DEVICES AND METHODS FOR DRAINAGE, INFUSION, OR INSTILLATION OF FLUIDS

Abstract

Valve devices are provided for draining fluids from and/or infusing fluids into a patient's body that include a housing including first, second, and third connectors, a primary fluid path communicating between the first and second connectors, and a secondary fluid path communicating from the primary fluid path to the third connector. First and second valve members are movable within the housing between first positions wherein the valve members do not obstruct the primary fluid path and second positions wherein the primary fluid path is at least partially closed. The third connector may be configured to prevent fluid flow therethrough unless a mating connector is fully coupled thereto. The valve members may be selectively closed to isolate portions of the flow path to allow a source of vacuum or fluid coupled to the third connector to aspirate or infuse fluid along portions of the primary fluid path.

Claims

1. A valve device for draining fluids from and/or infusing fluids into a patient's body, comprising: a housing comprising first, second, and third connectors, and a primary fluid path communicating between the first and second connectors and a secondary fluid path communicating from the primary fluid path to the third connector, wherein the third connector is configured to prevent fluid flow therethrough unless a mating connector is fully coupled thereto; a first valve member movable within the housing between a first position wherein the first valve member does not obstruct the primary fluid path and a second position wherein the primary fluid path is closed to prevent fluid flow through the first connector; and a second valve member movable within the housing between a first position wherein the second valve member does not obstruct the primary fluid path and a second position wherein the primary fluid path is closed to prevent fluid flow through the second connector.

2. The valve device of claim 1, wherein the first valve member is biased to the first position.

3. The valve device of claim 1, wherein the first valve member is biased to the first position to keep flow through the primary fluid path open when the first valve member is not intentionally directed to the second position.

4. The valve device of claim 1, wherein the second valve member is biased to the first position.

5. The valve device of claim 4, wherein the first valve member is biased to the first position to keep flow through the primary fluid path open when the first valve member is not intentionally directed to the second position.

6. The valve device of claim 1, wherein, with the first valve member in the first position and the second valve member in the second position, an open fluid path is provided between the first and third connectors.

7. The valve device of claim 1, wherein, with the first valve member in the second position and the second valve member in the first position, an open fluid path is provided between the second and third connectors.

8. The valve device of claim 1, wherein the housing comprises a recess and wherein the third connector is disposed within the recess.

9. The valve device of claim 1, wherein the third connector is a luer-activated connector.

10. The valve device of claim 1, wherein the first and second valve members are configured to prevent accidental closure or restriction of the primary fluid path.

11. The valve device of claim 10, wherein the first valve member is biased to the first position to keep flow through the primary fluid path open when the first valve member is not intentionally directed to the second position.

12. The valve device of claim 10, wherein the second valve member is biased to the first position to keep flow through the primary fluid path open when the second valve member is not intentionally directed to the second position.

13. A system for draining fluids from and/or infusing fluids into a patient's body, comprising: a valve device comprising a housing comprising first, second, and third connectors, a primary fluid path communicating between the first and second connectors and a secondary fluid path communicating from the primary fluid path to the third connector, wherein the third connector is configured to prevent fluid flow therethrough unless a mating connector is fully coupled thereto, the valve device further comprising first and second valve members for selectively closing flow along the primary fluid path through the first and second connectors, respectively; a tubular member comprising a first end sized for introduction in a patient's body and a second end comprising a tubular member connector configured to couple to the first connector; and a container for storing fluid from the patient's body comprising tubing including a container connector configured to couple to the second connector, thereby providing a fluid path from the tubular member through the primary fluid path and tubing into the container.

14. The system of claim 13, further comprising a source of vacuum comprising a vacuum connector configured to couple to the third connector, whereupon the secondary flow path is opened to provide a fluid path between the primary fluid path and the source of vacuum.

15. The system of claim 14, wherein the source of vacuum comprises a syringe.

16. The system of claim 13, further comprising a source of infusion media configured to couple to the third connector, whereupon the secondary flow path is opened to provide a fluid path between the primary fluid path and the source of infusion media.

17. The system of claim 16, wherein the source of infusion media comprises a syringe comprising an infusion media connector configured to couple to the third connector.

18. A method for draining fluids from and/or infusing fluids into a patient's body, comprising: providing a valve device comprising first, second, and third connectors, a primary fluid path communicating between the first and second connectors and a secondary fluid path communicating from the primary fluid path to the third connector, wherein the third connector is configured to prevent fluid flow therethrough unless a mating connector is fully coupled thereto, the valve device further comprising first and second valve members for selectively closing flow along the primary fluid path through the first and second connectors, respectively; providing a tubular member comprising a first end introduced in a patient's body and a second end extending from the patient's body; coupling the tubular member second end to the first connector; coupling tubing from a container to the second connector, thereby providing a fluid path from the tubular member through the primary fluid path and tubing into the container; coupling a source of at least one of vacuum and inflation media to the third connector to open the secondary flow path between the primary fluid path and the source; and activating at least one of the first and second valve members to close at least a portion of the primary fluid path.

19. The method of claim 18, wherein activating at least one of the first and second valve members comprises activating the second connector to prevent fluid flow to the container, the method further comprising activating the source to one of a) aspirate fluid through the primary fluid path and the tubular member and b) infuse fluid into the primary fluid path and the tubular member.

20. The method of claim 18, wherein the first and second valve members are biased to keep the primary fluid path open when the first and second valve members are not activated.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0071] 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.

[0072] FIGS. 1A through 1D are schematic illustrations of the different states of flow enabled by an exemplary embodiment of a valve device.

[0073] FIG. 2 is an exploded view of an exemplary embodiment of a valve device.

[0074] FIG. 3 is an isometric view of the embodiment shown in FIG. 2.

[0075] FIGS. 4A and 4B are cross-sectional views of an exemplary embodiment of a valve member that may be included in a valve device, such as that shown in FIG. 2.

[0076] FIG. 5 is a cross-sectional view of an alternative embodiment of a valve member that may be included in a valve device, such as that shown in FIG. 2.

[0077] FIG. 6A through 6C are cross-sectional views of alternative embodiments of valve members that may be included in a valve device, such as that shown in FIG. 2.

[0078] FIG. 7 is a cross-sectional view of an alternative embodiment of a valve member that may be included in a valve device, such as that shown in FIG. 2.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] FIGS. 1A through 1D are schematic illustrations of the flow paths through the internal components of an exemplary device when the device is in one of four states. The device is arranged identically in each of the figures and includes the following components: a connector 101 joined to a luer-activated valve 100 and to elongate tubular members 102 and 103. FIG. 1A illustrates the device at baseline, when no luer tipped coupling (e.g., a standard luer lock or slip luer syringe tip, not shown) is connected to the luer-activated valve 100. In this state, flow (as shown by the arrows) is diverted between elongate tubular member 102 and elongate tubular member 103 in both directions and flow is restricted between any of the components and the luer-activated valve 101.

[0085] FIG. 1B illustrates the device once a luer-tipped coupling is inserted into and/or otherwise coupled to the port of the luer-activated valve 100. In this state, flow is diverted between all components in all directions. FIG. 1C illustrates the flow paths present in the device when a luer-tipped coupling is inserted into and/or otherwise coupled to the inlet of the luer-activated valve 100 and the elongate member 103 is closed off, blocking flow through elongate member 103. In this state, bi-directional flow is diverted between elongate member 102 and luer-activated valve 100.

[0086] FIG. 1D illustrates the flow paths present in the device when a luer-tipped coupling is inserted into and/or otherwise coupled to the inlet of the luer-activated valve 100 and the elongate member 102 is closed off, blocking flow through elongate member 102. In this state, bi-directional flow is diverted between elongate member 103 and luer-activated valve 100.

[0087] FIG. 2 is an exploded view of an exemplary embodiment of a valve device 200 including two elongate members 201 and 202, a luer-activated valve 203, fittings 204 and 205, valves 206 and 207, and a housing including a pair of shells 208 and 212. A connector joining elongate member 201, elongate member 202, and luer-activated valve 203 is not shown for clarity. The elongate members 201 and 202 each includes a lumen that is in communication with the respective lumens of luer-activated valve 203 and fittings 204 and 205. In an exemplary embodiment, the elongate members 201 and 202 may be constructed using relatively elastic or compliant materials, e.g., as described elsewhere herein. Further, the design of elongate members 201 and 202 and the connector (not shown) is such that the size (i.e., inner diameter) of the respective lumens of these components is generally constant along the length of the component.

[0088] In this embodiment, the fitting 204 may be a female luer-lock coupling and the fitting 205 may be a male luer-lock coupling. The inlet of the luer-activated valve 203 may be a female luer-lock coupling. While this embodiment includes specific couplings for the fittings 204 and 205, and for the inlet of luer-activated valve 203, it should be clear to one of skill in the art that many types and designs of couplings are suitable for use in the valve devices herein, including but not limited to the examples listed previously.

[0089] For example, if a high flow rate through the fitting 205, elongate member 202, connector (not shown), elongate member 201, and fitting 204 is desired, the fittings 204 and 205 may include externally threaded couplings that do not include the reduction in inner diameter associated with a mated pair of standard luer couplings. Valves 206 and 207 may be of the disk and pillar design previously described, and are aligned substantially perpendicular to and centered over elongate members 201 and 202, respectively.

[0090] The shells 208 and 212 may enclose the assembly of the elongate members 201 and 202, the luer-activated valve 203, the fittings 204 and 205, and the connector (not shown), along with valves 206 and 207. The external faces of the shells 208 and 212 feature relatively flat and smooth surface and the edges rounded, filleted or contoured to enhance patient comfort during use. This may be useful in cases where the device is in body position whereby the user may be lying or sitting over the device.

[0091] 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 may otherwise potentially result in trauma, irritation, or injury, such as abrasion, cut, bruising, ulceration, and the like. Optionally, the shell 208 may further include a cutout 209 that provides a pocket or cavity in which the inlet of luer-activated valve 203 can reside. The cutout 209 may serve to protect the inlet of luer-activated valve 203 from breakage due to accidental contact, stress, or strain during use, as well as to provide comfort to the user by hiding the sharp edges or corners of the luer-activated valve 203.

[0092] The shell 212 may further include two openings 210 and 211 that are centrally aligned along and over elongate members 201 and 202, respectively. The openings 210 and 211 may be of a diameter that is larger than the diameter of the disk component of the valves 206 and 207. It is further contemplated that the diameter of the openings 210 and 211 may be optimized to accommodate access to the valves 206 and 207 via a user's fingers, for example with a diameter between about 0.25 inch and 1.0 inch (6.25 25.4 mm), or between about 0.5 inch and 0.75 inch (12.5 18.75 mm).

[0093] Optionally, the shells 208 and 212 may be fabricated to include a second material external to the outer surface of the shells 208 and 212 that is softer in property (not shown). The materials may include, but not limited to silicone, urethane, and the like, e.g., as previously discussed. These types of material may enhance patient comfort when the device is in direct contact with the tissue or skin. Further, it may provide a user with a more stable, gripping surface. The second softer material may be applied to the shells 208 and 212 using processes known in the art such as over-molding, coating, or the like.

[0094] While the embodiment shown in FIG. 2 is described as comprising a connector (not shown in the figure) that joins the elongate member 201, elongate member 202, and luer-activated valve 203, it should be clear to one of skill in the art that the elongate member 201, elongate member 202, and luer-activated valve 203 may be joined directly to each other, e.g., using methods known to the art, including but not limited to, bonding, welding, ultrasonic welding, over-molding, threading/tapping, crimping, combinations thereof, and the like.

[0095] Furthermore, the elongate members 201 and 202 may be fabricated out of a single length of tubing, and joined to luer-activated valve 203 using methods known to the art, including but not limited to bonding, welding, ultrasonic welding, over-molding, threading/tapping, crimping, combinations thereof, and the like. Furthermore, while the valves 206 and 207 are shown to be of the same design, it should be clear to one of skill in the art that each valve may have an independent design. For example, in an alternative embodiment of the valve device, the valve 206 may be externally threaded (e.g., as shown in FIG. 7) with complementary internal threads located about opening 210, while the valve 207 may further comprise a spring (e.g., as shown in FIG. 5) to assist the return stroke of the valve to its baseline state.

[0096] FIG. 3 is an isometric view of the components of an embodiment of the valve device 200 assembled together into a single unit. The inlet of luer-activated valve 203 and the couplings of fittings 204 and 205 are substantially inset into the housing 214 (comprising shells 208 and 212 shown in FIG. 2). The valves 206 and 207 are coaxially aligned with the openings 210 and 211 (shown in FIG. 2) and substantially flush with surface 213 of the housing 214.

[0097] FIGS. 4A and 4B show a cross sectional view of an exemplary configuration of a valve 400 and an elongate member 401 when the elongate member 401 is in the open and closed states. FIG. 4A shows valve 400 slidably disposed within opening 403 of shell 402. The valve 400 may further include a disk 404 and a pillar 405. The disk 404 may be tapered to mate with rim 407 located near the surface of the shell 402. The lower end of the pillar 405 may be rounded into a hemispherical shape. Alternatively, other shapes can be employed at the tip of the pillar 405 (i.e., where the pillar 405 makes contact with the elongate member 401), which may provide effective closing of the lumen 409 of the elongate member 401 such as a wedge, a fin, or the like.

[0098] The rim 407 may be oriented such that it is raised or elevated and adjoined from the external surface of the shell 402 and positions the valve 400 slightly recessed from the surface of the shell 402. The recessed configuration of the valve 400 may prevent the valve 400 from being depressed accidentally, for example, in cases where the device is in a body position where the outer face of the shell 402 is resting against a surface (i.e., skin/soft tissue or a pillow), which can potentially push the valve 400 and effectively close the lumen 409 of the elongate member 401.

[0099] The opening 403 may be of cylindrical shape and may further include one or more features, such as a keyway or a groove (not shown), positioned along the wall of the opening 403, whereby the valve 400 has a matching key or protrusion (not shown) that engages with the keyway or groove, and prevents the valve 400 from rotating within the cylindrical opening 403. Incorporation of this feature may be useful when the pillar 405 of the valve 400 is shaped to a wedge or a fin (not shown) by keeping the orientation or position of the wedge or fin (not shown) relative to the elongate member 401.

[0100] The elongate member 401 may further include a wall 408 and a lumen 409. In FIG. 4A, the valve 400 is in the baseline state wherein the lumen of the elongate member 401 is open and the disk 404 of the valve 400 is substantially flush with the rim 407 of the shell 402. In FIG. 4B, the valve 400 is in an active state wherein the valve 400 has been depressed within the opening 403 towards the elongate member 401 to a degree such that the tip of the pillar 405 has compressed the wall 408 of the elongate member 401 and closed the lumen 409.

[0101] In this valve configuration, the material used for the elongate member 401 may have a compliant or elastic property so that the wall 408 can provide sufficient spring force to push back and return the valve 400 to its original baseline state as soon as the external pressure applied to the valve 400 is released. The thickness of the wall 408 may also be varied along the length of the elongate member 401. In particular, the thickness of the wall 408 that is in alignment with the pillar 405 may be used to tune or define the spring force provided by the wall 408 in order to most effectively return the valve 400 to its original baseline state.

[0102] FIG. 5 shows a cross section view of an alternative embodiment of a valve device including a valve 500, shell 501, spring 504, and elongate member 505. The shell 501 further includes an opening 502 and a flange 503. The flange 503 further includes a flange opening 506. The spring 504 is disposed about the valve 500 and between the lower surface of the valve 500 and the upper surface of the flange 503. The flange opening 506 is sized to allow the pillar of the valve 500 to move freely within the flange opening 506 while preventing movement of the lower end of the spring 504. The valve 500 is coaxially aligned with the opening 502 and the flange opening 506.

[0103] Advancement of the valve 500 towards the elongate member 505 compresses the spring 504. When downward pressure on the valve 500 is released, the spring 504 applies force to the valve 500 and aids in returning the valve 500 to its initial baseline position within the opening 502. It should be clear to one of skill in the art that the spring 504 may comprise various lengths, widths, coil thicknesses, spring constants, and the like as needed to achieve desired functional characteristics. For example, a spring length may be chosen that is greater than the distance between the flange 503 and the underside of the disk of the valve 500. This would result in the spring 504 providing pressure against the valve 500 in the baseline condition (i.e., with no external pressure applied to the valve 500), and maintain the valve 500 in a position against the underside of the shell 501.

[0104] FIGS. 6A through 6C show cross sectional views of alternative embodiments of a valve device. FIG. 6A shows a valve 600 including a concave external surface 601 and a flange 602 slidably disposed within the shell 603. The shell 603 includes an undercut 604 and a receiving cavity 606. The interaction between the flange 602 and the undercut 604 prevents the surface 601 of the valve 600 from extending beyond the exterior of the shell 601. The receiving cavity 606 enables the elongate member 601 to more easily compress as the valve 600 is slidably translated towards the elongate member 601. As can be seen in FIGS. 6B and 6C, the lower face of the valve 600 may include a number of different contours, including but not limited to conical 607 and/or rounded 608. Likewise (not shown), the external surface of the valve 600 may have varied shapes, textures, and/or feature that are beyond those shown in this example.

[0105] FIG. 7 is a cross sectional view of yet another alternative embodiment of a valve device including a turn valve 700. The turn valve 700 includes external threads 701 that mate with internal threads 703 of shell 702. The turn valve 700 further includes a raised feature 704 that allows the patient to grasp and turn the turn valve 700 relative to the shell 702. In a housing where the threads 701 and 703 are right-handed, turning the turn valve 700 clockwise will advance the turn valve 700 towards the elongate member 705. Turning the turn valve 700 counter-clockwise will retract the turn valve 700 back towards the surface of the shell 702. In a housing where the threads 701 and 703 are left-handed, the turn valve 700 will respond in the opposite manner to clockwise or counter-clockwise rotation. Rims 706 and 707 in the shell 702 prevent the turn valve 700 from advancing too far in either direction.

[0106] During use, any of the devices herein may be used to drain fluids from and/or infuse fluids into a patient's body, e.g., via a catheter or other tubular member (not shown) at least partially implanted in the patient's body. For example, the catheter may include a first end implanted at or otherwise introduced into a surgical site, treatment site, or other location in the patient's body such that a second end of the catheter extends extracorporeally from the patient's body. The second end of the catheter may be coupled to one of the connectors of a valve device, such as the first connector 205 of the valve device 200 shown in FIG. 2. A container, e.g., bag, may be provided that includes tubing that may be coupled to another of the connectors of the valve device, such as the second connector 204 shown in FIG. 2. Once the catheter and container are coupled to the valve device 200, the primary fluid path through the elongate members 201, 202 allows fluid from the patient's body to be drained through the catheter into the bag, as described elsewhere herein. Alternatively, a container with a vacuum capability (e.g., a device commonly used in the field called Jackson Pratt) may be used to provide active suction of the fluid or other drainage materials in place of a passive container.

[0107] Because the third connector 203 is a luer-activated connector, it is configured to prevent fluid flow therethrough unless a mating connector is fully coupled thereto. Thus, the secondary fluid path between the elongate members 201, 202 and the third connector 203 remains closed, thereby preventing fluid from flowing other than between the catheter and the container.

[0108] At any time, a source of at least one of vacuum and infusion media, e.g., a suction ball, syringe, and the like (not shown) may be coupled to the third connector 203 to open the secondary flow path between the primary fluid path and the source. At least one of the first and second valve members 206, 207 may be activated to selectively close at least a portion of the primary fluid path. For example, the first valve member 206 may be activated to prevent fluid flow to the container, and the source may be activated, e.g., to aspirate fluid through the primary fluid path and the tubing to the catheter and/or infuse fluid into the primary fluid path and the catheter. Alternatively, the second valve member 207 may be activated to prevent fluid flow to the catheter, and the source may be activated, e.g., to aspirate fluid through the primary fluid path and the tubing to the container and/or infuse fluid into the primary fluid path and the tubing, as desired, e.g., to clear debris or otherwise enhance subsequent drainage and/or treatment of the patient.

[0109] 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.