Abstract:
A new and improved tube or catheter for administrating or withdrawing a substance from the human body which can be temporarily attached to the tissue site. The catheter consists of a dual lumen, side-by-side, tube. One lumen is used to administer or withdraw a substance. The second lumen contains an attachment means consisting of a loop of filament extending beyond the both ends of the lumen in the second tube. During use the surgeon fixes a suture at the tissue site and ties the suture around the filament loop extending from the distal end of the second tube. The surgeon then grasps the proximal end of the filament and slides the catheter over the filament and the suture until it rests against the tissue attachment site. The filament or suture is then tied around the proximal end of the tube to hold the catheter in place. To remove the catheter, the surgeon cuts the suture where tied to the proximal end of the tube, pulls off the catheter, and slides the suture out of the tissue.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a tube or catheter, and more particularly to a tube or catheter, which can be temporarily attached to a tissue site within the human body for infusion or withdrawal of a substance from the body. 
     2. Description of the Prior Art 
     Known methods of attaching a tube or catheter into the body involve suturing the catheter into place at the attachment site. However, since sutures can not be placed through the catheter, sutures are tied or otherwise secured around the outside of the catheter to hold it in place. Slippage of the catheter and collapsing of the tube are potential problems. To remove the catheter either surgical intervention is required or, if the catheter is pulled out, the sutures used to hold the catheter in place are left in-situ. 
     The patent literature describes several styles of catheters which can be fixated in the body while they are used to administer or withdraw a substance from the body. Balloon catheters, as described in U.S. Pat. No. 5,954,694 to Sunseri, and other similar patents, can be fixated in a vessel or body space (i.e. abdomen) by inflating a balloon at or near the distal end of the catheter. Additional lumens in the catheter can then be used to perform a variety of functions such as infusing and/or removing substances from the body or conducting a surgical procedure. However, when placed in vessels, these catheters function by occluding the vessel they are fixated in and therefore do not allow the normal functioning of the vessel to proceed. For instance they block the flow of blood in a blood vessel, or restrict the flow of urine from the bladder, and so forth. 
     Percutaneous style catheters as described in U.S. Pat. No. 4,311,148 to Courtney, and other similar patents, are fixated at the site they enter the body by an ingrowth means usually consisting of a fabric patch. In use body tissue will grow into the fabric patch and secure the catheter in place. In order to remove the catheter the ingrown area must be excised away. This style of catheter is not suitable for short duration use. 
     U.S. Pat. No. 6,042,577 to Chu et. al., and other similar patents, discloses a catheter with a suture running internally from the proximal to the distal end. However, this suture is not used to attach the catheter to tissue. Instead, it is used to open an anchoring device, such as bendable arms, which are part of the catheter distal end. 
     SUMMARY OF THE INVENTION 
     Accordingly, it is an object of the present invention to provide a tube or catheter which can be easily and reliably attached to a tissue site for a short, temporary no duration of time for the administration and/or withdrawal of a substance in the body. 
     It is a further object of the present invention to provide a tube or catheter attachable to a tissue site in a hollow body organ, such that the attachment means will not block the normal functioning of that body organ during use of the catheter. 
     Still another object of the present invention is to provide a tube or catheter which can be easily removed from the attachment site without surgical intervention and without leaving remnants of the attachment means at the attachment site. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The above and other objects and advantages of the present invention will become apparent from the following description when read in conjunction with the accompanying drawings wherein: 
     FIG. 1 is a schematic representation of a preferred embodiment of the invention, 
     FIG. 2 is a schematic representation of a second embodiment of the invention; 
     FIG. 3 is a schematic representation of a third embodiment of the invention; 
     FIG. 4 is a schematic representation of a fourth embodiment of the invention; 
     FIGS. 5 a - 5   d  are schematic representations showing the insertion into and removal of the first embodiment of the invention from a hollow body organ; 
     FIG. 6 is a schematic representations showing insertion of the second embodiment of the invention in a hollow body organ; 
     FIG. 7 is a schematic representations showing insertion of a further embodiment of the invention in a hollow body organ. 
    
    
     DESCRIPTION OF THE INVENTION 
     FIG. 1 shows a first embodiment of an attachable catheter  10  for administering or withdrawing a substance from the human body. The attachable catheter  10  is comprised of at least two tubes. In a preferred embodiment, a first tube is a long tube  11  and a second tube is a shorter tube  12 , the tubes being mounted side by side. The distal ends  13  of both tubes are joined along a portion of their length. The long tube  11  is used to administer or withdraw a substance from the body. The shorter tube  12  is used for placement of an attachment means  20  which secures the distal end  13  of the catheter  10  in place in the body for the duration of its use. 
     The attachment means  20  passes through the lumen of the shorter tube  12  and extends out of both ends of that tube. In the embodiment shown, attachment means  20  consists of a length of filament  21  which is folded over and inserted through the lumen of the shorter tube  12  such that an attachment loop  22  is formed at the distal end  13  of the catheter. A retaining means such as a button  23  is placed over the end of the filament  21  exiting the proximal end  80  of the shorter tube  12  to prevent the attachment means  20  from pulling back into the short tube  12 . The ends of the filament  24  extending out the proximal end may also be tied together in a knot  25  or otherwise joined beyond the proximal end  80 . 
     The tubing forming the various embodiments of this invention can be formed from a variety of materials suitable for medical application, for example, polyurethane, silicone elastomer, Teflon, Nylon, Pebax, etc. The long tube  11  and the shorter tube  12  can be made of the same or different materials. Both the long tube  11  and the shorter tube  12  are attached along at least a portion of their length. This attachment can be accomplished by several methods. Preferably the tubes  11 ,  12  are extruded together as a side-by-side tube. Alternatively, the tubes can be attached after extrusion by heat, solvent, or adhesive. Still further, a single tube with two lumens may be utilized. If the tubes are extruded side by side or heat bonded together, the tube containing the filament  21  can be cut to length and the unwanted section of tubing peeled away from the long tube  11  leaving behind the shorter tube  12 . While only two tubes are shown additional tubes or lumens can be provided. For example, one tube can be provided for delivery of fluid, such as an irrigation or an anesthetic fluid while a further tube can be provided to simultaneously provide drainage of fluids. 
     The filament forming the attachment means  20  must be of diameter suitable to fit through the lumen of the shorter tube  12  and be readily withdrawn from the tube. Materials having some stiffness are preferable for assembly of the catheter. For example, a polyester monofilament has been found most suitable for the preferred embodiment of this invention. However, more flexible filaments such as suture are also suitable alternatives. The retaining means or button  23  can be formed from any material, which will prevent the end of the attachment means from being pulled back up through the shorter tube  12 . Typically, this button would be plastic or a small section of tubing. However, a knot larger than the diameter of the tube lumen would also be adequate. 
     FIG. 2 shows an alternative embodiment of the invention. Instead of attaching the tubes along their length, the long tube  11  and the shorter tube  12  are separately formed and attached only near their distal end  13 . This attachment can be accomplished by several methods. As shown, long tube  11  and the shorter tube  12  are separately formed and attached by a band  30  of material securing the two tubes together. This band  30  can be a heat shrink plastic band or other suitable material that firmly grips and holds the tubes together. The tubes may also be bonded or glued together at the distal end  13  in place of the band. 
     It is not necessary that the attachment means be a looped filament. FIG. 3 shows an alternative attachment means  40  consisting of a single filament  41  passing through the lumen of the shorter tube  12 . Instead of the attachment loop  22  formed in FIG. 1, the end of the filament  44  is left extending from the distal end  13  of the catheter. On the other end of the shorter tube  12 , a retaining button  42  is placed over the end of filament  41  exiting the proximal end of the tube. The proximal end of filament  41  is tied in a knot  43  to prevent the attachment means  20  from pulling out of the short tube  12 . 
     FIG. 4 shows another alternative attachment means  50 . This attachment means is similar in construction to attachment means  40  shown in FIG. 3 except that the distal end  13  includes a needle  52  attached to the end of filament  51 . An optional hole  53  is also provided at the distal end  13  of the catheter as an alternative means to secure the attachment means  50  as described below. 
     Referring to FIGS. 5 a - 5   d,  a method of attaching and removing an attachable catheter incorporating features of the invention at a site within the body is illustrated. For illustration purposes the catheter  10  is attached within the rectum and may be used to deliver an anesthetic and/or antibotic following hemorrhoid surgery. In FIG. 5 a  a length of suture  60  containing a needle  61  is placed through tissue at a desired attachment site  63  inside the rectum. Both ends of the suture  60  are brought outside the anal opening, looped through the distal loop of attachment means  64 , and tied together with a knot  67 . 
     After both ends of the suture  60  are tied. The needle  61  is cut off the end of the suture and the knot  67  is pulled up into the rectum so that it is at the attachment site  63  as shown in FIG. 5 b.  After the knot is in place, the proximal end  66  of the attachment means is held and the catheter  65  is slid over the attachment means  64  and the suture  60  until the distal end  68  of the catheter is at the attachment site  63 . 
     Referring to FIG. 5 c,  the loop of suture  60  extending beyond the proximal end  70  of the catheter is cut and the attachment means  64  is discarded. The cut ends of the suture  60  are tied together around the catheter  65  forming knot  71 . This holds the catheter  65  in place at the attachment site  63 . It can be seen that the catheter is held securely in place and does not block the normal functioning of the rectum since the catheter is much smaller. One skilled in the art will recognize that other means can be used to secure the proximal ends of the suture such as a clip or button. 
     As shown in FIG. 5 d,  to remove the catheter  65 , the knot  71  holding the proximal ends of suture  60  is completely cut off. This frees the catheter which can now be pulled out of the rectum. By grasping the end of suture  60  which contains the knot  67  at the attachment site  63  inside the rectum, the suture  60  can also be pulled from the rectum. It can be seen that all components of the catheter, its attachment means, and the attachment suture are removed from the body. 
     In the alternative embodiment of the attachable catheter  10  as shown in FIG. 3, the distal end of the attachment means  64  is tied to the loop of suture  60  by knot  72  as shown in FIG.  6 . The needle  61  is cut from the suture and discarded. The proximal end of the attachment means  66  is held and the catheter  65  is slid over the attachment means  64  and the suture  60  until the distal end  68  of the catheter is at the attachment site  63 . In this embodiment, the lumen of the shorter tube  12  needs to be large enough so than the knots  72  and  67  can be pulled through the tube. The catheter is secured and removed as described previously. 
     In another embodiment of the attachable catheter  10  as shown in FIG. 4, the distal end of the attachment means  64  already contains a needle  61  at its distal end. The needle  61  and filament  64  of the attachment means are used instead of suture. In FIG. 7 the needle  61  is placed through tissue at a desired attachment site  63  inside the rectum and brought outside the anal opening. The distal end of the filament  64  containing the needle  61  can be placed through and tied to the optional hole  53  in the catheter  65  or tied to the filament at a location along its exposed length, for example at location  73 . The needle  61  is cut from the attachment means and discarded. The proximal end of the attachment means  66  is held and the catheter  65  is slid over the attachment means  64  until the distal end  68  of the catheter is at the attachment site  63 . The catheter is secured and removed as described previously. 
     In still another embodiment of the present invention, the distal loop of the attachment means can be fixed directly to the attachment site using resorbable suture or a resorbable clamp. In this embodiment, the catheter is slid up the filament attachment means so that the distal end of the catheter is at the attachment site. The proximal end of the filament attachment means is tied off around the catheter to secure the catheter in place. To remove, the proximal end of the filament attachment means is cut and the catheter is pulled off the filament attachment means. One end of the filament attachment means is then pulled which removes the filament from the suture or clamp attachment at the attachment site. This leaves the resorbable suture or clamp at the attachment site where it will eventually be reabsorbed. 
     The proximal end of the longer tube of the catheter may be attached to an infusion means to deliver gases, fluids, or medication to the body at the attachment site. Alternatively, the proximal end of the catheter may be attached to a suction means to withdraw gases or fluids from the body at the attachment site. Still further, a fluid delivery tube and fluid withdrawal tube along with the attachment placement tube may be used. In addition, the attachment delivery tube may also be used to feed or withdraw fluids, thus requiring placement of only a signal tube. The proximal end of the catheter may also be left free or placed in a collection bag so that the catheter acts as a drain of body fluids from the attachment site. Still further, while a shorter tube is shown for placement of the attachment means, there is no reason why the tubes can not be of the same length such as in a multilumen catheter. 
     While attachment to rectal tissue for use following a hemorrhoid procedure was described for illustration purposes, one skilled in the art will recognize that the described device can be used for numerous applications following various medical or surgical procedures. For example, the device has application in ob/gyn procedures, ENT procedures, various abdominal procedures and numerous endoscopic and less invasive procedures where it is desirable to deliver small amounts of topical anesthetic to relieve post surgical pain or discomfort or antibiotics or steroids, to prevent infection or inflammation at the surgical site. 
     Although this invention has been described in terms of certain preferred embodiments, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of this invention. Accordingly, the scope of the invention is intended to be defined only by reference to the appended claims.