WO2006098785A1

WO2006098785A1 - Shipping container for surgical devices/cases

Info

Publication number: WO2006098785A1
Application number: PCT/US2005/044725
Authority: WO
Inventors: Valentine T. Faust, Iii; Jon D. Shoemaker
Original assignee: Symmetry Medical, Inc.
Priority date: 2004-12-10
Filing date: 2005-12-08
Publication date: 2006-09-21
Also published as: US20060124486A1

Abstract

A method of storing, transporting and using a plurality of surgical devices organized in an instrument case. The method includes the steps of: assembling the plurality of surgical devices in the instrument case; and providing a shipping container including a plurality of walls. The walls define a shipping compartment. The shipping container includes a telescoping handle connected to at least one of the walls, and a set of at least partially recessed wheels connected to at least one of the walls. The method further includes the steps of captivating the instrument case within the shipping compartment; transporting the shipping container from a first location to a second location using the telescoping handle and the at least partially recessed wheels; removing the instrument case from the shipping container; and using at least some of the surgical devices to perform a surgical procedure.

Description

SHIPPING CONTAINER FOR SURGICAL DEVICES/CASES BACKGROUND OF THE INVENTION

1. Field of the invention. The present invention relates to orthopaedic devices, and, more particularly, to cases

or containers for such orthopaedic devices.

2. Description of the related art.

Cases, such as sterilization cases, are known that provide organization, storage and sterilization functionality for surgical devices. In order to avoid infection to a patient on which such devices are used, the devices are required to be cleaned and sterilized after a

procedure, and therefore, before use.

Surgical procedures are regularly performed using "sets" of pre-selected surgical devices, each set being a collection of instruments, implants, trials and the like, established from experience or design to be useful in a given surgical procedure. The surgical devices expected to be used in a particular procedure are grouped together to form a set, and, as a set, are sterilized, stored on or in a pan, tray or case, and finally transported on that pan, tray or case to the operating room when their use is required. Complex procedures typically involve a substantial number of instruments, implants and/or trials representing a substantial investment.

Major surgeries such as hip or knee replacements have larger instruments requiring multiple cases and trays of instruments. Additionally, there are specialized surgical procedures which require specialized and expensive surgical devices that a particular healthcare organization may only need rarely and when needed, given the procedure and patient condition, may require a particular size or type of surgical device that is not normally purchased by the healthcare organization or provided in a "standard" instrument set.

Rapidly advancing technology in the healthcare field further exasperates the challenges facing an organization when selecting and purchasing surgical devices. Healthcare professionals and organizations do not want to be locked into an outdated, or potentially outdated, surgical procedure by virtue of having purchased surgical devices associated therewith. Personnel changes and/or additions can also affect surgical device selection in that a given healthcare professional may be trained in, or have a preference for, a specific procedure for a given surgery requiring a specific set of surgical devices. Another healthcare professional at the same organization may be trained in a different procedure for a similar surgery thus requiring a different set of surgical devices. Similarly, a new surgical procedure may be developed which was formally unknown and without precedent, having

associated therewith totally new surgical devices for which a given healthcare professional or organization has no use, selection and/or purchasing experience.

As healthcare organizations, such as hospitals, are motivated to reduce costs in part by optimum use of resources while still providing the highest quality healthcare using the most

advanced technology and procedures, one potential cost effective option regarding surgical devices is to borrow, rent or lease a set of surgical instruments as the need arises. If a healthcare organization exercises such an option, the need to purchase a broad range of instruments to accommodate a broad range of potential patient conditions is eliminated, and the healthcare organization can instead borrow, rent or lease only the surgical devices required for the specific surgery and patient condition which is scheduled at the healthcare

organization. Not only is the original purchase price of the surgical devices eliminated, but there is also a considerable overhead cost which is also eliminated associated with the selection, purchase and maintenance of surgical devices. Further, healthcare consortiums or cooperatives can develop including a plurality of healthcare organizations which share a collection of surgical devices to optimize device utilization while at the same time keeping surgical device costs low for the consortium members.

One major impediment to the sharing of surgical devices among healthcare organizations, or the renting, leasing or borrowing of surgical devices from a third party such as a surgical device manufacturer, is the transportation of the surgical devices between organizations. While the case which holds a set of surgical devices may be suitable for the proper organization, handling and sterilization required by an operating room, such a case is grossly inadequate for transportation between facilities. Surgical devices are known to be highly refined precision instruments, which refinement and precision is required for the proper implementation of the surgical procedure. If surgical devices are mishandled during, or not properly packaged for, transportation between facilities separated by considerable distances damage to the devices can occur rendering the devices unsuitable for their intended use. Another consideration is the fact that air and ground transportation employees are not necessarily trained in the proper handling of surgical devices, as are cognizant hospital personnel, for example. Whereas a hospital employee may be trusted to transport a set of surgical devices from one building to another building on the same hospital campus, a truck driver for a transportation company generally cannot be expected to know the proper handling of specialized surgical devices. Generally speaking then, third or multiple party handling of surgical devices dramatically increases the need for proper packaging of such devices during transportation.

Known packaging such as a cardboard container and bubble pack can be used to package a case of surgical devices; however, such packaging has several disadvantages: a) cardboard and the like creates dunnage which healthcare organizations must discard and/or pay to discard, b) cardboard and the like may not be suitable for two way transportation, in other words may be single use, which then requires of the receiving organization the

responsibility of assembling suitable return packaging, c) cardboard and the like is not water resistant, or otherwise resistant to other environmental elements, d) cardboard and the like may provide only marginal protection, or possibly inadequate protection, of surgical devices such as protecting from impact and physical abuse during transporation, and e) a healthcare organization's quality procedures may require that a unique serialized lock be used on packaging, which lock is destroyed to open the packaging thereby providing proof that the package has been opened and the contents potentially tampered with, or that the package has remained unopened during transportation if the lock is undisturbed. A transportable medical cart is known that includes a frame assembly and a plurality of panels removably mounted on the frame assembly. The frame is mounted on wheels and includes drawers and extendable top panels. The desk like structure of this medical cart, which may be useful in transporting medical elements from room to room in a hospital for example, is wholly unsuited for protecting surgical devices during transportation between

facilities.

An integrated package suited to the packaging of medical devices and surgical equipment, including devices and equipment used in heart by-pass surgery, has a container and a snap-fit lid. The container and the lid have topographies suitable to conform to the medical components in the container and hold them securely. This container is not suitable for sterilization and the instruments contained therein are required to be removed from the container and placed in another container prior to sterilization and use. The topographies described only match a specific set of instruments, which renders the package suitable for only that set of instruments. This package also has the disadvantage of not including tamper proof locking elements as described above or any locking elements. Even if this container and contents were sterilizable, the container is unsuitable for surgical use in that it can't be

opened and stacked and still provide access to the instruments, which denotes that if multiple containers are used in the surgery room, as is often the case, the container takes up excessive horizontal space in the surgery room.

What is needed in the art is a shipping container for surgical devices/cases which is compatible with a variety of existing surgical devices/cases and which provides suitable protection for the same during ground, sea and/or air transportation of the surgical devices/cases between facilities.

SUMMARY OF THE INVENTION

The present invention provides a shipping container for surgical devices/cases which is compatible with a variety of existing surgical devices/cases and which provides suitable protection for the same during ground, sea and/or air transportation of the surgical

devices/cases between facilities.

The invention comprises, in one form thereof, a method of storing, transporting and using a plurality of surgical devices organized in an instrument case. The method includes the steps of: assembling the plurality of surgical devices in the instrument case; and providing a shipping container including a plurality of walls. The walls define a shipping compartment. The shipping container includes a telescoping handle connected to at least one of the walls, and a set of at least partially recessed wheels connected to at least one of the walls. The method further includes the steps of: captivating the instrument case within the shipping compartment; transporting the shipping container from a first location to a second location using the telescoping handle and the at least partially recessed wheels; removing the instrument case from the shipping container; and using at least some of the surgical devices to perform a surgical procedure.

The invention comprises, in another form thereof, a" shipping container for storing, transporting and using a plurality of surgical devices organized in an instrument case. The shipping container includes a plurality of walls which define a shipping compartment which has a first inside contour and a second inside contour. A telescoping handle is connected to at least one of the walls and a set of at least partially recessed wheels is also connected to at least one of the walls. A first insert is configured for placement at one end of the instrument

case. The first insert has a first outer contour approximately the same as the first inside

contour of the shipping compartment. A second insert is configured for placement at another end of the instrument case. The second insert has a second outer contour approximately the

same as the second inside contour of the shipping compartment.

The invention comprises, in another form thereof, a shipping assembly including an

instrument case, a plurality of surgical devices organized in the instrument case and a shipping container for shipping the plurality of surgical devices and the instrument case. The shipping container includes a plurality of walls which define a shipping compartment which has a first inside contour and a second inside contour. A telescoping handle is connected to at least one of the walls and a set of at least partially recessed wheels is also connected to at least one of the walls. A first insert is configured for placement at one end of the instrument case. The first insert has a first outer contour approximately the same as the first inside contour of the shipping compartment. A second insert is configured for placement at another end of the instrument case. The second insert has a second outer contour approximately the same as the second inside contour of the shipping compartment.

An advantage of the present invention is that it provides a shipping container for surgical devices/cases which is compatible with a large variety of existing surgical devices/cases.

Another advantage of the present invention is that it provides suitable protection for surgical devices/cases during ground, sea and/or air transportation of the surgical devices/cases between facilities.

Yet another advantage of the present invention is that it is water resistant and resistant to other environmental factors such as dust, oil, salt spray, etc.

Yet another advantage of the present invention is that it provides shock and vibration protection for the surgical devices/cases.

Yet another advantage of the present invention is that it can transport an instrument case with surgical devices in a ready to use state, i.e., the case with instruments can simply be removed from the shipping container, sterilized if necessary and provided to the surgical

room without the need to handle the surgical devices.

Yet another advantage of the present invention is that it can be constructed of rotationally molded polyethelyne with foam filled walls which are designed to eliminate damage to instrument cases and surgical devices during shipment.

Yet another advantage of the present invention is that it can be used with "loaner" sets

of instruments through original equipment manufacturer (OEM), and other healthcare organization's, loaner distribution logistics.

Yet another advantage of the present invention is that it is sized specifically for

surgical instrument cases.

Yet another advantage of the present invention is that it has recessed areas for shipping information protection.

Yet another advantage of the present invention is that it is stackable. Yet another advantage of the present invention is that the surgical device case is kept in the upright position for better surgical device retention and protection.

Yet another advantage of the present invention is that it has telescoping handles, recessed roller wheels and spring loaded lifting handles for ease of handling.

Yet another advantage of the present invention is that it is a cost effective durable shipping case.

Yet another advantage of the present invention is that it improves mobility of surgical devices and cases for OEM field representatives.

Yet another advantage of the present invention is that it protects surgical devices, such as implants, instruments and trials, and device investment through the entire loaner logistic cycle.

Yet another advantage of the present invention is that it ergonomic. Yet another advantage of the present invention is that it improves ease of return for users of the surgical devices and for field representatives.

Yet another advantage of the present invention is that it reduces cost in disposable

cardboard or other limited re-use dunnage. Yet another advantage of the present invention is that it reduces cost from damaged

surgical devices and associated cases.

Yet another advantage of the present invention is that it size compliant relative to common shipping companies' requirements.

Yet another advantage of the present invention is that it includes a shipping container

designed specifically for medical cases/trays.

Yet another advantage of the present invention is that it can be secured with tamper proof locks, or other locks, cable ties and the like.

Yet another advantage of the present invention is that it can include colors and graphics for customer identification and other purposes.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of an embodiment of the invention taken in conjunction with the accompanying drawings, wherein: Fig. 1 is a perspective view of an embodiment of a shipping container according to the present invention particularly illustrating the telescoping handle;

Fig. 2 is a perspective and partially fragmentary view of an embodiment of a shipping assembly according to the present invention which includes the shipping container of Fig. 1 with the telescoping handle recessed and the door pivoted open particularly illustrating instrument case and surgical devices therein; Fig. 3 is a perspective view of the shipping container of Fig. 1 particularly illustrating

the telescoping handle and recessed wheel construction; and

Fig. 4 is a perspective view of the shipping container of Fig. 1 particularly illustrating

the pivoting handle. Corresponding reference characters indicate corresponding parts throughout the several views. The exemplification set out herein illustrates one preferred embodiment of the invention, in one form, and such exemplification is not to be construed as limiting the scope of the invention in any manner.

DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, and more particularly to Fig. 2, there is shown a shipping assembly 10 which generally includes at least one instrument case 12, a plurality of surgical devices 14, 16 organized in instrument case 12, and a shipping container 18.

Instrument case 12 can include a plurality of apertures 20 which aids in the sterilization of case 12 and surgical devices therein, in which example instrument case 12 can

be considered a sterilization case which is used at least in part to sterilize surgical devices 14, 16. Instrument case 12 can include pans, trays, supports and the like (not shown) which further hold surgical devices 14, 16 within case 12.

Surgical devices 14, 16 can be at a surgical instrument 14, such as an orthopaedic reamer as shown, and/or a surgical implant 16, such as an acetabular cup prosthesis as shown, a surgical trial and the like. However, surgical devices 14, 16 are not limited to these

embodiments, and can in general include any surgical devices as are known the medical arts. Shipping container 18 can include a plurality of walls 22. Walls 22 define a shipping compartment 24 within walls 22, where shipping compartment 24 has a first inside contour 26 and a second inside contour 28. A telescoping handle 30 (Figs. 1 and 3) is connected to at least one of walls 22. A set of at least partially recessed wheels 32 (Fig. 3) is connected to at least one of walls 22. A first insert 34 is connected to one end of instrument cases 12. First insert 34 has a first outer contour 36 approximately the same as first inside contour of 26 of shipping compartment 24. A second insert 38 is connected to another end of instrument cases 12. Second insert 38 has a second outer contour 40 approximately the same as second inside contour 28 of shipping compartment 24.

Walls 22 includes a door 42 which pivots to an open position shown particularly in Fig. 2. Door 42 can be connected to shipping container 18 via hinges 44 or the like. With door opened as shown in Fig. 2, cases 12 are accessible even if a shipping assembly 10 is stacked on top of another shipping assembly 10. A first latch 46 and a second latch 48 are connected to front door 44. Each of first latch 46 and second latch 48 are rotatable to allow front door 44 to pivot to the open position. A seal can be installed at 50 to help protect the contents of shipping container 18 from environmental contaminants such as water, dust, oil, salt spray, and the like. Clasp 52 and slot 54 allow a tamper proof or other lock or seal (not shown) to be used to secure the contents within shipping container 18 and to ensure that shipping container 18 has not been opened.

Walls 22 can be manufactured using a rotational molding process. Each of walls 22 includes a polyethylene exterior 56 with a foam interior 58. At least one recessed handle 60 (Fig. 4) is connected to at least one wall 22, where handle 60 can pivot outward for easy of use, but also pivots inward so that it is out of the way when not needed. Handle 60 may be spring loaded to bias handle 60 inwardly.

In use, the present invention discloses a method of storing, transporting and using a plurality of surgical devices 14, 16 organized in an instrument case 12, where the method includes the steps of assembling surgical devices 14, 16 in instrument case 12 and providing a shipping container 18 including a plurality of walls 22. Walls 22 define shipping compartment 24. Shipping container 18 includes telescoping handle 30 connected to at least one of walls 22, and a set of at least partially recessed wheels 32 connected to at least one of walls 22. The method further includes the steps of: captivating instrument case 12 within shipping compartment 24; transporting shipping container 18 from a first location to a second location using telescoping handle 30 and wheels 32; removing instrument case 12 from shipping container 18; and using at least some of surgical devices 14, 16 to perform a surgical procedure. An example of a surgical procedure is hip replacement surgery where the hip socket or acetabulum and the femoral head are typically badly deteriorated due to arthritis, or some other condition. This type of surgical procedure can include dislocating the femur from the hip; removing the head (ball) of the femur; replacing the head of the femur by a polished metal (or other suitable material) ball with a shaft anchored in the intramedullary canal of the femur; reaming the acetabulum to provide a proper bearing surface for the ball, one that will not limit the normal motion of the leg, and to reform the normal socket, or acetabulum,

reaming away the diseased bone and cartilage to make a new structural base to receive an acetabular cup prosthesis 16 (socket) matched to the artificial femoral head; placing the artificial socket 16 within the reformed acetabulum by way of a suitable cement; and relocating the femur into the hip. The surgical procedure can be an orthopaedic surgical procedure, an example of which is described above, and/or other procedures related to the medical arts. The surgical devices can be orthopaedic surgical instruments, such as reamer 14 shown, an orthopaedic implant, such as an acetabular cup prosthesis 16 shown, surgical trials and/or other surgical devices related to the medical arts.

The method according to the present invention can further include the steps of:

placing first insert 34 at one end of instrument case 12 and second insert 38 at another end of instrument case 12; rotating both first latch 46 and second latch 48 to an open position; pivoting door 42 to an open position; sterilizing orthopaedic devices 14, 16 in instrument case 12; and manufacturing walls 22 using a rotational molding process. While this invention has been described as having a prelerred design, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A method of storing, transporting and using a plurality of surgical devices

organized in an instrument case, said method comprising the steps of: assembling said plurality of surgical devices in said instrument case; providing a shipping container including a plurality of walls, said plurality of walls defining a shipping compartment, said shipping container including a telescoping handle

connected to at least one of said plurality of walls, and a set of at least partially recessed

wheels connected to at least one of said plurality of walls; captivating said instrument case within said shipping compartment; transporting said shipping container from a first location to a second location using said telescoping handle and said set of at least partially recessed wheels; removing said instrument case from said shipping container; and using at least some of said plurality of surgical devices to perform a surgical procedure.

2. The method of claim 1, further including the step of placing a first insert at one end of said instrument case and a second insert at another end of said instrument case, said first insert having a first outer contour approximately the same as a first inside contour of said shipping compartment, said second insert having a second outer contour approximately the same as a second inside contour of said shipping compartment.

3. The method of claim 1, further including the step of rotating both a first latch and a second latch to an open position, said plurality of walls including a door, each of said first latch and said second latch being located on said door.

4. The method of claim 3, further including the step of pivoting said door to an open

position.

5. The method of claim 1, wherein said instrument case is a sterilization case.

6. The method of claim 1, wherein said surgical procedure is an orthopaedic surgical

procedure, said surgical devices are at least one of an orthopaedic surgical instrument and an

orthopaedic implant.

7. The method of claim 1 , further including the step of sterilizing said plurality of

orthopaedic devices in said instrument case.

8. The method of claim 1, further including the step of manufacturing said plurality

of walls using a rotational molding process.

9. The method of claim 8, wherein each of said plurality of walls includes a polyethylene exterior with a foam interior.

10. The method of claim 1, further including at least one recessed handle connected to at least one of said plurality of walls.

11. A shipping container for storing, transporting and using a plurality of surgical devices organized in an instrument case, said shipping container comprising: a plurality of walls, said plurality of walls defining a shipping compartment, said shipping compartment having a first inside contour and a second inside contour; a telescoping handle connected to at least one of said plurality of walls; a set of at least partially recessed wheels connected to at least one of said plurality of

walls; a first insert configured for placement at one end of the instrument case, said first insert having a first outer contour approximately the same as said first inside contour of said

shipping compartment; and a second insert configured for placement at another end of the instrument case, said second insert having a second outer contour approximately the same as said second inside contour of said shipping compartment.

12. The shipping container of claim 11, wherein said plurality of walls includes a

door which pivots to an open position.

13. The shipping container of claim 12, further including a first latch and a second latch connected to said door, each of said first latch and said second latch being rotatable to allow said door to pivot to said open position.

14. The shipping container of claim 11 , wherein said plurality of walls are manufactured using a rotational molding process.

15. The shipping container of claim 14, wherein each of said plurality of walls includes a polyethylene exterior with a foam interior.

16. The shipping container of claim 11 , further including at least one recessed handle connected to at least one of said plurality of walls.

17. A shipping assembly, comprising:

an instrument case; a plurality of surgical devices organized in said instrument case;

a shipping container including: a plurality of walls, said plurality of walls defining a shipping compartment

within said plurality of walls, said shipping compartment having a first inside contour and a

second inside contour; a telescoping handle connected to at least one of said plurality of walls; a set of at least partially recessed wheels connected to at least one of said

plurality of walls; a first insert connected to one end of said instrument case, said first insert having a first outer contour approximately the same as said first inside contour of said shipping compartment; and

a second insert connected to another end of said instrument case, said second insert having a second outer contour approximately the same as said second inside contour of said shipping compartment.

18. The shipping assembly of claim 17, wherein said plurality of walls includes a door which pivots to an open position.

19. The shipping assembly of claim 18, further including a first latch and a second latch connected to said door, each of said first latch and said second latch being rotatable to allow said door to pivot to said open position.

20. The shipping assembly of claim 17, wherein said instrument case is a sterilization

case.

21. The shipping assembly of claim 17, wherein said surgical devices are at least one of a surgical instrument and a surgical implant.

22. The shipping assembly of claim 17, wherein said plurality of walls are manufactured using a rotational molding process.

23. The shipping assembly of claim 22, wherein each of said plurality of walls includes a polyethylene exterior with a foam interior.

24. The shipping assembly of claim 17, further including at least one recessed handle connected to at least one of said plurality of walls.