Patent Abstract:
A surgical clip applier comprises a first arm ( 12 ) and a second arm ( 14 ) pivotable relative to each other and defining proximal ends ( 16, 18 ) for manually controlling the applier, and distal ends ( 26, 28 ); jaws ( 30 ) positioned between the distal ends such ( 26, 28 ) that pivot of the first arm ( 12 ) relative to the second arm ( 14 ) opens and closes the jaws ( 30 ); and a setting element ( 32 ) movably mounted in one ( 12 ) of the first arm and the second arm and extending into contact with the other ( 14 ) of the first arm and the second arm to define a maximum open position of the first arm ( 12 ) relative to the second arm ( 14 ), and wherein a change of position of the setting element ( 32 ) adjusts the maximum open position.

Full Description:
BACKGROUND OF THE INVENTION 
       [0001]    The invention relates to a surgical clip applier. 
         [0002]    Surgical clip appliers are used to apply surgical clips or fasteners to tissues and other areas of a surgical site during the course of various surgical procedures. Clip appliers include automatic and manual appliers, and the present invention is directed toward manual appliers. 
         [0003]    Known clip appliers include jaws which are used to hold a clip and a mechanism which is used to close the jaws so that the clip can be closed upon the desired location. These devices must be precise, reliable and user friendly for the surgeon. Producing these qualities, however, frequently requires the applier to be complicated and expensive, which is not conducive to a single-use item. In addition, the complex structures incorporated into such apparatus are problematic during cleaning and sterilization. 
         [0004]    Another issue with known clip appliers is over-opening of the jaws. This is problematic because if jaws open too far, a clip held in the jaws can inadvertently be dropped, potentially within the surgical site with obvious complications resulting therefrom. 
         [0005]    The focus of the present invention is to overcome the above-identified disadvantages. 
       SUMMARY OF THE INVENTION 
       [0006]    In accordance with the invention, the foregoing issues are addressed. As disclosed herein, a surgical clip applier is provided which has a setting screw advantageously positioned to allow precise setting of a maximum open width of the jaws. Further, the clip applier of the present invention can have jaws which are easily installed and removed from the body of the clip applier, thus making the jaws reposable and allowing for extended use of the components of the arms or handle portion of the applier. 
         [0007]    According to the invention, a surgical clip applier is provided which comprises a first arm and a second arm pivotable relative to each other and defining proximal ends for manually controlling the applier, and distal ends; jaws positioned between the distal ends such that pivot of the first arm relative to the second arm opens and closes the jaws; and a setting element movably mounted in one of the first arm and the second arm and extending into contact with the other of the first arm and the second arm to define a maximum open position of the first arm relative to the second arm, and wherein a change of position of the setting element adjusts the maximum open position. 
         [0008]    The surgical clip applier may further comprise the following features, taken alone or in combination whenever it is technically possible. 
         [0009]    The setting element may be a setting screw threadedly mounted in one of the first arm and the second arm and extending into contact with the other of the first arm and the second arm to define a maximum open position of the first arm relative to the second arm, and wherein rotation of the setting screw changes a position of the setting screw and thereby adjusts the maximum open position. 
         [0010]    The first arm and the second arm may each define portions which are proximal of a pivot point between the first arm and the second arm such that the portions move toward each other during opening of the arms, wherein the setting element extends from the portion of the first arm toward the portion of the second arm. 
         [0011]    The jaws may be releasably held between the distal ends. 
         [0012]    The jaws may have a proximal groove sized to fit around a pivot between the first arm and the second arm, and a snap structure defined between the jaws and the distal ends to releasably hold the jaws between the proximal ends. 
         [0013]    When the jaws are engaged with the distal ends for use of the applier, the groove may engage the pivot and the snap structure may be engaged. 
         [0014]    The jaws may be configured such that squeezing the jaws toward each other disengages the snap structure. 
         [0015]    The surgical clip applier may comprise at least one biasing member for resiliently biasing the jaws toward an open position. 
         [0016]    The biasing member may comprise a first prong positioned along the first arm and a second prong positioned along the second arm to apply an opening force to the first arm and the second arm, wherein the prongs are parts of the jaws. 
         [0017]    At least one of the prongs may have a knee for biaising the prong toward a bent configuration whenever the prong is straightened, the knee being further arranged to come into contact with the other prong then straighten the bent prong whenever the jaws are moved towards each other. 
         [0018]    The biasing member may comprise an opening spring positioned relative to the first arm and the second arm to apply an opening force to the first arm and the second arm. 
         [0019]    The first arm may be pivotably mounted to the second arm with at least one slidable plate on one arm engaged in a groove on the other arm. 
         [0020]    The first arm may be pivotally mounted to the second arm with a screw assembly. 
         [0021]    the first arm may be pivotably mounted to the second arm with a tapped rivet. 
         [0022]    According to the invention, a method for assembling a surgical clip applier is provided which comprises the steps of: engaging a first arm with a second arm along curved surfaces defining a pivot point between the first arm and the second arm; pivoting the first arm toward the second arm to engage the curved surfaces of the pivot point against separation from each other; adjusting a setting element in one arm relative to the other arm to set a maximum open position of the first arm relative to the second arm; and inserting a jaws member into engagement with distal ends of the first arm and the second arm, whereby the clip applier is assembled and ready for use. 
         [0023]    Other objects, advantages and details of the present invention will be further discussed hereinbelow. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]    A detailed description of preferred embodiments of the invention follows, with reference to the attached drawings, wherein: 
           [0025]      FIGS. 1 and 1A  are perspective illustrations of a surgical clip applier in accordance with the present invention; 
           [0026]      FIGS. 2 and 2A  are enlarged perspective illustrations of the jaws and distal portion of the surgical clip applier in accordance with the present invention; 
           [0027]      FIGS. 3 and 3A  are top views similar to  FIGS. 2 and 2A ; 
           [0028]      FIGS. 4-7  illustrate installation and removal of jaws from a surgical clip applier in accordance with the present invention; 
           [0029]      FIGS. 8 and 9  illustrate the snap in structure which hold jaws in the surgical clip applier in accordance with the present invention; 
           [0030]      FIGS. 10 and 11  illustrate an additional opening spring which may be included in certain embodiments of the present invention; 
           [0031]      FIG. 12  further illustrates aspects of the arms of the surgical clip applier as well as the pivot connection and setting screw; 
           [0032]      FIGS. 13 and 14  illustrate one embodiment of the structure of the pivot connection of a surgical clip applier in accordance with the present invention; 
           [0033]      FIGS. 15 and 16  illustrate alternate pivot connections; 
           [0034]      FIGS. 17-22  illustrate a method for assembling a surgical clip applier in accordance with the present invention; and 
           [0035]      FIGS. 23 and 23A  illustrate another embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0036]    The invention relates to a surgical clip applier which has enhanced adjustability to a maximum open position, reposable jaws and improved simplicity from an assembly, use, and sterilization standpoint. 
         [0037]      FIGS. 1 and 1A  show a surgical clip applier  10  in accordance with the present invention, wherein  FIG. 1A  shows some components of  FIG. 1  transparently to illustrate inner details. Applier  10  has a first arm  12  and a second arm  14 , which are pivotally connected with each other to form a scissor-like instrument. Proximal portions  16 ,  18  of arms  12 ,  14  can be formed as loops  20  or other suitable structures to facilitate the manual operation of the applier, for example by being gripped in one hand of a surgeon. 
         [0038]    Shaft portions  22  lead from proximal portions  16 , toward a pivot point  24  and distal portions  26 ,  28  extend from pivot point  24 . 
         [0039]    Jaws  30  are positioned between distal portions  26 ,  28  such that operation of arms  12 ,  14  to pivot around pivot point  24  serves to open and close distal portions  26 ,  28  and jaws  30  positioned therebetween. 
         [0040]    As is well known to persons skilled in this art, jaws  30  are used to manually apply surgical clips, one at a time, to desired locations or tissues within a surgical site. Arms  12 ,  14  define a scissor-like instrument which is manipulated by the surgeon or other person using the clip applier to open and close the jaws  30  such that a clip disposed between the jaws can be closed onto a desired location. After application of a clip, the jaws are opened and a new clip is positioned in the jaws for the next application. 
         [0041]    Also considering  FIGS. 2 and 2A , additional detail of the jaws  30  and distal portions  26  and  28  can be seen as can a setting element  32  which, in accordance with the invention, can advantageously be used to adjust the maximum open position of the clip applier  10 , preferably so that the jaws cannot accidentally open wide enough to inadvertently drop a clip before it is applied. 
         [0042]    As shown, arms  12 ,  14  have portions  34 ,  36  which are positioned proximally of pivot point  24 , and setting element  32  is a screw which is advantageously threadedly engaged in one portion  34  so that it extends toward contact with the other portion  36 . Arms  12 ,  14  are configured such that portions  34 ,  36  move toward each other as arms  12 ,  14  are opened. This can be accomplished, for example, by having portion  34  attached to arm  14  and having portion  36  attached to arm  12 . It should be readily appreciated that with such a configuration, spreading of arms  12 ,  14  results in closing of portions  34 ,  36 . 
         [0043]      FIGS. 2 and 2A  also show setting screw  32  threadedly engaged in portion  34  and extending toward contact with portion  36 . It should be appreciated that adjusting of setting screw  32  changes the position of setting screw  32  within portion  34  and thereby changes the relative position of arm  14  with respect to arm  12  at which setting screw  32  will contact portion  36 . Thus, adjusting setting screw  32  allows fine tuning and adjusting of the maximum open position of arms  12 ,  14  and, therefore, jaws of clip applier  10  in accordance with the present invention. 
         [0044]      FIGS. 3 and 3A  show similar details as  FIGS. 2 and 2A , from a top position, and additional details of jaws  30  can also be seen which will be discussed below. 
         [0045]    In accordance with the invention, and as discussed above, it is desirable that the jaws  30  be removable for special sterilization, etc. between uses, and eventually for being discarded and replaced with new jaws. Further, this removable nature of the jaws allows jaws of different sizes to be used with the same handle. For example, one handle could be configured to use with small, small-medium and medium jaws for applying clips of corresponding sizes. 
         [0046]    To this end, jaws  30  can advantageously be defined by a substantially flat member  38  having a proximal end and a distal end. The proximal end can advantageously having a groove  40  for passing around or engaging pivot point  24 , and two arms or prongs  42  extending distally from groove  40  to terminate in respective jaw members  44 . As will further be discussed below, each prong  42  advantageously has a snap structure which releasably engages with distal portions  26 ,  28  so that jaws  30  can be installed into and then released from distal portions  26 ,  28  as desired. It should also be noted that, as best seen in  FIG. 2 , the actual jaw members  44  of jaws  30 , which hold clips to be applied, can be angled somewhat downwardly from the plane of the prongs  42 , and can also have channels defined at inwardly facing surfaces thereof, which channels serve to better hold a clip between the jaws. 
         [0047]    In order to install jaws into a surgical clip applier in accordance with the present invention, one would follow the series of steps shown in  FIGS. 4-6 .  FIG. 4  shows jaws  30  outside of clip applier  10 , with groove  40  aligned with the distal portions  26 ,  28  of applier  10 . Sliding the substantially flat member  38  of jaws  30  into the position shown in  FIG. 5  aligns prongs  42  with ridges which extend longitudinally along distal portions  26 ,  28 . Jaws  30  are pushed into applier  10  in this manner until the position in  FIG. 6  is reached, wherein groove  40  engages pivot point  24  and a snapping structure between jaws  30  and distal portions  26 ,  28  engages to hold jaws  30  in place. In this position ( FIG. 6 ), surgical clip applier  10  in accordance with the invention is ready for use. 
         [0048]    When jaws  30  are to be removed from the clip applier, a pinching force (arrow A,  FIG. 7 ) can be applied to jaw members  44  to disengage the snapping structure between jaws  30  and distal portions  26 ,  28  and jaws  30  can then distally slide out from distal portions  26 ,  28  as shown in  FIG. 7 . 
         [0049]      FIGS. 8 and 9  show an enlarged portion of the snap assembly between jaws  30  and distal portions  26 ,  28 .  FIG. 8  shows distal portion  28  having a shoulder  46 , and shows prong  42  having an oppositely directed shoulder  48 . Because jaws are resilient and flexible, prongs  42  of jaws  30  will laterally compress as jaws  30  are inserted into distal portions  26 ,  28 , until shoulder  48  snaps past shoulder  46  into the position shown in  FIG. 9 . In this position, shoulders  46 ,  48  hold jaws  30  into distal portions  26 ,  28  until removal of the jaws following the process shown in  FIG. 7 . 
         [0050]      FIGS. 10 and 11  further illustrate an additional feature of the present invention wherein an opening spring can be included and positioned between shaft portions  22 , at a position which is proximal of pivot points  24 . Opening spring  50  serves to provide an additional opening force, as well as a resistive force against closing, which can be desirable depending upon the use and user of the device. As shown, opening spring  50  can have a coil portion  52  and two arms  54 ,  56  which can be extended into contact with shafts  22  as shown in  FIG. 10 . 
         [0051]    It should be appreciated that opening spring  50  is an optional feature in accordance with the present invention since jaws  30  are ideally designed to apply a sufficient opening force to distal portions  26 ,  28  of arms  12 ,  14 . Nevertheless, opening spring  50  can be incorporated into surgical clip applier  10  in accordance with the present invention, either in addition to or instead of the spring force which is otherwise generated by jaws  30  in accordance with the present invention. 
         [0052]      FIG. 12  further illustrates the shape and features of portions of arms  12 ,  14  in accordance with the present invention. Portions  34 ,  36  are illustrated, as is setting screw  32 , and this figure also further illustrates the relationship between portions  34  and  36 , setting screw  32  and operation of the device in accordance with the present invention. 
         [0053]    When applier  10  is to be opened, arms  12 ,  14  are opened as shown by arrows B in  FIG. 12 . It should be appreciated that this motion, translated to distal portions  26 ,  28  around pivot point  24  would also result in an opening of distal portions  26 ,  28  and jaws  30  positioned therebetween as shown by arrows C. Thus, portion  34  can be associated with arm  14  while portion  36  is associated with arm  12 . In this manner, when arms  12 ,  14  and jaws  30  are opened as shown by arrows B, C, portions  34 ,  36  move toward each other. Setting screw  32  engages portion  36  to stop opening of the arms and jaws in the pre-selected desired maximum position. 
         [0054]      FIGS. 13 and 14  illustrate a preferred embodiment of a structure for pivot point  24  in accordance with the present invention, wherein portions of the arms  12 ,  14  are in the form of plates  53  which can engage along rounded surfaces with grooves  55  of the other of first and second arm  12 ,  14 . In this embodiment, no screws or rivets of any kind are needed, and the arms  12 ,  14  engage each other along rounded surfaces that define a point of pivot therebetween. Once the plates  53  of one arm are engaged in grooves  55  of the other arm, the arms are pivotably held together in a desired position. The contacting edges of plates  53  and grooves  55  are referred to as rounded, and this rounding is in an arc which centers on the pivot point between arms  12 ,  14 . In this way, while plates  53  and grooves  55  are engaged, they provide for smooth and stable pivot as desired. 
         [0055]      FIG. 15  illustrates an alternate embodiment wherein a screw  57  is used to pivotably secure arms  12 ,  14  relative to each other. 
         [0056]      FIG. 16  illustrates a still further alternate embodiment of the invention wherein a tapped rivet  58  is used to define pivot point  24  between arms  12 ,  14  and also to manage the gap between the two arms in the z-direction. With this configuration, the box lock defined between the arms can be tightened as needed to reduce misalignment in the distal area. 
         [0057]      FIGS. 17-22  illustrate a sequence of assembly of a surgical clip applier in accordance with the present invention. As shown in  FIG. 17 , the assembly procedure can be started by aligning curved surfaces of a pivot point of a first arm  12  with corresponding surfaces on a second arm  14 . Once these surfaces are aligned, the arms  12 ,  14  can be positioned together as illustrated by arrow D in  FIG. 17 . This results in arms  12 ,  14  being in the position shown in  FIG. 18 . Arms  12 ,  14  can then be pivoted toward each other such that the structure of pivot point  24  engages, and arms  12 ,  14  are now held together. 
         [0058]      FIGS. 23 and 23A  show an alternate embodiment in a similar view to that illustrated in  FIGS. 2 and 2A  above. In these illustrations, jaws  30  are configured differently, and have more spring force built therein. Specifically, jaws  30  have inwardly arranged surfaces  60  which are positioned along inwardly bowed flexible prongs or arms  42  such that, when the applier is closed, portions  60  engage each other and outwardly flex prongs  42 . When the handles of the applier are released, the prongs or arms  42  bias the jaws back toward an open position. 
         [0059]    In the embodiment as illustrated on  FIGS. 23 and 23A , each of the prongs  42  comprise a knee defined giving the jaw a bent configuration at rest. Each knee is located between the jaw members  44  and a proximal part joining the two prongs to each other. Each knee protrudes towards the other prong. Each knee is adapted to biais a prong  42  toward its bent configuration whenever the prong is distorted into a shape different from its bent configuration. Knees may be arranged on prongs  42  so as to face each other. Each Knee may further have a curved surface facing the other knee. 
         [0060]    When the applier is closed, the jaws are moved toward each other and at some point the knees come into contact with each other. When the applier is further closed, each bent prong is flexed by the other prong into into a more straightened configuration, and more precisely by the knee of the other prong. Thus, when the handles of the applier are released, the knees biais the straightened jaws toward their bent configuration. It should be understood that bent prongs provide a greater opening force that straight prongs such as these of the embodiment illustrated on  FIGS. 4 to 6 . Nonetheless, the opening spring  50  may be combined with bent jaws in order to increase the opening force even more. 
         [0061]    Although not illustrated, only one of the jaws may be bent at rest whereas the other jaw is straight. Besides, the knees may be formed in any other biaising member than the jaws. 
         [0062]    A further alternative as illustrated in the embodiments of  FIGS. 23 and 23A  is that the structure supporting the pivot point of this embodiment is not positioned inside the jaws. Referring briefly, for example, to  FIGS. 3 and 3A , it can be seen that pivot point is within a portion of the jaw component. In the embodiment of  FIGS. 23 and 23A , rounded internal and external surfaces are incorporated into each of the arms  12 ,  14  such that these surfaces  24 ′ engage one another when the arms are engaged, for example following the procedure shown in  FIGS. 17-22 . 
         [0063]    All other aspects of the embodiment of  FIGS. 23 and 23  A are similar or identical to those discussed above. 
         [0064]    The device illustrated herein has plates  53  and grooves  55  as shown in  FIGS. 13-14 . Once pivot point  24  is engaged in the step shown in  FIG. 17  to  FIG. 18 , arms  12 ,  14  can then be pivoted toward each other around pivot point  24  until plates  53  engage in grooves  55  at which point arms  12 ,  14  are engaged with each other as shown in  FIG. 19 . 
         [0065]    Turning now to  FIG. 20 , setting screw  32  can be rotated such that the maximum open position of arms  12 ,  14  is adjusted. Next, jaws  30  are plugged into arms  12 ,  14 , preferably into the space between distal portions  26 ,  28 . At this point, applier  10  is now in condition for use as shown in  FIG. 22 . 
         [0066]    It should be appreciated that the present invention provides an applier for application of medical implants such as surgical clips and the like which is assembled as a scissor and which can, preferably, be permanently assembled or can be broken down into specific components as desired. 
         [0067]    In addition, the jaw members can be made reposable so as to further enhance the efficient and effective sterile use of clip applier  10  in accordance with the present invention. 
         [0068]    The maximum distal opening of the clip applier is readily adjustable through setting screw  32 . 
         [0069]    Loops  20  of arms  12 ,  14  can be provided with additional structures to render them more useful to manual operators, and this can for example include coatings and the like on the rings. 
         [0070]    As best illustrated in  FIG. 12 , once jaws  30  are released, cleaning is enhanced since water can enter and escape from surgical applier  10  via many areas, providing a good flushing flow. Further, there are no dead-ends in this new structure, which further helps to reduce any amount of dust which can adhere to the inside of the device. 
         [0071]    It is to be understood that the invention is not limited to the illustrations described and shown herein, which are deemed to be merely illustrative of the best modes of carrying out the invention, and which are susceptible of modification of form, size, arrangement of parts and details of operation. The invention rather is intended to encompass all such modifications which are within its spirit and scope as defined by the claims.

Technology Classification (CPC): 0