U.S. patent application number 13/960513 was filed with the patent office on 2013-12-05 for system and method for active bypass dialysis access disconnection detection.
This patent application is currently assigned to Baxter Healthcare S.A.. The applicant listed for this patent is Baxter Healthcare S.A., Baxter International Inc.. Invention is credited to Thore Falkvall, James Han, Thomas P. Hartranft, George Lamberson, Ramesh Wariar.
Application Number | 20130324900 13/960513 |
Document ID | / |
Family ID | 28790146 |
Filed Date | 2013-12-05 |
United States Patent
Application |
20130324900 |
Kind Code |
A1 |
Wariar; Ramesh ; et
al. |
December 5, 2013 |
SYSTEM AND METHOD FOR ACTIVE BYPASS DIALYSIS ACCESS DISCONNECTION
DETECTION
Abstract
A dialysis system comprising: a blood circuit including a blood
pump, a dialyzer, and an air removal apparatus; an arterial line of
the blood circuit extending from the blood pump to an arterial
access needle; a venous line of the blood circuit extending from
the air removal apparatus to a venous access needle; arterial and
venous conductive connections placed along the arterial and venous
lines, respectively; a first electrical potential source configured
to apply a first electrical potential between (i) the arterial and
venous conductive connections and (ii) the arterial and venous
access needles; and a second electrical potential source configured
to apply a second electrical potential between (a) the arterial and
venous conductive connections and (b) one of the blood pump,
dialyzer or air removal device.
Inventors: |
Wariar; Ramesh; (Blaine,
MN) ; Han; James; (Crystal Lake, IL) ;
Lamberson; George; (San Antonio, FL) ; Hartranft;
Thomas P.; (Clearwater, FL) ; Falkvall; Thore;
(Thorildsgatan, SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Baxter Healthcare S.A.
Baxter International Inc. |
Glattpark (Opfikon)
Deerfield |
IL |
CH
US |
|
|
Assignee: |
Baxter Healthcare S.A.
Glattpark (Opfikon)
IL
Baxter International Inc.
Deerfield
|
Family ID: |
28790146 |
Appl. No.: |
13/960513 |
Filed: |
August 6, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13157010 |
Jun 9, 2011 |
8529490 |
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13960513 |
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|
11338988 |
Jan 25, 2006 |
7959594 |
|
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13157010 |
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10120703 |
Apr 10, 2002 |
7022098 |
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11338988 |
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Current U.S.
Class: |
604/6.09 ;
604/111 |
Current CPC
Class: |
A61M 2205/3317 20130101;
A61M 2205/50 20130101; A61M 2205/3324 20130101; A61M 1/3661
20140204; A61M 1/3653 20130101; A61M 1/3659 20140204; A61M 1/3656
20140204; A61M 5/16831 20130101; A61M 1/16 20130101; A61M 2205/18
20130101; A61M 1/367 20130101; A61M 5/5086 20130101; A61M 1/30
20130101; A61M 2205/3334 20130101 |
Class at
Publication: |
604/6.09 ;
604/111 |
International
Class: |
A61M 1/30 20060101
A61M001/30; A61M 5/50 20060101 A61M005/50 |
Claims
1. A dialysis system comprising: a blood circuit including a blood
pump, a dialyzer, and an air removal apparatus; an arterial line of
the blood circuit extending from the blood pump to an arterial
access needle; a venous line of the blood circuit extending from
the air removal apparatus to a venous access needle; arterial and
venous conductive connections placed along the arterial and venous
lines, respectively; a first electrical potential source configured
to apply a first electrical potential between (i) the arterial and
venous conductive connections and (ii) the arterial and venous
access needles; and a second electrical potential source configured
to apply a second electrical potential between (a) the arterial and
venous conductive connections and (b) one of the blood pump,
dialyzer or air removal device.
2. The dialysis system of claim 1, wherein the second electrical
potential is applied between the arterial conductive connection and
the blood pump.
3. The dialysis system of claim 1, wherein the second electrical
potential is applied between the arterial conductive connection and
a third conductive connection placed along the blood circuit.
4. The dialysis system of claim 3, wherein the third conductive
connection is located along the arterial line between the arterial
conductive connection and the blood pump.
5. The dialysis system of claim 1, wherein the second electrical
potential is applied between the venous conductive connection and
the air removal apparatus.
6. The dialysis system of claim 1, wherein the second electrical
potential is applied between the venous conductive connection and a
third conductive connection placed along the blood circuit.
7. The dialysis system of claim 6, wherein the third conductive
connection is located along the venous line between the venous
conductive connection and the air removal apparatus.
8. The dialysis system of claim 1, which is configured such that
the second electrical potential at least substantially matches the
first electrical potential.
9. The dialysis system of claim 1, which includes electronics
configured to measure the first electrical potential and a
controller programmed to at least substantially match the second
electrical potential to the measured first electrical
potential.
10. The dialysis system of claim 1, which includes a controller
configured to determine a needle disconnection upon a threshold
change in a signal produced by the first electrical potential.
11. The dialysis system of claim 1, wherein the second electrical
potential causes a signal produced by the first electrical
potential to bypass at least one of the blood pump, dialyzer or air
removal apparatus.
12. A dialysis system comprising: a blood circuit including a
dialyzer, a blood pump, an arterial line and a venous line;
arterial and venous conductive connections placed along the
arterial and venous lines between the dialyzer/blood pump and the
distal ends of the arterial and venous lines, respectively; a first
electrical potential source configured to apply a first electrical
potential between (i) the arterial and venous conductive
connections and (ii) the distal ends of the arterial and venous
lines; and a second electrical potential source configured to apply
a second electrical potential between (a) the dialyzer/blood pump
and (b) the arterial and venous conductive connections.
13. The dialysis system of claim 12, wherein the second electrical
potential at least substantially matches the first electrical
potential, causing a signal produced by the first electrical
potential to bypass at least one of the dialyzer or the blood
pump.
14. The dialysis system of claim 12, which includes a controller
programmed to determine a needle access disconnection upon a
sufficient change in a sensed signal produced by the first
electrical potential.
15. An access disconnection method for a machine employing a blood
circuit, the blood circuit having a machine segment and a patient
access segment, the method comprising: injecting an electrical
signal into the blood circuit between the machine segment and the
patient access segment; attempting to cause the electrical signal
to flow through only the patient access segment and to bypass the
machine segment; and measuring the signal in the patient access
segment and determining that an access disconnection event has
occurred upon a threshold change in the measured signal.
16. The access disconnection method of claim 15, wherein attempting
to cause the electrical signal to bypass the machine segment
includes applying a potential to the blood circuit at a location
between the signal in the patient access segment and a machine
operating component of the machine segment of the blood
circuit.
17. The access disconnection method of claim 16, wherein applying
the potential includes applying a potential that is at least
substantially equal to a potential applied to cause the signal.
18. The access disconnection method of claim 15, the signal applied
via first and second conductive connections to the blood circuit,
and wherein attempting to cause the electrical signal to bypass the
machine segment includes applying a potential to the blood circuit
at a location between one of the first and second conductive
connections and a machine operating component of the machine
segment of the blood circuit.
19. The access disconnection method of claim 18, which includes
applying the potential to one of the first and second conductive
connections and a third conductive connection located between the
one of the first and second connections and the machine operating
component.
20. The access disconnection method of claim 15, wherein attempting
to cause the electrical signal to bypass the machine segment
includes, in addition to the signal, applying a potential to the
blood circuit downstream of the blood pump.
21. The access disconnection method of claim 15, which includes
taking into account an impedance associated with the vascular
access in determining the threshold change in the measured signal
by which the access disconnection is determined.
Description
PRIORITY
[0001] This application claims priority to and the benefit as a
continuation application of U.S. patent application Ser. No.
13/157,010, entitled "Systems And Methods For Dialysis Access
Disconnection", filed Jun. 9, 2011, which is a continuation of U.S.
Pat. No. 7,959,594, entitled "Access Disconnection Systems And
Methods," filed Jan. 25, 2006, which is a continuation of U.S. Pat.
No. 7,022,098, entitled "Access Disconnection Systems And Methods",
filed Apr. 10, 2002, the entire contents of each of which are
expressly incorporated herein by reference and relied upon.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to patient access
disconnection systems and methods for medical treatments. More
specifically, the present invention relates to the detection of
patient access disconnection, such as dislodgment of a patient
access device during medical treatments or therapies including
dialysis therapy.
[0003] A variety of different medical treatments relate to the
delivery of fluid to and/or from a patient, such as the delivery of
blood between a patient and an extracorporeal system connected to
the patient via a needle or needles or any suitable access device
inserted within the patient. For example, hemodialysis,
hemofiltration and hemodiafiltration are all treatments that remove
waste, toxins and excess water directly from the patient's blood.
During these treatments, the patient is connected to an
extracoporeal machine, and the patient's blood is pumped through
the machine. Waste, toxins and excess water are removed from the
patient's blood, and the blood is infused back into the patient.
Needles or other suitable access devices are inserted into the
patient's vascular access in order to transfer the patient's blood
to and from the extracoporeal machine. Traditional hemodialysis,
hemofiltration and hemodiafiltration treatments can last several
hours and are generally performed in a treatment center about three
to four times per week.
[0004] During any of these hemo treatments, dislodgment of the
access device can occur, such as dislodgment of a needle inserted
into the patient's vascular access including an arterio-venous
graft or fistula. If not detected immediately, this can produce a
significant amount of blood loss to the patient. The risks
associated with a needle dislodgment are considerable. In this
regard, important criteria for monitoring blood loss include, for
example, the sensitivity, specificity and response time with
respect to the detection of needle dislodgment. With increased
levels of sensitivity, specificity, and response time, the
detection of needle dislodgment can be enhanced, and blood loss due
to dislodgment can be minimized.
[0005] Typically, patients undergoing medical treatment, such as
hemodialysis, hemofiltration or hemodiafiltration, are visually
monitored in order to detect needle dislodgment. However, the
needle may not be in plain view of the patient or medical staff
(i.e., it may be covered by a blanket) such that it could delay
detection and, thus, responsive actions to be taken in view of
dislodgment, such as stopping the blood pump of the extracorporeal
machine to minimize blood loss to the patient.
[0006] Moreover, in view of the increased quality of life, observed
reductions in both morbidity and mortality and lower costs than
in-center treatments, a renewed interest has arisen for self care
and home hemo therapies. Such home hemo therapies (whether
hemodialysis, hemofiltration or hemodiafiltration) allow for both
nocturnal as well as daily treatments. During these self care and
home hemo sessions, especially during a nocturnal home hemo
session, when the patient is asleep, dislodgment risks are more
significant because nurses or other attendants are not present to
detect the dislodgment.
[0007] Although devices that employ a variety of different sensors
are available and known for detecting and/or monitoring a variety
of different bodily fluids, these devices may not be suitably
adapted to detect needle dislodgment. For example, known devices
that employ sensors including pH, temperature and conductivity have
been utilized to detect bedwetting and diaper wetness. Further,
devices that employ pressure sensors and/or flow sensing devices
are known and used during medical treatment, such as dialysis
therapy, to monitor fluid flow including blood flow to and/or from
the patient. However, these types of detection devices may not
provide an adequate level of sensitivity and responsiveness if
applied to detecting blood loss from the patient due to needle
dislodgment. Although venous pressure is known to be used to
monitor needle dislodgment, it is not very sensitive to needle
drop-out.
[0008] Additional other devices and methods are generally known to
monitor vascular access based on the electrical conductivity of
blood. For example, Australian Patent No. 730,338 based on PCT
Publication No. WO 99/12588 employs an electrical circuit which
includes two points through which current is induced into blood
flowing in an extracorporeal circuit that forms a closed conductor
loop. Current is induced in blood using a coil that is placed
around the outside of the tubing of the blood circuit. Thus, each
coil does not directly contact the blood as it circulates through
the tubing. In this regard, a current is generated into the blood
flowing in the extracorporeal circuit by an alternating current
that flows through one of the coils. The second coil is then
utilized to measure a change in amperage of the induced current as
it flows through the blood circuit.
[0009] In this regard, electrical current is coupled to a blood
treatment system that includes a number of high impedance
components, such a blood pump, air bubble traps, pinch clamps
and/or the like. Because of the large impedance of the conducting
fluid loop (due to the peristaltic pump and other components), the
induction and detection of a patient-safe current requires an
impractically complex design of the coil and system. Further, a
high level of noise would necessarily result from the use of such
levels of induced current. This can adversely impact the
sensitivity of detection. If lower currents are used, the field
coil would have to be increased in size to detect such low current
levels. This may not be practical in use, particularly as applied
during dialysis therapy.
[0010] PCT Publication No. WO 01/47581 discloses a method and
device for monitoring access to the cardiovascular system of a
patient. The access monitoring employs an electrical circuit which
can generate and detect a current at separate points along a blood
circuit connected to the patient. Current is injected into blood
using capacitive couplers that each have a metal tube placed around
the blood circuit tubing. In this regard, the metal tube defines a
first plate of a capacitor; the blood circuit tubing defines the
dielectric; and the blood inside of the blood circuit tubing
defines the second plate of the capacitor.
[0011] The generator applies a potential difference between a pair
of capacitive couplers to generate a current in blood flowing
through the blood circuit. A detector utilizes an additional and
separate pair of capacitive couplers to measure the current along
at least one section of the venous branch between a first contact
point and the venous needle. The change in voltage (dV) can then be
determined based on a measured change in current and compared to a
reference range (I) to monitor access conditions. In this regard,
PCT Publication No. WO 01/47581 requires a complex circuit design
that utilizes multiple sets of capacitive couplers to monitor
vascular access conditions. This can increase the cost and expense
of using same.
[0012] Further, the mere use of capacitive coupling to inject an
electric signal in the blood circuit and/or for detection purposes
can be problematic. In this regard, the signal must pass through
the tubing of the blood circuit as the tubing acts as a dielectric
of the capacitor. This may cause an excess level of noise and/or
other interference with respect to the detection of changes in
vascular access conditions.
[0013] In this regard, it is believed that known devices,
apparatuses, systems, and/or methods that can be used to monitor a
patient's access conditions may not be capable of detecting change
in access conditions, such as in response to needle drop out, with
sufficient sensitivity and specificity to ensure immediate
detection of blood loss such that responsive measures can be taken
to minimize blood loss. As applied, if twenty seconds or more of
time elapses before blood loss due to, for example, dislodgment of
the venous needle, over 100 milliliters in blood loss can occur at
a blood flow rate of 400 ml/min, which is typical of dialysis
therapy. Thus, the capability to respond quickly upon immediate
detection of dislodgment of an access device, such as a needle,
from a patient is essential to ensure patient safety.
[0014] Accordingly, efforts have been directed at designing
apparatuses, devices, systems and methods for detecting changes in
access conditions, such as in response to needle dislodgment,
wherein detection is sensitive, specific and immediate in response
to such access changes such that responsive measures can be
suitably taken to minimize blood loss from the patient due to
same.
SUMMARY OF THE INVENTION
[0015] The present invention provides improved devices,
apparatuses, systems, and methods for detecting dislodgment or
disconnection of an access device, such as dislodgment of a needle
inserted in a patient during dialysis therapy. The devices,
apparatuses, systems, and methods of the present invention utilize
an electrical circuit with a number of electrical contacts which
are in fluid contact with the fluid circuit such that an electrical
signal can be injected into at least a segment including, for
example, a loop defined along at least a portion of the conducting
fluid circuit. In this regard, a direct-contact measurement can be
used to provide immediate detection of a change in an electrical
value in response to a change in access conditions, such as a
change in impedance due to dislodgment of a needle or other access
device from the patient during medical therapy including, for
example, dialysis therapy and medication delivery.
[0016] An advantage of the present invention is to provide an
improved device, apparatus, system and/or method for detecting
access disconnection.
[0017] A further advantage of the present invention is to provide
an improved device, apparatus, system and/or method for detecting
dislodgment of an access device from a patient during medical
therapy including dialysis therapy.
[0018] Another advantage of the present invention is to provide an
improved device, apparatus, method and/or system for detecting
needle drop-out during dialysis therapy.
[0019] Yet another advantage of the present invention is to provide
a sensitive, specific and responsive apparatus and/or device for
detecting access disconnection during selfcare and home hemo
treatments.
[0020] Moreover, an advantage of the present invention is to
provide a viable device or apparatus for allowing a patient to self
administer or other non-medical personnel in a non-medical facility
a dialysis therapy that uses a portion of the patient's circulatory
system.
[0021] Still further, an advantage of the present invention is to
provide an improved apparatus for detecting access disconnection
that uses a direct conductivity measurement.
[0022] Yet still further, an advantage of the present invention is
to provide an access disconnection detection device, method and/or
system that employs an electrical circuit in fluid and electrical
contact with blood flowing through a blood circuit allowing direct
conductivity measurements to be made.
[0023] Furthermore, an advantage of the present invention is to
provide an improved device, system and method for monitoring and/or
controlling blood loss from a patient.
[0024] Another advantage of the present invention is an improved
method for dialysis that employs an apparatus, device and/or system
capable of detecting access disconnection, such as dislodgment of a
needle inserted into a patient through which blood flows during
dialysis therapy and minimizing any resulting blood loss.
[0025] Yet another advantage of the present invention is an
improved device for connecting an electrical contact to a fluid
circuit allowing fluid and electrical communication between the
electrical contact and fluid flowing through the fluid circuit.
[0026] Still another advantage of the present invention is an
improved apparatus, device, system and/or method for detecting
access disconnection, such as needle drop-out during dialysis
therapy, with enhanced sensitivity, accuracy and
responsiveness.
[0027] Yet still another advantage of the present invention are
improved apparatuses, devices, systems and/or methods for the
detection of fluid loss due to, for example, dislodgment of a
single access device during medical therapies, for example,
medication delivery and single needle hemo therapies.
[0028] Additional features and advantages of the present invention
are described in, and will be apparent from, the following Detailed
Description of the Invention and the figures.
BRIEF DESCRIPTION OF THE FIGURES
[0029] FIG. 1A illustrates a schematic view of an embodiment of the
present invention showing two needles insertable within a patient
through which blood flows to and from an extracorporeal system.
[0030] FIG. 1B illustrates a schematic view of an embodiment of the
present invention capable of detecting needle dislodgment during
dialysis therapy.
[0031] FIG. 1C illustrates a perspective view of an embodiment of
the present invention showing access disconnection detection
capabilities during medical therapies administered via a single
needle.
[0032] FIG. 2A illustrates an exploded view of an electrical
contact coupling device in an embodiment of the present
invention.
[0033] FIG. 2B illustrates a side sectional view of the coupling
device of FIG. 2A in an embodiment of the present invention.
[0034] FIG. 2C illustrates another embodiment of the coupling
device of the present invention.
[0035] FIG. 2D illustrates another embodiment of the coupling
device of the present invention showing a threaded engagement
between the components of same.
[0036] FIG. 2E illustrates a sectional view of FIG. 2D.
[0037] FIG. 2F illustrates another embodiment of a coupling device
of the present invention.
[0038] FIG. 3 schematically illustrates an embodiment of the
present invention relating to processing of a measurable voltage
signal to correct for changes in baseline impedance during
treatment.
[0039] FIG. 4A schematically illustrates a hemodialysis machine in
an embodiment of the present invention.
[0040] FIG. 4B schematically illustrates a hemodialysis machine
coupled to a patient's access via a tubing set in an embodiment of
the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0041] The present invention provides medical devices, apparatuses,
systems and methods for detecting access disconnection. More
specifically, the present invention provides medical devices,
apparatuses, systems, and methods that employ, in part, an
electrical circuit with electrical contacts in fluid contact and
electrical communication with a fluid circuit allowing a direct
conductivity measurement to be used such that dislodgment of a
needle or other access device through which fluid flows between a
patient and the fluid circuit can be immediately detected. In this
regard, fluid loss (i.e., blood loss) due to, for example,
dislodgment of a needle from a patient undergoing medical
treatment, such as dialysis therapy, medication delivery or the
like, can be controllably minimized.
[0042] It should be appreciated that the present invention is not
limited to the detection of needle dislodgment but can be utilized
to detect the dislodgment or disconnection of any suitable access
device. As used herein, the term "access disconnection" or other
like terms means any suitable condition or event which can cause a
loss or leak of an electrically conductive fluid flowing along a
fluid circuit connected to the patient provided that a change in
the electrical continuity between electrical contacts coupled to
the fluid circuit can be detected. It should be appreciated that a
change in the electrical continuity as measured by an electrical
value, such as impedance, may be detected even in the absence of
dislodgment of an access device from the patient. The term "access
device" as used herein or other like terms means a suitable device
that can be inserted within a patient such that fluid, including
blood, can pass to, through and/or from the patient via the access
device. The access device can include a variety of different and
suitable shapes, sizes and material make-up. Examples of an access
device includes needles, catheters, cannulas or the like. The
access device can be composed of any suitable material including,
for example, stainless steel, plastic or like biocompatible
materials.
[0043] Although in the embodiment set forth below the apparatus
and/or device is designed for use in a dialysis therapy, such as
hemodialysis, hemofiltration or hemodiafiltration, it should be
noted that the present invention can be used in a number of
different medical therapies that employ a variety of different and
suitable fluid systems, such as extracorporeal blood systems. For
example, the invention of the present application can be used
during intravenous infusion that can employ the use of a single
needle insertable within the patient for delivering a medical
solution or drug, blood, blood products, processed blood or the
like between the patient and the fluid system. In addition, the
present invention can be used in plasma exchange therapies, where a
membrane is used to separate whole blood into plasma and cellular
components.
[0044] With respect to dialysis therapy, the present invention can
be used in a variety of different therapies to treat kidney
failure. Dialysis therapy as the term or like terms are used
throughout the text is meant to include and encompass any and all
forms of therapies that utilize the patient's blood to remove
waste, toxins and excess water from the patient. Such therapies
include both intermittent, including hemodialysis, hemofiltration
and hemodiafiltration, and continuous therapies used for continuous
renal replacement therapy (CRRT). These continuous therapies
include slow continuous ultrafiltration (SCUF), continuous veno
venous hemofiltration (CVVH), continuous veno venous hemodialysis
(CVVHD), and continuous veno venous hemodiafiltration (CVVHDF).
Dialysis therapy can also include peritoneal dialysis, such a
continuous ambulatory peritoneal dialysis, automated peritoneal
dialysis and continuous flow peritoneal dialysis. Further, although
the present invention, in an embodiment, can be utilized in methods
providing a dialysis therapy for patients having chronic kidney
failure or disease, it should be appreciated that the present
invention can be used for acute dialysis needs, for example, in an
emergency room setting. Lastly, as one of skill in the art
appreciates, the intermittent forms of therapy (i.e.,
hemofiltration, hemodialysis and hemodiafiltration) may be used in
the in center, self/limited care as well as the home settings.
[0045] In an embodiment, the present invention includes an
electrical circuit with a number of electrical contacts, preferably
a pair of electrical contacts, in fluid contact and electrical
communication with the fluid circuit. The electrical contacts can
include any suitable device through which electrical connection can
be made with the fluid circuit thereby defining a conductive
pathway or conductor loop therein. Changes in an electrical value
or any suitable parameter associated with the conductor loop can
then be monitored in response to changes in access conditions as
described below. In an embodiment, the electrical contact includes
an electrode which can be coupled to the fluid circuit such that an
electrical connection can be made in fluid contact with fluid
flowing through the fluid circuit as discussed below.
[0046] For example, a constant current or other suitable electrical
signal can be injected into the fluid circuit via an electrode pair
in contact with fluid flowing between the electrodes thereby
defining a loop along at least a portion of the fluid circuit. A
change in an electrical value, preferably impedance, can then be
measured in response to access disconnection. This can provide a
direct conductivity measurement capable of detecting a change in
impedance or other suitable electrical parameter of the fluid, such
as an electrically conductive fluid including blood, medical
solutions or the like, as it flows between a patient and a fluid
system (i.e., an extracorporeal blood system) via a needle, needles
or other access device(s) inserted within the patient.
[0047] In this regard, the present invention can effectively detect
dislodgment of a needle (e.g., a venous needle and an arterial
needle) or other access device through which blood or other
suitable fluid can flow, for example, to, through and from the
patient, such as a blood circuit used during dialysis therapy. The
detection capability of the present invention is believed to be
immediate based on the measurable change in, for example, impedance
of the electrically conductive fluid or fluids due to fluid loss
resulting from disconnection of the access device from the
patient.
[0048] The immediate detection capabilities of the present
invention are important, particularly as applied to dialysis
therapy where a significant amount of blood loss can occur within a
relatively short period of time if delays in detection and
responsive actions to stop the blood loss occur. Under typical
dialysis conditions, if 20 seconds or more time elapses before
blood loss due to dislodgment is detected and stopped, over 100
milliliters of blood can be lost based on typical blood flow rates
of 400 milliliters/minute.
[0049] Applicants have discovered that the present invention can
detect access disconnection, particularly in response to venous
needle dislodgment during dialysis therapy, with a high degree of
sensitivity and specificity in addition to its immediate detection
capabilities. The direct-contact measurement of the present
invention is capable of detecting a change of an electrical value,
preferably impedance, due to needle dislodgment or the like as the
blood flows through the blood circuit during dialysis therapy. As
used herein, the term "electrical value" or other like terms means
any suitable electrical parameter typically associated with
electrical circuitry including, for example, impedance, resistance,
voltage, current, rates of change thereof and combinations thereof.
The detection of a change in impedance or the like is an indication
that the needle has become dislodged or other like condition has
occurred. It is noted that the detection capabilities of the
present invention can also effectively detect blood loss during
medical therapy even if the needle or needles have not become
dislodged or at least not entirely dislodged. In this regard, the
present invention can be effectively utilized to controllably
minimize blood loss from the patient based on the ability of the
present invention to immediately measure a change in impedance or
the like due to blood loss with a high degree of sensitivity and
specificity.
[0050] The devices and apparatuses of the present invention can
include a variety of different components and configurations
depending on the applied medical therapy such that fluid loss,
particularly blood loss due to needle dislodgment or the like, can
be effectively monitored.
Multiple Access Disconnection
[0051] Referring now to FIG. 1A, an embodiment of the apparatus 10
of the present invention includes a pair of electrical contacts 12
in fluid contact with a blood tubing set 14 of a blood circuit 16.
The blood circuit 16 connects a patient 18 to an extracorporeal
blood system 20 as applied to, for example, dialysis therapy
including hemodialysis, hemofiltration, hemodiafiltration,
continuous renal replacement or the like or plasma therapies. The
pair of electrical contacts 12 includes a first electrical contact
22 and a second electrical contact 24 which are attached to a
respective first tube member 26 and second tube member 28 of the
blood circuit 16. The first tube member 26 is connected to a venous
needle or other suitable access device inserted into a vascular
access region (not shown) of the patient. The second tube member 28
is connected to an arterial needle or the like also inserted into a
vascular access region (not shown) of the patient. During dialysis
therapy, for example, blood flows from the patient 18 through the
arterial needle to the extracorporeal blood system 20 includes, for
example, a dialysis machine, via the second tube member 28 where
the blood is treated and delivered to the patient 18 through the
venous needle via the first tube member 26.
[0052] As the blood flows through the blood circuit during dialysis
therapy, a constant electric current or the like generated by a
controller 29 can be injected or passed into the flowing blood via
the electrical contact pair, preferably an electrode pair as
described below. The electrode pair connected to the controller 29
or other suitable electronic device can then be used to measure a
voltage change across an unknown fluid (e.g., blood) impedance or
other like electrical value to detect a change in impedance or the
like across the vascular access region. In an embodiment, one
electrode can be used to inject the electrical signal into the
fluid circuit while the other electrode of the pair can be used to
sense a change in the electrical value and pass an electrical
signal indicative of the same to the controller for processing and
detection purposes. Upon dislodgment of at least one of the venous
needle and arterial needle from the blood circuit or other suitable
condition, an immediate and detectable increase in impedance or the
like can be measured as compared to the impedance or other suitable
parameter measured under normal operating conditions.
[0053] It should be appreciated that the present invention as
embodied in FIG. 1A can be modified in a variety of suitable ways
depending on the medical therapy as applied. For example, the
venous and arterial needles can be inserted into the vascular
access of the patient on any suitable part of the patient's body,
such as the upper arm, lower arm, upper thigh area or the like
during dialysis therapy. As previously discussed, the present
invention can be applied to a variety of different medical
therapies including intravenous infusions, plasma exchanges,
medication delivery, drug delivery, blood delivery and dialysis
therapies (i.e., hemofiltration, hemodialysis, hemodiafiltration
and continuous renal replacement).
[0054] As illustrated in FIG. 1B, an embodiment of an apparatus 30
of the present invention is shown as applied during dialysis
therapy. In an embodiment, the present invention includes a venous
needle 32 and arterial needle 34 inserted within a patient access
36. The venous needle 32 and arterial needle 34 are connected to
the dialysis system 35 via a number of tube members 38 that connect
the various components of the dialysis system 35 including, for
example, a venous drip chamber 40, a dialyzer 42, an arterial drip
chamber 44 and a blood pump 46. It should be appreciated that one
or more of the components of the dialysis system can be provided
within a dialysis machine coupled to the blood circuit. As shown in
FIG. 1B, a first electrical contact coupling device 48 and a second
electrical contact coupling device 50 are positioned between the
dialysis system 35 and the venous needle 32 and the arterial needle
34. As used herein, the term "electrical contact coupling device,"
"coupling device" or other like terms means any suitable device
that can be used to connect an electrical contact to the fluid
circuit. In an embodiment, the electrical contact coupling device
can be used to contact the electric contact to the fluid circuit
allowing fluid contact and electrical connection with the fluid
flowing through the fluid circuit as described below.
[0055] In an embodiment, the electrical contact pair, preferably an
electrode pair, are connected to a controller 52 or other suitable
electronic device. The controller can be used to inject an electric
signal via the electrode pair and into the blood and/or other fluid
as it flows through the blood circuit. This provides a conductor
loop along which changes in electrical parameters or values can be
measured. The controller 52 which is coupled to the electrode pair
can also be used to measure this change. It should be appreciated
that the controller can include a single electronic device or any
suitable number of devices in electrical connection with the
electrical contacts to input an electrical signal into the blood
circuit thereby defining a conductor loop, to measure a change in
an electrical parameter or value associated with the conductor loop
and/or perform any other suitable tasks, such as processing the
detectable signal as discussed below.
[0056] Preferably, the electrical signal is generated from a
constant current that is supplied to the electrodes until
dislodgment occurs. The voltage across an unknown impedance of the
fluid (e.g., blood) circulating through the blood circuit can then
be measured (not shown) to detect a change in impedance due to
changes in access conditions. However, it should be appreciated
that any suitable electrical parameter and changes thereof can be
monitored to detect needle drop-out or the like as previously
discussed.
[0057] As demonstrated below, the detection capabilities of the
present invention are highly sensitive, specific and virtually
immediate in response to access disconnection, such as needle
dislodgment. Further, the electronic circuit of the present
invention is relatively simple in design such that preferably one
electrode pair is necessary to conduct direct conductivity
measurement. This can reduce costs and effort as compared to known
vascular access monitoring techniques that only employ non-invasive
detection techniques, such as, capacitive couplers and induction
coils as previously discussed.
[0058] Applicants have discovered that the total impedance measured
("Z") can be modeled as two lumped impedances in parallel with one
impedance ("Z.sub.D") being produced by the pump segment, the
dialyzer, the drip chambers and/or other suitable components of the
dialysis system and/or the like. The other resistance impedance
component ("Z.sub.P") is formed by the patient's vascular access
and associated tubing which carries blood to and from the vascular
access and/or the like. In this regard, the total impedance
measured can be characterized as a function of both Z.sub.D and
Z.sub.P as follows:
Z=(1/Z.sub.D+1/Z.sub.P).sup.-1
[0059] Despite this parallel impedance, applicants have discovered
that the electrical contacts in connection with the controller can
be used to measure a change in impedance along the conductor loop
as blood flows through the blood circuit in response to access
disconnection, such as needle dislodgment. If needle dislodgment
occurs, the conductor loop along at least a portion of the fluid
circuit changes from a closed circuit to an open circuit and thus
Z=Z.sub.D where Z.sub.P approaches infinity. In this regard, the
direct conductive measurement capabilities of the present invention
can be effectively used to detect access disconnection.
[0060] Applicants note that the Z.sub.D component can produce a
level of electrical interference associated with the time-varying
high impedance of the components of a medical system coupled to the
fluid circuit, such as a dialysis system and its components
including, for example, a blood pump, a drip chamber and/or the
like. Applicants have discovered that the interference due to the
Z.sub.D component can be effectively eliminated, or at least
reduced, if necessary. In an embodiment, the signal associated with
the detection of Z or the like can be further processed as
discussed below. Alternatively, in an embodiment, the electrical
circuit of the present invention can be designed to block or bypass
one or more components of the dialysis system from the conductor
loop or pathway defined along the blood circuit as described below.
In this regard, the accuracy, sensitivity and responsiveness with
respect to the detection of access disconnection can be
enhanced.
[0061] In an embodiment, a third electrical contact point 53 can be
utilized to minimize or effectively eliminate the interferences
with respect to the high impedance components coupled to the blood
circuit, such as the blood pump and the like. The additional
contact point can be made in any suitable way. For example, the
third contact point can be an electrode or other suitable device
through which electrical continuity can be established between it
and one of the electrodes of the coupling devices. In an
embodiment, the third electrical contact can be attached to a fluid
circuit in fluid and electrical communication with fluid flowing
through same.
[0062] The third contact point 53 can be positioned at any suitable
position along the blood circuit. Preferably, the third contact
point 53 is positioned at any suitable location between the blood
pump 46 and the coupling device 50 as shown in FIG. 1B. An
equalization potential can then be applied between the third
contact point 53 and the electrode of the coupling device 50. The
potential is applied at a voltage that is equal to the potential
applied between the electrodes of the first coupling device 48 and
the second coupling device 50.
[0063] This effectively causes the electric current or the like,
once injected into the blood circuit, to bypass one or more of the
components of the dialysis system. In an embodiment, the third
contact point 53 can be positioned such that the electric current
or the like would effectively bypass all of the components of the
dialysis system as shown in FIG. 1B.
Single Access Disconnection
[0064] The electrical contacts of the present invention can be
positioned in any suitable location relative to the needle, needles
or suitable access device inserted within the patient. As
illustrated in FIG. 1C, an embodiment of the present invention as
applied with respect to the detection of access detection, such as
the dislodgment of a single access device inserted within the
patient is shown. This type of application is applicable to a
variety of different and suitable medical therapies administered
via a single access device, such as a single needle, including
intravenous infusion and dialysis therapy including hemodialysis,
hemofiltration, hemodiafiltration and continuous renal
replacement.
[0065] As applied, an electrically conductive fluid, such as blood,
a blood product, a medical fluid or the like flows between the
patient and a fluid system via a single access device. Dislodgment
detection of a single access device can include, for example, the
detection of needle dislodgment during the delivery of any suitable
and electrically conductive fluid or fluids including, for example,
blood or medical drug or solution (i.e., a medication contained in
an electrically conductive fluid, such as saline), processed blood,
blood products, intravenous solutions, the like or combinations
thereof. The fluid delivery can be made between an suitable
container, such as blood bags or like fluid delivery devices, and a
patient. In this regard, immediate and responsive detection of
access disconnection via the present invention can be effectively
utilized to monitor and control the transfer of blood or a medical
fluid, such as a medication or drug, during medical therapy
administered via a single needle.
[0066] As shown in FIG. 1C, an embodiment of the apparatus or
device 54 of the present invention includes an access device 56;
such as a needle, inserted into a blood vessel 58 within a needle
insertion site 60 of the patient 62. The needle 56 is connected to
the fluid system 63, such as a fluid infusion system, via a tube
member 64. The infusion system includes, for example, an infusion
pump 66 for transferring the blood or the like from a container 68
(e.g., blood bag) to the patient. A first electrical contact 70 is
spaced apart from the needle 56 along the tube member 64 and a
second electrical contact 72 is attached to the patient near the
insertion site 60. The first electrical contact 70 is in fluid
contact with the fluid as it flows from the delivery container 68
to the patient.
[0067] In this configuration, the first and second electrical
contacts, preferably electrodes, can be used to monitor changes in
an electrical value, preferably impedance, within a loop formed by
at least a portion of the fluid circuit as an electric signal
passes therein. The electrical contact points can be coupled to an
electronic device 74 which is capable of processing a detectable
signal transmitted through the electrodes in response to a change
in impedance or the like due to dislodgment of the single access
device as described in detail below. Preferably, the electrical
signal is generated by a constant current supplied to the
electrodes such that a direct conductivity measurement can be
conducted to detect a change in impedance or the like in response
to changes in vascular access conditions, such as dislodgment of
the access needle.
[0068] It is believed that the measured impedance, in the single
needle application, is a function of both the impedance of the
fluid (i.e., blood) and the impedance as measured across the
insertion site. In this regard, the electronic device 74 can be
adjusted to detect the impedance at the level equivalent to the
combined impedance of all items of the electrical path (i.e., the
conductive fluid in the tube, needle, blood stream of venous
vessel, body tissue, impedance across the skin with respect to the
sensing electrode 72 and the like).
Electrical Contacts
[0069] As previously discussed, the electrical contacts of the
present invention are in fluid contact with the fluid as it flows
through the fluid circuit. In this regard, the electrical contacts
allow for a direct conductivity measurement which is capable of
immediately detecting, with high sensitivity and specificity, a
change (e.g., an increase) in impedance or the like due to access
disconnection, such as dislodgment of a venous needle (arterial
needle or both) from the blood circuit during dialysis therapy.
[0070] The electrical contacts can be composed of any suitable
conductive and biocompatible material, such as, any suitable
electrode material including stainless steel, other suitable
conductive materials or combinations thereof. It is essential that
the electrode material is biocompatible.
[0071] It should be appreciated that the electrical contacts can be
constructed in a variety of different shapes and sizes,
illustrative examples of which are described below. For example,
the electrical contacts can be configured or designed as a plaster
electrode which includes an agent capable of expanding when in
contact with moisture. The agent can include a variety of suitable
materials including gels that are known to expand more than ten
times in volume upon contact with moisture.
[0072] In an embodiment, the plaster electrode can be utilized to
detect fluid (i.e., blood leakage) at an insertion site of an
access device insertable within a patient during the administration
of medical therapy via a single access device as previously
discussed. Upon contact with the fluid, the plaster electrode would
necessarily expand to such an extent that the electrode contact is
broken, thus causing a detectable increase in impedance of the
fluid as it flows from the fluid system to the patient via the
needle.
[0073] In an embodiment, one or more electrodes (not shown), such
as one or more plaster electrodes as previously discussed, can be
used in combination with the electrical contact pair as shown, for
example, in FIGS. 1A and 1B. For example, a plaster electrode can
be attached to the patient near the insertion site of either or
both of the arterial and venous needles. In this regard, the
plaster electrode(s) can be utilized to detect leakage of fluid,
such as blood, from the insertion site of the access device(s).
[0074] In an embodiment, an electrode pair is coupled to the blood
circuit in an invasive manner (illustrated in FIGS. 2A-2C as
discussed below) such that the electrodes contact the blood as
previously discussed. An excitation source that includes a constant
current source or the like can be applied to the electrodes to
inject an electric signal into the blood circuit thereby defining a
conductor loop along which direct conductivity measurements can be
performed.
[0075] To ensure patient safety, the excitation source is typically
isolated from the instrument power. Preferably, the excitation
source produces a constant electrical current that passes through
the blood via the electrodes. Any suitable amount of current can be
generated for detection purposes. In an embodiment, the electrical
current as it passes through the blood is maintained at a level of
about 10 microamperes or less, preferably about 5 microamperes or
less. It should be appreciated that the present invention can be
operated at low levels of current (e.g., 10 microamperes or less)
such that the level of current has negligible, if any, effect on
the health and safety of the patient.
[0076] It should be appreciated that the impedance or other
suitable parameter can be measured and calculated in a variety of
different and suitable ways. For example, the amplitude, phase
and/or frequency of the constant current excitation source can be
measured and varied during the detection of a change in impedance.
Impedance levels can then be detected by measuring the voltage
across the electrodes In this regard, the amplitude, frequency
and/or phase of the voltage can then be measured and utilized in
combination with the measured amplitude, frequency and/or phase of
the excitation source to calculate blood impedance levels based on
derivations or equations which are typically used to calculate
impedance.
[0077] The electrical contacts can be connected to the blood
circuit in a variety of different and suitable ways. For example,
the electrical contacts can be an integral component of the
extracorporeal system, a disposable component that can be connected
and released from the tubing members of the blood circuit, a
reusable component that can be autoclaved between uses, or the
like.
Electrical Contact Coupling Device
[0078] In an embodiment, the apparatus of the present invention
includes an electrical contact coupling device that can be utilized
to secure the electrical contacts, preferably electrodes, to the
blood circuit such that the electrodes effectively contact the
blood and, thus, can be used to effectively monitor changes in
access conditions as previously discussed. The coupling device of
the present invention can also be designed to facilitate the
protection of the user against contact with potential electrical
sources. In an embodiment, the device can include a conductive
element connected to the tube through which a medical fluid, such
as blood, can flow wherein the conductive element has a first
portion exposed to the medical fluid and a second portion external
to the tube.
[0079] The coupling device of the present invention can include a
variety of different and suitable configurations, components,
material make-up or the like. In an embodiment, the present
invention can include a device for connecting an electrical contact
to a fluid conduit providing fluid and electrical communication
between the electrical contact and fluid flowing through the fluid
conduit. The device can include a first member including an annular
portion capable of accommodating the electrical contact and a first
stem portion connected to the annular member wherein the stem
portion has an opening extending therethrough to the annular
portion; a second member including a base portion with a groove
region and a second stem portion with an opening extending
therethrough to the groove region allowing the first member to be
inserted and secured to the second member; and a contact member
adapted to fit the first and second stem portions allowing the
contact member to abut against at least a portion of the electrical
contact member allowing an electrical connection to be made between
the electrical contact and the contact member. Illustrative
examples of the electrical contact coupling device of the present
invention are described below.
[0080] As illustrated in FIGS. 2A and 2B, the electrical contact
coupling device 80 includes a probe member 82 that has a
cylindrical shape with an opening 84 extending therethrough. In
this regard, an electrical contact, preferably an electrode 86
having a cylindrical shape can be inserted into the opening 84 such
that the electrode 86 is secure within the probe member 82. In an
embodiment, the probe member 82 has a channel 85 extending along at
least a portion of the opening 84 within which the electrode 86 can
be inserted into the probe member 82. A tube member, for example,
from a blood tubing set, connector tube member of a dialysis
machine or the like, can be inserted into both ends of the opening
84 of the probe member 82 in contact with an outer portion of the
channel 85 allowing blood or other suitable fluid to make fluid
contact with the electrode 86 in any suitable manner. The electrode
86 has an opening 88 that extends therethrough within which blood
(not shown) or other suitable fluid from the fluid circuit can
flow. In an embodiment, the diameter of the opening 88 of the
electrode 86 is sized to allow blood flow through the electrode 86
such that blood flow levels under typical operating conditions,
such as during dialysis therapy, can be suitably maintained. In
this regard, the coupling device of the present invention can be
readily and effectively attached to a fluid circuit, including a
blood circuit or the like, for use during medical therapy
including, for example, dialysis therapy. It should be appreciated
that the coupling device 80 of the present invention can be
attached to the fluid circuit in any suitable way such that
electrical and fluid connection can be made with the fluid flowing
through the fluid circuit.
[0081] The probe member 82 also includes a stem portion 90 that
extends from a surface 92 of its cylindrical-shaped body. The stem
portion 90 has an opening 93 that extends therethrough. In an
embodiment, the stem portion 90 is positioned such that at least a
portion of the electrode 86 is in contact with the opening 93 of
the stem portion 90.
[0082] In order to secure the electrode 86 to the blood circuit,
the coupling device 80 includes a socket member 94 that includes a
body portion 96 with an opening 98 for accepting the probe member
82 and for accepting a blood tube member (not shown) of the blood
circuit such that blood directly contacts the electrode as it
circulates through the blood circuit during dialysis therapy. In an
embodiment, the socket member 94 includes a stem portion 100
extending from the body member 96 wherein the stem portion 100
includes an opening 102 extending therethrough. As the probe member
82 is inserted through the opening 98 of the body member 96, the
stem portion 90 of the probe member 82 can be inserted into the
opening 102 of the stem portion 100 of the body 96 of the socket
member 94.
[0083] In an embodiment, the socket member 94 includes a groove
region 104 extending along at least a portion of the body 96 of the
socket member 94. In this regard, the probe member 82 can be
inserted through the opening 98 and then moved or positioned into
the groove region 104 to secure the probe member 82 within the body
96 of the socket member 94.
[0084] In an embodiment, the coupling device 80 includes an
electrical contact member 106 that is inserted within the opening
102 of the stem portion 100 of the body 96 of the socket member 94
such that the electrical contact member 106 extends through the
opening 93 of the stem portion 90 of the probe member 82 to contact
at least a portion of a surface 108 of the electrode 86.
[0085] The electrical contact member 106 is utilized to connect the
electronics (not shown) of, for example, the excitation source, a
signal processing device, other like electronic devices suitable
for use in monitoring and/or controlling changes in access
conditions, such as needle dislodgment. The electrical contact
member 106 can be made of any suitable material, such as any
suitable conductive material including, stainless steel, other like
conductive materials or combinations thereof. In order to secure
the electrical contact member 106 in place, a contact retainer
member 110 is inserted within the opening 102 of the stem portion
100 at an end region 112 thereof.
[0086] In an embodiment, the coupling device is mounted to a
dialysis machine, device or system in any suitable manner. For
example, the coupling device can be mounted as an integral
component of the dialysis machine. As well, the coupling device can
be mounted as a separate and/or stand alone component which can
interface with any of the components of the apparatus and system of
the present invention. In an embodiment, the coupling device 80 can
be insertably mounted via the stem portion 100 of the socket member
94 to a dialysis machine or other suitable components.
[0087] It should be appreciated that the electrical contact
coupling device can include a variety of different and suitable
shapes, sizes and material components. For example, another
embodiment of the coupling device is illustrated in FIG. 2C. The
coupling device 114 in FIG. 2C is similar in construction to the
coupling device as shown in FIGS. 2A and 2B. In this regard, the
coupling device 114 of FIG. 2C can include, for example, a
cylindrical-shaped electrode or other suitable electrical contact,
a probe member for accepting the electrode and securing it in place
within a socket member of the sensing device. The probe member
includes a stem portion that is insertable within a stem portion of
the socket member. An electrical contact member is insertable
within the stem portion such that it can contact the electrode. The
coupling device of FIG. 2C can also include a contact retainer
member to hold the electrical contact member in place similar to
the coupling device as shown in FIGS. 2A and 2B.
[0088] As shown in FIG. 2C, the probe member 116 of the electrical
contact coupling device 114 includes a handle 118 which can
facilitate securing the probe member 116 within the socket member
120. The handle 118, as shown, has a solid shape which can
facilitate the use and manufacture of the coupling device 114. In
addition, the stem portion (not shown) of the probe member 116 is
larger in diameter than the stem portion of the probe member as
illustrated in FIG. 2A. By increasing the stem size, the probe
member can be more easily and readily inserted within the socket
member. Further, the probe member is greater in length as compared
to the probe member as shown in FIGS. 2A and 2B such that the end
regions 122 of the probe member 116 extend beyond a groove region
124 of the socket member 120. This can facilitate securing the
probe member within the groove region 124 of the socket member
120.
[0089] In an embodiment, an opening 126 of the socket member 120
can include an additional opening portion 128 to accommodate the
insertion of the stem portion of the probe member 116, having an
increased size, therethrough. This can ensure proper alignment of
the probe member with respect to the socket member before insertion
of the probe member into the socket member thus facilitating the
insertion process.
[0090] It should be appreciated that the probe member, socket
member and contact retainer member can be composed of a variety of
different and suitable materials including, for example, plastics,
molded plastics, like materials or combinations thereof. The
various components of the coupling device, such as the probe
member, socket member and contact retainer member, can be fitted in
any suitable way. For example, the components can be fitted in
smooth engagement (as shown in FIGS. 2A and 2B), in threaded
engagement (as shown in FIGS. 2D and 2E) and/or any suitable
fitting engagement or arrangement to one another.
[0091] As shown in FIGS. 2D and 2E, the coupling device 130 of the
present invention can be made of threaded parts which are removably
connected to one another to form the coupling device. The threaded
parts can facilitate securing the electrode to the blood circuit as
well as general use of same as described below.
[0092] In an embodiment, the stem portion 132 of the body 134 of
the coupling device 130 has a threaded region 136 which can be
insertably attached to a dialysis machine or other suitable
mounting device in threaded engagement. This can facilitate the
ease in which the coupling device is attached and detached from the
mounting device.
[0093] As shown in FIG. 2E, the stem portion 132 is threaded on
both sides allowing it to be in threaded engagement with an annular
member 138. The annular member 138 provides direction and support
allowing the electrical contact member 140 to abut against the
electrode 142 housed in the probe member 144 as previously
discussed.
[0094] In an embodiment, a plate member 146 made of any suitable
conductive material can be depressed against a spring 148 as the
probe member 144 is secured to the body 134. At the same time,
another spring 150 can be displaced against the electrical contact
member 140 in contact with the retainer 152 which is inserted
within an annular region of the annular member 138 to secure the
electrical contact member 140 to the body 134.
[0095] The spring mechanism in an embodiment of the present
invention allows the parts of the coupling device 130 to remain in
secure engagement during use. It can also facilitate use during
detachment of the parts for cleaning, maintenance or other suitable
purpose.
[0096] In an embodiment, the coupling device can include a device
with an electrical contact attached allowing the electrical contact
to pierce or puncture the a fluid conduit when the device is
movably attached to the fluid conduit. In this regard, the device
can act through a clamping mechanism to allow electrical and fluid
communication between the electrical contact and fluid flowing
through the fluid conduit. The device can be coupled to a
controller or the like allowing detection of access disconnection
using direct conductive measurement during medical therapy, such as
dialysis therapy, as previously discussed. The device can be made
in a variety of suitable ways.
[0097] In an embodiment, the device 153 includes a first member 154
and a second member 155 movably attached to the first member 154 at
an end 156 as shown in FIG. 2F. The first and second members can be
attached in any suitable way, such as by a hinge 157 or other
suitable mechanism that can allow movement of the first and second
members such that the device 153 can be attached to a fluid
conduit. The movable members of the device 153 can be composed of
any suitable material, preferably a conductive material, such as
stainless steel, that is compatible with the electrical contact
such that an effective electrical connection can be made.
[0098] The electrical contact 158 can be composed of any suitable
material, such as stainless steel, as previously discussed. The
electrical contact material defines a shape and is attached to a
portion of the first or second members in any suitable way. This
allows the electrical contact 158 to puncture or pierce a fluid
conduit when the device 158 is attached thereto such that the
electrical contact 158 can make electrical and fluid contact with
fluid flowing through the conduit.
[0099] In an embodiment, the device 158 is self-sealing upon
attachment to the fluid conduit. This can be done in any suitable
way, such as by applying any suitable adhesive, gel or other
sealing material to the device 158, if necessary, prior to
attachment to the fluid conduit. In this regard, the device 153
provides a simple design that can be effectively and readily used
to provide both fluid and electrical contact between an electrical
contact and fluid flowing through a fluid conduit, such as a blood
circuit.
[0100] As previously discussed, the present invention can be
effectively utilized to detect dislodgment of an access device,
such as a needle, inserted within a patient through which fluid can
pass between the patient and a fluid delivery and/or treatment
system. The present invention can be applied in a number of
different applications, such as medical therapies or treatments,
particularly dialysis therapies. In dialysis therapies, access
devices, such as needles, are inserted into a patient's arteries
and veins to connect blood flow to and from the dialysis
machine.
[0101] Under these circumstances, if the needle becomes dislodged
or separated from the blood circuit, particularly the venous
needle, the amount of blood loss from the patient can be
significant and immediate. In this regard, the present invention
can be utilized to controllably and effectively minimize blood loss
from a patient due to dislodgment of the access device, such as
during dialysis therapy including hemodialysis, hemofiltration,
hemodiafiltration and continuous renal replacement.
Signal Detection and Processing
[0102] As previously discussed, the electrical contacts in
connection with the controller can be used to detect a change in
impedance or the like in response to needle drop-out or other like
changes in access conditions. In an embodiment, the present
invention can be adapted to correct for any variations in the
baseline impedance over time. This can increase the level of
sensitivity with respect to the detection capabilities of the
present invention. In this regard, if changes in the baseline
impedance are too great and not adequately corrected for, changes
in impedance due to needle dislodgment may not be as readily, if at
all, detectable above baseline values.
[0103] From a practical standpoint, there are a number of different
process conditions that may influence a change in the baseline
impedance over time. For example, a gradual drift or change in the
baseline can occur due to a change in the characteristics, such as
the hematocrit, plasma protein, blood/water conductivity and/or the
like, of the blood or other suitable fluid during treatment. This
can arise due to changes in the level of electrolytes or other
components during dialysis therapy.
[0104] As illustrated in FIG. 3, the present invention can process
a measurable voltage signal to correct for changes in baseline
impedance over time. This can enhance the detection capabilities of
the present invention as previously discussed. In an embodiment, a
current source 160 or the like generates an electric current to
pass through the blood as it circulates into, through and out of
the patient along the extracorporeal blood circuit 162 which
connects the patient via venous and arterial needles to the
dialysis system including a variety of process components. The
electric current is injected into the blood circuit via a first
electrical contact 163a thereby defining a conductor loop or
pathway along the blood circuits. Preferably, the current is
maintained at a constant level until dislodgment occurs. The second
electrode 163b is used to sense voltage or the like along the
conductor loop and then pass a signal indicative of same and/or
changes thereof to an electronic device for detection and
processing as previously discussed. The voltage signal can be
measured and processed in any suitable manner.
[0105] In an embodiment, the signal is passed through a series of
components including a filter or filters 164 which can act to
filter noise from the signal, particularly noise derived from the
rotation from the pump in order to minimize a false negative and/or
positive detection of needle dislodgment, a rectifier 166, a peak
detector 168 and an analog to digital converter ("ADC") 170 to
digitize the signal. In this regard, the digital signal can then be
stored in a computer device (not shown) for further processing. The
voltage signal is continually measured and processed over time.
With each measurement, the digitized signals are compared to
evaluate changes due to baseline changes associated with variations
in process conditions over time, such as a change in the
characteristics of blood as previously discussed. If a baseline
change is determined, the digitized signal can be further processed
to correct for the change in baseline.
[0106] The voltage data is continually sent to a control unit 172
coupled to the ADC. The control unit continually performs a
calculation to determine whether a change in impedance or the like
in response to needle dislodgment has occurred. In an embodiment,
dislodgment of an access device is detected when
[V(t)-V(t-T)]>C1, where t is time, where T is the period of
blood pump revolution, where C1 is a constant and where
V(t)=I.sub.o*Z, where I.sub.o is current and where Z is the
impedance of the bloodline which is a function of the impedance
associated with patient's vascular access and the impedance
associated with various components of the dialysis system, such as
the dialyzer, as previously discussed.
[0107] If disconnection of the patient from the blood circuit is
detected, the control unit 172 can be utilized to process the
signal in order to minimize blood loss from the patient. In an
embodiment, the controller is in communication with a dialysis
system as applied to administer dialysis therapy including, for
example, hemodialysis, hemofiltration, hemodiafiltration and
continuous renal replacement. This communication can be either
hard-wired (i.e., electrical communication cable), a wireless
communication (i.e., wireless RF interface), a pneumatic interface
or the like. In this regard, the controller can process the signal
to communicate with the dialysis system or device to shut off or
stop the blood pump 174 associated with the hemodialysis machine
and thus effectively minimize the amount of blood loss from the
patient due to needle dislodgment during hemodialysis.
[0108] The controller can communicate with the dialysis system in a
variety of other ways. For example, the controller and hemodialysis
machine can communicate to activate a venous line clamp 176 for
preventing further blood flow via the venous needle thus minimizing
blood loss to the patient. In an embodiment, the venous line clamp
is activated by the controller and attached to or positioned
relative to the venous needle such that it can clamp off the venous
line in close proximity to the needle. Once clamped, the dialysis
system is capable of sensing an increase in pressure and can be
programmed to shut-off the blood pump upon sensing pressure within
the blood flow line which is above a predetermined level.
Alternatively, the venous line clamp can be controllably attached
to the dialysis system.
[0109] In an embodiment, an alarm can be activated upon detection
of blood loss due to, for example, needle dislodgment during
dialysis therapy. Once activated, the alarm (i.e., audio and/or
visual or the like) is capable of alerting the patient, a medical
care provider (i.e., doctor, registered nurse or the like) and/or a
non-medical care provider (i.e., family member, friend or the like)
of the blood loss due to, for example, needle dislodgment. The
alarm function is particularly desirable during dialysis therapy in
a non-medical facility, such as in a home setting or self care
setting where dialysis therapy is typically administered by the
patient and/or a non-medical care provider in a non-medical setting
or environment excluding a hospital or other like medical
facility.
[0110] In this regard, the alarm activation allows, for example,
the patient to responsively act to ensure that the dialysis therapy
is terminated by, for example, to check that the blood pump has
been automatically shut off to minimize blood loss to the patient.
Thus, the patient has the ability to act without the assistance of
a third party (i.e., to act on his or her own) to ensure that
responsive measures are taken to minimize blood loss. The alarm can
thus function to ensure the patient's safety during the
administration of dialysis therapy, particularly as applied to home
hemo treatments where at least a portion of the dialysis therapy
can be administered while the patient is sleeping.
Dialysis Machine
[0111] As previously discussed, the present invention can be
adapted for use with any suitable fluid delivery system, treatment
system or the like. In an embodiment, the present invention is
adapted for use with a dialysis machine to detect access
disconnection as blood flows between the patient and the dialysis
machine along a blood circuit during treatment, including, for
example hemodialysis, hemofiltration and hemodiafiltration.
[0112] The present invention can include any suitable dialysis
machine for such purposes. An example, of a hemodialysis machine of
the present invention is disclosed in U.S. Pat. No. 6,143,181
herein incorporated by reference. In an embodiment, the dialysis
machine 190 comprises a mobile chassis 192 and it has at the front
side 194 thereof with a common mechanism 196 for connecting tubing
or the like by which a patient can be connected to the dialysis
machine as shown in FIG. 4A. A flat touch screen 197 which can show
several operational parameters and is provided with symbols and
fields for adjustment of the dialysis machine by relevant symbols
and fields, respectively, on the screen being touched can be
adjusted vertically and can be universally pivoted on the dialysis
machine and can be fixed in the desired adjusted position.
[0113] In an embodiment, the dialysis machine includes a chassis
having one or more connectors for connecting a patient to the
dialysis machine via a blood circuit allowing blood to flow between
the patient and the dialysis machine during dialysis therapy
wherein one or more electrical contacts are connected to the blood
circuit in fluid communication with the blood allowing detection of
a change in an electrical value in response to access disconnection
as the blood flows through the blood circuit having an electrical
signal passing therein.
[0114] In an embodiment, the dialysis machine of the present
invention can be designed to accommodate one or more of the
electrical contact coupling devices, such as a pair of coupling
device, used to detect access disconnection as shown in FIG. 4B.
For example, one or more coupling devices 198 can be attached to
the front panel 194 of the dialysis machine 190. This can be done
in any suitable way. In an embodiment, the a stem portion of the
coupling device is insertably mounted via a threaded fit,
frictional fit or the like, as previously discussed. This connects
the patient to the dialysis machine 190 via a blood tubing set 202.
The blood tubing set includes a first blood line 204 and a second
blood line 206. In an embodiment, the first blood line 204 is
connected to the patient via an arterial needle 208 or the like
through which blood can flow from the patient 200 to the dialysis
machine 190. The second blood line 206 is then connected to the
patient 200 via a venous needle 210 or the like through which fluid
flows from the dialysis machine to the patient thereby defining a
blood circuit. Alternatively, the first blood line and the second
blood line can be coupled to the venous needle and the arterial
needle, respectively. The blood lines are made from any suitable
medical grade material. In this regard, access disconnection, such
as dislodgment of an arterial needle and/or a venous needle can be
detected as previously discussed. Alternatively, the coupling
device can be attached to the blood tubing set which is then
attached to the dialysis machine in any suitable way.
Dialysis Treatment Centers
[0115] As previously discussed, the present invention can be used
during dialysis therapy conducted at home and in dialysis treatment
centers. The dialysis treatment centers can provide dialysis
therapy to a number of patients. In this regard, the treatment
centers include a number of dialysis machines to accommodate
patient demands. The therapy sessions at dialysis treatment centers
can be performed 24 hours a day, seven days a week depending on the
locale and the patient demand for use.
[0116] In an embodiment, the dialysis treatment centers are
provided with the capability to detect access disconnection during
dialysis therapy pursuant to an embodiment of the present
invention. For example, one or more of the dialysis machines can be
adapted for use with an electrical contact coupling device along
with the necessary other components to detect access disconnection
as previously discussed.
[0117] In an embodiment, the electrical contact coupling device can
be directly attached to one or more of the dialysis machines of the
dialysis treatment center. It should be appreciated that the
apparatuses, devices, methods and/or systems pursuant to an
embodiment of the present invention can be applied for use during
dialysis therapy administered to one or more patients in the
dialysis treatment center in any suitable way. In an embodiment,
the treatment center can have one or more patient stations at which
dialysis therapy can be performed on one or more patients each
coupled to a respective dialysis machine. Any suitable in-center
therapy can be performed including, for example, hemodialysis,
hemofiltration and hemodiafiltration and combinations thereof. As
used herein, the term "patient station" or other like terms mean
any suitably defined area of the dialysis treatment center
dedicated for use during dialysis therapy. The patient station can
include any number and type of suitable equipment necessary to
administer dialysis therapy.
[0118] In an embodiment, the dialysis treatment center includes a
number of patient stations each at which dialysis therapy can be
administered to one or more patients; and one or more dialysis
machines located at a respective patient station. One or more of
the dialysis machines can include a chassis having one or more
connectors for connecting a patient to the dialysis machine via a
blood circuit allowing blood to flow between the patient and the
dialysis machine during dialysis therapy wherein a pair of
electrical contacts are connected to the blood circuit in fluid
communication with the blood allowing detection of a change in an
electrical value in response to access disconnection as the blood
flows through the blood circuit having an electrical signal passing
therein.
[0119] As previously discussed, the access disconnection detection
capabilities of the present invention can be utilized to monitor
and control a safe and effective dialysis therapy. Upon dislodgment
of an access device, such as a needle, from the patient, the direct
conductive measurement capabilities of the present invention can be
used to provide a signal indicative of dislodgment that can be
further processed for control and/or monitoring purposes. In an
embodiment, the signal can be further processed to automatically
terminate dialysis therapy to minimize blood loss due to
dislodgment as previously discussed. Further, the signal can be
processed to activate an alarm which can alert the patient and/or
medical personnel to the dislodgment condition to ensure that
responsive measures are taken. It should be appreciated that the
present invention can be modified in a variety of suitable ways to
facilitate the safe and effective administration of medical
therapy, including dialysis therapy.
[0120] Applicants have found that the direct conductive measurement
capabilities of the apparatus of the present invention can
immediately detect blood loss or the like due to access
disconnection, such as needle dislodgment, with high sensitivity
and selectivity such that responsive measures can be taken to
minimize blood loss due to same. The ability to act responsively
and quickly to minimize blood loss upon detection thereof is
particularly important with respect to needle dislodgment during
hemodialysis. If not detected and responded to immediately, the
amount of blood loss can be significant. In an embodiment, the
present invention is capable of taking active or responsive
measures, to minimize blood loss (i.e., shut-off blood pump,
activate venous line clamp or the like) within about three seconds
or less, preferably within about two to about three second upon
immediate detection of needle dislodgment.
[0121] In addition, the controller can be utilized to monitor
and/or control one or more treatment parameters during
hemodialysis. These parameters can include, for example, the
detection of blood due to blood loss upon needle dislodgment, the
change in blood flow, the detection of air bubbles in the arterial
line, detection of movement of the sensor during treatment,
detection and/or monitoring of electrical continuity of the sensor
or other like treatment parameters. In an embodiment, the
controller includes a display (not shown) for monitoring one or
more of the parameters.
[0122] As used herein "medical care provider" or other like terms
including, for example, "medical care personnel", means an
individual or individuals who are medically licensed, trained,
experienced and/or otherwise qualified to practice and/or
administer medical procedures including, for example, dialysis
therapy, to a patient. Examples of a medical care provider include
a doctor, a physician, a registered nurse or other like medical
care personnel.
[0123] As used herein "non-medical care provider" or other like
terms including, for example, "non-medical care personnel" means an
individual or individuals who are not generally recognized as
typical medical care providers, such as doctors, physicians,
registered nurses or the like. Examples of non-medical care
providers include patients, family members, friends or other like
individuals.
[0124] As used herein "medical facility" or other like terms
including, for example, "medical setting" means a facility or
center where medical procedures or therapies, including dialysis
therapies, are typically performed under the care of medical care
personnel. Examples of medical facilities include hospitals,
medical treatment facilities, such as dialysis treatment
facilities, dialysis treatment centers, hemodialysis centers or the
like.
[0125] As used herein "non-medical facility" or other like terms
including, for example, "non-medical setting" means a facility,
center, setting and/or environment that is not recognized as a
typical medical facility, such as a hospital or the like. Examples
of non-medical settings include a home, a residence or the
like.
[0126] It should be appreciated that the electrode output signal
can be combined with other less sensitive blood loss detection
methods, such as venous pressure measurements, systemic blood
pressure, the like or combinations thereof, to improve specificity
to needle dislodgment.
[0127] It should be understood that various changes and
modifications to the presently preferred embodiments described
herein will be apparent to those skilled in the art. Such changes
and modifications can be made without departing from the spirit and
scope of the present invention and without diminishing its intended
advantages. It is therefore intended that such changes and
modifications be covered by the appended claims.
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