U.S. patent application number 12/345095 was filed with the patent office on 2009-04-23 for systems and methods for controlling renovascular perfusion.
Invention is credited to Robert Kieval.
Application Number | 20090105631 12/345095 |
Document ID | / |
Family ID | 27789378 |
Filed Date | 2009-04-23 |
United States Patent
Application |
20090105631 |
Kind Code |
A1 |
Kieval; Robert |
April 23, 2009 |
SYSTEMS AND METHODS FOR CONTROLLING RENOVASCULAR PERFUSION
Abstract
Devices, systems and methods by which the real or apparent
renovascular perfusion and intrarenal pressure may be selectively
and controllably increased. By selectively and controllably
increasing renovascular perfusion and interstitial hydrostatic
pressure when the heart is unable to pump sufficient blood or when
renal perfusion is suboptimal, the present invention reduces or
reverses neurohormonal activation and fluid retention, and thereby
minimizes their deleterious effects on the heart, vasculature,
kidneys and other body systems.
Inventors: |
Kieval; Robert; (Medina,
MN) |
Correspondence
Address: |
PATTERSON, THUENTE, SKAAR & CHRISTENSEN, P.A.
4800 IDS CENTER, 80 SOUTH 8TH STREET
MINNEAPOLIS
MN
55402-2100
US
|
Family ID: |
27789378 |
Appl. No.: |
12/345095 |
Filed: |
December 29, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10453678 |
Jun 2, 2003 |
7485104 |
|
|
12345095 |
|
|
|
|
09702089 |
Oct 30, 2000 |
6616624 |
|
|
10453678 |
|
|
|
|
Current U.S.
Class: |
604/9 ;
604/8 |
Current CPC
Class: |
A61M 1/367 20130101;
A61M 2205/50 20130101 |
Class at
Publication: |
604/9 ;
604/8 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1. A method of treating a patient comprising the steps of:
providing a blood perfusion modification device, wherein the
modification device comprises a flow redirector, and wherein the
flow redirector is positioned downstream of a renal artery to
redirect blood flow to the renal artery; positioning the blood
perfusion modification device in the patient's renovascular
circulation or immediately adjacent thereto; and activating,
deactivating or otherwise modifying the blood perfusion
modification device to cause an increase in renal perfusion.
2. A method as in claim 1, wherein the flow redirector is
positioned in a descending aorta downstream of the renal artery to
redirect blood flow to the renal artery.
3. A method as in claim 1, wherein the flow redirector is
positioned in a common iliac artery downstream of the renal artery
to redirect blood flow to the renal artery.
4. A method as in claim 1, wherein the modification device
comprises a pump, and wherein the pump is positioned upstream of a
renal artery to supplement blood flow therein.
5. A method as in claim 1, wherein the modification device
comprises a pump, and wherein the pump is positioned downstream of
a renal vein to reduce blood flow or causes back flow therein.
6. A method as in claim 1, wherein the modification device
comprises a drug delivery device, and wherein the drug delivery
device is positioned patient's renovascular circulation or
immediately adjacent thereto.
7. A method as in claim 1, wherein the modification device is
positioned intravascularly.
8. A method as in claim 1, wherein the modification device is
positioned extravascularly.
9. A system for treating a patient, the system comprising: a blood
perfusion modification device positioned in the patient's
renovascular circulation or immediately adjacent thereto; a sensor
dimensioned and configured to be positioned upstream of the blood
perfusion modification device and upstream of the kidney of the
patient to generate a signal indicative of a need to modify renal
perfusion; and a control system operably connected to the sensor
and blood perfusion modification device, wherein the control system
generates a control signal to activate, deactivate or otherwise
modify the blood perfusion modification device as a function of the
sensor signal to cause an increase in renal perfusion.
10-16. (canceled)
17. A system as in claim 9, wherein the modification device
comprises a flow redirector dimensioned and configured to be
positioned downstream of a renal artery to redirect blood flow to
the renal artery.
18. A system as in claim 17, wherein the flow redirector is
dimensioned and configured to be positioned extravascularly.
19. A system as in claim 18, wherein the flow redirector comprises
an inflatable cuff.
20. A system as in claim 18, wherein the flow redirector comprises
a rotatable ring.
21. A system as in claim 18, wherein the flow redirector comprises
a piston.
22. A system as in claim 17, wherein the flow redirector is
dimensioned and configured to be positioned intravascularly.
23. A system as in claim 22, wherein the flow redirector comprises
an inflatable balloon.
24. A system as in claim 9, wherein the modification device
comprises a pump positioned upstream of a renal artery to
supplement blood flow therein.
25. A system as in claim 9, wherein the modification device
comprises a pump positioned downstream of a renal vein to reduce
blood flow or causes back flow therein.
26. A system as in claim 9, wherein the modification device
comprises a drug delivery device dimensioned and configured to be
positioned in or on the patient's renovascular circulation.
27. A system as in claim 9, wherein the control system includes a
processor and a memory.
28. A system as in claim 27, wherein the memory includes software
containing an algorithm defining a relationship between the control
signal and the sensor signal.
29. A system as in claim 28, wherein the algorithm dictates an
activation, deactivation or modification control signal when the
sensor signal falls below or rises above a predetermined threshold
value.
30. A method for treating a patient comprising: implanting a blood
perfusion modification device in the renovascular circulation of a
patient or immediately adjacent thereto; activating, deactivating
or otherwise modifying the blood perfusion modification device to
cause an increase in renal perfusion; and wherein the modification
device comprises a flow redirector, and wherein the flow redirector
is positioned downstream of a renal artery to redirect blood flow
to the renal artery.
31. A method as in claim 30, wherein the flow redirector is
positioned in a descending aorta downstream of the renal artery to
redirect blood flow to the renal artery.
32. A method as in claim 30, wherein the flow redirector is
positioned in a common iliac artery downstream of the renal artery
to redirect blood flow to the renal artery.
33. A method as in claim 30, wherein the modification device
comprises a pump, and wherein the pump is positioned upstream of a
renal artery to supplement blood flow therein.
34. A method as in claim 30, wherein the modification device
comprises a pump, and wherein the pump is positioned downstream of
a renal vein to reduce blood flow or causes back flow therein.
35. A method as in claim 30, wherein the modification device
comprises a drug delivery device, and wherein the drug delivery
device is positioned in patient's renovascular circulation or
immediately adjacent thereto.
36. A method as in claim 30, wherein the modification device is
positioned intravascularly.
37. A method as in claim 30, wherein the modification device is
positioned extravascularly.
38. A method of treating renal disorders or hypertension,
comprising: implanting a first renal modulation device that
contributes to renal function of a first kidney of a patient;
implanting a second renal modulation device that contributes to
renal function of a second kidney of the patient; and activating
and/or deactivating the first renal modulation device and/or the
second renal modulation device so to achieve bilateral renal
neurohormonal modulation.
39. A method for selectively and controllably increasing renal
perfusion, comprising: positioning a renal modulation device
proximate the renal vasculature; providing a means for sensing
cardiac output and/or renal perfusion; and activating and/or
deactivating the renal modulation device during periods of
decreased cardiac output or suboptimal renal perfusion, so as to
reduce or reverse neurohormonal activation and/or fluid
retention.
40. A method, comprising: implanting a renal modulation device
adjacent to an elongated biological structure associated with renal
function proximate a kidney of the patient, wherein the renal
modulation device includes a cuff placed around a renal blood
vessel of the kidney; and causing the renal modulation device to be
activated so as to at least partially block the renal vessel.
41. A method of treating renal disorders or hypertension,
comprising: providing a first renal modulation device that
contributes to renal function of a first kidney of a patient;
providing a second renal modulation device that contributes to
renal function of a second kidney of the patient; and providing
instructions, including: implanting the first renal modulation
device proximate a biological structure associated with renal
function; implanting the second renal modulation device proximate a
biological structure associated with renal function; activating
and/or deactivating the first renal modulation device and/or the
second renal modulation device so to achieve bilateral renal
neurohormonal modulation.
42. A method for selectively and controllably increasing renal
perfusion, comprising: providing a renal modulation device;
providing a means for sensing cardiac output and/or renal
perfusion; providing instructions, including: positioning a renal
modulation device proximate the renal vasculature; activating
and/or deactivating the renal modulation device during periods of
decreased cardiac output or suboptimal renal perfusion, so as to
reduce or reverse neurohormonal activation and/or fluid
retention.
43. A method, comprising: providing a renal modulation device,
including a cuff; providing instructions, including: implanting the
renal modulation device adjacent to an elongated biological
structure associated with renal function proximate a kidney of the
patient, such that the cuff placed around a renal blood vessel of
the kidney; and activating the renal modulation device so as to at
least partially block the renal vessel.
44. An apparatus, comprising: a renal modulation device configured
for placement proximate the renal vasculature; and a controller
configured to operate based on instructions to control activation
of renal baroreceptors with the renal modulation device.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 10/453,678, filed Jun. 2, 2003, which is a
divisional of U.S. patent application Ser. No. 09/702,089, filed
Oct. 30, 2000, the full disclosure of which is incorporated herein
by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention generally relates to medical devices
and methods of use for the treatment and/or management of
cardiovascular and renal disorders. Specifically, the present
invention relates to devices and methods for controlling renal
perfusion in the renovascular system for the treatment and/or
management of cardiovascular disorders such as hypertension and
congestive heart failure, and renal disorders such as renal
insufficiency and end stage renal disease.
[0003] Cardiovascular disease is a major contributor to patient
illness and mortality. It also is a primary driver of health care
expenditure, costing more than $326 billion each year in the United
States. Hypertension, or high blood pressure, is a major
cardiovascular disorder that is estimated to affect over 50 million
people in the United States alone. Of those with hypertension, it
is reported that fewer than 30% have their blood pressure under
control. Hypertension is a leading cause of heart failure and
stroke. It is the primary cause of death in over 42,000 patients
per year and is listed as a primary or contributing cause of death
in over 200,000 patients per year in the U.S. Accordingly,
hypertension is a serious health problem demanding significant
research and development for the treatment thereof.
[0004] Hypertension occurs when the body's smaller blood vessels
(arterioles) constrict, causing an increase in blood pressure.
Because the blood vessels constrict, the heart must work harder to
maintain blood flow at the higher pressures. Although the body may
tolerate short periods of increased blood pressure, sustained
hypertension may eventually result in damage to multiple body
organs, including the kidneys, brain, eyes and other tissues,
causing a variety of maladies associated therewith. The elevated
blood pressure may also damage the lining of the blood vessels,
accelerating the process of atherosclerosis and increasing the
likelihood that a blood clot may develop. This could lead to a
heart attack and/or stroke. Sustained high blood pressure may
eventually result in an enlarged and damaged heart (hypertrophy),
which may lead to heart failure.
[0005] Heart failure is the final common expression of a variety of
cardiovascular disorders, including ischemic heart disease. It is
characterized by an inability of the heart to pump enough blood to
meet the body's needs and results in fatigue, reduced exercise
capacity and poor survival. It is estimated that approximately
5,000,000 people in the United States suffer from heart failure,
directly leading to 39,000 deaths per year and contributing to
another 225,000 deaths per year. It is also estimated that greater
than 400,000 new cases of heart failure are diagnosed each year.
Heart failure accounts for over 900,000 hospital admissions
annually, and it is the most common discharge diagnosis in patients
over the age of 65 years. It has been reported that the cost of
treating heart failure in the United States exceeds $20 billion
annually. Accordingly, heart failure is also a serious health
problem demanding significant research and development for the
treatment and/or management thereof.
[0006] End stage renal disease (ESRD) affects over 300,000 people
in the United States, with an annual incidence of over 79,000.
Death from ESRD occurred in over 60,000 cases in 1998; the five
year survival rate is less than 30%. Medicare payments in 1998 for
the treatment of ESRD exceeded $10 billion. Accordingly, ESRD is a
major health problem demanding improved therapy and management.
[0007] Heart failure results in the activation of a number of body
systems to compensate for the heart's inability to pump sufficient
blood. Many of these responses are mediated by an increase in the
level of activation of the sympathetic nervous system as well as
activation of multiple other neurohormonal responses. Generally
speaking, this sympathetic nervous system activation signals the
heart to increase heart rate and force of contraction to increase
the cardiac output; it signals the kidneys to expand the blood
volume by retaining sodium and water; and it signals the arterioles
to constrict to elevate to the blood pressure. The cardiac, renal
and vascular responses increase the workload of the heart, further
accelerating myocardial damage and exacerbating the heart failure
state. Accordingly, it is desirable to reduce the level of
sympathetic nervous system and other neurohormonal activation in
order to stop or at least minimize this vicious cycle and thereby
treat or manage the heart failure.
[0008] A number of drug treatments have been proposed for the
management of hypertension, heart failure and other cardiovascular
and renal disorders. These include vasodilators to reduce the blood
pressure and ease the workload of the heart, diuretics to reduce
fluid overload, inhibitors and blocking agents of the body's
neurohormonal responses, and other medicaments.
[0009] Various surgical procedures have also been proposed for
these maladies. For example, heart transplantation has been
proposed for patients who suffer from severe, refractory heart
failure. Alternatively, an implantable medical device such as a
ventricular assist device may be implanted in the chest to increase
the pumping action of the heart. Alternatively, an intra aortic
balloon pump may be used for maintaining heart function for short
periods of time, but typically no longer than one month. Other
surgical procedures are available as well.
[0010] Although each of these alternative approaches is beneficial
in some ways, each of the therapies has its own disadvantages. For
example, drug therapy is often incompletely effective. Some
patients may be unresponsive (refractory) to medical therapy. Drugs
often have unwanted side effects and may need to be given in
complex regimens. These and other factors contribute to poor
patient compliance with medical therapy. Drug therapy may also be
expensive, adding to the health care costs associated with these
disorders. Likewise, surgical approaches are very costly, may be
associated with significant patient morbidity and mortality and may
not alter the natural history of the disease. Accordingly, there
continues to be a substantial and long felt need for new devices
and methods for treating and/or managing high blood pressure, heart
failure and renal disease, as well as their associated
complications.
BRIEF SUMMARY OF THE INVENTION
[0011] The present invention provides a number of devices, systems
and methods by which the real or apparent renovascular perfusion
and the renal interstitial hydrostatic pressure may be selectively
and controllably increased. By selectively and controllably
increasing renovascular perfusion and interstitial hydrostatic
pressure when the heart is unable to pump sufficient blood or when
renal perfusion is otherwise suboptimal, the renal system does not
experience the reduced perfusion. Because the renal system does not
experience the reduced perfusion, it does not initiate or
contribute to, and may reduce the neurohormonal activation normally
caused by reduced cardiac output and suboptimal renal perfusion,
nor does it begin or continue, and could reverse the process of
sodium and water retention that also would otherwise result. Thus,
by selectively and controllably increasing renovascular perfusion
during periods of decreased cardiac output or suboptimal renal
perfusion, the present invention reduces or reverses neurohormonal
activation and fluid retention, and thereby minimizes their
deleterious effects on the heart, vasculature, kidneys and other
body systems.
[0012] In the case of end stage renal disease (ESRD), the present
invention provides a number of devices, systems and methods by
which renal perfusion and pressure can be increased, thereby
restoring or augmenting perfusion of the kidney and blood
filtration. In addition, by increasing renal perfusion, the present
invention increases interstitial pressure to reduce sodium and
water reabsorption, which have been shown to be interrelated.
[0013] In an exemplary embodiment, the present invention provides a
method of treating a patient utilizing a blood perfusion
modification device, one or more physiologic sensors, and a control
system. The blood perfusion modification device may be positioned
in the renovascular circulation or immediately adjacent thereto.
The sensor is preferably positioned in a renal artery or upstream
thereof, but may also be placed in, on or adjacent the patient to
generate a signal indicative of the need to modify renal perfusion.
For example, the sensor may be positioned in a kidney, a renal
artery or vein or adjacent thereto to generate a signal indicative
of arterial blood perfusion, renal venous pressure or renal
interstitial pressure. The blood perfusion modification device may
be activated, deactivated or otherwise modified as a function of
the sensor signal to cause or simulate a change, and preferably an
increase, in renal perfusion and/or pressure. This method may be
used to treat a number of clinical conditions including congestive
heart failure, hypertension, renal failure, cardiovascular
abnormalities, and the like. In each instance, the method may
include the initial step of diagnosing or monitoring the clinical
condition or a symptom or sign thereof, and thereafter providing
treatment as needed.
[0014] The present invention also provides a system including a
blood perfusion modification device (e.g., a flow regulator, a flow
redirector or a pump), a physiologic sensor (e.g., a transducer or
a gauge), and a control system operably connected to both. The
blood perfusion modification device is preferably positioned in the
renovascular circulation. The control system (or a portion thereof)
may be implanted or carried externally by the patient. In the
closed loop mode, the sensor generates a sensor signal indicative
of the need to modify renovascular perfusion, and the control
system generates a control signal to activate the modification
device as a function of the sensor signal to thereby modify the
renovascular circulation. In the open loop mode, which may or may
not utilize feedback from the sensor, the control system generates
a control signal to activate the modification device as dictated
by, for example, a pre programmed algorithm, the patient or the
physician.
[0015] The sensor may comprise, for example, a piezoelectric
pressure transducer, an ultrasonic flow velocity transducer, a
thermodilution flow transducer, or a strain gauge. As such, the
sensor may generate a signal indicative of pressure (e.g., mean,
systolic, diastolic or pulse), blood flow velocity, vasoactivity,
or other fluid dynamic property. Alternatively, the sensor may
measure the blood concentration of a component (e.g., sodium,
renin, etc.) or an arterial/venous difference in concentration of
the component.
[0016] The blood perfusion modification device may comprise a flow
regulator positioned in a renal vein or immediately downstream
thereof to create backpressure in the renovascular circulation.
Alternatively, the blood perfusion modification device may comprise
a flow redirector positioned downstream of a renal artery to
redirect blood flow to the renal artery. As a further alternative,
the blood perfusion modification device may comprise a pump. The
pump may be positioned upstream of a renal artery to supplement
blood flow to the renal artery or positioned downstream of a renal
vein to supplement blood flow from the renal vein. As yet a further
alternative, the blood perfusion modification device may comprise a
drug delivery device. In each of these embodiments, the blood
perfusion modification device may be positioned intravascularly or
extravascularly. By way of example, not limitation, the blood
perfusion modification device may comprise an inflatable cuff, a
rotatable ring, a hydraulic piston, a solenoid, an inflatable
balloon, or a drug delivery device.
[0017] The control system may include a processor and memory. The
memory may include software containing one or more algorithms
defining one or more functions or relationships between the control
signal and the sensor signal. The algorithm may dictate activation
or deactivation control signals depending on the sensor signal or a
mathematical derivative thereof. The algorithm may dictate an
activation or a deactivation control signal when the sensor signal
falls below a lower predetermined threshold value, rises above an
upper predetermined threshold value or when the sensor signal
indicates a specific physiologic event.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a schematic illustration of the renovasculature
and associated anatomy;
[0019] FIG. 2 is a schematic illustration of a renal vein flow
regulator system in accordance with the present invention;
[0020] FIG. 3 is a schematic illustration of a flow redirection
system in accordance with the present invention;
[0021] FIG. 4 is a schematic illustration of an arterial flow pump
system in accordance with the present invention;
[0022] FIG. 5 is a schematic illustration of a venous flow pump
system in accordance with the present invention;
[0023] FIGS. 6A and 6B are side cross sectional schematic
illustrations of an extraluminal flow regulator/redirector in the
form of an inflatable cuff in accordance with the present
invention, shown in the deactivated (unconstricted) and activated
(constricted) states, respectively;
[0024] FIGS. 7A and 7B are side cross sectional schematic
illustrations of an intraluminal flow regulator/redirector in the
form of an inflatable balloon in accordance with the present
invention, shown in the deactivated (unconstricted) and activated
(constricted) states, respectively;
[0025] FIGS. 8A and 8B are side cross sectional schematic
illustrations of an extraluminal flow regulator/redirector in the
form of a hydraulic piston or solenoid in accordance with the
present invention, shown in the deactivated (unconstricted) and
activated (constricted) states, respectively;
[0026] FIGS. 9A and 9B are side cross sectional schematic
illustrations of an extraluminal flow regulator/redirector in the
form of a rotatable ring in accordance with the present invention,
shown in the deactivated (unconstricted) and activated
(constricted) states, respectively;
[0027] FIG. 10 is a side cross sectional schematic illustration of
an extraluminal flow supplementor/pump in the form of a series of
balloons or solenoids in accordance with the present invention,
shown in the deactivated (unconstricted) state;
[0028] FIG. 11 is a side cross sectional schematic illustration of
an intraluminal flow supplementor/pump in the form of an impeller
in accordance with the present invention; and
[0029] FIG. 12 is a side cross sectional schematic illustration of
an extraluminal site to specific drug delivery apparatus.
DETAILED DESCRIPTION OF THE INVENTION
[0030] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The drawings, which are not
necessarily to scale, depict illustrative embodiments and are not
intended to limit the scope of the invention.
[0031] Refer now to FIG. 1 which is a schematic illustration of the
renal system 10 of an adult human. The right and left sides of the
renal system 10 are substantially symmetrical and are identified by
the letters R and L, respectively. Blood is supplied to the kidneys
12 by way of the descending aorta 14 and the renal arteries 20.
Blood is removed from the kidneys 12 by way of the inferior vena
cava 16 and the renal veins 22.
[0032] The descending aorta 14 bifurcates downstream into the
common iliac arteries 28. The direction of the arterial blood flow
in the descending aorta 14 is indicated by arrows 24, and the
direction of the venous blood flow in the inferior vena cava 16 is
indicated by arrows 26. Waste products are removed from the blood
by the kidneys 12 and transported to the bladder (not shown) by way
of ureters 18.
[0033] As stated previously, a number of body systems are activated
to compensate for the heart's inability to pump sufficient blood or
in the presence of renal disease or restricted renal perfusion
(e.g., renal artery stenosis causing hypertension and/or renal
disease). In the case of heart failure, the renal system 10 senses
the heart's inability to pump sufficient blood by decreased blood
perfusion (flow, pressure, etc.) in the renal arteries 20 and other
parts of the renovasculature. The renal system 10 responds to this
to condition by initiating or contributing to a neurohormonal
sequence that signals the heart to increase heart rate and force of
contraction to increase the cardiac output, signals the kidneys to
expand the blood volume by retaining sodium and water, and it
signals the arterioles to constrict to elevate the blood pressure.
The cardiac, renal and vascular responses increase the workload of
the heart, further accelerating myocardial damage and exacerbating
the heart failure state. To address this problem, the present
invention basically provides a number of devices, systems and
methods by which the renal system experiences normal or supranormal
perfusion even in the face of reduced cardiac output and/or
vasoconstriction. By maintaining or augmenting renal perfusion, the
renal system 10 including renal baroreceptors and the
juxtaglomerular apparatus are not activated, and the viscous cycle
referred to above may be stopped or at least moderated.
[0034] In the case of end stage renal disease (ESRD), the kidney
has often undergone substantial scarring and fibrosis. Thus,
perfusion of the kidney and filtration of the blood are limited.
The present invention provides a number of devices, systems and
methods by which renal perfusion and pressure can be increased,
thereby restoring or augmenting perfusion of the kidney and blood
filtration. In addition, by increasing renal perfusion, the present
invention increases interstitial pressure to reduce sodium and
water reabsorption, which have been shown to be interrelated.
[0035] With reference to FIGS. 2 5, the present invention generally
provides a system including a physiologic sensor 30 (e.g., a
transducer or a gauge), a blood perfusion modification device 50,
60, 70 and/or 80 (e.g., a flow regulator, a flow redirector or a
pump), and a control system 40. As used herein, perfusion, blood
perfusion and renal perfusion generally refer to a fluid dynamic
property of blood flow such as volumetric flow rate, flow velocity
and/or pressure including absolute, mean or pulse pressure, or a
fluid static property such as interstitial pressure. The sensor 30
senses and/or monitors one or more fluid dynamic properties of
blood flow or renal pressure or function and is generically
referred to herein as a sensor. Similarly, the blood perfusion
modification devices 50, 60, 70, 80 modify one or more fluid
dynamic properties of blood flow and are generically referred to
herein as modification devices. In each embodiment, the connections
between the components 30/40/50/60/70/80 may be physical (e.g.,
wires, tubes, cables, etc.) or remote (e.g., transmitter/receiver,
inductive, magnetic, etc.). For physical connections, the
connection may travel intraarterially, intravenously,
intraabdominally, subcutaneously, or through other natural tissue
paths.
[0036] The need to preserve or augment renal blood perfusion or
pressure may be, for example, detected by the sensor 30, which may
be placed in one or both renal arteries 20, the descending aorta
14, or upstream thereof, within the kidney itself or in the urinary
bladder. The control system 40 generates a control signal as a
function of the received sensor signal. The control signal
activates, deactivates or modifies one or more parameters of the
blood perfusion modification device 50, 60, 70, 80. Thus, when the
sensor 30 detects a reduction in cardiac output, the control system
40 generates an activation control signal to activate the blood
perfusion modification device 50, 60, 70, 80 thereby increasing
renovascular perfusion such that the renal system 10 does not
experience reduced perfusion. When the sensor 30 detects
improvement or normalization in the sensed parameter, the control
system 40 generates a control signal to deactivate or otherwise
modify the activity of the blood perfusion modification device 50,
60, 70, 80.
[0037] With continued reference to FIGS. 2 5, the sensor 30 is
operably coupled to the control system 40 by electric sensor cable
or lead 32. The sensor 30 may comprise any suitable device that
measures a fluid dynamic property of blood flow or other
parameters) of interest which is (are) indicative of the need to
modify (i.e., increase) renal perfusion. For example, the sensor 30
may comprise a transducer or gauge that measures blood pressure
(systolic, diastolic, pulse or average pressure), blood volumetric
flow rate, blood flow velocity, etc. Alternatively, the sensor 30
may comprise a transducer or gauge that measures urine production
(e.g., volumetric), composition or concentration, a change in any
of which may be indicative of the need to modify renal perfusion.
Examples of suitable transducers or gauges for the sensor 30
include a piezoelectric pressure transducer, an ultrasonic flow
velocity transducer, an ultrasonic volumetric flow rate transducer,
a thermodilution flow velocity transducer, and a capacitive
pressure transducer. Although only one sensor 30 is shown, multiple
sensors 30 of the same or different type at the same or different
location may be utilized.
[0038] In this embodiment, the sensor 30 is preferably positioned
on the arterial side of the renal vasculature. In particular, the
sensor 30 may be located in or on one or both kidneys 12, renal
arteries 20, the descending aorta 14, or upstream thereof, such
that suboptimal renal perfusion may be readily ascertained. The
sensor may alternatively be implanted in the bladder to measure
urine production. The sensor 30 may be mounted intravascularly or
extravascularly, depending on the type of transducer or gauge
utilized.
[0039] With continued reference to FIGS. 2 5, control system 40
includes a control block 41 comprising a processor 43 and a memory
42. Control system 40 is connected to the sensor 30 by way of
sensor cable 32. Control system 40 is also connected to the blood
perfusion modification device 50, 60, 70, 80 by way of electric
control cable 38. Thus, the control system 40 receives a sensor
signal (also referred to as a transducer signal) from the sensor 30
by way of sensor cable 32, and transmits a control signal to the
blood perfusion modification device 50, 60, 70, 80 by way of
control cable 38.
[0040] The memory 42 may contain data related to the sensor signal,
the control signal, and/or values and commands provided by the
input device 44. The memory 42 may also include software containing
one or more algorithms defining one or more functions or
relationships between the control signal and the sensor signal. The
algorithm may dictate activation, deactivation or modification
control signals depending on the sensor signal or a mathematical
derivative thereof. For example, the algorithm may dictate an
activation control signal when the sensor signal falls below a
lower predetermined threshold value. The algorithm may also dictate
a deactivation control signal when the sensor signal rises above an
upper predetermined uphold threshold value.
[0041] The following predetermined threshold values are provided by
way of example, not limitation. If the sensor signal is indicative
of systolic pressure, the lower threshold value may be
approximately 80 mm Hg and the upper threshold value may be
approximately 120 mm Hg. If the sensor signal is indicative of
diastolic pressure, the lower threshold value may be approximately
60 mm Hg and the upper threshold value may be approximately 80 mm
Hg. If the sensor signal is indicative of mean pressure, the lower
threshold value may be approximately 70 mm Hg and the upper
threshold value may be approximately 110 mm Hg. If the sensor
signal is indicative of flow rate, the lower threshold value may be
approximately 500 ml/min and the upper threshold value may be
approximately 700 ml/min for each kidney. In essence, the algorithm
dictates activation or deactivation of the blood perfusion
modification device 50, 60, 70, 80 to thereby increase or decrease
real or apparent renovascular perfusion by instigating a control
signal transmission as a function of the sensor signal.
[0042] The control system 40 may operate as a closed loop utilizing
feedback from the sensor 30, or as an open loop utilizing commands
received by input device 44. The open loop operation of the control
system 40 preferably utilizes some feedback from the sensor 30, but
may also operate without feedback. Commands received by the input
device 44 may directly influence the control signal or may alter
the software and related algorithms contained in memory 42. The
patient and/or treating physician may provide commands to input
device 44. Display 45 may be used to view the sensor signal and/or
the software contained in memory 42.
[0043] The control signal generated by the control system 40 may be
continuous, periodic, episodic or a combination thereof, as
dictated by a preset or programmable algorithm contained in memory
42. Continuous control signals include a constant pulse, a constant
sequence of pulses, a triggered pulse and a triggered sequence of
pulses. Examples of periodic control signals include each of the
continuous control signals described above which have a designated
start time (e.g., beginning of each minute, hour or day) and a
designated duration (e.g., 1 second, 1 minute, 1 hour). Examples of
episodic control signals include each of the continuous control
signals described above which are triggered by an episode (e.g.,
activation by the patient/physician, an increase in blood pressure
above a certain threshold, ECG, etc).
[0044] The control system 40 may be implanted in whole or in part.
For example, the entire control system 40 may be carried externally
by the patient utilizing transdermal connections to the sensor lead
32 and the control lead 38. Alternatively, the control block 41 may
be implanted with the input device 44 and display 45 carried
externally by the patient utilizing transdermal connections
therebetween. As a further alternative, the transdermal connections
may be replaced by cooperating transmitters/receivers to remotely
communicate between components of the control system 40 and/or the
sensor 30 and blood perfusion modification device 50, 60, 70, 80.
If all of the components are implanted, the inter component
connections may be eliminated.
[0045] Refer now to FIG. 2 which schematically illustrates a renal
vein flow regulator 50 in accordance with an embodiment of the
present invention. The flow regulator 50 may be intravascularly or
extravascularly positioned in or on one or both renal veins 22 or
downstream thereof on the inferior vena cava 16. Flow regulator 50
may be activated or deactivated by a control signal received from
control cable 38. When activated, the flow regulator 50 constricts
the renal vein 22 or otherwise reduces the cross sectional area of
the lumen therein to create back pressure in the renovasculature,
thereby increasing blood and interstitial pressure in the renal
tissues. By creating back pressure in the renal tissues during
episodes of reduced renal perfusion, the renal system 10 does not
perceive the reduction in perfusion.
[0046] Refer now to FIG. 3 which schematically illustrates a flow
redirector 60 in accordance with another embodiment of the present
invention. The flow redirector 60 may be intravascularly or
extravasculary positioned in or on the descending aorta 14
downstream of the renal arteries 20, or in or on one or both of the
common iliac arteries 28. The flow redirector 60 may be activated
or deactivated by a control signal received from control cable 38.
When activated, the flow redirector 60 constricts the descending
aorta or otherwise reduces the size of the lumen therein to
redirect flow to the renal arteries 20 thereby increasing
renovascular perfusion. By artificially increasing renovascular
perfusion during a state of reduced cardiac output, renal artery
constriction or renal artery stenosis, renal perfusion is preserved
or enhanced. Preferably, the flow redirector 60 would be activated
in such a manner as to minimize the effects on downstream perfusion
into the lower extremities.
[0047] Refer now to FIG. 4 which schematically illustrates an
arterial blood flow pump 70 in accordance with another embodiment
of the present invention. The arterial flow pump 70 may be
positioned intravascularly or extravascularly in or on the
descending aorta 14 upstream of the renal arteries 20 or in the
renal arteries 20. The arterial flow pump 70 may be activated and
deactivated by a control signal received from control cable 38.
When activated, the arterial flow pump 70 supplements arterial
blood flow to the renal arteries 20 thereby increasing renal
perfusion.
[0048] Refer now to FIG. 5 which schematically illustrates a venous
blood flow pump 80 in accordance with another embodiment of the
present invention. Venous flow pump 80 may be intravascularly or
extravascularly may be positioned in or on the renal veins 22, or
in or on the inferior vena cava 16 downstream of the renal veins
22. The venous flow pump 80 may be activated and deactivated by a
control signal received from control cable 38. When activated, the
venous flow pump 80 reduces blood flow or causes back flow in the
renal veins 22 thereby increasing renal back pressure.
[0049] Refer now to FIGS. 6 12 which illustrate various embodiments
of flow regulators, flow redirectors and pumps that may be utilized
for the blood perfusion to modification devices 50, 60, 70, 80
described with reference to FIGS. 2 5. Each of FIGS. 6 12
schematically illustrate intravascular or extravascular devices
disposed in or on a generic vessel 90 having a vascular wall 92 and
a vascular lumen 94. The vessel 90 generically refers to the
portion of the vasculature in or on which the blood perfusion
modification device 50, 60, 70, 80 is positioned as described
previously. Each of the illustrations of FIGS. 6 12 are
longitudinal cross sectional views unless otherwise specified and
are generally circular in lateral cross section unless otherwise
specified.
[0050] Refer now specifically to FIGS. 6A and 6B which show side
cross sectional schematic illustrations of an external inflatable
cuff 100 in accordance with an embodiment of the present invention.
FIG. 6A illustrates the inflatable cuff 100 in the deactivated
(unconstricted) state, and FIG. 6B illustrates the inflatable cuff
100 in the activated (constricted) state. The inflatable cuff 100
may be used for the renal vein flow regulator 50 illustrated in
FIG. 2 or the flow redirector 60 illustrated in FIG. 3. Those
skilled in the art will recognize the inflatable cuff 100
illustrated is merely schematic and is intended to generically
refer to a wide variety of inflatable cuffs. Examples of inflatable
cuffs that may be adapted for use in the present invention are
disclosed in U.S. Pat. No. 4,256,094 to Kapp et al. and U.S. Pat.
No. 4,881,939 to Newman, the entire disclosures of which are hereby
incorporated by reference.
[0051] Inflatable cuff 100 includes a housing 102 which may be
connected to the vessel wall 92 utilizing conventional techniques
such as sutures 104. Housing 102 contains an inflatable annular
balloon 106 having an interior 107 which is in fluid communication
with a fluid line 108. The balloon 106 may be an annular geometry
with a central passageway to accommodate the vessel 90 therein as
illustrated, or may be a geometry without a passageway and reside
on one side of the vessel 90. In addition, one balloon 106 may be
utilized as shown, or a plurality of balloons 106 may be
utilized.
[0052] A pressure/vacuum source 110 (e.g., a closed volume piston
pump) selectively inflates and deflates the balloon 106 by way of
pressure line 108. The pressure/vacuum source 110 is preferably
implanted, but may be carried externally by the patient with a
transdermal connection to the pressure line 108. A saline liquid
inflation fluid is preferred, but other fluids (i.e. liquids and
gases) may be used.
[0053] The pressure/vacuum source 110 is connected to the control
cable 38, which provides a control signal from control system 40 to
activate or deactivate the pressure/vacuum source 110 and thereby
inflate or deflate the balloon 106. When activated, the
pressure/vacuum source 110 applies pressure and causes the balloon
106 to inflate thereby constricting the vascular wall 92 and
obstructing or reducing the size of the internal lumen 94. The
internal lumen 94 may be partially or totally occluded by
controlling the degree of balloon 106 inflation. When deactivated,
the pressure/vacuum source 110 applies vacuum and causes the
balloon 106 to deflate thereby permitting the vascular wall 92 to
return to its unconstricted state and restoring the nominal size of
the internal lumen 94.
[0054] The pressure/vacuum source 110 may be automatically actuated
by the control system 40 as discussed above, or may be manually
actuated. An example of an externally manually actuated
pressure/vacuum source is disclosed in U.S. Pat. No. 4,709,690 to
Haber, the entire disclosure of which is hereby incorporated by
reference. Examples of transdermally manually actuated
pressure/vacuum sources are disclosed in U.S. Pat. No. 4,586,501 to
Claracq, U.S. Pat. No. 4,828,544 to Lane et al., and U.S. Pat. No.
5,634,878 to Grundei et al., the entire disclosures of which are
hereby incorporated by reference.
[0055] In use, the sensor 30 detects a reduction in renal perfusion
or other change indicative of the need to activate the system as
indicated by a sensor signal transmitted by way of sensor cable 32
to the control system 40. In response, the control system 40
transmits a control signal as a function the sensor signal as
dictated by the algorithm contained in memory 42. The control
signal is transmitted by way of control cable 38 to the
pressure/vacuum source 110. Depending on the control signal, the
pressurized fluid source 110 is activated (pressure) or deactivated
(vacuum) to inflate or deflate the balloon 106.
[0056] If the inflatable cuff 100 is utilized as a renal vein flow
regulator 50 as illustrated in FIG. 2, the reduced size of the
vascular lumen 94 causes back pressure in the renal veins 22 and
ultimately the renal parenchyma and arterial circulation thereby
causing an apparent increase in renovascular perfusion and
pressure. If the inflatable cuff 100 is utilized as a flow
redirector 60 as illustrated in FIG. 3, the reduced size of the
vascular lumen 94 causes blood to be redirected into the renal
arteries 20 thereby causing an increase in renovascular perfusion.
In either instance, renovascular perfusion and/or intrarenal
pressure are maintained or augmented.
[0057] Inflatable cuff 100 is one example of many different
mechanisms for applying external compression to the vascular wall
92 to reduce the size of the internal lumen 94. Other mechanisms
for applying for external compression to the vascular wall 92 are
described in greater detail with reference to FIGS. 8A, 8B, 9A and
9B. In addition to the specific mechanisms mentioned herein, those
skilled in the art will recognize that to many other mechanisms may
be adapted for this application. For example, external compression
may be applied utilizing an electromagnetically actuated ferro
fluid device as disclosed in the U.S. Pat. No. 5,509,888 to Miller,
the entire disclosure of which is hereby incorporated by reference.
Another example of an electromagnetically actuated ferro fluid type
external compression device is disclosed in U.S. Pat. No. 4,053,952
to Goldstein, the entire disclosure of which is incorporated by
reference.
[0058] Refer now to FIGS. 7A and 7B which show cross sectional
schematic illustrations of an internal inflatable balloon device
200 in accordance with another embodiment of the present invention.
FIG. 7A illustrates the inflatable balloon device 200 in the
deactivated (unconstricted) state, and FIG. 7B illustrates the
inflatable balloon device 200 in the activated (constricted) state.
The inflatable balloon device 200 may be used for the renal vein
flow regulator 50 illustrated in FIG. 2 or the flow redirector 60
illustrated in FIG. 3.
[0059] Those skilled in the art will recognize that the internal
inflatable balloon device 200 is merely schematic and is intended
to generically refer to a wide variety of internal occlusion
devices. An example of an internal inflatable balloon device that
may be adapted for use in the present invention is disclosed in
U.S. Pat. No. 4,682,583 to Burton et al., the entire disclosure of
which is hereby incorporated by reference. Another example of an
internal inflatable balloon device that may be adapted for use in
the present invention is disclosed in U.S. Pat. No. 5,634,878 to
Grundei et al., the entire disclosure of which is hereby
incorporated by reference.
[0060] Inflatable balloon device 200 includes a housing 202 which
may be connected to the inside surface of the vessel wall 92
utilizing conventional techniques such as those used for implanting
vascular stents, grafts and filters. Housing 202 includes an
inflatable annular balloon 206 having an interior 207 which is in
fluid communication with a fluid line 208. The balloon 206 may be
an annular geometry with a central perfusion passageway as
illustrated, or may be a geometry without a passageway and reside
on one side of the vessel 90. In addition, one balloon 206 may be
utilized as shown, or a plurality of balloons 206 may be used.
[0061] A pressure/vacuum source 110 selectively inflates and
deflates the balloon 206 by way of pressure line 208. The
pressure/vacuum source 110 is connected to the control cable 38,
which provides a control signal from control system 40 to activate
or deactivate the pressure/vacuum source 110 and thereby inflate or
deflate the balloon 206. When activated, the pressure/vacuum source
110 applies pressure and causes the balloon 206 to inflate thereby
obstructing or reducing the size of the internal lumen 94. The
internal lumen 94 may be partially or totally occluded by adjusting
the degree of balloon 206 inflation. When deactivated, the
pressure/vacuum source 110 applies vacuum and causes the balloon
206 to deflate thereby restoring the nominal size of the internal
lumen 94. The internal inflatable balloon device 200 basically
operates on the same principles as the external compression device
100 described previously, except that inflatable balloon device 200
does not utilize external compression, but rather totally or
partially occludes the vascular lumen 94 without affecting the
vascular wall 92.
[0062] Refer now to FIGS. 8A and 8B which show side cross sectional
schematic illustrations of a piston device 300 in accordance with
another embodiment of the present invention. FIG. 8A illustrates
the piston device 300 in the deactivated (unconstricted) state, and
FIG. 8B illustrates the piston device 300 in the activated
(constricted) state. The piston device 300 may be used for the
renal vein flow regulator 50 illustrated in FIG. 2 or the flow
redirector 60 illustrated in FIG. 3. Those skilled in the art will
recognize that the piston device 300 illustrated is merely
schematic and is intended to generically refer to a wide variety of
piston type devices. An example of a piston type device that may be
adapted for use in the present invention is disclosed in U.S. Pat.
No. 4,014,318 to Dockum et al., the entire disclosure of which is
hereby incorporated by reference.
[0063] Piston device 300 includes a housing 302 which may be
connected to the vessel wall 92 utilizing conventional techniques
such as sutures 304. Housing 302 includes an internal chamber 307
in which piston 306 is slidably disposed. The internal chamber 307
is in fluid communication with a fluid line 308. A pressure/vacuum
source 110 selectively fills an empties the chamber 307 by way of
pressure line 308. The pressure/vacuum source 110 is connected to
the control cable 38, which provides a control signal from control
system 40 to activate or deactivate the pressure/vacuum source
110.
[0064] When activated, the pressure/vacuum source 110 fills the
internal chamber 307 with fluid thereby displacing the piston 306
to constrict the vascular wall 92 and reduce the size of the
internal lumen 94. The internal lumen 94 may be partially or
totally occluded by adjusting the displacement distance of the
piston 306. When deactivated, the pressure/vacuum source 110
empties the internal chamber 307 causing the piston 306 to be
displaced back into the chamber 307 thereby permitting the vascular
wall 92 to return to its unconstricted state and restoring the
nominal size of the internal lumen 94. The function and use of the
piston device 300 is otherwise essentially the same as the other
external compression device 100 discussed previously.
[0065] As illustrated and described, the piston device 300 operates
by hydraulic actuation. Alternatively, the piston device 300 may
operate by electromagnetic actuation such as provided by a solenoid
device. An example of an electromagnetic solenoid device is
disclosed in Dockum et al. '318 mentioned previously. If
electromagnetic actuation is utilized, the pressure/vacuum source
110 may be replaced by a suitable amplifier to power the
electromagnets in the solenoid. The function and use of the
solenoid alternative is otherwise essentially the same as the
hydraulic embodiment discussed above.
[0066] Refer now to FIGS. 9A and 9B which show side cross sectional
schematic illustrations of a rotatable ring device 400 in
accordance with another embodiment of the present invention. FIG.
9A illustrates the rotatable ring device 400 in the deactivated
(unconstricted) state and FIG. 9B illustrates the rotatable ring
device 400 in the activated (constricted) state. The rotatable ring
device 400 may be used for the renal vein flow regulator 50
illustrated in FIG. 2 or the flow redirector 60 illustrated in FIG.
3. Those skilled in the art will recognize that the rotatable ring
device 400 is merely schematic and is intended to generically refer
to a wide variety of rotatable ring devices. An example of a
rotatable ring device that may be adapted for use in the present
invention is disclosed in U.S. Pat. No. 4,551,862 to Haber, the
entire disclosure of which is hereby incorporated by reference.
[0067] Rotatable ring device 400 includes a housing 402 which may
be connected to the vessel wall 92 utilizing conventional
techniques such as sutures 404. Housing 402 includes one or more
rings 406 which are operably connected to a linear actuation cable
408 to cause rotation of the ring or rings 406 substantially as
described in Haber '862. The linear actuation cable 408 is
connected to a solenoid device 410 which selectively pushes or
pulls the linear actuation cable 408 to cause clockwise or counter
clockwise rotation of the rotatable rings 406.
[0068] The solenoid device 410 is connected to the control cable 38
which provides a control signal from the control system 40 to
activate or deactivate the solenoid device 410 and thereby rotate
the rings 406. When activated, the solenoid 410 causes the
rotatable rings 406 to constrict the vascular wall 92 and reduce
the size of the lumen 94. The internal lumen 94 may be partially or
totally occluded by adjusting the degree of rotation of the rings
406. When deactivated, the solenoid device 410 causes the rotatable
rings to unconstrict thereby permitting the vascular wall 92 to
return to its unconstricted state and restoring the nominal size of
the internal lumen 94. The function and use of the rotatable ring
device 400 is otherwise substantially the same as the other
external compression devices 100, 300 discussed previously.
[0069] Refer now to FIG. 10 which shows a side cross sectional
schematic illustration of an external pump 500 in accordance with
an embodiment of the present invention. FIG. 10 illustrates the
pump 500 in the deactivated state. The external pump 500 may be
used for the arterial flow pump 70 illustrated in FIG. 4 or the
venous flow pump 80 in FIG. 5. Those skilled in the art will
recognize that the external pump 500 is merely schematic and is
intended to generically refer to a wide variety of extraluminal
vascular pumps. An example of an extraluminal vascular pump that
may be adapted for use in the present invention is disclosed in
Dockum et al. '318 mentioned previously.
[0070] Extraluminal pump 500 includes a housing 502 which may be
connected to the vessel wall 92 utilizing conventional techniques
such as sutures 504. Housing 502 includes a plurality of inflatable
balloons 506 each having an interior 507 which is in fluid
communication with a plurality of fluid lines 508. Fluid
communication to each of the balloons 506 is maintained by separate
lumens within the fluid line 508 such that the balloons 506 may be
inflated independently.
[0071] A pressure/vacuum source 110 is fluidly connected to a
manifold 510 which sequentially inflates and deflates each of the
balloons 506 to cause a sequence of constrictions about the vessel
wall 92, thereby creating a pumping action within the vascular
lumen 94. The direction and speed of the inflation sequence may be
modified to change the pumping direction and flow rate. The
pressure/vacuum source 110 is connected to the control cable 38
which provides a control signal from the control system 40 to
activate and deactivate the pressure/vacuum source 110 and manifold
510. When activated, the pressure/vacuum source 110 and manifold
510 cause the balloons 506 to sequentially inflate thereby
producing the pumping action. After the balloons 506 have been
sequentially inflated, the pressure/vacuum source 110 applies a
vacuum to deflate the balloons 506. The pressure/vacuum source 110
and manifold 510 may be reactivated to initiate another pumping
cycle. If no further pumping action is desired, the pressure/vacuum
source 110 maintains a vacuum such that the balloons 506 remain
deflated.
[0072] If the external pump 500 is used for the arterial flow pump
70 illustrated in FIG. 4, the external pump 500 selectively
supplements arterial blood flow and/or perfusion pressure to the
renal arteries 200 thereby increasing renal perfusion. If the
external pump 500 is utilized for the venous flow pump 80
illustrated in FIG. 5, the external pump 500 reduces blood flow or
causes back flow in the renal veins 22 thereby increasing renal
back pressure. In either instance, the renovascular perfusion
and/or intrarenal pressure are maintained or augmented.
[0073] The external pump 500 may utilize hydraulically actuated
balloons 506 as illustrated and described, or may utilize
hydraulically actuated pistons similar to the embodiment described
with reference to FIGS. 8A and 8B. Alternatively, the pistons may
be electromagnetically actuated as with a solenoid type device as
described in Dockum et al. '318 and as described with reference to
the alternative embodiment of FIGS. 8A and 8B. Thus, the external
pump 500 may be hydraulically actuated by utilizing balloons 506,
or may be hydraulically or electromagnetically actuated by
replacing the balloons 506 with pistons slidably disposed in
chambers.
[0074] Refer now to FIG. 11 which shows a side cross sectional
schematic illustration of an internal pump 600 in accordance with
an embodiment of the present invention. FIG. 11 illustrates the
intraluminal pump 600 in the static or deactivated state. The
intraluminal pump 600 may be utilized for the arterial flow pump 70
illustrated in FIG. 4 or the venous flow pump 80 illustrated in
FIG. 5. Those skilled in the art will recognize that the
intraluminal pump 600 is merely schematic and is intended to
generically wide variety of intraluminal vascular pumps. An example
of an intraluminal vascular pump suitable for use in the present
invention is disclosed in U.S. Pat. No. 5,692,882 to Bozeman, Jr.
et al., the entire disclosure of which is hereby incorporated by
reference.
[0075] The intraluminal pump 600 includes a housing 602 which may
be connected to the vessel wall 92 utilizing the same anchoring
techniques used by intravascular stents, to grafts and filters.
Housing 602 includes proximal and distal struts 603 which support
rotatable axle 604. One or more impeller blades 605 are rigidly
connected to the axle 604 and rotate relative to the housing 602
and struts 603. When the impeller blades 605 are rotated, blood in
the vascular lumen 94 is biased in the proximal or distal
direction. Impeller blades 605 may be formed of a ferrous material
suitable for forming into permanent magnets. Alternatively, the
impeller blades 605 may be formed of a nonferrous material but
include a ferrous material disposed thereon for forming into
permanent magnets.
[0076] The housing 602 includes a plurality of electrical windings
606 which may be selectively activated by electrical cable 608.
Electrical cable 608 is connected to power amplifier 610 which may
be selectively activated or deactivated by the control system 40 by
way of control cable 38. By activating the power amplifier 610,
electrical power is supplied to the coil windings 606 in the
housing 602. The coil windings 606 generate a magnetic field
causing the permanent magnets disposed on the impeller blade 605 to
be displaced. Multiple coil windings 606 may be utilized about the
periphery of the housing 602 to sequentially activate and
deactivate magnetic fields causing rotation of the impeller blades
605. The direction and frequency of the sequential activation may
be modified to change the direction and speed of rotation, and thus
the direction and degree of pumping action. As an alternative,
supplemental fluid may be supplied to the pump 600 by connection to
a source of blood within the body or by connection to a fluid
reservoir containing a suitable fluid such as saline. The function
and use of internal pump 600 is otherwise essentially the same as
external pump 500.
[0077] Refer now to FIG. 12 which shows a side cross sectional
schematic illustration of a drug delivery device 700 in accordance
with an embodiment of the present invention. Those skilled in the
art will recognize that other site specific drug delivery devices
may be utilized in place of the delivery device 700 illustrated.
Delivery device 700 includes a housing 702 which may be connected
the vessel wall 92 utilizing conventional techniques such as
sutures 705. Housing 702 includes an annular recess 705 which is in
fluid communication with a fluid delivery line 708. Annular recess
705 is open to the exterior of the vascular wall 92. Housing 702
includes annular seals 706 disposed proximally and distally of the
annular recess 705 to create a fluid tight seal between the housing
702 and the vascular wall 92. By creating a fluid tight seal, the
annular seals 706 maintain fluid in the annular recess 705. With
this arrangement, fluid delivered to the annular recess 705 via
fluid delivery lines 708 remains in intimate contact with the
exterior of the vascular wall 92 at the desired location.
[0078] Fluid line 708 is connected to a fluid delivery
pump/reservoir 710 which is connected to the control cable 38. The
control cable 38 provides a control signal from the control system
40 to activate or deactivate the pump/reservoir 710. By selectively
activating the pump/reservoir 710, fluid contained in the reservoir
710 is delivered to the annular recess 705 by way of fluid line
708. The fluid contained in the reservoir 710 is preferably a
vasoconstrictor such as phenylephrine. Alternatively or in
addition, the reservoir may contain a vasodilator such as
hydralazine or nitroprusside.
[0079] Accordingly, when the pump/reservoir 710 is activated, the
vasoconstrictor is delivered to the annular recess 705 thereby
constricting the vascular wall 92 and obstructing or reducing the
size of the internal lumen 94. Internal lumen 94 may be partially
or totally closed by varying the amount and strength of the
vasoconstrictor. When deactivated, the pump/reservoir 710 may
deliver a dilution fluid or a vasodilator to reduce or reverse the
effects of the vasoconstrictor, thereby permitting or causing the
vascular wall 92 to return to its unconstricted state and restoring
the nominal size of the internal lumen 94. The function and use of
the vasoconstrictor delivery device 700 is otherwise substantially
the same as the external compression devices 100, 300 described
previously.
[0080] From the foregoing, it should be apparent to those skilled
in the art that the present invention provides a number of devices
100, 200, 300, 400, 500, 600, 700 and systems 30, 40, 50, 60, 70,
80 and methods by which the real or apparent renovasculature
perfusion and intrarenal pressure may be selectively and
controllably increased. By selectively and controllably increasing
renovascular perfusion and interstitial hydrostatic pressure when
the heart is unable to pump sufficient blood or when renal
perfusion is suboptimal, the present invention reduces or reverses
neurohormonal activation and fluid retention, and thereby minimizes
their deleterious effects on the heart, vasculature, kidneys and
other body systems.
[0081] Those skilled in the art will recognize that the present
invention may be manifested in a variety of forms other than the
specific embodiments described and contemplated herein.
Accordingly, departures in form and detail may be made without
departing from the scope and spirit of the present invention as
described in the appended claims.
* * * * *