Abstract:
The present disclosure relates to a surgical needle that includes a proximal end adapted for attachment to a surgical filament, a distal end, and a shaft extending therebetween. An outer surface of the shaft includes reduction structure configured and dimensioned to reduce contact between the outer surface and tissue without unnecessarily compromising the structural integrity or strength of the needle. Additionally, the configuration and dimensions of the reduction structure facilitate atraumatic insertion and passage of the surgical needle through the tissue during use.

Description:
BACKGROUND 
       [0001]    1. Technical Field 
         [0002]    The present disclosure relates generally to apparatus for securing together tissue. More particularly, the present disclosure relates to a needle for use during surgical procedures including a reduced surface area to facilitate advancement of the needle through tissue. 
         [0003]    2. Background of the Related Art 
         [0004]    In surgical procedures, sutures are used to repair openings in skin, internal organs, blood vessels, and the like, as well as to join various tissues together. Generally, sutures are attached to a surgical needle that is forced through tissue to create an opening through which the suture may be drawn. However, contact between the surgical needle and the tissue can create forces of adhesion that can inhibit advancement of the needle, thus necessitating the application of increased force and potentially resulting in increased tissue trauma. 
         [0005]    To address this concern, many surgical needles include structure that limits contact between the needle&#39;s outer surface and the tissue. For example, U.S. Pat. No. 3,160,157 to Chisman (hereinafter “Chisman”) and U.S. Pat. No. 5,002,565 to McGregor (hereinafter “McGregor I”) each describe surgical needles that include a plurality of raised edges or ribs defining recessed portions therebetween. U.S. Pat. No. 5,853,423 to McGregor et al. (hereinafter “McGregor II”) discusses a surgical needle that includes grooves defined in the outer surface. However, the edges discussed in both Chisman and McGregor I and the grooves described in McGregor II extend uninterruptedly along a substantial portion of the needle&#39;s length, thereby unnecessarily compromising the strength of the needle. Additionally, U.S. Patent Publication No. 2006/0173491 to Meade et al. (hereinafter “Meade”) describes an arcuate suturing needle that includes a plurality of notches formed in an outer surface. However, the notches constitute abrupt, pronounced variations in the outer surface of the needle, and are configured and dimensioned to facilitate engagement with an external structure, such as a drive mechanism or a pin. Consequently, were the Meade needle to be used in an alternate application, e.g., without the drive mechanism, the notches may snag or catch the tissue, thereby resulting in unnecessary trauma. 
         [0006]    Accordingly, a need remains in the art for a surgical needle including structure that facilitates atraumatic insertion of the needle through tissue by decreasing contact between the outer surface of the needle and the tissue, and thus, the amount of force required to advance the needle, without unnecessarily compromising the structural integrity or strength of the needle. 
       SUMMARY 
       [0007]    In one aspect of the present disclosure, a surgical needle is disclosed including a proximal end that is adapted for connection with a surgical filament, a distal end, and a shaft extending therebetween. An outer surface of the shaft includes reduction structure positioned intermittently along the length of the shaft. The reduction structure is configured and dimensioned to reduce contact between the surgical needle and tissue, and to facilitate atraumatic insertion and passage of the surgical needle through the tissue during use. 
         [0008]    In one embodiment, the reduction structure includes at least one protrusion that extends outwardly from the outer surface of the shaft. The at least one protrusion may define any suitable geometric configuration, including but not limited to a substantially oval, substantially circular, substantially arcuate, or substantially linear configuration. In this embodiment of the reduction structure, the at least one protrusion may be configured such that the outer surface of the shaft is threaded. In an alternative embodiment, the at least one protrusion may include a plurality of protrusions that are spaced about a periphery of the shaft. In this embodiment, the plurality protrusions may be positioned uniformly, or randomly, about the outer surface of the shaft. 
         [0009]    In an alternate embodiment of the reduction structure, the reduction structure includes at least one indentation extending inwardly from the outer surface of the shaft. The at least one indentation may define any suitable geometric configuration, including but not limited to a substantially oval, substantially circular, substantially arcuate, or substantially linear configuration. In one embodiment of the reduction structure, the at least one indentation may be configured such that the outer surface of the shaft is threaded. In an alternative embodiment, the at least one indentation may include a plurality of indentations that are spaced about a periphery of the shaft. In this embodiment, the plurality of protrusions may be positioned uniformly, or randomly, about the outer surface of the shaft. 
         [0010]    In an alternate aspect of the present disclosure, a surgical needle assembly is disclosed that includes a surgical filament connected to a needle. The needle includes a shaft with an outer surface having at least one protrusion associated therewith. The at least one protrusion extends outwardly from the shaft and is configured and dimensioned to reduce contact between the shaft, and to facilitate atraumatic insertion and passage of the surgical needle through the tissue during use. 
         [0011]    The at least one protrusion may include a plurality of protrusions spaced along a length of the shaft, and/or a plurality of protrusions spaced about a periphery of the shaft. 
         [0012]    In another aspect of the present, a method of manufacturing a surgical needle is disclosed that includes the steps of providing an elongate member and altering an outer surface of the elongate member to include reduction structure positioned along the elongate member. The reduction structure is positioned intermittently along a length of the elongate member and is configured and dimensioned to reduce contact between the elongate member and tissue, and to facilitate atraumatic insertion and passage of the elongate member through the tissue during use. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    Various embodiments of the present disclosure are described herein below with reference to the drawings, wherein: 
           [0014]      FIG. 1  is a side, perspective view of a surgical needle assembly including a filament and a needle incorporating reduction structure in accordance one embodiment of the present disclosure; 
           [0015]      FIG. 1A  is a side, perspective view of an alternate embodiment of the needle seen in  FIG. 1  exhibiting a substantially linear configuration; 
           [0016]      FIG. 2  is a front, end view of the needle seen in  FIG. 1 ; 
           [0017]      FIG. 3  is a side, plan view of the needle seen in  FIG. 1  including an alternate embodiment of the reduction structure; 
           [0018]      FIG. 4  is a side, plan view of the needle seen in  FIG. 1  including another embodiment of the reduction structure; 
           [0019]      FIG. 5  is a front, end view of the needle seen in  FIG. 4 ; 
           [0020]      FIGS. 6-11  are side, plan views of the needle seen in  FIG. 1  illustrating additional embodiments of the reduction structure; 
           [0021]      FIG. 12  is a front, end view of the needle seen in  FIG. 11 ; 
           [0022]      FIGS. 13-19  are side, plan views of the needle seen in  FIG. 1  illustrating additional embodiments of the reduction structure; and 
           [0023]      FIG. 20  is a side, perspective view of the needle seen in  FIG. 1  including an additional embodiment of the reduction structure. 
       
    
    
     DETAILED DESCRIPTION 
       [0024]    In the following description and in the accompanying drawings, in which like references numbers identify similar or identical elements, the term “proximal” should be understood as referring to the end of the presently disclosed surgical needle assembly, or any component thereof that is closest to a practitioner during proper use, while the term “distal” should be understood as referring to the end that is furthest from the practitioner during proper use. Additionally, the term “filament” should be understood as referring to any elongate member suitable for the intended purpose of joining tissue, including but not limited to sutures, ligatures, and surgical tape, and the term “tissue” should be understood as referring to any bodily tissue, including but not limited to skin, fascia, ligaments, tendons, muscle, and bone. 
         [0025]      FIG. 1  illustrates one embodiment of a surgical needle assembly, referred to generally by reference character  1000 , that includes a filament  100  and a needle  200  that is attachable to an end  102  of the filament  100 . The filament  100  can be formed from any suitable biocompatible material of either the absorbable or non-absorbable variety, including but not limited to catgut, silk, nylon, polyesters, polyethylene, polypropylene, steel, polymeric and copolymeric materials, and stainless steel. Desirably, the filament  100  has a measure of flexibility such that the filament  100  can be manipulated by a practitioner to join adjacent sections of tissue together. As an illustrative example, the filament  100  may be used to repair or close an incision, wound, or the like using conventional suturing techniques. 
         [0026]    With reference now to  FIG. 2  as well, the needle  200  will be discussed. The needle  200  may be formed of any suitable biocompatible material, including but not limited to stainless steel or polymeric materials, and may define a configuration that is partially or wholly arcuate, as shown, or substantially linear, as seen in  FIG. 1A . 
         [0027]    The needle  200  is an elongate member that includes proximal and distal ends  202 ,  204 , respectively, and a shaft  206  that extends therebetween. The proximal end  202  of the needle  200  is attachable, either releasably or fixedly to the end  102  of the filament  100 , and may be attached thereto in any suitable manner. For instance, in the embodiment of the needle assembly  1000  illustrated in  FIG. 1 , the proximal end  202  of the needle  200  includes a bore  208  that is configured and dimensioned to receive the end  102  of the filament  100 . In an alternate embodiment, however, the filament  100  and the needle  200  may be integrally formed. 
         [0028]    The distal end  204  of the needle  200  may exhibit any configuration suitable for the intended purpose of facilitating the penetration of tissue. While the needle  200  is illustrated as including a distal end  204  that is pointed or incisive, alternatively, the distal end  204  may be substantially blunt. 
         [0029]    The shaft  206  extends from the proximal end  202  to the distal end  204  along an axis “A” to define a length “L”. The shaft  206  includes reduction structure  210  that extends away, i.e., outwardly of, or inwardly from, an outer surface  212  of the shaft  206 . The reduction structure  210  is configured and dimensioned to create gradual, smooth topographical variations in outer surface  212  of the shaft  206  to decrease the surface area of the needle  200  that is in contact with tissue during use. By decreasing the surface area of the needle  200  that is in contact with tissue, the reduction structure  210  reduces the force necessary to advance the needle  200 , and facilitates the atraumatic insertion and removal thereof. 
         [0030]    In the embodiment of the reduction structure  210  seen in  FIGS. 1 and 2 , the reduction structure  210  includes one or more protrusions  214  extending outwardly of the outer surface  212  of the shaft  206 . As illustrated, the reduction structure  210  includes three protrusions  214  that are spaced about the periphery of the needle  200 . The protrusions  214  may be spaced equally from each other to define a distance “C” therebetween, as seen in  FIGS. 1-2 , or alternatively, the spacing between adjacent protrusions  214  may vary. The protrusions  214  may each define an equivalent dimension “D” as shown, or alternatively, may vary in size. In additional embodiments of the reduction structure  210 , the protrusions  214  may be present in fewer or greater numbers and/or may be arranged differently, as described below. 
         [0031]    Although illustrated as substantially oval in configuration, the protrusions  214  may exhibit any other suitable geometric configuration. For example, the reduction structure  210  may include protrusions  314  that are substantially circular, as seen in  FIG. 3 . Instead, the reduction structure  210  may include one or more protrusions  414  having an arcuate configuration such that the protrusions  210  extend continuously about the periphery of the shaft  206  to define one or more ribs  416 , as seen in  FIGS. 4-5 . The reduction structure  210  may alternatively include one or more protrusions  416  attributing a threaded configuration to the outer surface  212  of the needle  200 , as seen in  FIG. 6 . In another variation, the reduction structure  210  may include protrusions  514  that are substantially linear in configuration, as seen in  FIG. 7 . The linear protrusions  514  may extend along the axis “A”, as seen in  FIG. 7 , or alternatively, may extend in transversely in relation thereto, as seen in  FIG. 8 . While the reduction structure  210  has been described and illustrated as including only a single variety of protrusion in the embodiments seen in  FIGS. 1-8 , it should be appreciated that alternate embodiments of the reduction structure  210  may include any suitable combination of the aforedescribed protrusions. 
         [0032]    Referring again to  FIG. 1 , the protrusions  214  may be are arranged about the periphery of the shaft  206  to define a single band  218 . Alternatively, however, the protrusions  210  may be arranged to define a plurality of bands  218  that are spaced along the length “L” of the shaft  206 , as seen in  FIG. 9 , or the protrusions  214  may be positioned uniformly along the length “L” of the shaft, as seen in  FIG. 10 . 
         [0033]    Referring now to  FIGS. 11-19 , another embodiment of the reduction structure, referred to generally by reference character  210 ′, will be discussed. In this embodiment, the reduction structure  210 ′ includes one or more indentations  214 ′ extending inwardly from the outer surface  212  of the shaft  206 . 
         [0034]    In the embodiment of the reduction structure  210 ′ seen in  FIGS. 11-12 , the reduction structure  210 ′ is illustrate as including three indentations  214 ′ that are spaced about the periphery of the needle  200 . The indentations  214 ′ may be spaced equally from each other to define a distance “C 1 ” therebetween, as seen in  FIGS. 11-12 , or alternatively, the spacing between adjacent indentations  214 ′ may vary. The indentations  214 ′ may each define an equivalent dimension “D 1 ” as shown, or alternatively, may vary in size. In additional embodiments of the reduction structure  210 ′, the indentations  214 ′ may be present in fewer or greater numbers and/or may be arranged differently, as described below. 
         [0035]    While the indentations  214 ′ are illustrated as substantially oval on configuration, any other suitable geometric configuration may be employed. For example, the reduction structure  210 ′ may include indentations  314 ′ that are substantially circular, as seen in  FIG. 13 . Instead, the reduction structure  210 ′ may include indentations  414 ′ having an arcuate configuration such that the indentations  414 ′ extend continuously about the periphery of the shaft  206  to define one or more channels  416 ′, as seen in  FIG. 14 . The reduction structure  210 ′ may alternatively include one or more indentations  416 ′ attributing a threaded configuration to the outer surface  212  of the needle  200 , as seen in  FIG. 15 . In another variation, the reduction structure  210  may include indentations  514 ′ that are substantially linear in configuration, as seen in  FIG. 16 . The linear indentations  514 ′ may extend along the axis “A”, as seen in  FIG. 16 , or alternatively, may extend transversely in relation thereto, as seen in  FIG. 17 . 
         [0036]    Referring again to  FIG. 11 , the reduction structure  210 ′ may include indentations  214 ′ that are arranged about the periphery of the shaft  206  to define a single band  218 ′. Alternatively, however, the indentations  214 ′ may be arranged to define a plurality of bands  218 ′ that are spaced along the length “L” of the shaft  206 , as seen in  FIG. 18 , or the indentations  214 ′ may be positioned uniformly along the length “L” of the shaft  206 , as seen in  FIG. 19 . 
         [0037]      FIG. 20  illustrates the needle  200  including another embodiment of the reduction structure, referred to generally by reference character  310 . In this embodiment, the reduction structure  310 ′ includes a combination of protrusions and indentations. Although illustrated as including the protrusions  218  discussed above with respect to  FIG. 1  and the indentations  218 ′ discussed above with respect to  FIG. 11 , in alternate embodiments of the reduction structure  310 , any of the aforedescribed protrusions or indentations may be included, either alone or in combination. 
         [0038]    The reduction structure  210 ,  210 ′,  310  described above with reference to  FIGS. 1-10 ,  FIGS. 11-19 , and  FIG. 20 , respectively, may be formed through any suitable method of manufacture. Referring to  FIG. 18  as an example, the indentations  214 ′ of the reduction structure  210 ′ may be formed by grinding or milling the outer surface  212  of the needle  202 , e.g., through the use of mechanical apparatus or lasers, or alternatively, the needle  200  may be cast in a die configured and dimensioned to form the indentations  214 ′. 
         [0039]    Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are intended to be construed as non-limiting, exemplary embodiments, and that the features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Additionally, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. As such, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.