including a liquid
perfusion capability through the cannula. For example, perfusion
from one side of an occluded site to the other side of an occluded
site may be a constant flow, a controlled amount of flow, or a flow
that may be adjusted to start or stop the flow or provide different
flow rates as controlled by an operator. For instance, FIG. 83 is a
cross-sectional view of an occlusion balloon attached to a cannula
having holes through an exterior surface of the cannula proximate
to the balloon, where the holes extend to a lumen in the cannula
having an exit distal to the balloon. Thus, a cannula described
with respect to FIG. 83 may be referred to as a blood perfusion
catheter or a blood perfusion cannula. FIG. 83 shows apparatus 9600
that may be an apparatus similar to apparatus 9500 but including
proximal perfusion of section 9667 having at least one hole through
the exterior surface of cannula 9602 and to accessory lumen 9530 at
a location proximal to balloon 8810 to allow perfusion of a liquid
between a location in a blood vessel proximal to balloon 8810 and
to a treatment region, such as a region of the blood vessel distal
to balloon 8810. Specifically, FIG. 83 shows holes 9661, 9662,
9663, 9664, 9665, and 9666 at proximal perfusion section 9667
extending through cannula 9602 and to accessory lumen 9530.
[0453] Although FIG. 83 shows 6 holes through cannula 9602, it is
contemplated that various numbers, sizes, and shapes of holes may
be used at proximal perfusion section 9667. For example, between 4
and 8 holes may be used according to various embodiments. Moreover,
any of the holes, a combination of any of the holes, or a
combination of all of the holes may have a dimension to allow
perfusion of blood or treatment agent between a location of the
blood vessel proximal to balloon 8810 and accessory lumen 9530 or a
location of a blood vessel distal to balloon 8810. For example, the
holes may allow perfusion of blood at a flow rate between full flow
sufficient to prevent an ischemic event in the blood vessel of a
patient when all of the holes are open, and a flow of a fraction of
full flow to reduce or minimize wash off or washing away of a
treatment agent in an occluded area of the blood vessel.
Specifically, the holes at proximal perfusion section 9667 and
lumen 9530 may have a dimension to allow for a flow of liquid of
between 10 cubic centimeters per minute and 80 cubic centimeters
per minute of flow of liquid at balloon 8810 at a pressure of less
than 240 mmHg at perfusion section 9667 (e.g., such as a high
systolic blood pressure for a patient).
[0454] FIG. 84 is a cross-sectional view of FIG. 83 from
perspective "A". FIG. 84 shows cannula 9602 having support mandrel
9560, infusion lumen 9520, inflation lumen 9540, and guidewire
lumen 9530. Perfusion hole 9561 is shown through the exterior
surface of cannula 9602 and to lumen 9530. Perfusion hole 9661 may
represent any of the perfusion holes as described above with
respect to holes at proximal perfusion section 9667. Also, note
that according to some embodiments, lumen 9530 as described with
respect to FIGS. 83 and 84 may have its own sleeving, cannula, or
surrounding material or composite tube such with respect to lumen
9520 at FIGS. 69A-F. Thus, lumen 9530 is shown in FIG. 84 as being
disposed within or including a tube of material surrounding that
lumen (e.g., wherein that, too, may be formed such for forming a
lumen or tube).
[0455] Holes, such as holes 9661 through 9666, at proximal
perfusion section 9667 may be formed by inserting a reinforcing
mandrel within lumen 9530 and drilling the holes such as by a
mechanical drill using a drill bit or a laser drilling technology
to produce the holes as described herein.
[0456] It is also contemplated that cannula 9602 may have one or
more distal holes through the exterior surface of the cannula and
to lumen 9530 at a location distal to balloon 8810 to allow or
increase perfusion of liquid between a location in the blood vessel
proximal to balloon 8810 and treatment region or a location in the
blood vessel distal to balloon 8810. More particularly, blood
flowing through lumen 9530 toward distal end 9506 may exit lumen
9530 through holes in cannula 9602 distal to balloon 8810 in
addition to opening 9532. It is to be appreciated that distal holes
through the surface of cannula 9602 distal to balloon 8810 may have
a number, shape, and size or be formed as described above with
respect to holes at proximal perfusion section 9667.
[0457] According to some embodiments, accessory lumen 9530 may be
adapted to have a guidewire disposed therethrough to guide cannula
9602 to a treatment region, such with respect to lumen 9530 and a
guidewire disposed therethrough. Additionally, lumen 9530 may be
adapted or have a dimension such that a distal end of a guidewire
disposed therethrough can be extended past to a location distal to,
to a location along, or to a location proximal to proximal
perfusion section 9667. Additionally, lumen 9530 may have an inner
diameter and a guidewire disposed therein, may have an outer
diameter sufficient that the guidewire or a distal end thereof
occludes liquid from flowing through lumen 9530 or from perfusion
between the holes at proximal perfusion section 9667 and lumen
9530. Such a relationship between the guidewire and lumen allows
the guidewire to be slid past one or more of the holes towards
distal end 9506 to control or stop the perfusion of liquid from an
area of a blood vessel proximal to balloon 8810 and to a treatment
region distal to balloon 8810. For example, FIG. 85 is a
cross-sectional view of the apparatus shown in FIG. 83 advanced to
a treatment region of a blood vessel. Thus, FIG. 85 shows apparatus
9600 advanced to a treatment region 996 of blood vessel 990, and
having balloon 8810 inflated to occlude a flow of blood from
flowing between a location proximal to balloon 8810 to treatment
region 996.
[0458] Thus, apparatus 9600 and the process described with respect
to FIG. 82 may provide several benefits. For example, it may
provide adequate blood supply during self or treatment agent
infusion so that a patient will not enter in ischemic condition by
supplying adequate perfusion or flow of blood, such as a flow of
approximately four cc/minute.
[0459] Thus, guidewire 9692 may have a dimension to be slidably
adjustable to extend or retract distal end 9693 to a location past
none or any of holes at proximal perfusion section 9667, such as to
adjust an amount of liquid to perfuse between the location in the
blood vessel proximal to balloon 8810 and lumen 9530. Specifically,
FIG. 85 shows distal end 9693 extended distal to hole 9662 but
proximal to hole 9661. Thus, blood flow 9682 may perfuse through
hole 9661 into lumen 9530, out distal opening 9532 and to treatment
region 996. However, liquid is occluded or prohibited or reduced
from flowing through or perfusing between hole 9662 and lumen 9530
(fluid is similarly prohibited or reduced from perfusing through
any of the other holes shown in proximal perfusion section 9667,
other than hole 9661, and lumen 9530).
[0460] It is worth noting that by varying the size or shape of the
holes in proximal perfusion section 9667, such as by increasing the
radial size of the holes from most distal hole 9661 to a hole most
proximal to proximal end 9504, it is possible to control the
perfusion flow. Thus, larger holes towards proximal end 9504 and
smaller holes towards distal end 9506 allow distal end 9693 of the
guidewire to be slid to decrease the perfusion flow from full flow
to a fraction of full flow such as a fraction between 1/10 and
1/100 of full flow (e.g., a fraction that may be dictated by the
size of hole 9661). Note that although holes in proximal perfusion
section 9667 are shown oriented longitudinally with respect to an
axis of cannula 9602, it is contemplated that the holes may be
oriented otherwise as long as they extend with a sufficient
dimension to the lumen to allow for perfusion of liquid.
[0461] Another application for this apparatus or process is to
provide intermittent blood flow between treatment agent infusions
without deflating an occlusion balloon, such as balloon 8810. Thus,
instead of deflating the balloon to allow blood perfusion or flow,
the guidewire may be retracted past the holes at proximal perfusion
section 9667 to allow for adequate blood perfusion or flow.
[0462] Moreover, since the apparatus and process allows for various
amounts of liquid to perfuse, retraction or advancement of distal
end 9693 can be adjusted in response to the status of or
measurements taken with respect to a patient. For example, if a
patient is in severe chest pain or needs additional blood or
treatment agent flow into an occluded area of a blood vessel,
guidewire 9692 can be retracted sufficiently or past proximal
perfusion section 9667 to allow for a maximum blood flow, such as
40 cubic centimeters/minute. On the other hand, if the patient is
only in slight discomfort, and does not require greater blood flow,
a lower flow rate may be used by locating distal end 9693 to a
midpoint or distal to a midpoint along proximal perfusion section
9667 (e.g., minimizing flow by placing distal end 9693 at such a
location reduces treatment agent or cell wash off from a treatment
region or treatment zone). Another application of the apparatus or
process may be to continuously provide a perfusion flow rate that
is a small fraction of the full flow rate during treatment agent or
cell infusion for a prolonged occlusion. The low perfusion flow
rate will have less impact on washing the treatment agent or cells
away from the treatment region while providing some supply of blood
to the treatment region or occluded region to allow for a longer
infusion or treatment period.
[0463] Third, or in addition to allowing perfusion at block 9675 by
deflating the balloon or via a perfusion lumen, blood or treatment
agent may be allowed to perfuse between a location in the blood
vessel proximal and distal to an occluding balloon via a separate
perfusion lumen extending through the cannula the balloon is
attached to and exiting a hole distal to the balloon and a hole
proximal to the balloon.
[0464] For example, according to some embodiments, a blood
perfusion cannula may be used, such as a version of cannula 9502 or
a similar or modified process to that described with respect to
FIG. 82. For example, FIG. 86 is a cross-sectional view of a
cannula having a balloon attached to its distal end and a bypass
lumen extending from a hole distal to the balloon to a hole
proximal to the balloon. FIG. 86 shows apparatus 9910 having
cannula 9902 (e.g., such as a version of cannula 9502 described
with respect to FIGS. 69A-F, and 70) with proximal end 9504 and
distal end 9506, and balloon 8810 axially coupled to the exterior
of cannula 9902 (e.g., such as by balloon 8810 being axially
coupled similarly to as described above for FIGS. 69A-F, and 70
with respect to attachment of balloon 9510 to cannula 9502). FIG.
86 also shows guidewire lumen 9530 extending through cannula 9902
(e.g., such as by lumen 9530 extending similarly to for FIGS.
69A-F, and 70 with respect to guidewire lumen 9530 extending
through cannula 9502). Next, FIG. 86 shows infusion lumen 9920
extending from proximal end 9504 to a location proximal to balloon
8810 (e.g., such as by lumen 9920 being a lumen and extending such
as is described herein with respect to lumen 9520 extending through
cannula 9502 for FIGS. 69A-F, and 70).
[0465] Notably, FIG. 86 shows bypass lumen 9550 extending from
proximal hole 9952 proximal to balloon 8810 to distal hole 9954
distal to balloon 8810. Proximal hole 9952, lumen 9950, and distal
hole 9954 may have a dimension suitable to allow for perfusion of
liquid between a location in a blood vessel proximal to balloon
8810 and a location in the blood vessel distal to balloon 8810,
such as a treatment region as described herein. For example,
proximal hole 9952 and distal hole 9954 may be a hole such as is
described herein with respect to hole 9661. Thus, proximal hole
9952 and distal hole 9954 may be oriented longitudinally with
respect to an axis of cannula 9902. Also, lumen 9550, proximal hole
9952, and distal hole 9954 may have a dimension, such as a selected
radius, or selected radii to control or adjust an amount of liquid
to perfuse between a location distal to balloon 8810 and proximal
to balloon 8810 such as to control an amount of blood or treatment
agent perfusing between the locations to prevent an ischemic event
in the blood vessel of a patient.
[0466] For instance, apparatus 9910 may be helpful to deliver a
treatment agent such as a treatment agent described herein,
including a drug, a peptide, growth factors, and other therapeutic
agents (that may or may not be mixed with blood) to be delivered
locally. For example, VEGF-1, an angiogenic growth factor, may be
administered through infusion lumen 9920 to deliver treatment agent
to a blood vessel location to mix well with blood proximal to
balloon 8810, and then to flow mixed with the blood through bypass
lumen 9950 at a controlled flow rate and to a region of a blood
vessel distal to balloon 8810 to assist in more efficient
absorption of the treatment agent by local tissues proximal to
balloon 8810.
[0467] In another embodiment, FIG. 87 shows the apparatus of FIG.
86 where the infusion lumen extends to a location distal to balloon
8810. Specifically, FIG. 87 shows apparatus 9920 having infusion
lumen 9921 extending from proximal end 9504 of cannula 9903 to an
infusion exit through the exterior surface of the cannula at a
location distal to balloon 8810 to deliver treatment agent to a
blood vessel location distal to balloon 8810.
[0468] Thus, apparatus 9920 may be useful to deliver treatment
agent such as genes, viral vectors, stem cells, and other
therapeutic agents that require longer dwelling time at an infusion
site to enhance delivery period. For example, to deliver autologous
bone marrow mononuclear cells, apparatus 9920 may be used so that
those treatment agents dwell in a blood vessel distal to balloon
8810 while that location of the blood vessel receives some blood
flow as controlled by lumen 9950, proximal hole 9952, and distal
hole 9954.
[0469] Next, FIG. 88 is a cross-sectional view of a cannula having
a balloon attached to its distal end, and infusion lumen to provide
treatment agent to a location distal to the balloon, and a bypass
lumen to allow for perfusion of liquid from the location distal to
the balloon to the location proximal to the balloon. FIG. 88 shows
apparatus 9930 having cannula 9904 (e.g., such as a cannula
described herein with respect to cannula 9502 for FIGS. 69A-F, and
70). Cannula 9904 includes guidewire lumen 9530, infusion lumen
9920 and infusion lumen 9921. Cannula 9904 also includes bypass
lumen 9950, proximal hole 9952 and distal hole 9954 to perfuse
blood from a proximal location to a distal location of a blood
vessel occluded by balloon 8810.
[0470] Thus, apparatus 9930 may be useful for a combination of
therapies with multiple treatment or therapeutic agents. For
example, in order to infuse a transfection agent before delivery
liposome encapsulated therapeutic DNA, the transfection agent may
be infused through proximal infusion lumen 9920 to allow for
sufficient mixing and distribution of the agent with blood, and
then liposomes may be infused through distal infusion lumen 9921 to
treat a region of a blood vessel proximal to balloon 8810 with
transfection agents for a sufficient period of time, and a region
of the blood vessel distal to lumen 8810 with liposomes for a
sufficient period of time. It is to be appreciated that a pressure
sensing port may be added to cannula 9902, 9903, or 9904 to monitor
or control the re-perfusion rate via the cannula.
[0471] FIG. 89 is a cross-sectional view of a cannula having two
balloons attached to its distal end, and infusion lumen exiting the
cannula between the balloons, and a bypass lumen to allow perfusion
between a location proximal to both balloons and a location distal
to both balloons. FIG. 89 shows apparatus 9940 having cannula 9905
with proximal end 9504 and distal end 9506, proximal balloon 9910,
and distal balloon 9915 occluding treatment region 9996 from a
location of blood vessel 990 proximal to proximal balloon 9910 and
a location of blood vessel 990 distal to distal balloon 9915. For
example, proximal balloon 9910 and distal balloon 9915 may be a
balloon such with respect to balloon 8810 to have a property such
that when insulated to a selected inflation volume the balloons
expand to an outer diameter sufficient to occlude blood vessel 990
to occlude treatment region 9996. Treatment region 9996 may be a
treatment region with respect to treatment region 996.
[0472] FIG. 89 also shows infusion lumen 9921 and additional lumen
9981 extending from proximal end 9504 of cannula to exists through
the exterior surface of cannula 9905 at locations between proximal
balloon 9910 and distal balloon 9915. Infusion lumen 9921 may be an
infusion lumen such as described with respect to infusion lumen
9920 or 9921 of FIGS. 86 and 87. Additional lumen 9981 may be a
lumen similar to infusion lumen 9921 or may be a lumen to provide
pressure sensing at treatment region 9996, such as is described
herein. Note that treatment region 9996 may be described an
inter-balloon occlusion infusion space.
[0473] Thus, apparatus 9940 creates an inter-balloon
occlusion-infusion space to provide a more specific local delivery
of treatment agent because treatment agents infused to treatment
region 9996 are confined between proximal balloon 9910 and 9915 and
will not be washed away by blood circulation.
[0474] In addition, FIG. 89 shows bypass lumen 9960 extending from
proximal hole 9952 to distal hole 9954. Bypass lumen 9960 may
function similarly to bypass lumen 9950 as described above with
respect to FIG. 86. For example, bypass lumen 9960, proximal hole
9952, and distal hole 9954 may allow for perfusion of blood or
treatment agent from a location proximal to balloon 9910 and
balloon 9915 to a location distal to balloon 9910 and balloon
9915.
[0475] Specifically, apparatus 9940 allows perfusion of blood from
one side of the balloons to the other side of the balloons at all
times while treatment agent may be administered to treatment region
9996, such as to allow uninterrupted cardiac circulation through
blood vessel 990. Moreover, apparatus 9940 may create a static
environment between proximal balloon 9910 and distal balloon 9915
sufficient to reduce shear stress caused by circulation and to
assist treatment agent attachment to the wall of blood vessel 990.
Likewise, the wall tension to the walls of blood vessel 990, such
as at treatment region 9996 created by both balloons may cause the
wall to be more permeable to therapeutic agents.
[0476] It is also contemplated that cannula 9905 may include
infusion lumen or pressure sensing lumen extending from proximal
end 9504 of cannula 9905 to exit openings through the outer surface
of cannula 9905 at locations proximal or distal to proximal balloon
9910 and distal balloon 9915. Note that in such a case, the wall
tension created by both of the balloons may also make the wall of
blood vessel 9900 proximal and distal to the balloons more
permeable to therapeutic agents infused distal and proximal to the
balloons.
[0477] Thus, it is considered that balloon 8810, other occlusion
balloons described herein, other occlusion devices described
herein, cannula or catheters described herein may be used to
occlude a location or infuse treatment agent to a treatment region
or a location of a blood vessel, such as an artery or a vein of a
human being, such as those in the human heart.
[0478] Note that all embodiments of devices, catheter, balloon,
cannula, lumen, filter devices, perfusion devices, apparatus,
methods, or processes described herein are contemplated to include
treatment of one or more human or animal blood vessels (e.g.,
including veins or arteries), intra-coronary veins, and
intra-coronary arteries, such as by infusion of a therapeutic
treatment agent including by retrograde infusion, intra-venous
retrograde infusion, multiple catheter infusion, infusion involving
multiple occlusion devices, multiple treatment agent infusion, and
any combinations thereof.
[0479] Hence, such treatment may be used to treat or repair
ischemic and recently infarcted (dead) tissue, such as that
resulting from acute myocardial infarction (AMI) or heart disease.
For example such treatment may provide intracoronary infusion of
progenitor cells into an infarct artery within days after AMI to
allow the treatment agent to access capillaries and trans-migrate
into adjacent infarct artery tissues.
[0480] It is also contemplated that both, intra-coronary veins and
arteries could be treated or involved in treating a treatment
region or treatment zone. In one case, intra-coronary veins and
arteries are treated by retrograde insertion of a first catheter to
perform multiple occlusion of intra-coronary veins to occlude
around a treatment region, percutaneous insertion of a second
catheter to perform occlusion of one or more coronary arteries
occlude around the treatment region, and infusion of a treatment
agent from the second catheter to treat the treatment region with
respect to a multi-occlusion device or embodiment. It can be
appreciated that this process may allow the treatment agent to
access capillaries between the occlusions of the coronary veins and
the coronary arteries.
[0481] In the preceding detailed description, reference to specific
embodiments were described. It will, however, be evident that
various modifications and changes may be made thereto without
departing from the broader spirit and scope of the appended claims.
The specification and drawings are, accordingly, to be regarded in
an illustrative rather than a restrictive sense.
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