Stabilized Contamination Free Surgical Evacuator

Abstract

A contamination free surgical evacuator that includes a fluid stabilizer is disclosed. The evacuator container is bulbous in shape and formed of a material that has memory, i.e., tends to return to a "normal" configuration when external forces are released. A pair of input drip chambers and valves, one or both of which may be used to drain fluids from a wound, allow drained fluids to enter the evacuator container. A magnetic output or purge valve mounted in a graduated cup-like region, allows the evacuator container to be initially evacuated and allows drained fluids to be removed from the container thereafter. The graduations allow the evacuator to be used as a "rate of drainage" measuring instrument. The fluid stabilizer is in essence a compressible, perforated diaphragm mounted inside of the bulbous evacuator container. The fluid stabilizer prevents drained fluids from splashing around in the evacuator container, yet it does not inhibit the operation of the evacuator. Moreover, the fluid stabilizer prevents any sudden surge of fluids from accidentally actuating the magnetic purge valve.

Description

BACKGROUND OF THE INVENTION

This invention relates to surgical drainage devices and more particularly to contamination free surgical evacuators suitable for draining wounds or infected areas of a patient's body.

Various types of surgical evacuator devices have been proposed and some of them are in use. These devices vary from pumps to suction evacuator devices. Pumps generally have the disadvantage that they are bulky and, therefor, difficult to attach to a patient in a manner tha allows him to move about during recovery from an injury or operation. For this reason, vacuum or suction evacuators generally have been found to be more useful.

In operation, a vacuum or suction evacuator is first compressed to a small size. As the bag portion of the evacuator expands to it's normal size a suction is created. The suction is utilized to drain a patient's wound through suitable drainage tubes. Evacuators that use this principle of operation are disclosed in U.S. Pat. Nos. 3,115,138 to McElvenny et al.; 3,276,868 to Mondiadis; and, 3,572,340 to Lloyd et al. While evacuators of this general nature have been somewhat satisfactory, they all have one common disadvantage. Specifically, all of these evacuators are "open" evacuators whereby they allow bacteria and other contaminants to enter the region of the patient being drained. More specifically, these evacuators are first compressed to force air from the bags through a normally plugged opening. Then the plug is replaced and the desired fluids are drained into the evacuator bag. When the bag is suitably full, the plug is again removed and the bag is compressed to exhaust the fluids through the opening previously plugged. Then the plug is again replaced. The major problem with such an evacuation procedure is the time periods during which the plug is removed and fluid (or air) is not being exhausted. During these periods of time contaminant can enter the bag. From the bag the contaminants can then enter the body of the patient through the drainage tube where they can cause infection. For this, as well as other reasons, these devices have not found as widespread use as possible.

One device, described in U.S. Pat. application Ser. No. 189,563 filed Oct. 15, 1971 for "Contamination Free Surgical Evacuator," has been proposed to overcome the foregoing disadvantage. While this device has proven to be eminently successful in eliminating this and other problems, thre are further areas yet subject to improvement. For example, since the entire interior of the evacuator described in the noted patent application is essentially "open," blood or other fluids drained into the evacuator container are free to splash around inside the container. It will be appreciated that for ambulatory patients, and also for bed patients, such splashing is undesirable because it is noisy and may be uncomfortable.

Thus, it is one object of this invention to provide a new and improved surgical drainage devcie that reduces the amount of internal splashing of drained liquids.

Another disadvantage of the device described in the foregoing patent application, relates to its structure. More specifically, because the structure comprises a pair of plates and a plurality of internal springs, it is relatively complicated to manufacture. Consequently, it is desirable to provide a container structure that is less complex and therefor more economical.

Therefore, it is another object of this invention to provide a new and improved surgical evacuator that is formed of a limited number of components, yet readily expands toward a "normal" configuration after having been evacuated so as to create the desired drainage vacuum.

While the device described in the above noted patent application has been quite satisfactory in preventing contamination, it will be appreciated by those skilled in the art that a potential for contamination still exists, even though small, because there is an unrestricted "wet" surface between the evacuator container and the wound through the drainage tubing. This "wet" surface provides a surface for bacterial migration should bacteria enter the evacuator container in one manner or another.

Hence, it is a still further object of this invention to provide a dry wall region between the container and the drainage tubing to prevent the migration of bacteria and other organisms.

One further problem with the device described in the foregoing patent application relates to it's inability to directly drain more than one region of a wound, without the utilization of Y's of other connectors. It will be appreciated that Y's or other connectors reduce the contamination integrity of the system because each connection point is subject to separation and, thus, could allow the entry of contaminants. Consequently, it is desirable to reduce the number of connection points to an absolute minimum.

Hence, it is yet another object of this invention to provide a new and improved surgical evacuator that can drain one or more tubes directly, as desired.

SUMMARY OF THE INVENTION

In accordance with principles of this invention a stabilized contamination free surgical evacuator is provided. The evacuator container is generally bulbous in shape and is formed of materials that have "memory." That is, when external forces are not present, the container tends to assume a "normal" bulbous shape. Yet, the bulbous shape can be compressed to decrease the internal volume of the container. Upon release, the container tends to assume its "normal" bulbous shape, and, thus, creates the vacuum that drains wounds in the manner described above. More specifically, the evacuator includes "flap" inlet valves and a magnetic outlet or purge valve. The inlet valves allow fluids to be drawn into the container by the vacuum created as the container expands to its "normal" shape. The magnetic valve allows the container to be evacuated to air and fluids when the container is compressed by manual external pressure.

In accordance with other principles of this invention, a fluid stabilizer is mounted inside of the evacuator container. The stabilizer is, preferably, a generally cylindrical, perforated diaphragm which allows blood or other fluids to flow slowly from one region in the evacuator container to another region. Thus, splashing of contained fluids is prevented. The fluid stabilizer compresses when the evacuator container is manually compressed to create the desired vacuum so that there is no loss of evacuator operation by its inclusion.

In accordance with still further principles of this invention, two, or more, input terminals are provided. The input terminals include the "flap" valves and are adapted to either receive drainage tubes connected to a wound or be entirely closed. Thus, more than one wound, or several regions or the same wound, can be separately, directly drained into the evacuator container. In addition, the input terminals or drains are formed in a manner such that each drainage tube is separated by a drip chamber from the interior of the evacuator container. Thus, a dry wall section between the drainage tubes and the container is provided. The dry wall region prevents the migration of bacteria or other organisms from the container to the drainage tubes.

It will be appreciated from the foregoing brief description that a stabilized, contamination free surgical evacuator is provided by the invention. Because a compressible diaphragm that only allows the slow internal movement of fluids is included, the internal splashing of blood prevalent in prior art devices does not occur. Moreover, the compressible diaphragm prevents any sudden surge of fluids from accidentally actuating the magnetic purge valve. In addition, because the container is formed of a material having "memory," separate devices for expanding the container after the compression thereof, such as springs, are not necessary. Further, because dry wall drip chambers are provided, bacteria cannot migrate from the container through the tubing to the wound being drained to cause infection.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing objects and many of the attendant advantages of this invention will become more readily appreciated as the same becomes better understood by reference to the following detailed description when taken in conjunction with the accompanying drawings wherein:

FIG. 1 is an isometric view of a preferred embodiment of the invention;

FIG. 2 is a sectional view along line 2--2 of FIG. 1; and,

FIG. 3 is a sectional view of the drip chambers only, along line 3--3 of FIG. 1.

DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates a preferred embodiment of the invention and comprises an evacuator container 11 formed of a lower section 13 and an upper section 15. Preferably, the lower section 13 is formed of transparent flexible polypropylene and the upper section is formed of transparent semi-rigid polypropylene. In any event, the upper and lower sections are spin welded together along a junction 17 in a conventional manner to form an evacuator container that is unitary.

As with the device described in the U.S. Patent application referenced above, Ser. No. 189,563, the upper section 15 includes a cup-shaped region 19 having a plurality of graduations 21 written thereon. Since the cup-shaped region is transparent, when the evacuator container is inverted from the position illustrated in FIGS. 1 and 2, the graduations in combination with amount of fluid in the cup-shaped region provide measurement information. Thus, if a wound has been drained for a predetermined time and then the evacuator container is inverted from the position illustrated in FIGS. 1 and 2, the amount of fluid drained during the period of time can be determined by reading the nearest graduation or interpulating between graduations, as desired.

Located atop the cup-shaped region 19 is a cap 23 which surrounds a one-way magnetic outlet or purge valve 25. The magnetic purge valve comprises a ring magnet 24 surrounding an outlet aperture 26. The ring magnet 24 co-acts with a metal plate or cap 28, formed of iron or some other magnetic material, separated therefrom by a gasket 30. The gasket is fully attached along one surface to either the ring magnet 26 or the metal plate 28 and only partially attached to the other element so as to be able to separate therefrom when pressure is applied. Thus, internal pressure allows these elements to separate and provide an exhaust opening. More specifically, the magnetic valve allows the interior of the container 11 to be exhausted of air and fluids when it is compressed in the hereinafter described manner to cause the metal plate to move away from the ring magnet. A splash cap 32 prevents splashing of fluid during exhaustion.

Located adjacent to the cup-shaped region 19 are a pair of inlet terminals 27 and 29. As best seen in FIG. 3, the inlet terminals each include a drip chamber 31 which is an essentially funnel-shaped region that ends in a lower hole 33. The lower hole is normally closed by a flexible flap 35. Thus, the flap and the lower hole form a one-way inlet valve. Internal vaccum caused when the container expands towards its normal state opens the inlet valves. The flaps may be attached to the inner surface of the upper section 15 by any suitable means such as by a pin 37 located between the drip chambers 31. Alternatively they may be unitarily formed with the drip chambers 31 and the remaining portions of the upper section 15. Or, a suitable bonding agent may be used.

The tops of the drip chambers are closed by closure plates 39. The closure plates 39 have openings 41 which either allow a drain tube 43 to enter the drip chamber or allow a plug 45 to close the opening. Preferably, the closure plates 39 are removably mounted in the tops of the drip chambers so that plates with different size openings 41 can be used. More specifically, standard drain tubes come in 3/32 inches, 6/32 inches and 1/4 inches outside diameter. It is desirable that any of these sizes be usable with the invention. The use of removable clsoure plates 39 allows this to be done.

It should be noted that the drip chambers 31 are formed such that only the tip of the drainage tube 43 need be inserted into the drip chamber. Since the opening 41 in the closure plate 39 is aligned with the hole 33, the drainage tube is also aligned with the hole 33. Thus, fluids from the tube pass directly through the hole 33 past the flap 35 and into the interior of the evacuator container. This structural arrangement provides a "dry" region between the drainage tube 43 and the interior of the evacuator container. The dry region is along the inner surface of the drip chambers 31 and prevents the migration of bacteria and other organisms from the container into a wound being drained.

Located inside of the container 11 is a fluid stabilizer 51 (FIG. 2). The fluid stabilizer 51 is a generally cylindrical corrugated element preferably formed of flexible polypropylene. A plurality of perforations 53 extend through the corrugations. The perforations 53 allow fluid to flow through the fluid stabilizer. However, the rate of fluid flow is considerably less than if the stabilizer were not present. Thus, while blood or other fluids are free to move inside of the evacuator 11, they are prevented from splashing about and surging against the magnetic purge valve and unintentionally opening it, such as could occur if the evacuator were dropped, for example.

The fluid stabilizer 51 is held in place at the bottom of the evacuator container 11 by an upwardly projecting ring-shaped region 55. In addition, the fluid stabilizer is held in position at its upper end by a plurality of downwardly projecting pins 57, preferably four in number. Thus, the fluid stabilizer is maintained in position during formation of the unitary evacuator container and thereafter. That is, during spin welding of the lower and upper sections 13 and 15 the fluid stabilizer is held centered by the ring 55 and the pins 57. Further, it is held in position by these same items during use. Preferably, the ring 55 and the pins 57 are formed as a part of the lower and upper sections 13 and 15 respectively.

Because the fluid stabilizer is corrugated and formed of a flexible material, it is easily collapsible. That is, when the evacuator container is compressed to empty it of air and/or fluids through the magnetic valve 25, the fluid stabilizer also compresses. Thereafter, it expands as the evacuator container 11 expands to its "normal" bulbous shape.

Attached to the lower section 13 of the container 11 is an attachment tab 59 which is utilized to attach the surgical evacuator of the invention to an ambulatory patient, such as by "hanging" it from the waist of the patient, for example.

The operation of the surgical evacuator of the invention is generally similar to the operation of the surgical evacuator described in above noted patent application, Ser. No. 189,563. More specifically, a drainage tube or drainage tubes are inserted into the wound to be drained. The tube or tubes are connected to the evacuator container via the drip chambers 31 in the manner described above. The evacuator is evacuated by squeezing the bulbous container to empty it of air and/or fluids. More specifically, pressure formed by squeezing the container opens the magnetic valve 25 and allows air and/or fluids in the container to be evacuated therefrom. Fluids are evacuated when the container is inverted, of course. Upon release of the manually applied pressure, the magnetic valve immediately closes to prevent the entrance of contaminants. Thereafter, the evacuator tends to return to its "normal" bulbous state, illustrated in the drawings. This tendency causes a suction which opens the flap valve 35 and draws fluid from the wound via the drainage tube (or tubes) 43. After the evacuator returns to its normal state, it is emptied by inverting it and again manually compressing or squeezing it to open the magnetic valve 25 forcing fluids to flow out through the magnetic valve.

As alluded to above, the evacuator of the invention can be used as a fluid flow measuring device. Such a device is of particular importance to medical personnel as the rate of drainage decreases since it is desirable to remove the drainage tubes when the rate of drainage drops below a predetermined point. If this is not done the tube (or tubes) may adhere to the wound. The rate of flow of drained fluids can be measured over a predetermined unit of time by allowing the flow to continue for the predetermined unit of time. Thereafter, the amount of drained fluid is measured by inverting the evacuator and reading the graduation nearest the fluid level, or interpolating between graduations, as desired,

It will be appreciated by those skilled in the art and others that the invention provides an evacuator which is, structurally, considerably less complicated than prior art evacuators. In addition, it provides a means for preventing the splashing of blood or other fluids held in the evacuator container. Further, it provides a dry surface between the evacuator container and the patient. Thus the migration of bacteria and other organisms from the evacuator to the wound being drained is prevented. Hence, the invention provides a variety of improvements over prior art evacuators including the one illustrated and described in U.S. Pat. Application Ser. No. 189,563.

While a preferred embodiment of the invention has been illustrated and described, it will be appreciated by those skilled in the art and others that various changes can be made therein without departing from the spirit and scope of the invention. For example, three or more inlet regions, rather than two can be provided, if desired. Moreover, the fluid stabilizer can be attached to the interior of the container in a variety of manners and can take on other forms. Further, while the disclosure has primarily discussed the use of the invention in draining blood and other fluids from wounds, it will be appreciated that it can be used for other purposes. For example, the invention can be utilized to drain urine directly from the urinary tract under low suction by placing the drainage tube in a patient's bladder, ureters or pelvis of the kidney. Hence, the invention can be practiced otherwise than as specifically described herein .

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A stabilized, contamination free surgical evacuator comprising:

an evacuator container, said evacuator container being compressible and expandable to decrese and increse the internal volume of said container and thus create a vacuum;

an inlet region formed in said evacuator container, said inlet region including at least one one-way valve which allows fluid to be drawn into said container by the vacuum created therein;

an outlet region formed in said evacuator container, said outlet region including a one-way valve that allows fluids and air to be exhausted from said evacuator container when said evacuator container is compressed to decrease its internal volume; and,

a fluid stabilizer mounted inside of said evacuator container, said fluid stabilizer comprising a compressible diaphragm having a plurality of apertures therein which allow fluids to slowly flow from one region to another region inside of said container.

2. A stabilized, contamination free surgical evacuator as claimed in claim 1 wherein said evacuator container is bulbous in shape and formed of materials having memory which return to a normal state when no external forces are applied.

3. A stabilized, contamination free surgical evacuator as claimed in claim 2 wherein said inlet region includes at least one drip chamber.

4. A stabilized, contamination free surgical evacuator as claimed in claim 3 wherein said drip chamber is formed such that it includes an inlet aperture adapted to receive a drainage tube and an outlet aperture which forms the inlet to said one-way valve, said apertures being aligned so that fluids entering said drip chamber from said drainage tube pass directly through said aperture forming the inlet to said one-way valve whereby a dry wall region exists between said drainage tube and said aperture forming the inlet to said one-way valve.

5. A stabilized, contamination free surgical evacuator as claimed in claim 4 wherein said drip chamber includes a relatively large aperture and a closure plate for closing said apertures, said closure plate including an aperture through which said drainage tube extends.

6. A stabilized, contamination free surgical evacuator as claimed in claim 5 including a plurality of one-way valves and drip chambers.

7. A stabilized, contamination free surgical evacuator as claimed in claim 6 wherein said fluid stabilizer is generally cylindrical in shape and has a corrugated outer surface.

8. A stabilized, contamination free surgical evacuator as claimed in claim 6 wherein said evacuator container and said fluid stabilizer are formed of polypropylene.

9. A stabilized, contamination free surgical evacuator as claimed in claim 8 wherein said evacuator container comprises an upper section formed of semi-rigid polypropylene and a lower section formed of flexible polypropylene, said lower section including a ring-shaped inward projection inside of which said fluid stabilizer is mounted and said upper section including a plurality of inwardly projection legs which pass through apertures in said fluid stabilizer to hold said fluid stabilizer in a predetermined position.

10. A stabilized contamination free surgical evacuator as claimed in claim 1 wherein said fluid stabilizer is generally cylindrical in shape and has a corrugated outer surface.

11. A stabilized, contamination free surgical evacuator as claimed in claim 10 wherein said evacutor container and said fluid stabilizer are formed of polypropylene.

12. A stabilized, contamination free surgical evacuator as claimed in claim 11 wherein said evacuator container comprises an upper section formed of semi-rigid polypropylene and a lower section formed of flexible polypropylene, said lower section including a ring-shaped inward projection inside of which said fluid stabilizer is mounted and said upper section including a plurality of inwardly projecting legs which pass through apertures in said fluid stabilizer to hold said fluid stabilizer in a predetermined position.

13. A stabilized, contamination free surgical evacuator as claimed in claim 1 wherein said evacuator container comprises an upper section formed of semi-rigid polypropylene and a lower section formed of flexible polypropylene, said lower section including a ring-shaped inward projection inside of which said fluid stabilizer is mounted and said upper section including a plurality of inwardly projecting legs which pass through apertures in said fluid stabilizer to hold said fluid stabilizer in a predetermined position.

14. A stabilized, contamination free surgical evacuator as claimed in claim 1 including a plurality of one-way valves and drip chambers.