U.S. patent application number 15/009687 was filed with the patent office on 2016-05-26 for automated therapy system and method.
This patent application is currently assigned to TheraNova, LLC. The applicant listed for this patent is TheraNova, LLC. Invention is credited to Daniel Burnett, Gregory Hall, Christopher Hermanson, Amit Rajguru.
Application Number | 20160143774 15/009687 |
Document ID | / |
Family ID | 39595590 |
Filed Date | 2016-05-26 |
United States Patent
Application |
20160143774 |
Kind Code |
A1 |
Burnett; Daniel ; et
al. |
May 26, 2016 |
Automated therapy system and method
Abstract
An automated therapy system having an infusion catheter; a
sensor adapted to sense a patient parameter; and a controller
communicating with the sensor and programmed to control flow output
from the infusion catheter into a patient based on the patient
parameter without removing fluid from the patient. The invention
also includes a method of controlling infusion of a fluid to a
patient. The method includes the following steps: monitoring a
patient parameter with a sensor to generate a sensor signal;
providing the sensor signal to a controller; and adjusting fluid
flow to the patient based on the sensor signal without removing
fluid from the patient.
Inventors: |
Burnett; Daniel; (San
Francisco, CA) ; Hall; Gregory; (Los Gatos, CA)
; Hermanson; Christopher; (Santa Cruz, CA) ;
Rajguru; Amit; (Orinda, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TheraNova, LLC |
San Francisco |
CA |
US |
|
|
Assignee: |
TheraNova, LLC
San Francisco
CA
|
Family ID: |
39595590 |
Appl. No.: |
15/009687 |
Filed: |
January 28, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13937102 |
Jul 8, 2013 |
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15009687 |
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13354210 |
Jan 19, 2012 |
8480648 |
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13937102 |
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12098365 |
Apr 4, 2008 |
8100880 |
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13354210 |
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60921974 |
Apr 5, 2007 |
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Current U.S.
Class: |
607/105 |
Current CPC
Class: |
A61F 2007/0093 20130101;
A61B 5/14507 20130101; A61M 2230/202 20130101; A61F 2007/0063
20130101; A61M 2230/04 20130101; A61B 5/0022 20130101; A61B 5/207
20130101; A61F 7/12 20130101; A61M 2230/10 20130101; A61M 1/28
20130101; A61M 2230/205 20130101; A61M 5/1723 20130101; A61M
2230/208 20130101; A61M 5/142 20130101; A61F 2007/126 20130101;
A61B 5/024 20130101; A61B 5/02055 20130101; A61B 5/0402 20130101;
A61M 2205/3303 20130101; A61F 7/0085 20130101; A61F 2007/0022
20130101 |
International
Class: |
A61F 7/12 20060101
A61F007/12; A61F 7/00 20060101 A61F007/00 |
Claims
1. A method of inducing and reversing therapeutic hypothermia in a
patient, the method comprising: infusing a therapeutic agent
through a catheter into a peritoneal cavity of the patient;
monitoring an effect of the therapeutic agent on the patient with a
sensor which generates a sensor signal; providing the sensor signal
to a controller; and adjusting infusion of the therapeutic agent
from the catheter to the peritoneal cavity with the controller
based on the sensor signal to induce or reverse therapeutic
hypothermia in the patient without removing the therapeutic agent
from the patient; where access to the peritoneal cavity is sensed
via an access sensor to aid insertion into the peritoneal
cavity.
2. The method of claim 1 wherein the therapeutic agent is infused
into the patient with a peritoneal catheter.
3. The method of claim 1 wherein the infusing step comprises a
peritoneal lavage.
4. The method of claim 1 wherein the adjusting step is performed
after the infusing step.
5. The method of claim 1 wherein the therapeutic agent comprises a
chilled fluid.
6. The method of claim 1 wherein the sensor is positioned in the
catheter.
7. The method of claim 1 wherein the sensor is separate from the
catheter.
8. A system configured to induce and reverse therapeutic
hypothermia or hyperthermia in a patient, the system comprising: a
fluid source having a therapeutic agent; a peritoneal catheter
coupled to the fluid source, the peritoneal catheter configured to
infuse the therapeutic agent into a peritoneal cavity of the
patient; a sensor configured to generate a sensor signal based on
an effect of the therapeutic agent on the patient; and an access
sensor configured to sense access to the peritoneal cavity; and a
controller in communication with the sensor, the controller
configured to adjust infusion of the therapeutic agent from the
peritoneal catheter into the peritoneal cavity based on the sensor
signal to induce or reverse therapeutic hypothermia or hyperthermia
in the patient without removing the therapeutic agent from the
patient.
9. The system of claim 8 wherein the sensor is disposed in the
peritoneal catheter.
10. The system of claim 8 wherein the sensor is separate from the
peritoneal catheter.
11. The system of claim 8 wherein the controller is configured to
automatically adjust flow based on the sensor signal.
12. A method of inducing and reversing therapeutic hyperthermia in
a patient, the method comprising: infusing a therapeutic agent from
a catheter into a peritoneal cavity of the patient; monitoring an
effect of the therapeutic agent on the patient with a sensor which
generates a sensor signal; providing the sensor signal to a
controller; and adjusting infusion of the therapeutic agent from
the catheter to the peritoneal cavity with the controller based on
the sensor signal to induce or reverse therapeutic hyperthermia in
the patient without removing the therapeutic agent from the
patient; where access to the peritoneal cavity is sensed via an
access sensor to aid insertion into the peritoneal cavity.
13. The method of claim 12 wherein the therapeutic agent is infused
into the patient with a peritoneal catheter.
14. The method of claim 12 wherein the infusing step comprises a
peritoneal lavage.
15. The method of claim 12 wherein the adjusting step is performed
after the infusing step.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/937,102 tiled Jul. 8, 2013, which application is a
continuation of U.S. application Ser. No. 13/354,210, tiled Jan.
19, 2012, now U.S. Pat. No. 8,480,648; which application is a
continuation of U.S. application Ser. No. 12/098,365, filed Apr. 4,
2008, now U.S. Pat. No. 8,100,880; which application claims the
benefit of U.S. Provisional Patent Application No. 60/921,974,
filed Apr. 5, 2007 to Burnett, entitled "Safety Access Device,
Fluid Output Monitor & Peritoneal Organ Preservation", all
disclosures of which are incorporated by reference herein in their
entirety.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
BACKGROUND OF THE INVENTION
[0003] Fluids and other substances are infused into patients for a
variety of reasons. For example, fluids may be given to a patient
intravenously to hydrate the patient or to control overall blood
volume.
[0004] It is often important to control infusion of fluid into
patients in order to optimize the therapy being provided.
Monitoring of patient parameters can consume precious health care
time and resources, however. Fluid infusion into patients is
therefore not always optimized.
[0005] Mantle US 2006/0161107 describes a system that extracts
fluid from a body cavity, processes the fluid and then recirculates
fluid back into the cavity. Mantle does not describe infusion of a
fluid into a patient without extraction of the fluid from the
patient, however. In addition, the parameters on which the Mantle
system is controlled are limited.
SUMMARY OF THE INVENTION
[0006] One aspect of the invention provides an automated therapy
system having an infusion catheter; a sensor adapted to sense a
patient parameter; and a controller communicating with the sensor
and programmed to control flow output from the infusion catheter
into a patient based on the patient parameter without removing
fluid from the patient. In some embodiments, the sensor may be
incorporated into the catheter, and in other embodiments, the
sensor may be separate from the catheter. The sensor may be, e.g.,
an ECG sensor; an EEG sensor; a pulse oximetry sensor; a blood
pressure sensor; a cardiac output sensor; a thermodilution cardiac
output sensor; a cardiac stroke volume sensor; a heart rate sensor;
a blood flow sensor; a pH sensor; a blood pO.sub.2 sensor; an
intracranial pressure sensor; and/or a solute sensor.
[0007] In embodiments of the invention, the catheter may be a
peripheral venous catheter; a central venous catheter; an arterial
catheter; or a peritoneal catheter (possibly incorporating an
intraperitoneal pressure sensor).
[0008] Another aspect of the invention provides a method of
controlling infusion of a fluid to a patient. The method includes
the following steps: monitoring a patient parameter with a sensor
to generate a sensor signal; providing the sensor signal to a
controller; and adjusting fluid flow to the patient based on the
sensor signal without removing fluid from the patient. In some
embodiments, the method includes the step of monitoring cardiac
output with the sensor and, possibly, adjusting fluid flow to the
patient based on cardiac output monitored by the sensor. In
embodiments of the invention, the patient parameter includes an
electrocardiogram; an electroencephalogram; blood oxygen
saturation; blood pressure; cardiac output; cardiac stroke volume;
heart rate; blood flow; total circulating blood volume; whole body
oxygen consumption; pH; blood pO.sub.2; osmolarity; peritoneal
cavity compliance; intrathoracic pressure; bladder pressure; and/or
rectal pressure.
[0009] In some embodiments, the adjusting step includes the step of
adjusting fluid flow to achieve or maintain patient euvolumia;
adjusting flow of a therapeutic agent (such as a chilled medium) to
the patient; adjusting fluid flow to the patient through a
peripheral venous catheter; adjusting fluid flow to the patient
through a central venous catheter; adjusting fluid flow to the
patient through an arterial catheter; and/or adjusting fluid flow
to the patient's peritoneal cavity.
[0010] Yet another aspect of the invention provides a method of
treating hypotension in a patient. The method includes the
following steps: monitoring a patient parameter (such as blood
pressure or cardiac output) with a sensor to generate a sensor
signal; providing the sensor signal to a controller; and adjusting
fluid flow to the patient based on the sensor signal without
removing fluid from the patient.
[0011] Still another aspect of the invention provides a method of
treating sepsis in a patient. The method includes the following
steps: monitoring a patient parameter (such as blood pressure,
central venous pressure, or cardiac output) with a sensor to
generate a sensor signal; providing the sensor signal to a
controller; and adjusting fluid flow to the patient based on the
sensor signal without removing fluid from the patient. Prevention
of hypotension and/or hypovolemia is critical in the care of
patients that have suffered severe hemorrhage or are septic. These
patients are very difficult to monitor and treat, taking
significant nursing time and still resulting in suboptimal therapy
due to the intermittent nature of the blood pressure, central
venous pressure and/or cardiac output checks. The present
invention, then, will optimize fluid flow to the patient while also
freeing up the already over-taxed nursing staff for other
duties.
[0012] Yet another aspect of the invention provides a method of
inducing and reversing therapeutic hypothermia in a patient. The
method includes the steps of: monitoring intracranial pressure to
generate a sensor signal; providing the sensor signal to a
controller; and adjusting rate of hypothermia induction or
rewarming based on intracranial pressure such as by adjusting fluid
flow to the patient), or depth of hypothermia, based on the sensor
signal.
[0013] In some embodiments of the invention, irrigation and/or
lavage of bodily tissues, cavities or spaces (or other patient
interventions) may be optimized using a sensor or sensors to report
electrical, chemical, acoustic, mechanical properties, pressure,
temperature, pH or other parameters surrounding the access device
in order to automate and optimize the irrigation/lavage.
[0014] Embodiments of the invention include a peritoneal catheter
containing one or more sensors which may detect changes in
electrocardiograph monitoring, electroencephalograph monitoring,
pulse oximetry (either internally or peripherally), peritoneal
cavity compliance, intrathoracic pressure, intraperitoneal
pressure, intraperitoneal pressure waveforms, bladder pressure,
rectal pressure, cardiac output, cardiac stroke volume, cardiac
rate, blood flow (e.g., in superior mesenteric, celiac, renal or
other arteries), pressure in veins (particularly the inferior vena
cava or those that empty into the inferior vena cava, e.g., femoral
vein), pressure in arteries (particularly those distal to the
aorta, e.g., the femoral artery), total circulating blood volume,
blood oxygenation (e.g., in rectal mucosa, peripheral fingers and
toes, etc.), whole body oxygen consumption, pH and/or arterial
pO.sub.2 (or any other parameter that shows a measurable change
with increased peritoneal pressure) to ensure safety of automated
or manual peritoneal lavage. The invention also includes methods of
performing peritoneal lavage using such devices.
[0015] Embodiments of the invention include an intravascular
catheter containing one or more sensors which may detect changes in
electrocardiograph monitoring, electroencephalograph monitoring,
pulse oximetry (either internally or peripherally), partial
pressure of oxygen or CO.sub.2, pH, temperature, blood pressure,
central venous pressure, cardiac output, cardiac stroke volume,
cardiac rate, blood flow (e.g., in superior mesenteric, celiac,
renal or other arteries), total circulating blood volume, pressure
in veins (particularly those that empty into the inferior vena
cava, e.g., femoral vein), pressure in arteries (particularly those
distal to the aorta, e.g., the femoral artery), blood oxygenation
(e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole
body oxygen consumption, pH and/or arterial pO.sub.2 (or any other
parameter that shows a measurable change with intravascular volume
overload) to ensure safety of manual or automated intravascular
infusion. The invention also includes methods of using such
devices.
[0016] Other embodiments of the invention include control of the
rate of infusion to minimize negative effects observed by the
sensors. The invention may be used to induce and/or maintain
hypothermia or hyperthermia; maximize hydration and/or
intravascular volume in a patient receiving intravenous fluids
(such as, e.g., post-operative patients, post-hemorrhage patients,
septic patients or other intensive care patients).
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The novel features of the invention are set forth with
particularity in the claims that follow. A better understanding of
the features and advantages of the present invention will be
obtained by reference to the Wowing detailed description that sets
forth illustrative embodiments, in which the principles of the
invention are utilized, and the accompanying drawings of which:
[0018] FIG. 1 shows an automated infusion system in which infusion
is controlled based on patient parameters sensed by multiple
sensors.
[0019] FIG. 2 shows an automated infusion system in which a sensor
controlling infusion is separate from the infusion catheter.
[0020] FIG. 3 shows an automated infusion system in which sensing
and infusion are performed with the same catheter.
DETAILED DESCRIPTION OF THE INVENTION
[0021] FIGS. 1-3 show embodiments of the invention wherein
intravenous fluid delivery may be automated, or manually adjusted,
based on feedback from one or more sensors. In these embodiments,
the infusion catheter may have a sensor to aid in insertion, but
this is not necessary for this invention.
[0022] In one embodiment, the infusion catheter also is used to
detect the parameters used to optimize therapy. FIG. 1 shows an
infusion system with an infusion controller 10 operably connected
to an intravenous infusion catheter 12 via an infusion line 14.
Infusion catheter 12 also has a sensor (not shown) attached to or
associated with it to monitor a patient parameter. The sensor also
communicates with controller 10 either through line 14 or via some
other communication channel. Suitable patient parameters include
electrocardiograph monitoring, electroencephalograph monitoring,
pulse oximetry (either internally or peripherally), blood pressure,
central venous pressure, cardiac output, cardiac stroke volume,
cardiac rate, blood flow (e.g., in superior mesenteric, celiac,
renal or other arteries), total circulating blood volume, pressure
in veins (particularly those that empty into the inferior vena
cava, e.g., femoral vein), pressure in arteries (particularly those
distal to the aorta, e.g., the femoral artery), blood oxygenation
(e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole
body oxygen consumption, pH, arterial pO.sub.2, or any other
parameter that shows a measurable change with intravascular volume
overload.
[0023] As shown in FIG. 1, additional catheters, here envisioned as
a peripherally inserted central catheter (PICC) 16 and/or a
peritoneal catheter 18, or additional sensors on infusion catheter
12 may be used to monitor these or other parameters, and to
optimize the infusion rate and achieve euvolemia without fluid
overload or dehydration. Flow of fluid and or a fluid solid mixture
(e.g., an ice slurry) to catheters 16 and/or 18 is controlled by
controller 10 through lines 14, 15 and/or 17, respectively. The
information from the sensors may then be transmitted to central
controller 10, which integrates all of this information to
determine the flow of intravenous fluid through catheter 12 and/or
catheter 16 and flow of peritoneal fluid through catheter 18. This
information may be used to achieve or maintain euvolemia (e.g., in
sepsis, hemorrhagic shock, etc.) or to maximize infusion for
delivery of a therapeutic agent, e.g., chilled fluid and/or solids
to achieve hypothermia. Alternatively, catheters 16 and 18 may be
used with sensors to obtain patent information, and fluid may be
infused into the patient solely through catheter 16 or catheter 18.
In yet further embodiments, the depth of hypothermia and/or rate of
hypothermia induction or rewarming may be tailored based on
intracranial pressure sensor(s) (not shown) communicating with
controller 10 via communication line 35. This system and method may
be used with any method of inducing hypothermia (e.g., cooling
blankets, intravascular catheters, intravenous fluid infusion,
peritoneal lavage, etc.) so long as the change in temperature,
particularly rewarming, is controlled at least in part by an
intracranial pressure sensor.
[0024] The sensor or sensors, whether cables/catheters or
percutaneous monitoring technologies, and whether wired or
wireless, may also be separate from the infusion line so long as
the information from this sensor or sensors is transferred to the
control unit in order to optimize fluid flow. Thus, as shown in
FIG. 2, the patient parameter sensor may be associated with PICC 24
and communicate with controller via line 26, and infusion to the
patient may be via line 22 and infusion catheter 20, as controlled
by controller 10. In some embodiments, of course, sensing and
infusion may be performed through a single catheter, such as PICC
30, and controlled by controller 10 through lines 32 and 34, as
shown in FIG. 3. In some embodiments, the infusion and monitoring
device of the current invention may incorporate an access sensor,
such as that described in a commonly owned patent application, U.S.
patent application Ser. No. 12/098,355, filed Apr. 4, 2008, titled
"Device And Method For Safe Access To A Body Cavity".
[0025] One example of such a device is a peripheral venous, central
venous or arterial catheter that is capable of maintaining
hydration without causing fluid overload. The catheter may
incorporate a sensor that may detect central venous pressure, total
circulating blood volume, peripheral venous pressure, cardiac
output or osmolarity, and/or solute concentrations e.g., chloride,
sodium, etc.) in order to prevent fluid overload. The sensor may
also be external to catheter, so long as the output of said sensor
is capable of controlling fluid flow through the catheter. In this
embodiment, fluid flow is controlled by the output of the sensor,
which is integrated by a fluid flow control unit which alters the
rate of fluid flow based on this output. This embodiment may allow
the user to bolus large volumes of fluids or solids into the
vascular space in order to rehydrate, induce hypothermia or reverse
hypothermia, or deliver a therapeutic agent or maintain blood
pressure in sepsis.
[0026] In addition, this technology may provide a fully automated
mechanism to optimize fluid flow into the vessel without fluid
overloading the patient. Without this automated fluid delivery
coupled to hemodynamic parameter monitoring, the patient is in
danger of dehydration or fluid overload from infusion of fluid into
any body cavity. This technology may also be applied to liquid or
solid infusion into any body cavity or space in so long as the
fluid flow is automated based on feedback from sensors within the
body (possibly incorporated into the catheter itself) in order to
optimize the volume of infusion.
[0027] This device and method of automating fluid flow based on
hemodynamic sensor-based feedback may also be used to generate
intravenous hypothermia. In its current state, IV hypothermia
induction is limited due to concerns of fluid overload. If the
hemodynamic parameters of the patient can be measured and fluid
flow directly or indirectly controlled based on the output of these
measurements, the volume of fluid can be maximized while ensuring
hemodynamic instability. In this embodiment, the sensor may be
incorporated within the catheter, and fluid flow into the
vasculature may be tailored based on central venous pressure, total
circulating blood volume, peripheral venous pressure, cardiac
output or osmolarity, and/or solute concentrations (e.g., chloride,
sodium, etc.) in order to prevent fluid overload.
[0028] In one embodiment, the fluid infusion catheter also may
function as a thermodilution cardiac output sensor such that the
same fluid that is used to generate hypothermia may also be used to
detect cardiac output. This information may then be relayed, either
directly or indirectly, back to the fluid infusion controller to
increase, decrease or even halt fluid flow based on these
parameters. For example, if cardiac output is low and venous
pressure or total circulating volume is low, the patient has a low
circulating volume and large volumes of fluid may be safely
delivered. If the cardiac output is normal, fluid may also be
safely delivered, but the cardiac output must be monitored to
ensure that it does not begin to decrease (an indication of fluid
overload). Blood flow, as detected by, for instance, thermodilution
may be determined in a peripheral vessel as well. These data, while
relatively useless on their own in a clinical setting due to
variability in peripheral blood flow, may provide a baseline flow
profile which may be rechecked over time in order to compare flow
within that individual vessel to the baseline flow. Relatively
improved flow may be correlated to improved cardiac output, while a
relative reduction in flow may be correlated to fluid overload.
[0029] This same system may be used to infuse normal fluids or
hypothermic fluids to sepsis patients or patients requiring
intensive maintenance of their hemodynamic status. Sepsis patients
that are aggressively monitored do much better than those that are
not. Aggressive monitoring is very nurse-intensive, however. A
system that provides automated optimal fluid infusion based on
sensed parameters to ensure that fluid overload does not occur and
that fluid infusion is not insufficient would be an improvement
over current methods of treating sepsis patients. The devices and
methods for automated sensor-based input to control fluid flow to a
patient may be applicable to a wide range of conditions and should
not be limited to the narrow scope of the conditions requiring
fluid infusion described here.
[0030] The logic controller of the present invention may provide
improved safety by monitoring for any of the deleterious changes
expected with excess fluid flow, e.g., into the peritoneal cavity
or vascular space. Examples of monitored parameters that may signal
a warning or automatically result in an adjustment to rate of fluid
infusion/extraction and/or fluid temperature include:
electrocardiograph monitoring, electroencephalograph monitoring,
pulse oximetry (either internally or peripherally), peritoneal
cavity compliance, intrathoracic pressure, intraperitoneal
pressure, intraperitoneal pressure waveforms, bladder pressure,
rectal pressure, cardiac output, cardiac stroke volume, cardiac
rate, total circulating blood volume, blood flow (e.g., in superior
mesenteric, celiac, renal or other arteries), pressure in veins
(particularly those that empty into the IVC, e.g., femoral vein),
pressure in arteries (particularly those distal to the aorta, e.g.,
the femoral artery), blood oxygenation (e.g., in rectal mucosa,
peripheral fingers and toes, etc.), whole body oxygen consumption,
pH and arterial pO.sub.2 and any other parameter that shows a
measurable change once the peritoneal or vascular spaces have been
overloaded.
[0031] These parameters in particular have been found to change
with increases in peritoneal pressure, with significantly negative
impact on each parameter found at 40 mmHg. Thus, monitoring for
these changes in conjunction with a peritoneal infusion catheter of
the present invention will allow for even greater safety with
peritoneal infusion. These parameters may be measured a variety of
ways and the data transmitted either wirelessly or via wires to the
logic controller in order to alert the healthcare provider or to
automatically adjust the fluid flow/temperature in order to
optimize both the flow of the peritoneal fluid and patient
safety.
* * * * *