Bhaskar, Surindar N. (Bethesda, MD)
Cutright, Duane E. (Chevy Chase, MD)
Gross, Arthur (Silver Spring, MD)

05/218950

09/11/1973

01/19/1972

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The United States of America as represented by the Secretary of the Army (Washington, DC)

134/191

134/200, 134/34, 134/36, 134/199, 601/166

A61C17/028; A61H35/00; A61B19/00; A61C17/00; B08B3/02; A61H33/00

134/1,34,36,199 128/66,366,368,370 15/320,21D 239/101 21/2,61

3687369	CLEANING APPARATUS	August 1972	Johnstone
3517676	QUENCH APPARATUS FOR PROVIDING PULSATING AND SWEEPING FLOW OF QUENCH FLUID	June 1970	Paddock
3699984	CLEANING AND STERILIZING DEVICE	October 1972	Davis

Scovronek, Joseph

Hagan, Tim

We claim

1. A lavage device for hands and arms comprising:

2. A lavage device for hands and arms comprising:

3. a substantially cylinder-like outer wall having at least one inlet for receiving a washing fluid,

4. a substantially cylinder-like inner wall having multiple inwardly directed outlet openings for discharging a washing fluid,

5. a boundary wall joining the edges of said outer wall and said inner wall in a mutually spaced relationship, and

6. terminal portions of corresponding ends of said outer wall and said inner wall of said washing chamber turned inwardly toward the longitudinal axis of said washing chamber;

7. The lavage device of claim 2 in which the entrance to said washing chamber is closed with a flexible material so that an object to be washed is inserted in said washing chamber through said flexible material.

8. A lavage device for hands and arms comprising:

9. an arcuate outer wall having an inlet for receiving a washing fluid,

10. an arcuate inner wall having multiple inwardly directed openings for discharging a washing fluid,

11. boundary walls joining the edges of said outer wall and said inner wall in a mutually spaced relationship, and

12. terminal portions of corresponding ends of each of said manifold units being turned inwardly toward the longitudinal axis of said washing chamber;

13. The lavage device of claim 4 in which said washing chamber comprises at least three of the specified manifold units circumferentially arranged.

14. The lavage device of claim 4 in which said washing chamber is securely positioned within an enclosure means adapted so that an object to be washed may be inserted in said washing chamber, said enclosure means having drain means for removing discharged washing fluid.

15. The lavage device of claim 6 in which said enclosure means has an entrance which is closed with a flexible material so that an object to be washed is inserted in said washing chamber through said entrance.

16. A lavage device for hands and arms comprising:

17. a substantially cylinder-like outer wall having at least one inlet for receiving a washing fluid,

18. a substantially cylinder-like inner wall having multiple inwardly directed outlet openings for discharging a washing fluid,

19. boundary walls joining the edges of said outer wall and said inner wall in a mutually spaced relationship, and

20. terminal portions of corresponding ends of said outer wall and said inner wall of each of said washing chambers being turned inwardly toward the longitudinal axis of each of said washing chambers;

21. The lavage device of claim 8 in which the entrance to each of said washing chambers is closed with a flexible material so that objects to be washed are inserted in said washing chambers through said flexible material.

22. A lavage device for hands and arms comprising:

23. an arcuate outer wall having an inlet for receiving a washing fluid,

24. an arcuate inner wall having multiple inwardly directed outlet openings for discharging a washing fluid,

25. boundary walls joining the edges of said outer wall and said inner wall in a mutually spaced relationship, and

26. terminal portions of corresponding ends of each of said manifold units being turned inwardly toward the longitudinal axis of each of said washing chambers;

27. The lavage device of claim 10 in which each of said washing chambers comprises at least three of the specified manifold units circumferentially arranged.

28. The lavage device of claim 10 in which said washing chambers are securely positioned within an enclosure means adapted so that objects to be washed may be inserted in each of said washing chambers, said enclosure means having drain means for removing discharged washing fluid.

29. The lavage device of claim 12 in which said enclosure means has an entrance before each of said washing chambers, each of said entrances being partially closed with a flexible material so that objects to be washed may be inserted in each of said washing chambers through said entrances.

30. A lavage device for hands and arms comprising:

The invention described herein may be manufactured and used by, or for, the Government without the payment to us of any royalty thereon.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to the field of lavage devices which employ jets of pressurized fluid.

2. Description of the Prior Art

Spray type washing machines are known. For example, U.S. Pat. No. 2,666,439 to L. D. Bechtol describes a spray type washing machine adapted to receive a basket of objects (such as eggs) and to wash the objects in the basket. Bechtol describes a structure comprising a plurality of spray pipes situated in a tank, each of the pipes having two legs disposed at right angles to each other.

Lavage devices which employ jets of pressurized fluid are known in the field of oral hygiene. For example, U.S. Pat. Nos. 3,227,158 and 3,393,673, to J. W. Mattingly, describe a method and apparatus for oral hygiene employing pulse jets of fluid. The Mattingly '158 patent has a discussion of the relationship of the principal factors affecting the evaluation of a pulsed jet for oral hygiene.

In the field of surgical washing, a patient's survival often depends on whether he can endure the 10 minutes of waiting while the surgical team scrubs before entering the operating room. Despite the time factor, the presurgical cleansing of the hands of surgeons and operatory personnel has changed little during the twentieth century. Although there have been many different chemicals and drugs used, the actual method of scrubbing with a brush and dipping into different solutions has not changed. Currently, preparations containing hexachlorophene or iodine are often used for presurgical scrubbing. The typical presurgical scrub requires a minimum of 5 minutes to a maximum of 15 minutes according to the type and duration of the planned operation. This diligent scrubbing is time consuming and irritating to the skin. Further, the results are often variable due to differences in length of scrub, diligence of the scrub and the type and amount of detergent or disinfectant used. This scrubbing removes the transient surface bacteria quite readily but has little effect upon the resident bacteria present in the follicles and skin depressions. These bacteria multiply on the gloved hand and may act as contaminants during surgery. Hence, the problems inherent in presurgical scrubs include the following:

1. Time consuming.

2. Resident bacteria not removed.

3. Bacteria not removed from beneath and around fingernails.

4. Long scrubs are irritating to tissue.

5. Sensitivity of individuals to disinfectants and detergents.

In other fields, such as the electronics industry and the aerospace industry, the cleanliness of the hands is of technological importance. Hence, in these fields, the aforementioned disadvantages of conventional manual scrubbing will also be inherent.

SUMMARY OF THE INVENTION

The present invention is a lavage device comprising a curvilinear manifold means arranged about a longitudinal axis, said manifold means including fluid inlet means and fluid outlet means, a pump means for pumping with pulsating pressure a washing fluid, and a supply means for conveying the washing fluid from the pump means to the manifold means. The washing fluid may be a mixture of water, detergents and antiseptic fluids. In operation, the hand is inserted in the device and washed by the pulsating jets of pressurized washing fluid discharged by the manifold means. If desired, the device may be adapted to provide a final rinse cycle of water without antiseptic fluids or detergents.

Accordingly, it is an object of this invention to provide a lavage device using pulsating jets of pressurized washing fluid for the purpose of quickly preparing personnel where cleanliness of the hands is of critical importance.

It is another object of this invention to provide a process for washing comprising the steps of inserting the object to be washed in a washing chamber comprising a curvilinear manifold means arranged about a longitudinal axis, and subjecting the object to be washed to pulsating jets of a washing fluid discharged from the manifold means.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the pulsating hydrojet lavage device partially cut away to show the interior construction of the lavage device, and also showing one type of washing chamber which may be used in the lavage device;

FIG. 2 is a longitudinal vertical cross-sectional view of one type of washing chamber which may be used in the lavage device, and also showing a human hand and forearm in the washing position;

FIG. 3 is an end view along the longitudinal axis of a washing chamber of the type shown in FIG. 2;

FIG. 4 is a perspective view of another embodiment of the invention;

FIG. 5 is a perspective view of the washing chamber used in in the embodiment of the invention shown in FIG. 4, partially cut away to show the interior construction;

FIG. 6 is a perspective view of another type of washing chamber which may be used in the lavage device shown in FIG. 1;

FIG. 7 is a partial perspective view of the construction of the central portion of the washing chagber shown in FIG. 6; and

FIG. 8 is a diagram of a spray pattern which may be employed in the washing chamber.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

This invention satisfies the long-felt need for a lavage device which will solve the problems inherent in presurgical scrubs (as described above in Background of the Invention) and the need for a lavage device which will quickly clean the hands of personnel in situations where cleanliness is of critical importance.

EXAMPLE I

The lavage device 10 shown in FIG. 4 is designed to wash the hand and forearm. FIG. 5 shows the internal construction of this design. Lavage device 10 comprises a washing chamber 11 consisting of a cylindrical outer wall 12 and a concentric cylindrical inner wall 13 (shown in FIG. 5). Outer wall 12 and inner wall 13 are joined at their upper edges by a boundary wall 14. A drain 16 permits the washing fluid to leave the washing chamber after spraying the object to be washed. The entrance to washing chamber 11 is covered with a flexible material 15, such as sheet rubber, in order to prevent washing fluid spraying outside the washing chamber. The outer wall 12 has an inlet 17 for receiving a pulsating pressurized washing fluid from a conventional pump means via a supply pipe 18 connecting the inlet 17 and the pump means. The inner wall 13 has multiple inwardly directed outlet openings 19 for discharging the washing fluid. A pressure gauge 20 may be included in order to measure the pressure of the washing fluid.

A working model of this embodiment has a total of 140 openings 0.025 inches in diameter in the inner wall 13. The openings are arranged in 20 vertical columns equally spaced apart around the circumference of the inner wall. In 10 of the vertical columns, there are five openings vertically spaced 2 inches apart. In the other ten columns, there are nine openings vertically spaced 1 inch apart. The openings extend down the inner wall to the drain as shown in FIG. 5. The pump employed in this working model is a commercially-available Teel roller pump (Model No. 1P736) which has six internal rollers. It is these rollers which impart a pulsating effect in the washing fluid. A commercially-available 1 horsepower electric motor is used to drive the roller pump. The electric motor runs at 1,725 rpm, hence with a pulley ratio of 2:1, the roller pump rotates at approximately 860 rpm. Each roller in the roller pump causes a pulse, so at 860 rpm this roller pump produces approximately 5,160 pulses per minute in the pressurized washing fluid. The number of pulses per minute may be reduced by increasing the pulley ratio, or by removing some of the rollers from the roller pump. The pressure of the washing fluid may be regulated by placing a by-pass valve in the supply pipe.

In operation, the object to be washed (such as the hand and forearm) is inserted through the flexible material 15 into the washing chamber 11. The motor is then activated causing the washing fluid to be discharged from the openings 19 striking the object to be washed. If the object being washed is the hand and forearm, the arm may be slowly rotated to achieve uniform exposure to the pulsating jets of washing fluid discharged from the openings 19. The hand may be slightly cupped during the washing operation. If desired, the washing fluid may be recycled, and also a rinse cycle of water only may be employed after washing. Details as to the composition of the washing fluid are given below in the section entitled Experiment Demonstrating Utility. As described therein, good results on human hands are obtained with the lavage unit operating for 11/2 minutes at either 50 pounds per square inch (PSI) pressure or at 80 PSI pressure. When the lavage device is operated with a pulse frequency of approximately 1,500 pulses per minute, the spray jets will cause a compression-decompression effect on human skin. This compression-decompression effect is particularly effective in removing dirt and bacteria in the follicles and skin folds. At higher pulse rates, the rebound capacity of the human skin is insufficient to exhibit this compression-decompression effect.

EXAMPLE II

FIG. 1 shows an embodiment of the invention designed to wash both hands simultaneously. In FIG. 1, lavage unit 30 comprises a pair of washing chambers 31 securely positioned inside a cabinet-like enclosure 32. Enclosure 32 has a pair of sliding doors 33 (only one door is shown) which may be operated from a foot-pedal control.

Door 33 has a rubber diaphragm 34 to prevent washing fluid from splashing out. Alternately, the door may consist of a standard rotating-type iris sleeve port instead of the construction shown in FIG. 1. Enclosure 32 has a drain 35 for removal of discharged washing fluid. FIG. 2 shows washing chamber 31 in greater detail. In FIG. 2, washing chamber 31 comprises three manifold units 36 arranged circumferentially with respect to the longitudinal axis of the washing chamber. Each manifold unit 36 comprises an arcuate outer wall 37 having an inlet 38 for receiving washing fluid and an arcuate inner wall 39 having multiple inwardly directed openings 40 for discharging washing fluid. Boundary walls 41 join the edges of the outer wall and inner wall. Supply pipes 42 convey the pulsating pressurized washing fluid from a pump to each manifold unit 36. FIG. 3 shows an end view of this embodiment of the washing chamber.

FIG. 6 shows an alternate embodiment of the washing chamber. This version of the washing chamber may be employed in the lavage device shown in FIG. 1 in lieu of the type of washing chamber shown therein. In FIG. 6, washing chamber 50 comprises six tubular elements 51 circumferentially arranged about the longitudinal axis of the washing chamber. The terminal ends of tubular elements 51 in FIG. 6 come together at a central header 52 (shown in detail in FIG. 7) which is connected to a supply pipe 53. Supply pipe 53 is then connected to a conventional pump. Tubular elements 51 have multiple inwardly directed openings 54 for discharging the washing fluid. The forward ends of tubular elements 51 are held rigidly by a circular support 59. FIG. 8 illustrates a spray pattern for a washing chamber of this type with an internal diameter of 10 1/4 inches. Dotted lines 55 indicate the direction of the jets of washing fluid. The openings 54 in tubular element 51 are canted at approximately 10° from normal to the axis, and the openings are alternately staggered at this 10° angle. The result is that the spray jets will intersect and impinge at an acute angle at circle 56 which represents a 2 11/16 inch diameter between circle 57 which represents the average diameter of the male human wrist and circle 58 which represents the average diameter of the male human bicep.

A working model of the type shown in FIG. 1 with washing chambers of the type shown in FIG. 6 has 300 spray openings in each washing chamber. There are 50 openings spaced one-half inch apart in each of the six tubular elements. As mentioned above, the openings are alternately angled at approximately 10° from normal to give a spray pattern shown in FIG. 8. One version of this washing chamber has openings which are 0.020 inch in diameter, and another version has openings which are 0.032 inch in diameter. The pump employed in this working model is a commercially-available HYPRO pump (Model No. N1502) having six rollers. A commercially-available 5 horsepower electric motor drives the pump. The motor runs at 1,745 rpm, and using a variable radius pulley permits the pump speed to be varied in the range 500 - 800 rpm. Hence, the spray jets pulsate from 3,000 to 4,800 times per minute. The pulse frequency may be lowered by removing pump rollers or by changing the pulley radius as described above in Example I. The pressure of the washing fluid may be adjusted by using a by-pass valve as in Example I. Also the motor may be conveniently connected to a timer switch so that the washing action stops after a preselected time interval. The composition of the washing fluid, the fluid pressure level and the actual washing operation is similar to that described above in Example I.

EXPERIMENT DEMONSTRATING UTILITY

The working model of the lavage device described above in Example I was employed in an experiment to demonstrate utility. The working model was operated at approximately 5,160 pulses per minute in this experiment. The experiment was divided into two parts.

Part I. To determine efficacy of a high pressure jet lavage for cleansing hands and forearms.

Part II. To compare the results of high pressure jet lavage against the proven method of scrubbing with PHISOHEX.

PART I

In the first section of Part I, 12 volunteers participated. They included 11 dental officers and one lab technician. The lavage experiment was as follows. After the fingertips of the dominant hand were pressed gently against the bacteriological culture medium, the same hand and forearm was placed into the lavage device and subjected to the pressure jet lavage for 1.5 minutes at 50 PSI. The pressure jet lavage device used a washing fluid consisting of 750 ml of PHISOHEX and 24 gallons of warm tap water. After lavage, the hand was rinsed with running tap water, dried with a sterile towel and a culture of all five fingertips was taken again as described above. Next a sterile rubber glove was placed over the hand, taped tightly around the wrist and worn for 1 hour. The glove was then carefully removed, the impression of all fingers was made again on the surface of the culture medium. The glove was filled with 50 ml of sterile saline containing 1 percent of TWEEN 80. The cuff portion of the glove was tied and the glove moved up and down several times in order to wash the inside of the glove. One ml of this fluid was removed aseptically, placed in a Petri dish and a pour count plate was prepared.

The culture medium used for the fingertip impression cultures was trypticase soy broth with 1 percent TWEEN 80. TWEEN 80 was incorporated into the sampling fluid and trypticase soy agar for the purpose of inactivating any hexachlorophene that might have been carried over to the culture media and thus give possible false negative results.

All plates were incubated aerobically at 37°C for up to 72 hours. The lavage of the dominant hand of the participants was repeated on the second day and the bacteriological cultures were obtained in the same manner as on the first day.

In the second section of Part I, the methods were identical as above except that the hands of nine participants were lavaged at a pressure of 80 PSI. This experiment was carried out 10 days after the completion of the first experiment.

PART II

In Part II, there were 10 volunteers. After cultures of fingertips of both hands were taken, the participants scrubbed their hands and forearms with a surgical brush and 5 ml of PHISOHEX for 2 1/2 minutes. The hands were rinsed and the scrub repeated for 2 1/2 minutes using again 5 ml of PHISOHEX. The hands and forearms were rinsed, dried with a sterile towel and cultures of the fingertips of the right hand were obtained. The right hand was gloved and the glove worn for 1 hour. After the glove was removed the touch plates were obtained and the inside of the glove washed with 50 ml of saline and 1 percent of TWEEN 80. One milliliter of this fluid was removed for the pour count plate. Pour plates and incubation of all plates were done as in Part I. Bacterial colonies were counted as in Part I. The cultures of some fingertips showed a confluent growth making it impossible to count the colonies. In such cases counts of 50 bacteria per finger were used or a total of 250 bacteria.

RESULTS

The results of this body are summarized in Tables 1, 2 and 3, below. A comparison chart of the average figures is presented as Table 4, below. All figures in Tables 1-3 are averages of two readings taken on different days.

TABLE 1

Effectiveness of Presurgical Preparation of the Hands by Lavage Device (1.5 ------------------------------------------------------------ --------------- Minutes at 50 p.s.i.)

Subject Bacterial Count of Fingertip Cultures Bacterial Count of 1 ml of Before After After 1 Glove Lavage Lavage Hr. Glove Fluid ____________________________________________________________ ______________ LWJ 195 13 0.5 1 GL 250 22 0.5 3 HJL 229 8.5 1 4 BJD 208 8 1.5 3.5 GMF 214 4 1 3.5 CDE 151 6.5 1.5 3 PWR 76 8 0 4 PB 61 1.5 0 1 BJM 124 21 0 2 MDM Contaminated 1 1 1 by fungi NWA 228 8.5 0 2 GA 171 10 0 1 ____________________________________________________________ ______________

TABLE 2

Effectiveness of Presurgical Preparation of the Hands by Lavage Device (1.5 ------------------------------------------------------------ --------------- Minutes at 80 p.s.i.)

Subject Bacterial Count of Fingertip Cultures Bacterial Count of 1 ml of Before After After 1 Glove Lavage Lavage Hr. Glove Fluid ____________________________________________________________ ______________ PWR 62 0 0 6 BJM 90 1 0 4 MDM 89 0 0 0 NWA 246 2 0 3 GA 249 13 0 0 LWJ 141 2 0 1 GL 230 8 0 0 HJL 250 9 0 2 BJD 162 0 0 7 ____________________________________________________________ ______________

TABLE 3

Effectiveness of Presurgical Preparation of the Hands by PHISOHEX Scrub ------------------------------------------------------------ --------------- (Duration 5 Minutes)

Subject Bacterial Count of Fingertip Cultures Bacterial Count of 1 ml of Before After After 1 Glove Scrub Scrub Hr. Glove Fluid ____________________________________________________________ ______________ PWR 250 8 0 0 PB 137 36 3 0 BJM 250 2 0 1 MDM 250 2 0 3 HJL 139 46 46 14 GA 250 17 1 1 LWJ 90 1 0 0 BJD 107 12 0 10 GMF 211 9 0 0 CDE 40 57 0 15 ____________________________________________________________ ______________

TABLE 4 ------------------------------------------------------------ --------------- Average Numbers of Bacteria for Each Method

50 p.s.i. 80 p.s.i. Lavage Scrub Lavage Device (10 indi- Device 12 indi- viduals) (9 indi- viduals) viduals) ____________________________________________________________ ______________ Bacterial Count Before Lavage or 172 172 166 Scrub Bacterial Count After Lavage or 9 19 4 Scrub Bacterial Count in 1 Hour Glove 0.6 5 0 Bacterial Count in 1 ml Fluid 1.2 4.4 2.5 ____________________________________________________________ ______________

In the 50 PSI lavage the bacterial count from the touch plates made of the fingertips before lavage varied from 61 to 250, (250 being the highest count possible.) In the 80 PSI lavage the prelavage bacterial count of the fingertips varied from 62 to 250. Similarly the 5 minute PHISOHEX scrub varied from 40 to 250. These figures averaged out almost identically as shown in Table 4. The 80 PSI lavage being lowest at 166 bacteria per hand, while the 50 PSI lavage and the scrub showed 172 bacteria each.

The post preparation counts showed a range of 0-13 bacteria at 80 PSI, 1 to 22 bacteria at 50 PSI and 1 to 57 bacteria with the scrub. Similar figures were reflected by the averages in Table 4. The 80 PSI showed only 4 bacteria post lavage, 50 PSI 9 bacteria, and the manual scrub showed 19 bacteria.

After the glove had been worn for 1 hour the 80 PSI touch plates showed no bacterial growth. The 50 PSI ranged from 0-1.5 bacteria and the scrub showed 0-46 bacteria. However, the average count was 0 for 80 PSI and 0.6 for the 50 PSI and 5 for the scrub.

The 1 milliliter sample taken from the glove washing showed a range of 0 to 7 bacteria for the 80 PSI, 1 to 4 for the 50 PSI and 0 to 15 for the scrub. The average figures were 1.2 for 50 PSI 2.5, for 80 PSI and 4.4 for the PHISOHEX scrub.

The results of this experiment indicate that both the 50 PSI and 80 PSI lavage maintained for 90 seconds are better than a conventional scrub of 5 minutes duration.