Patent ID: 12220198

DETAILED DESCRIPTION

The embodiment ofFIG.1illustrates an exemplary power tool10for use in medical procedures such as surgical procedures. A removable, single use, contamination-blocking cover12is provided for blocking excessive contamination of the power tool10during use. The cover12is replaceable, e.g.: after the procedure, the cover12may be removed and replaced by a new cover12.

The tool10includes a housing14comprising a handle portion16and in this example, a power source portion such as a receiver18for a portable battery pack and a tool attachment portion20having a chuck21provided for releasably receiving and holding an attachment tool such as a drill bit or a saw blade. The handle16includes a control portion including but not limited to an actuating trigger22, a trigger lock24and a forward-reverse switch, all of which may not be visible inFIG.1. The attachment point of a saw blade may vary depending on whether it is a reciprocating or oscillating blade.

The cover12preferably includes a two-piece hard or soft outer shell including portions12aand12b. The tool10is illustrated at10aprior to application of the cover12, and is illustrated at10bafter application of the cover12. A first opening12cis provided in cover12adjacent chuck21when the cover is applied to the tool10. A second opening12d, which may be closed by a sealable door19, is provided in power source portion18. Regardless of the material used for the cover12, a flexible portion12eof the cover12is provided on the handle16to provide a user with a tactile feel and operable movement of for example, the trigger22and the trigger lock24.

The replaceable cover12is applied to tool10by a tool re-processor. Once the tool10is used in a procedure, the cover has become contaminated along with portions of the tool10which are adjacent the openings12c,12d. The tool10, including cover12, is returned to the tool re-processor where the cover12is removed and discarded. The tool10is then cleaned and a new cover12is mounted on the tool10, rendering the tool10ready for re-use.

More specific information regarding the tool10and cover12of theFIG.1embodiment as described above are set forth below as follows:a. Existing product or new product uses a rigid body mechanical housing14in conjunction with either a hard or soft/flexible shell outer shield12that covers and protects the majority of the tool10from 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.i. Materials and alloys/laminates of these materials appropriate for this concept include but are not limited to:a. PETG & A/PET;b. Polystyrene;c. Acrylic;d. Polycarbonate;e. ABS;f. Nylon;g. Polyolefin;h. Polyetheretherketone PEEK;i. Polyetherimide PEI;j. Polyetersulfone PES;k. Polyvinylidene PVDF;l. Polymethylpentene PMP;m. Polysulfone PSO;n. Ethylene-chlorotrifluoroethylene ECTFE;o. Metals;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:a. Synthetic Paper;b. C-Flex;c. Flexible PVC;d. Polycarbonate;e. Polyester;f. Polyethylene;g. Polypropylene;h. Nylon;i. Polyolefin;b. Methods appropriate for fastening the outer shell to/around the inner structure include but are not limited to:i. Fasteners such as:1. Screws;2. Rivets;3. Bolts;ii. Molded features such as:1. Clips;2. Press fits;3. Slip fits;iii. Adhesive in multiple forms:1. Tape;2. Glue;3. Pressure sensitive adhesive;4. Hot melt adhesives;5. Contact adhesives;iv. Secondary operations:1. Heat Seal;2. Pierce;

Several further embodiments are described below. More specific information regarding the tool10and a stretch membrane cover12including upper member12aand lower member12b, of theFIG.2embodiment is described below as follows:a. This embodiment uses a rigid body mechanical housing14in conjunction with a highly stretchable membrane12(balloon like) to cover and protect the tool10from contamination by blood/bone/tissue during a procedure. This cover12is 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 tool10(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. Members12aand12bare stretched over housing14and combined to form cover12. Tool10is shown at10aprior to application of cover12and is shown at10bafter the application of cover12.i. Flexible membranes can be produced using blow molding, dip molding, thermoforming, or other processes. Members12aand12bare stretched over housing14and combined to form cover12. Tool10is shown at10aprior to application of cover12and is shown at10bafter the application of cover12.1. Materials and alloys of these materials appropriate for this concept include but are not limited to:a. Silicone;b. Latex Rubber;c. Synthetic Rubber;d. Polychloroprene;e. Flexible PVC;b. Methods appropriate for applying the membrane around the outer shell include but are not limited to:i. Stretching:1. Manually;2. Automated;3. Individual sections (i.e.: main body separate from Battery Pack area);ii. Secondary operation:1. Additional seals/retention elements at operation interfaces such as drill chuck or saw adaptor;2. Additional tape reinforcements in high stress areas

More specific information regarding the tool10and a shrink wrap cover12,FIGS.3a,3b, is described below as follows:a. This embodiment uses a rigid body mechanical housing14in conjunction with a secondary shrink-wrap element12to cover and protect the device from contamination by blood/bone/tissue during a procedure. Cover12is 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 tool10(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. Tool10is shown at10aprior to application of cover12and is shown at10bafter the application of cover12and shrink activation,FIGS.3a,3b.i. Flexible shrink-wrap can be produced using extrusion processes, and are available in tape,FIG.3a, sheet or tube form,FIG.3band 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 cover12x,FIG.3b, is trimmed at12yafter shrink activation at12z. Shrink-wrap tape,FIG.3ais shown prior to wrapping at12xand after wrapping and shrink activation at12y.1. Materials and alloys/laminates of these materials appropriate for this concept include but are not limited to:a. Acetate;b. Polyethylene;c. PVC;d. Polyester;e. Polyolefin;f. Polypropylene;b. Methods appropriate for applying the membrane around the outer shell include but are not limited to:i. Tape Wrapping:1. Manually;2. Automated;3. Individual sections (i.e.: main body separate from Battery Pack area);ii. Film Wrap:1. Manually;2. Automated;3. Individual sections (i.e.: main body separate from Battery Pack area);iii. Secondary operations:1. Heat seal for complex geometries;2. Shrink Tunnel;3. Heat Gun;4. Refrigeration;5. Additional tape reinforcements in high stress areas;6. Adhesive application to tape wrap;

InFIG.4, an embodiment utilizes no traditional housing14, as described above, but provides the inner frame and working parts as tool110and the outer hard-shell cover12of tool110is provided as a disposable cover, as described below:a. This embodiment uses a rigid sub-frame110carrying all mechanical components. The hard-shell cover12has 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. Cover12comprises cover portions12a,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 cover12functions as a combination previously provided by a traditional housing14and cover12.i. Hard outer shells can be produced using injection molding, thermoforming, or other processes.I. Materials and alloys/laminates of these materials appropriate for this concept include but are not limited to:a. PETG & A/PET;b. Polystyrene;c. Acrylic;d. Polycarbonate;e. ABS;f. Nylon;g. Polyolefin;h. Polyetheretherketone PEEK;i. Polyetherimide PEI;j. Polyetersulfone PES;k. Polyvinylidene PVDF;l. Polymethylpentene PMP;m. Polysulfone PSO;n. Ethylene-chlorotrifluoroethylene ECTFE;o. Metals;b. Methods appropriate for fastening the outer shell to/around the inner structure include but are no limited to:i. Fasteners such as:1. Screws;2. Rivets;3. Bolts;ii. Molded features such as:1. Clips;2. Press fits;3. Slip fits;iii. Secondary operation:1. Tape;2. Glue;3. Pressure sensitive adhesive;4. Hot melt adhesives;5. Contact adhesives;6. Heat seal;7. Pierce;

InFIG.5, another embodiment includes a tool10having a protective spray cover12further described as follows:a. This embodiment uses a rigid body mechanical housing14in conjunction with a secondary spray-on protective layer12to cover and protect the tool10from 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 portion18at the start of a procedure. Additional reinforcements or seals can be used in areas subject to contaminant intrusion. Layer12is a removable, single-use cover of contamination blocking material.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.1. Materials and alloys/laminates of these materials appropriate for this concept include but are not limited to:a. Natural rubber;b. Synthetic rubber;c. Polyurethane;d. Acrylic;e. Polyethylene;f. PVC;g. Polyester;h. Polyolefin;i. Polypropylene;b. Methods appropriate for applying the membrane around the outer shell include but are not limited to:i. Aerosol application:1. Manually;2. Automated;3. Individual section (i.e.: main body separate from Battery Pack area);ii. Secondary operations:1. Drying/curing;

InFIG.6, another embodiment includes a tool10having a protective dip layer as a cover12further described as follows:a. This embodiment uses a rigid body mechanical housing in conjunction with a secondary dipping operation to apply a protective layer12intended to cover and protect the tool10from 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 portion18at the start of a procedure. Additional reinforcements or seals can be used in areas subject to contaminant intrusion. Layer12is a removable, single-use cover of contamination blocking material.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.1. Materials and alloys/laminates of these materials appropriate for this concept include but are not limited to:a. Natural rubber;b. Synthetic rubber;c. Polyurethane;d. Acrylic;e. Polyethylene;f. PVC;g. Polyester;h. Polyolefin;i. Polypropylene;b. Methods appropriate for applying the membrane around the outer shell include but are not limited to:i. Dip application:1. Manually;2. Automated;3. Individual sections (i.e.: main body separate from Battery Pack area);4. Secondary operations drying/curing;

InFIG.7, another embodiment includes a tool10with battery door19providing access to power source portion18and having a protective header bag formed to shape as a cover12further described as follows:a. This embodiment uses a rigid body mechanical housing14in conjunction with a formed header bag outer shielding cover12that protects the majority of the tool10from contamination by blood/bone/tissue during a procedure. Additional reinforcements or seals can be used in high stress areas. Header bag cover12comprises a removable, single-use cover of contamination blocking material.i. Header bag cover12can be produced using an extrusion process for the base material with secondary forming and sealing operations to create a sealed enclosure. The header bag12is a shaped, non-stretchable, bag-like shell loosely fitted over the housing14.1. Materials and alloys of these materials appropriate for this concept include but are not limited to:a. Synthetic paper;b. C-Flex;c. Flexible PVC;d. Polycarbonate;e. Polyester;f. Polyethylene;g. Polypropylene;h. Nylon;i. Polyolefin;b. Methods appropriate for fastening the header bag to/around the inner structure include but are not limited to:i. Adhesive in multiple forms1. Tape;2. Glue;3. Pressure sensitive adhesive;4. Hot melt adhesives;5. Contact adhesives;

InFIG.8, another embodiment includes a tool10having a protective die cut wrap as a cover12further described as follows:a. This embodiment uses a rigid body mechanical housing14in conjunction with a Precut Wrap outer shielding cover12that once applied protects the majority of the tool10from 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.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.1. Materials and alloys of these materials appropriate for this concept include but are not limited to:a. Synthetic paper;b. C-Flex;c. Flexible PCV;d. Polycarbonate;e. Polyester;f. Polyethylene;g. Polypropylene;h. Nylon;i. Polyolefin;b. Methods for cutting the wrap to conform to the device include but are not limited to:i. Manual cutting;ii. Die cutting;iii. Rotary cutting;c. Methods appropriate for securing the wrap to/around the device include but are not limited to:i. Creation of appropriate flattened geometry that once wrapped conforms to the geometry of the device.ii. Adhesive in multiple forms:1. Tape;2. Glue;3. Pressure sensitive adhesive;4. Hot melt adhesives;5. Contact adhesives;

InFIG.9, similar toFIG.2, another embodiment discloses a power tool10including a first inner stretch membrane cover112and a second outer stretch membrane cover212. This embodiment adds the outer cover212so that after use of the tool10, the outer cover212is removed and the inner membrane112stays in place on the tool10. 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:a. This embodiment uses a rigid body mechanical housing14in conjunction with a two-layer soft/flexible shell outer cover112and212that 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 cover212is removed presenting the inner cover112that is a non-biohazard product and can economically be returned for re-processing.

InFIG.10, tool housing14, including tool attachment portion20, handle portion16and power source portion18are illustrated from a backside perspective. The power source portion18, as stated above, may be closed by the sealable door19, shown removed. A cavity25in power source portion18may receive a battery on-site when the sterilized tool is being made ready for use. When sterilized, cavity25is exposed due to door19being removed and thus, the interior or cavity25of the power source portion18is also sterile. InFIG.11, door19is illustrated in attachment with power source portion18, thereby sealingly closing cavity25. Also, a rear cannulation opening23,FIGS.10and11, not required for saw blade attachment tools, is shown on a backside wall or surface of tool attachment portion20opposite a front sidewall where chuck21is located. In this manner, a guide wire or pin can be fed through the tool attachment portion20via the cannulation opening23and exit via the chuck end for use with a cannulated attachment. A seal23a, is provided to seal opening23. The seal23amay be either a removable seal or a penetratable seal.

The limited use tool10,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 cover12is removed. During repackaging, the tool10is placed in a partitioned tray300for shipping. Also, the removable, sealing access door19is placed in the tray300to be used after a battery is placed in a cavity within the power source portion18on-site. The tray300, containing the tool10, access door19and a handle305available for two-handed operation (optional), are trayed and covered with a Tyvek lid or cover310. Then a known ETO sterilization process, or other suitable process, sterilizes the contents of tray300in a gas chamber. Typically, a substantial number of the trayed tools are sterilized together for efficiency. Repackaged, sterilized trays300containing the tool10and access door19are then shipped to the user. When used, a battery, stored at the user's surgical facility is placed into the sterile cavity25in the power portion18. The sterile door19is then installed in the access opening of cavity25(discussed above, see alsoFIG.10).

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.

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.

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.