Title:
Surgical sponge
United States Patent 3911922
Abstract:
A surgical sponge is made of a porous fabric coated on both sides with an aqueous liquid absorbing flexible foamed polymer. The sponge also contains an X-ray detectable material.
US Patent References:
Reinforced tear-resistant material
Lappala - September 1961 - 2999041
Process of forming a cured foam rubber layer having a textile fabric embedded therein
House - November 1961 - 3007205
SURGICAL SPONGE AND METHOD OF PRODUCING SAME
Brownlee - October 1967 - 3464415
HYDROPHILIC MEDICAL SPONGE AND METHOD OF USING SAME
Richter - March 1971 - 3566871
/3669786.html
Moore - June 1972 - 3669786
Reinforced tear-resistant material
Lappala - September 1961 - 2999041
Process of forming a cured foam rubber layer having a textile fabric embedded therein
House - November 1961 - 3007205
SURGICAL SPONGE AND METHOD OF PRODUCING SAME
Brownlee - October 1967 - 3464415
HYDROPHILIC MEDICAL SPONGE AND METHOD OF USING SAME
Richter - March 1971 - 3566871
/3669786.html
Moore - June 1972 - 3669786
Application Number:
05/478334
Publication Date:
10/14/1975
Filing Date:
06/11/1974
View Patent Images:
Export Citation:
Primary Class:
Other Classes:
604/375, 604/369, 604/372, 604/370, 428/159, 604/371
International Classes:
A61F13/44; A61B19/00; A61F13/00
Field of Search:
128/296,290,154,152 161/159-161
US Patent References:
Primary Examiner:
Gaudet, Richard A.
Assistant Examiner:
Layton, Henry S.
Attorney, Agent or Firm:
Cushman, Darby & Cushman
Claims:
What is claimed is
1. A surgical sponge comprising an intermediate reinforcing layer having laminated to both sides thereof a layer of an aqueous liquid absorbing flexible, water-insoluble foamed polymer, said sponge having disposed therein an X-ray opaque material whereby the presence of the sponge can be detected by X-ray if it is accidentally left in a patient.
2. A surgical sponge according to claim 1, wherein the X-ray detectable material is present in a fiber adjacent the reinforcing layer and held in place by one of said foamed polymer layers.
3. A surgical sponge according to claim 2 having a degree of stretch in each direction of not over 10 percent and a rebound to within 2 percent of its original shape, said sponge being strong in all directions, tightly adhered and non-friable along the edges.
4. A surgical sponge according to claim 3 wherein the X-ray detectable material containing fiber extends substantially along the length of the sponge, said sponge also having handle means attached thereto.
5. A surgical sponge according to claim 4 wherein the foamed polymer is an open-celled thermoplastic polyurethane foam.
6. A surgical sponge according to claim 5 wherein the reinforcing layer is a fabric layer.
7. A surgical sponge according to claim 6 wherein said fabric layer is a cotton gauze fabric.
8. A surgical sponge according to claim 7 wherein the X-ray opaque material is a barium sulfate containing polyvinyl chloride fiber and the handle means is a loop handle.
9. A surgical sponge according to claim 8 wherein the foamed polymer layers include a surfactant.
10. A surgical sponge according to claim 1 wherein the X-ray opaque material is disposed adjacent the fabric layer and the foamed polymer is an open-celled polyurethane foam.
11. A surgical sponge comprising an intermediate reinforcing layer having laminated to both sides thereof a flexible polyurethane foam, said polyurethane foam being characterized by (i) an open cell structure ranging from 50 to 110 cells per linear inch, (ii) a density no greater than 10 cubic pounds per cubic foot, (iii) a capability of being stretched up to ten percent without rupture and substantially returning to its original dimensions upon release of the stretching pressure, and (iv) an ability to absorb and retain an amount of water which is at least 1.5 times the weight of water absorbed by cotton gauze pads of comparable dimensions; said sponge containing an X-ray detectable material therein.
12. A polyurethane sponge according to claim 11 wherein said open cell structure is in the range of from 70 to 100 cells per linear inch, wherein said density is in the range of from 2 to 7 pounds per cubic foot, and wherein said foam is characterized by an ability to absorb and retain an amount of water which is at least twice the weight of water absorbed by cotton gauze of comparable dimensions.
1. A surgical sponge comprising an intermediate reinforcing layer having laminated to both sides thereof a layer of an aqueous liquid absorbing flexible, water-insoluble foamed polymer, said sponge having disposed therein an X-ray opaque material whereby the presence of the sponge can be detected by X-ray if it is accidentally left in a patient.
2. A surgical sponge according to claim 1, wherein the X-ray detectable material is present in a fiber adjacent the reinforcing layer and held in place by one of said foamed polymer layers.
3. A surgical sponge according to claim 2 having a degree of stretch in each direction of not over 10 percent and a rebound to within 2 percent of its original shape, said sponge being strong in all directions, tightly adhered and non-friable along the edges.
4. A surgical sponge according to claim 3 wherein the X-ray detectable material containing fiber extends substantially along the length of the sponge, said sponge also having handle means attached thereto.
5. A surgical sponge according to claim 4 wherein the foamed polymer is an open-celled thermoplastic polyurethane foam.
6. A surgical sponge according to claim 5 wherein the reinforcing layer is a fabric layer.
7. A surgical sponge according to claim 6 wherein said fabric layer is a cotton gauze fabric.
8. A surgical sponge according to claim 7 wherein the X-ray opaque material is a barium sulfate containing polyvinyl chloride fiber and the handle means is a loop handle.
9. A surgical sponge according to claim 8 wherein the foamed polymer layers include a surfactant.
10. A surgical sponge according to claim 1 wherein the X-ray opaque material is disposed adjacent the fabric layer and the foamed polymer is an open-celled polyurethane foam.
11. A surgical sponge comprising an intermediate reinforcing layer having laminated to both sides thereof a flexible polyurethane foam, said polyurethane foam being characterized by (i) an open cell structure ranging from 50 to 110 cells per linear inch, (ii) a density no greater than 10 cubic pounds per cubic foot, (iii) a capability of being stretched up to ten percent without rupture and substantially returning to its original dimensions upon release of the stretching pressure, and (iv) an ability to absorb and retain an amount of water which is at least 1.5 times the weight of water absorbed by cotton gauze pads of comparable dimensions; said sponge containing an X-ray detectable material therein.
12. A polyurethane sponge according to claim 11 wherein said open cell structure is in the range of from 70 to 100 cells per linear inch, wherein said density is in the range of from 2 to 7 pounds per cubic foot, and wherein said foam is characterized by an ability to absorb and retain an amount of water which is at least twice the weight of water absorbed by cotton gauze of comparable dimensions.
Description:
The present invention relates to a surgical sponge.
Cotton gauze is generally employed as a surgical sponge. However, it must normally be used in plural thickness, e.g., a dozen layers. Furthermore, it has the disadvantage that it produces linting. Also there is no means of detecting the sponge if it is accidentally left in the patent after an operation.
According to the present invention, there is provided a surgical sponge comprising an intermediate reinforcing layer such as textile fabric or perforated plastic film having on both sides thereof an aqueous liquid absorbing flexible, water-insoluble foamed polymer. There is also provided an X-ray detectable material, e.g., barium sulfate powder in a polyvinyl chloride medium is included in the foamed laminate, preferably next to the gauze itself, so that in the event the sponge is left in the human body it can be detected by X-ray techniques before (or after) closing the incision.
The preferred novel foamed pads are characterized by (i) an open cell structure ranging from 50 to 110, preferably from 70 to 100 cells (or pores) per linear inch, (ii) a density no greater than 10 pounds per cubic foot, desirably from 2 to 7 pounds per cubic foot, and preferably from about 2.5 to 5 pounds per cubic foot, (iii) a capability of being stretched (elongated) by as much as 10 percent, and even 15 percent, without tearing or ripping, and upon release of the stretching pressure substantially returning to its original dimensions, e.g., to within 2-30percent of its normal shape, and (iv) an ability to absorb and retain an amount of water which is at least 1.5, preferably 2, times the weight of water absorbed by cotton gauze pads of comparable dimensions; said foam pads containing an X-ray detectable material therein. The noval foamed pad is flexible, soft to hand touch, non-shrinking when dry, and non-toxic to human body. A laminate according to the invention 2' × 2' having a thickness of 1/16 inch to 1/4 inch, e.g., 1/8to inch, has the absorption capacity of approximately 12 layers of a conventional gauze.
As intimated above, the laminated product of the present invention is strong in all directions, tightly adhered and nonfriable along the edges. When wet it has a soft, pliable structure which can be used internally as a surgical sponge which contains no contamination and is acceptable as a surgical sponge. It has a better hand than a conventional surgical sponge. The reinforcing layer can be any fabric layer of porous or open weave structure, e.g., it can be in the nature of gauze, cheesecloth, birdseye linen, and can be woven, e.g., gauze, loose-woven sheeting, woven scrim, loose woven cloth, knit or non-woven, e.g., spun-laced non-woven fabric or non-woven scrim fabric and can be made of cotton, viscose, rayon, e.g., cellulose acetate rayon, nylon, wool, flax, polyester, e.g., polyethylene terephthalate, polyacrylonitrile, polypropylene, polyethylene or other material. It can also be a perforated plastic film. Preferably, it is made of cotton. The foamed polymer of the sponge is preferably an open cell sponge. Preferably, it is a polyurethane sponge. The flexible polyurethane foam can be made in conventional fashion either by a step-wise procedure (pre-polymer formation) or by the one shot technique by reacting a polyol with a polyisocyanate. The polyol can be any compound containing at least 2 hydroxyl groups, preferably two hydroxyl groups, or the equivalent, e.g., polyether polyester or polylactone. A small amount of a polyol of higher functionality can be included with the diol, e.g., polyoxyethylated glycerine molecular weight 1000 or polyoxyethylated trimethylol propane or polyoxyethylated 1,2,6-hexanetriol. The polyol preferably has a molecular weight of 500 to 5000 and even higher. Thus, there can be used diols such as polyethylene glycol molecular weights of 500, 1000, 1500 2000, 2500, 3000, 4000, or 5000 or polypropylene glycol molecular weights of 500, 1000, 2025, 3000, 4000 or 5000 and other polyether diols as well as polyesters of molecular weights 500-5000, e.g., polymerized diethylene glycol adipate molecular weight 1,000-3500, preferably 2000, polyethylene glycol adipate-maleate of molecular weight 500-5000, ethylene glycol-propylene glycol-pimelate polyester molecular weight 500-5000, etc. Any conventional diisocyanate can be employed to make the polyurethane, e.g., toluene diisocyanate, p,p'-diisocyanatodiphenyl methane. Typical examples of suitable polyurethane sponges of both the polyester and polyether types are set forth in Blair U.S. Pat. No. 3,806,474, Examples 1, 2 and 3. The entire disclosure of Blair is hereby incorporated by reference. At present, polyurethanes prepared from either a polyether polyol or polyester polyol and toluene diisocyanate are preferred. Tailor-made properties can be achieved by fabricating the foamed pad from components containing polyether blocks or segments and as well polyester blocks or segments.
To decrease the surface tension and increase the wettability of the sponge, it can be pre-treated with a surfactant, e.g., Tween 80 (polyoxyethylene sorbitan monooleate containing 20 ethylene oxide units), or Igepon AC-78 (coconut oil acids ester of sodium isethionate). The surfactant (or mixture of surfactants) is used in an amount of 1-10 percent by weight of the sponge. The surfactant can be present during formation of the sponge or can be applied to the finished sponge.
The polyurethane sponge is preferably flame laminated to the porous textile fabric. Each sponge layer, for example, can be 1/32 inch or they can be slightly thinner or they can be thicker, e.g., 1/8 inch or even thicker.
In place of the polyurethane sponge there can be used any other flexible, thermoplastic sponge, preferably open-celled which does not dissolve or disintegrate in water, i.e., is relatively hydrolytically stable. Thus, there can be used foams of polyethylene, polyvinyl alcohol modified, e.g., with acetal groups such as formed groups to render it water insoluble, polypropylene, polyvinyl chloride, hydroxyethylmethacrylate polymer, etc. The foam must be one which is capable of absorbing water.
Flame lamination is the preferred way of adhering the foam layers to the fabric. Various non-toxic adhesives may also be used including an adhesive which contains the X-ray detectable material. The intermediate layer, e.g., fabric layer, acts as reinforcement for the foam.
The novel laminate desirably does not stretch more than 15 percent, preferably not more than 10 percent, in any direction and for optimum results it should rebound to within a few percent of its normal shape, e.g., 2-3 percent.
As the X-ray detectable, i.e., X-ray opaque, material, barium sulfate is preferred but there can be employed any other medically acceptable X-ray opaque indicators suitable for use in the human body such as carbon, e.g., finely divided, bismuth trioxide powder, verr finely divided particles of stainless steel or tantalum, etc. The X-ray detectable material is provided next to the gauze or other fabric and is preferably supplied adhered to a thermoplastic fiber, e.g., polyvinyl chloride, nylon, polyethylene, polypropylene, polyethylene terephthalate, polyacrylonitrile, polyvinylidene chloride, polytetrafluoroethylene, etc. The particles of barium sulfate or other X-ray detectable material can be adhered to the thermoplastic fiber when it is in the heated softened condition or simply can be mixed with the fiber forming material prior to extrusion so that the X-ray opaque material is homogeneously distributed throughout the fiber.
The X-ray detectable material containing fiber can be of the thickness of a pencil lead for example and it can be simply placed on the reinforcing member fabric, e.g., prior to the flame lamination of the foam or a plurality of such fibers can be dispersed at random on the fabric.
Desirably the surgical sponge is provided with a handle, e.g., a loop made of cloth or other material, which can be sewn or otherwise secured to the laminate at a corner or along one of the edges.
The invention will be understood best in connection with the drawings wherein:
FIG. 1 is a perspective view, partially broken away in section showing a surgical sponge according to the invention; and
FIG. 2 is a fragmentary perspective view illustrating a preferred form of the invention.
Referring more specifically to the drawings wherein like numerals indicate like parts, there is shown a surgical sponge approximately 1' × 1' designated generically as 2 composed of an intermediate cotton gauze fabric layer 4 having flame laminated thereto polyester polyurethane open cell foam layers 6 and 8. The foam layers are each about 1/32 inch and the overall thickness of the sponge about 1/16 inch. There are provided on the surface of the gauze layer 4 cut polyvinyl chloride fibers 10 having dispersed throughout finely divided barium sulfate designated as 12. At one side of the sponge there is attached a handle 16 by stitching through the foam layers.
As shown in FIG. 2 rather than a plurality of polyvinyl chloride fibers there is provided a single barium sulfate loaded extrude polyvinyl chloride fiber 14 running substantially the entire length of the sponge on one side of the fabric layer 4 and having the appearance of a pencil lead. The polyvinyl chloride fiber has a diameter of about 1/64 inch.
The X-ray detectable material containing film is held in place by one of the foamed polymer layers.
The surgical sponge of the invention will imbibe fluid during surgery. Before closing the wound a simple X-ray scan will reveal whether the sponge has accidentally been left in the body.
The sponges of the present invention are capable of being compressed in a liquid medium, e.g., aqueous liquid such as water, blood or other body fluids, and upon releasing the compression, absorbing the surrounding liquid therein.
The sponges of the present invention can be readily sterilized, e.g., by heat, steam, gas, radiation, etc., either before or after packaging. They can be packaged in bags or other containers either in dry form or they can be packaged in bags or other containers containing water or other aqueous or non-aqueous liquid.
Cotton gauze is generally employed as a surgical sponge. However, it must normally be used in plural thickness, e.g., a dozen layers. Furthermore, it has the disadvantage that it produces linting. Also there is no means of detecting the sponge if it is accidentally left in the patent after an operation.
According to the present invention, there is provided a surgical sponge comprising an intermediate reinforcing layer such as textile fabric or perforated plastic film having on both sides thereof an aqueous liquid absorbing flexible, water-insoluble foamed polymer. There is also provided an X-ray detectable material, e.g., barium sulfate powder in a polyvinyl chloride medium is included in the foamed laminate, preferably next to the gauze itself, so that in the event the sponge is left in the human body it can be detected by X-ray techniques before (or after) closing the incision.
The preferred novel foamed pads are characterized by (i) an open cell structure ranging from 50 to 110, preferably from 70 to 100 cells (or pores) per linear inch, (ii) a density no greater than 10 pounds per cubic foot, desirably from 2 to 7 pounds per cubic foot, and preferably from about 2.5 to 5 pounds per cubic foot, (iii) a capability of being stretched (elongated) by as much as 10 percent, and even 15 percent, without tearing or ripping, and upon release of the stretching pressure substantially returning to its original dimensions, e.g., to within 2-30percent of its normal shape, and (iv) an ability to absorb and retain an amount of water which is at least 1.5, preferably 2, times the weight of water absorbed by cotton gauze pads of comparable dimensions; said foam pads containing an X-ray detectable material therein. The noval foamed pad is flexible, soft to hand touch, non-shrinking when dry, and non-toxic to human body. A laminate according to the invention 2' × 2' having a thickness of 1/16 inch to 1/4 inch, e.g., 1/8to inch, has the absorption capacity of approximately 12 layers of a conventional gauze.
As intimated above, the laminated product of the present invention is strong in all directions, tightly adhered and nonfriable along the edges. When wet it has a soft, pliable structure which can be used internally as a surgical sponge which contains no contamination and is acceptable as a surgical sponge. It has a better hand than a conventional surgical sponge. The reinforcing layer can be any fabric layer of porous or open weave structure, e.g., it can be in the nature of gauze, cheesecloth, birdseye linen, and can be woven, e.g., gauze, loose-woven sheeting, woven scrim, loose woven cloth, knit or non-woven, e.g., spun-laced non-woven fabric or non-woven scrim fabric and can be made of cotton, viscose, rayon, e.g., cellulose acetate rayon, nylon, wool, flax, polyester, e.g., polyethylene terephthalate, polyacrylonitrile, polypropylene, polyethylene or other material. It can also be a perforated plastic film. Preferably, it is made of cotton. The foamed polymer of the sponge is preferably an open cell sponge. Preferably, it is a polyurethane sponge. The flexible polyurethane foam can be made in conventional fashion either by a step-wise procedure (pre-polymer formation) or by the one shot technique by reacting a polyol with a polyisocyanate. The polyol can be any compound containing at least 2 hydroxyl groups, preferably two hydroxyl groups, or the equivalent, e.g., polyether polyester or polylactone. A small amount of a polyol of higher functionality can be included with the diol, e.g., polyoxyethylated glycerine molecular weight 1000 or polyoxyethylated trimethylol propane or polyoxyethylated 1,2,6-hexanetriol. The polyol preferably has a molecular weight of 500 to 5000 and even higher. Thus, there can be used diols such as polyethylene glycol molecular weights of 500, 1000, 1500 2000, 2500, 3000, 4000, or 5000 or polypropylene glycol molecular weights of 500, 1000, 2025, 3000, 4000 or 5000 and other polyether diols as well as polyesters of molecular weights 500-5000, e.g., polymerized diethylene glycol adipate molecular weight 1,000-3500, preferably 2000, polyethylene glycol adipate-maleate of molecular weight 500-5000, ethylene glycol-propylene glycol-pimelate polyester molecular weight 500-5000, etc. Any conventional diisocyanate can be employed to make the polyurethane, e.g., toluene diisocyanate, p,p'-diisocyanatodiphenyl methane. Typical examples of suitable polyurethane sponges of both the polyester and polyether types are set forth in Blair U.S. Pat. No. 3,806,474, Examples 1, 2 and 3. The entire disclosure of Blair is hereby incorporated by reference. At present, polyurethanes prepared from either a polyether polyol or polyester polyol and toluene diisocyanate are preferred. Tailor-made properties can be achieved by fabricating the foamed pad from components containing polyether blocks or segments and as well polyester blocks or segments.
To decrease the surface tension and increase the wettability of the sponge, it can be pre-treated with a surfactant, e.g., Tween 80 (polyoxyethylene sorbitan monooleate containing 20 ethylene oxide units), or Igepon AC-78 (coconut oil acids ester of sodium isethionate). The surfactant (or mixture of surfactants) is used in an amount of 1-10 percent by weight of the sponge. The surfactant can be present during formation of the sponge or can be applied to the finished sponge.
The polyurethane sponge is preferably flame laminated to the porous textile fabric. Each sponge layer, for example, can be 1/32 inch or they can be slightly thinner or they can be thicker, e.g., 1/8 inch or even thicker.
In place of the polyurethane sponge there can be used any other flexible, thermoplastic sponge, preferably open-celled which does not dissolve or disintegrate in water, i.e., is relatively hydrolytically stable. Thus, there can be used foams of polyethylene, polyvinyl alcohol modified, e.g., with acetal groups such as formed groups to render it water insoluble, polypropylene, polyvinyl chloride, hydroxyethylmethacrylate polymer, etc. The foam must be one which is capable of absorbing water.
Flame lamination is the preferred way of adhering the foam layers to the fabric. Various non-toxic adhesives may also be used including an adhesive which contains the X-ray detectable material. The intermediate layer, e.g., fabric layer, acts as reinforcement for the foam.
The novel laminate desirably does not stretch more than 15 percent, preferably not more than 10 percent, in any direction and for optimum results it should rebound to within a few percent of its normal shape, e.g., 2-3 percent.
As the X-ray detectable, i.e., X-ray opaque, material, barium sulfate is preferred but there can be employed any other medically acceptable X-ray opaque indicators suitable for use in the human body such as carbon, e.g., finely divided, bismuth trioxide powder, verr finely divided particles of stainless steel or tantalum, etc. The X-ray detectable material is provided next to the gauze or other fabric and is preferably supplied adhered to a thermoplastic fiber, e.g., polyvinyl chloride, nylon, polyethylene, polypropylene, polyethylene terephthalate, polyacrylonitrile, polyvinylidene chloride, polytetrafluoroethylene, etc. The particles of barium sulfate or other X-ray detectable material can be adhered to the thermoplastic fiber when it is in the heated softened condition or simply can be mixed with the fiber forming material prior to extrusion so that the X-ray opaque material is homogeneously distributed throughout the fiber.
The X-ray detectable material containing fiber can be of the thickness of a pencil lead for example and it can be simply placed on the reinforcing member fabric, e.g., prior to the flame lamination of the foam or a plurality of such fibers can be dispersed at random on the fabric.
Desirably the surgical sponge is provided with a handle, e.g., a loop made of cloth or other material, which can be sewn or otherwise secured to the laminate at a corner or along one of the edges.
The invention will be understood best in connection with the drawings wherein:
FIG. 1 is a perspective view, partially broken away in section showing a surgical sponge according to the invention; and
FIG. 2 is a fragmentary perspective view illustrating a preferred form of the invention.
Referring more specifically to the drawings wherein like numerals indicate like parts, there is shown a surgical sponge approximately 1' × 1' designated generically as 2 composed of an intermediate cotton gauze fabric layer 4 having flame laminated thereto polyester polyurethane open cell foam layers 6 and 8. The foam layers are each about 1/32 inch and the overall thickness of the sponge about 1/16 inch. There are provided on the surface of the gauze layer 4 cut polyvinyl chloride fibers 10 having dispersed throughout finely divided barium sulfate designated as 12. At one side of the sponge there is attached a handle 16 by stitching through the foam layers.
As shown in FIG. 2 rather than a plurality of polyvinyl chloride fibers there is provided a single barium sulfate loaded extrude polyvinyl chloride fiber 14 running substantially the entire length of the sponge on one side of the fabric layer 4 and having the appearance of a pencil lead. The polyvinyl chloride fiber has a diameter of about 1/64 inch.
The X-ray detectable material containing film is held in place by one of the foamed polymer layers.
The surgical sponge of the invention will imbibe fluid during surgery. Before closing the wound a simple X-ray scan will reveal whether the sponge has accidentally been left in the body.
The sponges of the present invention are capable of being compressed in a liquid medium, e.g., aqueous liquid such as water, blood or other body fluids, and upon releasing the compression, absorbing the surrounding liquid therein.
The sponges of the present invention can be readily sterilized, e.g., by heat, steam, gas, radiation, etc., either before or after packaging. They can be packaged in bags or other containers either in dry form or they can be packaged in bags or other containers containing water or other aqueous or non-aqueous liquid.