Abstract:
A closure device and method to close the abdomen between surgical procedures and maintain a normal physiologic tension on the fascia to prevent undue retraction. In one embodiment, the closure device includes a “needled carabiner” attached to a rubberband of specific tension. The rubberband mimics the physiologic tension the abdominal wall normally experiences during daily activities and allows the abdominal compartment to expand as needed to maintain a healthy intra-abdominal pressure. The bands contract to maintain the intra-abdominal pressure and slowly pull the abdominal fascia back to the midline to facilitate surgical closure of the abdomen. In one embodiment, the “needled carabiner” includes a hinged surgical needle with a protected cap. The hinged needle is placed outside the normal suture line, thereby limiting the amount of surgical trauma the fascia endures. The strength of the rubberbands may be varied to accommodate differently sized individuals.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not applicable. 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The present invention relates to devices for temporarily closing the abdomen between open surgical procedures. 
         [0005]    2. Brief Description of the Related Art 
         [0006]    After abdominal trauma, abdominal compartment syndrome scenarios, pediatric abdominal malformations, or major open abdominal procedures, surgeons leave the abdomen “packed” open, which allows the abdomen to decompress. During this time, the fascia (sheets of fibrous connective tissue enveloping, separating or binding together muscles, organs and other structures) and the muscles retract and pull apart, preventing future primary surgical closure of the fascia and necessitating various surgical procedures to close the abdomen or repair the hernia at a later date. 
         [0007]    The limitations of the prior art are overcome by the present invention as described below. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    The present invention is a closure device to temporarily close and stabilize the abdomen between surgical procedures and maintain a normal physiologic tension on the fascia to prevent undue retraction. The closure device incorporates a pair of “needled carabiners” attached to either end of tensioning means, including in one embodiment a rubberband of specific tension. The term “carabiner” is borrowed from the terminology of mountaineering where the term refers to a ring with a spring catch used for fastening ropes. Although the “needled carabiner” of the present invention does not operate in the same fashion, its appearance is suggestive of the mountaineering “carabiner.” It is not intended, however, that the use of the term limits in any way the scope of the present invention as described herein. 
         [0009]    The “needled carabiner” comprises a surgical needle portion hinged to a locking portion with a securing element. The securing element prevents injury to surgical staff, nursing and the patient from the needle tip and locks the needle into a closed position. The needled carabiner allows a one-time placement of the closure device into muscle tissue outside the normal suture line, thereby limiting the amount of surgical trauma the fascia endures. Limiting the trauma increases the strength of a future surgical closure of the abdomen and prevents recurrent incisional hernias. 
         [0010]    In one embodiment, rubberbands of specific tension mimic the physiologic tension the abdominal wall normally experiences during daily activities. During times of stress, the tension of the rubberbands allows the abdominal compartment to expand as needed to maintain a healthy intra-abdominal pressure of 15 mm Hg or less. As swelling decreases, the rubberbands contract to maintain the intra-abdominal pressure and slowly pull the abdominal fascia back to the midline to facilitate surgical closure of the abdomen. The present invention is not limited to rubberbands, but may use other tensioning means such as springs or other tensioning devices known to those of ordinary skill in the art. 
         [0011]    The strength of the rubberbands may be varied to accommodate different abdominal pressures of differently sized individuals. For example, various sizes and strengths of rubberbands may be employed based on the patient&#39;s height and/or waist circumference. The rubberbands may also be interchangeable to accommodate various degrees of abdominal expansion based on the patient&#39;s disease process. 
         [0012]    The closure device of the present invention prevents fascial trauma from repeated operations, allows the abdomen to expand as needed to prevent renal, pulmonary, hepatic and cardiac failure, and provides specific tension to slowly approximate the fascia once the inflammatory process has resolved. 
         [0013]    The closure device may also be used with chronic open abdominal wounds, chronic pressure sores, and fasciotomy sites. The closure device may be used with known wound vacuum systems to decrease wound closure times, such as V.A.C.® Abdominal Dressing, available from KCI Licensing, Inc. 
         [0014]    These and other features, objects and advantages of the present invention will become better understood from a consideration of the following detailed description of the preferred embodiments and appended claims in conjunction with the drawings as described following: 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0015]      FIG. 1  is a front elevation view of one embodiment of the closure device of the present invention showing one needled carabiner in the closed, locked and protective position and one needled carabiner in the open position. 
           [0016]      FIG. 2A  is a partial perspective view of one embodiment of the lock portion of the needled carabiner showing a hollow screw affixed to an end of the lock portion. The hollow screw is shown with external screw threads. 
           [0017]      FIG. 2B  is a perspective view of a protective cap showing internal screw threads for threadedly advancing the protective cap over the hollow screw of  FIG. 2A  and an internal flange in the protective cap to limit the distance the cap is able to advance over the hollow screw. 
           [0018]      FIG. 2C  is a perspective view of the protective cap disposed on the end of the lock portion prior to advancing over the hollow screw. 
           [0019]      FIG. 3  is a top plan view of the abdomen of a patient showing an open abdominal incision and peritoneal contents. 
           [0020]      FIG. 4  is a cross sectional elevation view of the patient and abdominal incision of  FIG. 3  along the line  4 - 4 . 
           [0021]      FIG. 5  is a close-up partial view of the incision of  FIG. 4  showing a water permeable protective sheet over the peritoneal contents of the patient. 
           [0022]      FIG. 6  is the close-up partial view of  FIG. 5  showing a closure device of the present invention where a needle portion of one of the needled carabiners is driven through the abdominal rectus muscle on one side of the abdominal incision. 
           [0023]      FIG. 7  is the close up partial view of  FIG. 5  showing the needle portions of both needled carabiners driven through the respective rectus muscles on respective sides of the abdominal incision. 
           [0024]      FIG. 8  is the close up partial view of  FIG. 5  showing both needled portions locked and protectively capped by the threaded advance of the respective protective caps over the respective hollow screws of the lock portions of the needled carabiners and connected to one another by a rubberband. 
           [0025]      FIG. 9A  is a partial exploded bottom plan view of the lock portion and needle portion of an alternative embodiment in which a recess in the needle portion interlocks with a complementary recess in the lock portion. 
           [0026]      FIG. 9B  is a partial exploded side elevation view of the lock portion and needle portion in cross section of the embodiment of  FIG. 9A . 
           [0027]      FIG. 9C  is a partial side elevation view of the lock portion and needle portion of the embodiment of  FIG. 9A  showing the lock portion and the needle portion in the interlocked position. 
           [0028]      FIG. 10A  is a partial exploded side elevation view of the lock portion and needle portion of a further alternative embodiment in which the needle portion is provided with an externally threaded section for threadedly receiving the protective cap. 
           [0029]      FIG. 10B  is a side elevation view of the lock portion and the needle portion in the closed position before the protective cap is advanced over the threaded section of the needle portion. 
           [0030]      FIG. 10C  is a side elevation view in cross section of the alternative embodiment of  FIG. 10B  in the locked and protective position with the protective cap advanced over the threaded section of the needle portion. 
           [0031]      FIG. 11A  is an exploded side elevation view in cross section of a still further embodiment of the lock portion and the needle portion showing the lock portion with a spring loaded ball for locking into a complementary socket on the needle portion. 
           [0032]      FIG. 11B  is a side elevation view of the embodiment of  FIG. 11A  in the locked position. 
           [0033]      FIGS. 12-14  are elevation views of an additional alternative embodiment of the closure device of the present invention where the needle portion comprises a circular arc of approximately ⅜ of the circular circumference and the lock portion comprises a circular arc of approximately ⅝ of the circular circumference.  FIG. 12  shows the needled carabiner in the open position.  FIG. 13  shows the tip of the needle portion received into the screw tip of the lock portion.  FIG. 14  shows the protective cap screwed over the needle tip to lock the needle portion. 
           [0034]      FIGS. 15-17  are views of the screw tip of  FIGS. 12-14 .  FIG. 15  is a top plan view of the screw tip of  FIG. 12  showing a recess for receiving the needle tip.  FIG. 16  is a side elevation view of the screw tip in cross section.  FIG. 17  is a side elevation of the screw tip in cross section showing the disposition of the needle tip when received into the recess. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0035]    With reference to  FIGS. 1-17 , the preferred embodiments of the present invention may be described as follows: 
         [0036]    As shown in  FIG. 1 , the closure device of the present invention comprises two needled carabiners  11 ,  12  connected to either end of a tensioner for maintaining a desired tension between the two needled carabiners. In the described embodiment, the tensioner is a rubberband  13 . Although the invention is described with reference to an embodiment employing a rubberband  13 , the present invention is not so limited and may employ other tensioners such as springs or the like, or other tensioning devices known to those of ordinary skill in the art. The rubberband  13  or other tensioner is provided with a specific tension to mimic the physiologic tension the abdominal wall normally experiences during daily activities. During times of stress, the tension of the rubberbands  13  allows the abdominal compartment to expand as needed to maintain a healthy intra-abdominal pressure of 15 mm Hg or less. As swelling decreases, the rubberbands  13  contract to maintain the intra-abdominal pressure and slowly pull the abdominal fascia back to the midline to facilitate surgical closure of the abdomen. 
         [0037]    In the embodiment of  FIG. 1 , one needled carabiner  11  is shown in the closed, locked and protective position and one needled carabiner  12  is shown in the open position. The needled carabiner  11 ,  12  comprises a needle portion  14  having a first end connected by a hinge  16  to a lock portion  17  and a needle tip  15  at an opposite second end. The lock portion  17  has a first end connected at the hinge  16  to the needle portion  14 . A securing element locks the lock portion  17  to the needle portion  14  and desirably provides protection to the needle tip  15  to protect the patient and medical personnel. In the described embodiment, the securing element is hollow screw  18  affixed (for example by spot welding) at an opposite second end of the lock portion  17 . Other embodiments of the securing element are described below. The needle portion  14  and the lock portion  17  may conveniently be in the shape of circular arcs but the present invention is not limited to such shapes. For example, and not by way of limitation, the needled carabiners may be triangular or elliptical in outline. The particular shape may be varied as desirable for particular applications or the preferences of the user. Factors that may be significant in determining the shape of the needled carabiners include structural integrity, ease of use, and ease of manufacture. 
         [0038]    As shown in the embodiment of  FIG. 2A , the hollow screw  18  has a hollow end  19  and external screw threads  20 . The hollow end  19  is disposed so as to receive the needle tip  15  of the needle portion  14  when the needle portion  14  is rotated around the hinge  16  into a closed position as shown by needled carabiner  11  in  FIG. 1 . 
         [0039]    With reference to FIGS.  1  and  2 A- 2 C, a protective cap  21  having a central bore  24  is slidably received on lock portion  17  between hollow screw  18  and hinge  16 . Protective cap  21  is provided with internal screw threads  22  for being threadedly received onto the external screw threads of hollow screw  18 . An internal flange  23  limits how far the protective cap  21  may be advanced over the hollow screw  18 . The protective cap  21  is allowed to advance over hollow screw  18  to a sufficient degree that needle tip  15  is prevented from being removed from hollow end  19 . Needle tip  15  is thus covered by protective cap  21  to protect the patient and surgical staff from accidental contact. By angling the needle tip  15  with respect to the protective cap  21 , when the protective cap  21  is advanced over the hollow screw  18 , needle portion  14  is locked into position and cannot be opened with respect to lock portion  17 . If the needle portion  14  and the lock portion  17  are in the shape of circular arcs, the appropriate angle may be obtained if the needle portion  14  describes less than ½ of the circular circumference and the lock portion  17  describes greater than ½ of the circular circumference. In the preferred embodiments, the needle portion  14  describes approximately ⅜ of the circular circumference and the lock portion  17  describes approximately ⅝ of the circumference. If the needle portion  14  and the lock portion  17  overlap by at least 3 degrees of radial angle, the needle portion  14  will be locked by advancing the protective cap  21  over the needle tip  15  as shown in  FIGS. 12-17 . As described below, various other securing elements may be employed either alone or in combination to lock needle portion  14  with respect to lock portion  17  and to protect patients and medical personnel from needle tip  15 . For example, the embodiment of  FIGS. 9A-9C  may be used in combination with the embodiment of  FIGS. 1-2C . 
         [0040]    The closure device  10  is used in the following manner. The abdomen  30  of a patient is shown with an open abdominal incision  31  revealing the peritoneal contents  32 .  FIG. 4  is a cross sectional view of the patient and abdominal incision  31  of  FIG. 3  along the line  1 - 4 . Also shown is the skin  25  of the patient, the oblique muscle  33 , rectus muscle  34 , and the linea alba  35 . The linea alba  35  is a vertical medial line of tendinous tissue in the abdominal wall formed of fibers covering the rectus muscle  34 . The peritoneal contents are not shown in  FIG. 4  for the sake of clarity. 
         [0041]    As shown in  FIG. 5 , a water permeable protective sheet  26 , preferably polyurethane, is placed to cover the entire peritoneal contents to prevent bowel herniation.  FIG. 6  shows a closure device  10 . The needle portion  14  of one of the needled carabiners  12  is attached on one side of the abdominal incision  31  away from the normal suture line, preferably by driving the needle portion  14  through the rectus muscle  34  on one side of the abdominal incision  31 . As shown in  FIG. 7 , the needle portion  14  of the other needled carabiner  11  is attached to the opposite side of the abdominal incision  31 , preferably by driving the needle portion  14  through the rectus muscle  34  on the opposite side of the abdominal incision  31 . Both of the needle portions  14  of the respective needled carabiners  11 ,  12  are closed as shown in  FIG. 8  to secure the respective needle tips  15  which have been received into the hollow ends  19  of the respective hollow screws  18 . The respective protective caps  21  are then screwed over the respective hollow screws  18  and over the respective needle tips  15  to secure and lock both needled carabiners  11 ,  12  as described in more detail below. 
         [0042]    Typically four to eight of the closure devices  10  of the present invention will be required depending on the length of the abdominal incision  31  and the size of the patient. When fully deployed, the abdominal contents of the patient are held in place and a physiologic pressure of 15 mm Hg or less is maintained. As swelling subsides, the two sides of the incision  31  are drawn together without damage to the fascia. 
         [0043]    The intra-abdominal pressure is the steady state pressure within the abdominal cavity. The elasticity of the abdominal walls and the character of the contents of the abdominal cavity determine the intra-abdominal pressure. It is therefore necessary to take various factors into consideration in determining the appropriate strength of the rubberbands needed to maintain healthy intra-abdominal pressure of less than about 15 mm HG. The size of the individual patient, including the patient&#39;s height and the circumference of the abdomen, as well as the length of the incision  31  may affect the selection of the size and strength of the rubberbands  13 . The rubberbands  13  may also be interchangeable to accommodate various degrees of abdominal expansion based on the patient&#39;s disease process. 
         [0044]    The tension of the rubberbands  13  can be estimated for a particular individual by considering the abdomen to be approximately a cylinder (for a slender individual) or a sphere (for an obese individual). The determination of whether the abdomen should be considered a cylinder or sphere may also be affected by such factors as the height of the individual and the length of the incision. The intra-abdominal pressure, P, is therefore approximated by the formula P=2πT/C (for a cylinder) or P=4 πT/C (for a sphere), where T is the tension and C is the circumference. As an example, consider an individual with a 36.0 inch (91.4 cm) waist circumference and a desired intra-abdominal pressure of 10 mm Hg. In this case, the total tension required for a sphere would be 72.8 mm Hg cm and for a cylinder 145.0 mm Hg cm. The total tension would be divided over the number of rubberbands  13  employed for closing a particular incision to estimate an average tension per rubberband. The actual tension of each rubberband  13  would probably vary somewhat from the estimated average value. 
         [0045]    The present invention may be used in combination with the known technology of wound vacuums (also known as vacuum-assisted closure), such as V.A.C.® Abdominal Dressing, available from KCI Licensing, Inc., to accelerate healing. 
         [0046]    The securing element is further described with reference to  FIGS. 9A-9C . In one embodiment, the needle portion  14  is provided with a recess  50  which interlocks with a complementary recess  51  in the lock portion  17 . As seen in  FIG. 9C , when the needle portion  14  and the lock portion  17  are interlocked, the tip  15  of the needle portion  14  is flush with the surface of the lock portion  17  so as to avoid the dangers of an exposed needle tip. Alternatively, this embodiment may also be provided with threaded sections on needle portion  14  and lock portion  17  and a protective cap as described with reference to  FIGS. 2A-C  and  10 A-C. 
         [0047]    In the further alternative embodiment of  FIGS. 10A-C , the needle portion  14  is provided with an externally threaded section  52  for threadedly receiving a protective cap  53  which is provided with internal threads. The lock portion  17  also has a threaded section  55  and a complementary hollow  54  for receiving the tip  15  of the needle portion  14 . The protective cap  53  may be threaded over either the lock portion  17  or the needle portion  14 . The protective cap may also be provided with a flange as described with respect to  FIGS. 2A-C . In order to protect the tip  15  and to lock the needle portion  14  to the lock portion  17 , the tip  15  is placed within the complementary hollow  54  and the protective cap  53  is threadedly advanced over the threaded sections  55 ,  52  as shown in  FIG. 10C . 
         [0048]    A still further alternative embodiment may be described with respect to  FIGS. 11A-B . This embodiment is similar to that of  FIGS. 10A-C  with the addition of a spring loaded ball  56  associated with the lock portion  17  and a complementary socket  57  on the needle portion  14 . (The spring is not shown.) The spring loaded ball  56  is disposed on the interior of the protective cap  53 . As in the previously described embodiment of  FIGS. 10A-C , in order to protect the tip  15  and to lock the needle portion  14  to the lock portion  17 , the tip  15  is placed within the complementary hollow  54  and the protective cap  53  is threadedly advanced over the threaded sections  55 ,  52  of the needle portion  14  and the lock portion  17  as shown in  FIG. 11C . When the spring loaded ball  56  is advanced along with the protective cap  53  to the point where it is disposed adjacent to the complementary socket  57 , the spring loaded ball  56  falls into the socket  57  and thus serves to further secure the needle portion  14  to the lock portion  17 . 
         [0049]    As noted above, angling the needle tip with respect to the protective cap, allows the protective cap to lock the needle portion with respect to the lock portion. If the needle portion and the lock portion are in the shape of circular arcs, the appropriate angle may be obtained if the needle portion describes less than ½ of the circular circumference and the lock portion describes greater than ½ of the circular circumference.  FIGS. 12-14  are elevation views of an additional alternative embodiment of the closure device of the present invention where the needle portion  60  comprises a circular arc of approximately ⅜ of the circular circumference of the entire needled carabiner  61  and the lock portion  62  comprises a circular arc of approximately ⅝ of the circular circumference of the needled carabiner  61 . The needle portion  60  and the lock portion  62  are connected together at respective first ends by a hinge  63 . The needle tip  64  thus rotates along a circular arc that is smaller in radius than the radius of the entire needled carabiner  61 . Therefore, when the needle portion  60  is rotated away from the lock portion  62 , it moves outwardly rather than along a tangent as would occur if the needle portion  60  and the lock portion  62  were equal circular arcs. Thus, a protective cap  65  placed over the needle tip  64  effectively locks the needle portion  60  to the lock portion  62 . 
         [0050]    A screw tip  66  is disposed on a second end of the lock portion  62  to receive the needle tip, which is disposed on a second end of the needle portion  60 , the respective second ends being disposed oppositely to the respective first ends. As shown in  FIGS. 15 and 16 , the screw tip  66  is provided with a recess  67  which is shaped and angled to provide a complementary space to securely received the needle tip  64 . 
         [0051]      FIG. 12  shows the needled carabiner  61  in the open position, while  FIG. 13  shows the needle tip  64  received into the recess  67  of the screw tip  66 . The screw tip  66  is provided with external screw threads for threadedly receiving the protective cap  65  which is provided with complementary internal screw threads. After the needle tip  64  is received into the recess  67 , the protective cap  66 , as shown in  FIGS. 14 and 17  is screwed over the needle tip  66  to lock the needle portion  60  to the lock portion  62 . 
         [0052]    The present invention has been described with reference to certain preferred and alternative embodiments that are intended to be exemplary only and not limiting to the full scope of the present invention as set forth in the appended claims. For example, various other forms of securing elements known to those of skill in the art are contemplated as being within the scope of the present invention.