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[0001] This application is a continuation in part of Ser. No. 10/412,938 filed Apr. 15, 2003.
[0002] The present invention relates to organizers and counters for surgical instruments retractable or expandable at an operative end by opposing action of the thumb and/or fingers in loops therefor at another end, cleaning and sterilization supports for such surgical instruments and thumb/finger loop hold down mechanisms for maintaining a single such loop of such surgical instruments secured to an organizer or counter therefor.
[0003] In U.S. Pat. No. 4,342,391, a device is described for storing sterile instruments and memorizing the count thereof. A main frame includes a plurality of juxtaposed boots, individually and selectively rotatable from open to closed positions. Each open boot stores the handle of an instrument and a rotatable cover plate is locked into position overlaying open and closed boots to apply holding contact pressure against instrument handles inserted in open boots. The number of open boots indicates the number of instruments selected to be stored by the device.
[0004] The present invention for a surgical instrument counter relates to the handling of tools and particularly surgical instruments, which must be sterilized, counted and carried securely without contact with each other, into an operating room. More specifically, the invention relates to a carrying, cleaning, security and sterilization device for surgical instruments, which retains the instruments in selected positions and indicates the total number of surgical instruments carried into an operating room, even though some or all of such instruments are removed from the device during a surgical procedure. Instruments selected for use in a surgical procedure are usually placed in a sterilization tray in which they are immovably positioned in a manner such that the opposing grasping or position extensions of such instruments do not come into contact with each other, thereby to reduce the surface area of small crevices produced by a certain range of operation of the device which makes full sterilization more difficult. Locked instruments may not be sterilized due to lack of steam penetration during the sterilization cycle.
[0005] The tray and instruments are next sterilized together and then presented to operating room personnel for their intended use. It is extremely important that an accurate count be made of the number of instruments so sterilized and presented, and that a count of the number of dirty instruments removed after the surgical procedure is completed be equal to the first count. Otherwise, there is a great risk that one or more instruments unknowingly may have been left inside of a patient after the surgical procedure has been completed, and the surgical incision closed. Although a member of the operating room personnel is usually designated to keep track of the counts, the mental alertness and memory of such person must be relied upon not to make a mistake in counts.
[0006] In U.S. Pat. No. 4,229,420, a surgical instrument rack is described for holding, carrying, organizing, and counting a plurality of ring handled surgical instruments. The rack is formed of autoclavable polymeric material and includes two movable or separable members which coact with each other and with the surgical instruments to secure such instruments against release in parallel side-by-side relation with the handles and jaws (or blades) of such instruments separated slightly to facilitate sterilization of their surfaces. The structural relationship of parts responsible for the retention and automatic camming of the instruments into such slightly open positions is disclosed. Surgical procedures are regularly performed using “sets” of preselected surgical instruments, each set being a collection of instruments established from experience to be useful for a given surgical procedure. For example, the surgical instruments expected to be used in an obstetrical procedure are grouped together to form a set and, as a set, are sterilized, stored on a tray or pan, and finally transported upon that tray to the operating arena when their use is required.
[0007] Ring-handled instruments (clamps, forceps, scissors, needle holders, etc.) have often been grouped together in such sets by the use of clips which are extended through the corresponding handle loops of the instruments which comprise the sets, usually with the handles of such instruments spread apart to facilitate cleaning and sterilization. Instead of clips, some hospitals use instrument racks having upstanding pegs for holding a stack of ring-handled instruments with the pegs of the rack projecting upwardly through the handle loops. In still other instances, sets of ring-handled surgical instruments have been grouped together by fashioning a makeshift clip from a pair of instruments in such a way that each set is locked together. Clips, holders, and racks typifying the structures used in the past for supporting ring-handled surgical instruments are disclosed in catalogs for such instruments.
[0008] It is well known that such surgical instrument sets often must include, in a side by side relationship, two general classes of instruments, for purposes of handling, cleaning and organizing, representing extremes in instrument lengths. A general longest length group includes those instruments with long sets of opposing jaws, towel clamps, and the like, the group generally comprising instruments with a length from tip to ring handle of about 9-18 inches. The general shortest length group includes small hemostats, dissection scissors and the like, the group generally comprising instruments with a length from tip to ring handle of about 4-5 inches. The requirement to include these instruments in a side by side relationship whereafter they must be quickly and with high efficiency cleaned, sterilized, used in a surgical procedure and returned for another such sequence poses clear difficulties for the cleaning, counting and handling staff.
[0009] In U.S. Pat. No. 3,925,014, a rack is described for storing and supporting, at the time of use, sterile hinged instruments. The rack is comprised of an openwork frame and includes a pair of removable retaining bars which respectively hold the instruments in the open position during sterilization and retain the instruments on the rack until use thereof is desired regardless of the position of the rack.
[0010] As described above, In the routine handling of surgical instruments care must be taken to insure that all instruments have been thoroughly cleaned prior to sterilization. Thus, the instruments will first be subjected to a cleaning which may include immersion in an ultra-sonic bath to remove all foreign matter. Thereafter, the instruments will be assembled into a basic set, and the set will be arranged in a perforated or wire-meshed bottom tray for sterilization. During cleaning and sterilization all jointed instruments must be open or unlocked to permit contact of the steam with all surfaces.
[0011] In the operating room the instruments will typically be removed from the tray in which they have been sterilized and will be arranged between a sterile back table and Mayo stand, the Mayo stand typically located over the patient, in a manner which permits their being handed to the surgeon as needed without delay. The arrangement of a plurality of instruments, for example jointed clamps, in loose fashion on the stand presents the possibility of accidental droppage thus often necessitating emergency sterilization. The numerous manipulative steps required between each use also presents the possibility that an instrument may be inadvertently misplaced and thus will not be in a basic set when needed.
[0012] For the reasons briefly discussed above, there is a need and desire for a technique and apparatus which will minimize the handling of instruments during the cleansing process by eliminating the preparation for each basic step in the cleaning technique. For jointed instruments this requires that some means be provided for facilitating the opening and retaining of the instruments in the open condition during cleaning and sterilization. A concomitant desire is the elimination of the possibility of loss of any instrument from a basic set during processing. This desire may be expressed in terms of the objective of keeping the instruments of a basic set together at all times except when the instruments are in the surgeon's hands.
[0013] In U.S. Pat. No. 5,145,655, a support rack for ring handled instruments is described with an expandable two-section base. The device suffer from an unavoidable lack of lateral supports for instruments other than two supports, one at the end of each base section.
[0014] Thus, for groups of instruments over a count of about five, removal of a few instruments results in the instruments falling substantially as flat on the surface of the device as if there had been no device at all.
[0015] The present invention comprises an instrument counter with a plurality of counting zones each comprising a lower ring handle well for a single instrument, lower shaft support surface and opposing separation fins extending upward from the lower shaft support surface, thereby providing counting separation and support such that the tips of all the ring handled instruments, from longest to shortest, rest on the same flat surface as the instrument counter and each instrument is held in a substantially horizontally vertical position.
[0016] The present invention also comprises an instrument organizer comprising an end well extending to a lower shaft support surface for a lower ring handle loop for single instrument which thereby becomes the end support for an instrument rack. The instrument organizer further comprises a multi-instrument lower ring handle well immediately adjacent to the single instrument well, the multi-instrument well also extending to a multi-instrument lower shaft support surface, such support surface further comprising a support fin parallel to supported instruments located on the multi-instrument lower shaft support surface from 2-5 instrument thicknesses from the single instrument support surface.
[0017] The present invention also comprises a top ring handle support having a certain range of support. The range is defined by a particular configuration of a ring handle instrument for cleaning, carrying and sterilization. Any ring handle instrument rack may benefit from providing support within this range, such that the instrument rack provides that the tip of a horizontally vertical (i.e., on its long edges) instrument rests on a surface with the lowest surface of its lower ring handle being about less than one inch above that surface. The present invention includes a range of support for side by side ring handled instruments such that the instruments from the longest and shortest group may be held open sufficiently for current practice in cleaning, carrying and sterilization using the same elevation. There exists a range bounded by the arc travel of the inside open loops of the ring handles of the side by side instruments which will accommodate a single straight support wire or bar such that the shortest group instruments are not opened beyond the widest point at which they still contact the tip support surface while the longest group instruments are not so allowed to close enough to permit the opposing jaws of the instrument to close or to latch closed.
[0018] The present invention also comprises a ring handle instrument restraint wire or bar with a short travel arc for securing the lower ring handle of those instruments to an instrument rack. Preferably, a pivot attachment is made to each side of an instrument rack of a relatively short arm connected to the restraint wire. The novel short travel arc is just sufficient to restrain longest group instruments' lower ring handle loops (at or less than about 29 mm×35 mm) in a side by side relationship with the lower ring handle loops of the shortest group instruments. It has been found that providing an instrument rack with this restraint wire permits single hand carrying of a full rack of large and small group instruments with no loss or dropping of instruments. The restraint is mostly self actuating, i.e., as the rack to which the instruments are secured by this restraint wire is lifted, the heavier shaft end levers downward and the fulcrum of the lower shaft support surface of the instrument rack causes the furthest end of the lower ring handle to lever upwards. The location of the wire restraint across the inner edge of the lower ring handle is sufficiently close to the fulcrum surface so that the levering action forces the wire restraint into a more secure position for the ring handles than when the assembled items were on a horizontal surface.
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[0055] FIGS.
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[0073] The instrument counter of the present invention is shown in
[0074] Top ring handle support bar holes
[0075] Slot
[0076] Two attachment hooks
[0077] The rectangular dimensions of surface
[0078] As shown in
[0079] As in
[0080] The combination of these specific measurements of the aspects of each counting section
[0081] The bottom of counter
[0082]
[0083] With respect to the support bar
[0084] It has not been previously known to use a single, removable L-shaped support bar for raising top ring handles for instruments according to the present invention. Support bar
[0085] With respect to the embodiment of the present invention relating to a restraint wire, such a wire is shown in
[0086] Height
[0087]
[0088] An instrument organizer
[0089] The counting function of the above instrument counter is not intended, as single instrument slots are not provided for more than two of the instruments. The object of this instrument organizer is to minimize structure (as well as cost) while providing sufficient structure so that when any number of instruments are removed in a surgical procedure, any remaining instrument will present to the instrument remover an easily grasped top ring handle and/or pair of shafts. The easy grasping is achieved by maintaining a plane through the shaft axes at always above 45 degrees from the horizontal of the surgical tray on which the organizer rests. Since all handling of surgical instruments is done with gloved hands, maintaining this orientation is critical to effectiveness of any instrument holding device in surgery. The prior art shows many devices with much unnecessary structure or insufficient structure, as in U.S. Pat. No. 5,145,655, whereby when adjacent instruments are removed, the remaining instruments just fall on their side. Especially notable in U.S. Pat. No. 5,145,655 is the requirement for structure for an end wall above the surface supporting the lowest edge of the lower shaft of the instruments.
[0090] The present instrument organizer, on the other hand, has no end wall above top surface
[0091] A second multi-instrument well
[0092] As shown in
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[0095] Restraint wire
[0096] Height
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[0099] Restraint wire and support bar
[0100] Height
[0101] The location and function of slots
[0102] FIGS.
[0103] In making the first section slide into and beneath the second section, a top row of shank ribs on the upper surfaces of the first section are adapted to easily retain and organize shorter, smaller surgical instruments. In contrast, a top row of shank ribs on the upper surfaces of the second section are elevated substantially higher than that top row on the first section to allow the nesting action of the first section into the second section. The higher elevation of the top row of the second section means that it is better suited to retaining and organizing longer, larger surgical instruments. It is intended that when the phrase “surgical instruments” is used, it shall mean scissor action instruments with two shanks that rotate about a pivot with finger rings at two proximate ends of the shanks. The finger rings are adapted to allow a user to insert a thumb and forefinger into them to operate the scissor action instrument, such as hemostats or scissors. The scissor action of the surgical instruments causes them to operate in an operation plane defined by the scissor action.
[0104] When such instruments rotate about their pivot, they become easily entangled in other similar instruments. Most surgical procedures require such a large number of surgical instruments that they must be very carefully counted to reduce the risk of leaving an instrument in a patient. Thus, an effective surgical instrument organizer has multiple roles—retaining the surgical instruments in the most easily accessible and countable way while minimizing space on the operating room. Keeping the surgical instruments side by side and vertically edgewise is an excellent way to pick them up and count them. However, surgical instruments are made in a wide array of shaft lengths in order to perform tasks that are close to or far from the hand of the surgeon. In addition, stacking surgical instruments vertically edgewise against one another means that when one instrument is withdrawn, the remaining instruments collapse in a somewhat disorderly head while an attendant pushes them back together again.
[0105] The present multi-level embodiment solves the problem of finding a surgical instrument organizer that can stand surgical instruments independently and vertically edgewise in separated slots with minimal ribbing—and forming separate sections for large and small instruments. The nested first section is so substantially smaller in elevation than a second section that the ribbed surfaces of the first section are especially adapted to retain and organize smaller instruments.
[0106] In addition, the multi-level embodiment includes the use of small bumps or slot end ribs at an open end of a finger ring slot to keep the surgical instrument from sliding rearward. Some of the previous and above embodiments use boxed end slots to keep the lower finger rings fixed in the organizer. The multi-level embodiment can eliminate the boxed end with the use of the small bumps or slot end ribs to keep the lower finger ring from sliding rearward, reducing size, cost and manufacturing complexity of the entire organizer.
[0107] In the most preferred form, the multi-level embodiment is formed entirely of two continuously molded pieces of plastic. The hollowed out shapes of the first and second sections are especially adapted to be formed in a molding operation from polymer resin, keeping the cost very low.
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[0109] The combination of an aligned set of U-shaped slots in the upper rows and the lower rows of ribbed surfaces results in a operational slot for a segregating a surgical instrument in a vertically edgewise position. In section
[0110] Section
[0111] Continuing the insertion operation, when section
[0112] It is preferred that surface
[0113] A particular fault of the prior art organizers has been that ribs that could conceivably have been used to separate surgical instruments at their shanks have in operation failed for their intended purpose for being too short. While surgical instruments will remain separated with relatively short ribs if perfectly vertical, the fact of working with surgical instruments is that they fall from side to side against each other when one or more instruments are removed from a side by side group. Side by side and substantially vertically edgewise in the context of surgical instruments means that a lower finger ring rests on a support surface while an upper finger ring is held vertically above it while a tip of the surgical instrument or a part of a shank are also supported on a support surface. The surgical instrument is prevented from falling on its side by other adjacent surgical instruments or a rib. In the other invention embodiments, a deep well or boxed end slot was described as necessary for vertically supporting the surgical instrument. In the present multi-level embodiment, it has been found that a combination of relatively short ribs for the upper and lower rows results in a stable operational slot for a single surgical instrument, if the user is given a choice of section
[0114] It is a surprising benefit of the present embodiment that such stable and separated support for surgical instruments can be put into a single device where section
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[0118] In operation, section
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[0121] It is well illustrated that the upper rows of sections
[0122] The objects of the invention will be achieved with other shaped slots than U-shaped slots, i.e., with V-shaped slots, etc. Such other shapes are intended when reference is made to U-shaped slots in this application.
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[0125] Each device
[0126] Each of the supporting means
[0127] A lower cavity contains the lower supports. The lower cavity is defined by an inside surface of one of the base length walls
[0128] Lower loop slots
[0129] An upper floor
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[0132] The above design options will sometimes present the skilled designer with considerable and wide ranges from which to choose appropriate apparatus and method modifications for the above examples. However, the objects of the present invention will still be obtained by that skilled designer applying such design options in an appropriate manner.