U.S. patent number RE43,860 [Application Number 12/917,433] was granted by the patent office on 2012-12-11 for reusable pulse oximeter probe and disposable bandage apparatus.
This patent grant is currently assigned to Masimo Corporation. Invention is credited to Brent Parker.
United States Patent |
RE43,860 |
Parker |
December 11, 2012 |
Reusable pulse oximeter probe and disposable bandage apparatus
Abstract
Pulse oximeter apparatus and method comprising a reusable pulse
oximeter probe and a disposable bandage. The bandage has
receptacles for receiving and aligning the oximeter's light
emitting diode and photocell detector.
Inventors: |
Parker; Brent (Gig Harbor,
WA) |
Assignee: |
Masimo Corporation (Irvine,
CA)
|
Family
ID: |
46604217 |
Appl.
No.: |
12/917,433 |
Filed: |
November 1, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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11432798 |
May 11, 2006 |
Re. 41912 |
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09679828 |
Oct 5, 2000 |
6519487 |
|
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09417898 |
Oct 14, 1999 |
6343224 |
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09289647 |
Apr 12, 1999 |
6144868 |
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60104332 |
Oct 15, 1998 |
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Reissue of: |
10237038 |
Sep 9, 2002 |
6735459 |
May 11, 2004 |
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Current U.S.
Class: |
600/344;
600/310 |
Current CPC
Class: |
A61B
5/14552 (20130101); A61B 5/6838 (20130101); A61B
5/6826 (20130101) |
Current International
Class: |
A61B
5/1455 (20060101) |
Field of
Search: |
;600/310,322,323,340,344,473,476 |
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|
Primary Examiner: Winakur; Eric
Attorney, Agent or Firm: Knobbe Martens Olson & Bear,
LLP
Parent Case Text
.[.Reference to Related Application.]. .Iadd.REFERENCE TO RELATED
APPLICATIONS .Iaddend.
.Iadd.Notice: More than one reissue application has been filed for
the reissue of U.S. Pat. No. 6,735,459. The reissue applications
which is a continuation application Ser. No. 11/432,798, filed May
11, 2006, now U.S. Pat. No. Re. 41,912 and the present application,
which is a continuation reissue application of the 11/432,798
application and claims the benefit thereof, both of which are
broadening reissues of U.S. Pat. No. 6,735,459..Iaddend.
.[.This.]. .Iadd.U.S. Pat. No. 6,735,459 .Iaddend.is a continuation
application of application U.S. Ser. No. 09/679,828 filed Oct. 5,
2000 (now U.S. Pat. No. 6,519,487), which in turn is a
continuation-in-part of U.S. Ser. .[.No..]. .Iadd.Nos. 09/417,898
filed Oct. 14, 1999 (now U.S. Pat. No. 6,343,224) and
.Iaddend.09/289,647 filed Apr. 12, 1999 (now U.S. Pat. No.
6,144,868) .[.and 09/417,898 filed Oct. 14, 1999 (now U.S. Pat. No.
6,343,224).].; which in turn claims benefit of provisional
application No. 60/104,332 filed Oct. 15, 1998.
Claims
What is claimed is:
.[.1. In a reusable pulse oximeter probe having a light-emitting
diode and a photocell detector, the improvement comprising a pair
of modular housings and wherein the light emitting diode and the
photocell detector of said probe are mounted on, or incorporated
into, one of said modular housings, respectively, each housing
having means for matedly engaging at least one bandage receptacle,
and being retained, at least in part, thereon or therein, by means
of a locking tab or lever..].
.[.2. The pulse oximeter probe of claim 1 wherein at least one of
said housings has mounted thereon, or incorporates therein, said
locking tab or lever..].
.[.3. The pulse oximeter probe of claim 1 wherein at least one of
said housings incorporates therein, a slot or indentation, said
slot or indentation for the purpose of retaining therein said
locking tab or lever, said locking lever being located on or in
said bandage receptacle or receptacles..].
.[.4. A disposable bandage apparatus comprising at least one face,
adhesive on at least a portion of said at least one face thereof,
and at least two receptacles mounted on said disposable apparatus,
each receptacle having means for matedly engaging at least one
housing of a pulse oximeter probe, and a locking mechanism
retaining at least a portion of said probe housing thereon or
therein..].
.[.5. An adhesive bandage apparatus, said adhesive bandage
apparatus comprising at least two receptacles mounted thereon, said
at least two receptacles each having at least one aperture or
radiation transparent window therein; at least a first of said
receptacles being adapted to matedly engage, and lock into place,
the housing of a pulse oximeter probe, said probe housing
containing, or having mounted thereon, at least one light emitting
diode; and a second of said receptacles being adapted to matedly
engage, and lock into place, the housing of a pulse oximeter probe,
said probe housing containing, or having mounted thereon, at least
one photocell detector; wherein when so mated, said probe housings
and bandage receptacles allow for the transmission and reception of
light through the apertures or radiation transparent windows of
said mated housings and receptacles, and through the appendage of a
patient..].
.[.6. An oximeter probe attachment system comprising, a first
adhesive bandage apparatus having at least one receptacle mounted
thereon, said at least one receptacle having at least one radiation
transparent window therein; said at least one receptacle being
adapted to matedly engage, and lock into place, the housing of a
pulse oximeter probe component, said housing containing, or having
selectively mounted thereon, at least one light emitting diode, or
having mounted thereon, at least one photocell detector; and at
least one second adhesive bandage apparatus having at least one
receptacle mounted thereon, said at least one bandage receptacle
being adapted to matedly engage, and lock into place, the housing
of a pulse oximeter probe component, said probe housing containing,
or having mounted thereon, at least one light emitting diode, or
said probe housing containing, or having mounted thereon, at least
one photocell detector; wherein said at least two adhesive bandage
apparati can be positioned upon a patient to allow for the
transmission and reception of light through the radiation
transparent windows of said mated housings and receptacles, and
through the appendage of said patient..].
.Iadd.7. A method for positioning a reusable sensor on a patient,
comprising: providing a patient attachment device having adhesive
on at least a portion thereof and having first and second probe
couplers operably attached thereto and configured to be matingly
engageable with probe housings of a reusable light emitting and
detecting probe sensor assembly, wherein the first and second probe
couplers comprise respective first and second locking features that
engage and disengage probe housings of a reusable probe sensor
assembly; positioning said patient attachment device on the
patient; and engaging probe housings of a reusable probe sensor
assembly with the first and second probe couplers..Iaddend.
.Iadd.8. The method of claim 7, further comprising sensing a light
signal transmitted through the patient..Iaddend.
.Iadd.9. The method of claim 7, further comprising disengaging
probe housings of the reusable probe sensor assembly from the first
and second probe couplers..Iaddend.
.Iadd.10. The method of claim 7, further comprising disposing of
the patient attachment device..Iaddend.
.Iadd.11. The method of claim 7, further comprising reusing the
probe sensor assembly..Iaddend.
.Iadd.12. A bandage apparatus configured to receive a sensor for
sensing a physiological parameter of a patient, the bandage
apparatus having adhesive on at least a portion thereof and
comprising first and second receptacles operably attached thereto
and configured to matedly engage first and second housings of the
sensor, and said receptacles being releasably securable to the
housings by one or more engagement mechanisms..Iaddend.
.Iadd.13. The bandage apparatus of claim 12, wherein at least one
of said first and second receptacles comprises at least one of the
one or more engagement mechanisms comprising a locking
element..Iaddend.
.Iadd.14. The device of claim 12, wherein at least one of said
first and second receptacles comprises at least one component
selected from the group consisting of a fastener, a hook-and-loop
type material, a snap-on connector, a ring, a groove, a notch, a
twistable connector, a contoured portion of a receptacle, a
threaded connector, a flange, a tab, an indentation and a
slot..Iaddend.
.Iadd.15. A device for use with a reusable probe sensor assembly in
a system for sensing a physiological parameter of a patient, the
device comprising a patient attachment having adhesive on at least
a portion thereof and first and second probe couplers, the first
and second probe couplers being operably attached to the patient
attachment and configured to be matingly engageable with probe
housings of a reusable probe sensor assembly, wherein the first and
second probe couplers comprise respective first and second locking
features that engage and disengage probe housings of a reusable
probe sensor assembly..Iaddend.
.Iadd.16. A probe system for sensing a physiological parameter of a
patient comprising a bandage apparatus having adhesive on at least
a portion thereof and having first and second receptacles mounted
thereon and being adapted to matedly engage, and lock into place,
first and second housings of a probe component, the first housing
comprising a light emitter and the second housing comprising a
light detector, wherein said bandage apparatus can be positioned
upon a patient to allow for the transmission and reception of a
signal through an appendage of the patient..Iaddend.
.Iadd.17. The device of claim 16, wherein at least one of said
first and second receptacles comprises at least one component
selected from the group consisting of a fastener, a hook-and-loop
type material, a snap-on connector, a ring, a groove, a notch, a
twistable connector, a contoured portion of a receptacle, a
threaded connector, a flange, a tab, an indentation and a
slot..Iaddend.
.Iadd.18. A system for sensing a physiological parameter of a
patient comprising: a probe assembly having a light emitter, a
light detector, and first and second housings for the light emitter
and light detector, respectively; and a bandage apparatus having
adhesive on at least a portion thereof and having first and second
receptacles operably attached thereto, and said receptacles having
locking features to engage and disengage with said housings of said
probe..Iaddend.
.Iadd.19. The device of claim 18, wherein at least one of said
locking features comprises at least one component selected from the
group consisting of a fastener, a hook-and-loop type material, a
snap-on connector, a ring, a groove, a notch, a twistable
connector, a contoured portion of a receptacle, a threaded
connector, a flange, a tab, an indentation and a slot..Iaddend.
.Iadd.20. A method of providing a sensor capable of sensing a
physiological parameter of a patient, the method comprising:
providing a sensor having first and second housings comprising a
light emitter and a light detector, respectively; providing a
bandage having adhesive on at least a portion thereof and having
first and second receptacles operably attached thereto and
configured to matedly engage said first and second housings; and
releasably securing said first and second housings to said first
and second receptacles by one or more engagement
mechanisms..Iaddend.
.Iadd.21. The method of claim 20, wherein said providing the sensor
comprises providing at least one of said first and second housings
including a locking element..Iaddend.
.Iadd.22. The method of claim 20, wherein said providing the
bandage comprises providing at least one of the first and second
receptacles including a locking element..Iaddend.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a method of making and affixing a
reusable probe to a patient by means of disposable bandage
apparatus so that there is no contact between the costly, reusable
portion of the probe and the patient. The contaminated bandage
apparatus, which is relatively inexpensive, can then be discarded
after single patient use and the probe can be re-used with a new
bandage apparatus.
Heretofore the use of pulse oximeter probes has been limited to the
use of a costly reusable probe, which is contaminated by use on a
patient, or cheaper, single-use probes, which, in the aggregate,
amount to a considerable expenditure for a health care
institution.
Other individuals have attempted to convert single use probes into
multi-use probes through a lamination process. In that process, the
original adhesive material is removed from the original
manufacturer's sensor. The sensor is then laminated in a plastic
sheath and the entire sheath is then inserted into a transparent,
adhesive-backed sleeve, which is then adhered to a patient. After
use, the probe can then be extracted from the sleeve and inserted
into a new sleeve for use on another patient.
There are certain disadvantages to this method. Firstly, it is
difficult to insert the flexible laminated sensor into a long
sleeve. Secondly, the thickness of a laminated sensor inside of a
sleeve makes it difficult to bend around, and to stick properly to,
a human appendage. Thirdly, transmission and reception of infrared
light can be affected by extraneous light entering from the sides
of the sleeve. And fourthly, there is some dispute as to the affect
on infrared light transmission when passing through the sleeve and
the adhesive material coupled thereto.
THE PRESENT INVENTION
The present invention not only solves the problems outlined above,
but offers an alternative that is cheap to manufacture and easy to
use.
The present invention is directed to improving the form and
affixation method of a reusable pulse oximeter sensor. It comprises
a reusable pulse oximeter probe with at least one light emitting
diode and one photocell detector wherein said emitter and detector
are enclosed in plastic housings, one housing having an aperture or
radiation transparent window aligned with said emitter, and the
other housing having an aperture or radiation transparent window
aligned with said detector. Also included is a disposable bandage
apparatus which is at least one bandage strip having adhesive on at
least a portion of at least one face thereof and at least two
plastic receptacles mounted thereon, each receptacle having at
least one aperture or radiation transparent window located therein.
The probe housings can matedly engage said bandage receptacles and
transmit and receive light through the apertures or radiation
transparent windows of said mated housings and receptacles, and
through the appendage of a patient. The housings of the reusable
pulse oximeter probe may also be made of a material selected from
plastic, rubber, metal, wood, or other composite material. The
receptacles of the disposable bandage apparatus may also be made of
a material selected from plastic, rubber, metal, wood, or other
composite material. Additionally, the apertures of said receptacles
are large enough to accept the tubular protrusions of the housings
for the purpose of concentric location and alignment of the
housings to the receptacles and the proper transmission and
reception of light therethrough. Sandwiched between the adhesive
strip and the receptacles attached thereto, are translucent
silicone windows or windows of another radiation transparent
material for isolation of the reusable probe assembly from the
patient. The bandage apparatus may be discarded after single
patient use and the reusable probe may be used again on another
patient in conjunction with another bandage apparatus.
Additionally, the receptacles of the bandage apparatus may have a
concave surface on one side thereof in order to seat conformably on
a human digit, or they may have a flat surface on at least one side
thereof in order to attach conformably to a human foot, nose, or
ear. The housings and receptacles also contain "mushroom hook" type
hook and loop material for the purpose of adhering and detaching
said housings to and from said receptacles. Additionally, the
housings and receptacles have recessed areas for adhesion of the
"mushroom hook" hook and loop material.
In another embodiment of the invention, the receptacle of the
disposable bandage apparatus may be the mushroom hook material
itself which may be attached directly to the adhesive strip for the
selective engagement of the housings of the probe assembly.
In another embodiment of the invention, the housings of the pulse
oximeter probe may be affixed to the receptacles of the disposable
bandage apparatus by means of a "ring and groove" type snap-on
connector.
In yet another embodiment of the invention, the housings of the
reusable pulse oximeter probe may be affixed to the receptacles of
the disposable bandage apparatus by means of a "twist and lock"
type connector.
In a further embodiment of the invention, the housings of the pulse
oximeter probe may be affixed to the receptacles of the disposable
bandage apparatus by means of a "threaded flange" type of
connector.
Finally, and in the first preferred embodiment of the invention,
The light emitting diode and photocell detector of the probe
assembly may be mounted in modular housings with locking levers
which can engage an indentation or slot in the receptacles of the
disposable bandage apparatus and securely lock the housings into
proper position within the receptacles, thus allowing the
transmission and reception of infrared light through the mated
housings and receptacles and through the appendage of a
patient.
In another variation of this preferred embodiment of the invention,
the levers and indentations are reversed, and the light emitting
diode and photocell detector of the probe assembly may be mounted
in modular housings having indentations therein, and the
receptacles of the disposable bandage apparatus may have the
locking lever located on them. In such an embodiment, the locking
levers of the bandage receptacles lockingly engage the slots or
indentations in the probe housings, thus locking them into place
within the receptacles and allowing the transmission and reception
of infrared light through the mated probe housings and bandage
receptacles, and through the appendage of a patient.
In these modular housing and receptacle embodiments the radiation
transparent windows, may be of hard plastic and may be mounted
against the skin of a patient, thus being used to secure the
receptacles on the opposite side of the bandage strip. This is
accomplished by the incorporation of locking levers on the
radiation transparent windows which are pushed through holes or
slots in the bandage and engage holes in the receptacles mounted on
the opposite side of the bandage, thus sandwiching the bandage in
between. A foam strip with holes in it may also be adhered to said
radiation transparent windows in order for them to rest comfortably
on a patient's appendage.
In another variation of the above, the bandage receptacles may be
secured to the bandage through the use of small plastic protrusions
or "heat stakes" mounted on the receptacles themselves. These
protrusions can be pushed through slots in the bandage and can be
melted on the other side of the bandage strip by means of an
ultrasonic welding machine, thus locking the receptacles into
position on the bandage strip. In this embodiment a radiation
transparent window may then be adhered to the underside of the
bandage strip and the heat stakes and radiation transparent windows
may then be overlaid with a foam pad with holes in it, the purpose
of which is to allow for the transmission and reception of infrared
light through the holes while aiding in patient comfort.
DESCRIPTION OF THE DRAWINGS
The above and other objects and features of the invention will
become more clear when considered with the following specifications
and accompanying drawings wherein:
FIG. 1 is an exploded view of the reusable pulse oximeter probe and
disposable bandage apparatus incorporating the invention;
FIG. 2 is a view of the reusable pulse oximeter probe and
disposable bandage apparatus shown individually as components of
the invention;
FIG. 3 illustrates the invention in use on a human finger or
digit;
FIG. 4 illustrates an exploded view of another embodiment of the
invention in which the "mushroom hook" material itself is used as
the receptacle of the disposable bandage apparatus;
FIG. 5 illustrates an assembled view of another embodiment of the
invention in which the housings of the pulse oximeter probe are
affixed to the receptacles of the disposable bandage apparatus by
means of ring and groove type, snap-on connectors;
FIG. 6 illustrates an assembled view of another embodiment of the
invention in which the housings of the pulse oximeter probe are
affixed to the receptacles of the disposable bandage apparatus by
means of "twist and lock" type connectors;
FIG. 7 illustrates an assembled view of another embodiment of the
invention in which the housings of the of the pulse oximeter probe
are affixed to the receptacles of the disposable bandage apparatus
by means of a "threaded flange" type of connector;
FIG. 8 illustrates an exploded view of the first preferred
embodiment of the reusable pulse oximeter probe in which the light
emitting diode and photocell detector of the probe are encased in
housings having a radiation transparent window therein and locking
levers for affixing the reusable pulse oximeter probe to the
disposable bandage apparatus;
FIG. 9 illustrates an exploded view of the first preferred
embodiment of the disposable bandage apparatus in which the
receptacle tops incorporate a slot for engaging the locking levers
of the modular probe housings, and wherein the radiation
transparent windows are mounted on the opposite side of the bandage
strip thus sandwiching and securing the bandage in between the two
receptacle halves by means of locking tabs or heat stakes that can
be ultrasonically welded;
FIG. 10 illustrates the first preferred embodiment of the invention
as it would appear ready for use on a human digit;
FIG. 11 illustrates an exploded view of the second preferred
embodiment of the invention in which the probe housings have a slot
or indentation incorporated therein and the bandage receptacles
have a locking lever for securing the housings to the
receptacles;
FIG. 12 illustrates an assembled view of the second preferred
embodiment of the invention in which the probe housings have a slot
or indentation incorporated therein and the bandage receptacles
have a locking lever for securing the housings to the
receptacles.
DESCRIPTION OF THE REUSABLE PULSE OXIMETER SENSOR
The Reusable Pulse Oximeter Sensor constitutes a "Y" style pulse
oximeter probe shown as FIG. 1, Item F. Said probe incorporates two
plastic housings shown as FIG. 1, Items G, said housings containing
apertures or radiation transparent windows therein, said apertures
or windows shown as FIG. 1, Items L. One housing contains the light
emitting diode of the probe, FIG. 1, item H, and the other contains
the photocell detector, FIG. 1, Item I. The emitter and detectors
are aligned with the apertures or windows of said housings in order
to transmit and receive light through a human appendage. Seated
within a recessed area of each housing, and attached permanently
thereto, is a "mushroom hook" adhesive-backed pad, FIG. 1, Item K.
The purpose of these pads is to selectively engage the "mushroom
hook" pads, FIG. 1, Items J, attached permanently to the plastic
discs, FIG. 1, Items D, and to attach the reusable probe assembly
to the Disposable Bandage Apparatus. The Reusable Pulse Oximeter
Sensor is shown assembled as FIG. 2, Item A.
In another embodiment of the invention the light emitting diode and
photocell detector of the reusable pulse oximeter-sensor are
enclosed in housings (FIG. 5, Items A) having a groove on the inner
diameter of the housings that is designed to matedly engage rings
(FIG. 5, Items B) located on the outer diameter of the disposable
bandage apparatus, thus securing and locking the sensor housings to
the bandage receptacles.
In another embodiment of the invention the light emitting diode and
photocell detector of the reusable pulse oximeter sensor are
enclosed in housings (FIG. 6, Items A) which are designed to enter
the bandage receptacles (FIG. 6, Items B) and to twist 90 degrees
thus locking the sensor housings to the bandage receptacles.
In yet another embodiment of the invention, the light emitting
diode and photocell detector of the reusable pulse oximeter sensor
are enclosed in housings (FIG. 7, Items A) having a threaded flange
(FIG. 7, Items B) that threadedly engages the bandage receptacles,
(FIG. 7, Items C) thus securing and locking the sensor housings to
the bandage receptacles.
In the first preferred embodiment of the Reusable Pulse Oximeter
Sensor, the light emitting diode (FIG. 8, Item A) and photocell
detector (FIG. 8, Item B) of the probe assembly are housed in
modular receptacles (FIG. 8, Items C) having locking levers, (FIG.
8, Items D) for engaging the receptacles (FIG. 9, Items A) of the
disposable bandage apparatus, and locking them into place.
In the second preferred embodiment of the Reusable Pulse Oximeter
Sensor, the light emitting diode (FIG. 11, Item A) and the
photocell detector (FIG. 11, Item B) are encased in modular
housings having a radiation transparent bottom (FIG. 11, Items C)
and having opaque housing tops (FIG. 11, Items D). These housing
tops and bottoms are ultrasonically welded together thus
encapsulating the light emitting diode and photocell detector of
the probe assembly. The housing tops incorporate indentations or
slots (FIG. 11, Items E) designed to matedly engage a protrusion on
the locking levers of the bandage receptacles thus snapping into
place and securing the probe housings within the bandage
receptacles.
DESCRIPTION OF THE DISPOSABLE BANDAGE APPARATUS
The components of the apparatus include an adhesive-backed, strip,
shown as FIG. 1, item A, said strip incorporating two oval
protrusions centered thereon and shown as FIG. 1, Item B. Said
strip also incorporates two apertures, centrally located within
said oval protrusions, FIG. 1, Item C, each aperture having a
diameter sufficient in size to accommodate the transmission and
reception of light from a light emitting diode and photocell
detector of a pulse oximeter probe.
On top of said apertures are seated two plastic discs, FIG. 1, Item
D, each having a concave base designed to conform to the radius of
a human digit, and an aperture of slightly larger diameter than the
apertures in the adhesive backed planar strip. Said plastic discs
are affixed to the adhesive planar strip by means of a permanent
adhesive. Seated in a recessed area on top of each plastic disc is
a "mushroom hook", adhesive backed pad shown as FIG. 1, Item J. The
purpose of the "mushroom hook" pads is to selectively engage the
"mushroom hook" pads attached to the probe, FIG. 1, Items K, and to
attach the probe to the disposable bandage apparatus. Sandwiched
between the two plastic discs and the planar adhesive strip are two
translucent silicone windows, FIG. 1, Item E. Said windows are
designed to permit the passage of infrared light and yet prevent
contact between probe and patient, and consequently, contamination
of the reusable probe itself.
The above items constitute the Disposable Bandage Apparatus of the
invention, said apparatus being shown assembled as FIG. 2, Item
B.
In another embodiment of the invention, the Disposable Bandage
Apparatus may be configured as in FIG. 4 of the drawings. In that
drawing there is an exploded view of the apparatus in which the
"mushroom hook" pads of the bandage apparatus, FIG. 4, Items J, are
bonded directly to the adhesive planar strip, FIG. 4, Item A, for
the selective engagement of the "mushroom hook" pads of the probe,
FIG. 4, Items K, said pads being attached permanently to the
housings of the probe, FIG. 4, Items G.
In other embodiments of the disposable bandage apparatus, the
bandage may have mounted thereon receptacles having means of
matedly engaging the housings of the reusable pulse oximeter sensor
by way of "ring and groove" snap-on type connectors (FIG. 5, Items
B); "Twist and Lock" type connectors (FIG. 6, Items B); or
"threaded flange" type connectors (FIG. 7, Items C).
In the first preferred embodiment of the Disposable Bandage
Apparatus, the bandage strip (FIG. 9, Item B) is sandwiched between
interlocking receptacle halves. The top halves of the receptacles
(FIG. 9, Items A) each contain 4 holes (FIG. 9, Items C) that are
designed to matingly engage locking tabs (FIG. 9, Items D) on the
bottom half of the receptacles (FIG. 9, Items E) that are pushed
through slots cut in the bandage strip (FIG. 9, Items F) thus
securing and locking the bandage in between.
The bandage strip contains two apertures or radiation transparent
windows (FIG. 9, Items G) allowing for the transmission and
reception of light from the light emitting diode and photocell
detector of the pulse oximeter sensor which are encased in modular
housings having locking levers (FIG. 8, Items D) wherein said
levers_engage slots in the receptacles (FIG. 9, Items H) thereby
locking the housings into place within the receptacles. In
addition, the bottom halves of the receptacles (FIG. 9, Items E)
can be of a radiation transparent material, or may contain
apertures (FIG. 9, Items I) thus allowing the light emitting diode
and photocell detector contained in the probe housings, when
engaged in the bandage receptacles, to transmit and receive light
through the apertures of the bandage strip and through the
radiation transparent material, or apertures, of the bottom halves
of the receptacles, and through the appendage of a patient. The
disposable bandage apparatus may also incorporate a foam strip
(FIG. 9, Item J) in order to cushion a patient's appendage from any
discomfort caused by the bottom half of the bandage receptacles.
The complete Reusable Pulse Oximeter Sensor, engaged in the
disposable Bandage Apparatus, and ready for use on a human
appendage, is shown in FIG. 10.
In the second preferred embodiment of the disposable bandage
apparatus, the bandage receptacles (FIG. 11, Items G) are secured
to the bandage (FIG. 11, Item K) by means of four protrusions or
"heat Stakes" (FIG. 11, Items H) which are pushed through slots
(FIG. 11, Items J) on the bandage (FIG. 11, Item K) and are
ultrasonically welded on the other side, thus securing the
receptacles to the bandage. A radiation transparent window (FIG.
11, Item M) is then adhered to the underside of the bandage and the
radiation transparent windows and melted heat stakes are then
overlaid by a foam pad (FIG. 11, Item L) to aid in patient comfort.
This foam pad also incorporates two holes which are in alignment
with the two holes on the bandage itself, and when the foam pad is
overlaid on the underside of the bandage, the radiation transparent
windows are sandwiched in between.
The probe housings are designed to matedly engage the bandage
receptacles (FIG. 11, Items G) and are held in place: within the
receptacles by means of protrusions (FIG. 11, Items F) on the
locking levers (FIG. 11, Items I) which snap into place when the
probe housings are pushed into the bandage receptacles. When the
probe housings are locked into place within the bandage receptacles
the light emitting diode and photocell detector are in alignment
with the holes in the bandage and the foam overlay, and the probe
is then able to transmit and receive light through the mated
housings and receptacles, through the holes contained in the
bandage and foam overlay, and through the appendage of a patient.
The complete assembled Reusable Pulse Oximeter Sensor engaged
within the Disposable Bandage Apparatus, as it would appear ready
for use on a patient, is shown in FIG. 12.
Other Fastening Means
As can be appreciated there are many ways of fabricating the above
components of the invention. The above description describes
attachment of the Reusable Pulse Oximeter Sensor to the Disposable
Bandage Apparatus by way of a "mushroom hook" type hook and loop
material, by the use of "ring and groove" type snap-on connectors,
"push and twist" type Luerlock connectors, and threaded flange type
connectors' as well as telephone type, modular connectors and
receptacles. While these means are fairly comprehensive, they
should in no way be considered exhaustive.
Method of Use
For use on each individual patient, the probe is affixed in the
following manner:
Firstly, the backing is removed from the adhesive strip of the
Disposable Bandage Apparatus. One of the apertures of the apparatus
is visually positioned on the center of the nail bed of the
patient's appendage and one side of the adhesive strip and the oval
protrusions are adhered to the patient's digit. The rest of the
strip is then looped over the end of the patient's appendage, and
the plastic disc is aligned so as to exactly oppose the plastic
disc already attached to the other side of the digit. Once the
Disposable Bandage Apparatus has been properly adhered to the
patient, the plastic housings of the probe assembly can be easily
snapped into place on opposing sides of the digit. The entire
assembled probe is shown as it would appear in use on a patient in
FIG. 3.
For use with the "ring and groove" type snap-on connectors, "twist
and lock", and "threaded flange" connectors, the backing is firstly
removed from the adhesive strip. The strip is then folded in half
where indicated on the bandage and the bandage apparatus is adhered
to either side of the human digit. Once the bandage apparatus is in
place the probe housings are simply snapped, twisted or screwed
into place.
For use with each patient, the modular probe and bandage assembly,
in both of_its embodiments, which are the preferred embodiments of
the invention, would be attached as follows:
Firstly, the backing is removed from the adhesive strip. The strip
is then folded where indicated on the bandage and the strip is then
adhered to opposing sides of the human digit. Once the bandage
apparatus is in place, the housings of the probe are pushed into
the receptacles and locked in place by means of the locking
levers.
In all embodiments of the invention, when the probe is no longer
required on the patient, the housings of the Reusable Probe are
simply unsnapped from the Disposable Bandage Apparatus, the bandage
apparatus is thrown away, and the probe can then be reused on a new
patient in conjunction with a new bandage apparatus.
ADVANTAGES OF THE PRESENT INVENTION
Current reusable pulse oximeter probes are either "Clam Shell" type
clamping devices which can restrict circulation or "Y" type probes
which are taped directly to the patient. Both types also come in
direct contact with the patient's skin and bodily fluids and need
sterilization after use. Because of the fact that these devices
incorporate many surfaces and at times, porous materials, proper
sterilization is very difficult. With the present invention there
is no contact between the reusable probe and the skin or bodily
fluids of the patient.
Disposable probes are very costly because of the fact that the
cable, connectors and photodiodes are all disposed of after use.
The present invention accomplishes the same goals as a disposable
probe from a cleanliness standpoint, but since only the attachment
apparatus is discarded after use, the cost is much less to a
healthcare institution.
The present invention, with the concave shape of the plastic discs
of the bandage apparatus, when backed by the adhesive strip, is
extremely effective in preventing the entrance of extraneous light
from the sides of the patient's digit. Current probes on the
market, whether disposable or reusable, because of the nature of
their shape and affixation means, have problems in dealing with
extraneous light reception.
The present invention utilizes an easy snap on, snap off, or
modular connector attachment means for attaching the probe to the
Disposable Bandage Apparatus. Probe-Shield type devices available
in the past not only required the modification of the original
manufacturer's probe, but required the difficult procedure of
inserting a flexible laminated probe into a sheath for each
patient.
Probe-Shield devices, because of the lamination process involved,
raised some concern over the transmission and reception of infrared
light through the laminating material. The present invention uses a
silicone window for the isolation of the probe from the patient.
Infrared light transmission and reception is not affected by
passage through translucent silicone.
In these days of environmental consciousness the annual waste
generated from tens of millions of disposable probes is enormous.
The present invention, if used in considerable numbers, would
greatly reduce the amount of environmental waste generated by
disposable pulse oximeter probes.
While the invention has been described in relation to preferred
embodiments of the invention, it will be appreciated that other
embodiments, adaptations and modifications of the invention will be
apparent to those skilled in the art.
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