Note: Descriptions are shown in the official language in which they were submitted.
CA 02895640 2015-06-26
STERILE READY-TO-USE SURGICAL TOOL HAVING WIRELESS CHARGING
SYSTEM CAPABILITY
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority from U.S. Provisional Application No
62/099,204 filed January 2, 2015, incorporated herein by reference.
BACKGROUND
[0002] This disclosure relates to single and limited use surgical power tools
and
more specifically such tools which can be provided as a pre-packaged, pre-
sterilized
tool including a pre-installed charged battery.
[0003] Important factors for any surgical instrument include sterility, cost
of
acquisition, maintenance, and reliability during use in the surgical suite.
Each of
these factors can have a significant impact on the cost of medical care for
both the
patient and the provider.
[0004] In recent years, there has been significant focus on the ever
increasing
cost of medical care. These cost increases have led to skyrocketing insurance
premiums, reduced coverage, reduced reimbursements, increased fees for
services,
severe reductions in services for some patient groups by some providers, and
unfortunately an apparent increase in infections and medical mishaps.
[0005] In an effort to reduce costs and improve profitability, both service
providers
and medical device suppliers are continuously looking for ways to streamline
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procedures, cut time, cost, and risk from their products and services without
reducing the quality of the products or services they provide to their
customers. One
area to benefit from these savings and improvements has been in the orthopedic
surgical field through the use of high precision, battery powered surgical
instrumentation. In the late 1960's and early 1970's, battery operated drills
were
bulky, ill-balanced and required multiple batteries to perform some surgeries
due to
the limited energy storage capacity and poor efficiency of the electric
motors.
[0006] Since then, manufacturers have attempted to make batteries more
efficient
with higher energy storage capacity, reduced size, and improved rechargeable
lifespans. Likewise, motor housings such as saw and drill bodies have become
more ergonomic, balanced, lightweight and energy efficient. As with many
standard
hand tools having multiple moving components, instrument manufacturers have
reduced weight by utilizing lighter materials such as plastic housings, and
gears, and
put weight reducing apertures in what were previously solid housings. In some
cases, standard mountings for attachments have been replaced with modular
fittings, allowing for greater interchangeability and component selections.
Additionally, manufacturers have attempted to improve electrical components by
upgrading them with more modern components wherever possible.
[0007] All of these improvements in equipment construction have improved
efficiencies, costs and quality in some areas while at the same time
increasing costs
for acquisition, maintenance and increasing risks in other ways that were not
previously seen or predicted. Often times cost and quality can be inversely
proportional to one another. One example of the increased cost and patient
risk is
seen in the cleaning and maintenance of instruments.
[0008] Recent published reports suggest that many of the surgical instruments
used in operations were not being cleaned and/or sterilized appropriately in
the very
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hospital facilities that were established and tasked for that purpose. In
numerous
reports, following cleaning and sterilization, it was noted that upon closer
secondary
inspection, the inside of small diameter cannulas and intricate mini-
components of
arthroscopic shavers that are used for many of today's minimally invasive
procedures, contained human tissue and bone fragments from previous surgeries.
In other cases, modular components of drills and saws such as chucks, drill
bits and
blades were found to have similar debris or pieces of cleaning brushes and/or
bristles embedded in or on them. These investigations have demonstrated that
in
most cases the instruments were not cleaned according to manufacturer's
specifications which has likely lead to many documented cases of serious,
multiple,
serial infections for subsequent patients. A pilot program conducted by the
Centers
for Medicare and Medicaid Services (Schaefer et al., 2010; JAMA 2010;
303(22):2273-2279) inspected 1500 outpatient surgery centers and found that
28%
had been cited for infectious control deficiencies associated with equipment
cleaning and sterilization. The costs to the patients and the hospitals in
both
expense and liability to deal with these infections can be and has been
staggering.
[0009] In other cases, critical battery-operated, motorized tools such as
drills or
bone saws have ceased to function due to dead batteries that no longer
maintain
their capacity to hold a charge, or due to internal part failure, often
attributable to
overuse or lack of proper maintenance. The resultant downtime in the operating
suite is extremely costly, as the procedure step must be put on hold while
replacement or substitute tools are obtained. Wait times may often exceed 20-
30
minutes, resulting in additional anesthesia exposure for the patient,
additional
operating room time (charged to the patient) and potential delays to other
procedures where the replacement or substitute equipment had been scheduled
for
use in a later procedure. Recent estimates (2005) establish the average cost
of
operating room time to range between $62/min. (range $21.80 -$133.12)
depending
on the procedure. These figures did not include extra resources provided by
the
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hospital for special, non-routine situations which often occur during standard
procedures, and did not include the surgeon and anesthesia provider fees,
(anesthesia fees are estimated to be $4/min; range $2.20 - $6.10).
[0010] Hospitals and instrument manufacturers are continuously attempting to
find
improved ways to reduce risk associated with infection in general, and more
recently, specifically from improperly cleaned instruments. One approach has
been
to use more disposable, single-use instruments such as drills, saw blades and
plastic cannulas. Additionally, many laparoscopic devices such as, surgical
staplers
and trocars, are designed as single use items that are intended to be
immediately
disposed of after use. Unfortunately, at today's acquisition costs, the total
cost of
ownership and benefits are not always clear for high-use battery-operated,
motorized instruments such as saws, drills and reamers used in orthopedic
procedures and the idea of disposable powered instruments has not been readily
embraced.
[0011] A recent trend in the medical community is reprocessing of single use
medical instruments, by parties ci.her than the original equipment
manufacturer,
instead of discarding them after use. During reprocessing, the medical
instruments
are disassembled, cleaned and sterilized. They are then reassembled for future
use. However, because the medical instruments reprocessed for further use are
specifically provided for use during a single procedure, the performance of
the
medical instruments tends to decline after reprocessing, because the
components
making up the medical instrument are not adapted for multiple uses and will
degrade in performance when used beyond their intended life span. For example,
reprocessing of the cutting devices on trocars is intended to extend these
devices
beyond their intended mission life, but often results in duller cutting edges
on the
blades because neither the materials used nor the reprocessing method can
restore
the device to the original manufacturing specifications. A greater force,
therefore, is
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needed to make an initial incision, causing more trauma to the patient. In
addition,
the use of greater force increases the potential for error during the surgical
procedure.
[0012] Most hospitals and surgery centers buy high-use, reusable motorized,
pneumatic, wired or battery operated, orthopedic surgical equipment and are
expected to clean, sterilize, and maintain them internally within the
hospital.
Unfortunately, the technicians hired to perform this work are typically not
qualified or
trained to perform this work adequately for the many varieties of powered
instruments used. Further, manufacturers rarely provide the hospital / client
with the
training or diagnostic equipment necessary to evaluate or test the equipment.
Often
times the hospital employees responsible for cleaning and maintenance are not
technicians at all, being paid slightly more than minimum wage, working at a
fast
pace to merely wash, count, and reload instruments into their appropriate
system
trays and flash sterilize them as quickly as possible, in an effort to keep
the
equipment in rotation in the hospital operating rooms, where higher throughput
dictates profitability for the hospital or surgery center.
[0013] As a result of high throughput requirements, general maintenance is
rarely
done and preventative monitoring and maintenance is almost never done on this
type of equipment. Hospital budgets for internal maintenance of equipment are
generally geared toward high-end, multi-million dollar capital equipment such
as x-
ray and radiological equipment. It is generally assumed that it is faster,
simpler, and
more economical for the hospital to wait for hand-held instruments, such as
drills,
saws and reamers to fail, then, send them back to the manufacturer for repair
or
replacement.
[0014] Thus it has become apparent that there is a need for an improved system
of cost-effective, battery-operated, motorized tools in conjunction with
better
CA 02895640 2015-06-26
cleaning and maintenance protocols which can provide the hospital, surgeon,
and
most importantly, the patient, with a higher degree of efficiency and
cleanliness
while reducing risk and keeping the costs of cleaning, maintenance, and repair
as
low as possible.
SUMMARY
[0015] A sterile reusable medical procedure power tool includes an integrated
housing having a power and drive housing portion, a handle portion and a
battery
housing portion including a battery. The sterile power tool is packaged in a
sterile
tray or equivalent sterile package including a compartment receiving the
sterile
power tool. A removable cover is sealingly attached to the sterile package.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Fig.1 is a side view illustrating an embodiment of a surgical power
tool
having an integrated housing including a power and attachment portion, a
handle
portion, a battery housing portion, a rechargeable battery and a battery
housing
door.
[0017] Fig. 2 is a side view illustrating an embodiment of a surgical power
tool
having the integrated housing of Fig. 1 and a battery in the battery housing
portion
having the battery housing door attached.
[0018] Fig. 3 is a side view illustrating an embodiment of the battery housing
door,
[0019] Fig. 4 is a top view of the battery housing door of Fig. 3,
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[0020] Fig. 5 is a top cut-away view illustrating an embodiment of the battery
housing door attached to the battery housing portion.
[0021] Fig. 6 is a side view illustrating an embodiment of the power tool and
an
auxiliary part nested in a compartmentalized shipping tray.
[0022] Fig. 7 is a perspective view illustrating an embodiment of a barrier
lid for
sealing the tray.
[0023] Fig. 8 is a perspective view illustrating an embodiment of the sealed
tray
and a polyethylene header bag.
[0024] Fig. 9 is a plan view illustrating an embodiment of a sterile packaged
re-
usable medical procedure power tool.
[0025] Fig. 10 is a frontal view illustrating an embodiment of a portable
tool
support member for carrying one or more tools.
[0026] Fig. 11 is a frontal view illustrating an embodiment of a stationary
tool
support member for storing one or more tools.
[0027] Fig. 12 is a diagrammatic view illustrating an embodiment of a wireless
transceiver coupled to communicate with a wireless communication device in the
tool, and with a centralized database of a tool supplier, and further
illustrates the
centralized database being accessible by a user of the tool.
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DETAILED DESCRIPTION
[0028] A medical procedure power tool 10 is illustrated in Fig. 1 and includes
an
integrated housing 12 having a power and attachment portion 14, a handle
portion
16 and a battery housing portion 18. The power and attachment portion 14
contains
an electric motor (not shown) and a chuck for securing various tools (not
shown) to
the tool 10. The handle portion 16 includes a trigger 20, and the battery-
housing
portion 18 defines a battery compartment 22. The housing 12 is preferably
formed
of a synthetic material and comprises first and second halves. A battery 24
may be
either rechargeable or disposable. A single unit molded door 26 includes a
pair of
snap-on attachment members 28 and a pair of grip-to-remove members 30. The
door 26 is discussed below in more detail.
[0029] In Fig. 2, the battery 24 is mounted in the battery compartment 22, and
the
door 26 is snapped on to the battery housing portion 18. The door 26, Fig. 3,
includes an end cap 26a, a pair of ramped snap-on attachment members 28, Fig.
4,
and grip-to-remove members 30 which extend on opposed flexible arms 27 from
the
end cap 26a. The end cap 26a, one of the snap-on attachment members 28 and
one of the grip-to-remove members 30 are illustrated in Fig. 3. In Fig. 5, the
door 26
is attached to the battery-housing portion 18. As such, the snap-on attachment
members 28 are engaged in reliefs 29 in opposed walls 32 of the battery-
housing
portion 18. For removal of the door 26, a manual pinching action of the
opposed
flexible arms 27, disengages the attachment members 28 from the respective
reliefs
29, and the door 26 is removed from the battery-housing portion 18.
[0030] A tray 40, Figs. 6, 7 and 8 includes one or more sunken compartments
42,
42a formed therein. The compartment 42 is formed to receive tool 10, and the
compartment 42a is formed to receive an auxiliary handle 44, which if needed,
can
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be attached to tool 10 via a receptacle 46 formed in housing 12. Attachment of
handle 44 enhances control of tool 10. Additional compartments may be added to
tray 40 as needed to receive other auxiliary parts for use with the tool 10.
The
compartments 42 and 42a are sufficient to permit nesting of the tool 10 and
handle
44 in the tray 40. The tray 40, or any equivalent form of sterile packaging,
suitable
for shipping tool 10, may be used.
[0031] A sealable lid 50, Fig. 7, is attached to a planar surface 52 of tray
40, thus
protecting the tool 10 and handle 44, nested in the compartments 42, 42a of
tray 40.
A header bag 60 receives sealed tray 40, Fig. 8. The bag 60 is sealed and the
entire package is shipped ready-for-use in a sterile shipping package 62. The
user
is required only to remove the sterile tool 10 from the bag 60 and covered
tray 40.
[0032] With any single-use or limited-use tool system, the cost per tool must
be
minimized because this cost is spread over a minimum number of procedures.
With
a traditional tool, the battery enclosure is a separate item from the base
tool,
requiring an expensive attachment scheme to both secure the battery pack to
the
tool, and to also connect the electrical terminals to transfer power from the
battery
into the tool. For a single-use or limited-use tool, it would be preferable to
have an
integrated battery enclosure to reduce the cost of the combined tool, battery
pack,
and external battery enclosure.
[0033] Additionally, current battery door covers include multiple components,
many times a hinge mechanism, that drive up the production costs of a door
system.
For a single-use or limited-use tool, it would be preferable to have a single
component door, with no additional parts required to create a door assembly.
This
will reduce the total cost per procedure.
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[0034] The tool and system of this disclosure minimizes cost and complexity
for a
single-or limited use powered surgical tool, ultimately helping to drive down
per-
procedure cost. Whereas a traditional powered surgical tool utilizes 3
components
(the tool, a battery enclosure, and a battery pack), the new disclosure
requires only
a tool and a battery pack. This eliminates the need for complicated, expensive
hardware required to attach the battery enclosure both physically and
electrically to
the power tool.
[0035] This disclosure is further enhanced by pre-loading the battery which
further
negates the need for surgical operators to transfer batteries/battery packs to
the tool
prior to or during surgery.
[0036] The disclosure further minimizes cost and complexity for a single-or
limited
use powered surgical tool, ultimately helping to drive down per-procedure
cost.
Whereas any existing surgical power tools utilize a complex latching system
for the
battery door, the current disclosure allows installation, latching, and
removal of a
battery door system in a single component made of a plastic or other rigid
material.
This disclosure could be utilized in a format where the door is either
installed at the
manufacturer's facility, prior to sterilization and eventual use by the
medical facility,
or it could be installed by medical personnel at the medical facility, after
battery
installation.
[0037] Today's tools, reusable or otherwise, require a hospital to recharge
and re-
sterilize, as well as transfer a battery into the tool in preparation for the
procedure.
This system requires the purchase, storage and maintenance of expensive
charging
systems and batteries. With traditional tools, there was no choice in the
matter but
to follow this process. With new single-use and limited-use tool systems,
tools enter
the hospital-prepackaged sterile and ready for use, with the exception of the
battery
system which is identical to the system utilized with reusable tools. There is
a need
CA 02895640 2015-06-26
for a system that eliminates the requirement of the hospital to store, charge
and
transfer batteries into their tool systems.
[0038] Because the standard method of utilizing a powered surgical tool
involves
both a reusable tool and reusable battery, which in most cases has been
purchased
by a hospital or some other medical facility, it has also been a standard part
of the
process to require that these facilities maintain an inventory of batteries
and
charging systems to power the tools. With single-use and limited-use tools,
the tool
is now delivered pre-packaged and sterile to the medical facility. As with a
traditional reusable tool, there is still a requirement to maintain a stock of
batteries
and charging systems. This process also requires either the sterilization of
the
battery pack, and/or the transfer of a battery (sterile or non-sterile) to the
tool prior to
use,
[0039] Alternatively, a power tool 110, Fig. 9, includes a handle portion 112,
a
power source portion 114 and a tool attachment portion 116. The power source
portion 114 includes an integrated, wirelessly charged battery pack 114a. The
handle portion 112 includes a trigger portion 112a and an integrated, wireless
communication device 112b utilizing Wi-Fi, ultra-wideband, Bluetooth, or any
other
form of standardized or proprietary communication protocols. The tool 110
illustrates an exemplary power tool for use in medical surgical procedures.
The tool
110 is seated in a pocket 118 formed in a tray 120, which is sealed by a cover
122.
The tool 110 is sterile packed in tray 120 and is ready for use, including the
internal
battery pack 114a that is not intended to be field removable. The battery pack
114a
includes the capability to be charged wirelessly while remaining sealed in the
tray
120. The tray 120, or any equivalent form of sterile packaging, suitable for
shipping
tool 110, may be used.
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[0040] An exemplary portable and carryable tool support member 130, Fig. 10,
includes a horizontal base member 132 and a pair of vertical end members 134,
136. The base member 132 includes a plurality of slots S, formed by dividers
138
which extend from the base member 132. In this manner, a plurality of the
sealed
tool-containing trays or other sterile packages 120 can be positioned in the
slots S
for portability. Base member 132 also includes a charging coil 140 for
wireless
proximity charging of tools 110 as described above. Energy is selectively
provided
to charging coil 140 by either of an internal battery source 142 (DC) or by an
AC
accessible power cord 144.
[0041] A stationary storage shelving unit 150, Fig. 11, similarly includes a
base
member 152 which also includes a plurality of slots SS, formed by dividers 154
which extend from base member 152. In this manner, a plurality of the sealed,
tool-
containing trays 120, can be positioned in the slots SS for storage. Base
member
152 also includes a charging coil 156 for wireless proximity charging of tools
110 as
described above. Energy is selectively provided to charging coil 156 by either
of an
internal battery source 158 (DC) or an AC accessible power cord 159.
[0042] A wireless communication system 160, Fig. 12, includes the wireless
communication device 112b, in tool 110, as described above, a wireless
transceiver
162, a centralized database 64 of a supplier of tool 110 and a communication
device
166 of a user of the tool 110. The transceiver 162 communicates wirelessly
with the
communication device 112b and centralized database 164 including unique
location
and other unique data for each tool 110. This allows for enhanced inventory
management to regional and hospital-specific product quantities and replenish
requirements. In addition, the user communication device 166 can also access
some of the data in the centralized database 164 to remain aware of inventory
needs.
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[0043] This new device and system solves the problem of purchasing and
managing inventory for batteries and charging systems, thereby reducing costs
and
complexity for the medical facilk using powered surgical tools. A pre-
packaged,
pre-sterilized tool, including a pre-installed, charged battery, eliminates
the need for
the operator to own batteries or chargers, and simplifies the process of
operating
the tool by eliminating the need to transfer a battery to the tool prior to
use.
Following the procedure, the battery can either be:
Disposed of with the tool (single-use disposable tool and battery);
Returned within the tool (limited-use tool with battery); or
Removed and returned to vendor (single-use disposable tool).
[0044] In addition, the power tool may include a wirelessly charged battery
pack
provided in the tool and an integrated wireless communication device provided
in
the tool. A wireless transceiver is coupled to communicate with the wireless
communication device in the tool, and with a centralized database of a tool
supplier,
the centralized database may be accessed by a user of the tool.
[0045] Although illustrative embodiments have been shown and described, a wide
range of modification, change and substitution is contemplated in the
foregoing
disclosure and in some instances, some features of the embodiments may be
employed without a corresponding use of other features. Accordingly, it is
appropriate that the appended claims be construed broadly and in a manner
consistent with the scope of the embodiments disclosed herein.
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