A typical surgical scalpel includes a handle portion and a blade portion. The cutting blades are very sharp and often pointed, so care must be taken to prevent accidental cuts when the scalpel is being handled, both prior to and after use. Additionally, it is generally desirable to dispose of contaminated surgical instruments after a single use. Disposal of used scalpels can pose a hazard because their shape blades can puncture trash bags and body fluids on the blades must be treated as a biohazard.
The various embodiments provide devices and methods for an interchangeable cutting knife, such as a surgical scalpel, that allows safe handling and disposal of used and/or contaminated portions.
Various embodiments of an interchangeable cutting knife, such as surgical scalpel overcome limitations of existing cutting knives, including surgical scalpels, by using a pen-type activation mechanism in conjunction with an interchangeable blade tip that locks the cutting blade within a sheath during assembly, storage (e.g., while on a surgical tray), handling, and/or disassembly for disposal. The separate handle and interchangeable blade tip allow for the disposal of the interchangeable blade tip with the blade retracted and secure, as well as reuse of the handle (e.g., after sterilization in an autoclave in the case of surgical scalpels).
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate 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.
The various embodiments will be described in detail with reference to the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. References made to particular examples and implementations are for illustrative purposes, and are not intended to limit the scope of the invention or the claims.
The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other implementations.
The words “surgical scalpel,” “interchangeable surgical scalpel,” and “surgical scalpel assembly” as applied to the description of embodiments are used interchangeably to refer to an example cutting knife assembly. The words “handle,” “spring-loaded handle,” “pen-type handle,” and “handle assembly” as applied to the description of embodiments are used interchangeably. The words “interchangeable blade tip” and “blade tip assembly” as applied to the description of embodiments are also used interchangeably.
Embodiments are described herein with reference to a cutting blade or scalpel. However, a number of different knife or cutting implements may be used with and in the embodiments and are contemplated in the future, all of which may benefit from the various embodiments. Example surgical cutting implements include, e.g., incision scalpels, stab scalpels, crescent scalpels, round scalpels, keratome/slit scalpels, paracentesis scalpels, MVR scalpels, implant scalpels, side port scalpels, and the like. Example non-surgical cutting implements include trimming tools, carpet cutting tools, woodworking tools, dissection tools, and fabric cutters. The embodiments may also be used with sharp points, such as may be used to make holes in fabrics, animal hides, plastics, and the like. For ease of references, the term cutting blade is used generically to refer to any of a variety of knife, cutting blades and sharp points, and it should be understood that references to terminology and/or technical details related to a cutting blade are for illustrative purposes only, and are not intended to limit the scope of the claims to a particular type of cutting implement or technology unless specifically recited in the claim language.
Existing cutting blades are either fixed to handles (and can employ a guard when not in use) or retract into the handle in a manner similar to a utility knife. The majority of known surgical scalpels can result in exposure to the blade during assembly, storage (i.e., while on a surgical tray), handling, and/or disassembly by surgical personnel. For cutting blades that retract in the manner of a utility knife, the operation requires that the user maintain force for a sufficient time to fully retract the blade, and a user may believe the blade to be fully retracted when, in fact, the blade is still partially exposed. Additionally, since many retractable scalpels use activation mechanisms in different locations, operating room personnel will often position the blade in its exposed use position on the surgical tray, and thus expose the blade when passing the scalpel to the operating physician. Thus, it would be beneficial to have a surgical scalpel that minimizes exposure of the blade during assembly, storage (i.e., while on a surgical tray), handling, and/or disassembly by surgical personnel, yet is as easy to operate as a retractable pen.
The various embodiments of an interchangeable cutting knife overcome limitations of existing scalpels by using a pen-type activation mechanism in conjunction with an interchangeable blade tip that locks the cutting blade within a sheath during assembly, storage (i.e., while on a surgical tray), handling, and/or disassembly for disposal by surgical personnel. The separate handle and interchangeable blade tip allow for the disposal of the interchangeable blade tip with the blade retracted and secure, as well as reuse of the handle if desired (e.g., after sterilization in an autoclave). In certain embodiments, the activation mechanism of the handle and the blade tip can be configured for selected activation and retraction of multiple blade tips. The embodiments of an interchangeable cutting knife may also meet critical OSHA requirements. The safety device cannot be reused after a procedure is completed and surgical instruments are disposed (because the disposed tip requires the plunger to unlock. One-hand activation allows users to extend and retract the blade with one hand during the procedure due to the easy pen-style push button actuator structure. The one-hand operation allows users to keep their hands behind the blade during procedures. The enclosed sheath of the disposable tip holds a contaminated blade after use to prevent spread of contamination from body fluids and hazards posed by an exposed blade.
A surgical scalpel in accordance with an embodiment may include a pen-type handle and an interchangeable blade tip. The pen-type handle has an activation button at a proximal end. The pen-type handle may be configured so that depressing the button moves a spring-loaded plunger between retracted and extended positions at a distal end of the pen-type handle. The interchangeable blade tip has a sheath dimensioned to be removably attached at a proximal end to the distal end of the pen-type handle. The interchangeable blade tip further may include a spring-loaded cutting blade configured to engage the spring-loaded plunger and extend to an exposed use position when the spring-loaded plunger is in the extended position. The cutting blade may be any form of sharp point or knife blade, including a surgical scalpel blade. The spring-loaded cutting blade of the interchangeable blade tip may further be configured to disengage the spring-loaded plunger and retract to a safe position when the spring-loaded plunger is in the retracted position.
An embodiment of the cutting knife may include a lock mechanism configured to secure the cutting blade within the sheath. The spring-loaded cutting blade may further include a resilient member that engages a portion of the sheath when in a retracted position so as to lock the cutting blade within the sheath. The spring-loaded plunger may then unlock the cutting blade from the sheath by using a member that disengages the resilient member of the cutting blade from the sheath during initial movement into an extended position. In one embodiment, the resilient member may include a tapered catch at an end of a leaf spring. To assist in the operation of the locking mechanism, the sheath and pen-type handle may be dimensioned to align the resilient member of the cutting blade with the member that disengages on the plunger.
In an embodiment the interchangeable blade tip may further include a grip surface on a proximal portion of the sheath, and the interchangeable blade tip may further include a channel on an inner portion of the sheath to guide the cutting blade, and the interchangeable blade tip may further include a bar spring between an inner portion of the sheath and the cutting blade.
In another embodiment, the cutting knife may include a handle and an interchangeable blade tip. The handle has a hollow barrel with a proximal opening in a proximal end and a distal opening in a distal end. A button may be used for activation and has a proximal end, a distal end, and a flange, wherein the button is dimensioned to extend its proximal end through the proximal opening of the hollow barrel and be retained by the flange. A cam follower may be positioned adjacent the distal end of the button and configured to engage a cam on an inner surface of the hollow barrel to move between an extended position and a retracted position. A plunger may be located within the hollow barrel and have a proximal end, a distal end, and spring stop. The proximal end of the plunger may be dimensioned to engage a distal end of the cam follower, such that activation of the button moves the plunger through the four step-down positions as found in operation of a pen. A plunger spring may be configured to engage the spring stop on the plunger and the hollow barrel so as to retract the plunger from an engagement position when the cam follower is in the retracted position. The interchangeable blade tip may include a hollow sheath having proximal opening in a proximal end, a distal opening in a distal end, blade guides on an inner surface, and a blade stop at a distal end of the blade guides. The proximal end may be dimensioned and configured for removable attachment to the distal opening of the hollow barrel. A cutting blade may be located within the sheath and has a cutting surface at a distal end, a longitudinal edge for engaging the blade guides, a spring stop, and a proximal end dimensioned to engage a distal end of the plunger when the plunger is in the engagement position. A blade spring may be configured to engage the spring stop on the cutting blade and the hollow sheath so as retract the cutting blade within the sheath when the plunger is disengaged from the proximal end of the cutting blade.
Optionally, this embodiment of the cutting knife also may include a lock mechanism for the cutting blade to secure it within the sheath. The cutting blade may further include a resilient member that engages a portion of the sheath when in a retracted position so as to lock the cutting blade within the sheath. The plunger may then unlock the cutting blade from the sheath by using a member that disengages the resilient member of the cutting blade from the sheath during initial movement into an extended position. In one embodiment, the resilient member may include a tapered catch at an end of a leaf spring. To assist in the operation of the locking mechanism, the sheath and hollow barrel may be dimensioned to align the resilient member of the cutting blade with the member that disengages on the plunger.
In a further embodiment of the surgical scalpel, the blade tip may include a plurality of spring-mounted cutting blades. A pen-type mechanism in the handle of the scalpel assembly can include blade-selection actuators so that a selected one of the plurality of cutting blades will engage a plunger for movement into the extended and retracted positions.
In these and additional embodiments, the handle may be made from autoclavable materials, the interchangeable blade tip may be made from autoclavable materials, the interchangeable blade tip may be made from disposable materials, and the interchangeable blade tip may further include a grip surface on a proximal portion of the sheath.
A spring (not illustrated in
In an embodiment the blade tip assembly 220 may include a sheath 224 that has a grip portion 222 and encloses a cutting blade 226. The cutting blade 226 may include a proximal end 228 positioned and dimensioned to engage the plunger 218 of the handle assembly 210. The interior of sheath 224 may include guides/stops 223/227 to control the position of the cutting blade 226. The cutting blade 226 may include a resilient locking member 229 that may include a catch portion that engages a recess or similar corresponding structure 231 on the interior of the sheath 224. In this manner, the cutting blade 226 can be locked in a safe position inside the sheath 224.
In this embodiment, the proximal end of the sheath 224 adjacent the grip portion 222 may be dimensioned slightly smaller than the distal opening in the hollow barrel 212 of the handle assembly 210 so that it may be inserted into the barrel 212 to attach the blade tip assembly 220 to the handle assembly 210. The proximal end of the sheath 224 may further include a structure (e.g., an indentation) 225 for securing to a corresponding structure (e.g., a protrusion) 215 inside the hollow barrel 212. This attachment is merely exemplary, and it is possible to use other forms, such as a blade tip assembly 220 that slides over the handle assembly 210, or a blade tip assembly 220 that abuts or is joined by flanges to the handle assembly 210. In other embodiments, other mechanisms may be used, such as bayonet mounts, screw threads, keyed friction fits, and the like to removably secure the blade tip assembly 220 to the handle assembly 210. In cases where the resilient locking member 229 must align with a corresponding release member 219, the attachment mechanism may use keyed elements or surfaces to assure the proper orientation of the members 229 and 219. Additionally, the handle assembly may use guides for the plunger 218 to assure proper orientation of the release member 219, in much the same way the guides 223/227 control orientation of the resilient locking member 229.
In
In
The proximal end 328 may include a protrusion for initial engagement in a corresponding portion of the plunger 318. The plunger 318 has a further portion and an end wall for full engagement with the proximal end 328. During full engagement, a key or release member 319 may engage an angled surface of the resilient locking member 329 so as to release it from the corresponding structure 331 on the inside of the sheath 324. The plunger 318 can then act to move the cutting blade 326 along the guide/channel 333 and out of the sheath 324 against the forces of the bar spring 335.
The embodiment interchangeable surgical scalpel 500 illustrated in
In
While this multiple-blade embodiment is disclosed as using flexible plungers 518 and 548 to alternately select particular surgical cutting blades 526, other mechanisms such as typically used in multi-color pen or pencil mechanisms may be used. In such embodiments, each separate plunger activates a separate cutting blade. Such alternate selection mechanisms are disclosed in U.S. Pat. Nos. 2,113,320, 2,849,983, 3,260,242, 3,700,340, 3,989,389, and 6,899,482, which are hereby incorporated by reference.
While the various embodiments have been described above as surgical scalpels, the embodiments are not limited to medical applications. More generally, the embodiments are usable with any cutting knife that implements the structures for deploying and retracting blades described above that may be useful for a variety of applications, particularly applications in which a retractable blade provides important safety advantages. Thus, the claims are not limited to surgical scalpels unless specifically recited in the claims themselves.
The preceding description of the embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the following claims and the principles and novel features disclosed herein. Further, any reference to claim elements in the singular, for example, using the articles “a,” “an,” or “the” is not to be construed as limiting the element to the singular.
This application claims the benefit of priority to U.S. Provisional Application No. 61/684,317, filed Aug. 17, 2012, the entire contents of which are hereby incorporated by reference.
Number | Date | Country | |
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61684317 | Aug 2012 | US |