U.S. patent application number 15/415624 was filed with the patent office on 2018-07-26 for single-use disposable sterile kit.
The applicant listed for this patent is DEPUY SYNTHES PRODUCTS, INC.. Invention is credited to Steven Greco, Richard Healey, David Moszak, Philip Watt.
Application Number | 20180206934 15/415624 |
Document ID | / |
Family ID | 61188912 |
Filed Date | 2018-07-26 |
United States Patent
Application |
20180206934 |
Kind Code |
A1 |
Healey; Richard ; et
al. |
July 26, 2018 |
SINGLE-USE DISPOSABLE STERILE KIT
Abstract
A single use disposable surgical kit, including a sterile sealed
container including a module configured to fit within the sterile
sealed container including surgical instruments housed in a bottom
tray including a first fastening feature; and a lid including a
second fastening feature congruently aligned with the first
fastening feature, wherein the first fastening feature is one of a
tab portion and a mating slot, the second fastening feature is the
other of the tab portion and the mating slot, and the second
fastening feature is configured to engage with the first fastening
feature.
Inventors: |
Healey; Richard; (West
Chester, PA) ; Watt; Philip; (West Chester, PA)
; Greco; Steven; (West Chester, PA) ; Moszak;
David; (West Chester, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DEPUY SYNTHES PRODUCTS, INC. |
Raynham |
MA |
US |
|
|
Family ID: |
61188912 |
Appl. No.: |
15/415624 |
Filed: |
January 25, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/88 20130101;
A61B 90/94 20160201; A61B 2050/3008 20160201; A61B 17/17 20130101;
A61B 17/16 20130101; A61B 50/33 20160201; A61B 2050/0084 20160201;
B65D 25/205 20130101; A61B 50/30 20160201; A61B 2050/005 20160201;
A61B 2090/061 20160201; A61B 50/20 20160201; A61B 17/865
20130101 |
International
Class: |
A61B 50/33 20060101
A61B050/33; B65D 25/20 20060101 B65D025/20 |
Claims
1. A single use disposable surgical kit, comprising: a sterile
sealed container comprising; a module configured to fit within the
sterile sealed container comprising: surgical instruments housed in
a bottom tray comprising a first fastening feature; and a lid
comprising a second fastening feature congruently aligned with the
first fastening feature, wherein the first fastening feature is one
of a tab portion and a mating slot, the second fastening feature is
the other of the tab portion and the mating slot, and the second
fastening feature is configured to engage with the first fastening
feature.
2. The kit of claim 1, wherein the first fastening feature
comprises at least two tab portions positioned diagonally opposite
each other in at least two corners of the bottom tray.
3. The kit of claim 1, wherein the second fastening feature
comprises at least two mating slots positioned diagonally opposite
each other and congruently aligned with the tab portions of the
bottom tray.
4. The kit of claim 3, wherein the mating slots include arm
extensions that enclose the tab portion to lock the bottom tray and
lid together.
5. The kit of claim 2, wherein the tab portions include ridges to
facilitate gripping of the tab.
6. The kit of claim 1, wherein the bottom tray includes a plurality
of cutout areas to house the surgical instruments.
7. The kit of claim 6, wherein the bottom tray comprises a
plurality of partitions that allow for the surgical instruments to
sit up above the floor of the tray.
8. The kit of claim 1, wherein the lid contains a plurality of
cutout areas to enclose the instruments.
9. The kit of claim 1, wherein the bottom tray and lid are formed
from a transparent polymer.
10. The kit of claim 1, wherein the surgical instruments are
selected from the group consisting of drill bits, K-wires, depth
gauges, drill guides, and screwdrivers, and combinations
thereof.
11. A single use disposable surgical kit, comprising: a sterile
sealed container comprising; a first module configured to fit
within the sterile sealed container comprising: a single bone plate
comprising a plurality of fastener apertures; and a fastener
housing; and a second module configured to fit within the sterile
sealed container comprising: instruments used to fixate a bone
fracture housed in a bottom tray comprising a first fastening
feature; and a lid comprising a second fastening feature
congruently aligned with the first fastening feature, wherein the
first fastening feature is one of a tab portion and a mating slot,
the second fastening feature is the other of the tab portion and
the mating slot, and the second fastening feature is configured to
engage the first fastening feature to lock the bottom tray and the
lid together.
12. The kit of claim 11, wherein the first fastening feature
comprises at least two tab portions positioned diagonally opposite
each other in at least two corners of the bottom tray.
13. The kit of claim 12, wherein the second fastening feature
comprises at least two mating slots positioned diagonally opposite
each other and congruently aligned with the tab portions of the
bottom tray.
14. The kit of claim 13, wherein the mating slots include arm
extensions that enclose the tab portion to lock the bottom tray and
lid together.
15. The kit of claim 12, wherein the tab portions include ridges to
facilitate gripping of the tab.
16. The kit of claim 11, wherein the bottom tray includes a
plurality of cutout areas to house the instruments.
17. The kit of claim 16, wherein the bottom tray comprises a
plurality of partitions that allow for the instruments to sit up
above the floor of the tray.
18. The kit of claim 11, wherein the lid contains a plurality of
cutout areas to enclose the instruments.
19. The kit of claim 11, wherein the bottom tray and lid are formed
from a transparent polymer.
20. The kit of claim 11, wherein the instruments are selected from
the group consisting of drill bits, K-wires, depth gauges, drill
guides, and screwdrivers, and combinations thereof.
21. The kit of claim 11, wherein the fastener housing comprises a
plurality of protrusions on the top of the fastener housing, a
plurality of stairs extending downward from the top of the fastener
housing and a plurality of concave depressions located on the top
surface of the plurality of stairs for housing a plurality of
fasteners, each of the plurality of fasteners comprising a head and
a shaft.
22. The kit of claim 21, wherein the plurality of protrusions
extend upward and away from the top of the fastener housing.
23. The kit of claim 21, wherein the plurality of concave
depressions are integrally formed on the top surface of the
plurality of stairs.
24. The kit of claim 11, wherein the fastener housing further
comprises a first fastener receptacle and a second fastener
receptacle.
25. The kit of claim 11, wherein the fastener housing further
comprises a first cavity that extends from a sidewall of the
fastener housing.
26. The kit of claim 25, wherein the plurality of stairs and the
plurality of concave depressions are contained within the first
cavity.
27. The kit of claim 25, wherein the fastener housing comprises a
second cavity that is separated from the first cavity by a dividing
wall.
28. The kit of claim 27, wherein the plurality of stairs and the
plurality of concave depressions are located within the second
cavity.
29. The kit of claim 21, wherein the plurality of fasteners sit
within the fastener housing in a staggered configuration.
30. The kit of claim 21, wherein the plurality of fasteners are
arranged in the fastener housing in a plurality of groupings of
fasteners of similar shaft length.
31. The kit of claim 11, wherein the fastener housing further
comprises a fastener length gauge.
32. The kit of claim 11, wherein the fastener housing is an
injection molded part.
Description
TECHNICAL FIELD
[0001] Various exemplary embodiments disclosed herein relate
generally to a single-use disposable sterile kit.
BACKGROUND
[0002] Conventional surgical kits are typically provided by
manufacturers in non-sterile, reusable instrument sets that are too
cost-prohibitive for use in smaller healthcare facilities, such as
Ambulatory Surgical Centers. Such kits are also problematic for
high-volume periods of usage in hospitals due to the need for
reprocessing steps which are time and cost dependent.
[0003] Disposable orthopedic surgical kits are generally sold as
sterile kits that contain bone plate(s) and a plurality of
fasteners as well as housings for the fasteners. The kits also may
contain wires, drill bits, drill guides, depth gauges and
screwdrivers. Disposable kits help provide streamlined,
cost-effective instrument sets to a wider range of healthcare
facilities.
SUMMARY
[0004] A brief summary of various exemplary embodiments is
presented below. Some simplifications and omissions may be made in
the following summary, which is intended to highlight and introduce
some aspects of the various exemplary embodiments, but not to limit
the scope of the invention. Detailed descriptions of an exemplary
embodiment adequate to allow those of ordinary skill in the art to
make and use the inventive concepts will follow in later
sections.
[0005] This disclosure relates generally to a single-use disposable
sterile kit. An example of such a sterile kit is a single-use
disposable orthopedic surgical sterile kit that allows for the
implantation of bone plates for the fixation of bone fractures. The
single-use disposable orthopedic surgical sterile kit will be used
as an example sterile kit, but sterile kits for other applications
may be carried out according to the disclosure below.
[0006] Various embodiments relate to a single-use disposable
sterile kit, including a sterile sealed container, a first module
including a single bone plate having a plurality of fastener
apertures, a fastener housing including a plurality of protrusions,
stairs and concave depressions for housing a plurality of
fasteners; and a second module including instruments required to
fixate a bone fracture. In various embodiments, the first and
second modules sit within two separate cutout sections of the
sterile sealed container.
[0007] Various additional embodiments relate to a single use
disposable orthopedic surgical kit including a sterile-sealed
container including a first module configured to fit within the
sterile sealed container including: a single bone plate including a
plurality of fastener apertures and a fastener housing including a
plurality of protrusions on the top of the fastener housing, a
plurality of stairs extending downward from the top of the fastener
housing, and a plurality of concave depressions located on the top
surface of the plurality of stairs for housing a plurality of
fasteners, each of the plurality of fasteners including a head and
a shaft.
[0008] Various additional embodiments relate to a single use
disposable orthopedic surgical kit including a first module
including: a single bone plate including a plurality of fastener
apertures and a fastener housing including a plurality of
protrusions on the top of the fastener housing, a plurality of
stairs extending downward from the top of the fastener housing and
a plurality of concave depressions located on the top surface of
the plurality of stairs for housing a plurality of fasteners, each
of the plurality of fasteners including a head and a shaft. The kit
further includes a second module including instruments used to
fixate a bone fracture.
[0009] Various additional embodiments relate to a single use
disposable orthopedic surgical kit including a first module
including a single bone plate including a plurality of fastener
apertures and a fastener housing including a plurality of
protrusions on the top of the fastener housing, a plurality of
stairs extending downward from the top of the fastener housing and
a plurality of concave depressions located on the top surface of
the plurality of stairs for housing a plurality of fasteners, each
of the plurality of fasteners including a head and a shaft. In
various embodiments of the kit, the plurality of protrusions extend
upward and away from the top of the fastener housing and the
plurality of concave depressions are integrally formed on the top
surface of the plurality of stairs. The kit additionally includes a
second module including instruments used to fixate a bone
fracture.
[0010] Various embodiments relate to a first module including a
first well and a second well. In various embodiments, the fastener
housing is included in the first well and the bone plate included
in the second well.
[0011] Various embodiments are described wherein the first module
includes a one-shot injection-molded fastener housing having a
plurality of protrusions extending upward from the top of the
fastener housing and having a plurality of stairs and a plurality
of concave depressions included within a first and second cavity of
the fastener housing to prevent the fasteners from threading into
the fastener housing. In various embodiments, the plurality of
concave depressions are integrally formed with the top surface of
the stairs. In various embodiments, the plurality of protrusions,
plurality of stairs and plurality of concave depressions work
together to prevent fastener angulation or jamming during transit
and handling.
[0012] In various embodiments of the first module, the plurality of
fasteners is arranged in the fastener housing in a plurality of
groupings of the fasteners. The first one of the plurality of
groupings includes only fasteners having a first shaft length and
the second one of the plurality of groupings includes only
fasteners having a second shaft length that is different from the
first shaft length. The fasteners in the first one of the plurality
of groupings are segregated from the fasteners in the second one of
the plurality of groupings. In various embodiments, the fastener
housing may include a first fastener receptacle to house the first
one of the plurality of groupings of fasteners and a second
fastener receptacle to house the second one of the plurality of
groupings of fasteners. In various embodiments, the fasteners sit
within the fastener housing in a staggered configuration. The heads
of the fasteners are dimensioned to mate with the fastener
apertures in the bone plate. In one embodiment, the head and shaft
of the fasteners both include threads.
[0013] In various embodiments of the first module, the lengths of
the fasteners are based on the included bone plate and anatomic
study. The fasteners may include a first sized head or a second
sized head. All of the fastener apertures of the bone plate may be
dimensioned to receive either the first sized head or the second
sized head. The kit may include forty-four or fewer fasteners, each
of which may have one of seven different shaft lengths. The
fasteners may be arranged in the fastener housing in a plurality of
groupings of four or fewer fasteners, each having the same shaft
length.
[0014] Various embodiments are described wherein the fastener
housing may include labels to indicate the shaft length of each of
the plurality of groupings of fasteners. The fastener housing may
include a fastener length gauge to aid the user in determining the
length of each of the plurality of fasteners.
[0015] Various embodiments of the first module are described
wherein the bone plate, fasteners and fastener housing are housed
in a double-sterile barrier to ensure sterility.
[0016] Various further embodiments relate to a single use
disposable surgical kit including a sterile sealed container
including: a first module configured to fit within the sterile
sealed container including a single bone plate including a
plurality of fastener apertures and a fastener housing; and a
second module configured to fit within the sterile sealed container
including instruments used to fixate a bone fracture housed in a
bottom tray including a first fastening feature and a lid including
a second fastening feature congruently aligned with the first
fastening feature wherein the first fastening feature is one of a
tab portion and a mating slot, the second fastening feature is the
other of the tab portion and the mating slot and the second
fastening feature is configured to engage with the first fastening
feature.
[0017] Various further embodiments relate to a single use
disposable surgical kit including a sterile sealed container
including a module configured to fit within the sterile sealed
container including surgical instruments housed in a bottom tray
including a first fastening feature, and a lid including a second
fastening feature congruently aligned with the first fastening
feature wherein the first fastening feature is one of a tab portion
and a mating slot, the second fastening feature is the other of the
tab portion and the mating slot and the second fastening feature is
configured to engage with the first fastening feature.
[0018] Various additional embodiments are described wherein the
second module includes instruments required to fixate a bone
fracture. In various embodiments, the module includes a disposable
torque limiting screwdriver adapted to engage the fastener heads
and further includes a torque limiting stop. The module may
additionally include a depth gauge, K-wires, a drill bit and a
drill guide.
[0019] In various embodiments of the module, the instruments are
presented in approximate order of clinical use in a bottom tray. In
various embodiments, the bottom tray includes a plurality of cutout
areas to house the instruments. In various embodiments, the bottom
tray additionally includes a plurality of partitions that allow for
the surgical instruments to sit up above the floor of the bottom
tray for easier removal during use. The handle and pick-up area of
the instruments may be oriented towards the user.
[0020] In various embodiments of the module, the bottom tray may
include locking tabs diagonally aligned on at least two corners of
the tray. In various embodiments, the locking tabs include ridges
to facilitate gripping of the tab.
[0021] In various embodiments of the module, the bottom tray is
covered by a lid, which includes a plurality of cutout areas to
enclose the instruments. In various embodiments, the lid may
include mating slots present in at least two corners of the lid.
Such mating slots may be congruently aligned with the locking tabs
included on the tray. In various embodiments, the mating slots may
include arm extensions that enclose the locking tab to lock the
bottom tray and lid together.
[0022] In various embodiments, the first module and the second
module may be removable from the sterile sealed container. The
sterile sealed container may include cutouts to aid with removal of
the first and second modules.
[0023] Various embodiments of the kit are described wherein the
instruments may be packaged separately from the bone plates,
fasteners and fastener housing so that the instrument tray may also
be used for an instrument-only sterile kit.
[0024] In various embodiments, the sterile container, the first
module and the second module, may all be made of a thermoformed
plastic material. In various embodiments, the sterile container,
the first module and the second module may all be formed from a
transparent polymer.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] In order to better understand various exemplary embodiments,
reference is made to the accompanying drawings, wherein:
[0026] FIG. 1 illustrates a top perspective view of an embodiment
of the disposable, single use orthopedic surgical kit showing an
embodiment of a sterile container which includes a first module
including a bone plate, a fastener housing and a plurality of
fasteners and a second module including instruments required to
fixate a bone fracture.
[0027] FIG. 2A illustrates a top perspective view of an embodiment
of the second module including a bottom tray including locking tabs
in the upper right-hand and lower left-hand corners, and a lid
covering the bottom tray, wherein the lid includes mating slots in
the upper right-hand and lower left-hand corners that align and
mate with the locking tabs on the bottom tray. The bottom tray
includes cutouts to house the instruments required to fixate a bone
fracture. The lid includes cutouts to enclose the instruments.
[0028] FIG. 2B illustrates a top perspective, detailed view of an
embodiment of the locking tab and mating slot configuration.
[0029] FIG. 2C illustrates a side perspective, detailed view of an
embodiment of the locking tab and mating slot configuration.
[0030] FIG. 3 illustrates a top perspective view of an embodiment
of the bottom tray portion of the second module.
[0031] FIG. 3A illustrates a top perspective detailed view of an
embodiment of the locking tab included on the bottom tray portion
of the second module.
[0032] FIG. 4 illustrates a bottom perspective view of an
embodiment of the lid portion of the second module showing the
instrument cutouts and mating slots.
[0033] FIG. 4A illustrates a bottom perspective detailed view of an
embodiment of the mating slot contained on the lid portion of the
second module.
[0034] FIG. 5 illustrates a top perspective view of an embodiment
of the first module including a tray with wells for a fastener
housing and a bone plate. A fastener housing is included in the
first well and a bone plate in the second well.
[0035] FIG. 6 illustrates a top perspective view of an embodiment
of the fastener housing.
[0036] FIG. 6A illustrates a top view of an embodiment of the
fastener housing.
[0037] FIG. 6B illustrates a front view of an embodiment of the
fastener housing showing a plurality of protrusions on the top of
the fastener housing and a first and second cavity each including a
plurality of stairs, and a plurality of concave depressions that
sit on the top surface of the stairs.
[0038] FIG. 6C illustrates a top view of an embodiment of the
fastener length gauge included on the top of the fastener
housing.
[0039] FIG. 6D illustrates a side view of an embodiment of the
fastener housing showing a cross-sectional view of the plurality of
protrusions included on the top of the fastener housing and the
stairs included in the first cavity.
[0040] FIG. 7 illustrates a top perspective view of an embodiment
of the sterile sealed container having a cutout portion to house
the second module.
[0041] FIG. 7A illustrates a top perspective view of an embodiment
of the sterile sealed container having a cutout portion to house
the first module.
[0042] To facilitate understanding, identical reference numerals
have been used to designate elements having substantially the same
or similar structure and/or substantially the same or similar
function.
DETAILED DESCRIPTION
[0043] The description and drawings illustrate the principles of
the invention. It will thus be appreciated that those skilled in
the art will be able to devise various arrangements that, although
not explicitly described or shown herein, embody the principles of
the invention and are included within its scope. Furthermore, all
examples recited herein are principally intended expressly to be
for pedagogical purposes to aid the reader in understanding the
principles of the invention and the concepts contributed by the
inventor(s) to furthering the art, and are to be construed as being
without limitation to such specifically recited examples and
conditions. Additionally, the term, "or," as used herein, refers to
a non-exclusive or (i e , and/or), unless otherwise indicated
(e.g., "or else" or "or in the alternative"). Also, the various
embodiments described herein are not necessarily mutually
exclusive, as some embodiments can be combined with one or more
other embodiments to form new embodiments.
[0044] Below embodiments of a disposable single-use sterile kit are
described. The kit generally includes a sterile sealed container
with cutout portions to house a first and second module. The first
module includes a fastener housing and a bone plate and the second
module includes instruments required for fixing a bone fracture.
The first and second modules are described in more detail in the
figures below.
[0045] FIG. 1 illustrates an embodiment of the sterile kit in an
open configuration including a sterile tray 100 with cutout
portions to house a first module 110 and a second module 120. The
sterile tray 100, first module 110 and second module 120 are
thermoformed from any one of a number of polymers, for example
polyethylene terephthalate glycol-modified. Sterile tray 100 can
have a rectangular shape defined by four tray sides 101-104,
although other shapes may be desirable depending on functional,
economic, aesthetic or other reasons. Sterile tray 100 includes a
tray bottom 105. Sterile tray 100 is compartmentalized by several,
integrally formed partitions 106 that may extend from the inside of
tray bottom 105 and/or the inside of tray sides 102, 104 to form
cutouts 107, 108 where the integrally formed partitions separate
the first and second modules from each other. The first module 110
includes wells 111, 112 to house a fastener housing 130 and a bone
plate 140. The first module 110 additionally includes a plastic
covering 113 that lies on top of the fastener housing 130 and the
bone plate 140.
[0046] In the embodiment of FIG. 1, the second module 120 includes
a drill bit 121, K-wires 122, a depth gauge 123, a variable angle
drill guide 124, a coaxial drill guide 125, a torque limiting
screwdriver 126 and a torque limiting stop 127.
[0047] FIG. 2A illustrates a top perspective view of an embodiment
of the second module 220. The second module includes a bottom tray
250 and a lid 260 positioned to sit on top of the bottom tray 250.
The bottom tray 250 and lid 260 are locked together using locking
tabs 251 positioned diagonally opposite of each other in the upper
left-hand corner and lower right-hand corner of the tray 250 as
shown. Either one or both of the bottom tray 250 and lid 260 may be
formed from a transparent polymer to allow viewing of the
components included therein without opening the second module
220.
[0048] FIGS. 2B and 2C illustrate a more detailed view of an
embodiment of the locking tabs 251. The locking tabs 251 positioned
diagonally opposite each other in two corners of the bottom tray
250 lock into mating slots 261 congruently positioned on the lid
260 to receive the locking tabs 251.
[0049] FIG. 3 illustrates a top perspective view of an embodiment
of the bottom tray 350. The bottom tray 350 can have a generally
rectangular shape defined by four tray sides 352-355, although
other shapes may be desirable depending on functional, economic,
aesthetic or other reasons. Bottom tray 350 is compartmentalized by
partitions 356 that form cutout areas 357 in which the instruments
required for fixing a bone fracture 121-127 are placed. The
partitions 356 are positioned to allow for the instruments 121-127
to sit up above the floor of the bottom tray 350. The bottom tray
350 includes locking tabs 351 diagonally positioned in the upper
left-hand corner and lower right-hand corner.
[0050] FIG. 3A illustrates a more detailed view of an embodiment of
the locking tab 351. The locking tab includes a tab portion 351a
which is connected to the bottom tray 350 by way of a connecting
piece 351b that is narrower than the tab portion 351a. The tab
portion 351a also includes ridges 351c to facilitate gripping of
the locking tab 351.
[0051] FIG. 4 illustrates a bottom perspective view of an
embodiment of the lid 460. The lid 460 can have a generally
rectangular shape defined by four sides 462-465, although other
shapes may be desirable depending on functional, economic,
aesthetic or other reasons. Lid 460 is compartmentalized by
partitions 466 that form cutout areas 467 that fit over the
instruments required for fixing a bone fracture 121-127. The lid
cutout areas 467 fit together with the bottom tray cutout areas 357
to enclose the individual instruments. The lid 460 includes mating
slots 461 in which the locking tabs 351 are inserted to lock the
bottom tray 350 and lid 460 together.
[0052] FIG. 4A illustrates a more detailed view of the mating slot
461 which includes arm extensions 461a that enclose the connecting
piece 351b and lock the tab portion 351a of the bottom tray 350
within the mating slot 461 of the lid 460.
[0053] FIG. 5 illustrates a top perspective view of an embodiment
of the first module 510. The first module may be in the form of a
tray 511 having a generally rectangular shape, although other
shapes may be desirable depending on functional, economic,
aesthetic or other reasons. The tray 511 includes a first well 512
and a second well 513. The first well 512 includes a fastener
housing 530 and the second well 513 includes a bone plate 540.
[0054] FIG. 6 illustrates a top perspective view of the fastener
housing 630. The fastener housing 630 includes a fastener length
gauge 631 configured and labeled by a size label 631a for measuring
incremental lengths of a plurality of fasteners. The incremental
lengths may range, for example, between 10 mm and 30 mm by 2 mm
increments. As illustrated in more detail in FIG. 6C, the fastener
length gauge 631 has a channel 631b and a seat 631c. Using fastener
length gauge 631, the surgeon may quickly confirm the length of a
selected fastener prior to implantation of the fastener into the
patient, and ensure that the fastener is of sufficient length to
properly engage bone, but not so long as to protrude too far from
the bone and into soft tissue.
[0055] FIGS. 6 and 6A illustrate a perspective and top view of the
fastener housing 630 wherein the fastener housing 630 includes a
plurality of first fastener receptacles 632 to house a first
plurality of fasteners and a plurality of second fastener
receptacles 633 to house a second plurality of fasteners. Each of
the first and second receptacles 632, 633 is sized and shaped to
loosely retain a first plurality of fasteners and a second
plurality of fasteners, respectively.
[0056] The fastener housing 630 may be prepared using
injection-molding to form a first cavity 634 extending from the
left sidewall 639a to a molded dividing wall 639b, which is located
directly underneath the plurality of first fastener receptacles
632. The fastener housing 630 may further include a second cavity
635 separated from the first cavity by the molded dividing wall
639b, which is located directly underneath the plurality of second
fastener receptacles 633. The first cavity 634 and second cavity
635 are surrounded by the molded walls of the fastener housing 630
on three sides with the fourth side open so that the shafts of the
fasteners are visible.
[0057] As illustrated in FIGS. 6B and 6D, the fastener housing 630
additionally includes a plurality of protrusions 637 that extend
upwards and away from the top of the fastener housing 630. The
first cavity 634 and the second cavity 635 each include a plurality
of stairs 636 that extend downward from the top of the fastener
housing, and a plurality of concave depressions 638 that sit on the
top surface of the stairs 636. In one embodiment, the heads of the
fasteners sit atop the plurality of protrusions 637 while a small
portion of the shaft of the fasteners sit within the plurality of
concave depressions 638. The stairs 636 cause the fasteners to sit
within the fastener housing 630 in a staggered configuration. The
plurality of protrusions 637, plurality of stairs 636 and plurality
of concave depressions 638 act in combination to prevent fastener
angulation or jamming during transit and handling.
[0058] The first plurality of fasteners may be arranged in the
first fastener receptacle 632 in a plurality of groupings of 7 or
fewer fasteners and the second plurality of fasteners may be
arranged in the second fastener receptacle 633 in a plurality of
groupings of 4 or fewer fasteners. Each grouping corresponds to a
particular one of a number of distinct fastener lengths. As shown
in FIG. 6, receptacles 632 and receptacles 633 are arranged in
groupings, such that each grouping may include up to 4 fasteners of
the same shaft length.
[0059] When the kit is opened, the user may easily grasp the
exposed end of each fastener and remove it from fastener housing
630. Alternately, the user may pick each fastener from the fastener
housing 630 using a suitable drive instrument. Since each
single-use kit may include only the number of fasteners required
for the particular surgical indication, with a few extra, a number
of first fastener receptacles 632 and second fastener receptacles
633 may be empty.
[0060] FIGS. 7 and 7A illustrate the cutout portions included in
sterile tray 700 in which the first module 710 and second module
720 are housed.
[0061] It should be appreciated by those skilled in the art that
any diagrams or schematic drawings herein represent conceptual
views of illustrative structures embodying the principles of the
invention.
[0062] Although the various exemplary embodiments have been
described in detail with particular reference to certain exemplary
aspects thereof, it should be understood that the invention is
capable of other embodiments and its details are capable of
modifications in various obvious respects. As is readily apparent
to those skilled in the art, variations and modifications can be
effected while remaining within the spirit and scope of the
invention. Further, various elements from the various embodiments
may be combined to form other embodiments that are within the
spirit and scope of the invention. Accordingly, the foregoing
disclosure, description, and figures are for illustrative purposes
only and do not in any way limit the invention, which is defined
only by the claims.
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