WOUr^> IBBIGATIONJ>EyiC£

RELATED APPLICATIONS

The present application claims priority to U, S, Provisional Application 60/799,062, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to medical devices utilized in. the cleansing of wounds on patients prior to treatment of wounds,

BACKGROUND

The current standard of care in the medical profession calls for all types of wounds to be copiously demised with sterile irrigation fluid prior to treatment or repair- Abrasions, lacerations, ulcerations, and puncture wounds are all irrigated to remove particulate material deleterious to the future healing of wounds. Contaminants .include bacteria, necrotic tissue, and solid debris such as dirt and foreign bodies. Standard clinical practice involves vigorously spraying wounds with a stream of sterile irrigant ilnid. The stream of irrigant fluid mechanically removes bacteria and debris and must be of sufficient pressure as to strike bacteria and debris and physically dislodge the particles from the tissue. At such pressures, significant splashing of contaminated fluid is encountered. Methods have previously been devised to decrease exposure of medical practitioners to such contaminated fluids during irrigation. Known devices and associated methods suffer from a number of shortcomings, which arc described briefly below.

The most frequently employed method of irrigation involves use of a syringe (usually 20 ce ϊo 60 cc) attached to a shield device described by Stamler U.S. Pat. No. 4,769,003. This method is effective, but labor-intensive. Firs!, a sterile irrigant bottle must be located and poured into a sterile container or basin, The .syringe is filled with the irrigation iiuid. withdrawn from the basin. A shield is then affixed to the syringe. Fluid is forcibly expressed from the syringe through the shield and into the wound. ^' The shield blocks liquid splashed .from the wound, which might otherwise contact the practitioner.

The syringe must then be refilled repeatedly by removing the shield, drawing up sterile irrig&nt fluid into the syringe, replacing the shield, and further irrigating the wound. The process is typically repeated many limes to adequately cleanse the wound. Most literature suggests a minimum of 250 cc of irrigation fluid volume to adequately cleanse a wound (see, e.g.. ian S. Wedmore. Wound care: modern evidence in the treatment of Man's age-old injuries. Emergency Medicine Practice 7:3 2005). No precise volume of irrigation fluid used per length of wound is known Io be effective. There is limited data to suggest a minimum of 60 cc per centimeter of wound length should be used as a guideline above arsd beyond the minimum of 250 cc (dowel! JM, Chishαlm CD: Wound care. ϊtmerg Med Clin North Am 15:417, J 99?.). Therefore, even a wound of average size (requiring the minimum 250 cc's) would require approximately 12 refills of the syringe using a typical .20 cc .syringe or 4 refills using a large 60 cc syringe. This is obviously relatively time consuming and inconvenient, particularly in a busy emergency room setting. Other devices address the aforementioned problems by providing a more readily accessible fluid reservoir. One involves a specific shield device attached to a syringe and an arrangement of check valves. This device utilizes an intravenous (i.Y.), line and I. V, hag as a reservoir of irrigant fluid (Li. S. Pat No, 5,496,290 to Aekeπnan). Another device also uses check valves and a shield combined with a syringe. This second device requires sterile irrigani fluid to be poured into a separate container (U.S. Fat. No.

5,860,947 to Stamler), Both of these devices have significant shortcomings and are not widely used. First, cost has proven to be a barrier to the generalised acceptance of both, due to the specific equipment retjuired. Secondly, additional steps must be initiated prior to irrigation. For example, an f .V. pole with LV. bag and LV. tubing most be set up and attached to the Ackeπnan device. Often this step is performed by different medical personnel, such as nursing staff. For the Stamler device, a sterile imgant basin must be located and sterile fluid poured into the basin. The device must be removed from direct contact with wound to refill the swinge. Both devices have relatively cumbersome tubing extending from the syringe area to the fluid reservoir. Neither device is widely employed in the ikki

Another approach involves cap- like devices formed to engage a standard bottle of sterile irrigation solution. A shield is disclosed for these as either permanent!]/ attached to the tap device, or affixed to it after the device is placed on sterile irrigation bottle. The.se methods require manual compression of the bottle, which causes ϊϊiήά to exit the bottle through, the cap device. However, it is difficult to generate sufficient pressure with these devices, irrigation pressures of 5 to 8 psi at the tissue surface axe recommended (Singer Al Hollander JE, Subramanian S, et tύ: Pressure dynamics of various irrigation techniques commonly used in the emergency department. Ami Kmerg Ivk-d 24:36, 1994.), Adequate pressures have been demonstrated using a 30-60 cc syringe and 19- gauge catheter using maximal ham! pressure (Singer AJ, Hollander JE, Subramanian S, et al: Pressure dynamics of various irrigation techniques commonly used in emergency department. Ann Emerg Med 24:36, 1994,}, Other methods occasionally employed as a time saving measure such as manual compression of a bulb syringe or sterile irrigant container, e.g., an LV, bag or sterile irrigant bottle with punctured needle hole are not recommended. As demonstrated in the Literature, manual compression of saline fluid bottles resulted in median peak pressures of 2.3 psi with a range of i.2 pύ to 4.5 psi (Singer Ai, Hollander JE, Subramanian S, et aS; Pressure dynamics of various irrigaiioπ tεchniqiies commonly used in emergency department. Ann Emerg Med 24:36, 1994.). A recent review article irj the emergency medicine literature lists failure to irrigate with a pressure of approximately 8 psi as the number one of eleven pitfalls to avoid in the care of wounds (Ian S. Wed.mo.re. Wound care: modern evidence in the treatment of Man's age-old injuries, Emergency Medicine Practice 7;3 2005),

Another disadvantage of these methods relates to the aagle of use. Often it is helpful for the patient to cooperatively position the wound to attain adequate exposure of the wound, Occasionally a patient is unable to assist with positioning of the wound, if repositioning is not possible, the wound must be irrigated and repaired at a inconvenient angle, As fluid is expressed from the bottle it will be replaced by air within the bottle. If the bottle is tipped to horizontal air may be expressed from the bottle instead of irrigant fluid.

SUMMARY

Devices that can assist and protect a medical practitioner dining the process of irrigating wounds is provided herein. In general, the device comprises a cap that can be attached to as irrigation fluid bottle. This close association with the fluid reservoir obviates multiple steps in the process of wound irrigation and vastly improves the efficiency of the overall process. The device provides a simple, inexpensive, solution to the problems described above. hi one aspect, the specification provides a fluid delivery device for engaging a vessel. The device can include a cap (e.g., including an interior threaded wall) and a base comprising an aperture and a lube structure (e.g., a substantially T-shaped lube structure) comprising a syringe port (e.g., a threaded syringe port), a discharge port, and an intake port, the intake port being connected to and m fluid communication with the cap through the aperture. The discharge port can include a one-way check valve and the intake port can include & one-way check valve. Alternatively, the tube structure can be a dual check valve (e.g., a substantially T-shaped dual check valve). The cap and lube structure can be reversibly connected. For example, the intake port can include a threaded portion and an interior wall of the aperture is configured to receive the threaded portion, and the cap and tube structure can be reversibly connected by engaging the threaded portion with the interior wall of the aperture. The device can be a unitary structure, e.g., formed of plastic- or any other useful material. hi another aspect, the specification provides a wound irrigation device. The device can include a fluid delivery device, e.g., a device discussed above, and a syringe comprising an end adapted to engage the syringe port (e.g., by interlocking threads), wherein the end is engaged with the syringe port and the syringe is in fluid communication with the tube structure, e.g., a dual check, valve. The device cars further include a shield comprising an aperture configured to engage the discharge port. The device can include a vessel comprising a neck (e.g., a threaded neck) configured to engage the cap. wherein the neck is engaged with the cap and the vessel is in fluid communication with the cap, the tube structure, and the syringe. In still another aspect, the specification provides a method of irrigating a wound.

The method can include providing a wound irrigation device, e.g., a device discussed

above, wherein She vessel comprises irrigation fluid, withdrawing the plunger on the wound irrigation device, thereby causing fluid to flow from the vessel through the cap arid tube structure (e.g., a dual check valve) and into the syringe, positioning the irrigation device for wound irrigation, and depressing the plunger, thereby causing fluid Io flow from the syringe through the tube structure and into the wound.

In yet another aspect, the specification provides a kit for irrigating a wound. The kit can include a fluid delivery device, e.g., a device described above, and a syringe comprising an end adapted to engage the syringe port of the tube structure, The kit can farther include a shield comprising an aperture adapted to engage the discharge port.. The kit can include a vessel, e.g., a vessel that includes irrigation fluid, comprising a threaded neck configured to engage the cap.

Unless otherwise defined, all technical and scientific terras used herein have the same meaning as commonly understood by one of ordinary skill in the art to winch this disclosure belongs. Although methods and materials similar or equivalent Io those described herein can be used in the practice or testing of the present disclosure, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference m their entirety. In ease of conflict, the present specification will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. Other features and advantages of the invention will be apparent from the following detailed description, and .from the claims.

BRIEF BESCR] PTlON OF THE DRAWINGS

FlG. 1 is a perspective view of an exemplary wound irrigation device. FiG. 2 is a perspective view of an exemplary device in a position of operation with attached shield, syringe, and bottle.

FIG, 3A is a perspective view of device of FIG. I with an indication of iiuki flow upon withdrawal of syringe plunger.

FIG. 38 is a perspective view of device of FIG. 1 with an indication of fluid flow upon depression of the syringe plunger.

FIG. 4A is a perspective view of an exemplary device with an extended cylindrical shield,

FiG. 4B is a perspective view υf an exemplary device with a shield having a conical shape, FIG. 4C is a perspective view of an exemplary device with a shield having a cylindrical shape,

FIG. 4D is a perspective view of an exemplary device with a shield having a partially spherical shape,

FK], 5A is a perspective view of an exemplary device with a dual check valve instead of two one- way check valves.

FiG. 58 is a perspective view of an exemplary device wit.li a dual check valve and a tube set. at an angle.

FIG. SC is a perspective view of an exemplary device with a dual check valve attached to tube 3 Sh, FICl SD is a perspective view of an exemplary de-vice with a dual check valve indicating fluid flow upon withdrawal of the syringe plunger.

FIG, 5e is a perspective view of an exemplary device with a dual check valve indicating iliskl tlow upon depression of the syringe plunger.

FIG. 6 A is a perspective view of an exemplary fluid delivery device that includes a dusl check valve comprising a discharge port, a syringe port and ats intake port, a cap, ami optional tube portion,

FIG. 6B is a perspective view of an exemplary assembly that includes a fluid delivery device as shown in FIG. 6A, a syringe, and an optional shield, l he depicted assembly includes an optional tube portion and is engaged with the neck of a vessel, which may include irrigation Oυid.

DETAILED DESCRIPT] ON

FfG. 1 is a perspective view of an exemplary wound irrigation device. A cylindrical cap i0 is connected to a T-shaped hollow tube 24. The device may be made lrora plastic, but may be also constructed from any other suitable material. Cap 10 is shaped to corøpiemersiarily fit onto irrigation fluid bottles. Cap 10 is therefore sized with

dimensions similar to thai of a bottle cap packaged with such bottles and includes interior threads 20 that, engage exterior threads on the necks of suck bottles, allowing it to be screwed into place on the bottle necks, fn one example cap 10 is a thin wailed structure with maximum outer diameter Dl of approximately 4.3 em, and a minimum inner 5 diameter D2 of approximately 3.8 mm. Hie height 111 of side wall 1 1 of the cap 10 is approximately 2.5 cm in tins example. Cap 10 is cylindrical in shape with one end opers 16, arsd a border of the open end defined by upper rim 15, The opposite end is flat and closed, save for an optional aperture, and is referred Io as base 18.

Tube 24 includes several portions, all of which are either integral or connected to

1(5 one another. Tube portion 38a resides in the interior of cap 30, and terminates at fluid entry port. 34. Tube portion 38a is in fluid communication with tube portion 38b, which is external to the cap 10, and terminates at fluid discharge port 36. Extending from, and in fluid communication with, tube portion 38b, is tube portion 48, which terminates at syringe port 42.

15 Fluid flow within tube 24 is controlled by valves connected to the tube, m this example, two one-way check, valves 26, 28 are used to limit fluid ikw direction vaiά& different conditions. Valve 26 allows fluid to flow from within the tube 24 out through discharge port 36, hut prevents flow in the opposite direction. Valve 28 allows fluid to How irsto the tube through entry port 34, hut prevents flow in the opposite direction. How

20 these valves conlribute to the operation of the invention is discussed in more detail below.

FIG. 1 also shows an optional splash shield 14, which includes an aperture 46 thai engages a tip 44 surrounding port 36, allowing it to he held in place by a pressure fit The figure also shows a syringe .12 with barrel 54 and plunger 56 - the configuration of

.25 which is well known in the art. The syringe may be a LIIBR-LOK™ type syringe having tip 52, Mow the syringe 12 operates with the device is also discussed below.

As shown in FIG. 2, the interior of the cap wall 1 1 is threaded 20 to eonipiementarily affix to a standard wound irrigation fluid bottle 22. Such bottles are typically available in patient treatment facilities such as hospitals, hi this example, when

^■ ^ the cap is affixed to bottle 22, tube portion 38a extends into the bottle neck. Contiguous with tube portion 38a is tube portion 38b. This longitudinal tube comprised of portions

3Sa and 38b is firmly affixed UJ cap base 18 at point of contact 30, which may include an aperture in. cap base 18. The tube portions 38b and 48 are external to rite bottle. The whole T-tube configuration 24 consisting of tubes 38a, 38b and 48 will function as a closed fluid conduit with three access ports: entry port 34, discharge port 36, and syringe port' 42.

When, the device is attached to bottle 22 the entry port 34 and discharge port 36 will be at opposite ends of the conduit formed by tube portion 3Sa and tube portion 3Sb. Connected to tube portion 38a is one-way check valve 28. Check valves are known in the art and maybe procured from various manufacturers. With cap 10 threaded onto bottle 22, entry port 34 is positioned within the bottle in direct communication with the sterile irriganr fluid therewuhin when the bottle is in an inverted position. This entry port 34 allows ingress of irrigant fluid through check valve 28 and Into tube portion 38a. Tube portion 3Sb has a second one-way check valve 26 at the opposite end, A conical shaped tip 44 surrounding discharge port 36 is located adjacent to eheel' valve 26, and is designed to engage an available shield device 14 at an aperture 46 of the shield. An example of such a shield is described in U.S. PAT. NO. 4,759,003. The conical shaped tip 44 can also engage a catheter of an appropriate gauge needle, and irrigation may optionally be accomplished without a shield device.

Discharge port 36 has an aperture diameter appropriate for generating a desired fluid velocity sufficient to provide the force necessary for dislodging contaminants from a wound site. For example, the device can have an aperture diameter at discharge port 36 designed to optimize the force of the fluid stream delivered at the wound sue, either alone or with the use of a shield device or needle catheter, hi this example, tube portion 48 extends at a roughly 90 degree angle from tube portion 38b. At the opposite end tube portion 48 is the syringe port 42, which is configured to engage tip 52 of standard LUER- LGK™ syringe 12. The syringe is of standard configuration, comprising a syringe barrel 54 and syringe plunger 56.

In operation, the cap 10 is screwed onto top of sterile irrigaiit bottle 22, via threads 20 (see FIG. 2). Once the device is threaded onto top of sterile irrigant bottle opening, a fluid tight seal is created, The bottle and device are then inverted, as illustrated in FIG. 2, Tube portion 38b with associated check valve 26 is coupled to shield 14 by a pressure fit

between shield aperture 46 onto tip 44. A standard syringe 12 with LUER-L-OK ™ tip 52 is secured to syringe port 42.

The device with shield 14 and bottle 22 are placed directly adjacent to the patient wound. Syringe plunger 56 is withdrawn as shown in FIG. 3 A, which results in negative pressure within tube portions 38a, 38b and 48. Check valve 2S opens, allowing irrigant fluid to pass through entry port 34 into the tube 24, and fluid fills syringe barrel 54. Check valve 26 remains closed during the filling process, preventing the ingress of air into the tube 24,

Once the syringe is filled, the device is placed adjacent to the wound and the swinge plunger 56 is depressed, forcing fluid into tube 48 as shown in FIG. 3B. Positive pressure causes check valve 26 to open while cheek valve 28 remains closed. The closed stale of check valve 28 prevents flow of irrigant fluid back into bottle, ϊrrigaπt fluid is forced through tube portion 38b past check valve 26, and through tip 44 and out discharge port 36, FIG. 3B uses a dashed line to illustrate a fluid stream forced out of discharge port 36 at high pressure, which passes through shield 14 and subsequently impacts the wound site.

With the devices disclosed herein, the filling and discharging of the syringe may be immediately and efficiently repeated until the wound is cleansed with an adequate volume of irrigant fluid and at a pressure that is precisely controlled by the user. There is no need for a separate basin or for the removal of the shield 14 from the syringe 12 in order to refill the swinge. Indeed, the syringe 12, shield 14, and irrigant fluid bottle 22 all operate as a single unit without the need for removing any of the components from the wound site until irrigation is completed. The device can remain relatively stationary and in relatively constant contact with the patient, obviating multiple, steps eomτnoniy employed when irrigating wounds on patients. The invention significantly facilitates wound irrigation by allowing multiple steps to be combined, No preparatory set up is required as the cap device is simply screwed onto a standard sterile irrigaαt bottle commonplace in the hospital setting. The device is configured to interact with any size syringe with a LUER-LOK™ tip, which are also commonplace in hospital settings.

The use of the syringe complies with known practice guidelines in tliai adequate pressure is easily generated. The present configuration also allows refilling of the syringe in any position In which the entry port 34 of the tube portion 3Sa is submerged, and the syringe, once filled, can be positioned at any angle while attached to the bottle. This allows irrigation at any angle, in contrast with many prior art methods of irrigation. The present invention provides access to a plentiful sterile irrigant reservoir thai can be rapidly and conveniently accessed to provide adequate volumes delivered to wounds at sirfii ci erst pressure s ,

Device components may be produced from any useful material, e.g., injection molded pϊasik, and may be distributed in a sterile package, although, other materials, methods of manufacture and types of packaging are also anticipated.

The foregoing description is but one example of how the present invention may be configured. For example, cap 10 is formed for cormecύvity with sterile irrigate container 22 and may attach by various methods including, but not limited to, typical threads, snaps, clips, ridges, grooves, or other mechanisms. The shield may be permanently attached adjacent to the discharge port 36, or may be removable. The shield may be shaped variously as a cone, partial sphere, cylinder, dome, concavity, or other appropriate shape that reduces the fluid splashed back from the wound site. Some of these variations are depicted in PIGS 4A-4D. FIGS. 4A-4D show shields with different attachment points and skiewall shapes.

The shield may attach ai various locations on tube portion 38b, or may attach to the cap base 18. Alternative shields may have different diameters. The shield may also be shaped as a cylinder such that it is contiguous with sidewall 11 , as shown in FlG 4A. This shape shield would therefore enclose all of tube portion 38b and have an opening in its side wall for tube 48, FIG. 4B, depicts shield 14b which is generally cone-shaped. pfoxirrmlly affixed OH to tube 3Sb at attachment point 30 on cap base 1 S, FfG. 4C depicts a cylinder- shaped shield, affixed to tube 38b adjacent to check valve 26. FIG. 4D discloses a shield with sidewalis curved as a partial sphere.

The dimensions of tube portions 38a, 38b, and 48 of tube 24 can vary depending OΏ optimum fluid pressure or volume. Tube 24 can have eonfiguralioαs other than T- shape. The tubing portions can also have different relative angles with respect to cap 10.

For example, tube 48 may be angled or curved. Tube portions 38a and 38b am also be angled. Tube 24 can be simplified depending on valve arrangement and consist of only one or two of the described tube porticos 38a, 38b, or 48. The lube portions can be formed from pliable or bendabie material such that bottle and shield positions may be 5 adjusted by a user while performing irrigation. For example, tube portion 3Sb may be bent at an angle while the irrigant fluid bottle remains in a vertical position. This would allow rapid refilling of the syringe without movement of the device from the wound site, even Lf the wound itself is relatively vertical. Tube portion 38a can pass through cap base 18 at attachment point/aperture 30 at various points other than the center Oi ^" cap base 1 S, i 0 Tube portions 3Ha ₅ 38b, and 48 may have various structural supports of different shapes and sizes attached to more finely stabilize tube portions 38a, 38b. and 48 while the syringe plunger 5(S is moved. Tube portion 48 may also be firmly seated against cap base 18. 'Tube arrangement 24 can be attached to an irrigation fluid container by other mechanisms, other than those described for cap 10. For example, a fluid irrigation

15 container may have tube 24 permanently attached without use of a cap. A syringe or analogous device can be permanently attached to swinge port 42.

Ilie valves may be check valves, or other types of valves restricting fluid How to one or two directions. In some embodiments, valves maybe placed in multiple locations iii the channel system. Valves can be one-way or dual cheek valves, A single dual check 0 valve may be employed m place of two one-way check valves,

PIGS. 5λ-5C depict a dual check valve attached to a simplified tube 24 without all three tube portions 38a, 38b, and 48, Dual check valves are known in the art and may be procured from multiple manufacturers. This alternative configuration retains the basic structure of the single tube 24 with the entry port 34, syringe pott 42 and discbarge port 5 36. FKl 5A depicts the dual check vaive 27 attached to relatively horizontal tube 48. FKl SB depicts the dual check valve attached to tube 48 which is angled. Syringe port 42 or check vaive 27 may be attached at various angles, FIG. SC depicts dual cheek valve 27 attached to relatively vertical tube portion 38b. In these examples the direction of fluid flow is governed by the single dual check valve 2? instead of two one-way check 0 valves 26 and 28, FIGS. 5 D aαd 5E depict the direction of the fluid flow using the dual check valve 27 when the syringe 12 is withdrawn and depressed respectively. Flow of

1 !

the fluid may be governed by stopcock devices or other manual switch devices instead of check valves.

FIGS. 6A and 66 depict a fluid delivery device for engaging a vessel and an assembly including the fluid delivery device, respectively. Using such a device, a user can re fill syringe 12 while sterile irrigarst bottle 22 is hi an ^" upright or upside-down position, in this device, direction of fluid flow is controlled by a dual check valve. A dual check valve used in this example can be a unitary structure feat includes a syringe port 42 adapted to engage a syringe, a discharge port 36 adapted Io engage a shield _* and Bxi Intake port 3Sc. Particularly useful, dual check valves are those comprising a LIJ ER- LOK ^{ϊ M} configuration at the syringe port for engaging syringe 54. Such dual check valves are commercially available from numerous sources, e.g., front Qostna Corporation (Edgewooti NY) and S. Braim Medical Inc. (Bethlehem, PA). Alternatively, two oneway check valves may be used to direct fluid How. Optional tube portion 3Sa may be formed of flexible or rigid material, e.g., rubber or plastic, and may extend into the sterile irrtgant bottle 22, Extending tube portion 3Sa toward the bottom of sterile irrigant bottle 22 allows reiiOmg of syringe with bottle 22 in a relatively upright position.

Irs an exemplary wound irrigation procedure using the assembly depicted m PiG. 6.8, a user withdraws syringe plunger 56 creating a negative pressure inside syringe 12, causing fluid to flow from bottle 22 through cap 10 and dual check valve 2? and into syringe 1.2. After syringe 12 is filled with irrigant fluid, the assembly can be tilted approximately 90 degrees, thereby placing the entire assembly substantially vertically over a wound, FUmger 56 can then be depressed causing irrigant fluid to Sow irom syringe 12 through dual check valve 27 and shield 14 and on/into the wound. Sterile irrigant bottle 22 may then be tilted to the upright position in order to refill syringe 12 and repeal the process.

Optional tube portion 38a may be made in various lengths and shapes which allow tube portion 38a to be compressed for packaging then lengthened once attached to sterile irrigant bottle 22. Such designs include, but are not limited to, a spirakd shape, a coiled shape, a curled shape, or a telescoping shape. Optional tube portion 38a may have other one-way valves or filters in place preventing back flow of contaminants from awoimd therefore enabling reuse of sterile irrigant solution.

Skilled practitioners will appreciate thai in certain configurations, optional tube portion 38a can be excluded. In such configurations, the device cars, be used in an ^■ inverted position relative to that shown in RG. 6B ₅ allowing a user to refill svτmge 12 without tilting the assembly to an upright position. Such a configuration enables rapid

5 refilling and discharging of syringe 12.

Entry port 34 of optional tube portion 38a may be shaped to fit standard IV. tubing and therefore ^' utilize an LV, bag as an irrigation solution reservoir as opposed to sterile iπigaπt bottle 22, Entry port 34 and discharge port 36 may have various aperture diameters and shapes. Various filters or valves may be placed anywhere in the channel

K) system, e.g., between the entry port 34 and discharge port 36 restricting back flow of contaminants in Io sterile irriganl solution. In one configuration, entry port 34 and discharge port 36 are adjacent to check valves, however, these ports 34 and 36 may ha located further away from valves 26 and 28. Discharge port 36 may have a small aperture, such as 16-20 gauge, to optimize the pressure and velocity of the fluid stream

! 5 delivered at the tissue site.

Cap IG may be shaped or sized to fit irrigation bottles from various manufacturers available currently or in the future. Upper rim 15 may have a narrow channel to tightly engage the gasket present on certain sterile irrigant bottles. Cap 10 and sidewat! 1 1 may be flexible and expandable with the ability to increase in diameter to fit a multitude of 0 bottles. Cap 10 may have a variety of shapes. For example, cap 10 may be shaped as a longer cylinder extending sidewall 1 1 for easier tactile gripping while in operation. Outer aspect of sidewall 1 1 may be ergonomieally shaped, e.g., with grooves or ridges, to provide a more comfortable grip while the device Is in operation. Cap 10 may have a short barrel -shaped handle projecting from sidewall 11. This handle cmi include grooves 5 or indentations to facilitate gripping with one hand. Cap 10 may be permanently or reversibly attached to a bottle or other type of irrigation fluid container.

OHfEE EMBODIMENTS

A number of embodiments have beers described. Nevertheless, it will be 0 understood that various modifications may be made without departing from the spirit and scope of the invention. Other embodiments are within the scope of the following claims.