U.S. patent application number 15/293612 was filed with the patent office on 2017-02-09 for use of sterile sleeve in production of surgical slush.
The applicant listed for this patent is C.degree. Change Surgical LLC. Invention is credited to Philip Morrison Allred, III, Patrick Kammer, Kevin Joseph Rackers.
Application Number | 20170035603 15/293612 |
Document ID | / |
Family ID | 58488443 |
Filed Date | 2017-02-09 |
United States Patent
Application |
20170035603 |
Kind Code |
A1 |
Kammer; Patrick ; et
al. |
February 9, 2017 |
Use of Sterile Sleeve in Production of Surgical Slush
Abstract
Production of sterile therapeutic medium such as sterile
surgical slush for use in surgery. A sterile slush container with a
sterile sleeve assembly so that the outside of the sterile slush
container remains sterile after placement in a non-sterile slush
making machine so that the sterile slush container may be returned
to the sterile field after removal of the sterile slush container
from the sleeve assembly.
Inventors: |
Kammer; Patrick;
(Greensboro, NC) ; Rackers; Kevin Joseph;
(Summerfield, NC) ; Allred, III; Philip Morrison;
(Kernersville, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
C.degree. Change Surgical LLC |
Winston-Salem |
NC |
US |
|
|
Family ID: |
58488443 |
Appl. No.: |
15/293612 |
Filed: |
October 14, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US16/55524 |
Oct 5, 2016 |
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15293612 |
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14875589 |
Oct 5, 2015 |
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PCT/US16/55524 |
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62237525 |
Oct 5, 2015 |
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62085590 |
Nov 30, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2007/101 20130101;
F25C 2400/12 20130101; A61B 46/00 20160201; B65D 85/1054 20130101;
B65D 2205/00 20130101; F25C 2301/002 20130101; A61F 7/00 20130101;
A61L 2202/23 20130101; A61F 2007/0063 20130101; A61B 2050/0054
20160201; A61B 42/40 20160201; A61F 7/10 20130101; A61F 2007/108
20130101; A61F 2007/0098 20130101; A61B 50/30 20160201; F25C 5/06
20130101; A61B 50/00 20160201; A61B 50/31 20160201; B65D 77/0486
20130101; A61B 42/10 20160201; A61F 7/0085 20130101; F25C 1/125
20130101; F25C 1/00 20130101 |
International
Class: |
A61F 7/00 20060101
A61F007/00; F25C 5/06 20060101 F25C005/06; F25C 1/12 20060101
F25C001/12 |
Claims
1. A method for production of sterile surgical slush outside of a
sterile field and subsequent delivery of sterile surgical slush to
the sterile field; the method comprising: placing a quantity of
sterile saline into a non-sterile slush making device located
outside of the sterile field, the sterile saline contained in a
slush container, a set of interior and exterior surfaces of the
slush container starting as sterile; the slush container enveloped
by a sleeve assembly comprising a container sleeve that covers at
least a portion of the slush container and a sleeve cap engaged
with the container sleeve, the sleeve assembly is initially sterile
but an exterior of the sleeve assembly is deemed not sterile not
later than once the sleeve assembly with slush container is placed
into the slush making device; removing the slush container
enveloped by the sleeve assembly from the slush making device after
conversion of the sterile saline to sterile surgical slush;
separating the sleeve cap from the container sleeve to expose a
portion of the slush container; and maintaining the slush container
as sterile while removing the slush container from the container
sleeve and moving the slush container into the sterile field so
that the slush container may be opened and the sterile saline slush
may be used when needed.
2. The method of claim 1 wherein separating the sleeve cap from the
container sleeve to expose a portion of the slush container is
achieved by separating the sleeve cap from the container sleeve to
expose a lid and on a lid end of the slush container.
3. The method of claim 1 wherein separating the sleeve cap from the
container sleeve to expose a portion of the slush container is
achieved by separating the sleeve cap from the container sleeve to
expose a bottom end of the slush container.
4. The method of claim 1 wherein the slush container comprises a
flexible bag of saline.
5. The method of claim 1 further comprising providing sterile
saline slush to a receptacle within the sterile field.
6. The method of claim 1 wherein the sleeve cap becomes engaged
with the container sleeve and subsequent separating the sleeve cap
from the container sleeve to expose the portion of the slush
container requires destruction of a portion of the sleeve assembly
so that the sleeve assembly is not accidentally used a second
time.
7. The method of claim 6 wherein the destruction of the portion of
the sleeve assembly requires destruction of a portion of the
container sleeve.
8. The method of claim 6 wherein the destruction of the portion of
the sleeve assembly requires destruction of a portion of the sleeve
cap.
9. The method of claim 1 wherein the slush container comprises a
slush bottle with a lid engaged with a lid end of the slush
bottle.
10. The method of claim 9 wherein the sterile saline is poured into
the slush bottle to partially fill the slush bottle; the lid is
fastened to the slush bottle; the slush bottle is placed into the
container sleeve; and the sleeve cap is placed over the slush
bottle and engaged with the container sleeve before placing the
sterile saline within the slush container within the sleeve
assembly into the slush making device.
11. The method of claim 9 wherein the slush bottle is placed into
the container sleeve; the sterile saline is poured into the slush
bottle to partially fill the slush bottle; the lid is fastened to
the slush bottle; and the sleeve cap is placed over the slush
bottle and engaged with the container sleeve before placing the
sterile saline within the slush container within the sleeve
assembly into the slush making device.
12. The method of claim 1 wherein the container sleeve has a set of
at least one longitudinal vent which allows air to move from a top
end of the container sleeve to a space between an exterior bottom
of the slush container and an interior bottom of the container
sleeve to facilitate removal of the slush container from the
container sleeve.
13. The method of claim 1 wherein insertion of the slush container
into the container sleeve expands the container sleeve.
14. A sleeve assembly comprising a container sleeve and a sleeve
cap which may be engaged with the container sleeve to envelope a
slush container; the container sleeve having a set of at least one
vent which allows air to move from a top end of the container
sleeve to a space between a bottom of an inserted slush container
and a bottom of the container sleeve to facilitate removal of the
slush container from the container sleeve; and the sleeve assembly
including an attachment system to allow the sleeve cap to be
engaged with the container sleeve and then become disengaged so
that the slush container may be removed from the container
sleeve.
15. The sleeve assembly of claim 14 wherein the attachment system
to allow the sleeve cap to be engaged with the container sleeve and
then become disengaged with the container sleeve uses a single-use
attachment system to allow the sleeve cap to be engaged with the
container sleeve and then become disengaged by destroying a portion
of the single-use attachment system so that a previously used
sleeve assembly is not mistaken for an un-used sleeve assembly.
16. The sleeve assembly of claim 15 wherein destroying a portion of
the single-use attachment system destroys a portion of the
container sleeve.
17. The sleeve assembly of claim 15 wherein destroying a portion of
the single-use attachment system destroys a portion of the sleeve
cap.
18. The sleeve assembly of claim 14 further comprising a sticker
placed across a joint between the container sleeve and the engaged
sleeve cap so that disengaging the engaged sleeve cap from the
container sleeve modifies the sticker so that the sticker indicates
that the sleeve cap has been disengaged from the container sleeve
after the sticker was placed across the joint between the container
sleeve and the engaged sleeve cap.
19. A kit for use in production and delivery of sterile surgical
slush, the kit comprising: a slush container for containing sterile
saline; a container sleeve with a bottom, an open top end, and a
sleeve wall between the bottom and the open top end, the container
sleeve sized to receive the slush container so that a bottom of the
slush container makes contact with the container sleeve bottom; a
sleeve cap which is sized to fit over a portion of the slush
container extending out of the open top end of the container
sleeve, and a single-use attachment system to join the container
sleeve and the sleeve cap so that the slush container may be
enveloped by the container sleeve and sleeve cap, and subsequent
separation of the container sleeve and sleeve cap to expose the
slush container extending out the open top end of the container
sleeve destroys a portion of the single-use attachment system so
that the container sleeve and sleeve cap are not joined together a
second time.
20. The kit of claim 19 wherein the slush container cannot entirely
fit within the container sleeve and extends out of the open top end
of the container sleeve.
21. The kit of claim 19 wherein the slush container comprises: a
slush bottle with a bottom, an open lid end, and walls between the
bottom and the lid end to form a receptacle for containing sterile
saline; and a lid which may be removably engaged with the lid end
of the slush bottle to form a water tight seal.
22. The kit of claim 19 wherein the slush container comprises a
sterile flexible bag that may receive sterile saline after shipment
of the kit, the received sterile saline may be cooled to form
sterile surgical slush.
23. The kit of claim 19 wherein the slush container comprises a
sterile flexible bag at least partially filled with sterile saline
before shipment of the kit, the sterile saline may be subsequently
cooled to form sterile surgical slush.
24. The kit of claim 19 wherein the single-use attachment system
uses a tear tab rim which is removed to allow subsequent separation
of the container sleeve and sleeve cap to expose a lid end of the
slush container.
25. The kit of claim 24 wherein the tear tab rim is located on the
container sleeve.
26. The kit of claim 24 wherein the tear tab rim is located on the
sleeve cap.
27. The kit of claim 19 wherein the sleeve wall contains at least
one vent to allow air to move through the vent to a space between
the bottom of the container sleeve and a bottom of the slush
container.
28. The kit of claim 19 further comprising a slush making machine
adapted to receive a sleeve and joined sleeve cap containing a
slush bottle and an engaged lid, the slush bottle and engaged lid
containing a volume of sterile saline, the slush making machine
adapted to cool the sterile saline so that the sterile saline
becomes sterile saline slush.
29. The kit of claim 19 further comprising a volume of sterile
saline for use in the production of sterile slush.
30. The kit of claim 19 wherein the sterile saline is within a
sterile slush bottle with engaged sterile lid, the slush bottle and
engaged lid within a sleeve assembly having a sleeve engaged with a
sleeve cap such that the sleeve assembly is ready for insertion
into a slush making machine.
Description
[0001] This application is a continuation of co-pending and
commonly assigned PCT Application No. PCT/US16/55524 filed Oct. 5,
2016 for Use of Sterile Sleeve in Production of Surgical Slush. The
'524 application is incorporated by reference. Through the '524
application, this application claims the benefit of and
incorporates by reference U.S. Provisional Patent Application No.
62/237,525 filed Oct. 5, 2015 for Use of Sterile Sleeve in
Production of Surgical Slush.
[0002] This application claims priority to and incorporates by
reference co-pending U.S. patent application Ser. No. 14/875,589
filed Oct. 5, 2015 for Production of Well-Mixed Slush.
[0003] Through the '589 application, this application claims
benefit of and incorporates by reference U.S. Provisional
Application No. 62/085,590 filed Nov. 30, 2014 for Production of
Well-Mixed Surgical Slush via Eccentric Oscillation.
BACKGROUND
Field of the Disclosure
[0004] This disclosure relates generally to the production of
sterile therapeutic medium such as sterile surgical slush for use
in surgery. More particularly, this disclosure is related to
covering a sterile slush container with a sterile sleeve assembly
so that the outside of the sterile slush container remains sterile
after placement in a non-sterile slush making machine so that the
sterile slush container may be returned to the sterile field after
removal of the sterile slush container from the sleeve
assembly.
[0005] Sterile saline slush is used in a variety of surgical
applications to slow organ and tissue metabolic rates thereby
protecting organs from irreversible tissue damage during cardiac,
neurological organ transplant, vascular, urologic and other complex
surgeries. It is important that the slush has as smooth and
spherical a configuration as possible to ensure atraumatic slush
without sharp crystal edges that could puncture or damage tissue.
The slush should have a substantially uniform consistency to
maintain optimal thermodynamic cooling performance. Surgical slush
is a mix of ice crystals formed while cooling saline and some
amount of liquid saline that remains in liquid form.
[0006] Unless explicit to the contrary, the word "or" should be
interpreted as an inclusive or rather than an exclusive or. Thus,
the default meaning of or should be the same as the more awkward
and/or.
[0007] This disclosure discusses the delivery of sterile surgical
slush to a slush receptacle such as a basin shown in FIG. 3. The
term basin is used in subsequent descriptions. There are many slush
receptacles that may receive and hold surgical slush for subsequent
use. Those of skill in the art will recognize that the teachings of
the present disclosure for delivery of sterile surgical slush to a
basin apply to other wide mouth receptacles, whether the receptacle
is called a: trough, barrel, pitcher, vat, reservoir or tank, pot,
pail, jar, bucket, tub, or some other term. The term slush
receptacle is intended to include the term basin and all other
items that that may receive and hold surgical slush for subsequent
use.
[0008] This disclosure discusses the placement of a sleeve around a
slush container. One example of slush container is a bottle or
elongated jar with a reversibly removable lid. As described below,
other slush containers may be used including bags containing slush
or bag/jar hybrids with a threaded cap on one end of a bag.
SUMMARY OF THE DISCLOSURE
[0009] This summary is meant to provide an introduction to the
concepts that are disclosed within the specification without being
an exhaustive list of the many teachings and variations upon those
teachings that are provided in the extended discussion within this
disclosure. Thus, the contents of this summary should not be used
to limit the scope of the claims that follow.
[0010] Inventive concepts are illustrated in a series of examples,
some examples showing more than one inventive concept. Individual
inventive concepts can be implemented without implementing all
details provided in a particular example. It is not necessary to
provide examples of every possible combination of the inventive
concepts provide below as one of skill in the art will recognize
that inventive concepts illustrated in various examples can be
combined together in order to address a specific application.
[0011] One way to summarize some of the many teachings of the
present disclosure is a method for production of sterile surgical
slush outside of a sterile field and subsequent delivery of sterile
surgical slush to the sterile field. The method may be described
as: [0012] placing a quantity of sterile saline into a non-sterile
slush making device located outside of the sterile field, the
sterile saline contained in a slush container, a set of interior
and exterior surfaces of the slush container starting as sterile;
[0013] the slush container enveloped by a sleeve assembly
comprising a container sleeve that covers at least a portion of the
slush container and a sleeve cap engaged with the container sleeve,
the sleeve assembly is initially sterile but an exterior of the
sleeve assembly is deemed not sterile not later than once the
sleeve assembly with slush container is placed into the slush
making device; [0014] removing the slush container enveloped by the
sleeve assembly from the slush making device after conversion of
the sterile saline to sterile surgical slush; [0015] separating the
sleeve cap from the container sleeve to expose a portion of the
slush container; and [0016] maintaining the slush container as
sterile while removing the slush container from the container
sleeve and moving the slush container into the sterile field so
that the slush container may be opened and the sterile saline slush
may be used when needed.
[0017] Another way to summarize some of the many teachings of the
present disclosure is a sleeve assembly with a container sleeve and
a sleeve cap which may be engaged with the container sleeve to
envelope a slush container. The container sleeve having a set of at
least one vent which allows air to move from a top end of the
container sleeve to a space between a bottom of an inserted slush
container and a bottom of the container sleeve to facilitate
removal of the slush container from the container sleeve. The
sleeve assembly including an attachment system to allow the sleeve
cap to be engaged with the container sleeve and then become
disengaged so that the slush container may be removed from the
container sleeve.
[0018] The sleeve cap may be engaged with the container sleeve with
a single-use attachment system that destroys a portion of the
single-use attachment system when the sleeve cap is disengaged from
the container sleeve. The portion destroyed may be on the sleeve
cap or on the container sleeve.
[0019] Yet another way to summarize some of the many teachings of
the present disclosure is a kit for use in production and delivery
of sterile surgical slush. The kit having:
[0020] a slush container for containing sterile saline;
[0021] a container sleeve with a bottom, an open top end, and a
sleeve wall between the bottom and the open top end, the container
sleeve sized to receive the slush container so that a bottom of the
slush container makes contact with the container sleeve bottom;
[0022] a sleeve cap which is sized to fit over a portion of the
slush container extending out of the open top end of the container
sleeve, and
[0023] a single-use attachment system to join the container sleeve
and the sleeve cap so that the slush container may be enveloped by
the container sleeve and sleeve cap, and subsequent separation of
the container sleeve and sleeve cap to expose the slush container
extending out the open top end of the container sleeve destroys a
portion of the single-use attachment system so that the container
sleeve and sleeve cap are not joined together a second time.
[0024] Other systems, methods, features and advantages of the
disclosed teachings will be immediately apparent or will become
apparent to one with skill in the art upon examination of the
following figures and detailed description. It is intended that all
such additional systems, methods, features and advantages be
included within the scope of and be protected by the accompanying
claims.
BRIEF DESCRIPTION OF THE FIGURES
[0025] The disclosure can be better understood with reference to
the following figures. The components in the figures are not
necessarily to scale, emphasis instead being placed upon
illustrating the principles of the disclosure. Moreover, in the
figures, like reference numerals designate corresponding parts
throughout the different views.
[0026] FIG. 1 shows a slush container 100 with a slush bottle 110
and a lid 104.
[0027] FIG. 2 shows a front plan view of a slush making machine
130.
[0028] FIG. 3 shows a basin that may be placed in a sterile field
and receive the surgical slush.
[0029] FIG. 4 provides a high-level overview of a process 1000 to
deliver surgical slush into a sterile field.
[0030] FIG. 5 shows is a process 2000 for production of sterile
surgical slush and delivery of the sterile surgical slush to a
basin within a sterile field.
[0031] FIG. 6 shows a side perspective view of sleeve 200.
[0032] FIG. 7 shows a top perspective view of sleeve 200.
[0033] FIG. 8 shows the relationship between the sleeve 200, slush
container 400, with slush bottle 440 that substantially fits within
the sleeve 200, and removable lid 404 that extends beyond the
sleeve 200, and sleeve cap 300 that engages with the sleeve 200
until the tear tab rim 204 is removed from the sleeve 200.
[0034] FIG. 9 shows a slush bottle 440 with engaged lid 404
inserted into sleeve 200.
[0035] FIG. 10 shows the upper portion of the sleeve 200 and the
sleeve cap 300.
[0036] FIG. 11 shows the sleeve assembly before the removal of the
tear tab rim 204.
[0037] FIG. 12 shows the sleeve assembly immediately after the
removal of the tear tab rim 204.
[0038] FIG. 13 illustrates that sleeve cap 300 may be removed from
the sleeve 200 after removal of tear tab rim 204 as window 208 is
now a ruptured window 210 which does not constrain catch tab
304.
[0039] FIG. 14 shows the lid end of the slush bottle 440 and the
engaged lid 404 protruding from the sleeve 200 after removal of the
sleeve cap 300.
[0040] FIG. 15 shows the slush bottle 440 and lid 404 free of the
sleeve 200.
[0041] FIG. 16 shows a cross section of a sleeve 200 before
insertion of a slush bottle 440.
[0042] FIG. 17 shows a cross section of a sleeve 200 after
insertion of a slush bottle 440.
[0043] FIG. 18 shows a side view of slush bottle 440 with lid 404,
as well as sleeve 1200 with sleeve cap 1300.
[0044] FIG. 19 show top perspective view of sleeve 1200.
[0045] FIG. 20 shows another top perspective view of sleeve 1200
but is taken from an orientation that allows the bottom end 1216 of
the interior of the sleeve 1200 to be seen.
[0046] FIG. 21 is a bottom side perspective view of sleeve cap
1300.
[0047] FIG. 22 is a top side perspective view of the upper portion
of the sleeve assembly 1390 with a sleeve 1200 and sleeve cap
1300.
[0048] FIG. 23 shows a sticker based solution for detecting
tampering.
[0049] FIG. 24 includes a textured section 298 to illustrate the
concept of adding texture to a sleeve.
[0050] FIG. 25 shows is a process 3000 for production of sterile
surgical slush and delivery of the sterile surgical slush to a
basin within a sterile field using a slush container that is a
flexible container.
DETAILED DESCRIPTION
[0051] FIG. 1 through FIG. 3 illustrate the problem to be solved.
FIG. 1 shows a slush container 100 with a slush bottle 110 and a
lid 104. The lid 104 may be reversibly engaged with a set of
threads 116 on the lid end of the slush bottle 110. A sterile slush
bottle may be at least partially filled with sterile saline and a
sterile lid 104 may be engaged. The sterile slush container 100
with contents of sterile saline and air may be then subject to
chilling and agitation within a slush making machine.
[0052] FIG. 2 shows a front plan view of a slush making machine
130. The slush making machine 130 may have one or more cooling
compartments. The slush making machine 130 of FIG. 2 has two
cooling compartments 134 and 138. This slush making machine 130 has
at least one refrigeration unit (not shown here) to cool ambient
air circulated around the interiors of the cooling compartments 134
and 138. The ambient air in the first cooling compartment 134 may
be isolated from the ambient air in the second cooling compartment
138 so that one cooling chamber may be operated at a different
temperature from the other cooling chamber. For example, one
cooling chamber may be actively cooled for the production of slush
while the other cooling chamber is either not in use or is being
used to maintain slush that has been created but has not been
removed for use.
[0053] Each cooling compartment 134, 138 may have an access door
144 or 148. The access door 144 or 148 may be transparent to allow
viewing of the activities within the cooling compartment 134 or 138
without opening the access door 144 or 148.
[0054] A slush container 100 filled with sterile saline may be
placed in a slush making machine 130. For purposes of this
disclosure, it does not matter how the slush making machine 130
operates beyond the fact that the slush making machine 130 creates
slush within a slush container 100.
[0055] The slush making machine 130 is not considered sterile, thus
after the slush container 100 is placed in the slush making machine
130, the outside of the slush container 100 even if previously
sterile is now non-sterile. Thus, once the sterile saline in the
slush container 100 has been converted into sterile saline slush in
the slush making machine 130, it is necessary to transfer the
sterile saline slush to a basin 120 (See. FIG. 3) or other suitable
reservoir on a surface within the sterile field.
[0056] The concept of maintaining a sterile field to protect a
surgical patient from potential pathogens is an important part of
running an operating room. We need not cover all the nuances here.
These points should be sufficient to introduce the relevant
issues.
[0057] Not everyone in the operating room is part of the sterile
field. There are people that perform necessary duties outside the
sterile field but within the operating room such as the OR
Circulating Nurse ("Circulator") and other non-sterile personnel.
The scrubbed personnel that are in the sterile field are not
allowed to touch non-sterile items as that would make the scrubbed
personnel no longer sterile.
[0058] Extreme care must be taken to avoid splashing or spillage of
sterile fluids.
[0059] Thus, there is a challenge to move the sterile saline slush
from the slush container 100 after conversion into sterile saline
slush in the slush making machine 130 and transfer the sterile
saline slush into a basin 120 within the sterile field given that
the non-sterile assistant holding the non-sterile exterior of the
slush container 100 containing sterile slush cannot enter the area
above the sterile field and the non-sterile assistant cannot hand
the slush container 100 of sterile slush to a scrubbed member of
the team to carry slush container 100 into the sterile field. A
further complication is the desire to minimize splashing and
spillage of the sterile surgical slush.
[0060] U.S. Provisional Application No. 62/085,590 filed Nov. 30,
2014 for Production of Well-Mixed Surgical Slush via Eccentric
Oscillation (referenced above) includes a process for creating
surgical slush in a slush making machine located outside of the
sterile field and then transferring the sterile slush back into the
sterile field. It is instructive for appreciating this disclosure
to review that process.
[0061] FIG. 4 provides a high-level overview of a process 1000 to
deliver surgical slush into a sterile field. Passing surgical slush
into a basin 120 in the sterile field may be a challenging task.
Unlike pouring a fluid which can be moderated by the tilt angle of
the open container, pouring the semi-solid slush slurry out of an
open mouth container can be a binary event where nothing comes out
until the entirety of a clump of slush slurry comes out. The
release of a large mass of slush can cause splashing or spillage of
sterile materials from the target basin in the sterile field.
[0062] Step 1004--Remove the lid 104 from the closed slush
container 100 after removal of the slush container 100 from the
cooling compartment 134 of the slush making machine 130. Keep the
slush container substantially upright so that slush material does
not leave the open end of the slush bottle after the lid is removed
from the slush container.
[0063] Step 1008--Squeezing the middle of the open slush bottle.
Squeezing the middle of the open slush bottle 110 allows a user to
reduce the cross sectional area of the open slush bottle to prevent
a rapid slide of all contents out the open mouth of the slush
bottle.
[0064] Step 1012--Tilt the open slush bottle 110 to direct the open
end of the slush bottle 110 towards the target basin 120.
[0065] Step 1016--Allow some slush located between the squeezed
middle and the open top to leave the slush bottle 110. As the open
end of the slush bottle 110 is lowered to release slush, some slush
will break away from the mass of slush as the mass of slush from
the squeeze point to the bottle bottom of the slush bottle is
retained by the reduction in inner cross section of the middle of
the slush bottle from the squeeze.
[0066] Further tilting of the open end of the slush bottle downward
may cause additional slush to release from the retained mass.
Having a slush container 100 that is sufficiently translucent to
allow the clump of surgical slush to be seen through the slush
bottle walls is helpful with this process.
[0067] Step 1020--Optional step--Increase squeeze on the slush
bottle to cause some slush to break off and leave the slush
bottle.
[0068] Step 1024--Place open slush bottle 110 close to
horizontal.
[0069] Step 1028--Allow retained slush to move towards open end of
slush bottle 110. Slowly reducing the amount of squeeze while the
open end of the slush bottle 110 is only slightly below horizontal
will allow the mass of slush to move slowly towards the open end of
the slush bottle 110.
[0070] Step 1032--Squeeze to retain a fraction of the slush still
in the open slush bottle 110. Increasing the amount of squeeze will
now retain a fraction of the slush mass as the distal end of the
slush mass has moved from the bottle bottom of the slush bottle 110
but is still precluded from leaving the open slush bottle 110.
[0071] Step 1036--Tilt open end of slush bottle 110 towards target
basin 120.
[0072] Step 1040--Allow slush between squeezed portion and open end
to break off and leave the mass of slush retained by the
squeeze.
[0073] Step 1044--Optional step--Increase squeeze on the slush
bottle to cause some slush to break off and leave the slush bottle
and enter the target basin while some slush is retained between the
squeeze and the bottle bottom of the slush bottle.
[0074] Step 1048--Slowly removing the squeeze will allow the slush
bottle to return to the original shape and release the remaining
slush.
[0075] The delivery of slush to the sterile field may be modified
by adding steps which initially provide a squeeze towards the lid
end of the middle for an initial delivery of slush followed by one
or more subsequent deliveries from setting the slush bottle in a
substantially vertical orientation, releasing the squeeze and then
imposing a squeeze closer to the bottle bottom of the slush bottle
before tiling the slush bottle to deliver more slush.
[0076] While the process set forth above, is one viable way to
deliver sterile surgical slush from a non-sterile bottle back to a
sterile field, some hospitals may prefer another method.
[0077] FIG. 5 shows is a process 2000 for production of sterile
surgical slush and delivery of the sterile surgical slush to a
basin within a sterile field.
[0078] Step 2004--A slush container with a slush bottle and lid is
provided to the sterile field. Both items are sterile.
[0079] Step 2008--A container sleeve and sleeve top are provided to
the sterile field.
[0080] Both items are sterile
[0081] Step 2012--Sterile saline is poured into the slush bottle to
partially fill the slush bottle.
[0082] Step 2016--The lid is applied to the slush container. This
may be achieved by engaging threads on the lid end of the slush
bottle with corresponding threads inside the lid.
[0083] Step 2020--The slush bottle is placed within the container
sleeve. An alternative process might place the slush bottle into
the sleeve before filling and tightening the removable lid but it
may be better to tighten the removable lid before placing in the
sleeve to allow the slush bottle to be firmly gripped to allow the
removable lid to be tightened sufficiently.
[0084] Step 2024--A sleeve top is placed over top of the lid and
engages container sleeve. Now the sterile saline material is
contained within a sterile slush container which is totally
enveloped by a sterile sleeve assembly comprising a container
sleeve and a sleeve top.
[0085] Step 2028--The sleeve assembly is passed out of the sterile
field and placed within a slush making machine. The outside of the
sleeve assembly is no longer sterile.
[0086] Note-the exterior of the sleeve assembly may be first deemed
non-sterile when the sleeve assembly is placed into the slush
making machine or may be deemed non-sterile before then. The
exterior of the sleeve assembly could be deemed non-sterile even
before the slush container is placed within the sleeve assembly as
long as the interior of the sleeve assembly remains sterile.
[0087] Step 2032--After a period of time, the sterile saline is
converted into sterile surgical slush. At least a portion of the
sleeve or sleeve top is sufficiently translucent to allow the slush
formed within the closed container to be viewed. Alternatively, the
process can work without observation through the sleeve or sleeve
top and simply rely on the slush making cycle being sufficiently
long to create slush.
[0088] Step 2036--Optional step--The sleeve assembly with sterile
slush container and sterile surgical slush may be held within the
slush making machine at a maintain mode to maintain the sterile
surgical slush until needed.
[0089] Step 2040--The sleeve assembly with the sterile slush
container and the sterile surgical slush is removed from the slush
making machine and brought to the edge of the sterile field.
[0090] Step 2044--The sleeve top is removed by someone out of the
sterile field to expose the lid end of the sterile slush container.
Care is taken to avoid touching the slush container as the slush
container is sterile and cannot be handled by someone outside of
the sterile field. The sleeve top may be removed in a way
consistent with the type of sleeve top. It is optional but
advantageous to have a sleeve top that is removed by a
non-reversible process such as removal of the tear tab ring
discussed below or some other seal with a tamper proof indicator
that that allows a prior attempt to remove the sleeve top to be
noticed.
[0091] The inclusion of a clear indication that the sleeve top has
not been removed from the sleeve and then put back on the sleeve is
particularly useful if the sterile slush container encapsulated in
the sleeve and sleeve top is removed from view of the sterile
field. This may happen where a large capacity slush making machine
is placed close to several operating rooms.
[0092] Step 2048--A scrubbed staff member from the sterile field
takes the sterile slush container protruding from the non-sterile
container sleeve without touching the non-sterile container sleeve
that is held by a staff member outside of the sterile field.
[0093] Step 2052--The scrubbed staff member can open the sterile
slush container immediately or later when additional sterile slush
is needed. The exterior of the slush container is still sterile and
thus does not pose any complications for transfer of the sterile
surgical slush within the sterile field.
[0094] While the method set for in process 2000 could be
implemented in a number of ways, in an effort to fulfill the
enablement requirement of patent laws within the United States of
America, this disclosure will go into great detail for the
geometries of a slush container and sleeve assembly that would work
with that slush container. Those of skill in the art would be able
to translate the teachings of the present disclosure for use with
other slush containers used in other slush making machines to
obtain the benefits of the present disclosure. Thus, the geometries
should be deemed educational rather than limiting.
[0095] Sleeve.
[0096] FIG. 6 shows a side perspective view of sleeve 200. Features
visible include tear tab rim 204, windows 208, vents 212, and
expanded bottom end 216.
[0097] FIG. 7 shows a top perspective view of sleeve 200. Features
visible include tear tab rim 204, vents 212, and expanded bottom
end 216. Bottom ridges 220 maintain a small separation between the
bottom of the slush bottle 440 and the bottom of the sleeve 200.
The bottom ridges 220 may be helpful for allowing air to flow back
into the bottom of the sleeve through the vents 212 as the slush
bottle 440 is removed from the sleeve 200. To the extent that the
bottom of the outside of the slush bottle 440 is not flat but had
an external ring or raised area from the injection molding process,
the bottom ridges 220 may be omitted.
[0098] FIG. 8 shows the relationship between the sleeve 200, slush
container 400, with slush bottle 440 that substantially fits within
the sleeve 200, and removable lid 404 that extends beyond the
sleeve 200, and sleeve cap 300 that engages with the sleeve 200
until the tear tab rim 204 is removed from the sleeve 200.
[0099] FIG. 9 shows a slush bottle 440 with engaged lid 404
inserted into sleeve 200. Sleeve cap 300 fits over the portion of
the slush bottle 440 and the engaged lid 404. Sleeve cap 300 has a
set of at least one catch tab 304. FIG. 9 shows an embodiment with
two catch tabs 304 that engage two windows 208 in the sleeve 200
until the tear tab rim 204 is removed to remove the top edge of the
windows 208 and thus free the catch tabs 304.
[0100] FIG. 10 shows the upper portion of the sleeve 200 and the
sleeve cap 300. The slush bottle 440 and lid 404 are omitted from
this figure to focus attention. The catch tab 304 has an asymmetric
shape so that when the sleeve cap 300 moves towards the sleeve 200,
the wedge shape of the advancing catch tab 304 presses outward on
the tear tab rim 204 until the catch tab 304 engages with window
208. The substantially flat face 308 of the catch tab 304 engages
with the tear tab rim 204 that forms a portion of the perimeter of
the window 208.
[0101] One can observe that if the tear tab rim 204 is separated
from the sleeve 200 starting at start 244 and continuing to end
248, that the window 208 would no longer hold the catch tab 304
captive. Removal of the tear tab rim 204 is facilitated by a groove
224 that has less wall thickness than the adjacent surfaces to help
channel the tearing action. The groove 224 runs along the lid side
of the window 208.
[0102] FIG. 11 and FIG. 12 show the upper end of the sleeve
assembly 390 with the sleeve 200 and sleeve cap 300. FIG. 11 shows
the sleeve assembly before the removal of the tear tab rim 204.
FIG. 12 shows the sleeve assembly immediately after the removal of
the tear tab rim 204. With the tear tab rim 204 removed, the catch
tab 304 is no longer captive to the window 208 on the sleeve 200 as
the tear tab rim 204 was a portion of the perimeter of the window
208.
[0103] FIG. 13 illustrates that sleeve cap 300 may be removed from
the sleeve 200 after removal of tear tab rim 204 as window 208 is
now a ruptured window 210 which does not constrain catch tab 304.
In order to provide focus on the elements of interest, slush bottle
440 and lid 404 have been rendered invisible.
[0104] One of skill in the art will appreciate that having to
remove the tear tab rim 204 in order to remove the slush sleeve cap
300 from the sleeve 200 precludes someone from accessing the slush
container 400 and returning the sleeve cap 300 without leaving an
unmistakable indication that someone had removed the tear tab rim
204. Thus, a tear tab rim 204 or some other sealing mechanism that
must be permanently altered to allow access is desirable as it
reduces the chance that a slush container 400 that had been
previously accessed and may no longer be sterile be accidently used
thinking that the slush container was still ensured to be sterile.
One may call such a seal a tamper proof indicator.
[0105] FIG. 14 shows the lid end of the slush bottle 440 and the
engaged lid 404 protruding from the sleeve 200 after removal of the
sleeve cap 300 (not shown here). Viewing FIG. 14, it is easy to
envision a person outside the sterile field holding the sleeve 200
near the expanded bottom end 216 and maintaining the position of
the sleeve 200 as someone from within the sterile field pulls the
protruding but still sterile slush bottle 440 and lid 404 out the
open end of the sleeve 200.
[0106] FIG. 15 shows the slush bottle 440 and lid 404 free of the
sleeve 200.
[0107] Vents.
[0108] The vents 212 in the sleeve 200 serve two important purposes
when the outer dimensions of the slush bottle are substantially
equal to the inner dimensions (excluding vents) of the sleeve 200.
The vents 212 allow air to flow out of the sleeve 200 as the slush
bottle 440 is inserted into the sleeve 200. Likewise the vents 212
allow air to enter into the sleeve 200 as the slush bottle 440 is
being removed from the sleeve 200. This venting action reduces the
forces that would otherwise need to be applied to work against a
pressurized zone ahead of a slush bottle 440 during insertion or a
vacuum formed below a slush bottle 440 during removal of a slush
bottle 440 from a sleeve 200.
[0109] A second function of the vents 212 is to serve as hinges to
allow the inner diameter of the sleeve 200 to expand slightly when
a slush bottle 440 is inserted into the sleeve 200. The hinge
function is illustrated in FIG. 16 which expands as the slush
bottle 440 is inserted to assume the expanded shape shown in FIG.
17. The change is shape of FIG. 17 is exaggerated here to help
convey the hinge concept.
[0110] Using the ability of the vents 212 to serve as hinges and
expand the diameter of the sleeve 200, the outer diameter of the
slush bottle 440 can be selected to slightly exceed the inner
diameter of an empty sleeve 200. Stretching the sleeve 200 a bit
helps ensure contact between the thin sleeve 200 and the slush
bottle 440 to avoid a layer of air that would retard heat
transfer.
[0111] As both the slush bottle 440 and the sleeve 200 are created
with a taper of approximately one degree to facilitate removal from
the injection molding mold, the slush bottle 440 may be inserted
within the sleeve 200 without a need for stretching of the hinges
until about the last half inch of insertion.
[0112] The actual size difference of the slush bottle 440 outer
diameter versus the inner diameter of the sleeve 200 may be in the
range of 0.010 inches which is sufficient to promote intimate
contact and effective heat transfer but not require as significant
of a hinge effect as illustrated in FIG. 17.
[0113] One could use a sleeve 200 that has an inner diameter that
is slightly greater than the outer diameter of the slush bottle 440
so that the hinge effect is not required. However, using a sleeve
200 that has an inner diameter that is slightly greater than the
outer diameter of the slush bottle 440 leaves an air gap over the
bulk of the surface of the slush bottle 440. This air gap serves as
an insulator and may impede the heat transfer to more than double
the required time to create slush.
[0114] The areas of the vents 212 will have reduced heat transfer
as they vents 212 will have a layer of air between the vent 212 and
the slush bottle 440 but this is a relatively small percentage of
the surface area of the slush bottle 440.
[0115] Sleeve with Tear Tab on Sleeve Cap.
[0116] The sleeve assembly disclosed above had a tear tab rim 204
on the sleeve 200 as a single use fastener so that once the sleeve
cap 300 was engaged with the sleeve 200, the tear tab rim 204 would
need to be removed to release the sleeve cap 300 from the sleeve
200. Once the tear tab rim 204 was removed, the sleeve 200 would be
easily recognized as a sleeve that had been used and the exterior
can no longer be assumed to be sterile.
[0117] While the teachings of this disclosure favor the use of a
single use fastener, the single use fastener may have the tear tab
on the sleeve cap instead of the sleeve. Demonstration of this
variation is shown in sleeve 1200 and sleeve cap 1300 shown in FIG.
18 to FIG. 22.
[0118] FIG. 18 shows a side view of slush bottle 440 with lid 404,
as well as sleeve 1200 with sleeve cap 1300. Sleeve cap 1300 has
tear tab rim 1320 with tear tab handle 1324. As discussed below,
pulling on the tear tab handle 1324 peels off the tear tab rim 1320
to release an engaged sleeve cap 1300 from a sleeve 1200.
[0119] Sidewall 1240 runs from the bottom end 1216 to the open top
1220 of the sleeve 1200. As discussed below, the sleeve 1200 has a
set of at least one vent 1212 (in this example four vents). The
sleeve 1200 has an annular flange 1230 and an upper lip 1250 for
engagement with the sleeve cap 1300.
[0120] FIG. 19 show top perspective view of sleeve 1200. Visible
are bottom end 1216, sidewall 1240, vents 1212, the top side of
annular flange 1230 and upper lip 1250. Visible in this view are
optional ribs 1254 which help to stiffen annular flange 1230 so
that the annular flange 1230 stays sufficiently rigid for the
sleeve cap 1300 to engage the upper lip 1250. One of skill in the
art may choose to alter the thickness of annular flange 1230 or
make other accommodations rather than use the optional ribs
1254.
[0121] FIG. 20 shows another top perspective view of sleeve 1200
but is taken from an orientation that allows the bottom end 1216 of
the interior of the sleeve 1200 to be seen. Vents 1212 connect the
air above the annular flange 1230 with a vented space 1260 at the
bottom end 1216 of the interior of the sleeve 1200. The vented
space 1260 is below the inserted slush container 400 as the bottom
of the slush container 400 cannot go beyond the raised areas 1264.
The vents 1212 and vented space 1260 allow the slush container 400
to be inserted and removed from the sleeve 1200 which is sized to
be a snug fit with the slush container 100. The sleeve 1200 may be
sized to slightly expand through a hinge action at the vents 1212
to have an interference fit with the lower portions of the slush
bottle 440.
[0122] FIG. 21 is a bottom side perspective view of sleeve cap
1300. The tear tab rim 1320 has a tear tab handle 1324 and a set of
protrusions 1328. The protrusions 1328 are used to engage the upper
end of the sleeve 1200. Once the set of protrusions 1328 are
engaged with the upper end of the sleeve 1200, the sleeve cap 1300
is disengaged from the sleeve 1200 to expose the slush container
400 by pulling on the tear tab handle 1324 to remove the tear tab
rim 1320 including the protrusions 1328 engaged with the upper end
of the sleeve 1200.
[0123] FIG. 22 is a top side perspective view of the upper portion
of the sleeve assembly 1390 with a sleeve 1200 and sleeve cap 1300.
The sleeve cap 1300 has been rendered transparent to show the
engagement of the set of protrusions 1328 with the upper lip 1250
of the sleeve 1200. The lid 404 and slush bottle 440 are visible
through the transparent sleeve cap 1300.
[0124] Pulling on the tear tab handle 1324 to remove the tear tab
rim 1320 from the sleeve cap 1300 disengages the set of protrusions
1328 from the upper lip 1250 of the sleeve 1200 to disengage the
sleeve cap 1300 from the sleeve 1200. Once the tear tab rim 1320
has been removed, the sleeve cap 1300 is readily identified as
having been used and thus presumably no longer sterile on the
exterior surface.
[0125] Means for Releasing.
[0126] The term "means for releasing" includes a tear tab on the
sleeve as illustrated in connection with sleeve 200 and a tear tab
on the sleeve cap 1300. These solutions may alternatively be
referenced within the set of single-use attachment systems as the
partial destruction of the sleeve assembly to disengage the sleeve
cap from the container sleeve marks the container sleeve as
unsuitable for subsequent use.
[0127] Material choices.
[0128] The sleeve 200 may be made of a polyethylene such as Linear
Low Density Polyethylene (LLDPE). The sleeve 200 may be relatively
thin such as between 0.010 inches thick to 0.025 inches thick. Thin
walls help heat transfer.
[0129] Sleeves may be made from other materials such as
polypropylene, polyolefin, or analogous materials.
[0130] Alternatives And Variations.
[0131] Single Use Versus MuIt-Use.
[0132] The teachings of the present disclosure may be used with a
slush bottle 440 and lid 404 that are suitable for sterilization
and reuse. Alternatively, the present disclosure may be used with
single use slush containers including slush containers that are
pre-filled with sterile saline and an air gap and provided with the
exterior of the single use slush container sterilized.
[0133] While the use of a tear tab ring or other tamper proof
indicator on the sleeve cap 1300 would render the sleeve cap 1300 a
single use item, the sleeve 1200 could be made in a way that allows
for sterilization and reuse. The thin wall of the sleeve 1200 and
the need for a conforming fit with the slush bottle 440 may lead
designers to prefer a single use sleeve 1200.
[0134] One of skill in the art will recognize that if the tear tab
ring or other tamper proof indicator was placed on the top end of
the sleeve 200 rather than the lower end of the sleeve cap 300,
that the sleeve cap may be made in a way that allows for
sterilization and reuse.
[0135] Orientation of the Slush Container within the Container
Sleeve.
[0136] In some instances a slush container will have a larger end
and a smaller end. One example of this is when there is a threaded
lid that engages with external threads on a cylindrical container.
When the slush container has a larger end, many designers may find
that a suitable design places the larger end at the open top end of
the container sleeve so that the sleeve top can be sized to cover
this larger end.
[0137] In the event that the slush container does not have a larger
end, such as when a slush bottle has a lid that engages a threaded
section on the interior of a slush bottle, or when a bag is used
instead of a bottle, it is possible that the end of the slush
container that is opened to dispense sterile saline slush may be
placed in the bottom of the container sleeve rather than the
top.
[0138] Use of Other Single Use Sleeve Assemblies
[0139] While the present disclosure shows the use of a tear tab on
either the sleeve or the sleeve cap to require a partial
destruction of a sealed sleeve assembly 390, this is not required
for all uses of the teachings of the present disclosure. Those of
skill in the art will appreciate that there are a number of sealing
mechanisms that allow a container to be sealed and require some
destructive action in order to open the container. This sort of
tamper resistant packaging is common for the peace of mind of the
consumer or to reduce opportunities for theft. Sleeve assemblies
may for use consistent with the teachings of the present disclosure
may use any of these known sealing techniques as adapted for a
sealing assembly.
[0140] Use of Other Forms of Tamper Indicators.
[0141] As noted above, both components of the sleeve assembly 390
may be configured so that unsealing the sleeve assembly 390 does
not alter either component. When using a sleeve assembly with at
least one component that is irreversibly altered when opened one
may choose to use other tamper indicators. One known tamper
indicator is to place a sticker across a sealing interface such
that subsequent opening of the sealed item rips or otherwise alters
the sticker. There are stickers that change appearance when placed
under strain. These stickers would be altered by either the opening
of the container or by efforts to remove the sticker and place the
sticker back upon the container.
[0142] FIG. 23 shows a sticker based solution for detecting
tampering. After the sleeve cap is placed upon the sleeve, a
sticker 500 is placed across a border 550 between a sleeve and a
sleeve cap. The sleeve and sleeve cap may connected by a threaded
connection to allow the sleeve and sleeve cap to be sterilized and
reused. Other reversible connections may be used that are suitable
for the conditions that the sleeve assembly will be subjected to,
including the treatment of the sleeve assembly in the slush making
machine. As the specifics of the reversible connection are not
material to the discussion of the sticker, these details are not
shown in FIG. 23.
[0143] The sticker 500 may come in this barbell shape with two
enlarged adhesive areas 504 connected by a thin connector 508. The
thin connector 508 may have one or more frangible sections 520 and
524. These frangible sections 520 and 524 are easily broken when
the sleeve cap is removed from the container sleeve as it takes
much less energy to break one of the frangible sections 520 or 524
compared with pulling one of the enlarged adhesive areas 504 from
the container sleeve or sleeve cap. Note there is not a requirement
that the sticker 500 be placed so that the midpoint of the sticker
500 aligns with the gap 550 separating the container sleeve from
the sleeve cap.
[0144] An optional additional level of security may be added by
obtaining stickers 500 that have a sequence of serial numbers
written on the sticker such is in location 512. The serial number
of the sticker 500 may be noted after application of the sticker
500. When the sleeve assembly 390 is brought back after the
conversion of sterile saline to sterile surgical slush, the serial
number may be compared with the previously recorded serial number.
One vendor for a barbell sticker 500 is NovaVision
(www.novavision.com) which sells a non-residue security label that
is 2.875 inches by 0.5 inches in footprint and is perforated at
each end of the thin connector 508.
[0145] The sticker 500 could be applied after the sleeve and sleeve
cap have left the sterile field. This would avoid the need to have
the stickers 500 sterilized so that they could be applied within
the sterile field. Alternatively, the stickers may be sterilized
and applied from within the sterile field.
[0146] No Use of Tamper Indicators.
[0147] While the use sleeve assemblies which are altered when
opened or other tamper indicators may be done in accordance with
the teachings of the present disclosure, the use of a sleeve
assembly 390 to maintain the sterility of the outer surface of a
slush container may be done without the use of tamper indicators.
Tamper indicators may not be valued if the slush making machine is
in secured or is in sight of the surgical team.
[0148] Sterilized and Ready for Slush Making Machine.
[0149] One of skill in the art will recognized that a slush
container 400 that was prefilled with saline and an air gap and
enclosed in a sleeve and sleeve cap could be delivered to the
hospital sterilized and in protective wrapping. The procedure for
use for would be to remove the sleeve assembly from the protective
wrapping and insert into the slush making machine.
[0150] The process could then continue as set forth in this
disclosure to deliver the still sterile slush container to the
sterile field with the surgical slush within.
[0151] Textured Surface of Sleeve.
[0152] Some or all of the container sleeve may be designed to have
a texture. The texture would serve two purposes. The texture may
make the sleeve easier to grasp and carry. The texture may help
with heat transfer by converting the air flow within the slush
making device from laminar flow to turbulent air flow or at least
flow that is approaching turbulent.
[0153] Many different textures could be used. One suitable texture
has a series of relatively flat dimples that project outward from
the exterior surface of the sleeve. The height of the flat dimples
may be on the order of magnitude of 0.003 to 0.004 inches. The
diameter of the dimple may be on the order of magnitude of 0.03
inches. FIG. 24 includes a textured section 298 on container sleeve
296 to illustrate the concept of adding texture to a sleeve.
[0154] Other Vent Patterns.
[0155] This disclosure has shown two examples of vent systems with
vents running down the sidewalls of the sleeves to allow air to
flow from and to an area below the bottom of the slush bottle 440.
In both instances, there were a set of four vents (212 and 1212)
running down the sidewall of the sleeve (200 and 1200). The number
of vents can be one or more and does not have to be four.
[0156] Likewise the pattern of vented space below the bottom of the
slush bottle 440 may be any pattern that provides a path for air to
move to and from the vents. The particular patterns shown in FIG. 7
and FIG. 20 are not required.
[0157] Container is a Flexible Bag.
[0158] FIG. 24 includes a slush container 480. Slush container 480
is a flexible container such as a bag. The slush container 480 may
be filled with sterile saline at the point of manufacture or at the
location seeking to use the surgical slush. An advantage of having
the saline placed into the slush container 480 at the point of
manufacture is that the staff at the location seeking to use the
surgical slush would not need to seal the saline in the slush
container 480 in a manner sufficient to withstand any mechanical
agitation present in the slush making process. As there are a
number of options for how slush is removed from the slush container
480, slush container 480 is shown without any particular feature
used for removal of slush. A hybrid bag may have a wide mouth
threaded opening that engages with a corresponding lid.
[0159] The slush container 480 may be partially filled with saline
and contain air in addition to saline so that the slush making
device may utilize the movement of the air within the slush
container 480 as part of the process to agitate the slush as it
forms. Alternatively the slush container 480 may be partially
filled with saline and not contain air in addition to saline. In
this latter case, the fact that the flexible bag is only partially
filled may be useful as part of the process to agitate the slush as
it forms as the shape of the flexible slush container 480 may
change during stimulus to the sleeve assembly. In either case, the
flexible slush container 480 may be said to be partially filled
with saline as the flexible slush container 480 may receive
additional saline. This flexing of the flexible slush container 480
will be reduced if the slush container 480 is filled to maximum
capacity which may require a slush making device or process that is
suitable for a maximally filled slush container 480.
[0160] FIG. 25 shows is a process 3000 for production of sterile
surgical slush and delivery of the sterile surgical slush to a
basin within a sterile field using a slush container that is a
flexible container.
[0161] Step 3004--A flexible slush container 480 filled with
sterile saline is placed within a sterile container sleeve. The
slush container 480 and sterile container sleeve and sterile sleeve
top are sized so that the slush container 480 may fit within the
container sleeve or if the slush container 480 extends beyond the
open end of the container sleeve, the slush container 480 is sized
to be encapsulated by the combination of the container sleeve and
an engaged sleeve top.
[0162] A developer may need to optimize the size of the flexible
slush container 480 for a given sleeve assembly (or adjust a sleeve
assembly for a given flexible slush container). The rate of cooling
will be maximized if the sterile slush container 480 has lots of
contact with the inner walls of the sleeve assembly. However, the
slush making process may require some level of mechanical agitation
of the sterile slush container 480 in order to avoid having a
permanent layer of ice crystals on the inner wall of the sterile
slush container 480. Thus, there may need to be some ability of the
sterile slush container 480 to move relative to the sleeve assembly
during the slush making process. Vents as described above may help
with the insertion and removal of the slush container 480 from the
container sleeve.
[0163] Step 3008--A sleeve top engages the open end of the
container sleeve. Now the sterile saline material is contained
within a sterile slush container 480 which is totally enveloped by
a sterile sleeve assembly comprising a container sleeve and a
sleeve top.
[0164] Step 3012--The sleeve assembly is placed within a slush
making machine. The outside of the sleeve assembly is no longer
sterile.
[0165] Note-the exterior of the sleeve assembly may be first deemed
non-sterile when the sleeve assembly is placed into the slush
making machine or may be deemed non-sterile before then. The
exterior of the sleeve assembly could be deemed non-sterile even
before the slush container is placed within the sleeve assembly as
long as the interior of the sleeve assembly remains sterile.
[0166] Step 3016--After a period of time, the sterile saline is
converted into sterile surgical slush. At least a portion of the
sleeve or sleeve top is sufficiently translucent to allow the slush
formed within the slush container 480 to be viewed. Alternatively,
the process can work without observation through the sleeve or
sleeve top and simply rely on the slush making cycle being
sufficiently long to create slush.
[0167] Step 3020--Optional step--The sleeve assembly with sterile
slush container 480 and sterile surgical slush may be held within
the slush making machine at a maintain mode to maintain the sterile
surgical slush until needed.
[0168] Step 3024--The sleeve assembly with the sterile slush
container 480 and the sterile surgical slush is removed from the
slush making machine and brought to the edge of the sterile
field.
[0169] Step 3028--The sleeve top is removed by someone out of the
sterile field to expose an end of the sterile slush container 480.
Care is taken to avoid touching the slush container 480 as the
slush container 480 is sterile and cannot be handled by someone
outside of the sterile field. The sleeve top may be removed in a
way consistent with the type of sleeve top. As previously
discussed, it is optional, but advantageous, to have a sleeve top
that is removed by a non-reversible process such as removal of the
tear tab ring discussed above or some other seal with a tamper
proof indicator that that allows a prior attempt to remove the
sleeve top to be noticed.
[0170] The inclusion of a clear indication that the sleeve top has
not been removed from the sleeve and then put back on the sleeve is
particularly useful if the sterile slush container 480 encapsulated
in the sleeve and sleeve top is at least temporarily out of view of
the sterile field. This may happen where a large capacity slush
making machine is placed close to several operating rooms.
[0171] Step 3032--A scrubbed staff member from the sterile field
takes the sterile slush container 480 protruding from the
non-sterile container sleeve without touching the non-sterile
container sleeve that is held by a staff member outside of the
sterile field. A slush container 480 that does not protrude from
the open end of the container sleeve may be encouraged outward by
placing the container sleeve substantially horizontally and
squeezing near the bottom end of the container sleeve or providing
other controlled stimulus while the container sleeve is
substantially horizontal.
[0172] Step 3036--The scrubbed staff member can open the sterile
slush container 480 immediately or later when additional sterile
slush is needed. The exterior of the slush container 480 is still
sterile and thus does not pose any complications for transfer of
the sterile surgical slush within the sterile field. The slush
container 480 may have any traditional type of opening included a
large threaded cap at one end of the slush container or a
destructive rip to open feature that allows for dispensing of the
slush. Alternatively, the slush container 480 may be cut open.
[0173] Passing a sterile slush container 480 into the sterile field
allows for a controlled delivery of sterile saline slush to the
basin or other receptacle by a person within the sterile field.
This minimizes the complications that might otherwise be present
when a person outside of the sterile field attempts to pass sterile
slush into the sterile field from a non-sterile container.
[0174] One of skill in the art will recognize that some of the
alternative implementations set forth above are not universally
mutually exclusive and that in some cases additional
implementations can be created that employ aspects of two or more
of the variations described above. Likewise, the present disclosure
is not limited to the specific examples or particular embodiments
provided to promote understanding of the various teachings of the
present disclosure. Moreover, the scope of the claims which follow
covers the range of variations, modifications, and substitutes for
the components described herein as would be known to those of skill
in the art.
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