The present application claims the filing benefit of U.S. Provisional Application Ser. No. 60/688,036, filed Jun. 7, 2005, the disclosure of which is hereby incorporated herein by reference in its entirety.
FIELD OF THE INVENTION The present invention relates generally to medical equipment, and more particularly, to a surgical tray for operations on a patient's limb or extremity.
BACKGROUND OF THE INVENTION Many emergency room and other surgical operations require a doctor to operate on a patient's limb or extremity. Hands are some of the most commonly operated upon extremities because they are required to complete many tasks and activities and are thus highly at risk to injury. For example, approximately 10 percent or more of typical emergency room operations involve some form of acute hand surgery. Operating on a hand requires a great deal of care because tendons, nerves, and blood vessels must all be meticulously rejoined to assure proper alignment of any lacerated tissues. Additionally, microsurgical techniques are generally required because the tissues that make the functions of the hand possible are small by nature. Control of the position of a patient's hand and fingers during surgery is therefore an important aspect of a successful operation.
Current techniques for performing hand surgery in the emergency room and elsewhere are inefficient and frustrating. For example, when a patient is rushed into the emergency room with deep laceration or similar hand injury, a surgeon must arrange the patient in the proper position for surgery and gather the necessary materials. Typically this requires positioning the hand on an arm table adjacent to a hospital bed and arranging it in a manner that provides the surgeon with easy access to the intended surgical site. Maintaining the hand in a desired position can be a difficult task when qualified assistants are not readily available, which is often the case during late-night, weekend, or very busy emergency room situations.
Additionally, gathering the necessary supplies from various areas in the emergency room prior to operation can be a burdensome task. Due to a lack of centralized storage, the surgeon may find himself or herself walking back and forth between the patient and various areas of the room to gather surgical tools, sutures, needles, gauze, and other items required to complete the surgery. The surgeon may experience additional frustration if supply amounts have not been maintained or if items have changed locations.
As a result of the manner by which items are gathered for surgery, the surgical operation itself becomes more difficult. For example, the various items are typically contained in individual packages and are not designed to be collectively organized in any particular manner. After all of the packages are opened and the items are placed together on a separate instrument table or the like, the surgeon may have to sort through any resulting clutter on the table to find the instrument he or she is looking for. The clutter typically increases throughout the operation as surgeon uses different tools and instruments and places them back on the table. Any increased operating time resulting from the lack of instrument management increases the overall cost of the surgery and can compromise the quality of the operation. Additionally, the lack of instrument management increases the potential of accidental injury from exposed scalpel blades and the like.
Use of the tools themselves can also be a challenging task. In particular, areas of tissue on the hand typically obstruct access to the surgical site being operated upon. As a result, surgical stays and retractors are used to pull the tissue back. Because assistants are not always available to hold the stays during an operation, many surgeons place some sort of retractor frame around the surgical site. The frames typically include notches that are spaced about a peripheral edge and adapted to secure a portion of the surgical stays, as shown in U.S. Pat. No. 4,274,398. Although such frames may slightly facilitate the surgical operation, they are better suited for (and were originally developed for) areas of the body other than limbs and merely represent an improvised solution for hand surgeries. The ability to use a stay to retract tissue in a desired three-dimensional direction is limited by the spacing of the notches and their position relative to the tissue.
During the course of the operation, the surgeon must take measures to maintain a sterile surgical site. This typically involves disinfecting and irrigating the surgical site and draining any resulting fluids. Oftentimes the drainage is done in an ad-hoc manner by merely placing a plastic bin or basin under the patient's hand. Such a technique, however, may not sufficiently capture the fluids due to splashing while the fluids are being applied. Moreover, the bin or basin may not be large enough to cover the entire area where drainage is likely to occur and can create a mess when attempting to dispose of its contents. As a result, the surgeon has a more difficult time maintaining a sterile surgical site and reducing his or her own exposure to potentially contaminated and biohazardous fluids.
Although several attempts have been made to facilitate surgical operations on a patient's extremities, these attempts merely focus on one or few of the challenges associated with the operations and do not adequately ease the burden on surgeons. For example, many surgeons use a sheet of metal (typically aluminum or lead) cut into the shape of a hand to help stabilize and position a patient's extremities. After using straps or the like to attach the patient's hand to the metal sheet, the sheet can be bent into desired positions by applying sufficient force. Variations of this type of hand device are shown in U.S. Pat. Nos. 4,798,195, 5,560,375, and 5,855,209. Despite the improvements in stability, however, such devices do not adequately address the challenges associated with tissue retraction, instrument management, and fluid management. Indeed, assistants are still typically required to keep an incision open or to hold nerves, blood vessels, and tendons or the like during surgery.
The same can be said with respect to various surgical tables or trays that have been developed facilitate surgery on a patient's extremities. In particular, although most of the tables provide some means for securing a hand or the like during surgery, the tables still limit the manner by which surgical stays may be used to retract tissue. As shown in U.S. Pat. Nos. 3,779,211, 4,082,257, 4,807,864, and 6,077,221, the tables typically include notches around a peripheral edge to secure a portion of the surgical stays. This row of notches, or “Scott fencing,” suffers from the same drawbacks as the notched framing discussed above—the desired direction of retraction is limited by the spacing of the notches and their position in 3 dimensions relative to the tissue. If blood vessels need to be held in a particular manner or if tissue needs to be retracted in a direction away from the plane formed by the fencing and surgical table, one or more assistants will be needed to manually complete these tasks.
As can be appreciated, there is a need for a surgical tray that helps reduce the frustration surgeons currently experience when attempting to operate on a patient's limb or extremity. A surgical tray is needed to address the issues of hand positioning, tissue retraction, instrument and sharps management, and irrigation/waste fluids management without significantly compromising the comfort and wellbeing of the patient.
SUMMARY OF THE INVENTION The present invention overcomes the foregoing and other shortcomings and drawbacks of surgical trays heretofore known. While the invention will be described in connection with certain embodiments, it will be understood that the invention is not limited to these embodiments. On the contrary, the invention includes all alternatives, modifications and equivalents as may be included within the spirit and scope of the present invention.
The present invention provides a surgical tray that facilitates surgical operations on a patient's limb or extremity. In particular, the surgical tray is configured to retain a patient's limb and retract tissue or the like to reduce the surgeon's reliance upon medical assistants to complete a surgical operation. The surgical tray is also configured to provide an organized, sterile field for an operation by incorporating integral irrigation/waste fluids management, instrument management, and sharps management.
To this end, a surgical tray according to the invention generally comprises a surgical site board adapted to support a portion of a patient's body, such as a hand. The site board also includes a plurality of apertures. A retention device or retraction device is removably securable in at least one of the apertures to retain or retract a portion of the patient's body. More specifically, a retention device is configured to overlap and retain a portion of the patient's body, such as the patient's fingers. The retention device may therefore be a rigid component shaped for this purpose or a component moldable to a desired shape. For example, the retention device may include an anchor configured to be inserted into one of the apertures and a body portion formed from a malleable sheet of material. Alternatively, the retention device may comprise a pliable wire configured to be at least partially inserted into one of the apertures and a cushioning layer surrounding at least a portion of the wire.
The retraction device, on the other hand, is configured to retract tissue or the like to provide the surgeon with increased access to the intended surgical site on the patient's extremity. In general, the retraction device comprises a post member configured to be retained in one of the apertures and a surgical stay configured to be secured to the post member. Similar to the retention device, the post member may be a rigid component or a component moldable to a desired shape. For example, in one embodiment, the post member includes a body having edges and a plurality of notches spaced along the edges. The notches are configured to retain a portion of the surgical stay during a surgical operation. Thus, the surgical stay may be secured to the appropriate notch depending upon the desired angle of retraction in each of the x, y, and z planes.
In another aspect of the invention, the surgical tray further includes a housing configured to support the surgical site board. The housing defines a basin positioned below the site board for collecting any fluids that may drain through the plurality of apertures during a surgical operation. For example, irrigation fluid applied to the surgical site, or bodily fluids, may drain through the apertures into the basin. Gutters and run-off guides may be provided around the site board to direct drainage fluids into the basin as well. The basin may be drained manually after an operation, using an integrated pour spout or aperture, or continuously during the operation by attaching a vacuum hose or drain to a port communicating with the basin. Thus, in addition to helping prevent the spillage of blood, disinfectants, and washes, the integrated fluid management system of the surgical tray may retain waste liquids and other fluids for convenient disposal.
The housing may also include one or more storage compartments positioned proximate to the site board. The storage compartments may contain all of the medications and instruments commonly needed for surgery on a patient's extremity, including sutures, disinfectants, dressing materials, anesthetics, and the retention and retraction devices discussed above. Thus, the surgical tray reduces the need for a surgeon to walk back and forth between various areas in an operating room to gather the necessary materials for a surgical procedure. If desired, the storage compartments may be sterilized and sealed when the surgical tray is produced so that the surgeon need only open the compartments to make sterile surgical instruments readily available for use.
During an operation, the surgical instruments and suture needles may be inserted into one or more foam pads received by the housing. For example, one or more foam islands may be received by the housing adjacent to the site board. Scalpels, scissors, forceps, and other surgical instruments are supported by the foam when inserted therein so that they are readily available for use or reuse during an operation. Alternatively, the foam islands, other areas of the housing, or the site board itself may include a plurality of pre-formed holes or slots for receiving the surgical instruments.
By virtue of the foregoing, there is thus provided a surgical tray that reduces the time and frustration occasionally experienced by surgeons when preparing for and performing a surgical operation on a patient's limb or extremity. The retention and retraction devices cooperate with the apertures in the site board to secure the extremity and provide the surgeon with visual access to the intended surgical site without relying upon additional personnel. Integrated fluid management improves overall cleanliness during operations and facilitates disposal of contaminated waste liquids, while integrated sharps and instrument management helps increase overall efficiency and prevents misplacement of items. In addition, safety is promoted by providing containment of biohazardous liquids and protection from exposure to needles, scalpels, and other sharps.
These and other objects and advantages of the present invention will be made apparent from the accompanying drawings and the description thereof.
BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description given below, serve to explain the principles of the invention.
FIG. 1 is a perspective view of a surgical tray according to one embodiment of the invention;
FIG. 2 is an enlarged perspective view of a portion of the surgical tray inFIG. 1 showing a removable sharps pad and integrated needle covers;
FIG. 3 is a perspective view showing one embodiment of a retention device according to the invention;
FIG. 4 is a perspective view showing another embodiment of a retention device according to the invention;
FIG. 5 is a perspective view showing another embodiment of a retention device according to the invention;
FIG. 6 is a perspective view showing another embodiment of a retention device according to the invention;
FIG. 7 is a perspective view showing one embodiment of a retraction device according to the invention;
FIG. 8 is a perspective view showing another embodiment of a retraction device according to the invention;
FIG. 9 is a perspective view similar toFIG. 1 showing various aspects of fluid management;
FIG. 10 is a cross-sectional perspective view taken along line10-10 inFIG. 9; and
FIGS. 11 and 12 are perspective views illustrating a disposal bag included in the tray ofFIG. 1.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference toFIG. 1, asurgical tray10 according to one embodiment of the invention is shown. Thesurgical tray10 generally comprises asurgical site board12 adapted to support a portion of a patient's body and ahousing14 configured to support thesite board12. AlthoughFIG. 1 illustrates thesite board12 being used to support a patient'shand16, those skilled in the art will appreciate that thetray10 may also be used during surgical operations on other areas of the patient's body or on small animals. Additionally, although thesurgical tray10 may be particularly advantageous for emergency-room situations, thetray10 may also be utilized for small outpatient operative areas, treatment rooms, minor surgical procedure rooms, clinics, military field hospitals, and anywhere extremity surgery can be done. In such environments thetray10 may be secured to an operating table18 by one ormore straps22 connected to thehousing14. Thestraps22 may be secured by lockingdevices19, velcro, knots, a pin and belt holes, or any other suitable method.
Both thesite board12 andhousing14 may be constructed from plastic, although other materials are possible as well. For example, thesite board12 orhousing14 may alternatively be constructed from foam or a similar material. In one embodiment, thehousing14 is adapted to receive one or more foam pads orislands20 for the management of sharps and other surgical instruments. Thefoam islands20 may be a polyurethane, polyethylene, or similar foam having a density sufficient to support the instruments at the angles with which they are inserted therein. For example,FIG. 1 showsscissors24 and asurgical knife26 inserted into thefoam islands20 at various angles. Because the instruments are inserted at angles with theirrespective grip portions28,30 elevated off thesite board12 andhousing14, a surgeon can quickly and easily grab the instruments when they are needed during an operation. Thefoam islands20 may be coupled to thehousing14 or may be removable components inserted into corresponding pockets (not shown) formed in thehousing14. Thefoam islands20 may also have different configurations and be located in various areas on thehousing14. Thus, althoughFIG. 1 shows first andsecond foam islands20 on opposite sides of thesite board12, a foam island may alternatively extend substantially around the periphery of thesite board12 to form a “racetrack” (not shown) or may be positioned in a localized area of thetray10, such as in abase area32 of thehousing14.
To further facilitate instrument management during surgical operations, thehousing14 may also include a plurality of pre-formed slots orholes36 adapted to receivescissors38 and other surgical instruments. Theslots36 may be provided in a predetermined matrix array and at desired angles in thehousing14. Preferably theslots36 are formed in a compressible material such as foam and define openings sized to provide a close fit for the common instruments provided with thetray10 or commonly used during surgery. AlthoughFIG. 1 only shows thehousing14 andfoam islands20 incorporating thepre-formed slots36, similar slots or holes may also be provided in thesite board12.
In one embodiment, a special type of foam island and slot array is provided in thehousing14 to manage sharps (including suture needles, scalpel blades, and other sharp objects) during a surgical operation. More specifically and with reference toFIG. 2, thehousing14 may receive aremovable sharps pad40 and include one or more needle covers orprotective shields42 molded, pressed, or otherwise secured in specially designatedslots36. Thesharps pad40 is preferably formed from foam, but may alternatively be constructed from other materials pierceable by suture needles43, such as elastomeric sheets, penetrable films, felts, and the like. A suture count is printed on thesharps pad40 to identify the type and number of sutures used during the surgical procedure. Upon completing an operation, thesharps pad40 may be removed intact for disposal in a designated sharps container (not shown) provided by the hospital or clinic.FIG. 2 also illustrates how asyringe46 may be docked in one of the integrated needle covers42 to protect the associatedneedle44 during an operation.
Referring back toFIG. 1, thehousing14 may also include one ormore storage compartments48 for storing various surgical tools and accessories. For example, in a manner not shown herein, thecompartments48 may store surgical gloves, syringes, needles, gauze, irrigation splash guards, and other items often used in surgical operations. Thecompartments48 may also store specific modules or packages containing the various items needed to complete a particular step of the surgical operation, such as a pre-prep module (not shown) containing an alcohol-prewetted swab, a pre-filled anesthetic syringe, and other materials. To prevent contamination prior to use, thecompartments48 may be sealed by a removable cover (not shown), such as a removable sheet of sterile material, that may be peeled off of thehousing14 to expose the contents of the associatedcompartment48.
As shown inFIG. 1, thesurgical site board12 includes a plurality ofapertures34 for the selective placement and positioning ofvarious retention devices50,52,54 and/orretraction devices56,58,60. The retention and retraction devices are each removably securable in at least one theapertures34 and configured to retain a portion of the patient's body or retract tissue or the like during a surgical operation, as will be described in greater detail below. A wrist restraint62 and one or more positioning blocks64 (FIG. 9) may also be secured into theapertures34 to further immobilize and position the patient'shand16 during an operation. The positioning blocks64 may have different shapes, sizes, and contours to provide the surgeon with many options. Additionally, the positioning blocks64 may alternatively rest upon thesite board12 without being secured to theapertures34. In such an embodiment the positioning block may be designed with one or more textured surfaces adapted to create friction between theblock64 and thesite board12, thereby preventing thepositioning block64 from sliding relative to thesite board12.
Still referring toFIG. 1, one ormore flanges66 having spaced apart notches orfencing68 may be provided on thehousing14 orsite board12 to secure surgical stays70, which also retract tissue during an operation.Similar flanges74 and76 may be pivotally coupled to thehousing14 orsite board12 so as to be movable between a closed position in which the flange is generally planar with thesite board12 and an open position in which the flange is angled relative to thesite board12.FIG. 1 illustratesflange74 in the closed position andflange76 in the open position.
Now referring toFIGS. 3-8, the retention devices and retraction devices are shown in further detail. Theretention devices50,52,54 are configured to overlap and retain a portion of the patient's body, such as the patient's fingers80 (FIG. 1). Accordingly, the retention devices may be shaped for this purpose or may be moldable to a desired shape.FIGS. 3 and 4 illustrate exemplary embodiments of the latter, where theretention device50 comprises an L-shaped post86 (FIG. 3) or a J-shaped post88 (FIG. 4). Acollar90 may be integrally formed with or provided on theposts86,88 to ensure that theretraction devices50 do not extend past a certain depth in theapertures34.
Meanwhile,FIGS. 5 and 6 illustrate exemplary embodiments of moldable retention devices. The retention device52 (FIG. 5) comprises awire96 having aportion98 configured to be inserted into one of theapertures34 and a foam orother cushioning layer100 surrounding at least a portion of thewire96. The wire may be bent to a desired position upon the application of force, but has sufficient rigidity to hold the shape while retainingfingers80 or other body parts during a surgical operation. In one embodiment, the gauge of thewire96 is sized to provide a slight interference fit with theapertures34 in thesite board12. Also, if desired, acollar90 may be provided on thewire96 much like theretention device50. And finally, in another embodiment, thewire96 may be pre-formed in plastic or metal to fit around the finger.
The retention device54 (FIG. 6) includes abody portion106 formed from a malleable sheet of material and ananchor108 configured to be inserted into one of theapertures34. For example, thebody portion106 may be formed from a bendable sheet of metal such as aluminum or lead, or from a cold-forming plastic. To provide additional comfort for the patient, theretention device54 may also include a foam orother cushioning layer110 on one or both sides of the formable sheet. Alternatively, the device may be pre-formed of plastic or metal to fit over the finger.
FIGS. 7 and 8 illustrate theretraction devices56,58 in further detail. As shown inFIG. 7, theretraction device56 comprises apost member116 configured to be retained in one of theapertures34 and asurgical stay118 secured to the post member. Like theretention device50, acollar90 may be integrally formed with or provided on thepost member116 to ensure that theretraction device56 does not extend past a certain depth in theapertures34. Additionally, post members of various heights and shapes may be provided with thetray10 so that the surgeon can select theretraction device56 and secure it into theappropriate aperture34 according to the desired 3-dimensional angle and position of retraction.
Theretraction device58 ofFIG. 8 includes abody126 havingedges128 and plurality ofnotches130 spaced along the edges. Thenotches130 are configured to retain a portion of asurgical stay132, much like thenotches68 in theflanges66,74, and76. If desired, thebody126 may be formed from a malleable sheet of material so that theretention device58 is moldable to a desired shape. Accordingly, theretraction device58 may further include a foam orcushioning layer127 on one or both sides of thebody126 and therefore be constructed in substantially the same manner as theretention device54, with the addition of thenotches130 for securing thesurgical stay132.
Although specific embodiments of retention and retraction devices according to the invention are described above, those skilled in the art will appreciate that a wide variety of shapes and configurations are possible for such devices. For example, the retraction device60 (FIG. 1) may be constructed substantially the same as theretraction device58 but have a semi-circular configuration. The variety of retention and retraction devices and various locations to which they can be secured to thesite board12 helps enable the surgeon to retain thehand16 in a particular manner or retract tissue in a particular direction without relying upon medical assistants. Also note that the retention and retraction devices, along with the other components of thesurgical tray10, may be made radiolucent so that x-rays may be taken after the patient'shand16 is positioned or any time during or after the surgical operation. Such an embodiment provides a “hands-free” radiologic positioner that allows x-rays in various planes—anterior, posterior, lateral, or obliques—while providing safety to the operator.
FIGS. 9 and 10 illustrate various fluid management aspects incorporated into thetray10. In particular,FIG. 9 illustrates how one of the storage compartments48 may be used as an instrument cleaning station. Thus, during an operation, thecompartment48 may be filled withcleaning solution140 and include a foam pad or abrasive material142 on which to wipe surgical instruments.FIG. 9 also illustrates anirrigation squirt gun144 configured to drawirrigation fluid146 from areservoir148 within thehousing14. Thereservoir14 in such an embodiment is a closed storage compartment formed in thehousing14 and may be filled with irrigation fluid prior to use by opening a lid, door, or port (not shown) on the asurface150 of thehousing14 and subsequently pouring the fluid in. In other embodiments, thereservoir148 may be an open storage compartment and the squirt gun may be configured to manually draw fluid from thereservoir148. Such a squirt gun may require additional manipulation to dispense the fluid146 and thus operate much like a syringe. Traditional techniques for irrigating a surgical site may also be used with the invention.
No matter which manner of irrigating the surgical site is employed, however, theirrigation fluid146 and bodily fluids may drain through theapertures34 into a basin160 (FIG. 10) defined by thehousing14. Thebasin160 is positioned below thesite board12 and may include one or more ports (not shown) at abottom end162 communicating with aportion164 of a vacuum ordrainage hose165. Thehose165 is connected to a collection system167 so that collected fluids are drawn away from thetray10 for safe and convenient disposal. Alternatively, thehose165 may rely upon the force of gravity to direct fluids to a container or area below the operating table18. To further facilitate drainage into thebasin160 and towards thebottom end162, thesite board12 may be inclined relative to abottom surface166 defined by thehousing14. Additionally, a drape168 (FIG. 1) may be provided with the tray to wrap around the patient'sarm170 and direct fluids to adrainage slot172 or absorbent material (not shown) positioned at a lower end of thesite board12.
FIGS. 11 and 12 illustrate a further aspect to assist cleanup of thetray10 and waste fluids after an operation. As shown in the figure, thetray10 may include abiohazard waste bag180 attached to the bottom or side of thehousing14. Thus, when a surgical operation has been completed, thebag180 may be pulled out from thetray10 and turned inside out while being pulled back over the exterior of thetray10. A sealing surface orstrip184 may be provided on thebag180, along withappropriate biohazard markings186.
While the invention has been illustrated by the description of one or more embodiments thereof, and while the embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope or spirit of Applicants' general inventive concept.