DEVICES AND METHODS FOR FLUID INFUSION, DRAINAGE, AND COLLECTION

Abstract

Containers for collecting fluid are provided that include a reservoir comprising a plurality of panels enclosing an interior, side panels of the reservoir are movable from an expanded position towards to a compressed position and biased to the expanded position for generating a vacuum within the interior. An elongate housing extends along a top side of the reservoir including a passage extending between proximal and distal ends thereof and communicating with the interior of the reservoir. An elongate member extends through the housing including a distal extension, a proximal extension, and a lumen extending therebetween. One-way valves are coupled to the distal and proximal extensions for permitting fluid flow proximally from the distal extension into the interior of the reservoir via and permitting fluid flow proximally from the proximal extension while preventing fluid flow distally out the distal extension and distally into the proximal extension and lumen.

Claims

1. A container for collecting fluid, comprising: a reservoir comprising a plurality of panels enclosing an interior thereof, the panels comprising side panels generally opposite one another that are movable from an expanded position towards one another to a compressed position and biased to the expanded position for generating a vacuum within the interior; an elongate housing extending along a top side of the reservoir and comprising a proximal end, a distal end, and a passage between the proximal and distal ends communicating with the interior of the reservoir; an elongate member extending through the housing between the proximal and distal ends, the elongate member comprising a distal extension extending from the housing distal end, a proximal extension extending from the housing proximal end, and a lumen extending between the distal and proximal extensions, the lumen comprising an opening communicating with the passage; a distal one-way valve coupled to the distal extension for permitting fluid flow proximally from the distal extension into the interior of the reservoir via the lumen and opening while preventing fluid flow distally out the distal extension; and a proximal one-way valve coupled to the proximal extension for permitting fluid flow proximally from the proximal extension while preventing fluid flow distally into the proximal extension and lumen.

2. The container of claim 1, wherein the passage extends longitudinally along the housing at least partially between the proximal and distal ends, and wherein the housing further comprises a window extending between the proximal and distal ends to permit viewing fluid within the passage.

3. The container of claim 2, further comprising indicia on or adjacent the window to indicate a volume of fluid within the interior of the reservoir and passage when the housing is oriented substantially vertically.

4. The container of claim 1, further comprising an elongate recess in the housing extending partially from the proximal end towards the distal end, the recess configured to receive the proximal tubular extension when the proximal tubular extension is folded and inserted into the recess, thereby preventing fluid flow through the proximal tubular extension.

5. The container of claim 4, wherein the recess comprises (1) a first region having a cross-section smaller than the tubular extension such that the tubular extension is compressed when inserted into the recess and (2) a second region larger than the first region configured to receive the proximal one-way valve when the tubular extension is inserted into the recess.

6. The container of claim 1, further comprising a visual indicator on the housing or the reservoir configured to provide a visual output indicating pressure status of the interior of the reservoir.

7. The container of claim 1, wherein the elongate member is substantially permanently fixed relative to the housing such that a fixed length of the elongate member defines the proximal and distal extensions.

8. The container of claim 1, wherein the side panels pivot relative to one another when directed between the expanded and compressed positions.

9. The container of claim 8, wherein the side panels define planes that intersect one another in the expanded position.

10. A container for collecting fluid, comprising: a reservoir comprising a plurality of panels enclosing an interior thereof, the panels comprising side panels generally opposite one another that are movable from an expanded position towards one another to a compressed position and biased to the expanded position for generating a vacuum within the interior; an elongate housing comprising a valve device extending along a top side of the reservoir and comprising a proximal end, a distal end, and a passage between the proximal and distal ends communicating with the interior of the reservoir, the valve device comprising an elongate member having a proximal end, a distal end, and a lumen therethrough extending between the proximal and distal ends of the valve device, and at least two ports communicating with the elongate member; wherein the elongate member communicates with a distal one-way valve and the passage; wherein the distal one-way valve is coupled to the elongate member permitting fluid flow proximally from the valve device while preventing fluid flow distally; a proximal extension having a proximal and distal end with a lumen therethrough coupled to the proximal end of the elongate housing communicating with the passage; and a proximal one-way valve coupled to the proximal extension for permitting fluid flow proximally from the proximal extension while preventing fluid flow distally into the proximal extension and lumen.

11. The container of claim 10, wherein the valve device comprises a first port that may be selectively opened for infusion of fluids and a second port configured to couple to a catheter.

12. The container of claim 10, further comprising an actuator for selectively isolating the second port from the first port.

13. The container of claim 10, further comprising a source of fluid coupled to the first port to deliver fluid from the source via the first port into the proximal extension when the actuator isolates the second port from the first port.

14. The container of claim 10, further comprising an actuator for selectively isolating the distal one-way valve, the reservoir, and the proximal extension from the first port.

15. The container of claim 14, further comprising a source of fluid coupled to the first port to deliver fluid from the source via the first port into the second port when the actuator isolates the proximal extension from the first port.

16. The container of claim 10, further comprising a safety lever engageable to prevent the side panels from being subsequently directed towards the compressed position to maintain the vacuum within the interior.

17. A method for collecting fluid within a container, comprising: providing a container comprising a reservoir defining an interior and compressible to from an expanded position to a compressed position to reduce a volume of the interior, the container further comprising an elongate member coupled to a housing coupled to the reservoir, the elongate member comprising a fluid path from a distal extension through the housing to a proximal extension that communicates with the interior of the reservoir; coupling a drainage device to the distal extension; compressing the reservoir to the compressed position, a one-way valve in the distal extension preventing air within the interior from flowing back through the distal extension into the drainage device such that the air is evacuated out the proximal extension; releasing the reservoir such that reservoir is biased to return towards the expanded position, thereby generating a vacuum within the interior to draw fluid from the drainage device through the distal extension into the interior; and securing the proximal extension within a recess in the housing to prevent leakage from the interior via the proximal extension.

18. The method of claim 17, wherein securing the proximal extension comprising folding the proximal extension back towards the distal extension and inserting the proximal extension into the recess such that a one-way valve on the proximal extension is received in a pocket adjacent the recess.

19. The method of claim 17, further comprising orienting the housing such that a window on the housing is oriented substantially vertically, whereby fluid within the interior flows through a passage in the housing adjacent the window to align with indicia on or adjacent the window to identify the volume of the fluid within the reservoir.

20. The method of claim 17, further comprising, after fluid has been collected within the interior: removing the proximal extension from the recess; and compressing the reservoir to evacuate fluid from the interior out the proximal extension, the one-way valve in the distal extension preventing the fluid from flowing back through the distal extension into the drainage device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0078] The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Included in the drawings are the following figures.

[0079] FIGS. 1A through 1B are schematic illustrations of the different states of flow enabled by an exemplary embodiment of the device.

[0080] FIG. 2 is a perspective view of an embodiment of the device.

[0081] FIG. 3 is a perspective view of the embodiment of the device shown in FIG. 2 illustrating the use of the extended recess to secure the proximal portion of the elongate member.

[0082] FIG. 4 is a side view of the device of FIGS. 2 and 3.

[0083] FIG. 4A is a cross-sectional view of the interaction between elements of the device taken along line A-A of FIG. 4.

[0084] FIG. 5 is a top view of the device in the configuration depicted in FIG. 3.

[0085] FIG. 6A through 6D are schematic illustrations of the different states of flow enabled by an exemplary device and system.

[0086] FIG. 7 is a schematic illustration of an embodiment of a device comprising at least one valve incorporated into the housing.

[0087] FIG. 8 is a schematic illustration of another embodiment of a device comprising at least two valves incorporated into the housing.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0088] Before the exemplary embodiments are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope will be limited only by the appended claims.

[0089] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the recited range. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither, or both limits are included in the smaller ranges is also encompassed within the recited range, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the recited range.

[0090] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the embodiments described, some potential and preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.

[0091] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymer and equivalents thereof known to those skilled in the art, and so forth.

[0092] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

[0093] FIGS. 1A and 1B are schematic illustrations of the flow paths through the components of the device when the device is in one of two states. The device is arranged identically in each of the figures and comprises the following components: an elongate tubular member 101 containing a distal one-way valve 102, a proximal one way valve 103, and an opening 104 joined to collection reservoir 100. Distal one-way valve 102 and proximal one-way valve 103 are oriented such that flow through elongate member tubular member 101 is possible in the distal to proximal direction and prevented in the proximal to distal direction. The black arrow in FIG. 1A illustrates the direction of flow when the collection reservoir 100 is at a pressure that is below that of the external environment (i.e., a vacuum pressure within collection reservoir 100). Fluid passes through distal one-way valve 102, along elongate member 101, through opening 104 and into the collection reservoir 100. FIG. 1B illustrates the direction of flow when the collection reservoir 100 is at a pressure greater than that of the external environment. Fluid passes from the collection reservoir 100, through opening 104, along elongate member 101, through proximal one-way valve 103 and into the external environment.

[0094] FIG. 2 is a perspective view of an embodiment of the device 200, comprising an elongate member 205, a housing 201, one way valves 206 and 207, and collection reservoir 208. Elongate member 205 is disposed within and joined to housing 201. Elongate member 205 further comprises a lumen (not shown) that is in communication with the collection reservoir 208. In this embodiment, one-way valves 206 and 207 are duckbill valves and are oriented such that flow through the lumen of elongate member 205 is possible in the distal to proximal direction and prevented in the proximal to distal direction. One-way valve 206 is joined to the distal end of elongate member 205 and further comprises a male luer-lock fitting (not shown) on the distal end of one-way valve 206. One-way valve 207 is joined to the proximal end of elongate member 205.

[0095] Housing 201 further comprises an observation window 202 enabling a patient or physician to determine how much fluid exudate is resident within the collection reservoir 208, a extended recess 203, and pocket 204. Extended recess 203 may be sized smaller than the outer diameter of elongate member 205. Pocket 204 is sized to accept one-way valve 207. The external faces of the housing 201 feature relatively flat and smooth surfaces and the edges are rounded, filleted, or contoured to enhance patient comfort during use. This may be useful in cases where the device is in a body position whereby the user may be lying or sitting over the device. In this exemplary scenario, the external surface of the device that is in direct contact with the user does not present discomfort to the user such as pinching or poking of the skin or tissue which can potentially result in trauma, irritation or injury such as abrasions, cuts, bruising, ulcerations and the like.

[0096] FIG. 3 is a perspective view and FIG. 4 is a side view of the embodiment 200, wherein the one-way valve 207 and the proximal portion of elongate member 205 are secured within pocket 204 and extended recess 203, respectively. In this configuration, the elongate member 205 is bent or kinked about the proximal edge of extended recess 203 within the housing 201 sufficiently to obstruct flow through its lumen in any direction thereby providing security against inadvertent loss or spillage of fluid.

[0097] FIG. 4A is a cross-sectional view of the embodiment 200 describing the relationship between the housing 201, elongate member 205, and collection reservoir 208. This view depicts additional elements of each of the major components of the device. Elongate member 205 further comprises lumen 214 and opening 211. Housing 201 further comprises port 213, observation window 202, and extended recess 203. Collection reservoir 208 further comprises membrane 209 and living hinge 210. Elongate member 205 is disposed within housing 201 such that opening 211 allows lumen 214 to communicate with port 213 in housing 201. Furthermore, the proximal portion of elongate member 205 is secured within extended recess 203 as previously described. Port 213 is sealed by observation window 202. Living hinge 210 is embedded within membrane 209 to form collection reservoir 208. In this embodiment, membrane 209 is fabricated from a soft, opaque, flexible, gas-impermeable material. Both living hinge 210 and membrane 209 are joined to housing 201 such that an air-tight seal is formed between housing 201 and collection reservoir 208. Compression of living hinge 210 decreases the internal volume of collection reservoir 208 thereby generating a negative pressure within the device which evacuates exudate from the collection reservoir 208. Evacuation of the exudate from the collection reservoir 208 in this manner requires that the proximal portion of elongate member 205 be released from extended recess 203. In doing so, the constriction at the bent or kinked portion of lumen 214 of elongate member 205 is opened to allow unrestricted passage of fluid.

[0098] FIG. 5 is a top view of the device 200, showing the arrangement of housing 201 and observation window 202. Observation window 202 is oriented parallel to the long axis of housing 201 and allows a patient, physician, or other caregiver to view the contents of collection reservoir 208. While observation window 202 is specified in FIG. 5 as a component of housing 201 and oriented parallel to the long axis of housing 201, other configurations (e.g. embedding the observation window within the membrane of the collection reservoir) have been duly contemplated. Note that proximal one-way valve 207 is secured within pocket 204. While the graduation marks adjacent to observation window 202 are illustrated in this example use cubic centimeters (i.e., cc) as the unit of measure, it should be clear to one of skill in the art that the relative sizes of the components, size of the collection reservoir 208, and the corresponding scale and choice of unit of measure of the graduation marks adjacent to the observation window 202 may be altered to accommodate any range of fluid collection applications.

[0099] FIGS. 6A through 6D are schematic illustrations of the fluid flow paths through the internal components of the device when the device comprises elements of the valve device described in U.S. patent application Ser. No. 60/083,142. Direction of fluid flow is illustrated in FIGS. 6A to 6D using the arrows within each schematic. The elements of the valve device comprise a luer-activated valve 300 known in the art and elongate members 301 and 302 that are, in this example, incorporated into the housing (not shown) of the device. The device is arranged identically in each of the FIGS. 6A to 6D; the luer-activated valve 300 is joined to elongate members 301 and 302 such that luer-activated valve 300, elongate member 301 and elongate member 302 are in fluid communication with each other. Elongate member 302 is further connected to and in fluid communication with one-way valve 303, which is in turn connected to and in fluid communication with vacuum source 304, which is in turn connected to and in fluid communication with one-way valve 305.

[0100] FIG. 6A illustrates the device when no infusion syringe is connected to the luer-activated valve 300 and the vacuum source 304 is generating negative pressure. In this embodiment, fluid can flow between elongate member 301 and vacuum source 304 in one direction. The closure of luer-activated valve 300 and the orientation of one-way valve 305 maintain negative pressure within the system as long as vacuum source 304 is active (i.e., under negative pressure).

[0101] FIG. 6B illustrates the device once a luer-tipped coupling is inserted into the inlet of the luer-activated valve 300. Flow is possible in two directions between luer-activated valve 300 and elongate member 301 and flow is simultaneously possible in one direction between luer-activated valve 300 and the remaining components (elongate member 302, one-way valve 303, vacuum source 304 one-way valve 305) due to the presence of one-way valves 303 and 305. FIG. 6C illustrates the flow paths present in the device when a luer-tipped coupling is inserted into the inlet of the luer-activated valve 300 and elongate member 302 is compressed, blocking flow through the lumen of elongate member 302. In this state, bi-directional flow is possible between elongate member 301 and luer-activated valve 300.

[0102] FIG. 6D illustrates the flow paths present in the device when a luer-tipped coupling is inserted into the inlet of the luer-activated valve 300, elongate member 301 is compressed, and vacuum source 304 is inactive (i.e., no longer under negative pressure or neutral). The compression of elongate member 301 blocks flow through elongate member 301, enabling flow in one direction between luer-activated valve 300 and the remaining of the components (elongate member 302, one-way valve 303, vacuum source 304 one-way valve 305).

[0103] It is contemplated that all embodiments provided in FIGS. 6A to 6D may incorporate any of the design elements described in FIGS. 1 5. Specifically, the device may incorporate an elongate member 205 and an extended recess 203 such as those shown in FIG. 4, as well as an pocket 204 such as that shown in FIG. 3. This configuration would allow the elongate member 205 to be bent or kinked to provide an additional security measure against inadvertent or accidental fluid release from the device.

[0104] FIG. 7 is a schematic illustration of the components of another embodiment of the invention 400 comprising elements of the valve device described in U.S. patent application Ser. No. 60/083,142. The device 400 comprises a first elongate member 401, a second elongate member 402, a collection reservoir 403, a housing 404, a luer activated valve 405, a first valve 406, a first one-way valve 407, a second one-way valve 408, a first connector 409, and a second connector 410.

[0105] First elongate member 401 comprises a distal end 401′, a proximal end 401″, and at least one lumen extending therethrough. First elongate member 401 further comprises a t-connection 411 that is in fluid communication with the lumen of first elongate member 401 and terminates in luer activated valve 405. At least a portion of the length of first elongate member 401 is at least partially enclosed by housing 404 and the proximal end 401″ of first elongate member 401 is in fluid communication with the collection reservoir 403. The distal end 401′ of first elongate member 401 is joined to and in fluid communication with the first connector 409. First elongate member 401 may further comprise a first valve 406 and a first one-way valve 407, wherein the first one way valve 407 is located proximal to the first valve 406.

[0106] Second elongate member 402 comprises a distal end 402′, a proximal end 402″, and at least one lumen extending therethrough. A portion of the length of second elongate member 402 is at least partially enclosed by housing 404 and the distal end 402′ of first elongate member 401 is in fluid communication with the collection reservoir 403. The proximal end 402″ of second elongate member 402 is joined to and in fluid communication with the second connector 410. Second elongate member 402 may further comprise a one-wave valve 408. Collection volume 403 may further function as a vacuum source as previously described herein.

[0107] Likewise, housing 404 may comprise features and functions previously described herein, such as recesses, means of connection to collection reservoir 403, and the like. Luer activated valve 405 may preferably be biased into a closed position, such that in the absence of a complementary luer fitting (e.g., a mated male luer for a female luer activated valve) flow through luer activated valve 405 is prevented. The first valve 406 may be any of those described in patent application Ser. No. 60/083,142, and may be biased in the open position such that flow through the first valve 406 is allowed in the neutral or un-active state.

[0108] One-way valve 407 may be any design that at least substantially allows flow in one direction and at least substantially prevents flow in the opposite direction. For example, one-way valve 407 may any known to the art including but not limited to a check valve, duckbill valve, crack valve, ball valve, ball and spring valve, umbrella valve, flapper valve, clapper valve, diaphragm check valve, and the like. One-way valve 407 is oriented such that flow is allowed from the distal end 401′ of first elongate member 401 towards the proximal end of the proximal end 401″ first elongate member 401.

[0109] One-way valve 408 may be any design that at least substantially allows flow in one direction and at least substantially prevents flow in the opposite direction. For example, one-way valve 408 may any known to the art including but not limited to a check valve, duckbill valve, crack valve, ball valve, ball and spring valve, umbrella valve, flapper valve, clapper valve, diaphragm check valve, and the like. One-way valve 408 is oriented such that flow is allowed from the distal end 402′ of second elongate member 402 towards the proximal end of the proximal end 402″ second elongate member 402. In an exemplary embodiment, the first connector 409 may be a male luer lock and second connector 410 may be a female luer lock. Additionally (not shown), embodiment of the device 400 may further comprise impermeable caps that are respectively mated to the first and second connectors 409 and 410.

[0110] In one embodiment of the device 400, the resistance to flow in the section of first elongate member 401 lying between the luer activated valve 405 and the proximal end 401″ of first elongate member 401 may be lower than that of the portion of first elongate member 401 distal to luer activated valve 405. In this manner flow is directed from luer activated valve 405 through first valve 406, one-way valve 407, out of proximal end 401″ of first elongate member 401, and into the collection reservoir 403. A user wishing to direct flow or flush from luer activated valve 405 towards the proximal end 401′ of first elongate member 401 would need to activate valve 406. For example, the lumen of first elongate member 401 proximal to luer activated valve 405 (and the lumens of valve 406 and one-way valve 407) may be larger than the lumen of first elongate member 401 distal to luer activated valve 405.

[0111] A vacuum pressure may be generated in collection reservoir 403 by removing the optional cap from second connector 410 and compressing, squeezing, or applying positive pressure to the outer walls of collection reservoir 403. When doing so, air, exudate, effusion, exudate or other fluids/solids contained within collection reservoir 403 are prevented from flowing through first elongate member 401 by first one-way valve 407, and directed through second one way valve 408 and out of second elongate member 402 and second connector 410.

[0112] When positive pressure applied to the collection reservoir 403 is released, second one-way valve 408 prevents the ingress of air or any other external fluid back into collection reservoir 403. The optional cap may optionally be re-connected to second connector to provide a secondary means of preventing inadvertent expulsion of fluids/solids in collection reservoir 403 when the second elongate member 402 is not also pinched, kinked or closed. The second connector 410 (capped or un-capped) may be secured in an external recess of housing 404 as previously described herein. The act of securing second connector 401 in a recess of housing 404 may provide a mechanism for preventing flow through second elongate member 402 by pinching, kinking or closing second elongate member 402, e.g., as shown for embodiment 200 in FIG. 2 and FIG. 3.

[0113] While FIG. 2 and FIG. 3 are shown with a single elongate member 205, it should be clear to one of skill in the art that the concepts and designs presented in FIG. 2 and FIG. 3 may easily be extended to an embodiment of the device comprising multiple elongate members such as device 400. The negative pressure present in collection reservoir 403 may induce flow from first elongate member 401 into collection reservoir 403. This negative pressure may, for example, be used to draw exudate from a wound in a patient through an indwelling drainage line or drainage catheter in fluid communication with the first connector 409.

[0114] FIG. 8 depicts yet another embodiment of the device 400 comprising a second valve 412 located distal to the junction of t-connection 411 and first elongate member 401 and in fluid communication with first elongate member 401. The second valve 412 may be any of those described patent application Ser. No. 60/083,142, and may be biased in the open position such that flow through the second valve 412 is allowed in the neutral or un-active state. The incorporation of second valve 412 into embodiment of the device may provide an optional mechanism for preventing flow through the proximal portion of first elongate member of 401 when activated thereby enabling active flushing of proximal end 401″ of elongate member 401 using a syringe connected to luer activated valve 405.

[0115] The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope of present invention is embodied by the appended claims.