U.S. patent application number 10/045501 was filed with the patent office on 2003-05-08 for aseptic enclosure for medical equipment and method of making same.
Invention is credited to Gabriele, Joseph M..
Application Number | 20030085147 10/045501 |
Document ID | / |
Family ID | 21938249 |
Filed Date | 2003-05-08 |
United States Patent
Application |
20030085147 |
Kind Code |
A1 |
Gabriele, Joseph M. |
May 8, 2003 |
Aseptic enclosure for medical equipment and method of making
same
Abstract
An aseptic enclosure for medical equipment having a flat end
wall, an integral frustoconical side wall and a retaining means
such as an elastic band adjacent the open end of the side wall. In
the preferred embodiment, the end wall includes a light-sensitive
audio chip coated with an opaque coating soluble in a disinfectant
or antiseptic solution and the thickness of the opaque coating
determines the number of washings required to expose the audio
chip, which provides a warning to the healthcare worker to replace
the aseptic enclosure. The method of forming the aseptic enclosure
includes heating a film, clamping the film and drawing the film to
the desired shape with a platen which is driven through an opening
in the clamp member.
Inventors: |
Gabriele, Joseph M.;
(Fenton, MI) |
Correspondence
Address: |
HOWARD & HOWARD ATTORNEYS, P.C.
THE PINEHURST OFFICE CENTER, SUITE #101
39400 WOODWARD AVENUE
BLOOMFIELD HILLS
MI
48304-5151
US
|
Family ID: |
21938249 |
Appl. No.: |
10/045501 |
Filed: |
November 7, 2001 |
Current U.S.
Class: |
206/570 |
Current CPC
Class: |
A61B 46/10 20160201;
A61B 2017/00119 20130101 |
Class at
Publication: |
206/570 |
International
Class: |
B65D 069/00 |
Claims
1. A method of forming an aseptic enclosure for medical equipment,
comprising the following steps: heating a thin sheet of a
thermoformable polymer to the thermoforming temperature of said
polymer; clamping a peripheral portion of said sheet at spaced
locations while said sheet remains at said forming temperature; and
driving a platen including an end face having a diameter less than
the distance between said spaced locations against said sheet and
through the plane of said sheet, said platen drawing said sheet,
reducing the thickness of said sheet and forming a bag-like
enclosure having an end wall conforming to said end face and an
integral conical side wall.
2. The method of forming an aseptic enclosure for medical equipment
as defined in claim 1, wherein said method includes clamping said
sheet with an annular clamp having a generally circular internal
diameter greater than said end face of said platen and driving a
platen generally circular end face against said sheet having an
outer surface generally equally spaced from said peripheral portion
forming a frustoconical side wall between said clamp and said
platen.
3. The method of forming an aseptic enclosure for medical equipment
as defined in claim 1, wherein said platen includes a generally
flat end face and said method including drawing a vacuum through
said end face of said platen and driving said generally flat end
face against said sheet, forming a bag-like enclosure having a
generally flat bottom wall and a frustoconical side wall.
4. The method of forming an aseptic enclosure for medical equipment
as defined in claim 1, wherein said method includes clamping said
sheet with an annular clamp having an internal diameter less than
an external diameter of said platen and drawing a vacuum through
said annular clamp.
5. The method of forming an aseptic enclosure for medical equipment
as defined in claim 1, wherein said method includes affixing a
light-sensitive audio chip to an external surface of said sheet and
coating said chip with a soluble opaque coating.
6. The method of forming an aseptic enclosure for medical equipment
as defined in claim 5, wherein said platen includes a generally
flat end face, wherein said method includes driving said end face
of said platen against said sheet and forming a bag-like enclosure
with a generally flat end face and embedding said light-sensitive
audio chip in said generally flat end face of said enclosure.
7. The method of forming an aseptic enclosure for medical equipment
as defined in claim 1, wherein said method includes securing an
elastic band around a surface of said bag-like enclosure adjacent
an open end of said enclosure.
8. The method of forming an aseptic enclosure for medical
equipment, comprising the following steps: heating a thin film of a
thermoformable medical grade polymer to the thermoforming
temperature of said polymer; clamping said film with a clamp having
an opening therethrough while said sheet remains at said
thermoforming temperature; driving a generally flat end face of a
platen having an outer diameter less than an internal diameter of
said opening through said clamp against said film through the plane
of said film, said platen drawing said sheet, reducing the
thickness of said film and forming a bag-like enclosure having a
generally flat closed end and a frustoconical side wall.
9. The method of forming an aseptic enclosure for medical equipment
as defined in claim 8, wherein said method includes drawing a
vacuum through said clamp.
10. The method of forming an aseptic enclosure for medical
equipment as defined in claim 8, wherein said method includes
drawing a vacuum through said end face of said platen.
11. The method of forming an aseptic enclosure for medical
equipment as defined in claim 8, wherein said method includes
affixing a light-sensitive audio chip to an outer surface of said
film and coating said chip with a soluble opaque coating.
12. The method of forming an aseptic enclosure for medical
equipment as defined in claim 11, wherein said method includes
embedding said light-sensitive audio chip in said end face of said
enclosure.
13. The method of forming an aseptic enclosure for medical
equipment as defined in claim 12, wherein said method includes
coating said light-sensitive audio chip with a coating soluble with
an antiseptic solution.
14. The method of forming an aseptic enclosure for medical
equipment as defined in claim 8, wherein said method includes
heating a thin film of a partially translucent polyolefin medical
grade polymer having a thickness of about 4 to 6 mils and drawing
said film through a thickness of less than 3 mils, forming a
transparent bag-like enclosure.
15. The method of forming an aseptic enclosure for medical
equipment, comprising the following steps: forming a flexible film
of a medical grade polymer into an enclosure having a closed end
and an open end adapted to receive medical equipment; affixing a
light-sensitive audio chip to an external surface of said
enclosure; and coating said light-sensitive audio chip with an
opaque film soluble in an antiseptic solution.
16. The method of forming an aseptic enclosure for medical
equipment as defined in claim 15, wherein said method includes
coating said light-sensitive audio chip with an opaque coating
which is soluble and removable with a predetermined number of
washings with an antiseptic solution.
17. The method of forming an aseptic enclosure for medical
equipment as defined in claim 15, wherein said method includes
embedding said light-sensitive audio chip in said film with an end
face of said light-sensitive audio chip flush with said film.
18. The method of forming an aseptic enclosure for medical
equipment as defined in claim 15, wherein said method further
includes the following steps: heating said film to the
thermoforming temperature of said film; clamping a peripheral
portion of said film at spaced locations while said film remains at
said thermoforming temperature; and driving a platen having an
external diameter less than a distance between said spaced
locations against said film through the plane of said film, wherein
said platen draws said film, reduces its thickness and forming a
bag-like enclosure having an end wall and a conical side wall.
19. The method of forming an aseptic enclosure for medical
equipment as defined in claim 18, wherein said method includes
affixing said light-sensitive audio chip to said end wall of said
enclosure.
20. A bag-like aseptic enclosure for medical equipment formed of a
flexible film of a medical grade polymer having a closed end and an
open end for receipt of medical equipment including a
light-sensitive audio chip affixed to an outer surface of said
enclosure coated with an opaque coating soluble in an antiseptic
solution.
21. The bag-like aseptic enclosure as defined in claim 20, wherein
said closed end of said enclosure is generally flat and said
light-sensitive audio chip is affixed to said generally flat closed
end of said enclosure.
22. The bag-like aseptic enclosure as defined in claim 21, wherein
said light-sensitive audio chip is embedded in said generally flat
closed end of said enclosure having an end face generally flush
with said flat end.
23. The bag-like aseptic enclosure as defined in claim 21, wherein
said enclosure includes a frustoconical side wall surrounding said
generally flat end.
24. The bag-like aseptic enclosure as defined in claim 20, wherein
said enclosure includes a flexible elastic band adjacent said open
end of said enclosure.
25. The bag-like aseptic enclosure for medical equipment formed of
a flexible film of a medical grade polymer comprising a generally
flat end wall, a frustoconical side wall integral with said end
wall having a minor diameter adjacent said end wall, an open end
adjacent a major diameter of said frustoconical side wall and a
flexible elastic band adjacent said open end.
26. The bag-like aseptic enclosure for medical equipment as defined
in claim 25, wherein said bag-like aseptic enclosure includes a
light-sensitive audio chip affixed to an outer surface of said
enclosure and an opaque coating over said light-sensitive audio
chip wherein said opaque coating is soluble in an antiseptic
solution.
27. The bag-like aseptic enclosure as defined in claim 26, wherein
said opaque coating may be removed by a predetermined number of
washings with an antiseptic solution.
28. The bag-like aseptic enclosure as defined in claim 26, wherein
said light-sensitive audio chip is affixed to said end wall of said
enclosure.
Description
FIELD OF THE INVENTION
[0001] This invention relates to an aseptic enclosure for medical
equipment and instruments and a method of forming such enclosures.
The method of this invention is particularly adapted to form an
aseptic enclosure which may be tailored to be received over and
enclose particular designs of medical equipment and washed with an
antiseptic solution for continued use following contamination. The
aseptic enclosure of this invention further includes an audio
warning system to signal when the enclosure should be replaced.
BACKGROUND OF THE INVENTION
[0002] Good medical practice now requires enclosure of medical
apparatus and equipment with an aseptic or antiseptic enclosure. As
used herein, "medical equipment" is intended to broadly cover any
equipment or apparatus which is subject to biological or other
contamination, including but not limited to equipment and apparatus
used by the medical and dental professions. For example, medical
equipment and apparatus in the surgical theater must be enclosed
with an aseptic or antiseptic enclosure which is now replaced after
each surgery. Such enclosures are generally formed by folding over
a rectangular sheet of plastic and sealing the side edges, forming
a rectangular bag. Such bag-like medical enclosures are not
designed for a particular apparatus and therefore include loose
side edges which require a medical technician to fold over the
excess material which is then generally taped or otherwise secured
to avoid contact by the medical personnel. Surgical procedure, for
example, requires the surgeon and medical personnel in an operating
theater to re-scrub if they contact the enclosure.
[0003] There is, therefore, a longstanding need for an improved
medical enclosure which is tailored to enclose particular designs
of medical equipment which does not include loose side edges and
which conforms to the shape of the medical equipment to be
enclosed. It would also be desirable to be able to clean such
enclosures with an antiseptic solution for continued use. However,
such enclosures are not suitable for reuse because the fastening
means used to secure the sides of the enclosure, such as tape, may
become contaminated. Finally, conforming the shape of the present
enclosures to the shape of the medical equipment is a time-wasting
and expensive procedure, particularly with the critical shortage of
medical technicians.
[0004] The method of forming an aseptic enclosure for medical
equipment of this invention solves these problems by providing a
form-fitting aseptic enclosure for medical equipment which may be
sterilized or disinfected for reuse and which preferably provides
an audio warning when the enclosure should be replaced.
Alternatively, the aseptic enclosure of this invention may be
disposable.
SUMMARY OF THE INVENTION
[0005] The method of forming an aseptic enclosure for medical
equipment of this invention includes heating a thin sheet or film
of a thermoformable polymer to its thermoforming temperature. In
the preferred embodiment, the thin polymeric sheet is a film of
medical grade polymer having a thickness of between 4 to 6 mils
(100 to 150 .mu.m), most preferably a polyolefin film. Medical
grade polyolefin films are generally made of organic ethylene
polymers which are translucent. As used herein, the term "aseptic,"
is intended to broadly cover polymeric sheets or film which are
free from pathogenic microorganisms including sterile applications.
Most preferably, the aseptic sheet or film may be washed with an
antiseptic solution for continued use as described further
below.
[0006] The method of this invention then includes clamping a
peripheral portion of the polymeric sheet or film at spaced
locations while the sheet or film remains at the forming
temperature. In the most preferred embodiments, the method includes
clamping the sheet or film with an annular clamp. As will be
understood, the shape of the annular clamp will depend upon the
particular application for the aseptic enclosure. For example, the
annular clamp may be rectangular to form an enclosure having a
rectangular shape. But in the most preferred embodiment, the
annular clamp is curvilinear, most preferably circular, wherein the
annular clamp clamps the heated sheet or film from both sides and
most preferably includes a vacuum to securely retain the film
during forming.
[0007] The method of this invention then includes driving a platen
having a diameter less than the distance between the spaced
locations of the clamp having an outside diameter less than the
inside diameter of the annular clamp against the heated sheet or
film and through the plane of the sheet or film, thereby drawing
the film, reducing its thickness, and forming a bag-like enclosure
having a continual conical side wall integral with the end wall. In
the most preferred embodiment, the platen has the same shape as the
inside surface of the clamp, such that where the clamp is annular
or circular, the outside surface of the platen is similarly shaped.
As will be understood, the outside shape of the clamp is not
material and the clamp may include, for example, a rectangular
outside surface conforming to the shape of the sheet and a circular
opening. In the most preferred embodiment, the platen has a flat or
generally flat end surface, forming an enclosure having a flat
bottom wall and a frustoconical side wall, wherein the minor
diameter of the frustoconical side wall is integral with the bottom
wall formed by the platen and a major diameter at the opening to
the enclosure. As will be understood, an aseptic enclosure having a
generally circular bottom wall and a frustoconical side wall will
conform to the shape of most medical equipment as defined above and
eliminates the loose side edges of a rectangular enclosure which
must be taped or otherwise secured to avoid contact with surgeons
and other healthcare workers, thereby reducing cost and providing a
more sterile atmosphere in a surgical theater, for example.
[0008] In the most preferred embodiments of the aseptic enclosures
and methods of this invention, the enclosure may be washed with an
antiseptic solution following a surgical procedure, for example,
thereby reducing cost and saving labor. As set forth above, the
aseptic medical enclosure of this invention eliminates the
requirement for taping or other means of securing the side portions
of a rectangular enclosure and therefore it is possible to continue
use of the aseptic enclosure of this invention by wiping or
cleaning the enclosure with an antiseptic, disinfecting or
sterilizing solution. However, because the film following drawing
is preferably relatively thin (e.g., 1 to 2 mils), there is a limit
to the number of times that the aseptic enclosure can be sterilized
with a sterilizing solution. The most preferred embodiment of the
aseptic enclosure of this invention therefore includes an audio
warning system to alert the healthcare worker to replace the
aseptic enclosure, which is preferably activated by repeated
washings of the enclosure with an antiseptic solution.
[0009] The preferred embodiments of the aseptic enclosure of this
invention includes a light-sensitive or light-actuated audio chip
affixed to an outer surface of the enclosure coated with an opaque
coating which is soluble or partially soluble in an antiseptic
solution. The opaque coating preferably has a thickness which may
be tailored to a predetermined number of washings with an
antiseptic solution, such as 3 to 5 or more washings. When the
opaque coating is removed after a predetermined number of washings
with an antiseptic solution, the light-sensitive audio chip will
then provide an audio warning to replace the aseptic enclosure. In
the preferred embodiment of the aseptic enclosure of this
invention, the light-sensitive or light-actuated audio chip is
imbedded in the generally flat end or bottom face of the enclosure,
such that the face of the audio chip is flush with the outer
surface of the bottom face of the enclosure. This not only makes it
easier to wipe clean the end surface of the enclosure, but also
avoids entrapment of microorganisms and other contaminants between
the chip and the film.
[0010] The light-sensitive audio chip may be embedded in the
polymeric film during the method of forming the enclosure of this
invention, most preferably while the polymeric sheet or film
remains at its thermoforming temperature. For example, a die member
may be positioned opposite the platen and the light-sensitive audio
chip may be placed on the die member, such that the light-sensitive
audio chip is imbedded in the bottom wall of the enclosure during
forming. The light-sensitive audio chip is then coated with an
opaque coating soluble in a suitable antiseptic disinfectant or
sterilizing solution either by spraying or painting.
[0011] The aseptic enclosure of this invention also preferably
includes a means of securing the enclosure to the medical equipment
to form fit the medical equipment enclosed. The securement means
may comprise an elastic band, a drawstring or the like. In the
preferred embodiment, an elastic band is applied to the side wall
of the enclosure adjacent the open end. Other advantages and
meritorious features of this invention will be more fully
understood from the following description of the preferred
embodiments, the appended claims and the drawings, a brief
description of which follows.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a side view of a conventional mobile imaging
system including the aseptic enclosures of this invention;
[0013] FIG. 2 is an end elevational view of one embodiment of the
aseptic enclosure of this invention;
[0014] FIG. 3 is a side cross-sectional view of the aseptic
enclosure shown in FIG. 2 in the direction of view arrows 3-3;
[0015] FIG. 4 is an enlarged view of the portion identified by
reference No. 4 in FIG. 3;
[0016] FIG. 5 is an enlarged view of FIG. 3 as indicated by view
arrow 5;
[0017] FIG. 6 is a schematic side view illustrating the method of
this invention;
[0018] FIG. 7 is a top view of FIG. 6;
[0019] FIG. 8 is a schematic view of the method illustrated in FIG.
6 following forming of the enclosure; and
[0020] FIG. 9 is a schematic illustration of coating the
light-sensitive audio chip.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] As set forth above, the aseptic enclosure of this invention
may be utilized to enclose medical equipment in various aseptic and
sterile environments and may be cleaned or washed with an
antiseptic solution for continued use following contamination. FIG.
1 illustrates a typical use for the aseptic enclosure of this
invention, but should be considered for illustrative purposes only.
FIG. 1 illustrates a conventional mobile imaging system 20 for
surgical and interventional procedures. The mobile imaging system
20 illustrated in FIG. 1 includes a fluoroscopic head 22 and an
intensifier head or tube 24. The fluoroscopic head 22 and
intensifier 24 are supported on a rotational C-arm 26. The
fluoroscopic head 22 and intensifier must be covered with a
transparent aseptic enclosure for many surgical and medical
applications. However, because the mobile imaging system forms no
part of this invention, but is disclosed for illustrative purposes
only, no further description of the mobile imaging system is
required.
[0022] FIGS. 2 to 5 illustrate a preferred embodiment of the
aseptic enclosure 30 of this invention which is also illustrated in
FIG. 1 enclosing the fluoroscopic head 22 and intensifier 24 of the
mobile imaging system 20. The disclosed embodiment of the aseptic
enclosure 30 includes a generally flat end or bottom wall 32 and a
frustoconical side wall 34 integral with the end wall 32. The
enclosure further includes an open end 36, wherein the end wall 32
is integral with the minor diameter of the frustoconical side wall
34 and the open end 36 is located at the major diameter of the
frustoconical side wall 34. As will be understood, however, from
the following description of the aseptic enclosure and method of
this invention, FIGS. 2 and 3 illustrate the extended or expanded
form of the aseptic enclosure 30 because the enclosure is formed
from a thin polymeric film and the enclosure preferably includes a
fastening means for securing the enclosure over a medical
instrument. In the disclosed embodiment, the enclosure 30 includes
an elastic band 38 as best shown at FIGS. 2 and 4 which is bonded
to the frustoconical side wall 34 by adhesive or heat-bonded. As
will be understood, the side wall 34 may be folded over the elastic
band 38 (not shown), or other conventional securement means
including a drawstring may be substituted for the elastic band to
retain the open end 36 to medical equipment, preferably providing
an air seal to prevent escape or entry of microorganisms and other
contaminants.
[0023] As set forth above, the most preferred embodiments of the
aseptic enclosures of this invention also include an audio warning
to alert healthcare workers that it is time to change the aseptic
enclosure 30. In this embodiment, the audio warning is provided by
a light-sensitive or light-actuated audio chip 40 which is imbedded
in the end surface 32 of the aseptic enclosure 30 as best shown in
FIG. 5. The light-sensitive audio chip 40 is then coated with an
opaque coating 42 which is soluble or partially soluble in a
suitable conventional liquid antiseptic or disinfectant solution.
The opaque coating 42 will then be removed following cleaning of
the aseptic enclosure 30 with an antiseptic solution. In the
preferred embodiment, the opaque coating 42 has a predetermined
thickness, such that the opaque coating will be removed only after
a predetermined number of washings with an antiseptic solution,
such that the light-sensitive audio chip 40 will be exposed to
light and provide a suitable audio warning as discussed further
below.
[0024] FIGS. 7 to 9 illustrate one preferred method of forming the
aseptic enclosure of this invention. The aseptic enclosure 30 shown
in FIGS. 1 to 5 of this invention is formed from a thin sheet or
film 44 of a thermoformable, preferably flexible polymer,
preferably a medical grade polyolefin film and most preferably a
metalocene polyethylene, such as MDF 7200 polyolefin film available
from The Dow Chemical Company. The polyolefin film 44 is a tough
soft flexible film having a thickness of between 4 to 6 mils. In
mass production applications, the thin film 44 is received from a
roll 46 to a heater 48 which heats the film to its thermoforming
temperature which, in the case of metalocene polyethylene is about
120.degree. F. The heater 48 may be any conventional heater
including a conventional radiant or infrared heater.
[0025] The heated film 44 is then received in a die clamp assembly
50 which, in the disclosed embodiment, includes a stationary lower
die clamp 52 and a moveable upper die clamp 54. In the preferred
embodiment, the upper and lower die clamp members 54 and 52,
respectively, are generally annular as shown in FIG. 7, such that
the die members fully clamp the heated film 44 and the inner
surfaces 53 of the lower die member 52 and 55 of the upper die
member 54 define an opening for receipt of the die platen 62
discussed below. As used herein, the term "annular" is intended to
be broadly interpreted to include any generally ring-shaped clamp
including opposed clamps having a rectangular opening or more
preferably a circular opening as shown in the drawings. The outer
shape of the die clamps may be any shape including circular or
rectangular. In a most preferred embodiment, the lower die clamp 52
has a circular opening 53 having a smaller diameter than the
circular opening 55 in the upper die clamp as shown. At least one
of the die clamps is preferably connected to a source of vacuum 58
by line 56 as shown in FIGS. 6 and 8 to securely retain the film 44
during forming as described below. In the disclosed embodiment, the
lower die clamp 52 is stationary and supports the heated film 44
and the upper die clamp 54 is moved to engage the film as shown by
arrow 60 in FIGS. 6 and 8 and the ramparts in FIG. 7. As will be
understood, either die clamp member or both die clamp members 52
and 54 may be relatively moveable.
[0026] The heated film is then formed by a platen 62 preferably
having a relatively flat end face 64 and a side face 66 having a
configuration similar to the configuration of the openings 53 and
55 through the die clamp members 52 and 54, respectively. Thus, in
the disclosed embodiment, the side face 66 of the platen 62 is
cylindrical where the openings 53 and 55 through the die clamps 52
and 54 are circular or cylindrical as shown. Further, the diameter
of the cylindrical side face 66 of the platen 62 is less than the
smallest diameter of the cylindrical openings 53 and 55 and
centered in the openings as shown. In the disclosed embodiment, the
die platen 62 is supported on a ram 68, such that the end face 64
of the platen 62 is moveable to engage the film 44 and moves
through the plane of the film 44, as shown by arrow 70 in FIG. 8.
The movement of the platen 62 deforms the heated film 44, as shown
in FIG. 8, and forms a frustoconical side wall 34 and the end face
64 of the platen 62 forms the generally flat end face 32 of the
aseptic enclosure 30 described above in regard to FIGS. 2 and 3. In
the disclosed embodiment, the platen 62 is also connected to the
source of vacuum 58 by line 56, assuring full contact of the end
face 64 of the platen 62 with the film 44. The outer edge of the
frustoconical side wall 34 may then be die cut by a die member (not
shown) which engages the upper surface of the lower platen 52
adjacent the opening 53 and a retaining means, such as the elastic
strip 38 described above may be attached to the frustoconical side
wall adjacent the opening 36 as described above.
[0027] In the most preferred embodiment of the aseptic enclosure 30
having an audio warning system as described above, the
light-sensitive or light-actuated audio chip 40 may be imbedded in
the end wall 32 of the aseptic enclosure during the forming process
shown in FIGS. 6 to 8. In this embodiment, the forming apparatus
includes a lower die member 72 opposite the die platen 62 having a
flat upper end face 74 which includes the light-sensitive audio
chip 40 as shown in FIGS. 6 and 8. In this embodiment, the lower
die member 72 is preferably connected to a source of vacuum 76 by
line 78, assuring that the heated film 34 is drawn taught over the
upper face 74 of the die member 72 and the light-sensitive audio
chip 40 is embedded in the end face 32 of the aseptic enclosure as
best shown in FIG. 5. Finally, the light-sensitive audio chip 40 is
coated with an opaque coating soluble or partially soluble in a
suitable antiseptic or sterilizing solution as shown in FIG. 9,
wherein the opaque coating is sprayed onto the audio chip 40 by a
nozzle 90 as shown. Alternatively, the opaque coating may be
applied to the exposed surface of the light-sensitive audio chip 40
by any other suitable means including painting with a brush or the
light sensitive audio chip may be purchased from the manufacturer
precoated with an opaque coating.
[0028] Having described the preferred embodiments of the aseptic
enclosure 30 and the method of forming the aseptic enclosure of
this invention, it will be understood that various modifications
may be made to the aseptic enclosure and method of forming the
enclosure described above within the purview of the appended
claims. In the preferred embodiment, the end wall 32 of the aseptic
enclosure 30 is circular as best shown in FIG. 2, which assures
that the aseptic enclosure form-fits most medical equipment or
apparatus, such as the head and intensifier of a mobile imaging
system shown in FIG. 1. However, as set forth above, the end
surface may also be rectangular by utilizing a platen 62 having a
rectangular end face and preferably annular die clamp members
having rectangular openings as set forth above. Further, the side
wall 34 of the enclosure is preferably frustoconical for ease of
receipt of the enclosure on the medical apparatus. Where the film
44 initially has a thickness of between 2 to 4 mils as described
above, the drawn aseptic enclosure 30 then has a thickness of
between 2 to 3 mils. The light-sensitive or light-actuated audio
chip may be any conventional sound chip of this type including
conventional light-sensitive or light-actuated sound chips
available from various sources including Honsitak Electronics Co.
Ltd. of Taipei, China. As will be understood by those skilled in
this art, any audio message may be included in the light-sensitive
or light-actuated sound chip. In the preferred embodiment, the
audio message includes a warning to replace the aseptic enclosure
following cleaning and washing with an antiseptic or disinfectant
solution, such as chlorhexidine or alcohol.
[0029] The thickness of the opaque coating or "ink" will determine
the number of washings with an antiseptic or disinfectant solution
required to expose the light-sensitive face of the light-sensitive
or light-actuated audio chip. Thus, the thickness can provide for
any number of washings with a disinfectant or antiseptic solution,
such as four to six washings. The audio chip then provides an audio
"replacement warning" to the healthcare worker requiring the
healthcare worker to replace the aseptic enclosure.
[0030] Finally, the method of forming an aseptic enclosure of this
invention may also be modified within the purview of the appended
claims. As set forth above, the film 44 is preferably heated prior
to clamping and forming as shown in FIGS. 6 to 8. As set forth
above, the die clamp is preferably annular, but may have any
suitable shape, but the method of forming preferably draws a
frustoconical side wall 34 as discussed above. The use of a vacuum
on the die platen 62 and the clamp members 52 and 54 is optional.
However, when the light-sensitive or light-actuated sound chip is
imbedded in the end wall as disclosed, the lower die member 72
preferably includes a vacuum as disclosed to imbed the chip in the
end wall of the enclosure. Alternatively, the light-sensitive audio
chip may be affixed or embedded in the side wall, particularly
where the side wall is more convenient to washing by the healthcare
worker. Finally, the length of the frustoconical side wall 34 will
depend upon the particular application and the stroke of the die
platen 62. Having described the preferred embodiments of the
aseptic enclosure and method of this invention, the invention is
now claimed as follows.
* * * * *