|Publication number||US3566871 A|
|Publication date||Mar 2, 1971|
|Filing date||Jun 11, 1968|
|Priority date||Jun 11, 1968|
|Publication number||US 3566871 A, US 3566871A, US-A-3566871, US3566871 A, US3566871A|
|Inventors||Charles Teets Riall, Ferdinand Joseph Richter|
|Original Assignee||American Cyanamid Co|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (9), Referenced by (59), Classifications (9)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent  Inventors Ferdinand Joseph Richter;
Charles Teets Riall, Danbury, Conn.  Appl. No. 736,181  Filed June 11, 1968 p  Patented Mar. 2, 1971  Assignee American Cyanamid Company Stamford, Conn.
 HYDROPHILIC MEDICAL SPONGE AND METHOD OF USING SAME 8 Claims, 11 Drawing Figs.
52 us. Cl 128/296 [5 1] Int. Cl. A611 13/00  Field ot'Search 128/285, 290, 296, 156
 References Cited UNITED STATES PATENTS 2,440,141 4/1948 Donovan 128/285 2,849,000 Lewing 128/285 2,880,726 4/1959 Stieg 128/285 2,884,925 5/1959 Meynier, Jr. 128/285 3,024,207 3/1962 Shaw et a1 l28/285X 3,094,494 6/1963 Hopkins et a1.. 128/285X 3,113,568 12/1963 Robins 128/296X 3,157,178 11/1964 Bentov 128/296X 3,306,966 2/1967 Matejcek et a1. 128/285X Primary Examiner-Charles F. Rosenbaum Attorney-Samuel Branch Walker ABSTRACT: A hydrophilic polyurethane sponge adapted for medical usage, in which the sponge pores contain a surfactant coating to accelerate absorption of body fluids into the pores at medically preferred rates, the fluids being retained therein by capillarity to affect removal of the fluids from the body. The sponge is flexible, and substantially free from lint, toxicity, and abrasiveness, making it particularly suitable for use as a surgical laparotomy pad.
PATENTED HAR 2 IQYI SHEET 1 0F 4 INVENTORS FERDINAND JOSEPH RICH TE R CHARLES TEETS R/ALL AGE/VT 5500/1/03 r0 AEsmE A map 0F wan (AVERAGE VALUE} P-ATENTED MAR 21971 DATA EXTRAPOLAT/ON GRAMS BLOOD RETA/NED PER GRAM OF DR) SPONGE (AVERAGE VALUE) l l l l 5 l0 /5 20 25 SURFACTANT (BASED ON OR) SPONGE WEIGHT) fIE. 5
INVENTORS F E RD/NAND JOSEPH R/GH TE R CHARLES TEETS R/ALL AGENT PATENTEU m 2m 3,666,871
SHEET 3 OF 4 CU TT/NG' INFRA -RED BLADE 8 L AMPS /4 i U ,5 /3 Y 7 FOAM PAD/OPAOUE 7 Z TRACER APPLIED l6 SURFAC TAN T I FIN/SHED SPONGE INVENTORS FERDINAND JOSEPH RICH TE R CHAgFES TEETS l-P/ALL fan/amen ddm AGENT PATENTED MAR 2 |97| SHEET 0F 4 v/// E /%r m 7 T U Nwu w R v V U4 4 P M 5 w J 0 W N B a WLY OR mm FC AGE/VT HYDROPHKLEC MEDICAL SPONGE AND METHOD OF USMJGSAME BACKGROUND OF THE lNVENTION During surgery, there is frequent need for sponging various portions of the body to remove body fluids such as blood, serum, plasma, lymph, spinal fluid, tissue fluid, urine, sweat, bile juice, and digestive juice. For example, during an initial surgical incision it is common practice to blot the incision and the area adjacent to the incision with sponges to remove blood and other fluids emanating from the incision. After entering the thoracic cavity, abdominal cavity, or other operating field, it is customary to use sponges which have been moistened in saline solution to isolate various organs from the'operating field. This is done by packing the organs with sponges to restrain them from entering the operating field and thereby interfering with the operation. The sponges are moistened in oAUzs PAD PRIOR ART At the prese'nttime, gauze padsare the most'com'nionly used medical sponges-These pads are prepared from modified cellulose or rayon and are comprised of multilayers-of sheets woven from multifilament yarns. A radiopaque marker,'such as barium sulfate dispersed in a suitable carrier, is usually attached to the pad to assist in locating the pad by X-ray it be inadvertently left in the body after surgery.
These pads have many disadvantages. Their edges often fray and they tend to shed large amounts of lint. The lint is particularly undesirable. It may pick up bacteria from nonsterile sections of the operating room and then serve as a carrier of bacteria into the exposed body cavity of the operative patient. Furthermore, the lint particles, upon entering the body cavity, may create undesirable foreign body reaction such as granulemata or adhesions, as discussed in greater detail by Sturdy et al. in Annals of Surgery 165', pgs. 128 l 34 (1967).
Dry gauze pads may accumulate electrical charges, adding to the explosion hazard in the operating room when anesthetics, such as ether, are being used.
Gauze pads, particularly when dry, are highly abrasive towards sensitive internal body organs. Since these pads are used to sponge these organs and to pack the organs during surgery, the pads are necessarily in intimate contact with the organs and can cause serious trauma to the organs because of their abrasiveness. As the pads absorb blood and other body fluids, they become progressively less pliable and harder thus tending to continue their undesirable abrasive affect upon organs even after becoming moist. In considering the seriousness of the abrasive character of gauze pads, it should be remembered that the surgeon or his assistant may reposition the pad in the course of an operation, and may frequently remove used pads and insert new ones.
During an operation, the surgeon may desire to cut a pad to a smaller size for a special use. Not only are gauze pads difficult to cut but, after cutting, they tend to fray extensively and to shed lint.
A further disadvantage of the gauze pad is the risk of cross contamination, arising from the common hospital practice of rewashing and reusing the pads several times before they are discarded. After the first laundering, the size of the pad may be reduced as much as 30 percent. Shrinking continues in subsequent washings, but at a reduced rate. The softness and flexibility progressively diminish during repeated laundering. Before pads can be reused, they must be resterilized as well as rewashed.
This invention envisions elimination of the above disadvantages by providing a novel hydrophilic polyurethane should sponge which is eminently suitable for usage in medical applications such as those described hereinabove.
POLYURETHANE SPONGE PRIOR ART tivator mixture to produce a hydrophilic foam capable of absorbing up to 3.1 grams of water per gram of dry'sponge (measured by passing the sponge over the surface of water without pressure), an amount unsuitable for useasa' medical sponge wherein water pick up of from 20 t'o'25 tirnes the dry sponge weight is desirable. US. Pat. No. 3,098,048 describes a similar procedure for preparing a'sponge containing an ethylene oxide content of 30 to percent. Unfortunately, this sponge jfoams when wetted to release surfactant over long periods'of time; clearly, such a sponge would be unsuitable for medical use, especially within a bodycavity.
.Thesecond category comprises polyurethane foams which "have been impregnated with a h ydrophilic agent For example US. Pat. No. 3,224,889 describesa foa'm whose poresare coatedwith fine silica. The sponge is "capable ofalziso rbing from 9.5 to 17 grams of water per gram of dry sponge; Were this sponge to be used in surgery, it is possible that silica solids could spill into the bodycavity and cause tissuepoisoning which could develop into silicosis. Furthermore, this sponge loses wettability when washed in hot or cold water containing fatty acids soaps, thus restricting reuse of the sponges unless special care is taken during laundering. US. Pat. No. 3,149,000 describes a polyurethane foam impregnated with polyacrolein. However, acrolein monomer is aknown body irritant and the possibility of some monomer being present in the polyacrolein would be a deterent to the medical usage of the sponge.
The third category comprises polyurethane foams impregnated with various substances for the'purpose of releasing the substance from the sponge at a controlled rate upon wetting of the sponge. Generally, thepores of such sponges are substantially filled with impregnant, the pores functioning primarily as a reservoir for the impregnant. Obviously, when the pores of the foam are so filled, any substantial inward flow of fluids such as would be required with a medical sponge, could not be achieved. This third category of polyurethane foam is amply illustrated by US. Pat. No; 3,088,158 which describes a sponge impregnated with an'emulsion' suitable for washing and waxing auto finishes upon wetting, and by US. Pat. No. 3,262,450 which describes a moistened foam containing a layer of foaming surfactants which, when repeatedly compressed, produces foam for a cleaning. purpose. Also included in this category are polyurethane foams impregnated with a germicide and soap solution, having at'least one surface sufficiently abrasive for surgical scrubbing so that upon moistening and squeezing'the sponge, foamfwill .be produced at the abrasive surface for scrubbing. US. Pat. Nol 3,002,937 describes a sponge containing zones of fine pore size and zones of much coarser pore size, the sponge containing a detergent. In addition to foaming upon wetting, the sizeof the large pores (up to one-half inch in diameter) tends to make the sponge excessively abrasive. Furthermore, these large pores, particularly when they appear-on the surface jot the sponge, will not retain fluids by capillarity whenithesponge is of retaining sufliciently large amounts of liquids, or because they foam excessively upon wetting.
The fourth category comprises polyurethane foam having an external surface coating of a detergent or disinfectant. Such a product is shown in US. Pat. No. 3,283,357 in which the polyurethane foam contains a substantially impermeable outer layer of a germicide-detergent mixture which foams upon wetting. Although the inner pores of the sponge are unfilled, access to these pores is blocked by the continuous impermeable surface layer. As a result, this sponge would be unsuitable for medical use.
SUMMARY OF THE INVENTION This invention relates to novel hydrophilic polyurethane sponges which are particularly suitable for use as medical sponges. More particularly, this invention relates to a flexible hydrophilic polyurethane foam whose surfaces are nonabrasive towards exposed internal body organs and which contains at least one zone of pores extending inwardly from a surface of the sponge. The sponge is rendered hydrophilic by a thin coating on the internal surfaces of the pores of at least one surfactant which is a nonflowable liquid at room temperature. It is important that substantially all of the internal pore surfaces be coated with surfactant to insure uniformity of fluid absorption throughout the entire zone of pores. An amount of surfactant is required which accelerates absorption of body fluids into the pores, without compression of the sponge, at a medically preferred rate, while not simultaneously causing any substantial reduction in the volume of the pores so as to interfere with the capacity of the sponge to absorb fluid.
Once fluids have entered the pores of the sponge, they are retained therein primarily by capillary action and are thereby conveniently removed from their body environment when the sponge is so removed. The sponge pores must be properly dimensioned to insure said capillary retention of fluid therein.
It is important that the surfactant be nontoxic to the body and also that it not foam when the sponge is wetted with body fluids. It is also important that there be no substantial blockage of access to the pores whereby body fluids are prevented from entering the pores.
The sponges of this invention are conveniently prepared in many different sizes and can be tagged with radiopaque markers, if desired. They can be used in a variety of surgical applications as described hereinbelow. The sponges of this invention are substantially free from toxicity, abrasiveness, and lint; they resist fraying and can be readily cut to any size desired.
Although the sponges are designed for disposibility after being used once, thereby eliminating the risk of cross contamination, they may be washed, resterilized, and reused many times without noticeable shrinkage or diminishment of their hydrophilic properties. Repeated autoclaving of the sponges, for example, enhances their surgical handleability.
Despite the presence of surfactant in the sponges, the sponges are free from a greasy texture. The sponges will rapidly absorb up to about t0 times their dry weight of fluids. Furthermore, they will absorb such fluids merely by contacting the fluids with the sponge; compression of the sponge is not required to achieve absorption.
It is an object of this invention to provide a novel hydrophilic polyurethane medical sponge which eliminates the numerous disadvantages of the currently used gauze pads as described hereinabove.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a typical disposable polyurethane sponge of this invention, the sponge having a radiopaque tracer attached thereto.
FIG. 2 is an enlarged cross sectioned view of the sponge taken along plane 2-2 of FIG. 1, and illustrates the nature of the surfactant coating upon the pore walls of the sponge.
FIG. 3 shows graphically the affect of the surfactant concentration in the sponge upon blood absorption rate and the amount of blood retained per weight of dry sponge.
FIG. 4 is a schematic diagram illustrating a preferred method of preparing the sponges of this invention.
FIGS. 5 and 6 illustrate sponge configurations which are particularly suitable for use in ophthalmic surgery.
FIG. 7 is a cubed configuration of the sponge of this invention which finds general utility in surgery.
FIGS. 8 and 9 illustrate configurations of the sponge of this invention which are particularly useful in neurosurgery.
FIG. 10 is a frontal sectional view of a patient on an operating table and illustrates usage of the sponge of this invention for the removal of body fluids during an initial surgical inci- SlOl'l.
FIG. 11 is a frontal sectional view ofa patient of an operating table and illustrates usage of the sponge of this invention for packing internal organs in the body cavity during surgery for purposes of maintaining a clear surgical field.
DESCRIPTION OF THE PREFERRED EMBODIMENTS Polyurethane foam suitable for preparing the sponges of this invention may be either the polyester or the polyether type. Polyurethane polyester foams such as those supplied by Scott Paper Company, Chester, Pa., under the names of Scott 2" or Scott O polyurethane foam, having about pores per inch, said pores being fully reticulated, i.e., open pores, are preferred. A polyurethane polyether foam such as that supplied by Nopco Chemical Co., Newark, N.J., under the name Nopco ST-l840 polyurethane foam, having about 60 to 100 pores per inch, said pores being about 60 percent reticulated, is also quite suitable. Although reticulated or nonreticulated foam is generally acceptable, 100 percent reticulated foam is preferred. Reticulated foam may be prepared by a physical or chemical reticulation process. A typical physical reticulation process involves blowing out connecting windows in the foam matrix under high pressure; a typical chemical reticulation process involves removing the connecting windows by treating the foam with a dilute aqueous caustic solution.
The size of the pores of the foam must be sufficiently small to insure retention of fluids therein substantially by capillary action. Foams having from about 60 to about pores per linear inch meet this requirement, with about 100 pores per inch representing a preferred pore density. Should the foam contain less than about 60 pores per inch, the sponge surfaces are too abrasive for medical usage and the pores are too large to retain fluid by capillary action. When foam contains more than 150 pores per inch, pore size becomes too small to permit flow of fluids into the pores at a medically preferred rate.
Since the sponges are frequently used in a bloody surgical field, it is desirable to dye the polyurethane foam a color which will offset the sponges from the surgical field. Blue and green are particularly suitable colors for this purpose and polyurethane foam dyed with these colors is readily available commercially. The dye selected should be nontoxic and generally innocuous toward living tissue.
For medical usage, it is important that the foam be extremely flexible and pliable to permit the surgeon to wrap and contour the foam around various internal organs or to otherwise use the foam to pack such organs with assurance that the foam will stay in place during the operation. To achieve the desired flexibility, coupled with the required foam free volume for adequate absorbency, foam thicknesses of from one thirtysecond to onehalf of an inch give good results with a thickness of about one-eighth of an inch preferred for many application.
An acceptable polyurethane foam typically has a void fraction of about 97 percent; were all the voids to be filled with a fluid such as water, the foam would be capable of retaining about 30 times its dry weight of water.
The sponges can be conveniently cut to a variety of sizes, the size depending on the particular application of the sponge. For example, 4" X 4 and 4" X 8" sponges are particularly suitable for sponging during an initial surgical incision. Larger size sponges are preferred for packing internal organs once the body cavity has been opened and exposed. Sponge sizes suitable for this latter purpose are 4" X 12, 4" X 30'', 14" x 14", and 16" X 16"; the 4" X 30" sponge, for example, is typically rolled into a cylindrical configuration for use in packing body organs. The other sized sponges may be similarly used, or they can be used as is, i.e. without rolling or forming into special configurations.
Sponges suitable for other types of surgery such as ophthalmic and neurosurgery, for example, are of different sizes and configurations as discussed hereinbelow.
FIG. I depicts a typical sponge of this invention. Attached to sponge 1 is a radiopaque tracer 2 to permit X-ray detection of the sponge should it be inadvertently left in the body following surgery. A suitable radiopaque tracer is a black polyvinyl chloride filament containing not less than 60 percent of X-ray grade barium sulfate. This filament is conveniently attached to polyurethane foam by conventional heat sealing techniques whereby the filament is compressed into a ribbon and affixed to the foam as shown in FIG. I. A tracer material could also be incorporated into the foam during its formation by addition of a suitable amount thereof to the reaction mixture.
The foam is rendered hydrophilic by coating the pore walls of the foam with a thin layer of a surfactant which is a nonflowable liquid at room temperature. Nonflowability eliminates the danger of the surfactant dripping out of the sponge and into the body cavity. The surfactant must be nontoxic to human tissue and, furthermore, must not foam when the sponge is wetted with water, blood, or other body fluids. Surfactants of the anionic, nonionic, and cationic variety are suitable for imparting the desired hydrophilicity to the polyurethane foam. More particularly, suifactants such as lauryl sulfate (anionic), stearamido propyldimethyl-B-hydroxyethyl ammonium nitrate (cationic), alkylaryl polyethoxylated glycol ethers (nonionic) and polyoxyethylene sorbitan mono-oleatc (nonionic) have been successfully used.
A preferred surfactant is polyoxyethylene sorbitan monooleate; this surfactant is sold by Atlas Incorporated, under the trademark of Tween-80. This surfactant is preferred because it is known to be physiologically innocuous and has already been approved by the Federal Food and Drug Administration for internal consumption in such items as food and candy. It has also been approved for use in intravenous and intramuscular pharmaceutical preparations such as those of tetracycline and chlortetracycline. This surfactant is listed under the name of Polysorbate 80 in the Merck Index, 7th ed. (1960) at pg, 833 and in the U.S. Pharmacopoeia XV at pg, 566, said publications being incorporated herein by reference.
Two important considerations arise in .determining the preferred amount of surfactant. First, sufficient surfactant must be provided to insure accelerating the absorption of body fluids into the sponge, without compression to the sponge, at a medically preferred rate. A medically preferred rate exists when there is no undue lag time between contact of the sponge with the fluid and the disappearance of the fluid into the sponge. It is difficult to precisely define such a rate since it varies depending upon the application in which the sponge is being used. For example, when a surgeon desires to have the cutting field cleared of blood during an initial surgical incision, almost instantaneous removal of blood by the sponge is required. On the other hand, when the sponge is inserted into the body cavity for purposes of preventing blood and other body fluids from cascading into the surgical field, instantaneous fluid absorption is not necessarily required provided the rate of absorption is sufficient to prevent the fluids from noticeably obscuring the surgeons view of the operating field.
The second consideration is that the free volume of the sponge must be maintained at a sufficiently high value to provide a reservoir for a substantial amount of fluid flowing into the sponge. The sponge should have the capability of absorbing at least 20 times its dry weight of water as discussed hereinabove. While increasing the surfactant concentration increases hydrophilicity of the sponge, it tends to decrease the free volume of the sponge by increasing the thickness of surfactant coating on the pore walls. This is best understood by reference to FIG. 2 which is a greatly enlarged cross-sectional view of the foam showing the network of pores 3 within sponge 1 and the thin layer of surfactant coating 4 on the walls of pores 3.
The thin continuous surfactant coating shown in FIG. 2 is ilustrative only. The natureof the coating can vary provided its function of accelerating absorption of fluids into the sponge is retained. For example, the coating could be a network of fine beads of surfactant resting on the internal pore surfaces; or it could be a continuous or partially continuous thin film of surfactant.
FIG. 3 shows graphically the effect of surfactant concentration in the sponge upon the average time required to absorb a single drop of blood, FIG. 3 also shows the effect of surfactant concentration in the sponge upon the average quantity of blood retained by the sponge. Generally, a surfactant concentration of from about 0.1 percent to about 25 percent, based on dry sponge weight, is operable. Surfactant concentrations below 2 percent, while acceptable for less demanding medical applications, would be not be generally acceptable because of the reduced rate of fluid absorption. Surfactant concentrations above 25 percent do not noticeably enhance hydrophilicity of the sponge. However, such high surfactant concentrations tend to decrease the quantity of fluid retained by the sponge and, furthermore, tend to impart an undesirable greasy texture to the sponge. A surfactant concentration of about 3 to about 15 percent, based on the dry weight of the sponge, is quite acceptable with a surfactant concentration of from about 5 to about 10 percent preferred.
Hygroscopic agents may also be incorporated with the surfactant into the foam, the purpose of such agents being to pick up sufficient moisture from the environment to impart antistatic properties to the foam thereby minimizing any explosion hazard as heretofore discussed.
Generally, any well-known nontoxic drying agent or humectant is suitable, although liquid agents are preferable because they may be readily and uniformly mixed with the liquid surfactant for convenient impregnation into the sponge. Illustrative hygroscopic agents are propylene glycol, diethylene glycol, or other homologs of glycol. A highly preferred hydroscopic agent in U.S.P. grade glycerin since it is known to be nontoxic and readily assimilable by the' body. Glycerine is listed in the Merck Index, 7th ed. (1960) at pages 489490 and in the U.S. Pharmacopoeia XV at pages 309-310, said publications herein incorporated by reference.
The hygroscopic agents have substantially no effect upon hydrophilicity of the sponge. The amount added is not critical; however, sufficient hygroscopic agent must be provided to achieve the desired degree of antistatic behavior while, at the same time, if an excessive amount of hygroscopic agent is added, the quantity of fluid retained by the sponge will be accordingly decreased due to the reduction in available pore volume, The incorporation of equal amounts of surfactant and hygroscopic agent, or of a minor amount of hygroscopic agent based on the amount of surfactant, has been found quite suitable.
Other additives, particularly germicidal and therapeutic agents such as, for example, hexachlorophene, chlorotetracycline, neomycin, and penicillin can also be incorporated into the sponges.
A preferred method for preparing the sponges of this invention is shown in FIG. 4. Referring to FIG. 8, surfactant and water are fed to mixing tank 5' where the surfactant is uniformly dispersed throughout the water. The surfactantwater dispersion is then pumped to impregnation tank 6. The radiopaque tracer is applied at 8 to a continuously advancing ribbon of polyurethane foam 7. Foam 7 advances through compression rolls 9 into impregnation bath 10 which is contained in tank 6. As foam 7 expands, bath l0 rushes into the foam pores to impregnate foam 7. Recirculating line 11 containing filter 12 is provided to remove loose pieces of foam introduced into bath 6 by the mechanical working of foam 7 by rolls 9. These loose particles must be removed to prevent their appearance in the final product. Immediately prior to emerging from bath 10, foam 7 passes through compression rolls 13 wherein a portion of impregnant is squeezed out of foam 7. Foam 7 then emerges from bath 10 and tank 6 prior to any substantial expansion thereof and passes under infrared lamps 14 whereby water is vaporized and removed from foam 7. The dry sponge is then cut by cutting blade 15 into the desired size. Sponge pieces 16 are then packaged l7 and sterilized 18.
The amount of surfactant in the final product can be controlled in several ways. The concentration of bath 10 may be fixed to insure impregnation of the required amount of surfactant into the pores of foam 7, in which case foam 7 would bypass rolls 13, proceeding directly to lamps 14 where water would be vaporized and removed. On the other hand, bath 10 may contain a higher surfactant concentration in which case foam 7 passes through rolls 13 which are preset at an experimentally determined setting whereby excessive impregnant is squeezed from foam 7 prior to removal of water by lamps 14. The latter method is preferred since less water must be evaporated with consequent savings in manufacturing costs.
Bath 10 should not contain more than about 10 percent surfactant in order to avoid imparting a greasy surface to foam 7. When it is desired to add a hygroscopic agent to the foam, the agent can be conveniently added to mixing tank along with water and surfactant to produce a uniform impregnation bath. A preferred impregnation bath composition is 95.5 percent water, 3 percent surfactant, and 1.5 percent hygroscopic agent. When a hygroscopic agent is not desired, the composition of the above bath becomes 3 percent surfactant and 97 percent water. Foam impregnation is preferably performed with bath at room temperature.
The sponges are conveniently marketed in conventional dual envelope packages wherein an inner envelope containing one or more sponges is contained in an outer strippable envelope. An illustrative package of this type is described in US. Pat. No. 2,949,181. Alternatively, the sponges can be wrapped in one or more layers of tissue paper which would then be packaged in a strippable outer envelope. Up to 8 10 pound tissue paper is satisfactory. A suitable outer envelope is a peelable bleached microporous kraft paper (up to 30 pounds) zone coated with a cold sealable adhesive.
The packaged sponges can be sterilized using conventional methods such as heat sterilization, X-rays, beta or gamma radiation, or various liquid and gaseous chemical sterilants. A preferred method of sterilization is by gaseous ethylene oxide. For example, the packaged sponges are sterilized by placing them in an oven, evacuating the oven under vacuum for 30 minutes and then filling the oven with a mixture of percent ethylene oxide and 80 percent carbon dioxide vapor for 18 hours at an oven temperature of 124 F., a pressure of 40 psia, and 50-65 percent relative humidity (steam charged to oven separately); the oven is then evacuated for 90 minutes, after which the oven pressure is raised to atmospheric pressure by the admittance of carbon dioxide. Sterile packaged sponges are then removed from the oven.
The sponge of this invention is may be cut, shaped or otherwise fabricated into various configurations suitable for a host of applications. FIG. 5 shows a sponge of suppository configuration having two slightly rounded narrow ends 19 and a relatively thick central portion 20 for grasping with the hand. Points 19, due to their small size, can be readily inserted into the eye during ophthalmic surgery to remove fluids therefrom.
FIG. 6 shows another embodiment of a sponge useful in ophthalmic surgery. The sponge 21 is in the shape of a triangular wedge having a fine point 22, which can be inserted into the eye. Sponge 21 is mounted on shaft 23 which is provided for ease of handling.
FIG. 7 is a sponge cube useful in general surgery and in a variety of other medical applications such as surgical prepping, swabbing, sponging, etc.
FIGS. 8 and 9 illustrate sponges particuarly suitable for use in neurosurgery. These sponges are typically offered in smaller sizes ranging anywhere from as small as A X 1% to as large as 3" X 3". Attached to each sponge is thread 23a which, in view of the relatively small size of these sponges, is provided for easy removal of the sponges from the operating field. Thread 23a ordinarily contains a radiopaque tracer material as a precaution.
Other sponge configurations and embodiments designed in accordance with particular medical and surgical applications also fall within the scope of this invention although not shown in this specification. For example, the sponges with a proper impervious backing can be used as a catamenial bandage or napkin to absorb menstrual fluid, or as a catamenial tampon for insertion into the vaginal cavity for a similar purpose. The sponges of this invention may also be used as aerated bandages or wound dressings. To be useful in such an application, the sponge surface in contact with the wound should not stick to the wound when the bandage is removed. Small amounts of a release agent or a nonsticking agent may be applied to the bandage surface for this purpose. Cosmetic grade silicones are effective release agents for this purpose. Other additives such as germicides and therapeutic agents may also be incorporated into such bandages.
FIG. 10 is a front sectional view of a patient 24 lying on operating table 25 and illustrates use of the sponges of this invention to remove blood and other body fluids during a surgical incision. Sponge 26 is grasped with forceps 27 by the surgeon 28 or other operating room personnel and applied to the external body surfaces 29 immediately adjacent to incision 30. Sponge 26 is also inserted into incision 30 to provide a clear cutting field for the surgeon as he continues incision 30 until he gains entry into body cavity 31.
FIG. 11 illustrates the use of the sponges of this invention within body cavity 31. Once the surgeon has gained entry into cavity 31 it is necessary to push aside internal organs 32 which cover the diseased organ. To insure that organs 32 remain out of the operative field and do not interfere with the surgery, sponges 33 are inserted into cavity 31 and packed against organs 32 to retain them in the desired position. Organs 32 may be conveniently packed either by rolling a sponge into a cylindrical configuration such as is shown at 34 or by placing the sponges directly over organs 32 without rolling or otherwise altering their configuration as shown at 35.
Prior to inserting sponges in the body cavity, the dry sponges are usually placed in a basin containing saline solution and it is desirable for the sponges to be sufficiently hydrophilic to sink immediately. Untreated polyurethane foam floats for days on the surface of such solutions; however the treated polyurethane sponges of this invention sink rapidly into the solution (see Example 3 hereinbelow). Immediately before insertion of the sponge into the body cavity, the sponge is removed from the saline solution and squeezed to remove most of the liquid. It is then inserted in the body cavity as described hereinabove. The presence of some saline solution in the sponge minimizes drying out of tissue with which the sponge comes into contact. On the other hand, the sponge retains sufficient porosity to serve as a reservoir for blood and other free flowing fluids within the body cavity which could otherwise cascade into the operating field to obscure it.
The following examples are provided to further illustrate the invention.
EXAMPLE 1 RATE OF BLOOD ABSORPTION AND QUANTITY OF BLOOD RETAINED BY THE NOVEL SPONGES Sponges were prepared in accordance with the process described above and contained varying amounts of impregnated Tweenand glycerine. The rate of blood absorption was measured by placing a drop of blood on a 4" X 4" X Va pad and measuring the time for the blood bubble to completely soak into the foam. When a drop of blood is placed on untreated polyurethane foam, it remains as a spherical bubble on the surface of the foam for about 30 minutes whereupon the blood begins to thicken and coagulate.
Blood retention of the sponges was determined by weighing a dry treated sponge, then completely wetting the sponge with blood by immersion therein, draining for 40 seconds, and then weighing to determine the amount of blood in the sponge.
Data are presented below in Table I which clearly show the rapid rate of blood absorption and high degree of blood retention demonstrated by the sponges of this invention. The relationship between surfactant concentration and the average absorption times of Table I is shown graphically in FIG. 3.
Surfactant and glycerine concentrations listed in Table I and shown in FIG. 3 were calculated by measuring the total amount of impregnant and then apportioning this amount between surfactant and glycerine based on the proportion of surfactant to glycerine in the impregnating bath used to prepare the sponges.
TABLE 1 2O Grams ofblood retained per Sponge Seconds to absorb gram of dry Sponge impregnant Number one drop of blood sponge 1 8 16 22 3--.. 18 2 8 12 5 10 29 3 4 6 5 5 27 4 11 15 17 7-- 28 5110 8.5% Tween-80; 5 15 11 14 25 4 24 5to8.5% glycerine-.- 6 9 12 16 12 4 20 g 12 6 10 60 5 2 9 24 10 25 Average value: Average value: 14 seconds 24 grams 1 4 6 3 12 5 22 2 12 5 12 15 5 23 3 3 3 4 2 3 23 4 3 4 3 5 6 23 10.5 to13.5% Tween-80; 5 5 3 4 3 3 16 10.5 to 13.5% glycerlne. 6 2 3 3 2 3 21 7 6 3 3 3 2 26 8 8 3 2 2 3 29 9 22 2 4 7 3 24 10 4 6 4 10 27 Average value: Averagevalue:
5 seconds 23.3 grams 1 2 3 2 3 2 23 2 2 3 2 3 3 17 3 4 3 3 2 3 12 4 2 3 2 3 3 24 13.4to17.4%'1ween80; 5 4 3 3 3 3 27 6.7 to 8.7% glycerine 6 2 3 3 3 2 22 7 2 2 2 3 2 22 8 5 4 3 2 2 25 9 5 3 7 3 3 15 10 3 2 3 2 2 22 Average value: Average value:
3 seconds 20.9 grams EXAMPLE2 RATE OF WATER ABSORPTION OF THE NOVEL SPONGES The hydrophilicity of the inventive sponges as indicated by rate of water absorption was demonstrated by taking four 2'' X 2" squares of untreated polyurethane foam and foam which had been prepared in accordance with the process described hereinabove, stacking the four squares vertically and placing them on the surface of 25 ml. of water in a petri dish. A penny was placed on the top of the sponges to increase their weight. The amount of time required for complete absorption of the 25 ml. of water in a petri dish. A penny was placed on the top of the sponges to increase their weight. The amount of time required for complete absorption of the 25 ml. of water was measured for both treated and untreated foam. These results are summarized in Table II and clearly show the improvement in the rate of absorption resulting when the foam is treated according to the present invention. Treated sponges in Table II contain from about 0.09 to about 1.28 percent total impregnant, i.e. Tweenand glycerine, said sponges prepared using an impregnation bath containing 1.5 percent Tween-80, 1.5 percent glycerine, and 97 percent water.
TABLE II.RATE OF ABSORPTION OF 25 ml. TAP WATER Polyurethane foam, polyester type, thick, 100 pores per inch, 100% reticulated Polyurethane foam, polyether type, 5 thick, 60-100 pores per inch, 60% reticulated *Treated, sponges impregnated with Tween-80, glycerin and water; passed through rollers and dried.
"Controls, sponges used with no treatment.
EXAMPLE 3 WETTING TIME IN WATER AND QUANTITY OF WATER RETAINED BY THE NOVEL SPONGES The quantity of water retained was measured by placing a square of both treated and untreated polyurethane foam on the surface of water. The wetting time, defined as the time required before the last corner of the square had submerged in the water, was recorded. The sample was then removed from the water, drained one minute, and weighed. The resultant data are presented in Table III and indicate that wetting time is substantially decreased with treated foam. The results further indicate that the sponges of this invention can absorb up to about 23 times their dry weight of water. Treated sponges in Table III contain from about 0.09 to about 1.28 percent total impregnant, i.e. Tween-80 and glycerine, said sponges prepared using an impregnation bath containing 1.5 percent Tween-80 1.5 percent glycerine, and 97 percent water.
TABLE III-TOTAL WATER ABSORPTION or SPONGE Polyurethane foam, polyester type, A thick, 100 pores per inch, 100% reticulated Polyurethane foam polyether type, thick, 60-100 pores per inch,
60% reticulated Weight Weight Weight water Weight water Sinking Weight before retained Weight before retained time, wet, sinking, per sponge, wet, sinking, per sponge, min-sec. grams grams grams Controls grams grams grams Controls" 23. 0 0. 22. 2 19. 8 1. 0 18. 8 17. 5 0. 8 16. 7 9. 1 0.9 18. 2 20. 5 0. 8 19. 7 22. 1 0. 9 21. 2 20.5 1. 0 19. 5 Sinking time of controls, 19. 3 1. 0 18. 3 Sinking time of controls, 20.5 0.9 19. 6 100 hours or more. 20.6 1.0 19.6 100 hours or more. 22. 5 0. 9 21. 6 20. 7 1. 0 19. 7 21. 6 0. 9 20. 7 21. 0 0. 9 20. 1 21. 1 0. 9 20. 2 20. 0 0. 9 19. 1
"Used with no treatment.
1. A hydrophilic sponge, adapted for medical usage, comprising a flexible polyurethane foam:
a. the surfaces of said foam being nonabrasive towards internal body organs;
b. said foam containing at least one zone of intercommunicating pores extending inwardly from a surface of the foam;
. said pores are of sufficiently small dimension to insure retention of body fluids therein substantially by capillarity; d. the surface of said pore zone is substantially free from obstructions which inhibit flow offluids into the pores;
e. substantially all of the internal surfaces of said pores having a coating of at least one surfactant;
. said surfactant being substantially nonfoaming when the sponge is moistened;
g. said surfactant being nontoxic to living tissue;
h. said surfactant being a nonflowing liquid at room temperature;
. the thickness of said surfactant coating being insufficient to causeasubstantial reduction in pore volume, but sufficient to initiate, without compression of said sponge, flow of body fluids in contact with said sponge into the pore volume at a medically preferred rate, said pores functioning as a reservoir for said fluids; and the quantity of surfactant is about 0.1 percent to about 25 percent by weight, based on the dry weight of the foam whereby substantial amounts of fluid, based on the dry weight of the sponge, are removable from their environment upon contact of said fluid with said pore zone and subsequent removal of the sponge from said environment. 2. The sponge ofclaim 1, having an X-ray opaque therein. 3. The sponge of claim 2, wherein the quantity of surfactant is about percent to about percent by weight, based on the dry weight of the foam, and said sponge is sterile at time of use.
4. The sponge of claim 3, wherein said surfactant contains a hygroscopic agent uniformly dispersed throughout.
5. A medical sponge package comprising a sterile enclosure containing therein the sponge of claim 2 in sterile condition.
6. A medical sponge package comprising an internally sterile strippable outer envelope containing at least one sponge, as defined in claim 2, in sterile conditions, in a sterile inner envelope, whereby on stripping the outer envelope, the separate sterilely wrapped sponges are sterilely released.
7. A hydrophilic sponge, adapted for medical usage, comprising a flexible polyurethane foam:
a. the surfaces of said foam being nonabrasive towards internal body organs;
b. said foam containing at least one zone of intercommunicating pores extending inwardly from a surface of the foam;
said pores are of sufficiently small dimension to insure retention of body fluids therein substantially by capillarity; d. the surface of said pore zone is substantially free from obstructions which inhibit flow of fluids into the pores;
e. substantially all of the internal surfaces of said pores having a coating of at least one surfactant;
said surfactant being substantially nonfoaming when the sponge is moistened;
g. said surfactant being nontoxic to living tissue;
h. said surfactant being a nonflowing liquid at room temperature;
i. the thickness of said surfactant coating being insufficient to cause a substantial reduction in pore volume, but suffcient to initiate, without compression of said sponge, flow of body fluids in contact with said sponge into the pore volume at a medically preferred rate, said pores functioning as a reservoir for said fluids;
j. the quantity of surfactant is about 5 percent to about 10 percent by weight, based on the dry weight of the foam;
k. said surfactant contains a hygroscopic agent uniformly dispersed throughout; and
l. the surfactant is polyoxyethylene sorbitan mono-oleate and the hygroscopic agent is glycerine and wherein said sponge comprises, in its entirety, a single zone of intercommunicating pores, said foam being polyurethane of the polyester type, being about percent reticulated, and having about 100 pores per inch, whereby substantial amounts of fluid, based on the dry weight of the sponge, are removable from their environment upon contact of said fluid with said pore zone and subsequent removal of the sponge from said environment.
8. The sponge of claim 7, having an X-ray opaque therein, and being sterile at time of use.
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|U.S. Classification||604/362, 604/369|
|International Classification||C08J9/40, A61L15/42|
|Cooperative Classification||C08J9/40, C08J2375/04, A61L15/425|
|European Classification||C08J9/40, A61L15/42E|