RELATED APPLICATION

[0001] This application hereby claims priority under 35 U.S.C § 119 to U.S.

Provisional Patent Application No. 61/448,513 filed March 2, 2011, entitled "DEVICE FOR SECURING DRAIN TUBE," the disclosure of which is incorporated herein by reference.

BACKGROUND

[0002] In certain surgical procedures, medical professionals may use a closed suction device system that includes a bulb (sometimes referred to as a "grenade"), which is a soft plastic container with generally two openings at the top. The openings facilitate the creation of a vacuum after the drain tubing has been inserted and facilitate the emptying of drained fluid from the grenade. One such drain, known as a JACKSON-PRATT™ ("JP") drain, also includes a drainage tube, made of a soft, flexible (typically TEFLON™) tubing having a base portion with a long flat surface that contains multiple small holes. The flat surface can be trimmed to fit the desired drainage area. The base is connected to a longer flexible round tubing, which is then secured or attached to the grenade. A variety of sizes and design are available.

[0003] The JP drain and other surgical devices are used in situations where there is a risk of post-operative fluid accumulation, as may be the case with bowel anastomosis, neck surgery, spinal surgery and cranial surgery/subdural hematoma evacuation. Such drains prevent fluid build-up in the tissues, which could result in poor wound healing and a greater propensity for infection. In the case of neurosurgical procedures, such drains allow for continued drainage of fluids in the subdural space and/or prevention of compressive hematoma or other fluid collections in the epidural space. [0004] When the JP drain is used, the long flat surface is placed into the surgical area to draw fluid out of the area by suction. When the grenade is compressed and then released, the release generates suction that draws fluid into the flat surface of the tube. The JP drain is generally withdrawn through the skin via a separate "stab" wound a few centimeters from the primary wound incision. This not only allows for removal of the drain without disrupting the primary suture line, but it also enables skin opening to provide a "tight fit" for the drain tubing, which helps create the desired suction effect. Since the base of the JP drain has a width that is larger than the diameter of the drain's round exiting tubing, it is the skin's elastic flexibility that allows for the wider base to pass through this "tight" stab wound when the drain is removed.

[0005] To avoid inadvertent removal of the JP drain, the drain's round tubing portion is often secured to the skin at the exit site. A suture is tied to the skin, wrapped a number of times around the tubing and tightly tied. However, it is not uncommon for the drain to be removed prematurely by inappropriate accidental pulling upon the tubing, by a non-compliant patient, or by getting caught up on some other stationary device to which the JP drain is tethered while the patient moves about. Furthermore, the suture itself is easily torn or broken by such an inadvertent maneuver since the tethering point is at the skin exitus.

[0006] Accordingly, it would be beneficial to provide a surgical drain device that solves some or all of the problems described above.

SUMMARY

[0001] Embodiments are directed to a surgical drain device that prevents inadvertent removal of the drain by countering the elastic flexibility of the skin. The drain takes advantage of the size differential between the base of the flexible tubing and the exteriorized round drain tubing. [0002] In an embodiment, a surgical drain device is disclosed. The surgical drain device may have a drainage tube comprising a housing that defines a cavity therein, as well as a proximal end and an opposite distal end, wherein the distal end comprising one or more openings. The surgical drain device may further have a flexible tube comprising a first end and an opposite second end, wherein the first end is in fluid communication with the proximal end of the drainage tube. The surgical drain device may further have a securing device configured and arranged to slidably surround an exterior surface of the flexible tube, as well as at least one connection element integrated with a portion of the flexible tube, wherein the connection element is configured and arranged to receive and immobilize the securing device in a selected position.

[0001] In an embodiment, a surgical drain device is disclosed. The surgical drain device may have a drainage tube comprising a housing that defines a cavity therein, as well as a proximal end and an opposite distal end, wherein the distal end comprising one or more openings. The surgical drain device may further have a flexible tube comprising a first end and an opposite second end, wherein the first end is in fluid communication with the proximal end of the drainage tube. The surgical drain device may further have a securing device configured and arranged to slidably surround an exterior surface of the flexible tube, as well as at least one connection element integrated with a portion of the securing device, the connection element configured and arranged to immobilize the securing device in a selected position.

BRIEF DESCRIPTION OF THE DRAWINGS

[0002] For a fuller understanding of the nature and advantages of the present embodiments, reference should be made to the following detailed description taken in connection with the accompanying drawings. [0003] FIG. 1 illustrates a surgical drain device comprising a drainage tube, a flexible tube, a rigid securing device and a connection element.

[0004] FIG. 2 illustrates a cross-sectional view of the drainage tube depicted in FIG. 1.

[0005] FIG. 3 illustrates a cross-sectional view of the flexible tube depicted in FIG. 1.

[0006] FIG. 4 illustrates a perspective view of a rigid securing device in accordance with an aspect of the present disclosure.

[0007] FIG. 5 illustrates a cross-sectional top view of the rigid securing device in accordance with an aspect of the present disclosure.

[0008] FIG. 6 illustrates a side view of the rigid securing device in accordance with an aspect of the present disclosure.

[0009] FIG. 7 illustrates a perspective view of the securing device in combination with the surgical drain device in accordance with an aspect of the present disclosure.

[0010] FIG. 8 illustrates a frontal view of a connection element in accordance with an aspect of the present disclosure.

[0011] FIG. 9 illustrates a cross-sectional view of a connection element in accordance with an aspect of the present disclosure.

[0012] FIG. 10 illustrates a perspective side view of a connection element in accordance with an aspect of the present disclosure.

DETAILED DESCRIPTION

[0013] This invention is not limited to the particular processes, compositions, or methodologies described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or embodiments only, and it is not intended to limit the scope of the present invention. All publications mentioned herein are incorporated by reference in their entirety. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention.

[0014] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. In addition, the word "comprising" as used herein is intended to mean "including but not limited to." Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0015] As used herein, all claimed numeric terms are to be read as being preceded by the term "about," which means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, a claim to "50%" means "about 50%" and encompasses the range of 45%-55%.

[0016] FIG. 1 illustrates an example of a surgical drain device, generally designated 5, having a drainage tube 10, a flexible tube 40, a rigid securing device 70 and a connection element 80.

[0017] The drainage tube 10 may generally be the portion of the surgical drain device 5 that is placed through an exit/stab wound in the skin and into a subject's body, while the remaining portions of the surgical drain device 5 remain external to the subject's body.

[0018] The drainage tube 10 may include a housing 12 with proximal end 20 and an opposite distal end 30, and may further define a cavity 11 (FIG. 2) within the housing 12. The drainage tube 10 may be comprised of rubbers, polymers, or other similar materials now known or later developed, as well as compositions thereof, that is common in the art for drainage tubes and the like. The drainage tube 10 may further be coated with polytetrafluoroethyline (TEFLON™) or other non-stick material. The housing 12 and resulting cavity 11 may be of a hollow rectangular, oval, cylindrical or other shape. [0019] The distal end 30 may further comprise one or more openings 31 and/or passages 32 therethrough that allow fluid to be drawn into the cavity 11 (FIG. 2) of the drainage tube 10. The opening 31 and/or distal end 30 may be placed within a subject's body. The openings 31 and/or passages 32 may receive fluid from within the body and may further direct the fluid towards the proximal end 20, and then out of the body. The proximal end 20 may include at least one end cap 19, which may further comprise a passage 21 for receiving the flexible tube 40.

[0020] The flexible tube 40 may include a first end 50, an opposite second end 60 and a housing 41 having a diameter Di, comprising an exterior surface 42, and further defining a cavity 43 (FIG. 3) therein. The diameter Di may be substantially equal or similar to a diameter or width of the drainage tube 10. The second end 60 may be adapted to connect to other elements, including, but not limited to, a vacuum, a suction bulb (grenade), a tube, a device or combinations thereof. The first end 50 may be in fluid communication with the opening 21 of the proximal end 20 of the drainage tube 10. The commumcation between the first end 50 of the flexible tube 40 and the opening 20 of the drainage tube 10 may comprise a seal, such as, for example, a heated seal. The communication between the first end 50 of the flexible tube 40 and the opening 20 of the drainage tube 10 may be a friction fit so that the first end 50 fits snugly around opening 20. The first end 50 of the flexible tube 40 may generally be positioned inside the body, outside the body, or in proximity to the skin of the subject.

[0021] The rigid securing device 70 may be configured and arranged to slidably surround a portion of the exterior surface 42 of the housing 41. The securing device 70 may include a collar, collet or a grommet. The securing device 70 may further include a means 71 for attaching the surgical drain device 5 to the skin of a subject. The means 71 may include, for example, a a number of holes, openings, protruberances, catch elements and the like. The means 71 may further be capable of receiving and holding an attachment apparatus 73 (FIG. 7) such as a suture, a wire, an adhesive and/or the like.

[0022] As illustrated in FIG. 1, the surgical device may include at least one connection element 80 located around a portion of the flexible tube 40. Alternatively, the connection element 80 may be integrated as a stationary portion and/or component of the flexible tube 40. As another alternative, the connection element may be integrated with the securing device 70. The connection element 80 may be configured and arranged to receive and immobilize the securing device 70 in a selected position. The connection element 80 may be immobilized in a selected position relative to the proximal end 21 of the drainage tube 10. Alternatively, the connection element 80 may be immobilized in a selected position relative to the first end 50 of the flexible tube 40. The connection element 80 may include at least one outwardly-facing frictional surface 81 on the exterior surface 42 of the flexible tube housing 41. Alternatively, the frictional surface may be located on the internal surface of the securing device 70.

[0023] The frictional surface 81 may further include one or more protruding members 82. The protruding members 82, as described in more detail hereinafter, may be comprised of one or more ridges, buttons, bumps and/or combinations thereof.

[0024] As illustrated in FIG. 4, the securing device 70 may be a collet, collar or any other similar holding device, such as a chuck and/or the like, that forms a collar surrounding the object to be held. For example, the securing device 70 may be positioned around the flexible tube 40 and may further work in conjunction with the connection element 80 to secure the flexible tube 40 (FIG. 1) to the skin. The securing device 70 may be comprised of a rigid material such as a hard plastic and/or the like.

[0025] As illustrated in FIG. 6, the securing device 70 may have a length Lj and a width Wi. The length Li may be, for example, approximately 1-2 cm. The width Wi may be, for example approximately 5-10 mm. Referring to FIG. 5, the securing device 70 may have an internal diameter D2 and an external diameter D3. The internal diameter D2 may be approximately 1 mm greater than that of the external diameter Di of the flexible tube 40 (FIG. 3).

[0026] As shown in FIGS. 4-6, the securing device 70 may further comprise a means 71 for attaching the securing device 70 to the skin, such as a plurality of small holes positioned along an external surface of the securing device 70. The means 71 may be positioned at a suitable location on the securing device, such as a distance approximately half the length Li, or approximately 3 mm from its base. The means 71 may be used to receive the attachment apparatus 73 (FIG. 7), such as a suture, a thread, an adhesive or a wire. Those skilled in the art may appreciate the use of other attachment apparatuses, including, but not limited to, clips, pins, other structures or combinations thereof, for securing the means 71 to the skin. The suture 73 may be drawn through the means 71 in such a way so as not to hinder passage of the flexible tube 40 laterally through the securing device 70, as illustrated in FIG. 7. The suture 73 may then be attached to the skin at a suitable location, such as at the point of entry for the surgical drain device 5 (the exit/stab wound site).

[0027] The rigid nature of the securing device 70 may prevent the withdrawal of the end cap 19 of the drainage tube 10 from within the subject's body because the diameter or width of the end cap 19 exceeds the external diameter D3 of the securing device 70. Furthermore, the securing device 70 and the connection element 80 (FIG. 1) may securably attach to one another at the exit/stab wound site. This engagement at the skin surface prevents a tether-up effect upon the suture 73 and therefore the suture 73 cannot be broken and/or disrupted.

[0028] At an appropriate time, the suture 73 may be severed, thereby releasing the securing device 70 from its connection to the skin. This may then allow removal of the securing device from the connection element 80 (FIG. 1), and for the withdrawal of the surgical drain device 5 through the opening in the skin.

[0029] As illustrated in FIG. 1, the flexible tubing 40 may comprise a portion containing the connection element 80, which may provide an additional securing surface to maintain a connection of the flexible tube 40 with the securing device 70. As illustrated in FIGS. 8-10, an exemplary connection element 80 may have a frictional surface 81 containing one or more protruding members 82.

[0030] The protruding members 82 may be arranged as a matrix of small excrescences, wherein each of the excrescences may be similar to the type typically found in the snap button design for height adjustments on a walker-assist device or the means for holding an umbrella in the opened position. The protruding members 82 may be made of a flexible material, and may optionally be molded in such a way that the protruding members are an integral component of the flexible tube 40 (FIG. 1). The protruding members 82 may be depressible or otherwise capable of moving inward toward the flexible tube 40 when the securing device 70 is secured over the location of the connection element 80 on the flexible tube 40. The protruding members 82 may be of any suitable shape, including, but not limited to, hemispheres, ridges, bumps, depressible buttons or any other structures that extend outward from the friction surface 81 of the connection element 80.

[0031] As shown in FIG. 9, the connection element 80 may define a cavity 85 within. The connection element 80 may generally be the same diameter as the flexible tube 40 (FIG. 1). The connection element 80, in addition to the protruding members 82, when not in a collapsed state, may have a width W2. The width W2 may be, for example, approximately 9mm, and may generally be the same measurement of the internal diameter D2 of the securing device. [0032] As shown in FIG. 10, the connection element 80 may have a length L2. The length L ₂ may be, for example, approximately 2cm. The connection element 80, when it comprises a matrix of protruding members 82 as described herein, may contain protruding members that are spaced apart at a spacing S. The spacing S may be, for example, approximately 4mm.

[0033] The surgical drain device 5 may be positioned so that the drainage tube 10 (FIG. 1) is placed inside the body and the connection element 80 rests at the exit/stab wound site so that the protruding members 82 may engage the securing device 70 when the securing device 70 is slid into place and attached with sutures 73 (FIG. 7) as described herein. Accordingly, upon an attempted withdrawal of the drain, the engaged protruding members 82, in conjunction with the other elements discussed herein, may prevent withdrawal of the drain. Upon release of the sutures 73 and the securing device 70 (FIG. 7) from the exit/stab wound site, the flexibility of the skin will allow for the usual withdrawal of the drain despite the additional diameter.

[0034] The above-disclosed features and functions, as well as alternatives, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements may be made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.