Patent ID: 12255380

DETAILED DESCRIPTION

Some embodiments of this disclosure provide a surgical sponge having an absorbent body and one or more identifiers attached to or embedded within the sponge. Certain embodiments of this disclosure also provide a surgical sponge counting and detection system for counting surgical sponges, and a method for counting and detection of surgical sponges. The present disclosure may reduce the likelihood that a sponge will remain in a patient after surgery and may reduce the time involved in accounting for sponges during surgery.

FIGS.1,2and3illustrate identifiers for surgical sponges according to an embodiment of the present disclosure. In the illustrated embodiments, the identifiers may be Radio Frequency (RF) or Radio Frequency Identification (RFID) identifiers may be made in a relatively flat configuration. WhileFIG.1illustrates the identifier in a generally square shape,FIG.2illustrates the identifier in a generally circular shape, andFIG.3illustrates the identifiers to be of a generally rectangular shape. However, identifiers can be virtually any other shape. In some embodiments, the identifier10may consist of an antenna12which may be made of etched metal foil traces or printed traces of conductive ink or multiple loops of wire. Other antenna constructions are anticipated.

With reference toFIGS.1,2and3, in non-limiting illustrative embodiments, the antenna12is attached to a base layer14. In the case of an etched metal foil antenna, the metal foil may be applied to the base layer14before the etching process occurs. In the case of a printed conductive ink antenna, the conductive ink may be printed on to the base layer14. The base layer14provides structural strength for the very fragile metal or ink traces, especially preventing stretching that would fracture the traces. In the case of antennae made of multiple loops of wire, the wire loops may be attached to the base layer14during or after the winding process.

In some advantageous aspects of the disclosure, the base layer14can be made of a relatively stretch-resistant polymeric film, to prevent the identifier10from stretching and fracturing the fragile antenna traces12. Suitable stretch-resistant polymeric films include but are not limited to: polyethylene terephthalate (PET), polypropylene (PP), polyester (PE) and nylon. In some embodiments, paper may be substituted for the stretch-resistant polymeric base film layer14.

Referring again to the non-limiting illustrative embodiments ofFIGS.1-3, an electrically responsive member16is electrically connected to the antenna12. The electrically responsive member16may include an integrated circuit (IC) chip.

In some embodiments, the electrically responsive member16may include a capacitor with our without a resistor or other electrical components. In this case, the resulting identifier10is a Radio Frequency (RF) or Low Frequency (LF) identifier.

In some embodiments, when the identifier10is made with an etched foil antenna or a printed conductive ink antenna12, the identifier10can called an “inlay.” In some such embodiments, the identifiers10can be made by an economical, fully automated process with excellent quality controls.

As shown in the illustrative embodiment ofFIG.4, inlay identifier10may be laminated between one or more protective film layers18,20. First protective film layer18may be laminated over the exposed etched metal foil or printed conductive ink traces12and the electrically responsive member16. First protective film layer18protects certain components of the identifier10from mechanical damage as well as damage from liquids such as blood. First protective film layer18also reduces the chance of liquids (e.g., blood or medical fluids) from electrically shorting out the RFID or RF circuit. The laminated identifier can also be referred to as a tag24.

With continued reference to the non-limiting exemplary embodiment ofFIG.4, a second protective film layer20may be laminated to the identifier. The second protective film layer20can be opposite the first protective film layer18. This configuration sandwiches the identifier10in between two protective film layers18,20, for added security and durability. Further, when laminated on both sides, the identifier10can sometimes be referred to as a tag24.

In certain aspects of the disclosure, the protective film layers18,20may be made of polymeric film that is flexible and may also be relatively resistant to tearing. Suitable tear-resistant polymeric films include but are not limited to: urethane, nylon and polyvinylchloride (PVC).

The thickness of the one or more protective film layers18,20may be greater than 0.003 in. (3 mil.) in some exemplary embodiments. This may reduce kinking of the inlay antenna12(and associated fracture) during severe bending because the radius of the bend may be greater than the 0.003 in. thickness of the protective film.

In some embodiments, the base layer14is bonded to one or more protective film layers18,20. The layers may be bonded together using adhesive22. Suitable adhesives include but are not limited to: pressure sensitive adhesives (PSA), hot melt adhesives and various liquid applied adhesives that require curing. Curing may include the application of UV light. In the case of other adhesives such as epoxy, curing may include the addition of a catalyst.

While some desirable properties of the adhesive22are mentioned above, it may be additionally desirable for the adhesive22to be flexible, water resistant, heat tolerant (up to steam autoclave temperatures, 250° F.), relatively fast curing and durable.

In some embodiments, the base layer14and/or the one or more protective film layers18,20may be plasma etched prior to the application of adhesive22to improve the adherence of the adhesive22to the film layers14,18,20. Alternatively, the base layer14and/or the one or more protective film layers18,20may be bonded together using heat bonding, ultrasound (US) bonding, radio-frequency (RF) bonding or other bonding methods.

As shown inFIGS.1-3and5in some embodiments when the antenna12is square, circular, or rectangular, a space26is present within the inner perimeter of the antenna that is void of metal foil traces.

As shown by the embodiments ofFIGS.1-3,5and6, the base layer14and the one or more protective film layers18,20within the area26defined by the inner perimeter of the antenna trace28may be removed, creating a hole30through the central area of the tag24. Removing the layers of film substantially in the middle of the tag24may improve the flexibility of the tag. The hole30in the tag24can allows a stretching or planar deformation of the tag24(e.g., along arrows3A indicated inFIG.4) that cannot generally occur with complete sheets of polymeric film. In addition, the tag24may be flexible, such that edges24A,24B may be brought toward each other, permitting the tag24to be bent. The hole30in the tag24allows the tag to feel much like the layers of the fabric sponge that it will be embedded in, rather than feel like a sheet of plastic in the sponge. The flexible and stretchable tag24can thus be generally inconspicuous to touch when attached to the surgical sponge.

Referring back to the illustrative embodiments ofFIGS.1-3, the hole30in the identifier10or tag is substantially square, circular, or rectangular, though other shapes including oval and irregular shapes are contemplated within the scope of the present disclosure. The shape of the hole30may match the shape of the tag10and may also be square, circular or rectangular. The hole30may advantageously include rounded corners to reduce the chances of tearing.

In some embodiments, if the antenna shape is more complex (e.g., a four-leaf clover), there may be cuts made through the base and protective film layers between the antenna traces, without removing film material to create a hole. The cuts, even in the absence of holes, improve the flexibility and stretch-ability of the tag. Alternately, the cuts may be made inward from the outer perimeter of the tag.

In some such embodiments, cuts may be made through the base and protective film layers in any areas of the tag not occupied by either the antenna or electrically responsive member. The cuts improve the flexibility and stretch-ability of the tag, making it feel more like a surgical sponge.

As shown by the non-limiting illustrative embodiments ofFIGS.5and6, some of the material of the base14and protective film layers18,20may be left within the perimeter28of the hole30in the tag24. The film layers of material may be in the shape of one or more tabs32extending radially inward from the inner perimeter28of the hole30. The tabs32can be any shape or size, including less than 0.5 inches square. As shown inFIG.10, if flexibility is desired, tabs32may be attached to the tag24by way of a narrowed isthmus36of laminated base14and protective film layers18,20.

As shown by the non-limiting exemplary embodiment ofFIGS.7and8, some of the material of the base14and protective film layers18,20may be left extending outward from the outer perimeter34of the tag24. The material may be in the shape of one or more tabs32extending radially outward. The tabs32can be of any shape or size, including less than 0.75 inches square. If flexibility is desired, tabs32may be attached to the tag24by way of a narrowed isthmus36of laminated base14and protective film layers18,20.

Referring now to the non-limiting exemplary embodiment ofFIG.9, the tab32may be in the form of one or more elongate protrusions from the outer perimeter34of the tag24. In such embodiments, it may be advantageous if the elongate protrusion32extends beyond the border of the sponge (not shown) that the tag24may be embedded within. In this exposed position, the tab32may provide added visibility of a sponge having blood to the surgeon or a handle to grasp by the surgeon or nurse. This may be useful when removing a sponge during laparoscopic surgery. The exposed tab32may provide enhanced visibility, differentiation and pattern recognition to the nurse or surgical technician for identifying individual sponges. In this exposed position, the tab32may provide an object for accurate indexing during both the placement and securement of the tag to the sponge during an automated manufacturing process and an object for machine vision optical inspections and counting during manufacturing, or other uses.

FIG.10illustrates a tag according to another non-limiting exemplary embodiment. As seen inFIG.10, the tab32may be a substantially semicircular or “D” shaped protrusion from the outer perimeter34of the tag24. An optional hole38may be provided in the central portion of the tab32. Tab32can protrude from the outer perimeter34of the tag24. The tab32can be of any shape. In some embodiments, it may be advantageous if the tab32extends beyond the border of the sponge (not shown) that the tag24may be embedded within. In this exposed position, the tab32may provide added visibility of a sponge having blood to the surgeon or a handle to grasp by the surgeon or nurse. This may be useful when removing a sponge during laparoscopic surgery. The exposed tab32may provide enhanced visibility, differentiation and pattern recognition to the nurse or surgical technician for identifying individual sponges. In this exposed position, the tab32may provide an object for accurate indexing during both the placement and securement of the tag to the sponge during the manufacturing process and an object for machine vision optical inspections and counting during manufacturing, or other uses.

Referring back toFIGS.6and8, the tabs32may, optionally, extend inward into the hole30or outward from the outer perimeter34of the tag24are used for anchoring the tag24to the sponge (not shown) without damaging the fragile antenna. As shown inFIGS.5and7, the tabs32can be spatially separated from the antenna trace12and electrically responsive member16of the inlay identifier10. Therefore, the attachment of the tag24to the sponge (not shown) at the tab32may be less likely to damage the electronics and antenna of the identifier10during the attachment process.

FIG.11illustrates a sponge provided with a tag according to an exemplary embodiment. In the illustrated embodiment ofFIG.11, the tag24can be sewn to the sponge40, though, other methods of securely attaching the tag24to the sponge40is contemplated within the scope of the present disclosure. The tag24can be attached to the sponge40by sewing through both the sponge material40and the base layer and protective film layer of the tag24. Sewing through the one or more tabs32(e.g., along marks42) reduces the chance of cutting a foil trace of the antenna, a printed conductive ink trace or a wire of the antenna with the sewing needle. The tab32also allows the backstitch anchoring44of the sewing seam42to occur off the side edge of the tab32, in the sponge material40only. The sewing seam42may cross the tab but may be backstitch anchored44adjacent each side of the tab32in the sponge material40. The multiple sewing pierces created by a backstitch anchor seam44, could substantially weaken the film laminate and allow tearing of the film to start at that location if the backstitching44were to land on the tab32.

As shown inFIG.12, in some embodiments, the one or more tabs32may be a safe area for heat bonding46the tag24to the sponge40. Heat bonding may be accomplished by applying a hot object to one or more layers of the sponge fabric40while pushing the threads of the fabric down onto the one or more protective film layers of the tab32. The heated object warms and partially melts the polymeric film, embedding the threads of the sponge40into the melted film46. When the polymeric film cools, the fabric of the sponge40is securely adhered to the plastic film of the tag24. The tabs32create an area for heating that is geographically separated from the from the antenna trace12and electrically responsive member16of the identifier, thus reducing the potential of damaging the identifier during the process of heat bonding the sponge40to the tag24.

Heat bonding46may be advantageous if an automated manufacturing process is used for manufacturing the sponges. Accordingly, the present disclosure provides a method of manufacturing surgical sponges that include tags24or markers (markers are tags without an inlay RFID identifier) that have an outer protective layer18,20of polymeric film.FIGS.13and14illustrate some such exemplary embodiments. In an example, a method of manufacturing surgical sponges40includes folding a sheet of gauze fabric56one or more times and interposing the tag24or marker between the folded layers of gauze fabric56. As shown inFIG.14, one or more heated metal members54may be pushed against the one or more layers of gauze fabric56, pushing the gauze fabric56firmly against the polymeric film18,20. The one or more heated metal members54are shaped, positioned and indexed to apply heat to areas of the tag24or marker that will not be damaged by the heat46.

The heated metal member54is heated to a temperature that is greater than the melting point of the selected polymeric film18,20. The heat from the heated metal member54melts the polymeric film18,20and the pressure against the gauze fabric56from the heated metal member54pushes one or more layers of the fabric56into the melted polymeric film18,20. The heated metal member54is then retracted from the fabric56, and as the melted polymeric film layer18,20cools, it bonds to the embedded gauze fabric56. Applying the heat through the gauze fabric56may reduce the chances of the melted polymeric film18,20from adhering to the heated metal member54. If speed is desirable, the heated metal member54may be heated to a temperature significantly greater than the melting temperature of the polymeric film18,20. The folding of the gauze fabric56, the indexing of the tag24or marker within the layers of gauze fabric56and the application of heat from the heated metal member54may be automated for economical manufacturing.

FIG.14illustrates a method of manufacturing sponges according to another exemplary embodiment. In the embodiment ofFIG.14, heat may be simultaneously applied to both sides of the sponge thus heat bonding the gauze fabric56to both sides of the tag24. Applying the heat simultaneously to both sides of the tag24, reduces the time required to melt the polymeric film18,20and create a bond with the gauze fabric56. Alternatively, it is anticipated that the heat may be applied to only one side of the tag24.

Referring back toFIGS.11and12, in certain exemplary embodiments, an attached, flexible RFID or RF inlay tag24may also be attached to the sponge40according to the above-disclosed method of manufacturing surgical sponges. The attachment location between the sponge40and the tag24may be at the one or more tabs32. Because the tabs32are physically separated from the functional parts of the identifier10, less precision is sufficient when applying pressure and heat or piercing with sewing needles to avoid damaging the identifier10, and thereby permitting automation of the manufacturing process.

As mentioned above, the one or more tabs become a safe and flexible area for adhesively bonding the tag to the sponge. Fast curing adhesives such as epoxy are frequently stiff. Applying a stiff adhesive to the tag24may result in a stiff tag24. Applying a stiff adhesive to a tab32may maintain the general flexibility of the tag24.

As shown by the non-limiting illustrative embodiment ofFIG.9, the metal foil inlay identifier12or the metal wire of a loop antenna12creates a densely radio-opaque area that is easy to visualize by x-ray. Metal foil or wire is much more radio-opaque than barium sulfate. In some embodiments, extra conductive ink may be applied, especially conductive inks that contain metals, to increase the radio-opacity of the tag.

Excess metal foil48may be purposefully left on the base layer14during the etching process, substantially increasing the square area of the metal foil x-ray opacity at no extra cost. The extra metal foil48may or may not be electrically connected to the antenna12. The extra foil adds additional radio-opacity to the tag for better x-ray visualization. In some such aspects, the extra metal foil48may be located substantially within the outer perimeter34of the tag24. In addition, the extra metal foil48may be located substantially outside the outer perimeter34of the tag24.

With continued reference toFIG.9, the extra metal foil48may be located in the one or more tabs32. The tabs32can fold and bend relative to the main body of the tag24. Including a layer of metal foil48in the tabs32therefore increases the probability of some of the foil48being oriented substantially perpendicular to the x-ray beam when the sponge (not shown) is crumpled into a three dimensional wad-shape and left in the body.

The protective layer of polymeric film18,20may optionally be colored. For instance, the protective layer of polymeric film18,20may not be clear. Additionally, the protective layer18,20may be coated with pigment to make the tag24more visible to the surgeon. Bright colors may contrast with blood and tissue and therefore improve visibility. Suitable colors include but are not limited to: green, yellow, purple, blue and white. In an example, the protective layer18,20can be coated with simple bright pigments or “neon” or “fluorescent” pigments, for instance, those made by the DayGlo Color Corp. (Cleveland, OH).

Continuing with the advantageous exemplary aspects described above, the protective layers18,20, when coated with pigments may optionally “fluoresce” when illuminated by UV light or colored lights, causing the fluorescent pigments in the tag24to become more visible. For instance, particles or spheres of material such as glass or plastic that reflect light may be embedded in the polymeric film. Alternatively, a layer of reflective film may be used for one or more of the protective film layers18,20. In further aspects of the disclosure, one or more layers of reflective film may be laminated to the one or more protective film layers18,20.

In certain exemplary embodiments, the one or more protective film layers18,20may be made of a substantially hydrophobic polymeric material to prevent blood from coating the brightly colored film and obscuring the tag24or marker from the surgeons view. Alternatively, a hydrophobic material may be coated on to the protective layers18,20. For instance, polymeric films that are hydrophobic relative to the absorbent, hydrophilic properties of a fabric sponge are contemplated for use. Additionally, the surface of the protective film layers18,20may be coated with a hydrophobic material that further enhances the hydrophobic nature of the film.

Enhanced surgical sponge visualization and/or enhanced surgical sponge x-ray opacity may be desirable without RFID. Accordingly, in certain cases, inexpensive and easily identifiable polymeric film “markers” may be made similarly to the RFID tags24previously discussed except that the inlay identifier10is omitted. For instance, the markers may be made of one or more layers of colored, hydrophobic polymeric film18,20as previously discussed for RFID tags. The markers may include a metal foil layer for x-ray opacity.

The marker may be any size or shape that can fit within the area of a sponge. In some cases, the marker may include tabs32as previously disclosed on tag24. The polymeric film marker may then be positioned between the layers of the surgical sponge. As shown by the non-limiting example ofFIG.10, and as described previously, tabs32may extend radially outward from the outer perimeter of the marker and the radial extension may be positioned to extend beyond the perimeter of the sponge (not shown). In this location, the colored marker is more visible to the surgeon when the sponge is in the patient and the sponge is saturated in blood.

Without RFID tags, these sponges with markers will have to be hand-counted by the nurse. Colored markers extending beyond the edge of the surgical sponges are much easier to identify individually and count than is a stack of homogeneous white sponges. Exposed tabs32may reduce the need to unfold each blood-laden sponge to assure that two sponges are not stuck together during manual counting. This makes manual counting much easier and faster.

The colored marker may optionally be attached to the fabric of the sponge by heat bonding or sewing as previously described for a tag24. As illustrated by the exemplary embodiment ofFIGS.13and14, heat bonding or sewing the marker to the sponge may allow the surgical sponge manufacturing process to be automated, and thereby more economic.

While the description generally focuses on attachment of brightly colored flexible markers or RFID tags24to surgical sponges, a skilled artisan would appreciate that such markers or RFID tags24described in the present disclosure may also be attached to other surgical articles for enhanced visual identification or RFID identification. The bright colors of a tag24or marker make the surgical item easier to see both inside and outside the patients' body. Other surgical items may include but are not limited to: surgical instruments, pledgets, cannulas, tubing, drains, stints, clamps, foam, retractors and sutures.

Traditionally a number of surgical sponges (e.g., a set of five or ten sponges) may be packaged together (e.g., stacked on top of each other). If smaller sponges that contain RFID tags are packaged side-by-side in a bundle, the RFID antennae may proximate each other and cause interference or “coupling” during the sponge entry process.

FIGS.15and16illustrate a packaged bundle of sponges according to a non-limiting exemplary embodiment. WhileFIGS.15and16illustrate a package of sponges, other surgical articles including but are not limited to: surgical instruments, pledgets, cannulas, tubing, drains, stints, clamps, foam, retractors and sutures may also be used instead of sponges. As seen by the embodiments ofFIGS.15and16, the sponges40may be removably attached to a sponge dispensing card50. The sponge dispensing card50can spread the sponges40out so that their antennae12only partially overlap, decreasing the chances of “coupling.”

The sponge dispensing card50may be made of cardboard or plastic in some cases. The sponge dispensing card50may be of any shape including but not limited to round, square and rectangular.

In an example, the sponges40may be attached to the sponge dispensing card50by one or more slits52in the card50through which a portion of the sponge40can pass. The slits52may spread the sponges40out over the face of the card50and retain the sponge40and yet allow ease of removal of the sponge40from the sponge dispensing card50. The slits52through the card50may be generally straight, generally semi-circular, angled or any other shape and length. A semi-circular slit52may be advantageous during the process (e.g., an automated process) of loading the sponge40into the slit52. A semi-circular slit52allows a greater opening of the space for insertion of the sponge40. The slits52can additionally reduce the possibility of adhesive from sticking to the material of the sponge40upon removal from the card50. The slits52can be sized to allow between about ⅓ and about ⅔ of the area of each sponge to fit through the corresponding slit52. When inserted as such at least opposite edges40A and40B of each sponge can be positioned on the opposite side of the card.

As illustrated inFIGS.15and16, according to an embodiment, sponges40can be attached the sponge dispensing card50by a releasable adhesive. In some embodiments, the attachment of sponges40to the sponge dispensing card50may be made by folding the card50to create a pocket that can accommodate a portion of each sponge. Other attachment methods are anticipated. When assembled according to some exemplary embodiments, the sponges40may be spread out over the surface of the sponge dispensing card50so that their antennae may overlap or crossover but do not stack.

Spreading the sponges40out over the surface of the sponge dispensing card50also decreases the chances of erroneously packaging the wrong number of sponges40in the pack at the factory. If each location on the sponge dispensing card50is occupied by a single sponge40, the correct number of sponges40can be reliably identified with a cursory visual or machine inspection during the manufacturing process. Added visibility for a cursory inspection can be achieved by adding a colored spot58to the card50in a location that will be covered and obscured by properly inserted sponges40. Any missing sponge40will expose the easily identifiable bright colored spot58. To prevent two sponges40from being inadvertently inserted into a single slit52, the length of the slit52may be limited to a shorter length that does not accommodate two sponges. In the alternative, if the sponges are in a stack, they may be hand separated and counted one at a time to determine if the right number is in the package.

In some embodiments, spreading the sponges40out over the surface of the sponge dispensing card50may allow the nurse or surgical technician to quickly and accurately visually count the sponges40during the entry process. If each location on the sponge dispensing card50is occupied by a single sponge40, the correct number of sponges40can be reliably identified with a cursory visual inspection rather than the manual counting of the sponges40. This may be advantageous in the case of sponges40that contain markers that do not have RFID or RF capability and therefore may have to be counted manually.

In some embodiments, the sponge dispensing card50may include a pressure sensitive adhesive area designed to stick the card to the surgical instrument table. This pressure sensitive adhesive may secure the card50to the table allowing easier dispensing of the sponges40from the card50.

Various examples have been described. These and other examples are within the scope of the following claims.