SURGICAL CLIP APPLIER

[0001] This application is a continuation of U.S. patent application Ser. No. 12/939,296 filed Nov. 4, 2010, which claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/285,006, filed on Dec. 9, 2009, the entire content of which is incorporate herein by reference.

[0002] 1. Technical Field

[0003] The present application relates to surgical instruments, and more particularly, to surgical clip appliers having a plurality of clips for applying the clips to body tissues and vessels during surgical procedures.

[0004] 2. Discussion of Related Art

[0005] Surgical clip appliers are known in the art and have increased in popularity among surgeons by offering an alternative to conventional suturing of body tissues and vessels. Typical instruments are disclosed in U.S. Pat. No. 5,030,226 to Green et al. and U.S. Pat. No. 5,431,668 to Burbank, III et al. These instruments generally provide a plurality of clips which are stored in the instrument and which are fed sequentially to the jaw mechanism at the distal end of the instrument upon opening and closing of the handles at the proximal end of the instrument. As the handles are closed, the jaws close to deform a clip positioned between the jaw members, and as the jaws are opened to release the deformed clip, a new clip is fed from the series to a position between the jaws. This process is repeated until all the clips in the series of clips have been used.

[0006] A need exists for a user of the clip applier to know how many clips remain in the clip applier and/or to know when a final clip of the plurality of clips has been fired.

[0007] The present application relates to surgical clip appliers having a plurality of clips for applying the clips to body tissues and vessels during surgical procedures and their methods of use.

[0008] According to an aspect of the present disclosure, a surgical clip applier is provided including a housing; at least one handle pivotably connected to the housing; a channel assembly extending distally from the housing; a plurality of clips loaded in the clip carrier; a drive channel translatably supported in the housing and the channel assembly, the drive channel being translated upon actuation of the at least one handle; and a counter mechanism supported in the housing, the counter mechanism including indicia visible through the housing, wherein the indicia corresponds to a quantity of clips loaded in the clip applier, wherein the indicia decrements upon each firing of the clip applier resulting in a reduction in the quantity of clips remaining of the plurality of clips.

[0009] The counter mechanism may be rotatably supported in the housing and may include a uni-directional clutch member permitting rotation of the counter mechanism in a single direction. The counter mechanism may include a counter dial rotatably supported in the housing, wherein the counter dial includes the indicia thereof; and a counter clutch operatively connected to the counter dial such that rotation of the counter clutch in a first direction results in rotation of the counter dial in the first direction, and rotation of the counter clutch in second direction results in no rotation of the counter dial.

[0010] The counter mechanism may include a latch member operatively engaged with the counter dial. In use, the latch member permits rotation of the counter dial in the first direction and inhibits rotation of the counter mechanism in a direction opposite to the first direction.

[0011] The counter dial may include a plurality of grooves formed in an outer periphery thereof, and the latch member may include a resilient finger biased into engagement with the plurality of grooves of the counter dial.

[0012] The counter clutch may be concentrically, rotatably nested in a bore defined in the counter dial. The counter clutch may include at least one resilient finger extending therefrom for engagement with uni-directional teeth formed in a perimetrical surface of the bore of the counter dial.

[0013] The drive channel may define an angled slot therein, and the counter clutch may include a clutch pin extending from a surface thereof and may be slidably disposed in the angled slot of the drive channel. In use, translation of the drive channel in a first direction relative to the counter mechanism would cause the clutch pin to be cammed by the angled slot thereof thereby causing the counter clutch to rotate in the first direction, and translation of the drive channel in a second direction relative to the counter mechanism would cause the clutch pin to be cammed by the angled slot thereof thereby causing the counter clutch to rotate in the second direction.

[0014] The counter mechanism may include a latch member operatively engaged with the counter dial. In use, the latch member permits rotation of the counter dial in the first direction and inhibits rotation of the counter mechanism in a direction opposite to the first direction.

[0015] The counter mechanism may include a counter dial defining a lock out groove formed in an outer perimetrical edge thereof; and a lock out supported in the housing. The lock out may be biased such that a first catch thereof engages against the outer perimetrical edge of the counter dial. In use, as the counter dial is rotated and the lock out groove of the counter dial is brought into registration with the first catch of the lock out, the first catch of the lock out is urged into the lock out groove thereby preventing a rotation of the counter dial in an opposite direction.

[0016] The lock out may include a second catch. In use, the second catch of the lock out moves into a path of a translating member of the clip applier when the first catch of the lock out is moved into the lock out groove of the counter dial, thereby inhibiting a translation of the translating member of the clip applier.

[0017] The lock out groove of the counter dial may move into registration with the first catch of the lock out when a final clip of the plurality of clips has been fired. The lock out groove of the counter dial may be associated with an indicia on the counter mechanism indicating that the final clip has been fired. The indicia on the counter mechanism, indicating that the final clip of the plurality of clip has been fired, may be represented by the number “zero.”

[0018] The clip applier may further include a ratchet mechanism having a ratchet pawl pivotably supported in the housing; and a rack member provided on the translating member. The rack member may be in operative registration with the ratchet pawl. In use, the rack member translates across the ratchet pawl as the translating member translates. The ratchet mechanism may be prevented from re-setting when the rack member has not completed a fully translation.

[0050] Embodiments of surgical clip appliers in accordance with the present disclosure will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical structural elements. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term “proximal” refers to the end of the apparatus which is closer to the user and the term “distal” refers to the end of the apparatus which is further away from the user.

[0051] Referring now to FIGS. 1-5, a surgical clip applier in accordance with an embodiment of the present disclosure is generally designated as 100. Surgical clip applier 100 generally includes a handle assembly 102 including a housing 104 having an upper housing half 104a and lower housing half 104b. Handle assembly 102 further includes a pair of handles 106 pivotably secured to housing 104 and extending outwardly therefrom. A channel assembly 108 is fixedly secured to housing 104 and extends outwardly therefrom, terminating in a jaw assembly 110.

[0052] As seen in FIGS. 1-5, housing halves 104a and 104b of clip applier 100 fit together by snap fit engagement with one another. Housing 104 defines a window 104c formed in lower housing half 104b for supporting and displaying a counter mechanism, as will be discussed in greater detail below.

[0053] As seen in FIG. 4, handles 106 are secured to housing 104 by handle pivot posts 104d extending from lower housing half 104b and into respective apertures 106a formed in handles 106. Handle assembly 102 includes a link member 122 pivotally connected to each handle 106 at a pivot point 106b formed in a respective handle 106. A distal end of each link member 122 is pivotally connected to a pivot point formed in a drive channel 140 via a drive pin 124. Each end of drive pin 124 is slidably received in an elongate channel formed in a respective upper and lower housing half 104a, 104b. In use, as will be described in greater detail below, as handles 106 are squeezed, link members 122 push drive channel 140 distally via drive pin 124.

[0054] Channel assembly 108 includes a channel or cartridge cover 130 and an outer or lower channel 132 each having a proximal end retained in housing assembly 102, between upper and lower housing halves 104a, 104b.

[0055] As seen in FIG. 5, clip applier 100 includes a clip pusher bar 160 slidably disposed beneath cartridge cover 130, a stabilizer 162 configured to overlie and engage pusher bar 160, a motion multiplier system 155 supported in housing 104, a clip carrier 170 disposed within channel assembly 108 and beneath pusher bar 160, a stack of surgical clips “C” loaded and/or retained within clip carrier 170 in a manner so as to slide therewithin and/or therealong, a clip follower 174 slidably disposed within clip carrier 170 and positioned behind the stack of surgical clips “C,” a wedge plate 180 slidably disposed within handle assembly 102 and channel assembly 108, a wedge plate pivot arm 179 pivotally supported in lower housing half 104b of housing 104 for transmitting translation of drive channel 140 to translation of wedge plate 180, a drive channel 140 reciprocally supported in and extending between housing 104 of handle assembly 102 and channel assembly 108, an audible/tactile indicator 148 connected to drive channel 140 via drive pin 124, and a jaw assembly 110 mounted on or at a distal end of channel assembly 108 and actuatable by handles 106 of handle assembly 102.

[0056] Reference may be made to U.S. Provisional Application No. 61/091,467, filed on Aug. 25, 2008, entitled “Surgical Clip Applier” and U.S. Provisional Application No. 61/091,485, filed on Aug. 25, 2008, entitled “Surgical Clip Applier and Method of Assembly,” the entire contents of each of which being incorporated herein by reference, for a detailed discussion of the structure, operation, and method of assembly of various components surgical clip applier 100. Reference may also be made to U.S. Provisional Application No. 61/286,569, filed on Dec. 15, 2009, entitled “Surgical Clip Applier”, the entire contents of which is incorporated herein by reference, for additional detailed discussion of the structure, operation, and method of assembly of various components of surgical clip applier 100.

[0057] As seen in FIGS. 1-12, clip applier 100 further includes a mechanical counter mechanism 190 supported in housing 104 of handle assembly 102. Counter mechanism 190 includes a counter dial 192 rotatably disposed within housing 104 so as to overlie window 104c formed in lower housing half 104b, a counter clutch 194 operatively connected to counter dial 192 and configured to permit uni-directional rotation of counter dial 192, and a latch member 196 configured to engage counter dial 192.

[0058] As seen in FIGS. 4-11, counter dial 192 includes a first face 192a disposed adjacent window 104c formed in lower housing half 104b. First face 192a includes a plurality of indicia 192b, in the form of sequential numbers disposed thereof and substantially around a radial periphery thereof. Indicia 192b may correspond to the number of clips that are loaded in clip applier 100. By way of example only, indicia 192b may be numerals from “0-22.” Indicia 192b are located on first face 192a so as to be in registration with window 104c formed in lower housing half 104b. Counter dial 192 includes a second face 192c, opposite first face 192b, and defining a bore 192d therein. Bore 192d includes a radial array of uni-directional teeth 192e formed therein. Counter dial 192 further includes a first or outer rim defining a plurality of grooves 192f formed around an outer periphery thereof, and a second or inner rim defining a single groove 192g formed in an outer periphery thereof.

[0059] With continued reference to FIGS. 4-11, counter clutch 194 is concentrically and rotatably nested in bore 192d of counter dial 192. Counter clutch 194 of mechanical counter mechanism 190 includes a body portion 194a configured and dimensioned for rotatable disposition in bore 192d of counter dial 192. Counter clutch 194 includes a pair of opposed resilient fingers 194b, 194c extending substantially tangentially from body portion 194a. Resilient fingers 194b, 194c extend from body portion 194a by an amount sufficient so as to resiliently engage uni-directional teeth 192e of dial 192. Counter clutch 194 includes a clutch pin 194d extending from body portion 194a and projecting out of bore 192d of counter dial 192.

[0060] As seen in FIGS. 4-9, latch member 196 of mechanical counter mechanism 190 is secured to lower housing half 104b. Latch member 196 includes a resilient finger 196a configured to contact and selectively engage grooves 192f formed around the outer periphery of counter dial 192.

[0061] As seen in FIGS. 5 and 6, drive channel 140 defines an angled slot 140a formed therein at a location so as to slidably receive clutch pin 194d extending from body portion 194a of counter clutch 194. Angled slot 140a of drive channel 140 extends in a direction away from a longitudinal axis of clip applier 100 from a proximal to a distal direction.

[0062] As seen in FIGS. 4, 5, 7 and 8, clip applier 100 includes a ratchet rack member 141 slidably disposed in lower housing half 104b. Rack member 141 is pinned to drive pin 124 such that translation of drive pin 124 relative to housing 104 results in concomitant translation of rack member 141. Rack member 141 is disposed in housing 104 such that clutch pin 194d of counter clutch 194 rides along or contacts a side edge 141b thereof. Rack member 141 includes ratchet teeth 141a formed along an edge thereof and are configured and adapted to engage with a ratchet pawl 142 supported in housing 104. Rack member 141 and pawl 142 define a ratchet mechanism 144.

[0063] In use, as drive channel 140 is moved axially by drive pin 124, rack member 141 is also moved. Rack teeth 141a of rack member 141 has a length which allows pawl 142 to reverse and advance back over rack member 141 when rack member 141 changes between proximal and distal movement as drive channel 140 reaches a proximal-most or distal-most position.

[0064] Pawl 142 is pivotally connected to lower housing half 104b by a pawl pin at a location wherein pawl 142 is in substantial operative engagement with rack member 141. Pawl 142 is engageable with rack member 141 to restrict longitudinal movement of rack member 141 and, in turn, drive channel 140. Ratchet mechanism 144 further includes a pawl spring 145 configured and positioned to bias pawl 142 into operative association with rack member 141. Pawl spring 145 functions to maintain the teeth of pawl 142 in engagement with the teeth 141a of rack member 141, as well as to maintain pawl 142 in a rotated or canted position.

[0065] As seen in FIGS. 4, 5, 7-9 and 13, clip applier 100 further includes a lock out 146 pivotally connected or supported in housing 104. Lock out 146 includes a body portion 146a, a first catch 146b formed at one and of body portion 146a, and a second catch 146c extending from a side edge of body portion 146a. First catch 146b is configured and dimensioned to engage groove 192g formed in the outer periphery of the inner rim of counter dial 192. Second catch 146c is configured and dimensioned to engage a notch 141c formed in a side edge of rack member 141. A biasing member 147 is provided to maintain first catch 146b of lock out 146 in contact with the outer periphery of the inner rim of counter dial 192.

[0066] Turning now to FIGS. 14-19B, the operation of clip applier 100 is provided. Prior to any initial squeezing of handles 106 of clip applier 100 and with clip applier 100 fully loaded with clips “C,” as seen in FIGS. 14-14C, drive channel 140 is located at a proximal-most position, indicia 192b of counter dial 192 of mechanical counter mechanism 190, relating to a fully loaded clip applier 100, in the present instance being fully loaded with twenty-two (22) clips, is visible through window 104c formed in housing half 104b. Accordingly, as seen in FIG. 14B, the numeral “22” is visible through window 104c. Also, as seen in FIG. 14B, resilient finger 196a of latch member 196 is engaged in a groove 192f formed around the outer periphery of counter dial 192.

[0067] As seen in FIG. 14C, prior to any squeezing of handles 106, clutch pin 194d of counter clutch 194 is disposed at a distal end of angled slot 140a of drive channel 140. Also, first catch 146b of lock out 146 is in contact with the outer periphery of the inner rim of counter dial 192 so that second catch 146c of lock out 146 is disengaged from rack member 141. Moreover, prior to any squeezing of handles 106, and when clip applier 100 is fully loaded with clips, groove 192g formed in the outer periphery of the inner rim of counter dial 192 is oriented distal of first catch 146b of lock out 146.

[0068] As seen in FIGS. 15-15B, during an initial squeeze of handles 106, as indicated by arrow “A1,” drive pin 124 translates drive channel 140 and rack member 141 in a distal direction, as indicated by arrow “B1.” As drive channel 140 is translated in a distal direction, angled slot 140a of drive channel 140 is moved in a distal direction relative to clutch pin 194d of counter clutch 194, clutch pin 194d is cammed through angled slot 140a of drive channel 140 causing counter clutch 194 to rotate in the direction of arrow “C1.” As counter clutch 194 is rotated in the direction of arrow “C1,” as seen in FIG. 15B, resilient fingers 194b, 194c thereof engage uni-directional teeth 192e of dial 192, thereby causing dial 192 to also rotate in the direction of arrow “C1.” Moreover, as dial 192 is rotated in the direction of arrow “C1,” groove 192g formed in the outer periphery of the inner rim of counter dial 192 is rotated away from first catch 146b of lock out 146 as first catch 146b continues to ride along the outer periphery of the inner rim of counter dial 192.

[0069] As dial 192 is rotated in the direction of arrow “C1,” as seen in FIG. 15A, indicia 192b of numeral “22” is moved relative to window 104c formed in housing half 104b, thereby beginning to decrement. Additionally, as dial 192 is rotated in the direction of arrow “C1,” resilient finger 196a of latch member 196 begins to disengage the groove 192f formed around the outer periphery of counter dial 192.

[0070] As seen in FIGS. 16-16B, during a final or complete squeeze of handles 106, as indicated by arrow “A1,” drive pin 124 further translates drive channel 140 and rack member 141 in a distal direction, as indicated by arrow “B1.” As drive channel 140 is further translated in a distal direction, angled slot 140a of drive channel 140 is further moved in a distal direction relative to clutch pin 194d of counter clutch 194, clutch pin 194d is further cammed through angled slot 140a of drive channel 140 causing counter clutch 194 to further rotate in the direction of arrow “C1.” As counter clutch 194 is further rotated in the direction of arrow “C1,” as seen in FIG. 16B, resilient fingers 194b, 194c continue to cause dial 192 to rotate in the direction of arrow “C1.” Moreover, as dial 192 is further rotated in the direction of arrow “C1,” groove 192g formed in the outer periphery of the inner rim of counter dial 192 is further rotated away from first catch 146b of lock out 146 as first catch 146b further continues to ride along the outer periphery of the inner rim of counter dial 192.

[0071] As dial 192 is further rotated in the direction of arrow “C1,” as seen in FIG. 16A, indicia 192b of numeral “22” is completely moved out of view of window 104c formed in housing half 104b and new numeral “21” is moved into view of window 104c, thereby fully being decremented. This change of numeral, or decrementing, coinciding with a formation and/or firing/ejection/release of a clip from clip applier 100. In this manner, the user is shown the number of clips remaining in clip applier 100 and available to fire. Additionally, as dial 192 is further rotated in the direction of arrow “C1,” resilient finger 196a of latch member 196 moves into engagement in a groove 192f′ adjacent to groove 192f formed around the outer periphery of counter dial 192.

[0072] Turning now to FIGS. 17-18, during an opening of handles 106, as indicated by arrow “A2,” drive pin 124 translates drive channel 140 and rack member 141 in a proximal direction, as indicated by arrow “B2.” As drive channel 140 is translated in a proximal direction, angled slot 140a of drive channel 140 is moved in a proximal direction relative to clutch pin 194d of counter clutch 194, clutch pin 194d is cammed through angled slot 140a of drive channel 140 causing counter clutch 194 to rotate in the direction of arrow “C2,” opposite to “C1.” As counter clutch 194 is rotated in the direction of arrow “C2,” as seen in FIG. 17B, resilient fingers 194b, 194c are caused to deflect and snap over uni-directional teeth 192e of dial 192. as seen from FIG. 17A, any frictional forces tending to cause dial 192 to also rotate in the direction of arrow “C2” and negated by the engagement of resilient finger 196a of latch member 196 in groove 192f′ formed around the outer periphery of counter dial 192, thereby maintaining the rotational orientation of dial 192.

[0073] With dial 192 being held or maintained in this rotational orientation, indicia 192b of numeral “21” is maintained in view in window 104c.

[0074] As seen in FIG. 18, when drive channel 140 has been moved back to the fully proximal position, resilient fingers 194b, 194c of counter clutch 194 are re-set in engagement with adjacent uni-directional teeth 192e of dial 192.

[0075] Additionally, as dial 192 is further rotated in the direction of arrow “C1,” resilient finger 196a of latch member 196 moves into engagement in a groove 192f adjacent to groove 192f formed around the outer periphery of counter dial 192.

[0076] Turning now to FIGS. 19-19B, during the squeezing of handles 106, upon the firing of a final clip loaded in clip applier 100, indicia 192b of dial in the form of numeral “0” is completely moved into view of window 104c formed in housing half 104b, thereby indicating to the user that no more clip are present in clip applier 100. When dial 192 has been rotated to this position, as seen in FIGS. 19A and 19B, groove 192g formed in the outer periphery of the inner rim of counter dial 192 is rotated into registration with first catch 146b of lock out 146. In this position, biasing member 147, acting on lock out 146, urges first catch 146b of lock out 146 into groove 192g of dial 192.

[0077] Additionally, in the present position, second catch 146c of lock out 146 is moved into notch 141c formed in side edge of rack member 141 and thus into the path of proximal translation of rack member 141. Accordingly, as handles 106 are released and drive pin 124 begins to move rack member 141 in a proximal direction, notch 141c of rack member 141 engages second catch 146c of lock out 146 thereby prohibiting rack member 141 from returning to a proximal most or home position. With rack member 141 being inhibited or blocked from returning to the proximal most position, ratchet pawl 142 of ratchet mechanism 144 (see FIG. 5) is prevented from resetting itself. Since pawl 142 is prevented from resetting itself, handles 106 can not be re-actuated or re-squeezed since they have only been partially opened. Once again, reference may be made to U.S. Provisional Application No. 61/091,467, filed on Aug. 25, 2008, entitled “Surgical Clip Applier;” U.S. Provisional Application No. 61/091,485, filed on Aug. 25, 2008, entitled “Surgical Clip Applier and Method of Assembly;” and U.S. Provisional Application No. 61/286,569, filed on Dec. 15, 2009, entitled “Surgical Clip Applier”, for a detailed discussion of the structure, operation, and method of assembly of various components of surgical clip applier 100.

[0078] It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawing figures are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.