U.S. patent application number 13/423068 was filed with the patent office on 2012-07-05 for injectable vascular access port with discernable markers for identification.
Invention is credited to Donn K. Harms, Marshall Kerr, Alain Rosier.
Application Number | 20120172711 13/423068 |
Document ID | / |
Family ID | 46381368 |
Filed Date | 2012-07-05 |
United States Patent
Application |
20120172711 |
Kind Code |
A1 |
Kerr; Marshall ; et
al. |
July 5, 2012 |
Injectable Vascular Access Port with Discernable Markers for
Identification
Abstract
An improved injection port identification for injection ports
implanted under the skin of a patient. The injection port has an
x-ray discernable marker allowing for the determination of a
pressure rating for the injection port when so implanted. A
plurality of concurrent visual, RF, light emitting and sonic means
for signaling the port's pressure rating are also employable to
provide multiple concurrent affirmations of the port's readiness
for high pressure injections.
Inventors: |
Kerr; Marshall; (Carlsbad,
CA) ; Rosier; Alain; (Carlsbad, CA) ; Harms;
Donn K.; (Del Mar, CA) |
Family ID: |
46381368 |
Appl. No.: |
13/423068 |
Filed: |
March 16, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12700695 |
Feb 4, 2010 |
|
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13423068 |
|
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61149967 |
Feb 4, 2009 |
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Current U.S.
Class: |
600/411 ;
600/424 |
Current CPC
Class: |
A61B 6/12 20130101; A61M
2039/0238 20130101; A61M 39/0208 20130101; G06K 2209/057 20130101;
A61M 2205/6054 20130101; A61M 2205/6036 20130101 |
Class at
Publication: |
600/411 ;
600/424 |
International
Class: |
A61B 6/00 20060101
A61B006/00; A61B 5/055 20060101 A61B005/055 |
Claims
1. A method for marking an implantable injection port comprising
the step of: engaging a marker formed of material which is clearly
discernable in an X-ray image, to said injection port.
2. The method of claim 1 additionally comprising the step of:
engaging said marker from a plurality of said markers each of which
has a non alphanumeric shape which is clearly discernable from the
others in said plurality, in said x-ray image; forming a lookup
table of respective shapes of each said marker in said plurality
and matching a respective pressure rating to each respective said
shape; with said injection port implanted in a patient, discerning
said respective shape of a said marker in said x-ray image of said
injection port while implanted; matching said discerned respective
shape of said marker in said x-ray image to a respective matching
image shape in said lookup table; ascertaining a pressure rating of
said injection port implanted in said patient by discerning the
respective pressure rating related to said respective matching
image shape in said lookup table matching said shape of said marker
in said x-ray image; and providing means for users speaking any
language, to ascertain a said pressure rating of said injection
port without a language translation through the employment of said
non alphanumeric markers to ascertain a pressure rating of said
implanted port,
3. The method of claim 2, additionally comprising the steps of:
employing software adapted to the task and running on a
microprocessor, to identify said discerned respective shape of said
marker in said x-ray image; employing said software to ascertain,
from said lookup table of pressure ratings matched to respective
marker images, a determined said pressure rating for said marker so
identified; and employing said software to take an action to
prevent an injection from a communication to said injection port,
should said determined pressure rating of said implanted pressure
port be less than a required injection pressure rating.
4. The method of claim 2 additionally comprising the step of:
placing an RFID in an engaged position on a body of said injection
port or a clip configured to engage upon a lumen outlet of said
port; programming electronic memory of said RFID with
identification information about a pressure rating of said
injection port; communicating RF energy to said injection port when
implanted in a patient to generate a transmission of said
identification information; and employing said transmission to
discern said pressure rating.
5. The method of claim 4 additionally comprising the step of:
engaging one or a plurality of additional port identifiers which
allow an identification of a said injection port while implanted in
a patient from a group of additional port identifiers including, a
light source activated to an illuminated state to communicate light
through the skin of said patient by said RF transmission and, a
buzzer activated to communicate sound through the skin of said
patient by said RF transmission.
6. An injection port for implantation under the skin of a patient,
comprising: a body having an injectable reservoir for receiving
fluid from a injection through a septum covering said reservoir; a
first marker in a communicating mount with said injection port,
said first marker formed of a marker material which is clearly
discernable for shape from surrounding material in an X-ray image
of said port when implanted in a patient; and said first marker
when viewed upon said x-ray image of said injection port, providing
means to discern a pressure rating of said injection port, without
removing said pressure port from said implantation.
7. The injection port of claim 6 additionally comprising: said
first marker formed of a nonferrous material including one or a
combination of marker materials from a group including, nonferrous
materials including nitenol, tungsten, titanium, stainless steel,
teflon, silicone nitride, Zirconium, gadolinium oxysulfide, and
inks formed of a bio-compatible carrier and one or a combination of
said marker materials; and the employment of such non-ferrous
marker materials singularly or in combination providing means to
minimize interaction of said injection port while implanted, with
radiated energy during an MRI.
8. The injection port of claim 7 additionally comprising: said
first marker having a non alphanumeric shape clearly identifiable
in said x-ray image; and said shape discernible to indicate a
pressure rating for said injection port to viewers speaking and
reading any language.
9. The injection port of claim 6 additionally comprising: a second
marker being an RFID having electronic memory and a data processor
configured to broadcast port identification information when
energized from outside a patient's body by RF; and a receiving
device configured to receive said broadcast port information and
provide a video display discernible by a user to ascertain said
port identification information.
10. The injection port of claim 7 additionally comprising: a second
marker being an RFID having electronic memory and a data processor
configured to broadcast port identification information when
energized from outside a patients body by RF; and a receiving
device configured to receive said broadcast port information and
provide a video display discernible by a user to ascertain said
port identification information.
11. The injection port of claim 8 additionally comprising: a second
marker being an RFID having electronic memory and a data processor
configured to broadcast port identification information when
energized from outside a patients body by RF; and a receiving
device configured to receive said broadcast port information and
provide a video display discernible by a user to ascertain said
port identification information.
12. The injection port of claim 9 additionally comprising: one or a
plurality of supplemental markers from a group of supplemental
markers including, an LED in electrical communication with said
RFID which illuminates to communicate light through the patient's
skin when said RFID is energized by said RF, an electronic sound
generator in electrical communication with said RFID which
communicates a sound through the patient's skin when said RFID is
energized by said RF, a shape of an antenna engaged to said RFID,
said antenna shape discernible in an x-ray to identify a pressure
rating for said pressure port, and said RFID configured to
broadcast identification information to a receiving display device
when energized by said RF.
13. The injection port of claim 10 additionally comprising: one or
a plurality of supplemental markers from a group of supplemental
markers including, an LED in electrical communication with said
RFID which illuminates to communicate light through the patient's
skin when said RFID is energized by said RF, an electronic sound
generator in electrical communication with said RFID which
communicates a sound through the patient's skin when said RFID is
energized by said RF, a shape of an antenna engaged to said RFID,
said antenna shape discernible in an x-ray to identify a pressure
rating for said pressure port, and said RFID configured to
broadcast identification information to a receiving display device
when energized by said RF.
14. The injection port of claim 11 additionally comprising: one or
a plurality of supplemental markers from a group of supplemental
markers including, an led in electrical communication with said
RFID which illuminates to communicate light through the patient's
skin when said RFID is energized by said RF, a electronic sound
generator in electrical communication with said RFID which
communicates a sound through the patient's skin when said RFID is
energized by said RF, a shape of an antenna engaged to said RFID,
said antenna shape discernible in an x-ray to identify a pressure
rating for said pressure port, and said RFID configured to
broadcast identification information to a receiving display device
when energized by said RF.
Description
[0001] This application is a Continuation in Part of U.S.
application Ser. No. 12/700695 filed on Feb. 4, 2010 which claims
the benefit of U.S. Provisional Application Ser. No. 61/149967
filed on 4 Feb. 2009, both herewith included in their respective
entirety by this reference thereto.
FIELD OF THE INVENTION
[0002] The disclosed device relates to power-injectable vascular
access ports which are implanted in a patient and conventionally
employed for powered injection of medicine and medical related
injectables such as during an injection of contrast media for a CT
scan. More particularly, it relates to such a vascular access port
which provides users one or a plurality of pressure rating markers
which may be X-ray discernable, audible, discernible using RF
energy for digital reporting, or through visual observation of the
skin. Pressure rating is determinable using one or a plurality of
the discernible markers to ascertain the port itself is rated for
powered injection under high pressure.
BACKGROUND OF THE INVENTION
[0003] Intravenous therapy or IV therapy is the giving of liquid
substances directly into a blood vessel. Such therapy may be
intermittent or may be continuous and during the therapy a fluid
conduit must be established into the vascular system of the patient
and maintained.
[0004] The simplest form of intravenous access is a syringe with an
attached hypodermic needle. The needle is inserted through the skin
into a blood vessel, and the contents of the syringe are injected
through the needle into the bloodstream. Since direct injection
only allows for the delivery to a patient of a single dose of
medication, where prolonged therapy using multiple doses is to the
regimen, a more popular mode employs a peripheral IV line
consisting of a short catheter (a few centimeters long) inserted
through the patient's skin into a sealed engagement with a
peripheral vein. A body or hub in sealed communication with the
axial passage of the catheter is engaged on the distal end of the
catheter and remains outside the patient's body, usually on the
skin surface. In this position the hub can be connected to a
syringe or an intravenous infusion line to communicate fluid to the
bloodstream of a patient, or capped when not in use. The hub and
engaged catheter thus allows for multiple treatments with the same
line.
[0005] However, on many patients a more direct route to the central
blood vessels is required for provision of medication, treatments,
and injections employed during X-ray and other imaging.
Conventionally, a central venous line provides access for this
purpose and consists of a catheter being inserted into a
subclavian, internal jugular, or (less commonly) a femoral vein and
advanced toward the heart until it reaches the superior vena cava
or right atrium. Because all of these veins are larger than
peripheral veins, central lines can be employed to deliver a much
higher volume of fluid and can also have multiple lumens feeding
the central line.
[0006] Implantable ports are a type of central venous line which
does not employ an external connector positioned outside the
patient's body. Instead, such implantable ports have a small
reservoir which is covered with a flexible cover and the entire
device is implanted under the skin of the patient.
[0007] A catheter or other means for sealed communication of a
lumen between a blood vessel and the reservoir, communicates
between an outlet of the reservoir and an internal blood vessel
such as a vein. Often, a rigid cap or similar capping means is
employed with the communication means to further secure the distal
end of the catheter to the reservoir outlet. Such a cap known in
the art is typically a small cylindrical member that is slidably
and coaxially engaged upon the lumen or catheter enhancing the
coaxially fictional engagement of the catheter to the outlet. In
use, the rigid cap is slidably engaged upon the catheter surface by
sliding it over the catheter which is engaged around the outlet. A
force imparted circumferentially to the catheter by the cap,
sandwiches the catheter between the cap and the conduit over which
it engages and thereby acts to further bias the catheter against
its contact with the outlet, and securely engage the catheter to
the outlet exterior surface.
[0008] Once so implanted, medication may be administered to the
patient thereafter by communicating a small huber needle through
their skin, piercing the septum or flexible cover of the port, and
injecting the medication directly into the reservoir under the
flexible cover provided by the septum. When the needle is
withdrawn, the reservoir cover, which is formed of a material which
reseals, seals itself.
[0009] Since the septum formed by the implanted port reservoir
cover can accept hundreds of needle piercings during its lifetime,
it is possible to leave the port in the patient's body for years.
This semi-permanent implantation under the skin, helps avoid
infection by leaving the skin barrier intact. Further, over time
employment of the implant is much less painful to the patient since
they need not endure pokes and needle sticks and the incision
generally required by exterior mounted ports.
[0010] However, a particular problem occurs for medical
professionals during the implantation process with many
conventional ports. During assembly, the secure engagement of the
reservoir outlet to the catheter can be particularly troublesome.
This difficulty is caused by the relatively small size of the cap
which must be held by the gloved hand of the medical professional.
It is often difficult to grip the small cap and slide it along the
catheter and over a sealing bulge in the outlet conduit to
correctly and securely engage the cap circumferentially around and
to the catheter which itself is engaged to the tubular conduit
providing the outlet. The friction of the catheter against the
inside circumference of the cap can cause the cap to slip from the
user's fingers.
[0011] The problem is further exacerbated because the professional
is wearing gloves, and the cap and catheter can become wet and
slippery. This combination of circumstances often causes the
medical professional to drop the cap which becomes non-sterile on
landing, wherein it must be immediately discarded. This problem is
sufficiently prevalent that some manufacturers provide a plurality
of caps with the kit of the implantable port.
[0012] If the medical professional is able to correctly engage the
cap over and onto the catheter and secure it to the tube forming
the outlet, there is an additional problem which occurs when
implantable ports are to be infused using power injection. Such
infusions communicate the liquid into the reservoir of the
implanted port, under high pressure, in order to move a large
amount of liquid into the body of the patient in a short time. Such
powered injection devices communicate fluid at high pressure levels
through the septum covering the reservoir of the implanted infusion
port which must be rated to handle the high pressure or the port
could malfunction. The user must ascertain before such a high
pressure injection, that the implanted port is rated for the
anticipated high fluid pressure or a rupture of the port and
related serious problems will occur.
[0013] Because the implanted port is positioned under the skin of
the patient, conventionally there is no means for the professional
to visually inspect it and ascertain a pressure rating during and
after use. Consequently, it can be a vexing task for medical
personnel to ascertain if in fact an implanted port is rated for
high pressure and the communication of a high volume of the
anticipated infusion to be given the patient. Hidden from view by
the patient skin layer, it is conventionally not possible to
examine the implanted port prior to use and ascertain visually the
port is rated for the upcoming procedure.
[0014] However, because of the potential for patient harm should a
rupture occur, most medical protocols require two independent means
of ascertaining the implanted port is high-pressure rated. The dual
confirmation must be ascertained prior to using the port during a
subsequent high pressure injection through the septum covering the
reservoir of the port. Currently, one means to ascertain the port
pressure rating is to read the patient's chart which may be marked
with the pressure rating on the hidden port. Another means is to
look for and read exterior identification means where the patient
may wear an ID bracelet, or other means to denote that the
implanted port is rated to the pressure to which it is about to be
connected.
[0015] However, there is currently no means for visual confirmation
of the implanted and skin-covered port's pressure rating by an
inspection of the implant site by the medical professional.
Consequently, they must depend upon the accurate charting and
labeling by themselves and by other workers. With charts and
bracelets being known to be less than accurate on occasions, or in
cases where a chart indicates one pressure rating and a bracelet
indicates another, it would be especially helpful to provide one or
a combination of alterative means to ascertain the pressure rating
of an implanted port. In cases where the records and charts
disagree, multiple alternative pressure determination means would
also prevent needless patient procedures to remove or replace
implanted ports when two means of identification cannot be found.
Further, all of this confirmation required slows the progress of CT
scans for the patient which costs the medical facility valuable
time where the scanner by be employed elsewhere.
[0016] As such, there exists a continual unmet need, for a means
for medical professional to identify that an implanted infusion
port, hidden by skin and other patient tissue, is actually rated
for the high pressure use for which it is about to be employed.
Such a means of identification should be easy to employ, and allow
for the use of the installed base of medical equipment already in
hospitals and medical offices to lower costs and insure widespread
easy deployment. Such means for identification should ideally
provide a plurality of means to ascertain a high pressure rating on
the implanted port to allow the medical professional to choose a
favorite or supplement another determinable means on the port.
[0017] In addition to the need to better identify the ports
pressure ratings, there is a further unmet to need for an improved
means for engaging the cap member to the catheter to insure its
secure engagement to the outlet conduit of the port. Such an
improved securing means should employ a similar procedure as the
current cap engagement to the catheter to thereby encourage use by
not requiring the learning of a new skill. Further, such an
improved engagement should eliminate the dropping of conventional
clips and the need to provide multiple clips for that eventuality
and to provide an improved gripping means for the cap that will
more easily allow the user to grasp it even while wearing
gloves.
[0018] With respect to the above, before explaining at least one
preferred embodiment of the invention in detail or in general, it
is to be understood that the invention is not limited in its
application to the details of construction and to the arrangement
of the components or the steps set forth in the following
description or illustrated in the drawings. The various apparatus
and methods of the invention are capable of other embodiments, and
of being practiced and carried out in various ways, all of which
will be obvious to those skilled in the art once the information
herein is reviewed. Also, it is to be understood that the
phraseology and terminology employed herein are for the purpose of
description and should not be regarded as limiting.
[0019] As a consequence, those skilled in the art will appreciate
that the conception upon which this disclosure is based may readily
be utilized as a basis for designing new X-ray or fluoroscope
discernable markers, and combinations of other visual, sonic, and
RF enabled markers, allowing for a power and a pressure rating
verification of implanted infusion ports and the like, and for
carrying out the several purposes of the present disclosed device
and method. It is important, therefore, that the embodiments,
objects and claims herein, be regarded as including such equivalent
construction and methodology insofar as they do not depart from the
spirit and scope of the present invention.
SUMMARY OF THE INVENTION
[0020] The marker device allowing the identification method herein
is employed in combination with an injection port (or portacath)
which is a small medical appliance that is conventionally installed
beneath the skin. Such ports are designed for implantation under
the skin of a patient and the port employs a septum or membrane
cover on an upper surface closest to the patient's skin. This
septum or cover provides a self-sealing means to communicate with
an underlying reservoir and is adapted to be pierced by a needle or
other means to communicate medicine and drugs into the underlying
reservoir or for the taking of blood samples therefrom on numerous
occasions.
[0021] The marker device allowing for identification of the
implanted port, is engaged to, or within, the implanted port and is
formed of a material such as nitenol or tungsten or titanium, or
stainless steel, or other non-ferrous metal which can easily be
discerned on a CT scan or X-ray or on a fluoroscope. In a preferred
mode, the marker is placed within the reservoir of the port. Such
as location is preferable in that there is know chance of the
marker be scraped off or otherwise damaged during instillation or
removal within a patient.
[0022] In other preferred modes however, the marker device may be
any X-ray discernable material such as a high density ceramic, or
X-ray excitable polymer. The marker may be a planar piece of
material that is positioned within the interior of the reservoir,
or upon the exterior of the septum cover or implanted port, or it
may be a piece of the preferred discernable material which is free
floating within the reservoir cavity within the implanted port.
Other materials which will be substantially discernable on an
x-ray, may be employed such as ink infused with metallic material
such as a high density ceramic, an x-ray excitable polymer,
titanium, stainless steel, or other non-ferrous metal and which may
be imparted to an interior or exterior surface of the implanted
port. Still further, the marker device formed employing such an ink
may also be imparted on the conduit, septum, or for ease of reading
without the port body obscuring it, the marker may be positioned on
the conduit cap of the implanted port.
[0023] It is most preferred that a visual marker employ a
non-alphanumeric identifier because some technicians may have
trouble reading letter and numbers indicating pressure ratings.
Further, such ports are employed in many countries with many
languages, and the use of letters and words in one country may not
be understandable in another. Still further, in some countries,
x-ray technicians may not be able to read at all and the use of
letters or number designators will not provide information to such
users that a simple symbol can.
[0024] It is preferred therefor that the symbol be singular in
nature so as not to be confusing and a simple shape that is easily
discerned. A current preferred symbol is that of a triangle as
rectangles and multiple sided figures are easily confused when
reading them. A triangle on the other hand is the only three sided
shape, is readily identifiable by technicians who read, and those
that are illiterate.
[0025] In use, the metal triangle is placed free floating in the
reservoir as a simple universal marker to identify an implanted
port as high pressure rated. During a CT scan, which concurrently
requires the injection of a large volume of liquid by a power
injection under high pressure, the medical professional performing
the procedure, even if illiterate, can easily first ascertain if
the implanted port has the high pressure rating required for the
procedure. The user can do so quickly by simply taking a quick
X-ray of the patient in the vicinity of the implanted port. If the
port is pressure rated for the procedure, the triangle shaped
formed of the material which will show on the X-ray, will be easily
discernable on the X-ray as engaged to or within the plastic
implanted port. This will provide one visually discernable positive
affirmation as to whether the port is or is not pressure rated for
the upcoming procedure.
[0026] In another particularly preferred mode, the identification
marker is imparted on the cap member in its engagement on the
catheter. The clip or cap member in this mode is formed larger for
two reasons. First a larger surface area provides an area to print
or form the triangle or other x-ray discernible symbol is a
reasonably large fashion.
[0027] A second reason for the larger cap member is the provision
of one or a plurality of finger engageable recesses or ridges
formed on the surface of planar members extending from and
communicating with the typically cylindrical cap body.
[0028] The planar members extending from the catheter engaged clip
add utility in a number of ways. First, the planar protrusions
provide a large surface to allow the user to better grip the cap
between finger and thumb, when engaging the cap to catheter as
described previously. Further as noted, the larger surface of the
planar members provide a distinguishable location at or near the
implanted port to impart the identification marker ink.
[0029] As an additional safety protocol, the software which
controls the CT scan or other X-ray procedure may be programmed
with image recognition program to be employed prior to the
procedure moving forward. In this mode, the scanner or x-ray
machine would be adapted to initially seek out the port and
identify the marker in an initial scan of the patient before
allowing the medical professional to continue with the procedure.
Once identified by software adapted to recognize acceptable
identifiers engaged to the port, a microprocessor will allow the
employment of the next procedural step which would involve a
powered injection to be communicated through the cover and into the
reservoir of the port under high pressure.
[0030] Still further, the markers so engaged to or near the port,
may be cross referenced with a database of pressure ratings. This
would allow for the employment of multiple ports with higher and
lower pressure ratings wherein a triangular shape for example would
verify on pressure rating and a rectangular shape would verify a
different pressure rating.
[0031] Even further, another identification marker may be employed
in the form of a Radio-frequency identification (RFID) transponder.
The technology can be used for automatically identifying the port
as high pressure or otherwise. The relatively small RFID employing
combined radio receiver and transmitter, or employing other audio
or visual means for reporting, will thereby communicated identity
information over a short distance, when energized by a detector
placed close to the RFID antennas.
[0032] When configured to transmit a message, the RFID when
energized by the RF field placed proximate to its antennas, will
transmit numbers and/or text held in memory. The transmissions from
an energized RFID can be read from several meters away and beyond
the line of sight of the reader. The RFID tags can be programmed
and hold information such as the port serial number, brand, install
date, and pressure rating, during the manufacturing process.
Thereafter, when implanted in a patient in combination with a
pressure port, the RFID when energized by a reader device or other
means of RF generation of sufficient power to energize the RFID,
will transmit the stored information such as the noted serial
number and high pressure rating along with other stored
information.
[0033] Using an interface and software adapted to the task, this
information could be automatically logged to a patient's chart,
and/or can be employed in combination with software controlling the
pressure pump, to enable the high pressure pump only when a high
pressure rating is determined.
[0034] In an additional favored mode of the device herein, in
addition to the RFID when energized, there may also be operatively
engaged with the RFID, or independently activated or operated, one
or both of an audio or visual reporting component, which will
provide sonic and or visual affirmation when activated by either an
RFID scanner or other means to activate an audio or visual report
from outside the body of the patient. In this mode of operation,
alone, or in combination with the RF transmission of data above, a
electronic sound generator or beeper, or even a speaker capable of
synthetic speech, can be also energized to make a sound discernible
through the skin which would provide a sonic signal discernible by
medical professionals without computers or x-rays, that the port is
high pressure. Such a simple sound-based confirmation would be
extremely useful in medical facilities without an x-ray but a need
to use high pressure ports on patients. In addition to the
electronic sound generator such as a buzzer or beeper, a small
speaker engaged with an amplifier on the RFID or engaged with it,
and a memory chip holding speech sounds in ROM, could combine to
speak the words "high pressure" when the RFID is energized.
[0035] As noted, another mode of pressure port pressure from the
exterior of the patient body is an LED operatively engaged to
illuminate when the RFID circuit is energized. Such products are
commercially available for instance from the Montie Design. LED's
exist which are tremendously bright at low power and capable of
illumination independently with their own remotely located
operation component or concurrently when the RFID circuit is
energized by RF energy sufficiently to be seen through the skin of
the patient. From a small red dot visible through the skin to a
series of LED's which render a red triangle through the skin, this
visible means to determine a high pressure rating also needs no
x-ray to provide the medical technician with confirmation of high
pressure ratings. A light transmitting LED also would work well in
instances where an X-ray is not convenient. It would also be
preferred in some cases to employ a signaling scheme with the LED
illumination. This can be in a similar fashion to Morse code where
the LED will illuminate a specific number of times to confirm high
pressure which will eliminate the possibility a manufacturer of a
low pressure port might have an illuminating LED upon it could be
mistaken. A set number of individual illuminations and darkenings
signifying high pressure, such as three blinks, would be desirable.
Further, both the sonic reporting and LED reporting, could also be
used to simply save power and machine-use of the x-ray machine or
CT scanner to simply ascertain the port rating. In this fashion,
the CT scanner or x-Ray need not be employed since the LED, Sonic
generator, or RFID, in combinations would provide a dual
confirmation of the presence of a high pressure port. Further, with
an RF transmission, or light through the skin, or sound transmitted
through the skin, the user has three independent means to ascertain
a high pressure rating of the implanted port.
[0036] The ability to view a marker engaged to or upon the
implanted port or receive port information via transmitted data,
sound, or light from LED's controlled in concert with energized
RFID's, will thus provide a plurality of independent means to
determine a proper pressure rating of the port. A sound can be
generated, a light stream or plurality of blinks visible through
the skin can be initiated, or an RF message can be transmitted and
displayed on a computer screen. All three modes independently
confirming that an implanted port, hidden under the patient's skin,
is rated for the pressure to which it will be exposed in an
upcoming procedure.
[0037] Yet another mode of visual confirmation of high pressure
rating is available using another mode of the device herein wherein
the RFID employs RF antennas which are shaped as triangles, or
other easily discernable shapes which signify a high pressure port.
The triangle of the antenna is metallic and will appear very
distinct on an x-ray, thereby verifying using a symbol that the
port is high pressure rated. The triangular antennas, the LED, the
data transmission from the RFID, the sound transmitted, and the
triangular member positioned on the clip, form a group of
identifiers which all be employed singularly, or in combinations of
all or any individual member of the group with any other, to
provide one or a plurality of individual identifiers for a high
pressure port. Further, it is anticipated that they may be used
alone or in combination with the physical markers provided by a
triangular metal member positioned in the reservoir of the port, or
positioned on the clip engaged to the catheter o the port. This
employment of icons and shapes such as a triangle will also allow
technicians in countries where reading may be a challenge, and easy
manner to visually confirm the presence of a high pressure
port.
[0038] Further, in all preferred modes it is additionally preferred
that the RFID may include a wideband transmission antenna element
to allow the RFID and or a second transmitter to singularly or
concurrently broadcast on multiple frequencies such as needed for
bluetooth and WiFi. As the RFID is read or energized with a
scanner, the transmitted information such as port serial number,
brand, lot, manufacture date, install date, and pressure rating may
be transmitted to a physicians electronic database and/or computer
screen such that the information can be visually displayed. If the
device employs an antenna capable of concurrent broadcasts in
multiple frequencies a plurality of electronic input needs may be
met such as broadcasting on bluetooth to input information to the
patient chart, and wifi to transmit the information to a remote
physician or medical database being served by a wireless
router.
[0039] The foregoing has outlined rather broadly the more pertinent
and important features of the device and method herein employing
X-ray discernable markers upon or within implantable ports in order
that the detailed description of the invention that follows may be
better understood so that the present contribution to the art may
be more fully appreciated.
[0040] Additional features of the invention may be described
hereinafter which form the subject of the claims of the invention.
It should be appreciated by those skilled in the art that the
conception and the disclosed specific embodiments may be readily
utilized as a basis for modifying or designing other X-ray
discernable marking systems for implanted ports for carrying out
the same purposes of the present invention. It should also be
realized by those skilled in the art that such equivalent
constructions and methods do not depart from the spirit and scope
of the invention as set forth in the appended claims.
[0041] In this respect, before explaining at least one embodiment
of the invention in detail, it is to be understood that the
invention is not limited in its application to the details of
construction and to the arrangement of the components set forth in
the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced
and carried out in various ways. Also, it is to be understood that
the phraseology and terminology employed herein are for the purpose
of description and should not be regarded as limiting.
THE OBJECTS OF THE INVENTION
[0042] It is, therefore, an object of the present invention to
provide a computer displayed visual means to determine if an
implanted and skin-covered port is power-rated for engagement to
high pressure.
[0043] It is another object of this invention to provide such a
device and method that may be easily incorporated into existing
implantable ports and be identified with the installed base of
medical equipment at medical facilities.
[0044] It is yet another object of this invention, to employ one or
a plurality of such identifiable pressure rating markers which may
be identified by a computer running software adapted to the task
and thereby prevent accidental injection in a subsequent step if
the proper pressure rating is not discerned.
[0045] It is still another object of the invention to provide a
failsafe mechanism for determining the two means of pressure
identification, wherein if the two means are not ascertained, the
CT scan and/or power injection will be deactivated.
[0046] It is yet still another object of the invention to provide a
conduit cap employing finger engageable gripping means and sized to
hold symbols identifying the high pressure port.
[0047] Another object of the invention is to provide one or a
combination of nonferrous metal, high density ceramic, teflon, or
other x-ray excitable polymer identification marker which are
easily discerned from the surrounding port body.
[0048] A further object of the invention is to provide a non
ferrous metal, high density ceramic, x-ray excitable polymer
identification marker in the form of one or a combination of
alphanumeric characters or symbols/icons imparted on one or a
combination of the body of the port, the cap, or the conduit.
[0049] Still another object of the invention is to provide a RFID
identification marker imparted on one or a combination of the body
of the port, the cap, or the conduit.
[0050] A still further object of the invention, is the provision of
a concurrent means of multiple determination of the presence of a
high pressure port using one or a plurality of a wireless, a visual
signal and/or a sonic signal which identify the port as high
pressure and which may be discerned through the user's skin.
[0051] Yet another object of the invention is the employment of
discernible signals and figures which may be discerned by a
reading-challenged staff which allow them to identify a high
pressure port without the need to read.
[0052] The foregoing has outlined some of the more pertinent
objects of the invention. These objects should be construed to be
merely illustrative of some of the more prominent features and
applications of the intended invention. Many other beneficial
results can be attained by applying the disclosed method and device
in a different manner or by modifying the invention within the
scope of the disclosure. Accordingly, other objects and a fuller
understanding of the invention may be had by referring to the
summary of the invention and the detailed description of the
preferred embodiment in addition to the scope of the invention
defined by the claims taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0053] The accompanying drawings, which are incorporated in and
form a part of this specification, illustrate embodiments of the
invention and together with the detailed description, serve to
explain the principles of this invention.
[0054] FIG. 1 depicts a perspective view of the device herein
engaged to, or floating within an interior cavity or the reservoir
of an implanted port shown in dotted line.
[0055] FIG. 2 depicts an X-ray of the device of FIG. 1 wherein the
marker is rendered visible by a human or computer with operative
recognition software, within the implanted port, and showing the
device positioned within a reservoir under the septum.
[0056] FIG. 3 depicts graphically a method of implementation of the
device in a method to prevent high pressure injections to ports not
recognized as capable of handling the intended pressure.
[0057] FIG. 4 shows an perspective view of a preferred mode of the
device wherein a finger engageable cap member having protruding
planar members employs the identification marker.
[0058] FIG. 5 shows a top view of the device of FIG. 4 in another
preferred mode wherein the identification marker is imparted on the
septum, also providing a substantially larger finger engageable cap
member
[0059] FIG. 6 shows a bottom view of the device of FIG. 4 in still
another preferred mode wherein the identification marker is
imparted on the bottom surface.
[0060] FIG. 7 shows still yet another particularly preferred mode
of the device employing a dual port system with the identification
marker imparted on the body of the port.
[0061] FIG. 8 shows a mode of the device employing an RFID
reader/energizer to elicit a data transmission from the RFID
engaged with the device on the port body or catheter engaged
clip.
[0062] FIG. 9 depicts an energizable RFID configured to report
electronically and a means to illuminate through the skin such as
an LED visible through the skin and or activate an sonic alarm such
as a buzzer or beeper.
[0063] FIG. 10 shows and RFID, employable on the body of the device
or clip, having antennas configured in segments to yield an x ray
discernible triangular shape which would be visible on X-ray to
identify the port.
[0064] FIG. 11 shows an overhead view of a port device employing a
clip engaged upon the catheter having an RFID positioned for less
interference of the body of the port during energizing as in FIG. 9
and a triangular marker thereon.
[0065] FIG. 12 depicts a port device having an RFID such as that of
FIG. 9 having one or both antennas configured with segments
yielding the depiction of triangles which are visible on X-ray to
confirm pump pressure ratings which as with others can be on the
clip or the body.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0066] Referring now to the drawings 1-12, wherein similar parts of
the invention are identified by like reference numerals, the device
10 as shown in FIG. 1 is seen having a symbol shaped marker 16
engaged to, or preferably floating within an interior cavity 12 of
the body of a port 14 shown in dotted line. The marker 16 formed of
metal such as stainless steel or one of the other noted discernible
markers individually or in combination of the device 10 will be
produced in combination with a high pressure port 14 and deployed
in a conventional sterile container for implantation. Such other
materials which are highly discernible from the surrounding tissue
and polymeric material forming the port and/or the septum, are
those that are excitable by x rays such as ceramics such as
gadolinium oxysulfide, and in particular silicone nitride,
Zirconium and zirconium Oxide and synthetics such as teflon.
[0067] An elongated conduit forming the outlet 15 of the port 14 is
engageable to a catheter 23 or other device providing a lumen which
is placed in sealed communication with a blood vessel of the
patient. Any such implanted port 14 may employ any or all of the
discernible markers enabling an identification of the device 10
herein as a high pressure port. The metal or other material
discernible easily from the plastic body, such as a member marker
16 is engaged by the inclusion of the marker 16 in an engagement to
the body 18 of the port 14, or more preferably by a positioning
within an interior cavity 12 of the port 14 which will not require
adhesive or heating or other engagement means that could damage the
wall or other surfaces of the high pressure port. Such positioning
without attachment provides a means to protect against an
accidental damaging of the walls forming the port or its parts
which must maintain high pressure capability.
[0068] As noted the marker 16 is best formed of a metal or another
material that is easily visually discernable from surrounding
plastic material of the device, by the eye of a viewer of an X-ray
as shown in FIG. 2. Such materials may include one or a combination
of marker materials from a group including non ferrous metals such
as nitenol, tungsten, titanium, stainless steel, and synthetic or
ceramic materials such as teflon, silicone nitride, Zirconium,
gadolinium oxysulfide or inks formed of a bio-compatible carrier
containing one or a combination of the x-ray discernable materials
noted herein which may be printed or adhered to the port 14, or
other materials which will contrast with surrounding tissue and
port materials to show on an X-ray.
[0069] In a preferred mode of the invention, the marker 16 may be a
formed from a solid piece of metal material in a non-letter symbol.
In other modes it may be painted or appliqued to the port 14
carefully so as to not damage it during manufacturing or long
storage.
[0070] Additionally should the port 14 have multiple pressure
ratings for differing procedures, indicia indicating the pressure
rating for the port 14 may be included in the marker 16, or the
marker 16 itself may be shaped differently such as the triangle
marker 16 indicating a high pressure rating or a rectangular shaped
marker 17 indicating a different pressure rating, each of which are
cross referenced to a specific pressure rating. As noted above, it
is preferred that the marker 16 be a symbol so the user need not
have to read or discern any letters or numbers or language and risk
mis-reading, or be unable to read them. Further, because a symbol
is recognizable without a need for translation or reading ability,
it is employable as a marker in any country, and any medical
facility no matter the local language or ability of the technicians
to read.
[0071] Positioned unattached within the body of the port 14, the
marker 16 identifying the disclosed device 10 in combination with a
port 14, will be clearly visible on an X-ray 17 as shown in FIG. 2.
In one mode in FIG. 2 the marker 16 is engaged to the body 18 of
the port 14 and in another image in the X-ray the marker 16 is
shown floating within an interior cavity 12 below the septum 20
through which a needle penetrates to communicate an injection of a
volume of fluid under high pressure to the port 14 in a medical
procedure such as a CT scan. This floating mode allows for
inclusion of the marker with the device, without the need to attach
it and risk damage from heat, inks, or corrosion during long term
storage as might occur if welded on, heated on, or glued onto the
device.
[0072] As depicted FIG. 3 a method of implementation employing the
marker 16 is shown providing a means to prevent high pressure
injections to ports not recognized as capable of handling the
intended pressure may be employed with the device 10. As noted the
software running the CT scanning device, or other X-ray device, or
running on the medical facility computer system, may be adapted for
use during medical procedures which require a positive
identification of a high pressure rated port 14.
[0073] The software will employ the scanner to run an initial scan
of the patient and use image recognition software to ascertain the
presence of the marker 16, prior to allowing the technician to
inject the port 14 under high pressure in a second step. Because
the port 14 is easily visually identifiable for pressure rating
based on the marker 16 or 17 discerned, multiple ports 14 with
multiple pressure ratings might be use without worry. Since ports
14 which must survive higher pressures generally cost more, the
employment of markers 16 or 17 in solid or printed format which
provide visual confirmation of the rating of the hidden port 14,
will allow for less expensive ports 14 to be employed where
subsequent pressures are anticipated to be lower.
[0074] If the software mode of the method herein is employed, the
CT Scanner or other software and wireless adapted device would in a
first step take an initial scan and employ visual recognition
software to discern shape of the marker 16 or 17. In a second step
the software adapted to the task and running on a microprocessor,
using the discerned shape, will calculate if the shape discerned is
the shape employed to designate an acceptable high pressure-rated
port. If the proper port is ascertained as present, the injection
would be permitted. Software controlled locks can be employed to
lock out the high pressure injection until confirmation is
ascertained of the port.
[0075] If more than one shape of the identifier is employed on
multiple ports, due to multiple ratings on multiple ports, the
software and microprocessor would use the initial scan to ascertain
the identifier present, and the would then match the ascertained
shape of the identifier in the patient, to a relational database of
identifier shapes. Using the match, the shape as related to a
predetermined pressure rating for ports bearing the recognized
identifier will be determined. Once the identification of the port
imaged is determined, the procedure would only be allowed to
proceed to the high pressure injection, if the proper pressure
rating is discerned from the discerned identifier ascertained from
the data regarding its rating which is accessed by the software in
the identification step with a relational database.
[0076] FIG. 4 shows an additional preferred mode of markers in
combination with a single port 14 yielding a device 10. In the
figure there is depicted the port 14 and fluid communication means
such as a catheter 34 or similar lumen engaged. The catheter 34 is
shown employing a particularly preferred cap 21 of this invention
which is secured to the catheter 34 to aid its engagement to the
outlet 15. As mentioned previously a conventional cap (not shown)
is typically a small and hard to handle cylindrical body coaxially
and slidably engaged over the catheter 34 and is used to further
secure the distal end 35 of the catheter 34 to the outlet 15 of the
port 14.
[0077] The preferred cap 21 of the present invention however,
employs one or a plurality of projecting members 22 engaged to and
communicating with a cylindrical body 25. The projecting member 22
provide a large surface area as a means to grip and maneuver the
cap 21 such as with the thumb and forefinger (not shown). Further
the surface of the planar member 22 may be employed as a mount for
an identification marker 23, such as lettering shown, or using
symbols such as a triangle as noted above to allow wider use in
different countries. Materials for the marker would be those
yielding a high contrast from surrounding tissue and plastic.
[0078] The marker 23 in this mode may be inlayed solid metal or ink
infused with one or a combination of marker materials from a group
including a nonferrous metal such as nitenol, tungsten, titanium,
stainless steel, and synthetic or ceramic materials such as teflon,
silicone nitride, Zirconium, gadolinium oxysulfide or inks formed
of a bio-compatible carrier containing one or a combination of the
x-ray discernable materials noted herein high density ceramic, or
an x-ray excitable polymer or plastic such as teflon, which will
yield a contrast on an x-ray with the surround material.
[0079] Such a marker 23 will be easily distinguishable in an MRI or
x-ray by being adjacent to the thicker body thereby providing a
means to identify the port 14 as high pressure or otherwise. The
maker 23 of such material may include alphanumeric characters, or
preferably non alphanumeric symbolic marker 16, 17 such as a
triangle shown previously. By positioning the marker on the cap,
which provides a means to anchor the high pressure catheter to the
body, the risk of damaging the plastic walls of the body is
eliminated as is the risk of damage from long term storage with
inks applied to the body of the device. As noted, the marker 23 may
be applied using one or a plurality of the aforementioned x-ray
discernible materials yielding high contrast from surrounding
materials.
[0080] FIG. 5 shows a top view of a device 10 of FIG. 4 however in
another preferred mode wherein the infused ink alphanumeric or a
symbolic or iconic marker 23 is imparted on the septum 20 of the
port 14 alone or in combination with such on the body of the
catheter 34. The marker would be as with all markers herein, formed
of one or a combination of the aforementioned marker materials. It
must be noted that the mode currently shown as well as the other
modes disclosed may be employed separately or in combination with
one another and should therefor not be considered limiting by the
figures.
[0081] Further shown in the FIG. 5 is yet another preferred mode of
the cap member 21 wherein the cap 21 is a substantially planar body
26 employing a finger ingressable recess 28 providing means to
better grip the cap 21 for operative employment as described
previously. The cap 21 is shown in the engaged as used mode,
engaged to the catheter 34 and wherein the distal end 35 of the
catheter 34 is engaged to the outlet 15 of the port 14 while the
cap 21 is additionally frictionally and slidably engaged over and
providing a compression toward the catheter-engaged outlet 15.
[0082] A still further means for identification of the port 14 is
provided via the employment of an electronically activated tag
having an RFID 24 shown engaged to the cap 21. The RFID 24 employed
concurrently with an RFID reader 41 which will allow a medical
professional to merely scan over the users chest or other probable
location of the port 14 and receive port 14 information transmitted
via radio frequency (RF). Such information may include, but is not
limited to, the port serial number, install date, and the pressure
rating. As shown in FIG. 8, such radio frequency information may
also be received by Wi-Fi, bluetooth, or other transmitted means to
communicate directly with a computer or the CT scanner or power
injector as a fail safe means. For example, if RFID returns that
the port 14 is not high pressure rated, the CT or injector will
remain locked and deactivated. This is commonly referred to as a
`Go, No-go` type failsafe system.
[0083] It is within the scope of the present invention that the
infused ink alphanumeric marker 23, may be formed of one or a
combination of marker materials, from a group of marker materials
including non ferrous metals such as nitenol, tungsten, titanium,
stainless steel, and synthetic or ceramic materials such as teflon,
silicone nitride, Zirconium, gadolinium oxysulfide or inks formed
of a bio-compatible carrier containing one or a combination of the
x-ray discernable materials noted herein, and be imparted on the
body 18 of the port 14 such as shown in FIG. 6. In the figure, the
marker 23 provides a first means to discern a pressure rating and
the RFID 24 provides another means to discern a pressure rating.
The marker 23 is carefully imparted on the bottom surface 19 of the
body 18.
[0084] Again, it must be noted that, the marker 23 may preferably
instead be an iconic or symbolic marker 16, 17 such as a triangle
as previously shown and formed as noted above from the marker
materials group. A symbolic marker is more readably and positively
discernible by nonreaders and even by readers since they may be
sight impaired or without their reading glasses.
[0085] Shown in FIG. 7 is yet another preferred mode of the device
10 employing a dual system port 30 having a bifurcated outlet 32.
The maker in the form of an RFID 24 such as those of FIGS. 9 and 10
provides means to discern pressure rating and is shown imparted on
the top surface or engaged in a slot in the cap 21. There is an
additional employed marker shown on top of the septum 20 as
lettering. However, a symbol not requiring reading by a user can
also be employed. As noted two discernible markers provide dual
confirmation in all modes of the device without an x ray or CT scan
needed.
[0086] FIG. 8 shows a mode of the body 14 of the device employing
an RFID 24 in a conventional capacity which when energized by the
reader 41 transmits a data from the RFID 24 and RAM or ROM or other
means for electronic storage engaged with the within the RIFD and
located on the port body or catheter engaged clip. The transmit and
receive antennas for the RFID 24 are shaped in the triangle symbol
and are formed of metal adapted to receive RF energy from the
reader 41 so they appear on an x-ray as a visual symbol confirming
pressure rating. This combination provides dual confirmation of the
pressure rating of the port without the need for exposing the
patient to an x-ray or CT scan.
[0087] FIG. 9 depicts an energizable RFID 24 and other components
configured to provide a naked-eye-visible, or clearly audible
signal identifying its presence under a patient's skin. When
energized by a reader 41 or other RF emitted transmission, the LED
may either employ energy generated from the passive RFID board
using energy generated from the RF, or the LED 43 or may have its
own power supply and thereby be electronically activated to switch
on and illuminate which will be visible through the skin of the
patient if mounted in position adjacent thereto, thereby providing
a visibly discernible signal, through the skin of the patient, of
the hidden underlying port's high pressure readiness, without an
x-ray or scan.
[0088] In combination or as an alternative, energizing the RFID 24
may concurrently cause activation of an electronic sound generator
to activate a sonic alarm 45 such as a buzzer or beeper as well as
an LED 43 as well as the RFID 24. The multiple signaling component
configuration of the device 10 may be employed on any of the ports
herein. This provides, in one pass, a triple certification of high
pressure readiness.
[0089] FIG. 10 shows an RFID 24 having antennas 29 configured in
segments to yield a triangular shape on an X-ray thereby providing
the non alphanumeric symbol, which would be visible on X-ray to
identify the port. The RFID 24 is shown with the LED 43 and alarm
45. It is particularly preferred in all modes of the device herein,
that the RFID 24 be MRI-safe in that ferrous metal is minimized or
eliminated from the structure. Consequently, it is particularly
preferred that the antennas 29 and larger portions of the RFID 24
is formed of substantially non ferrous metal which will not be
moved or dismounted by the forces of an MRI such as aluminum,
copper, titanium or an alloy, tin, or nickel. These metals will not
be attracted to the magnetic force, and will not heat substantially
and will generally alone or in combinations and alloys receive and
transmit a sufficient signal to and from the RFID.
[0090] As noted earlier, the RFID 24 may be placed on the catheter
securement clip, to allow attachment to the port without attaching
to the walls forming it which can cause damage during manufacture
or long term storage which might not be noticed and potentially
cause harm to a patient if such a wall failed during use.
[0091] As additionally noted, the RFID 24 may include a wideband
broadcast antenna 29 for broadcasting upon multiple frequencies
with one or a plurality of RF data streams, employing frequencies
such as those associated with bluetooth and Wi-Fi transmissions.
When energized by RF, the RFID would transmit information stored in
ROM on the RFID 24 concerning the nature of the port. This dual
broadcast may also be employed as a fail safe or as a means for
transmission of a plurality of data streams about the device which
will allow the RFID 24 to communicate for instance with a
physician's medical record database configured to receive
transmitted identification data, or a visual display means such as
a computer or smartphone having software adapted to receive the
information broadcast from the ROM or RAM of the RFID and convert
it to a displayed image on the screen thereof.
[0092] FIG. 11 shows an overhead view of a port device employing
the clip 21 engaged upon the catheter 34 and having an RFID 24 on
or in a cavity in the clip 21 where such positioning will avoid
potential damage of placing a marker on the body of the port and
will also position it better to transmit and receive RF energy. The
RFID 24 is as in FIG. 9 and a triangular marker is shown on another
planar side of the clip.
[0093] FIG. 12 depicts a port device having an RFID 24 such as that
of FIG. 10 having one or both antennas 29 configured with segments
yielding the depiction of triangles which are visible on X-ray to
confirm pump pressure ratings. The RFID 24 is also shown with the
LED 43 and alarm 45. As noted, any of the audio, visual, or other
discernable markers shown or describe herein, may be employed
singularly or in combination with any other one or plurality of
such markers.
[0094] While all of the fundamental characteristics and features of
the disclosed device and method herein have been described herein,
with reference to particular embodiments thereof, a latitude of
modification, various changes and substitutions are intended in the
foregoing disclosure and it will be apparent that in some instance,
some features of the invention will be employed without a
corresponding use of other features without departing from the
scope of the invention as set forth. It should be understood that
such substitutions, modifications, and variations may be made by
those skilled in the art without departing from the spirit or scope
of the invention. Consequently, all such modifications and
variations are included within the scope of the invention as
defined herein.
* * * * *