Patent Publication Number: US-2009234376-A1

Title: Surgical material applicator

Description:
This application claims priority to U.S. Provisional Patent Application Ser. No. 61/066,071 filed on Feb. 15, 2008, which is incorporated by reference herein in its entirety. 
    
    
     STATEMENT OF RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH 
     This work was supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases grant number 2R44 DK062571. The government has certain rights in the invention. 
    
    
     BACKGROUND TO THE INVENTION 
     In many surgical procedures, a surgical material is introduced into a body cavity and placed over a wound or tissue defect. For example, in a hernia repair procedure, a mesh is placed over a hernia in order to repair it. Many different meshes have been developed for this purpose. For example, meshes having different thicknesses and other structural properties are used for different size hernias. Moreover, meshes have been coated with materials to reduce inflammation of adjacent tissues and to minimize adhesions. 
     In all these repair methods there is a need for an apparatus for quickly introducing and manipulating a prosthetic material while performing open or laparoscopic procedures. Conventional methods, including a variety of mesh applicators, are inefficient, time consuming and unreliable. The mesh is often difficult to attach to the rod and thus may slip about the rod. As a result, the mesh may not unfurl through the opening in the housing. Alternatively, the mesh may crumple within the housing. 
     SUMMARY OF THE INVENTION 
     Consistent with an aspect of the present disclosure a surgical tool is provided that comprises a sheath having an opening. The opening extends along a length of the sheath, the sheath having an inner surface that defines a cavity. The surgical tool also includes a shaft having a surface. The cavity of the sheath is adapted to receive the shaft and a material disposed about the shaft. A plurality of protrusions are also provided that extend from the surface of the shaft. The plurality of protrusions are provided at a plurality of locations along a length of the shaft, and the plurality of protrusions are configured to grip a first portion of the material. Upon rotation of the shaft within the cavity, a second portion of the material is output from the opening for application to a biological tissue. 
     Consistent with a further aspect of the present disclosure, a surgical tool is provided that comprises a first shaft configured such that a material may be wrapped around the first shaft. The surgical tool also includes a second shaft spaced from the first shaft by a gap. A first member is also provided having first and second recessed portions. The first recessed portion is configured to receive a first end portion of the first shaft, and the second recessed portion is configured to receive a first end portion of the second shaft. In addition, a second member is provided that has first and second recessed portions. The first recessed portion of the second member is configured to receive a second end portion of the first shaft, and the second recessed portion of the second member is configured to receive a second end portion of the second shaft. The first end portion of the first shaft is provided opposite the second end portion of the first shaft, and the first end portion of the second shaft is provided opposite the second end portion of the second shaft. A first portion of the surgical material is inserted through the gap between the two shafts such that the two shafts will grip the first portion of the surgical material. Upon rotation of the two shafts together within the cavity a second portion, of the material is output from the opening for application to a biological tissue. 
     Additional objects will be set forth in part in the description which follows, or may be learned by practice of the disclosure. The objects and advantages of the will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. 
     It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. 
     The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments and together with the description, serve to explain the principles of the disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         FIG. 1  is a perspective view of a surgical tool consistent with an aspect of the present disclosure; 
         FIG. 2  is a perspective view of a sheath consistent with an additional aspect of the present disclosure; 
         FIG. 3  is perspective view of a shaft consistent with a further aspect of the present disclosure; 
         FIGS. 4   a  and  4   b  show example of the surgical tool consistent with the present disclosure with a mesh retained ( FIG. 4   a ) and a deployed mesh ( FIG. 4   b ); 
         FIG. 5  shows a partial perspective view of the surgical tool consistent with the present disclosure; 
         FIG. 6-10  show perspective views of examples of a shaft consistent with the present disclosure; 
         FIG. 11  illustrates an alternative embodiment of a portion of a surgical tool consistent with the present disclosure; 
         FIG. 11   a  illustrates a cross-sectional view of the surgical tool of  FIG. 11  with the surgical material wound onto the shaft; 
         FIG. 12  illustrates an example of an application of a surgical tool consistent with the present disclosure; and 
         FIGS. 13   a - 13   d  illustrate different views of tips of a shaft consistent with the present disclosure. 
     
    
    
     DESCRIPTION OF THE EMBODIMENTS 
     Consistent with an aspect of the present disclosure, surgical material is contained within the sheath while it is introduced into the abdominal cavity, thereby preventing a premature discharge of the mesh before it is properly positioned over the defect. As a result, material introduction is low risk, quick, inexpensive and reproducible. Specifically, the surgical material is prevented from folding over on itself and will provide the necessary control to achieve the desired registration and orientation of the surgical material within the abdominal cavity. Commonly used composite materials including relatively thin meshes that are structurally weak as well as thick, rigid materials can be reliably positioned so that the coated or adhesion barrier side of the material will typically be placed toward the bowel while the uncoated side will face the abdominal wall. In this manner, adhesion formation and viscus erosion can be prevented. Furthermore thick, large sheets of a surgical material can be compressed onto the apparatus, eliminating complications associated with use of large-bore cannulas. In addition, components of the apparatus protect the surgical material from damage as it is transported through a hard trocar material. Alternatively, the apparatus can be inserted directly into a trocar opening once the trocar is removed. Benefits to this disclosure include a shaft that is populated with spines, bristles or rounded features that gently grasp any surgical material preventing it from slipping on the shaft and faciliting tightly winding it onto the shaft. As a result large-sized, stiff materials as well as delicate thin materials can be compressed within this device for easy application to the defect site. Another benefit is the outer sheath of the device that protects the surgical material that is wound onto the shaft preventing damage to the material when it is inserted into a trocar in order to execute laparoscopic procedures. Another benefit is a specially designed tunnelling member that facilities insertion into the trocar as well as an aid in positioning the surgical material at the defect site once the material has been released from the shaft. The combination of controlled release of the material from the device with placement assistance of the distal tip, facilitates the correct registration of composite materials to ensure that the coated or postoperative adhesion barrier surface is positioned toward abdominal tissues. Another benefit is a seal within the device to prevent escape of suffalation gas during a laparoscopic procedure. 
     Reference will now be made in detail to the present exemplary embodiments, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. 
       FIG. 1  illustrates a surgical tool  10  consistent with an aspect of the present disclosure. Surgical tool  10  includes a shaft  102  provided in a sheath  100 . A tip  103  may be provided at a distal or first end portion  98  of sheath  100  and a handle or knob  101  may be provided at a proximal or second end portion  99  of sheath  100 . As shown in greater detail in  FIG. 2 , sheath  100  has an inner surface  105  that defines a cavity  106 . An opening  104  is provided in sheath  100  that extends along a length  107  of sheath  100 . 
       FIG. 3  illustrates an exemplary shaft  102  in greater detail. Shaft  102  includes a plurality of protrusions  110  that are provided at a plurality of locations that extend from surface  85  along the length of shaft  102  from distal end  109  to proximal end  111 . Shaft  102  may also include a raised diameter portion  108 , which may include an O-ring, for example, near proximal end  111 . Raised diameter portion  108  will be discussed in greater detail below with reference to  FIG. 5 . 
     The operation of surgical tool  10  will next be described with reference to  FIGS. 4   a  and  4   b.  In  FIG. 4   a,  at least a first portion  112 - a  of material, such as a mesh  112  is wrapped around shaft  102  within cavity  106  of sheath  100 . In  FIG. 4   b,  handle  101  is rotated in a direction indicated by arrow  89  by a user, for example, such that at least a second portion  112 - b  of mesh  112  is unfurled and supplied from opening  104 . Preferably, protrusions  110  along shaft  102  are configured to grip mesh  112 , such that mesh  112  may be reliably unfurled from shaft  102  without slippage. As a result, mesh  112  may be properly positioned over a biological tissue or surgical site, such as a hernia. Moreover, the height and width of protrusions  110  are preferably selected so that a variety of meshes having a wide range of thicknesses may be effectively engaged and suitably wound and unwound by shaft  102 . 
       FIG. 5  illustrates proximal end  111  of shaft  102  in greater detail. As noted above, a raised diameter portion  108  may be provided near proximal end  111  in order to form a seal against a portion  75  of space seal  114 . Spacer seal  114  forms a seal between the shaft and the shealth inner surface  105 . Accordingly, gasses or fluids released from a body cavity when surgical tool  10  is inserted therein may be contained. An additional spacer seal  114 , which may include a glass, may be provided to provide a proper fit of surgical tool  10  within a trocar (discussed in greater detail below with respect to  FIG. 12 ). Preferably, seals  108  and  114  have a central opening to thereby facilitate a connection or attachment between handle  101  and shaft  102  to facilitate rotation of shaft  102  by turning handle  101  either manually or with a motor, for example. 
       FIG. 6  shows shaft  102  in greater detail. In this example, a plurality of protrusions  55 , having a rounded shape, are provided on opposite sides of shaft  102 . In  FIG. 7 , a plurality of protrusions  116  or spikes, having a conical shape, are provided on opposite sides of shaft  102 . In an additional example shown in  FIG. 8 , rounded ( 55 ) and conical ( 116 ) protrusions are provided at alternating positions along shaft  102 . In  FIG. 9 , a further example, conical-shaped protrusions  116  are provided on opposing first ( 910 ) and second ( 912 ) sides along the length of shaft  102 , and rounded protrusions  55  are provided on opposing first ( 914 ) and second ( 916 ) sides of shaft  102 . Depending upon the thickness, rigidity, and other physical properties of the mesh or other material to be deployed with surgical tool  10 , different protrusion stapes provided at different locations along the length of shaft  102  may facilitate better gripping of the mesh or other surgical material. 
       FIG. 10  illustrates another example of shaft  102 . Here, shaft  102  includes a plurality of bristles, arranged in clumps  117  spaced along the length of the shaft. Bristles may be used to grip the mesh or other surgical material in a manner similar to that discussed above in connection with protrusions  55  and  116 . 
       FIG. 11  illustrates an example of a dual-shaft configuration  1100  consistent with a further aspect of the present disclosure. Configuration  1100  includes first  1118  and second  1119  shafts that are spaced from one another by a gap. At distal end  1121 , first ends  1118 - a  and  1119 - a  of the first and second shafts, respectively, are provided in corresponding recessed portions  1120 - a  and  1120 - b  in distal member  1120 . At proximal end member  1122 , second ends  1118 - b  and  1119 - b  of shafts  1118  and  1119 , respectively, are provided in recessed portions  1122 - a  and  1122 - b.  Portion  120  is also provided which is may extend in and connect to handle  101  (not shown in  FIG. 11 ) to facilitate rotation of shafts  1118  and  1119 . In addition, recessed portion  1125  may accommodate an O-ring or other seal to thereby realize raised diameter portion  108 . 
       FIG. 11   a  shows a cross-sectional view AA from  FIG. 11 . In operation, a first portion  1175  of mesh  112 , for example, is secured in gap  1180  between shafts  1118  and  1119 , and then wrapped around both shafts, as shown in the cross-sectional view of surgical tool  10  and shown in  FIG. 11   a.  Preferably, portion  120  (extension or portion of handle  101  not shown) is turned to facilitate rotation of shafts  1118  and  1119  and unfurling of at least a second portion of mesh  112  through opening  104  in sheath  100 . Gap  1180  is typically set to approximate the thickness of the mesh to retain portion  1175  of mesh  112  and avoid crimping or crumpling of the mesh while it is unfurled. Although the shafts  1118  and  1119  and corresponding recessed portions  1120 - a  and  1120 - b  of member  1120  are shown having the same diameter, it is understood that each may have a different cross-sectional area when taken transverse to the axes  1130  and  1131  of shafts  1118  and  1119 , respectively and shown in  FIG. 11 . In the example shown in  FIGS. 11 and 11   a,  the material is gripped by gap  1180  between shafts  1118  and  1119 , instead of or in addition to protrusions  110  discussed above. 
       FIG. 12  illustrates an exemplary application of surgical tool  10  consistent with an additional aspect of the present disclosure. In the example shown in  FIG. 12 , surgical tool  10 , including mesh  112 , is provided within first trocar  124 - 1  and inserted into abdominal wall  123 . A second trocar  124 - 2 , including a grabber mechanism  125 , may also be inserted into abdominal wall  123 . Grabber mechanism  125 , which may include a pair of tongs  1210 , for example, may be used to grab mesh  112  and unfurl or extend, as well as position, it over a hernia or other surgical site  1220 . Typically, sheath  100  protects mesh  112  during insertion into trocar  124 - 1 . 
       FIGS. 13   a  and  13   b  illustrate examples of tunneling members or tips that may be placed at the distal end  98  of sheath  100 .  FIGS. 13   a  and  13   b  illustrate front and rear views, respectively, of tunneling member  103  having a rounded shape.  FIG. 13   b,  in particular, shows an opening  103 - 1  for receiving distal end  109  of shaft  102 .  FIGS. 13   c  and  13   d  illustrate front and rear views, respectively, of a tunneling member  126  having a conical shape, and  FIG. 13   d  shows opening  126 - 1  for receiving the distal end  109  of shaft  102 . In each of  FIGS. 13   a - 13   d,  the tips have a rounded (in the case of tip  103 ) or conical (in the case of tip  126 ) that protrudes in a direction away from proximal end  111  of shaft  102 . For the two shaft configuration shown in  FIG. 11 , the round and conical shaped tips are similar to those shown in  FIGS. 13   a  and  13   c  but the two shaft configuration requires two openings as shown in  FIG. 11  view  1120  ( 1120 - a  and  1120 - b ). 
     Tips or tunneling members  103  and  126  permit easy movement of surgical tool  10  without snagging or damaging underlying biological tissue. Accordingly, surgical tool  10  may be readily positioned over a desired location, and the mesh or other surgical material may be properly deployed in the manner described above. 
     As noted above and consistent with aspects of the present disclosure, protrusions provided along the shaft are provided to facilitate gripping of the mesh, thereby facilitating crimp-free deployment and accurate positioning of the mesh over the surgical site, such as hernia, preventing damage or irritation to adjacent tissues and possible reducing the formation of postoperative adhesions. Alternatively, the mesh may be gripped by securing a portion thereof in a gap between two closely spaced shafts. 
     Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. For example, in each of the above-noted examples, the shafts may be made of a suitable plastic or metal. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.