U.S. patent application number 14/557948 was filed with the patent office on 2015-10-08 for medical device placement system and a method for its use.
The applicant listed for this patent is Skender Daerti, Eric M. Harris, Michael Joyce, Rose Rowan, Timothy Schweikert. Invention is credited to Skender Daerti, Eric M. Harris, Michael Joyce, Rose Rowan, Timothy Schweikert.
Application Number | 20150282734 14/557948 |
Document ID | / |
Family ID | 54208653 |
Filed Date | 2015-10-08 |
United States Patent
Application |
20150282734 |
Kind Code |
A1 |
Schweikert; Timothy ; et
al. |
October 8, 2015 |
MEDICAL DEVICE PLACEMENT SYSTEM AND A METHOD FOR ITS USE
Abstract
A system and method for locating a medical device within a body
uses wireless technology to transmit the information obtained from
the sensors to a mobile device or other computing system. A
software application on the mobile device or computing system can
be used to display the information, wherein the user can control
the display without needing to contact any items that are not
sterile.
Inventors: |
Schweikert; Timothy; (West
Chester, PA) ; Daerti; Skender; (Philadelphia,
PA) ; Rowan; Rose; (Mantua, NJ) ; Harris; Eric
M.; (Carol Stream, IL) ; Joyce; Michael;
(Philadelphia, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Schweikert; Timothy
Daerti; Skender
Rowan; Rose
Harris; Eric M.
Joyce; Michael |
West Chester
Philadelphia
Mantua
Carol Stream
Philadelphia |
PA
PA
NJ
IL
PA |
US
US
US
US
US |
|
|
Family ID: |
54208653 |
Appl. No.: |
14/557948 |
Filed: |
December 2, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61976891 |
Apr 8, 2014 |
|
|
|
Current U.S.
Class: |
600/424 |
Current CPC
Class: |
A61B 5/0006 20130101;
A61B 5/002 20130101; A61B 5/742 20130101; A61B 5/04085 20130101;
A61B 5/0402 20130101; A61B 2562/247 20130101; A61B 5/042 20130101;
A61B 5/04286 20130101; A61B 5/062 20130101 |
International
Class: |
A61B 5/06 20060101
A61B005/06; A61B 5/00 20060101 A61B005/00; A61B 5/0402 20060101
A61B005/0402 |
Claims
1. A medical device placement system, comprising: a paddle
comprising at least one tracking coil and a device wireless
transceiver; at least one electrocardiogram electrode; and a
peripherally inserted central catheter comprising a catheter tip
and a stylet, wherein the paddle is configured to communicate
wirelessly by passing electrocardiograph data and catheter tip
location data between the device wireless transceiver and a remote
mobile device.
2. The medical device placement system as recited in claim 1,
further comprising: the remote mobile device comprising a mobile
wireless transceiver.
3. The medical device placement system as recited in claim 1, the
paddle further comprising at least one electrocardiogram electrode
housing, wherein the at least one electrocardiogram electrode
housing is configured to house the at least one electrocardiogram
electrode.
4. The medical device placement system as recited in claim 3, the
at least one electrocardiogram electrode housing further comprising
at least one shield piece; wherein the at least one shield piece is
configured to protect the at least one electrocardiogram electrode
when housed within the at least one electrocardiogram electrode
housing.
5. The medical device placement system as recited in claim 3,
wherein the at least one electrocardiogram electrode housing
further comprising at least one sterile cover; wherein the at least
one sterile cover is configured to cover the at least one
electrocardiogram electrode when not housed in the at least one
electrocardiogram electrode housing.
6. The medical device placement system as recited in claim 3,
wherein the at least one electrocardiogram electrode and the at
least one electrocardiogram electrode housing are configured to be
modular and replaceable.
7. The medical device placement system as recited in claim 1,
wherein the paddle and the at least one electrocardiogram electrode
are connected by at least one electrocardiogram wire.
8. The medical device placement system as recited in claim 7, the
paddle further comprising at least one electrocardiogram input
port, wherein the at least one electrocardiogram electrode is
connected to the at least one electrocardiogram input port by the
at least one electrocardiogram wire.
9. The medical device placement system as recited in claim 1,
wherein the paddle and the at least one electrocardiogram electrode
are configured to communicate wirelessly.
10. The medical device placement system as recited in claim 1,
wherein the paddle and the peripherally inserted central catheter
are connected by at least one peripherally inserted central
catheter wire.
11. The medical device placement system as recited in claim 1,
wherein the paddle and the peripherally inserted central catheter
are configured to communicate wirelessly.
12. The medical device placement system as recited in claim 1,
wherein the remote mobile device is configured to capture and
display a snapshot of electrocardiograph data generated from the at
least one electrocardiogram electrode.
13. The medical device placement system as recited in claim 1,
wherein the remote mobile device is configured to capture and
display a snapshot of electrocardiograph data generated from the
stylet.
14. The medical device placement system as recited in claim 1,
wherein the remote mobile device is configured to capture and
display a snapshot of catheter tip location data generated from the
at least one tracking coil.
15. The medical device placement system as recited in claim 1,
wherein the mobile device is configured to be controlled through a
touch screen.
16. A method of using a medical device placement system,
comprising: providing a medical device placement system, comprising
a paddle comprising at least one tracking coil and a device
wireless transceiver; at least one electrocardiogram electrode; a
peripherally inserted central catheter comprising a catheter tip
and a stylet; and a mobile device comprising a mobile wireless
transceiver, wherein the paddle and the mobile device are
configured to communicate wirelessly by passing data between the
device wireless transceiver and the mobile wireless transceiver;
identifying an insertion site on a patient; placing the paddle on
the chest over a heart on the patient; adhering at least one
electrocardiogram electrode to the patient; inserting a
peripherally inserted central catheter into the patient through the
insertion site; pushing the peripherally inserted central catheter
towards the heart via a superior vena cava of the patient;
automatically and wirelessly transmitting catheter tip location
data from the medical device placement system to the mobile device;
automatically and wirelessly transmitting ECG data from the medical
device placement system to the mobile device; displaying the
location data and the ECG data on the mobile device; and utilizing
the catheter tip location data displayed on the mobile device to
position the catheter.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefit to provisional patent
application No. 61/976,891 filed Apr. 8, 2014, which is
incorporated by reference herein in its entirety.
FIELD OF THE INVENTION
[0002] The present inventive concept relates to a system and method
to properly locate a medical device, such as a catheter, within a
patient's body while maintaining a sterile environment. The present
system and method uses wireless technology to transmit data
relating to the location of the catheter's tip as well as to an
electrocardiogram to a computing device such that information can
be displayed and controlled on the computing device without contact
with any device outside of the sterile environment.
BACKGROUND
[0003] Many types of medical devices are inserted into the body.
Often, the precise location of these devices within the body must
be determined in order for them to function properly. Specifically,
infusion catheters must be placed in a precise location near the
heart for the delivered medications to work properly. Precise
location is required in order for medication to be delivered to an
area with a high rate of blood flow. This enables proper dilution
and mixing of the infused medication prior to its distribution
throughout the rest of the body. In addition to catheters, other
medical devices must be placed in proper locations in order to
accomplish their intended functions. For example, enteral feeding
tubes must be located within the stomach for the patient to obtain
required nutrition from the tube. Improper positioning of many of
these internal medical devices can result in catastrophic
consequences. Therefore, the precise location of medical devices
needs to quickly and easily be determined so that the proper
medical treatment can continue in a timely fashion.
[0004] A variety of different systems are currently used to
determine the location of a device within the body. There are
several methods and technologies that are used to locate a catheter
within the Superior Vena Cava (SVC) near the heart. Some of these
methods include the use of magnets, ultrasound, x-rays or
fluoroscopy. However, each of these methods have drawbacks that
make their use less than ideal. For instance, using x-rays exposes
the patient to radiation, while readings provided by magnets are
easily interfered with by external sources, such as nearby
electrical devices.
[0005] One of the most commonly practiced methods for determining
the precise location of a medical device, specifically a catheter
tip within the SVC, is through the use of Electrocardiography (ECG)
technology along with a location-based technology. The ECG output
is a graph showing electrical currents within the heart. The graph
comprises significant peaks that occur during specific events
within the heart. Of these significant peaks, the P-wave is used to
determine the location of a medical device near the heart. The
P-wave is measured at the time when the main electrical vector of a
heart contraction is directed from the sinoatrial node towards the
atrioventricular node, spreading from the right atrium to the left
atrium. The P-wave represents atrial depolarization, which causes
atrial contraction.
[0006] The first operation to be performed by this system is to
determine the general location of the catheter tip near the heart
using triangulation, location determination technology. This
technology includes a paddle comprising three coils, along with an
additional sensor coil located on the tip of the catheter and
attached to a guide wire within the catheter. The software can
energize two or more of the coils within the paddle, creating
different magnetic fields that are picked up by the sensor coil at
the end of the catheter. Through triangulation analysis made by
software algorithms based on the energized coils, the location of
the catheter tip can be determined. The location is then displayed
onto a screen to show the user where the tip is in relation to the
heart. Once the tip is in close proximity to the heart, the
technology can be switched to the ECG determination such that the
precise location can be determined.
[0007] The ECG of the patient is generated through the use of
electrodes that are placed on the patient's chest across the heart,
such that the electrical currents within the heart can be
determined and displayed graphically. The ECG graph comprises
several peaks that can provide the medical practitioner with
important information. For location purposes, the user focuses on
the P-wave. As the tip of the catheter approaches the lower third
of the SVC, the peak of the P-wave increases in height because the
tip is getting closer to the Sinoatrial (SA) node and receiving a
stronger signal. The catheter tip is in the correct location in the
lower third of the SVC when the P-wave height is at a maximum.
Therefore, the process requires that the tip is inserted past the
peak, or optimal position. When this occurs, the P-wave is
reflected and a negative peak is seen on the graph because the tip
has passed the SA node. At this time, the user knows that the tip
has passed the optimal point and can pull the tip back until the
reflected wave disappears, which correspondingly indicates that the
P-wave is at maximum and the tip of the catheter is located in the
lower third of the SVC.
[0008] An issue with the current method of determining device
location inside the body is the need to control the technology. The
electrodes used during the ECG method and the paddle used for the
triangulation method must be connected to a computer. Moreover, the
stylet, a portion of the catheter that is controlled and located
with this system, must also be connected to the computer. A remote
control is located on the cable connecting the stylet to the
computer, which allows the user to control the information
displayed on the screen as well as which technology is being used
at the time. The use of the remote by the person inserting the
catheter is a great concern, as the inserter's hands must remain
sterile. The remote is not sterile, so the current method of
maintaining a sterile environment involves applying an autoclaved
plastic wrap over the remote so that the user's hands only contact
the sterile environment.
[0009] What is needed is a system and method of determining the
location of a medical device within a person's body that eliminates
the need for the user to contact any element that is not in the
sterile environment. Such as system should be easy to prepare and
comprise an interface that is well-known and easy to use.
SUMMARY OF THE INVENTION
[0010] An aspect of the present device is to provide a system and a
method of determining the location of a medical device within a
person's body, which eliminates, or reduces the need for the user
to contact any element that is not in the sterile environment. The
system is easy to prepare and comprises an interface that is
well-known and easy to use.
[0011] These together with other aspects and advantages which will
be subsequently apparent, reside in the details of construction and
operation as more fully hereinafter described and claimed,
reference being had to the accompanying drawings forming a part
hereof, wherein like numerals refer to like parts throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Further features and advantages of the present device, as
well as the structure and operation of various embodiments of the
present device, will become apparent and more readily appreciated
from the included drawings.
[0013] FIG. 1 is a view of the prior art medical device placement
system and its location on the body when being used to determine
the location of a catheter tip near the heart.
[0014] FIG. 2 is a view of a medical device placement system and
its location on the body when being used to determine the location
of a catheter near the heart, according to an embodiment.
[0015] FIG. 3 is a view of a paddle and its components in a
retracted state, according to an embodiment.
[0016] FIG. 4 is a view of a paddle and its components in an
extended state, according to an embodiment.
[0017] FIG. 5 is a reverse view of a paddle, according to an
embodiment.
[0018] FIG. 6 is a view of a paddle and its components, according
to an alternate embodiment.
[0019] FIG. 7 is a view of a paddle and its components, according
to an alternate embodiment.
[0020] FIG. 8A is a side view of an extendable ECG electrode
housing, according to an embodiment.
[0021] FIG. 8B is a top view of an extendable ECG electrode
housing, according to an embodiment.
[0022] FIG. 9 is a diagram showing the interaction of a medical
device placement system with a wireless computing device, according
to an alternate embodiment.
[0023] FIG. 10 is a schematic diagram showing the communication
between elements comprising a device placement system, according to
an embodiment.
[0024] FIG. 11 is a flowchart describing the process by which the
PICC can be properly positioned, according to an embodiment.
[0025] FIG. 12 is a schematic diagram illustrating the inputs and
functional components of a software application designed to
interface with a medical device placement system, according to an
embodiment.
[0026] FIG. 13 is an exemplary mobile device screen illustrating a
default home display, according to an embodiment.
[0027] FIG. 14 is an exemplary mobile device screen illustrating a
patient information entry display, according to an embodiment.
[0028] FIG. 15 is an exemplary mobile device screen illustrating a
surface ECG display, according to an embodiment.
[0029] FIG. 16 is an exemplary mobile device screen illustrating a
surface ECG display snapshot, according to an embodiment.
[0030] FIG. 17 is an exemplary mobile device screen illustrating a
surface snapshot save screen, according to an embodiment.
[0031] FIG. 18 is an exemplary mobile device screen illustrating an
internal ECG display, according to an embodiment.
[0032] FIG. 19 is an exemplary mobile device screen illustrating an
ECG zoom feature, according to an embodiment.
[0033] FIG. 20 is an exemplary mobile device screen illustrating an
internal snapshot save screen, according to an embodiment.
[0034] FIG. 21 is an exemplary mobile device screen illustrating a
normal application functioning, according to an embodiment.
[0035] FIG. 22 is an exemplary mobile device screen illustrating a
procedural checklist, according to an embodiment.
[0036] FIG. 23 is an exemplary mobile device screen illustrating a
patient procedure information display, according to an
embodiment.
[0037] FIG. 24 is an exemplary mobile device screen illustrating a
print function, according to an embodiment.
[0038] FIG. 25 is a schematic diagramming illustrating the elements
of a remote mobile device and a patient data network, according to
an embodiment.
DETAILED DESCRIPTION
[0039] This description of the exemplary embodiments is intended to
be read in connection with the accompanying drawings, which are to
be considered part of the entire written description. In the
description, relative terms such as "lower," "upper," "horizontal,"
"vertical,", "above," "below," "up," "down," "top" and "bottom" as
well as derivative thereof (e.g., "horizontally," "downwardly,"
"upwardly," etc.) should be construed to refer to the orientation
as then described or as shown in the drawing under discussion.
These relative terms are for convenience of description and do not
require that the apparatus be constructed or operated in a
particular orientation. Terms concerning attachments, coupling and
the like, such as "connected" and "interconnected," refer to a
relationship wherein structures are secured or attached to one
another either directly or indirectly through intervening
structures, as well as both movable or rigid attachments or
relationships, unless expressly described otherwise.
[0040] Reference will now be made in detail to the presently
preferred embodiments of the present system and method for properly
locating a medical device within a body, examples of which are
illustrated in the accompanying drawings.
[0041] FIG. 1 is a view of the prior art medical device placement
system and its location on the body when being used to determine
the location of a catheter tip 102 near the heart. The current
technology used to locate a catheter tip 102 within a patient 105
requires the use of several pieces of equipment, all of which
provide a direct connection through cords 107, 109 between the
patient and a computer. Specifically, a stylet 101 controls the
insertion of a peripherally inserted central catheter (PICC) 100. A
catheter tip 102 can comprise a sensor coil (not pictured) for
sensing the magnetic field created by the two or more coils (not
pictured) housed within a paddle 104. The electrocardiogram (ECG)
electrodes 103 and the paddle 104 can each contact the surface of a
patient 105 and can also be plugged into a computer 106 through a
corded connection 107. Most importantly, a remote control 108 is on
the cord 109 that runs from the stylet 101 to a computer 106. This
remote control 108 is not sterile and requires special treatment
prior to each user, who must keep his or her hands sterile while
touching the remote 108 in order to control the display on a
computer screen 110. Control of the display 110 is necessary to
document the screen images, as well as switch from the
location-based technology to the ECG system when necessary. The
current practice requires the user to place a bag 150 that has been
sterilized by autoclave over the entire remote 108 and plug the
stylet 101 cord 109 into the remote 108 through this bag 150. This
process must be carefully followed to prevent contamination of the
user's hands.
[0042] The present medical device placement system provides a
wireless connection via Bluetooth technology between the sensor
devices and the computer. The use of wireless technology removes
the cords that are required to connect the patient and the
computer. Therefore, with the present invention the patient can be
completely isolated from the computer displaying information from
the location determination system. Moreover, the computer system
that can only serve this single display function can be replaced
with the use of a common mobile computing device, such as a tablet
computer or smart phone. The software used to display and control
the system can be integrated into a software application, which can
allow the user to control the system without contacting a surface,
maintaining the sterile environment without additional
time-consuming processes.
[0043] FIG. 2 is a view of a medical device placement system and
its location on the body when it is being used to determine the
location of a catheter near the heart, according to an embodiment.
When positioning a catheter near the heart, the PICC 100 is
initially inserted into a peripheral location, such as an arm or a
leg, through the use of an insertion site 221 that comprises an
incision. The PICC 100 can then be guided through veins within the
body to the heart using the stylet 101. The location of the PICC
100, particularly its tip 102, must be precisely determined so that
the medical procedure being performed is beneficial, not harmful,
to the patient.
[0044] When inserting a PICC 100 into the SVC for use in
hemodialysis procedures, the patient can be prepped for the
procedure to ensure the insertion site 221 is sterile. ECG
electrodes 103 can be located on the patient's chest 105 in
locations that are known to provide a good ECG signal. The paddle
104 can then be placed onto or above the center of the patient's
chest 105 as well. The electrodes 103 can be connected the paddle
104. Specifically, the electrodes 103 can be housed within the
paddle 104 when not in use. The electrodes 103 can be extended from
the paddle 104 using spring-loaded coils 227 that are housed within
the paddle 104. After use, the coils 227 can be retracted back into
the paddle 104.
[0045] Data as used herein can comprise at least two types of data,
electrocardiograph (ECG) data and catheter tip location data. Data
includes both the original analog signals which are detected from
the respective components (e.g., electrodes, sensor coils, stylet.)
and also the digital representations of the analog signals.
[0046] A bridge wire 229 can also connect the stylet 101 to the
paddle 104 at a connection juncture 230 in order for the stylet to
transmit the ECG detected from the heart to the paddle. As an
alternative embodiment, the stylet 101 can also communicate the ECG
data obtained from the catheter tip 102 via Bluetooth or other
wireless transmitter to the paddle 104, in which case, the bridge
wire 229 between the stylet 101 and the paddle 104 would not be
necessary. The paddle 104 can house a processor (not pictured) that
is used to convert and interpret the catheter tip location data
supplied from the paddle 104, and the ECG data, in the form of
electrical signals, generated from the electrodes 103 and stylet
101. The location data and ECG data can then be encrypted and sent
via Bluetooth or other wireless transmission means to the mobile
device 228. Alternatively, the location data and ECG data entering
the paddle 104 can be sent to the mobile device 228 using Bluetooth
or another wireless communication means. In an alternate
embodiment, if each element comprising the system houses a
Bluetooth or other wireless transmitter the data generated from
each element can be sent directly from the electrodes 103, stylet
101 and paddle 104 without the need for the location data and ECG
data to be sent to the paddle 104 first.
[0047] FIG. 3 is a view of a paddle 104 and its components in a
retracted state, according to an embodiment. In this view, the ECG
electrodes 103 can be contained within the paddle 104. The paddle
can have at least three ECG electrodes 103 and extendable ECG
electrode housings 950. The ECG cords 227 can be coiled under the
ECG electrodes 103 when contracted. The paddle 104 can also contain
a wireless transmitter 300, which can be a Bluetooth transmitter.
The paddle 104 can also contain a battery 301, which can be a
rechargeable lithium ion battery, or other suitable energy storage
mechanism. Additionally, the paddle can contain a jack 302
configured to receive the PICC lead cable 229. Alternatively, the
PICC lead cable 229 can attach at the bottom of the paddle 104.
[0048] FIG. 4 is a view of a paddle 104 and its components in an
extended state, according to an embodiment. In this view, the ECG
electrodes 103 can be extended from the paddle 104. The paddle can
have at least three ECG electrodes 103 and extendable ECG electrode
housings 950. The ECG cords 227 can be visible when the ECG
electrodes 103 are extended away from the paddle 104.
[0049] FIG. 5 is a reverse view of a paddle 104, according to an
embodiment. In an embodiment, the backside of the paddle 104 can
have multiple feet 905, in order for the paddle 104 to rest on a
patient's chest (not shown) comfortably. The feet 905 can be made
of a non-slip material, such as rubber, in order for the paddle 104
to rest securely on the patient's chest. The feet 905 can be
positioned in such a manner so as not to interfere with any of the
extendable components of the paddle 104.
[0050] FIG. 6 is a view of a paddle 104 and its components,
according to an alternate embodiment. In an alternate embodiment,
the paddle 104 can contain at least two tracking coils 500, which
can be used to detect the catheter tip (not shown) as it moves into
the proper position. The tracking coils 500 can be made of a
ferrous metal or composite such that an electrical current is
generated as the stylet wire enters its detectable area. Catheter
tip location data can be three analog signals, generated by
measuring the electrical current values of the individual tracking
coils as the stylet wire passes in proximity. The location data can
be compiled and triangulated either by the processor in the paddle
or the processor in the mobile device after being converted to a
digital form in order to graphically display to a user the general
location of the catheter tip. The tracking coils 500 can be
positioned such that they do not interfere with any of the
extendable components of the paddle 104. Additionally, the paddle
104 can contain at least three extendable ECG electrode housings
905, a wireless transmitter, a battery, and a PICC lead cable
port.
[0051] FIG. 7 is a view of a paddle 104 and its components,
according to an alternate embodiment. In an alternate embodiment,
the paddle 104 can contain ECG lead input ports 911, 912, 913, such
that ECG electrodes (not shown) can be attachable to the paddle
104. The paddle can have a power button 910 located on the top of
the paddle 104, surrounded by a ring of material 915, such as
silicone, to prevent accidental activation or deactivation of the
medical device placement system. The paddle 104 can have grips 916
placed on the sides of the paddle 104 in order for a user to more
easily maneuver the paddle 104. The grips 916 can be made of a
non-slip material, such as rubber or composite, in order for the
user to be able to maintain a strong grip on the paddle 104. The
paddle can additionally comprise a wireless transmitter (not
shown), a battery (not shown), and a PICC lead cable port 914.
[0052] FIG. 8A is a side view of an extendable ECG electrode
housing 950, according to an embodiment. The extendable ECG
electrode housing 950 is modular in nature, such that a system 950
can be snapped into and out of a paddle (not shown) after it has
outlived its usefulness. The ECG electrode 103 can slip into a
shield piece 904 when contracted, in order for the ECG electrode
103 to be protected. The system base 902 can have a raised rim 901
in order for a sterile cover 900 to be attached over the ECG
electrode 103 and its cable 227. The sterile cover 900 can be
ridged in shape to allow greater expansion. The sterile cover 900
can be made of plastic, latex, or other elastic, sterilized
material.
[0053] FIG. 8B is a top view of an extendable ECG electrode housing
950, according to an embodiment. The ECG electrode 103 and its
cable 227 can be connected to a wire spool 903 mounted inside the
extendable ECG electrode housing 950. The wire spool 903 can be
under tension, such that when the ECG electrode 103 is finished
being used, the user can retract the ECG electrode cable 227 back
into the system 950. When in use, the ECG electrode 103 can remain
extended due to the wire spool 903 being unable to rotate because
it locked by a latch (not shown).
[0054] FIG. 9 is a diagram showing the interaction of a medical
device placement system with a mobile computing device 228,
according to an embodiment. The mobile device 228 can utilize a
software application (e.g., an app) to receive and display (such as
in a graph form) the ECG data and location data supplied from the
paddle 104. Additionally, the software application can comprise
software for controlling the display screen (not shown) and
capturing location and ECG data. The control methods can be a touch
screen, voice command, motion activation, or any other process that
can be used to indicate an action that should be performed by the
application. Preferably, the method used to control the application
does not require contact between the user and any surface that is
not sterile. When the application is selected, the software can
prompt the user to input required and optional information
regarding the patient to open a case file. Once the case file has
been opened the data received and interpreted by the application
can be displayed on the screen and the process of properly locating
the PICC inside the patient can begin. The software should also
pair the mobile device to the transmitter 303 so that it only
receives signals from the transmitter 303 (such that if another
patient is in the next room with a similar system those
transmissions will be ignored).
[0055] The PICC can be inserted into the body through a vein 440 in
the patient's arm 441 and the location-based system information can
be displayed on the mobile device 228. As the PICC 100 enters the
viewable radius for the location system, the path of travel can be
depicted on the screen. This display can show the location and
direction of the PICC 100 in relation to the SVC 442 and the heart
443. If the PICC 100 is following the correct path while it is
above the heart 443, it will move downwardly towards the heart 443.
If the PICC 100 does not have the proper alignment and direction of
travel at any time, the user can pull the PICC 100 back and realign
it until it is traveling properly as seen on the display. The PICC
can then be used for its intended medical purpose. The paddle 104
and electrodes 103 can be removed from the patient using the same
procedure as commonly known in the art. The electrodes 103 can be
completely wireless, wherein each electrode 103 would wirelessly
send its ECG data to the paddle 104 using Bluetooth or other
wireless technology. In which case, no wire connections would be
necessary between the electrodes 103 and the paddle 104. Moreover,
the Bluetooth transponders in the electrodes can communicate
directly with a mobile device 228, without the need for the paddle
104 to receive the ECG data.
[0056] In an alternative embodiment, the paddle 104 can be a
central information gathering station, in which case the
location-based coils (not pictured) can be located in a separate
device (not pictured) that can be placed directly on the patient's
chest. In such an embodiment, the separate device can either be
connected by wire to the paddle 104, or can comprise a Bluetooth or
other wireless transmitter to communicate data with the paddle 104
or directly to the mobile device 228. As described above, in an
alternative embodiment, the paddle 104 can house the location-based
coils (not pictured) directly within the paddle 104 itself.
[0057] The paddle 104 can be powered using a rechargeable battery
(not shown). After use, the paddle 104 can be stored in a charging
dock (not shown) located at a central location. Additional features
can be included in the charging dock that can allow for software
updates and secure data transfer as well.
[0058] FIG. 10 is a schematic diagram showing the communication
between elements comprising a device placement system 100,
according to an embodiment. The location data and ECG data from the
sensors, comprising the ECG electrodes 600, the ECG sensor on the
catheter tip 601 that can be contained in the stylet (not shown),
and the tracking coils (not shown), can be transferred to a
processing unit 603, located in the paddle 604. The ECG data from
the electrodes 600 and the catheter tip 601, as well as the
location data generated by the tracking coils, are typically
generated in analog form and can be converted to digital format
using a digital/analog converter 602, before being sent to the
processing unit 603. The processing unit 302 within the paddle can
be a microprocessor, and can compact the data and encrypt it for
transmission. The processing unit 603 (microprocessor) can be
programmed to perform any operation associated with the paddle and
associated devices. A device wireless transceiver 605, which can be
a Bluetooth transceiver, can also be located within the paddle 604,
and can then be used to wirelessly transmit and receive encrypted
data to and from a mobile device 607 via the mobile wireless
transceiver 606, which can be a tablet, smart phone, etc. The
mobile device 607 can have its own mobile wireless transceiver 606,
which can be a Bluetooth receiver, and which receives wireless
signals from the wireless transceiver 605.
[0059] FIG. 11 is a flowchart describing the process by which the
PICC can be properly positioned, according to an embodiment. In
operation 700, the PICC can be inserted into the body through a
vein in a patient's arm and the location-based system information
can be displayed on a mobile device. In operation 701, as the PICC
enters the viewable radius for the location system, the path of
travel can be depicted on the screen by using the catheter tip
location data generated by the paddle. This display can show the
location and direction of the PICC in relation to the SVC and the
heart. At this point, the user can switch the display to show the
patient's ECG.
[0060] In operation 702, as the catheter tip is pushed towards the
desired location in the SVC, the height of the P-wave increases. In
operation 703, the maximum P-wave height can indicate that the PICC
has been pushed to the proper location. To find the exact location
for maximum P-wave height, the user must push the catheter tip past
this P-wave maximum, as in operation 704. Once the tip passes the
most desirable location, the P-wave is reflected and a negative
deflection can be observed, showing a P-wave decrease. The user can
then indicate to the application software that this image should be
stored or printed. The PICC can then be pulled back until the
reflected peak disappears, returning to operation 703. This point
can correspond with the maximum height of the p-wave, which is the
desired position for the catheter tip. If the PICC is pulled too
far back, then operations 702, 703, and 704 can be repeated until
proper positioning of the PICC is obtained.
[0061] In operation 705, once the PICC is in the proper location as
indicated by the picture showing the general location of the PICC
in proximity to the heart within the SVC, the user can use a
software application to perform several post-positioning processes.
The user can: save the images to local storage 706, print the
images 707, send the images to the medical facility's main file
system 709, store the images in the patient's case file 710, or
transfer the images to a hard transfer device, such as a CD or USB
drive 708.
[0062] FIG. 12 is a schematic diagram illustrating the inputs and
functional components of a software application 800 designed to
interface with a medical device placement system, according to an
embodiment. The mobile device (not shown) can utilize a software
application 800 (e.g., an app) to receive and display (such as in a
graph form) data 809 supplied from the paddle 104 or from the
medical facilities central storage (not shown). Additionally, the
software application can comprise software for controlling the
display screen (not shown) 806 and capturing data 805. The control
methods can be a touch screen 803, voice command 801, motion
control 802, or by remote control 804. Preferably, the method used
to control the application 800 does not require contact between the
user and any surface that is not sterile. When the application 800
is selected, the software can prompt the user to input required and
optional information regarding the patient to open a case file.
Once the case file has been opened the data received and
interpreted by the application can be displayed on the screen and
the process of properly locating the PICC inside the patient can
begin. The software should also contain a device differentiator
810, pairing the mobile device (not shown) to the transmitter
located on the paddle (not shown) such that it only receives
signals from that unique transmitter (such that if another patient
is in the next room with a similar system those transmissions will
be ignored).
[0063] The use of a software application 800 can also provide many
advantages over the current system. The software can also comprise
a support interface, wherein the user can contact a live help agent
any time help is needed 807, which prevents the need to stop a
procedure if a technical problem arises. The use of the application
software 800 can also allow the system to interact with other
software systems in the medical facility, including other systems
that are currently affixed to the particular patients, such as
vital signs, or patient chart history 808. Moreover, the system can
be scalable to interact with many different processes in the
future.
[0064] Case files and the information within the case file can be
viewable on the mobile device and can also be deleted if necessary
809. The user can also switch the image display to the ECG mode of
the system 806. In this mode, the P-wave of the ECG graph is the
indicator of the PICC (not shown) location in relation to the SVC
(not shown). The user can indicate to the software application to
take, store, or print an image of the normal ECG 805. The software
application can then be programmed to display an adjusted view of
the P-wave such that changes in this wave are more easily viewable
by the user 806.
[0065] The use of a software application on a mobile device can
allow the user to utilize hardware that he or she is already
familiar with, which reduces training time and mistakes that can be
made due to unfamiliar equipment. The user, already familiar with
the touch, swipe, and pinch actions used by most touchscreen
devices, would be able to use the same gestures in the same manner
on the present device. The present system can also reduce
manufacturing costs, as well as the cost for the end users. Without
the need for a dedicated computing device, the end user can utilize
equipment that is already in its possession. Moreover, the use of a
mobile device can be much more convenient than the current
technology due to its decreased size and weight and its inherent
mobility in that it can be located in more positions that increase
visibility and may increase performance and comfort of the
user.
[0066] FIG. 13 is an exemplary mobile device screen illustrating a
default home display, according to an embodiment. From this screen,
the user can have the option of selecting: a file manager, having a
list of procedures performed with associated patient information;
settings and support, allowing the user to pair the app with
another device or other administrative functions; launching an
electronic medical records (EMR) database for the transferal of
patient records; or beginning a new procedure.
[0067] FIG. 14 is an exemplary mobile device screen illustrating a
patient information entry display, according to an embodiment. From
the home screen, if the user begins a new procedure, the patient
entry screen can appear. The user can enter a patient's name, and
also add any optional notes in the "Notes" box. For training
purposes, the user can elect to use the application in demo mode.
For a live procedure, which can require the mobile device to be
paired with an actual paddle, the user can select "Begin
Procedure."
[0068] FIG. 15 is an exemplary mobile device screen illustrating a
surface ECG display, according to an embodiment. Before any usable
data can be obtained, a user can place the ECG pads upon the
patient's body at the prescribed locations. From this screen, the
user can observe and record the patient's normal ECG rhythm and
heart rate. Pinch and zoom can be used to increase or decrease the
view of the ECG data being displayed. All data generated and
displayed on the mobile device can be saved in the patient's
electronic record for later retrieval.
[0069] FIG. 16 is an exemplary mobile device screen illustrating a
surface ECG display snapshot, according to an embodiment. As the
patient's surface ECG rhythm is generated, the user can take a
snapshot of the ECG waveform by selecting the camera button. Using
a digit, the user can drag the slider left or right until the
desired ECG output is in the frame. While this is occurring, the
ECG output can continue to be generated and read by the
application. Once the user has framed the waveform, the user can
accept the selection by pressing the "accept" button. If no
snapshot is needed, the user can hit the "cancel" button. The
snapshot taken can be saved and associated with the patient's
record in the database.
[0070] FIG. 17 is an exemplary mobile device screen illustrating a
surface snapshot save screen, according to an embodiment. After the
user accepts the surface ECG screenshot, another screen can appear
for the user to input a surface measurement. The surface
measurement can be the distance from the insertion site (determined
by ultrasound) to the axillary junction (armpit) added to the
distance from the axillary junction to the clavicle added to the
distance from the clavicle to the intercostal space. The
measurement can be taken by a physical ruler. The user can swipe a
finger along the screen until the measured length is displayed, at
which point the user can hit accept. The screenshot, along with the
measurement, can be saved and displayed in one of the screenshot
boxes along the upper portion of the display.
[0071] FIG. 18 is an exemplary mobile device screen illustrating an
internal ECG display, according to an embodiment. After the user
has performed the surface ECG and physical measurements, the user
can use a digit to swipe the slider from "Surface" to "Internal."
The user can then insert the catheter into the insertion site. At
that point, the ECG input can switch from the signal being measured
by the surface ECG pads to the signal being measured by the tip
stylet. As described above, as the catheter nears the SA node, the
signal received by the stylet grows stronger, resulting in a p-wave
of increasing intensity being displayed. In an embodiment, the
color of the ECG line displayed can be changed to provide further
visual cues to the user that the signal input has changed from the
surface ECG pads to the internal stylet.
[0072] FIG. 19 is an exemplary mobile device screen illustrating an
ECG zoom feature, according to an embodiment. As patients' heart
rates may vary, the user can alter the display of the ECG signal to
more effectively visualize and isolate the P-wave during a
procedure. In particular, a patient with an elevated heart rate
would generate an ECG with a compacted waveform, making
identification difficult. The user can select the zoom slider, and,
by sliding the slider, widen and extend the displayed ECG waveforms
such that they widen and heighten in amplitude. Similarly, a user
can narrow and contract the displayed ECG waveforms using the
opposite gesture. Zooming can apply to signals generated by the
internal stylet, as well as the external ECG pads.
[0073] FIG. 20 is an exemplary mobile device screen illustrating an
internal snapshot save screen, according to an embodiment. The user
can select an internal ECG snapshot to be saved in the same manner
as the surface ECG. Once the catheter has been properly inserted
the user can input the internal measurement of the length of the
catheter that has been inserted into the patient. This can be
determined by subtracting the amount of visible tick marks on the
catheter, which can be marked at one centimeter intervals, from the
total length of the catheter taken before insertion. The user can
slide a finger until the proper catheter length is displayed, and
can hit accept to save and display the screenshot with the
measurement.
[0074] FIG. 21 is an exemplary mobile device screen illustrating a
normal application functioning, according to an embodiment. As
screenshots are generated, they, along with the measurements
associated with them, can be saved and displayed on the main
display. A typical procedure can require three screenshots: one of
normal surface sinus rhythm, one illustrating a dip in the P-wave
caused by the over extension of the catheter such that the stylet
moves past the SA node, and final snapshot showing maximum P-wave
after the catheter is drawn back from the dip point. Once the
catheter is positioned, the user can hit the "Finish" button.
[0075] FIG. 22 is an exemplary mobile device screen illustrating a
procedural checklist, according to an embodiment. Before exiting
procedure mode, the application can display a bundle protocol
checklist for the user to utilize. The user can announce the
protocol list members orally, or perform a silent check. If every
member of the list has been accomplished, the user can press "Yes,"
but if one or more of the checklist parameters have not been met,
the user can press "No." After selection, the user can press "OK"
to exit the procedure mode.
[0076] FIG. 23 is an exemplary mobile device screen illustrating a
patient procedure information display, according to an embodiment.
Finishing a procedure, or selecting "File Manager" from the home
display, can take the user to the patient procedure information
display. The date, time, and patient name can be indexed as a file
name, which, if selected, can display the patient ID, date of
procedure, notes, status of bundle protocol list being met, along
with the screenshots captured during the procedure. The procedural
history can be uploaded to the EMR system, saved, or printed.
[0077] FIG. 24 is an exemplary mobile device screen illustrating a
print function, according to an embodiment. The mobile device can
be paired with a wireless printer. From the patient procedure
information display, the user can select the wireless printer,
select the amount of copies, and direct the wireless printer to
print the procedural record for placement in the patient's physical
file.
[0078] FIG. 25 is a schematic diagramming illustrating the elements
of a remote mobile device 1000 and a patient data network,
according to an embodiment. The remote mobile device 1000 can have
a touch screen 1001, which can be used to control the device, the
system, as well as to display and manipulate data. The mobile
device 1000 can have random access memory (RAM) 1002 for the rapid
storage and retrieval of data necessary for the mobile device's
1000 function. The mobile device 1000 can have read only memory
(ROM) 1003 for the storage of the mobile device's basic input and
output system (BIOS). The mobile device 1000 can have a processor
1004 for the manipulation of data and general computation. The
processor 1004 (microprocessor) can be programmed to perform any
operation performed by the mobile device. The mobile device 1000
can have local storage 1005, which can be a hard disk drive or
solid state drive, for the long-term storage of patient records,
along with their associated location data and ECG data. The mobile
device 1000 can have a wireless transceiver 1006 for the
communication of data to and from the device 1000. The transceiver
can be configured for Bluetooth and/or wireless internet.
[0079] The mobile device 1000 can communicate patient records to a
central database 1007 through its wireless transceiver 1006. The
central database 1007 can store the patient records, and can
transmit and deliver those records to other similar mobile devices
1008 that can be located in other rooms of the medical facility.
The central database 1007 can communicate with the mobile devices
1000 1008 through a facility intranet, or through an internet
protocol such as FTP or WebDAV.
[0080] Although the present system has been described in terms of
exemplary embodiments, it is not limited thereto. Rather, the
present invention should be construed broadly, to include other
variants and embodiments of the system and method, which may be
made by those skilled in the art without departing from the scope
and range of equivalents of the present inventive concept.
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