Abstract:
A new flexible surgical drain/catheter system is provided. The flexible system encompasses a flexible section that can be incorporated in the design of surgical drains/catheters of any kind. By incorporating this flexible system, a surgical. drain/catheter will possess three significant additional characteristics. These additional characteristics will make the herein designs superior to the existing designs. The first characteristic is that the surgical drain/catheter can be bent without causing any fold/crease to its outer and inner surfaces. The second characteristic prevents internal occlusions while the drain/catheter is bent. The third characteristic is that the flexible section can also be used as a reliable region of drain/catheter anchorage to the patient&#39;s body.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit U.S. Provisional Application No. 61/825943 filed May 21, 2013 and herein incorporated by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable. 
         [0003]    INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
         [0004]    Not Applicable. 
       BACKGROUND OF THE INVENTION 
       [0005]    1. Field of the Invention 
         [0006]    Surgical drains and catheters are efficient and reliable means to extract or relocate undesirable bodily fluids from or within the body of a patient during and after a surgery. Surgical drains and catheters have been circular-bodied or rectangular-bodied. The shape of the device is typically chosen by the surgeon according to the type of surgical procedure being conducted as well as the location and placement of the device inside or outside of a patient&#39;s body. 
         [0007]    For instance, after the removal of an abdominal cancerous tumor, the remaining cavity is usually tilled with bodily fluids such as blood that can cause infections and delay the healing process of the affected area. Usually for an abdominal surgical procedure, circular devices are utilized. After employing the catheter within or extending out of the body, they are connected to vacuum chambers, which extract the undesirable fluids via the suction forces induced by the vacuum chambers. 
         [0008]    The catheters are held in place by suture-threads that are knotted around the outer surface of the catheter and then sutured to the skin or the surrounding tissue. Then the remainder of the extruding drain is folded and taped flush against the skin of the patient. This is the most widely used catheter-to-the-body attachment technique. 
         [0009]    Several problems arise after using this mode of attachment. Upon constant respiration of the patient, the knots involved in the anchoring sutures might loosen and the catheter can move and be displaced from its intended position. In situations where the catheter is attached to the skin of a patient, it has been reported that the natural respiratory motion of the patient may cause knots to loosen within a period of 2 to 3 weeks. Furthermore, it has also been reported that upon accidental events (e.g. such as the catheter getting stuck to a doorknob) the entire device can be pulled out due to the rupture of the sutures or the anchoring skin/tissue. Hence, a second surgery will be needed to place a new drain/catheter. 
         [0010]    Another problematic pattern is developed when the catheter is folded and taped along the skin. The folding of the catheter causes internal occlusion in the lumen of the device that leads to reduced fluid drainage. Moreover, folding induces creases along the internal and external surfaces of the catheter, which may lead to internal and external damage to the catheter. 
         [0011]    Another problem is faced in sonic cases of chest and abdominal trauma. When a patient has severe internal bleeding, the use of large diameter drains (0.75 cm to 2.0 cm external diameter) is routine. The high diameter drain is usually run through the ribs of the patient connecting the internal and external environments of the patient&#39;s body. The high diameter drains are highly inflexible and maintain an almost perpendicular position to the patient&#39;s skin. En other words, after they exit the body through the ribs, the device protrudes outwardly and cannot be made flush with the skin unless brute force is used. This forcing action not only induces severe internal drain occlusions but also causes tensile and compressive forces in the skin/tissue, which in turn cause severe pain to the patient. 
         [0012]    Moreover, the above-described conventional catheter-to-the-body attachment becomes more and more unreliable as the diameter of the catheter increases. This is because as the diameter of the drain increases, more suture material is needed to be wrapped around the drain to hold it in place. The longer the sutures, the higher the probability of the suture&#39;s slippage and their tangling. 
       BRIEF SUMMARY OF THE INVENTION 
       [0013]    In one aspect, a preferred embodiment of the present invention provides a new drain and/or catheter having flexible sections that act as segments around which sutures can be securely wrapped. The rims and grooves of the flexible section provide the perfect geometry within which sutures can securely fit without any subsequent slippage. The sutures can then be run through the skin or any other underlying tissue to ensure a secure mode of attachment. It should be noted that the herein-described flexible sections can be incorporated in lost if not all of the conventional surgical drains and/or catheters, namely devices without the flexible section. In other aspects, the devices may be manufactured from biocompatible and flexible polymer material. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0014]      FIG. 1  is a right view of one embodiment of the invention having rims and grooves having semicircular edges. 
           [0015]      FIG. 2  is a cross-sectional the embodiment show in  FIG. 1  at a bend of 90 degrees. 
           [0016]      FIG. 3  front view of the embodiment shown in  FIG. 1  at a bend of 180 degrees. 
           [0017]      FIG. 4  is an isometric view of the embodiment shown in  FIG. 1  illustrating the use of sutures to affix the device. 
           [0018]      FIG. 5  is a right view of one embodiment the invention having rims at and grooves having triangular edges. 
           [0019]      FIG. 6  is a cross-sectional of the embodiment shown in  FIG. 5  at a bend of 90 degrees. 
           [0020]      FIG. 7  is a right view of one embodiment of the invention having rims and grooves having rectangular edges. 
           [0021]      FIG. 8  is a cross sectional of the embodiment shown in  FIG. 7  at a bend of 90 degrees. 
           [0022]      FIG. 9  is an isometric view of an embodiment having rectangular body. 
       
    
    
     DETAILED DESCRIPTION OF INVENTION 
       [0023]    This description is not to be taken its a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The scope of the invention is defined by the appended claims. In a preferred embodiment, as shown in  FIGS. 1 through 4 , the drain/catheter  100  of one preferred embodiment is comprised of a tube that may have three segments comprised of sections  101  and  102  with a flexible section  103  disposed in between. As shown in  FIG. 2 . catheter  100  has a lumen  130  that runs from distal end  132  to proximal end  134 . As show in  FIG. 3 , lumen  130  may have perforations  125  that are in communication with the lumen to assist in the intake of fluids. 
         [0024]    As shown in  FIGS. 1 and 2 , section  103  includes a plurality of rims grooves  152  on outer wall  154  and a plurality of rims  160  and grooves  162  on inner wall  164 . The rims and grooves stretch apart and compress together as shown in  FIGS. 2 and 3  so as to permit the device to have the ability to be sharply bent. As shown, the rims at groves on the outer side of the bend stretch apart and the rims and grooves on the inner side of the bend co p together. As is also shown, the internal diameter of lumen  130  in section  103  remains nearly constant for any bend. Specifically, internal diameters “I” and “II” of lumen  130  remain equal or equal or equal in bends up to 90 degrees and in bends up to 180 degrees. 
         [0025]    The above-mentioned increased flexibility prevents the formation of internal and external transverse folds and creases when the device is bent or folded into position. Without an internal or external fold or crease, the lumen of the device does not close or collapse and maintains its initial diameter, i.e., the internal diameter of lumen  130 . By doing so, the flow of fluids within the lumen is not hindered and stays continuous at the same as within the straight portion of the drain/catheter. 
         [0026]    When a surgeon applies a sharp bend, i.e. a bend with a relatively low radius of curvature to a catheter that incorporates section  103 , no transverse folds or creases will be induced to the cross-section of the device even if the device undergoes a 180-degree bend. This means that the lumen remains fully open and no hindrance is introduced to any fluid flow within the lumen. 
         [0027]    As shown, there is also no expansion or collapse of the external diameter of outer wall  154  along any of the transverse directions. This means that the device does not expand into its surrounding space once it is bent. 
         [0028]    Section  103  can also be utilized as a suitable and reliable point of the catheter anchorage to the underlying skin/tissue.  FIG. 4  illustrates how catheter  100  can be securely attached to the underlying skin/tissue. The same kind of attachment can be applied to other geometries as well. As illustrated, a major portion of section  102  is within the body of the patient and comprises a smooth outer wall for ease of use. The upper part of section  102 , namely its connecting part to section  103 , penetrates and is surrounded by the skin/tissue of the patient. As seen, the bend occurs within section  103  at the junction where the main tube transitions from a smooth surface to bendable section  103  at the skin surface. Locating section adjacent to the patient avoids having to locate the rims and grooves inside the tissue. 
         [0029]    Depending on the geometry of the underlying skin/tissue, the angle of the bend can vary from 0 to 180 degrees. Note the bend occurs within the z-y plane. However, the bend can be made within other planes that are parallel to the z-axis and also pass through it. Bends with an angle greater than 180 degrees are also possible if the geometry/space of the underlying skin/tissue allows it. After the bend terminates, the remaining and straight portion of section  103  can be used for additional bends and/or anchorage purposes. 
         [0030]    A safe anchorage to the underlying skin/tissue  200  is made by utilizing surgical sutures  201 . As shown in  FIG. 4 , the sutures pass through the underlying skin/tissue and then wrap around the drain/catheter by fitting within the external grooves  152  of section  103 . Once the sutures are in place and tightened, they can no longer slip along the surface. This is because rims  150  and grooves  152  of act as physical barriers, which prevent dislodgement of the sutures. 
         [0031]    A number of different geometries may be used for the edges of the rims and grooves including, but not limited to semicircular, triangular and rectangular. A semicircular configuration is shown in  FIGS. 1 through 4 .  FIGS. 5 and 6  represent a catheter  300  with sections  301  and  302  as well as a flexible section  303 . As illustrated, section  303  provides a plurality of rims  350  and grooves  352  on outer wall  354  and a plurality of rims  360  and grooves  362  on inner wall  364 . The edges of the rims and grooves for this embodiment are triangular. All the triangles defined by the rims  350  and grooves  352  may be equilateral triangles. 
         [0032]    A shown in  FIG. 6 , “I” represents the shortest internal diameter within section  303 , namely the distance between the internal rims. “II” represents the diameter of the internal passage of lumen  330  of catheter  300 . As shown, the external triangular rims do not extend much into the surrounding space around catheter  300 . Therefore, catheter  300  can be placed through natural or incised openings with diameters that are very close to the external diameter of the device. Therefore, no occlusions are introduced within the internal passage of catheter  300 . Hence, the flow of fluids within catheter  300 , which incorporates a flexible section  303 , is not hindered by internal occlusions. 
         [0033]    Analogous to the anchoring method described above, surgical sutures pass through the underlying skin/tissue of the patient and then wrap around section  303  with the rims and grooves preventing any motion of the catheter unit along the y-axis. Moreover, other movements of the drain/catheter unit are prevented as well. 
         [0034]      FIGS. 7 and 8  depict a catheter  400  having sections  401  and  402  as well as a flexible section  403 . As illustrated, section  403  provides a plurality of rims  450  and grooves  452  on outer wall  454  and a plurality of rims  460  and grooves  462  on inner wall  464 . The edges of rims and groves are rectangular in shape. 
         [0035]    As shown in  FIG. 8 , “I” represents the shortest internal diameter within section  403 , namely the distance between the internal rims. “II” represents the diameter of the internal passage of lumen  430  of catheter  400 . As shown, the external rectangular rims  450  do not extend much into the surrounding space around catheter  400 . Therefore, the catheter can be placed through natural or incised openings with diameters that are very close to the external diameter of sections  401  and  402 . Therefore, no occlusions are introduced within the internal passage of the catheter. Hence, the flow of fluids within a catheter, which incorporates a flexible section  403 , is not hindered by internal occlusions. 
         [0036]    Analogous to the anchoring, method described above, surgical sutures pass through the underlying skin/tissue of the patient and then wrap around section  403  with the rims and grooves preventing any motion of the drain/catheter unit along the y-axis. Moreover, other movements of the drain/catheter unit are prevented as well. 
         [0037]      FIG. 9  illustrates a rectangular drain/catheter  500  that may use the semicircular, triangular and rectangular rim and groove configurations described above. Moreover, for the embodiments described above, the flexible sections impart a three-dimensional bendability to the device with almost infinite degrees of rotational freedom. This flexibility is maintained without 1) inducing any occlusion or tightening of the lumen of the bent section; 2) inducing any transverse folds or creases in the flexible section; 3) inducing any expansion or collapse of the lumen within the flexible section; 4) inducing any change in the external and internal diameter of the flexible section; 5) inducing any strain/stress to the underlying/surrounding skin/tissue of the patient&#39;s body; and 6) inducing any unnecessary pain to patient caused by the bending of the device. 
         [0038]    The three-dimensional flexibility also dampens the longitudinal forces involved in any natural or accidental pulling action on the device. The pulling action can he internal or external to a patient&#39;s body and reduces the risk of accidental dislodgment. The three-dimensional flexibility reduces the risk of accidental removal from to patient&#39;s body. The three-dimensional flexibility reduces the risk of a drain&#39;s/catheter&#39;s accidental slippage and with that the need of a secondary operation to replace the drain/catheter at its intended position. 
         [0039]    The rims and grooves described above enable a drain/catheter to be securely attached to its underlying/surrounding skin/tissue. They also allow surgical sutures to nest within the grooves for retaining the device by acting as physical barriers that restrict the slippage of the surgical sutures along the external surface of the device. In addition, one or more flexible sections may be provided in a single device. In addition, other cross-sectional geometries may be used as well such a square, rectangular, oblong, triangular and other known shapes for the shape of the overall device. 
         [0040]    A method of securing a catheter to a patient using the embodiments described above includes inserting a portion of the catheter into a patient wherein, as set forth above, the catheter comprises a main tube comprising a distal end, a proximal end, and outer wall having an outer diameter and an inner wall defining a lumen having an inner diameter that extends from a distal end to a proximal end. The main tube includes at least one bendable section connected to a smooth tube section. The bendable section has a first set of a plurality of rims and grooves on an outer wall and a second set of a plurality of rims and grooves on an inner all that forms a lumen. The first and second sets of rims and grooves are adapted to stretch and compress when the bendable section is bent from a straight position to an angled position and the inner and outer diameters of the bendable section remain constant when the bendable section is bent. The smooth portion of the main tube is positioned in the patient and the bendable section is positioned adjacent to patient&#39;s skin or the tissue surface. This locates the bendable section in a position in which the bendable section is substantially parallel to the skin surface of the patient. The catheter is then sutured in place by wrapping sutures around the bendable section with the sutures located in one or more of the grooves on the outer wall to secure the catheter in place.