Abstract:
Viscera retainer which facilitates wound closure, for example, in the abdominal region, includes a body portion containing a tear seam. The body portion is inserted into the wound prior to closure to act as a physical barrier between the peritoneum and the viscera. A free extension of the body, or an attachment to the body, remains accessible outside the wound while a membranous layer of the abdominal wall is closed. When that closure is almost complete, the body portion is withdrawn from the abdomen by extracting it as a continuous ribbon through an opening. As the ribbon is withdrawn, the body tears along the tear seam generating free ribbon and shrinking the size of the residual body, until the entire body is removed from the abdominal cavity. The closure is then completed. A surgical drain has a planar body portion formed from a wound or wrapped tubular form having perforations in the body portion.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims priority under 35 U.S.C. § 119(e) of U.S. provisional patent application Ser. No. 60/673,169 filed Apr. 20, 2005, incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to surgical devices. In particular, the present invention concerns a viscera retainer, a surgical aid to facilitate closure of a wound following a surgical procedure. The viscera retainer is especially useful in abdominal surgery and it will be convenient to hereinafter describe the invention in relation to that exemplifying surgical application. It should be understood however that the viscera retainer in accordance with the invention is not limited to use in abdominal surgery and is capable of wider application and use.  
         [0003]     The present invention also concerns a surgical drain, useful in, for example, draining body cavities following a surgical procedure.  
       BACKGROUND OF THE INVENTION  
       [0004]     Following surgery in the abdominal region, a wound, often of considerable size, needs to be closed by suturing. This is a delicate and time-consuming procedure as the surgeon must carefully suture the membranes of the abdominal wall back together while being very cautious not to nick or puncture the soft internal organs of the abdomen, known as the viscera. The procedure is made even more difficult if the patient is overweight because there is a greater need to retain, or hold down, the viscera while simultaneously pulling together the edges of the membrane being sutured, such as the peritoneum or fascia. In this situation, the risk of nicks or punctures to internal organs, such as the bowel, becomes even greater.  
         [0005]     To alleviate this problem, surgeons have occasionally used a rectangular piece of rubber, or similar material, to retain the viscera and provide a physical barrier against accidental nicks or punctures. The rubber was inserted into the wound over the viscera prior to closure. The wound was then partially closed, by suturing together the edges of the peritoneum, over the rubber, until a hole of just sufficient size to remove the rubber remained. The rubber was then removed through that hole and the remainder of the wound closed. This procedure did, to some extent, address the problem but the stiffness of rubber and the awkward shape made it difficult to remove the piece of rubber from the wound through the hole.  
         [0006]     One known device, sold under the name Glassman Viscera Retainer, the “Fish” by Adept-Med International Inc. partly addresses this problem. It includes a viscera retaining part, to be inserted into the wound, and a circular ring, to act as a handle to facilitate extraction of the retaining part from the wound. The retaining part includes a roughly diamond shaped, pliable web extending from a solid central rib. Attached to an end of the rib is a string, and at the end of the string is the circular ring. In use, the retaining part is inserted into the wound prior to closure and the wound is then partially closed by suturing over the retaining part. The retaining part is then withdrawn by pulling on the string using the ring. It has been found, however, that the solid central rib reduces the ability to remove the retaining part through a small hole.  
         [0007]     Another product referred to as a “SurgiFish”, and sold by Greer Medical under U.S. Pat. No. 6,736,141, is purported to be easier to use and capable of being withdrawn through a smaller hole upon partial closure of the wound and can be re-used in subsequent surgical procedures.  
         [0008]     Both these products are best used when a wound is closed from one end to the other. The products are more difficult to use when a surgeon closes the wound from both ends and completes his closure in the center. When the surgeon closes the wound in this manner, he often removes and replaces the product so that it can be removed through the center of the wound. This is an added inconvenience, which consumes times and effort.  
         [0009]     Surgical drains to drain body cavities are well known and frequently used. Drains are frequently linear structures. They may be tubular, having a circular or rectangular profile, and are usually perforated in the portion that remains internally, within the body cavity, after surgery. An example of a rectangular drain with perforations in the portion that remains within the body is the Jackson Pratt drain. A squeeze bulb is attached the end of the non-perforated, circular external portion of the Jackson Pratt drain to apply gentle suction to withdraw fluid from the abdominal cavity. “Blake” drains, such as shown in U.S. Pat. No. Des. 288,962, have longitudinal undercut grooves in the portion that remains within the body cavity, instead of a tubular form. “Pigtail” drains are catheters that spiral in the perforated portion that remains within a body cavity, which aids in retention within the body cavity. However, each coil or spiral turn of these catheters remain separated, unattached, from the adjacent turn.  
       OBJECTS AND SUMMARY OF THE INVENTION  
       [0010]     It is an object of the present invention to provide a new and improved viscera retainer to facilitate wound closure.  
         [0011]     It is another object of the present invention to provide a new and improved viscera retainer which enables a surgeon to close a wound from both ends and complete the closure in the center while allowing easy removal fo the viscera retainer through a hole in the center of the wound.  
         [0012]     It is yet another object of the present invention to provide a new and improved surgical drain for use in, for example, draining body cavities following a surgical procedure.  
         [0013]     In order to achieve these objects and others, a viscera retainer in accordance with the invention comprises a generally planar body incorporating a tear seam. The body is made predominantly of a flexible and resiliently stretchable material, for example, surgical grade silicone or PVC. The body may be entirely removed from a cavity or lumen, after the wall of the cavity or lumen has been nearly completely closed, by pulling on an end thereof. As a portion of the body is drawn out through a small opening in the wall, the body tears along the tear seam, transforming the body into a continuous strip that can be easily withdrawn through the small opening in the wall.  
         [0014]     A first embodiment comprises a ribbon wound as a spiral in a single plane to form a planar body. The ribbon has an exaggerated obround (racetrack)cross-section. The ribbon is fixed in a spiral formation either by heat welding or solvent welding or by some other process that joins the edges of adjacent convolutions or turns of the spiral to one another. The spiral joint formed thereby serves as a tear seam along which the spiral separates as the body unwinds when withdrawn from the cavity or lumen. Alternatively, the body may be formed by a molding process and the tear seam formed either in the molding process by creating a spiral of thinned material, or after the molding process forming a spiral of perforations by pressing the teeth of a spiral toothed blade through the body. Near the center of the spiral, the end of the ribbon remains free, unattached to any adjacent convulution, and may extend for a length outside the plane of the spiral.  
         [0015]     The viscera retainer described above is especially useful to facilitate closing of a wound following abdominal surgery. In use, the body is inserted into the wound prior to closure, to act as a physical barrier protecting the viscera. The inner free end of ribbon is not inserted into the wound, and remains accessible to facilitate later withdrawal of the entire body from the wound. If the wound is to be closed from both ends toward the middle, the inner free end is brought out of the wound at the center of the wound. If the wound is to be closed from one end to the other, a free end of ribbon is created at the perimeter by tearing ribbon from body, and is brought out at the end of the wound to be closed last. The inner free end, if present, may be excised. A membranous layer of the abdominal wall (peritoneum or fascia) is then drawn together and sutured over the body of the viscera retainer. All sutures may be placed. The body portion is then withdrawn from the wound by pulling on the accessible free end. As the free end is pulled, the ribbon is progressively torn from the body at the tear seam and the body unwinds as it is withdrawn. The entire body can thus be removed through a small opening in the membranous layer being closed.  
         [0016]     A rigid extraction probe containing a loop with a narrow obround aperture facilitates removal of the device from the abdomen after closure of the peritoneal or fascial membranes is nearly complete. The accessible end of the ribbon is passed through the loop, and the loop is slid over the ribbon through the wound to a point just beneath the membrane being closed. To withdraw the body, the ribbon is pulled through the loop, which facilitates separation of the adjacent convolutions of the ribbon along the tear seam.  
         [0017]     The optimum size of the viscera retainer will depend on the size of the wound being closed. However, this device has the advantage that it can easily be reduced in size by unwinding convolutions of the spiral and excising the unwound parts of the ribbon at the body&#39;s perimeter.  
         [0018]     Fabricating the body from silicone or polyvinyl chloride (PVC) is also advantageous because the surfaces of these materials, when in contact with body fluids present during surgery, slide easily with respect to the organs and tissues of the patient. This further facilitates withdrawal of the viscera retainer from the wound through a small opening.  
         [0019]     Impregnating the device with barium sulphate to render it radiopaque is also advantageous. In this way, if by any chance a segment or fragment of the viscera retainer remained within the abdomen of the patient after the wound had been closed, it would be detectable in an X-ray.  
         [0020]     Other embodiments include those where the width of the ribbon varies along its length. Having the ribbon narrow near the center of the spiral has the advantage of permitting a smaller aperture at the center of the spiral, where a wider ribbon could not assume a small radius of curvature. When the ribbon widens towards the periphery of the body, a shorter overall length of ribbon can be provided for a given body diameter. Having the most peripheral segment of the ribbon narrow may have an advantage when closing a wound from one end to the other and arranging for withdrawal of the body from its periphery. In this case, the peripheral end of the ribbon remains outside the wound and accessible while the wound is closed, and functions as a handle to initiate withdrawal of the body. A narrower, more supple handle interferes less with wound closure. The loop of the extraction probe for a device having a ribbon of variable width, would be just wide enough to accommodate the maximum ribbon width.  
         [0021]     Another embodiment of a viscera retainer in accordance with the invention replaces the ribbon, which has an obround cross-section, with a cord, which has a circular cross-section. The corresponding extraction probe would have a circular loop. The cord may have a constant diameter, or its diameter may vary, in a similar manner and for a similar purpose that the width of the ribbon varies in the embodiment described above. Other cross-sectional shapes, such as rectangular or elliptical, can be used instead of obround or circular, combined with extraction probes having loops of corresponding shape.  
         [0022]     Rather than having solid profiles, the coiled or wrapped structure can have tubular profiles. For example, instead of a circular cord wound into a planar structure, a tube can be wound or coiled into a planar structure. This may have the advantage of saving on material. The tubular structure may be perforated with multiple holes. A planar coil of such a tube could then have an additional function other than a visceral retainer, namely as a drain. Such a device could be left in the abdominal cavity with its tail end exiting either through the incision, or through a separate stab wound in the abdominal wall. In the postoperative period, vacuum pressure could be applied to the tail end of the device extending out of the body, and the device would function as a drain, withdrawing fluids from the abdominal cavity. This could be particularly useful if those fluids are contaminated or infected. When no longer needed, this device could then be removed from the body merely by pulling on the tail end, and slowly drawing it out (as the tube uncoils or unwinds). If the tube is provided with multiple perforations (with the exception of the tail end which is not perforated and is operatively positioned to be the only part extending out of the body), vacuum applied to the tail end would not only draw fluid through the tube, but also across the walls of the tube. For example, if the tube were circular with multiple perforations, and was wound in a coil, then suction applied at the non-perforated tail end emerging from the inner aspect of the coil would not only draw fluids into the tube through the perforations and then along the axis of the tube, but would also move fluid from the periphery of the coil to the center of the coil by fluid exiting the tube through a perforation at a more peripheral coil and re-entering the tube through an adjacent perforation of the adjacent more central coil.  
         [0023]     Another aspect of the present invention provides a method of closing a wound following a surgical procedure. The method includes providing a viscera retainer of a type described above and inserting the body portion of the viscera retainer into the wound to act as a physical barrier between underlying tissue and the membrane to be closed. An end of the ribbon which forms the body is retained outside the wound and remains accessible. The membrane is almost completely closed and the body portion is withdrawn by pulling on the exterior end of the ribbon. The body tears along the tear seem as it is extracted. Closure of the wound is then completed.  
         [0024]     A further aspect of the present invention provides a method of closing a wound following abdominal surgery. The method includes providing a viscera retainer of the type described above and inserting the body portion of the viscera retainer into the wound to act as a physical barrier between the abdominal wall and the viscera. A free end of the ribbon which forms the body is placed outside the wound and remains accessible. The peritoneum or fascia are then partially closed by suturing over the body portion and when the wound is almost completely closed, the body portion is withdrawn by pulling on the accessible end. Closure of the wound is then completed.  
         [0025]     A still further aspect of the present invention is the use of a probe as described above to facilitate extraction of the body. When the wound is almost completely closed, the accessible end of ribbon is passed through the loop of the probe. The loop of the probe is passed over the ribbon and introduced into the wound beneath the closed membrane and the body is extruded through the loop, which facilitates separation of adjacent convolutions of ribbon form the body along the spiral tear seam. When the body is completely removed, the wound is completely closed.  
         [0026]     It will be convenient to hereinafter describe the invention by reference to the accompanying drawings which illustrate a preferred embodiment thereof. Other embodiments of the invention are possible, and consequently the particularity of the accompanying drawings is not to be understood as superceding the generality of the preceding description of the invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0027]     The invention, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals identify like elements.  
         [0028]      FIG. 1  illustrates a top view of a first embodiment of a viscera retainer in accordance with the invention.  
         [0029]      FIG. 2  illustrates a cross-sectional view of the viscera retainer shown in  FIG. 1  through the plane marked A-A.  
         [0030]      FIG. 3  illustrates a probe that is useful in aiding withdrawal of the viscera retainer illustrated in  FIGS. 1 and 2  from a cavity through a small opening left in the wound.  
         [0031]      FIG. 4  illustrates the viscera retainer shown in  FIG. 1  in use wherein the viscera retainer has been inserted into the abdominal cavity through an abdominal wall wound prior to closure;  
         [0032]      FIG. 5  illustrates the wound nearly completely closed and the viscera retainer illustrated in  FIG. 1  being drawn out of the abdominal cavity with the aid of the probe shown in  FIG. 5 .  
         [0033]      FIG. 6  illustrates a perspective view of a second embodiment of a viscera retainer in accordance with the invention  
         [0034]      FIG. 7  illustrates a top view of a third embodiment of a viscera retainer in accordance with the invention.  
         [0035]      FIG. 8  illustrates a perspective view of a fourth embodiment of a viscera retainer in accordance with the invention.  
         [0036]      FIG. 9  illustrates a perspective view of a fifth embodiment of a viscera retainer in accordance with the invention.  
         [0037]      FIG. 10  illustrates a segment of a perforated tube that may be coiled into a viscera retainer or abdominal drain.  
         [0038]      FIG. 11  illustrates a cross-sectional view of a sixth embodiment of a viscera retainer, which can also be used as an abdominal drain. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0039]     Referring to the accompanying drawings wherein like reference numerals refer to the same or similar elements, with reference to  FIGS. 1 and 2 , there is shown a viscera retainer  10  in accordance with the invention for facilitating wound closure following surgery, for example, in the abdominal region of a patient. Viscera retainer  10  includes a body portion  12  which is substantially round and may be formed as a spiral from a continuous ribbon  11  of an elastomeric material such as, but not limited to, silicone or PVC. The ribbon  11  has an obround cross-section (see  FIG. 2 ). An inner end  13  of the ribbon  11  is free and extends outside the plane of the body portion  12 . The convolutions of the ribbon  11  are fixed to adjacent convolutions along a spiral joint. The spiral joint defines a tear seam  14  along which the convolutions of ribbon  11  separate as they are pulled away from a remaining portion of the body portion  12 , which occurs, for example, as the body portion  12  is extracted from the abdominal cavity through a small opening in the abdominal wall wound.  
         [0040]     To ensure that fragments of the viscera retainer  10  are not left undetected within the abdomen of the patient after the wound has been closed, the elastomeric material may be impregnated with a material such as barium sulphate to render it radiopaque. In this manner, if a fragment of the viscera retainer  10  were left within the body after closure of the wound, it would be detectable using a conventional X-ray. A final step in a wound closure procedure using such a radiopaque viscera retainer would thus be to take an X-ray of the wound to ascertain whether any portion of the viscera retainer  10  remains in the body.  
         [0041]      FIG. 3  shows an extraction probe  20  with a handle  21  and a ring or loop  22  defining an obround aperture  23  of a size just large enough to accommodate ribbon  11 . The probe  20  is rigid and may be made out of metal or plastic.  
         [0042]      FIGS. 4 and 5  show the viscera retainer  10  in use. As shown in  FIG. 4 , the body portion  12  of the viscera retainer  10  is introduced into an abdominal wound  33  before its closure. Viscera retainer  10  acts as a physical barrier between the peritoneum  31  and the viscera. The inner free end  13  of the ribbon  11  which forms the viscera retainer  10  remains accessible outside the wound  33 .  
         [0043]     The peritoneal layer  31  or fascial layer  32  of the abdominal wall  30  is closed by suturing over the body portion  12  of the viscera retainer  10  starting from the ends of the wound  33  with two separate sutures  41  and  42  and sewing with each toward the middle. When closure of the fascia  32  is almost complete ( FIG. 5 ), the body portion  12  is extracted from the wound  33  by pulling first on the free end  13  of ribbon  11  and then withdrawing the entire ribbon  11  comprising body portion  12 . During withdrawal of the ribbon  11 , the ribbon  11  unwinds, i.e., the convolutions of the ribbon  11  separate from one another along tear seam  14  to form a long strip which passes through the small opening remaining the fascia  32 .  
         [0044]     Alternatively, in order to assist in the extraction of ribbon  11 , probe  20  is utilized. To this end, free end  13  of ribbon  11  is passed through aperture  23  of loop  22  of probe  20 . Loop  22  is then slit over ribbon  11  through wound  33 . Ribbon  11  is then pulled up through loop  22 . Loop  22  facilitates separation of adjacent convolutions of ribbon  11  along tear seam  14 .  
         [0045]     After removal of the entire body portion  12 , closure of the fascia  32  is completed by placing additional sutures, if necessary, or by pulling taught on sutures already placed, and tying the suture ends to one another.  
         [0046]     The inner free end  13  of the ribbon  11  may optionally be provided with an aperture to enable a surgeon to insert his finger or forceps into the aperture to facilitate removal of the body portion  12  from the wound. If such an aperture is provided, the area around the aperture may be widened to ensure the inner free end does not tear when pulled by the surgeon.  
         [0047]     With reference to  FIG. 6  which shows a viscera retainer  10 A similar to viscera retainer  10 , instead of providing a length of the ribbon  11  as the inner free end  13  to enable removal of the body portion  12  from the wound, it is possible to attach a loop of material  44  to the inner end of the ribbon  11  which lies in the plane of the body portion  12 , e.g., pass the loop of material  44  through a small aperture  46  formed in the body portion  12  at or proximate the innermost part of the body portion  12  and in the innermost convolution of the body portion  12 . Part of the loop of material  44  is designed to be maintained outside of the wound so that it can be grasped by the surgeon when it is desired to remove the body portion  12  from the wound. Pulling on the loop of material  44  will cause the ribbon  11  to separate along the tear seam  14 . A similar loop of material  48  could alternatively or additionally be attached to the outer free end of the ribbon  11 , e.g., by passing it through an aperture  50 , to enable the possibility of removal of the body portion  12  from either end.  
         [0048]     Although viscera retainers  10 ,  10 A each include body portion  12  shaped as a spiral, viscera retainers in accordance with the invention can be constructed having other shapes. For example, with reference to  FIG. 7 , a viscera retainer  52  in accordance with the invention may have a substantially rectangular or square body portion  54  with a tear seam  56  formed as a series of linear, interconnected segments  58  defining elongate strips  60  therebetween. The tear seam  56  allows the body portion  54  to separate into a ribbon of elongate strips  60  when an inner free end  62  of the viscera retainer  52  is pulled.  
         [0049]     With reference to  FIGS. 8 and 9 , another alternative shape of a body portion  66  of a viscera retainer  64 ,  64 A in accordance with the invention is a generally rectangular shape wherein, instead of a series of linear, interconnected segments forming a tear seam as described immediately above, a series of individual, parallel tear seams  68  are provided to give the body portion  66  a serpentine form. Alternating ones of the tear seams  68  extend inward from opposite sides of the body portion  66 . The tear seams  68  define elongate sections  70  of the body portion  66 , and the end of the sections  70  may be rounded.  
         [0050]     As shown in  FIG. 8 , a free end portion  72  of the viscera retainer  64  is connected to or extends from an outermost one of the sections  70 , for example, from the medial end of the section  71  as shown. When the surgeon pulls the free end portion  72  during the wound closure procedure, the sections  70 ,  71  separate from one another along the tear seams  68  to form an elongate ribbon.  
         [0051]     The free end portion  72  may be provided with an aperture  74  to enable a surgeon to insert his finger or forceps into the aperture  74  to facilitate removal of the body portion  66  from the wound. If such an aperture  74  is provided, the area around the aperture  74  may be widened as shown to ensure the free end portion  72  does not tear when pulled by the surgeon.  
         [0052]     As shown in  FIG. 9 , in viscera retainer  64 A, a loop of material  76  is attached to an outermost one of the sections  70  by passing it through an aperture  78  therein. Viscera retainer  64 A is thus not provided with a free end portion  72  as shown in  FIG. 8 . The surgeon can then remove the viscera retainer  64 A by pulling on the loop of material  76 .  
         [0053]     The viscera retainers of the present invention thus make wound closure faster and easier, and reduces the risk of needle stick and needle perforation injury, to both the viscera of the patient and to the surgeon.  
         [0054]     Referring now to  FIGS. 10 and 11 , a device  80  which functions as a viscera retainer may be constructed from a round tube  81 , which is wound into a coil and sealed into the coil by heat, or adhesive or solvent welding. Device  80  may be made of plastic. A top view of device  80  could be similar to the top view of the first embodiment as shown in  FIG. 1 . In use in the abdominal cavity, the inner or outer end of the coil can be left long as a tail (i.e., a tail end), unattached to the adjacent coil, which can then be operatively brought or maintained outside the abdomen, as a handle to withdraw the device  80  through a small defect between stitches in a wound when the fascial closure is nearly complete, or whenever otherwise desired.  
         [0055]     Tube  81  which forms the device  80  can have multiple perforations  82 , as shown in  FIG. 10 . When tube  81  is wound into a coil, perforations  82  allow the interior of the tube  81  to communicate with the exterior of the tube  81 , so that the device  80  could function as a drain, in addition to a viscera retainer. Left inside the abdomen after abdominal wound closure, the tail end of the tube  81  which had been exteriorized through the wound or through a separate stab wound in the abdominal wall, could be connected to a suction source. Fluid in the abdomen can then pass into the lumen of the device  80 , i.e., the interior channel defined by the tube  81 , and would be suctioned through the tube  81  and out through the tail end of the tube  81  that passes through the abdominal wall. Either end, or both ends of the coiled device  80  could be brought out through the abdominal wall.  
         [0056]     Since some perforations of adjacent coils would line up with perforations of an adjacent coil, as seen in  FIG. 11 , fluid suctioned through the device  80  could travel not only in a spiral direction by staying within the lumen, but also in a radial direction, as the fluid may pass directly from one coil to the other through the aligned perforations. When the device  80  is no longer needed, it may be withdrawn from the abdominal cavity by pulling on the tail end that is situated exterior of the abdomen.  
         [0057]     Other shapes of the drain, for examples rectangular shapes, where a perforated tube oscillates rather than spirals to form the wider planar form, are also included in this invention.  
         [0058]     Although a preferred embodiment of the invention has been described herein in detail, it will be understood by those skilled in the art that variations may be made thereto without departing from the spirit of the invention. For example, although mention is made of the use of the devices described above for abdominal surgeries, it will be understood by one skilled in the art of medical devices that the same devices can be used for other purposes not associated with abdominal surgery.