System and method of tracking surgical sponges

BACKGROUND

[0001] 1. Technical Field

[0002] The invention relates generally to an apparatus and method for tracking surgical supplies and, more specifically, to counting and accounting for all disposable surgical sponges used in a surgical procedure.

[0003] 2. Related Art

[0004] During surgical procedures, absorbent sponges are employed to soak up blood and other fluids in and around the incision site. In a study entitled “The Retained Surgical Sponge” (Kaier, et al., <i>Annals of Surgery, vol. </i>224, No. 1, pp. 79-84), surgical sponges were found to have been left inside a patient following surgery in 67 of 9729 (0.7%) medical malpractice insurance claims reviewed. In those 67 cases, the mistake was attributed to an incorrect sponge count in seventy-six percent (76%) of the cases studied, and attributed to the fact that no count was performed in ten percent (10%) of the cases studied. Typically, a sponge left inside a patient is presumed to indicate that substandard and negligent care has taken place. Clearly, it is in both a patient's and the health care providers' best interest to account for every surgical sponge used in any particular surgical procedure.

[0005] As explained in U.S. Pat. No. 5,923,001 entitled Automatic Surgical Sponge Counter and Blood Loss Determination System, sponge counts are an essential step in operating room procedure. Sponge counts are a difficult procedure for a number of reasons. For example, the handling of soiled sponges carries the risk of transmission of blood borne diseases such as hepatitis B virus (HBV) and human immunodeficiency virus (HIV). Therefore, used sponges are handled with gloves and/or instruments and the handling is kept to a minimum. Another difficulty is that the counting process is typically tedious, time-consuming and frustrating.

[0006] Sponge counts are typically performed multiple times during a surgical procedure, both at the beginning and throughout the procedure as sponges are added, before closure of a deep incision or body cavity, and during personnel breaks and shift changes. Thus, within all the activity of an operating room, maintaining an accurate sponge is difficult, as evidenced by the error rate mentioned in the Keiter article, quoted above.

[0007] There do exist products to make the procedure both simpler and more reliable. For example, various systems facilitate the hand-counting of surgical sponges by arranging the sponges into visually inspectible groups or arrangements (see U.S. Pat. Nos. 3,948,390, No. 4,364,490, No. 4,784,267, No. 4,832,198, No. 4,925,048 and No. 5,658,077). These systems are problematic because surgeons and anesthesiologists often determine blood loss by means of visual inspection or a manual weighing of soiled sponges and so soiled sponges are typically kept in one area of an operating room during a surgical procedure, thus creating the possibility that groupings are co-mingled or counted twice. In addition, operating room workers are often too rushed, fatigued and/or distracted to accurately count a large number of soiled sponges lumped together in one or more groups. This method also depends upon the accuracy of an initial count and, if the number of sponges in the original package is mislabeled by the manufacturer, then a missing sponge may be missed during a final count.

[0008] A second solution to the surgical sponge tracking problem is the inclusion of a radiopaque thread in the sponges. A radiopaque thread can be identified and located if a sponge is accidentally left inside a patient. Thus, if a patient develops a problem such as an abscess, a bowel obstruction, or internal pain at any time following an operation, a sponge that has been left in the body can be detected by x-ray. Companies that market sponges with radiopaque threads include Johnson &amp; Johnson, Inc. of New Brunswick, N.J., Medline Industries of Mundelein, Ill. and the Kendall Company of Mansfield, Mass.

[0009] A third solution to the sponge problem is the inclusion of a radio frequency identification (RFID) tag in each sponge (see U.S. Pat. No. 5,923,001). The RFID tag enables a patient to be scanned to detect the presence of a sponge within a body cavity, but RFID tags may cost several times what a typical surgical sponge costs and are also bulky, impairing the usefulness of the sponge.

[0010] Another solution to the sponge problem is a device that counts sponges as they are dropped, one-by-one, into an opening, or “entry gate,” of the device (see U.S. Pat. No. 5,629,498). This solution is restricted by the accuracy of the original count and the precision of operating room assistants as they separate sponges from one another and drop them into the entry gate, one-by-one.

[0011] A final, exemplary solution involves attaching a magnetic resonance device, or marker tag, to each sponge, which are then scanned by appropriate equipment (see U.S. Pat. Nos. 5,057,095 and No. 5,664,582). The problem with this solution is that both the marker tags and the scanning equipment are expensive and do not necessarily work well in an operating room environment. As acknowledged in the '582 patent, the scanner must be essentially parallel to the marker tag inside a wadded up sponge. If the marker tag is bent or folded, a signal from the tag may be difficult to identify. In addition, the scanning equipment may give false counts if the operating room contains objects, other than the marker, that also generate or respond to magnetic energy.

[0012] Many other problems and disadvantages of the prior art will become apparent to one skilled in the art after comparing such prior art with the present invention as described herein.

SUMMARY OF THE INVENTION

[0013] The apparatus and method provided employ a “radiopaque” object to count and account for surgical sponges in an operating room. The term “radiopaque” refers to an object that is detectable by a scanning device using an x-ray or other penetrating wave or particle such as neutron beams or gamma rays, and infrared, near-infrared, laser, electromagnetic or radio waves. Within the context of the claimed subject matter, a “surgical sponge” is any device or material used in human or animal surgery for the purpose of absorbing blood or other fluids, or for packing off, containing, or isolating bodily structures within a surgical field.

[0014] A radiopaque object is embedded in each surgical sponge so that a scanning device can detect and count a large number of the sponges within a container designed to eliminate the need for contact by humans with the sponges. In this manner, a surgical team can insure that no surgical sponge is left in a patient without performing the messy and time-consuming job of individually counting sponges as they are entered and removed from the surgical site.

[0015] The claimed subject matter includes specially designed surgical sponges for use in the scanning device. Also included in the claimed subject matter is the use of radiopaque objects of differing sizes and/or types embedded in surgical sponges of differing sizes and/or types. For example, a large sponge may contain a large object and a small sponge may contain a small object so that the scanning device can distinguish and count multiple sizes and types of sponges. In one embodiment of the invention, the scanning device also weighs discarded surgical sponges so that a calculation can be made of the sponges' retained fluids, i.e. patient fluid loss.

[0016] Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures, which are not necessarily drawn to scale, and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE FIGURES

[0017] While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of this invention.

[0018]FIG. 1 is an exemplary surgical supply tracking system (SSTS) employing the techniques of the claimed subject matter.

[0019]FIG. 2 is an exemplary PC-based SSTS employing the techniques of the claimed subject matter.

[0020]FIG. 3 is an illustration of a surgical sponge in relation to a radiopaque object according to the claimed subject matter.

[0021]FIG. 4 is an illustration of an exemplary surgical sponge in which the radiopaque object is woven or glued into the surgical sponge.

[0022]FIG. 5 is an illustration of an exemplary surgical sponge in which the radiopaque object is affixed to the surgical sponge by means of a fixture patch.

[0023]FIG. 6 is an illustration of an exemplary surgical sponge in which the radiopaque object is affixed to the surgical sponge by means of a fixture thread.

[0024]FIG. 7 is an illustration of an exemplary surgical sponge in which the radiopaque object is affixed to the surgical sponge by means of both a fixture patch and a fixture thread.

[0025]FIG. 8 is a flowchart that illustrates the processing performed by the SSTS.

DETAILED DESCRIPTION OF THE FIGURES

[0026] Although described with particular reference to a system for tracking surgical supplies within an operating room, the surgical supply tracking system (SSTS) of the disclosed subject matter can be implemented in any system in which it is desirable to count and/or track objects with a minimum of handling and a very high degree of accuracy.

[0027] Selected portions of the SSTS can be implemented in software, hardware, or a combination of hardware and software. Hardware portions of the invention can be implemented using specialized hardware logic. Software portions can be stored in a memory and executed by a suitable computing system such as a microprocessor or a personal computer (PC). Furthermore, software of the SSTS, which comprises an ordered listing of executable instructions for implementing logical functions, can be embodied in any computer-readable medium for use by or in connection with the computing system.

[0028] Turning now to the figures, FIG. 1 illustrates an exemplary SSTS <b>100</b> for use in an operating room. A sponge container <b>101</b> includes a disposal opening <b>105</b> through which surgical sponges, such as a surgical sponge <b>111</b>, are placed after use. For the purposes of this disclosure, a “surgical sponge” is any device or material used in either human or animal surgery for the purpose of absorbing blood or fluids, or for packing off, containing, or isolating bodily structures within a surgical field. The sponge container <b>101</b> includes rollers <b>115</b> to facilitate its movement within and outside the operating room. By pressing a foot pedal <b>109</b>, a user of the SSTS <b>100</b> opens a door (not shown) in the disposal opening <b>105</b> so that the used surgical sponge <b>111</b> can be placed into the sponge container <b>101</b>. In addition, the pressing of the foot pedal <b>109</b> causes hardware and/or software logic (not shown) in the SSTS <b>100</b> to activate a radiation source <b>103</b>. The hardware and/or software logic, with input from a sensor (not shown), then calculates the number of sponges in the sponge container <b>101</b>. Once the hardware and/or software logic has calculated the number of sponges in the sponge container <b>101</b>, this number is displayed on a display <b>107</b>. It should be apparent to those with skill in the electronic arts that the hardware and/or software logic of the SSTS <b>100</b> can be implemented in a number of ways, including, but not limited to, specialized circuits incorporating both hardware and software components.

[0029] The sponge container <b>101</b> also includes a clear plastic covering (not shown) such as a plastic bag or a form-fitted covering that fits into the disposal opening <b>105</b>, thus containing the surgical sponges <b>111</b>, and drapes over the outside of the container <b>101</b> in order to keep fluids from the surgical sponges <b>111</b> from contaminating the surface of the container <b>101</b> and its components. In addition to the number of sponges in the container <b>101</b>, the display <b>107</b> may also display a calculation of the weight of the contained sponges so that operating room personnel can determine patient fluid loss. A set of user controls <b>113</b> are employed to turn the SSTS <b>100</b> on or off, initiate the display <b>107</b> and calibrate the sensors. In alternative embodiments of the SSTS <b>100</b>, the calculation of the sponges in the container <b>101</b> and the display of this number may also be initiated by the user controls <b>113</b> rather than, or in addition to, the depression of the foot pedal <b>109</b>.

[0030]FIG. 2 illustrates an exemplary PC-based SSTS <b>200</b> employing the techniques of the claimed subject matter. The SSTS <b>200</b> includes a sponge container <b>201</b> in which surgical sponges, such as the surgical sponge <b>111</b> (FIG. 1), can be disposed following the sponge's <b>111</b> use in a surgical procedure. The container <b>201</b> is positioned on a platform <b>221</b> that is connected via a connection <b>223</b> to a radiation source <b>203</b>, which is similar to the radiation source <b>103</b> (FIG. 1). The platform may also include a weight sensor (not shown) for measuring the weight of the container <b>201</b> and its contents. The platform <b>221</b> is also connected via a connection <b>207</b> to a computing system <b>209</b>. The connections <b>223</b> and <b>207</b> may be hard-wired, wireless or network connections. In this example, the computing system <b>209</b> includes a processor <b>213</b>, a display <b>215</b>, a keyboard <b>217</b> and a mouse <b>219</b>. The exact configuration of the computing system <b>209</b> is not critical to the spirit of the invention. For example, all or portions of the computing system <b>209</b> may be incorporated into the platform <b>221</b> in order to provide a compact and integrated system with fewer discrete pieces than the illustrated system <b>200</b>.

[0031] The radiation source <b>203</b> emits a scanning beam <b>205</b> that enables detectors (not shown) in the platform to detect a small radiopaque object <b>301</b> (see FIGS. <b>3</b>-<b>7</b>) in each sponge <b>111</b> in the container <b>201</b>. The term “radiopaque” means the object <b>301</b> is able to obscure or block some type of scanning beam <b>205</b> such as x-ray or other penetrating wave or particle such as neutron beams, gamma rays, infrared, near-infrared, laser, electromagnetic waves or radio waves. The specific type of scanning beam <b>205</b> is not critical to the spirit of the inventions other than that the detectors in the platform <b>201</b> must be able to detect the scanning beam <b>205</b> with sufficient resolution to count each radiopaque object <b>301</b> in each sponge <b>111</b> in the container <b>101</b>. As with the computing system <b>209</b>, the radiation source <b>203</b> and the platform may be integrated into a single device, in which case the SSTS <b>200</b> would look more like the SSTS <b>100</b> (FIG. 1).

[0032]FIG. 3 is an illustration of a surgical sponge <b>311</b> (FIG. 1) in relation to a radiopaque object <b>301</b>. The surgical sponge <b>311</b> is one embodiment of the surgical sponge <b>111</b> (FIGS. 1 and 2). The surgical sponge <b>311</b> is comprised of an absorbent material <b>307</b> contained within vertical threads <b>303</b> and horizontal threads <b>305</b>. Other examples of suitable surgical sponges include foam sponges or other sponges made of non-woven, non-knitted or non-fabric material. The surgical sponge <b>311</b>, except for the radiopaque object <b>301</b>, should be familiar to those with experience with surgery and the equipment employed in surgery. Although not necessarily drawn to scale, the radiopaque object <b>301</b> is small in relation to the surgical sponge <b>311</b>. Typically, the radiopaque object <b>301</b> is less than one (1) centimeter wide in any direction. Although, the radiopaque object <b>301</b>, illustrated in FIG. 3, is a metal sphere there can be different types of radiopaque objects; i.e., many different shapes and materials can be employed. For example, the radiopaque object <b>301</b> may be cylindrical, cubic, rectangular, triangular or some other polygon, either regularly or irregularly shaped. The radiopaque object <b>301</b> may also be some other shape such as a hexagonal nut, either with or without a hole in the middle. Different types of radiopaque objects can be used to indicate different types or sizes of surgical sponges. In addition, the radiopaque object may be something other than metal. For example, the object <b>301</b> may be barium sulfate encased in a non-water-soluble material such as plastic, latex, rubber, silicone or silastic, or even encased in a tightly woven fabric.

[0033] FIGS. <b>4</b>-<b>7</b> show alternative methods of affixing a radiopaque object, such as the radiopaque object <b>301</b>, to a surgical sponge, such as surgical sponges <b>111</b> and <b>311</b>. FIG. 4 is an illustration of an exemplary surgical sponge <b>411</b> with a radiopaque object <b>401</b> woven or glued into the surgical sponge <b>411</b>. In other words, the radiopaque object <b>401</b> is held between vertical threads <b>403</b> and horizontal threads <b>405</b> by means of a second layer of vertical threads <b>413</b> and a second layer of horizontal threads <b>415</b> and/or glued into the surgical sponge <b>411</b>. FIG. 5 is an illustration of an exemplary surgical sponge <b>511</b> with a radiopaque object <b>501</b> affixed by means of a fixture patch <b>507</b>. The fixture patch <b>507</b> is a piece of latex, tape or fabric mesh that firmly attaches by means of sewing, gluing or weaving to the radiopaque object <b>501</b> and either or both of threads <b>503</b> and <b>505</b> and absorbent material <b>509</b>. FIG. 6 is an illustration of an exemplary surgical sponge <b>611</b> with a radiopaque object <b>601</b> affixed by means of a fixture thread <b>607</b>. The fixture thread <b>607</b> can be either tied to, threaded through or clamped by the radiopaque object <b>601</b> and then woven into vertical and horizontal threads <b>603</b> and <b>605</b>. FIG. 7 is an illustration of an exemplary surgical sponge <b>711</b> with a radiopaque object <b>701</b> affixed by means of both a fixture patch <b>707</b>, similar to the fixture patch <b>507</b> (FIG. 5) and a fixture thread <b>709</b>, similar to the fixture thread <b>607</b> (FIG. 6).

[0034]FIG. 8 is a flowchart of a Count Sponge process <b>800</b> executed by either the SSTS <b>100</b> of FIG. 1 or the SSTS <b>200</b> of FIG. 2. The process <b>800</b> starts in a Begin Scan step <b>801</b> and proceeds immediately to an Activate Scan Beam step <b>803</b> in which the radiation source, such as the radiation source <b>103</b> (FIG. 1) or the radiation source <b>203</b> (FIG. 2) is activated. In the SSTS <b>100</b>, the radiation source <b>103</b> is activated either by the foot pedal <b>109</b> or the user controls <b>113</b>. In the SSTS <b>200</b>, the radiation source <b>200</b> is activated by the computing system <b>209</b>, either in response to user input on the keyboard <b>217</b> or mouse <b>209</b> or in response to a timer (not shown) that periodically updates a sponge count produced by the SSTS <b>200</b> and displayed on the display <b>215</b>. In another embodiment of the SSTS <b>200</b>, the radiation source <b>203</b> may be activated in response to the weight sensor in the platform <b>221</b> so that information displayed on the display <b>215</b> is updated in real time. Control then proceeds to a Count Radiopaque Objects step <b>805</b>.

[0035] In step <b>805</b>, a sensor detects the number of radiopaque objects such as object <b>301</b> (FIG. 3) in the surgical sponges such as surgical sponge <b>111</b> in the container <b>201</b> by detecting the scanning beam generated by either radiation source <b>103</b> or <b>203</b>. A signal from the sensor is transmitted to the logic (SSTS <b>100</b>) or the computing system <b>209</b> via the connection <b>207</b> (SSTS <b>200</b>), enabling the logic or computing system <b>209</b> to calculate the specific number of sponges in the container <b>101</b> or <b>201</b>, respectively. In one embodiment of the invention, surgical sponges of differing sizes or types each contain a radiopaque object of a size or shape that corresponds to the different size sponges. Using the different sizes or shapes, the logic or computing system <b>209</b> processes the signal from the sensor to determine not only a count but a specific count for each of the different sizes or types of sponges.

[0036] Following step <b>805</b>, process <b>800</b> proceeds to a Fluid Measurement Requested step <b>807</b> in which, using the SSTS <b>200</b> as an example, the SSTS <b>200</b> determines whether information on the collective weight of the sponges in the container <b>201</b> is requested. If a weight measurement is not requested, then control proceeds to a Display Results step <b>815</b>, in which the specific number of sponges calculated in step <b>805</b> is displayed on the display <b>215</b>. In an alternative embodiment, rather than using the display <b>215</b>, the number may simply be rendered in a display device such as a light emitting diode (LED) device on the platform <b>221</b> itself. Of course, if the SSTS <b>200</b> does not include a weight sensor in the platform <b>221</b>, control proceeds directly from step <b>805</b> to step <b>815</b>. If in step <b>807</b>, process <b>800</b> determines that a fluid measurement step is required or requested, then control proceeds to a Weigh Container step <b>709</b>, in which a weight sensor in the platform sends a signal representing the weight of the container <b>201</b> and its contents via the connection <b>207</b> to the computing system <b>209</b>. Control then proceeds to a Subtract Sponge Weight step <b>811</b> in which the computing system <b>209</b> employs the weight signal, in conjunction with the count signal, to calculate a tare weight for the container <b>201</b> and its contents. Control then proceeds to a Calculate Fluids step <b>813</b> in which the computing system <b>209</b> determines, based upon the tare and the weight signal from the platform <b>201</b>, the amount of fluids that have been absorbed by the sponges in the container <b>201</b>. Control then proceeds to the Display Results step <b>815</b> in which both the sponge count and the fluid weight is displayed on the display <b>215</b> or other display device, such as the display <b>107</b> in the case of the SSTS <b>100</b>. Following step <b>815</b>, control proceeds to an End Scan step <b>817</b> in which processing is complete. Of course, as explained above, process <b>800</b> may execute periodically or be initiated by a user.

[0037] While various embodiments of the application have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of this invention. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.