Abstract:
A drainage catheter, including a catheter tube body that can have a pig-tail loop in a distal end, a rigid member configured to be placed inside of the catheter, a pig-tail straightening sleeve configured to move axially along the tube body, the sleeve having a lip formed on an end of the sleeve, the lip being configured to be positioned towards the distal end of the tube body, thereby straightening the catheter tube body and facilitating entry of the rigid member into the catheter tube body when the pig-tail straightening sleeve is positioned to straighten the catheter tube body.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to catheters. In particular, the present invention relates to a catheter device including, a drainage catheter, at least one rigid member, such as a cannula, or a trocar, and a pig-tail straightener. 
         [0002]    One problem often encountered in modern medicine relates to volumes of fluids that collect in a patient&#39;s tissue, body cavities, or other positions within a patient&#39;s body that exceed normal volumes. Collected fluids can contribute to infection, exert harmful pressure on the patient&#39;s organs, or otherwise impede the proper care and recovery of a patient. Drainage catheters have long been utilized to drain such excess volumes of fluids from a patient&#39;s body. Typically, the catheter is adapted to be introduced into the patient to the site where the excess fluid is accumulated. A plurality of drainage bores are positioned in the distal end of the catheter to allow passage of the fluids and any materials suspended in the fluids from the volume of fluid to the drainage bore of the catheter. 
         [0003]    The distal end of drainage catheters are typically adapted to form an anchor configuration to secure the drainage catheter at the site where excess fluid is accumulated. However, the tissue surrounding drainage sites often does not provide a solid or reliable substrate to maintain the position of the catheter. As a result, the anchor configuration of the catheter is typically formed in a relatively large pigtail type loop that provides a reliable anchor regardless of the characteristics of the surrounding tissue. The pigtail loop is formed by curling the tip of the catheter tube such that the tip of the catheter contacts a more proximal position on the catheter tube. This is accomplished utilizing a suture that is threaded between the proximal position and the tip of the catheter. Some examples of such catheters are disclosed in U.S. patent application Ser. No. 11/205,609 filed Aug. 17, 2005 which is incorporated herein by reference. When the suture is foreshortened, the tip of the catheter is securely positioned relative to the proximal position on the catheter tube. A portion of the distal end of the catheter tube between the tip of the catheter and the proximal position where the suture exits the catheter tube forms a resulting pig-tail type loop. 
         [0004]    The pig-tail type loop may be formed in the catheter tube such that the catheter tube is biased towards the pig-tail configuration, or the catheter tube may maintain a pig-tail type after the catheter tube has been held in position for some time. In such circumstances, it may be difficult to straighten the pig-tail for insertion or removal. Cannulas, trocars and other rigid members can be inserted into the catheter tube to straighten out the pig-tail. In some cases, the cannula, trocar, or rigid member can be difficult to fully insert because the end of the cannula, trocar, or rigid member may catch on or puncture the wall of the catheter. 
         [0005]    One approach has been to place a sleeve, as shown in U.S. Pat. No. 4,738,667, over the catheter tube. The sleeve can slide along the length of the catheter tube to straighten the pig-tail for insertion or removal. However, these sleeves have the disadvantage of having an abrupt end, which can cause the sleeve to catch on or tear into the catheter member. 
         [0006]    What is needed is a device that allows a practitioner to straighten a pig-tail in a catheter tube to allow for easier insertion or removal of the catheter tube while limiting or preventing damage to the catheter tube. 
       BRIEF SUMMARY OF AN EMBODIMENT OF THE INVENTION 
       [0007]    The present invention relates to catheters. In particular, the present invention relates to a drainage catheter including a tube body configured to assume a pig-tail configuration in a distal end of the tube body, at least one rigid member, such as a trocar or cannula, that can be placed inside of the tube body, and a pig-tail straightener, such as a sleeve, for straightening the tube body to provide easier insertion of a rigid member into the tube body. 
         [0008]    To insert a catheter, the practitioner may use a trocar and cannula placed inside of the tube body of the catheter to create an opening in a patient&#39;s body to accommodate the catheter, or a cannula may be placed in the tube body alone to make the catheter body more rigid. In some instances, the tube body may be made of a relatively soft and pliable material to accommodate desirable design characteristics of a catheter. The distal end of the tube body may also be biased in a pig-tail configuration to aid in anchoring the catheter in place once placed in a patient. Similarly, the tube body may become biased in a pig-tail configuration after being held in the pig-tail configuration for a period of time. In such instances, placing the cannula or trocar may be difficult or may cause damage to the wall of the tube body 
         [0009]    To place the trocar or cannula into the catheter, a pig-tail straightener, such as a sleeve member slidably placed on the outside of the catheter tube body, may be used. The sleeve member has a lip, such as a rounded end, rolled end, smoothly flanged end, or other smooth feature, to aid in sliding along and straightening the catheter tube body without catching on or damaging the outside surface of the tube body. A practitioner slides the pig-tail straightener along the tube body to the distal end of the tube body, thereby straightening any bends or pig-tail loops in the tube body. The pig-tail straightener is positioned proximate the distal end of the tube body. The rigid member is then placed inside of the tube body through the proximal end. With the rigid member in place, the pig-tail straightener may then be removed from the catheter entirely. The catheter is thus retained in an extended, rigid position. 
         [0010]    To place the catheter, the practitioner may use the catheter with the rigid member inside of the tube body to place the distal end of the catheter at a desired location inside of a patient. In some cases, the rigid member may include a trocar that can be used to create the insertion hole in the patient. In other cases, the catheter may be placed in an existing opening by advancing the tube body with cannula over a guidewire. Once the catheter is in place, the rigid member may be removed, and the practitioner may secure the distal end of the tube body in the pig-tail configuration. 
         [0011]    In some embodiments, once the distal end of the catheter tube is positioned in the desired location within the patient&#39;s body, the practitioner may grasp a proximal end of a suture and pull to shorten the suture, drawing the tip of the catheter tube in a curved, pig-tail position so that an anchor loop is formed in the distal end of the catheter tube body. The pig-tail prevents removal of the distal end of the catheter from the desired position in the patient, minimizing risk of injury. 
         [0012]    In some embodiments, the lip on the pig-tail straightener sleeve may be 
         [0013]    formed such that the diameter of the lip is greater that the diameter of the sleeve body. In some embodiments, an end of the pig-tail straightener sleeve may be rounded such that it has a rounded edge on the inside and/or the outside of the sleeve. In other embodiments, the lip may include a smooth flange, or a rolled end. 
         [0014]    As will be appreciated by those skilled in the art, a variety of types and configurations of catheters and of suture securement mechanisms can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment the securement mechanism may include a locking rotatable lever handle for securing a suture in an anchored position. In another embodiment, the pig-tail may be secured by bias in the tube body such that the distal end of the tube body is normally in the pig-tail configuration. The catheter may be a bladder catheter, or other type of conventional catheter. 
         [0015]    These and other aspects of the present invention will become more fully apparent from the following description and appended claims. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
           [0017]      FIG. 1A  is a perspective view of a drainage catheter illustrating a catheter tube body in a pig-tail configuration and a pig-tail straightener sleeve; 
           [0018]      FIG. 1B  is a perspective view of a drainage catheter illustrating a pig-tail straightener positioned to straighten a catheter tube body and a rigid member partially within the catheter tube body of  FIG. 1A ; 
           [0019]      FIG. 1C  is a perspective view of the drainage catheter of  FIG. 1A , with rigid members and pig-tail straightener sleeve, being placed within a body with rigid members; 
           [0020]      FIG. 2  is a perspective view of the drainage catheter of  FIG. 1A  in place and secured with a pig-tail; 
           [0021]      FIG. 3A  is a cross-sectional view of an embodiment of a pig-tail straightener; 
           [0022]      FIG. 3B  is a cross-sectional view of an embodiment of a pig-tail straightener; and 
           [0023]      FIG. 3C  is a cross-sectional view of an embodiment of a pig-tail straightener. 
       
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0024]    The present invention relates to catheters. In particular, the present invention relates to a drainage catheter including a catheter tube body configured to assume a pig-tail configuration in a distal end of the catheter tube body, at least one rigid member, such as a trocar, or cannula that can be placed inside of the catheter tube body, and a pig-tail straightener, such as a sleeve, for straightening the tube body to provide easier insertion of a rigid member into the catheter tube body. 
         [0025]      FIGS. 1A-1C  are perspective views of drainage catheter  10  illustrating a catheter tube body  12  having a distal end  13 , a proximal end  16 , a locking catheter hub  14  having a rotatable lever handle  28 , securement suture  26 , and pig-tail straightener sleeve  20 . 
         [0026]      FIG. 1A  shows distal end  13  of catheter tube body  12  in a pig-tail configuration. Pig-tail configuration may also be any loop, bend, hook, spiral, twist, or similar alteration that would secure distal end  13  of catheter  10  in a desired location. Distal end  13  may be normally biased in a pig-tail configuration, as shown in  FIG. 1A , or it may be normally straight, requiring modification to a pig-tail configuration through any number of methods. 
         [0027]    In the example embodiments disclosed, drainage catheter  10  is configured to be utilized for potentially prolonged periods to drain fluid from a patient. Catheter hub  14  and rotatable lever handle  28  provide a simple and effective mechanism to allow a user to selectively implement and maintain the anchor configuration of a distal end  13  of catheter tube body  12 . Rotatable lever handle  28  is adapted to secure a suture thread  26  to maintain the anchor configuration of distal end  13  of catheter tube body  12  so that the position of catheter tube body  12  is secured within a patient&#39;s body  18  (as shown in  FIGS. 1C-2 ). The rotatable lever handle  28  has a released position for allowing movement of the suture, and a secured position for preventing movement of the suture. Rotatable lever handle  28  is shown in the released position in  FIG. 1A . 
         [0028]    To maintain the desired positioning of distal end  13  within the patient  18 , the practitioner grasps the free end of suture  26  extending from catheter hub  14 . The user then pulls suture  26  in a rearward direction away from distal end  13  of catheter tube body  12  such that distal end  13  forms a pig-tail type anchor configuration. The anchor loop configuration in distal end  13  of catheter tube body  12  maintains the position of distal end  13  in patient  18 , even where the wall of a body cavity is insufficiently rigid to secure traditional catheter securement devices. 
         [0029]    Typically, once distal end  13  of catheter tube body  12  is positioned in the pig-tail configuration, the drainage catheter  10  will remain positioned within the body of the patient for a considerable period of time to facilitate ongoing drainage of the volume of bodily fluid from the patient. 
         [0030]    In the illustrated embodiment, locking catheter hub  14  is utilized in connection with catheter tube body  12  of drainage catheter  10 . Catheter tube body  12  comprises an elongate tubular member having a drainage lumen for allowing the fluid to exit patient  18 , through the distal end  13  of catheter tube body  12 . The configuration of catheter tube body  12  allows fluids to be drained from a patient  18  through drainage catheter  10 , exiting at proximal end  16 . 
         [0031]    Pig-tail straightener  20  may have a sleeve body  24  slidably engaged with catheter tube body  12 . Pig-tail straightener  20  may be a sleeve or tube having an inner diameter larger than the outer diameter of catheter tube body  12 , allowing pig-tail straightener  20  to slide along the length of catheter tube body  12 . Pig-tail straightener  20  includes lip  22  to facilitate sliding pig-tail straightener  20  from a proximal location near hub  14 , as illustrated in  FIG. 1A , to a distal location covering, at least in part, distal end  13  of catheter tube body  12 . Lip  22  may be a raised ring around one end of pig-tail straightener  20 , as illustrated in  FIGS. 1A-IC ,  3 A- 3 B such that lip  22  has a diameter greater than the diameter of sleeve body  24 . Alternatively, lip  22  may be a rounding of the distal end of sleeve body  24  such that a smooth edge is presented, as shown in  FIGS. 3A-3C . In  FIG. 3A , lip  22   a  is a rounded projection extending from sleeve body  24   a , such that lip  22   a  has a diameter greater than the diameter of sleeve body  24   a . In  FIG. 3B , lip  22   b  is a gradually expanding projection extending from sleeve body  24   b , such that lip  22   b  has a diameter greater than the diameter of sleeve body  24   b . In  FIG. 3C , sleeve body  24   c  has thick walls allowing lip  22   a  to have a rounded end. In other embodiments, the lip may include a rounded end formed on the gradually expanding projection extended from the sleeve body. 
         [0032]    As pig-tail straightener  20  is moved distally, lip  22  engages distal end  13 , straightening the pig-tail to a straight configuration, as illustrated in  FIG. 1B . Lip  22  is sufficiently rounded or smooth to slide along catheter tube body  12  rather than catching on or damaging catheter tube body  12 . Once the catheter tube body  12  is in a straightened configuration, as shown for example in  FIG. 1B , the catheter tube body may then be prepared to be introduced into a patient, as shown in  FIG. 1C . 
         [0033]    Distal end  13  is introduced into patient  18  at a position configured to optimize the drainage of fluid from patient  18 . To facilitate the correct positioning of drainage catheter  10 , distal end  13  can be introduced into patient  18  through an existing lumen, or made rigid by insertion of one or more rigid members  30 ,  36  into the lumen of catheter tube body  12 . In this example embodiment, cannula  30  can be attached to drainage catheter  10  by engaging a threaded connecting member  17  at proximal end  16  with threaded end  32  of cannula  30 . As illustrated in  FIGS. 1B-1C , cannula  30  may be attached at one end to proximal end  16  of catheter tube body  12 . Trocar  36  may also be introduced into catheter tube body  12  to allow drainage catheter  10  to be inserted directly into the patient  18  through an opening created by a sharp end of trocar  36 . 
         [0034]    Cannula  30  may have a blunt end and a lumen to allow passage of trocar  36  through cannula  30  and catheter tube body  12 , creating a nested arrangement, as illustrated in  FIGS. 1B-1C . Cannula  30  may have a threaded portion  33  to releasably engage threaded end  38  of trocar  36 . Cannula  30  and trocar  36  may be the approximate length of catheter tube body  12  and contained entirely or substantially by catheter tube body  12 . 
         [0035]    With pig-tail straightener  20  in place over distal end  13 , cannula  30  and/or trocar  36  may be inserted into catheter tube body  12  without catching on, puncturing, or otherwise damaging catheter tube body  12  with the distal end of cannula  30  or the sharp distal end of trocar  36 . 
         [0036]    As illustrated in  FIG. 1C , drainage catheter  10  may be inserted into patient  18  with both cannula  30  and trocar  36  in place within catheter tube body  12 . Alternatively, cannula  30  may be employed separately as may be expedient to a practitioner. Some embodiments of cannula  30  may be made of plastic, metal, or other appropriate material, and may have varying degrees of rigidity, depending on the required application. 
         [0037]    As illustrated in  FIG. 2 , pig-tail straightener  20  is removed from catheter tube body  12  after insertion of rigid members  30 ,  36  and prior to placement of drainage catheter  10  in patient  18  by sliding pig-tail straightener off of distal end  13  of catheter tube body  12  and discarded as appropriate. 
         [0038]    As will be appreciated by those skilled in the art, a variety of types and configurations of catheters can be utilized for draining bodily fluids from a patient without departing from the scope and spirit of the present invention. For example, in one embodiment, the fluids to be drained exit from a portion of the drainage catheter other than the catheter hub. In another embodiment, the drainage catheter  10  is adapted to be positioned adjacent an organ or in the vasculature of the patient. In another embodiment, the drainage catheter  10  is introduced utilizing a guidewire or rigid stylet. 
         [0039]    In some embodiments, a kit according to the present invention may include, in addition to the components discussed above, additional tubing, sterile gloves, sterilization pads, additional members configured to be inserted into the drainage catheter such as diagnostic testing implements or devices, structural support elements, or other devices and implements used in conjunction with drainage catheters. 
         [0040]    The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.