U.S. patent application number 10/800323 was filed with the patent office on 2005-01-20 for infusion treatment agents, catheters, filter devices, and occlusion devices, and use thereof.
Invention is credited to Asongwe, Gabriel, Bai, Hongzhi, Bei, Nianjiong Joan, Bly, Mark J., Chan, Gregory Waimong, Chiu, Jessica G., Chow, Mina, Esselstein, Robert C., Gesswein, Douglas, Hatten, Thomas R., Schaible, Stephen G., Shen, Yan, Sridharan, Srinivasan, Webler, William E..
Application Number | 20050015048 10/800323 |
Document ID | / |
Family ID | 32995884 |
Filed Date | 2005-01-20 |
United States Patent
Application |
20050015048 |
Kind Code |
A1 |
Chiu, Jessica G. ; et
al. |
January 20, 2005 |
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 and/or co-linear lumen, a supporting
mandrel, and/or an occlusion device at its distal end. Moreover,
according to 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, and/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
12400 WILSHIRE BOULEVARD
SEVENTH FLOOR
LOS ANGELES
CA
90025-1030
US
|
Family ID: |
32995884 |
Appl. No.: |
10/800323 |
Filed: |
March 11, 2004 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10800323 |
Mar 11, 2004 |
|
|
|
10387048 |
Mar 12, 2003 |
|
|
|
60467402 |
May 1, 2003 |
|
|
|
Current U.S.
Class: |
604/101.04 |
Current CPC
Class: |
A61M 2025/1052 20130101;
A61M 25/1002 20130101; A61M 25/10 20130101 |
Class at
Publication: |
604/101.04 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A system comprising at least one of the following: a guide
catheter comprising an occlusion device; a delivery catheter
comprising at least one occlusion device having a property to
occlude a blood vessel without radially expanding the blood vessel,
wherein the delivery catheter is received within the guide
catheter; and a guidewire comprising an occlusion device, wherein
the guidewire is received within the guide catheter and/or the
delivery catheter.
2. A kit comprising: a delivery catheter comprising: a shaft
comprising a proximal end and a distal end and defining a delivery
lumen through a portion thereof, the delivery lumen comprising a
proximal end and a distal end; a monitoring cannula defining a
lumen therethrough, comprising a proximal end and a distal end, a
portion of the monitoring cannula disposed within the shaft; a port
coupled to the distal end of the monitoring cannula; a balloon
inflation cannula defining a lumen therethrough, comprising a
proximal end and a distal end, a portion of the balloon inflation
cannula within the shaft; a balloon adjacent to the distal end of
the flexible shaft, the balloon comprising at least one material
selected from the group consisting of polyether block amide resins,
blends of polyether block amide resins, polyetheramides, a
composite including an elastomeric material and EPTFE, a
styrene-isoprene-styrene tri-Block co-polymer, and blends and
mixtures thereof; wherein the balloon is adapted to inflate to at
least one of a predetermined volume sufficient to occlude a blood
vessel without radially expanding the blood vessel and to a
pre-determined pressure of about 0.5 to about 5.0 atmospheres.
3. The kit of claim 2, further comprising: a guide catheter having
a length and a lumen adapted to access a blood vessel, and having a
diameter sufficient to receive a portion of the delivery catheter;
a pressure increasing device adapted to connect to the proximal end
of the delivery lumen; a sensing device adapted to connect to the
proximal end of the monitoring cannula to sense one of pressure and
fluid flow; an inflation device adapted to connect to the proximal
end of the balloon inflation cannula; and a guidewire comprising an
occlusion device, wherein the guide catheter has a diameter
sufficient to receive a portion of the guidewire.
4. The kit of claim 2, further comprising a pressure relief valve
coupled to the proximal end of the balloon inflation lumen, and a
pressure transferring device comprising a proximal end and a distal
end, wherein the distal end is adapted to connect to the proximal
end of the delivery lumen.
5. The kit of claim 2, wherein at least one of the delivery lumen
and the monitoring cannula is adapted to have a guide wire disposed
therethrough to guide the guide catheter through the blood vessel
to a region of interest, and wherein the delivery lumen is distal
to the monitoring cannula defining at least one of a tapered and a
staggered tip.
6. The kit of claim 2, wherein the guide catheter comprises 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 curved portion.
7. The kit of claim 2, wherein the guide catheter comprises a first
guide catheter portion having a first diameter, and a second guide
catheter portion having a second diameter, and the first guide
catheter portion and the second guide catheter portion are
coaxially and slidingly engaged.
8. The kit of claim 2, wherein the balloon is adapted to inflate to
a diameter range of about 2 mm to about 20 mm, wherein the shaft
comprises one of a polyether block amide resin having a durometer
hardness of about 50 to about 70 shore D, a polyimide, and a
polyethylene.
9. The kit of claim 2, further comprising a treatment agent to
infuse into the delivery lument, wherein the treatment agent
comprises at least one material selected from the group consisting
of cells, stem cells, progenitor cells, bone marrow derived
progenitor cells, antibodies against CD18, CD11/18, P-selectin,
L-selectin, ICAM, VCAM, and TNF, estrogen and estrogen receptor
agonists, growth factors, and their isoforms and downstream
signaling mediators, heat shock proteins and their downstream
signaling mediators, GIK, adenosine and adenosine receptor
agonists, NO donors, Na/H exchange inhibitors, Na/K channel openers
and their downstream signaling mediators, Ca channel inhibitors,
beta-adrenergic receptor inhibitors, alpha-adrenergic receptor
inhibitors, free radical scavengers, anti-oxidants, platelet
inhibitors, complement system inhibitors, anti-apoptotic drugs,
genes that encode the peptides listed above or their ligands, or
bio-engineered cells or materials that express the peptides or
glycoproteins listed above or their ligands, and mixtures
thereof.
10. The kit of claim 3, wherein the pressure increasing device is
disposable and is selected from the group consisting of a syringe,
a syringe pump, a reciprocating pump, a gear pump, and a
centrifugal pump having a removable and disposable rotor and pump
housing; and wherein the pressure-sensing device comprises a
disposable piezo-electric pressure sensor.
11. The kit of claim 3, wherein the inflation device comprises: 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.
12. The catheter kit of claim 3, wherein the pressure-sensing
device further comprises a pressure measurement outlet, and the
pressure increasing device further comprises a pressure measurement
inlet, and the catheter kit further comprises a connection between
the pressure measurement outlet of the pressure-sensing device and
the pressure measurement inlet of the pressure increasing
device.
13. The catheter kit of claim 2, wherein the balloon comprises at
least two materials selected from the group consisting of a
polyether block amide resins, polyetheramides, and mixtures
thereof; wherein at least two materials have a Shore D Hardness
less than about 70D; and wherein the balloon, upon inflation, has
at least one of a conical and a tapered shape.
14. A method comprising: accessing a vessel selected from the group
consisting of external femoral, interior femoral, carotid, jugular,
brachial, subclavian, and cephalic with a guide catheter; accessing
a coronary sinus with the guide catheter; feeding a guidewire with
an occlusion device and a retroinfusion balloon catheter to the
coronary sinus, great cardiac vein, posterior vein of left
ventricle, middle cardiac vein, small cardiac vein, or anterior
cardiac vein of right ventricle through the guide catheter;
performing a venogram; deploying the guidewire and the balloon
catheter to one or more targeted vessels; measuring a baseline
parameter in the vein adjacent to a distal end of the balloon
catheter; inflating a balloon at the distal end of the balloon
catheter and engaging the occlusion device at a distal end of the
guidewire, sufficient to make a pressure waveform in the vein
become ventricularized; after inflating the balloon and after
engaging the occlusion device, delivering a liquid comprising at
least one of a drug and a treatment agent through the balloon
catheter to an outlet port on the balloon catheter distal to the
balloon and proximal to the occlusion device.
15. The method of claim 14, further comprising: stopping the
delivering of the liquid; deflating the balloon and disengaging the
occlusion device; removing the catheter from the vessel; and
performing an infusate-uptake-enhancing procedure selected from the
group consisting of electroporation, ultrasonic excitation, and
photodynamic therapy.
16. An apparatus comprising: a cannula having a dimension suitable
for percutaneous advancement through a blood vessel, the cannula
comprising a proximal end and a distal end; a balloon axially
coupled to an exterior surface of the cannula at or adjacent the
distal end of the cannula, the balloon comprising a property such
that when inflated the balloon will expand in size to an outer
diameter sufficient for occlusion of a blood vessel at an inflation
pressure less than sufficient to cause an axial force on an inner
diameter of the blood vessel and sufficient to cause a radial
expansion of the blood vessel.
17. The apparatus of claim 16 wherein the balloon comprises a
property such that during inflation and deflation of the balloon,
the balloon forms a plurality of radial outer diameters; has a
property to cause a post inflation deflated outer diameter of the
balloon to retract to within 20 percent of a pre inflated outer
diameter of the balloon; and includes a balloon material having one
of a modulus of less than 1.5 Mpa, an elongation of at least 500%
at breaking, a tension set of less than 30%, and a tension strength
of at least 200 MPa.
18. The apparatus of claim 16, wherein the balloon comprises one of
a first wall thickness at a first axial distance from the distal
end of the cannula and a different second wall thickness at a
different second axial distance from the distal end of the cannula,
and a first pre inflated outer diameter at a first axial distance
from the distal end of the cannula and a second pre inflated outer
diameter at a second axial distance from the distal end of the
cannula such that when inflated the balloon will expand in size to
a first outer diameter at a first axial distance from the distal
end of the cannula and will expand in size to a different second
outer diameter at a different second axial distance from the distal
end of the cannula.
19. The apparatus of claim 16, wherein the balloon includes a
material comprissing one of polyurethane, and a silicone rubber, a
styrene-isoprene-styrene tri-block co-polymer with between 50
percent and 100 percent isoprene and between zero percent and 50
percent styrene, a silicone polyether urethane, and an aliphatic
polymethane with polydimethyl siloxane backbone; wherein the
silicone rubber is vulcanized with amino-mercaptobenzothrazole; and
wherein the a styrene-isoprene-styrene tri-block co-polymer
includes an additives comprising one of: thiuram disulfide
derivatives (R'R"N--(C=5)-S--S--(C=5- )-NR'R"),
mercaptobenzothiazoles, amino-mercaptobenzothrazole, sulfides, and
azides.
20. A method comprising: winding a plurality of layers of ePTFE
onto a large mandrel; bonding a seam between two of a plurality of
second ePTFE windings; fusing together the layers of ePTFE; heating
the layers of ePTFE at a temperature of approximately 380 degrees
celsius for a duration of between 20 minutes and 30 minutes;
stretching the fused layers of ePTFE onto a small mandrel, wherein
stretching comprises: putting the small mandrel within an inner
diameter of fused ePTFE layers; stretching apart a distal end and a
proximate end of the ePTFE sufficiently to stretch the inner
diameter of fused ePTFE layers onto an outer diameter of the small
mandrel; compacting the stretched fused layers of ePTFE axially;
one of wrapping an outer diameter of the stretched fused layers of
ePTFE with a polytetrafluoroethylene, and constraining the outer
diameter of the stretched fused layers of ePTFE within a steel tube
prior to compacting, and then sufficiently compacting axially
inwards a distal end and a proximate end of the stretched fused
layers of ePTFE, such that during inflation of the lined ePTFE
balloon, the compacted stretched fused layers of ePTFE may not
expand axially bonding a balloon liner to the compacted stretched
fused layers of ePTFE to form a lined ePTFE balloon.
21. An apparatus comprising: a cannula having a dimension suitable
for percutaneous advancement through a blood vessel, the cannula
comprising a proximal end and a distal end; and a filter device
having a proximal portion axially coupled to an exterior surface of
the cannula at or adjacent the distal end of the cannula, and a
distal portion having a first diameter under a first set of
conditions and a different second diameter that under a second set
of conditions is at least equivalent to an inner diameter of a
blood vessel at a region of interest.
22. The apparatus of claim 21, wherein the filter device comprises
a property such that under the second condition, the filter device
will restrain from flowing through the filter device a plurality of
particles having a particle size greater than an average particle
size of blood cells and contained in a fluid flowing through the
filter device, and will allow aspiration of the plurality of
particles from being restrained.
23. The apparatus of claim 21, wherein the filter device comprises
a frame portion defined by the proximal portion and the distal
portion, and a material stretched on the frame portion to form,
under the second condition, a generally conical shaped inner
surface, wherein the material has a plurality of openings, each of
the plurality of openings having a dimension suitable to allow a
fluid to pass therethrough, wherein the frame portion comprises a
plurality of longitudinally disposed elements circumferentially
spaced and defining a conical shape extending from the proximal
portion to the distal portion, and wherein the frame portion
comprises a plurality of anchors proximate to the distal portion,
each of the plurality of anchors comprising a protruding barb
capable of engaging tissue of a blood vessel.
24. The apparatus of claim 21, wherein the filter device has a
property such that the first diameter can be transformed to become
the second diameter in response to one of at least one tendon
coupled to the distal portion of the filter device and the cannula
such that actuation of the tendon transforms the distal portion of
the filter device from the first diameter to the second diameter,
an expansion pressure of between approximately 0.5 atmospheres in
pressure and six atmospheres in pressure applied to the generally
conical shaped inner surface, a self-expanding frame portion to
provide the second set of conditions, at least one balloon coupled
to the filter device and the cannula such that inflation of the
balloon transforms the distal portion of the filter device from the
first diameter to the second diameter.
25. The apparatus of claim 21, wherein the filter device has a
property such that the second diameter can be transformed to become
the first diameter in response to one of at least one balloon
coupled to the filter device and the cannula such that deflation of
the balloon transforms the distal portion of the filter device from
the second diameter to approximately the first diameter, and at
least one tendon coupled at the distal portion of the filter device
and the cannula such that manipulation of the tendon transforms the
distal portion of the filter device from the second diameter to
approximately the first diameter.
26. An apparatus comprising: a cannula having a dimension suitable
for percutaneous advancement through a blood vessel, the cannula
comprising a proximal end and a distal end; a balloon axially
coupled to an exterior surface of the cannula at or adjacent the
distal end of the cannula, the balloon comprising a polymer moiety
represented by the formula: 3wherein PA represents a polyamide
moiety, and PEth represents a polyether moiety, and n represents an
integer of at least one.
27. The apparatus of claim 26, wherein the balloon comprises a
thermoplastic blend copolymer material having one of a polyether
block amide resin moiety and a polyetheramide moiety; comprises a
property such that the balloon will inflate to an inflated outer
diameter that will occlude a blood vessel and deflate to a
post-inflated deflated diameter that will allow the balloon to be
withdrawn from the blood vessel; and comprises a property such that
the balloon has a pre-inflated volume and a post-inflated deflated
volume approximately equal to the pre-inflated volume.
28. The apparatus of claim 26, wherein the balloon comprises a
property such that the balloon will have at least 3 wings prior to
being inflated and after being deflated, wherein 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, wherein a
pre-inflated wing length for each wing is approximately equal to a
post-inflated deflated wing length of each wing; wherein each wing
has an outer diameter point defined by a point of the wing radially
farthest away from an axis of the cannula, and a wing diameter
defined by a length of a straight line extending from the axis of
the cannula, radially out to the outer diameter point, wherein a
pre-inflated wing diameter for each wing is approximately 30
percent less than a post-inflated deflated wing diameter.
29. The apparatus of claim 26, wherein the balloon comprises a
property such that the balloon can achieve a volumetric expansion
of greater than about 40% during inflation and can expanded to an
inflated outer diameter between 1.5 mm and 18 mm in diameter, will
have a double wall thickness between 0.0003 and 0.0038 inches in
thickness and a minimum hoop strength of at least about 23,000 psi
strength; and will have a durometer hardness of between 50 Shore D
and 70 Shore D.
30. An apparatus comprising: a cannula having a dimension suitable
for percutaneous advancement through a blood vessel, the cannula
comprising a proximal end and a distal end; a balloon axially
coupled to an exterior surface of the cannula at or adjacent the
distal end of the cannula, the balloon comprising a property such
that the balloon will inflate to an inflated outer diameter that
will occlude a blood vessel and at a predetermined pressure of
between 0.5 atmospheres and 5.0 atmospheres of pressure.
31. The apparatus of claim 30, wherein the balloon comprises a
property such that the balloon will inflate to one of a
predetermined volume and a predetermined inflated outer
diameter.
32. The apparatus of claim 30, wherein the balloon comprises a
property such that the balloon will inflate to an inflated outer
diameter in a range of between 1.25 mm and 18 mm in diameter, and:
at an inflation pressure of 1 atmosphere the balloon will inflate
to an inflated outer diameter of approximately 10% of a
pre-inflated outer diameter; at an inflation pressure of 2
atmospheres the balloon will inflate to an inflated outer diameter
of at least 20% of the pre-inflated outer diameter; at an inflation
pressure of 3 atmospheres the balloon will inflate to an inflated
outer diameter of at least 30% of the pre-inflated outer diameter;
at an inflation pressure of 4 atmospheres the balloon will inflate
to an inflated outer diameter of at least 40% of the pre-inflated
outer diameter; at an inflation pressure of 5 atmospheres the
balloon will inflate to an inflated outer diameter of at least 50%
of the pre-inflated outer; and at an inflation pressure of 6
atmospheres the balloon will inflate to an inflated outer diameter
of least 60% of the pre-inflated outer diameter.
33. An apparatus comprising: a cannula having a dimension suitable
for percutaneous advancement through a blood vessel, the cannula
comprising a proximal end and a distal end; a balloon axially
coupled to an exterior surface of the cannula at or adjacent the
distal end of the cannula, the balloon comprising a property such
that when inflated to a plurality of selected increasing inflation
volumes the balloon forms a plurality of predictably increasing
radial outer diameters and has an inflation pressure that increases
by less than five percent in pressure.
34. The apparatus of claim 33, wherein the plurality of selected
increasing inflation volumes increase from 0.05 cubic centimeters
to 0.2 cubic centimeters by steps of between 0.005 cubic
centimeters and 0.05 cubic centimeters in volume, the inflation
pressure of the balloon is between 0.5 atmospheres and 5
atmospheres in pressure, the plurality of predictably increasing
outer diameters increase from 2.5 millimeters and 8 millimeters in
diameter by steps of 0.25 millimeters in diameter, includes a
length of the balloon between 5 millimeters and 10 millimeters in
length, and wherein the plurality of predictably increasing outer
diameters are equally spaced increments in diameter of between 0.2
millimeter and 0.4 millimeter increase in diameter.
35. The apparatus of claim 33, wherein the balloon material is at
least one of 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.
36. An apparatus comprising: a cannula having a dimension suitable
for percutaneous advancement through a blood vessel, the cannula
comprising a proximal end and a distal end; a balloon axially
coupled to an exterior surface of the cannula at or adjacent the
distal end of the cannula, the balloon comprises a property such
that when inflated to a first inflation volume, the balloon has a
first inflated axial length and an outer diameter of the balloon
exerts a first inflation pressure on an inner diameter of a blood
vessel sufficient to occlude the blood vessel at a region of
interest, and when inflated to a second greater inflation volume,
the balloon has a second inflated axial length that is sufficiently
greater than the first inflated axial length to allow the outer
diameter of the balloon to exert a second inflation pressure that
is less than five percent greater than the first inflated pressure
on the inner diameter.
37. The apparatus of claim 36, wherein the balloon has a
pre-inflated outer diameter of between 1 millimeter and 3
millimeters in diameter, an inflated outer diameter between 2
millimeters and 20 millimeters at an inflation pressure of between
0.5 atmosphere and 4 atmospheres in pressure, and an inflated axial
length that increases with increasing inflation volume to allow the
balloon to occlude the blood vessel while the balloon inflated
outer diameter maintains an inflation pressure of between 3
atmosphere and 4 atmospheres pressure on an inner diameter of the
blood vessel; and wherein the balloon material is at least one of 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.
38. The apparatus of claim 36, wherein the balloon has a
pre-inflated outer diameter of between 0.025 inches and 0.065
inches in diameter, a pre-inflated length of between 2 millimeters
and 30 millimeters in length, and a pre-inflated wall thickness of
between 0.002 inches and 0.02 inches in thickness, has an inflated
outer diameter of between 1.25 millimeters and 12 millimeters in
diameter, and a wall thickness that decreases by between ten
percent and 75 percent in thickness at an inflation pressure of
between 3 atmosphere and 4 atmospheres in pressure.
39. The apparatus of claim 36, wherein the cannula functions as one
or more of a guide catheter, a delivery catheter, and a guidewire
catheter; and wherein the axial coupling of the balloon to the
cannula includes shrink tube bonding the balloon to a cannula such
that an exterior surface of the balloon forms a symmetrical shape
with respect to an axis of the cannula when the balloon is inflated
over a range of inflation volumes.
40. An apparatus comprising: a cannula having an outer diameter
less than 0.090 inches, a proximal end, and a distal end; a balloon
axially coupled to an exterior surface of the cannula at or
adjacent the distal end of the cannula, the balloon comprising a
property such that when inflated to a selected inflation volume the
balloon will expand in size to an outer diameter sufficient to
occlude the blood vessel; and an infusion lumen having an inner
diameter greater than 0.010 inches extending from the proximal end
to the distal end of the cannula and exiting an infusion opening
distal to the balloon; an accessory lumen extending from the
proximal end to the distal end of the cannula and exiting an
accessory opening distal to the balloon; wherein at least one of
the infusion lumen and the accessory lumen is adapted to have a
guide wire disposed therethrough to guide the cannula through the
blood vessel to a region of interest.
41. The apparatus of claim 40, wherein the cannula has a dimension
suitable to be received within a guide catheter having an outer
diameter in a range between 5 French and 9 French the accessory
lumen has an inner diameter that is less than the inner diameter of
the infusion lumen, and the cannula has a shaft having an outer
diameter less than 0.060 inches.
42. The apparatus of claim 40, wherein the balloon comprises a
property such that the balloon has an inflation pressure of less
than five atmospheres of pressure at the selected inflation volume,
the balloon comprises 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, and
the balloon will expand in size to an outer diameter in a range of
between 1 millimeter and 15 millimeters in diameter controlled by
volume injection of one of a gas and a fluid.
43. The apparatus of claim 40, wherein the cannula further includes
a balloon inflation lumen extending from the proximal end of the
cannula to the balloon; wherein the accessory lumen extends a first
length, the infusion lumen extends a second length, and the
inflation lumen extends a third length in distance beyond the
proximal end of the cannula, and at least one of the first, second
and third length is a different distance in length; and wherein the
accessory lumen has a dimension suitable to infuse a first volume
of treatment agent to the region of interest; and the balloon
inflation lumen has a dimension suitable to inflate the balloon
with a volume of one of a gas and a liquid to an inflation pressure
of less than six atmospheres.
44. The apparatus of claim 40, wherein at least one of the
accessory lumen, the infusion lumen, and the inflation lumen are
attached to a luer adapter at the proximal end of the cannula, and
the luer adapter includes: an infusion port having a spring-loaded
pressure seal; and a balloon inflation port having a syringe.
45. The apparatus of claim 40, wherein the accessory lumen has a
dimension suitable to allow on of a device to be coupled to a
proximal end of the accessory lumen and a device to be disposed
through the accessory lumen to measure of one of CRF, EKG, 02
level, pressure, flow, blood sampling, and temperature at the
region of interest; wherein the infusion lumen and the accessory
lumen each include one of a reinforcing mandrel disposed within the
cannula and extending from the proximal end of the cannula to the
balloon, a braid reinforced polymer tube, and a coil reinforced
polymer tube; and, wherein at least one of the infusion lumen and
the accessory lumen is adapted to receive the guide wire, have the
guide wire disposed therein and exiting a proximal opening at the
proximal end of the cannula such that the cannula can be used in an
over-the-wire fashion, and have the guide wire removed
therefrom.
46. The apparatus of claim 40, wherein the cannula further
comprises a support mandrel disposed within the cannula and
extending from the proximal end of the cannula to the balloon, and
the support mandrel has one of a constant outer diameter of less
than 0.017 inches in diameter, and a proximal outer diameter of
less than 0.017 inches in diameter and steps down to a plurality of
lesser outer diameters to a distal diameter of between 0.012 inches
and 0.003 inches in diameter.
47. The apparatus of claim 46, wherein the support mandrel is
anchored to at least one of a proximal adapter at the proximal end
of the cannula and the cannula where the balloon is coupled to the
exterior surface of the cannula.
48. An apparatus comprising: a cannula having a proximal end, and a
distal end; a balloon axially coupled to an exterior surface of the
cannula at or adjacent the distal end of the cannula, the balloon
comprising a property such that when inflated the balloon will
expand in size to an outer diameter sufficient to occlude the blood
vessel at a region of interest; a guidewire tube extending from the
proximal end to the distal end of the cannula and exiting a
guidewire opening in the distal end of the cannula; an infusion
tube around the guidewire tube extending from the proximal end to
the distal end of the cannula and exiting an infusion opening in
the distal end of the cannula; an inflation lumen defined between
the infusion tube and the cannula; wherein the guidewire tube,
infusion tube, and inflation lumen are co-axially aligned with an
axis of the cannula.
49. The apparatus of claim 48, wherein the inflation lumen extends
from the proximal end of the cannula to the balloon and has a
dimension suitable to inflate the balloon, the infusion tube has an
outer diameter sufficient to infuse a treatment agent to the region
of interest distal to the balloon, and the guidewire tube has a
sufficient outer diameter and is adapted to have a guide wire
disposed therethrough to guide the cannula through the blood vessel
to a region of interest.
50. The apparatus of claim 48, wherein the guidewire tube, the
infusion tube, and the inflation lumen have a circular cross
sectional shape with respect to an axis of the cannula; wherein the
cannula exterior surface has a circular cross sectional shape with
respect to an axis of the cannula where the balloon is axially
coupled to the exterior surface of the cannula; and wherein the
infusion tube is coupled to the exterior surface of the guidewire
tube at a location distal to the balloon.
51. An apparatus comprising: a cannula having a proximal end, and a
distal end; a balloon axially coupled to an exterior surface of the
cannula at or adjacent the distal end of the cannula, the balloon
comprising a property such that when inflated the balloon will
expand in size to an outer diameter sufficient to occlude the blood
vessel at a region of interest; a guidewire tube extending from the
proximal end to the distal end of the cannula and exiting a
guidewire opening in the distal end of the cannula, the guidewire
tube co-linearly or co-axially aligned with an axis of the cannula;
an infusion lumen defined between the guidewire tube and the
cannula; an inflation tube extending from the proximal end of the
cannula to the balloon, the inflation tube co-linearly aligned with
an axis of the cannula.
52. The apparatus of claim 59, wherein the infusion lumen is
co-linearly or co-axially aligned with the cannula; and wherein the
inflation tube extends from the proximal end of the cannula to the
balloon and has a dimension suitable to inflate the balloon, the
infusion lumen has a dimension sufficient to infuse a treatment
agent to the region of interest distal to the balloon, and the
guidewire tube has a sufficient outer diameter and is adapted to
have a guide wire disposed therethrough to guide the cannula
through the blood vessel to a region of interest.
53. The apparatus of claim 59, wherein the guidewire tube and the
infusion lumen have a circular cross sectional shape with respect
to an axis of the cannula; wherein the cannula exterior surface has
a circular cross sectional shape with respect to an axis of the
cannula where the balloon is axially coupled to the exterior
surface of the cannula; and wherein the infusion tube is attached
to the exterior surface of the guidewire tube at a location distal
to the balloon.
54. 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.
55. The apparatus of claim 54, further comprising a first lock
mechanism to releasably secure the first plunger to lock the first
piston at at least one location along the hollow body, a second
lock mechanism to releasably secure the second plunger to lock the
second piston at 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.
56. The apparatus of claim 55, wherein the second lock mechanism
includes an adjustment mechanism to adjust the position of the
second piston to at 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 at
least one location along the hollow inner diameter by rotating the
knob.
57. The apparatus of claim 56, 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.
58. An apparatus comprising: a cannula having a proximal end, and a
distal end; a balloon axially coupled to an exterior surface of the
cannula at or adjacent the distal end of the cannula, the balloon
comprising a property such that when inflated to a selected
inflation volume the balloon will expand in size to an outer
diameter sufficient to occlude the blood vessel at a region of
interest; a lumen extending from the proximal end to the distal end
of the cannula and exiting an opening in the cannula distal to the
balloon; at least one hole through the exterior surface of the
cannula and to the lumen at a location proximal to the balloon to
allow perfusion of a blood and/or a treatment agent between a
location in the blood vessel proximal to the balloon and the region
of interest.
59. The apparatus of claim 58, further including a guidewire
disposed through lumen and slidably adjustable such that a distal
end of the guidewire can be extended past the at least one hole;
wherein guidewire lumen has an inner diameter and the guidewire has
an outer diameter sufficient in diameter to occlude the guidewire
lumen; and wherein the at least one hole includes between four and
eight holes and the guidewire has a dimension to be slidably
adjustable to extend or retract a distal end of the guidewire to a
location past none or any of the holes.
60. The apparatus of claim 58, wherein the at least one hole
includes a plurality of holes having different sizes to perfuse
blood at a flow rate of between a full flow and a plurality of
fractions of the full flow, the different sizes increase in size
from a most distal hole to a most proximate hole, and the holes are
oriented longitudinally with respect to an axis of the cannula.
61. A method comprising: advancing a cannula percutaneously through
a blood vessel to a region of interest, the cannula having a
proximal end, a distal end, and an exterior surface at or adjacent
the distal end of the cannula axially coupled to a balloon,
inflating the balloon from a first diameter to a different second
diameter that is at least equivalent to an inner diameter of a
blood vessel to occlude the blood vessel at the region of interest;
infusing a treatment agent to the region of interest distal to the
balloon; perfusing a blood and/or a treatment agent flow between a
location in the blood vessel proximal to the balloon and the region
of interest.
62. The method of claim 61, wherein perfusing includes: perfusing
blood and/or treatment agent via a lumen extending through the
cannula from a location proximal to the balloon to a location
distal to the balloon, via a proximal hole through the exterior
surface of the cannula and to the lumen at a location proximal to
the balloon, and a distal hole through the exterior surface of the
cannula and to the lumen at a location distal to the balloon.
63. The method of claim 61, wherein inflating includes inflating
the balloon for a first period of time and perfusing includes
deflating the balloon for a second period of time; and at least one
more repetition of inflating, infusing, and deflating.
64. The method of claim 61, wherein perfusing includes: retracting
back a guidewire disposed through a guidewire lumen extending from
the proximal end to the distal end of the cannula and exiting an
opening in the cannula distal to a balloon, for a first period of
time; wherein retracting includes retracting a distal end of the
guidewire from a location distal to at least one hole from the
guidewire lumen through the exterior surface of the cannula and
proximal to the balloon to a location proximal to the at least one
hole.
65. The method of claim 64, further comprising advancing the
guidewire to a location distal to the at least one hole to prohibit
a blood and/or a treatment agent perfusion between a location in
the blood vessel proximal to the balloon and the region of
interest, for a second period of time, and repeating infusing,
retracting and advancing at least once more.
66. The method of claim 64, wherein retracting includes retracting
a distal end of the guidewire to control an amount of a blood
and/or a treatment agent perfusion between a location in the blood
vessel proximal to the balloon and the region of interest by
adjusting the guidewire to extend or retract a distal end of the
guidewire to a location amongst a plurality of the at least one
hole to allow a blood and/or a treatment agent to perfuse between
the holes and the lumen at a selected perfusion rate.
67. The method of claim 61, wherein infusing includes infusing a
volume of a progenitor cell suspension including bone
marrow-derived progenitor cells.
68. The method of claim 61, wherein inflating includes: increasing
an axial length of the balloon; maintaining the inflation pressure
on the inner diameter of the blood vessel.
69. An apparatus comprising: a cannula having a proximal end, and a
distal end; a balloon axially coupled to an exterior surface of the
cannula at or adjacent the distal end of the cannula, the balloon
comprising a property such that when inflated to a selected
inflation volume the balloon will expand in size to an outer
diameter sufficient to occlude the blood vessel at a region of
interest; the cannula having a lumen having a proximal end at a
location proximal to the balloon and extending to a distal end at a
location distal to the balloon, a proximal hole through the
exterior surface of the cannula and to the lumen at a location
proximal to the balloon, and a distal hole through the exterior
surface of the cannula and to the lumen at a location distal to the
balloon.
70. The apparatus of claim 69, wherein the lumen, the proximal hole
and the distal hole have a dimension suitable to allow perfusion of
a blood and/or a treatment agent between a location in the blood
vessel proximal to the balloon and the region of interest, and the
proximal hole has a selected diameter and the distal hole has a
selected diameter to control an amount of a blood and/or a
treatment agent to perfuse between the selected holes and the
lumen.
71. The apparatus of claim 69, wherein the cannula further
comprises one of an infusion lumen extending from the proximal end
of the cannula to a infusion exit through the exterior surface of
the cannula at a location proximal to the balloon to deliver
treatment agent to the blood vessel proximal to the balloon, and an
infusion lumen extending from the proximal end of the cannula to a
infusion exit through the exterior surface of the cannula at a
location distal to the balloon to deliver treatment agent to the
blood vessel distal to the balloon.
72. The apparatus of claim 69, wherein the cannula further
comprises a first infusion lumen extending from the proximal end of
the cannula to a infusion exit through the exterior surface of the
cannula at a location proximal to the balloon to deliver treatment
agent to the blood vessel proximal to the balloon, and a second
infusion lumen extending from the proximal end of the cannula to a
infusion exit through the exterior surface of the cannula at a
location distal to the balloon to deliver treatment agent to the
blood vessel distal to the balloon.
73. The apparatus of claim 69, further comprising: a proximal
balloon axially coupled to an exterior surface of the cannula
proximal to the balloon, the proximal balloon comprising a property
such that when inflated to a selected inflation volume the balloon
will expand in size to an outer diameter sufficient to occlude the
blood vessel proximal to the a region of interest; wherein the
cannula further comprises a first infusion lumen extending from the
proximal end of the cannula to a first exit through the exterior
surface of the cannula at a location between the balloon and the
proximal balloon to deliver treatment agent to the region of
interest, and a second infusion or pressure sensing lumen extending
from the proximal end of the cannula to a second exit through the
exterior surface of the cannula at a location between the balloon
and the proximal balloon to deliver treatment agent to or sense
pressure at the region of interest.
74. A catheter comprising: a shaft comprising a proximal end and a
distal end, and defining a delivery lumen through a portion
thereof, the delivery lumen comprising a proximal end and a distal
end; a delivery port coupled to the distal end of the delivery
lumen; a pressure monitoring lumen, a portion of the pressure
monitoring lumen disposed within the shaft, comprising a proximal
end and a distal end; a pressure port coupled to the distal end of
the pressure monitoring lumen; a balloon inflation lumen, a portion
of the balloon inflation lumen disposed within the shaft,
comprising a proximal end and a distal end; a balloon adjacent to
the distal end of the flexible shaft, the balloon comprising at
least one material selected from the group consisting of polyether
block amide resins, blends of polyether block amide resins, a
composite including an elastomeric material and EPTFE, a
styrene-isoprene-styrene tri-Block co-polymer, and blends and
mixtures thereof; wherein the balloon is adapted to inflate to at
least an elasticity of about 40% at a pre-determined gauge pressure
of about 0.5 to about 6.0 atmospheres; a balloon inflation port
within the balloon and coupled to the distal end of the balloon
inflation lumen; wherein at least one of the delivery lumen and
pressure monitoring lumen are adapted to receive a guidewire.
75. The catheter of claim 74, wherein the delivery lumen is distal
to the pressure monitoring lumen defining at least one of a tapered
and a staggered tip, and the delivery lumen is adapted to receive
the guidewire; or wherein the pressure monitoring lumen is distal
to the delivery lumen defining at least one of a tapered and a
staggered tip, and the pressure monitoring lumen is adapted to
receive the guidewire.
76. A catheter comprising: a shaft comprising a proximal end and a
distal end and defining a delivery lumen through a portion thereof,
the delivery lumen comprising a proximal end and a distal end; a
delivery port coupled to the distal end of the delivery lumen; a
pressure monitoring lumen comprising a proximal end and a distal
end, a portion of the pressure monitoring lumen disposed within the
flexible shaft; a pressure port coupled to the distal end of the
pressure monitoring lumen; a balloon inflation lumen comprising a
proximal end and a distal end, a portion of the balloon inflation
lumen within the flexible shaft; a balloon adjacent to the distal
end of the flexible shaft, the balloon comprising at least one
material selected from the group consisting of polyether block
amide resins, blends of polyether block amide resins, a composite
including an elastomeric material and EPTFE, a
styrene-isoprene-styrene tri-Block co-polymer, and blends and
mixtures thereof; a balloon inflation port coupled to the distal
end of the balloon inflation lumen and the balloon inflation port
within the balloon; wherein a first wall thickness of the balloon
adjacent a proximal end of the balloon is smaller than a second
wall thickness of the balloon adjacent a distal end of the balloon;
and wherein upon inflation, a first diameter of the balloon
adjacent to a proximal end of the balloon is larger than a second
diameter adjacent a distal end of the balloon.
77. The catheter of claim 76, wherein the balloon, upon inflation,
has one of a tapered balloon shape, and a conical balloon
shape.
78. A catheter comprising: a shaft comprising a proximal end and a
distal end, and defining a delivery lumen through a portion
thereof, the delivery lumen comprising a proximal end and a distal
end; a delivery port coupled to the distal end of the delivery
lumen; a pressure monitoring lumen, a portion of the pressure
monitoring lumen disposed within the shaft, comprising a proximal
end and a distal end; a pressure port coupled to the distal end of
the pressure monitoring lumen; a balloon inflation lumen, a portion
of the balloon inflation lumen disposed within the shaft,
comprising a proximal end and a distal end; a balloon adjacent to
the distal end of the flexible shaft, the balloon comprising at
least one material selected from the group consisting of polyether
block amide resins, blends of polyether block amide resins, a
composite including an elastomeric material and EPTFE, a
styrene-isoprene-styrene tri-Block co-polymer, and blends and
mixtures thereof; a balloon inflation port within the balloon and
coupled to the distal end of the balloon inflation lumen; wherein
the delivery lumen is distal to the pressure monitoring lumen
defining at least one of a tapered and a staggered tip, and the
delivery lumen is adapted to receive the guidewire.
Description
[0001] This application 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
co-pending application Ser. No. 10/387,048, filed Mar. 12, 2003,
entitled "Multiple Occlusion Device"; and claims the priority
benefit thereof.
FIELD
[0002] Cardiovascular catheters and occlusion devices.
BACKGROUND
[0003] It is increasingly important that a physician or surgeon
delivering substances, such as a treatment agent or drug, is able
to efficiently and accurately locate the desired target tissue for
effective delivery of the substance. This is particularly true when
the concentration of the substance required at the target site
cannot be safely or effectively achieved by introduction of the
substance to a location remote from the target site. Moreover, the
physician may only want to treat the diseased portion of an organ
or tissue and avoid treating the healthy portions.
[0004] Such localized treatment is desired not only for substance
delivery but is necessary for other treatments, such as myocardial
revascularization. Myocardial revascularization is a procedure in
which "holes" are formed in ischemic ventricular tissue to increase
blood flow to the treated area. It is thought that the tissue
damage (e.g., holes) encourages growth of blood vessels in the
treated area. Thus, similar to substance delivery, myocardial
revascularization is a procedure that is preferably performed only
on specific areas that require treatment.
[0005] For example, to achieve localized treatment of tissue, such
as tissue in a heart, physicians and surgeons can use catheters and
occlusion devices. Specifically, cardiovascular guide catheters are
generally percutaneous devices used to advance through a
vasculature of a patient to a region of interest and are devices
through which another catheter or device may be inserted. Delivery
catheters are generally catheters used to deliver a treatment agent
to a region of interest in a vasculature of a patient and typically
may be inserted through another catheter (e.g., a guide catheter).
Moreover, occlusion devices, such as balloons, may be attached to a
delivery catheter to occlude a region of interest in a vasculature.
Guidewires are generally devices used to guide through a
vasculature of a patient to a region of interest and typically may
be inserted through another catheter (e.g., an introducer).
SUMMARY
[0006] In one embodiment, there is disclosed an infusion-occlusion
system for infusing a treatment agent to a region of interest 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.
[0007] 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 and/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, and/or a filter device that
restricts particles from passing through but does not restrict
fluid, such as blood. Also, according to 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 and/or
a polyetheramide moiety. Likewise, according to 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.
[0008] For instance, according to 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 and/or may have
lumen or tubes in a coaxial or co-linear orientation with the
longitudinal axis of the catheter.
[0009] 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 and/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 prior to 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 region of
interest of the blood vessel for a first time period, then allowing
blood and/or treatment agent perfusion or flow to the region of
interest for a second period of time, and repeating infusing and
perfusion as necessary to accomplish sufficient treatment.
[0010] Specific examples of apparatus to allow for blood and/or
treatment agent perfusion or flow to the region of interest 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
[0011] The embodiments of the invention are illustrated by way of
example and not by way of limitation in the figures of the
accompanying drawings in which like references indicate similar
elements. It should be noted that references to "an" embodiment of
the invention in this disclosure are not necessarily to the same
embodiment, and they mean at least one.
[0012] FIG. 1 schematically illustrates a cross-section of the
heart showing blood flow throughout the heart.
[0013] FIG. 2 schematically illustrates a vertical cross-section of
the heart.
[0014] FIG. 3A illustrates a catheter system having a guide
catheter, delivery catheter, guide wires, and multiple occlusion
devices.
[0015] FIG. 3B shows a sectional side view of FIG. 3A through line
C--C' of FIG. 3A.
[0016] FIG. 4 schematically illustrates the placement of the
catheters of FIGS. 3A and 3B in the coronary sinus.
[0017] FIG. 5 schematically illustrates a guide catheter.
[0018] FIG. 6 shows a sectional view of FIG. 5 through line C--C'
of FIG. 5.
[0019] FIG. 7 is a side view of a cannula and a filter device in a
sheath.
[0020] FIG. 8 is a view of FIG. 7 from perspective "A".
[0021] 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 region
of interest.
[0022] FIG. 10 is a view of FIG. 9 from perspective "B".
[0023] 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 and/or the cannula.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] FIG. 19 is a flow diagram of a process for using a filter
device to restrain and aspirate particles.
[0032] FIG. 20 illustrates a guide catheter with an occlusion
device.
[0033] FIG. 21 illustrates a telescoping guide catheter system.
[0034] FIG. 22 illustrates a balloon catheter tip with a
guidewire.
[0035] FIG. 23 illustrates a balloon catheter tip proximal end.
[0036] FIG. 24 shows a section view of FIG. 23 through Line
D-D'.
[0037] FIG. 25 schematically illustrates a delivery catheter
system.
[0038] FIG. 26 schematically illustrates a side elevational view of
a delivery catheter.
[0039] FIG. 27 schematically illustrates a side view of the distal
portion of the delivery catheter of FIG. 26.
[0040] FIG. 28 schematically illustrates transverse cross-sections
of the delivery catheter of FIG. 26 taken along the line 9-9.
[0041] FIG. 29 schematically illustrates transverse cross-sections
of the delivery catheter of FIG. 26 taken along the line 9-9.
[0042] FIG. 30 schematically illustrates a catheter system.
[0043] FIG. 31 schematically illustrates a sectional view of a
catheter with a self inflating balloon.
[0044] FIG. 32 schematically illustrates the placement of a
catheter in the coronary sinus.
[0045] FIG. 33 schematically illustrates the diaphragmatic surface
of the heart.
[0046] FIG. 34 schematically illustrates the sternocostal surface
of the heart.
[0047] FIG. 35 schematically illustrates a partial cross-sectional
perspective view of a catheter within the coronary sinus.
[0048] FIG. 36 illustrates a tapered balloon catheter tip.
[0049] FIG. 37 illustrates a balloon catheter tip with a
guidewire.
[0050] FIG. 38 illustrates a balloon catheter tip with a
guidewire.
[0051] FIG. 39 schematically illustrates a catheter within a
vein.
[0052] FIG. 40 illustrates a guidewire tip with an occlusion
device.
[0053] FIG. 41 illustrates a guidewire with an occlusion
device.
[0054] FIG. 42 illustrates the guidewire of FIG. 41 with the
occlusion device open.
[0055] FIG. 42B, is a front view of FIG. 42A from perspective
"A".
[0056] FIG. 42C, is a side of the occlusion device of FIG. 42A
showing the occlusion device overlapping leaflets.
[0057] FIG. 43 illustrates a guidewire with an occlusion
device.
[0058] FIG. 44 is a cross-sectional view of a cannula and a
balloon.
[0059] FIG. 45 is a cross-section view of a cannula and a lined
ePTFE balloon.
[0060] FIG. 46 is a flow diagram of a process for forming a lined
ePTFE balloon.
[0061] FIG. 47 is an elevated cut-away view of layers of ePTFE
windings.
[0062] FIG. 48 is a cross section view of a cannula and a
balloon.
[0063] FIG. 49A is a cross sectional view of a cannula and a
balloon inflated to occlude a blood vessel.
[0064] FIG. 49B may be a cross sectional view of FIG. 49A from
perspective "A", according to an embodiment.
[0065] FIG. 50 is a cross sectional view of a cannula and a
postinflated deflated balloon.
[0066] FIG. 51 is a cross sectional view of FIG. 48 from
perspective "A".
[0067] FIG. 52 is a cross sectional view of FIG. 49A from
perspective
[0068] FIG. 53 is a cross sectional view of FIG. 50 from
perspective
[0069] FIG. 54 is a flow diagram of a process for using a balloon
to occlude a blood vessel or vein.
[0070] FIG. 55 illustrates a balloon outside diameter growth
rate.
[0071] FIG. 56 illustrates a graph of blood vessel pressure over
time.
[0072] FIG. 57 illustrates a cross-sectional view of a centrifugal
pump.
[0073] FIG. 58 schematically illustrates a pressure increasing
device.
[0074] FIG. 59 schematically illustrates a pressure increasing
device.
[0075] FIG. 60 schematically illustrates a pressure transferring
device.
[0076] FIG. 61 schematically illustrates a pressure-maintaining or
dampening device.
[0077] FIG. 62 schematically illustrates a pressure-maintaining or
dampening device with inlet and outlet.
[0078] FIG. 63 is a flow diagram of a method of treating a patient,
in accordance with an embodiment.
[0079] FIG. 64A is a cross sectional view of a cannula and a
balloon.
[0080] FIG. 64B is a cross-sectional view the apparatus of FIG. 64A
from perspective "A".
[0081] FIG. 65A shows the balloon and cannula of FIG. 64A, with the
balloon inflated to a second inflation volume.
[0082] FIG. 65B is a cross-sectional view the apparatus of FIG. 65A
from perspective "A".
[0083] FIG. 66A shows the cannula and balloon of FIG. 65A, with the
balloon inflated to a third inflation volume.
[0084] FIG. 66B is a cross-sectional view the apparatus of FIG. 66A
from perspective "A".
[0085] FIG. 67A shows the cannula and balloon of FIG. 66A, with the
balloon inflated to a selected fourth inflation volume.
[0086] FIG. 67B is a cross-sectional view the apparatus of FIG. 67A
from perspective "A".
[0087] 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.
[0088] 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.
[0089] FIG. 69B is a cross section view of the first section of
FIG. 69A from perspective "A".
[0090] FIG. 69C is a cross sectional view of the second section of
FIG. 69A from perspective "B".
[0091] FIG. 69D is a cross sectional view of the balloon section of
FIG. 69A from perspective "C".
[0092] FIG. 69E is a cross sectional view of the third section of
FIG. 69A from perspective "D".
[0093] FIG. 69F is a cross section view of the fourth section of
FIG. 69A from perspective "E".
[0094] 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.
[0095] FIG. 71A is a cross-sectional view of a cannula and a
balloon, where the cannula includes coaxially aligned lumens.
[0096] FIG. 71B is a cross-sectional view of the apparatus of FIG.
71A from perspective "A".
[0097] FIG. 72A is a cross-sectional view of a cannula and a
balloon, where the cannula includes coaxially and co-linearly
aligned lumens.
[0098] FIG. 72B is a cross-sectional view of the apparatus of FIG.
72A from perspective "B".
[0099] FIG. 73 is a cross-sectional view of a cannula and a
balloon, where the cannula has coaxially and co-linearly aligned
lumens.
[0100] FIG. 74 is a cross-sectional view of the apparatus of FIG.
71A from perspective "C" prior to forming tack joints between the
guidwire tube and the infusion tube.
[0101] FIG. 74B is the structure of FIG. 74A after forming tack
joints between the guidwire tube and the infusion tube.
[0102] FIG. 75A is a cross sectional view of an apparatus to
inflate a low volume balloon to occlude a blood vessel.
[0103] FIG. 75B is a cross-sectional view of the apparatus of FIG.
75A from perspective "A".
[0104] FIG. 76 shows the latch mechanisms of FIG. 75A in an
unlatched position.
[0105] FIG. 77 shows the latch mechanisms of FIG. 76 relatched.
[0106] FIG. 78 shows FIG. 77 after the inflation volume adjustment
knob has been rotated or turned to retain fluid.
[0107] 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.
[0108] FIG. 80 shows FIG. 79 after unlatching inner the plunger
lock to deflate the balloon.
[0109] FIG. 81 shows an alternate embodiment of an apparatus to
perform the functions of FIG. 75A-80.
[0110] FIG. 82 is a flow diagram of a process for treating a region
of interest of a blood vessel with one or more treatment agents
and/or progenitor cells.
[0111] 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.
[0112] FIG. 84 is a cross-sectional view of FIG. 83 from
perspective "A".
[0113] FIG. 85 is a cross-sectional view of the apparatus shown in
FIG. 83 advanced to a region of interest of a blood vessel.
[0114] 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.
[0115] FIG. 87 shows the apparatus of FIG. 86 where the infusion
lumen extends to a location distal to balloon 8810.
[0116] 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.
[0117] 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
[0118] Referring first to FIG. 1, a simplistic 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.
[0119] 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.
[0120] Referring now to FIG. 3A, a catheter system having a guide
catheter, a delivery catheter, guidewires and multiple occlusion
system is illustrated. In one embodiment, 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 and/or guidewire 330. In one embodiment, lumen 304
extends the length of guide catheter 302 from proximal portion 305
to distal portion 306. Representatively, in a procedure, a
guidewire, such as guidewire 320 and/or 330 may be initially placed
through a region of interest in a physiological lumen (e.g., a
blood vessel) and guide catheter 302 is advanced on/over the
guidewire to or through a region of interest 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). It is appreciated that a guidewire, such as guidewire 320
and/or guidewire 330 may be retracted or removed once system 300 is
placed at a region of interest.
[0121] System 300 includes guide catheter 302 having lumen 304
therethrough. 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 is provided
at distal end 312. Notch 316 is located at distal end 312 and
guidewire opening 318 into lumen 313 of delivery catheter 310 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 as described herein attached to the
exterior surface of guidewire 320 at or adjacent distal end 322 by
adhesive, heat bonding, laser bonding, and/or shrink wrap bonding,
such is as described herein. 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 as described herein attached to the
exterior surface of guidewire 330 at or adjacent distal end 332 by
adhesive, heat bonding, laser bonding, and/or shrink wrap bonding,
such is as described herein. 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.
[0122] Proximal portion 305 of system 300 may reside outside the
body of a patient while the remainder of system 300 is
percutaneously introduced into, for example, the vascular system of
a patient via 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 one
embodiment, 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. In accordance with embodiments,
treatment agent delivery lumen 319 may be used to infuse a
treatment agent including a liquid, a drug, infusion pellets,
suspended cells, stem cells, microspheres, a peptide, a growth
factor, and/or various other appropriate liquids, materials, and
therapeutic agents (mixed or not mixed with blood) to be delivered
locally and/or to a region of interest in a blood vessel, as
described herein. Also, a treatment agent may include performing an
infusate-uptake-enhancing procedure such as of electroporation,
ultrasonic excitation, and/or photodynamic therapy. A proximal
portion of hub 351 flares to separate 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, and/or hub 351 may include additional
lumen, tubes, cannula, as described herein, such as to inflate or
expand occlusion devices, balloons, and/or to provide pressure
measurements and/or relief.
[0123] For example, in one embodiment, 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 and/or particles from a region of interest 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.
[0124] 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,
and/or control of a guidewire, such as guidewire 320 and/or
guidewire 330, a catheter, such as guide catheter 302 and/or
delivery catheter 320, and/or other functions identified above for
hub 351.
[0125] 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.
[0126] According to 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 and/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; and/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 and/or lumen tubes, such as described below with respect to
infusion lumen 9520 and/or accessory lumen 9530 of FIGS. 69A-F),
syringes, pressure increasing devices, pressure transfer devices,
pressure maintaining devices, and/or pumps described below made of
a material including materials described above.
[0127] In use, system 300 may be refered 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 and/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 lumen 131 over guidewire 320. This "over the wire"
(OTW) is also known as monorail. Then, balloon 314 may be inflated
to occlude the blood vessel and/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 and that occlusion devices 324
and/or 334 may be expanded to occlude blood vessels, such as at one
or more locations to define a distal end of a region of interest or
treatment area to be treated by a treatment agent infused into the
blood vessel from treatment agent delivery lumen 319 of delivery
lumen 310 (e.g., where the region of interst, treatment agent, and
infusion of treatment agent from the delivery catheter are in
accordance with corresponding descriptions herein).
[0128] 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 after guide catheter 302 is placed through a
region of interest in an OTW fashion, or before guide catheter 302
is placed through a region of interest 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 and/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 coronary sinus.
[0129] 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.
[0130] 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 and/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
and/or balloon 510 may correspond to lumen 304 and/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.
[0131] 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 fed through or
disposed through guide catheter opening 514 and extended into a
portion of balloon 510, such as to provide opening 513 to inflate
balloon 510.
[0132] In one embodiment, proximal end 504 includes guide catheter
opening 514 and balloon inflation cannula 512. Also provided is
valve device 516, with selector mechanism 518. Guide catheter 502
may have an opening extending from 1 umen 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, such as into
collecting reservoir 524 which may or may not be attached to nozzle
520 such as by a hose over and fastened by friction or a clamp to
nozzle 520. Thus, selector mechanism 518 may be engaged, for
example, to aspirate fluid such as blood and/or particles such as
described herein (e.g., see hole 988 of FIG. 9 and accompanying
text), form a region of interest 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, prior to deflating balloon
510 so that fluid will be removed from the vessel.
[0133] According to embodiments, guide catheter 502 may be an
appropriate length for reaching a region of interest 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 as described
above. 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.
[0134] In another embodiment, 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, and/or a synthetic or natural latex or
rubber, and/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 and/or treatment agent from flowing by flap
519. Thus, flap 519 serves to seal off guide catheter opening 514
when there are no devices disposed in or through guide catheter
opening 514 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, cannula or cannula is removed from guide catheter opening
514 and/or pushing flap 519 open, flap 519 has a property that
causes flap 519 to resist or occlude a flow of any liquid or
particles flowing from lumen 508 towards guide catheter opening
514. Hence, after the device, cannula or cannula is removed from
pushing flap 519 open, flap 519 has a property and/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 forrce 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.
[0135] In another embodiment, proximal end 504 of guide catheter
502 includes sealing cap 530 adapted to seal off guide catheter
opening 514 instead of valve device 516 or flap 519. Sealing cap
530 serves to seal off guide catheter opening 514 such as by having
threads that engage 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 region of interest of a vessel as described above with
respect to valve device 516. More particularly, cap 530 may be
attached to guide catheter 502 until such time as it is desired to
aspirate a vessel distal to balloon 510 (e.g., such as after the
balloon is inflated and prior to 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.
[0136] Furthermore, according to embodiments, catheters described
herein, such as a guide catheter, include a filter device capable
of restricting certain particles from passing therethrough but not
restricting the flow of fluid, such as blood. 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 described herein
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 region of interest 996 as described
below.
[0137] 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, for example, 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.
[0138] 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 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
first diameter in a range 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.
[0139] 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.
[0140] 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
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 prior to
removal) so that sheath 790 may be entirely or partially removed
from encasing cannula 710 and/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 different 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.
[0141] In one embodiment, 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 region of interest. 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
region of interest 996.
[0142] Note that region of interest 996 may be a region of interest
proximate to where distal portion 724 contacts blood vessel 990,
and optionally including 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
region of interest, or a diameter slightly greater than that of a
diameter of a blood vessel at a point or region of interest. More
particularly, second diameter D2 may be greater than the diameter
of blood vessel 990 at a point or region of interest, 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.
[0143] 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 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 blood 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.
[0144] Also, according to embodiments, filter device 720 may
include 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.
[0145] Furthermore, according to embodiments, filter device 720 may
have a property, such as by 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, and/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 region of interest 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.
[0146] Consequently, according to embodiments, filter device 720
may include a material, such as material 930 having or pierced by
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 therethrough, 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,
and/or a strainer of particles to restrain particles 980. Moreover,
according to 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 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, and/or
various other appropriate filtration materials.
[0147] 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
structure having space between pieced of the structure or holes in
the frame), and or various other appropriate attachment methods as
described herein.
[0148] For example, filter device 720 may include a frame portion
defined by proximal portion 722 and distal portion 724. According
to 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), and/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 region of interest 996, such as is described
herein (e.g., see hole 988 of FIG. 9 and accompanying text).
[0149] 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), and/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 and/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.
[0150] 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 and/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 and/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 one embodiment, it is contemplated that second
diameter D2 approximates an inner diameter of a coronary sinus of a
subject at a region of interest, 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 and/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.
[0151] 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 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.
[0152] Furthermore, according to 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 a "M" shape, a flat shape, a "C" shape, a
"S" shape, and/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 as
described herein 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.
[0153] Once particles are restrained, such as is described above
with respect to filter device 720 restraining particles, material,
and matter, according to 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, and/or microspheres out of the
treatment zone or region of interest, 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 embodiments lumen
989 may include a surrounding material, sleeve, cannula or lumen,
such as described below with respect to infusion lumen 9520 and/or
accessory lumen 9530 of FIGS. 69A-F. Hole 988 may be located
between 0.2 mm and 10 mm cm from the end of distal end 714.
[0154] 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, and/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 and/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 ata 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 embodiments,
the balloons may be attached to the filter device and/or cannula at
attachments locations 1129 and/or 1139, such as by an adhesive,
heat bonding, laser bonding, welding, or stitching.
[0155] 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).
[0156] 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 one embodiment, inflated balloons
1142 and 1144 may be balloons 1132 and 1134 respectively, after
inflation to become balloons 1142 and 1144. Note that according to
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.
[0157] Also, according to embodiments, filter device 720 may
include anchors proximate to distal portion 724 for engaging
tissue, to anchor filter device 720, and/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 as described
herein. 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 and/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.
[0158] 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 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 one
embodiment, 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).
[0159] 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 betweeen 100 percent and 130 percent of D10.
[0160] 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 prior to actuation.
[0161] Moreover, tendons 1430 and 1440 may be of various suitable
materials such as natural or synthetic fiber, plastic, stainless
steel and/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, and/or an
aspiration hole such as hole 988 (see FIG. 9 and accompanying
text), and/or a small wheel.
[0162] 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 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.
[0163] 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.
[0164] Suitable actuation and/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.
[0165] According to 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).
[0166] 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.
[0167] Note that FIG. 14 also shows third angle A.sub.3 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 embodiments, third angle A.sub.3 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..
[0168] According to 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, and/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 and/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
and/or manipulation of tendons attached to the distal portion, as
described above.
[0169] 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 andlumens 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 FIGS. 12 and/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,
and/or 1740 may exit cannula 710 through exit holes or openings in
the proximal end, distal end, and/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, and/or
1740 may be lumens sufficient for passing inflation gas and/or
fluid through, such as for inflating and deflating balloons 1132,
1134, 1142, and/or 1144 as described above (see FIGS. 11-13 and
accompanying text). Also, lumens 1712, 1714, 1716, 1718, and/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, and/or 1740 may be lumens
sufficient for extending, acuating, releasing, extending,
maniuplating, and/or pulling tendons 1430, 1440, 1450, and/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, and/or 1470).
[0170] 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,
and/or 1740 may be include a surrounding material, sleeve, cannula
or lumen, such as described below with respect to infusion lumen
9520 and/or accessory lumen 9530 of FIGS. 69A-F
[0171] In addition, according to embodiments, any or all of lumens
1712, 1714, 1716, 1718, and/or 1740 may be used to inflate and/or
deflate a balloon (e.g., such as balloons 1132, 1134, 1142, and/or
1144 as described above with resepect to FIGS. 11-13 and
accompanying text) as well as have a tendon extending therethrough
(e.g., such as for acuating, releasing, extending, manipulating,
and/or pulling tendons 1430, 1440, 1450, and/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.
[0172] 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 and/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, and/or to provide
for pressure release, such as by providing those capabilities as
described herein for filter 720, devices other than filter 720,
and/or at various regions of interest other than region of interest
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.
[0173] Although FIG. 17 shows four lumens extending through cannula
710, according to embodiments, any number of lumens may be
associated with cannula 710, filter device 720 other devices,
and/or regions of interest as described herein. Constraints on the
number of lumens that may be associated with cannula 710, include
the number lumen and/or cannula necessary for a particular purpose
and the overall size (e.g, inner and/or outer diameter) of a system
for delivery of a treatment agent to a region of interest. 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, and/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, and/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, and/or 1818 may be a
lumen such as is described above with respect to lumen 1712.
[0174] 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 region of interest such as a
region in a coronary sinus of a subject.
[0175] 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 region of
interest, such as diameter of vessel DV of blood vessel 990 at
region of interest 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 region of interest. 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.
[0176] At block 1930 particles, material, and/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, and/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 region of interest 996 (e.g., to treat vessel 990 at
region of interest 996). During or after delivery of the liquid,
particles, material, and/or matter, such as described above, as
well as stem cells, microspheres, metal, particles from devices,
pieces of tissue, and/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.
[0177] For instance, in one embodiment, at block 1935 a treatment
agent mentioned herein is infused to a region of interest of a
blood vessel, such as described herein with respect to FIGS. 3, 63,
69A-70, and 82. Specifically, a treatment tagent may be infused to
a region of interest 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, as
described herein.
[0178] 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 and/or lumen 1712 (e.g., see FIG. 9 and
accompanying text). It is contemplated that aspirating may occur
during delivery of liquid and/or after delivery of liquid as
described above at block 1930.
[0179] 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).
[0180] 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).
[0181] Note that according to 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 as described herein attached to cannula 710
instead of and at the location of filter device 720. Specificially,
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 ballon in place of filter
device 720.
[0182] 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 one embodiment, material 2012 may act as an
occlusion device, such as by having no holes through it, and/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.
[0183] 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.
[0184] 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.
[0185] 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 and/or particles from a vessel distal to device 2006.
[0186] 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.
[0187] 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 and/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 as described herein such as occlusion device 2006,
or may be filter device such as filter device 720.
[0188] Inner guide catheter 2102 has first curve 2114, and outer
guide catheter 2100 has second curve 2116. For example, according
to 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
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
and/or inner guide catheter 2102, distal end 2103 may be steered
and tracked through a vessel network.
[0189] Note that according to embodiments proximate end 712 of FIG.
7, a proximate end of guide catheter 2000, and/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, and/or
guide catheter 2100, or any other guide catheter as described
herein.
[0190] 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 and/or deflate first balloon
2204. There is also provided second balloon 2250, with second
balloon 2250 distal to first balloon 2204. First balloon 2204
and/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, and/or heat bonding) as
described herein.
[0191] First balloon 2204 may be a distance from second balloon
2250 sufficient to block a proximal and a distal end of a region of
interest, 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.
[0192] Moreover, according to embodiments, first balloon 2204
and/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 embodiments, first balloon 2204 and/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).
[0193] First balloon 2204 and second balloon 2250 may be the same
shape, size, and/or material, or first balloon 2204 may have a
different shape, size, and/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 and/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.
[0194] Pressure-sensing cannula 2210 has distal end and pressure
sensing opening 2212, which enables pressure-sensing, such as via a
pressure sensing device as described herein 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.
[0195] In one embodiment, 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 one embodiment,
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; and/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.
[0196] 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, and/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 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.
[0197] 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.
[0198] 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 as
described herein 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.
[0199] 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 as described
herein 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
and/or treatment agent as described herein and to a region of
interest, to provide a treatment or treatrnent 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 and/or occlusion device 2248 at a desired region within a
vessel as described herein.
[0200] 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.
[0201] 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 as described herein 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 embodiments, delivery catheter 2520 or any
delivery catheter as described herein 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, and/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 as
described herein may have cross-sectional area suitable for
advancing into a cardiovascular system of a patient and to deliver
a treatment agent to a region of interest 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.
[0202] 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 as described herein
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 and/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.
Cptionally, 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 and/or accessory lumen 9530 of FIGS. 69A-F.
[0203] 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 and/or accessory lumen 9530 of FIGS. 69A-F.
[0204] 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.
[0205] In one embodiment, 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, as
described herein, can be used for measuring other parameters
including flow, oxygen saturation, pH, and/or temperature.
Similarly, a pressure-sensing device, as described herein, 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 as
described herein (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).
[0206] 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 one embodiment, 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 one
embodiment, shaft 2622 is made of a biocompatible polymer such as a
polyether block amide resin, for example, PEBAX.RTM., 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.
[0207] To allow percutaneous introduction of delivery catheter 2620
in a peripheral vein, in one embodiment, 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.
[0208] In some embodiments, delivery cathters described herein
(e.g., such as balloon catheter 2200, delivery catheter 2520,
and/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, and/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 as described herein (e.g., such as catheter 302, 502,
2000, and/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 region of interest of
a blood vessel to be treated by infusing a treatment agent (e.g.,
such as by infusion through system 2500, as described above).
[0209] In one embodiment, 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).
[0210] In one embodiment, 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.
[0211] 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 one embodiment, delivery lumen 2628 preferably has a
cross-sectional area no less than about 4 mm.sup.2 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 one embodiment,
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.
[0212] 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 one
embodiment, 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 one
embodiment, 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,
and/or by an inflation device such as apparatus 9700 or 9800 of
FIG. 75A-81.
[0213] In one embodiment, 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.
[0214] In one embodiment, 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.
[0215] 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 one embodiment, 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 and/or
accessory lumen 9530 of FIGS. 69A-F.
[0216] 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."
[0217] 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.
[0218] 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 and/or accessory lumen 9530 of FIGS. 69A-F.
[0219] 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 and/or protecting the coronary
sinus from excessive infusion pressure. In one embodiment, pressure
in the range of aboutzero to about five mmHg could be measure at
port 2644.
[0220] 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 and/or the guidewire may be provided with a
balloon on a distal end of the guidewire.
[0221] 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 one
embodiment, 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 one embodiment configuration,
first bend 2650 subtends an angle A of between about 200 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.
[0222] 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).
[0223] In one embodiment, 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).
[0224] 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 one embodiment, the treatment
agent is a mixture of blood and a treatment agent such as an
antioxidant, in one embodiment at a ratio or four parts blood to
one part antioxidant solution (by volume). This antioxidant
solution may be mixed into oxygenated blood.
[0225] 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 one embodiment 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.
[0226] 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, as described herein).
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, as described herein)
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, and/or pressure-dampening device 3052
(for example, 5900, 6000, 6100).
[0227] 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, as described herein), where
inflation lumen has opening 3037 (for example, 2637, 3172), which
serves to inflate and/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,
as described herein) 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
and/or accessory lumen 9530 of FIGS. 69A-F.
[0228] 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, as described herein),
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 and/or
accessory lumen 9530 of FIGS. 69A-F.
[0229] In one embodiment, 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, and/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, and/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, and/or any device or
apparatus, as described herein. Specifically, controller 3080 may
be used to control inflation and/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 as described herein with a selected inflation pressure or
volume.
[0230] 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), and/or a period of time during which blood and/or
treatment agent is allowed to perfuse or flow through a region of
interest 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, and/or
processes described herein (e.g., such as according to the process
described with respect to FIGS. 3, 19, 54, 55, 63, and/or 82).
[0231] 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.
[0232] 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.
[0233] 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 and/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.
[0234] 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.
[0235] 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.
[0236] 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 one embodiment, markers 3218
are radiopaque.
[0237] 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.
[0238] 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.
[0239] 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.
[0240] 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.
[0241] 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.
[0242] 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 and/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.
[0243] Staggered tip of catheter 3600 may enable easier tracking of
distal end 3602 of catheter through a blood vessel. In one
embodiment, pressure-sensing lumen 3610 and/or catheter body 3620
adjacent pressure-sensing lumen 3610 have tapered cut 3622 which
may be curved. According to 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 one embodiment, distance
L, 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 one embodiment, L, 3624 may be between
about 0.5 millimeters and five millimeters.
[0244] 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 and/or curved shape 3622.
[0245] 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.
[0246] 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 and/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 one embodiment, pressure-sensing lumen 3710 and/or
catheter body 3720 adjacent pressure-sensing lumen 3710 have
tapered cut 3722 which may be curved. According to 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.
[0247] 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 and/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.
[0248] Staggered tip of catheter 3800 may enable easier tracking of
distal end 3802 of catheter through a blood vessel. In one
embodiment, pressure-sensing lumen 3810 and/or catheter body 3820
adjacent pressure-sensing lumen have tapered cut 3822 which may be
curved. According to 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 one embodiment, 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 one embodiment, L.sub.1 3824 may be between
about 0.5 mm and about five mm.
[0249] 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.
[0250] 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.
[0251] 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 one embodiment, 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.
[0252] In one embodiment, 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 and/or formed in a tapered shape,
or otherwise formed so that balloon 3947 will assume a tapered
shape when inflated.
[0253] In one embodiment, 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 one embodiment, 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 one embodiment, pressure-sensing device
is disposable. In another embodiment, pressure-sensing device is a
disposable piezo-electric pressure sensor, for example, a
piezo-electric pressure sensor manufactured by Utah Medical
Products, Inc., which is attached to fitting 2648 (shown in FIG.
26).
[0254] In one embodiment, 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 one
embodiment, 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,
and/or contrast medium by the inflation device.
[0255] 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 and/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 one embodiment,
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 one embodiment, L,
is between about 0.005 inches and 0.025 inches.
[0256] 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.
[0257] 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).
[0258] 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, prior to 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, and/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.
[0259] In one embodiment, occlusion device 4108 may be provided
with leaflets and/or fold lines to ease deployment and recapture of
occlusion device. For instance, in one embodiment, 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.
[0260] 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, and/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), and/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 and/or restrain
occlusion device 4304 (e.g., sheath 4310 may be a material and/or
function as described above for sheath 790 or 4106 as described
above with respect to FIGS. 7-9, and 41 respectively).
[0261] According to 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.
[0262] 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.
[0263] According to embodiments, occlusion devices may include
various types of balloons made of various materials and according
to various manufacturing techniques. For example, in one
embodiment, 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; and/or any other catheter, cannula, tube,
sheath, balloon or occlusion device, as described herein, 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 one embodiment, 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.
[0264] In fact, in some embodiments, balloons mentioned above, or
other balloons or occlusion device, as described herein, may
include various types of a high-compliance and/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,
as described herein) 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.
[0265] According to 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 (and/or at an inflation volume as described
herein with respect to balloon 8810 and/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.
[0266] 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 embodiments, pressure PR may be
a pressure sufficient to cause balloon 4520 to occlude the blood
vessel without radially expanding the blood vessel.
[0267] 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
one embodiment, 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 one embodiment, 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.
[0268] 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 one embodiment, 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.
[0269] 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 one embodiment, 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.
[0270] 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, and/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.
[0271] 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; styrene-isoprene-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.
[0272] 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 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,
as described herein.
[0273] According to 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 (and/or at an inflation volume as described
herein with respect to balloon 8810 and/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 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.
[0274] 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
and/or low-tension balloon, such as a balloon that expands radially
and longitudinally upon inflation and/or forms a plurality of
radial outer diameters during inflation and deflation, but does not
form wings. In addition, according to embodiments, pressure PR may
be a pressure sufficient to cause balloon 4520 to occlude the blood
vessel without radially expanding the blood vessel.
[0275] 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,
and/or windings of ePTFE material may be porous and/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 and/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 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.
[0276] Thus, according to 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.
[0277] 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 and/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 region of interest
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 and/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 and/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 region of interest 4496).
[0278] 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.
[0279] Likewise, according to embodiments, balloon 4420, and/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 and/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 and/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 and/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
embodiments, cannula 4410 of FIGS. 44 and 45 may be a guide
catheter, a delivery catheter, and/or a guidewire, such as
described herein.
[0280] In addition, according to 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.
[0281] 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 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.
[0282] In addition, according to 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 and/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, and/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..
[0283] 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
embodiments, sufficient ePTFE layers and windings may be provided
so that ePTFE layers and/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.
[0284] At block 4630, layers and/or windings of ePTFE, such as from
block 4620, are fused together, such as by heating the layers
and/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 and/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.
[0285] 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 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 prior to inflation. For example,
the small mandrel may have an outer diameter between two and three
mm larger than deflated diameter DM of balloon 4520.
[0286] 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 maybe
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
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
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.
[0287] Furthermore, according to 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.
[0288] Moreover, it is contemplated that the large mandrel and/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.
[0289] 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 prior to
bonding to a balloon liner. Specifically, inner diameter 4538 of
ePTFE layers 4510 may be modified with a plasma polymerization of
acrylic acid and/or a chemical etch of sodium naphthalene prior to
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 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.
[0290] 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 and/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 prior to bonding the balloon liner to the compacted
stretched fused layers of ePTFE.
[0291] According to one embodiment, 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, and/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.
[0292] After bonding the liner to the layers of ePTFE, the
constraining tape and/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
and/or distal end 4424 of balloon 4420 and/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
and/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.
[0293] 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, as described herein 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, and/or a co-polymer of an olefin and one
or more other material(s). In one embodiment, a filter device,
catheter, cannula, tube, sheath, or balloon or occlusion device, as
described herein, may have a coating applied to its inside and/or
outside surface, such as, for example, a hydrophilic coating.
[0294] Additionally, in one embodiment, a filter device, catheter,
cannula, tube, sheath, balloon or occlusion device, as described
herein, may be made of or include a material that minimizes
allergic reactions and/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 and/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.
[0295] In one embodiment, 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 as described herein 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 one embodiment, 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.
[0296] It is also considered that a balloon as described herein 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 prior to 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.
[0297] In some embodiments, a balloon as described herein may be
made from or include material such as a polyether block amide, a
polyetheramide, and mixtures thereof. Similarly, a balloon as
described herein 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 as described herein 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: 1
[0298] (Where PA represents a polyamide segment, and PEth
represents a polyether segment, and "n" represents an integer of at
least one.)
[0299] In an embodiment, a balloon as described herein to be
inflated to a selected inflation pressure and/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 and/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, and/or tube as described herein.
[0300] In some embodiments, a balloon or occlusion device, as
described herein 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 and/or treatment agent). Balloon 4820 may
be a balloon, occlusion device, or filter device such as described
herein.
[0301] Furthermore, according to embodiments, balloon 4820 may
include material or matter having a polymer moiety represented by
the formula 2
[0302] 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 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 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.
[0303] According to 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.
[0304] Consequently, according to 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 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, and/or a
predetermined inflated outer diameter, such as second diameter
D2.
[0305] 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 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.
[0306] 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.
[0307] According to 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.
[0308] Furthermore, according to embodiments, balloon 4820 may
include a property such that it has at least three wings prior to
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 prior to 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.
[0309] 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 region of interest.
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 embodiments, second diameter D2 may be a
diameter sufficient to occlude a blood vessel, such as blood vessel
4890.
[0310] Further, balloon 4820 may include a property such that the
balloon will have at least three wings prior to 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 prior to
inflation in FIG. 49A and after being inflated and deflated in FIG.
53, the wing length of wing 4852 prior to inflation is
approximately equal to that for wing 4852 after being inflated and
deflated.
[0311] However, according to 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 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.
[0312] 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, and/or a treatment process for
infusion of a treatment agent into an artery or vein of a patient
using devices, apparatus, methods, and/or processes described
herein (e.g., such as according to the process described with
respect to FIGS. 3, 19, 54, 55, 63, and/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 region of interest such as a region in
a coronary sinus or vein of a subject (e.g., such as region of
interest 4996).
[0313] 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
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 region of interest such
as region 4996. Moreover, according to 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), and/or a predetermined pressure of between 0.5
atmospheres and six atmospheres in pressure (e.g., such as pressure
PR).
[0314] 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
region of interest and/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.
[0315] At block 5435 a treatment agent is delivered, such as to a
region of interest. For example, a treatment agent may include
infusion pellets, suspended cells, stem cells, microspheres, blood
cells, drugs, and/or various other appropriate liquids and
materials as described herein. Likewise, it is contemplated that
such treatment agents may be delivered to region of interest 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
and/or deflated using fluids, including fluids described herein as
a treatment agent.
[0316] At block 5440 the option of aspirating a region of interest
is provided. For example, region of interest 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 region of interest 4996 may optionally
be aspirated. It is contemplated that liquid 4980 may include a
drug, treatment agent, infusion pellets, suspended cells, stem
cells, microspheres, and/or various other appropriate liquids or
materials as mentioned herein.
[0317] 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.
[0318] At block 5460 cannula 4810 may be retracted, such as to
withdraw balloon 4820 back out of vessel 4890 and out of the
subject.
[0319] 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, as described herein). 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.
[0320] In one embodiment, balloon outer diameter sizing (e.g., such
as to occlude a blood vessel with a balloon, as described herein)
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.
[0321] 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 region of interest 996 to be infused with a
treatment agent, where the region of interest may be distal to, or
proximal to a balloon occluding a blood vessel, as described
herein). 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), and/or a treatment process for infusion of a treatment agent
into an artery or vein of a patient using devices, apparatus,
methods, and/or processes described herein (e.g., such as according
to the process described with respect to FIGS. 3, 19, 54, 55, 63,
and/or 82). Reference numeral 6501 illustrates time t1 during which
a catheters and/or cannula as described herein is advance
percutaneously so that a distal end of the catheter or cannula can
be located in the coronary sinus or another vessel.
[0322] Reference numeral 5602 corresponds to time t2 during which a
balloon, such as described herein 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.
[0323] 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
(and/or at region of interest 996).
[0324] 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.
[0325] 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 and/or treatment agent can resume in the coronary sinus or
another vessel.
[0326] In one embodiment, the plot illustrated in FIG. 56 allows
for an efficient treatment agent and/or drug infusion from a vein
or artery to tissue to be treated with the possibility of
"hands-off" operation. In one embodiment, 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).
[0327] Suitable treatment agents to be used with catheters and/or
cannula as described herein include a liquid carrying one or more
treatment agents. In another embodiment, a treatment agent or
liquid includes one or more drugs and/or treatment agents, such as
is used to prevent reperfusion injury. For instance, according to
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, and/or VCAM. In another
embodiment, the liquid includes IGF-I, estrogen, and/or GIK
solution. In another embodiment, the liquid includes drugs like
adenosine or its isoforms, Na/H exchangers, and/or Na/K exchangers.
In another embodiment, the liquid can include cells, for example,
cardiomyocites and/or multi-potent or ologo-potent cells like stem
cells and/or progenitor cells. Also, the liquid may include
angiogenic cells, and/or other types of structural cells like
skeletal or smooth muscle cells. In another embodiment the liquid
includes biological agents and/or genes, for example, VEGF, FGF,
and/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.sup.+-H+exchange inhibitors, caroporide (HOE 642), agents that
open KATP channels, nitric oxide (NO), endothelin receptor
antagonists, tetrahydrobiopterin, statins, sevoflurane, propofol,
pinacidil, morphine, verapamil, and blends or mixtures thereof.
[0328] 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, as described herein, through delivery lumen and to
a blood vessel, such as at region of interest 996 (e.g., such as
via a catheter, cannula, or deliver lumen as described herein). In
one embodiment, 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 one embodiment, 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 pumphousing 5708 to contain fluid and
rotor 5710 which has impeller 5712 attached. In one embodiment,
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 one
embodiment, rotor 5710 is removably connected to stator 5714, and
there is no direct mechanical connection between stator 5714 and
rotor 5710. In one embodiment, rotor 5710 and impeller 5712 are
driven by a magnetic force generated by winding 5716. In one
embodiment, 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.
[0329] 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.
[0330] 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 one embodiment, 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.
[0331] 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 and/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 and/or sterilized prior to the next
treatment. In some embodiments, the pump, such as pump 5900 may
have multiple syringes with different treatment agents.
[0332] 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 one
embodiment, 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.
[0333] 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.
[0334] 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.
[0335] 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.
[0336] 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 and/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, and/or temperature
at the target location. Inflate balloon 6316 to occlude coronary
sinus and/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, and/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 and/or
saturation. Deflate balloon 6328. Remove catheter, guide catheter
and/or guidewire, from vessel 6330.
[0337] 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, and/or
pressure maintaing devices described herein may be controlled
manually, automatically, and/or by a machine, such as by system
controller 3080, and/or according to a treatment process for
infusion of a treatment agent into an artery or vein of a patient
using devices, apparatus, methods, and/or processes described
herein (e.g., such as according to the process described with
respect to FIGS. 3, 19, 54, 55, and/or 82).
[0338] 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.
[0339] Note that all embodiments of devices, apparatus, methods,
and/or processes described herein are contemplated to include
treatment including by one or more balloons, occlusion devices,
and/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, as described
herein) that may have an outer diameter that is volume controlled
(e.g., see balloon 8810) and/or pressure controlled (e.g., see
balloons 4520, 4620, and 4820) to expand to, occlude, and/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.
[0340] For instance, according to embodiments, additional inflation
fluid volume does not increase pressure because the high compliance
balloon grows in outer diameter. Furthermore, according to
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, and/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 withing the
balloon).
[0341] 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, as
described herein. 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.
[0342] According to 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.
[0343] 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
and/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 diamter of about 20 mm to occlude a blood
vessel having an inner diameter of about 19.5 mm.
[0344] 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 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.
[0345] 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.
[0346] 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.
[0347] Thus, according to 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 region
of interest 996.
[0348] 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 region of
interest 996, such as to occlude a flow or volume of fluid such as
blood and/or treatment agent from passing through blood vessel 990
past balloon 8810 in directions 8860. According to 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 withing balloon 8810).
[0349] 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
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.
[0350] Also, according to 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
region of interest (e.g., such as region of interest 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.
[0351] 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 region of interest, 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.
[0352] 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
region of interest 996).
[0353] 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.
[0354] 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.
[0355] 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.
[0356] 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 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.
[0357] Furthermore, according to 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; and/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.
[0358] 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, and/or adhesive bonding to a catheter or
cannula. Specifically, according to 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
region of interest of the blood vessel.
[0359] According to 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.
[0360] 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.
[0361] 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.
[0362] 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
and/or of the materials described herein and may have a dimension,
characteristic, deflated outer diameter, and/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 and/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.
[0363] Hence, a balloon as described herein (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 region of interest, such as arterial
vessels and/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 as described herein such as a cannula
similar to cannula 710 or any of the various other guide, delivery,
and/or guidewire catheters or cannulas described herein. For
instance, cannula 9502 may be include materials as described above
for catheter 302 and/or 512, such asmay 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.
[0364] 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, as described herein. 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 and/or it may function similarly to
balloon 8810 as described herein.
[0365] 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.
[0366] Thus, according to embodiments, infusion lumen 9520 and/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 region of
interest (e.g., such as region of interest 996). For instance,
infusion lumen 9520 and/or accessory lumen 9530 may be adapted to
have a guidewire disposed therethrough to guide cannula 9502 to a
location in a blood vessel as described herein 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,
and/or cannula 9902-9904 as shown and described with respect to
FIGS. 86-89. More particularly cannula 9502 may have a dimension
and/or profile compatible with or suitable to be received within,
and/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.
[0367] 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
embodiments inner diameter ALID1 may be less than inner diameter
ILIDI. In addition, it is contemplated that infusion lumen 9520 may
have inner diameter ILIDI greater than 0.01 inches in diameter.
[0368] 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 region of interest,
and/or to aspirate fluids from a region of interest (e.g., see hole
988 of FIG. 9 and accompanying text).
[0369] 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, and/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, and/or temperature, such as
at region of interest 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
region of interest 996 distal to balloon 9510.
[0370] According to embodiments infusion lumen 9520 and/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 and/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.
[0371] Infusion lumen 9520 and/or accessory lumen 9530 may be
adapted to receive a guidewire and/or have a guidewire disposed
therein and exiting a proximal opening at proximal end 9506 (e.g.,
such as opening 9532 and/or opening 9522), so that cannula 9502 can
be used in an over-the-wire fashion, and/or have the guidewire
removed therefrom. It is also considered that infusion lumen 9520
and/or accessory lumen 9530 may have a proximal opening, such as
port 9554 and/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.
[0372] 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 CH1 between 0.04 inches and
0.06 inches, such as a height of 0.055 inches.
[0373] 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.
[0374] Moreover, according to 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 and/or a fluid.
[0375] 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.
[0376] 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 embodiments, each of
infusion lumen 9520, accessory lumen 9530, inflation lumen 9540,
and/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 as described herein with that sleeving.
[0377] 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, and/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
region of interest (e.g., such as region of interest 996) and to
ask for a second volume of blood and treatment agent from the
region of interest. Similarly balloon inflation lumen 9540 may have
a dimension suitable to inflate balloon 9510 with a volume of
(e.g., such as volume BIVI) a gas and/or liquid to an inflation
pressure (such as inflation pressure BPI1) of less than 6
atmospheres and maintain the inflation volume and/or inflation
pressure for at least 4 minutes.
[0378] 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, and/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, and/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 ballooninflation port
9553 may include a label on its surface such as to identify a
purpose and/or information related to the device or syringe.
[0379] According to embodiments luer adaptor may have a dimension
suitable to allow a first volume of treatment agent to be infused
to a region of interest, to allow a second volume of blood and
treatment agent to be aspirated from the region of interest (e.g.,
see hole 988 of FIG. 9 and accompanying text), and to allow a
volume of a gas and/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.
[0380] 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 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 and/or wider than second section 9557, such
as a profile shown in FIG. 69E resulting from third section 9558
including balloon 9510.
[0381] 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
embodiments, balloon inflation lumen 9540 does not extend into
either third section 9558 or fourth section 9559.
[0382] 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 and/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 and/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, and/or adhesive
gluing.
[0383] Also, according to 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 and/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, and/or infusion
lumen 9520 within balloon section 9511. For example, as described
below, a radio-opaque marker band, material infused from third
section 9558, and/or material that is included in third section
9558 may extend through a portion or all of balloon section 9511 to
connecte together or be a part of inflation lumen 9540, accessory
lumen 9530, infusion lumen 9520, and/or support mandrel 9560.
[0384] 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 and/or third section 9558 as described herein.
[0385] Moreover, according to 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.
[0386] 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.
[0387] Support mandrel 9560 may be used to add stiffness to and/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, and/or other
suitable materials or metals, such as those having a sufficient
stiffness to prevent 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 region of interest.
[0388] Note that material coupling infusion lumen 9520, accessory
lumen 9530, mandrel 9560, and/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, and/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, and/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.
[0389] According to 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,
and/or infusion lumen 9520 at midpoint 9516 of the balloon,
proximal end 9517 of the balloon and/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.
[0390] According to embodiments, lengths, diameters, materials, and
other characteristics of cannula 9502, infusion lumen 9520,
accessory lumen 9530, inflation lumen 9540, mandrel 9560, balloon
9510, and/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 and/or cell infusion to treat acute
myocardia infraction (AMI) or other forms of loss of heart function
due to heart muscle damage.
[0391] 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 region of interest, such as arterial vessels and/or
venous vessels is a cannula having coaxial and/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.
[0392] 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
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).
[0393] 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 region of interest 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 region of interest, such as described
herein with respect to guiding cannula or catheters (e.g., such as
cannula 9502) to a region of interest of a blood vessel.
[0394] 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.
[0395] 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.
[0396] FIGS. 72A and B also show infusion lumen 9220 defined
between guidewire tube 9232 and cannula 9202. According to
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, and/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.
[0397] 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 region of interest 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 region of interest, such as described
herein with respect to guiding cannula or catheters to a region of
interest of a blood vessel.
[0398] 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.
[0399] 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.
[0400] Moreover, according to 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, and/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 as described herein with respect to lumen 9520 at
FIGS. 69A-F.
[0401] 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 and/or
co-linearly located. In addition, a coaxial and/or co-linearly
constructed catheters can be easier to fabricate. For instance,
various processes may be used to form apparatus 9100, 9200, and/or
9300 of FIGS. 71A-73. For example, one or more materials may be
melt-extruded to form a multi-lumen 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).
[0402] 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.
[0403] 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.
[0404] 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.
[0405] For example, FIG. 74A is a cross-sectional view of the
apparatus of FIG. 71A from perspective "C" prior to 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 infustion 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.
[0406] 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 and/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".
[0407] 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 and/or catheter system 3000, such as by coupling male
Luer Lock connector 9716 to fitting 2640 as shown in FIGS. 26-29
and/or fitting 3040 as shown in FIG. 30.
[0408] 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.
[0409] According to 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.
[0410] 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.
[0411] 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.
[0412] 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 (and/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.
[0413] In addition, according to 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.
[0414] 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 and/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.
[0415] 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.
[0416] For example, in order to allow a balloon (e.g., such as a
low pressure, high compliance, and/or low tension occlusion balloon
as described herein with respect to balloons 4420, 8810, and/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.
[0417] 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.
[0418] It can be appreciated that piston 9710 and/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).
[0419] 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 and/or
apparatus 9700. For instance, FIGS. 76-80 show what effect latching
and unlatching mechanisms 9760 and 9762, and/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 and/or bubbles my
be removed therefrom.
[0420] 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.
[0421] 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 as a safety feature) to prevent over-inflation/bursting of
the balloon and/or over-stretching of the blood vessel to be
occluded.
[0422] 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.
[0423] 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 region of interest of the blood
vessel, such as region of interest 996 of blood vessel 990. More
particularly, after a blood vessel is sufficiently occluded and
treatment agent is infused through a region of interest 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.
[0424] 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 prior to deflation.
[0425] 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, and/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.
[0426] 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 and/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.
[0427] 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) and/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).
[0428] 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 and/or to withdraw/inject a controlled small
volume of contrast to subsequently rapidly and safely deflate and
re-inflate the balloon.
[0429] 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.
[0430] 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.
[0431] 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 region of
interest, such as arterial vessels and/or venous vessels is
described.
[0432] For example, FIG. 82 is a flow diagram of a process for
treating a region of interest of a blood vessel with one or more
treatment agents and/or progenitor cells. At block 9610, a region
of interest of a blood vessel is identified. For example, a region
of interest may be similar to region of interest 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 region of
interest 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).
[0433] Moreover, if sufficient ischemic signal does not exist prior
to treatment of a blood vessel, it is possible to precondition a
region of interest to allow for marking as described above. For
example, at block 9620 ischemic preconditioning of a region of
interest can be performed, such as by occluding a region of
interest (e.g., such as region of interest 996 or a region of
interest in the myocardium) for a period of time between 30 minutes
and 180 minutes prior to releasing the marker fluid into the blood
vessel. More particularly, a balloon or occlusion device as
described herein 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.
[0434] 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 as described herein (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 region of interest 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
region of interest.
[0435] 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.
[0436] At block 9640 it is determined whether the tip of the
cannula and/or the balloon has been advanced to the region of
interest. If at block 9640 the cannula and/or balloon is not at a
region of interest, the process returns to block 9630 or the
cannula and/or balloon may be advanced further. On the other hand,
if at block 9640 the cannula and/or balloon is at a region of
interest, the process continues to block 9650.
[0437] 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 region of
interest (e.g., such as a region of interest 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 and/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
region of interest.
[0438] Furthermore, according to 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.
[0439] At block 9660 treatment agents are infused to the region of
interest. For example, a treatment agent as described herein and/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
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, and/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, and/or (3) ex-vivo culturing of
mononuclear cells. It is to be appreciated that the region of
interest 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).
[0440] 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.
[0441] In addition, infusing at block 9660 may include infusing
treatment agent and/or progenitor cells at a low pressure and
distal to the occluding balloon such that a flow of blood through
the region of interest is precluded and does not wash the treatment
agent away from the region of interest. For example, the occluding
balloon may completely preclude blood flow through the region of
interest, such as region of interest 996. Thus, an occluding
balloon or device may block off blood flow from region of interest
996 to increase treatment agent residence time in region of
interest 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 and/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).
[0442] At block 9670 it is determined whether the first period of
time has expired. According to 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 and/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
and/or desired during an infusion treatment. Specifically,
measurement and/or procedures such as those described above with
respect to accessory lumen 9530 may be performed during the first
period of time.
[0443] In accordance with embodiments, one way to balance the
benefit of having a long treatment agent or progenitor cell
residence time at the region of interest 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 region of
interest in a controlled amount or during a controlled time period
during treatment of the region of interest.
[0444] 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 and/or a treatment agent) is allowed to
perfuse from a location in the blood vessel proximal to the balloon
to the region of interest (or vice versa depending on the direction
of blood flow). In other words, at block 9675, a liquid, such as
blood and/or treatment agent, may be allowed to perfuse between a
location in the blood vessel proximal to the balloon and the region
of interest, 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 region of
interest 996) to be open to a flow of fluid, such as blood. Thus,
the balloon may be deflated as described herein (e.g., such as
described herein with respect to balloon 8810 or 9510) to allow a
reflow of blood through the region of interest, such as to minimize
extensive ischemia. According to 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.
[0445] 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 region of interest
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,
and/or 9940 may be used at block 9675.
[0446] Likewise, instead of or in addition to deflating the
balloon, perfusion of a liquid (e.g., such as blood and/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 region of interest, 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.
[0447] 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 region of interest.
[0448] 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 and/or other processes or
measurements may be performed. For example, measurements and/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, and/or 9600. According to 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.
[0449] 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
embodiments treatment may include repetition of blocks 9650 through
9685 to infuse treatment agent and/or progenitor cells a number of
times to the region of interest. Specifically, blocks 9650 through
9685 may be repeated 2, 3, 4, 5, 6, or more times to infuse
treatment agent and/or progenitor cells at the region of interest.
In one case, region of interest 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 and/or progenitor cells
are infused to the region of interest, then blood and/or treatment
agent may be allowed to perfuse into the region of interest (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.
[0450] 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.
[0451] Note that it is contemplated that the process described
above with respect to FIG. 82 may be controlled manually,
automatically, and/or by a machine, such as by system controller
3080, and/or according to a treatment process for infusion of a
treatment agent into an artery or vein of a patient using devices,
apparatus, methods, and/or processesdescribed herein (e.g., such as
according to the process described with respect to FIGS. 3, 19, 54,
55 and/or 63).
[0452] Now, specifically addressing three types of apparatus for
allowing blood and/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
region of interest 996) to be open to a flow of fluid, such as
blood.
[0453] Second or in addition to allowing perfusion at block 9675 by
deflating the balloon, blood and/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.
[0454] Thus, according to embodiments, liquid, blood, and/or
treatment agent perfusion between the region of interest 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, and/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 as described herein 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 region of
interest, 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.
[0455] 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 one embodiment. 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 and/or treatment agent between a location of the blood vessel
proximal to balloon 8810 and accessory lumen 9530 and/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).
[0456] 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 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 as described herein
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 as described herein for forming a lumen or tube).
[0457] 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 and/or a laser drilling
technology to produce the holes as described herein.
[0458] 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 region of interest 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 and/or be formed as described above with
respect to holes at proximal perfusion section 9667.
[0459] According to embodiments, accessory lumen 9530 may be
adapted to have a guidewire disposed therethrough to guide cannula
9602 to a region of interest, such as described herein with respect
to lumen 9530 and a guidewire disposed therethrough. Additionally,
lumen 9530 may be adapted and/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
and/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 region of interest distal to balloon 8810.
For example, FIG. 85 is a cross-sectional view of the apparatus
shown in FIG. 83 advanced to a region of interest of a blood
vessel. Thus, FIG. 85 shows apparatus 9600 advanced to a region of
interest 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 region of interest 996.
[0460] 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.
[0461] 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 region of
interest 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).
[0462] It is worth noting that by varying the size and/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.
[0463] 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.
[0464] Moreover, since the apparatus and process allows for various
amounts of liquid to perfuse, retraction and/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 and/or needs additional blood
and/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
region of interest 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 region of interest while providing
some supply of blood to the region of interest or occluded region
to allow for a longer infusion or treatment period.
[0465] Third, or in addition to allowing perfusion at block 9675 by
deflating the balloon and/or via a perfusion lumen, blood and/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.
[0466] For example, according to embodiments, a blood perfusion
cannula may be used, such as a version of cannula 9502 and/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 as described herein 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).
[0467] 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 region of interest 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 and/or
treatment agent perfusing between the locations to prevent an
ischemic event in the blood vessel of a patient.
[0468] 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.
[0469] 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.
[0470] 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.
[0471] 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.
[0472] 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.
[0473] 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 region of interest 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 as described herein 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 region of interest 9996. Region
of interest 9996 may be a region of interest as described herein
with respect to region of interest 996.
[0474] 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 and/or may be a lumen to
provide pressure sensing at region of interest 9996, such as is
described herein. Note that region of interest 9996 may be
described an inter-balloon occlusion infusion space.
[0475] 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 region of
interest 9996 are confined between proximal balloon 9910 and 9915
and will not be washed away by blood circulation.
[0476] 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 and/or
treatment agent from a location proximal to balloon 9910 and
balloon 9915 to a location distal to balloon 9910 and balloon
9915.
[0477] 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 region of
interest 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 region of interest 9996 created by both balloons may cause
the wall to be more permeable to therapeutic agents.
[0478] It is also contemplated that cannula 9905 may include
infusion lumen and/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 and/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.
[0479] Thus, it is considered that balloon 8810, other occlusion
balloons described herein, other occlusion devices described
herein, cannula and/or catheters described herein may be used to
occlude a location or infuse treatment agent to a region of
interest 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.
[0480] Note that all embodiments of devices, catheter, balloon,
cannula, lumen, filter devices, perfusion devices, apparatus,
methods, and/or processes described herein are contemplated to
include treatment of one or more human or animal blood vessels
(e.g., including veins and/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.
[0481] 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) and/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
transmigrate into adjacent infarct artery tissues.
[0482] It is also contemplated that both, intra-coronary veins and
arteries could be treated or involved in treating a region of
interest 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 region of interest, percutaneous insertion of a second
catheter to perform occlusion of one or more coronary arteries
occlude around the region of interest, and infusion of a treatment
agent from the second catheter to treat the region of interest as
described herein 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.
[0483] 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.
* * * * *