U.S. patent application number 17/492206 was filed with the patent office on 2022-04-07 for flow restricting intravascular devices for treating edema.
The applicant listed for this patent is White Swell Medical Ltd. Invention is credited to Eamon Brady, Ilan Grunberg, Or Inbar, Ronan Keating, Gerry Mccaffrey, Sagi Raz.
Application Number | 20220104828 17/492206 |
Document ID | / |
Family ID | 1000005927861 |
Filed Date | 2022-04-07 |
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United States Patent
Application |
20220104828 |
Kind Code |
A1 |
Keating; Ronan ; et
al. |
April 7, 2022 |
FLOW RESTRICTING INTRAVASCULAR DEVICES FOR TREATING EDEMA
Abstract
This disclosure relates to a catheter with a fluid flow
restrictor (e.g., a balloon) that includes a flow path. The
catheter is useful for creating, and maintaining, an area of
reduced pressure within a blood vessel for removing excess fluid
from a patient's body. In particular, the catheter is dimensioned
for insertion into a blood vessel and includes a fluid flow
restrictor that, when deployed, partially occludes the blood
vessel. Pressure is reduced within the blood vessel downstream of
the occlusion. The flow path allows some blood to flow past the
restrictor, which prevents the blood vessel from stretching due to
excessive pressure buildup, thereby allowing the area of reduced
pressure to be maintained for extended periods of time.
Inventors: |
Keating; Ronan; (Galway,
IE) ; Inbar; Or; (Tel-Aviv, IL) ; Grunberg;
Ilan; (Kibbutz Shefayim, IL) ; Raz; Sagi;
(Tel-Aviv, IL) ; Mccaffrey; Gerry; (Galway,
IE) ; Brady; Eamon; (Galway, IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
White Swell Medical Ltd |
Kibbutz Shefayim |
|
IL |
|
|
Family ID: |
1000005927861 |
Appl. No.: |
17/492206 |
Filed: |
October 1, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
63086272 |
Oct 1, 2020 |
|
|
|
63086217 |
Oct 1, 2020 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2562/0247 20130101;
A61B 17/12136 20130101; A61B 17/12109 20130101; A61B 17/12036
20130101 |
International
Class: |
A61B 17/12 20060101
A61B017/12 |
Claims
1. A catheter comprising: a catheter body; and a restrictor
operably coupled to the catheter body, wherein the restrictor
comprises a retracted and a deployed configuration, and in the
deployed configuration, an exterior surface of the restrictor is
shaped to form at least one flow path along the exterior surface of
the restrictor.
2. The catheter of claim 1, wherein the flow path comprises at
least two inflection points formed by the exterior surface of the
restrictor.
3. The catheter of claim 2, wherein each of the inflection points
defines a transition region between a convex surface to a concave
surface.
4. The catheter of claim 2, wherein each of the inflection points
are defined by a change in curvature around a circumference of the
exterior surface of the restrictor.
5. The catheter of claim 1, wherein the at least one flow path is
disposed between two inflection points defining a concave surface
for promoting fluid flow.
6. The catheter of claim 1, wherein, when the restrictor is
deployed inside a blood vessel, the flow path is formed between the
exterior surface of the restrictor and a wall of the blood
vessel.
7. The catheter of claim 6, wherein, when the restrictor is
deployed inside the blood vessel, the restrictor forms a plurality
of flow paths.
8. The catheter of claim 1, wherein, when the restrictor is
deployed inside a blood vessel, fluid flows through the blood
vessel via the flow path.
9. The catheter of claim 1, wherein, when the restrictor is
deployed inside a blood vessel, the flow path allows a
predetermined amount of fluid to bypass the restrictor.
10. The catheter of claim 1, wherein deployment of the restrictor
inside a blood vessel creates a region of reduced pressure
downstream of the restrictor.
11. The catheter of claim 1, further comprising a pump connected to
a distal end of the catheter body.
12. The catheter of claim 11, wherein the pump comprises an
impeller rotatably disposed within an impeller assembly.
13. The catheter of claim 12, wherein the impeller assembly
comprises an inlet and an outlet and, when the impeller is
actuated, the impeller pumps fluid through the impeller assembly
via the inlet and the outlet.
14. The catheter of claim 11, wherein the pump is external to the
catheter and is connected to the distal end of the catheter body
via a lumen extending through the catheter.
15. The catheter of claim 14, wherein actuation of the pump, when
the catheter is inserted into a blood vessel, sucks fluid from the
blood vessel to a reservoir outside the body.
16. A method for treating edema, the method comprising: inserting a
catheter comprising a restrictor into a blood vessel, the
restrictor comprising a retracted configuration and a deployed
configuration, and in the deployed configuration, an exterior
surface of the restrictor is shaped to form at least one flow path
along the exterior surface of the restrictor; and deploying the
restrictor inside the blood vessel.
17. The method of claim 16, wherein the restrictor is deployed
upstream of a lymphatic duct to reduce pressure in the vicinity of
the lymphatic duct and facilitating flow of lymph fluid from the
duct and into the blood vessel, thereby alleviating symptoms
associated with edema.
18. The method of claim 16, wherein, when the restrictor is
deployed inside the blood vessel, the flow path is formed between
the exterior surface of the restrictor and a wall of the blood
vessel.
19. The method of claim 16, wherein deploying the restrictor inside
the blood vessel restricts fluid flow to a predetermined amount of
flow through the blood vessel via the flow path, thereby
controlling cardiac preload.
20. The method of claim 16, wherein, when the restrictor is in the
deployed state, the exterior surface forms at least two inflection
points defining a transition region from a convex to a concave
surface.
21. The method of claim 20, wherein the flow path is formed between
the two inflection points, the two inflection points defining a
convex surface that facilitates fluid flow.
22. The method of claim 18, wherein deployment of the restrictor
creates a plurality of flow paths.
23. The method of claim 16, wherein the catheter further comprises
a pump operably connected to a distal end of the catheter.
24. The method of claim 23, further comprising activating the pump
to pump fluid from the blood vessel.
25. The method of claim 23, wherein the pump comprises an impeller
housed within an impeller assembly that is connected to the distal
end of the catheter.
26. A catheter system comprising: a sheath; a catheter disposed
within the sheath; and a restrictor mounted onto one of the sheath
or the catheter, wherein the restrictor comprises a retracted and a
deployed configuration, and in the deployed configuration, an
exterior surface of the restrictor is shaped to form at least one
flow path along the exterior surface of the restrictor.
27. The catheter system of claim 26, wherein the flow path
comprises at least two inflection points formed by the exterior
surface of the restrictor.
28. The catheter system of claim 26, wherein each of the inflection
points defines a transition region from a convex to a concave
surface.
29. The catheter system of claim 26, wherein the at least one flow
path is disposed between two inflection points that define a
concave surface for promoting fluid flow.
30. The catheter system of claim 26, wherein, when the restrictor
is deployed inside a blood vessel, the flow path is formed between
the exterior surface of the restrictor and a wall of the blood
vessel.
31. The catheter system of claim 30, wherein the restrictor
comprises a plurality of flow paths.
32. The catheter system of claim 26, wherein the restrictor is
located on the sheath.
33. The catheter system of claim 26, further comprising a second
restrictor, the second restrictor mounted onto the catheter.
34. The catheter system of claim 33, wherein the second restrictor
does not comprise a fluid flow path.
35. The catheter system of claim 26, wherein at least one of the
catheter or the sheath comprises a pressure sensor.
Description
TECHNICAL FIELD
[0001] This disclosure relates to devices and methods for treating
edema.
BACKGROUND
[0002] Dysfunction of the fluid management systems of the body
exerts an enormous impact on human health and leads to diseases
such as coronary artery disease, hypertension, hypotension,
myocardial infarction, cardiogenic shock, heart failure, edema,
lymphedema, ascites, ischemia, hemorrhage and many others. These
diseases typically involve one or more of: (i) an upstream
restriction of blood flow to an organ, (ii) downstream resistance
to blood flow in a vessel, (iii) inability of a pumping element to
deliver pressure or volume, (iv) the accumulation of excess fluids
in the vasculature, in an organ, in a body cavity or in a tissue
or, (v) the rupture, leakage or dysfunction of a fluid boundary.
Many of the diseases listed above have multiple underlying
mechanisms.
[0003] Heart failure is a clinical syndrome that occurs when
dysfunction of either cardiac structure or cardiac function
prevents the heart from delivering sufficient oxygen to the tissues
to meet the metabolic requirements of tissue despite normal filling
pressure. Heart failure is a chronic condition and over the course,
patients present at hospital emergency departments with an acute
worsening of heart failure signs and symptoms. This acute
condition, known as acute decompensated heart failure (ADHF) is a
life-threatening clinical syndrome which requires immediate
treatment. The signs and symptoms of ADHF include difficulty
breathing (dyspnea), swelling of the leg or feet, and fatigue.
There are many underlying etiologies to heart failure and these
include problems with the heart, lung, kidney and lifestyle, and
may also additionally include prior myocardial infarction, valvular
disease, cardiomyopathy, cardiac rhythm defects and others.
Irrespective of the underlying cause, pulmonary and systemic
congestion as a result of increased right heart and left heart
filling pressures is a very common finding in ADHF. Episodes of
ADHF become more likely and more severe as the disease
progresses.
[0004] In heart failure patients, the inability of the heart to
meet the demands of the tissues results in insufficient perfusion
to the kidneys and other tissues in the body. Reduced blood supply
to the kidneys causes fluid and water retention. This additional
fluid is firstly accommodated in the venous compartment, which has
a great ability to accommodate additional volume and results in an
increase in venous pressure. This increased venous pressure has a
profound impact on fluid exchange in the blood capillaries leading
to an increase in the volume of fluid that enters the tissue. When
the rate of fluid entering the tissue exceeds the body's ability to
remove that fluid then edema results and the patient experiences
swollen ankles, legs, weight gain and fluid on the lungs and other
organs.
[0005] The increased venous pressure leads to an increase on the
pressure experienced by the right atrium and so the right ventricle
is filled at a higher pressure. This is helpful initially and can
increase right heart output. However as venous pressure increases
this filling pressure puts too much strain on the muscles of the
right heart and this reduces the ability of the right heart to
pump. Since the left heart output is limited by the output of the
right heart then reduced right heart output directly impacts left
heart output and prefusion to the body tissues. Reducing the
excessive right heart preload experienced by many ADHF patients may
improve cardiac output and help them to more rapidly diurese excess
fluid.
[0006] Current proposed solutions to the management of right heart
preload during diuretic therapy include the use of an inflatable
balloon occlude or restrictor. This approach involves inflating a
balloon in a central vein to reduce the fluid returning to the
right heart from the pressurized venous system. This reduced volume
returning to the heart reduces right heart preload. However,
occlusion of a central vein can only be temporary and so the
current proposed solutions overcome this issue by cycling the
balloons between an inflated, occlusion state and a deflated state
in which flow is restored. Since it can take several days for
patients to lose the excessive fluid that has accumulated in the
tissues this approach has significant limitations. For example,
there is potential for trauma to the vein in cycling the balloon
over and over. Additionally, visualization of central veins is
difficult by ultrasound and this makes control of balloon diameter
more difficult. Furthermore, since ADHF patients are very sick,
administering contrast for fluoroscopy is not a desirable solution.
Also, preload is increased each time the balloon is deflated and so
the right heart is cycled between a stressed state and a reduced
stress state. Finally, the control system needed to cycle the
balloon catheter is complex and expensive.
[0007] Controlling blood flow in a vessel with expandable
restrictors is extremely difficult. Restrictors that are partially
expanded in a blood vessel have little or no impact on net flow. By
way of example, if a restrictor is expanded and occupies 50% of the
diameter of the vessel one might anticipate a 50% reduction in
flow. This is not the case for two reasons: (i) 50% of the diameter
is not 50% of the cross-sectional area. It is only 25% of the
cross-sectional area since area of a circle depends on the square
of the diameter. Secondly, the fluid passing the restrictor briefly
accelerates as it passes the restrictor and then decelerates to its
normal velocity downstream. These mechanisms explain how at low
levels of inflation that a restrictor has little noticeable effects
on blood flow. Meaningful reductions in blood flow are achieved at
restrictor diameters of between 70% and 90% of the vessel diameter.
Restrictors with diameters of 95% or greater of the vessel are
almost completely occlusive of the vessel. This provides a
relatively small range of restrictor diameters in which a doctor
can exert control over the fluid flow in a vessel or to an
organ.
[0008] It is difficult in many clinical situations to accurately
measure the vessel in which the doctor is placing the restrictor.
In heart failure patients and patients with kidney dysfunction
administering contrast media to conduct a fluoroscopic dimensional
assessment is not desired and so non-contrast imaging is required
(ultrasound) but these techniques are often unable to assess the
dimensions of deeper vessels and are typically only accurate to
+/-2% of the target dimension
[0009] Furthermore, in some of these disease states the vessel
dimensions can vary significantly with time, even over the time
taken to deliver a therapy. Arterial dimensions are relatively
fixed during the timeframe of a therapeutic intervention. This is
due to the fact that arteries are muscular vessels and that
arterial pressure tends to vary less than venous pressure. However,
as mentioned earlier, the venous system has a great ability to
increase its volume to store excess fluid in patients with fluid
retention issues. Excess blood volume is not stored in the arterial
compartment to any great extent. In holding excess blood volume in
the venous compartment central venous pressure (CVP) increases and
so do the diameters of almost all of the veins in the venous
system. Vein dimensions can change dramatically, even over the
course of a therapy. At the start of a therapy in a patient with
venous congestion CVP might be 25 mmHg and at the end of therapy
the CVP may have reduced to 3 mmHg. This example is a 78% reduction
in the CVP. Acutely decompensated heart failure patients with
elevated CVP on admission undergo significant reductions in CVP
associated with decongestive therapies and this leads to a
continuous change in vessel dimensions over the course of therapy.
Clinical conditions wherein the vessel dimensions are changing over
time require restrictor solutions with more sophistication than
current approaches.
[0010] A further problem with restricting blood flow is that it
increases to velocity of blood passing the restrictor which in turn
leads to more blood shearing and greater risks of thrombosis (clot
formation on the device surface). This risk is further compounded
by the fact that, in decongestive therapies, therapy times can be
extended which provides longer time for clot formation and
increased risk of embolization. Embolization of clot fragments can
be a significant complication in any therapy procedure.
SUMMARY
[0011] The current invention provides ways of overcoming these and
other problems with currently proposed solutions. It has been
discovered that standard occlusion balloons, while being effective
at occluding vessels, are not optimal for flow control and are in
fact very imprecise at controlling fluid flow. Standard occlusion
balloons operate by expanding until a diameter of the expanded
balloon is proximate a diameter of the vessel in which flow is to
be occluded. The limitations of standard balloons as fluid flow
management devices is particularly true in the venous circulation
where the diameter of a given vein is very dependent on the
pressure in that vein. The small space existing between the
exterior surface of the expanded balloon and the vessel walls
determines an amount of fluid that flows past the occlusion
balloon.
[0012] Multiple problems exist with this approach. For example, an
operator does not have a precise manner of determining a
relationship between an exterior surface of the expanded balloon
and a vessel wall. Accordingly, an operator cannot precisely
determine an amount of occlusion or restriction being provided by
the expanded balloon. Additionally, blood vessels frequently
stretch or contract during treatment. The stretching or contraction
of blood vessels allows blood to circumvent the device making it
difficult to maintain the localized region of reduced pressure. As
such, cardiac preload is not optimally controlled through use of
standard prior art occlusion balloons. These problems have been
somewhat circumvented by using occlusion balloon and then cycling
the balloon between an occluded state and a collapsed state. This
approach leads to other problems with the right heart being
seesawed between high preload and reduced preload states, as well
as challenges in controlling the level of inflation required in the
balloons.
[0013] The invention solves these problems with a newly designed
type of restrictor that provides for passive precision restriction.
Unlike prior occlusion balloons, the restrictors of the invention
include one or more contoured flow paths along an exterior surface
of the restrictor. The flow paths are of a defined architecture, so
that an amount of flow past the deployed restrictor is completely
predetermined and known by the operator. Furthermore, because the
restrictors of the invention include flow paths, vessel occlusion
is not based on imprecisely guessing as to how much to expand the
restrictor relative to the vessel wall. Rather, the restrictor can
be fully deployed to the vessel wall and the configuration of flow
paths determines the amount of fluid allowed to pass beyond the
restrictor.
[0014] Another advantage of the precision restrictors is that
restrictors of the invention can adjust to the compliance of the
vessel wall while still providing the same precise and predictable
flow past the restrictor via the one or more flow paths in the
restrictor.
[0015] In that manner, the restrictors of the invention provide
significantly more precise restriction than prior art standard
occlusion balloons and are therefore better at controlling cardiac
preload.
[0016] In one aspect, the invention provides a catheter comprising
with a catheter body and
[0017] a restrictor that is operably coupled to the catheter body.
The restrictor comprises a retracted configuration and a deployed
configuration. In the deployed configuration, an exterior surface
of the restrictor is shaped to form at least one flow path along
the exterior surface of the restrictor. The fluid flow path is
designed to precisely regulate fluid flow when the restrictor is
deployed inside a blood vessel. The flow path regulates fluid flow
by only allowing a predetermined amount of fluid to bypass the
restrictor inside the blood vessel. As such, in some aspects, the
invention provides a catheter with precision restriction that is
capable of controlling cardiac preload.
[0018] In one embodiment the outer surface of the contoured
restrictor comprises an undulating surface. In another embodiment
the outer surface comprises an undulating surface of a monolithic
membrane. Preferably the undulating surface of the monolithic
membrane comprises a biocompatible surface. Preferably the
undulating surface comprises a smooth surface with smooth
transitions between the catheter shaft and the body of the
undulating membrane.
[0019] In another embodiment the contoured surface of the
restrictors of the invention comprises a membrane that in its
inflated state comprises a curved surface when viewed in a first
cross section and also comprises a curved surface when viewed in a
second cross section wherein said second cross section is
orthogonal to said first cross section. This multiplanar curvature
creates an undulating surface across over which blood flows without
disturbance.
[0020] Preferably this multiplanar curvature comprises a convex
outer surface. The contoured surface of the restrictor further
comprises at least one region of concavity. The at least one region
of concavity extends from a proximal side of the restrictor to the
distal side of the restrictor. The region of concavity is
configured to interpenetrate with the multiplanar convex region at
one or more regions of inflection. The region of inflection
comprises a continuous surface that is macroscopically smooth with
no surface discontinuities.
[0021] In a preferred embodiment the restrictor comprises a
continuous membrane with an outer surface and an inner surface and
the membrane is connected to the catheter at a proximal end by a
proximal joint and in one variation at the distal end by a second
distal joint. In one embodiment the proximal and or distal joint
comprises a collar of the membrane circumnavigating the shaft of
the catheter. The one or more collars may be welded or glued to the
catheter using any of a variety of processes known in the art. The
membrane and the catheter together define a hollow space for the
inflation of the membrane, an inflation cavity. Fluid is
transferred through one of the catheter lumens into the inflation
cavity to expand the restrictor. In one embodiment the proximal
collar comprises the outer jacket of the catheter. Preferably in
the expanded state (under pressure) the membrane is configured to
assume an undulating outer surface without the need for internal
support members, tethers, internal membranes or other structural
features in the inflation cavity of the restrictor. The restrictor
comprises a compliant or semi compliant material for applications
where it is required to either change the level of restriction
during the procedure or where the restrictor is being used in
applications where the vessel diameter may vary over the course of
therapy. In the latter case, devices of the invention configured
for use in the venous circulation for treating conditions involving
venous distention, changes in blood volume, diuresis, lymph flow
stimulation would preferably be made with more compliant
restrictors. In situations where the vessel diameter is unlikely to
change significantly over therapy and where the desired level of
restriction is known and fixed then a less compliant or
non-compliant material can be used.
[0022] Preferably the inflation cavity of the balloon is defined
only by the structural and geometric features of outer membrane,
and the catheter shaft extending through the outer membrane only.
In this embodiment the membrane comprises a longitudinal region
that is resistant to axial stretching, the longitudinal stretch
resistant strip. The longitudinal stretch resistant strip may
simultaneously be resistant to stretch in the axial direction but
amenable to stretch in the circumferential direction (orthogonal to
the axis). Alternatively, the longitudinal stretch resistant region
may be configured to resist both axial stretch and circumferential
stretch. The membrane further comprises at least one region that is
amenable to biaxial stretching, a biaxial stretch region. The
biaxial stretch region is configured such that it can
simultaneously undergo stretch in a first and second direction
where the first and second directions are orthogonal to each other.
The compliance of the membrane of the restrictor in the first and
second direction may adjusted such that they are equal or that they
are different. In one embodiment the compliance of the biaxial
stretch region is higher in the circumferential direction than in
the axial direction. With this embodiment the restrictor will
expand more quickly in diameter and less quickly in restrictor
length. In another embodiment the compliance of the biaxial stretch
region is lower in the circumferential direction than in the axial
direction. In another embodiment the compliance of the biaxial
stretch region is equal both the circumferential direction and the
axial direction.
[0023] In one embodiment the material of the restrictor comprises
an isotropic material. In another embodiment the material of the
restrictor comprises an anisotropic material. In another embodiment
the material of the restrictor comprises a material wherein
anisotropic is introduced to the material during the processing of
the membrane. In another embodiment the material of the restrictor
comprises a reinforcement. In another embodiment the membrane of
the restrictor comprises at least one thickened section and one
relatively thin section. In another embodiment the membrane of the
restrictor comprises a bead made from a first material. Preferably
the bead comprises the longitudinal stretch resistant strip. With
this embodiment the bead may be made from the same material as the
biaxial stretch region. Alternatively, the bead may be made from a
different but compatible material such that the two can bond during
processing. Alternatively, the bead may be made from a different
and immiscible material to either the strip or the biaxial stretch
region. In this case the bead is integrated to the membrane
mechanically or in a post processing bonding or joining step.
[0024] Preferably the at least one biaxial stretch region comprises
the majority of the outer surface on the resistor. Preferably the
at least one biaxial stretch region comprises at least 70% of the
outer surface of the restrictor in the expanded state. In one
embodiment the biaxial stretch region comprises at least 80% of the
area of the outer surface of the membrane in the expanded state. In
one embodiment the biaxial stretch region comprises at least 90% of
the area of the outer surface of the membrane in the expanded
state.
[0025] It will be appreciated that designing a membrane that has no
internal structure and yet exhibits regions of concavity in its
outer surface when under pressure is difficult. Even if the
membrane is formed with regions of concavity these regions can
invert under pressure and become convex regions in the expanded
state thus rendering the initial geometry not representative of the
expanded geometry.
[0026] By manipulating parameters of the regions of biaxial stretch
and the longitudinal stretch resistant strip the invention allows a
variety of restrictors with functional undulating surfaces to be
created. These functional undulating membrane surfaces allow the
restrictors to appose the wall of the target vessel and yet allow a
controlled amount of flow across the restrictor while it apposes
the vessel. The compliance and stiffness of the longitudinal
stretch resistant strip and the biaxial stretch regions are
important parameters in this embodiment of the invention.
Preferably the longitudinal stretch resistant strip regions are
relatively stiff in the axial direction. Preferably the biaxial
stretch region are relatively compliant in the circumferential
direction. Where the one or more longitudinal stretch resistant
region are axially stiff and the one or more biaxial stretch
regions are circumferentially compliant and the material comprises
a compliant material then such a resistor will expand at a
relatively higher rate in the biaxial regions than in the
longitudinal stretch resistant strip and the longitudinal stretch
resistant strip will comprise a region of concavity, thus
facilitating flow in the expanded state, even when the restrictor
apposes or is a force fit in the vessel.
[0027] The level of axial stretch and circumferential stretch in
both the biaxial stretch region and the longitudinal stretch
resistant region allows one to tailor the undulating surface of the
balloon. Where the restrictor comprises a proximal and distal neck
then the level of axial stretch can be measured as follows:
[0028] Measure the length of the balloon surface from the distal
end of the proximal neck to the proximal end of the distal neck
when the balloon is in the as formed (but not pressurized) state.
Let this be L.sub.o.
[0029] Inflate the balloon to a target OD or pressure and again
measure the length of the balloon surface from the distal end of
the proximal neck to the proximal end of the distal neck. Let this
length be L.sub.1.
[0030] NOTE: In some embodiments the measurements from step 1 and 2
above are measurements along the length of a curved surface.
[0031] The level of axial stretch (L.sub.s) can be expressed as
L.sub.s=L.sub.1/L.sub.o.
[0032] These measurements and the equation for L.sub.s can be
applied to the longitudinal stretch resistant strip regions and to
the biaxial stretch regions so that the two can be compared at
given levels of inflation.
[0033] In one embodiment the level of axial stretch in a biaxial
stretch region of a restrictor is 20% greater than the level of
axial stretch in a longitudinal stretch resistant strip region of
the restrictor when the restrictor is in the expanded state. In one
embodiment the level of axial stretch in a biaxial stretch region
of a restrictor is 40% greater than the level of axial stretch in a
longitudinal stretch resistant strip region of the restrictor when
the restrictor is in the expanded state. In one embodiment the
level of axial stretch in a biaxial stretch region of a restrictor
is 60% greater than the level of axial stretch in a longitudinal
stretch resistant strip region of the restrictor when the
restrictor is in the expanded state. In one embodiment the level of
axial stretch in a biaxial stretch region of a restrictor is 100%
greater than the level of axial stretch in a longitudinal stretch
resistant strip region of the restrictor when the restrictor is in
the expanded state. In one embodiment the level of axial stretch in
a biaxial stretch region of a restrictor is 200% greater than the
level of axial stretch in a longitudinal stretch resistant strip
region of the restrictor when the restrictor is in the expanded
state.
[0034] Preferably the surface geometry of the restrictors of the
invention are configured to allow restricted blood passage without
inducing blood flow patterns that are pro-thrombotic. Preferably
the outer surface of the membrane is configured to allow
controlled, restricted blood flow without inducing a recirculation
blood flow pattern ether adjacent the restrictor or downstream of
the restrictor. Preferably blood flows past the restrictor in a
controlled and restricted manner with the creation of little or no
boundary layer separation. Preferably the restrictor is designed
such that under computational fluid dynamics analysis of the
restricted blood flow pattern that restricted blood flow is induced
by the restrictor with no boundary layer separations and/or no
blood flow recirculation predicted.
[0035] Boundary layer separation or flow separation happens when
the fluid momentum causes the fluid to flow against the local
pressure gradient. With boundary layer separation, the fluid is
unable to continue to follow the profile of the restrictor as it
flows around the restrictor and it separates from it. The
disconnected fluid often comprises a region of turbulent flow.
Boundary layer separation leads to the disconnected body of fluid
adhering to the surface, a condition that is very pro-thrombotic.
Boundary layer separation happen when the upstream or downstream
geometry creates a region of surface that is protected from the
higher shear forces that occur in the main body of flowing
fluid.
[0036] The undulating restrictor geometries of the invention are
configured to make it easy for the flow to follow the pattern of
the restrictor and thus avoid boundary layer separation. In one
embodiment the restrictor is configured such that no disconnected
fluid contacts the surface of the flow channel across the
restrictor. In one embodiment the restrictor is configured such
that no disconnected fluid body contacts the surface of the
restrictor. In one embodiment the restrictor of the invention is
geometrically configured to be non-thrombogenic. The restrictors of
the invention are configured to promote non-thrombogenic flow
patterns both in the region of restriction and downstream of the
region of restriction.
[0037] In one embodiment the restrictor comprises a
non-thrombogenic material. A variety of compliant, semi compliant
and non-compliant materials are possible. Elastomers including
polyurethane, PEBAX, fluoroelastomers and olefins are suitable
compliant materials. Preferably the elastomers comprise two phase
materials and said two phases comprise a phase separated
microstructure. Polyurethanes are a preferred elastomeric material.
Preferably the compliant materials are selected to allow for the
restrictor to expand to a variety of diameters. In one embodiment
the deformation of the restrictor material in expanding is not
recoverable. In one embodiment the deformation of the restrictor in
expanding is recoverable. With this embodiment, when the pressure
of expansion is increased the restrictor enlarges and when the
pressure of expansion is reduced the restrictor reduces in
diameter, it contracts. It will be appreciated that with the
compliant and semi compliant restrictors of the invention that
multiple expanded diameters and sizes are possible from the one
restrictor. Preferably the restrictor comprises a flow channel in
each of a plurality of expanded states. Where the restrictor
comprises a semi-compliant or non-compliant material then different
materials or grades of material may be employed. Stiffer materials
suited to semi compliant or non-compliant restrictors comprise
stiffer grades of polyurethane, nylon polymers, Polyethylene
terephthalate polymers (PET), Polyethylene naphthalate (PEN), PEEK,
PVC, polyoxymethylene (POM), other biocompatible engineering
polymers and polymer composites comprising polymer materials with
embedded fiber reinforcements.
[0038] In one embodiment the restrictor comprises an
anti-thrombotic material. The anti-thrombotic material of the
restrictor is configured such that its surface layers of the
restrictor are anti-thrombogenic. In one embodiment the surface
layers of the restrictor comprise a hydrophilic material. In one
embodiment the surface layers of the restrictor comprise a first
polymer wherein at least one moiety of the polymer chain comprises
an anti-thrombogenic moiety. Suitable anti-thrombogenic chemical
moieties include (without limitation) (i) a polyethylene oxide
chain segment, (ii) a phosphorylcholine polymer chain, (iii) a
polyvinyl alcohol chain segment, (iv) a fluoropolymer, (v) a
phosphate moiety (vi) a heparin fragment, (vii) a combination of
the preceding or (viii) other commercially available coating with
anti-thrombotic properties.
[0039] The restrictor can include a plurality of flow paths. For
example, the restrictor may include at least two flow paths, at
least three flow paths, or more. Preferably, each flow path
comprises at least two inflection points formed by the exterior
surface of the restrictor. Each of the inflection points defines a
transition region between a convex surface to a concave surface.
The flow path may be formed by a concave surface section interposed
between two convex surface sections. In particular, each of the
inflection points can be defined by a change in curvature on a
circumference of the exterior surface of the restrictor in the
expanded state. The flow path may be disposed between two
inflection points that together define a concave surface for
promoting fluid flow.
[0040] In one embodiment the precision restrictor is expanded to
exert a circumferential tension on a segment of the vessel at the
site of placement of the precision restrictor. The precision
restrictor is configured to induce a shape change on vessel cross
section in the region of placement. The shape change comprises a
shape change to a cross section that comprises the minimum
circumference needed to circumnavigate the restrictor. In one
embodiment the vessel cross-section shape change comprises a change
to a rounded-rectangle cross section. In another embodiment the
vessel cross-section shape change comprises a change to a
rounded-triangle cross section. In another embodiment the vessel
cross-section shape change comprises a change to a round cross
section with one substantially flattened surface (flat tyre
shape).
[0041] In one variation of this embodiment the precision restrictor
comprises an orifice cross-sectional area for fluid flow in the
expanded state. In one variation of this embodiment, wherein the
restrictor induces a shape change on the vessel cross section, the
orifice cross sectional area of the restrictor comprises the sum of
the cross-sectional area of a plurality of orifices. In one
embodiment the restrictor is configured such that the physician is
aware of the cross-sectional area of the orifice and can adjust the
orifice cross sectional area. In one embodiment the orifice cross
sectional area of the restrictor is defined by the shape of the
region of concavity and the degree of inflation of the restrictor.
Since the region of concavity is predefined by the geometry of the
undulating restrictor the orifice cross sectional area for flow is
substantially controlled by the degree to which the precision
restrictor is inflated by the physician.
[0042] In one embodiment the flow path comprises a first boundary
surface and a second boundary surface. With this embodiment the
first boundary surface of the flow path comprises an undulating
surface segment of the precision restrictor and the second boundary
surface of the flow path comprises the endothelially lined wall of
the native vessel. It will be appreciated that defining a flow path
that partially includes an endothelially lined vessel is a
configuration that has very positive biocompatibility implications
and allows the precision balloons of this invention to be placed in
a blood vessel for an extended period of time without
thrombogenicity concerns.
[0043] In preferred instances, a flow path is formed between the
exterior surface of the restrictor and a wall of a blood vessel.
Specifically, when the restrictor is deployed inside the blood
vessel, e.g., a jugular vein or an inferior vena cava, the flow
path is formed between the exterior surface of the restrictor and a
wall of the blood vessel. When the restrictor is deployed inside
the blood vessel, the restrictor can form a plurality of flow
paths, through which, only a predetermined amount of fluid
flows.
[0044] Deployment of the restrictor inside a blood vessel of the
central venous system creates a region of reduced pressure
downstream of the restrictor and a region of relatively higher
pressure upstream of the restrictor. The region of low pressure
downstream may be useful in relieving excess stress on the heart
muscle of a patient with a weakened heart (ex: heart failure) and
elevated central venous pressure. In this embodiment the restrictor
is configured to reduce the flow of central venous blood by an
amount sufficient to reduce the filling pressure of the right
ventricle.
[0045] In one embodiment the precision restrictor is placed in a
major central vein (superior or inferior vena cava). In another
embodiment the precision restrictor is placed in an innominate
vein, or an iliac vein. In another embodiment the precision
restrictor is placed in a vessel that branches off either an
inferior vena cava, a superior vena cava or an innominate vein. In
another embodiment a plurality of precision restrictors are placed
in a plurality of veins. In one variation of this embodiment the
plurality of precision restrictors comprises a plurality of
catheters. In another variation of the embodiment, the plurality of
restrictors comprises a single catheter, said catheter comprising a
first proximal precision restrictor and a second distal precision
restrictor. With this variation the proximal restrictor may be in a
more proximal vessel while the second precision restrictor may be
in a more distal vessel. In this way the restrictors may target
specific pairs of vessels to maximize or optimize the pressure
reduction effect. It will be appreciated that many combinations of
vessel pairs are possible with this embodiment including (i) an
internal jugular vein and a subclavian vein, (ii) an internal
jugular vein and a contralateral innominate vein, (iii) a
subclavian vein and a contralateral subclavian vein, (iv) a
superior vena cava vein and an inferior vena cava vein (v) a right
iliac vein and a left iliac vein, (vi) a right and left innominate
vein, (vii) a right and left internal jugular vein or (viii) any
combination of the foregoing.
[0046] In one embodiment the second restrictor is placed in a vein
segment that carries blood from a different segment of the
vasculature to the first restrictor. In another embodiment the
first and second restrictors are placed in the same vascular bed.
With this embodiment, one restrictor (first or second) is placed in
a more central vein and the other (first or second) restrictor is
placed in a more peripheral branch of the same region. For example,
the first restrictor may be placed is a segment of the inferior
vena cava and the second restrictor may be placed in an iliac vein.
This embodiment creates a double step in flow and pressure and
allows certain branch vessels to drain intermediate said first and
second restrictors.
[0047] In another embodiment of the invention the catheter or
catheters are configured to improve the function of critical organs
during diuresis. In patients with increased central venous pressure
the rate of filtration of blood micro-fluids into organ tissues
through the walls of the capillary bed is increased. Critical
organs are thus fluid overloaded as well as the body tissues
generally. Critical organs like the heart, liver, kidneys or lungs
can be protected from this excessive filtration by their inclusion
in the low-pressure region created with the precision restrictors
of the invention. For example, the liver may be protected from
excessive blood micro-fluid filtration by placing a first precision
restrictor upstream of the hepatic veins. With this embodiment the
precision restrictor may be placed in the inferior vena cava
between the junctions with the hepatic veins and the junctions with
the renal veins.
[0048] In another embodiment, if it is desired to protect the
kidneys from excessive blood micro-fluid filtration, then a
precision restrictor is placed in the inferior vena cava
circulation upstream of the junctions of the renal veins. In one
embodiment this precision restrictor is placed in the inferior vena
cava circulation downstream of the iliac veins. Placing the
restrictor in the inferior vena cava between the renal vein and
iliac vein branches reduces the volume of blood being returned to
the central circulation from both legs. In one embodiment the
restrictor is placed in the inferior vena cava between the renal
veins and at least the lowest lumbar vein. Since a substantial
portion of venous fluid drains into the inferior vena cava from the
liver, kidneys and the gut downstream of the placement point of
said first restrictor a second precision restrictor may be required
to achieve a protective pressure reduction. The second precision
restrictor is preferably at a location that does not attenuate the
hydrostatic connection between the organ that is been protected (in
this case the kidneys) and the right heart. Placing the second
restrictor in the superior vena cava or a branch thereof will
reduce blood flow back to the right heart and thus pressure and
will not attenuate the hydrostatic connection between the right
heart and the organ being protected, in this example the kidneys.
Branches of the superior vena cava may be primary branches (right
innominate vein, right innominate vein and azygos vein) or
secondary branches (including, a subclavian vein, an internal
jugular vein or an external jugular vein).
[0049] In one embodiment for example, a restrictor may be deployed
upstream of the thoracic duct thus including the thoracic duct
outflow in the region of low pressure. With this embodiment the
region of low pressure may facilitate the movement of lymph fluid
from the duct and into circulation as well as reducing the pressure
on the right heart. Since the position of the thoracic duct is
variable in the region of the venous angle it is preferred that the
precision restrictor be placed in the left internal jugular vein or
the left subclavian vein so as to ensure depressurization of the
thoracic duct outflow. Where the precision restrictor is placed in
the internal jugular it is preferable that it be placed 2 cm or
more upstream of the venous angle. Where the precision restrictor
is placed in the left subclavian vein it is preferable that it be
placed upstream of the bifurcation with the external jugular. Both
of these points of restriction ensure that the thoracic duct is
downstream of the point of restriction and part of the low-pressure
region.
[0050] In another embodiment the catheter comprises a catheter
shaft with a first restrictor and a second restrictor, the first
restrictor configured for placement in a first vessel segment and
said second restrictor positioned distal of said first restrictor
and configured for placement in a second vessel segment, the
catheter shaft extending between said first restrictor and said
second restrictor. In a preferred variation of this embodiment said
first restrictor is placed upstream of the thoracic duct (as
described above) and the second restrictor is placed in a distal
venous segment. The distal venous segment in which the second
restrictor is placed comprises a vein that is not in the fluid path
of fluid coming from the venous angle. In other words, the second
restrictor is placed in a large vein that is peripheral to the
fluid connection between the right atrium and the venous angle.
Suitable vessels include (i) the inferior vena cava (or branches
therefrom), (ii) the right innominate vein or upstream branches. It
will be appreciated that where the second restrictor is placed in
the circulation of the right innominate vein that it could be
placed upstream of the right lymphatic duct such that the
low-pressure region now includes the right heart, the left thoracic
duct and the right lymphatic duct.
[0051] In one embodiment the precision restrictors comprise a
smooth undulating surface with no steps or discontinuities. It will
be appreciated that this smooth and continuous surface provides a
thromboresistant blood contacting interface. In another embodiment
the restrictors are configured to promote a streamlined flow
pattern across the surface when expanded in a vessel segment. In
another embodiment the precision restrictor comprises a lead-in
section, the lead-in section configured to smoothly direct blood
towards the flow channel. The lead-in section of the precision
restrictor is configured to ensure that the wall shear stress
gradually increases along the entrance to the flow channel. The
lead-in section of the precision restrictor is configured to ensure
that there is a gradual acceleration of fluid as it is funneled
towards the restrictive section of the flow channel. In another
variant the lead-in section of the precision restrictor is
configured to funnel fluid towards the flow channel.
[0052] In another embodiment the precision restrictor comprises an
outflow section, said outflow section configured to transition
fluid from the most restrictive section of the flow channel
gradually outward and distribute said high shear fluid smoothly to
the downstream body of fluid. In one variation the outflow section
is configured to be similar in geometry to the inflow section. In
another variant the outflow section is configured to minimize
downstream recirculation.
[0053] In one variation the restrictors comprise an expansion of
the catheter shaft in the expanded state, said expansion being
substantially coaxial with the catheter shaft and said expansion
comprises at least partially a bullet shaped proximal end. The
restrictor further comprises an at least partially bullet shaped
distal end. In one embodiment the flow pathway comprises at least
one flow channel in the restrictor said flow channel comprising a
contoured channel recessed into the proximal and distal bullet
shaped surfaces of the restrictor.
[0054] In one embodiment the precision restrictor comprises a
single piece stretch blow molded membrane. The stretch blow molded
membrane comprises an undulating surface and a streamlined
geometry. In one embodiment the precision restrictor comprises a
polyurethane, a PEBAX, nylon or fluoropolymer or another
biocompatible elastomeric polymer. In one embodiment the precision
restrictor comprises a hydrophilic, hydrophobic, non-thrombogenic
or biocompatible coating.
[0055] Those skilled in the art will appreciate that the first
restrictor could be placed up stream of the outlet of the right
lymphatic duct with the second restrictor being placed in a major
vein that is peripheral to the fluid connection between the right
lymphatic duct outflow and the right atrium.
[0056] In one embodiment the catheter comprises at least one
pressure sensor configured to measure pressure in the low-pressure
region. In one variation of this embodiment said at least one
pressure sensor is distal of a restrictor and the catheter and
sensor are further configured to ensure that blood (fluid) adjacent
to the pressure sensor is in unattenuated hydrostatic connection to
blood (fluid) in the right atrium of said patient. Preferably the
catheter comprises a lumen to accommodate said pressure sensor and
said lumen comprises a pressure port and said pressure port is
configured to facilitate an unattenuated hydrostatic connection to
vascular fluid adjacent the port.
[0057] In one embodiment the at least one pressure sensor is
configured to measure blood pressure adjacent to a lymphatic duct
outflow. In one embodiment the at least one pressure sensor is
configured to measure blood pressure in a heart chamber. In one
embodiment the at least one pressure sensor is positioned adjacent
the precision restrictor. In one embodiment the catheter distal end
is configured for placement in a pulmonary artery and said at least
one pressure sensor is configured to measure pressure in said
pulmonary artery. In another embodiment the at least one pressure
sensor is spaced apart from the precision restrictor. In another
embodiment the catheter comprises a second pressure sensor.
Preferably said second pressure sensor is configured to measure
pressure proximal of said precision restrictor. In another
embodiment the catheter comprises a blood flow sensor.
[0058] In a preferred embodiment the catheter and precision
restrictors of the invention is used in treating patients with
acute decompensated heart failure with elevated central venous
pressure. With this embodiment, the method may additionally
optionally comprise providing a drug, therefore providing a
combination therapy whereby a diuretic drug is used to diurese the
patient while the catheters and precision restrictors of the
invention are used to reduce cardiac preload, promote drainage of
lymph fluid and/or protect specific organs from excessive
micro-vascular filtration. With this embodiment in which a drug
therapy is used, the diuretic drug may comprise a loop diuretic, a
thiazide, a potassium-sparing diuretic or a combination of these.
Specific diuretic drugs may include Furosemide, Bumetanide,
Torasemide, Bendroflumethiazide, Hydrochlorothiazide, Metolazone,
Indapamide, Spironolactone/eplerenone, Amiloride, or
Triamterene.
[0059] The methods herein may include any combination of the
following steps (any of which may also be omitted and any order
thereof): (i) diagnosing a patient with acute decompensated heart
failure and with elevated CVP, (ii) initiating intense diuretic
therapy, preferably with intravenous diuretic agent, (iii)
accessing the venous system at a peripheral location (jugular,
subclavian, iliac or femoral). (iv) inserting a catheter into the
venous system through the access site, said catheter comprising a
first restrictor, (v) positioning the first restrictor in a first
target vessel segment, (vi) expanding said first precision
restrictor into apposition with the target vessel segment said
first precision restrictor apposing at least a portion of the wall
of the vessel segment and reducing fluid flow in the vessel segment
while preserving a predefined flow channel across the vessel
apposing precision restrictor, (vii) measuring the pressure at a
location between said first precision restrictor and the right
atrium, (viii) adjusting the precision restrictor to further
decrease flow across the restrictor or adjusting the precision
restrictor to allow additional flow across the precision
restrictor, (ix) monitoring fluid loss as the combination therapy
progresses, (x) monitoring the pressure in the target region as
combination therapy progresses, (xi) adjusting the restrictor to
allow additional flow as combination therapy advances and blood
volume decreases, (xii) deflating said precision restrictor,
allowing a new steady state to establish and monitoring pressure at
a central venous location, (xiii) adjusting the dosage of drug
based on measurements, including fluid loss measurements, central
venous pressure measurements or pulmonary artery pressure
measurements, (xiv) placing a second precision restrictor in a
second vessel segment, (xv) expanding said second precision
restrictor such that a portion of the exterior surface of said
second precision restrictor apposes the wall of said second vessel
segment, (xvi) further inflating said first or second precision
restrictor so as to anchor said first or second precision
restrictor to the wall of the vessel, said further inflation
preserving the flow path across said precision restrictor, (xvii)
distending the wall of the vessel segment in which said first or
second precision restrictor is placed, (xviii) implanting said
first and/or said second precision restrictor in said first and/or
said second vessel segments, (xix) deflating said first or second
precision restrictor while maintaining said first or second
precision restrictor in the inflated state, (xx) monitoring the
difference between the pressure upstream of said first and/or
second precision restrictor and the pressure downstream of said
first and/or second precision restrictor, (xxi) positioning said
first and or second precision restrictor such that the hepatic
veins are down stream of at least one of said precision restrictor,
(xxii) positioning said first and or second precision restrictor
such that a lymphatic outflow duct is down stream of at least one
of said precision restrictor, (xxiii) positioning said first and or
second precision restrictor such that the renal veins are down
stream of at least one of said precision restrictor, (xxiv)
providing a first and/or second precision restrictor said
restrictors configured to facilitate blood flow across its/their
surface in the inflated state without fluid turbulence, regions of
fluid recirculation, or flow discontinuities, (xxv) taking a
performance measurement of a visceral organ and adjusting the
position or flow rate associated with at least one precision
restrictor, (xxvi) monitoring a cardiac, hepatic, renal, or
pulmonary parameter and adjusting the catheter or at least one
precision restrictor in response to said monitoring (xxvii)
monitoring patient symptoms and adjusting the position or flow rate
associated with at least one precision restrictor.
[0060] In other aspects, this disclosure provides additional
methods for treating edema. The methods can include inserting a
catheter comprising a restrictor into a blood vessel, the
restrictor comprising a retracted configuration and a deployed
configuration, and in the deployed configuration, an exterior
surface of the restrictor is shaped to form at least one flow path
along the exterior surface of the restrictor; and deploying the
restrictor inside the blood vessel. Deploying the restrictor inside
the blood vessel is useful for regulating blood flow inside the
blood vessel. The blood flow can be regulated so as to, for
example, reduce blood pressure in the vicinity of an outflow port
of a lymph duct--thereby facilitating removal of lymph--while
controlling cardiac preload. By removing lymph, methods of the
invention are useful for treating symptoms associated with
edema.
[0061] Preferably, when the restrictor is deployed inside the blood
vessel, the flow path is formed between the exterior surface of the
restrictor and a wall of the blood vessel. The restrictor inside
the blood vessel restricts fluid flow to a predetermined amount of
flow through the blood vessel via the flow path, thereby
controlling cardiac preload. When the restrictor is in the deployed
state, the exterior surface forms at least two inflection points
defining a transition region from a convex to a concave surface.
The flow path is preferably formed between the two inflection
points, which define a convex surface that facilitates fluid flow.
Deployment of the restrictor may create a plurality of flow paths.
For example, deployment of the restrictor may lead to the formation
of one, two, three, four, or more flow paths within the blood
vessel. The restrictor may change the shape of the vein when
expanded. The precision restrictor may make the vessel assume the
shape similar to a rounded rectangle or a rounded triangle. A
number of restrictor geometries will induce a rounded rectangle
shape on the vessel cross section including but not limited to the
following restrictor cross sectional shapes:
[0062] a rectangle with two semicircular ends,
[0063] a rectangle with two curved ends,
[0064] a rectangle with four rounded corners,
[0065] any of the foregoing wherein the long sides of the rectangle
comprise a concave curve,
[0066] a shape defined by two opposing and spaced apart convex
curves connected by two opposing and spaced apart concave curves
wherein the four points of interpenetration of these curves are
rounded.
[0067] It will be appreciated that the above geometries are based
on alterations to a square or rectangular shape. Similar
alterations can be made to triangular, circular or other
conventional shape to achieve geometries that induce shape change
on a vessel and simultaneously create at least one flow channel.
Restrictor geometries that induce preferred shapes typically
combine convex curves, flat sections, rounded corners and concave
curves. These can be combined in a large variety of ways but it is
preferred that at least one concave curve be included.
[0068] In other aspects, this disclosure provides an intravascular
device (e.g., an intravascular catheter) with a blood flow
restrictor that modulates blood flow for the efficient removal of
excess fluid. Devices and methods of the disclosure use an
intravascular catheter with a deployable restrictor, preferably a
balloon, to create a localized region of reduced pressure in a
patient's body, for example, in a vessel (e.g., a blood vessel) in
the vicinity of a lymph duct. The restrictor includes a fluid flow
path that allows some blood to flow past the restrictor. By
allowing some blood to flow past the restrictor, the device
prevents excessive buildup of pressure upstream of the restrictor,
thereby reducing the likelihood of the blood vessel stretching
during treatment. As such, systems and methods of this disclosure
can maintain regions of reduced pressure for longer durations of
time providing for the efficient and complete removal of fluid from
the lymphatic system to treat edema.
[0069] In particular, this disclosure describes systems and methods
that use an intravascular catheter to deploy a restrictor inside a
blood vessel. In one preferred embodiment the restrictor reduces
the volume of fluid that returns to the right heart and thereby
reduces the pressure in the right heart. This reduced pressure
means that the right ventricle fills at a lower pressure and
reduces the stress on the right heart muscle. In other preferred
embodiments, the restrictor is deployed up stream of a lymph duct.
Deployment of the restrictor creates a pressure drop across the
restrictor and a region of low pressure downstream of the
restrictor and this low downstream pressure allows lymph to drain
from the lymph duct and into circulation. The fluid flow path
allows a predetermined amount of blood flow to move around the
restrictor. Venous vessels are sensitive to pressure and because
they are elastic, they stretch when internal pressure is high and
they reduce in diameter when pressure reduces. This dynamic
response makes it difficult for conventional balloons to provide a
consistent level of restriction (i.e. reducing blood flow by a
controlled amount) over the course of a procedure, especially the
procedure contemplated for ADHF patients, namely removing fluids
(water and sodium especially) from blood thereby reducing blood
volume--diuresis. The restrictors of the current invention are
configured to appose the venous wall and provide a flow pathway
while apposed and to maintain said flow path even as blood volume
decreases and the vein contracts adjacent to the restrictor.
[0070] In an aspect, this disclosure relates to a catheter system
for modulating fluid flow within a blood vessel. The system is
useful for establishing, and maintaining, a localized region of
reduced pressure within the blood vessel in order to facilitate the
removal of lymph fluid and enhance cardiac function. Accordingly,
this disclosure provides a catheter system that is useful for
treating edema. The catheter system includes a sheath with a distal
end dimensioned for insertion into the blood vessel (e.g., a
jugular vein) and a catheter that is partially disposed within the
sheath. The catheter includes an elongated body with a distal
portion that extends from the distal end of the sheath. The
catheter system further includes a restrictor, and optionally, more
than one restrictor, wherein each one of the restrictors is mounted
onto one of the sheath or the catheter. The restrictors may
optimally be approximately 2 to 5 centimeters in length. The
restrictors are deployable within the blood vessel to at least
partially occlude the blood vessel and create a region of low
pressure for draining lymph fluid and enhancing cardiac function.
In one embodiment the catheter and sheath are configured to enhance
lymph drainage, reduce right heart cardiac preload and reduce
micro-fluid filtration to at least one additional visceral organ.
Each of the restrictors includes a fluid flow path that permits
flow of some fluid across the at least one restrictor. By
permitting flow of some fluid across the restrictor, the catheter
system prevents an excessive amount of pressure from accumulating
upstream of the restrictor and ensures that upstream tissues and
organs (if applicable) continue to be perfused.
[0071] For the purposes of this invention a "therapy target" means
an organ, or part of an organ or bodily system or part of a bodily
system. By way of example organ includes but is not limited to one
or more of Adrenal glands, Bronchi, Heart, Kidneys, Large
intestine, Liver, Lungs, Lymph nodes, Mesentery, Pancreas, Skin,
Small intestine, Stomach, Blood cells, Thoracic ducts, Arteries,
Veins, Capillaries and Lymphatic vessels. By way of another example
bodily systems include any of the respiratory system, digestive and
excretory system, circulatory system, urinary system, integumentary
system, skeletal system, muscular system, endocrine system,
lymphatic system, nervous system, and reproductive systems. A
therapy directed at a therapy target has a `mode of action` and
this mode of action is designed to improve the performance of the
therapy target in some way. Some examples of the mode of action of
some therapies include (i) the mechanical action of a stent in
dilating and holding open a diseased artery, (ii) the ablation of
aberrant conductive tissues in an electrophysiology procedure,
(iii) the physical and thrombotic occlusion of an embolic coil in
treating cerebral aneurysms, (iv) a diuretic drug therapy
stimulates the kidneys to diurese more urine.
[0072] Since diseases like edema, acute decompensated heart
failure, heart failure and ascites involve multiple organs or
bodily systems then therapies that simultaneously target multiple
therapy targets are advantageous. It is an objective of this
invention to describe the drugs, devices and methods of therapies
that target multiple therapy targets simultaneously.
[0073] In one embodiment the invention comprises a system for
managing venous blood pressure at three therapy targets. With this
embodiment the system comprises one or more medical devices
comprising one or more restrictors.
[0074] The first therapy target is managing venous blood pressure
at the outflow of one or more lymph ducts (the right lymphatic duct
or the left thoracic duct). In patients suffering with venous
congestion (from heart failure or other origins) central venous
pressure (CVP) is elevated and high central venous pressure forms a
barrier to the normal drainage of lymph fluid. Reduced lymph flow
means that excess fluid that is stored in the interstitial tissues
of these patients cannot be removed from the interstitial
compartment for diuresis. Reducing the pressure at the outflow of
at least one lymph duct (right lymphatic duct or left thoracic
duct) helps the lymphatic system move fluid from the interstitial
compartment to the vascular compartment from where it can be
subjected to diuretic therapy. This therapy target (lymphatic
outflow decompression) works best in combination with diuretic
therapy to decongest patients more quickly and effectively.
[0075] The second therapy target is managing right heart cardiac
preload. Cardiac preload is the load (or pressure) experienced by
the heart as it fills with blood. This load is the force that
stretches the cardiac muscle prior to contraction. In patients with
venous congestion CVP is elevated and this elevated CVP increases
cardiac preload. When cardiac preload is excessively high then
right heart output decreases. This in turn impacts left heart
output as blood supply to the left heart is reduced. Reducing
excessive right heart preload can help the right heart to pump more
effectively.
[0076] Venous congestion is associated with poor renal function.
Renal function depends on many parameters including the blood
pressure in the renal veins. When CVP is high then the pressure in
the renal veins is also high and this pressure resists blood flow
through the kidneys. Reducing venous outflow pressure reduces this
resistance to blood flow in the kidneys and this facilitates an
increase in blood volume flowing through the kidneys and thus renal
performance is improved. Reducing renal venous outflow pressure is
a third therapy target.
[0077] In one embodiment a system of this invention targets all
three of these therapy targets at once in patients with elevated
central venous pressure and venous distention. The mode of action
of the system is to inflate one or more precision restrictors in
one or more veins, the position of the one or more precision
restrictors being chosen so as to ensure a fluidic interconnection
between the three therapy targets, (i) a lymphatic outflow, (ii) a
renal vein and (iii) a right atrium. For the purpose of this
embodiment the three fluidically interconnected veins will be
referred to as a central region. The one or more precision
restrictors comprise an outer surface which is configured to appose
the one or more veins. The one or more precision restrictors
comprises an undulating outer surface (as described in the
specification) configured to provide at least one a flow channel
across the precision restrictor. The one or more flow channels
allows continuous flow from an upstream side of the precision
restrictor to the down streamside of the precision restrictor. The
precision restrictor is configured to effect a pressure drop across
the precision restrictor when in the expanded state. The system is
configured to create a low-pressure zone that extends across the
central region thus impacting all three therapy targets. It will be
appreciated by one of ordinary skill in the art that the pressure
in this low-pressure zone will not be exactly the same at all three
therapy targets due to hydrostatic head differences between the
locations and patient posture. The pressure upstream of the one or
more balloons will be relatively higher. In maintaining the
interconnection between the three therapy targets of the central
region the one or more precision restrictors may be placed in one
or more of the following veins (i) left internal jugular, (ii)
right internal jugular, (iii) left subclavian, (iv) right
subclavian (v) right innominate, (vi) left innominate (vii) left
external jugular, (viii) right external jugular, (ix) infrarenal
inferior vena cava, (x) right iliac vein, (xi) left iliac vein,
(xii) right femoral vein, (xiii) left femoral vein. In one
variation the one or more precision restrictors are delivered on a
catheter that is advanced from an upstream access site. In another
variation the one or more precision restrictors are delivered on a
catheter that is advanced through the central region to the target
site of deployment. In one variation the system comprises a
catheter that comprises a first restrictor placed in a first vein
and a second restrictor placed in a second vein, the catheter shaft
extending between said first and second vein. The veins that
comprise the central region will at a minimum comprise (i) superior
vena cava, (ii) right atrium, (iii) retrohepatic inferior vena cava
and (iv) supra renal inferior vena cava.
[0078] The central region comprises a central body of fluid. Where
catheters extend across the central body of fluid these catheters
are small in diameter relative to the veins of the central region
and so they do not significantly interfere with the fluidic
interconnection between the three therapy targets of the central
region. It will be appreciated that it is the combination of fluid
restriction into the central region by the one or more precision
restrictors and the pumping action of the right heart that leads to
a lower relative pressure in the central region.
[0079] In one variation the one or more precision restrictor is
configured to be adjustable. In one variation increasing the
inflation level of the one or more precision restrictor expands the
OD of said precision restrictor but does not change the flow rate
across the precision restrictor. With this embodiment the precision
restrictor is configured to provide a constancy of flow
irrespective of its level of over inflation. In one variation the
one or more precision restrictors are configured to be inflated for
extended durations without needing to be collapsed or adjusted.
Preferably the one or more precision restrictors are configured to
be compliant and non-thrombogenic or anti thrombogenic (as
described elsewhere in this specification).
[0080] To facilitate implantation and removal, each of the
restrictors are selectively deployable. Accordingly, each of the
restrictors includes a deployed state and a collapsed state. In the
collapsed state, the catheter system is easily implanted and
removed from the blood vessel. In the deployed state, the
restrictors at least partially occlude the blood vessel to create
an area of reduced pressure for treatment. In preferred
embodiments, when the restrictor is in the deployed state, the flow
path is defined by an outer surface of the restrictor and a wall of
the blood vessel. For example, the flow path may be established by
a shape of the restrictor. Due to the shape of the restrictor, when
the restrictor is fully deployed, one or more openings between the
restrictor and the blood vessel wall are created of specific
cross-sectional area through which a predictable amount of fluid
may pass. The amount of fluid that passes the restrictor through
the flow path may be regulated by the changing the shape or size of
the flow path. It will be appreciated that the upstream and
downstream pressure are important parameters that influence the
flow volume and it will be further appreciated that these
parameters can be adjusted by the degree of shape change induced by
the restrictor on the vessel cross section. The flow path may
comprise an inflection point on a surface of the restrictor. The
inflection point may be defined by a change in curvature around a
circumference of the restrictor. Alternatively, the flow path may
be formed within the restrictor, or may be disposed underneath the
restrictor, for example, between the restrictor and a surface of
the shaft of the sheath or catheter.
[0081] In some instances, the catheter system includes at least two
restrictors. One of the restrictors may be mounted on the sheath
and one of the restrictors may be mounted on the distal portion of
the catheter. This arrangement is advantageous because it permits
each of the restrictors to be independently positioned within the
blood vessel. In particular, because the restrictors are mounted
onto two separately moveable parts (i.e., sheath and catheter) the
restrictors are separately movable along the length of the blood
vessel by moving one of the catheter or the sheath. In one
embodiment the catheter comprises two restrictors and in a further
embodiment these resistors are configured for relative movement in
vivo.
[0082] The flow path, or each one of the flow paths, preferably
includes at least two inflection points formed by the exterior
surface of the restrictor. Each of the inflection points may define
a transition region from a convex to a concave surface. The flow
path is disposed between two inflection points that define a
concave surface for promoting fluid flow. When the restrictor is
deployed inside a blood vessel, the flow path may be formed between
the exterior surface of the restrictor and a wall of the blood
vessel. The restrictor may comprise a plurality of flow paths.
[0083] In some instances, deployment of one or more restrictors
inside a patient's blood vessel is enough to remove excess fluid.
Accordingly, in some instances, a portion of a catheter that
extends from the distal end of the sheath to the restrictor is
smooth and continuous, with no inlets or outlets for moving fluid
through the catheter. In other instances, an inlet and an outlet
are disposed on the distal portion of the catheter such that, when
inside the blood vessel, fluid flows through the distal portion of
the catheter via the inlet and the outlet.
[0084] In one embodiment the sheaths, catheters and restrictors of
this invention are configured for use in at least one artery. With
this embodiment any of the previously disclosed embodiments can be
applied. However, in the arterial system blood flow is moving from
the heart rather than returning to the heart. The use of the
restrictors of this invention in the arterial system comprises
adjusting the balance of fluid flow in the arterial system. This is
achieved by using the restrictors to reduce perfusion to one tissue
so as to increase perfusion to other tissues. This is particularly
advantageous in clinical situations where there is an insufficiency
of cardiac output to meet tissue and organ demand and some organs
are dramatically impacted by that insufficiency. In a heart failure
the kidneys and the heart itself are impacted by cardiac
insufficiency and enhancing the distribution of the reduced blood
supply is impactful. In ADHF patients the kidneys serve a critical
role in diuresing the patient and the heart muscle needs oxygen to
pump blood to the kidneys and other tissues. In heart failure
patients precision restrictors may be configured for placement in
locations that reduce perfusion to the lower limbs, and/or the
upper limbs and/or the cerebral circulation. Such arteries include
the lower aorta, iliac, femoral, subclavian, carotid and/or
vertebral arteries. In a patient with an acute stroke it may be
desirable to reduce flow to the abdominal region so as to increase
flow to the brain. In this situation placing at least one precision
restrictor in one or more of the aorta, lower aorta, iliac, femoral
arteries may benefit the patient. In a patient with hypertension
undergoing an interventional procedure to an organ the precision
restrictor may be deployed upstream of the organ to locally reduce
the hypertensive effect and reduce the risk of bleeding during the
procedure. During surgery devices of the invention may be placed
upstream of the tissue or organ to reduce pressure during the
procedure and reduce blood loss. In one variation of this
embodiment the precision restrictor comprises a balloon guide
catheter wherein the balloon comprises a precision restrictor.
[0085] In a preferred embodiment the system of the invention is
used in treating patients with acute decompensated heart failure
with elevated central venous pressure. With this embodiment the
method of using the system comprises:
[0086] Accessing the blood stream of the patient through a vein.
Preferably the vein comprises a peripheral vein (not a central
region vein).
[0087] Advancing a segment of the catheter in at least one venous
segment so as to position a precision restrictor of said catheter
at a target location for restriction, said target location for
restriction being outside of a central region. In one variation the
target location is down stream of the site of venous access.
[0088] Expanding the at least one precision restrictor at the
target location. In one embodiment the expanding of the at least
one precision restrictor comprises apposing the vein wall with the
precision restrictor. In one embodiment the expanding the at least
one precision restrictor comprises force fitting the at least one
precision restrictor in the vein. In one embodiment the expanding
the at least one precision restrictor comprises reshaping the
cross-sectional shape of the vein. In one variation of this
embodiment the reshaping the cross-sectional shape of the vein
comprises the precision restrictor forcing the vein to adopt a
cross sectional shape that is different to the cross-sectional
shape of the precision restrictor.
[0089] Taking at least one pressure measurement of the central
region. Averaging the pressure measurements at two or more
locations in the central region.
[0090] Measuring the pressure in at least one location of the
peripheral region.
[0091] Maintaining during therapy at least one of the at least one
precision restrictor in the expanded state so as to maintain the
pressure in the central region substantially constant. In one
variation the substantially constant pressure in the central region
is maintained at a pressure that is lower than the pressure in at
least a part of the peripheral region.
[0092] Partially collapsing during therapy at least one of the at
least one precision restrictors so as to maintain the pressure in
the central region substantially constant.
[0093] Collapsing during therapy at least one of the at least one
precision restrictors so as to maintain the pressure in the central
region substantially constant.
[0094] Measuring during the course of therapy one or more of (i) a
cardiac output parameter, (ii) a lymph flow parameter, or a (iii)
kidney function parameter. The cardiac output parameter may be a
measure of contractility, a measure of ejection fraction, a measure
of blood pressure, a measure stroke index or other commonly used
cardiac output measures. The lymph flow parameter may be a measure
of vein blood pressure at the lymphatic outflow, a measure of flow
rate from a lymphatic duct, a measure of interstitial volume, a
measure of interstitial pressure. The kidney function parameter may
be a measure of creatinine clearance, an eGFR measure, a blood urea
nitrogen test, or a urine analysis test.
[0095] Administering a diuretic agent in either a bolus
administration or as a continuous drip administration simultaneous
while maintaining the pressure in the central region substantially
constant.
[0096] In one embodiment the system of the invention comprises a
catheter configured for advancement into a blood vessel of a
patient, the catheter having a distal end and a proximal end. The
distal end comprises a restrictor wherein the restrictor comprises
an at least partially vacuumed state and an at least partially
pressurized state, the partially vacuumed state facilitating low
profile delivery of the catheter and restrictor to a site of
therapy and the at least partially pressurized state comprising a
treatment configuration (at the target site). The restrictor in the
at least partially pressurized state comprises a plurality of
definite geometries, each depending on extent of pressurization,
the plurality of definite geometries further comprising a plurality
of pore-less geometries.
[0097] A poreless geometry is a geometry that has no fluid pathways
through its body and blood must flow around said poreless geometry.
The poreless restrictors of this embodiment may be expanded to a
variety of sizes but at any given size the poreless restrictor
induces the same fluid behaviour as if it were a solid body.
[0098] The system further comprises an inflation device or pump for
pressurizing the restrictor, at least one pressure sensor and a
controller.
[0099] One method of using this embodiment comprises:
[0100] Advancing a catheter in a depressurized state into a blood
vessel,
[0101] Positioning a first restrictor of the catheter at a target
location,
[0102] Measuring a baseline pressure in a blood vessel,
[0103] Pressurizing the first restrictor to a first diameter the
first diameter comprising a force fit in the blood vessel,
[0104] Maintaining the force fit between the restrictor and the
blood vessel for an extended period of time without loss of
vascular homeostasis,
[0105] Depressurizing the first restrictor at the end of the
therapy.
[0106] The step of pressurizing the first restrictor to a force fit
in the vessel might include pressurizing the first restrictor until
the first restrictor induces a shape change in the vessel. The
shape change in the vessel may comprise a local shape change. The
local shape change may comprise a local expansion of the vessel or
it may comprise a local change in cross sectional shape. The force
fit between the restrictor and the vessel may comprise straining
the wall of the blood vessel in the region of the restrictor. The
step of pressurizing the first restrictor to a force fit in the
vessel may comprise forcing the blood vessel to conform to at least
a part of the outer surface of the restrictor. In one variation the
method comprises forcing the blood vessel to conform to one part of
the outer surface of the restrictor. In one variation the method
comprises forcing one part of the blood vessel to conform to one
part of the outer surface of the restrictor while simultaneously
forcing another part of the blood vessel to not conform to another
part of the outer surface of the restrictor. This simultaneous
forcing of blood vessel partial apposition and blood vessel
non-apposition to the surface of the restrictor may in a preferred
embodiment occur at the same cross section of the restrictor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0107] FIG. 1 shows a catheter according to some aspects of the
invention.
[0108] FIG. 2 shows a precision restrictor.
[0109] FIG. 3 illustrates a catheter during a treatment.
[0110] FIG. 4 shows a catheter system.
[0111] FIG. 5 shows a sheath according to aspects of the
invention.
[0112] FIG. 6 is a cross-section of the sheath in a blood
vessel.
[0113] FIG. 7 shows a sheath with a restrictor.
[0114] FIG. 8 shows an alternative embodiment of the flow path
shown in FIG. 7.
[0115] FIG. 9 shows a medical dilator.
[0116] FIG. 10A shows a distal looking view of the catheter.
[0117] FIG. 10B is a cross section.
[0118] FIG. 11A illustrates a second approach for regulating blood
flow with a restrictor.
[0119] FIG. 11B is a cross section of the restrictor in the second
approach.
[0120] FIG. 12A illustrates another approach for regulating blood
flow inside a blood vessel.
[0121] FIG. 12B is a cross section.
[0122] FIG. 13A illustrates a different approach for regulating
fluid flow inside a blood vessel.
[0123] FIG. 13B is a cross section.
[0124] FIG. 14 illustrates one system of the disclosure.
[0125] FIG. 15 shows another treatment system of the
disclosure.
[0126] FIG. 16 shows another treatment system of the
disclosure.
[0127] FIG. 17 shows the distal end of a flow restricting
catheter.
[0128] FIG. 18 shows the precision restrictor in the inflated
state.
DETAILED DESCRIPTION
[0129] The invention provides a restrictor that provides for
precision restriction. The restrictor provides for precision
restriction on account of one or more flow paths along an exterior
surface of the restrictor. The flow paths are of a defined
construction, so that an amount of flow past the restrictor, in the
deployed state, is completely predetermined and known by an
operator. Because the restrictors of the invention include flow
paths, vessel occlusion is not based on imprecisely guessing as to
how much to expand the restrictor relative to the vessel wall.
Rather, the restrictor can be fully deployed to the vessel wall and
the flow paths determine the amount of fluid allowed to pass beyond
the restrictor. Moreover, another advantage is that restrictors of
the invention can adjust to the compliance of the vessel wall while
still providing the same precise and predictable flow past the
restrictor via the one or more flow paths in the restrictor.
According, the restrictors of the present invention provide
significantly more precise restriction than prior art standard
occlusion balloons and are therefore, among other things, are
better at controlling cardiac preload.
[0130] The fluid dynamics of the precision resistors mean that they
can be placed in a vessel for a long period of time without need
for a controller or cyclic deflations and inflations. It will
further be appreciated that the restrictor(s) control flow and they
are relatively insensitive to fluctuations in the dimensions of the
vein during the course of a procedure. In that manner, the
invention encompasses the concept that restrictors can be placed at
one or more locations in a patient's body to achieve different
effects. Many examples are described in the summary above. Three
general therapeutic embodiments include the following examples.
[0131] In one embodiment, devices including a restrictor as
described herein can be used for reduction in fluid returning to a
right heart to thereby reduce right heart preload. A low-pressure
region is defined as the region downstream of the restrictors and
in fluid communication with the heart. Upstream of the restrictors
is by definition the higher-pressure region. In patients where
preload is elevated, this takes stress off the heart and improves
performance. Since the left heart cannot pump more fluid than it
gets from the right heart, improved right heart performance has a
positive impact on cardiac output of the left heart.
[0132] In another embodiment, if the boundaries of a low-pressure
zone include the lymphatic outflow ducts then the invention will
stimulate lymph flow. For example, a first precision restrictor
placed in the inferior vena cava and a second restrictor also in
the left internal jugular vein will define a low-pressure zone that
includes the right heart, the superior vena cava, left innominate,
left subclavian, the thoracic duct, all of the right innominate
circulation and by implication the right lymphatic duct. Such an
embodiment stimulates lymph flow.
[0133] In another embodiment, if the low-pressure zone includes the
venous circulation of an organ, then that organ can be targeted for
benefit. For example, if the restrictor is placed in the inferior
vena cava below the hepatic veins, then the liver circulation forms
part of the low-pressure zone. In this embodiment, liver filtration
is reduced, which has beneficial impacts on liver disorders. The
skilled artisan can envision how such an approach could apply to
additional organs.
[0134] The invention also envisions the use of multiple precision
restrictors to obtain beneficial effects. For example, a first
precision restrictor can be placed to be operably associated with
an organ (e.g., liver or kidney) and a second precision restrictor
can be placed to be operably associated with the vascular bed
proximate the heart. This second restriction can be placed at many
different locations, such as the right innominate vein or the
inferior vena cava. This approach provides benefits to both the
heart as well as other organs. In such embodiment, a third
precision restriction may optionally also be placed, such as in the
internal jugular vein.
[0135] Embodiments of precision restrictors are now described. The
invention encompasses devices that include a single precision
restrictor and embodiments that include multiple precision
restrictors. For the use of multiple restrictors, the invention
encompasses the use of a precision restrictor on a sheath plus one
or more on a catheter. The invention also encompasses having two
precision restrictors on a single catheter and having multiple
catheters.
[0136] FIG. 1 provides an exemplary embodiment of a device within
the scope of the invention. As shown in FIG. 1, devices of the
invention can include a restrictor with a flow path that allows
some blood to flow around the restrictor, thereby alleviating
buildup of pressure upstream of the restrictor that can otherwise
cause the blood vessel to stretch, reducing the effectiveness of
the restrictor and preventing the maintenance of a low-pressure
zone. In particular, catheter systems of the invention may include
an intravascular catheter that is implantable in a blood vessel to
deploy a restrictor near a lymph duct. As discussed, deployment of
the restrictor can create a region of reduced pressure that allows
lymph to drain from the lymph duct and into circulation. The flow
path allows a predetermined amount of blood flow to move around the
restrictor so as to prevent excessive pressure buildup, which would
otherwise cause the vessel to stretch.
[0137] As shown in FIG. 1, the invention in certain embodiments may
include a catheter 1001. The catheter 1001 includes a proximal
portion 1041 and a distal portion 1043. The distal portion 1043 is
dimensioned for insertion into a blood vessel (e.g., a jugular
vein). A precision restrictor 1009 is mounted to the distal portion
1043 and is shown in the deployed configuration.
[0138] The restrictor 1009 includes flow paths 1011, for allowing a
predetermined amount of fluid to pass over an external surface of
the restrictor 1009. The restrictor 1009 can include any number of
flow paths 1011, for example, the restrictor 1009 can include one,
two, three, four, five, six, or more flow paths 1011. The flow
paths 1011 are of a defined architecture (discussed further in FIG.
2), so that an amount of flow past the deployed restrictor 1009 is
completely predetermined and known by the operator. Inclusion of
the flow paths 1011 provide several advantages over the prior art.
For example, because the restrictors 1009 include flow paths,
vessel occlusion is not based on imprecisely guessing as to how
much to expand the restrictor relative to the vessel wall. Rather,
the restrictor 1009 can be fully deployed to the vessel wall and
the flow paths 1011 determine the amount of fluid allowed to pass
beyond the restrictor. Moreover, the flow paths 1011 address issues
of blood vessel compliances by allow some fluid to bypass the
restrictor and thereby reduce likelihood of the blood vessel
stretching during a treatment.
[0139] In preferred embodiments, the catheter 1001 further includes
at least one pressure sensor, and preferably at least two pressure
sensors. The pressure sensors may be connected to a sensor lead
1013 disposed at the proximal end of the catheter 1001 for
connecting to a controller, discussed below. The pressure sensors
can be disposed upstream and downstream of the restrictor 1009. For
example, in preferred embodiments, the catheter 1001 includes a
proximal sensor 1056 and a distal sensor 1055. The sensors 1055,
1056 provide pressure measurements upstream and downstream of the
restrictor, which can help establish and maintain a low-pressure
zone in a preferred region of the circulatory system. For example,
using the catheter 1001, the physician can establish and monitor a
low-pressure zone upstream of an inflow tract of the patient's
heart, such as, for example, in the inferior vena cava, which is a
large vein that carries the deoxygenated blood from the lower and
middle body into the right atrium of the heart. By establishing a
low-pressure zone upstream of the right atrium of the heart, fluid
pressure on the heart is decreased, thereby helping the heart pump
blood. During a treatment, if a measured pressure downstream of the
restrictor 1009 elevates above a value of, for example, 8 mmHg, the
physician may be alerted by, for example, an alarm connected to a
control module operably associated with the sensor, to either
re-position the catheter, adjust a size of the restrictor 1009.
[0140] FIG. 2 shows a precision restrictor 209. The precision
restrictor 209 is shown in a deployed configuration. In the
deployed configuration, an exterior surface 202 of the restrictor
209 defines flow paths 211 between the exterior surface 202 and a
blood vessel wall (not shown for clarity). In particular, the
exterior surface 202 comprises inflection points 203, or inflection
regions, that are formed by a shape of the exterior surface 202.
The inflection points 203 are preferably neither concave or convex
and instead define a transition region between a convex surface 205
and a concave surface 207. As illustrated, each fluid flow path 211
may be disposed between two inflection points 203 defining a
concave surface 207. The fluid flow paths 211 are designed to allow
only a predetermined amount of fluid to bypass the restrictor 209
when the restrictor 209 is the deployed inside the blood
vessel.
[0141] FIG. 3 illustrates a catheter 1001 during a treatment.
During treatment, the catheter 1001 is inserted through a patient's
skin 1117 and into a vein, such as a jugular vein 1121. The
catheter 1001 can be advanced inside the vein 1121 by, for example,
using an image guiding system, e.g., ultrasound imaging. Further,
the catheter 1001 can be advanced down the jugular vein 1121 past a
thoracic duct 1118 and into an innominate vein 1126. Once inside
the innominate vein 1126 the restrictor 1009 may be deployed to
partially occlude the vein and define one or more flow paths for
allowing some blood to bypass the restrictor. It may alternatively
be advanced further downstream to the superior vena cava (as
shown). In this embodiment the precision restrictor 1009 now
restricts flow from the vascular bed of both right and left
innominate vascular beds. In FIG. 3 there are multiple flow paths
across the restrictor 1009 (two are indicated by the arrows). In
the deployed state, the restrictor 1009 establishes a region of low
pressure downstream of the deployed restrictor to, for example,
reduce workload on a patient's heart. According, a pressure at P2
is lower than a pressure at P1. Preferably, the catheter 1001
includes pressure sensors. For example, the catheter 1001 can
include a proximal pressure sensor 1056 and a distal pressure
sensor 1055. The proximal and distal pressure sensors 1056, 1055
provide pressure measurements upstream and downstream of the
restrictor 1009 to monitor and maintain the low-pressure region
downstream of the restrictor 1009.
[0142] FIG. 4 shows a catheter system 1200. The catheter system
1200 includes a pressure control catheter 1201 with a flow
restrictor 1209 and one or more pressure sensors, e.g., a distal
pressure sensor 1255 and proximal pressure sensor 1256, for
measuring pressures downstream and upstream, respectively, of the
restrictor 1209. On a proximal portion of the pressure control
catheter is a hub 1259 that, among other things, includes a
connector 1213 for receiving data from the pressure sensors. The
connector 1213 comprises a port for attaching a cable. Preferably,
the cable is attachable to a mobile pressure monitoring cart 1221
comprising a computer linked to a graphic interface 1223 for
displaying and interacting with data received by the one or more
pressure sensors. Alternatively, the computer and graphics
interface 1223 may be miniaturized and placed on the bed. The
graphic interface may be touchscreen.
[0143] In some embodiments, the pressure control catheter system
1200 can be used to regulate pressure inside the inferior vena cava
1215. For example, the pressure control catheter 1201 can be
inserted into the inferior vena cava 1215 via the femoral vein
1216. Upon insertion into the inferior vena cava 1215 the catheter
1201 is operable to deploy a restrictor 1209 having at least one
flow path. Upon deployment of the restrictor 1209, pressure
downstream of the restrictor is reduced. Reducing pressure
downstream of the restrictor inside the inferior vena cava reduces
pressures on the heart, thereby allowing the heart to effectively
eject blood.
[0144] FIG. 5 shows a sheath 407 according to aspects of the
invention. The sheath 407 includes a proximal portion 441 and a
distal portion 443. The distal portion 443 is dimensioned for
insertion into a vein or artery. The sheath 407 may comprise an
elongated cylindrical body 447 that is substantially smooth across
its surface with a precision restrictor 409 that is mounted near a
distal tip 405. The body 447 may be comprise multiple parts that
offer certain structural features. For example, the body 447 may
comprise a jacket 449 disposed over a shaft 451 with a coil 453
disposed therein. The coil 453 can provide structural support
around a circumference of the body 447 to prevent an interior lumen
(e.g., a lumen for receiving a catheter) from collapsing after
insertion into the blood vessel.
[0145] The restrictor 409 preferably comprises a balloon designed
to be inflated (corresponding to a deployed configuration) and
deflated (corresponding to a relaxed configuration). In the
inflated state, the restrictor at least partially occludes the
blood vessel. Preferably, the restrictor is inflated in response to
delivery of a fluid. Accordingly, the restrictor can be made from
any one or more of a variety of materials configured to expand upon
the delivery of a fluid thereto and to contract upon the withdrawal
of the fluid. Exemplary materials from which the restrictor 409 can
be made includes polymeric materials such as PEBAX, silicones,
polyurethanes, and nylons.
[0146] The device 407 includes an inflation lumen 455. The
inflation lumen 455 is fluidically coupled with the first
restrictor 409 to provide a mechanism for inflating the first
restrictor 409 inside the blood vessel. The first restrictor 409 is
inflatable via the inflation lumen 455 by delivering a fluid such
as saline through the inflation lumen to the first restrictor 409.
A pump may be used to facilitate the delivery of the fluid through
the lumen 455 and into the first restrictor 409.
[0147] In at least some embodiments, the distal tip 405 is a soft
atraumatic tip that facilitates smooth, safe introduction of the
sheath 407 into the vein. Exemplary materials from which the
atraumatic tip can be made include polyurethanes.
[0148] The proximal portion 441 of the sheath 407 is external to a
patient's body during a treatment. The proximal portion 441 can
include a number of features for navigating and securing the
catheter system in place during the treatment. For example, the
proximal portion may include a suture ring 457 to secure sheath 407
during catheter manipulation or during prolonged vascular access.
Additionally, the proximal portion 441 may include multi-lumen
tubing. The multi-lumen tubing may include the inflation lumen 455.
The multi-lumen tubing may also include a lumen for one or more
pressure sensors disposed on the sheath 407.
[0149] FIG. 6 is a cross-section taken along line A-A of FIG. 5
when the sheath is disposed inside a blood vessel 520. This view
highlights a flow path 511 defined between an exterior surface 516
of the restrictor 409 and a wall 521 of the blood vessel 520. The
exterior surface 516 of the first restrictor 409 includes an
inflection point 518 defining a change in curvature around a
circumference of the first restrictor 409. The inflection point
defines a transition between a convex surface 601 and a concave
surface 603.
[0150] FIG. 7 shows a sheath 701 with a restrictor 709. The
restrictor 709 is illustrated in a deployed/inflated state and in
the inflated state, the restrictor 709 forms a flow path 711. The
sheath 701 also includes a distal portion 743 that is dimensioned
for insertion into a blood vessel. The distal portion 743 can
include a distal atraumatic tip 705 that has a soft material (e.g.,
polyurethane) in order to prevent damage to the blood vessel during
insertion of the sheath.
[0151] At a proximal portion 741 of the sheath 701, is a hub 759.
The hub 759 may be designed to facilitate inflation of the
restrictor 709. For example, the hub 759 may provide access to one
or more inflation lumens that extend through the sheath 701 and
connect to the restrictor 709. The restrictor 709 can be inflated
by infusing a fluid into an inflation port 757 at the hub 759. The
hub 759 may also provide access to a flush port 758. For example, a
fluid, such as, a purge fluid may be delivered via the flush port
which is external to the patient. The purge fluid can be used to
purge or clear debris; for example, as described in co-owned U.S.
Provision Application 62/629,914, which is incorporated by
reference. The proximal portion 741 may also include a sensor lead
756, for receiving input from a sensor 754 disposed on the distal
portion 743 of the sheath 701.
[0152] FIG. 8 shows an alternative embodiment of the flow path 811
that is shown in FIG. 7. In particular, the flow path 811 is
non-linear. A non-linear flow path 811 may be desired to resist the
flow of fluid passing through the channel 811, helping maintain a
reduced pressure downstream of the restrictor 809. The restrictor
809 is depicted in the retracted configuration. In some instances,
the restrictor 809 may include an inlet and an outlet as an
alternative, or in addition to, the flow path 811. The inlet and
outlet may allow fluid to pass through an interior chamber of the
restrictor 809.
[0153] FIG. 9 shows a medical dilator 901. The medical dilator 901
is useful for dilating a blood vessel in preparation for a
treatment. For example, the dilator may be used to dilate a blood
vessel before advancing a catheter therein. The medical dilator 901
includes an elongated shaft that is preferably substantially
cylindrical for passing through a cylindrical lumen of a sheath.
The medical dilator includes a guide wire lumen 967 through which a
guide wire can extend for moving the dilator within a blood vein or
blood vessel. The medical dilator 901 further includes a distal tip
966, which may include features that prevent damage to the blood
vessel, such as, an atraumatic tip comprising a soft material.
[0154] In at least some embodiments, the restrictor(s) of a
catheter can be inflated and deflated from time to time to enable
free flow of blood in a patient's vein in which the restrictor(s)
are positioned and thus enable the system to stop working for a
period of time. This period of time can be required in such
treatments to allow for the assessment of the patient's clinical
condition, allow the patient to undergo other treatments or enable
him to go to the bathroom and/or to wash any stagnation points that
might have occurred.
[0155] Furthermore, various systems and methods are provided for
reducing pressure at an outflow of a duct such as the thoracic duct
or the lymphatic duct. In general, the systems and methods may be
effective to reduce edema conditions, such as pulmonary edema, in a
patient by lowering an outflow pressure in a region around the
patient's thoracic/lymphatic duct outflow. As a result of lowering
the outflow pressure at the thoracic and/or lymphatic ducts, higher
lymphatic return will be achieved, enabling the lymphatic vessel
flow to be at or near normal levels. The systems and methods may be
effective to rapidly alleviate conditions of the edema and increase
the patient response rate. In an exemplary embodiment, the systems
and methods may be particularly useful to treat acute pulmonary
edema. However, a person skilled in the art will appreciate that
the systems and methods can be used in various procedures for
treating a lymphatic system fluid clearance imbalance.
[0156] Systems and methods of the invention, according to some
embodiments, rely on the insight that allowing some blood to flow
past at least one of the fluid flow restrictor s is helpful for
regulating pressures within a blood vessel. The invention considers
a variety of approaches for achieving this benefit. Some of these
approaches are further described in FIGS. 10-13.
[0157] FIG. 10A and FIG. 10B illustrate an approach for regulating
blood flow with a restrictor 2009 having flow paths 2011. Blood
flows between the restrictor and the vessel wall.
[0158] FIG. 10 A shows a portion of a catheter 2003 with a
restrictor 2009 inside a blood vessel. Arrows indicate blood flow.
As depicted, blood flows between the restrictor 2009 and a blood
vessel wall 2013.
[0159] FIG. 10B shows a cross section of the restrictor that is
illustrated in the top panel. The flow paths are defined between
the restrictor 2009, which is illustrated in an inflated state, and
the blood vessel wall 2013. The flow paths may comprise holes that
are approximately 0.3-1.0 millimeters in diameter.
[0160] FIG. 11A shows a second approach for regulating blood flow
with a restrictor 2109. In this approach, the restrictor 2109,
illustrated in an expanded state, is sized such that a gap exists
around at least a portion of a circumference of the restrictor 2109
and the blood vessel wall 2113. Blood flows between the restrictor
and the vessel wall.
[0161] FIG. 11B is a cross section of the restrictor 2109. When the
catheter 2103 is inside the blood vessel, blood flows around the
restrictor 2109 via the gap. The gap may be approximately 0.07
millimeters-016 millimeters.
[0162] FIG. 12A and FIG. 12B illustrate another approach for
regulating blood flow inside a blood vessel 2213.
[0163] FIG. 12A illustrates a portion of a catheter 2203 with a
restrictor 2209 inside a blood vessel 2213. Blood flows between the
restrictor and the catheter/sheath. Disposed between the restrictor
2209 and the catheter 2203 is a fluid bypass tube 2211. Blood flows
past the restrictor 2209 by flowing through the tube 2211. The tube
2211 can be sized so as to determine an amount of flow through the
tube 2211. The tube 2211 may comprise a hole that is sized
approximately 0.4-1.5 millimeters. Arrows indicate blood flow.
[0164] FIG. 12B shows a cross section of the catheter 2203
illustrated in the top panel. The fluid bypass tube 2211 can
comprise any size or shape. Preferably the restrictor comprises a
torus shape.
[0165] FIG. 13A illustrates a different approach for regulating
fluid flow inside a blood vessel 2313. According to this
embodiment, the restrictor 2309 may fully occlude the blood vessel
2309. Blood flows past the restrictor 2303 by traversing a lumen
2311 disposed within a shaft of the catheter 2303. Blood flows in
catheter/sheath multilumen.
[0166] FIG. 13B is a cross section of the restrictor 2309. In
particular, blood flows into an inlet 2315 and out an outlet 2317
disposed on either side of the restrictor 2309, thereby
circumventing the restrictor 2309. The lumen may comprise a
diameter of approximately 1.0-1.5 millimeters.
[0167] FIG. 14 illustrates a system 800 for treating patients with
edema and/or acute decompensated heart failure. The system 800 is
configured to facilitate a combination therapy wherein the first
therapy comprises a venous therapy and the second therapy comprises
an arterial therapy. In one embodiment the venous therapy of the
combination therapy comprises supporting the return of blood and/or
lymph to the right heart. In one embodiment the venous therapy of
the combination therapy comprises one or more of: (i) reducing the
outflow pressure in a large vein that drains blood from one or more
visceral organs, (ii) reducing the outflow pressure at a lymphatic
duct, (iii) reducing elevated right heart preload to within an
optimal range. In one embodiment the arterial therapy of the
combination therapy comprises supporting a weakened left heart in
pumping arterial blood to at least one abdominal organ.
[0168] In one embodiment the arterial therapy comprises an arterial
catheter 812, said arterial catheter 812 configured to support
improved blood perfusion to at least one visceral organ. The
arterial catheter 812 comprises a catheter shaft 830, the catheter
shaft 830 configured for advancement from an access site into the
aorta 808, the catheter 812 comprising a plurality of lumens 831, a
distal region 812d and a proximal region 812p wherein the distal
region 812d comprises a pump assembly 817 and the proximal region
812p extends exterior of the patient. The proximal end of the
arterial catheter 812p is connected to a console 813 to monitor the
arterial therapy, control the arterial therapy and display arterial
therapy information to the physician. The pump assembly 817
comprises an impeller 818 and a housing 819. The catheter 812
comprises a drive shaft 834 connected to the impeller 818 and
configured to drive the impeller 818 to pump blood.
[0169] In one variation, the pump assembly 817 comprises an
expandable housing 819 and an expandable impeller 818. With this
embodiment the larger diameter of the impeller 818 allows large
volume of blood to be pumped at relatively lower revolutions per
minute (RPM) of the impeller 818. In one embodiment the expandable
housing 819 comprises a sealing element exterior of the housing 818
and the sealing element 825 apposes the wall of the artery 809.
With this embodiment the sealing element 825 prevents blood flow in
a retrograde direction outside the housing 819. The sealing element
825 may be configured to provide a bidirectional seal. With this
embodiment the sealing element 825 applies a positive pressure to
the vessel wall 809 and the energy source for the positive pressure
is intrinsic to the assembly of the sealing element 825. In one
embodiment the sealing element 825 is expandable. In one embodiment
the sealing element 825 is inflatable. Alternatively, the sealing
element 825 may be configured to facilitate flow in one direction,
like a valve. A one directional sealing element allows blood to
flow in an antegrade direction but not in a retrograde direction.
With this type of sealing element 825 the pressure of sealing is at
least partially extrinsic to the sealing element. In one variation
the geometry of the sealing element is collapsed onto the housing
819 when upstream pressure is higher than the downstream pressure
and the geometry of the sealing element is expanded against the
vessel wall 809 when the downstream pressure is higher than the
upstream pressure.
[0170] The impeller assembly 817 of the system 800 comprises a
blood flow inlet 838 and a blood flow outlet 839. The blood flow
inlet 838 comprises at least one opening that facilitates the
movement of blood into the housing 819 of the blood pump assembly
817. The blood flow outlet 839 comprises at least one opening that
facilitates blood flow out of the housing 819 of the blood pump
assembly 817. The blood flow inlet 838 is generally upstream of the
impeller 818 and the blood flow outlet 839 is generally downstream
of the impeller 818. In one embodiment the blood flow inlet 838 to
the pump assembly 817 comprises at least one inlet strut 840. In
one embodiment the blood flow outlet 839 from the pump assembly 817
comprises at least one outlet strut 841.
[0171] In one embodiment the arterial catheter 812 comprises a
first arterial pressure sensor 820e upstream of the pump assembly
817. The first arterial pressure sensor is configured to measure
pressure upstream of the pump assembly 817. In one embodiment the
first arterial pressure sensor is spaced apart from the pump
assembly 817. In one embodiment the first arterial pressure sensor
820e is placed in the left ventricle of the patient. In one
embodiment the first arterial pressure sensor is placed in the
descending aorta of the patient. In one embodiment the catheter 812
comprises a second arterial pressure sensor 820f wherein said
second arterial pressure sensor 820f is configured on the catheter
for placement downstream of the pump assembly 817. The second
arterial pressure sensor 820f is configured to measure the pressure
of blood flowing to at least one visceral organ. The second
arterial pressure sensor 820f is configured in one variation to be
spaced apart from the pump. In one variation the second arterial
pressure sensor 820f is configured on the catheter for placement in
the abdominal aorta adjacent a renal artery. The first arterial
pressure sensor 820e and the second arterial pressure sensor 820f
comprise data transfer cables extending through a first arterial
catheter lumen and second arterial catheter lumen respectively said
data transfer cables configured for connection to the console 813
at the proximal end of the arterial catheter 812.
[0172] In one embodiment the venous therapy comprises a first
venous catheter 810, the first venous catheter comprising a
proximal end 810p and a distal end 810d, the distal end 810d
comprises a first blood flow restrictor 821a and the proximal end
810p extends exterior of the patient. The proximal end of the first
venous catheter 810p is connected to a console 813 to monitor the
therapy, control the therapy and display therapy information to the
physician. The distal end of the first therapy catheter 810d
comprises a first pressure sensor 820a, the first pressure sensor
820a positioned downstream of the first blood flow restrictor 821a
to measure venous pressure between the first blood flow restrictor
821a and the right heart. The first blood flow restrictor 821a and
the catheter 810 are configured for placing the first blood flow
restrictor 821a in any one of: (i) the superior vena cava 801, (ii)
the supra-hepatic inferior vena cava 803, (iii) the retro-hepatic
inferior vena cava 804, (iv) the suprarenal inferior vena cava 805,
(v) the infrarenal inferior vena cava 807, or (vi) a major branch
vein of any of the above (including an innominate, internal
jugular, subclavian or iliac vein). In one embodiment the first
blood flow restrictor 821a is a precision restrictor as described
in this patent. In one embodiment the first therapy catheter distal
end 810d comprises a second pressure sensor 820b wherein the second
pressure sensor 820b is proximal of the first blood flow restrictor
821a, the second pressure sensor 820b configured to measure blood
pressure on the upstream side of the restrictor.
[0173] In another embodiment the venous therapy comprises a third
pressure sensor 820g, said third pressure sensor 820g mounted on an
elongate member 826 said elongate member 826 configured for
insertion into a peripheral vein, advancement through at least one
central vein and a right heart chamber, crossing a pulmonary valve
and placement in a pulmonary artery. The third pressure sensor 820g
comprises a cable 827 said cable extending exterior of the patient
and connected to a console 813 to display the pressure in a
pulmonary artery to the doctor. In one embodiment the pressure
measured by the third pressure sensor 820g is used to control at
least one therapy parameter.
[0174] In one variation of this embodiment the third pressure
sensor 820g is mounted on said first venous catheter 810. With this
variation the first venous catheter 810 comprises a distal
extension 828, said distal extension 828 extending through at least
one central vein, the right heart and across the pulmonary valve.
The distal extension 828 of first venous catheter 810 carries the
third pressure sensor into the pulmonary artery. In one embodiment
the distal extension 828 is integral with the venous catheter 810.
In another embodiment the distal extension 828 is moveable relative
to the venous catheter 810. With this embodiment the venous
catheter may comprise a lumen for the transit of the distal
extension 828.
[0175] In one embodiment the first venous catheter 810 comprises a
multilumen catheter. With this embodiment the catheter 810
comprises a first lumen 829 configured for the inflation and
deflation of the first blood flow restrictor 821a. The catheter
comprises one or more pressure sensor lumen 830 (each) configured
to hold a pressure sensor at a distal end 810d of each of the one
of more pressure sensor lumens 830. The one or more pressure sensor
lumen 830 comprises a pressure port 831 that brings the pressure
sensor contained in the one or more pressure sensor lumen 830 into
fluid connection to the venous fluid adjacent the one or more
pressure sensors. In one embodiment the one or more pressure ports
831 comprise a skive in the wall of the shaft of the catheter 810.
Preferably the one or more pressure sensors 820 is sealing mounted
in the one or more pressure sensor lumens 830. With this embodiment
fluid pressure is transmitted to the pressure sensor 820 without
blood flowing farther down the lumen. Preferably the one or more
pressure sensor lumens 830 comprises a proximal seal and a distal
seal, the proximal seal proximal of at least a part of the sensing
element 832 of the pressure sensor 830 and the distal seal distal
of the one or more pressure ports 831.
[0176] In one embodiment the venous therapy and the arterial
therapy are operated at the same time. In one embodiment the venous
therapy and the arterial therapy are operated at least partially in
series. In one embodiment the venous therapy uses a first console
813a and the arterial therapy uses a second console 813b. In one
embodiment the venous therapy and the arterial therapy use the same
console.
[0177] In one embodiment of the system 800, the console 813
comprises a controller 814, a user interface 815, and a cart 833.
The controller 814 is configured to receive data from the at least
one pressure sensor 820. The controller 814 is configured to
compare the data from the at least one pressure sensor 820 to a
stored value or to data from a second pressure sensor. The system
800 further comprises digital storage element 836 and a computer
program 837. The computer program 837 comprises program code stored
on a machine readable medium the computer program configured to
execute on at least some of the methods associated with the use of
the system 800. The system 800 comprises at least one output device
835 for outputting data measured by one or more system elements or
stored data or calculated data. The system 800 further comprises an
input apparatus 834 configured facilitate the inputting of data
into the controller 814 or said digital storage element 836. The
input apparatus 834 may comprise a touch screen display 816, a USB
port, a keypad, or other standard data input devices known in the
art. In one embodiment the program 837 comprises at least one
decision criterion. The at least one decision criterion may result
in an action wherein said action comprises one of the following (i)
displaying charted or graphic information to the user, (ii)
displaying a user alert, (iii) inflating the restrictor of the
venous catheter, (iv) deflating the restrictor of the venous
catheter, (v) increasing the impeller speed of the artery catheter,
(vi) decreasing the speed of the impeller of the artery catheter,
(vii) testing a bodily fluid or tissue sample. The at least one
decision criterion may be calculated or determined by the
controller 814 or any other item of the system 800 or a device
interconnected to the system 800. The results of an evaluation,
calculation, comparison data filtration or assessment performed by
the controller 800 or device connected to it may be displayed on
the monitor 816 or sent to an output device 835 or stored on a
database.
[0178] For the purposes of FIG. 14 and FIG. 15 the venous central
region shall mean any region that includes two or more of (i) a
lymphatic outflow, (ii) a renal vein and (iii) the right atrium. In
one embodiment the venous therapy comprises reducing flow into the
central region using a plurality of restrictors placed in large
feeder veins peripheral to the central region. With this embodiment
the venous therapy comprises a first restrictor 810 (as described
above) and a second restrictor 811. The first restrictor 821a and
second restrictor 821b are configured to restrict blood flow to the
venous central region. The second restrictor 821b may be mounted on
the first venous catheter 810. With this embodiment the first
venous catheter 810 may extend across the venous central region
with the first restrictor on one side of the central region and the
second restrictor on the other side of the venous central region.
For example, the first venous catheter 810 of this embodiment may
access the venous system through a femoral vein and the first
restrictor 821a may be placed in the infrarenal IVC, the catheter
810 may extend distally through the aorta, the SVC and the second
restrictor mounted on the catheter 810 is configured for placement
in the left innominate vein. It will be appreciated that the first
venous catheter of this invention facilitates many configurations
of said first restrictor 821a and second restrictor 821b. Table 1
below highlights 17 potential combinations grouped into categories
and all of these combinations define slightly different central
regions but each central region comprises at least two venous
therapy targets
TABLE-US-00001 Catheter configured so that first Catheter
configured so that second restrictor 821a is placed in a restrictor
821b is placed in first target vein second target vein Infrarenal
IVC or Iliac SVC, or Innominate, or Internal Jugular, or
Subclavian. Suprarenal inferior vena cava or Innominate, or
Internal Jugular, or retrohepatic inferior vena cava or Subclavian.
suprahepatic inferior vena cava.
[0179] In another embodiment the second restrictor 821b may be
mounted on a second catheter 811 and delivered to a separate vein
separate of the first venous catheter 810. With this embodiment the
catheter 811 can have all of the features of the first venous
catheter 810 as described above and is connected to the console 813
and operated by the console 813 in a likewise fashion. An example
of this is depicted in FIG. 14 where the two catheters 810 and 811
are connected to the console 813 but inserted into two different
veins. It will be appreciated that the first venous catheter and
second venous catheter and their respective restrictors can equally
be applied to the targets of Table 1 as the single catheter
embodiment describes above.
[0180] The system 800 of this invention facilitates a number of
methods of use. In one embodiment the method comprises the steps
of:
[0181] Selecting a patient with reduced cardiac output and
congestion,
[0182] Inserting a distal segment of a cardiac support catheter 812
into the aorta of the patient,
[0183] Actuating an impeller 818 in a distal region of the catheter
812 to pump blood and off load at least some of the pumping burden
from the left ventricle,
[0184] Inserting a distal segment of a venous catheter 810 into an
access vein,
[0185] Expanding a restrictor 821a associated with the catheter 810
in a vein adjacent to a central region, the restrictor 821a
reducing the volume flow rate of blood returning to the central
region and thereby improving the patients venous or lymphatic fluid
dynamics,
[0186] Operating the cardiac support catheter 812 and the venous
catheter 810 with a console 813 to manage the treatment of the
patient,
[0187] Removing the venous catheter 810 and the cardiac support
catheter 812 from the patient either together or at separate
times.
[0188] In one variation the selecting of a patient with fluid
congestion and reduced cardiac output comprises selecting a patient
with signs and symptoms of excess extracellular fluid. This
includes selecting a patient with venous congestion, or
interstitial congestion or both. In one variation the selecting of
a patient with reduced cardiac output comprises selecting a patient
with reduced left ventricular ejection fraction. This may include
selecting a patient with poor blood circulation to the patient's
peripheral regions (hands and feet).
[0189] In one variation the inserting of a distal segment of a
cardiac support catheter 812 into the aorta of the patient
comprises placing the pump assembly 817 in the descending aorta
between the aortic arch and the renal arteries. In one variation
the inserting of a distal segment of a cardiac support catheter
into the aorta of the patient comprises advancing the catheter
until the blood pump inlet 838 to the pump assembly 817 is across
the aortic valve and within the left ventricle of the patient's
heart.
[0190] In one variation the actuating of an impeller 818 in a
distal region of the catheter 812 comprises rotating the impeller
818 at a speed of greater than 100 meters per minute. Preferably
the actuating of the impeller 818 comprises rotating the impeller
818 at a speeds between 100 meters per minute and 600 meters per
minute. With this embodiment the speed refers to the linear speed
of the impeller 818 at its maximum diameter and can be calculated
by multiplying the outer circumference of the impeller 818 by the
number of revolutions per minute at which it operates.
[0191] In another variation the inserting a distal segment of a
venous catheter 810 into a vein comprises inserting the venous
catheter 810 through a femoral vein, iliac vein, internal jugular
vein or subclavian vein.
[0192] The central region as described in the method above is a
region of the central venous circulation that includes the right
atrium and at least one and preferably more of (i) a renal vein or
(ii) a lymphatic duct outflow. The central region may also include
a hepatic vein. The central region may include two lymphatic duct
outflows. The central region may include both renal veins.
[0193] In a variation the expanding a restrictor 821 associated
with the catheter 810 in a vein adjacent to a central region
comprises expanding the restrictor 821 in a vein segment upstream
of one or more of (i) the right atrium, (ii) a renal vein or (iii)
a lymphatic duct outflow. In a variation the method comprises
expanding a first restrictor 821a associated with the venous
catheter 810 in a first vein segment adjacent to a central region
and expanding a second restrictor 821b associated with the venous
catheter 810 in a second vein adjacent to a central region. In
another variation the method comprises expanding a first restrictor
821a associated with a first venous catheter 810 in a first vein
segment adjacent to a central region and expanding a second
restrictor 821b associated with a second venous catheter 811 in a
second vein adjacent to a central region.
[0194] In a variation the method comprises configuring the at least
one restrictor 821 of the at least one venous catheter 810 to
provide a defined level of restriction in a fully expanded state.
With this variation on the method the restrictor 821 may configured
to appose the vein wall yet still provide flow restriction. In one
embodiment the method comprises providing a restrictor with at
least one region of concavity in at least one fully expanded
state.
[0195] In one variation the improving the patients venous or
lymphatic fluid dynamics comprises reducing the preload on the
right heart thereby reducing the strain on the myocardium in the
end diastolic phase. This variation of the method is configured to
reduce pathologic right heart preload thereby improving right heart
function and overall cardiac output. In another variation the
improving the patients venous or lymphatic fluid dynamics comprises
reducing the venous pressure in a renal vein. With this variation
the method comprises an increased flow in the renal vein and thus
better renal function and faster diuresis of excess extracellular
fluid. In another variation the improving the patients venous or
lymphatic fluid dynamics comprises reducing the pressure at a
lymphatic duct outflow thereby stimulating lymph drainage and
interstitial congestion. With this variation of the method, the
stimulating of lymph drainage comprises protecting the kidneys from
damage from a vascular volume depletion episode in a setting of
high dose diuretics. The method of this variation further comprises
reducing organ interstitial pressure and as a result improving
organ function. For example, stimulating lymph drainage at the
thoracic duct allows the cardiac tissue of the heart to off load
excess interstitial fluid which drains to the thoracic duct and
this in turn improves cardiac contractility. Similarly, lung
function, liver function, intestinal function and kidney function
will be improved by stimulating lymph drainage and reducing
pathologic organ interstitial pressures.
[0196] In a variation of the method operating the cardiac support
catheter 812 and the venous catheter 810 with a console 813
comprises measuring one or more pressures in the aorta and/or left
ventricle. The method may comprise the step of comparing the one or
more pressure measurements from the aorta or left ventricle to a
stored value or to a data measure from a second sensor
820(a,b,c,d,e,f). The method may comprise the step of displaying
the results of an evaluation, calculation, comparison, data
filtration or assessment on a monitor 816 for the physician. The
method may comprise the step of increasing or decreasing the
impeller speed in response to an evaluation, calculation,
comparison, data filtration or assessment of a measured
pressure.
[0197] In a variation of the method operating the cardiac support
catheter 812 and the venous catheter 810 with a console 814
comprises measuring one or more pressures in the central venous
region. The method may comprise the step of measuring a pressure
upstream of the restrictor 821. The method may comprise the step of
comparing the pressure in the central region to a stored value or
to a data measure from said measurement upstream of the restrictor
821. The method may comprise the step of activating a second
restrictor 821 in response to a measurement taken from said central
region pressure sensor 820a or said pressure sensor upstream 820b
of the restrictor or both. The step of activating the second
restrictor 821b may comprise activating said second restrictor 821b
in a vein adjacent to but outside of the central region. The method
may comprise the step of increasing the level of restriction to
blood flowing to the central region. The method may comprise the
step of decreasing the level of restriction to blood flowing to the
central region. The method may comprise graduating the increasing
or decreasing in the level of blood flow restriction proportionate
to a measurement taken by a pressure sensor of at least one venous
catheter or a calculation or comparison of said measurement.
[0198] In another embodiment the method may comprise the step of
measuring a parameter indicative of cardiac output, where said
parameter may be ejection fraction, a pressure measurement in the
heart or the aorta, a contractility measure, a biomarker
measurement or other cardiac measurement. The method may comprise
the step of measuring a parameter indicative of congestion status.
Said measure of congestion status may comprise a central venous
pressure, pulmonary artery wedge pressure, pulmonary artery
pressure, an NT pro BNP measure, an interstitial pressure
measure.
[0199] In another embodiment the method comprises one or more of
the steps of (i) providing a venous catheter configured for
insertion into a vein, the venous catheter comprising a first
restrictor configured for placement in a first vein and a second
restrictor configured for placement in a second vein the first
restrictor and second restrictor spaced apart on the catheter
shaft, (ii) Inserting the venous catheter into the venous system
via an internal jugular vein, (iii) Advancing the venous catheter
through a first innominate vein, (iv) Navigating the venous
catheter into a second innominate vein, (v) Advancing the venous
catheter into a second internal jugular vein, (vi) Expanding a
first and second restrictors in said first internal jugular vein
and said second internal jugular vein, (vii) Providing a cardiac
support catheter 812 the cardiac support catheter 812 comprising an
impeller blood pump assembly 817, (viii) Advancing the cardiac
support catheter 812 into the aorta of a patient, (ix) Operating
the cardiac support catheter 812 to pump blood towards a renal
artery, and/or (x) Operating the venous catheter to restrict blood
flow towards the right atrium.
[0200] In another embodiment the method comprises one or more of
the steps of (i) providing a venous catheter 810 configured for
insertion into a vein, the venous catheter 810 comprising a first
restrictor 821a the first restrictor 821a comprising a precision
restrictor (ii) Inserting the venous catheter 810 into the venous
system via a peripheral access vein, (iii) Advancing the venous
catheter 810 until the first restrictor 821a is in the infrarenal
inferior vena cava 807, (iv) expanding the first restrictor 821a in
the infrarenal inferior vena cava and restricting blood flow across
the restrictor 821a, (v) Providing a cardiac support catheter 812
configured for insertion into an artery the cardiac support
catheter 812 comprising an impeller blood pump assembly 817, (viii)
Advancing the cardiac support catheter 812 into the aorta of a
patient, (ix) Operating the cardiac catheter 812 to pump blood to
reduce left ventricular end systolic pressure.
[0201] In another embodiment the method comprises one or more of
the steps of (i) providing one or more venous catheters configured
for insertion into a vein, the one or more venous catheters
comprising a first restrictor and a second restrictor said first
and second restrictors comprising an activated state wherein the
first and second restrictors restrict blood flow and a deactivated
state wherein the first and second restrictors do not restrict
blood flow, (ii) advancing the one or more venous catheters in one
or more veins until the first restrictor is in a large supra-atrial
vein (a vein above the right atrium) and the second restrictor is
in an infra-atrial vein (a vein below the atrium), (iii) activating
the first restrictor while the second restrictor is substantially
deactivated, (iv) deactivating the first restrictor while
substantially simultaneously activation the second restrictor.
[0202] In one variation the method comprises a programmed
activation of said first and said second restrictors. In another
variation the method comprises activating and deactivating the
first and second restrictors in response to measurements taken by
sensors on the one or more catheters. In one embodiment the
activation and deactivation of the first and second restrictors is
coordinated in time. In one variation the activation of the
supra-atrial restrictor is configured to reduce cardiac preload and
the pressure in a renal vein. In one variation the activation of
the infra-atrial restrictor is configured to reduce cardiac preload
and the outflow pressure at the lymphatic ducts. In one variation
the method comprises providing first and second restrictors that
are precision restrictors. In one variation the step of advancing
the first restrictor comprises placing the first restrictor in a
super-atrial vein said vein comprising one of (i) the superior vena
cava, (ii) an innominate vein or (iii) a jugular vein. In one
variation the step of advancing the second restrictor comprises
placing the second restrictor in an infra-atrial vein said vein
selected from one of (i) the supra-hepatic inferior vena cava, (ii)
the retro-hepatic inferior vena cava, (iii) the suprarenal inferior
vena cava, (iv) the infrarenal inferior vena cava or (v) an iliac
vein.
[0203] FIG. 15 illustrates a system 900 for treating patients with
edema or heart failure or edema in a heart failure patient. The
system 900 is configured to facilitate a combination therapy
wherein the first therapy comprises a venous therapy and the second
therapy comprises an arterial therapy. In one embodiment the venous
therapy of the combination therapy comprises reducing elevated
right heart preload to within an optimal range. In one embodiment
the arterial therapy of the combination therapy comprises
supporting the cardiac output of a weakened left heart by pumping
arterial blood to at least one abdominal organ. In one embodiment
both venous and arterial therapies function to improve cardiac
output. The venous therapy improves cardiac output by reducing
right atrial preload to within a normal range and the arterial
therapy improves cardiac output by improving ventricular
performance. In one embodiment the arterial therapy comprises an
arterial catheter 912, said arterial catheter 912 configured to
support the left ventricle in improving cardiac output. The
arterial catheter 912 comprises a catheter shaft 930, the catheter
shaft 930 configured for advancement from an access site into the
aorta 808, the catheter 912 comprising a plurality of lumens 931, a
distal region 912d and a proximal region 912p wherein the distal
region 912d comprises an impeller pump 917 and the proximal region
912p extends exterior of the patient. The proximal end of the
arterial catheter 912p is connected to a console 813 to monitor the
arterial therapy, control the arterial therapy and display arterial
therapy information to the physician. The pump assembly 917
comprises an impeller 918 (hidden) and a housing 919. The catheter
912 comprises a drive shaft 934 connected to the impeller 918 and
configured to drive the impeller 918 to pump blood. In one
variation, the pump assembly 917 comprises an expandable housing
919 and an expandable impeller 918. With this embodiment the larger
diameter of the impeller 918 allows a large volume of blood to be
pumped at relatively lower revolutions per minute (RPM) of the
impeller 918. The impeller assembly 917 of the system 900 comprises
a blood flow inlet 938 and a blood flow outlet 939. The blood flow
inlet 938 comprises at least one opening that facilitates the
movement of blood into the housing 919 of the blood pump assembly
917. The blood flow outlet 939 comprises at least one opening that
facilitates blood flow out of the housing 919 of the blood pump
assembly 917. The blood flow inlet 938 is generally upstream of the
impeller 918 and the blood flow outlet 939 is generally downstream
of the impeller 918. In one embodiment the blood flow inlet 938 to
the pump assembly 917 comprises at least one inlet strut 940. In
one embodiment the blood flow outlet 939 from the pump assembly 917
comprises at least one outlet strut 941. The left ventricular
orientation of the inlet 938 will vary throughout the cardiac cycle
as a result of the pumping heart. This movement can cause the inlet
to be positioned next to cardiac structures that have the potential
to occlude or partially occlude the inlet 938 leading to loss of
performance or the development of adhesion between the vascular
therapy device and surrounding cardiac structures as a result of
suction developing between the vascular therapy device and
surrounding cardiac structures. In another embodiment a balloon 950
is incorporated adjacent to the inlet 938 functioning to maintain a
minimum distance from cardiac structures thereby preventing suction
events at the pump inlet 938. In this embodiment the balloon 950 is
inflated and deflated through one of the plurality of lumens 931
within the catheter shaft 930. A pre-shaped polymeric tip or
polymeric tip combined with a shape memory material such as Nitinol
may also be utilized to achieve the same function of preventing
adhesions or inlet flow restriction or suction events. In one
embodiment the housing 919 and impeller 918 comprise an expandable
housing and expandable impeller and are located in the ascending
aorta or aortic arch with a part of the expandable housing 919 or
an extension to the expandable housing 919 extending into the left
ventricle. In this embodiment the inlet 938 comprises the distal
end of the expandable member and the outlet 939 is positioned
adjacent to the impeller 918. With this embodiment blood is pumped
from the ventricle to the aorta thereby increasing cardiac output.
The inlet 938 may be predominantly axially aligned relative to the
catheter shaft or constitute a radial terminus to the expandable
housing 919. In another embodiment the expandable housing 919 and
expandable impeller 918 are located in the left ventricle with the
expandable housing extending proximally through the aortic valve to
the ascending aorta or aortic arch. In this arrangement, blood is
also being pumped from the ventricle to the aorta thereby
increasing cardiac output. Non expandable impellers 918 and/or
housings 919 may be used in both of the aforementioned embodiments.
In one embodiment the arterial catheter 912 comprises a first
arterial pressure sensor 920c upstream of the inlet 938 and is
configured to measure pressure upstream of the pump assembly 917 in
the left ventricle. In one embodiment the first arterial pressure
sensor is spaced apart from the pump assembly 917. In one
embodiment the first arterial pressure sensor 920c is placed in the
left ventricle of the patient. In one embodiment a second arterial
pressure sensor is placed in the descending aorta of the patient
920d. In one embodiment the catheter 812 comprises a second
arterial pressure sensor 920d wherein said second arterial pressure
sensor 920d is configured on the catheter 912 for placement
downstream of the pump assembly 917. In one embodiment the second
arterial pressure sensor 920d (or a third arterial pressure sensor
920e) is configured to measure the pressure of blood flowing to at
least one visceral organ. The second arterial pressure sensor 920d
is configured in one variation to be spaced apart from the pump
917. In one variation the second arterial pressure sensor 920d is
configured on the catheter for placement in the abdominal aorta
adjacent a renal artery. The first arterial pressure sensor 920c
and the second arterial pressure sensor 920d comprise data transfer
cables extending through an arterial catheter first lumen and
arterial catheter second lumen respectively said data transfer
cables configured for connection to the console 813 at the proximal
end of the arterial catheter 912. It will be appreciated that the
functions, features, and method of use of the venous catheters and
arterial catheters described with regard to FIG. 14 can be
replicated in whole or in part of the embodiment shown in FIG. 15.
It will also be appreciated by those with knowledge in the art that
the devices herein described require the implementation of
miniaturized and precision engineered componentry manufactured to
micrometer level accuracy.
[0204] In one embodiment the method comprises one or more of the
steps of (i) providing a venous catheter 910 configured for
insertion into a vein, the venous catheter 910 comprising a first
restrictor 921a and at least one pressure sensor the first
restrictor 921a comprising a precision restrictor (ii) Inserting
the venous catheter 910 into the venous system via a peripheral
access vein, (iii) Advancing the venous catheter 910 until the
first restrictor 921a is in the superior vena cava vein 801, (iv)
expanding the first restrictor 921a in the superior vena cava 801
and restricting blood flow across the restrictor 921a, (v)
operating the venous catheter 910 to maintain right atrial pressure
within a targeted range, (vi) Providing an arterial cardiac support
catheter 912 configured for insertion into an artery the cardiac
support catheter 912 comprising an impeller blood pump assembly 917
and at least one pressure sensor, (vii) Advancing the cardiac
support catheter 912 into the ventricle of a patient, (viii)
Operating the cardiac catheter 912 to pump blood towards at least
one visceral organ, (ix) providing a console and synchronously
operating said venous catheter and said arterial catheters with the
console to enhance overall cardiac output.
[0205] FIG. 16 shows a system 1000 for treating patients with edema
or acute decompensated heart failure or acute decompensated heart
failure with edema. The system 1000 is configured to facilitate a
combination therapy wherein the first therapy comprises a venous
therapy delivered in a major supra-atrial vein and the second
therapy comprises a venous therapy delivered in a major infra
atrial vein. In one embodiment the major supra-atrial vein
comprises the superior vena cava 801. In one embodiment the major
supra-atrial vein comprises an innominate vein. In one embodiment
the major infra-atrial vein comprises the one of the following
positions: i) the infrarenal inferior vena cava 807, ii) the
suprarenal inferior vena cava (805), iii) the retrohepatic inferior
vena cava (804), or iv) the suprahepatic inferior vena cava (803).
In one embodiment the combination therapy comprises reducing
elevated right heart preload to within an optimal range by
restricting both the superior vena cava 801 and infrarenal inferior
vena cava 807 flow simultaneously or in a sequence based on
measurement and interpretation of hemodynamic parameters to achieve
said optimal range.
[0206] In one embodiment the first venous therapy comprises a first
venous catheter 1010, the first venous catheter comprising a
proximal end 1010p and a distal end 1010d, the distal end 1010d
comprises a first blood flow restrictor 1021 and the proximal end
1010p extends exterior of the patient. The proximal end of the
first venous catheter 1010p is connected to a console 1013 to
monitor the therapy, control the therapy and display therapy
information to the physician on the display/user interface 1016 of
the console. The distal end of the first therapy catheter 1010d
comprises a first pressure sensor 1020a, the first pressure sensor
1020a positioned downstream of the first blood flow restrictor
1021a to measure venous pressure between the first blood flow
restrictor 1021a and the right heart. The first therapy catheter
1010 further comprises a second pressure sensor 1020b upstream of
the first therapy catheter restrictor 1021. The first pressure
sensor 1020a and second pressure sensor 1020b can be used to
measure the pressure gradient across the restrictor and the console
1013 comprises a body of software configured increase or decrease
the level of restriction or to direct the physician to change the
level of restriction manually. In the same embodiment a second
venous therapy comprises a second venous catheter 1012, the second
venous catheter comprising a proximal end 1012p and a distal end
1012d, the distal end 1012d comprises a second blood flow
restrictor 1022 and the proximal end 1012p extends exterior of the
patient. The proximal end of the second venous catheter 1012p is
connected to a console 1013 to monitor the therapy, control the
therapy and display therapy information to the physician on the
user interface/display 1016. The distal end of the second therapy
catheter 1012d comprises a third pressure sensor 1020c, the third
pressure sensor 1020c positioned downstream of the second blood
flow restrictor 1022 to measure venous pressure between the second
blood flow restrictor 1022 and the right heart. The second therapy
catheter 1012 further comprises a fourth pressure sensor 1020d
upstream of the second therapy catheter restrictor 1022. The third
pressure sensor 1020c and fourth pressure sensor 1020d can be used
to measure the pressure gradient across the restrictor 1022. In one
embodiment the console 1013 comprises a body of software configured
to analyze or process data received from said first, second, third
and fourth pressure sensors. In one embodiment the system is
configured to increase or decrease the level of restriction of the
first blood flow restrictor 1021 and/or the second blood flow
restrictor 1022. In a preferred variation the increase or decrease
in restriction comprise an increase or decrease in the inflated
volume or pressure of the first and/or second precision
restrictors.
[0207] In one embodiment the method of the combination therapy
comprises expanding the first precision restrictor 1021 to reduce
right atrial pressure and the venous outflow pressure of at least
one visceral organ. In one embodiment the method comprises
collapsing the first precision restrictor 1021 to reduce the
outflow pressure of at least one lymphatic duct. In one embodiment
the method comprises expanding the first precision restrictor 1021
for a first time period and then collapsing the first precision
restrictor 1021 for a second time period so as to sequentially
reduce right atrial pressure and the venous outflow pressure of at
least one visceral organ in the first time period and then to
reduce the outflow pressure of at least one lymphatic duct outflow
in the second time period. It will be appreciated that the first
time period and second time period may be equal in length or the
first time period may be longer than the second or the second time
period may be longer than the first time period. It will also be
appreciated that repeating the pattern of inflating and deflating
the precision restrictor 1021 allows the doctor to target cardiac,
lymphatic and visceral organ therapy targets in a single
procedure.
[0208] In one embodiment the method of the combination therapy
comprises expanding the second precision restrictor 1022 in a
region of the inferior vena cava (as outlined above) to reduce the
right atrial pressure and the pressure at an outflow of at least
one lymphatic duct. In one embodiment the method comprises
collapsing the second precision restrictor 1022 in a region of the
inferior vena cava. The depressurizing of the second restrictor in
the inferior vena cava may achieve one or more of the following
depending on the location in the IVC (i) reduce the (outflow)
pressure in a major vein of at least one visceral organ, (ii) allow
the drainage of fluid from the peripheral venous circulation. As
with the first precision restrictor it will be appreciated that the
second precision restrictor may be inflated for a third time period
and then deflated for a fourth time period and that this pattern
may be repeated so as to create a continuous pattern of inflation
and deflation.
[0209] It will further be appreciated that the inflation/deflation
patterns of the first precision restrictor and the second precision
restrictor may be coordinated such that drainage and filling needs
of the circulation are being optimized even though the patient has
an excess of blood volume (held primarily in the venous
compartment). In one embodiment the pattern comprises the first
restrictor being inflated while the second restrictor is deflated.
In one embodiment the pattern comprises the first restrictor being
deflated while the second restrictor is inflated. In one embodiment
the pattern comprises the first restrictor and the second
restrictor being simultaneously inflated or deflated for a part of
the pattern.
[0210] In one embodiment the method comprises placing the second
restrictor in the supra-hepatic inferior vena cava 803, the
retro-hepatic inferior vena cava 804, the suprarenal inferior vena
cava 805 or the infrarenal inferior vena 807. In one preferred
embodiment the method comprises placing the first precision
restrictor in the superior vena cava and placing the second
precision restrictor 1022 in the infrarenal inferior vena cava and
simultaneously operating both restrictors to a defined inflation
and deflation pattern while in these locations. In another
preferred embodiment the method comprises placing the first
precision restrictor in the superior vena cava and placing the
second precision restrictor 1022 in the supra-hepatic inferior vena
cava and simultaneously operating both restrictors to a defined
inflation and deflation pattern while in these locations. It will
be appreciated that in a variation of the system and the method
that the first and second precision restrictors may be configured
on a single venous catheter and this catheter may be advanced from
a single access vessel (ex internal jugular vein, or subclavian
vein or femoral vein) and the steps and variations of the method
conducted accordingly.
[0211] It will be further appreciated that inflating and deflating
the first precision restrictor 1021 and second precision restrictor
1022 in a coordinated pattern allows the doctor to target cardiac,
lymphatic and visceral organ therapy targets to great effect in a
single procedure. An important feature of this combined therapy is
that the precision restrictors, even when fully inflated, never
completely occlude flow, and so a limited degree of venous drainage
is provided for every tissue and organ at all times during
therapy.
[0212] FIG. 17 shows the distal end of a flow restricting catheter
1170 including the catheter shaft 1171, with an inflation lumen
1172 extending therethrough, pressure sensors 1173a and 1173b
disposed either side of the precision restrictor 1175 shown in the
collapsed state. The flow restricting catheter 1170 further
comprises an atraumatic tip 1176.
[0213] FIG. 18 shows the precision restrictor 1175a in the inflated
state. In this embodiment the precision restrictor comprises two
flow paths 1181 disposed diametrically opposite each other. The
flow paths 1181 comprise regions of concavity 1182 extending the
length of the precision restrictor 1175a. It will be appreciated
that when this restrictor balloon is inflated in a vein that the
restrictor will induce a shape change in the vein that is
non-circular. The vein will conform to the curve of the convex
regions but will take the shortest path across the concave region.
In this case the vein will assume a shape of a rounded rectangle
when expanded. It will be appreciated that a variety of shapes are
possible depending on the number of regions of concavity on a
precision restrictor. Preferably there are just two flow paths and
thus two regions of concavity.
[0214] The catheter is dimensioned such that a distal portion of
the catheter is insertable into a proximal portion of the sheath.
Upon insertion, the distal portion of the catheter extends from the
distal end of the sheath such that the second restrictor, which is
mounted to the catheter, is distal to the first restrictor mounted
on the sheath. Advantageously, because the first restrictor is
introduced into the body via the sheath, and does not need to pass
through a component of the catheter system, e.g., a tube, the first
restrictor is less likely to tear or acquire abrasions caused by
friction due to rubbing against a component of the catheter system.
Accordingly, catheter systems of the present invention are less
prone to breaking during treatment.
[0215] The catheter can be made to be slidable within the sheath.
Because the catheter is slidable within the sheath, a distance
between the first restrictor and the second restrictor is
adjustable by moving the catheter longitudinally (indicated by the
double arrows) relative to the sheath. Advantageously, this allows
the restrictors to be placed at precise locations within the body.
For example, the restrictors can be placed at precise locations on
either side of a lymph duct to define an exact low-pressure zone
for withdrawing lymph fluid. Because the low-pressure zone can be
exactly defined, the low-pressure zone can be made small, thereby
reducing the amount of work that a pump must do to further reduce
pressure within the zone and withdraw fluid therefrom.
Additionally, because the restrictors are separately movable, the
restrictors can be placed at various locations within the body
depending on the type of treatment to be performed. Accordingly,
the utility of catheters of the invention are improved.
[0216] In some embodiments, a first restrictor and a second
restrictor can be positioned at desired locations within one or
more blood vessels. The first and second restrictor can be
positioned at desired locations by moving (e.g., sliding) the
sheath comprising the first restrictor into the blood vessel and
guiding the sheath within the blood vessel until the first
restrictor is in the desired location, for example, immediately
upstream of a lymph duct. The catheter comprising the second
restrictor may be advanced through the sheath by sliding the
catheter through a lumen of the sheath. The second restrictor can
be placed in a desired location by sliding the catheter relative
and through the sheath inside the vein. The first and second
restrictors can then each be activated (simultaneously or
sequentially) to transition from the relaxed configuration to the
activated configuration. The first and the second restrictors when
activated provide two occlusions within the vein.
[0217] Certain aspects of the invention employ a pump to withdraw
fluid from a target zone (established between a first and second
restrictor) to reduce pressure and withdraw fluid. One insight of
the invention is that the right ventricle of the heart may be used
as the pump for withdrawing fluid. For example, if the right
ventricle is connected to a target zone then it will reduce
pressure in that zone. However, in some patients the heart is weak
and too much flow is coming to the heart (the entire venous
system). Therefore, it may not be possible to get the desired
reduction in pressure. However, if the size of the target region is
reduced (i.e., moving the restrictors) then the right heart can
deal with the reduced volume and pressure would come down.
[0218] In alternative embodiments, multiple catheters, each with a
separate restrictor can be used for multi-restrictor placement.
[0219] It is envisioned that precision restrictors may be
incorporated into other devices, such as those described for
example in U.S. patent application publication number 2020/0268951,
U.S. Pat. Nos. 9,901,722, 10,149,684, U.S. patent application
publication number 2018/0126130, U.S. patent application
publication number 2018/0250456, U.S. Pat. No. 9,393,384, U.S.
patent application publication number 2017/0049946, U.S. patent
application publication number 2018/0243541, and U.S. patent
application publication number 2019/0126014, the content of each of
which is incorporated by reference herein in its entirety.
INCORPORATION BY REFERENCE
[0220] References and citations to other documents, such as
patents, patent applications, patent publications, journals, books,
papers, web contents, have been made throughout this disclosure.
All such documents are hereby incorporated herein by reference in
their entirety for all purposes.
EQUIVALENTS
[0221] Various modifications of the invention and many further
embodiments thereof, in addition to those shown and described
herein, will become apparent to those skilled in the art from the
full contents of this document, including references to the
scientific and patent literature cited herein. The subject matter
herein contains important information, exemplification and guidance
that can be adapted to the practice of this invention in its
various embodiments and equivalents thereof.
* * * * *