Abstract:
An insertion device has pivotable elongated members manipulable by a hand, one of which holds a trocar, and the other a target through which the trocar will pass as the elongated members are pivoted. A tube is connected to the trocar or elongated member holding the trocar, and the tube is passed through body tissue from a position interior to the body to a position exterior to the body, together with the trocar. An end of the tube is positioned in a fluid accumulating area of the body, and passes to a container external to the body. The container contains markings which enable a determination of the quantity of passed fluid. At intervals, the quantity of fluid is determined, and the container is replaced with another container.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention relates to surgical instruments and related systems for draining fluid from wounds. 
       BACKGROUND OF THE INVENTION 
       [0002]    Surgical procedures can cause excess fluid to accumulate in the body. If left untreated, the accumulation of excess fluid may cause pain and increase the risk of infection of the surrounding tissue. Even so called “minimally or less” invasive procedures can lead to fluid accumulation. As a result, it is often desirable to provide a way for this fluid to drain out of the body, such as by inserting a drainage tube into the treated area to drain any excess fluids that may otherwise accumulate. 
         [0003]    Insertion of a drainage tube into the treated area typically involves use of a trocar or other piercing object having a sharp point for piercing through tissue. The drainage tube is connected to the rearward portion of the trocar in a manner that, once the tube is in a desired position, it may then be removed or separated from the trocar. The trocar is then discarded and other components of the drain, such as fluid reservoirs, anchors, and the like, are then added to the drain assembly. 
         [0004]    Previously, the procedure of inserting a drainage tube required the surgeon to manipulate the trocar from multiple locations and manually navigate it through a surgical incision toward a fluid sac. Then, the surgeon would guide the trocar back toward the outer surface of the body. Once the sharp tip of the trocar pierced the outer surface of the patient&#39;s skin, the surgeon would grip it and pull the remainder of the trocar and a portion of the tubing out of the body. 
         [0005]    This manual procedure can be time consuming, difficult to perform, and potentially dangerous for the surgeon and assisting medical staff. For example the process of gripping a rearward part of the trocar to first push it through, and then gripping a portion near the sharp forward tip to pull it through required the surgeon to reposition their grip on the trocar, which can be both time-consuming and difficult to perform successfully. It also means that the physician would not know precisely where to expect the trocar to pierce the outer surface of the skin, thereby making the process inefficient and potentially more dangerous. 
         [0006]    One reason why this process is inefficient is because it requires some steps of assembly of the drain to be delayed until others are fully completed. For instance, an anchor often is used to help hold the drainage tube in place. The anchor typically surrounds the tubing and is attached to a portion of the patient&#39;s skin where the trocar and tubing exit the body. Not knowing precisely where this exit would be meant that the anchor could not be added until after the trocar and portion of tubing had exited the body. The anchor would then be guided onto the tubing and attached to the patient. Thus, the insertion of the drain was time consuming because positioning of the anchor could not begin until other steps were completed first. 
         [0007]    In addition to the added time and complexity involved with past procedures, not knowing where the trocar will exit the body also increases the risk that the surgeon or assistants also may be punctured by the sharp tip of the trocar. Physicians incorrectly expecting the trocar to protrude through the patient&#39;s skin in one location, for example, may inadvertently puncture themselves or their assistants as the trocar exits the patient&#39;s body at a different location. 
         [0008]    Once installed, traditional drains utilize a container where excess fluid is collected over time. Part of assessing a patient&#39;s recovery progress involves monitoring the amount of fluid that is collected by the drain. As a result, the container is removed from the drain periodically so that the fluid can be emptied into a measuring cup. The emptied container is then be reconnected to the drainage tube so that it can resume collecting fluid. This process continues until a determination is made that the drain may be removed, which often does not occur for a day or more. 
         [0009]    Thus, the container of conventional drains may be reused several times over the course of treatment with medical personnel periodically removing the container to empty it, measuring fluid output, and then reattaching the container to the drainage tubing. This process of repeated detachment, emptying, and reattachment of the container, however, requires several time-consuming steps. Moreover, the amount of handling of the container and transfer of fluid increases the risk of contamination and disease transmission. 
       SUMMARY OF THE INVENTION 
       [0010]    The invention is generally directed toward insertion tools, installation kits, and related components for a wound drainage system. 
         [0011]    One embodiment of the invention is directed to a surgical device having two elongated members that mutually rotate to open or close two respective ends away from, or toward, each other. One end of one elongated member has a trocar, advantageously curved, that is used to guide drainage tubing to a desired position in the patient&#39;s body, and then return out of the body. The other elongated member has an end that may be pressed against, or disposed near, the location where the surgeon desires the trocar to exit the body. Rotation of the elongated members toward a closed position causes the trocar to follow a path having a known exit point. Gripping surfaces, for example curved loops, advantageously with flattened and or knurled or roughened surfaces, may be provided on the elongated members, to allow better manipulation or control of the device. 
         [0012]    In one embodiment of the invention, the drain insertion tool rotates about a fixed axis so that the ends of the elongated members follow a partially circular path of a predetermined radius of curvature. The curvature of the trocar may be similarly curved so that as it moves during closing and opening of the device the sharp tip of the trocar moves in relatively the same direction as its curved shape, facilitating penetration of the trocar through body tissue. In another embodiment, the elongated members rotate about a moving axis of rotation, such as by rotating over cammed surfaces, to provide a more complex pathway for the trocar to follow. 
         [0013]    Another embodiment of the invention includes a surgical kit for installing a wound drain. In addition to having an insertion tool as described above, the kit advantageously also include a drainage tube, an anchor for the drainage tube, one or more fluid receptacles, suture, and the like. Some embodiments of the invention provide an agent (such as an antibiotic or disinfectant) on or within one or more components, and in other embodiments the fluid receptacles may be interchangeably replaced, so that requirements for handling of drained fluids, and the attendant risk of infection and or disease transmission, are reduced. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is an illustration of one embodiment of a drain insertion device of the invention; 
           [0015]      FIG. 2  is an illustration of the drain insertion device of  FIG. 1  in use; 
           [0016]      FIG. 3  is another illustration of the drain insertion device of  FIG. 1  in use; 
           [0017]      FIG. 4  is an illustration of an embodiment of an anchor that may be used with the invention; 
           [0018]      FIG. 5  is an illustration of another embodiment of an anchor that may be used with the invention; 
           [0019]      FIG. 6  is an illustration of a drain installation kit of the present invention; 
           [0020]      FIG. 7  is an illustration of an embodiment of fluid containers of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0021]    The invention is directed toward improved devices and methods for inserting and maintaining a fluid drain in a patient. While several features and aspects of the invention will be discussed in detail below, the invention generally relates to an improved insertion tool and an installation kit having many components useful for inserting and maintaining the drain during use. 
         [0022]      FIG. 1  shows an embodiment of an insertion tool  10  of the present invention. As shown the insertion tool  10  includes two arms or elongated members  12 ,  14  that are pivotally connected together. One elongated member  12  can be manipulated to guide a trocar  16  to its desired location. The other elongated member  14  may be used to position and align the location at which a piercing object, such as a needle, cannula, or trocar  16  exits the patient. 
         [0023]    Referring again to  FIG. 1 , the elongated members  12 ,  14  may be manipulated in a manner similar to operation of a pair of scissors. Thus, the proximal ends of the elongated members may be configured for handling and manipulation by a human hand. For example, a proximal end of one or both elongated members may have a loop through which a physician may place one or more fingers or thumb in order to grip the device securely. Alternatively, one or both of the proximal ends of the elongated members may have an open gripping surface that may permit the user to hold it in a variety of positions and apply pressure urging the proximal ends of the elongated members to move toward each other. The gripping portions may additionally be provided with a knurled or roughened surface to improve a grip thereof. 
         [0024]    A distal end  20  of one of the elongated members  14  may be configured to allow attachment and manipulation of a trocar  16 , as by a clip, friction fit, set screw, threadable connection, tightenable loop, or other means as would be understood by one skilled in the art. As discussed above, the leading edge of the trocar  16  has a sharp point that allows it to pierce the patient&#39;s tissue near the area to be drained. As shown in  FIG. 1 , the trocar  16  may advantageously be curved to more easily penetrate tissue, particularly if the curve of the trocar is aligned to match an arc of curvature of the pivoted elongated members  12 ,  14 . Alternatively stated, the curvature of the trocar  16  is advantageously selected so that, as the elongated members  12 ,  14  are closed toward each other, the path through which the trocar  16  moves corresponds at least generally to the curvature of the trocar  16  itself. 
         [0025]    Thus, if the pivoting motion of the two elongated members  12 ,  14  is about a fixed axis of rotation, the curvature of at least the leading portion of the trocar  16  may have a similar radius of curvature as the circular path through which it travels. Alternatively, the rotational movement of one elongated member  12 ,  14  relative to the other may be more complex, such as by rotation about cammed surfaces that provide more complex path through which the trocar  16  moves. An example of this may be found in the four bar linkage of vice gripping pliers, or the known crank slider, truss, or five bar linkages, or a cam within a groove, the cam being provided on one elongated member, and the groove provided on another elongated member. This may allow, for instance, the trocar  16  to be more easily guided toward the fluid during an initial portion of closing movement of the elongated members  12 ,  14 , while subsequently allowing the trocar  16  to return outward more easily during further closure of the elongated members  12 ,  14 . In one embodiment, the trocar  16  is aligned more parallel to at least one of elongated members  12 ,  14  initially, and is then rotated due to the cammed configuration to turn more perpendicularly with respect to the elongated member in order to pass more directly outside of the body. 
         [0026]    Regardless of the path through which the trocar  16  travels due to different configurations of the pivoting connection of the elongated members  12 ,  14 , it is desired that the leading edge of the trocar  16  generally point in the direction of travel so that its sharp point may help navigate through the tissue. Thus, a tangent of the curved trocar near its leading edge preferably differs from the direction of travel by less than about 20 degrees, and more preferably differs by less than 10 degrees while the leading edge of the trocar is disposed within the patient&#39;s body. 
         [0027]    The drainage tube  18  may be directly connected to a nearby portion of the trailing end of the trocar  16 . For instance, the rearward portion or end of the trocar  16  may be configured so that the drainage tube  18  may be connected directly to it. For example, the rearward portion of the trocar  16  may have one or more outwardly extending protrusions or teeth over which the drainage tube  18  may be fitted. Alternatively, the drainage tube may be connected to elongated member  12 , adjacent trocar  16 , to follow the path of trocar  16  through body tissue. Similarly, clamping mechanisms may be used to hold the trocar  16  and drainage tube  18  together during insertion. Skilled artisans would appreciate that these examples are representative, but not limiting, and that other ways of connecting the drainage tube  18  and trocar  16  may be used without departing from the invention as described herein. 
         [0028]    More particularly, the drainage tube  18  need not be directly connected to the trocar  16 , but instead may be connected to the elongated member  12  that is associated with the trocar  16 . In this manner, the trocar  16  may either be integrally formed with the elongated member  12 , may be permanently connected to it, or may be removably associated with the elongated member  12 . In turn, a portion of the distal end of the elongated member  12  may be configured to receive the drainage tubing  18 . For example, a portion of the distal end of the elongated member  12  associated with the trocar  16  may have a partially hollowed portion or receptacle where an end of the drainage tube  18  may be connected. Preferably, the connection of the drainage tube  18  to the elongated member  12 , trocar  16 , or other associated component is such that the tube follows the pathway to the treated area being created by the trocar  16 . 
         [0029]    Returning again to  FIG. 1 , the distal end  20  of the second elongated member  14  may be configured such that it may be placed against the outer surface of the tissue and provide a visual indication, or target, of where the trocar  16  will exit the body. This may be accomplished, for instance, by providing a rounded end having an eye through which the trocar  16  will travel upon closing of the elongated members. The material that forms the distal end  20  of the second elongated member  14  may then be placed against the patient&#39;s skin at a location where it is desired that the trocar  16  exits the body. 
         [0030]    The eye of the rounded end may be fully surrounded by material as illustrated, or alternatively may be only partially surrounded by material. For example, the distal end  20  may be open-ended, such as having a c-shape or u-shaped configuration. This open-ended configuration may be beneficial if the curvature of the portion of the trocar  16  that will pass through the eye or opening defined by the distal end  20  of the second elongated member  14  is different from the curved path through which this portion of the trocar  16  travels as the members are closed toward each other. In such cases, the open end may allow greater clearance for a portion of the trocar  16  as it passes through the distal end  20  of the second elongated member  14 . 
         [0031]    Distal end  20 , if sufficiently rigid, advantageously additionally serves as a supporting member for holding body tissue in place during penetration of trocar  16 , facilitating insertion of trocar  16  and drainage tube  18  through the body tissue. 
         [0032]    Providing a predictable location through which the trocar  16  will exit the patient also allows an anchor  22  to be removably disposed on the distal end  20  of the second elongated member  14 . In this manner, the step of threading the anchor onto the drainage tubing  18  can begin earlier and more efficiently than could be achieved in the past. The distal end  20  of the second elongated member  14  has a lower surface that may contact the patient&#39;s body and an upper surface that is more readily visible to the physician performing the procedure. 
         [0033]    Anchor  22  and distal end  20  may be mutually adapted to remain in connection until trocar  16  and drainage tube  18  have been passed through anchor  22 . Further, anchor  22  may be placed on, or secured to the target body tissue site, as by adhesive, suturing, stapling, or other known method, and the distal end of elongated member  14  then placed over or into connection with anchor  22 . In this manner, it may be known not only that trocar  16  will pass through anchor  22 , but also that anchor  22  is in a desired location. 
         [0034]    More particularly, in an embodiment of the invention, anchor  22  may be associated with the distal end  20  of the second elongated member  14  by placing it in communication with the lower surface so that when the distal end  20  is pressed toward the patient&#39;s body it holds the anchor  22  in a desired position. Alternatively, the anchor  22  may be disposed on the outward facing side of the distal end  20  of the second elongated member  14 . Once the anchor  22  is threaded onto the drainage tube  18 , the distal end  20  of the second elongated member  14  may be moved out of its position in contact with the patient so that the anchor  22  may then be attached to the patient. 
         [0035]    Referring to  FIGS. 4 and 5 , the anchor  22  may have an adhesive on at least a portion of the surface that contacts the patient. In addition, or as an alternative to using an adhesive, the anchor  22  may be configured with other ways of attaching it to the patient. For instance,  FIG. 5  illustrates that the anchor  22  may be configured with one or more eyelets or recesses  24  through which a suture may be threaded. Skilled artisans having the benefit of this disclosure may recognize that still other alternatives for holding the anchor  22  in a desired position may be used as well. 
         [0036]    The eye or opening of the anchor through which the drainage tube  18  is threaded may be configured to grip or hold the tube in place so that it resists inadvertent attempts to move or dislodge the drainage tube  18  relative to the anchor  22 . One way this may be achieved is by making the opening or eye of the anchor  22  approximately the same size or slightly smaller than the outer perimeter of the drainage tube  18 . This allows the anchor  22  to fit snugly around the drainage tube  18  and hold it in place with an interference fit. 
         [0037]    Alternatively, the anchor  22  may not be configured with an opening or eyelet. Instead, the portion of the anchor  22  contacting the patient may be a sheet of material having no opening or eye until the trocar  16  forms one by piercing through it. In this embodiment, it may be beneficial for the outer perimeter of the trocar  16  to be smaller than that of the drainage tube  18  so that as the tube is pulled through the anchor  22  the pierced material may stretch and grip the tubing. 
         [0038]    In yet another embodiment, the anchor  22  may be configured with other ways of gripping the drainage tube  18 . As shown in  FIG. 5 , for instance, the anchor  22  may be configured with a strap  24  that can be tightened around the drainage tube  18  when desired. Other devices, such as clamps or clips, may also be used in conjunction with the anchor  22  to grip the drainage tube  18 . 
         [0039]    In use, the trocar  16  and drainage tube  18  are attached to the first elongated member  12  of the insertion device  10 , while an anchor  22  is attached to the distal end  20  of the second elongated member  14 . The trocar  16  is then advanced along a curved path and moved through the skin or tissue to a location near the wound that the surgeon believes may require draining. This may be done by gradually closing the elongated members  12 ,  14  while holding or pressing the distal end  20  of the second elongated member  14  at a location where the surgeon prefers the trocar  16  to exit the body. 
         [0040]    Eventually, as the elongated members  12 ,  14  are closed further, the tip of the trocar  16  moves through the eye or opening of the distal end  20  of the second elongated member  14  as well as through the anchor  22 . This continues until the proximal end of the drainage tube  18  also passes through the distal end  20  of the second elongated member  14  and the anchor  22 . In this manner, the drainage tube  18  may be threaded onto the anchor  22  without having to wait until the insertion device  10  is removed. 
         [0041]    Once the trocar  16  and a portion of the drainage tube  18  have exited the patient, further closing of the elongated members  12 ,  14  or advancement of the trocar  16  and drainage tube  18  by the insertion device  10  may not be needed. Instead, it may be preferable that the insertion device  10  be prevented from unintended re-opening of the elongated members  12 ,  14  while the anchor  22  is being attached to the patient. Thus, the elongated members  12 ,  14  may be configured such that once they are closed a predetermined distance or amount a ratchet or locking mechanism engages to prevent inadvertent reopening. 
         [0042]    The ratchet or locking mechanism may be disposed near the pivoting connection between the first and second elongated members  12 ,  14 , or may by disposed on proximal ends of the elongated members  12 ,  14  so that they engage when they are less than a predetermined distance apart. Preferably, any ratchet or locking mechanism does not engage until at least the leading edge of the trocar  16  has exited the patient. 
         [0043]    The distal end of the drainage tube  18  generally resides in or near the wound, and the proximal end of the tube resides outside of the body. The tube is connected to the anchor  22  as previously described. The anchor  22  is fastened to the surface of the skin with an adhesive, or one or more sutures, for example. Once the tube  18  and anchor  22  are positioned, the inserter device  10  may be removed. 
         [0044]    After the anchor  22  and drainage tube  18  are in their desired position, a receptacle  28  may be connected to the drainage tube to collect fluid from the wound. As discussed above, prior drains reused the same receptacle over the period of use of the drain. As a result, monitoring and maintenance of the drain was time-consuming and presented increased risks of contamination, disease transmission, and patient infection. 
         [0045]    Referring to  FIG. 7 , the present invention reduces the time and risks of prior drains by providing a plurality of disposable receptacles  28 . Each of the receptacles  28  of the invention is configured so that a health provider may easily measure the output of fluid without needing to transfer the fluid to a different container or receptacle. 
         [0046]    As such, at least a portion of the receptacle  28  allows a health provider to view the fluid contained therein and compare it to a gauge that indicates fluid volume at multiple, graduated levels. For example, the receptacle may be formed of a low-cost transparent or translucent material such a plastic. Once a determination is made that the receptacle  28  is sufficiently full, it may be removed and properly discarded along with its contents, or used to store or transport the fluid if further analysis is desired. A second receptacle  28  is then connected to the drainage tube  18  to resume collecting fluid. 
         [0047]    To reduce the likelihood of infection or disease transmission further, one or more components such as the drainage tubing  18 , anchor  22 , or receptacle  28  may be impregnated, coated, or filled at least in part, with an antibiotic, disinfectant, or similar agent or combination of agents. Preferably, the agent is present in sufficient quantity to function for at least half of the duration of the usage of the drain, and more preferably is present in sufficient quantities to last throughout the entire period of use of the drain. 
         [0048]    Referring now to  FIG. 6 , two or more of the components described herein also may be combined to for a single use peel pack, including a bin and a releasably sealed surface layer, or surgical kit  30 . Preferably, the kit  30  includes at least the insertion tool  10 , trocar  16 , drainage tube  18 , anchor  22 , and a plurality of holders or receptacles  28 . Optionally, the kit  30  may also have suture for attaching the anchor to the patient or for other potential uses with the drain. Other components that may be provided include a drain exchange wire or drain unclogging wire. 
         [0049]    Once used, the component parts of the kit may be discarded. As a result, it is preferable that the materials used for the insertion tool, receptacles, drainage tube, anchor, and other components are low cost. The component pieces of the kit  30  may be sterilized or assembled in a sterile environment and then sealed to prevent contamination during storage. When the surgeon is ready to install the drain, the protective packaging thereby helps minimize the risk of contamination without requiring the components to be sterilized when the kit is opened at surgery. 
         [0050]    It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. For example, although reference is made to surgery and surgeons, the present invention contemplates use by any suitable healthcare provider in other procedures, such as minimally invasive or less invasive procedures. In addition, unless mention was made above to the contrary, it should be noted that not all of the accompanying drawings are to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention.