U.S. patent application number 16/110509 was filed with the patent office on 2019-01-03 for sterile surgical tray.
The applicant listed for this patent is Doheny Eye Institute. Invention is credited to Lawrence Chong, Mark Humayun, Ralph Kerns, Jaw Chyng Lue, Matthew T. McCormick, Trent Spencer Wells.
Application Number | 20190000581 16/110509 |
Document ID | / |
Family ID | 46001882 |
Filed Date | 2019-01-03 |
View All Diagrams
United States Patent
Application |
20190000581 |
Kind Code |
A1 |
Kerns; Ralph ; et
al. |
January 3, 2019 |
STERILE SURGICAL TRAY
Abstract
A surgical apparatus for use by a surgeon can include a tray and
a plurality of surgical instruments. The tray can have a plurality
of structures located on an upper side of the tray for receiving
the plurality of surgical instruments. The tray can receive a
separate control unit. The tray can also have a fluid reservoir
receiver for receiving a bottle or container of fluid, such as
balanced salt solution. The fluid reservoir receiver can include
one or more features, including, a spike, an air vent, and a light.
A separate container can be used to place the bottle or container
of fluid into the fluid reservoir receiver on the tray. This
separate container can include a collapsible section.
Inventors: |
Kerns; Ralph; (Laguna
Niguel, CA) ; Humayun; Mark; (Glendale, CA) ;
McCormick; Matthew T.; (Yucaipa, CA) ; Wells; Trent
Spencer; (Altadena, CA) ; Chong; Lawrence;
(Seal Beach, CA) ; Lue; Jaw Chyng; (Alhambra,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Doheny Eye Institute |
Los Angeles |
CA |
US |
|
|
Family ID: |
46001882 |
Appl. No.: |
16/110509 |
Filed: |
August 23, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15284156 |
Oct 3, 2016 |
10070934 |
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16110509 |
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14035786 |
Sep 24, 2013 |
9463070 |
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15284156 |
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13312948 |
Dec 6, 2011 |
8568391 |
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14035786 |
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12684850 |
Jan 8, 2010 |
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13312948 |
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12256420 |
Oct 22, 2008 |
8323271 |
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12684850 |
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12107038 |
Apr 21, 2008 |
8177776 |
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12256420 |
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12106962 |
Apr 21, 2008 |
8177064 |
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12256420 |
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60925546 |
Apr 20, 2007 |
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60925548 |
Apr 20, 2007 |
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61481637 |
May 2, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2217/005 20130101;
A61M 2205/7536 20130101; A61M 1/0001 20130101; A61B 90/30 20160201;
A61F 9/00736 20130101; A61B 2017/00221 20130101; A61B 2017/00398
20130101; A61F 9/007 20130101; A61B 50/20 20160201; A61M 3/0254
20130101; A61B 50/33 20160201; A61B 2217/007 20130101; A61B
2017/00477 20130101; A61B 90/50 20160201; A61B 2017/00734 20130101;
A61B 2017/00225 20130101 |
International
Class: |
A61B 50/33 20160101
A61B050/33; A61M 3/02 20060101 A61M003/02; A61B 90/30 20160101
A61B090/30; A61F 9/007 20060101 A61F009/007; A61M 1/00 20060101
A61M001/00 |
Claims
1-23. (canceled)
24. A method of preparing for an ophthalmic surgical procedure
comprising: aligning a sterile container for holding and
surrounding a bottle of fluid with a recess in a sterile surgical
tray, the recess configured to receive the bottle of fluid; placing
the container around the recess so that the bottle of fluid can be
advanced into the recess; and compressing the container such that
the container is forced into contact with the sterile surgical tray
causing a side wall section of the container to collapse and
decreasing an overall length of the container and thereby inserting
the bottle of fluid into the recess.
25. The method of claim 24, wherein compressing the container
comprises collapsing an accordion-style section of the side wall of
the container.
26. The method of claim 24, wherein compressing the container
comprises pressing downward on a bottom surface of the container
while the container is in contact with the sterile surgical
tray.
27. The method of claim 24, further comprising puncturing a
membrane of the bottle of fluid with a spike positioned within the
recess.
28. The method of claim 27, further comprising advancing the bottle
of fluid onto the spike in the recess.
29. The method of claim 24, further comprising removing the
container from covering the bottle while leaving the bottle within
the recess.
30. The method of claim 24, further comprising discarding the
container.
31. An apparatus for use in preparation for an ophthalmic surgical
procedure comprising: a sterile container having an internal
chamber, the container comprising: a side-wall including a
collapsible/expandable section for allowing a length of the
container to change; a bottom surface; and a top surface; a lid
positioned on and covering the top surface; a bottle of balanced
salt solution positioned within the internal chamber of the
container; wherein the container is configured to collapse as the
bottle of balanced salt solution is inserted into a recess of a
sterile tray.
32. The apparatus of claim 31, wherein the collapsible/expandable
section comprises an accordion shaped section.
33. The apparatus of claim 31, wherein the lid comprises a TYVEK
lid.
34. The apparatus of claim 31, wherein the collapsible/expandable
section is an accordion-style section of the side wall.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/312,948, titled STERILE SURGICAL TRAY, filed Dec. 6, 2011,
which is a continuation-in-part application of U.S. application
Ser. No. 12/684,850 (DOHENY2.009CPCP1), filed Jan. 8, 2010, which
is a continuation-in-part application of U.S. application Ser. No.
12/256,420 (DOHENY2.009CP1), filed Oct. 22, 2008, which is a
continuation-in-part application of U.S. application Ser. No.
12/107,038 (DOHENY2.009A), filed Apr. 21, 2008, which claims the
benefit of U.S. Provisional Application No. 60/925,546 filed. Apr.
20, 2007. U.S. application Ser. No. 12/256,420 is also a
continuation-in-part application of U.S. application Ser. No.
12/106,962 (DOHENY2.011A), filed Apr. 21, 2008, which claims the
benefit of U.S. Provisional Application No. 60/925,548 filed Apr.
20, 2007. U.S. application Ser. No. 13/312,948 also claims the
benefit of U.S. Provisional Application No. 61/481,637
(DOHENY2.059PR) filed May 2, 2011, titled STERILE BOTTLE CONTAINER
AND METHOD. Each of the foregoing applications is hereby
incorporated by reference herein in its entirety and should be
considered a part of this application.
BACKGROUND
Field
[0002] The present invention relates generally to surgical systems
and more particularly to sterile surgical trays that can be used
with a plurality of surgical instruments in surgical
procedures.
Description of the Related Art
[0003] It is well known to use, in surgery, a sterile pack shipped
from a manufacturer to a surgery center, an example of which is
ophthalmic surgery (vitreoretinal or cataract surgery, in
particular). These packs typically contain several items that are
used in surgery and may include one-time use surgical instruments,
fluid cassettes, tubing sets, drapes, needles, and other devices.
The particular content of a pack depends on the type of surgery and
perhaps the individual preference of the surgeon or surgery
center.
[0004] When preparing for surgery, typically a sterile drape is
placed over what is commonly referred to as a Mayo tray. The
contents of the sterile pack and perhaps additional sterile
instruments and materials are spread-out over the tray so that the
materials and instruments necessary for the surgery are readily
available to a nurse or surgeon.
[0005] It is also known to provide a sterile pack where many of the
instruments and tubing sets are organized and placed in mating
recesses of the pack so that the pack can act as a tray for at
least some of the instruments in surgery.
[0006] A sterile field is generally established for many medical
procedures. Such a sterile field can be used to maintain the
instruments, medications, and other devices in a sterile condition.
For example, in surgical procedures, the sterile field is typically
defined by the area adjacent the surgical site that is covered by a
sterile drape and the area where the previously sterilized surgical
instruments and materials are placed for access by the surgeon
during surgery.
[0007] In general, surgical instruments and medications that are to
enter the body (such as the bloodstream, or penetrating the skin)
must be sterilized to a high sterility assurance level. Further,
the preparation of injectable medications and intravenous solutions
requires not only a high sterility assurance level, but also
well-designed containers to prevent entry of adventitious agents
after initial product sterilization. In addition, such instruments
and medications must be maintained in a manner to remain sterile
prior to use.
SUMMARY
[0008] There exists a continuing need for improvements in surgical
packs and surgical trays and systems. There also exists a
continuing need for improvements in systems and methods to maintain
sterility of the sterile field while simplifying the number of
people and systems needed for a procedure. According to some
embodiments a surgical tray can function as both a pack to
transport surgical materials and devices to a surgery site and as a
sterile tray for receiving a plurality of surgical instruments. The
sterile surgical tray and system can also provide sterile tools and
instruments associated with a surgical procedure and can reduce the
need for sterile assistants to the surgeon or additional
hardware.
[0009] A surgical apparatus for use by a surgeon during a surgical
procedure can comprise a sealed sterilized surgical pack and a
control unit. The sealed sterilized surgical pack can include a
plurality of surgical instruments and a surgical tray. The surgical
tray can have many shapes such as being substantially shaped to fit
around the body part to be operated on. The surgical tray can have
a top surface configured to be part of a sterile field of a
surgical procedure and a side or bottom surface configured to be
outside of the sterile field. The side or bottom surface can
include a control unit receiver. The control unit can be configured
to be received into the control unit receiver of the tray after the
surgical pack has been opened. The control unit can be configured
to power and control operation of at least one of the plurality of
surgical instruments.
[0010] In some embodiments, a surgical apparatus can comprise a
sealed sterilized surgical pack and a control unit similar to that
above with a plurality of surgical instruments and a surgical tray.
The surgical tray may also include one or more of the following
features: a plurality of receiving structures, at least one
electrical connector, at least one fluid connector, and at least
one pump connected. The plurality of receiving structures can be
located on the top surface, each of the plurality of surgical
instruments removably positioned in a corresponding one of the
receiving structures. At least one of the plurality of surgical
instruments can be connected to the at least one electrical
connector. At least one of the plurality of surgical instruments
can be connected to the at least one fluid connector. The at least
one pump can be connected to the at least one fluid connector. The
control unit can be configured to power and control operation of at
least one of the plurality of surgical instruments and the
pump.
[0011] In some embodiments, the control unit receiver is positioned
below the sterile field. The control unit may or may not be
sterile. The tray can be disposable while the control unit is
reusable. The plurality of surgical instruments can comprise a
biological tissue cutter, and a tissue illuminator. The tray can be
configured to sit on a surgical stand to the side of or on top of
the patient. The procedure may be an ophthalmic surgical
procedure.
[0012] A surgical apparatus according to some embodiments can
comprise a plurality of surgical instruments and a surgical tray.
The surgical tray can be shaped to substantially fit around the
head of a patient and can include a plurality of receiving
structures located on an upper side of the tray and a recess for
receiving a container of fluid, each of the plurality of surgical
instruments removably positioned in a corresponding one of the
structures. The recess can comprise a spike for insertion into the
container of fluid, and a light positioned within the recess for
shining light through the container of fluid to indicate a fluid
level to the surgeon. The plurality of surgical instruments and the
surgical tray can be prepackaged and sterilized together.
[0013] According to certain embodiments, a surgical apparatus for
use by a surgeon during an ophthalmic surgical procedure can
comprise a plurality of surgical instruments and a surgical tray.
The surgical tray can be substantially shaped to fit around the
head of a patient. The surgical tray can include a plurality of
structures located on an upper side of the tray, at least one pump,
and a recess for receiving a container of balanced salt solution
(BSS). Each of the plurality of surgical instruments can be
removably positioned in a corresponding one of the structures. The
recess can have a vented spike and a light. The vented spike can
have a first channel, a second channel, and a hydrophobic filter.
The first channel can be connected to the at least one pump via
tubing and the second channel can be connected to the hydrophobic
filter to allow air into the channel. The light can be positioned
adjacent or within the recess, such as at a bottom or side of the
recess, for shining light through the container of BSS to highlight
the meniscus of the fluid and thereby indicate the fluid level to
the surgeon.
[0014] In some embodiments, the tray is configured to sit on a
surgical stand to the side of or on top of the patient. The tray
may include or house a processing unit to control operation of at
least one of the plurality of surgical instruments and the pump.
The plurality of surgical instruments can comprise a biological
tissue cutter, and a tissue illuminator. The light source of the
tissue illuminator can be any type of light including a light
emitting diode (LED). The light source can be any color, but in
particular may be one of blue, amber, purple, and green or the
like.
[0015] A surgical apparatus according to some embodiments for use
by a surgeon during a surgical procedure can comprise a plurality
of surgical instruments and a surgical tray. The surgical tray can
comprise a substantially U-shaped cutout at the center of the tray
to allow the tray to fit around the body part to be operated on of
a patient. The surgical tray can have a U-shaped recess on a bottom
side of the tray positioned along the U-shaped cutout. The U-shaped
recess can be configured to receive a portion of a support on a
surgical table or chair such as a tray support and that the tray
can be attached to the tray support. Two holes in a front surface
of the tray can provide access to the U-shaped recess. Each hole
can be configured to receive an end of the portion of the tray
support. The tray can also include a plurality of structures
located on an upper side of the tray, where each of the plurality
of surgical instruments is removably positioned in a corresponding
one of the structures.
[0016] In some embodiments, a method of preparing for an ophthalmic
surgical procedure can comprise one or more of the following steps.
Removing a lid from a lip of a container surrounding a sterile
bottle. Aligning the container with a recess in a sterile surgical
tray, the recess configured to receive the sterile bottle. Placing
the lip of the container around the recess so that the bottle can
be advanced into the recess. Compressing the container such that
the lip is forced into contact with the sterile surgical tray
causing a side wall section of the container to collapse decreasing
an overall length of the container. Inserting the bottle into the
recess in the sterile surgical tray. Removing the container from
covering the bottle, leaving the bottle within the recess.
[0017] Additional embodiments of a method may also include one or
more of the following additional steps. Compressing the container
comprising collapsing an accordion-style section of the side wall
of the container. Compressing the container comprises pressing
downward on a bottom surface of the container while the lip is in
contact with the sterile surgical tray. Puncturing a membrane of
the bottle with a spike positioned within the recess. Advancing the
bottle onto the spike in the recess. Discarding the container.
[0018] A method of preparing for an ophthalmic surgical procedure
according to some embodiments can comprise one or more of the
following steps. Removing a lid from a container holding a sterile
bottle of balanced salt solution. Inserting the bottle of balanced
salt solution into a recess in a sterile surgical tray. Collapsing
an accordion-style section of a cylindrical side wall of the
container by pressing on a bottom surface of the container while a
top lip surface engages a rim on the recess in the tray. Removing
the container from covering the bottle of balanced salt solution;
leaving the bottle on the tray. Discarding the container.
[0019] The method may also include one or more of: puncturing a
membrane of the bottle of balanced salt solution with a spike in
the recess and advancing the bottle of balanced salt solution onto
the spike in the recess.
[0020] In some embodiments, an apparatus for use in preparation for
an ophthalmic surgical procedure can comprise a container having an
internal chamber, a lid on the container, and a bottle of balanced
salt solution positioned within the internal chamber. The container
can have a generally cylindrical side wall including a
collapsible/expandable section that can change the length of the
container. The container can be configured to collapse as the
bottle of balanced salt solution is inserted into a receptacle of a
sterile tray.
[0021] In some embodiments, the collapsible/expandable section
comprises an accordion shaped section. The lid can be a TYVEK lid
or other similar material.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Various embodiments are depicted in the accompanying
drawings for illustrative purposes, and should in no way be
interpreted as limiting the scope of the inventions, in which like
reference characters denote corresponding features consistently
throughout similar embodiments.
[0023] FIG. 1 illustrates a patient in position for a surgical
procedure.
[0024] FIG. 2 shows a tray support.
[0025] FIG. 2A shows a surgical chair or bed with a tray
support.
[0026] FIG. 2B shows a surgical chair or bed with a tray support
and a tray.
[0027] FIG. 3 is a perspective view of a tray.
[0028] FIG. 4 shows a top view of the tray of FIG. 3.
[0029] FIG. 5 shows a front view of the tray of FIG. 3.
[0030] FIG. 6 shows a back view of the tray of FIG. 3.
[0031] FIG. 7 is the bottom of the tray of FIG. 3.
[0032] FIG. 7A shows a bottom view of a tray connected to a tray
support.
[0033] FIG. 8 is a block diagram of a fluid-air exchange
system.
[0034] FIGS. 9 and 10 illustrate the sides of the tray of FIG. 3
with a balanced-salt solution (BSS) container connected to the
tray.
[0035] FIG. 11 shows a tray with a removable control unit.
[0036] FIGS. 12-16 are top, bottom, and side views of the control
unit.
[0037] FIG. 17 is a block diagram of the components of a control
unit.
[0038] FIG. 18 is a section of the tray showing the fluid reservoir
receiver.
[0039] FIG. 19 is a cross-section taken along line 19-19 of FIG.
18.
[0040] FIG. 20 shows a container.
[0041] FIG. 21 shows a container with lid.
[0042] FIG. 22 shows a bottle within a container.
[0043] FIG. 23A shows a bottle within a container.
[0044] FIG. 23B shows the bottle within a container with the
container in a compressed state.
[0045] FIGS. 24-27 illustrate part of a method of using a sterile
bottle container.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0046] The following description will be disclosed for illustrative
purposes relative to ophthalmic surgery but those skilled in the
art will appreciate that the embodiments as described herein and as
claimed may equally apply to other types of surgery and medical
procedures.
[0047] A sterile surgical tray and system can beneficially provide
a user such as a doctor, surgeon, or nurse with the instruments,
tools, and/or materials that are needed for a medical procedure.
The surgical tray and system can provide the needed elements in a
sterile manner and in a configuration that is ready to use after
opening of the tray. The tray and system can be designed for a
particular type of medical procedure and can allow the doctor,
surgeon, nurse to perform the procedure without having to obtain
other materials, or only requiring a minimal amount of other
materials and/or assistance to allow the surgical procedure to be
performed outside of an operating room, for example, in a doctor's
office or a military operating room war setting. For example, the
tray and system can provide all necessary surgical tools for an
operation, as well, as power and control systems for those tools.
Additionally, the tray and system can provide the tools in a ready
to use configuration, such as already plugged in to power
connectors, fluid connectors, aspiration connectors, etc. As
another example, the tray and system can include a disposable tray
with all of the necessary surgical tools for an operation, and a
reusable control box/unit that can be plugged into or otherwise
connected to the disposable tray.
[0048] In addition to providing necessary materials on a sterile
tray that can be used during the procedure, the tray and system can
provide additional benefits. For example, the tray can provide the
materials organized in a manner that has been optimized for the
procedure. As another example, the tray can allow the user to
perform the procedure without requiring an assistant to help
organize, obtain, and/or provide the materials to the user. This
can simplify the procedure as well as greatly reducing the cost of
the procedure. The tray and system can also allow a non-sterile
assist to prepare the surgical tray and system without compromising
the sterile field, including connecting the control system and
connecting a container of balanced-salt solution (BSS) to the
tray.
[0049] By way of example, FIG. 1 shows a patient 2 lying down on
his or her back with a surgical tray 10 surrounding the head of the
patient 2. Such a patient can be prepared for a surgical procedure,
including an ophthalmic procedure on one or both eyes of the
patient. In this type of procedure, the tray 10 can be part of the
sterile field and can contain or hold instruments and/or
medications that have previously been sterilized.
[0050] In general terms, a surgical tray can provide rapid access
to packaged components without requiring the transfer of the
components to a separate tray or table. In this regard, the
surgical tray, upon opening, serves as a sterile tray for a
surgical procedure. The surgical tray can contain instrumentations
ready for use already setup on the tray. The instrumentations can
be positioned at suitably convenient locations from which the
surgeon can remove, use, and put back the instrumentation when not
in use.
[0051] The tray can be a sterile surgical tray that has been
manufactured and assembled as a prepackaged sterile pack that
functions as a tray during surgery. The term pack is meant to
collectively identify the surgical instruments and other items
contained in a sterile package that is shipped from the
manufacturer to a customer, such as a hospital, ambulatory surgery
center, doctor's office, military setting, etc. and is for use by a
surgeon, doctor, nurse, etc. to perform a medical procedure, such
as surgery. The term tray refers to a structure that defines at
least a portion of a surgical field and can hold fluid handling
devices, surgical instruments, and other miscellaneous items to be
used during surgery.
[0052] In a preferred embodiment, the pack can be synonymous with
the tray. The surgical tray may be manufactured and assembled with
the necessary equipment for surgery and then enclosed in a bag or
other container and sterilized. Then when the bag is opened, the
tray is removed from the bag, a lid or cover is potentially
removed, revealing several if not all the instruments and other
items needed for the medical procedure, such as surgery.
[0053] The tray 10 may take the place of a traditional Mayo tray
and may be placed between the surgeon and the surgical site. During
an operation, after the pack is opened by removing the covering or
removing the tray from an enclosure, the tray 10 may be placed at
the left or right side of the surgeon, on or over the patient's
chest, or on another surgical apparatus such as a surgical stand in
close proximity to the surgeon and the patient. The tray can also
be positioned between the surgeon and the head of the patient.
[0054] The tray can surround the head, or other desired area of the
patient where the procedure is to be performed. For example, the
tray can surround the head of the patient 2 to thereby position the
tray around the head of the patient and between the surgeon and the
head of the patient. In such a configuration, the tray can also
define and/or confine the sterile field by surrounding the head or
other desired area and limiting access thereto.
[0055] The tray can be placed on or attached to a structure
surrounding or near the surgical bed, chair, table, etc. The tray
can be connected to or placed on a structure such as a rail system,
a stand, a tower, a bed side, a cart, a table, etc. For example, in
some embodiments, the tray is configured to attach to an arm or
wrist support attached to a surgical chair. The tray itself can
then be used as both a tray and a wrist or arm support.
[0056] Wrist supports are commonly used in many procedures,
especially procedures on the eye where precision and a steady hand
is needed. A wrist support and/or the tray can be adapted to allow
the wrist support to be used to support the tray. Thus, the wrist
support 12 is repurposed here as a tray support. The tray can then
provide support for users wrists and/or arms.
[0057] FIGS. 2 and 3 show respectively, a tray support 12 and the
tray support 12 mounted to a headrest of a surgical table or chair
13. A patient lying on the table 13 can have his or her head
positioned on the headrest such that the tray support 12 surrounds
the patient's head. This can provide a support for the doctor,
surgeon, nurse, etc. to rest or steady the hands or arms during a
procedure.
[0058] A tray 10 placed on the tray support 12 can surround a
patient's head as shown in FIG. 1. The tray 10 can surround the
patient's head while still providing support to one or more of a
user's wrists and/or arms. For example, a surgeon could rest his or
her forearms on the support portions 11 of the tray 10. The support
portions 11 can be free of instruments, tools or other features so
that the surgeon is free to rest and reposition his or her arms on
the support portion 11 without interference from other
features.
[0059] In some embodiments, the support portion 11 is raised up
higher than some other parts of the tray. The support portion 11
may be substantially flat. In some embodiments, the support portion
11 can be an elongated protrusion with a rounded or flat top
surface above the other surfaces of the tray 10. In some
embodiments, the support portion 11 can be configured to be
positioned at the sides of the doctor, so that the doctor can be
positioned closer to the patient with his or her elbows or forearms
supported at his or her sides and at the sides of the tray. The
tray 10 is shown with an inward contour 9 that allows the body of
the doctor to be closer to the patient while his or her arms are
supported at the sides of the body and possibly near the back of
the doctor's body.
[0060] Returning to FIG. 2, an example tray support 12 is
illustrated. The tray support 12 can also be used for positioning a
tray 10 within the surgical field. The illustrated tray support 12
can connect to a surgical stand, table, chair 13, etc. at end 14,
as shown in FIG. 2A. The tray support 12 can have a top support bar
16, such as the illustrated U-shaped ring. The support bar 16 can
have a fixed or adjustable relationship to the surgical stand,
table, chair 13, etc. to which it is attached. The support bar 16
can have one of many different shapes. For example, the support bar
16 can be circular, semi-circular, U-, V-, or L-shaped, or a box
with three sides. The support bar 16 can be made of a round or
square bar, tube, or pipe. As illustrated, the support bar 16 is
made of a square tube formed in a U-shape.
[0061] As has been mentioned, the tray 10 can be placed on or
attached to structure surrounding or near the medical bed, chair
13, or table such as on the support bar 16 of the tray support 12.
The tray 10 can be placed on, slid onto, or otherwise secured to
the support bar 16 (FIG. 2B). The tray 10 can attach to the support
bar 16 or other structure in one of many different ways.
[0062] Looking at FIGS. 3-6, the contour and shape of the tray 10
can be seen. The tray 10 can be shaped to not only surround a head
or other desired area of a patient, but also to allow a particular
positioning of the surgeon with relationship to the patient. For
example, the tray can be positioned between the surgeon and the
patient while also placing some or all of the instruments off to
the sides of the patient. The instruments can also be within the
doctor's peripheral vision. The shape of the tray 10 can also
facilitate attaching the tray to a particular structure such as a
tray support 12.
[0063] The shape of the tray 10 can optimize the utilization of
available space next to or around the area of the patient 2 to be
operated on. For example, around the patient's head, the combined
tray 10 and the tray support 12 can allow the surgeon to be
sufficiently close to the patient while providing all of the
necessary instruments within short reach of the surgeon. In
addition, while utilizing the tray 10, the surgeon generally does
not need to even turn to the side or extend his or her reach as the
instruments are at hand right where they are needed.
[0064] For example, as shown in FIGS. 3 and 6, the back of the tray
10 can include a cutout 50 that can, for example, allow for more
room for the surgeon's legs or body beneath the tray 10. The back
(FIG. 6) of the tray is closest to the body of the surgeon and the
front (FIG. 5) is the side closest to the patient (see FIG. 1),
where the surgeon is sitting or standing directly behind the top of
the patient's head. The cutout 50 can also provide additional
visual access below the tray 10 to assist in mounting the tray 10
to an appropriate structure, such as the support bar 16 on the tray
support 12.
[0065] The bottom of the tray, as shown in FIGS. 7 and 7A, as well
as other portions, can be shaped and/or contoured to facilitate
attachment to particular structures such as the support bar 16. The
tray 10 can include a slot or space 54 sized to allow the tray 10
to fit on top of the support bar 16 of the tray support 12 (FIG.
7A). The slot 54 is shown formed across the various support ribs on
the underside of the tray 10. The slot can also be formed in other
ways. The slot 54 or other attachment structure can allow the tray
to attach to and/or cover all or only part of the support bar
16.
[0066] In the front view of FIG. 5, it can be seen that the tray 10
can also include one or more holes 52. The holes 52 can cooperate
with the slot 54 cut into the supporting ribs on the underside of
the tray 10 (FIGS. 7 and 7A) to fit over and onto the support bar
16. The holes 52 can be one of many different shapes. For example,
the holes 52 can be round (as shown), or square. In addition, the
holes can be shaped to work with different shaped and/or sized
support bars. For example, in the illustrated embodiments, the
holes a round and the support bar has a square cross-section. In
some embodiments, the holes and the support bar have corresponding
shapes.
[0067] The tray 10 may include one or more mechanisms for latching
of the tray onto a surgeon's chair, a surgical platform, a separate
stand, wrist support 12, support bar 16, etc. The latching
mechanism may include, for example, a snap fit, a screw, a lock, a
spring loaded locking handle, etc. Additionally, the slot 54 can be
tight fitting over the support bar 16 to minimize and possibly
prevent undesired movement of the tray. In some embodiments, the
slot can be a deep slot that extends the entire height of the
support bar 16. The slot may also include one or more tabs that
extend around a portion of the underside of the support bar 16.
[0068] The tray 10 is preferably secured to or positioned on the
support bar 16 in a manner to not tip, tilt, or fall off the
support bar 16 when the tray experiences downward or sideways
pressure on any point of the tray.
[0069] The illustrated tray 10 can be mounted onto the support bar
16 as follows: 1) the tray 10 is placed over the support bar 16
such that the front of the tray is forward of the front ends or top
of the "U" of the support bar 16, 2) when the holes 52 are near the
front ends or top of the "U" of the support bar 16 the front of the
tray is tilted downwards and the tray is advanced backwards onto
the support bar 16, with the front ends or top of the "U" of the
support bar 16 advancing through the holes 52, 3) the tray is then
slid backwards onto the support bar 16 until the entire length of
the slot 54 is substantially positioned over the support bar 16, 4)
the tray 10 is un-tilted or straightened by lowering the back of
the tray, thereby placing the tray completely on the support bar
16. The curved shape of the support bar 16, the holes 52 and the
slot 54 all cooperate to maintain the tray on the support bar 16
such that the tray will not be easily displaced from, tipped over,
or titled on the support bar 16.
[0070] Returning now to FIGS. 3 and 4, features relating to the use
of the sterile surgical tray 10 will now be discussed. The tray 10
includes receiving or mating structures 18 for receiving a
plurality of surgical instruments. The receiving or mating
structures 18 for receiving the instruments may generally conform
to the shape of a particular instrument or may be general areas
where instruments can be placed or held that does not have a
specific structure for a specific instrument. As used herein the
term "mating" means without limitation a receptacle having a
complementary shape for receiving part or all of an article. The
mating structure 18 can include a recess or cavity in the tray 10
having a shape that may hold a variety of instruments. The mating
structure 18 can have a protrusion, a cradle, a guide member, or
other structures which receive and/or position an instrument on the
tray 10.
[0071] The tray 10 can have sufficient area on the top surface to
receive the surgical instruments necessary for the surgery to be
performed with sufficient space between the instruments to allow
the surgeon to easily and conveniently pick-up an instrument and
return it to the tray 10.
[0072] The tray and/or pack can include a number of different
surgical components which may be prepackaged and sterilized with
the tray 10. For example, surgical components of the surgical pack
can include: a biological tissue cutter, a tissue illuminator, an
aspiration/infusion device, a disposable speculum/drape
combination, cotton swabs, a container containing BSS, an infusion
line, trocars, cannulas, forceps, etc.
[0073] If the sterile surgical tray 10 is for ophthalmic surgery
the surgical instruments preferably include at least a biological
tissue cutter, an aspiration instrument, and an infusion
instrument. The biological tissue cutter may be at least one of a
vitreous cutter, a lens emulsification, fragmentation, or cutting
device, scissors, and a cautery knife. Aspiration may be
incorporated into the biological tissue cutter, such as is known in
vitreous cutters and phacoemulsification (phaco) devices. The
aspiration and infusion instruments may be a combined infusion and
aspiration instrument, commonly referred to as an
irrigation/aspiration (I/A) handpiece. If the surgical tray 10 is
for vitreoretinal surgery the infusion instrument may be an
infusion cannula with connected tubing.
[0074] Preferably tray 10 includes all or nearly all the
instruments necessary to perform the desired surgery. For instance,
if the desired surgery is a vitrectomy of the eye, it can include a
vitreous cutter, an irrigation instrument, an illumination
instrument, an aspiration source, an infusion source, and passive
surgical instruments (for example, not powered), and possibly an
air/fluid exchange source. If the desired surgery is a cataract
removal from the eye, the instruments included in the tray can be
cataract extraction instruments such as a phaco device, a phaco
needle, a capsule polish tool, an aspiration source, an infusion
source, and passive surgical instruments, and possibly an oil
filled syringe.
[0075] In the illustrated embodiment of FIGS. 3 and 4, the tray 10
can be used for ophthalmic surgery and includes a vitreous cutter
26, a diathermy or electrocautery device 28, and an illumination
device 30. The diathermy or electrocautery device 28 can be used to
stop bleeding from small vessels by destroying tissue using heat
conduction, as is known.
[0076] Tray 10 also preferably includes structure for receiving
additional instruments beyond the plurality of instruments that are
prepackaged and sterilized with the tray 10; an example of which is
the structure 18 shown without any instrument thereon.
[0077] Also, at least one surgical instrument may be connected at
manufacture to the tray 10 at various electrical, and/or fluid
connections. As best seen in FIG. 4, the tray 10 includes various
electrical connectors 32, as well as various fluid connectors 34.
The electrical connectors 32 can be used to connect the surgical
instruments to various features such as a power source and a
controller. The fluid connectors 34 can be used to connect the
surgical instruments to various sources including fluid and vacuum
sources.
[0078] Tray 10 may include structure forming a priming fluid
reservoir 20 for receiving one or more instruments during priming
of the instruments with a surgical fluid such as balanced-salt
solution (BSS). If a reservoir is not provided the user may need to
use a beaker or other container for priming the surgical
instruments and tubes with BSS. Fluid reservoir 20 can be a self
filling fluid reservoir 20. The fluid reservoir 20 can fill such as
during a self check procedure after the control system has been
turned on. Self filling can be a step in the start up routine of
the controller. The fluid reservoir 20 can fill with BSS.
[0079] The tray 10 can have a recessed top surface forming one or
more troughs 22, as best seen in FIG. 3. The tray 10 can also
include one or more fluid wells 24 as best seen in FIG. 4. The
trough 22 and fluid well 24 can be used to retain fluid such as
fluid ejected or leaked from the instruments and fluid runoff from
the surgical procedure.
[0080] A drape can be placed over a patient, such as over a portion
of a patient's head (not shown) during ophthalmic surgery. If
desired, the drape can be attached to the tray 10 by any suitable
structure such as adhesive tape, hook and loop material, or other
structure. Fluid runoff from the drape that occurs during surgery
can be controlled using at least one fluid retention trough 22
and/or fluid well 24 to collect the fluid.
[0081] Additional features, shown in FIGS. 3 and 4, some of which
are described in more detail below, include: power button 36,
indicator panel 38, air infusion control 40, oil infusion control
42, fluid reservoir receiver 44, recessed storage bins 46 for
trocars and other tools, and an aspirant fluid container 48. The
aspirant fluid container 48 can receive fluid aspirated from the
surgical site. In some embodiments, the aspirant fluid container 48
can include a colored float, ball, or bobber that floats at the
fluid surface to indicate the fluid level. The aspirant fluid
container 48 may also include a light. The light can function
similar to the light in the fluid reservoir receiver 44 as
described below.
[0082] The indicator panel 38 may include at least one status
indicator. The status indicator can take many forms including a
light emitting diode (LED), a display, numbers, icons, bar graphs,
and/or an audible signal generator. In FIGS. 3 and 4, five groups
of status indicators are shown. Each group of status indicators can
be associated with a particular instrument or function of the tray
10. The status indicators can provide different types of feedback
to a user. The status indicators can be different colors or have
different numbers of lights. For example, if a fluid reservoir
includes a sensor the indicators could be red, yellow, and green in
color to indicate to the user that a vacuum level is unacceptable
(red), a vacuum level is approaching an unacceptable level
(yellow), or the vacuum level is acceptable (green). Another
example is that the number of indicators illuminated can indicate
the speed or energy level. The indicator panel 38 may also indicate
a power level of a battery or fuel cell, a fluid level of a pump
fluid reservoir attached to the input and output connectors or an
illumination level of an illuminator attached to the input and
output connectors.
[0083] The tray 10 may also have a control unit 60 including a
processor for receiving inputs from a user, from a plurality of
surgical instruments, and from other devices and for transmitting
signals to the same. The control unit 60 is preferably connected to
tray 10 after tray 10 is opened and is being prepared for surgery.
The control unit 60 may alternatively be prepackaged and sterilized
with tray 10.
[0084] As can be seen in FIGS. 3 and 4, the surgical tray 10 can
provide the needed tools in a configuration that is ready to use
after opening of the tray. The tray can provide these tools
organized in a manner that has been optimized for the particular
surgical procedure. For example, the support portions 11 can be
free of instruments, tools or other features, while the some or all
of the instruments are off to the sides of the patient providing
easy access to the doctor or surgeon. The surgeon generally does
not need to even turn to the side or extend his or her reach as the
instruments are at hand right where they are needed. In addition,
various features of the tray 10 have been optimally positioned. For
example, the power button 36 is spaced away from the doctor and
away from the support portions 11 to prevent accidental depressing
of the power button 36. Also, the fluid container in the fluid
reservoir receiver 44 is also spaced away from the doctor. This
ensures that the bottle in the fluid reservoir receiver 44 is not
in the way, but also provides line of sight access for the surgeon
to be able to view the fluid level.
[0085] The panel 38 and the fluid reservoir receiver 44 can also he
positioned to the outside of the tray. This can allow the surgeon
to use peripheral vision or only eye movement without diverting her
head, for example, from a surgical microscope. This can increase
the ergonomics of the tray and decrease distractions from head
movements. Additionally, the main fluid and electrical components
are separated to the opposite sides of the tray 10. The power
button 36, control unit 60, and indicator panel 38 are on one side
and the fluid reservoir receiver 44 and the aspirant fluid
container 48 are on the other side.
[0086] In certain embodiments, the sterile surgical tray 10, as
best seen in FIG. 7, also includes one or more pumps 56. As shown,
each pump 56 is driven by an electric motor 58. The one or more
pumps 56 can be used for various purposes, such as to provide
aspiration, to provide a pressurized source of fluid, to remove
material from the eye, etc.
[0087] A pump 56 can be an infusion pump operatively connected to
the fluid reservoir or receptacle receiver 44. The fluid reservoir
receiver 44 may be for receiving a fluid reservoir (described and
shown below) for infusing fluid such as a surgical irrigation
solution into a surgical site. A pump 56 can be an aspiration pump
for collecting aspirated tissue and fluid during surgery. In some
embodiments, the aspiration pump can pump aspirated tissue and
fluid into the aspirant fluid container 48. The pump 56 may be one
of a vacuum pump (for example, a rotary vein or diaphragm) or a
positive displacement pump (for example, peristaltic or
scroll).
[0088] Tray 10 may also include a syringe pump (not shown) for
injecting oil or other fluids into the eye. With reference to FIGS.
4 and 7, the syringe pump can connect to one of the fluid
connectors 34 and possibly to one of the electrical connectors 32.
In particular, one of the fluid connectors 34 can be connected to
the oil infusion control 42. The oil infusion control 42 can be
used to control the flow of oil. The oil infusion control 42 as
shown is the handle of a stopcock 62, but the control 42 can
include a pump and/or solenoid valve. The stopcock 62 can be
fluidly connected to one or more of the fluid connectors 34, and/or
a surgical instrument.
[0089] The infusion pump 56 can also be connected to a stopcock 64.
The stopcock 64 can be connected to the fluid reservoir through a
fluid reservoir receiver 44. The stopcock 64 can be used to inject
air into the eye during a procedure. For example, after fluid has
been removed from the eye, air can then be injected into the retina
during all or part of a procedure on the retina. The stopcock can
control whether fluid or air is injected by an instrument such as
the vitreous cutter 26. The air infusion control 40 as shown is the
handle of a stopcock 64, but the control 40 can include a pump
and/or solenoid valve.
[0090] The infusion pump 56 may also be connected to the syringe
pump or an oil reservoir. Thus, the infusion pump 56 in this
configuration can be connected to an infusion device that can
infuse one or more of a fluid, such as balanced-salt solution
(BSS); air; or oil into the eye.
[0091] FIG. 8 shows a block diagram of a fluid-air exchange system
300 that may be incorporated into a sterile surgical tray, such as
tray 10. System 300 preferably includes a BSS reservoir 302, a
reservoir 304 of air, connected to a selector valve 306 for
selecting which fluid, BSS or air, will be allowed to flow into
infusion pump 308. Infusion pump 308 may be any suitable pump for
infusing fluid into an eye or other body part. A bypass valve 310
connects a flow path from infusion pump 308 and an oil reservoir
312. Oil reservoir 312 is connected to a source of oil 314 via a
check valve 316. Oil source 314 may be a syringe, as shown or may
be another source that is connected to a pump (not shown) for
automatically pumping oil into reservoir 312. Oil reservoir is then
connected to a three-way stopcock valve 318 via another check valve
320. Depending on the positions of the valves 306, 310, and 318
air, BSS, or oil (typically silicone oil) will be infused into an
eye. Bypass valve 310 allows infusion pump and air or BSS to push
oil from reservoir 312 into an eye.
[0092] Turning now to FIGS. 9-10, the two sides of the tray 10 are
shown. The tray 10 in these views also includes a BSS container 70
that has been connected to the tray 10, as described in more detail
below.
[0093] In FIG. 10, and also in FIG. 11, it can be seen that a
control unit 60 may be connected to the tray 10. The control unit
60 can include a processor for receiving inputs from a user, from a
plurality of surgical instruments, and/or from other devices and
can transmit signals to the same.
[0094] The control unit 60 can be made as a cartridge that can be
received into the tray 10. Referring in particular to FIG. 11, it
can be seen that the cartridge-like control unit 60 can be inserted
into a slot 66 in the tray 10.
[0095] The tray 10 with control unit 60 can provide all necessary
surgical tools for an operation, as well, as power and the control
systems for those tools. Additionally, the tray can provide the
tools in a ready to use configuration, such as already plugged in
to power connectors, fluid connectors, aspiration connectors, etc.
so that once the cartridge-like control unit 60 is plugged into the
tray 10 the surgeon can start the procedure with minimal to no
additional preparation. The tray can be a disposable tray with all
of the necessary surgical tools for an operation, and the control
unit 60 can be a reusable control unit 60 that can be plugged into
or otherwise connected to the disposable tray.
[0096] The cartridge-like control unit 60 can have a pair of rails
68 on the sides of the control unit 60. The rails 68 can be
received by grooves 72 in the slot 66 on the tray. The cartridge
can be slid into the slot 66 with the rails 68 engaging the grooves
72 until the button lever 74 engages the tray 10. The grooves and
rails and/or housing shape can be arranged such that the cartridge
control can only be inserted in one orientation to prevent the user
from inserting the cartridge incorrectly. The button lever 74 can
include a handle 76 that can allow the button lever to be moved.
The button lever 74 can be hingedly attached to the control unit 60
and biased towards an upright position. The button lever 74 can
include internal spring. Pressing down on the handle 76 can move
the button lever 74 downwards. An outer edge of the button lever 74
can engage an edge of the slot 66 in the tray. This engagement can
keep the control unit 60 locked in place in the tray. It can also
be seen that the control unit 60 has a handle 78 on underside of
the control unit. The handles 78 and 76 can be used in conjunction
to secure the control unit 60 while installing or removing the
control unit 60 from the tray 10.
[0097] The control unit 60 can be provided with electrical
connections (FIG. 14). The tray can also have corresponding
electrical connections. This can allow the control unit to
automatically engage the electrical connections of the tray when
the control unit is inserted into the slot and engaged with the
tray. The control unit 60 may be entirely self-contained or may
require additional plug-ins such as outside power sources and other
electrical or network-type connections.
[0098] In the case where the control unit 60 is connected to the
tray 10 after the tray/pack is opened, it may not be necessary for
the control unit 60 to be sterile. This is because the slot 66 in
the tray is on a lower portion of the tray 10 which generally would
not be in the sterile field or may be covered by a sterile
drape.
[0099] The control unit 60 can have a processor (e.g., a
microprocessor, ASIC, and/or circuitry and drive mechanism) and
power configured to control and provide power to various
instrumentations that require power and control on or attached to
the tray 10. For example, the control unit 60 may be configured to
power and control the vitreous cutter 26, the diathermy device 28,
the illumination device 30, the motors 58 and/or the pumps 56. The
control unit 60 may be equipped for wired or wireless
communication. For example, the control unit 60 may communicate
with the illumination device 30 for receiving current operating
parameters, such as, for example, a current illumination level. In
this manner, all the necessary logic, circuitry, and power can
reside within the tray 10 itself and/or instruments in
communication with the tray without having to resort to a separate
control console. The control unit 60 preferably includes batteries
and is rechargeable.
[0100] Looking to FIG. 17, there is illustrated one embodiment of a
control unit 60 that can be used with the tray 10. FIG. 17
illustrates a block diagram of a control unit 60 that is in
communication with one or more handheld instruments 516 and/or
computing systems 517 and/or data sources 519 via one or more
networks 510. The control unit 60 may be used to implement one or
more of the systems and methods described herein. In addition, in
one embodiment, the control unit 60 may be configured to process
status data and/or information from surgical devices. While FIG. 17
illustrates one embodiment of a control unit 60, it is recognized
that the functionality provided for in the components and modules
of control unit 60 may be combined into fewer components and
modules or further separated into additional components and
modules.
[0101] In one embodiment, the control unit 60 comprises a central
processing unit ("CPU") 502, which may comprise a microprocessor.
The control unit 60 further comprises a memory 504, such as random
access memory ("RAM") for temporary storage of information and/or a
read only memory ("ROM") for permanent storage of information, and
a mass storage device 508, such as a hard drive, diskette, or
optical media storage device.
[0102] The control unit 60 can comprise one or more commonly
available input/output (I/O) devices and interfaces 512, such as a
keyboard, mouse, touchpad, and printer. In one embodiment, the I/O
devices and interfaces 512 comprise one or more display devices or
touch screen display devices, such as a monitor, that allows the
visual presentation of data to a user. The I/O devices and
interfaces 512 can also provide a communications interface to
various external devices. The control unit 60 may also comprise one
or more multimedia devices 510, such as speakers, video cards,
graphics accelerators, and microphones, for example. It will be
understood that in some embodiments, the components discussed with
regard to the control unit 60 can be physically located in the
control unit 60, in the tray 10, or in another location.
[0103] In the embodiment of FIG. 17, the control unit 60 is coupled
to a network 510, such as a LAN, WAN, or the Internet, for example,
via a wired, wireless, or combination of wired and wireless.
communication link 514. The network 510 communicates with various
computing devices and/or other electronic devices via wired or
wireless communication links. In the exemplary embodiment of FIG.
17, the network 510 is communicating with one or more handheld
instruments 516, computing systems 517, and/or data sources 519.
The control unit 60 may also include one or more pumps 56.
Alternatively, the one or more pumps 56 can be part of a separate
module or unit that can be connected to the tray. In this way, the
one or more pumps can also be reusable which can reduce the cost of
the tray 10.
[0104] Moving now to FIGS. 18 and 19, a detail of the tray 10 is
shown. In particular, a fluid reservoir receiver or receptacle 44
is shown. The fluid reservoir receiver 44 can receive a reservoir
or container of fluid, such as a bottle of balanced-salt solution
(BSS). The fluid reservoir receiver 44 can be used to receive the
fluid and then the fluid can be used by other components of the
tray 10. For example, the fluid can be used by an infusion device
and can be connected to the infusion pump 56 to pump the fluid to
the infusion device and into the eye.
[0105] The fluid reservoir receiver 44 can be shaped like a bowl or
a container. The fluid reservoir receiver 44 can be contoured to
accommodate the shape of the desired fluid container. Preferably,
the fluid reservoir receiver 44 can hold at least some fluid, if
the fluid were to leak or be spilled from the container. As shown,
the fluid reservoir receiver 44 has a substantially cylindrical
wall and a planer bottom surface, though other cross-sectional
shapes could be used, such as square, rectangular, polygon,
etc.
[0106] The fluid reservoir receiver 44 can include a spike 80 or
other device to gain access to the fluid within the bottle or
container. As shown, the spike 80 is a vented spike having a fluid
channel 82 and an air channel 84. Fluid can flow from the bottle or
container through fluid channel 82 which passes into the tubing 90
connected with the spike 80. The tubing 90 can be connected to an
infusion pump and/or an infusion instrument. The spike 80 can also
include an air vent such as air channel 84. A filter 86, such as a
hydrophobic air filter, can be used to allow air to flow into the
spike while preventing fluid from exiting the spike through the air
channel 84 and through the filter 86. In this way, the vented spike
80 allows for fluid to be removed from the container or bottle
while at the same time allowing air to be introduced into the
bottle. This reduces any pressure differential between the interior
of the bottle and the atmosphere. This also allows the fluid to
continuously exit the bottle as desired without becoming plugged or
forced out because of the pressure differentials. Or alternatively,
the air channel 84 may be connected to an infusion pump to
pressurize the bottle or container so as to force fluid through
tubing 90 as desired.
[0107] The fluid reservoir receiver 44 can also include a light 88.
As many procedures in the eye are performed in the dark, a light 88
in the fluid reservoir receiver 44 can beneficially inform the
surgeon as to the fluid level of the container or bottle of BSS
fluid. The light 88 can be within, around, or outside of the fluid
reservoir receiver 44. The light 88 is preferably located in the
bottom surface of the fluid reservoir receiver 44, but can be
positioned in other locations as well.
[0108] As illustrated in FIGS. 18 and 19, the light 88 is
positioned next to the spike 80. The light 88 can be positioned in
a radially middle location between the center of the fluid
reservoir receiver 44 where the spike is located and the side wall.
This allows the light 88 to be positioned next to a thin wall
portion of the fluid bottle that is connected to the spike 80
within the fluid reservoir receiver 44. It will be understood that
generally a conventional BSS bottle will have a thin wall portion
between the neck and shoulder of the bottle. This will allow for
increased light transmission through the bottle.
[0109] The light 88 can be received to form a fluid tight seal in
the bottom of the fluid reservoir receiver 44. This way, if fluid
leaks from the bottle it will be less likely to leak out of the
tray 10 or the fluid reservoir receiver 44.
[0110] With the light 88 positioned in the bottom surface of the
fluid reservoir receiver 44, the rays of light from the light 88
pass through bottle or container and through the fluid. The light
88 can highlight the fluid meniscus showing the level of fluid
within the bottle. The meniscus is the curved upper surface of a
column of liquid, the curvature of which is caused by surface
tension between the fluid and the wall of the bottle or container.
The light 88 is preferably an LED and is preferably a darker color
so as to not distract from the surgical procedure. Example colors
include blue, amber, purple, green, etc. Other types of lights,
such as incandescent, florescent, and halogen, can also be
used.
[0111] The illustrated configuration also beneficially prevents the
light from shining directly into the surgeon's eyes or from
otherwise becoming a distraction during the surgical procedure.
Other systems can also be used to highlight the fluid level in the
dark while not shining the light directly into the surgeon's eyes
or otherwise being a distraction during the surgical procedure.
[0112] In many instances, a sterile user, such as a surgeon, may
require the assistance of a non-sterile user without compromising
the sterile field. For example, the surgeon may need the assistance
of a non-sterile user to place or replace a sterile BSS bottle or
other fluid, medication, injectable medication, intravenous
solution or other container within the sterile field, such as on
the tray 10, without compromising the sterile field.
[0113] FIG. 20 illustrates a device 110 that can be used to place a
sterile item, such as a bottle within a sterile field without
comprising the sterile field. The device 110 can also be used for
other purposes.
[0114] The device 110 can be a container configured to hold a
bottle, instruments, medication, tools, etc. The container 110 can
have an internal chamber 120 with at least one opening 122. The
internal chamber 120 and opening 122 can be used to hold or store
other items. In some embodiments, the container 110 can further
include a lip 124.
[0115] Turning now to FIG. 21, it can be seen that some embodiments
a lid 126 can cover the top of the container 110. The lid 126 can
seal the opening 122 and internal chamber 120. For example, the
container and/or the internal chamber 120 can be sterilized and a
sterile lid 126 can then be attached to the container 110.
Alternatively, the lid 26 can be a TYVEK.RTM. lid that can allow
the container 110, the internal chamber 120, and anything within
the internal chamber 120 to be sterilized together. This can
maintain the internal chamber 120 in a sterilized configuration, at
least until the lid 126 is removed or the sealed internal chamber
120 is otherwise breached.
[0116] The lid 126 can attach to the lip 124. As shown, the lid 126
is a TYVEK.RTM. lid or other similar material. The lid 126 can be
any type of lid that can maintain the internal chamber 120 in a
sterile condition.
[0117] In some embodiments, an item that has been previously
sterilized can be placed within the internal chamber 120. The lid
can then be placed on the container 110. Alternatively, or in
addition, an item and the internal chamber 120 can be jointly
sterilized prior to attaching the lid 126, or after the lid 126 has
been attached.
[0118] In some embodiments, the container 110 and an item can be
sterilized (jointly or separately), the item can be placed within
the container, and the container is then placed within a further
container such that a lid 126 is unnecessary. The further container
could be packaging or a medical kit, for example. The container 110
and the item could also be sterilized while within the further
container.
[0119] FIG. 22 illustrates an embodiment of the container 110 with
a bottle 70 within the internal chamber 120 of the container 110.
The bottle 70 can contain any of a number of different substances
including IV fluid, saline, and medication. In a preferred
embodiment, the bottle 70 is a sterile bottle containing
balanced-salt solution (BSS).
[0120] In some embodiments, all or part of the container 110 can be
flexible and/or malleable. This flexibility and malleability can
allow a user to exert forces on the container that can be imparted
to item(s) within the container 110. For example, the container 110
can have a compressible section 130. In some embodiments, the
compressible section 130 comprises an accordion shaped feature that
can allow the container to be compressed and/or decrease in
size.
[0121] FIGS. 23A-B illustrate one embodiment of a container 110
where the compressible section 130 is moved to the compressed
state, decreasing the size of the container 110. In comparison to
FIG. 23A, where the bottle 70 was completely within the container
110, in FIG. 23B the bottle 70 now extends past the opening 122 and
lip 124 of the container. The compressible section 130 can allow a
user to have increased control over the movement of an item within
the container. The compressible section 130 can be used to, for
example, force an item out of the container 110. The compressible
section 130 can also allow the force to be applied to the item as
it leaves the container 110, as will be further explained
below.
[0122] As one example, the container 110 can be used to advance the
bottle 70 onto a spike in the fluid reservoir receiver 44 of the
tray 10. The compressible section 130 can allow the doctor or nurse
to apply the necessary pressure on the bottle, so that the spike
can pierce the septum or lid of the bottle. This can provide access
to the BSS fluid within the bottle 70 to the various instruments on
the tray. For example, the infusion pump 56 can be used to pump BSS
fluid from the bottle 70 to the vitreous cutter 26. The container
110 can advantageously allow a non-sterile user, such as a nurse to
load the BSS fluid onto the sterile tray 10 without compromising
the sterile field.
[0123] Some example uses of the container 110 will now be
described.
[0124] As has been previously mentioned, a sterile field can be
established for a medical or surgical procedure that may involve a
tray or pack 10. In surgery, a sterile pack can be shipped from a
manufacturer to a surgery center. An example of which is ophthalmic
surgery (vitreoretinal or cataract surgery, in particular). These
packs can contain several items that are typically used in surgery
and include one-time use surgical instruments, fluid cassettes,
tubing sets, drapes, needles, and other devices. The particular
content of a pack depends on the type of surgery and perhaps the
individual preference of the surgeon or surgical center.
[0125] When preparing for surgery, a sterile drape can be placed
over a tray. The contents of the sterile pack and perhaps
additional sterile instruments and materials are spread-out over
the tray so that the materials and instruments necessary for the
surgery are readily available to a nurse or surgeon. A sterile pack
can also be provided where many of the instruments and tubing sets
are organized and placed in mating recesses of the pack so that the
pack can act as a tray for at least some of the instruments in
surgery. In such an example, a sterile drape may not be needed.
[0126] Often times, after the pack is opened, the components within
the pack are retrieved and transferred to a conventional tray, as
is known in the art, or back table in an operating room such that a
surgeon can retrieve and, if he/she desires, place back any of the
components during an operation. Often times, a scrub nurse or
surgical assistant performs this transfer.
[0127] The components within a pack or for a surgical procedure can
vary substantially. For example, surgical components of a surgical
pack for an ophthalmic procedure can include: a biological tissue
cutter; a tissue illuminator; an aspiration/infusion cassette; a
disposable speculum/drape combination; a self stabilizing lens ring
with the lens pre-mounted; a gas exchange syringe; Q-tips; a
sterile container containing balanced salt solution (BSS); an
infusion line; trocars with cannulas pre-mounted; and goniosol.
[0128] In some procedures, the aspiration/infusion cassette is
mounted directly into the tray. This eliminates the need for
separate setup of the aspiration/infusion cassette. An aspiration
line connects the biological tissue cutter to the aspiration
chamber of the cassette for removing tissue cut or dislodged by the
cutter during surgery. The infusion line connects the infusion
chamber of the cassette and allows infusion of fluids such as, for
example, the balanced salt solution, to replace the aspirated
materials.
[0129] Referring now to FIGS. 24-27, the tray 10 can accept a
sterile container 70 of balanced salt solution directly into the
tray. This can allow the container 70 to be connected to a pump
that can allow the infusion of fluids into the eye, for example.
The container 110 can be used to facilitate the installation,
placement and/or replacement of the container 70 into the fluid
reservoir receiver 44 of the tray 10.
[0130] The following steps may be taken during a surgical procedure
to mount the container 70 onto the tray 10. The below steps can be
performed by a non-sterile user without comprising the sterile
field.
[0131] 1) The lid 126 can be removed from the container 110, and/or
the container 110 can be removed from packaging. The container 110
can contain a sterile bottle 70 of IV fluid, such as BSS.
[0132] 2) The container 110 can be turned upside down to insert the
bottle 70 into the fluid reservoir receiver 44 of the tray 10 as
shown in FIG. 24. The bottle 70 can be held in place within the
container 110 by grip of the user, or by a slight friction fit
between the bottle and the container. The bottle 70 may be loose
inside the container 110 so as to be able to slide out without
additional force, or with minimal force.
[0133] 3) The container 110 can be placed over the fluid reservoir
receiver 44 of the tray 10 with the top down so that the opening
122 of the container is adjacent the top opening of the fluid
reservoir receiver 44 (FIG. 25). The bottle 70 can be allowed out
of the container into the fluid reservoir receiver 44.
[0134] 4) With the bottle placed within or over the fluid reservoir
receiver 44 (FIG. 25), a downward force can be applied to the
bottom of the container 110 (FIG. 26). This force can be a way to
ensure that the bottle is securely attached to the tray. This
movement may also serve to provide other functions such as
puncturing an end of the bottle with the spike 80 (FIGS. 18-19)
within the tray or locking the bottle in place.
[0135] This downward force can collapse the collapsible section
130. This is because the lip 124 of the container is positioned on
the tray 10 so the force can be sufficient to cause the collapsible
section to decrease in size. The force can cause the compressible
section 130 to compress, such as in an accordion fashion.
[0136] The force can also push the bottle 70 downward. This can
cause the bottle to leave the container. When the fluid reservoir
receiver 44 includes a spike 80, the force can also press the
bottle onto the spike. The spike can advance through the bottle,
such as through a septum or lid of the bottle. The bottle can then
be fluidly connected to the tray so that the pump 56 can draw fluid
from the container to be used at one or more parts of the tray. For
example the fluid can be provided to an instrument, such as a
vitreous cutter 26 and to a priming fluid reservoir 20.
[0137] 5) Once the bottle 70 is securely in place, the container
110 can be removed and discarded. The BSS container is then
contained in the fluid reservoir receiver 44 of the tray 10 as
shown in FIG. 27.
[0138] Preferably, the above method steps are performed by a
non-sterile user. Because the container 110 is removed and
discarded, and the user does not contact the bottle 70 and the
sterile field is generally not compromised. The outside surface of
the bottle 70 is preferably sterile and the sterile container 110
which may have been touched by the non-sterile user has been
removed. The container 110 allows the non-sterile user to attach
the bottle 70 to the tray without having to touch any part of the
tray or the bottle.
[0139] Should the surgeon or sterile user require an additional or
new bottle 70, such as of BSS solution, the sterile user can assist
without compromising the sterile field. The sterile user can remove
and discard the empty sterile bottle 70 from the tray 10 and the
above steps can then be repeated to install a new bottle 70.
[0140] A person of skill in the art should recognize that one or
more of the steps may vary depending on the type of surgery
performed. For example, all of the above steps can be performed by
a sterile user such as a surgeon.
[0141] As another example, the container 110 can also be used to
cover a device having a non-sterile exterior. For example, the
container 110 can be sterilized and a bottle having a non-sterilize
exterior or other item can be placed within the container 110. The
container. 110 can provide a protected, sterile covering for the
bottle so as to not compromise the sterile field.
[0142] As an example for a method of use, a bottle having a
non-sterile exterior, such as a bottle containing BSS can be placed
within the container 110. The container 110 can then be used as
described above, to secure the bottle 70 to the tray 10. The
container 110 can remain covering the bottle 70, as in FIG. 26.
This can provide for a sterile surface within the sterile field,
while still allowing for the use of a bottle or item having a
non-sterile exterior.
[0143] Although this invention has been disclosed in the context of
certain preferred embodiments and examples, it will be understood
by those skilled in the art that the present invention extends
beyond the specifically disclosed embodiments to other alternative
embodiments and/or uses of the invention and obvious modifications
and equivalents thereof. In addition, while a number of variations
of the invention have been shown and described in detail, other
modifications, which are within the scope of this invention, will
be readily apparent to those of skill in the art based upon this
disclosure. It is also contemplated that various combinations or
sub-combinations of the specific features and aspects of the
embodiments may be made and still fall within the scope of the
invention. Accordingly, it should be understood that various
features and aspects of the disclosed embodiments can be combined
with or substituted for one another in order to form varying modes
of the disclosed invention. Thus, it is intended that the scope of
the present invention herein disclosed should not be limited by the
particular disclosed embodiments described above, but should be
determined only by a fair reading of the claims that follow.
[0144] Similarly, this method of disclosure, is not to be
interpreted as reflecting an intention that any claim require more
features than are expressly recited in that claim. Rather, as the
following claims reflect, inventive aspects lie in a combination of
fewer than all features of any single foregoing disclosed
embodiment. Thus, the claims following the Detailed Description are
hereby expressly incorporated into this Detailed Description, with
each claim standing on its own as a separate embodiment.
* * * * *