Schachet, Eli (St. Louis, MO)
Deuschle, Fritz (St. Louis, MO)

05/206307

05/07/1974

12/09/1971

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Sherwood Medical Industries Inc. (St. Louis, MO)

604/133

417/479

A61M1/00; A61M1/00

128/276-278,297-300,281 417/234,395,437,470,472,474,479,544,568

3316903

Inhalator

May 1967

Richards

Rosenbaum, Charles F.

1. A portable, manually operable body wound suction drainage device comprising a vessel having a bottom wall, and a peripheral side wall connected thereto, a plate member connected to said side wall, resiliently urged fluid displacement means including an elastic sheet diaphragm sealingly connected to said side wall and movable within said side wall toward and away from said bottom wall to define a variable volume fluid pressure chamber therebetween, said fluid displacement means being normally resiliently urged toward a position spaced from said bottom wall with said chamber having a relatively large volume, said fluid displacement means including an actuating member disposed between said plate member and said diaphragm and movable in response to an applied force thereon for stretching and moving said diaphragm toward said bottom wall to a position wherein the volume of said chamber is relatively small, actuator means on said plate member responsive to a force manually applied thereto for applying a force on said actuating member for moving said actuating member and said diaphragm toward said bottom wall, tube connector means connected in continuous fluid communication with said chamber during the drainage operation of the device, and a body fluid drainage tube having one end connectable in sealed fluid communication with said tube connector means and the other end insertable in a body wound for transferring drainage fluid from the wound to said chamber in response to negative pressure in said chamber due to movement of said fluid displacement means away from said bottom wall, said side wall being substantially rigid in a direction parallel to the direction of movement of said fluid displacement means preventing an inadvertent compressive force applied to said side wall from effecting movement of said fluid displacement means toward said bottom wall and drainage fluid flow back to

2. The device according to claim 1 wherein the periphery of said diaphragm member is clamped between peripheral portions of said plate member and

3. The device according to claim 1 wherein said plate member has an opening therethrough, said actuator means is movable in said opening and engageable with said actuating member for moving the same in a direction toward said bottom wall, said actuating member engaging said diaphragm closely adjacent the outer periphery of said diaphragm to substantially

4. A portable, manually operable body wound drainage device comprising a vessel having a bottom wall, and a substantially rigid peripheral side wall connected thereto, resiliently urged fluid displacement means comprising a flexible resilient diaphragm member in the form of an elastic sheet member sealingly connected with said wall in normally spaced relation with said bottom wall, said diaphragm member being resiliently urged in a direction away from said bottom wall and movable within said peripheral side wall toward and away from said bottom wall to define a variable volume fluid pressure chamber therebetween, a plate member connected to said side wall and having an opening therethrough, said fluid displacement means including an actuating member disposed between said plate member and said diaphragm member and engaging said diaphragm member closely adjacent the outer periphery of said diaphragm member to substantially evenly distribute an applied force thereto, said actuating member being movable in response to an applied force thereon for stretching and moving said diaphragm member toward said bottom wall, actuator means on said plate member movable in said opening and engageable with said actuating member for moving said actuating member and said diaphragm member in a direction toward said bottom wall in response to a force manually applied to said actuator means, and releasable locking means for holding said actuator means in a predetermined position in which said actuator means has moved said actuating member to a location in which said volume of said chamber is at a predetermined minimum, and passage means enabling the interior of said chamber to be connected in fluid

5. The device according to claim 4 wherein said locking means includes abutment means on said plate member, and abutment means on said actuator means engageable with said first named abutment means for holding said

6. The device according to claim 5 wherein said plate member, said

7. The device according to claim 5 wherein said actuator means is movable relative to said actuating member and comprises a generally U-shaped element pivotally movable from a position substantially parallel to the plane of said plate member to a position generally normal to the plane of

8. A portable, manually operable body wound drainage device comprising a vessel having a bottom wall, and a substantially rigid peripheral side wall connected thereto, an effectively rigid plate member connected to said side wall and having an opening therethrough, resiliently urged fluid displacement means disposed between said plate member and said bottom wall and movable within said peripheral side wall toward and away from said bottom wall to define a variable volume fluid chamber therebetween, effectively rigid movable actuator means associated with said plate member and responsive to a manually applied force thereon for moving said fluid displacement means, said actuator means including a portion thereon reciprocal in said opening and engageable with said fluid displacement means for moving said fluid displacement means against the resiliency thereof toward said bottom wall, releasable latching means for maintaining said device in a cocked condition when said fluid displacement means is in a position in which the volume of said chamber is at a predetermined relatively small value, said latching means including first abutment means on said plate member and second abutment means on said actuator means engageable with said first abutment means when said fluid displacement means is in said position, and passage means enabling the interior of said

9. The device according to claim 8 wherein said actuator means comprises an effectively rigid elongated member pivotally connected to said plate member and movable to a position in which its lengthwise axis is

10. The device according to claim 8 wherein said actuator means comprises an elastic sheet member with the periphery thereof connected in sealing engagement with said side wall, and an effectively rigid force transmitting member disposed between said plate member and engaged with said sheet member and movable relative thereto to stretch said sheet member and move the same toward said bottom wall in response to the application of a predetermined force on said force transmitting member.

11. The device according to claim 10 further including a lubricant disposed between the engaging surfaces of said sheet means and said force

12. A portable, manually operable, wound suction drainage device comprising a fluid pressure chamber including a peripheral side wall, and a pair of oppositely disposed walls, at least one of said pair of walls being movable toward and away from the other wall of said pair to vary the volume of said chamber, said one wall being resiliently urged toward a first position spaced from said other wall wherein said chamber has a predetermined maximum volume, a plate member connected in fixed spaced relation from said other wall, actuator means for moving said one wall in a direction toward said other wall in response to an applied force thereon to a second position wherein said chamber has a predetermined minimum volume, releasable locking means for holding said one wall in said second position after removal of said applied force, said releasable locking means including first abutment means on said plate member, and second abutment means on said actuator means, said actuator means being movable to effect engagement between said first and second abutment means after said actuator means moves said one wall to said second position to thereby prevent movement of said one wall from said second position, said actuator means being manually movable to effect disengagement of said first and second abutment means to permit movement of said one wall toward said second position, and passage means in operative connection with said

13. The device according to claim 12 wherein said plate member has an opening therethrough, said actuator means includes an elongated member movable in said opening with its lengthwise axis perpendicular to the plane of said plate member, said elongated member is pivotal into a stored position in which said axis is substantially parallel with the plane of said plate member, said second abutment means is disposed on said

14. The device according to claim 13 further including an actuating plate disposed between said actuator means and said one wall and for engagement by said elongated member for moving said one wall toward said second position, said actuating plate having a recess therein for receiving an

15. The device according to claim 14 wherein said actuating plate has and said elongated member have cooperating engagement means preventing pivotal movement of said actuator means when said elongated member is in said actuation plate recess and said axis is perpendicular to the plane of said plate member, and said plate member has a recess for receiving said

16. A portable, manually operable, wound suction drainage device comprising a fluid pressure chamber including a peripheral side wall, and a pair of oppositely disposed wall members, at least one of said pair of wall members being movable toward and away from the other wall member of said pair to vary the volume of said chamber, said one wall being resiliently urged toward a first position spaced from said other wall wherein said chamber has a predetermined maximum volume, said one wall member being movable in a direction toward said other wall member in response to an applied force thereon to a second position wherein said chamber has a relatively small volume, tube connector means connected in fluid communication with the interior of said container, drainage tube means having one end connectable in fluid communication with said tube connector means and the opposite end thereof adapted to be disposed in a wound to be drained of body fluid, and releasable locking means actuatable into holding engagement with said one wall member for holding said one wall member in said second position without requiring a manual force thereon to permit fluid communication connection of said drainage tube means with said tube connector means and insertion of said drainage tube means in the wound while said one wall member is held in said second position by said locking means, and actuatable out of holding engagement to release said one member to permit movement of said one wall member away from said other wall member to expand said chamber and produce a negative pressure therein for drawing body fluid through said drainage tube means from the wound to

17. The device according to claim 16 wherein said one wall member includes

18. The device according to claim 17 further including a substantially rigid cover plate member substantially closing the upper end of said peripheral side wall, and wherein said one wall member further includes a substantially rigid actuating plate on said sheet member between said plate member and said sheet member, and wherein said locking means includes actuator means engaged between said cover plate member and said actuating plate when said locking means is actuated to hold said one wall

19. In combination with a portable wound suction pump for connection with a body wound for draining body fluid therefrom including a collapsible container adapted to be collapsed by a manual force applied thereto to reduce the internal volume thereof including means for expanding the volume thereof from a collapsed condition to produce a negative pressure for drawing body fluid into the container, the improvement comprising tube connector means connected in fluid communication with the interior of said container, body fluid drainage tube means having one end connectable in fluid communication with said tube connector and the opposite end thereof insertable in a wound to be drained of body fluid, and manually operable means for selectively locking said container in a substantially collapsed condition and for maintaining it in a collapsed condition without requiring a manual force thereon to permit fluid communication connection of said drainage tube means with said tube connector means and insertion of said drainage tube means in the wound while said container is held locked in a substantially collapsed condition by said locking means, and for unlocking said container to permit expansion thereof to produce a negative pressure therein to draw body fluid through said drainage tube

20. A portable, manually operable body wound drainage device comprising a vessel having a bottom wall, and a substantially rigid peripheral side wall connected thereto, resiliently urged fluid displacement means movable within said peripheral side wall toward and away from said bottom wall to define a variable volume fluid pressure chamber therebetween, passage means enabling the interior of said chamber to be connected in fluid communication with a body wound, and releasable locking means for selectively holding said resiliently urged fluid displacement means in a position in which the volume of said chamber is reduced and for releasing said resiliently urged fluid displacement means from said position for

21. The device according to claim 20 wherein said locking means includes engagement means engageable with said resiliently urged fluid displacement means for selectively applying a restraining force on said resiliently urged fluid displacement means to maintain the same in a position in which the volume of said chamber is reduced without requiring the application of a manually applied force on said resiliently urged fluid displacement means, and releasing said engagement means to remove said restraining force and permit movement of said resiliently urged displacement means to increase the volume of said chamber and produce a negative pressure in

22. A portable, manually operable body wound suction drainage device comprising a variable volume fluid pressure chamber including an effectively rigid peripheral side wall, and a pair of oppositely disposed walls connected to the said peripheral side wall, at least one of said pair of walls being movable relative to the other wall of said pair and normally resiliently urged toward a position spaced therefrom, said one wall being movable toward said other wall in response to an applied force thereon to expel fluid from said chamber and reduce the volume thereof, passage means for operatively connecting said chamber to a body wound so that upon movement of said one wall toward said spaced position to increase the volume of said chamber a negative pressure is developed in said chamber for drawing body fluid into said chamber from the wound, and releasable locking means for selectively holding said one wall in a position wherein a volume of said chamber is reduced after removal of the applied force and for releasing said one wall to increase the volume of

23. A portable, manually operable body wound suction drainage device comprising a vessel having a bottom wall, and a peripheral side wall connected thereto, a substantially rigid plate member connected to said side wall in fixed spaced relation with said bottom wall and extending generally parallel to said bottom wall, resiliently urged fluid displacement means including an elastic sheet diaphragm sealingly connected to said side wall between said plate member and said bottom wall and movable within said side wall toward and away from said bottom wall to define a variable volume fluid pressure chamber between said diaphragm and said bottom wall, said diaphragm being normally resiliently urged toward a position spaced from said bottom wall with said chamber having a relatively large volume, said fluid displacement means including an actuating member engageable with said diaphragm and movable in response to an applied force thereon to stretch and move said diaphragm toward said bottom wall to a position wherein the volume of said chamber is relatively small, said plate member having an opening therethrough for applying said force on said actuating member, tube connector means connected in continuous fluid communication with said chamber during the drainage operation of the device, and a body fluid drainage tube having one end connectable in sealed fluid communication with said tube connector means and the other end insergable in a body wound for transferring drainage fluid from the wound to said chamber in response to negative pressure in said chamber due to movement of said diaphragm away from said bottom wall, said side wall being substantially rigid in a direction parallel to the direction of movement of said diaphragm preventing an inadvertent compressive force applied to said side wall from effecting movement of said diaphragm toward said bottom wall and drainage fluid flow back to the body wound.

BACKGROUND OF THE INVENTION

This invention relates to wound drainage devices, and more particularly, to wound drainage devices of the portable, hand-operated type.

Some past drainage devices consisted of a container having pliable side walls and metal springs between top and bottom walls. In some cases, the side walls were resiliently flexible or made of resiliently flexible plastic in the form of bellows. Such containers were manually compressed to reduce the volume of the container. With these constructions, the resiliency of the springs or bellows-like side walls of the container urged the top and bottom walls away from each other to increase the container volume and cause the necessary suction force.

In general, these past wound drainage devices had certain disadvantages. For example, the manual forces required to compress the springs or bellows were relatively great and had to be sustained while the drainage tube connection was made. Activation and connection of such devices generally required the services of two people. In some cases, one person would compress the suction device and then hand it to a second person for connection. This was difficult and inconvenient because the device had to be maintained under manually applied compressive forces while being transferred from one person to another. Also, it was generally necessary to apply relatively even forces over a large area of the device in order to obtain adequate compression. This was somewhat difficult because the walls tended to tilt unless care was taken to apply the force near the center of the device or evenly over the sides thereof. Obviously, the amount of suction obtained with a given suction device of this type depended on the person applying the compressive forces to that, in practice, the amount of suction generally varied with each use even though the devices were identical in construction.

Another serious disadvantage to some suction devices of the above type was that it was possible for the fluid drained into the device to be inadvertently pumped back into the wound area. For example, if the patient turned over onto a filled device, the weight of his body would collapse or partially collapse the device thereby forcing fluid back into the wound. In order to avoid such backflow of fluid, some devices have incorporated one-way valves, such as of the ball-type. There is, however, the danger that such valves will become clogged due to the accumulation of fluids at the valve thereby causing the device to become inoperative. Also, because of the possible accumulation of fluids at the valve, the valve may become inoperative in preventing fluid flow-back into the wound from the device.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a wound drainage device wherein the above mentioned disadvantages are substantially obviated.

It is another object of the present invention to provide an improved wound drainage device which obviates the possibility of inadvertent flow of drainage fluid back into the wound from the device.

Another object is to provide a novel, manually operated, wound drainage device which is extremely convenient in use and which can be readily placed in an operative condition by one person where desired.

Another object is to provide a wound drainage device which can be packaged in a sterile condition, reliably connected in operation under aseptic conditions and which can be conveniently and economically disposed of after a single use.

A further object is to provide a manually operated wound drainage device having improved activating means, wherein the device can be maintained in an operational condition, ready for use, without requiring continuous manual forces being applied thereto.

Still another object is to provide an improved wound drainage device wherein the actuation thereof is positive and is repeatable.

Yet another object is to provide a wound drainage device wherein the manual compressive forces required to activate the device are directed to substantially the optimum area of the device for simple manual activation thereof.

In accordance with one form of the present invention, a wound drainage device is provided which includes an expansible chamber having a rigid side wall and a resiliently urged fluid displacement wall movable toward an oppositely facing wall to reduce the volume of the chamber, the displacement member being thereafter movable in a direction away from the facing wall for creating a suction force for drawing fluid into the chamber. In accordance with another aspect of the invention, a manually operable locking device is arranged to hold a chamber of a wound drainage device in a compressed or evacuated condition, the locking device being releasable to permit expansion of the chamber when desired.

These as well as other features and advantages of the present invention will become apparent from the following detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a portion of a human body having a wound drainage device in accordance with the present invention attached thereto for draining fluid from a wound;

FIG. 2 is an enlarged exploded perspective view of the drainage device of FIG. 1;

FIG. 3 is an enlarged elevational view of the wound drainage device of FIG. 1;

FIG. 4 is an enlarged top plan view of the drainage device of FIG. 1;

FIG. 5 is a cross-sectional view of the drainage device taken along the line 5--5 of FIG. 4;

FIG. 5a is an enlarged fragmentary sectional view of a peripheral portion shown in FIG. 5;

FIG. 6 is a sectional view taken along the line 6--6 of FIG. 4 but with the handle of the device in a raised position;

FIG. 7 is a sectional view similar to FIG. 6 but with the device in a cocked position;

FIG. 8 is a sectional view taken along line 8--8 of FIG. 7; and

FIG. 9 is a sectional view similar to FIG. 7 but with the device in an operating condition.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, and particularly to FIG. 1, there is shown a wound drainage device or suction pump 10 attached to a human body 12 by strap or belt 13, and operatively connected to the interior of a wound 14 by one or more flexible drainage or evacuating tubes, such as a tube 16. Where desired, tube 16 may be connected in fluid communication with the interior of the wound, for example, by a t or y tube connector such as indicated at 15, and a pair of tube sections 16a and 16b connected between the connector 15 and the wound.

With particular reference to FIGS. 2, 3, 4, 5 and 5a, the suction device 10 is shown including a vessel 18, a fluid displacement or piston member 20 illustrated as including a piston element shown as a diaphragm or gland member 22 and an actuating or backing plate 24, a cover or top plate member 26, and an actuator member 28.

Vessel 18 includes a bottom wall 30, a relatively rigid or noncollapsible peripheral side wall 32 shown integral with bottom wall 30, an inlet port or passage 33, a tube connector 34 connected at passage 33 to the side wall 32 adjacent the bottom wall, such as by cement or a weld, and an outlet or drain port 35 in the side wall having a drain passage member 36 connected therewith, such as by cement or a weld, and an enclosure cap or sealing plug 37 shown integrally connected with member 36. A pair of like belt loops 38 (both shown in FIG. 8) are provided for receiving the belt 13 shown in FIG. 1. A continuously extending peripheral groove 39 is provided in the upper edge of the vessel at the top of side wall 32 to receive a peripheral bead 40 on the diaphragm 22, as is more clearly seen in FIG. 5a. The groove 39 is shown formed by a peripheral rim 41 which is L-shaped in cross-section, and the upper edge portion 45 of the side wall 32, the bottom horizontal portion of the L-shaped rim 41 being shown formed integrally connected to the outside of the side wall 32 below the upper edge thereof. The entire vessel 18 is preferably formed of a rigid material such as a relatively hard plastic.

The diaphragm 22 is shown formed of a relatively highly flexible and resilient, relatively thin elastic sheet material, such as stretchable rubber or the like. The diaphragm 22 in its relaxed or unstretched condition has a configuration generally complementary to the open end of the vessel 18 and serves as a membrane closing the vessel. With the bead 40 disposed in the groove 39, as seen in FIG. 5, the diaphragm 22 is in fluid tight sealed engagment with the side wall 32 and the upper end of vessel 18 is closed by the diaphragm. The diaphragm 22 forms an upper wall which defines with bottom wall 30 and side wall 32 of vessel 18, a variable volume or expansible fluid pressure chamber or container indicated at 42.

The actuating plate 24 is disposed between the cover member 26 and diaphragm 22 in limited, free-floating relation with the diaphragm, the plate 24 resting upon the upper surface of the diaphragm and being slidable a limited amount relative thereto. Plate 24 is complementary in shape to the diaphragm 22, and has a slightly smaller area or periphery than the open upper end of the vessel 18 so that the plate 24 is movable within the vessel between or within side walls 32, as will be explained more fully hereinafter. Plate 24 is provided with two spaced, similar recesses 43 and 44 respectively provided with keyways or laterally extending slots 46 and 47 for receiving portions of actuator 28, as will be explained in greater detail hereinafter. The recesses 43 and 44 are disposed adjacent to the geometric center of the plate. The plate 24 is formed of a relatively rigid material and may be, for example, of a relatively hard plastic material. Plate 24 is shown having a plurality of integral strengthening ribs indicated in phantom at 48 in FIG. 2.

The cover member 26 includes an upper plate 49 having a peripheral depending side wall 50 integral with the plate. In the illustrated embodiment, the side wall 50 fits within the rim 41 with the lower edge of the side wall 50 engaging the upper side of the bead 40 of diaphragm 22, as seen in FIGS. 5 and 5a. The cover member 26 is connected to the rim 41 by any suitable means, for example, by welding, such as solvent welding, at the junction of the outer periphery of top plate 49 and the upper edge of rim 41, as indicated at 51 in FIG. 5a. The cover member 26 provides an effectively rigid, non-bending, surface which substantially closes the entire open end of the vessel 18. The cover is provided with a generally U-shaped recess 53 which is adapted to receive the actuator 28 (FIG. 4). Adjacent the ends of the legs of the U-shaped recess 53 are provided a pair of similar openings 55 and 56 which are in registration with recesses 43 and 44 in the actuating plate 24, as more clearly seen in FIG. 2. Openings 55 and 56 are respectively provided with oppositely extending lateral slots 58 and 59 which are respectively in registration with slots 46 and 47 of recesses 43 and 44 in plate 24. Cover member 26 is shown having a plurality of strengthening ribs or beams shown in phantom at 60 in FIG. 2 which extend both laterally and longitudinally adjacent the underside of the cover. The ribs 60 may be attached to the cover by cement or may be formed integrally therewith. The cover member 26 is formed of a relatively rigid material, for example, a relatively hard plastic. Cover member 26 is also provided with a pair of abutments or catches 62 and 63 for actuator 28 which extend vertically from the underside of the top plate adjacent the openings 55 and 56. In the illustrated embodiment, the catches 62 and 63 are shown as portions of one of the ribs 60.

The actuator 28 is in the form of a generally U-shaped manually operated actuator handle. The actuator is provided with a pair of spaced vertical legs 65 and 66 and an upper horizontal connecting member 67. The legs 65 and 66 are respectively provided with latches defined by horizontally extending ledges or abutments 70 and 71 which are adapted to respectively engage catches 62 and 63 on the cover member 26. The legs 65 and 66 have connected to the ends thereof abutment members 73 and 74 respectively. The abutment members 73 and 74 are shown as cylindrical members integrally connected to their respective legs. These abutment members have oppositely extending keys 77 and 78 respectively disposed at the ends thereof. In FIG. 3, 4 and 5, the actuator 28 is disposed in its recess 53 in the cover member 26.

As seen in FIGS. 2 and 3, one outer side of the vessel is shown provided with graduation marks to indicate the quantity of fluid in the device at any given time, the vessel being preferably formed of a transparent material, such as transparent plastic.

The drainage device 10 is readily assembled. The diaphragm 20 may be placed into the vessel 18 with the diaphragm bead 40 entering the peripheral groove 39 and preferably being forced into the groove in tight frictional engagement therewith. The actuating plate 24 is placed on top of the diaphragm 22 and then the cover member 26 is placed such that the lower edge of side wall 50 enters the groove 39 in the vessel and engages the upper surface of the bead 40 of diaphragm 22 to maintain the bead in place in the groove and further ensure sealed engagement between the diaphragm and side walls 32. A suitable lubricant, such as of the silicone type, is preferably applied to the top surface of diaphragm 22 during assembly to ensure that the plate 24 will readily slide relative to the diaphragm 22. The cover member 26 may then be secured to the upper edge of the vessel rim 41 by solvent welding as previously mentioned herein. The actuator handle 28 is then inserted into the cover 26 by manually moving the two legs 65 and 66 vertically into openings 55 and 56 and with the keys 77 and 78 entering their respective slots 58 and 59 adjacent these openings. Once the keys 77 and 78 are moved downwardly past the cover slots 58 and 59, the actuator handle can be pivoted to its horizontal or stored position shown in FIGS. 3, 4 and 5. In this position of the actuator handle 28, the plane of the keys 77 and 78 are horizontal and cannot inadvertently pass through the slots 58 and 59 in the cover 26. The cover 26 is also shown having a pair of abutment members 80 and 81 (FIG. 4) in the recess 53 which are frictionally engaged by the handle to maintain the handle positioned in the recess 53 substantially horizontal or parallel to the plane of the cover 26. The cover 26 is shown in FIGS. 2 and 5a provided with a peripheral recess 83 which receives a plurality of resilient tabs or inwardly extending protrusions 85 so that the cover 26 may be mechanically held in place prior to the forming of the weld 51.

The drainage device 10 is shown in FIGS. 3-5 in its assembled condition with the manual actuator 28 in the stored horizontal position in the U-shaped recess 53, and with the diaphragm 22 in its normally substantially relaxed or untensioned condition, the drainage device being in its normally unactuated or inactive condition. In the normally inactive condition of the device 10, the diaphragm 22 is resiliently urged away from the bottom wall 30 by the inherent resiliency thereof to a position in which it is spaced a maximum amount from wall 30 so that chamber 42 is in an expanded condition and has a maximum volume. This is the preferred condition for packaging, shipping, and storing the drainage device.

In utilizing the wound drainage device 10, the actuator handle 28 may be manually lifted from the recess 53 in the cover member 26 so that the handle is raised to the vertical position as shown in FIG. 6. When handle 28 is in the vertical position normal to the plane of cover 26, the keys 77 and 78 are in position to enter the slots 46 and 47 (FIGS. 2 and 8) in the actuating plate 24 so that the handle moves vertically downwardly a small distance with the abutment members 73 and 74 entering the recesses 43 and 44 in the plate 24.

Actuator handle 28 is moved vertically downwardly by applying a downward manual force thereto such as by grasping the horizontal handle member 67 by hand and urging it downwardly. This applied manual force is transmitted by the handle abutments 73 and 74 to the plate 24 of the fluid displacement member 20 to move the plate 24 which, in turn, moves diaphragm 22 downwardly. During the downward movement of the handle 28 and actuating plate 24, the diaphragm 22, which serves as an upper movable wall of the container or chamber 42, stretches and moves downwardly towards the bottom wall 30 of the vessel to compress expansible container or chamber 42 and evacuate fluid, in this case air, therefrom. Air is expelled through either or both of the vessel ports 33 or 35 as desired. When the central portion of the diaphragm 22 is at or near the bottom wall 30, the handle 28 is moved slightly forward so that the lands 70 and 71 move under the catches 62 and 63 respectively, whereby the handle is latched in the downward position, the condition indicated in FIGS. 7 and 8. In this condition the fluid displacement member 20 and handle 28 are maintained in latched or locked position opposing the resilient force of the stretched diaphragm 22. Under these conditions the manually applied force can be removed from the handle 28 and the device 10 moved or handed to another person while the device remains locked in its actuated or cocked position with the volume of the chamber at a minimum and the device ready for use.

The closure 37 is then inserted into the drain member 36 and the drainage tube 16, which may have been previously inserted into the patient's body in a suitable or conventional manner, is sealably connected to the connector 34, such as by a sliding frictional slip fit. Under these conditions the device 10 can be unlocked or tripped from its cocked condition to its activated or operating condition by unlatching handle 28. This is simply accomplished by moving the handle 28 slightly to the left from the position shown in FIG. 7 until the lands 70 and 71 move out of engagement with catches 62 and 63. Since the handle 28 is movable relative to the actuating plate 24, it can be raised and then pivoted towards the cover 26 and into recess 53. The drainage device 10 is seen in FIGS. 1 and 9 in its activated or operative condition wherein body fluid is drawn into inlet connector 34 through tube 16 and into the expansible chamber 42 by the suction force or negative pressure developed by the force tending to return diaphragm 22 to its upward normally unstretched position. In other words, the inherent resiliency of the stretched diaphragm 22 creates a partial vacuum or negative pressure in the chamber 42 and fluid is drawn in as the expansible chamber expands or increases in volume due to the movement of fluid displacement member 20 in a direction away from bottom wall 30.

With the drainage device 10 activated as described above and connected by belt 13 to a human body as indicated in FIG. 1, wound drainage will flow into the vessel 32 until the diaphragm is returned to its normally substantially unstretched condition, such as indicated in FIG. 5. After the chamber 42 is filled, the device 10 may be readily removed and suitably discarded. Alternatively, after the device 10 is filled, it may be drained, for example, by removing plug 37 from drain member 36, for use again with the same patient.

The actuating plate 24, as shown in the drawings, has a relatively large area and a continuous outer peripheral portion which engages the diaphragm 22 closely adjacent the outer periphery of the diaphragm and entirely around the vessel 18 so that the plate 24 tends to distribute the actuating force applied to it evenly around the diaphragm. In this way, the diaphragm is substantially evenly stretched as the actuating plate moves toward the bottom wall 30.

The keys 77 and 78 on the actuator handle 28 tend to maintain the handle in a vertical position and this facilitates the application of the actuating force to the handle. Where desired, the keys 77 and 78 may be formed to have slightly different shapes or lengths and with the cover slots 58 and 59 respectively conforming to them, so that the actuator 28 can only be inserted into the cover 26 in its properly oriented position with the lands 70 and 71 located to engage the catches 62 and 63 when the device is cocked.

Because the handle 28 can be latched with the device 10 in its actuated or cocked position shown in FIG. 7, the handling of the device 10 is greatly facilitated. Since the device 10 can be maintained in a cocked position without manually applied forces on handle 28, the connection of the device to the body and the connection of the drainage tube 16 to the cocked device can be made easily and without haste. With the construction described herein, the device 10, once it is connected to the body and tripped or activated by unlatching handle 28 and returning it to its recess 53 in cover 26, cannot be reactuated or compressed to inadvertently return fluid accumulated in the chamber 42 to the body. This is because the side walls 32 are formed of relatively rigid and non-compressive material such as a hard plastic. Thus, even where the patient carrying the device 10 places his weight on the device, it cannot return wound drainage fluid back into the wound.

Because the device has a predetermined latching position, that is, when handle 28 is latched in place against the catches 62 and 63, such as indicated in FIG. 7, the actuating plate 24 and diaphragm 22 will always be in a predetermined location regardless of the person applying the actuating force or the manner in which it is applied. In this way, the partial vacuum or negative pressure created by the expansion of chamber 42 as a result of the resilient force of diaphragm 20, will be the same for any given design.

Vessel 18, actuating plate 24 and cover 26, in the preferred embodiment are formed of a relatively hard and effectively rigid plastic so that they are effectively non-flexible and this further ensures against any inadvertent compression of the device that would return fluid from the device to the body. Device 10 may be shipped and stored in a sterile packaged condition ready for use. Because it can be formed of economical materials, such as plastic materials, the device 10 can be economically disposed of after a single use.

From the foregoing it will also be apparent that there has been provided a portable wound drainage device which is convenient to use and which is portable and efficient in operation. Also, it will be apparent that device 10 is economical and reliable in operation and may be used in aseptic conditions, and wherein its operating characteristics are repeatable, that is, the same amount of negative pressure of partial vacuum is obtained regardless of the person operating the device and this ensures a predetermined negative fluid pressure is obtained in use.

While there is shown and described a preferred form of the invention herein it will be understood by those skilled in the art that various changes and modifications thereto may be made without departing from the true spirit of the invention, the scope of the invention being defined only by the appended claims.