CA2060930A1 - Endoscopic surgical instrument cleaning and fog abatement composition and method - Google Patents
Endoscopic surgical instrument cleaning and fog abatement composition and methodInfo
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- CA2060930A1 CA2060930A1 CA 2060930 CA2060930A CA2060930A1 CA 2060930 A1 CA2060930 A1 CA 2060930A1 CA 2060930 CA2060930 CA 2060930 CA 2060930 A CA2060930 A CA 2060930A CA 2060930 A1 CA2060930 A1 CA 2060930A1
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- weight
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- fog
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Abstract
E???ess Mail No. 183 159 702 ENDOSCOPIC SURGICAL INSTRUMENT CLEANING
AND FOG ABATEMENT COMPOSITION AND METHOD
ABSTRACT OF THE DISCLOSURE
An endoscopic surgical instrument cleaning and fog abatement composition comprises a surfactant, an evaporator solution, and pyrogen-free water. The composition may be sterilized by gamma radiation exposure and may be thereafter screened and evaluated for free-radical concentration.
A method for abatement of fog upon an endoscopic surgical instrument includes applying the fog abatement composition onto a sterile sponge and contacting the instrument with the fog abating composition and thereafter removing excess, non-evaporated composi-tion from the instrument.
Subsequent to application of the fog abatement composition onto the surface of the instrument, the instrument may be intro-duced into a human body during endoscopic surgery without accumu-lation of fog upon the surface of the instrument.
AND FOG ABATEMENT COMPOSITION AND METHOD
ABSTRACT OF THE DISCLOSURE
An endoscopic surgical instrument cleaning and fog abatement composition comprises a surfactant, an evaporator solution, and pyrogen-free water. The composition may be sterilized by gamma radiation exposure and may be thereafter screened and evaluated for free-radical concentration.
A method for abatement of fog upon an endoscopic surgical instrument includes applying the fog abatement composition onto a sterile sponge and contacting the instrument with the fog abating composition and thereafter removing excess, non-evaporated composi-tion from the instrument.
Subsequent to application of the fog abatement composition onto the surface of the instrument, the instrument may be intro-duced into a human body during endoscopic surgery without accumu-lation of fog upon the surface of the instrument.
Description
Z~ 93~
2 (1) FIELD OF THE INVENTION: The invention is directed to an 3 endoscopic surgical instrument cleaning and fog abatement composi-4 tion; to a method of preparing such composition; a method of sur-gery using the composition and instrument; and to a method for 6 abatement of fog upon a pre-determined surface area of a surgical 7 instrument.
8 (2) BRIEF DESCRIPTION OF THE PRIOR ART: During endoscopic or 9 laryngoscopic surgery, including laparoscopy, gastroscopy or arthroscopy, a scope, probe and/or camera is inserted through the 11 human skin and into a cavity, using a cannula housing, or the like.
12 In the case of endoscopic surgery using a laparoscope, 13 surgical techniques have made it possible to conduct endoscopic 14 surgery using the laparoscope which is relatively non-invasive, without the necessity of large incisions, resulting in the 16 reduction of trauma and the risk of infection to the patient. Such 17 laparscopic surgery involves the use of several small incisions in 18 the body. Through one such incision, the surgeon introduces the 19 laparoscope, allowing the physician to insert a light source that permits the surgeon to view the interior of the body.
21 Nicrosurgical tools may also be inserted through the channel 22 without impeding the physician's vision, permitting simultaneous ; 23 viewing of the surgical area on a television monitor and .:
24 manipulation of microsurgical tools at the surgical site.
~ 25 Particularly, lasers have been adopted for use with a laparoscope :. .
~ 26 to conduct such surgery.
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8 (2) BRIEF DESCRIPTION OF THE PRIOR ART: During endoscopic or 9 laryngoscopic surgery, including laparoscopy, gastroscopy or arthroscopy, a scope, probe and/or camera is inserted through the 11 human skin and into a cavity, using a cannula housing, or the like.
12 In the case of endoscopic surgery using a laparoscope, 13 surgical techniques have made it possible to conduct endoscopic 14 surgery using the laparoscope which is relatively non-invasive, without the necessity of large incisions, resulting in the 16 reduction of trauma and the risk of infection to the patient. Such 17 laparscopic surgery involves the use of several small incisions in 18 the body. Through one such incision, the surgeon introduces the 19 laparoscope, allowing the physician to insert a light source that permits the surgeon to view the interior of the body.
21 Nicrosurgical tools may also be inserted through the channel 22 without impeding the physician's vision, permitting simultaneous ; 23 viewing of the surgical area on a television monitor and .:
24 manipulation of microsurgical tools at the surgical site.
~ 25 Particularly, lasers have been adopted for use with a laparoscope :. .
~ 26 to conduct such surgery.
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5~9"0 1 Typically, the operating room in which the surgery is per-2 formed is kept at a temperature slightly below typical room 3 temperature, i.e. about 68F., or, perhaps, lower. Consequently, 4 when such scope, camera, or other endoscopic surgical instrument is inserted into a warmer and more humid environment, i.e., an 6 abdomen, liquid vapor condensate (hereinafter referred to as "fog") 7 will collect upon the surfaces of such instrument, resulting in 8 interference with normal vision through inserted scopes, by cameras 9 and the like. Additionally, the formation of such fog upon the surface areas of such instruments also is enhanced by oil, mucous, 11 or other bodily substances and particles which may collect upon the 12 surface area of the surgical instrument, even though such instru-13 ment may have been previously sterilized prior to such surgery.
14 Such debris has a tendency to form a light, thin film upon all or a portion of the critical viewing surface of such endoscopic 16 instruments and will, accordingly, attract or enhance the 17 accumulation of fog thereon.
18 The present invention is directed to abating the problems, 19 described above.
22 The invention is directed to an endoscopic surgical instrument 23 cleaning and fog abatement composition and method. The fog abate-24 ment composition typically may comprise from between about 0.5% and about 20%, by weight of the total composition, of a succinic 26 surfactant. The succinic surfactant preferably will have the 27 formula:
~. ~
, ' 4 Rooc--c---so3Na 8 wherein R is an alkyl linear or branched chain selected from the 9 elass eonsisting of an isobutyl, hexyl, octyl, or tridecyl radical.
14 Such debris has a tendency to form a light, thin film upon all or a portion of the critical viewing surface of such endoscopic 16 instruments and will, accordingly, attract or enhance the 17 accumulation of fog thereon.
18 The present invention is directed to abating the problems, 19 described above.
22 The invention is directed to an endoscopic surgical instrument 23 cleaning and fog abatement composition and method. The fog abate-24 ment composition typically may comprise from between about 0.5% and about 20%, by weight of the total composition, of a succinic 26 surfactant. The succinic surfactant preferably will have the 27 formula:
~. ~
, ' 4 Rooc--c---so3Na 8 wherein R is an alkyl linear or branched chain selected from the 9 elass eonsisting of an isobutyl, hexyl, octyl, or tridecyl radical.
10 The eomposition also includes from between about 2% and about 30%, 11 by weight of the total composition, of a human tissue non-toxic 12 sueeinate surfactant evaporator. Such evaporator preferably com-13 prises a member selected from the class consisting of ethanol and 14 isopropanol. The eomposition also ineludes from between about 40~
15 and about 98%, by weight of the total eomposition, of pyrogen-free 16 water. The composition is sterilized, preferably by gamma 17 radiation exposure.
18 The endoscopic surgical instrument cleaning and fog abatement 19 eomposition is prepared by first introdueing into a vessel the surfaetant evaporator solution. Thereafter, the surfaetant 21 evaporator solution is admixed with said sueeinie surfaetant. The 22 surfaetant and the evaporator thereafter are introduced into a 23 vessel eontaining pyrogen-free water with mixing. Thereafter, the 24 composition is plaeed into single use paekages and the eomposition is sterilized, sueh as by exposure to gamma radiation, suffieient ~26 to destroy eontaminant baeteria therein. If gamma sterilization is 27 used, the eomposition may be sereened and tested for free radieal 28 presenee resulting from such gamma sterilization by segregating a 29 sample of the eomposition and eontacting the sample with a peroxide indieator, such as ammonium thioeyanate and ferrous iron or other 31 suitable indicator, such as potassium permanganate.
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1 ~hen it is desired to perform endoscopic surgery using a sur-2 gical instrument, a sterile sponge is applied onto a surface proxi-3 mate the area of surgery, such as a sterile drape covering the 4 patient on the operating table. The spon~e is wetted with several drops of the fog abatement composition which is applied thereto 6 from an appropriate container. The surgical instrument surface is 7 placed into contact with the fog abatement composition on the 8 sterile sponge, and a dry sterile sponge is used to remove any 9 excess, non-evaporated composition from the surface of the surgical instrument. The instrument may now be applied through the human 11 body, in conventional endoscopic surgical operations.
14 The endoscopic surgical instrument cleaning and fog abatement composition is comprised of three (3) components. The first 16 component is provided in the composition in an amount from between 17 about 0.5% and about 20% by weight of the total composition, and is 18 a mild, non-irritating surfactant, such as a succinic surfactant, 19 preferably having the formula:
23 ROOC--C---SO3Na H
27 wherein R is an alkyl linear or branched chain selected from the 28 class consisting of an isobutyl, hexyl, octyl, or tridecyl radical.
29 Numerous succinic surfactants of the formula may be utilized, such as sodium-diisobutyl sulfosuccinate; sodium dihexyl sulfosuccinate;
31 sodium-dioctyl sulfosuccinate; and sodium-ditridecyl sulfosuc-3 lI:h;11~:03~ 10~ ~rll 5 :
2~5~
l c Ite. SUCil succinic surfactants typically are anionic and may be 2 obtained commercially from a number of suppliers. Such succinic 3 surfactants typically are commercially provided in an activity from 4 between about 4s% and about ~3%. Such sulfosuccinates typically have a ph on the acid side of about 6, to neutral, and will 6 typically have a surface tension in water at 100% activity at 25~C
7 (measured in Dynes/cm.) as follows:
8ACTIVITY SU~FACE TENSION
101.00~ 26-46 110.10% 29-54 120.02% 39-64 14 Preferably, the selected succinic surfactant will be sodium-dioctyl sulfosuccinate, and will be provided in an amount of about 16 2% by weight of the total composition.
17 The second component in the endoscopic surgical instrument 18 cleaning and fog abatement composition is the succinic surfactant 19 evaporator solution. Such solution is provided in an amount from between about 2~ and about 30% by weight of the total composition.
21 Typical of such succinic surfactant evaporator components is 22 ethanol or isopropanol. Such evaporator solution may be provided ~23 with an activity from about 95% to about 99%, preferably about 99%, 24 with the balance of the solution comprising water. Preferably, the instrument cleaning and fog abatement composition will be comprised ~26 of isopropanol in an amount of about 10%, be weight of the entire 27 composition.
28 The third component in the composition is pyrogen-free water.
.
29 It has been found that simply sterilizing an aqueous solution for use in similar compositions is ineffective because, while all of hillr~:Ol<V.I(~I.~O~OI 11:48~1n 6 ;~51~93~) ~ b~lcteri~ ma~ be de~troyed, the toxins which are carried by the 2 bacteria will no~ ~e destroyed and if transmitted to a human during 3 surgery, may cause a reaction that will result in a fever, or the 4 like. Therefore, for use with the present invention, it is important that pyrogen-free water be utilized, such that the water 6 is filtered for bacteria prior to sterilization. Preferably, the 7 pyrogen-free water will be provided in an amount of about 88% by 8 weight of the total composition.
9 It is critical that the total composition formulation be non-toxic to human tissue. A determination of non-toxicity to the 11 human tissue is readily available to those skilled in the art by 12 determining the toxicity of the final solution to intraperitoneal 13 injection in rabbits.
14 It is important that the instrument cleaning and fog abatement composition be completely sterilized. For this purpose, gamma 16 radiation sterilization is preferred. The minimum and maximum 17 sterilization doses are about 1.75 MRADS and about 2.75 MRADS, 18 respectively. However, dosemetric release studies should be 19 conducted to determine proper gamma radiation dosage levels.
The endoscopic surgical instrument cleaning and fog abatement 21 composition is prepared ~y first introducing into an open vessel at 22 ambient temperature and pressure the desired amount of the 23 evaporator solution. To the evaporator solution is added the 24 selected succinic surfactant, during agitation. Thereafter, the ~25 combination of the succinic surfactant and the evaporator solution 26 are preferably transferred to a second vessel containing pyrogen-27 free water, and the agitation continued. The total co~position is :
,, .
2~ 93~) 1 ~ Iced in small single use containers with a dropper tip thereon 2 and adequately covered to assure continued sterility during shelf 3 life and prior to use. The containers are exposed to gamma 4 radiation to destroy the contaminant bacteria.
Gamma radiation sterilization in rare instances may result in 6 a division of the molecular structure of the composition, possibly 7 generating free radical molecules. Accordingly, the method of the 8 present invention contemplates testing the composition for free 9 radical presence subsequent to gamma radiation sterilization. In such tests, a determination of free radicals in the form of ozone 11 or peroxide is made. It has been determined that a satisfactory 12 product can be obtained when the free radical concentration 13 (defined as free oxygen or hydrogen peroxide) subsequent to gamma 14 radiation sterilization is 4 parts per million, or less.
In the use of the composition of the present invention during 16 a surgical procedure, a sterile sponge, such as polyester or 17 polyurethane, or the like, is used. The sponge has a pressure 18 sensitive backing for adhering to a patient's drape, and a 19 radiopaque strip to verify the location of the sponge on the x-ray in the event a sponge is not accounted for after surgery. The 21 sponge is affixed to a surgical drape by means of the pressure 22 sensitive backing. Thereafter, several drops of the surgical 23 instrument cleaning and fog abatement composition of the present 24 invention are applied to the sponge. The selected surgical instrument surface, such as the end of a scope, lens of a camera, 26 or the like, is contacted with the composition on the sponge. A
27 sterile gauze or other absorbing material may be utilized to remove ~ 97 ~
1 a non-evaporated composition from the surface of the surgical 2 instrument by a light ~kiss~ of the surface of the gauze to the 3 instrument surface.
4 The following examples further illustrate the present invention:
6 EXAMPLE I.
7 The present example demonstrates a preferred procedure to 8 prepare the composition of the present invention.
9 99% U.S.P. isopropanol is added at ambient temperature and pressure to a stainless steel mixing vessel in an amount of about 11 10% by weight of the total composition. Thereafter, 2% sodium 12 dioctyl sulfosuccinate is added to the mixing vessel under agita-13 tion. In a separate stainless steel mixing vessel is added 14 sterile pyrogen-free water in an amount of 88% by weight of the total composition. The content of the first mixing vessel is added 16 to the second vessel and admixed therewith until the composition is 17 clear.
19 The present example demonstrates a preferred procedure for determining the existence of free radicals within the gamma 2} radiation sterilized composition of the present invention.
22 The composition of Example I is sterilized using gamma ;~23 radiation. The material is tested for the existence of free ~24 radicals; by comparing the color of a hydrogen peroxide indicator ~25 after mixture with a sample of the composition. Free radical 26 concentration is determined by the use of a pre-made set of color 27 comparator tubes.
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EXAMPLE I I I
2 The procedure utilizing Example I is followed, with a 3 percentage of additives, as follows: 2% sodium-dioctyl sulfo-4 succinate; 5% isopropanol; and 88% pyrogen-free water. The sample is sterilized and the free radical test is performed as in Example 6 II.
8 The procedure described in Example I is utilized to prepare a g composition having the following percentages of additives: 2%
sodium dioctyl sulfosuccinate; 15% isopropanol; and 88% pyrogen-11 free water. The composition is sterilized, and tested for free 12 radicals, as in Example II.
14 The present Example demonstrates an actual test which has been performed to determine non-toxicity of the composition of the 16 present invention to human tissue. As stated previously, it is 17 critical to the present invention that the total composition be 18 non-toxic to human tissue. Such a determination is made by using 19 a 72 hour acute intraperitoneal toxicity study in the albino rabbit. A sample of the composition made in Example I is dosed by 21 intraperitoneal injection, at a dose of 0.5ml per animal, into a 22 test group of six female albino rabbits. In addition, a group of ~23 three female rabbits is dosed using the same procedure, with a . ~
24 solution of sterile 0.9 sodium chloride injection, USP.
The rabbits were ~ to 12 weeks old and weighed from 2.02 to 26 2.96 kilograms at the start of the study. They were individually 27 housed in a stainless steel cage in a temperature, humidity and :::
'.~
.' ', ~ ' .
1 l ~nt control]ed room. The rabbits were maintained according to 2 recommendations contained in the DHS Publication Number 86-23(NIH):
3 Revised 1985, "Guide for the Care and Use of Laboratory Animals."
4 They were conditioned for at least four days prior to study initiation. Purina~ Rabbit Chow and water were available ad 6 libitum during the conditioning and the test. All animals used for 7 this study were considered to be in good health at the start of th~
8 study, and individually identified by ear tags.
9 Six female rabbits were selected as the experimental test group. The test material was prepared as in Example 1 and was 11 injected into the abdomen of the test animals at a dose of 0.5ml 12 per rabbit. An additional group of 3 rabbits was selected as a 13 control group and dosed using the same procedure with the solution 14 of sterile 0.9 sodium chloride injection.
All animals were observed frequently following dosing, and 16 twice daily during the three day observation period. Following the 17 72 hour observation period, all animals were sacrificed by lethal 18 injection and subjected to a gross necropsy. There were no signs 19 of toxicity observed in any of the animals in the experimental group or in the control group during the 72 hour observation 21 period. All animals were sacrificed as per schedule and subjected ~22 to a gross necropsy. There were no gross changes observed in the 23 organs of the thorax and abdomen in any of the animals in the 24 experimental or control groups.
EXAMPLE VI
26 The present Example demonstrates the ability of the present 27 composition to clean the surface of the selected instrument and 2~9~
1 a~ _e fog thereon. compositions containing the amount of additives 2 as in Example I, III and IV, each are prepared and sterilized and 3 tested for free radicals. Each of these materials is separately 4 applied to the surface of a sterile sponge and the surface of a laproscopic lens is contacted to the sponge to permit the 6 composition to be applied to the surface of the surgical 7 instrument. Excess non-evaporated composition is removed from the 8 surface of the surgical instrument by touching a sterile gauze g lightly to the surface of the endoscopic lens. The application of the composition to the sterile sponge surface and the contact of 11 such sterile surface sponge to the surface of the surgical 12 instrument is conducted at a temperature of approximately 72C.
13 After the procedure, described above, the surgical instrument 14 is exposed to an increased humidity and temperature environment by introducing same through a cannula housing and into the interior of 16 a human body, during endoscopic surgery. The absence of the 17 accumulation of fog upon the surface of the surgical instrument is 18 readily apparent by visual inspection, and satisfactory surgical 19 procedure is performed in a fog-free environment relative to the instrument.
21 Although the invention has been described in terms of speci-22 fied embodiments which are set forth in detail, it should be under-23 stood that this is by illustration only and that the invention is ~24 not necessarily limited thereto, since alternative embodiments and ~Z5 operating techniques will become apparent to those skilled in the 26 art in view of the disclosure. Accordingly, modifications are ~.C<i311:~Dbl1~}c~ m 12 1 c templated which can be made without departing from the spirit of 2 the described invention.
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bilLIl:03~ 391~ 4 .
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1 ~hen it is desired to perform endoscopic surgery using a sur-2 gical instrument, a sterile sponge is applied onto a surface proxi-3 mate the area of surgery, such as a sterile drape covering the 4 patient on the operating table. The spon~e is wetted with several drops of the fog abatement composition which is applied thereto 6 from an appropriate container. The surgical instrument surface is 7 placed into contact with the fog abatement composition on the 8 sterile sponge, and a dry sterile sponge is used to remove any 9 excess, non-evaporated composition from the surface of the surgical instrument. The instrument may now be applied through the human 11 body, in conventional endoscopic surgical operations.
14 The endoscopic surgical instrument cleaning and fog abatement composition is comprised of three (3) components. The first 16 component is provided in the composition in an amount from between 17 about 0.5% and about 20% by weight of the total composition, and is 18 a mild, non-irritating surfactant, such as a succinic surfactant, 19 preferably having the formula:
23 ROOC--C---SO3Na H
27 wherein R is an alkyl linear or branched chain selected from the 28 class consisting of an isobutyl, hexyl, octyl, or tridecyl radical.
29 Numerous succinic surfactants of the formula may be utilized, such as sodium-diisobutyl sulfosuccinate; sodium dihexyl sulfosuccinate;
31 sodium-dioctyl sulfosuccinate; and sodium-ditridecyl sulfosuc-3 lI:h;11~:03~ 10~ ~rll 5 :
2~5~
l c Ite. SUCil succinic surfactants typically are anionic and may be 2 obtained commercially from a number of suppliers. Such succinic 3 surfactants typically are commercially provided in an activity from 4 between about 4s% and about ~3%. Such sulfosuccinates typically have a ph on the acid side of about 6, to neutral, and will 6 typically have a surface tension in water at 100% activity at 25~C
7 (measured in Dynes/cm.) as follows:
8ACTIVITY SU~FACE TENSION
101.00~ 26-46 110.10% 29-54 120.02% 39-64 14 Preferably, the selected succinic surfactant will be sodium-dioctyl sulfosuccinate, and will be provided in an amount of about 16 2% by weight of the total composition.
17 The second component in the endoscopic surgical instrument 18 cleaning and fog abatement composition is the succinic surfactant 19 evaporator solution. Such solution is provided in an amount from between about 2~ and about 30% by weight of the total composition.
21 Typical of such succinic surfactant evaporator components is 22 ethanol or isopropanol. Such evaporator solution may be provided ~23 with an activity from about 95% to about 99%, preferably about 99%, 24 with the balance of the solution comprising water. Preferably, the instrument cleaning and fog abatement composition will be comprised ~26 of isopropanol in an amount of about 10%, be weight of the entire 27 composition.
28 The third component in the composition is pyrogen-free water.
.
29 It has been found that simply sterilizing an aqueous solution for use in similar compositions is ineffective because, while all of hillr~:Ol<V.I(~I.~O~OI 11:48~1n 6 ;~51~93~) ~ b~lcteri~ ma~ be de~troyed, the toxins which are carried by the 2 bacteria will no~ ~e destroyed and if transmitted to a human during 3 surgery, may cause a reaction that will result in a fever, or the 4 like. Therefore, for use with the present invention, it is important that pyrogen-free water be utilized, such that the water 6 is filtered for bacteria prior to sterilization. Preferably, the 7 pyrogen-free water will be provided in an amount of about 88% by 8 weight of the total composition.
9 It is critical that the total composition formulation be non-toxic to human tissue. A determination of non-toxicity to the 11 human tissue is readily available to those skilled in the art by 12 determining the toxicity of the final solution to intraperitoneal 13 injection in rabbits.
14 It is important that the instrument cleaning and fog abatement composition be completely sterilized. For this purpose, gamma 16 radiation sterilization is preferred. The minimum and maximum 17 sterilization doses are about 1.75 MRADS and about 2.75 MRADS, 18 respectively. However, dosemetric release studies should be 19 conducted to determine proper gamma radiation dosage levels.
The endoscopic surgical instrument cleaning and fog abatement 21 composition is prepared ~y first introducing into an open vessel at 22 ambient temperature and pressure the desired amount of the 23 evaporator solution. To the evaporator solution is added the 24 selected succinic surfactant, during agitation. Thereafter, the ~25 combination of the succinic surfactant and the evaporator solution 26 are preferably transferred to a second vessel containing pyrogen-27 free water, and the agitation continued. The total co~position is :
,, .
2~ 93~) 1 ~ Iced in small single use containers with a dropper tip thereon 2 and adequately covered to assure continued sterility during shelf 3 life and prior to use. The containers are exposed to gamma 4 radiation to destroy the contaminant bacteria.
Gamma radiation sterilization in rare instances may result in 6 a division of the molecular structure of the composition, possibly 7 generating free radical molecules. Accordingly, the method of the 8 present invention contemplates testing the composition for free 9 radical presence subsequent to gamma radiation sterilization. In such tests, a determination of free radicals in the form of ozone 11 or peroxide is made. It has been determined that a satisfactory 12 product can be obtained when the free radical concentration 13 (defined as free oxygen or hydrogen peroxide) subsequent to gamma 14 radiation sterilization is 4 parts per million, or less.
In the use of the composition of the present invention during 16 a surgical procedure, a sterile sponge, such as polyester or 17 polyurethane, or the like, is used. The sponge has a pressure 18 sensitive backing for adhering to a patient's drape, and a 19 radiopaque strip to verify the location of the sponge on the x-ray in the event a sponge is not accounted for after surgery. The 21 sponge is affixed to a surgical drape by means of the pressure 22 sensitive backing. Thereafter, several drops of the surgical 23 instrument cleaning and fog abatement composition of the present 24 invention are applied to the sponge. The selected surgical instrument surface, such as the end of a scope, lens of a camera, 26 or the like, is contacted with the composition on the sponge. A
27 sterile gauze or other absorbing material may be utilized to remove ~ 97 ~
1 a non-evaporated composition from the surface of the surgical 2 instrument by a light ~kiss~ of the surface of the gauze to the 3 instrument surface.
4 The following examples further illustrate the present invention:
6 EXAMPLE I.
7 The present example demonstrates a preferred procedure to 8 prepare the composition of the present invention.
9 99% U.S.P. isopropanol is added at ambient temperature and pressure to a stainless steel mixing vessel in an amount of about 11 10% by weight of the total composition. Thereafter, 2% sodium 12 dioctyl sulfosuccinate is added to the mixing vessel under agita-13 tion. In a separate stainless steel mixing vessel is added 14 sterile pyrogen-free water in an amount of 88% by weight of the total composition. The content of the first mixing vessel is added 16 to the second vessel and admixed therewith until the composition is 17 clear.
19 The present example demonstrates a preferred procedure for determining the existence of free radicals within the gamma 2} radiation sterilized composition of the present invention.
22 The composition of Example I is sterilized using gamma ;~23 radiation. The material is tested for the existence of free ~24 radicals; by comparing the color of a hydrogen peroxide indicator ~25 after mixture with a sample of the composition. Free radical 26 concentration is determined by the use of a pre-made set of color 27 comparator tubes.
, ;~55~9~
EXAMPLE I I I
2 The procedure utilizing Example I is followed, with a 3 percentage of additives, as follows: 2% sodium-dioctyl sulfo-4 succinate; 5% isopropanol; and 88% pyrogen-free water. The sample is sterilized and the free radical test is performed as in Example 6 II.
8 The procedure described in Example I is utilized to prepare a g composition having the following percentages of additives: 2%
sodium dioctyl sulfosuccinate; 15% isopropanol; and 88% pyrogen-11 free water. The composition is sterilized, and tested for free 12 radicals, as in Example II.
14 The present Example demonstrates an actual test which has been performed to determine non-toxicity of the composition of the 16 present invention to human tissue. As stated previously, it is 17 critical to the present invention that the total composition be 18 non-toxic to human tissue. Such a determination is made by using 19 a 72 hour acute intraperitoneal toxicity study in the albino rabbit. A sample of the composition made in Example I is dosed by 21 intraperitoneal injection, at a dose of 0.5ml per animal, into a 22 test group of six female albino rabbits. In addition, a group of ~23 three female rabbits is dosed using the same procedure, with a . ~
24 solution of sterile 0.9 sodium chloride injection, USP.
The rabbits were ~ to 12 weeks old and weighed from 2.02 to 26 2.96 kilograms at the start of the study. They were individually 27 housed in a stainless steel cage in a temperature, humidity and :::
'.~
.' ', ~ ' .
1 l ~nt control]ed room. The rabbits were maintained according to 2 recommendations contained in the DHS Publication Number 86-23(NIH):
3 Revised 1985, "Guide for the Care and Use of Laboratory Animals."
4 They were conditioned for at least four days prior to study initiation. Purina~ Rabbit Chow and water were available ad 6 libitum during the conditioning and the test. All animals used for 7 this study were considered to be in good health at the start of th~
8 study, and individually identified by ear tags.
9 Six female rabbits were selected as the experimental test group. The test material was prepared as in Example 1 and was 11 injected into the abdomen of the test animals at a dose of 0.5ml 12 per rabbit. An additional group of 3 rabbits was selected as a 13 control group and dosed using the same procedure with the solution 14 of sterile 0.9 sodium chloride injection.
All animals were observed frequently following dosing, and 16 twice daily during the three day observation period. Following the 17 72 hour observation period, all animals were sacrificed by lethal 18 injection and subjected to a gross necropsy. There were no signs 19 of toxicity observed in any of the animals in the experimental group or in the control group during the 72 hour observation 21 period. All animals were sacrificed as per schedule and subjected ~22 to a gross necropsy. There were no gross changes observed in the 23 organs of the thorax and abdomen in any of the animals in the 24 experimental or control groups.
EXAMPLE VI
26 The present Example demonstrates the ability of the present 27 composition to clean the surface of the selected instrument and 2~9~
1 a~ _e fog thereon. compositions containing the amount of additives 2 as in Example I, III and IV, each are prepared and sterilized and 3 tested for free radicals. Each of these materials is separately 4 applied to the surface of a sterile sponge and the surface of a laproscopic lens is contacted to the sponge to permit the 6 composition to be applied to the surface of the surgical 7 instrument. Excess non-evaporated composition is removed from the 8 surface of the surgical instrument by touching a sterile gauze g lightly to the surface of the endoscopic lens. The application of the composition to the sterile sponge surface and the contact of 11 such sterile surface sponge to the surface of the surgical 12 instrument is conducted at a temperature of approximately 72C.
13 After the procedure, described above, the surgical instrument 14 is exposed to an increased humidity and temperature environment by introducing same through a cannula housing and into the interior of 16 a human body, during endoscopic surgery. The absence of the 17 accumulation of fog upon the surface of the surgical instrument is 18 readily apparent by visual inspection, and satisfactory surgical 19 procedure is performed in a fog-free environment relative to the instrument.
21 Although the invention has been described in terms of speci-22 fied embodiments which are set forth in detail, it should be under-23 stood that this is by illustration only and that the invention is ~24 not necessarily limited thereto, since alternative embodiments and ~Z5 operating techniques will become apparent to those skilled in the 26 art in view of the disclosure. Accordingly, modifications are ~.C<i311:~Dbl1~}c~ m 12 1 c templated which can be made without departing from the spirit of 2 the described invention.
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Claims
THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
(1) An endoscopic surgical instrument cleaning and fog abate-ment composition, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic sur-factant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a mem-ber selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure.
(2) The composition of Claim 1 wherein the succinic surfact-ant is sodium-dioctyl sulfosuccinate.
(3) The composition of Claim 1, comprising: (a) about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) a? ?t 88%, by weight of the total composition, of pyrogen-free water.
(4) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel containing said succinate surfactant and said evaporator solution from between about 40% and about 98%, by weight of the total com-position, of pyrogen-free water; and (d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to destroy contaminant bacteria therein.
(5) The method of Claim 4 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(6) The method of Claim 4 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(7) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40%
and about 98%, by weight of the total composition, of pyrogen-free water;
(d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to sub-stantially destroy contaminant bacteria therein; and (e) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contact-ing said sample with a peroxide indicator and measuring the level of ozone or peroxide in said sample.
(8) The method of Claim 7 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(9) The method of Claim 7 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sul-fosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(10) An endoscopic surgical instrument cleaning and fog abate-ment composition, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure, said composition containing no more than about four (4) parts per million of free radical ozone or peroxide.
(11) The composition of Claim 10 wherein the succinic sur-factant is sodium-dioctyl sulfosuccinate.
(12) The composition of Claim 10 comprising: about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(13) A surgery method including the steps of abating the formation of fog upon an endoscopic surgical instrument when said instrument is introduced into a human body cavity during surgery, said surgery method comprising the steps of:
(1) contacting a pre-determined surface area on said surgical instrument with a fog abating amount of a composition comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure; and (2) introducing said surgical instrument subsequent to performance of step "(1)" into the human body cavity.
(14) The method of Claim 13 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(15) The method of Claim 13 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(16) A method for abatement of fog upon a predetermined surface area of an endoscopic surgical instrument, comprising the steps of:
(1) applying a sterile sponge onto a surface proximate the area of surgery;
(2) wetting said sponge with a fog abatement composi-tion, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure;
(3) contacting said predetermined surface area of said surgical instrument with the fog abating composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(17) The method of Claim 16 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(18) The method of Claim 16 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(19) A method for abatement of fog upon a predetermined surface area of an endoscopic surgical instrument, comprising the steps of:
(1) applying a sterile sponge onto a surface proximate the area of surgery;
(2) wetting said sponge with a fog abatement composition;
(3) contacting said predetermined surface area of said surgical instrument with the fog abatement composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(20) The method of Claim 19 wherein the fog abatement composition comprises a succinic surfactant.
(21) The method of Claim 19 wherein the surfactant is sodium dioctyl sulfosuccinate.
(22) The method of Claim 19 wherein the fog abatement composi-tion comprises: about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of total composition, of pyrogen-free water, said total composition being sterilized by gamma radiation exposure.
(23) The method of Claim 19 wherein the fog abatement composition comprises: a succinic surfactant; an evaporator solution for said surfactant; and pyrogen-free water, said composition being sterilized by gamma radiation exposure.
(24) A method for abatement of fog upon a predetermined surface of an endoscopic surgical instrument, comprising the steps of:
(1) applying a sterile sponge onto a surface proximate the area of surgery;
(2) wetting said sponge with a fog abatement composition comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water;
(3) contacting said predetermined surface area of said surgical instrument with the fog abating composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(25) The method of Claim 23 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(26) The method of Claim 23 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water, said total composition being sterilized by gamma radiation exposure.
(27) An endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water.
(28) The composition of Claim 26 wherein the succinic surfact-ant is sodium-dioctyl sulfosuccinate.
(29) The composition of Claim 26, comprising: (a) about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, of pyrogen-free water.
(30) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 0.5%
and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl or tridecyl radical;
(b) adding to said succinate surfactant in said vessel from between about 2% and about 30%, by weight of the total com-position, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40% and about 98%, by weight of the total composition, pyrogen-free water;
(d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein; and (e) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample.
(31) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel containing said succinate surfactant and said evaporator solution from between about 40% and about 98%, by weight of the total com-position, of pyrogen-free water;
(d) introducing said composition into single use containers; and (e) sterilizing said composition in said containers by exposing said composition to gamma radiation sufficient to destroy contaminant bacteria therein.
(32) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40%
and about 98%, by weight of the total composition, of pyrogen-free water;
(d) introducing said composition into single use containers;
(e) sterilizing said composition in said containers by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein; and (f) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample.
(33) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 0.5%
and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl or tridecyl radical;
(b) adding to said succinate surfactant in said vessel from between about 2% and about 30%, by weight of the total com-osition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40% and about 98%, by weight of the total composition, pyrogen-free water;
(d) introducing said composition into single use containers;
(e) sterilizing said composition in said containers by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein; and (f) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample.
(34) A method for abatement of fog upon a predetermined surface area of an endoscopic surgical instrument, comprising the steps of:
(1) wetting a sterile sponge with a fog abatement composition;
(2) applying said sponge onto a surface proximate the area of surgery;
(3) contacting said predetermined surface area of said surgical instrument with the fog abatement composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(35) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 0.5%
and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl or tridecyl radical;
(b) adding to said succinate surfactant in said vessel from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40% and about 98%, by weight of the total composition, pyrogen-free water;
(d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein;
(e) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample; and (f) applying said fog abatement composition onto a sterile surface for contact with said endoscopic surgical instrument proximate the area of surgery.
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
(1) An endoscopic surgical instrument cleaning and fog abate-ment composition, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic sur-factant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a mem-ber selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure.
(2) The composition of Claim 1 wherein the succinic surfact-ant is sodium-dioctyl sulfosuccinate.
(3) The composition of Claim 1, comprising: (a) about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) a? ?t 88%, by weight of the total composition, of pyrogen-free water.
(4) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel containing said succinate surfactant and said evaporator solution from between about 40% and about 98%, by weight of the total com-position, of pyrogen-free water; and (d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to destroy contaminant bacteria therein.
(5) The method of Claim 4 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(6) The method of Claim 4 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(7) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40%
and about 98%, by weight of the total composition, of pyrogen-free water;
(d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to sub-stantially destroy contaminant bacteria therein; and (e) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contact-ing said sample with a peroxide indicator and measuring the level of ozone or peroxide in said sample.
(8) The method of Claim 7 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(9) The method of Claim 7 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sul-fosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(10) An endoscopic surgical instrument cleaning and fog abate-ment composition, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure, said composition containing no more than about four (4) parts per million of free radical ozone or peroxide.
(11) The composition of Claim 10 wherein the succinic sur-factant is sodium-dioctyl sulfosuccinate.
(12) The composition of Claim 10 comprising: about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(13) A surgery method including the steps of abating the formation of fog upon an endoscopic surgical instrument when said instrument is introduced into a human body cavity during surgery, said surgery method comprising the steps of:
(1) contacting a pre-determined surface area on said surgical instrument with a fog abating amount of a composition comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure; and (2) introducing said surgical instrument subsequent to performance of step "(1)" into the human body cavity.
(14) The method of Claim 13 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(15) The method of Claim 13 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(16) A method for abatement of fog upon a predetermined surface area of an endoscopic surgical instrument, comprising the steps of:
(1) applying a sterile sponge onto a surface proximate the area of surgery;
(2) wetting said sponge with a fog abatement composi-tion, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water, said composition being sterilized by gamma radiation exposure;
(3) contacting said predetermined surface area of said surgical instrument with the fog abating composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(17) The method of Claim 16 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(18) The method of Claim 16 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water.
(19) A method for abatement of fog upon a predetermined surface area of an endoscopic surgical instrument, comprising the steps of:
(1) applying a sterile sponge onto a surface proximate the area of surgery;
(2) wetting said sponge with a fog abatement composition;
(3) contacting said predetermined surface area of said surgical instrument with the fog abatement composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(20) The method of Claim 19 wherein the fog abatement composition comprises a succinic surfactant.
(21) The method of Claim 19 wherein the surfactant is sodium dioctyl sulfosuccinate.
(22) The method of Claim 19 wherein the fog abatement composi-tion comprises: about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of total composition, of pyrogen-free water, said total composition being sterilized by gamma radiation exposure.
(23) The method of Claim 19 wherein the fog abatement composition comprises: a succinic surfactant; an evaporator solution for said surfactant; and pyrogen-free water, said composition being sterilized by gamma radiation exposure.
(24) A method for abatement of fog upon a predetermined surface of an endoscopic surgical instrument, comprising the steps of:
(1) applying a sterile sponge onto a surface proximate the area of surgery;
(2) wetting said sponge with a fog abatement composition comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water;
(3) contacting said predetermined surface area of said surgical instrument with the fog abating composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(25) The method of Claim 23 wherein the succinic surfactant is sodium-dioctyl sulfosuccinate.
(26) The method of Claim 23 wherein the composition comprises:
about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, pyrogen-free water, said total composition being sterilized by gamma radiation exposure.
(27) An endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) from between about 0.5% and about 20%, by weight of the total composition, of a succinic surfactant, having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl, or tridecyl radical;
(b) from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic, succinic surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol; and (c) from between about 40% and about 98%, by weight of the total composition, of pyrogen-free water.
(28) The composition of Claim 26 wherein the succinic surfact-ant is sodium-dioctyl sulfosuccinate.
(29) The composition of Claim 26, comprising: (a) about 2%, by weight of the total composition, sodium-dioctyl sulfosuccinate; (b) about 10%, by weight of the total composition, isopropanol; and (c) about 88%, by weight of the total composition, of pyrogen-free water.
(30) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 0.5%
and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl or tridecyl radical;
(b) adding to said succinate surfactant in said vessel from between about 2% and about 30%, by weight of the total com-position, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40% and about 98%, by weight of the total composition, pyrogen-free water;
(d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein; and (e) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample.
(31) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel containing said succinate surfactant and said evaporator solution from between about 40% and about 98%, by weight of the total com-position, of pyrogen-free water;
(d) introducing said composition into single use containers; and (e) sterilizing said composition in said containers by exposing said composition to gamma radiation sufficient to destroy contaminant bacteria therein.
(32) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 2%
and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(b) adding to said succinate surfactant evaporator in said vessel from between about 0.5% and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl and tridecyl radical;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40%
and about 98%, by weight of the total composition, of pyrogen-free water;
(d) introducing said composition into single use containers;
(e) sterilizing said composition in said containers by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein; and (f) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample.
(33) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 0.5%
and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl or tridecyl radical;
(b) adding to said succinate surfactant in said vessel from between about 2% and about 30%, by weight of the total com-osition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40% and about 98%, by weight of the total composition, pyrogen-free water;
(d) introducing said composition into single use containers;
(e) sterilizing said composition in said containers by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein; and (f) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample.
(34) A method for abatement of fog upon a predetermined surface area of an endoscopic surgical instrument, comprising the steps of:
(1) wetting a sterile sponge with a fog abatement composition;
(2) applying said sponge onto a surface proximate the area of surgery;
(3) contacting said predetermined surface area of said surgical instrument with the fog abatement composition on said sponge; and (4) removing excess, non-evaporated composition from said predetermined surface of said surgical instrument.
(35) A method of preparing an endoscopic surgical instrument cleaning and fog abatement composition, comprising:
(a) introducing into a vessel from between about 0.5%
and about 20%, by weight of the total composition, a succinate surfactant having the formula:
wherein R is an alkyl linear or branched chain selected from the class consisting of an isobutyl, hexyl, octyl or tridecyl radical;
(b) adding to said succinate surfactant in said vessel from between about 2% and about 30%, by weight of the total composition, of a human tissue non-toxic succinate surfactant evaporator solution comprising a member selected from the class consisting of ethanol and isopropanol;
(c) admixing in a vessel said succinate surfactant and said evaporator solution, and from between about 40% and about 98%, by weight of the total composition, pyrogen-free water;
(d) sterilizing said total composition by exposing said composition to gamma radiation sufficient to substantially destroy contaminant bacteria therein;
(e) screening and testing said composition for free radical presence resulting from said gamma sterilization by segregating a sample of said composition and contacting said sample with an indicator to measure the level of free ozone or peroxide in said sample; and (f) applying said fog abatement composition onto a sterile surface for contact with said endoscopic surgical instrument proximate the area of surgery.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US681,113 | 1984-12-13 | ||
| US68111391A | 1991-04-05 | 1991-04-05 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2060930A1 true CA2060930A1 (en) | 1992-10-06 |
Family
ID=24733885
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2060930 Abandoned CA2060930A1 (en) | 1991-04-05 | 1992-02-10 | Endoscopic surgical instrument cleaning and fog abatement composition and method |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2060930A1 (en) |
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7976501B2 (en) | 2007-12-07 | 2011-07-12 | Ethicon Endo-Surgery, Inc. | Trocar seal with reduced contact area |
| US8100929B2 (en) | 2007-06-29 | 2012-01-24 | Ethicon Endo-Surgery, Inc. | Duckbill seal with fluid drainage feature |
| US8568362B2 (en) | 2008-04-28 | 2013-10-29 | Ethicon Endo-Surgery, Inc. | Surgical access device with sorbents |
| US8579807B2 (en) | 2008-04-28 | 2013-11-12 | Ethicon Endo-Surgery, Inc. | Absorbing fluids in a surgical access device |
| US8636686B2 (en) | 2008-04-28 | 2014-01-28 | Ethicon Endo-Surgery, Inc. | Surgical access device |
| USD700326S1 (en) | 2008-04-28 | 2014-02-25 | Ethicon Endo-Surgery, Inc. | Trocar housing |
| US8690831B2 (en) | 2008-04-25 | 2014-04-08 | Ethicon Endo-Surgery, Inc. | Gas jet fluid removal in a trocar |
| US8870747B2 (en) | 2008-04-28 | 2014-10-28 | Ethicon Endo-Surgery, Inc. | Scraping fluid removal in a surgical access device |
| US9033929B2 (en) | 2008-04-28 | 2015-05-19 | Ethicon Endo-Surgery, Inc. | Fluid removal in a surgical access device |
| US9358041B2 (en) | 2008-04-28 | 2016-06-07 | Ethicon Endo-Surgery, Llc | Wicking fluid management in a surgical access device |
| US11235111B2 (en) | 2008-04-28 | 2022-02-01 | Ethicon Llc | Surgical access device |
-
1992
- 1992-02-10 CA CA 2060930 patent/CA2060930A1/en not_active Abandoned
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8100929B2 (en) | 2007-06-29 | 2012-01-24 | Ethicon Endo-Surgery, Inc. | Duckbill seal with fluid drainage feature |
| US8771307B2 (en) | 2007-06-29 | 2014-07-08 | Ethicon Endo-Surgery, Inc. | Duckbill seal with fluid drainage feature |
| US8672890B2 (en) | 2007-12-07 | 2014-03-18 | Ethicon Endo-Surgery, Inc. | Trocar seal with reduced contact area |
| US7976501B2 (en) | 2007-12-07 | 2011-07-12 | Ethicon Endo-Surgery, Inc. | Trocar seal with reduced contact area |
| US8690831B2 (en) | 2008-04-25 | 2014-04-08 | Ethicon Endo-Surgery, Inc. | Gas jet fluid removal in a trocar |
| US8636686B2 (en) | 2008-04-28 | 2014-01-28 | Ethicon Endo-Surgery, Inc. | Surgical access device |
| USD700326S1 (en) | 2008-04-28 | 2014-02-25 | Ethicon Endo-Surgery, Inc. | Trocar housing |
| US8579807B2 (en) | 2008-04-28 | 2013-11-12 | Ethicon Endo-Surgery, Inc. | Absorbing fluids in a surgical access device |
| US8568362B2 (en) | 2008-04-28 | 2013-10-29 | Ethicon Endo-Surgery, Inc. | Surgical access device with sorbents |
| US8870747B2 (en) | 2008-04-28 | 2014-10-28 | Ethicon Endo-Surgery, Inc. | Scraping fluid removal in a surgical access device |
| US9033929B2 (en) | 2008-04-28 | 2015-05-19 | Ethicon Endo-Surgery, Inc. | Fluid removal in a surgical access device |
| USD735852S1 (en) | 2008-04-28 | 2015-08-04 | Ethicon Endo-Surgery, Inc. | Fluid remover |
| USD736926S1 (en) | 2008-04-28 | 2015-08-18 | Ethicon Endo-Sugery, Inc. | Trocar housing |
| US9358041B2 (en) | 2008-04-28 | 2016-06-07 | Ethicon Endo-Surgery, Llc | Wicking fluid management in a surgical access device |
| US9827383B2 (en) | 2008-04-28 | 2017-11-28 | Ethicon Llc | Surgical access device |
| US11235111B2 (en) | 2008-04-28 | 2022-02-01 | Ethicon Llc | Surgical access device |
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