Abstract:
Devices, systems and methods for closing incisions and puncture wounds, such as those trocar openings necessary for port based surgery. An insertion tube is passed through the puncture wound, as by insertion through a trocar, to allow access therethrough. A wound sealing apparatus including a body and a number of attachment elements, such as retaining hooks, is passed from the insertion tube. The attachment elements pierce the fascia around the wound to retain the apparatus in position as the body seals the opening. Actuation may occur through the use of a plunger that extends down a bore of the insertion tube to actuate the apparatus. In some embodiments, actuation rotates a number of arms from the insertion tube to place the attachment elements in the appropriate position.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to the field of surgical instruments and is directed to apparatus and methods for closing and suturing wounds. More particularly it is related, but not necessarily limited, to apparatus and methods for suturing and closing incisions, puncture wounds and the like.  
         BACKGROUND  
         [0002]    For surgeries using scopes, pointed surgical instruments, called trocars or ports, are used to provide access to body cavities by creating puncture openings allowing access therethrough. For a typical laparoscopic surgery, for example, three or four trocars are used, each creating a corresponding puncture wound in the abdominal wall. Trocars range from about 2 mm to about 18 mm in diameter. For adult patients, the most commonly used are from about 10 to about 12 mm in diameter. For pediatric surgery, trocars of from about 3 mm to about 5 mm in diameter are most commonly used.  
           [0003]    Each trocar forms a puncture wound, passing through the skin, subcutaneous fatty tissue, surface fascia, muscle, deep fascia and peritoneum into the underlying cavity, such as the abdominal cavity or the thoracic cavity. Once the surgery is complete, each puncture wound in the abdominal cavity provides an opening through which the peritoneum and intestines may protrude forming a postoperative incisional hernia. In order to reduce the occurrence of postoperative incisional hernia, it is customary to close or suture the trocar openings upon trocar removal. In the thoracic cavity, airtight closures must be formed to alleviate the concern that air may leak into or out of the pleural space, causing the lung to collapse. Similar concerns arise in other body cavities.  
           [0004]    Where multiple trocars are used, one or more trocar openings can be sutured using the camera and surgical instrument to observe and return the needle and suture from below. In laparoscopic closure, this allows the practitioner to suture through the abdominal wall while returning the needle using the instrument and monitoring the needle to prevent it from contacting the internal organs. Unfortunately, this method cannot be used for all trocar openings. Once the camera and instrument are removed, at least two trocar openings remain to be closed.  
           [0005]    The most common way to close the remaining trocar openings has traditionally been suturing with a curved suture needle. The skin, subcutaneous fat and muscle are retracted from the puncture site. The curved needle and an attached suture are passed through the fascia on one side and back through the fascia on the opposite side. The ends of the suture are then pulled tight and tied to close the opening. Complications may arise from the use of this method. For example, if a patient is obese, several inches of subcutaneous fat must be retracted for the fascia to be isolated. The thick layer of fat causes the fascial tissue to be recessed several inches from the exterior of the abdominal wall, making manipulation of the needle between the thick walls of fat and tissue difficult. Because the procedure involves passing the needle into the body cavity, poor control of the needle may result in damage to the underlying organs, as by puncture of an underlying bowel or inadvertent incorporation of the bowel into the fascial closure of the abdomen.  
           [0006]    Attempts have been made to provide instruments for suturing trocar openings that do not require the use of the camera. Typical of these attempts are devices that use an elongated “hook” needle, similar in shape to a shepherd&#39;s crook. The hook needle is passed through the puncture wound and then maneuvered to pierce the abdominal wall on the side of the wound. Using the hook needle, suture material is then passed through the wall. This process is repeated on the opposite side of the wound. The suture may be retracted through the puncture wound and drawn together to close the wound. Representative examples of such hooked needle instruments are disclosed in U.S. Pat. No. 5,632,752 to Buelna, U.S. Pat. No. 5,662,663 to Shallman, and U.S. Pat. No. 5,434,69 to Heaven et al., the disclosure of each of which is incorporated by reference herein. Other attempts have involved instruments that use two needles located on either side of the trocar to pierce the abdominal wall from the exterior. Suture is then passed through the needles into the abdominal cavity where it is captured and drawn through the trocar, allowing the wound to be drawn closed. Examples of such devices include U.S. Pat. No. 6,203,554 to Roberts and U.S. Pat. No. 5,476,470 to Fitzgibbons, the disclosure of each of which is incorporated by reference herein. These attempts still require removable needles and/or loops of suture material to be present in the abdomen. These may capture portions of the bowel into the sutures or otherwise injure the internal organs, similar to suturing with a curved needle.  
           [0007]    It would be desirable to provide an instrument and methods for closing a puncture wound, such a trocar opening. It would be further desirable for such systems and methods to be insertable and functional through a trocar, resulting in the closure of the wound on trocar removal.  
         BRIEF SUMMARY OF THE INVENTION  
         [0008]    The present invention is directed to devices, systems and methods for closing incisions and puncture wounds, such as those trocar openings necessary for port based surgery, such as laparoscopy, thorascopy, retroperitoneuoscopy, preperitoneuoscopy, and the like. An insertion tube is passed through the puncture wound, as by insertion through a trocar or port, to allow access therethrough. A wound sealing apparatus including a body and a number of attachment elements, such as retaining hooks, is passed from the insertion tube. The attachment elements pierce the fascia around the wound to retain the apparatus in position as the body seals the opening. Actuation may occur through the use of a plunger that extends down a bore of the insertion tube to actuate the apparatus. In some embodiments, actuation rotates a number of arms from the insertion tube to place the retaining hooks in the appropriate position. A further element may include a sheet member interlocking between the attachment elements to protect further the interior of the wound. 
       
    
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS  
       [0009]    The nature of the present invention as well as other embodiments of the present invention may be more clearly understood by reference to the following detailed description, to the appended claims, and to the several drawings herein, wherein:  
         [0010]    [0010]FIG. 1 is an exploded view of one embodiment of a system for closing a puncture wound;  
         [0011]    [0011]FIG. 2 is a side view of a portion of the system of FIG. 1, showing details of some components thereof, including one embodiment of a puncture wound sealing apparatus;  
         [0012]    [0012]FIG. 3 is a side view of the puncture wound sealing apparatus of FIG. 2, in position to close an abdominal puncture wound;  
         [0013]    [0013]FIG. 4 is a side view of a second embodiment of a puncture wound sealing apparatus, shown in connection with a portion of a system for emplacing the apparatus;  
         [0014]    [0014]FIG. 5 is a side view of the puncture wound sealing apparatus of FIG. 4, in position to close an abdominal puncture wound;  
         [0015]    [0015]FIG. 6 is a side view of a third embodiment of a puncture wound sealing apparatus, shown in connection with a portion of a system for emplacing the apparatus; and  
         [0016]    [0016]FIG. 7 is a side view of the puncture wound sealing apparatus of FIG. 6, in position to close an abdominal puncture wound. 
     
    
     DETAILED DESCRIPTION  
       [0017]    The following describes several embodiments of this invention. It will be appreciated that the examples used herein are illustrative only and do not limit the invention. For example, for the purposes of clarity, the systems and methods of the present invention are discussed in connection with the closure of a puncture wound formed as an abdominal trocar puncture site for a laparoscopic procedure. Such discussion is not intended to limit, and does not limit, the present invention, which may be used to close any suitable wound in any suitable tissue. For example, trocar puncture sites in other tissues created for surgical procedures, such as laparoscopy, thorascopy, retroperitoneuoscopy, preperitoneuoscopy, and the like, may be closed using the methods and systems of the present invention. Similarly, accidental wounds, including, but not limited to, puncture wounds, of appropriate size may be closed using the present invention and all such uses are within the scope of the present invention.  
         [0018]    [0018]FIG. 1 depicts an exploded view of a system  10  for closing a puncture wound, such a trocar puncture site opening. A wound sealing apparatus  100  is disposed near the distal end of an insertion tube  102 . The wound sealing apparatus  100  and distal end of the insertion tube  102  are discussed in further detail in connection with the remaining FIGS. The insertion tube  102  and wound sealing apparatus  100  may be inserted through a hollow trocar  104  (not depicted in FIG. 1) to allow for closure of the puncture site. An appropriately sized, elongated plunger  106  may be inserted through the bore  103  of insertion tube  102  to actuate the wound sealing apparatus  100 . A locking mechanism, such as projection  107  interacting with a channel  108  on the insertion tube  102  may be used to retain the plunger  106  in the unactuated position or to guide the plunger  106  during actuation. Insertion tube  102 , plunger  106  and the wound sealing apparatus  100  may all be appropriately sized to pass through the bore of a trocar  104  and cover a trocar puncture site, having a wound opening size of from about 2 mm to about 18 mm in diameter. The invention includes different diameter insertion tubes  102 , plungers  106 , and different sized wound sealing prostheses  100  to accommodate to differently sized wound openings.  
         [0019]    Turning to FIG. 2, details of a first embodiment of a wound sealing apparatus  100 A may be seen in connection with the remainder of the wound closure system  10 . Insertion tube  102  has been inserted through a trocar  104 , such that the distal end thereof protrudes therefrom. The distal end of insertion tube  102  and the wound sealing apparatus  100 A thus reside within a patient. In the exemplary abdominal trocar puncture site wound  120  (FIG. 3) usage, the distal end of the insertion tube  102  and wound sealing apparatus  100 A reside within the abdominal cavity of the patient. It will be appreciated that although depicted as a circular hollow tube with a sold wall, insertion tube  102  may be any suitable shape, such as circular, ovoid, square, or any other shape in cross-section, and, where appropriate, may have open sides or side openings, consisting of a number of guide members or rails forming the outline of the bore.  
         [0020]    Wound sealing apparatus  100 A consists of a number of attachment elements, shown as hooks  110 , that are used to attach the apparatus  100 A to the patient tissues adjacent the puncture wound  120  and a body  112  that is used to close the wound  120 . Hooks  110  may be made from any suitable material that is biologically acceptable and may be retained in the body, similar to a surgical staple. For example, hooks  110  may be surgical steel or an acceptable plastic, polymeric or bioabsorbable material. It will be appreciated that any desired number of hooks  110  may be used, surrounding the body  112 . For example, embodiments with  3 ,  4 ,  6 , or any other desired number of hooks  110  may be used. The hooks  110  may be spaced at equal intervals around the body  112 . In addition to hooks  110 , the attachment elements may comprise pins, staples, needles or any other device capable of attaching the wound sealing apparatus  100  to the fascia or other tissue surrounding a puncture wound.  
         [0021]    In the depicted embodiment  100 A, the body  112  is formed from a sheet material. Examples of suitable sheet materials include any flexible sheet material that may be used to cover the opening of a puncture wound  120 . The sheet material may have elastic properties to allow for better conformation to the puncture site, as tissues relax around the site following trocar  104  removal. Examples include sheets of mesh materials formed from surgically acceptable materials, such as absorbable suture material, or any other commonly used surgical mesh. Commonly used surgical meshes include Gore-Tex™ meshes and biomaterials, polypropylene meshes, such as those offered under the SURGIPRO™ name by United States Surgical of Norwalk, Conn. or under the MARLEX™ name by C. R. Bard, Inc., polyglactin meshes offered by Ethicon, Inc. under the name VICRYL™, polyglycolic acid mesh, such as that available under the name DEXON™, and any other suitable materials. Some mesh materials may be formed from monofilament or multifilament yams and woven, molded or formed using any other known method of forming a prosthetic mesh material. Embodiments using any suitable mesh materials may be used and are within the scope of present invention. Additional sheet materials that may be used include silicone elastomer sheeting and oxidized regenerated cellulose, although it will be appreciated that any suitable sheeting material may be used. For example, a gas-impervious sheet material maybe used in embodiments intended to close puncture wounds to respiratory structures, such as the lungs or chest wall, to allow for an airtight closure to be made.  
         [0022]    As shown in FIG. 2, in the undeployed position, each hook  110  is attached to a swivel arm  103  that is rotatably attached to the insertion tube  102 . Hook  110  may be attached to the swivel arm  103  by a simple friction fit, residing in a slot located therein. Each swivel arm  103  is attached to the insertion tube  102  in such a manner that it may be actuated to swivel out from an unactuated position therefrom. For example, in the depicted embodiment each swivel arm  103  is disposed on a swivel pin  105  located in a notch  107  formed at the distal end of the insertion tube  102 , function as a hinge. In other embodiments, a swivel arm  103  may be formed as a living hinge, or other extension, extending from the insertion tube  102 , or may be attached in any other suitable manner. In the unactuated position, the swivel arms  103  may reside within the diameter of the trocar  104 . The body  112  of apparatus  100 A is in a collapsed position in the undeployed state. In some embodiments, the body  112  may be folded into a desired collapsed conformation. The sheet material of body  112  may be directly attached to each of the hooks  110 , or a hook line  113  of suture or other suitable material, may be used to make such an attachment.  
         [0023]    To deploy the apparatus  100 A, the swivel arms  103  are rotated out from the distal end of the insertion tube  102  bringing hooks  110  into contact with the deep fascia  232  (FIG. 3) of the abdominal wall. Hooks  110  pierce the deep fascia  232  and are retained therein. Barbs  111  or other enlarged retention structures may be used to retain the hooks  110  in the deep fascia  232 . The hooks  110  release from the swivel arms  103 , as by sliding out of the friction fit channel slots. As swivel arms  103  are actuated, the body  112  unfolds to an expanded position. These actions may occur as the trocar  104  and insertion tube  102  are withdrawn through the puncture wound  120 .  
         [0024]    As shown in FIG. 2, the swivel arms  103  may be activated by the distal end of plunger  106  pressing upon the actuation structure, such as the enlarged rear portion  117  of the swivel arms  103 . This simple blocking and pushing motion may be all that is required. The swivel arms  103  are actuated as the plunger is extended further down the bore of the insertion tube  102 . Where present, the channel  108  and projection  107  may interact to guide the plunger to be extended to the correct final depth for actuation.  
         [0025]    In other embodiments, a linkage may be established between the plunger  106  and the actuation structure, to allow for additional control, depicted by linkage line  119  that runs from swivel arm  103 A to the plunger  106 . In embodiments including such linkage, withdrawing the plunger may result in the contraction of the swivel arms. While using such an embodiment, the user may examine the position of the apparatus  100 A prior to “setting” the hooks  110  in the fascia  232 , then contract and reposition the apparatus if the position is not satisfactory. In other embodiments, the actuation may occur through a rack and pinion mechanism or gears attached to the swivel arms  103  that interact with the plunger  106 . Of course, it will be appreciated that embodiments not requiring a plunger  106 , where the swivel arms  103  are actuated by other mechanical means, such as an actuator strip sliding down the insertion tube surface, or a motorized swivel arm activated by an electrical current or other signal are within the scope of the present invention.  
         [0026]    Once the hooks  110  are set in the deep fascia  232  and the trocar  104  and insertion tube  102  are removed, the sheet material of the body  112  lies over the opening of the puncture wound  120 , effectively closing and sealing it from the extrusion of internal structures, as shown in FIG. 3. It will be appreciated that apparatus and methods associated with the embodiment of  100 A are not limited to the practice with trocar puncture sites, but may be used to close any suitable wound, including suitable sized accidental punctures. Similarly, although the usage and methods are discussed in connection with abdominal puncture wounds, any suitable wounds in any suitable tissue may be closed using the device.  
         [0027]    Turning to FIGS. 4 and 5, a second embodiment of a wound sealing apparatus  100 B is depicted. Wound sealing apparatus  100 B consists of a number of hooks  210  connected to a pledgett body  212 . As shown in FIG. 4, the pledgett body  212  may be directly connected to the hooks  210 , although embodiments where the hooks  210  are attached to the pledgett body through a short length of line, such as an absorbable suture material or other filament may be used.  
         [0028]    At least two attachment elements, shown as hooks  210 , located on opposite sides of the pledgett body  212  may be used to position and retain the wound sealing apparatus in the puncture wound  120  site. It will be appreciated that any desired number of hooks may be used, surrounding the pledgett body  212 . For example, embodiments with  3 ,  4 ,  6 , or any other desired number may be used. The hooks  210  may be spaced at equal intervals around the pledgett body  212 . As with hooks  110  discussed previously herein, hooks  210  may be formed from any suitable material, including surgical steel.  
         [0029]    Where hooks  210  are directly attached to the pledgett body  212 , the entire apparatus  100 B may be located in the distal end of the insertion tube  102 , with the hooks protruding therefrom. In such embodiments, the pledgett body  212  may have a diameter similar to, or only slightly smaller than, that of the bore of the insertion tube  102 . In embodiments where the pledgett body  212  is attached to the hooks using an intervening structure, the hooks  210  may be located in setting swivel arms, as discussed previously herein. Where the hooks  210  implanted by swivel arms, the pledgett body  212  may be pushed through the insertion tube  102  prior to hook set and then pulled into the puncture site by a guide cord.  
         [0030]    As the trocar  102  and insertion tube  104  are withdrawn, plunger  106  is manipulated to push the pledgett body  212  out of the bore of the insertion tube, once hooks  210  have pierced the internal surface of the abdominal wall. Once trocar  104  and insertion tube  102  are removed, the pledgett body  212  then resides within the abdominal wall retained in position by hooks  210 , as shown in FIG. 5. Pledgett body  212  acts a plug sealing the puncture wound  120 , which partially contracts to collapse around pledgett body  212 . It will be appreciated that a wound sealing apparatus  100 B may be used to close any puncture wound and that the closure of an abdominal trocar puncture site is only illustrative. For example, accidental wounds of appropriate size may be closed, as may be trocar puncture sites in other tissues.  
         [0031]    As shown in FIG. 5, pledgett body  212  resides within the abdominal wall, with hooks  210  attached to the deep fascia  232  to retain the wound sealing apparatus  100 B in position. Pledgett body  212  may pass through any of the various layers of the abdominal wall, including the deep fascia  232 , muscle wall  234 , and subcutaneous fascia and fat  235 . It will be appreciated that the pledgett body  212  need only result in sealing of the deep fascia  232  or the muscle wall  234  to effect closure of the puncture wound  120 .  
         [0032]    Pledgett body  212  may be formed from a biologically active template material, or substrate. In such embodiments, pledgett body  212  can act as a matrix to allow and encourage the surrounding tissues to grow therethrough and heal the puncture wound  120 . Examples of suitable biologically active substances include small intestine submucosa (SIS) and collagen biomatrix, among others. In other embodiments, the pledgett body may be formed from an absorbable suture material.  
         [0033]    Another embodiment of a wound sealing apparatus  100 C is depicted in FIGS. 6 and 7. FIG. 6 shows the apparatus  100 C in position in the distal end of the bore of an insertion tube  102  inserted into a trocar  104 . Wound sealing apparatus  100 C consists of a number of attachment element hooks  310  connected to a body generally indicated at  312 . At least two hooks  312 , located on opposite sides of the body  312  may be used to position and retain the wound sealing apparatus in the puncture wound  120  site. It will be appreciated that any desired number of hooks may be used. For example, embodiments with  3 ,  4 ,  6 , or any other desired number may be used. As with hooks  111  and  210  discussed previously herein, hooks  310  may be formed from any suitable material, including surgical steel.  
         [0034]    Body  312  is formed from the base shafts  316  of hooks  310  and a contracting mechanism, such as spring  314 . The contracting mechanism may be any device or mechanism that is capable of drawing the shafts  316  of the hooks towards one another. For example, a ribbon spring or a coil spring may be wrapped around the shafts  316  that retains the shafts against one another. Another structure, such as a band with contractile or elastic properties may placed around the shafts  316  to draw them together. Strands of a less elastic material wound in conformation to form a contractile band may also be used.  
         [0035]    As depicted in FIG. 6, when ready for deployment apparatus  100 C maybe located in the distal end of the insertion tube  102 , with the hooks  310  protruding therefrom. The distal end of plunger  106  is configured to retain the body  312  in an uncontracted position. This may be accomplished through the use of a slanted, or conical distal end  107  that resides between the shafts  316 , holding them apart.  
         [0036]    As trocar  104  and insertion tube  102  are withdrawn, plunger  106  may be manipulated to push body  312  out of the bore of the insertion tube  102 , as hooks  310  pierce the internal surface of the abdominal wall. The plunger  106  is then withdrawn as trocar  104  and insertion tube  102  are removed, contracting body  312  to close the puncture wound  120 . Apparatus  100 C is retained in position by hooks  310 , as shown in FIG. 7. The contraction of body  312  as the shafts  316  are drawn together contracts the puncture wound  120  around body  312  to achieve closure. Of course, it will be appreciated that wound sealing apparatus  100 C may be used to close any puncture wound and that the closure of an abdominal trocar puncture site is only illustrative. For example, accidental puncture wounds of appropriate size may be closed, as may be trocar puncture sites in other tissues.  
         [0037]    It will be appreciated that the systems and components of the present invention may be offered as kits for surgical use. One suitable kit would contain an insertion tube  102 , plunger  106 , and at least one wound sealing apparatus  100 , all appropriate sized to function together and accommodate a particular wound size. Each kit may further include an appropriately sized trocar  104  to provide all that is needed for a single laparoscope port in one kit. Each kit may further include an openable package having a top, bottom ,and sides defining a space for containing the surgical components. The package may keep the surgical components sterile until opened for use. Another kit may include a number of wound sealing apparatuses  100 , each of which maybe used for closing a single puncture wound. The plunger  106 , insertion tube  102  and trocar  104  for use with such a kit may all be reusable with each wound sealing apparatus  100 , and may be cleaned and sterilized for use in subsequent operations.  
         [0038]    Although the present invention has been shown and described with respect to preferred embodiments, various additions, deletions and modifications that are obvious to a person skilled in the art to which the invention pertains, even if not shown or specifically described herein, are deemed to lie within the scope of the invention as encompassed by the following claims.