U.S. patent application number 14/551080 was filed with the patent office on 2015-07-16 for limited-use tool disposable enclosure.
The applicant listed for this patent is Insurgical Inc.. Invention is credited to Richard Acevedo, Peter M. Aman, Matthew Jones, Frederick N. Matthews, Roy Melling, Daniel Tagtow.
Application Number | 20150196363 14/551080 |
Document ID | / |
Family ID | 53520339 |
Filed Date | 2015-07-16 |
United States Patent
Application |
20150196363 |
Kind Code |
A1 |
Aman; Peter M. ; et
al. |
July 16, 2015 |
LIMITED-USE TOOL DISPOSABLE ENCLOSURE
Abstract
A re-usable medical procedure power tool includes a handle
portion connected to a tool attachment portion and a power source
portion. A removable, single use, contamination-blocking cover
substantially covering the power source portion, the handle portion
and the tool attachment portion. The cover also includes a primary
opening adjacent an exposed first end of the tool attachment
portion, whereby a tool accessory is selectively attached to and
removed from the first end of the tool attachment portion during a
medical procedure.
Inventors: |
Aman; Peter M.; (Austin,
TX) ; Matthews; Frederick N.; (Key Largo, FL)
; Jones; Matthew; (Arlington, TX) ; Acevedo;
Richard; (Austin, TX) ; Tagtow; Daniel;
(Austin, TX) ; Melling; Roy; (Escondido,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Insurgical Inc. |
Austin |
TX |
US |
|
|
Family ID: |
53520339 |
Appl. No.: |
14/551080 |
Filed: |
November 24, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61913266 |
Dec 7, 2013 |
|
|
|
Current U.S.
Class: |
53/425 ;
173/170 |
Current CPC
Class: |
A61B 50/33 20160201;
A61B 50/30 20160201; B25F 5/02 20130101; A61B 2050/0065 20160201;
A61B 46/10 20160201; A61B 17/1622 20130101; A61B 2017/0023
20130101; A61B 2050/3008 20160201 |
International
Class: |
A61B 19/02 20060101
A61B019/02; A61B 17/16 20060101 A61B017/16; A61B 17/14 20060101
A61B017/14; B25F 5/02 20060101 B25F005/02 |
Claims
1. A re-usable medical procedure power tool comprising: a handle
portion connected to a tool attachment portion and a power source
portion; and a removable, single use, contamination blocking cover
substantially covering the power source portion, the handle portion
and the tool attachment portion, the cover further including a
primary opening adjacent an exposed first end of the tool
attachment portion, whereby a tool accessory is selectively
attached to and removed from the first end of the tool attachment
portion during a medical procedure.
2. The tool of claim 1, further comprising: a second end of the
tool attachment portion, opposite the first end, the second end
including a port, the port providing access to the first end of the
tool attachment portion.
3. The tool of claim 2, further comprising: a sealed access opening
in the cover, immediately adjacent the port.
4. The tool of claim 3 wherein the port is accessible by
penetration of the sealed access opening.
5. The tool of claim 3 wherein the port is accessible by removal of
a seal on the sealed access opening.
6. The tool of claim 1, further comprising: a housing enclosing the
power source portion, the handle portion and the tool attachment
portion.
7. The tool of claim 6 wherein the contamination blocking cover
comprises a first molded member attached to a mating second molded
member, the first and second molded members encapsulating the
housing.
8. The tool of claim 6 wherein the contamination blocking cover
comprises a flexible membrane stretched over the housing.
9. The tool of claim 6 wherein the contamination blocking cover
comprises a first flexible membrane stretched over the housing and
a second flexible membrane stretched over the first flexible
membrane.
10. The tool of claim 6 wherein the contamination blocking cover
comprises a shrink-wrap tape wound around the housing and shrunk to
envelop the housing.
11. The tool of claim 6 wherein the contamination blocking cover
comprises a shrink-wrap tube positioned over the housing and shrunk
to envelop the housing.
12. The tool of claim 6 wherein the contamination blocking cover
comprises a solution in which the housing is dipped and coated.
13. The tool of claim 6 wherein the contamination blocking cover
comprises a spray-applied coating sprayed onto the housing.
14. The tool of claim 6 wherein the contamination blocking cover
comprises a shaped, non-stretchable bag-like shell loosely fitted
over the housing.
15. The tool of claim 6 wherein the contamination blocking cover
comprises a die-cut flat wrap folded around the housing.
16. The tool of claim 1 wherein the contamination blocking cover
comprises a disposable hard-shell molded housing.
17. The tool of claim 1, further comprising: the power source
portion having a sterilized cavity therein; the cavity including an
access opening.
18. The tool of claim 17, further comprising: sterile means for
sealing the cavity opening, the sterile means including a removable
access door.
19. A method comprising: providing a sterile, re-usable medical
procedure power tool having a handle portion connected to a tool
attachment portion and a power portion; covering the power tool
with a removable, single-use contamination blocking cover having a
single opening adjacent an exposed first end of the tool attachment
portion, whereby a power tool accessory is selectively attached to
and removed from the first end of the tool attachment portion
during a medical procedure; following use of the power tool for the
medical procedure, removing the contamination blocking cover and
sterile cleaning the exposed first end of the tool attachment
portion; re-covering the power tool with a replacement, single-use,
contamination blocking cover; packaging the power tool; sterilizing
the packaged power tool; and re-using the sterile power tool for a
subsequent medical procedure.
20. A method comprising: providing a sterile, re-usable medical
procedure power tool having a handle portion connected to a tool
attachment portion and a power portion; covering the power tool
with a removable, single-use contamination blocking cover having a
single opening adjacent an exposed first end of the tool attachment
portion, whereby a power tool accessory is selectively attached to
and removed from the first end of the tool attachment portion
during a medical procedure; providing a sterilized cavity in the
power source portion, the cavity including an access opening;
providing a sterile, removable sealing access door for the access
opening; following use of the power tool for the medical procedure,
removing the contamination blocking cover and sterile cleaning the
exposed first end of the tool attachment portion; re-covering the
power tool with a replacement, single-use, contamination blocking
cover; packaging the power tool and the access door; sterilizing
the packaged power tool and the access door; and re-using the
sterile power tool for a subsequent medical procedure.
Description
[0001] This application is related to and claims priority to
Provisional Application No. 61/913,266 filed Dec. 7, 2013.
BACKGROUND
[0002] This disclosure relates generally to limited use power tools
and more particularly to an enclosure for such tools during use in
medical procedures; the enclosure being removed and discarded
during reprocessing of the tools for subsequent re-use.
[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 procedures, reduce 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 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 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 other 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 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 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] Accordingly, a reusable medical procedure power tool cover
comprises a removable, single use contamination blocking material
substantially covering the power tool, wherein the power tool
includes a control portion, a power access portion and an
attachment access portion. A first opening is provided in the cover
adjacent the attachment access portion, whereby a tool accessory is
selectively attached to and removed from a first end of the tool
attachment portion during a medical procedure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a perspective, assembly view illustrating an
embodiment of a power tool having a housing and a removable, single
use, hardshell or softshell wrap or cover formed of a contamination
blocking material.
[0017] FIG. 2 is a perspective assembly view illustrating an
embodiment of the power tool of FIG. 1 wherein the cover is a
stretch membrane.
[0018] FIGS. 3a and 3b are perspective assembly views illustrating
embodiments of the power tool of FIG. 1 wherein the covers include
a shrink-wrap tape and a shrink-wrap tube respectively.
[0019] FIG. 4 is a perspective assembly view illustrating an
embodiment of a mechanical sub-frame of a power tool having no
housing and wherein the cover is a disposable hardshell.
[0020] FIG. 5 is a perspective assembly view illustrating an
embodiment of the power tool of FIG. 1 wherein the cover is
spray-on applied.
[0021] FIG. 6 is a perspective assembly view illustrating an
embodiment of the power tool of FIG. 1 wherein the cover is dip
applied.
[0022] FIG. 7 is a perspective assembly view illustrating an
embodiment of the power tool of FIG. 1 wherein the cover is a
header bag.
[0023] FIG. 8 is a perspective assembly view illustrating an
embodiment of the power tool of FIG. 1 wherein the cover is a
pre-cut wrap.
[0024] FIG. 9 is a perspective assembly view illustrating an
embodiment of the power tool of FIG. 1 wherein the cover is double
layer stretch membrane.
[0025] FIG. 10 is a perspective view illustrating an embodiment of
the power tool housing as viewed from the backside of the tool and
having a sealable door removed to expose a cavity to receive a
portable battery.
[0026] FIG. 11 is a perspective view illustrating the tool of FIG.
10 having the sealable door installed.
[0027] FIG. 12 is a perspective view illustrating an embodiment of
a sterilized shipping tray and lid containing the power tool.
DETAILED DESCRIPTION
[0028] The embodiment of FIG. 1 illustrates an exemplary power tool
10 for use in medical procedures such as surgical procedures. A
removable, single use, contamination-blocking cover 12 is provided
for blocking excessive contamination of the power tool 10 during
use. The cover 12 is replaceable, e.g. after the procedure, the
cover 12 may be removed and replaced by a new cover 12.
[0029] The tool 10 includes a housing 14 comprising a handle
portion 16 and in this example, a power source portion such as a
receiver 18 for a portable battery pack and a tool attachment
portion 20 having a chuck 21 provided for releasably receiving and
holding an attachment tool such as a drill bit or a saw blade. The
handle 16 includes a control portion including but not limited to
an actuating trigger 22, a trigger lock 24 and a forward-reverse
switch, all of which may not be visible in FIG. 1. The attachment
point of a saw blade may vary depending on whether it is a
reciprocating or oscillating blade.
[0030] The cover 12 preferably includes a two-piece hard or soft
outer shell including portions 12a and 12b. The tool 10 is
illustrated at 10a prior to application of the cover 12, and is
illustrated at 10b after application of the cover 12. A first
opening 12c is provided in cover 12 adjacent chuck 21 when the
cover is applied to the tool 10. A second opening 12d, which may be
closed by a sealable door 19, is provided in power source portion
18. Regardless of the material used for the cover 12, a flexible
portion 12e of the cover 12 is provided on the handle 16 to provide
a user with a tactile feel and operable movement of for example,
the trigger 22 and the trigger lock 24.
[0031] The replaceable cover 12 is applied to tool 10 by a tool
re-processor. Once the tool 10 is used in a procedure, the cover
has become contaminated along with portions of the tool 10 which
are adjacent the openings 12c, 12d. The tool 10, including cover
12, is returned to the tool re-processor where the cover 12 is
removed and discarded. The tool 10 is then cleaned and a new cover
12 is mounted on the tool 10, rendering the tool 10 ready for
re-use.
[0032] More specific information regarding the tool 10 and cover 12
of the FIG. 1 embodiment as described above are set forth below as
follows:
[0033] a. Existing product or new product uses a rigid body
mechanical housing 14 in conjunction with either a hard or
soft/flexible shell outer shield 12 that covers and protects the
majority of the tool 10 from contamination by blood/bone/tissue
during a procedure. Combinations of materials such as a hard shell
with flexible inserted areas for controls actuation are also
contained in this area. Additional reinforcements or seals can be
used in high stress areas. [0034] i. Materials and alloys/laminates
of these materials appropriate for this concept include but are not
limited to: [0035] a. PETG & A/PET [0036] b. Polystyrene [0037]
c. Acrylic [0038] d. Polycarbonate [0039] e. ABS [0040] f. Nylon
[0041] g. Polyolefin [0042] h. Polyetheretherketone PEEK [0043] i.
Polyetherimide PEI [0044] j. Polyetersulfone PES [0045] k.
Polyvinylidene PVDF [0046] l. Polymethylpentene PMP [0047] m.
Polysulfone PSO [0048] n. Ethylene-chlorotrifluoroethylene ECTFE
[0049] o. Metals [0050] ii. Soft/flexible outer shell can be
produced using injection molding, thermoforming, dip molding,
compression molding or other processes. Materials and alloys of
these materials appropriate for this concept include but are not
limited to: [0051] a. Synthetic Paper [0052] b. C-Flex [0053] c.
Flexible PVC [0054] d. Polycarbonate [0055] e. Polyester [0056] f.
Polyethylene [0057] g. Polypropylene [0058] h. Nylon [0059] i.
Polyolefin
[0060] b. Methods appropriate for fastening the outer shell
to/around the inner structure include but are not limited to:
[0061] i. Fasteners such as: [0062] 1. Screws [0063] 2. Rivets
[0064] 3. Bolts [0065] ii. Molded features such as: [0066] 1. Clips
[0067] 2. Press fits [0068] 3. Slip fits [0069] iii. Adhesive in
multiple forms [0070] 1. Tape [0071] 2. Glue [0072] 3. Pressure
sensitive adhesive [0073] 4. Hot melt adhesives [0074] 5. Contact
adhesives [0075] iv. Secondary operations [0076] 1. Heat Seal
[0077] 2. Pierce
[0078] Several further embodiments are described below. More
specific information regarding the tool 10 and a stretch membrane
cover 12 including upper member 12a and lower member 12b, of the
FIG. 2 embodiment is described below as follows:
[0079] a. This embodiment uses a rigid body mechanical housing 14
in conjunction with a highly stretchable membrane 12 (balloon like)
to cover and protect the tool 10 from contamination by
blood/bone/tissue during a procedure. This cover 12 is a removable,
single use cover of contamination blocking material. Single and
multiple layer configurations can be considered for this version.
Single or multiple membranes may be used to protect various areas
of the tool 10 (main body vs. battery pack allowing access to
battery pack at the start of a procedure). Variable wall thickness
or reinforcements can be used in high stress areas. Members 12a and
12b are stretched over housing 14 and combined to form cover 12.
Tool 10 is shown at 10a prior to application of cover 12, and is
shown at 10b after the application of cover 12. [0080] i. Flexible
membranes can be produced using blow molding, dip molding,
thermoforming, or other processes. Members 12a and 12b are
stretched over housing 14 and combined to form cover 12. Tool 10 is
shown at 10a prior to application of cover 12, and is shown at 10b
after the application of cover 12. [0081] 1. Materials and alloys
of these materials appropriate for this concept include but are not
limited to: [0082] a. Silicone [0083] b. Latex Rubber [0084] c.
Synthetic Rubber [0085] d. Polychloroprene [0086] e. Flexible
PVC
[0087] b. Methods appropriate for applying the membrane around the
outer shell include but are not limited to: [0088] i. Stretching:
[0089] 1. Manually [0090] 2. Automated [0091] 3. Individual
sections (i.e. main body separate from Battery Pack area) [0092]
ii. Secondary operation: [0093] 1. Additional seals/retention
elements at operation interfaces such as drill chuck or saw adaptor
[0094] 2. Additional tape reinforcements in high stress areas
[0095] More specific information regarding the tool 10 and a shrink
wrap cover 12, FIGS. 3a, 3b, is described below as follows:
[0096] a. This embodiment uses a rigid body mechanical housing 14
in conjunction with a secondary shrink-wrap element 12 to cover and
protect the device from contamination by blood/bone/tissue during a
procedure. Cover 12 is a removable, single-use cover of
contamination blocking material. Single and multiple layer
configurations can be considered for this version (see
considerations for transport as non-biohazard state). Single or
multiple wraps may be used to protect various areas of the tool 10
(main body vs. battery pack allowing access to battery pack at the
start of a procedure). Additional reinforcements or seals can be
used in high stress areas. Shrink methods can include both heat
application or a chilling operation depending on the type of shrink
wrap utilized. Tool 10 is shown at 10a prior to application of
cover 12, and is shown at 10b after the application of cover 12 and
shrink activation, FIGS. 3a, 3b. [0097] i. Flexible shrink-wrap can
be produced using extrusion processes, and are available in tape,
FIG. 3a, sheet or tube form, FIG. 3b and can be either heat or cold
activated to create the wrap required for device isolation. Some
tape applications carry an adhesive layer. The shrink-wrap tube
cover 12x, FIG. 3b, is trimmed at 12y after shrink activation at
12z. Shrink-wrap tape, FIG. 3a is shown prior to wrapping at 12x
and after wrapping and shrink activation at 12y. [0098] 1.
Materials and alloys/laminates of these materials appropriate for
this concept include but are not limited to: [0099] a. Acetate
[0100] b. Polyethylene [0101] c. PVC [0102] d. Polyester [0103] e.
Polyolefin [0104] f. Polypropylene
[0105] b. Methods appropriate for applying the membrane around the
outer shell include but are not limited to: [0106] i. Tape
Wrapping: [0107] 1. Manually [0108] 2. Automated [0109] 3.
Individual sections (i.e. main body separate from Battery Pack
area) [0110] ii. Film Wrap: [0111] 1. Manually [0112] 2. Automated
[0113] 3. Individual sections (i.e. main body separate from Battery
Pack area) [0114] iii. Secondary operations: [0115] 1. Heat seal
for complex geometries [0116] 2. Shrink Tunnel [0117] 3. Heat Gun
[0118] 4. Refrigeration [0119] 5. Additional tape reinforcements in
high stress areas [0120] 6. Adhesive application to tape wrap
[0121] In FIG. 4, an embodiment utilizes no traditional housing 14,
as described above, but provides the inner frame and working parts
as tool 110 and the outer hard shell cover 12 of tool 110 is
provided as a disposable cover, as described below:
[0122] a. This embodiment uses a rigid sub-frame 110 carrying all
mechanical components. The hard shell cover 12 has minimal
mechanical content and is used as a disposable single-use housing
of a contamination blocking material to protect the mechanical
components from contamination by blood/bone/tissue during a
procedure. Cover 12 comprises cover portions 12a, 12b. The
sub-frame and mechanical components are intended for multiple
re-use. This configuration may also be used in conjunction with a
soft/flexible outer shell allowing for return of the device in a
non-biohazard state. Combinations of materials such as hard shell
with flexible inserted areas for controls actuation are also
contained in this area. Additional reinforcements or seals can be
used in areas subject to contaminant intrusion. Thus, the hard
shell, single-use disposable cover 12 functions as a combination
previously provided by a traditional housing 14 and cover 12.
[0123] i. Hard outer shell can be produced using injection molding,
thermoforming, or other processes.
[0124] I. Materials and alloys/laminates of these materials
appropriate for this concept include but are not limited to: [0125]
a. PETG & A/PET [0126] b. Polystyrene [0127] c. Acrylic [0128]
d. Polycarbonate [0129] e. ABS [0130] f. Nylon [0131] g. Polyolefin
[0132] h. Polyetheretherketone PEEK [0133] i. Polyetherimide PEI
[0134] j. Polyetersulfone PES [0135] k. Polyvinylidene PVDF [0136]
l. Polymethylpentene PMP [0137] m. Polysulfone PSO [0138] n.
Ethylene-chlorotrifluoroethylene ECTFE [0139] o. Metals
[0140] b. Methods appropriate for fastening the outer shell
to/around the inner structure include but are no limited to: [0141]
i. Fasteners such as: [0142] 1. Screws [0143] 2. Rivets [0144] 3.
Bolts [0145] ii. Molded features such as: [0146] 1. Clips [0147] 2.
Press fits [0148] 3. Slip fits [0149] iii. Secondary operation:
[0150] 1. Tape [0151] 2. Glue [0152] 3. Pressure sensitive adhesive
[0153] 4. Hot melt adhesives [0154] 5. Contact adhesives [0155] 6.
Heat seal [0156] 7. Pierce
[0157] In FIG. 5, another embodiment includes a tool 10 having a
protective spray cover 12 further described as follows:
[0158] a. This embodiment uses a rigid body mechanical housing 14
in conjunction with a secondary spray-on protective layer 12 to
cover and protect the tool 10 from contamination by
blood/bone/tissue during a procedure. Single and multiple layer
configurations can be considered for this version by using a
release layer between subsequent spray applications. This
configuration may be used in conjunction with previously described
protection systems to allow access to power source portion 18 at
the start of a procedure. Additional reinforcements or seals can be
used in areas subject to contaminant intrusion. Layer 12 is a
removable, single-use cover of contamination blocking material.
[0159] i. Spray on protective layers can be applied either manually
or automatically. Specific areas not to be coated can be masked to
ensure correct device function. It may also be desirable to coat
individual components prior to assembly to minimize masking issues.
[0160] 1. Materials and alloys/laminates of these materials
appropriate for this concept include but are not limited to: [0161]
a. Natural rubber [0162] b. Synthetic rubber [0163] c. Polyurethane
[0164] d. Acrylic [0165] e. Polyethylene [0166] f. PVC [0167] g.
Polyester [0168] h. Polyolefin [0169] i. Polypropylene
[0170] b. Methods appropriate for applying the membrane around the
outer shell include but are not limited to: [0171] i. Aerosol
application: [0172] 1. Manually [0173] 2. Automated [0174] 3.
Individual section (i.e. main body separate from Battery Pack area)
[0175] ii. Secondary operations: [0176] 1. Drying/curing
[0177] In FIG. 6, another embodiment includes a tool 10 having a
protective dip layer as a cover 12 further described as
follows:
[0178] a. This embodiment uses a rigid body mechanical housing in
conjunction with a secondary dipping operation to apply a
protective layer 12 intended to cover and protect the tool 10 from
contamination by blood/bone/tissue during a procedure. Single and
multiple layer configurations can be considered for this version by
using a release layer between subsequent dip applications. This
configuration may be used in conjunction with previously described
protection systems to allow access to power source portion 18 at
the start of a procedure. Additional reinforcements or seals can be
used in areas subject to contaminant intrusion. Layer 12 is a
removable, single-use cover of contamination blocking material.
[0179] i. Dip protective layers can be applied either manually or
automatically. Specific areas not to be coated can be masked to
ensure correct device function. [0180] 1. Materials and
alloys/laminates of these materials appropriate for this concept
include but are not limited to: [0181] a. Natural rubber [0182] b.
Synthetic rubber [0183] c. Polyurethane [0184] d. Acrylic [0185] e.
Polyethylene [0186] f. PVC [0187] g. Polyester [0188] h. Polyolefin
[0189] i. Polypropylene
[0190] b. Methods appropriate for applying the membrane around the
outer shell include but are not limited to: [0191] i. Dip
application: [0192] 1. Manually [0193] 2. Automated [0194] 3.
Individual sections (i.e. main body separate from Battery Pack
area) [0195] 4. Secondary operations drying/curing
[0196] In FIG. 7, another embodiment includes a tool 10 with
battery door 19 providing access to power source portion 18 and
having a protective header bag formed to shape as a cover 12
further described as follows:
[0197] a. This embodiment uses a rigid body mechanical housing 14
in conjunction with a formed header bag outer shielding cover 12
that protects the majority of the tool 10 from contamination by
blood/bone/tissue during a procedure. Additional reinforcements or
seals can be used in high stress areas. Header bag cover 12
comprises a removable, single-use cover of contamination blocking
material. [0198] i. Header bag cover 12 can be produced using an
extrusion process for the base material with secondary forming and
sealing operations to create a sealed enclosure. The header bag 12
is a shaped, non-stretchable, bag-like shell loosely fitted over
the housing 14. [0199] 1. Materials and alloys of these materials
appropriate for this concept include but are not limited to: [0200]
a. Synthetic paper [0201] b. C-Flex [0202] c. Flexible PVC [0203]
d. Polycarbonate [0204] e. Polyester [0205] f. Polyethylene [0206]
g. Polypropylene [0207] h. Nylon [0208] i. Polyolefin b. Methods
appropriate for fastening the header bag to/around the inner
structure include but are not limited to: [0209] i. Adhesive in
multiple forms [0210] 1. Tape [0211] 2. Glue [0212] 3. Pressure
sensitive adhesive [0213] 4. Hot melt adhesives [0214] 5. Contact
adhesives
[0215] In FIG. 8, another embodiment includes a tool 10 having a
protective die cut wrap as a cover 12 further described as
follows:
[0216] a. This embodiment uses a rigid body mechanical housing 14
in conjunction with a Precut Wrap outer shielding cover 12 that
once applied protects the majority of the tool 10 from
contamination by blood/bone/tissue during a procedure. Additional
reinforcements or seals can be used in high stress areas or areas
vulnerable to contaminant intrusion. [0217] i. The device can be
produced using an extrusion process for the base material with
secondary cutting operations and sealing components added to
provide a method for creating a sealed enclosure. [0218] 1.
Materials and alloys of these materials appropriate for this
concept include but are not limited to: [0219] a. Synthetic paper
[0220] b. C-Flex [0221] c. Flexible PCV [0222] d. Polycarbonate
[0223] e. Polyester [0224] f. Polyethylene [0225] g. Polypropylene
[0226] h. Nylon [0227] i. Polyolefin
[0228] b. Methods for cutting the wrap to conform to the device
include but are not limited to: [0229] i. Manual cutting [0230] ii.
Die cutting [0231] iii. Rotary cutting
[0232] c. Methods appropriate for securing the wrap to/around the
device include but are not limited to: [0233] i. Creation of
appropriate flattened geometry that once wrapped conforms to the
geometry of the device. [0234] ii. Adhesive in multiple forms:
[0235] 1. Tape [0236] 2. Glue [0237] 3. Pressure sensitive adhesive
[0238] 4. Hot melt adhesives [0239] 5. Contact adhesives
[0240] In FIG. 9, similar to FIG. 2, another embodiment discloses a
power tool 10 including a first inner stretch membrane cover 112
and a second outer stretch membrane cover 212. This embodiment adds
the outer cover 212 so that after use of the tool 10, the outer
cover 212 is removed and the inner membrane 112 stays in place on
the tool 10. This embodiment enables shipping the used tool to a
re-processor so as to avoid shipping a biohazard product. This
embodiment is further described as follows:
[0241] a. This embodiment uses a rigid body mechanical housing 14
in conjunction with a two layer soft/flexible shell outer cover 112
and 212 that protects the majority of the device from contamination
by blood/bone/tissue during a procedure. Following the procedure
and before return shipment of the device the outermost contaminated
cover 212 is removed presenting the inner cover 112 that is a
non-biohazard product and can economically be returned for
re-processing.
[0242] In FIG. 10, tool housing 14, including tool attachment
portion 20, handle portion 16 and power source portion 18 are
illustrated from a backside perspective. The power source portion
18, as stated above may be closed by the sealable door 19, shown
removed. A cavity 25 in power source portion 18 may receive a
battery on-site when the sterilized tool is being made ready for
use. When sterilized, cavity 25 is exposed due to door 19 being
removed and thus, the interior or cavity 25 of the power source
portion 18 is also sterile. In FIG. 11, door 19 is illustrated in
attachment with power source portion 18, thereby sealingly closing
cavity 25. Also, a rear cannulation opening 23, FIGS. 10 and 11,
not required for saw blade attachment tools, is shown on a backside
wall or surface of tool attachment portion 20 opposite a front
sidewall where chuck 21 is located. In this manner, a guide wire or
pin can be fed through the tool attachment portion 20 via the
cannulation opening 23 and exit via the chuck end for use with a
cannulated attachment. A seal 23a, is provided to seal opening 23.
The seal 23a may be either a removable seal or a penetratable
seal.
[0243] The limited use tool 10, FIG. 12, is returned to a
re-supplier or re-processor to be prepared for re-use by packaging
and sterilizing the tool. The single-use, contamination-blocking
cover 12 is removed. During repackaging, the tool 10 is placed in a
partitioned tray 300 for shipping. Also, the removable, sealing
access door 19 is placed in the tray 300 to be used after a battery
is placed in a cavity within the power source portion 18 on-site.
The tray 300, containing the tool 10, access door 19 and a handle
305 available for two-handed operation (optional), are trayed and
covered with a Tyvek lid or cover 310. Then a known ETO
sterilization process, or other suitable process, sterilizes the
contents of tray 300 in a gas chamber. Typically, a substantial
number of the trayed tools are sterilized together for efficiency.
Repackaged, sterilized trays 300 containing the tool 10 and access
door 19 are then shipped to the user. When used, a battery, stored
at the user's surgical facility is placed into the sterile cavity
25 in the power portion 18. The sterile door 19 is then installed
in the access opening of cavity 25 (discussed above, see also FIG.
10).
[0244] The present disclosure has recognized and addressed many of
the foregoing limitations and drawbacks of others concerning the
need to provide hospitals and surgery centers with an improved,
more reliable system of cost-effective, battery-operated, motorized
tools in conjunction with better cleaning and maintenance
protocols. In practice, the disclosed tooling system utilizes a
concept called limited-use tools (LUT) and specifically, a new
cover or enclosure system to make reprocessing of the LUT more
efficient. This cover or enclosure would be used only once in the
operating room, then would be removed and discarded at the
reprocessing facility. A new, single-use enclosure would be
installed at the reprocessing facility prior to final testing,
packaging and re-sterilization of the LUT. The term "limited-use"
as applied to orthopedic surgical tools can mean having a limited
useful life, or a restricted lifespan for intended use. Preferably
in this context, limited-use is intended to mean the number of
surgeries where the useful life of the tool ranges from more than
one use to less than 50 surgeries, and more preferably where the
useful life of the tool ranges from more than one use to less than
30 surgeries, and most preferably where the useful life of the tool
ranges from more than one use to less than 20 surgeries.
[0245] In a broad respect this disclosure teaches a method of
improving (i.e. reducing) potential risk factors associated with
infection control, and reduction of potential disease and infection
transmission due to lapses in cleaning and infection control
associated with routine maintenance of reusable powered surgical
instruments. In another broad respect, the disclosure teaches a
method of processing battery-operated tools used in surgery, to
improve the cleanliness of instruments used in multiple surgical
procedures and reduce the potential for disease and infection
transmission due to lapses in cleaning and infection control
procedures between procedures. In yet another broad respect, the
disclosure teaches a method of logistical process of powered tools
to improve cleanliness, operational efficiencies and performance.
Still further it is to be understood that although this disclosure
discusses the invention in terms of battery operated tools, one
skilled in the art would fully appreciate that this disclosure has
similar application to any pneumatic, wired or electric wall
socket-powered instruments as well.
[0246] 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.
* * * * *