WO1985004794A1

WO1985004794A1 - Improved surgical scrub

Info

Publication number: WO1985004794A1
Application number: PCT/US1984/000624
Authority: WO
Inventors: Marvin Gordon; Joseph Lichtenstein
Original assignee: Whitman Medical Corporation
Priority date: 1984-04-23
Filing date: 1984-04-23
Publication date: 1985-11-07
Also published as: EP0177500A1

Abstract

In many surgical procedures antiseptic swabbing is necessary. A simple, inexpensive and disposable dispensing device is needed. The solution to the above problem comprises a surgical scrub apparatus (60) including a liquid-containing rupturable cylindrical cartridge (65), which is slidable within a tubular handle (63) having at least one and preferably two hollow interior spikes (69, 70) projecting longitudinally from one end and an annular stop member defining a pre-deployed position of the cartridge. The cartridge (65) can be inserted sufficiently far past the stop member to cause rupture of the cartridge by both spikes (69, 70). Liquid from the ruptured cartridge flows from within the handle (63), preferably through the spikes (69, 70), to an applicator sponge (61) having two wide area applicator surfaces (73, 74). The spikes (69, 70) may include exterior projections (75, 76) which are received in respective recesses or flow passages (81, 82) in the applicator (61) to facilitate distribution of liquid through the applicator (61) to application surfaces (73, 74). The recesses (81, 82) are contoured as desired to aid in liquid contribution. The interior of the spikes (69, 70) may be coated with a non-wetting agent such as silicone to facilitate flow through the hollow spikes (69, 70). The spikes (69, 70) are oriented such that one is always disposed higher than the other when the device is in use, thereby creating a pressure difference between the punctures made by the spikes (69, 70) so as to facilitate liquid outflow from one puncture by promoting air inflow through the other.

Description

IMPROVED SURGICAL SCRUB Background of the Invention

Technical Field

The present invention relates generally to liquid dispensers and applicators of the type wherein a premeasured supply of liquid is disposed in an applicator handle and selectively dispensed through the applicator. The invention has particular applicability in the field of aseptic surgery preparation, as a pre-operative surgical scrub system for use in the operating room.

The Prior Art

As part of the preparation for many surgical procedures, for example, a surgical operation, it is required that the affected area of the patient be antiseptically cleansed. This requirement has existed for a very long time and the procedures used to meet this requirement have changed over the years. Originally, jars or cans of gauze, sponges or cotton balls were packed, sterilized and placed in operating rooms. These sponges and/or cotton balls are used for scrubbing procedures by holding them with sterile forceps and dipping them into a can containing a soap or antiseptic solution. After the cotton ball or sponge is saturated with solution, it is wiped onto the appropriate area. This procedure is inconvenient for a number of reasons. First, it tends to create a mess due to the open pan and the constant back and forth travel of the sponge or cotton ball between the pan and the patient. Further, the procedure takes an undesirably long time and results in an inordinate amount of liquid being lost due to splashing, scattering and waste. Moreover, this procedure tends to use more antiseptic solution than necessary because most medical personnel mistakenly believe that the antiseptic effect is more readily obtained if more solution is used. This is not true and, quite to the contrary, it has been noted that excess solution tends to form pools or puddles under the patient, resulting in iodine burns.

Apart from the disadvantage of the forceps and sponge or cotton ball procedures, the lack of standardization of techniques resulted in considerable confusion. Eventually, certain standards did develop. Specifically, the area of the incision on the patient's body must be cleansed thoroughly with a scrub or soap solution for a period of between 3-10 minutes. Most surgical operations, other than orthopedic surgery, require 3 minutes of scrubbing time; orthopedic surgery requires 10 minutes of scrubbing time due to the increased risk of infection. After the scrubbing procedure, the area is dried with a sterile wipe and antiseptic solution is applied. For some procedures, other than orthopedic surgery, the scrub portion of the procedure is eliminated and only the antiseptic solution is applied In either case, the standard procedure for applying either the scrub or antiseptic solution involves starting from the middle of the treated area and proceeding outward in circular or square motions, it being important never to return to a previously treated area with the same surface of the sponge. The sponge may be turned over and the same procedure started once again; that is, as long as a new sponge surface area is used, an already-prepared skin area may be re-contacted. However, one should never apply a used or contaminated sponge surface to a previously prepared skin area.

Attempts to overcome the drawbacks described above in relation to surgical swab and/or scrub apparatus and techniques involved the development of devices in which the liquid to be applied is contained within the device itself, generally in a hollow handle. Examples of such devices may be found in the following U.S. patents: 1,221,227; 2,333,070; 3,324,855; 3,508,547; 3,614,245; 3,774,609; 3,837,151; 3,891,331; 3,896,808; 3,958,571; 4,148,318; and 4,225,254. The devices disclosed in these patents present considerable improvements over the relatively primitive method of employing individual cotton balls or sponges with forceps and dipping these into the pan of solution as described above. However, many of the devices disclosed in the aforesaid patents are relatively complex to manufacture, thereby resulting in too high a cost for a device which is disposable after a single use. Moreover, many of the devices disclosed in these prior patents have only one available surface for the applicator sponge or swab. For example, the device disclosed in U.S. Patent 4,225,254 provides a generally conical-shaped sponge, thereby making it difficult to assure that the same surface area of the sponge does not contact an already treated area of the patient's skin. Further, the conical configuration minimizes the available surface area of the sponge. As noted above, available clean and unused surface area of the preparation sponge is one of the most important factors governing the pre-surgical preparation technique.

The device disclosed in U.S. Patent No. 3,847,151 had considerable promise toward solving most of the problems referred to above. That patent discloses a surgical scrub device wherein a sponge applicator is mounted on a nozzle which extends from a hollow handle containing antiseptic solution. The nozzle ineludes a joint which can be selectively ruptured prior to use so as to permit the solution to flow from the nozzle into the sponge. In practice, however, this device proved to have functional problems. Mass production techniques being what they are, the stress break at the rupturable joint in the nozzle is not always complete and fluid is not always available. In addition, the rupture is not always properly completed by the user of the device, again resulting in a situation where fluid is not available for use. An additional problem with, this device is that scrub solution (soap) tends to fill the sponge too slowly, whereas swab solution (antiseptic) tends to fill the sponge too quickly. In general, the product, although well conceived, has proven not to be reliable in use.

It has been suggested (see U.S. Patent No. 3,481,676 to Schwartzman) that a liquid applicator may take the form of a cylindrical rupturable liquid-filled cartridge disposed in a tube-like handle having a sharp-edged flow passage disposed therein. The cartridge can be forced against the sharp edge to rupture the cartridge and extend the flow passage throug the rupture. This permits liquid to flow from the car tridge, through the passage, to an applicator which surrounds the passage. The approach disclosed by Schwartzman is valid for many applicators wherein a slow rate of fluid application can be tolerated. More particulary, in order for the liquid to be able to flow from the ruptured cartridge, there must be air admitted into the cartridge to replace the outflowing liquid. In the Schwartzman device, inflowing air and outflowing liquid must flow in opposite directions through the single sharp-edged flow passage. This severely limites the liquid outflow rate. For surgical scrub applications, it is important that the sponge or applicator be quickly saturated so that the liquid can be quickly applied to the pre-surgical incision site without delaying the surgical procedure. This problem could be remedied in the Schwartzman applicator by providing the cartridge with a valved or other premanent vent opening, much like is done with the cartridge-type fountain pens. However, such opening would not be a satisfactory solution for surgical scrub applications wherein the administered liquid must be maintained sterile in the cartridge.

OBJECTS AND SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a simple, inexpensive, and disposable liquid dispensing device which is capable of being used in pre-surgical procedures for swabbing and scrubbing. It is a further ohject of the present invention to provide such a device which is devoid of the disadvantages ennumerated above in the devices of the aforementioned patents. It is another object of the present invention to provide such a device useful as a swab or a scrub, depending upon the selection of a replacement cartridge of the liquid to be applied. It is a particular object of the present invention to provide a surgical swab or scrub device of the type wherein liquid to be applied is contained within the handle and wherein the liquid can be reliably selectively applied to the applicator sponge. A still further specific object of the present invention Is to provide improved handle and applicator configurations to facilitate distribution of scrub or swab liquid to the applicator surfaces. In accordance with the present invention, an elongated tubular handle has a sponge secured to one end thereof and accepts a cartridge of liquid to be applied through its other end. A rigid hollow spike is secured within the handle proximate its first end oriented to rupture the cartridge when the cartridge is fully inserted into the handle. When the cartridge is ruptured a flow path for its contained liquid is provided, preferably through the hollow spike, to a multi-apertured chamber disposed within the sponge. Liquid from the cartridge can be fed from the handle, through the chamber to the sponge by gravity-feed or finger pressure applied radially by the user on the cartridge through the tubular handle. The apertured chamber serves to distribute the liquid evenly through the sponge and to provide support for the sponge during application of the liquid to the patient's body. Exertion of radially-applied pressure to the cartridge for the purpose of forcing liquid therefrom is facilitated by the provision of longitudinally extending cut-out portions of the handle. In the preferred embodiment, the inner wall of the handle is provided with an annular shoulder which serves as a stop for the forward end of the cartridge prior to dispensing of the liquid from the cartridge.

In order to effect dispensing, the cartridge is fully inserted into the handle, forcing its forward end past the annular stop and into rupturable engagement with the hollow spike. A check valve may be employed within the passageway between the spike and the apertured chamber to prevent back flow of contaminated solution into the sterile cartridge.

In another embodiment, the sponge, which receives a flexible projection from the handle paddle-like member, has two opposite applicator sides. Two rigid hollow spikes are transversely spaced on oppqsite sides of the paddle-like member inside one handle end so as to point toward the other handle end. The spikes are in position to rupture a forward end of the cartridge, when the cartridge is fully inserted Into the handle, and to conduct liquid from the cartridge out to the sponge or applicator. The spikes are also positioned such that one or the other is always vertically higher than the other when the sponge is deployed for use with its applicator surfaces substantially horizontal. This difference in height reflects itself as a difference in liquid pressure at the punctures in the cartridge, whereby vent air can freely enter the cartridge through the lower pressurized upper puncture, thereby permitting liquid to freely egress through the lower puncture. The spikes are formed on respective diagonals which reside in respective bias planes which converge toward the said one end of the handle. This maximizes the spacing between two given puncture locations and thereby increases the liquid pressure difference at the puncture.

In order to further improve transfer of liquid to the applicator surfaces, the hollow spike flow passages are projected a short distance beyond the end of the handle along opposite sides of the paddle-like member. In addition, the applicator is provided with corresponding flow channels which receive and extend beyond the projected flow passages. Outflow from the projected flow passages is thereby not directed Immediately int impeding saturated applicator material, but Instead flows through the extended channels. The channels may be extended In different contours, as desired, to optimize distribution of the flowing liquid along the applicator surfaces. In certain cases, the flow of liquid from the cartridge to the sponge applicator surfaces is improved even more by placing a thin coating of silicone or other non-wetting agent along the interior wall of each hollow spike and its external projection.

BRIEF DESCRTPTION OF THE DRAWINGS

The Invention will now be more fully understood, while still further objects and advantages will become apparent, in the following detailed description of embodiments thereof illustrated in the accompanying drawings wherein like components In the various figures are designated by the same reference numerals: Figure 1 is a view in perspective of the liquid dispensing device constructed in accordance with the principles of the present invention;

Figure 2 is an exploded view in perspective of the device of Figure 1;

Figure 3 is a view in longitudinal section of the device of Figure 1 showing the device in its storage or pre-dispensing condition;

Figure 4 is a view in section similar to that of Figure 3 but showing the device in its dispensing mode;

Figure 5 is a detailed view in section of a portion of the device of Figures 1-4, illustrating a check valve employed therein;

Figure 6 is a view in perspective of another embodiment of the present invention;

Figure 7 is a view in section of the handle member of the embodiment of Figure 6;

Figure 8 is a side view in partial section of the cartridge member of the embodiment of Figure 6;

Figure 9 is an exploded view in perspective of a preferred embodiment of the improved surgical scrub device of the present invention;

Figure 10 is a view in section taken along lines 10-10 of Figure 9; Figure 11 is a diagrammatic illustration of the cartridge shown in Figure 9, illustrating the pressure conditions established by rupture of the cartridge;

Figure 12 Is an enlarged detailed view in section of one end of the handle member and applicator of Figure 9, showing the manner In which flow from the handle is freely distributed into the applicator;

Figure 13 is a front view in elevation of the applicator of Figure 12;

Figure 14 is a view in section taken along lines 14-14 of Figure 13;

Figure 15 is a front end view in elevation of a modified applicator of the present invention;

Figure 16 is a view in section taken along lines 16-16 of Figure 15;

Figure 17 is a front end view in elevation of another modified applicator of the present invention;

Figure 18 is a view in section taken along lines 18-18 of Figure 17;

Figure 19 is a front end view In elevation of a modified applicator of the present invention;

Figure 20 is a view in section taken along lines 20-20 of Figure 19; Figure 21 is a front view in elevation of a further modified applicator of the present invention; and

Figure 22 is a view in section taken along lines 22-22 of Figure 21.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to the drawings in greater detail, the dispenser of the present invention comprises three major parts, namely: a sponge or applicator 10; a tubular handle 11; and a cartridge 12. The sponge 10 m may be made from a variety of medically accepted spongelike materials having a wide density range and coarse or fine textures. Coarse texture may be employed for scrubbing because it is more abrasive; the finer texture may be utilized for application of antiseptic solution. For general use, sponge 10 Is ideally two

Inches square by one inch thick; however, these dimensions are provided by way of example only and size is by no means a limiting factor on the present invention. The sponge is preferably configured to have two large measure flat application surfaces 13 and 14 , but again the configuration is not to be considered limiting on the scope of the present invention. Surfaces 13 and 14 may be generally rectangular, as shown, or may be circular, oval, triangular, etc. Sponge 10 is adapted to receive one end to tuoular handle 11 through a suitably provided opening in an end surface 16 of the sponge which resides generally perpendicular to the application surfaces 13 and 14. The end surface 16 of sponge 10 may be suitably die-cut in order to receive the end of handle member 11 in the manner descrihed below. For example, sponge 10 may be cut into a 2" x 4" x 1/2" piece which is folded in half and glued on portions of the inner surface to cover the received portion of handle 11. Alternatively, sponge 10 may be die-cut into a piece 2" x 2" and slotted at surface 13 to permit insertion of the handle member 11. Adhesive may be employed to stabilize the sponge onto the handle member.

Cartridge member 12 Is a generally tuhular member whose outside periphery matches the inside periphery of a portion of tubular handle 11. The outside dimensions of cartridge 12 substantially matchothe inside dimensions of tubular handle 11 so that the cartridge can freely slide longitudinally within the handle member. The overall size can range from as little as a 5 ml capacity to as large as a 240 ml capacity. In this regard, the entire unit can be selected to be of the appropriate size for the desired amount of liquid to be administered. For a sponge 10 having dimensions of 2" x 2" x 1", the average capacity of the cartridge would be 30 ml. Cartridge 12 may be produced on a form, fill and seal machine in a continuous operation. Under such circumstances, the container is blow molded, filled with the desired fluid, and sealed in continuous steps of one overall operation. The configuration of the cartridge should not be considered limited and may be fabricated by any plastic-forming equipment, as long as the resulting product has the overall density required to contain the liquid employed. The tubular cartridge should have a plastic density which permits simple placement into the tubular handle while providing suf ficient rigidity to permit sliding movement through the handle. The cap 17 for cartridge 12 Is disposed at one end thereof andmmay be formed integrally with the cartridge, if desired. The opposite end 18 of the cartridge, may be of the same density as the overall cartridge but In any event, must be suitable to permit rupture and penetration of the cartridge in the manner described herein below.

In this respect, the forward end 18 of the cartridge is preferably thinner than the cap 17 which should be considerably heavier to afford a more Figid plastic form and thereby facilitate application of a pushing force required to displace, cartridge 12 with the handle 11 so that forward end 18 can be ruptured.

Handle member 11 comprises, for the most part, a rigid plastic tube having an open end 19 adapted to receive cartridge 12 therein when the cartridge is inserted with its forward end 18 first. The opposite end 21 of handle 11 extends part-way into sponge 10 and includes, preferably formed as an Integral part thereof, a dispensing chamber 22. The dispensing chamber project forwardly of tube 21 Into sponge 10. A tubular spike 23 extends rearwardly from the dispensing chamber 22 into the tubular portion of handle 11 and Is provided with a plurality of radially-extending stablilizing fins 24 which fixedly engage the interior surface of the tubular handle member 11. As noted above, It Is preferable that the dispensing chamber 22, spike 23, and stabilizing fins 24 be formed integrally with tubular section 11 by means of an appropriate plastic-forming technique; alternatively, these components may form a part of a separate unit which is secured at the remote ends of stabilizing fins 24 to the interior wall of tubular member 11 by means of a suitable adhesive material or the like. For the latter configuration, an annular lip is formed, as shown, at the forward end 21 of tubular handle member 11 to retain the fins 24 in proper position.

Dispensing chamber 22 may take the form of a shallow cylinder, as shown, or any other suitable configuration. In the preferred shallow cylindrical configuration shown, the opposite circular ends of the chamber are provided with a plurality of apertures 26 which provide fluid communication between the interior of chamber 22 and the surrounding interior of sponge 10. The primary function of dispensing chamber 22 is to provide free flow of pressurized fluid therein into the sponge to soak the sponge for application to the appropriate body surface area. A secondary function of dispensing chamber 22 is to provide sufficient rigidity to the sponge during application of the liquid from the sponge to the patient's body. This latter function is best served when the apertured ends of dispensing chamber 22 have the largest possible surface area. However, smaller dispensing chambers can be utilized with effective results.

Spike 23 is in the form of a tube which projects rearwardly from dispensing chamber 22 and has its interior in flow communication therewith. The end of spike 23 remote from chamber 22 is tapered to a fine point, much like a conventional intravenous spike. A narrow annular shoulder 27 projects radially inward from the interior wall of tubular handle 11 at an axial location just beyond the tip of spike 23. More specifically, the tip of spike 23 is spaced a slightly shorter distance from end 21 of tubular handle 11 than is the annular lip 27. Lip 27 serves as a flexible stop for end 18 of cartridge 12. Specifically, as illustrated In Figure 3, the outer edges of the forward end 18 of cartridge 12 abut lip 27 In the stand-by condition of the unit.

Lip 27 thereby spaces the forward end 18 of the cartridge from the point of spike 23. When it is desired to apply fluid from the cartridge to a surface area of a patient, or the like, cartridge 13 is pushed forward within tube 11, causing lip 37 to flex and permitting the forward end 18 of cartridge 12 to move forwardly and be ruptured by the point of spike 23. This is best illustrated in Figure 4. The hollow spike 23 enters the cartridge via cartridge end 18 and permits liquid from the cartridge to flow thrqugh the spike to the dispensing chamber 22 where it flows through apertures 26 to soak the sponge 10. A sealing ring, for example, an O-ring, 28, projects from the interior surface of handle member 11 radially inward at an axial location between end 21 and stop lip 27. The sealing ring 28 prevents fluid from the sponge from flowing back past sealing member 28 into handle 11.

Tubular handle 11 is provided with a plurality of longitudinally-extending cut-out slots 29. These slots are provided to permit radial compression of the handle 11 so that cartridge 12 may be compressed and liquid forced therefrom Into the sponge. It will be appreciated that this compression can be readily achieved by grasping handle 11 in the palm of one's hand and squeezing the hand closed. Alternatively, liquid feed from cartridge 12 to sponge

10 may be effected by gravity flow by simply holding the unit with end 17 upward.

In some applications, it may be desirable to prevent back-flow of dispensed liquid from the sponge and/or dispensing chamber 22 to the cartridge 12. In such cases, a check valve may be supplied within the hollow spike 23 as Illustrated in Figure 5. Specifically, a ball member 31 is disposed within the hollow spike 23 and is biased rearwardly toward the sharp spike end by means of a spring

33. The rearwardly biased ball member 31 sits in a valve seat 32 In the non-operating position of the unit to block flow through the hollow spike. If fluid in the cartridge 12 is pressurized, such as by compressing the handle 11, ball member 31 is unseated from seat 32 by the pressurized liquid which is then permitted to flow into the dispensing chamber 22. When the pressure of the liquid in chamber 22 greater than the pressure of the liquid in cartridge 12, as would be necessary to result in a reversed flow of the liquid, spring 33 forces ball member 31 to Its closed position to preclude reverse flow.

The unit illustrated in Figures 1-5 is simple and Inexpensive to fabricate and is therefore readily disposable after a single use. Specifically, the unit in the optimal case may be fabricated from only three (3) separate components, namely: sponge 10; cartridge 12, which may be fabricated integrally with actuating end 17; and tubular handle 11, which may be fabricated integrally with dispensing chamber 22, spike 23, and positioning fins 24. Cartridges, of course, may be interchangeable so that a variety of different liquids may be employed. Likewise, plural cartridges may be employed during the same procedure, if an insufficient amount of liquid has been applied. The cartridges are easy to change and remain sealed and sterile until used. The user of the device need not wear a surgical glove in view of the sterility of the cartridge arrangement. The unit is simply activated by merely grasping the handle 11 in one's hand and gently rapping end 17 of cartridge 12 on a hard surface so as to force the forward end 18 of the cartridge against spike 23. Actuation is thus reliable and easily effected and the liquid to be dispensed flows freely to the sponge.

Referring now to Figures 6-8 of the accompanying drawings, a second embodiment of the dispenser of the present invention is illustrated. In this embodiment, the primary difference from the embodiment of Figures 1-5 relates to the forward or sponge-end of the handle member and the manner In which the sponge is supported and dispensed liquid flows to the sponge. Specifically, the second embodiment includes a sponge applicator 40, a hollow tubular handle 41 and a cartridge 42 which is slidably received by handle 41 through open rearward 43 of the handle. Sponge 40 is similar in function and configuration to sponge 10. of the embodiment illustrated In Figures 1-5 and partakes of all of the design features and considerations set forth above for sponge 10. Likewise, cartridge 42 is functionally and structurally similar to cartridge 12 illustrated and described in relation to the embodiment of Figures 1-5. In the embodiment of Figures 6-8, the forward end 44 of 42 is rounded and readily susceptible to puncture by a spike in the manner described below. The rearward end 45 of cartridge 42 is more rigid to facilitate insertion of cartridge 42 into handle 41 by pushing the rearward end 45 appropriately.

Handle member 41 is similar in function to handle 11 in the embodiments of Figures 1-5. As noted above, the rearward end 43 of handle 41 is open to receive the forward end of cartridge 42. The forward end of handle 41 tapers to form a paddle or paddle-shaped projection member 46 which projects forwardly of handle member 41. This paddle-shaped projection 46 is adapted to be received in a suitably provided slot 47 in sponge 40. Projection 46 thus serves to support sponge 40 into which it projects. For this purpose, projection 46 is made somewhat flexible to permit relative flexure between the sponge 40 and handle member 41. A conical spike 48 proj ects rearwardly of projection 46 into the interior of the forward end of handle 41. Spike 48 serves the purpose of rupturing the forward end 44 of cartridge 42 when that cartridge is sufficiently inserted into handle member 41. To this end, although spike 48 is shown as a sharp, conical projection, it may take other forms, such as a "bullet-nosed" configuration. The important point is that the rearward most part of spike 48 should be sufficiently sharp to permit it to rupture forward end 44 of the cartridge. Spike

48 differs from spike 23 in the embodiment of Figures 1-5 in that it does not provide an internal flow path whereby fluid from cartridge 42 can flow out of handle 41; in other words, spike 48 is not hollow. Instead, the forward end of handle 41, rearwardly of projection 46, is provided with a plurality of apertures 49 through which liquid can escape from the interior of handle 41 after it has been squeezed from the ruptured cartridge 42. Apertures 49 are disposed at a longitudinal position of handle 41 which is inserted within slots 47 of sponge 40 so that all of the liquid which escapes from apertures

49 is absorbed into sponge 40.

A narrow annular shoulder 51 projects radially inward from the interior wall of tubular handle 4l at an axial location just rearward of the rearward extremity of spike 48. The similar annular shoulder 52 projects radially inward from the interior wall of handle 41 at a location spaced slightly rearward of shoulder 51. Shoulder 52 serves as a stop for forward end 44 of cartridge 42 when the cartridge is inserted in handle 41. To this end, the axial position of shoulder 52 Is such that when it stops further insertion of the cartridge into handle 41, the forward end 44 of the cartridge is spaced from the rearward extremity of spike 48. In themmanner similar to that described above in relation to the embodiment of Figures 1-5, cartridge 42 can be forced beyond the stop shoulder 52 so that the forward end 44 of the cartridge 42 can be punctured by spike 48. Shoulder 51 serves as a fluid seal, in conjunction with the peripheral wall of the ruptured cartridge 42, to prevent the fluid from the ruptured cartridge from flowing rearwardly in the handle member 41. Handle member 41 may be provided with longitudinally-extending cut-out slots, such as slots 29

In handle member 11, to facilitate radial compression of handle member 41 and thereby force liquid from cartridge 42 through apertures 49 into sponge 40.

In a typical, but by no means limiting configuration of the embodiment of Figures 6-8 , the various parts have the dimensions noted below. Cartridge 42 Is 8 Inches long and has a 5/8 inch diameter. Sponge 40 has top and bottom surfaces which are 1 3/4" square and is 7/8" deep. The overall length of handle member 41 is 6 5/16", the paddle-shaped projection 46 being 1" long. The inner diameter of handle 41 is 5/8" and the thickness of the walls of handle 41 is approximately .050". The length of spike 48 is approximately 3/8". The tubular handie 41 may, If desired, have a taper on the order of 0.5° from rearward end 43 toward paddle member 46 in order to facilitate insertion of cartridge 42 and eventual retention of the cartridge in the handle. The paddle member or projection 46 is preferably as thin as possible to enhance flexibility and the end of the projection is preferably rounded rather than squared-off. The size of apertures 49 depends upon the desired flow characteristics for the device in view of the liquid being dispensed.

The unit Illustrated In Figures 6-8 is also simple and inexpensive to fabricate and is therefore readily disposable after a single use. Specifically, this unit in the optimal case may be fabricated from only three separate components, namely: sponge 40; cartridge 42, which may be fabricated integrally with actuating end 45; and tubular handle 41, which may be fabricated integrally with projection 46 and spike 48.

A further surgical scrub device 60, constituting the preferred embodiment of the present invention, is illustrated in Figures 9-14 to which specific reference is now made. Surgical scrub device 60 is made of three separate parts, namely, and applicator 61, a tubular handle 63 and. a liquid containing cartridge 65. Applicator 61 is the same type of applicator as applicators 10 and 40 and partakes of all the desired features and considerations set forth for those applicators. It should be noted that, although applicator 61 is preferably a sponge, it can be made of other materials which absorb liquid and distribute the absorbed liquid when compressed. Likewise, cartridge 65 is functionally and structurally similar to cartridges 12 and 43 and partakes of the same design features and considerations as those cartridges.

Handle member 63 is a rigid, plastic, hollow tube having an open rearward end 67 adapted to receive cartridge 65 therein when the forward end 66 of the cartridge Is inserted first into the handle. The opposite or forward end of handle member 63 has a paddle-shaped projection 68 which is adapted to be received in a suitably provided slot 64 In an applicator 61. In this manner, paddle 68 serves to support the applicator 61 and permits compression of one of the applicator surfaces 73, 74 against a presurgical incision site by tilting the paddle end of the handle downward against; that site. For this purpose, the paddle 18 is made somewhat flexible transversely of the longitudinal dimension of the handle in order to permit flexure and compression of the applicator relative to the handle.

The interior surface of the forward end of handle 63 is generally concave and has a pair of radially or transversely spaced hollow spikes 69, 70 projecting therefrom toward the open rearward end 67 of the handle. Spikes 69 and 70 are respective tubular projections which are terminated along respective bias planes 71, 72 which converge toward one another in a direction toward the paddle 68. This orientation of the spike-forming bias planes provides the greatest possible transverse spacing between the pointed ends of the spikes. This spacing feature, as described in detail below, increases the free flow of liquid from the punctured cartridge 65. The hollow interiors of spikes 69,70 are preferably coated with a lining of silicone or other non-wetting film to facilitate flow through the spikes. The spikes extend as respective projections 75, 76 beyond the forward end of handle 63. Spikes 69 and 70, and their respective projections 75 and 76, are disposed on opposite transverse sides of paddle 68. Preferably, the longitudinal center lines of the hollow spikes 69 and 70 and respective projections 75 and 76 reside in a plane which per pendicularly bisects paddle 68 so that the spikes and projections are centered relative to the transverse dimension of the paddle. The goal, In any event, is to maximize the spacing between the cartridge punctures made by spikes 69 , 70 to assure that one spike is always higher than the other when the applicator surface of the applicator 61 are oriented substantially horizontally, and to project the spike flow passages beyond the forward end of the handle.

A narrow annular shoulder 77 projects radially inward from the interior wall of tube handle 63 at an axial location just rearward of the rearward extremities of spikes 69, 70. A similar annular shoulder 78 projects radially inward from the interior wall of handle 63 at a location spaced slightly rearward of shoulder 77. Shoulder 78 serves as a stop for the forward end 66 of the cartridge 65 when the cartridge is inserted into the handle 63. To this end, the axial position of shoulder 78 is such that, when it stops further insertion of the cartridge into the handle 63, the forward end 66 of the cartridge is spaced from the rearward extremity of spikes 69,70. In a manner similar to that described above, cartridge 65 can be forced beyond the stop shoulder 78 so that the forward end 66 of the cartridge can be punctured by the spikes. Shoulder 77 serves as a fluid seal, in conjunction with the peripheral wall of ruptured cartridge 65, to prevent fluid from the ruptured cartridge from flowing rearwardly In the handle member 63. Handle member 63 may be provided with longitudinally-extending cut-out slots, if desired, to facilitate radial compression of the handle member and thereby force liquid from the cartridge into the applicator βl Free outflow from the cartridge can best be explained with the aid of the diagrammatic illustration of cartridge 65 presented in Figure 11. The forward end 66 of the cartridge is illustrated with two puncture 79 and 80 which are assumed to have been made by respective spikes 69 and 70. These spikes have been omitted from the illustration in Figure 11 for purposes of preserving diagrammatic clarity. Cartridge 65 is illustrated with its forward end tipped slightly downward from horizontal, as would be the case when the unit is in use. Since the applicator surfaces are substantially horizontal in use, paddle 68 is tilted slightly downward from horizontal and flexed back toward horizontal against the pre-surgical site. Therefore, puncture 79 will be disposed at a higher level than puncture 80. It should be noted that, if the handle is rotated 180° about Its central longitudinal axis, so that the applicator surfaces are reversed in position, puncture 80 will be disposed at a higher level than puncture 79 and the same advantageous free-flow operation ensues. In either case, the liquid pressure head at the higher level puncture (79 in the present example) is relatively small and Is designated P₁ in Figure 11. This pressure is determined by the vertical height of liquid subsisting in the cartridge above puncture 79. The pressure head at the lower puncture 80 is designated P₂ and is determined by the vertical height of liquid subsisting above puncture 80 in the cartridge. Since puncture 80 is considerably lower in the cartridge than puncture 79, the pressure P₂ is considerably greater than the pressu P₁. If P₁ is sufficiently low relative to atmospheric pressure, air enters puncture 79 via projection 75 and hollow spike 69, and liquid flows out through puncture 80, spike 70 and projection 76 to applicator 61. As the handle and cartridge are tilted more and more toward vertical (counter-clockwise in Figure 11), the vertical column of liquid above upper puncture 79 increases in height, thereby increasing liquid pressure P₁ at puncture 79. At some position of the cartridge the liquid pressure P₁ is sufficiently greater than atmospheric pressure so that air does not readily enter the cartridge via puncture 79. However, the normal orientation of the surgical scrub device, in use, is with Its forward end tilted just slightly downward from horizontal, in which position the pressure P₁ is close to a minimum and, in any event, is less than atmospheric pressure.

It wiil be appreciated that the greater the spacing between punctures 79 and 80, the greater will be the pressure differential caused by the liquid in the cartridge. Further, it is important that the punctures 79 and 80 be as close to the circumferential periphery of forward edge 66 of the cartridge as possible so that the pressure P₁ can be made as low as possible relative to ambient pressure More specifically, when the punctures are very close to the rim of the forward edge 66 of cartridge 65, the height of liquid in the cartridge above the puncture, which height produces the pressure P₁, is minimized for any orientation of the cartridge.

Free flow and distribution of liquid into applicator 61 is achieved by means of recesses 81 and 82 defined in the applicator. More specifically, recesses 81 and 82 are extended into the applicator from the front surface thereof on opposite sides of slit 64. These recesses are positioned to receive respective projections 75 and 76 of the handle and serve as flow passages for conducting liquid from projections 75 and 76 into the applicator Interior. It is noted that, in the preferred emhodiment, recesses 81 and 82 are parallel to one other and extend to a greater length within the applicator than the length of projections 75 and 76. The parallel relation is not crucial, as will be seen from the embodiments described hereinbelow. However, It is important that the length of recesses 81 and 82 be greater than the length of projections 75 and 76 so that flow from the projections can enter a portion of the applicator which is not impeded by saturated applicator material. From recesses 81 and 82 the liquid is readily distributed through the applicator to relatively large areas of applicator surfaces 73 and 74.

In the embodiment of Figures 9-14, slit 64, which is wide enough and of sufficient height to just receive and engage paddle member 68, extends in length throughout the entire length of applicator 61. In addition, silts 83 and 84 are defined in applicator 61 prependlcular to slit 64 and extending from slit 64 to respective recesses 81 and 82. These features facilitate formation of the applicator in accordance with the present invention, particularly when the applicator is a sponge. For example, the slits in the sponge are readily formed as part of a die cut. Recesses 81, 82 are more easily burned or otherwise bored into the sponge applicator. Variations from this specific configuration are illustrated in Figures 15-22 to which specific reference is now made.

In the applicator embodiment of Figures 15 and 16, applicator 91 has a paddle-receiving silt 92 and recesses 81, 82 defined therein without interconnecting slits 83, 84 of Figures 13 and 14. In addition, slit 92 extends only a relatively short distance lengthwise into the applicator, rather than throughout the applicator length. In a functional sense, it is only necessary that silt 92 be long enough to receive the entire paddle member 68 so that the paddle member Is properly engaged at the forward end of the handle.

In the applicator embodiment of Figures 17 and 18, applicator 95 has a paddle-receiving slit 64 which extends entirely through the length of the applicator. The flow projection receiving recesses 96, 97, instead of extending as tubular bores, are generally fan-shaped and diverge interlorally of the applicator from the applicator forward end. The widened internal areas of recesses 96, 97 are quite effective to distribute liquid received from projections 75, 76 to large areas of the applicator surfaces 73, 74. Recesses 96,97 are shown as being defined in parallel planes; however, the planes of these divergent recesses may be in skewed planes, if desired.

Applicator 101 illustrated in Figures 19 and 20 includes a paddle-receiving slit 102 which extends less than all the say through the applicator length, but which is longer than recesses 103 and 104. The recesses in this embodiment are generally tubular and diverge from one another and from slit 102. Thus, the interior terminations of recesses 103 and 104 are closer to respective applicator surfaces 73 and 74 than are the projection-receiving inlet ends of these recesses. For certain applications it may be desirable to provide converging rather than diverging recesses and this is certainly within the scope of the present invention.

In applicator 105 Illustrated in Figures 21 and 22, the paddle-receiving slit 64 extends lengthwise through the entire applicator. The fluid-receiving recesses 106 and 107 are each, bifurcated internally of the applicator to form two divergent flow passages. Of course, the concept of internally dividing the recesses is not limited to providing only two flow passages or to disposing the divided passages in a common plane as illustrated in Figures 21 and 22. Rather, within the scope of the present invention, there can be any number of divided passages, any of which may converge or diverge with respect to the paddle-receiving slit of 64.

In a typical hut by no means limiting configuration of the preferred embodiment of Figures 9-14, the various parts have the following dimensions. Cartridge 65 is six inches long and has a 0.652 inch diameter. Applicator 61 Is a sponge which is 7/8 inch deep and has top and bottom surfaces which are 1-3/4 Inches square. The overall length of handle member 63 is 5.512 inches, the paddle-shaped projection 68 being one inch long. The inner diameter of handle 63 is 0.687 inch and the thickness of the walls of handle 63 is approximately 0.069 inch. Each spike 69, 70 has an inner diameter of 0.114 inch and an outer diameter of 0.184 Inch. The spike-forming bias cut is made at a 30° angle from the longitudinal axis of the handle so that the bias planes 71, 72 converge at a 60° angle. The projections 75, 76 extend 1/8 inch from the end of handle 63. Paddle 68 Is preferably as thin as possible to enhance flexibility and its distal end is preferably rounded rather than squared off. Recesses 81, 82 extend approximately halfway into applicator 61. The unit as described is simple and inexpensive to fabricate and is therefore readily disposable after a single use. Specifically, the unit, in the optimal case, may be fabricated from only three separate components, namely, the applicator, the cartrigdge and the tubular handle. The cartridges, of course, may be interchangeable so that a variety of different liquids may be employed during the same procedure. The cartridges are easily changed and their contents remain sterile until used. The user of the device need not wear a surgical glove in view of the sterility of the cartridge arrangement as illustrated. The unit may be simply activated by merely grasping the handle in one hand and gently rapping the end of the cartridge on a hard surface so as to force the forward end of the cartridge against the spikes. Actuation is thus reliable and easily effected and the liquid to be dispensed flows freely to the applicator. While we have described and illustrated specific embodiments of our invention, it will be clear that variations of the details of construction which are specifically illustrated and described may be resorted to without departing from the true spirit and scope of the invention as defined in the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A surgical scrub device comprising:

an absorbent applicator member;

an elongated hollow handle member having first and second longitudinally-spaced ends, said first end being open, said second end being at least partially disposed in said absorbent applicator member, said handle member being adapted to receive an elongated fluid-containing cartridge in longitudinally slidably relation within said handle member, said cartridge having a rupturable forward end by which it is insertable into said open first end of said handle member; and

first and second transversely spaced hollow spikes disposed inside said handle member proximate said second end, each spike having a pointed end projecting longitudinally toward said first end, each hollow spike providing flow communication from within said handle member to within said applicator through said second end of said handle member;

wherein said spikes are positioned to provide two transversely-spaced punctures in said forward end of said cartridge in response to a predetermined slidable insertion of said cartridge in said handle member;

wherein said spikes include respective projecting portions which project In spaced relation externally of said hollow handle member beyond said second end; and wherein said applicator member has first and second flow passages defined therein oriented to receive respective projecting portions of said spikes, each flow passage extending beyond its received projecting spike portions.

2. The surgical scrub device according to Claim 1 further comprising a transversely flexible paddle extending from said second end of said handle member between and beyond said projecting portions of said spikes, wherein said applicator member has a slit defined therein between said flow passages to receive said flexible paddle and thereby said handle member.

3. The surgical scrub device according to Claim 2 wherein said applicator member is a sponge-like member and has first and second opposite applicator surfaces, wherein said paddle has first and second opposite flat surfaces, and wherein said first and second hollow spikes and said flow passages provide flow communication from the interior of said handle member to locations along said first and second flat surfaces, respectively, of said paddle.

4. The surgical scrub device according to Claim 3 wherein said first and second spikes are hollow tubes terminating along respective first and second bias planes to define said pointed ends, wherein said first and second bias planes converge in a direction toward said second end of said handle member.

5. The surgical scrub device according to Claim 3 further comprising additional silts defined in said sponge-like member and extending perpendicular to said first-mentioned slit between said first-mentioned slit and said first and second flow passages, respectively.

6. The surgical scrub device according to Claim! 3 wherein said first and second flow passages in said sponge-like member are generally tubular passages extending generally parallel to said slit.

7. The surgical scrub device according to Claim 6 wherein said first and second flow passages are each longer than said slit.

8. The surgical scrub device according to Claim 6 wherein said first and second flow passages are each shorter than said slit.

9. The surgical scrub device according to Claim 3 wherein said first and second flow passages each gradually widen along their lengths within said applicator.

10. The surgical scrub, device according to Claim 3 wherein said first and second flow passages define an acute angle in a plane which is perpendicular to said slit.

11. The surgical scrub device according to Claim 10 wherein said acute angle is a divergence between said first and second flow passages in a direction away from the received projecting portions.

12. The surgical scrub according to Claim 3 wherein said first and second flow passages each branch Into plural further flow passages.

13. The surgical scrub according to Claim 1 wherein the hollow spikes are interlorally coated with a non-wetting material.

14. A surgical scrub device comprising:

an absorbent applicator member;

an elongated hollow handle member having first and second longitudinally-spaced ends, said first end-heing open, said second end having a thin flexible member extending longitudinally therefrom to be received within said applicator member;

an elongated fluid-containing cartridge adapted for longitudinal slidability in said handle member, said cartridge having a rupturable forward end by which it is insertable into said open first end of said handle member;

at least one spike disposed inside said handle member proximate said second end, said spike having a pointed end projecting longitudinally toward said first end to puncture said forward end of said cartridge in response to a predetermined slidable insertion of said cartridge into said handle member; and flow passage means communicating with the interior of said handle member at said second end and projecting exteriorally of said handle member beyond said second end in a projecting portion;

wherein said applicator member has at least one recess defined therein oriented to receive the projecting portion of said flow passage means.

15. The surgical scrub device according to Claim 14 wherein said applicator member has a slit defined therei to receive the flexible member, thereby to engage said handle member.

16. The surgical scrub according to Claim 15 wherein said applicator member has an exterior application surface, wherein said flow passage means and said recess provides flow communication from the interior of said handle member to the interior of said applicator member to facilitate flow to locations along said application surfaces.

17. The surgical scrub device according to Claim 16 wherein said spike is a hollow tube, the interior of which comprises said flow passage means.

18. The surgical scrub device according to Claim 15 further comprising an additional slit defined in said applicator member extending perpendicular to said first-mentioned slit between said first-mentioned silt and said recess.