Surgical device with a moveable instrument protector

[0001] This application is a continuation of application Ser. No. 10/016,984 entitled Protection System for Surgical Instruments, filed on Dec. 7, 2001, which is incorporated herein by reference.

[0002] The present invention relates in general to surgical devices and more particularly to a surgical device having a protector moveable between an open position exposing an instrument and a closed position covering the instrument.

[0003] Surgical devices include a working end or instrument that may be delicate and/or have a sharp point or cutting edge. Examples of such instruments include scalpels, blades, hooks (such as Sinskey hooks, Bonn hooks, insertion hooks, twist hooks and the like), scissors (such as retinal scissors and the like), picks (such as retinal picks and the like), forceps, probes, lens manipulators, markers, collar buttons, choppers, cystotomes irrigation needles and cannulas, spatulas (such as Castroviejo spatulas and the like), and dilators. Most often, these surgical devices include at least one generally cylindrical handle with a distal end that houses instrument. Surgical knives that include a cutting blade at a distal end of the handle are typical of such instruments, and much of the prior art pertaining to protection for such instruments is directed at protection for surgical knives. However, the instant invention applies equally to the protection of non-sharp instruments.

[0004] Surgical devices typically have a body with a cutting blade or other operable instrument at one end of the body. The end of the body with the instrument sometimes has a portion that tapers down towards the instrument to provide good visibility of the instrument tip. The instruments can be extremely sharp, and the extreme sharpness may render them hazardous when passed back and forth during use in surgical procedures. If the instrument has already been used on the patient, then there is a potential danger of infection since any sharp or tapered instrument can very easily cut or rip through a surgical glove and the skin beneath the glove. Additionally, if the entire surgical device is not sterilized it may introduce infection in the patient.

[0005] In general, prior art systems for protection of surgical devices include some form of mechanically operable shield that covers the instrument when not in use, and that may be moved or removed in order to expose the instrument during use.

[0006] For Example, U.S. Pat. No. 5,254,128 to Mesa (incorporated herein by reference) discloses a surgical knife with a blade protector axially moveable between two positions, namely, opened for normal use and closed for storage or safe handling. The blade protector may be fixed in either position. While this arrangement solves some of the limitations of the prior art surgical devices, other common limitations still exist.

[0007] It is therefore a desire of the present invention to address the limitations and disadvantages of the prior art surgical devices.

[0008] In view of the foregoing and other considerations, the present invention relates to surgical devices having a movable guard for protecting the device's instrument.

[0009] Accordingly, a surgical device is provided. The surgical device includes a body having a reduced diameter portion between a handle portion and a tip portion carrying an instrument, an elongated, substantially cylindrical guard having an end wall forming a first opening for receiving the reduced diameter portion and a second opening formed opposite the first opening, is disposed on the body wherein the end wall portion is slidable along the length of the reduced diameter portion between a closed position with the guard substantially covering the instrument and an open position where the instrument is uncovered. A slot is formed between the first and second openings continuous with the first opening. The surgical device includes a locking mechanism for engaging a portion of the end wall portion for locking the guard in either the closed or open position.

[0010] The body may be formed of one or more elements, for example, by the interconnection between the tip portion with the reduced diameter portion and the handle portion. The body of the surgical device may be a unitary member, thus reducing costs of manufacturing a multipart body.

[0011] The locking mechanism may of numerous means known in the art. In a preferred embodiment the locking mechanism includes threads formed on the end wall engageable with a first set and a second set of threads formed on the reduced diameter portion.

[0012] The guard or the handle may include protrusions formed on the exterior thereof to prevent inadvertent rolling of the device and/or aide in gripping the device. The guard may be sized so that the outside diameter of the guard is substantially the same as the handle portion of the body when the guard is in the open position.

[0013] The guard may include one or more slots formed between the first and the second opening continuous with the first opening. The elongated slots provide a mechanism for expanding the first opening to prevent over tightening of the guard in a locked position, for facilitating complete cleaning and sterilization of the device and to aide in placing the guard on the body. The guard may include additional openings formed through the guard to facilitate cleaning of the device.

[0014] The surgical device may include various instruments well known in the art such as, but not limited to, hooks, choppers, collar buttons and blades. The instruments may be non-linear and/or not parallel to the longitudinal axis of the body. The instruments may include one or more bends or angles to facilitate placement of the instrument within the guard when the guard is in the closed position.

[0015] A method of constructing a surgical device is provided. The method includes the steps of forming a body having a reduced diameter portion between a handle portion and a tip portion, forming a first set of threads on the reduced diameter portion proximate the handle portion and a second set of threads proximate the tip portion, forming an elongated, substantially cylindrical guard having an end wall forming a first opening and a second opening formed opposite the first opening, wherein the end wall portion has end wall threads engageable with the first and second set of threads, forming at least two slots between the first and second opening continuous with the first opening, expanding the diameter of the first opening and passing the tip and second set of threads through the first opening and slidably positioning the end wall portion about the reduced diameter portion, attaching an instrument to the tip, engaging the end wall threads with the second set of threads locking the guard in a closed position with the guard covering the instrument, and engaging the end wall threads with the first set of threads locking the guard in an open position with the instrument uncovered.

[0016] As with the description of a surgical device above the method may include steps to provide those desired features.

[0017] The foregoing has outlined the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter which form the subject of the claims of the invention.

[0018] The foregoing and other features and aspects of the present invention will be best understood with reference to the following detailed description of a specific embodiment of the invention, when read in conjunction with the accompanying drawings, wherein:

[0019] FIG. 1 is a partial cross-section view of a surgical device of the present invention with a moveable guard in the open position;

[0020] FIG. 2 is a partial cross-section view of a surgical device of the present invention with a moveable guard in the closed position;

[0021] FIG. 3 is a side view of another surgical device of the present invention;

[0022] FIG. 3A is an end view of the moveable guard of FIG. 3 in isolation;

[0023] FIG. 4 is a side view of another surgical device of the present invention;

[0024] FIG. 5 is a side view of a surgical device of the present invention;

[0025] FIG. 6 is a side view of a surgical device of the present invention;

[0026] FIG. 7 is a side view of a surgical device of the present invention; and

[0027] FIG. 7A is an end view of the moveable guard of FIG. 7 in isolation.

[0028] Refer now to the drawings wherein depicted elements are not necessarily shown to scale and wherein like or similar elements are designated by the same reference numeral through the several views.

[0029] As mentioned above, many reusable surgical devices include at least one generally cylindrical handle with a distal end that carries an instrument for performing a medical procedure. Surgical knives, as more fully described below in accordance with preferred embodiments of the present invention, are typical of such reusable surgical devices. Although a surgical knife is illustrated in this specification, those skilled in the art will readily appreciate that the instant invention includes all surgical devices and the instrument that is carried.

[0030] FIG. 1 is a partial cross-section view of a surgical device of the present invention. The surgical device includes a body 10 carrying an instrument 16 and a protective guard 20. Body 10 includes a generally cylindrical handle portion 12 aft and a tip portion 14 forward. Tip 14 may have a flat distal end or, as is often the case, a frustoconical distal end. As would be understood by those skilled in the art, tip 14 also includes an appropriate mechanism (not shown) for mounting instrument 16.

[0031] Instrument 16 is illustrated as a cutting blade throughout the Figures, however, it should be reliezed that instrument 16 may include any medical instrument, such as, but not limited to, linear and non-linear blades, and linear and non-linear hooks, picks, scissors, picks, forceps, probes, lens manipulators, markers, collar buttons, choppers, cystotomes irrigation needles, cannulas, spatulas and dilators. Blade 16 may be a diamond or other gem, metal or synthetic blade that will, with proper handling, keep a very sharp edge over repeated uses. Blade 16 may include one or more bends or angles so as to be properly aligned with body 10 and so as to be disposed within guard 20 when guard 20 is in the closed position.

[0032] FIG. 1 also shows a reduced diameter portion 18 of knife body 10 disposed between and interconnected with handle portion 12 and tip 14. Guard 20 (shown in a locked open position) has an end wall portion 22 forming an opening disposed around reduced diameter portion 18. In this embodiment, end wall portion 22 includes a locking mechanism shown as interior female threads 24 which engage corresponding locking mechanisms shown as male threads 26 and male threads 28 formed on the exterior of reduced diameter portion 18. Thus, guard 20 may be rotated to engage threads 24 with threads 26 in order to lock guard 20 in an open position so that the surgical knife may be used normally. In this locked open position, guard 20 generally covers reduced diameter portion 18 in order to form a natural extension of handle portion 12. As shown in FIG. 1, the outside diameter of guard 20 is substantially the same as the outside diameter of handle 12, such that when guard 10 is in the open position and locking mechanism 24 is engaged a substantially continuous surface with handle 12 is provided.

[0033] Guard 20 is preferably formed from a translucent material through which a person handling the surgical knife in the safe or locked open position may be able to view the attached blade 16 without the necessity of moving guard 20 to the unsafe or locked open position. This configuration reduces the potential for selecting an improper surgical device during surgery by permitting rapid visual identification of the particular size and type of instrument 16. This configuration also improves safety during routine handling of the surgical knife by visibly differentiating handle portion 12 from tip 14 carrying blade 16.

[0034] As would be understood by those skilled in the art, body 10 and guard 20 should in the preferred, reusable embodiment be formed from hard, durable, and heat resistant plastics, composites, fiber-impregnated resins, or metals. When it is desirable to employ a translucent guard 20 as above, it should be formed from suitable translucent plastics. These types of materials are resistant to the heat and fluids required to clean and sterilize surgical devices after each use.

[0035] FIG. 2 illustrates the surgical device of the present invention with guard 20 locked in the closed position to protect and cover blade 16. Guard 20 has been moved forward in the direction of tip 14 of body 10. From the locked-open position discussed above, the locked-closed position is achieved by counter-rotating guard 20 to disengage threads 24 and 26 so that a user may slide guard 20 forward and engage threads 24 with a second set of threads 28 formed on the exterior of reduced diameter portion 18 forward of first threads 24.

[0036] Guard 20 is a generally a cylindrical sleeve having an inside diameter that is slightly greater than the corresponding outside diameter of the generally cylindrical portion of forward tip 14. When reduced diameter portion 18 is employed, the inside diameter of the opening formed by the end wall portion 22 should be slightly greater than the outside diameter of reduced diameter portion 18.

[0037] FIGS. 1 and 2 depict the outside diameter of the generally cylindrical portion of forward tip 14 as having generally the same outside diameter as that of handle portion 12 of knife body 10. However, it should be readily apparent that the outside diameter of forward tip 14 need not be the same as the outside diameter of handle portion 12. However, in order to function properly so as to lock guard 20 in a closed position, the outside diameter of tip 14 should be less than the inside diameter of guard 20. Preferably, when reduced diameter portion 18 is employed, handle portion 12 of body 10 should include at least a portion of larger diameter than the outside diameter of reduced diameter portion 18. This preferred arrangement facilitates securely locking guard 20 in an open position by forming a screw stop to mechanically prevent end wall portion 22 of guard 20 from extending onto handle portion 12 and past threads 24. Similarly, the outside diameter of the generally cylindrical portion of forward tip 14 must be larger than the outside diameter of reduced diameter portion 18 to serve as a forward physical stop when guard 20 is in the locked closed or instrument protective position. Moreover, handle portion 12 need not have the same diameter along its entire length; for some embodiments, handle portion 12 might have a tapered configuration (not shown), with the narrow portion of the taper at the end of body 10 opposite blade 16.

[0038] In general, the distance between threads 26 and 28 on reduced diameter portion 18 should be sufficient to allow for the length of guard 26 to cover threads 28 when guard 20 is in the locked open position and allow guard 20 to extend somewhat beyond blade 16 when guard 20 is placed in the locked closed position. Similarly, the length of guard 20 is selected so that it will extend beyond blade 16 when in the locked closed position, and is thus dependent upon the length of tip 14 and any mounting for blade 16, as well as the length of blade 16 when mounted. Once the approximate position of threads 28 (or other locking mechanism) are selected, then the length of guard 20 may be determined; then the position of threads 24 (or other locking mechanism) determined; and finally the length of reduced diameter portion 18 may be determined.

[0039] Reusable surgical devices must be cleaned and sterilized between uses. As is understood by those skilled in the art, this process typically involves exposing the surgical device to cleaning agents and high temperature sterilization (such as steam autoclaves, etc.). The present invention includes a guard with one or more slots, openings, or gaps therethrough sufficient to expose portions of underlying body 10 to the cleaning mechanisms and sterilizing steam. FIGS. 3 and 3A illustrate guard 20 with a slot 30 formed through a wall of the generally cylindrical, sleeve-shaped guard 20. As would be understood by those skilled in the art with reference to this specification, slot 30 facilitates the entry of cleaning agents and sterilizing steam into the small, otherwise covered spaces under guard 20, without the need to remove and potentially lose guard 20. As is illustrated in FIGS. 4 through 7A, alternative openings may be formed in guard 20 to serve this same purpose.

[0040] For example, FIG. 4 shows multiple slots 30 (designated with the single reference numeral 30) formed at different points around the circumference of guard 20 in order to facilitate the flow of cleaning agents and sterilizing steam from several different angles around the circumference of guard 20. Similarly, FIG. 5 shows a single slot 30 as shown in FIG. 3, but extending through threads 24 of guard 20. The configuration shown in FIG. 5 facilitates direct exposure of threads 24 and threads 26 to cleaning and sterilizing agents. A multitude of alternative openings may be provided in different shapes, sizes, and positions in order to facilitate cleaning and sterilizing. Examples are shown in FIG. 6, which illustrates a plurality of holes 32 (shown with common reference) in guard 20, and FIG. 7, which illustrates a spiral opening 34, both of which facilitate cleaning and sterilizing the underside of guard 20, portion 18, and threads 24 and 28 (or other locking mechanisms).

[0041] In an alternative to the embodiment as shown in FIG. 5 where a slot 30 extends through threads 24 of guard 20, slot 30 may be extended beyond threads 24. Such a configuration permits threads 24 on guard 20 to expand if guard 20 is overtightened on body 10. Expansion of threads 24 on guard 20 permits those threads 24 to “skip” on threads 26 and 28 on body 10. As a result, guard 20 is protected against overtightening, because excess torque causes threads 24 on guard 20 to loosen relative to corresponding threads 26 or 28 on body 10. In this way, instrument 16 remains easily accessible. Additionally, slots 30 permit the expanding of the opening in end wall 22 to facilitate placing guard 20 on body 10, by expanding over or “skipping” over corresponding threads 28.

[0042] Because surgical devices, including surgical knives, are typically handled with surgical gloves, guard 20 is preferably provided with a grip. The otherwise smooth outer surface of guard 20 may include a multitude of grips within the scope of the present invention. For example, as is shown in FIG. 3 and corresponding FIG. 3A (end view of guard 20), a plurality of ridges 40 may be spaced around the outside circumference of guard 20. In FIG. 7 and corresponding FIG. 7A (end view of guard 20) there is shown a plurality of bumps or nubs 42 dispersed around the outside circumference of guard 20. Any of the foregoing gripping mechanisms preferably form an exterior surface of guard 20 which is not substantially smooth and cylindrical, and thus forming a surgical device that is easier to manipulate and not prone to inadvertently rolling off a sterile surgical field.

[0043] As would be understood by those skilled in the art, many different ways exist for assembling guard 20 on body 10. For example, portion 18 may screw into (or otherwise be fixedly attached to) handle portion 12 at or near threads 26, thus allowing guard 20 to be positioned on portion 18 prior to attachment to handle portion 12. Alternatively, guard 20 may be placed on portion 18 prior to attachment of tip 14. In any event, to prevent loss of guard 20, the particular mechanism chosen for securing guard 20 onto body 10 should preferably prevent inadvertent removal of guard 20 from body 10 during normal handling. Accordingly, during normal operation, guard 20 stays on body 10 and forms an integral extension of handle portion 12 during use of instrument 16.

[0044] Although the foregoing figures and corresponding discussion illustrate threads as a preferred locking mechanism, other locking mechanisms may be employed, such as those disclosed in U.S. Pat. No. 5,254,128 which is incorporated herein by reference. For example, as would be understood by those skilled in the art, the locking mechanism may include two or more grooves formed on the interior of guard 20 that lock guard 20 open or closed by interaction with matching spring-loaded balls. In a similar manner, other types of spring-loaded (coiled spring or leaf spring) detents may be employed to “click” into grooves or notches in order to lock guard 20 into one of its two positions. Other examples not shown would include a bowed leaf spring attached at both ends of a reduced diameter portion, with a rounded projection on their upper-most portion to serve as a spring-loaded detent. In addition, a snap ring arrangement could be used as a detent to “click” into grooves to lock guard 20 into position.

[0045] From the foregoing detailed description of specific embodiments of the invention, it should be apparent that a surgical device with a moveable instrument protector that is novel has been disclosed. Although specific embodiments of the invention have been disclosed herein in some detail, this has been done solely for the purposes of describing various features and aspects of the invention, and is not intended to be limiting with respect to the scope of the invention. It is contemplated that various substitutions, alterations, and/or modifications, including but not limited to those implementation variations which may have been suggested herein, may be made to the disclosed embodiments without departing from the spirit and scope of the invention as defined by the appended claims which follow.