Patent Document

FIELD OF THE INVENTION 
       [0001]    The invention pertains to a method of placing a surgical mesh material into a body cavity laparoscopically, and, more particularly, to a method of introducing relatively large surgical meshes through small incisions, for example, the incision made by a 5 mm trocar. In addition, an insertion is provided to facilitate the surgical mesh placements. 
       BACKGROUND OF THE INVENTION 
       [0002]    Laparoscopic surgical techniques are both well known and widely practiced for performing a wide variety of surgical procedures. The major advantage of laparoscopic procedures is that no large incision need be made into a patient, thereby greatly reducing patient recovery time. In some cases, simple procedures performed laparoscopically may be done either on an outpatient basis, or with a limited hospitalization. Such procedures once may have required a multi-day hospitalization when conventional surgical techniques were used. 
         [0003]    Laparoscopic surgery typically utilizes multiple trocars for the insertion of a camera and surgical instruments, and the introduction of materials such as sutures, repair meshes, and the like required for the specific surgical procedure. One or more additional trocars may be used to inflate the abdomen or other body cavity to facilitate the surgery being performed. The camera provides an image on a monitor which is used by the surgeon to guide his or her manipulation of the instruments. 
         [0004]    It has been observed that patient discomfort is proportional to the diameter of the trocars utilized for the surgery, large diameter trocars resulting in more discomfort, small diameter trocars resulting in less discomfort. It has also been recognized that a puncture or incision made by a small diameter, for example, a 5 mm trocar may be virtually self healing requiring no suture to close the puncture or incision (i.e., fascial defect) upon withdrawal of the trocar. This provides additional incentive to utilize small diameter trocars whenever possible. 
         [0005]    One typical class of surgery commonly performed laparoscopically is the repair of hernias. A support mesh is typically utilized for such hernia repair. The mesh must, of course, be introduced into the abdominal cavity through a trocar. 
         [0006]    One specific type of hernia frequently repaired laparoscopically is a ventral hernia. Such hernias often occur in the abdominal wall at a site where a surgical incision was previously made. At such a site the abdominal muscles may have weakened resulting in a bulge or a tear. This situation may be likened to the way that an inner tube pushes through a damaged tire. The inner lining of the abdomen may push through the weakened area of the abdominal wall to form a balloon-like sac. This can allow a loop of intestines or other abdominal contents to push into the sac. If the abdominal contents get stuck within the sac, they can become trapped or “incarcerated.” This incarceration may lead to potentially serious problems that might conceivably require emergency surgery. 
         [0007]    To repair a ventral hernia, a patch of surgical mesh is inserted into the abdomen and used to reinforce the abdominal wall. In this approach, a laparoscope (a tiny telescope with a television camera attached) is inserted through a cannula (e.g., a trocar). The laparoscope and TV camera allow the surgeon to view the hernia from the inside. Other small incisions will be required for other small cannulas for placement of other instruments to remove any scar tissue and to insert a surgical mesh into the abdomen. This mesh, or screen, is fixed under the hernia defect to the strong tissues of the abdominal wall. It is typically held in place with special surgical tacks and in many instances, sutures. Usually, three or four ¼ inch to ½ inch incisions are necessary. The sutures, which go through the entire thickness of the abdominal wall, are placed through smaller incisions around the circumference of the mesh. This surgery is usually performed under general anesthesia. 
         [0008]    The size of the mesh required for the repair of ventral hernias is typically relatively large, for example 15×20 cm and 20×25 cm are typical mesh sizes. Procedures of the prior art require large trocars to effect the insertion thereof. 
       DISCUSSION OF THE RELATED ART 
       [0009]    Apparatus for the insertion of mesh into a body cavity may be found in the prior art. For example, Published United States Patent Application No. 2004/0092970 for PROSTHETIC MESH ANCHOR DEVICE, published May 13, 2004 upon application by Alfredo F. Xavier teaches a device wherein percutaneous mesh may be introduced into a patient&#39;s abdominal cavity, the mesh no larger than 11×14 cm. The diameter of the Xavier apparatus is relatively large (i.e., 10 mm) trocar. The apparatus is intended for mesh placement for the repair of hernias in the groin region. 
         [0010]    This published patent application is not seen to teach or suggest the novel apparatus for and method of laparoscopically introducing a relatively large mesh for the repair of a ventral hernia in accordance with the present invention. 
       SUMMARY OF THE INVENTION 
       [0011]    In accordance with the present invention there is provided a method of laparoscopically introducing relatively large pieces of surgical mesh into the abdominal cavity of a patient using a small incision, typically the incision made by a 5 mm diameter trocar. After placing traction sutures (typically at least four) around the perimeter of the mesh adjacent the outside edges, the surgical mesh is hydrated and tightly rolled. 
         [0012]    An insertion tube is ligated adjacent a proximal end and a small nick is cut through the tube wall adjacent the ligation. After lubricating the lumen of the insertion tube with surgical jelly, a laparoscopic grasper, for example, a 5 mm Maryland dissector is inserted into the lumen through the small nick. The grasper is advanced until the grasping elements protrude from the insertion tube at the distal end thereof. 
         [0013]    The grasper is used to pull the hydrated, tightly rolled surgical mesh into the lubricated lumen of the insertion tube. 
         [0014]    The proximal, ligated end of the insertion tube bearing the tightly rolled surgical mesh is inserted into the patient&#39;s abdominal cavity through a very small incision, typically an incision formed by a 5 mm trocar. 
         [0015]    Once inserted, the insertion tube is split or otherwise opened to release the surgical mesh that may then be used to perform the necessary surgery. 
         [0016]    A novel insertion tube having a thinned wall region extending along a longitudinal axis and a ripcord extending from a ligated, proximal end back to a point beyond a distal end of the insertion tube may be utilized to facilitate splitting the insertion tube to facilitate release of the rolled surgical mesh from within the insertion tube. 
         [0017]    The surgical mesh is typically utilized to laparoscopically repair a ventral hernia. 
         [0018]    It is, therefore, an object of the invention to provide a method of introducing a relatively large surgical repair mesh into the abdominal cavity through a small diameter incision (e.g., an incision made by 5 mm trocar). 
         [0019]    It is an additional object of the invention to provide an insertion tube to facilitate insertion of surgical mesh through such small incisions. 
         [0020]    It is a further object of the invention to provide an insertion tube weakened area along a longitudinal axis thereof to facilitate opening of the insertion tube. 
         [0021]    It is a still further object of the invention to provide an insertion tube that may readily be parted or separated from outside the abdominal cavity of a patient using a ripcord to part the insertion tube along the weakened area thereof. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    Various objects, features, and attendant advantages of the present invention will become more fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein: 
           [0023]      FIG. 1   a  is a pictorial, schematic view of some of the materials and instruments utilized to practice the method of the invention; 
           [0024]      FIG. 1   b  is a pictorial, schematic view of the instruments of  FIG. 1   a  and wherein an insertion tube is ligated at a proximal end thereof; 
           [0025]      FIG. 2  is a top, perspective, schematic view of a piece of surgical mesh prepared by placing traction sutures around the perimeter thereof; 
           [0026]      FIG. 3  is a perspective of the ligated insertion tube of  FIG. 1   b  with a laparoscopic grasper inserted therethrough; 
           [0027]      FIG. 4  is a side, perspective view of the ligated insertion tube of  FIG. 1   b  with rolled surgical mesh partially inserted in the lumen thereof; 
           [0028]      FIG. 5   a  is a side, perspective of an insertion tube in accordance with the invention; 
           [0029]      FIG. 5   b  is an end view of the insertion tube of  FIG. 5   a ; and 
           [0030]      FIG. 5   c  is a top plan view of the insertion tube of  FIGS. 5   a  and  5   b.    
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0031]    The present invention provides an apparatus for and method of inserting a large piece of surgical mesh into the abdominal cavity of a patient through a small incision, typically the incision formed by a 5 mm diameter trocar. As used herein, the term trocar is used to apply to any suitable small diameter cannula that may be used to provide access to a body cavity of a patient. 
         [0032]    As previously stated, the use of small diameter trocars is highly desirable for several reasons. First, small diameter trocars minimize patient discomfort. Also fascial defects resulting from the use of a 5 mm trocar usually do not require a suture for closing (i.e., they are generally self sealing) whereas fascial defects from larger diameter trocars generally do require suturing. Finally, the use of small diameter trocars minimizes the risk of future herniation at the site. 
         [0033]    The surgical mesh typically used to repair ventral hernias is typically a bilaminate having a first major surface that is bioresorbable while an opposing major surface is formed from non-bioresorbable material. One commercially available product Proceed™ Surgical Mesh manufactured by Ethicon, Inc., a division of Johnson and Johnson. Proceed™ Surgical Mesh is composed of an oxidized regenerated cellulose (ORC) fabric and a nonabsorbable polypropylene mesh that is encapsulated by a polydioxanone polymer. The polypropylene side of the mesh allows for tissue ingrowth while the ORC side of the mesh is a bioresorbable layer that separates the polypropylene mesh from the underlying tissue during the healing process to minimize tissue attachment thereto. There are other products, for example Seprafilm®, well known to those of skill in the art that provide similar bilaminate structure having both a tissue ingrowth side and an opposing side that is bioresorbable. 
         [0034]    Another mesh product suitable for practicing the method of the present invention is Parietex™ dual-sided mesh composite provided by Covidien whose US headquarters is in Mansfield, Mass. Parietex™ is a polyester mesh/resorbable film that is claimed to provide optimal tissue in-growth and fewer visceral attachments. A protective collagen-based barrier is provided to help prevent tissue attachment. Parietex™ features increased rigidity during implantation allowing ease of handling. However, the polyester material softens and conforms to the anatomy once implanted. 
         [0035]    Surgical mesh forms no part of the present invention, it will be recognized that any suitable surgical mesh having appropriate properties for the particular surgery being undertaken may be used. While Proceed™ or Parietex™ surgical mesh is used for purposes of disclosure, they are not considered limiting. 
         [0036]    For ventral hernia repair, surgical mesh in 15×25 cm and 20×25 cm is commonly used. It will be recognized that other sizes of surgical mesh may be required for a particular ventral hernia repair or other similar surgery. Consequently, the invention is not considered limited to a particular size surgical mesh. Rather, the invention includes any and all surgical mesh sizes. 
         [0037]    Referring first to  FIG. 1   a , there is shown a pictorial representation of several components required to practice the method of the present invention. 
         [0038]    An elongated, hollow, elastic insertion tube having a diameter in the range of approximately 9-10 mm  102  has an open proximal end  104  and an open distal end  106 . Insertion tube  102  is typically a silicon rubber or similar elastic material that may readily be dilated. Suitable materials are believed to be known to those of skill in the art. 
         [0039]    A syringe  108  of approximately ______ cc capacity [Dr. Knowles?] is filled with surgical jelly, not specifically identified. Surgical jelly is believed to be well known to those of skill in the art and is not further described or discussed herein. Syringe  108  has a flexible, tapered tip  110  attached to its discharge end  112 . Tapered tip  110  is sized and configured to fit into distal end  106  of insertion tube  102  and is similar to a  20  gauge “angiocath” tip. Angio catheters are believed to be well known to those of skill in the art and flexible, tapered tip  110  is not further discussed herein. 
         [0040]    A piece of surgical mesh  114  is shown proximate insertion tube  102 . Surgical mesh  114  is selected from one of the exemplary bi-layer surgical meshes described in detail hereinabove. Surgical mesh  114  as seen in  FIG. 1  has a central region  168  with a perimeter region  170  where the absorbable layer is partially visible. 
         [0041]    In the method of the invention, first the proximal end  104  of insertion tube  102  is suture ligated at a proximal end  104  thereof as seen in  FIG. 1   b . A traction suture  116 , such as an Ethibond® suture supplied by Ethicon, Inc. of Bridgewater, N.J. has been found suitable for the application. Ethibond® sutures are nonabsorbable, braided, sterile, surgical sutures typically composed of Poly (ethylene, terephthalate). The sutures are prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. They are uniformly coated with polybutilate or poly {oxy-1,4 butanediyloxy (1,6-dioxo-1,6 hexanediyl)}. The highly adherent coating is a relatively nonreactive nonabsorbable compound which acts as a lubricant to mechanically improve the physical properties of the uncoated sutures by improving handling quality as compared to the braided, uncoated fiber. The sutures are braided for optimal handling properties, and typically dyed green for enhanced visibility in the surgical field. It will be recognized that equivalent sutures may be provided by other manufacturers and suppliers and the invention is not considered limited to the Ethibond® sutures used for purposes of disclosure. A traction suture  116  of ______ cm [Dr. Knowles? length has been found suitable for the application. 
         [0042]    Referring now also to  FIG. 2 , there is shown a top, perspective, schematic view surgical mesh  114 . Four traction or retention sutures  118   a  . . .  118   d  are attached peripherally adjacent the edge of surgical mesh  114 . Sutures  118   a  . . .  118   d  are placed at approximately the midpoint of each edge, not specifically identified, of surgical mesh  114  (i.e., at approximately 12, 3, 6, and 9 o&#39;clock positions). 
         [0043]    Once insertion tube  102  has been suture ligated, and traction or retention sutures  118   a  . . .  118   d  have been placed in surgical mesh  114 , surgical jelly from syringe  108  is injected into the open distal end  106  of insertion tube  102 . 
         [0044]    Next, a small nick  122  is made completely through the wall into the lumen of insertion tube  102  adjacent the traction suture  116  and between traction suture  116  and distal end  106  of insertion tube  102 . 
         [0045]    Referring now also to  FIG. 3 , a 5 mm laparoscopic grasper  120 , for example, a Maryland grasper or dissector, is inserted into a hole formed in insertion tube  102  at nick  122 . The shaft of laparoscopic grasper  120  is pushed through the previously lubricated lumen of insertion tube  102  until its grasping jaws  124  emerge from distal end  106  of inspection tube  102 . 
         [0046]    Surgical mesh  114  is next hydrated and rolled tightly into a cigar-like configuration. Traction sutures  118   a  . . .  118   d  are contained within the tightly rolled surgical mesh  114 . 
         [0047]    Next, the grasping jaws  124  or laparoscopic grasper  120  are manipulated so as to grab an edge of tightly rolled surgical mesh  114 . Tightly rolled surgical mesh  114  is drawn into the lumen of insertion tube  102  as laparoscopic grasper  120  is withdrawn therefrom. Because insertion tube  102  is compliant, the combination of the hydrated surgical mesh  114  and the surgical jelly allows the rolled surgical mesh  114  to be readily slid into the lumen of insertion tube  102 . 
         [0048]    Referring now also to  FIG. 4 , insertion tube  102  is now loaded and ready for insertion in the abdominal cavity, not shown, of a patient, not shown. It is assumed that a laparoscope, not shown, is in proper position within the patient&#39;s abdominal cavity, that the abdominal cavity has been insufflated with carbon dioxide gas, and any other tasks normally associated with laparoscopic surgery have been accomplished. Such tasks are well known to practitioners of laparoscopic surgery and form no part of the method of the invention. Consequently, such tasks are not further described herein. 
         [0049]    At least two 5-mm trocars have already been or are now inserted into the patient&#39;s abdomen at sites selected by the surgeon. 
         [0050]    A second 5 mm laparoscopic grasper, not specifically identified, is passed into the abdominal cavity through a first of the at least two 5 mm trocars. The second 5 mm laparoscopic grasper is passed through the insufflated abdomen and back out through the second of the at least 5 mm trocars. 
         [0051]    The second of the at least two 5 mm trocars is then removed, leaving at least the jaws of the second 5 mm grasper protruding from the patient&#39;s abdomen. 
         [0052]    The grasping jaws of the second 5 mm grasper are then actuated to grasp the protruding the ligated proximal end  104  of insertion tube  102  and/or a portion of traction suture  116 . 
         [0053]    The second 5 mm grasper is then retracted thereby pulling the Traction suture  116  and, ultimately, the proximal end  104  of insertion tube  102  into the patient&#39;s abdominal cavity. Continued withdrawal of the second 5 mm grasper succeeds in pulling at least the major portion of insertion tube  102  containing the tightly rolled surgical mesh  114  completely into the abdominal cavity. 
         [0054]    Insertion tube  102  is then parted along its longitudinal axis or otherwise opened to free the tightly rolled surgical mesh  114 . Parting is accomplished using any combination of suitable instruments and surgical techniques not discussed herein. 
         [0055]    Once tightly rolled surgical mesh  114  is free, insertion tube  102  is withdrawn from the abdominal cavity and the second 5 mm trocar is reinstalled in the incision originally made thereby. 
         [0056]    Hernia repair or other surgery may then proceed using conventional techniques well known to practitioners of laparoscopic surgery. 
         [0057]    The most difficult step of this novel process has been found to be the parting of insertion tube  102  and the freeing of tightly rolled surgical mesh  114  from the parted insertion tube  102 . This has led to the development of another aspect of the present invention. 
         [0058]    Referring now to  FIGS. 5   a , and  5   b , there are shown side, perspective and end elevational schematic views, respectively, of an improved insertion tube  150 . Insertion tube  150  features a substantially cylindrical, elongated body  152 . Substantially cylindrical body  152  has a proximal end  154 , a distal end  156 , and a wall  158 . Wall  158  has a thinned area  160  running along the major, longitudinal axis of body  152 . Thinned area  160  may run along the entire length of body  152  or, in alternate embodiments, may run along only a portion of the length of body  152 . 
         [0059]    A ripcord  162  is attached to body  152  at thinned area  160  adjacent proximal end  154 . Ripcord  162  may be passed through the lumen of body  152 , extending beyond distal end  156  thereof. In alternate embodiments, ripcord  162  may be left outside body  152 . 
         [0060]    Referring now also to  FIG. 5   c , body  152  may be provided with a ligation using a traction suture  164  such as an Ethibond® or an equivalent suture, disposed adjacent proximal end  154 . In alternate embodiments, a suitable ligating traction suture  164  may be installed in situ at the time of use of insertion tube  150 . 
         [0061]    Further, insertion tube  150  may be provided with an appropriate nick  166  adjacent traction suture  164  or, alternately, a nick  166  may be placed in insertion tube  150  at the time of use. 
         [0062]    The improved insertion tube is used in a similar fashion to the insertion tube  102  discussed in detail hereinabove. However, at the step in the surgical process where the tightly rolled surgical mesh is to be freed from insertion tube  150 , ripcord  162  is pulled from the distal end of body  152 . The ripcord then separates (i.e., “unzips”) insertion tube  150  along weakened area  160 , thereby freeing tightly rolled surgical mesh  114  from insertion tube  150 . This eliminates the need for manipulation of laparoscopic instruments within the abdominal cavity and reduces the time required for the surgery. 
         [0063]    Since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure, and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention. 
         [0064]    Having thus described the invention, what is desired to be protected by Letters Patent is presented in the subsequently appended claims.

Technology Category: 1