CA1293601C - Surgical fabric with printed x-ray marker - Google Patents
Surgical fabric with printed x-ray markerInfo
- Publication number
- CA1293601C CA1293601C CA000554993A CA554993A CA1293601C CA 1293601 C CA1293601 C CA 1293601C CA 000554993 A CA000554993 A CA 000554993A CA 554993 A CA554993 A CA 554993A CA 1293601 C CA1293601 C CA 1293601C
- Authority
- CA
- Canada
- Prior art keywords
- fabric
- polymeric composition
- sponge
- ray
- pattern
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/44—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with radio-opaque material or signalling means for residual material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
Abstract
Abstract Woven and nonwoven fabrics for use in surgical procedures are printed with a radiopaque polymeric composition which bonds to the surface of the fabric. The composition is applied in a visually distinctive pattern, or may assume the pattern of the underlying fabric. The polymeric composition is readily recognized in an X-ray image and provides an improved means for detecting a surgical sponge inadvertently left in a patient.
Preferred compositions are latex or plastisols of a printable viscosity containing from 15 to 70% by weight BaSO4 having a particle size greater than about 5 microns.
Preferred compositions are latex or plastisols of a printable viscosity containing from 15 to 70% by weight BaSO4 having a particle size greater than about 5 microns.
Description
1~3t-`(~
SURGICAL FAB~IC WITH PRINTED ~-RAY MARKER
Field of Invention T~is invention relate~ to X-ray detectable fabrics and, more particularly, to surgical swabs and sponges which include a printed X-ray detectable marker a6 an integral component of the sponge fabric.
Backaround of the Invention ~arious ab60rbent fabric materials are used in surgical procedure~ for packing, wiping, and cleansing in or around the operating ~ite. Typical product6 include surgical 6ponges such as 4x4 inch folded surgical gauze of nonwoven fabric, and woven, nonwoven and knitted laparotomy pads. Although ~tandard operating room procedures require all materials brought into the operating area to be accounted for upon completion of the procedure, an occasional 6ponge may inadvertently be left in the patient. It i8 accordingly common practice in the medical field to include a radiopaque marker on all ~urgical sponges ~o that the pre6ence or absence of a sponge in a patient experiencing difficulty after an operation can be determined by ~-ray examination rather than by reoperating on the patient.
A common ~-ray detectable marker used in conjunction with surgical sponges is a polymeric filament or ribbon loaded with an ~-ray opaque filler material such as barium sulfate.
Suitable polymeric materials include polyisobutylene, polyvinyl chloride and copolymers of vinyl acetate and vinyl chloride.
Such ~-ray detectable elements have been incorporated into sponge material by a variety of techniques. In the ca~e of gauze swabs, a filament has been interwoven into the fabric of the gauze or fused to the surface of the fabric and folded into J~J 1209 ~..... .... .
t~e sponge construction. In the ca6e of laparotomy pads, an ~-ray detectable ribbon has been enclosed in a seam stitched along one end of the pad, or an X-ray detectable filament has been incorporated into the woven handle strap of the pad or into the body of the pad fabric. In the case of nonwoven fabric sponges, the filament ha~ been either heat fused onto the surface of the fabric or incorporated into the fabric by introducing the radiopaque element during the fabric manufacturing process.
In all cases, the X-ray detectable element has been preformed as a ribbon, yarn or monofilament, and it has been essential to ~ecurely attach the element to the sponge fabric since if the element is separated from the fabric during use, not only is the fabric no longer visible by X-ray, but the separated element i6 easily lost in the surgical field. For manufacturing considerations, it i6 desirable that the ~-ray detectable marker be secured to the sponge in a continuous and reliable manner with a minimum of labor. A final consideration is that the ~-ray detectable marker be easily identified in an X-ray image.
It i6 accordingly an object of the present invention to provide an improved ~-ray detectable marker on a surgical sponge. It is a further object of this invention to provide a surgical sponge having a distinctive and easily detected radiopaque marker. It is a yet further object to provide a method for applying a radiopaque marker to a fabric in a rapid, continuous and economical manner. These and other object~ of the present invention will be apparent from the ensuing description and claims.
Summar~ of the Invention A surgical sponge in accordance with the present invention J~J 1209 60~
.
comprises a fabric and a radiopaque marker bonded to said fabric in a visually distinctive pattern. The radiopaque marker is applied to the fabric by extruding or printing a radiopaque polymeric suspension or melt onto the surface of the fabric in such a way that the surface fibers of the substrate fabric are encapsulated. Upon heat-setting, curing or coalescing, the radiopaque material is securely bound to the fabric so that it becomes an integral part of the fabric and cannot be readily removed.
Emulsion polymers such as plastisols and latexes which are soft, rubbery materials even when heavily loaded with barium sulfate or other radiopaque salt are well suited for use in the present invention.
The pattern of the X-ray detectable marker is determined by the structure of the underlying fabric and the nature of the application means. The marker may be applied to the fabric in a continuous process at a high rate of speed by printing with a gravure roll. Suitable compositions for the marker comprise biocompatible polymers containing an effective amount of a radiopaque filler such as barium sulfate and having a viscosity suitable for printing or other application means.
According to a still further broad aspect of the present invention, there is provided a method of preparing a surgical sponge comprising an absorbent fabric having an X-ray detectable marker associated therewith. The improvement comprises applying a flowable, uniformly radiopaque polymeric composition to the fabric in a visually distinctive pattern and securely bonding the polymeric composition to the fabric to provide an X-ray discernable marker having 3~(31 - 3a -an X-ray detectable pattern corresponding to the pattern of the polymeric composition as applied to the fabric.
According to a still further broad aspect of the present invention, there is provided a surgical sponge including an X-ray detectable marker. The sponge comprises an absorbent fabric having a uniformly radiopaque polymeric composition bonded to the surface thereof in a visually distinctive pattern conforming to the structure of the underlying fabric.
The pattern defined by the polymeric composition is discernable by X-ray.
According to a further broad aspect of the present invention, the X-ray detectable marker is applied to a substantially non-apertured fabric having a uniformly radiopaque polymeric composition printed onto the surface of the fabric and bonded thereto in a visually distinctive pattern. The pattern defined by the polymeric composition is discernable by X-ray.
Description of the Drawings Fig. 1 is a view in perspective of a folded surgical sponge having an X-ray detectable marker in accordance with the present invention.
Fig. 2 is a print of an X-ray image of a double thickness of a non-woven fabric having two narrow X-ray detectable bands printed thereon.
Fig. 3 is a photograph of a non-woven fabric having a radiopaque marker applied to the surface thereof.
~t Fig. 4 i6 a print of an ~-ray image of the fabric of Fig. 3 illu6trating the pattern of the ~-ray marker.
Fig. 5 i~ a photograph of another nonwoven fabric having a radiopaque marker applied to the 6urface thereof.
Fig. 6 i6 a print of an ~-ray image of the fabric of Fig. 5 illu6trating the pattern of the ~-ray marker.
Fig. 7 i6 a photograph of a 6urgical gauze having a radiopaque marker applied to the 6urface thereof and al60 containing a conventional X-ray detectable monofilament.
Fig. 8 i6 a print of an ~-ray image of the fabric of Fig. 7.
De6cri~tion of the Invention The pre6ent invention consist6 of applying a polymeric material containing from about 15 percent up to about 70 percent by weight of a heavy metal radiopaque 6alt 6uch as barium sulfate onto the surface of surgical sponge fabrics. The polymeric material may be applied a6 a hot melt extrusion, or by printing or cold extruding a latex emulsion or a plasti601 onto the 6urface of the fabric in a continuou6 or intermittent pattern.
Upon heat-setting, curing or coale6cing, the upper layer of fiber6 of the underlying fabric are encap6ulated by the radiopaque material 60 that the marker i6 securely bound to the 6urface of the fabric and will not 6eparate during normal handling or u6e.
The radiopaque marker iB applied to the fabric in a di~tinctive pattern which i6 readily identified in an ~-ray image. In the case of those fabric6 having an open 6tructure such a6 woven gauze and certain nonwoven fabric6, the radiopague material may be applied to the fabric in 6uch a way a6 to preserve the open J~J 1209 . . ~ .,, 1~36~3~
spaces in the fabric whereupon the fabri~ structure itself become6 the distinctive pattern of the ~-ray ~arker.
In the ca6e of fabrics having no di6tinguishable pattern such as closely ~nit or tightly-woven $abrics or nonapertured nonwoven fabrics, it i5 preferable to apply the radiopaque material to the surface of the fabric in a predetermined pattern which is controlled by the configuration of the printing roll or other application means. Latex emulsions and plastisol formulations may be applied to the fabric ~y padding, gravure printing, 6creen printing, or other convenient method.
Patterned nonwoven fabrics useful in the practice of the pre~ent invention may be prepared according to conventional hydraulic entanglement methods. In brief, the~e methods con6igt of providing a fibrous web of randomly oriented ~taple length fibers, positioning the web on a patterned, apertured belt, and sub~ecting the web to a plurality of high pres~ure hydraulic jets to entangle the fibers into a pattern conforming to that of the supporting belt. The entangled fiber6 are thereupon separated from the belt and dried on hot drums to produce a patterned nonwoven fabric. This method of manufacturing is described in detail in U.S. Patents 3,068,547:
3,129,466; 3,485,706; 3,494,821: and 3,681,184 and is well known to those s~illed in the art.
The nonwoven fabric may compri6e any 6uitable combination of natural and/or synthetic textile material6 including cotton, rayon, acrylic~, polyester and nylon. A particularly preferred fiber compofiition is a blend of 70% rayon (l.5 denier, approximately 3 cm ~taple length) and 30% polyester (1.5 denier, approximately 3 cm staple length). The staple fibers are blended and converted to a fibrous web on conventional textile processing equipment such as a Rando-Webber which produces a web having random fiber orîentation.
J~J 1209 l;~ iC3~
The nonwoven fabric preferably has a dry weight of from about 1.0 to 3.0 ozs per square yard (30 to 100 g/m ), with the lighter weights limited by the processability of the fibrou~
web and the heavier weights limited by the desired utility and S construction of the sponge or swab. although higher weights may be preferred for 60me product applications such as laparotomy pads.
The radiopaque composition is preferably dyed or pismented blue or other suitable color which contrasts 6harply with blood.
The color permits ready identification of the X-ray detectable element in the sponge, facilitates sponge counting in the operating room and further helps locate the sponge when ~aturated with blood during use. As a characteristic of the sponge6 of the present inventin, the radiopague material may be applied primarily to one surface of the fabric, and i8 consequently visually more apparent from that side. This increased visibility may be capitalized on when folding the sponge by placing the radiopaque material to the outside of the sponge.
Turning now to ~igure 1 there is illustrated a surgical sponge, indicated generally by the numeral 10, which consists of folded fabric 11 having a radiopaque marker consisting of a pair of lines 12 and 13. The radiopaque marker lines are continuous over the length of the folded sponge and applied to the fabric during manufacture by, for example, printing a radiopaque plastisol directly onto the surface of the fabric. While lines 12 and 13 appear generally as two continuous lines of uniform width and depth, closer inspection reveals that the lines conform to the open pattern of the fabric and have a variable thickness on the surface of the fabric. The pattern of the radiopaque material on the fabric of the sponge results in the formation of a distinctive X-ray image of the radiopaque marker. Figure 2 is a print of the X-ray i~age of a double J~J 1209 1~3~
thickness of a fabric having two narrow X-ray detectable bands printed thereon. While the X-ray pattern i6 created entirely by the pattern of the underlying fabric, the fabric pattern itself is not apparent from the X-ray image due to the narrow width of the radiopaque lines.
Figure 3 is a photograph of an open patterned nonwoven fabric which is cbaracterized by a series of small, widely-6paced fiber masses interconnected by radial threads in what is commonly referred to as a "ro6ebud" pattern. A radiopaque material applied uniformly to the fabric over a width of from about 1 to 2 c~, appearing as dark bands in Figure 3, encompasses a sufficient area of fabric to make the actual pattern of the fabric visible in the X-ray image as illustrated in Figure 4. Where such a wide band of radiopaque material i6 applied to the fabric, it will usually be sufficient to apply the material in a discontinuous line 80 that one or two band~
of material appear in each sponge. For example, if the length of the fabric comprising each folded sponge i6 0.5 m, it would be sufficient to apply the radiopaque material in bands of 2 cm wide bv 10 cm long at a frequency of four bands per meter of fabric, thus assuring that each sponge would include two radiopaque markers, at least one of which would be a continuous 10 cm length.
Figures 5 is a photograph of another nonwoven fabric having a radiopaque marker applied to the surface thereof. The ~-ray image of the fabric as illustrated in Figure 6 clearly shows the pattern of the fabric to be different than that of Figure 4.
Figure 7 illustrates a conventional 20x8 woven surgical gauze printed with a band of radiopaque plastisol material which appears as the dark bands in the photograph of Figure 7. The radiopaque material uniformly coats each yarn of the gauze within the area of the coating and the pattern of the gauze is J~J 1209 readily identified in an X-ray image of the fabric as illustrated in Figure 8. Figures 7 and 8 also include a conventional monofilament marker which is clearly visible as the wavy line in the X-ray image of Fig. 8, and less evident in the photograph of the fabric of Fig. 7. It should also be noted that while the photograph and the ~-ray are of the same fabric, the displayed areas are noe precisely the same.
As illustrated in Figures 1-8, the radiopaque material may be applied to an open mesh fabric over an area 6ufficient to reveal the actual pattern of the underlying fabric in an X-ray image, or over an area which is too narrow to disclose the repeating pattern of the fabric, but nevertheless displays a distinctive pattern of its own in an X-ray image as a result of lS the underlying fabric pattern.
In the case of closely knit or woven fabric, the radiopaque material is applied in a predetermined pattern controlled by the application means. Por example, a plastisol may be applied to the fabIic by screen printing or by gravure sy6tem in a continuous line or in discontinuous bands and in any desirable pattern. ~n infinite variety of patterns is, of course, possible and may be utilized in the practice of the present invention. One desirable pattern would be in the name or initial6 of the supplier of the surgical product and perhaps the order number of the product, which would not only provide ~-ray detectability but also indicate the source of the product to the surgeon during the operating procedure. Since the surgical sponges are usually wadded up during use, it is unlikely that this information would be fully legible in an actual X-ray image, but even a single letter of the alphabetwould be distinctive and easily recognized as a foreign object in an X-ray following a surgical procedure.
J6J 1~09 _9_ The method of the present invention is urther illu~trated in the following examples where all parts and percentages are by weight unless otherwise indicated.
Example 1 A plastisol printing composition is prepared from polyvinyl chloride resin according to the following formulation:
100 parts Geon 125-A PVC resin 100 parts Dioctyl phthalate plasticizer 328 parts BaSO4 5 parts blue pigment Geon~ 125-A PVC resin is a low molecular weight, low viscosity polyvinylchloride powder available from B.F. Goodrich, Avon Lake, Ohio. The BaSO4 is suitably No. 1 Barytes~ HP
available from Pfizer, Inc., Easton, Pennsylvania. The blue pigment i5 sui~ably Ultramarine Blue available from Sun 2C3 Chemical Co., Cincinnati, Ohio. The PVC resin i6 sifted with stirring into the dioctyl phthalate plasticizer containing the blue dye, followed by addition of the BaSO4. The resulting composition contain~ 61.5~ BaSO4 and has a visc06ity of about 20,000 cps which is suitable for printing. Desirable viscosities for printing are generally ;n the range of 5,000 to 20,000 cps although higher or lower viscosities may be utilized in some applications.
Example 2 An emulsion latex printing composition is prepared according to the following formulation:
J~J 1209 3~
25 part6 water 10 parts blue pigment 2 2art~ antifoam 4 parts rheology modifier 3 parts ammonia (28%) ~00 parts Rhoplex X-3 (48%) 501 parts BaS04 ~he latex printing composition i~ prepared by first combining lQ the water, am~onia, antifoam, rheology modifier, pigmen~ and Rhoplex~ K-3, then slowly adding the BaS04 ~ith stirring to obtain a mix with 67~ BaS04 solids. The ammonia functions to increase the pH to about 8, the antifoam may be Colloids 999 available Erom Colloids, Inc., Newark, NJ, and the rheology modifier may be a poly (ethylene oxide) such as Poly-ox~
available from Union Carbide, Danbury, CN. ahoplex K-3, i~ a 46% aqueou6 acrylic emul~ion available from Rohm & Haas, Philadelphia, PA. After applica~ion to the fabric and removal of volatiles, the BaSOg content in the resulting polymeric composition is approximately 80 percent.
The radiopaque polymeric composition with BaSo4 i8 naturally white, but may be pigmented blue or other ~olor for enhanced visibility, or left uncolored except for some indication of its presence such as a thin blue line printed onto the marker after curing. A wide, unpigmented band of radiopaque material with a narrow blue line or the logo of the manufacturer printed thereon, may be more aesthetically pleasing to the surgeon and still provide all the advantages of a wide, ~-ray detectable marker as de~cribed herein~
The plastisol or latex printing composition is applied to the surgical fabric using conventional printing equipment and techniques a~, ~or example, by gravure rolls. The printed 35 fabric i8 passed through a heating station to polymerize the J&J 1209 resin and remove volatile components. The resulting polymeric deposit is securely adhered to the underlying fabric and typically comprises from about 60-90% BaS04 solids in the resin binder. We have found that at least 10% resin binder is desirable to assure the integrity of the polymeric ma~s and its adhesion to the fabric.
The BaS04 used in the printing formulations of the present invention preferably has an average particle size of at least S microns, and most prèferably 10 microns or greater, in order to obtain printing compositions having the desired flow c~aracteristics when containing up to about 70% BaS04 solids. We have found that when the average particle size is subgtantially less than 5 microns, as for example 2 microns, formulations containing such high levels of BaS04 solids are essentially dry mixes not suitable for application to fabric by conventional printing means. In the case of the No. 1 Barytes HP used in the preceding examples, the average particle size is about 10 microns with 75 percent of the particles being 5 microns or greater.
We have also found that the X-ray detectability of a cured latex or plastisol containing from 60 to 70 percent barium sulfate compares favorably with that of a conventional monofilament marker which usually contains about 60 percent barium sulfate. Moreover, the X-ray visibility of the radiopaque material is greater in the case of the present invention, since if the X-ray is taken in plan view, the pattern of the marker stands out while if the X-ray is taken in side view, the effective thickness of the marker is increased and the brightness of the marker in the X-ray image is enhanced.
The fabric may be printed on one or both sides with the radiopaque material and superimposed printing on both sides has the advantage of presenting thinner layers with greater surface J&J 1209 1~3~
area to speed drying or curing of the radiopaque material.
Wide lengths of fabric may be printed with parallel bands of radiopaque material spaced to conform to the desired final width of the sponge so that the fabric may be slit within the bands. The radiopaque material thereby performs the dual function of 6tabilizing the cut edge6 of the fabric against loose yarns or linting, while at the same time imparting X-ray detectability to the fabric.
These and other variations of the present invention which is directed broadly to printing polymeric compo6itions onto fabrics for use as surgical sponges will be apparent to those skilled in the art. The fabrics and polymeric compo~itions as de6cribed herein are for the purpo6es of illustration only and not limiting cf the present invention.
J~J 1209
SURGICAL FAB~IC WITH PRINTED ~-RAY MARKER
Field of Invention T~is invention relate~ to X-ray detectable fabrics and, more particularly, to surgical swabs and sponges which include a printed X-ray detectable marker a6 an integral component of the sponge fabric.
Backaround of the Invention ~arious ab60rbent fabric materials are used in surgical procedure~ for packing, wiping, and cleansing in or around the operating ~ite. Typical product6 include surgical 6ponges such as 4x4 inch folded surgical gauze of nonwoven fabric, and woven, nonwoven and knitted laparotomy pads. Although ~tandard operating room procedures require all materials brought into the operating area to be accounted for upon completion of the procedure, an occasional 6ponge may inadvertently be left in the patient. It i8 accordingly common practice in the medical field to include a radiopaque marker on all ~urgical sponges ~o that the pre6ence or absence of a sponge in a patient experiencing difficulty after an operation can be determined by ~-ray examination rather than by reoperating on the patient.
A common ~-ray detectable marker used in conjunction with surgical sponges is a polymeric filament or ribbon loaded with an ~-ray opaque filler material such as barium sulfate.
Suitable polymeric materials include polyisobutylene, polyvinyl chloride and copolymers of vinyl acetate and vinyl chloride.
Such ~-ray detectable elements have been incorporated into sponge material by a variety of techniques. In the ca~e of gauze swabs, a filament has been interwoven into the fabric of the gauze or fused to the surface of the fabric and folded into J~J 1209 ~..... .... .
t~e sponge construction. In the ca6e of laparotomy pads, an ~-ray detectable ribbon has been enclosed in a seam stitched along one end of the pad, or an X-ray detectable filament has been incorporated into the woven handle strap of the pad or into the body of the pad fabric. In the case of nonwoven fabric sponges, the filament ha~ been either heat fused onto the surface of the fabric or incorporated into the fabric by introducing the radiopaque element during the fabric manufacturing process.
In all cases, the X-ray detectable element has been preformed as a ribbon, yarn or monofilament, and it has been essential to ~ecurely attach the element to the sponge fabric since if the element is separated from the fabric during use, not only is the fabric no longer visible by X-ray, but the separated element i6 easily lost in the surgical field. For manufacturing considerations, it i6 desirable that the ~-ray detectable marker be secured to the sponge in a continuous and reliable manner with a minimum of labor. A final consideration is that the ~-ray detectable marker be easily identified in an X-ray image.
It i6 accordingly an object of the present invention to provide an improved ~-ray detectable marker on a surgical sponge. It is a further object of this invention to provide a surgical sponge having a distinctive and easily detected radiopaque marker. It is a yet further object to provide a method for applying a radiopaque marker to a fabric in a rapid, continuous and economical manner. These and other object~ of the present invention will be apparent from the ensuing description and claims.
Summar~ of the Invention A surgical sponge in accordance with the present invention J~J 1209 60~
.
comprises a fabric and a radiopaque marker bonded to said fabric in a visually distinctive pattern. The radiopaque marker is applied to the fabric by extruding or printing a radiopaque polymeric suspension or melt onto the surface of the fabric in such a way that the surface fibers of the substrate fabric are encapsulated. Upon heat-setting, curing or coalescing, the radiopaque material is securely bound to the fabric so that it becomes an integral part of the fabric and cannot be readily removed.
Emulsion polymers such as plastisols and latexes which are soft, rubbery materials even when heavily loaded with barium sulfate or other radiopaque salt are well suited for use in the present invention.
The pattern of the X-ray detectable marker is determined by the structure of the underlying fabric and the nature of the application means. The marker may be applied to the fabric in a continuous process at a high rate of speed by printing with a gravure roll. Suitable compositions for the marker comprise biocompatible polymers containing an effective amount of a radiopaque filler such as barium sulfate and having a viscosity suitable for printing or other application means.
According to a still further broad aspect of the present invention, there is provided a method of preparing a surgical sponge comprising an absorbent fabric having an X-ray detectable marker associated therewith. The improvement comprises applying a flowable, uniformly radiopaque polymeric composition to the fabric in a visually distinctive pattern and securely bonding the polymeric composition to the fabric to provide an X-ray discernable marker having 3~(31 - 3a -an X-ray detectable pattern corresponding to the pattern of the polymeric composition as applied to the fabric.
According to a still further broad aspect of the present invention, there is provided a surgical sponge including an X-ray detectable marker. The sponge comprises an absorbent fabric having a uniformly radiopaque polymeric composition bonded to the surface thereof in a visually distinctive pattern conforming to the structure of the underlying fabric.
The pattern defined by the polymeric composition is discernable by X-ray.
According to a further broad aspect of the present invention, the X-ray detectable marker is applied to a substantially non-apertured fabric having a uniformly radiopaque polymeric composition printed onto the surface of the fabric and bonded thereto in a visually distinctive pattern. The pattern defined by the polymeric composition is discernable by X-ray.
Description of the Drawings Fig. 1 is a view in perspective of a folded surgical sponge having an X-ray detectable marker in accordance with the present invention.
Fig. 2 is a print of an X-ray image of a double thickness of a non-woven fabric having two narrow X-ray detectable bands printed thereon.
Fig. 3 is a photograph of a non-woven fabric having a radiopaque marker applied to the surface thereof.
~t Fig. 4 i6 a print of an ~-ray image of the fabric of Fig. 3 illu6trating the pattern of the ~-ray marker.
Fig. 5 i~ a photograph of another nonwoven fabric having a radiopaque marker applied to the 6urface thereof.
Fig. 6 i6 a print of an ~-ray image of the fabric of Fig. 5 illu6trating the pattern of the ~-ray marker.
Fig. 7 i6 a photograph of a 6urgical gauze having a radiopaque marker applied to the 6urface thereof and al60 containing a conventional X-ray detectable monofilament.
Fig. 8 i6 a print of an ~-ray image of the fabric of Fig. 7.
De6cri~tion of the Invention The pre6ent invention consist6 of applying a polymeric material containing from about 15 percent up to about 70 percent by weight of a heavy metal radiopaque 6alt 6uch as barium sulfate onto the surface of surgical sponge fabrics. The polymeric material may be applied a6 a hot melt extrusion, or by printing or cold extruding a latex emulsion or a plasti601 onto the 6urface of the fabric in a continuou6 or intermittent pattern.
Upon heat-setting, curing or coale6cing, the upper layer of fiber6 of the underlying fabric are encap6ulated by the radiopaque material 60 that the marker i6 securely bound to the 6urface of the fabric and will not 6eparate during normal handling or u6e.
The radiopaque marker iB applied to the fabric in a di~tinctive pattern which i6 readily identified in an ~-ray image. In the case of those fabric6 having an open 6tructure such a6 woven gauze and certain nonwoven fabric6, the radiopague material may be applied to the fabric in 6uch a way a6 to preserve the open J~J 1209 . . ~ .,, 1~36~3~
spaces in the fabric whereupon the fabri~ structure itself become6 the distinctive pattern of the ~-ray ~arker.
In the ca6e of fabrics having no di6tinguishable pattern such as closely ~nit or tightly-woven $abrics or nonapertured nonwoven fabrics, it i5 preferable to apply the radiopaque material to the surface of the fabric in a predetermined pattern which is controlled by the configuration of the printing roll or other application means. Latex emulsions and plastisol formulations may be applied to the fabric ~y padding, gravure printing, 6creen printing, or other convenient method.
Patterned nonwoven fabrics useful in the practice of the pre~ent invention may be prepared according to conventional hydraulic entanglement methods. In brief, the~e methods con6igt of providing a fibrous web of randomly oriented ~taple length fibers, positioning the web on a patterned, apertured belt, and sub~ecting the web to a plurality of high pres~ure hydraulic jets to entangle the fibers into a pattern conforming to that of the supporting belt. The entangled fiber6 are thereupon separated from the belt and dried on hot drums to produce a patterned nonwoven fabric. This method of manufacturing is described in detail in U.S. Patents 3,068,547:
3,129,466; 3,485,706; 3,494,821: and 3,681,184 and is well known to those s~illed in the art.
The nonwoven fabric may compri6e any 6uitable combination of natural and/or synthetic textile material6 including cotton, rayon, acrylic~, polyester and nylon. A particularly preferred fiber compofiition is a blend of 70% rayon (l.5 denier, approximately 3 cm ~taple length) and 30% polyester (1.5 denier, approximately 3 cm staple length). The staple fibers are blended and converted to a fibrous web on conventional textile processing equipment such as a Rando-Webber which produces a web having random fiber orîentation.
J~J 1209 l;~ iC3~
The nonwoven fabric preferably has a dry weight of from about 1.0 to 3.0 ozs per square yard (30 to 100 g/m ), with the lighter weights limited by the processability of the fibrou~
web and the heavier weights limited by the desired utility and S construction of the sponge or swab. although higher weights may be preferred for 60me product applications such as laparotomy pads.
The radiopaque composition is preferably dyed or pismented blue or other suitable color which contrasts 6harply with blood.
The color permits ready identification of the X-ray detectable element in the sponge, facilitates sponge counting in the operating room and further helps locate the sponge when ~aturated with blood during use. As a characteristic of the sponge6 of the present inventin, the radiopague material may be applied primarily to one surface of the fabric, and i8 consequently visually more apparent from that side. This increased visibility may be capitalized on when folding the sponge by placing the radiopaque material to the outside of the sponge.
Turning now to ~igure 1 there is illustrated a surgical sponge, indicated generally by the numeral 10, which consists of folded fabric 11 having a radiopaque marker consisting of a pair of lines 12 and 13. The radiopaque marker lines are continuous over the length of the folded sponge and applied to the fabric during manufacture by, for example, printing a radiopaque plastisol directly onto the surface of the fabric. While lines 12 and 13 appear generally as two continuous lines of uniform width and depth, closer inspection reveals that the lines conform to the open pattern of the fabric and have a variable thickness on the surface of the fabric. The pattern of the radiopaque material on the fabric of the sponge results in the formation of a distinctive X-ray image of the radiopaque marker. Figure 2 is a print of the X-ray i~age of a double J~J 1209 1~3~
thickness of a fabric having two narrow X-ray detectable bands printed thereon. While the X-ray pattern i6 created entirely by the pattern of the underlying fabric, the fabric pattern itself is not apparent from the X-ray image due to the narrow width of the radiopaque lines.
Figure 3 is a photograph of an open patterned nonwoven fabric which is cbaracterized by a series of small, widely-6paced fiber masses interconnected by radial threads in what is commonly referred to as a "ro6ebud" pattern. A radiopaque material applied uniformly to the fabric over a width of from about 1 to 2 c~, appearing as dark bands in Figure 3, encompasses a sufficient area of fabric to make the actual pattern of the fabric visible in the X-ray image as illustrated in Figure 4. Where such a wide band of radiopaque material i6 applied to the fabric, it will usually be sufficient to apply the material in a discontinuous line 80 that one or two band~
of material appear in each sponge. For example, if the length of the fabric comprising each folded sponge i6 0.5 m, it would be sufficient to apply the radiopaque material in bands of 2 cm wide bv 10 cm long at a frequency of four bands per meter of fabric, thus assuring that each sponge would include two radiopaque markers, at least one of which would be a continuous 10 cm length.
Figures 5 is a photograph of another nonwoven fabric having a radiopaque marker applied to the surface thereof. The ~-ray image of the fabric as illustrated in Figure 6 clearly shows the pattern of the fabric to be different than that of Figure 4.
Figure 7 illustrates a conventional 20x8 woven surgical gauze printed with a band of radiopaque plastisol material which appears as the dark bands in the photograph of Figure 7. The radiopaque material uniformly coats each yarn of the gauze within the area of the coating and the pattern of the gauze is J~J 1209 readily identified in an X-ray image of the fabric as illustrated in Figure 8. Figures 7 and 8 also include a conventional monofilament marker which is clearly visible as the wavy line in the X-ray image of Fig. 8, and less evident in the photograph of the fabric of Fig. 7. It should also be noted that while the photograph and the ~-ray are of the same fabric, the displayed areas are noe precisely the same.
As illustrated in Figures 1-8, the radiopaque material may be applied to an open mesh fabric over an area 6ufficient to reveal the actual pattern of the underlying fabric in an X-ray image, or over an area which is too narrow to disclose the repeating pattern of the fabric, but nevertheless displays a distinctive pattern of its own in an X-ray image as a result of lS the underlying fabric pattern.
In the case of closely knit or woven fabric, the radiopaque material is applied in a predetermined pattern controlled by the application means. Por example, a plastisol may be applied to the fabIic by screen printing or by gravure sy6tem in a continuous line or in discontinuous bands and in any desirable pattern. ~n infinite variety of patterns is, of course, possible and may be utilized in the practice of the present invention. One desirable pattern would be in the name or initial6 of the supplier of the surgical product and perhaps the order number of the product, which would not only provide ~-ray detectability but also indicate the source of the product to the surgeon during the operating procedure. Since the surgical sponges are usually wadded up during use, it is unlikely that this information would be fully legible in an actual X-ray image, but even a single letter of the alphabetwould be distinctive and easily recognized as a foreign object in an X-ray following a surgical procedure.
J6J 1~09 _9_ The method of the present invention is urther illu~trated in the following examples where all parts and percentages are by weight unless otherwise indicated.
Example 1 A plastisol printing composition is prepared from polyvinyl chloride resin according to the following formulation:
100 parts Geon 125-A PVC resin 100 parts Dioctyl phthalate plasticizer 328 parts BaSO4 5 parts blue pigment Geon~ 125-A PVC resin is a low molecular weight, low viscosity polyvinylchloride powder available from B.F. Goodrich, Avon Lake, Ohio. The BaSO4 is suitably No. 1 Barytes~ HP
available from Pfizer, Inc., Easton, Pennsylvania. The blue pigment i5 sui~ably Ultramarine Blue available from Sun 2C3 Chemical Co., Cincinnati, Ohio. The PVC resin i6 sifted with stirring into the dioctyl phthalate plasticizer containing the blue dye, followed by addition of the BaSO4. The resulting composition contain~ 61.5~ BaSO4 and has a visc06ity of about 20,000 cps which is suitable for printing. Desirable viscosities for printing are generally ;n the range of 5,000 to 20,000 cps although higher or lower viscosities may be utilized in some applications.
Example 2 An emulsion latex printing composition is prepared according to the following formulation:
J~J 1209 3~
25 part6 water 10 parts blue pigment 2 2art~ antifoam 4 parts rheology modifier 3 parts ammonia (28%) ~00 parts Rhoplex X-3 (48%) 501 parts BaS04 ~he latex printing composition i~ prepared by first combining lQ the water, am~onia, antifoam, rheology modifier, pigmen~ and Rhoplex~ K-3, then slowly adding the BaS04 ~ith stirring to obtain a mix with 67~ BaS04 solids. The ammonia functions to increase the pH to about 8, the antifoam may be Colloids 999 available Erom Colloids, Inc., Newark, NJ, and the rheology modifier may be a poly (ethylene oxide) such as Poly-ox~
available from Union Carbide, Danbury, CN. ahoplex K-3, i~ a 46% aqueou6 acrylic emul~ion available from Rohm & Haas, Philadelphia, PA. After applica~ion to the fabric and removal of volatiles, the BaSOg content in the resulting polymeric composition is approximately 80 percent.
The radiopaque polymeric composition with BaSo4 i8 naturally white, but may be pigmented blue or other ~olor for enhanced visibility, or left uncolored except for some indication of its presence such as a thin blue line printed onto the marker after curing. A wide, unpigmented band of radiopaque material with a narrow blue line or the logo of the manufacturer printed thereon, may be more aesthetically pleasing to the surgeon and still provide all the advantages of a wide, ~-ray detectable marker as de~cribed herein~
The plastisol or latex printing composition is applied to the surgical fabric using conventional printing equipment and techniques a~, ~or example, by gravure rolls. The printed 35 fabric i8 passed through a heating station to polymerize the J&J 1209 resin and remove volatile components. The resulting polymeric deposit is securely adhered to the underlying fabric and typically comprises from about 60-90% BaS04 solids in the resin binder. We have found that at least 10% resin binder is desirable to assure the integrity of the polymeric ma~s and its adhesion to the fabric.
The BaS04 used in the printing formulations of the present invention preferably has an average particle size of at least S microns, and most prèferably 10 microns or greater, in order to obtain printing compositions having the desired flow c~aracteristics when containing up to about 70% BaS04 solids. We have found that when the average particle size is subgtantially less than 5 microns, as for example 2 microns, formulations containing such high levels of BaS04 solids are essentially dry mixes not suitable for application to fabric by conventional printing means. In the case of the No. 1 Barytes HP used in the preceding examples, the average particle size is about 10 microns with 75 percent of the particles being 5 microns or greater.
We have also found that the X-ray detectability of a cured latex or plastisol containing from 60 to 70 percent barium sulfate compares favorably with that of a conventional monofilament marker which usually contains about 60 percent barium sulfate. Moreover, the X-ray visibility of the radiopaque material is greater in the case of the present invention, since if the X-ray is taken in plan view, the pattern of the marker stands out while if the X-ray is taken in side view, the effective thickness of the marker is increased and the brightness of the marker in the X-ray image is enhanced.
The fabric may be printed on one or both sides with the radiopaque material and superimposed printing on both sides has the advantage of presenting thinner layers with greater surface J&J 1209 1~3~
area to speed drying or curing of the radiopaque material.
Wide lengths of fabric may be printed with parallel bands of radiopaque material spaced to conform to the desired final width of the sponge so that the fabric may be slit within the bands. The radiopaque material thereby performs the dual function of 6tabilizing the cut edge6 of the fabric against loose yarns or linting, while at the same time imparting X-ray detectability to the fabric.
These and other variations of the present invention which is directed broadly to printing polymeric compo6itions onto fabrics for use as surgical sponges will be apparent to those skilled in the art. The fabrics and polymeric compo~itions as de6cribed herein are for the purpo6es of illustration only and not limiting cf the present invention.
J~J 1209
Claims (21)
1. In a method of preparing a surgical sponge comprising an absorbent fabric having an X-ray detectable marker associated therewith, the improvement comprising applying a flowable, uniformly radiopaque polymeric composition to said fabric in a visually distinctive pattern and securely bonding said polymeric composition to said fabric to provide an X-ray discernable marker having an X-ray detectable pattern corresponding to the pattern of said polymeric composition as applied to said fabric.
2. The method of claim 1 wherein said polymeric composition is a plastisol or latex emulsion containing a heavy metal salt dispersed uniformly therein.
3. The method of claim 2 wherein the heavy metal salt is BaSO4 having an average particle size greater than about 5 microns.
4. The method of claim 1 wherein the polymeric composition has a printable viscosity.
5. The method of claim 4 wherein the polymeric composition is a PVC plastisol containing from 15 to 70% by weight BaSO4.
6. The method of claim 4 wherein the polymeric composition is an acrylic latex emulsion containing from about 15 to 70% by weight BaSO4.
7. The method of claim 4 wherein the polymeric composition is applied to the fabric by printing means.
8. The method of claim 7 wherein said printing means is gravure or screen printing.
9. The method of claim 7 wherein said polymeric composition is applied uniformly to the fabric and the visually distinctive pattern conforms to the structure of the underlying fabric.
10. The method of claim 9 wherein said underlying fabric is a woven surgical gauze or a non-woven fabric having an open structure.
11. The method of claim 7 wherein said polymeric composition is applied to the fabric in a visually distinctive pattern determined by the printing means.
12. The method of claim 11 wherein said fabric is a closely woven or knitted structure.
13. The method of claim 1 wherein said surgical sponge is a swab or laparotomy pad.
14. A surgical sponge including an X-ray detectable marker comprising an absorbent fabric having a uniformly radiopaque polymeric composition bonded to the surface thereof in a visually distinctive pattern conforming to the structure of the underlying fabric, the pattern defined by said polymeric composition being discernable by X-ray.
15. A sponge of claim 14 wherein said fabric comprises surgical gauze or a non-woven fabric having an open structure.
16. A sponge of claim 14 wherein said radiopaque polymeric composition contains from about 60 to 85% by weight BaSO4.
17. A sponge of claim 16 wherein said BaSO4 has an average particle size greater than about 5 microns.
18. A surgical sponge including an X-ray detectable marker comprising a substantially non-apertured fabric having a uniformly radiopaque polymeric composition printed onto the surface of said fabric and bonded thereto in a visually distinctive pattern, the pattern defined by said polymeric composition being discernable by X-ray.
19. A sponge of claim 18 wherein said fabric is a closely woven or knitted material or a non-apertured non-woven fabric.
20. A sponge of claim 18 wherein said radiopaque polymeric composition contains from about 60 to 85% by weight BaSO4.
21. A sponge of claim 20 wherein said BaSO4 has an average particle size greater than about 5 microns.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US944,135 | 1978-09-20 | ||
| US06/944,135 US5045080A (en) | 1986-12-22 | 1986-12-22 | Surgical fabric with printed X-ray marker |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1293601C true CA1293601C (en) | 1991-12-31 |
Family
ID=25480856
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000554993A Expired - Lifetime CA1293601C (en) | 1986-12-22 | 1987-12-21 | Surgical fabric with printed x-ray marker |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US5045080A (en) |
| EP (1) | EP0272901B2 (en) |
| JP (1) | JPS63189150A (en) |
| AT (1) | ATE82141T1 (en) |
| AU (1) | AU8289287A (en) |
| BR (1) | BR8706967A (en) |
| CA (1) | CA1293601C (en) |
| DE (1) | DE3782633T2 (en) |
| ES (1) | ES2035868T5 (en) |
| GR (1) | GR871952B (en) |
| HK (1) | HK63893A (en) |
| IE (1) | IE60978B1 (en) |
| NZ (1) | NZ222842A (en) |
| PT (1) | PT86454B (en) |
| SG (1) | SG39593G (en) |
| ZA (1) | ZA879581B (en) |
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-
1986
- 1986-12-22 US US06/944,135 patent/US5045080A/en not_active Expired - Lifetime
-
1987
- 1987-12-08 NZ NZ222842A patent/NZ222842A/en unknown
- 1987-12-18 JP JP62319085A patent/JPS63189150A/en active Pending
- 1987-12-18 GR GR871952A patent/GR871952B/en unknown
- 1987-12-21 AT AT87311238T patent/ATE82141T1/en not_active IP Right Cessation
- 1987-12-21 ZA ZA879581A patent/ZA879581B/en unknown
- 1987-12-21 AU AU82892/87A patent/AU8289287A/en not_active Abandoned
- 1987-12-21 EP EP87311238A patent/EP0272901B2/en not_active Expired - Lifetime
- 1987-12-21 ES ES87311238T patent/ES2035868T5/en not_active Expired - Lifetime
- 1987-12-21 CA CA000554993A patent/CA1293601C/en not_active Expired - Lifetime
- 1987-12-21 DE DE3782633T patent/DE3782633T2/en not_active Expired - Lifetime
- 1987-12-21 BR BR8706967A patent/BR8706967A/en not_active IP Right Cessation
- 1987-12-21 IE IE347587A patent/IE60978B1/en not_active IP Right Cessation
- 1987-12-22 PT PT86454A patent/PT86454B/en not_active IP Right Cessation
-
1993
- 1993-04-07 SG SG395/93A patent/SG39593G/en unknown
- 1993-07-01 HK HK638/93A patent/HK63893A/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| JPS63189150A (en) | 1988-08-04 |
| EP0272901B1 (en) | 1992-11-11 |
| ES2035868T5 (en) | 1996-10-16 |
| BR8706967A (en) | 1988-07-26 |
| EP0272901B2 (en) | 1996-07-17 |
| AU8289287A (en) | 1988-06-23 |
| IE60978B1 (en) | 1994-09-07 |
| EP0272901A2 (en) | 1988-06-29 |
| HK63893A (en) | 1993-07-09 |
| GR871952B (en) | 1988-04-19 |
| EP0272901A3 (en) | 1989-08-09 |
| NZ222842A (en) | 1989-09-27 |
| US5045080A (en) | 1991-09-03 |
| DE3782633T2 (en) | 1996-12-05 |
| ZA879581B (en) | 1989-08-30 |
| SG39593G (en) | 1993-06-11 |
| DE3782633D1 (en) | 1992-12-17 |
| PT86454A (en) | 1989-01-17 |
| PT86454B (en) | 1993-08-31 |
| ES2035868T3 (en) | 1993-05-01 |
| ATE82141T1 (en) | 1992-11-15 |
| IE873475L (en) | 1988-06-22 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |