WO2017137867A1 - Surgical instruments and/or implants packaging with sterilized surgical technique and method of using a surgical technique - Google Patents

Abstract

A surgical instrument and/or implant kit, including a casing, a surgical instrument and/or implant tray, sterilized surgical instruments and/or implants that are located inside the casing and placed on the surgical instrument and/or implant tray, and a sterilized surgical technique located inside the casing.

Description

SURGICAL INSTRUMENTS AND/OR IMPLANTS PACKAGING WITH STERILIZED SURGICAL TECHNIQUE AND METHOD OF USING A SURGICAL TECHNIQUE

CROSS-REFERENCE TO RELATED APPLICATIONS

(0001) The present invention claims priority to the International Patent Application No. PCT/IB2016/050692 that was filed on February 10, 2016, the entire contents thereof being herewith incorporated by reference.

(0002) FIELD OF THE INVENTION

(0003) The present invention is directed to the field of surgical techniques and methods of using such surgical techniques, for example for use with packaged surgical instruments and implants.

BRIEF DESCIPTION OF THE BACKGROUND ART

(0004) In the field of providing surgical operation instructions to a surgeon or other physician for a specific operation and a corresponding instrument tool set, a tool-set specific user instruction, often referred to as surgical techniques, is usually available in the form of a printed user instructions. These printed user instructions are usually available as paper printed booklets or brochures that are provided separately from the instrument tool set. Specifically, when the instrument tool set is prepared for operation, the instrument tool set needs to be sterilized. Recently, many manufacturers have made the surgical techniques for a specific instrument set for a surgical operation available online on their website, for example is a portable document format (PDF), and can be freely downloaded. Some companies also offer the surgical techniques as online available videos on different channels such as YouTube™, BroadcastMed™. It is possible that display monitors are used during surgery that have been sterilized themselves with autoclaving or cleaning, to either display static PDF documents with the surgical techniques.

(0005) However, despite all these available solutions to provide instructions for a specific instrument set to a surgeon or other physician, often the wrong surgical techniques are printed out or provided, because of the similarity of different toolsets and/or surgical techniques. In addition, in the heat of passion and stress of a surgical operation, surgical techniques often get lost, destroyed or torn, or are not brought into the operation room. Another problem with conventional surgical techniques is that they can be a carrier for contaminants that are brought into the operation or surgical room, and they may have to be sterilized in a separate process.

(0006) Therefore, there is a strong need for substantially improved solutions for providing surgical techniques to surgeons, physicians, laboratory operators, in light of the above-discussed deficiencies.

SUMMARY

(0007) According to one aspect of the present invention, a surgical instrument tray is provided. Preferably, the surgical instrument tray includes a casing having a sterilized interior, sterilized surgical instruments that are located inside the casing, and a sterilized surgical technique that is located inside the casing. More preferably, the sterilized surgical technique is placed on top of the surgical instruments inside the casing.

(0008) According to another aspect of the present invention, a method for using surgical instrument kit is provided. The method preferably includes the steps of packaging at least one of surgical instruments and implants usable for a corresponding surgical operation and a surgical technique having instructions for the corresponding surgical operation into a casing, and sterilizing the casing including the at least one surgical instruments and implant, and the surgical technique. Moreover, the method preferably further includes the steps of delivering the casing with the at least one surgical instruments and implant, and surgical technique to an operation room, and opening the casing and removing the surgical technique from the casing before performing the surgical operation in the operation room. (0009) The above and other objects, features and advantages of the present invention and the manner of realizing them will become more apparent, and the invention itself will best be understood from a study of the following description with reference to the attached drawings showing some preferred embodiments of the invention.

BRIEF DESCRIPTON OF THE SEVERAL VIEWS OF THE DRAWINGS

(0010) The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and together with the general description given above and the detailed description given below, serve to explain features of the invention.

(0011) FIG. 1 shows a perspective exploded view an instrument kit 100 with a sterilized, surgical technique 80 therein, according to one aspect of the present invention;

(0012) FIG. 2 shows a perspective view of a surgical technique according to another aspect of the present invention;

(0013) FIG. 3 shows a perspective exploded view of an instrument tray and a corresponding surgical technique according to still another aspect of the present invention; and

(0014) FIG. 4A and 4B show photos of an instrument kit 200 with and without the surgical technique, according to still another aspect of the present invention.

(0015) Herein, identical reference numerals are used, where possible, to designate identical elements that are common to the figures. Also, the images are simplified for illustration purposes and may not be depicted to scale.

BRIEF DESCRPTION OF THE SEVERAL EMBODIMENTS

(0016) FIG. 1 shows a perspective exploded view of one aspect of the present invention, showing an instrument kit 100 with a sterilized, surgical technique 80 located therein.

Instrument kit 100 is sterile-packaged and is ready to be opened for use by a surgeon or other person in the sterilized environment, for example but not limited to an operation room, surgery room or chamber, laboratory. Instrument kit 100 can include different types of instruments, and preferably, the instrument kit 100 includes a plurality of instruments that are needed for the surgeon to perform a particular operation or surgery. In the variant shown, an instrument kit for an orthopedic fixation operation is shown, but kit 100 could also include an implant kit, a combination of an implant kit and an instrument kit, or other types of kits that are necessary for performing a particular operation or surgery.

(0017) In the variant shown, the exemplary instrument kit 100 shown consists of a handle 10 that can mate with a drill guide 30. Instrument kit 100 also consists of one or more locating pins 20, drill bit 30, and tamp 40. Locating pins 20 are used to fit inside drill guide 30. Drill bits also fit inside drill guide 30 and can drill a hole in bone. Tamp 40 can be used to press down on an implant to push it flush to bone. The handle 10, one or more locating pins 20, drill bit 30, and tamp 40 all fit into instrument package 105 suitable to house handle 10, one or more locating pins 20, drill bit 30, and tamp 40 and maintain handle 10, one or more locating pins 20, drill bit 30, and tamp 40 sterile. In particular, the handle 10, one or more locating pins 20, drill bit 30, and tamp 40 all fit into instrument tray 50. Instrument tray 50 can be made from a thermoformed plastic or similar material that is shaped to conform and hold each instrument; namely, handle 10, one or more locating pins 20, drill bit 30, and tamp 40.

(0018) On top of instrument tray 50 and the instrument kit 105 with handle 10, locating pins 20, drill bit 30, tamp 40, a surgical technique 80 is placed, made from a sterilizable material. Surgical technique 80 includes all the instructions 85 for the surgeon to perform the operation associated with the instrument kit 105. Preferably, the instructions 85 are printed in a chronological order, being numbered or lettered in an increasing order, and includes different fields using symbols and showing the instruments involved for each step of the method for the surgical technique. Preferably, the instructions 85 on the sterilizable surgical technique 80 do not use any descriptive text, but only symbolic representations of the operation step to be performed. In the variant shown, surgical technique 80 is made of sheet of printed polymer that can be sterilized, and is flush with an outline of instrument tray 50, so that it covers all the tools of instrument kit 105. With this variant, surgical technique 80 is made such that the remove any of the tools of instrument kit 105, the surgical technique 80 needs to be removed, and therefore could serve for a second purpose as a protective sheet for instrument kit 105. In a variant, instead of providing for a separate sheet as surgical technique, the instructions of the surgical technique can also be printed or otherwise provided onto cover 60, the bottom cover 70, or both, so that the surgical technique is part of the packaging parts itself. Thereby, the packaging serves as a dual purpose, to enclose and protect the instruments 10, 20, 30, 40, and to provide for instructions on how to use the instruments 10, 20, 30, 40.

(0019) Moreover, instrument tray 50 and surgical technique 80 located above tray 50 fits inside cover 60. Both instrument tray 50 and cover 60 can be made from transparent plastic, and thereby the surgical technique 80 can be visible from outside. An instrument seal or base cover sheet 70 can secure over and enclose cover 60 using any suitable means such as a heat and pressure activated adhesive. Instrument seal or base cover sheet 70 can be made from a suitable material for insuring sterility while still allowing air passage. Instrument seal 70 adheres to cover 60 to allow tools or instruments 10, 20, 30, and 40, as well as surgical technique 80 to be sterilized and then maintain sterility. Instrument kit 100, including surgical technique 80 and tray 50, can be sterilized by any common method of sterilization such as gas or radiation. In a variant, when surgical technique 80 is placed onto instruments 10, 20, 30, and 40, the instrument tray 50 is made such that the surgical technique does not come into contact with instruments 10, 20, 30, 40. (0020) By providing the surgical technique 80 directly inside the casing of a corresponding instrument set 105, several advantages are provided. First, this arrangement allows to avoid the use of surgical techniques that have been brought separately from the instrument kit 100 into the operation room. This allows to prevent confusion of surgical techniques, as the surgical techniques of different instrument sets 105 can have only very slight variations, especially when very similar instruments sets 105 are used. Next, this allows to provide for a sterilized surgical technique 80, so that proper sterilization can be guaranteed. In addition, because every instrument set 105 can have a corresponding surgical technique, this also allows and facilitates the provision of custom surgical techniques for each instrument set 105, in particular if the instrument set includes patient-specific parts, for example parts that have been custom-made by three-dimensional printing for a specific patient.

(0021) According to another aspect of the present invention, a method of using a sterilized surgical technique is provided. The method preferably includes a step of inserting tools 10, 20, 30, 40 into an instrument tray 50, a step of providing a surgical technique 80 to the tools 10, 20, 30, 40 and instrument tray 50, a step of packaging the instrument tray 50 with tools 10, 20, 30, 40, and surgical technique 80 inside a casing, including cover 60 and instrument seal 70 to provide for a packaged instrument kit 100, a step of sterilizing the packaged instrument kit 100, to provide for a sterilized instrument kit 100, a step of delivering the sterilized instrument kit 100 to a sterilized environment, for example a surgical room, operation room, etc. Preferably, an additional step is provided to open the sterilized instrument kit 100 in the sterilized environment, and using the instruments 10, 20, 30, 40 based on instructions 85 of the surgical technique 80.

(0022) In this last step, the packaged and sterilized instrument kit 100 is opened, and the surgical technique 80 is removed and placed in an area where the surgeon or the sterile staff of the operation room can view the instructions 85 of surgical technique. Next, upon performing the operation, the surgeon accesses tools 10, 20, 30, 40 as needed from instrument tray 50 based on the instructions 85 of the surgical technique 80. In a preferred embodiment, the instrument kit 100 is for one-time use, and after surgeon has used tools 10, 20, 30, 40 and has performed operation or surgery that is described in surgical technique 80, the tools 10, 20, 30, 40, the surgical technique 80, the packaging including cover 60, seal 70, and the instrument tray 50 are disposed of.

(0023) In a variant, the instrument kit 100 is reusable, and the surgical technique 80 can be sterilized again and repackaged in a new casing including cover 60 and instrument seal 70, and the tools 10, 20, 30, 40 can also be sterilized again and repackaged. In another variant, after a one-time use of only the surgical technique 80, surgical technique 80 can be disposed of, and a new surgical technique 80 can be used to repackage the tools 10, 20, 30, 40. By the use of this method, it can be ascertained that that surgical technique is exposed to the operation room or other environment at the latest stage possible, e.g. when the surgeon openings the packaged instrument kit 100 to use the instruments or tools. This guarantees the best possible protection from contamination, but also prevents loss of the surgical technique in the preliminary steps that are performed before the surgery.

(0024) FIG. 2 show still another aspect in the present invention, showing a perspective view of a surgical technique 180 without any casing, in which the surgical technique 180 serves a dual functionality, first to provide for instructions to the surgeon during operation, and second as a holding sheet to provide for additional security to prevent tools 110, 120, 130, 140 from falling out of instrument tray 150 and as a protection from being inadvertently touched or contaminated. For this purpose, surgical technique 180 is equipped with holes 187 and instrument tray 150 is equipped with protruding snap-in tabs 155, each snap-in tab 155 corresponding to one of the holes 187 of surgical technique 180. Snap-in tabs 155 and holes 187 are configured such that surgical technique 180 can be removed by surgeon from instrument tray 150 by pulling surgical technique 180 off the tabs 155, but the snap-in mechanism being strong enough to prevent tools 110, 120, 130, 140 from falling out of tray 150, when tray 150 is flipped over.

(0025) FIG. 3 shows yet another aspect of the present invention, in which surgical technique 280 is made of several pages that are folded and placed inside a casing, like the one shown in FIG. 1. This permits to increase the usable surface area of surgical technique 280 by an integer multiple, in the case shown a factor three (3). To provide for guidance to the operating surgeon, the pages of the surgical technique 280 can be numbered.

(0026) FIG. 4A and 4B show photos of an additional embodiment with an instrument kit 200 having a bottom cover 270 and an integrated instrument tray 250 as a blister packaging, and different tools 210, 220, 230, 240 that are placed at different locations in the instrument tray 250, without the surgical technique 280 (FIG. 4A), and with the surgical technique 280 covering the instrument tray 250 and all the tools 210, 220, 230, 240 (FIG. 4B). The blister packaging that includes cover 270 and tray 250 can be made from thermoformed plastic, and is formed as a hollow pocket with spaces to hold the tools 210, 220, 230, 240. A backing can be provided behind the bottom cover 270, made from paperboard or a lidding seal of aluminum foil or plastic. In a variant, bottom cover 270 and instrument tray 250 are made of two separate parts. In the variant shown in FIGs. 4A and 4B, no upper cover is shown, and FIG. 4B depicts an instrument kit 280 once the upper cover has been removed from bottom cover 270. The bottom cover 270 includes side walls 274 and an upper ledge 272, the side walls 274 of bottom cover 270 being high enough such that instrument tray 250, tools 210, 220, 230, 240 and surgical technique 280 are located inside bottom cover 270, below an exposed surface defined by the upper ledge 272. Instrument tray 250 and tools 210, 220, 230, 240 are arranged such that surgical technique 280 does not get into contact with tools 210, 220, 230, 240 when packaged in tray 250.

(0027) The exposed surface of the upper ledge 272 can be used to connect to an upper cover (not shown). In this way, surgical technique 280 needs to be removed from bottom cover 270 so that the operator can access tools 210, 220, 230, 240. In this embodiment, upper cover can be made of a flat sheet of material that reaches to the outer edge of upper ledge 272. The kit 200 can be placed inside a pouch to provide for a double seal, and thereby providing another layer for double sterilization of kit 200. The kit 200 with the pouch can then be further packaged, for example with a carbon box. In variants, the kit 200 can be double packaged with a second, external blister packaging, or a second pouch, to provide for additional sterilization and protection.

(0028) While the invention has been disclosed with reference to certain preferred embodiments, numerous modifications, alterations, and changes to the described embodiments, and equivalents thereof, are possible without departing from the sphere and scope of the invention. Accordingly, it is intended that the invention not be limited to the described embodiments, and be given the broadest reasonable interpretation in accordance with the language of the appended claims.

Claims

1. A surgical instrument kit, comprising:

a casing;

a tray;

at least one of sterilized surgical instruments and an implant that are located inside the casing and placed on the tray; and

a sterilized surgical technique located inside the casing.

2. The surgical instrument kit according to Claim 1, wherein the sterilized surgical technique is placed on top of the at least one of sterilized surgical instruments and the implant inside the casing.

3. A method for using a surgical kit, comprising the steps of:

packaging at least one of surgical instruments and implants usable for a corresponding surgical operation and a surgical technique having instructions for the corresponding surgical operation into a casing;

sterilizing the casing including the at least one of surgical instruments and implants and the surgical technique;

delivering the casing with the at least one of surgical instruments and implants, and surgical technique to an operation room; and

opening the casing and removing the surgical technique from the casing before performing the surgical operation in the operation room.