Patent Publication Number: US-2017360435-A1

Title: Surgical closure apparatus and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/352,045 filed Jun. 20, 2016, the entire disclosure of which is incorporated by reference herein. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to wound closure and, more particularly, relates to an apparatus and associated method for closing a wound or port opening in the abdomen in conjunction with a laparoscopic surgical procedure. 
     2. Background of Related Art 
     Puncture wounds may result from trauma or may be intentionally created to provide access to a body cavity during a surgical procedure. In an endoscopic or laparoscopic surgical procedure, for example, a trocar is utilized to puncture the abdomen to provide access by way of a cannula through the abdominal wall. Generally, the cannula or other access portal device is placed through the abdominal wall for introduction of surgical instrumentation required to perform the surgical procedure. Once the procedure is complete, it is necessary to close the puncture wound. 
     Current methods of wound closure are highly skill dependent as advancing a needle into a small port and ensuring that the needle crosses through different layers of abdominal tissue, including subcutaneous tissue, fascia and muscle, is quite cumbersome and difficult. In addition, there is a potential of the needle inadvertently contacting and injuring organs within the abdominal cavity. 
     SUMMARY 
     Accordingly, the present disclosure is directed to further improvements in wound closure. In one embodiment, a surgical closure apparatus for facilitating closure of a wound includes an outer member dimensioned for positioning within a wound opening and defining a central longitudinal axis, a needle assembly at least partially positioned within the outer member, and a suture configured for at least partially closing the wound opening. The needle assembly includes an elongate member defining a longitudinal opening along a portion of a length thereof, a suture needle coupled to the elongate member and extending to a needlepoint and being configured for movement between an unarmed condition where the needlepoint is in a relative radial inward position and an armed condition where the needlepoint is in a relative radial outward position, and a deployment member extending at least partially through the longitudinal opening of the elongate member and coupled to the suture needle. The deployment member is movable within the longitudinal opening to permit the suture needle to transition between the unarmed condition and the armed condition. The suture is coupled to the suture needle and at least partially extends through the outer member. 
     In embodiments, the deployment member includes a flexible filament. In some embodiments, the deployment member is secured to the suture needle adjacent the needlepoint. In some aspects, the suture needle is normally biased toward the armed condition, and is configured to move to the unarmed condition in response to a tensile force exerted on the deployment member. In some embodiments, the needlepoint of the suture needle is disposed radial outward relative to the outer member when in the armed condition and is disposed radial inward relative to the outer member when in the unarmed condition. In some aspects, the elongate member defines an exit port in communication with the longitudinal opening where the deployment member extends through the exit port for securement to the suture needle. 
     In embodiments, the outer member defines a first longitudinal passage for reception of the elongate member of the needle assembly and may define a second longitudinal passage for accommodating the suture. In some embodiments, the suture needle is a curved suture needle. The suture needle may include an eye for receiving a portion of the suture. 
     A method for facilitating closure of a wound opening is also disclosed. The method includes: 
     positioning an outer member relative to a wound opening, the outer member having an elongate member at least partially disposed therein and a suture needle coupled to the elongate member and extending beyond the outer member, and terminating in a needlepoint; 
     securing a flexible deployment member at least partially extending within a longitudinal opening of the elongate member to the suture needle; 
     coupling a suture to the suture needle adjacent the needlepoint; 
     introducing the outer member within the wound opening while the suture needle is in an unarmed condition whereby the needlepoint is in a radial inward position relative to the outer member; 
     translating the deployment member within the longitudinal opening of the elongate member to transition the suture needle from the unarmed condition to an armed condition whereby the needlepoint is in a radial outward position relative to the outer member; 
     moving the elongate member within the wound opening through a first manipulation while the suture needle is in the armed condition such that the needlepoint and at least a portion of the suture needle penetrates first tissue portions surrounding the wound opening to cause a first suture segment of the suture to pass through the first tissue portions; 
     rearranging the outer member and the elongate member relative to the wound opening; 
     moving the elongate member within the wound opening through a second manipulation while the suture needle is in the armed condition such that the needlepoint and at least a portion of the suture needle penetrates second tissue portions surrounding the wound opening to cause a second suture segment of the suture to pass through the second tissue portions; and securing the first and second suture segments to at least partially close the wound opening. 
     In some embodiments, introducing the outer member includes applying a tensile force to the deployment member to at least partially bend the suture needle to move the suture needle to the unarmed condition. In embodiments, the suture needle is a curved suture needle and is normally biased toward the armed condition, and wherein translating the deployment member includes releasing the deployment member to permit the deployment member to advance within the longitudinal opening of the elongate member and allow the suture needle to assume the armed condition. In aspects, translating the deployment member includes extending the deployment member through a side exit port in the elongate member. In embodiments, introducing the outer member includes releasably securing the deployment member relative to the outer member to retain the suture needle in the unarmed condition. 
     In some embodiments, the method includes positioning the elongate member within a first longitudinal passage of the outer member and extending the suture through a second longitudinal passage of the outer member. 
     In embodiments, the wound opening extends through the abdominal cavity and wherein moving the elongate member through each of the first and second manipulations includes advancing the first and second suture segments through at least fascia tissue surrounding the abdominal cavity. 
     The surgical closure apparatus and method of use provides an effective and safe approach for closing a wound or port opening in tissue, particularly, within the abdominal cavity. The movement of the needle assembly between the unarmed and armed conditions of the suture needle is directly controlled by the clinician. The incorporation of the needle assembly within the apparatus removes the necessity of individually introducing one or more needles through an access port to suture the surrounding wound, which is a highly skill dependent surgical task and may introduce additional trauma and incur additional recovery time. 
     Other advantages of the present disclosure will be appreciated from the following description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING(S) 
       Embodiments of the present disclosure will be appreciated by reference to the accompanying drawings wherein: 
         FIGS. 1-2  are first and second perspective views of the surgical closure apparatus in accordance with the present disclosure illustrating the outer member, the needle assembly at least partially disposed within the outer member, and the suture for closing a wound opening; 
         FIG. 3  is an exploded perspective view of the surgical closure apparatus illustrating the elongate member, the suture needle and the deployment member of the needle assembly, and the outer member; 
         FIG. 4  is a partial side cross-sectional view of the surgical closure apparatus of  FIG. 1  illustrating the needle assembly in an armed condition through release of the deployment member coupled to the suture needle; 
         FIG. 5  is a partial side cross-sectional view of the surgical closure apparatus illustrating the suture needle of the needle assembly in an unarmed condition through application of a tensile force on the deployment member; and 
         FIGS. 6A-6F  illustrate a sequence of use of the surgical closure apparatus in closing a wound opening within the abdomen. 
     
    
    
     DETAILED DESCRIPTION 
     Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely examples of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present disclosure in virtually any appropriately detailed structure. 
     Referring now to the drawings where like reference numerals indicate similar components throughout the several views,  FIGS. 1-4  illustrate the surgical closure apparatus  10  of the present disclosure. The surgical closure apparatus  10  is adapted to facilitate the closure of a wound opening in tissue, and, has particular application in the closure of a puncture or port wound created within the abdomen, e.g., through the abdominal wall, in connection with a laparoscopic surgical procedure. However, the surgical closure apparatus  10  and associated method of use may be used to close a wound opening in other areas of the subject&#39;s body whether created during a surgical procedure or resulting from accident or trauma. 
     The surgical closure apparatus  10  includes an elongated outer member  12  defining proximal and distal end portions  14 ,  16 , a needle assembly  18  at least partially positionable within the outer member  12  and a suture  20  coupled to the needle assembly  18 . The outer member  12  may be monolithically formed, or alternatively, include several components secured to each other via conventional means. The outer member  12  defines a central longitudinal axis “k”, and has first and second longitudinal passages  22 ,  24 . The first longitudinal passage  22  is radially spaced relative to the central longitudinal axis “k” and the second longitudinal passage  24  is in general longitudinal alignment with the central longitudinal axis “k”. Other arrangements are also envisioned. The outer member  12  may be solid, in whole or in part, with the exception of the first and second longitudinal passages  22 ,  24 , or alternatively, may be hollow and include internal tubes which define the first and second longitudinal passages  22 ,  24 . The outer member  12  may be generally cylindrical along a majority of its length although other dimensions are also envisioned. 
     With continued reference to  FIGS. 1-4 , the needle assembly  18  includes an elongate member  26 , a suture needle  28  connected to the elongate member  26  and a deployment member  30  at least partially extending within the elongate member  26 . The elongate member  26  is at least partially, e.g., fully disposed, within the first longitudinal passage  22 , and may be secured within the first longitudinal passage  22  through conventional means. In the alternative, the elongate member  26  may move in a longitudinal direction within the first longitudinal passage  22 . The elongate member  26  of the needle assembly  18  defines a longitudinal opening  32  ( FIG. 4 ) along at least a portion of its length for accommodating the deployment member  30 . In one embodiment, the longitudinal opening  32  extends through the elongate member  26  and through at least a portion of the suture needle  28 , e.g., the elongate member  26  and the suture needle  28  are hollow. The elongate member  26  defines an exit port  34  in communication with the longitudinal opening  32  adjacent the distal end portion  16 . 
     The suture needle  28  is disposed beyond the distal end portion  16  of the outer member  12 . The suture needle  28  is a curved needle, e.g., generally J-shaped, which leads to a needlepoint  36 . In the alternative, the suture needle  28  may be linear and offset relative to the longitudinal axis “k” such that the needlepoint  36  extends toward the housing, e.g., generally V-shaped. The suture needle  28  may be monolithically formed with the elongate member  26  or a separate component secured to the elongate member  26  through conventional means. The suture needle  28  is fabricated from a relative rigid material including stainless steel, spring steel, shape memory alloys such as Nitinol and other metals or polymeric materials, but has sufficiently flexibility to be at least partially bent during use of the apparatus  10 . The suture needle  28  may include an eye  38  extending through the body of the needle  28  for reception and passage of the suture  20  and a second opening  40  for securement of the deployment member ( FIG. 2 ). 
     The deployment member  30  includes a flexible filament  42  and, optionally, a handle  44  ( FIGS. 1 and 2 ) which is coupled to the flexible filament  42  and dimensioned for engagement by the clinician. The flexible filament  42  has sufficient tensile strength to bend the suture needle  28  upon application of a tensile force to the flexible filament  42 . Suitable materials for the flexible filament  42  of the deployment member  30  include polymeric materials, nylon, steel or the like. The flexible filament  42  extends through the longitudinal opening  32  of the elongate member  26  and extends outwardly from the proximal end portion  14  of the outer member  12  where it is coupled to the handle  44 . The flexible filament  42  also extends through the exit port  34  of the elongate member  26  for securement to the suture needle  28 . In one embodiment, the flexible filament  42  extends through the second opening  40  in the suture needle  28  adjacent the needlepoint  36 , and is secured within the second opening  40  through conventional means including knotting, adhesives or the like. Alternatively, the flexible filament  42  may be welded, secured and/or adhered directly to the outer surface of the suture needle  28 . 
     With continued reference to  FIGS. 1-4 , the suture  20  extends through the eye  38  of the suture needle  28  and through the second longitudinal passage  24  of the outer member  12  external of the proximal end portion  14  of the outer member  12 . In one embodiment, the suture  20  is not secured relative to the suture needle  28  and freely passes through the eye  38 . In the alternative, the suture  20  may be secured relative to the eye  38 . The suture  20  is capable of advancing or sliding through the second longitudinal passage  24  during use of the apparatus  10  in closing the wound opening. Suitable materials of fabrication for the suture  20  include natural or synthetic degradable materials, non-degradable materials, or combinations thereof. 
       FIG. 4  illustrates the armed condition of the suture needle  28 . In the armed condition, the needlepoint  36  and, possibly, at least a portion of the suture needle  28  extending from the needle point  36  are disposed radially outward relative to the outer boundary “b” or external diameter of the outer member  12 , and positioned to engage the tissue surrounding the wound opening. The suture needle  28  is normally biased to the armed condition, i.e., it is the normal shape of the suture needle  28 . 
       FIG. 5  illustrates the unarmed condition of the suture needle  28 . The unarmed condition is effected by pulling or retracting the flexible filament  42  of the deployment member  30  in a proximal direction toward the clinician through engagement with, e.g., the handle  44 , to apply a tensile force to the flexible filament  42  which is conveyed to the suture needle  28 . When subjected to this force, the suture needle  28  bends toward the elongate member  26  or radially inwardly relative to the central longitudinal axis ‘k”. In the unarmed condition, the suture needle  28  is disposed radially inward relative to the central longitudinal axis “k” such that the suture needle  28  and the needlepoint  36  are generally confined within the outer boundary or diameter “b” defined by the outer member  12 . In one embodiment, the outer member  12  includes a catch or hook  46  ( FIG. 2 ) adjacent the proximal end portion  14  about, or through, which the flexible filament  42  is positioned to securely retain the flexible filament  42  in a tensioned state and the suture needle  28  in the unarmed condition. Other arrangements for releasably securing the flexible filament  42  in the tensioned state may include a compressible ferrule on the flexible filament  42 , which is slidable to be at least partially received within the first longitudinal passage  22 . In this manner, the ferrule would be compressed about the flexible filament  42  to secure the filament  42 , and also be secured with the outer member  12  through engagement with the portions of the outer member  12  defining the first longitudinal passage  22 . 
       FIGS. 6A-6F  illustrate a method of use of the closure apparatus  10  in closing a wound opening. The following discussion will focus on the use of the apparatus in closing a puncture or port wound created by an obturator or trocar during a laparoscopic procedure. However, it is envisioned that the apparatus  10  may have application in closure of wounds due to trauma in any area of the body. 
     Subsequent to the performance of a laparoscopic procedure or maneuver within the abdominal cavity, the attention of the clinician is directed to closing the puncture or port wound extending through the abdominal cavity. The clinician grasps the apparatus  10  and threads the suture  20  through the second longitudinal passage  24  and through the eye  38  of the suture needle  28 . In one method, the suture  20  is not secured relative to the eye  38 . The needle assembly  18  and suture needle  28  are placed in the unarmed condition of  FIG. 6A  by pulling on the flexible filament  42  of the deployment member  30  in the direction of directional arrow “m” through engagement with the handle  44 , which places the flexible filament  42  under tension and bends the suture needle  28  and the needlepoint  36  radially inwardly relative to the central longitudinal axis “k” (see also  FIG. 5 ). The flexible filament  42  may be secured to the catch  46  adjacent the proximal end portion  14  of the outer member  12  ( FIG. 2 ) to releasably retain the flexible filament  42  and, thus, the suture needle  28  in the unarmed condition. 
     In the unarmed condition, the apparatus  10  is then introduced or positioned within the wound opening “w” extending through the subcutaneous tissue “s”, fascia “f”, muscle and abdominal lining of the abdominal wall. The apparatus  10  is advanced such that at least the suture needle  28  enters the abdominal cavity “c”. 
     Once the suture needle  28  is disposed within the abdominal cavity “c”, the suture needle  28  is moved to the armed condition by releasing the flexible filament  42  from the catch  46  and permitting the flexible filament  42  to advance within the longitudinal opening  32  of the elongate member  26  with at least a portion of the flexible filament  42  exiting through the exit port  34  in response to the bias of the suture needle  28  to its outward armed condition. Specifically, the suture needle  28 , which is no longer subjected to the forces of the flexible filament  42 , assumes its normal armed condition depicted in  FIG. 6B . In the armed condition, at least the needlepoint  36  of the suture needle  28  is disposed outwardly of the outer member  12  with the suture  20  coupled to the eye  38  of the suture needle  28  and extending back through the second longitudinal passage  24 . Thereafter, the apparatus  10 , including the outer member  12  and/or the needle assembly  18 , is at least partially withdrawn relative to the wound opening “w”, e.g., pulled in a proximal direction toward the clinician, which causes the needlepoint  36  and the suture needle  28  to pierce through first tissue portions “t1”, including fascia “f”, abdominal muscle and/or subcutaneous tissue “s”, to thereby pass a first suture segment  20   a  of the suture  20  through the first tissue portions “t1”, as depicted in  FIG. 6C . The apparatus  10  is retracted a distance to expose the first suture segment  20   a  of the suture  20  to the clinician. The first suture segment  20   a  may be grasped with, e.g., forceps, to pull the first suture segment  20   a  through the tissue outwardly of the abdominal cavity “c”. During this movement of the first suture segment  20   a , the suture  20  advances or slides through the second longitudinal passage  24  of the outer member  12 . The apparatus  10  is then advanced back within the wound opening “w” while the first suture segment  20   a  is retained or secured external of the abdominal cavity “c”. As the apparatus  10  is advanced within the wound opening “w”, the suture  20  slides within the second longitudinal passage  24  of the outer member  12 . 
     Referring now to  FIG. 6D , the entire apparatus  10  is reoriented or rotated within the wound opening “w” through an arc segment of, e.g., 180°, to arrange the suture needle  28  adjacent the opposed tissue on the other side of the wound opening “w”. The apparatus  10  is again at least partially withdrawn relative to the wound opening “w” or pulled proximally toward the clinician as depicted in  FIG. 6E  which causes the needlepoint  36 , the suture needle  28  and attached suture  20  to pass through the second tissue portions “t2” surrounding the wound opening “w”, including fascia “f” and/or the subcutaneous tissue “s”, to expose the second suture segment  20   b  of the suture  20  from the abdominal cavity “c”. During this movement, the suture  20  slides through the second longitudinal passage  24  of the outer member  12  in a similar manner as discussed hereinabove. With the first and second suture segments  20   a ,  20   b  exposed from the abdominal cavity “c” and passing through respective first and second tissue portions “t1”, “t2” surrounding the wound opening “w”, the remaining slack in the suture  20  is removed by pulling on the second suture segments  20   b  which causes the suture  20  to translate through the second longitudinal passage  24  and be released from the suture needle  28  and the outer member  12 . The apparatus  10  is removed, and the suture  20  is tightened with the first and second suture segments  20   a ,  20   b  tied off in a conventional manner to close the wound opening “w” as shown in  FIG. 6F . 
     Although the above-described method of wound closure includes passing two segments through tissue surrounding the wound opening “w” to close the wound, it is envisioned that more than two suture segments may be utilized. For example, four suture segments may be applied around the wound opening, which would entail, e.g., rotating the apparatus  10  through an arc sector of approximately 90° within the wound opening subsequent to application of each suture segment. 
     The above description and the drawings are provided for the purpose of describing embodiments of the present disclosure and are not intended to limit the scope of the disclosure in any way. It will be apparent to those skilled in the art that various modifications and variations can be made without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.