Patent Publication Number: US-2022225996-A1

Title: Ligation clip with improved hinge

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation application of U.S. application Ser. No. 16/432,984, filed on Jun. 6, 2019, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/717,958 filed Aug. 13, 2018, the entire disclosure of each of which is incorporated by reference herein. 
    
    
     BACKGROUND 
     1. Technical Description 
     The present disclosure is directed to ligation clips for sealing body vessels and, more particularly, to ligation clips that have first and second legs joined together by a hinge. 
     2. Background of Related Art 
     Ligation clips are well known in the surgical arts and are commonly used during surgical procedures to ligate tissue, e.g., a body vessel. Ligation clips include first and second jaws that are coupled to each other by a hinge, e.g., a living hinge. Typically, the hinge is formed from inner and outer hinge portions and extends between proximal ends of the first and second jaws such that the ligation clip can pivot between open and clamped positions. Since the ligation clip has first and second jaws that can pivot between the open and clamped positions, the ligation clip can be compressed to facilitate passage through a small diameter cannula, subsequently opened to allow the ligation clip to be positioned about tissue, and clamped to ligate the tissue. 
     When known ligation clips are repeatedly moved between the open and clamped positions, stress or strain in the hinge of the ligation clip may cause the ligation clip to crack or fracture. It is important that the hinge be configured to facilitate repeated movement of the ligation clip between the open and clamped positions to allow the clip to remain structurally sound during insertion of the ligation clip through a trocar and placement about tissue. 
     A continuing need exists in the art for a ligation clip with an improved hinge that allows for repeated movement of the ligation clip between open and clamped positions while reducing the likelihood that the hinge will fracture. 
     SUMMARY 
     One aspect of the present disclosure is directed to a ligation clip including a first jaw, a second jaw, and a hinge. The first jaw includes a body having an inner surface defining a first clamping surface, and an outer surface. The second jaw includes a body having an inner surface defining a second clamping surface, and an outer surface. The hinge is integrally formed with the first and second jaws and includes an inner hinge portion and an outer hinge portion. The inner hinge portion has an inner surface that is contiguous with the first and second clamping surfaces of the first and second jaws, and an outer surface. The hinge is configured to facilitate pivotal movement of the first jaw in relation to the second jaw between an open position and a clamped position. The inner surface of the inner hinge portion is defined by a plurality of curved sections. 
     In embodiments, the plurality of curved sections includes a concave section and two convex sections. 
     In some embodiments, the concave section is bounded by the two convex sections. 
     In certain embodiments, the outer surface of the inner hinge includes a central convex section that is bounded by two concave sections. 
     In embodiments, the inner hinge portion has a thickness that is uniform between the two convex sections. 
     In some embodiments, the outer hinge portion includes an inner surface and an outer surface, wherein the inner surface of the outer hinge portion and the outer surface of the inner hinge portion define a cavity in the hinge. 
     In certain embodiments, the outer surface of the outer hinge portion includes a central concave section that is bounded by two convex sections. 
     In embodiments, the first jaw includes a longitudinal rib having a tissue engaging surface that is positioned in opposition to the second clamping surface of the second jaw when the ligation clip is in the clamped position. 
     In some embodiments, the second jaw has a first row of protrusions supported on one side of the second clamping surface and a second row of protrusions supported on an opposite side of the second clamping surface, wherein each of the protrusions of the first and second rows of protrusions has an inner side wall in opposition to a side wall of the longitudinal rib when the ligation clip is in the clamped position. 
     In certain embodiments, the inner side wall of each of the protrusions of the first and second rows of protrusions is angled towards the second clamping surface. 
     In embodiments, the first row of protrusions is laterally spaced from the second row of protrusions to define a channel that extends longitudinally between the first and second rows of protrusions, wherein the channel is positioned and configured to receive the longitudinal rib when the ligation clip is in the clamped position. 
     In some embodiments, the protrusions in the first row of protrusions are longitudinally aligned and spaced from each other and the protrusions in the second row of protrusions are longitudinally aligned and spaced from each other. 
     In certain embodiments, each of the protrusions in the first row of protrusions is longitudinally offset from the protrusions in the second row of protrusions such that the protrusions in the first and second rows of protrusions are alternatingly positioned on opposite sides of the second clamping surface along at least a portion of the length of the second clamping surface. 
     In embodiments, the first jaw includes a first locking element and the second jaw includes a second locking element, wherein the first locking element is movable into engagement with the second locking element to retain the ligation clip in the clamped position. 
     In some embodiments, the first locking element includes a hooked portion that extends downwardly and proximally from the first tissue clamping surface and the second locking element is configured to engage the hooked portion. 
     In certain embodiments, the second locking element defines a cam surface that engages the hooked portion to bias the hooked portion outwardly of the second locking element such that the hooked portion resiliently returns to an unbiased state after passing over the second locking element to position the hooked portion in contact with the engagement surface. 
     In embodiments, the ligation clip is formed of a polymeric material. 
     In some embodiments, the second jaw includes a distal portion including spaced teeth that are configured to engage tissue. 
     In certain embodiments, each of the spaced teeth has an apex that is configured to grip and stretch tissue as the ligation clip is moved to the clamped position. 
     In embodiments, the second jaw includes a spring arm that is positioned to engage and be deflected by the first locking element as the ligation clip is moved from the open position to the clamped position to urge the first and second locking elements to a latched position. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various exemplary embodiments of the presently disclosed ligation clip are described herein below with reference to the drawings, wherein: 
         FIG. 1  is a side perspective view from a distal end of an exemplary embodiment of the presently disclosed ligation clip in an open position; 
         FIG. 2  is an enlarged view of the indicated area of detail shown in  FIG. 1   
         FIG. 3  is side view of the ligation clip shown in  FIG. 1  in the open position; 
         FIG. 4  is side view of the ligation clip shown in  FIG. 3  in the clamped position; 
         FIG. 4A  is a top view of the ligation clip shown in  FIG. 4  in the clamped position; 
         FIG. 5  is an enlarged view of the indicated area of detail shown in  FIG. 3 ; 
         FIG. 5A  is an enlarged view of a hinge of a Prior Art ligation clip; and 
         FIG. 6  is an enlarged view of the indicated area of detail shown in  FIG. 4 . 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     The presently disclosed ligation clip will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. It is to be understood that the disclosed embodiments are merely exemplary 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. 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 variously employ the present disclosure in virtually any appropriately detailed structure. 
     In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel. 
     Referring to  FIGS. 1-4A , an exemplary embodiment of the presently disclosed ligation clip is shown generally as ligation clip  10 . The ligation clip  10  includes a first jaw  12 , a second jaw  14 , and a hinge  16  coupling the first jaw  12  to the second jaw  14 . The first jaw  12  is pivotable in relation to the second jaw  14  about the hinge  16  to move the ligation clip  10  between an open position ( FIG. 1 ) and a clamped position ( FIG. 4 ). In the clamped position, the first and second jaws  12 ,  14  define a longitudinal axis “X” ( FIG. 4A ). In embodiments, the first and second jaws  12 ,  14  are curved along the longitudinal axis ( FIG. 4 ) although other jaw configurations are envisioned. In embodiments, the hinge  16  is a living hinge that is integrally formed with proximal portions of the first and second jaws  12 ,  14 . 
     The first jaw  12  has a body  12   a  having a proximal portion  18 , a distal portion  20 , and a clamping surface  22 . The second jaw  14  has a body  14   a  having a proximal portion  24 , a distal portion  26 , and a clamping surface  28 . The proximal portions  18 ,  24  of the first and second jaws  12 ,  14 , respectively, are coupled to the hinge  16  such that the ligation clip  10  can pivot between the open position ( FIG. 1 ) and the clamped position ( FIG. 4 ). The distal portion  20  of the first jaw  12  includes a first locking element  30  and spaced bosses  32 . The first locking element  30  includes a hooked portion  30   a  that extends downwardly and proximally from the tissue clamping surface  22  to define a portion of a latching mechanism  34  ( FIG. 4 ) that is configured to retain the ligation clip  10  in the clamped position as described in further detail below. 
     Each of the spaced bosses  32  of the first jaw  12  extends outwardly of the body  12   a . In embodiments, the spaced bosses  32  are integrally formed as a single transverse member  36  ( FIG. 1 ) that is supported on the distal portion  20  of the first jaw  12 . The transverse member  36  can be cylindrical although other configurations are envisioned. The bosses  32  extend outwardly from the body  12   a  of the first jaw  12  and are positioned and configured to be received within slots (not shown) formed in jaws of a clip applicator (not shown) to retain the ligation clip  10  on the clip applicator. 
     The second jaw  14  includes a body  14   a . The distal portion  26  of the body  14   a  of the second jaw  14  includes a second locking element  40 , spaced bosses  42 , and spaced teeth  44 . The spaced teeth  44  are configured to engage and/or penetrate tissue. In embodiments, each of the teeth  44  has an apex or pointed end  44   a  that grips and stretches tissue as the ligation clip  10  is moved from the open position ( FIG. 1 ) towards the clamped position ( FIG. 4 ) to improve the ligating characteristics of the ligation clip  10 . The second locking element  40  defines a cam surface  48  ( FIG. 1 ) that is configured to receive and guide the first locking element  30  into locking engagement with the second locking element  40  when the ligation clip  10  is moved to the clamped position ( FIG. 4 ) to secure the ligation clip  10  in the clamped position. In particular, the cam surface  48  is configured to deflect the first locking element  30  outwardly in a distal direction as the first locking element  30  passes over the cam surface  48  such that when the first locking element  30  moves past the cam surface  48 , the first locking element  30  resiliently moves into engagement with the second locking element  40 . 
     The bosses  42  of the second jaw  14  are similar to the bosses  32  of the first jaw  12 . More specifically, each of the spaced bosses  42  extends outwardly of the body  14   a  of the second jaw  14  and is positioned to be received within slots (not shown) formed in jaws of a clip applicator (not shown) to retain the ligation clip  10  on the clip applicator. 
     The second jaw  14  includes a spring arm  56  that is positioned to engage the first locking element  30  when the ligation element  10  is moved to the clamped position to retain the first locking element  30  and the second locking element  40  in the latched position ( FIG. 4 ). The spring arm  56  is positioned to engage and be deflected by the first locking element  30  to create a compressive force within the spring arm  56  that presses against the second locking element  40 . 
     In embodiments, each of the first and second clamping surfaces  22 ,  28  of the first and second jaws  12 ,  14 , respectively, can include tissue retaining structure that is configured to prevent the ligation clip  10  from sliding along tissue while the ligation clip  10  is in the clamped position about the tissue. In embodiments, the clamping surface  22  of the first jaw  12  may include a longitudinal rib  60  that extends along all or a portion of the length of the clamping surface  22 . In embodiments, the second clamping surface  28  of the second jaw  14  may also include a series of first protrusions  62  that are positioned along one side of the clamping surface  28  of the second jaw  14  and a series of second protrusions  64  that are formed along an opposite side of the second clamping surface  28  of the second jaw  14 . In some embodiments, the first protrusions  62  are spaced from the second protrusions  64  to define an unobstructed channel that receives the longitudinal rib  60  when the ligation clip  10  is in the clamped position. In embodiments, the protrusions  62 ,  64  have an angled outer wall  70  ( FIG. 2 ), a flat top wall  72 , and an inner wall having a vertical portion  74 , and a tapered portion  76 . In certain embodiments, the first protrusions  62  are axially offset from the second protrusions  64  such that the first and second protrusions  62 ,  64  are alternatingly positioned along the longitudinal length of the second clamping surface  28 . 
     Referring to  FIGS. 5-6 , the hinge  16  includes an inner hinge portion  80  and an outer hinge portion  82 . The inner hinge portion  80  includes an inner surface  84  that is contiguous with the first and second clamping surfaces  22 ,  28  of the first and second jaws  12 ,  14 , respectively, and an outer surface  86 . The outer hinge portion  82  includes an inner surface  88  and an outer surface  90 . The outer surface  86  of the inner hinge portion  80  and the inner surface  88  of the outer hinge portion  82  define a cavity  92  within the hinge  16 . The outer surface  90  of the outer hinge portion  82  is contiguous with outer surfaces  96 ,  98  of the first and second jaws  12 ,  14  of the ligation clip  10 . 
     In the open position of the ligation clip  10  ( FIG. 5 ), the outer surface  86  of the inner hinge portion  80  includes a plurality of different curved sections. More specifically, the outer surface  86  of the inner hinge portion  80  includes a central convex section  100  that is bounded by concave sections  102 . Similarly, the inner surface  84  of the inner hinge portion  80  includes a plurality of curved sections including a central concave section  104  that is bounded by convex sections  106 . In embodiments, the convex sections  106  are contiguous with the clamping surfaces  22 ,  28  of the first and second jaws  12 ,  14  of the ligation clip  10 . In some embodiments, the inner hinge portion  80  has a substantially uniform thickness between the concave sections  102  and the convex sections  106  of the inner hinge portion  80 . 
     In the open position of the ligation clip  10 , the outer surface  90  of the outer hinge portion  82  also defines a convex section  110  that is bounded by less pronounced concave sections  112 . In contrast, the inner surface  88  of the outer hinge portion  82  defines a single arcuate surface. 
     Referring to  FIG. 5A , in contrast to the hinge  16  of the presently disclosed ligation clip  10 , the hinge  216  of known ligation clips  200  includes an inner hinge portion  280  that has inner and outer surfaces  284 ,  286  that define a single arc or curved surface. The hinge  216  also includes an outer hinge portion  282  that has inner and outer surfaces  288 ,  290  that define a single arc or curved surface. 
     Referring to  FIG. 6 , when the ligation clip  10  is moved to the clamped position, the configuration of the inner hinge  80  and to a lesser extent, the outer hinge portion  82 , reduces the stress or strain in the hinge  16  as the ligation clip  10  is moved between the open and clamped position as compared to the stress or strain in known ligation clips, e.g., clip  200 . As such, the ligation clip  10  is more capable of repeated movement between the open position and the clamped positions without fracturing and/or comprising the structural integrity of the ligation clip  10 . 
     In embodiments, the surgical ligation clip  10  may be made, in whole or in part, of a resilient bioabsorbable and/or biocompatible polymeric material. Examples of suitable bioabsorbable and/or biocompatible polymers include acetal polyoxymethylene (POM), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene, polyetheretherketone (PEEK), polypropylene, and polyethylene or other thermoplastic materials having similar properties that can be injection-molded. The clip may also be made of a polymer material or materials in combination with radiolucent metal alloys. Alternately, other materials may be used to form the clip  10  including biocompatible metals, plastics and composites. 
     Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.