US 8,545,486 B2Grant
Surgical clip applier
Issue Date:2013-10-01
•18 Claims
•43 Drawing Sheets
Abstract
Surgical clip appliers are provided and include a housing; at least one handle pivotably connected to the housing; a channel assembly extending distally from the housing; a clip carrier disposed within the channel assembly and defining a channel and a plurality of windows therein; and a plurality of clips slidably disposed within the channel of the clip carrier. The surgical clip appliers further include a drive channel reciprocally disposed within at least one of the housing and the channel assembly; a wedge plate reciprocally disposed within the channel assembly; a pusher bar reciprocally positioned within the housing and the channel assembly; and a motion multiplier system having a plurality of linkage members configured to distally move the pusher bar by an incremental amount upon an initial actuation of the handles, and configured to proximally move the pusher bar and the wedge plate subsequent to the initial actuation of the handles.
Metadata
Assignee
- Covidien LP
Inventor
- Jaroslaw T. Malkowski
Application Information
Application Number:US 12/943,045
Filing Date:2010-11-10
Priority Date:2009-12-15
Art Unit:3773
Classifications
IPC:
A61B17/00
Patent Drawings (43 sheets)
Description
Cross Reference to Related Application
[0001] The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/286,569, filed on Dec. 15, 2009, the entire content of which is incorporate herein by reference.
Background
[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] Surgical clip appliers are typically available in a variety of sizes and/or scales ranging from relatively small, relatively medium to relatively large. Generally, each particular size of surgical clip appliers includes different components. As such, the method of assembling the various sized surgical clip appliers differs from one size to another.
[0007] As a consequence, each different size clip applier requires a different stroke length of external components (e.g., clip applier actuation) that, in turn, affects different timing of internal components (e.g., clip deployment components). The need therefore exists where certain essential components can be configured for each different sized clip applier by only changing geometry without changing functionality.
[0008] In addition, the need therefore exists for a surgical clip applier that is configured to accommodate simple internal components that function in a similar fashion as all of the different sized clip appliers, with only changing the geometry of the components. At the same time not compromising a high clip pushing force with low driving force. Better motion and force characteristics and simpler components resulting in better performance of the device.
Summary
[0009] The present application relates to surgical clip appliers having a plurality of clips for applying the clips to body tissues and vessels during surgical.
[0010] 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 clip carrier disposed within the channel assembly and defining a channel and a plurality of windows therein; a plurality of clips slidably disposed within the channel of the clip carrier; a drive channel reciprocally disposed within at least one of the housing and the channel assembly, the drive channel having a first end operatively connected to the at least one handle and a second end operatively connected to a distal end of the channel assembly; a wedge plate reciprocally disposed within the channel assembly, the wedge plate being operatively connected to the at least one handle and including a plurality of apertures formed along a length thereof; a pusher bar reciprocally positioned within the housing and the channel assembly, the pusher bar having a proximal end operatively connected to at least one handle and a distal end defining a pusher, wherein the distal end of the pusher bar is configured for engagement with a distal-most clip of the plurality of clips; and a motion multiplier system having a plurality of linkage members configured to distally move the pusher bar by an incremental amount upon an initial actuation of the handles, and configured to proximally move the pusher bar and the wedge plate subsequent to the initial actuation of the handles.
[0011] The plurality of linkages of the motion multiplier system may include a proximal linkage member pivotally supported in the housing and operatively connected to the drive channel; a pivoting drive arm interconnecting the drive channel and the proximal linkage member; and a distal linkage member interconnecting the proximal linkage member the pusher bar, such that a distal translation of the drive channel causes a pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the pivotal rotation of the proximal linkage member causes a pivotal rotation of the distal linkage member. The pivotal rotation of the distal linkage member causes a distal translation of the pusher bar. The proximal linkage member may be pivotally connected to the housing by a pivot pin. The distal linkage member may be pivotally connected to the proximal linkage member.
[0012] A further distal translation of the drive channel may cause a further pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the further pivotal rotation of the proximal linkage member causes a further pivotal rotation of the distal linkage member, and wherein the further pivotal rotation of the distal linkage member causes a proximal translation of the pusher bar.
[0013] In embodiments, when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a first position, the proximal linkage member and the distal linkage member define a first angle. Proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby increasing the first angle to a second angle of about 180 degrees such that the proximal linkage member and the distal linkage member are linear to each other, such that the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a second position.
[0014] Further, when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in the second position, further proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby decreasing the second angle of about 180 degrees to a third angle, such that the distal linkage member, the pivoting drive arm, and the drive channel are in a third position, while the pusher bar is in the first position.
[0015] The rotation of the proximal linkage member via the pivoting drive arm causes the proximal linkage member and the distal linkage member to be linear to each other and along a longitudinal axis defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, such that the distal linkage member causes a distal translation of the pusher bar.
[0016] Further rotation of the proximal linkage member via the pivoting drive arm causes the proximal member and the distal linkage member to be angularly offset from each other, such that the distal linkage member causes a proximal translation of the pusher bar.
[0017] A longitudinal axis, defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, and the proximal linkage member define a first acute angle on a first side of the longitudinal axis, and the pusher bar is in a proximal position. The distal translation of the drive channel may cause the proximal linkage member and the distal linkage member to pivot such that the first acute angle on the first side of the longitudinal axis increases until the proximal linkage member and the distal linkage member are linear to each other and the pusher bar has been distally translated via the distal linkage member to a distal position.
[0018] Further distal translation of the drive channel causes the proximal linkage member and the distal linkage member to pivot from the side of the longitudinal axis to a second side of the longitudinal axis such that the proximal linkage member and the longitudinal axis define a second acute angle and the pusher bar has been proximally translated via the distal linkage member to a proximal position.
[0019] The clip follower is configured to engage the wedge plate and move distally upon distal translation of the wedge plate, and is configured to engage the clip carrier and stop proximal movement thereof upon proximal translation of the wedge plate.
[0020] The clip applier may further include a jaw assembly having a pair of jaws extending from an end of the channel assembly, opposite the housing. The jaw assembly may be adapted to accommodate a clip of the plurality of clips therein and is operable to effect formation of the clip in response to movement of the handles.
[0021] The pusher bar may be movable towards the jaws as the handles are approximated in a first direction by an initial amount in order to move a distal-most clip between the jaws. The pusher bar may be configured and adapted to move towards the housing as the handles are approximated an additional amount in the first direction to move the pusher behind a distal-most clip in the plurality of clips.
[0022] The drive channel may be configured and dimensioned to at least partially surround the jaws and the wedge plate. The drive channel may include a strap extending across a distal end thereof for maintaining the jaws and the wedge plate within the drive channel.
[0023] The drive channel may be moved towards the jaw assembly as the at least one handle is moved actuated in a first direction to move the second end of the drive channel against the jaws to close the jaws, the drive channel being moved away from the jaws as the at least one handle is moved a second amount to move the second end of the drive channel away from the jaws to allow the jaws to open.
[0024] In embodiments, the clip applier may further include a motion reversing mechanism operatively connected to the wedge plate and the drive channel. The rotation of the motion reversing mechanism, during distal movement of the drive channel, results in proximal movement of the wedge plate.
[0025] In embodiments, the clip applier may further include a clip follower slidably disposed within the channel of the clip carrier and disposed proximally of the plurality of clips, the clip follower being configured and adapted for selective engagement with the windows of the clip carrier and the apertures of the wedge plate. The clip follower may be configured and adapted to urge the plurality of clips, in a distal direction relative to the clip carrier, upon reciprocal movement of the wedge plate.
[0026] In embodiments, the clip applier may further include a motion reversing mechanism operatively connected to the drive channel and the wedge plate and selectively engageable with the pusher bar. The rotation of the motion reversing mechanism, during the distal translation of the drive channel, results in proximal movement of the wedge plate and the pusher bar.
[0027] In embodiments, the clip applier may further include a ratchet mechanism. The ratchet mechanism may further include a rack, having a plurality of ratchet teeth, associated with the drive channel; and a pawl, having at least one tooth, disposed at a location to selectively engage the rack. The pawl may be biased into engagement with the rack, wherein as the drive channel is longitudinally reciprocated, the plurality of teeth are passed over the pawl. The pawl may prevent inadvertent return of the drive channel before full actuation of the at least one handle.
[0028] In embodiments, the clip applier may further include a lockout disposed in a distal end of the channel assembly. The lockout may be actuated by the clip follower when a last clip is expelled from the clip applier. The lockout may be urged by the clip follower to extend across a path of the drive channel, thereby preventing the drive channel from moving distally.
[0029] In embodiments, the clip applier may further include a counter display mechanism supported in at least one of the housing and the channel assembly. The counter display mechanism is configured and adapted to display a change in status of the clip applier upon each actuation of the at least one handle.
Brief Description of the Drawings
[0030] The present clip applier will be more fully appreciated as the same becomes better understood from the following detailed description when considered in connection with the following drawings, in which:
[0031] FIG. 1 is a perspective view of a surgical clip applier according to an embodiment of the present disclosure;
[0032] FIG. 1A is a rear, perspective view of the surgical clip applier of FIG. 1 , shown with a shipping wedge in position;
[0033] FIG. 1B is a cross-sectional view as taken through 1B-1B of FIG. 1A ;
[0034] FIG. 1C is a cross-sectional view as taken through 1C-1C of FIG. 1A ;
[0035] FIG. 2 is a top, plan view of the surgical clip applier of FIG. 1 ;
[0036] FIG. 3 is a side, elevational view of the surgical clip applier of FIGS. 1 and 2 ;
[0037] FIG. 4 is an exploded perspective view of the surgical clip applier of FIGS. 1-3 ;
[0038] FIG. 4A is a perspective view of a motion multiplier system of the surgical clip applier of FIGS. 1-4 ;
[0039] FIG. 4B is an exploded perspective view of the motion multiplier system of the surgical clip applier of FIGS. 1-4 ;
[0040] FIG. 4C is a top, perspective view of a pivot arm of the surgical clip applier of FIGS. 1-4 ;
[0041] FIG. 4D is a bottom, perspective view of the pivot arm of FIG. 4C ;
[0042] FIG. 4E is a top, perspective view of a clip follower of the surgical clip applier of FIGS. 1-4 ;
[0043] FIG. 4F is a perspective view of an audible/tactile indicator of the surgical clip applier of FIGS. 1-4 ;
[0044] FIG. 4G is a perspective view of a rack member of the surgical clip applier of FIGS. 1-4 ;
[0045] FIG. 4H is a top, perspective view of a surgical clip;
[0046] FIG. 4I is a bottom, perspective view of the surgical clip of FIG. 4H ;
[0047] FIG. 4J is a front, cross-sectional view of the surgical clip of FIG. 4H , as taken through 4J-4J of FIG. 4H ;
[0048] FIG. 5 is a longitudinal cross-sectional view of the surgical clip applier of FIGS. 1-4 , illustrating the surgical clip applier in an unactuated condition;
[0049] FIG. 6 is an enlarged view of the indicated area of detail of FIG. 5 ;
[0050] FIG. 7 is an enlarged view of the indicated area of detail of FIG. 5 ;
[0051] FIG. 8 is an enlarged view of the indicated area of detail of FIG. 5 ;
[0052] FIG. 9 is a cross-sectional view of the surgical clip applier of FIGS. 1-4 , as taken through 9-9 of FIG. 8 ;
[0053] FIG. 10 is a perspective view of the surgical clip applier of FIGS. 1-4 , illustrated with an upper housing half removed therefrom;
[0054] FIG. 11 is an enlarged view of the surgical clip applier of FIGS. 1-4 , as shown in FIG. 10 ;
[0055] FIG. 12 is a top, perspective view of a distal end of a channel assembly of the surgical clip applier of FIGS. 1-4 , with a cover removed therefrom;
[0056] FIG. 13 is a top, perspective view of the surgical clip applier of FIGS. 1-4 , illustrated with the upper housing half and a pusher bar removed therefrom;
[0057] FIG. 14 is a top, perspective view of a distal end of the channel assembly of FIG. 12 , with the cover and the pusher bar removed therefrom;
[0058] FIG. 15 is a top, perspective view of a distal end of the channel assembly of FIG. 12 , with the cover, the pusher bar and a clip carrier removed therefrom;
[0059] FIG. 16 is a top, perspective view of a distal end of the channel assembly of FIG. 12 , with the cover, the pusher bar, the clip carrier, the surgical clips and the clip follower removed therefrom;
[0060] FIG. 17 is an enlarged view of the indicated area of detail of FIG. 16 ;
[0061] FIG. 18 is a top, perspective view of the surgical clip applier of FIGS. 1-4 , illustrated with the upper housing half, the pusher bar and a wedge plate removed therefrom;
[0062] FIG. 19 is a top, perspective view of a distal end of the channel assembly of FIG. 12 , with the cover, the pusher bar, the clip carrier, the surgical clips, the clip follower and the wedge plate removed therefrom;
[0063] FIG. 20 is a top, perspective view of the surgical clip applier of FIGS. 1-4 , illustrated with the upper housing half, the pusher bar, the wedge plate and a drive channel removed therefrom;
[0064] FIG. 21 is a bottom, perspective view of the surgical clip applier of FIGS. 1-4 , illustrated with a lower housing half, the drive channel and the wedge plate removed therefrom;
[0065] FIG. 22 is a top, plan view of the surgical clip applier of FIGS. 1-4 , with the upper housing half removed therefrom and shown in an un-actuated condition;
[0066] FIG. 23 is an enlarged view of the indicated area of detail of FIG. 22 ;
[0067] FIG. 24 is an enlarged view of the indicated area of detail of FIG. 22 ;
[0068] FIG. 24A is a schematic illustration of the motion multiplier system of FIG. 24 ;
[0069] FIG. 25 is a top, plan view of the surgical clip applier of FIGS. 1-4 , with the upper housing half removed therefrom and shown during an initial actuation thereof;
[0070] FIG. 26 is an enlarged view of the indicated area of detail of FIG. 25 ;
[0071] FIG. 27 is an enlarged view of the indicated area of detail of FIG. 25 ;
[0072] FIG. 27A is a schematic illustration of the motion multiplier system of FIG. 27 ;
[0073] FIG. 28 is an enlarged, longitudinal cross-sectional view of the distal end of the channel assembly during the initial actuation of the surgical clip applier;
[0074] FIG. 29 is a top, perspective view of the surgical clip applier of FIGS. 1-4 , illustrated with the upper housing half and a pusher bar removed therefrom and shown in during an initial actuation thereof;
[0075] FIG. 30 is an enlarged, longitudinal cross-sectional view of the distal end of the channel assembly during a further initial actuation of the surgical clip applier;
[0076] FIG. 31 is bottom, perspective view illustrating the operation of an audible/tactile indicator during the respective initial actuation of the surgical clip applier of FIGS. 1-4 ;
[0077] FIG. 32 is a top, plan view of the surgical clip applier of FIGS. 1-4 , with the upper housing half removed therefrom and shown during a further actuation of the surgical clip applier;
[0078] FIG. 33 is an enlarged view of the indicated area of detail of FIG. 32 ;
[0079] FIG. 34 is an enlarged, cross-sectional view illustrating an actuation of a counter mechanism of the surgical clip applier of FIGS. 1-4 ;
[0080] FIG. 35 is an enlarged view of the indicated area of detail of FIG. 32 ;
[0081] FIG. 36 is an enlarged view of a ratchet mechanism shown during the final actuation of the surgical clip applier of FIGS. 1-4 ;
[0082] FIGS. 37 and 38 are enlarged perspective view, illustrating the distal end of the channel assembly during the final actuation of the surgical clip applier of FIGS. 1-4 ;
[0083] FIG. 39 is a top, plan view of the surgical clip applier of FIGS. 1-4 , with the upper housing half removed therefrom and shown at a final condition after an actuation of the surgical clip applier;
[0084] FIG. 40 is an enlarged view of the indicated area of detail of FIG. 39 ;
[0085] FIG. 41 is an enlarged view of the indicated area of detail of FIG. 39 ;
[0086] FIG. 41A is a schematic illustration of the motion multiplier system of FIG. 41 ;
[0087] FIG. 42 is an enlarged view illustrating the position of the audible/tactile indicator following an actuation of the surgical clip applier of FIGS. 1-4 ;
[0088] FIG. 43 is a top, plan view of the jaw assembly illustrating the position of the jaw assembly following an actuation of the surgical clip applier of FIGS. 1-4 ;
[0089] FIG. 44 is a perspective view of a body vessel including a clip of the surgical clip applier, shown applied thereto;
[0090] FIG. 45 is an enlarged view of the indicated areas of detail of FIGS. 22 , 25, 32, and 39, illustrating the operation of the pivot aim during an opening or release of the surgical clip applier following a complete actuation thereof;
[0091] FIG. 46 is an enlarged view of the ratchet mechanism shown during the opening or release of the surgical clip applier of FIGS. 1-4 ;
[0092] FIG. 47 is an enlarged view illustrating the operation of the audible/tactile indicator during the opening or release of the surgical clip applier of FIGS. 1-4 ;
[0093] FIGS. 48 and 49 are longitudinal, cross-sectional views of the channel assembly illustrating the movement of the clip follower during the opening or release of the surgical clip applier of FIGS. 1-4 ;
[0094] FIGS. 50 and 51 are longitudinal, cross-sectional views of the distal end of the channel assembly illustrating the movement of the pusher bar and wedge plate during the opening or release of the surgical clip applier of FIGS. 1-4 ; and
[0095] FIG. 52 is a longitudinal, cross-sectional view of the distal end of the channel assembly illustrating the surgical clip applier of FIGS. 1-4 in a locked-out condition following firing of the last surgical clip therefrom.
Detailed Description of Embodiments
[0096] 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.
[0097] FIGS. 1-5 illustrate a surgical clip applier in accordance with an embodiment of the present disclosure and is generally designated as 100. 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 surgical clip applier 100.
[0098] Surgical clip applier 100 is a surgical instrument including 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.
[0099] As seen in FIGS. 1-4 , 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. Housing 104 is formed of a suitable plastic material.
[0100] 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 122a of each link member 122 is pivotally connected to a pivot point 140a formed in a drive channel 140 via a drive pin 124. Each end of drive pin 124 is slidably received in an elongate channel 104e 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.
[0101] 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. Cartridge cover 130 includes at least one retention element 130a configured and adapted to selectively engage, in a snap-fit engagement, a complementary or corresponding retention element 132a provided on outer channel 132.
[0102] As seen in FIGS. 4 and 6-12, clip applier 100 includes a clip pusher bar 160 slidably disposed beneath cartridge cover 130. Pusher bar 160 includes a distal end 160a defining a pusher 160c configured and adapted to selectively engage/move a distal-most clip “C1” stored in surgical clip applier 100. Pusher bar 160 further includes a proximal end 160b defining a first proximal window 160d and a second proximal window 160h therein. First proximal window 160d is configured for slidably receiving drive pin 124 therein and second proximal window 160h is configured for slidably receiving fixed rod 154a therein. Pusher bar 160 further defines a distal window 160e and a proximal window 160g therein for operative engagement with a stabilizer 162, as will be discussed in greater detail below. Pusher bar 160 further includes an aperture 160f configured to receive a sliding post 158c of a distal linkage member 158, as will described in greater detail below.
[0103] Clip applier 100 further includes a stabilizer 162 configured to overlie and engage pusher bar 160. Stabilizer 162 includes a distal tab 162a configured to engage distal window 160e of pusher bar 160, elongate windows 162b and 162d defined therein at a location to substantially overlie and be in registration with respective proximal windows 160d and 160h formed in pusher bar 160. As seen in FIGS. 4 and 6 , stabilizer 162 further includes a plurality of tabs 162e extending from a top surface thereof, at a proximal and a distal location, which are configured and dimensioned for receipt in respective channels formed in upper housing half 104a. Stabilizer 162 further includes an aperture 162f that overlies aperture 160f of pusher bar 160. Apertures 160f and 162f are both configured to receive sliding post 158c of distal linkage member 158.
[0104] As seen in FIGS. 4 , 4A, 4B, and 24, clip applier 100 further includes a motion multiplier system 155 in the form of a three-bar linkage system having a proximal linkage member 154 that is pivotally supported in housing 104 and operatively connected to drive channel 140 via a pivoting drive arm 156. Pivoting drive arm 156 is pivotably coupled by a pin 156a via aperture 156b to housing 104. Motion multiplier system 155 further includes a distal linkage member 158 that interconnects proximal linkage member 154 and pusher bar 160. A longitudinal axis “X1” is defined along an axis extending through fixed rod 154a of proximal linkage member 154 and sliding post 158c of distal linkage member 158. A side of longitudinal axis “X1,” that includes pivoting drive arm 156, defines a first side and the other side of longitudinal axis “X1” defines a second side. On the first side, proximal linkage member 154 is pivotally oriented at an angle “α” relative to longitudinal axis “X1” (as shown in FIG. 24 ). On the second side, proximal linkage member 154 is pivotally oriented at an angle “−α” relative to longitudinal axis “X1” (as shown in FIG. 35 ). In essence, when proximal linkage member 154 is oriented between angle “α” and angle “−α,” the angle is 0°, such that proximal linkage member 154 is aligned with longitudinal axis “X1” (as shown in FIG. 27 ). In this configuration, proximal linkage member 154 is also aligned with distal linkage member 158, as will be discussed in greater detail below. Pivoting drive arm 156 is pivotally supported via a pivot pin 156a secured and driven by drive channel 140. A longitudinal axis “X2” is defined along an axis extending along drive channel 140. In this manner, pivoting drive arm 156 is pivotally oriented at an angle “β” relative to longitudinal axis “X2” (as shown in FIG. 24 ).
[0105] Proximal linkage member 154 includes a hub 154b that is configured to receive a fixed rod 154a therethrough, such that a pivotable connection between proximal linkage member 154 and housing 104 is established. Proximal linkage member 154 also includes a proximal aperture 154c and a distal aperture 154d. Proximal aperture 154c is configured to receive a driving post 156c of pivoting drive arm 156 that selectively drives proximal linkage member 154 in a rotational manner, as will be discussed in greater detail below. Distal aperture 154d is configured to receive a coupling pin 158a via aperture 158b of distal linkage member 158 that pivotally couples proximal linkage member 154 to distal linkage member 158. Distal linkage member 158 further includes a post 158c that is slidably connected to aperture 160f of pusher bar 160 and aperture 162f of stabilizer 162. Distal linkage member 158 via sliding post 158c effectuates translation of pusher bar 160 and stabilizer 162 in a proximal and distal direction.
[0106] Clip applier 100 further includes a clip carrier 170 disposed within channel assembly 108 and beneath pusher bar 160. Clip carrier 170 is generally a box-like structure having an upper wall 170a, a pair of side walls 170b and a lower wall 170c defining a channel 170d therethrough. Clip carrier 170 includes a plurality of spaced apart windows 172 formed in upper wall 170a and extending longitudinally along a length thereof. Clip carrier 170 includes an elongate window 170e (as shown in FIG. 9 ) formed in lower wall 170c and extending longitudinally along a length thereof.
[0107] As seen in FIGS. 4H-4J , a surgical clip “C” includes a first leg “C2” and a second leg “C4.” Each of legs “C2” and “C4” of surgical clip “C” are connected to one another to form an apex “C14.” Apex “C14” of surgical clip “C” has a generally V-shaped configuration as shown in FIGS. 4H-4I . First leg “C2” of surgical clip “C” further includes a gripping pattern “C6” on an interior wall that defines a plurality of recesses “C8.” Second leg “C4” of surgical clip “C” includes a plurality of indentations “C10” on an exterior wall and a plurality of protrusions “C12” on an interior wall. When surgical clip “C” is applied to tissue, as the application a clip “C” to tissue will be described in greater detail below, legs “C2” and “C4” come together, such that plurality of indentations “C10” and plurality of protrusions “C12” grip and hold a tissue therebetween. For a more detailed discussion of surgical clip “C,” please refer to commonly owned U.S. Publication No. 2007/0173866, filed on Jan. 23, 2006, entitled “Surgical Hemostatic Clip,” the entire contents of which is incorporated herein by reference in its entirety.
[0108] As seen in FIGS. 4 , 9 and 14, a stack of surgical clips “C” is loaded and/or retained within channel 170d of clip carrier 170 in a manner so as to slide therewithin and/or therealong. Channel 170d is configured and dimensioned to slidably retain a stack or plurality of surgical clips “C” in tip-to-tail fashion therewithin.
[0109] As seen in FIGS. 12 and 14 , a distal end of clip carrier 170 includes a pair of spaced apart, resilient tangs 171. Tangs 171 are configured and adapted to selectively engage a backspan of a distal-most surgical clip “C1” of the stack of surgical clips “C” retained within carrier 170.
[0110] As seen in FIGS. 4 , 4E, 7 and 15, clip applier 100 further includes a clip follower 174 slidably disposed within channel 170d of clip carrier 170. As will be discussed in greater detail below, clip follower 174 is positioned behind the stack of surgical clips “C” and is provided to urge the stack of clips “C” forward during an actuation of clip applier 100. As will be described in greater detail below, clip follower 174 is actuated by the reciprocating forward and backward motion of wedge plate 180.
[0111] As seen in FIGS. 4E and 7 , clip follower 174 includes body portion 174a defining a plane, a distal tab 175 extending substantially upwardly and rearwardly from body portion 174a, and a proximal tab 176 extending substantially downwardly and rearwardly from body portion 174a. Distal tab 175 includes a distal portion 175a extending downwardly below the plane defined by body portion 174a and a proximal portion 175b extending upwardly above the plane defined by body portion 174a.
[0112] Proximal portion 175b of distal tab 175 is configured and dimensioned to selectively engage windows 172 formed in upper wall 170a of clip carrier 170. In use, engagement of proximal portion 175b of distal tab 175 of clip follower 174 in a window 172 formed in upper wall 170a of clip carrier 170 prevents clip follower from traveling or moving in a proximal direction.
[0113] Proximal tab 176 is configured and dimensioned to selectively engage windows 180b formed in wedge plate 180. In use, engagement of proximal tab 176 of clip follower 174 in a window 180b formed in wedge plate 180 allows for clip follower 174 to be advanced or moved distally upon a distal movement of wedge plate 180.
[0114] As seen in FIGS. 4 , 7-9, 16 and 17, clip applier 100 further includes a wedge plate 180 slidably disposed within handle assembly 102 and channel assembly 108. Wedge plate 180 is positioned or disposed below clip carrier 170. Wedge plate 180 includes a substantially tapered distal end 180a for selective operative interposition between jaws 120. Wedge plate 180 defines a plurality of spaced apart windows or apertures 180b extending longitudinally along a length thereof and formed in a raised section thereof, a distal window or aperture 180c located distal of apertures 180b, and a proximal-most transversely oriented slot 180d located proximal of aperture 180c.
[0115] As seen in FIGS. 4 , 8, 16 and 17, clip applier 100 includes a distal lockout 178 supported by cartridge cover 130. Distal lockout 178 includes a tail or tab 178a extending substantially rearwardly and downwardly and being configured and dimensioned for receipt in distal window or aperture 180c of wedge plate 180.
[0116] As seen in FIGS. 4 , 4C, 4D, 6, 11, 13, 18 and 20, clip applier 100 includes a wedge plate motion reversing mechanism, in the form of a pivot arm 179, pivotally supported in lower housing half 104b of housing 104 for transmitting the translation of drive channel 140 to a reverse translation of wedge plate 180. Pivot arm 179 includes a pivot boss 179a configured for pivotable connection to housing 104, a first stem or finger 179b provided at one end of pivot arm 179 and extending in a direction opposite to pivot boss 179a, and second stem or finger 179c provided at a second end of pivot arm 179 and extending in a direction alongside first stem or finger 179b and pivot boss 179a. First stem or finger 179b is configured and adapted for engagement in proximal-most slot 180d of wedge plate 180. Second stem or finger 179c is configured for engagement in a slot 140g formed in drive channel 140 which is connected in a window 140g defined in a drive channel 140. Slot 140g includes a longitudinally extending distal portion and a longitudinally extending proximal portion that are axially and transversely offset from one another, and a transverse portion interconnecting the distal and proximal portions.
[0117] In use, as will be discussed in greater detail below, as drive channel 140 is moved distally, after a dwell period (i.e., the length of the longitudinally extending distal portion of slot 140g of drive channel 140), second stem or finger 179c is moved in a distal direction, rotating pivot arm 179 and thereby moving first stem or finger 179b in a second direction. As first stem or finger 179b is moved in the second direction, first stem or finger 179b pulls wedge plate 180 out from between jaws 120 urges against. As wedge plate 180 is moved in a distal direction, as seen n FIG. 17 , distal end 180a of wedge plate 180 cams against an inner surface of jaws 120 to thereby maintain jaws 120 spaced apart from one another.
[0118] As seen in FIGS. 4 , 6-11, 13, 18 and 19, clip applier 100 includes a drive channel 140 reciprocally supported in and extending between housing 104 of handle assembly 102 and channel assembly 108. A proximal end of drive channel 140 is supported between upper and lower housing halves 104a, 104b of housing 104 and a distal end of drive channel 140 is supported between cartridge cover 130 and outer channel 132 of channel assembly 108, at a location below wedge plate 180.
[0119] A distal end of drive channel 140 is a substantially U-shaped channel including a pair of spaced apart side walls 140b extending from a backspan 140c thereof, in a direction away from outer channel 132 and toward cartridge cover 130. Drive channel 140 further defines a drive pin recess 140a formed in backspan 140c for pivotally receiving drive pin 124 therethrough. Drive channel 140 further defines a rib 140e projecting from backspan 140c at a location distal of drive pin recess 140a. Drive channel 140 further defines a reciprocation limiting slot 140f formed in backspan 140c at a location distal of slot 140e.
[0120] As seen in FIGS. 4 , 8, 9, 12, 14-16 and 19, clip applier 100 includes a drive channel strap 143 secured to drive channel 140. Strap 143 is secured to uprights 140b of drive channel 140 so as to extend transversely thereacross. Strap 143 is secured to drive channel 140 at a location distal of reciprocation limiting slot 140f. Strap 143 is secured to drive channel 140 such that wedge plate 180 extends beneath strap 143 and above jaws 120.
[0121] As seen in FIGS. 4 , 4F, 6, 10 and 21, clip applier 100 further includes an audible/tactile indicator 148 connected to drive channel 140 via drive pin 124. Indicator 148 includes a resilient finger 148a and a pair of bosses 148b. In use, as will be described in greater detail below, as clip applier 100 is actuated and drive channel 140 is reciprocated, first resilient finger 148a of indicator 148 interacts with corresponding complementary structure or ledge 149 provided in clip applier 100 to create an audible and/or a tactile feedback to the user. Bosses 148b of indicator 148 ride within channel 104e formed in upper housing half 104a and provide support to indicator 148 to prevent indicator 148 from rotating.
[0122] As seen in FIGS. 4 , 6, 10, 11, 13, 18 and 20, clip applier 100 further includes a biasing member 146, in the form of a tension spring, operatively secured to and between a proximal end of drive channel 140 and housing 104, tending to maintain drive channel 140 in a retracted or proximal-most position. Biasing member 146 functions to retract or facilitate retraction of drive channel 140 following formation of a clip “C” positioned between jaws 120.
[0123] As seen in FIGS. 4 , 4G, 11, 13, 18 and 20, a proximal end of drive channel 140 includes a ratchet rack member 141 secured to drive pin 124 and movable with drive channel 140. Ratchet member 141 includes a slot 141b to slidably receive fixed rod 154a. Ratchet member 141 further includes a tab 141c extending from a proximal end thereof that slidably translates within lower housing half 104b. Ratchet rack member 141 is configured and adapted to engage with a ratchet pawl 142 supported in housing 104. Rack member 141 and ratchet pawl 142 define a ratchet mechanism 144. In use, as drive channel 140 is moved axially, rack member 141 is also moved. Rack member 141 defines a series of rack teeth 141a having 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.
[0124] Pawl 142 is pivotally connected to lower housing half 104b by a pawl pin 147 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 engagement 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.
[0125] As seen in FIGS. 1-4 , 8, 10, 12, 14-17 and 19, clip applier 100 includes a pair of jaws 120 mounted on or at a distal end of channel assembly 108 and actuatable by handles 106 of handle assembly 102. Jaws 120 are formed of a suitable biocompatible material such as, for example, stainless steel or titanium.
[0126] Jaws 120 are mounted in a distal end of drive channel 140 via one or more rivets 120c or the like extending through reciprocation limiting slot 140f of drive channel 140 such that jaws 120 are longitudinally stationary relative to outer channel 132 and drive channel 140. As seen in FIGS. 12 , 14, 17 and 19, jaws 120 define a channel 120a therebetween for receipt of a surgical clip “C1” therein.
[0127] As seen in FIGS. 1-4 , 6, 11, 13 and 20, clip applier 100 further includes a counter mechanism 190 supported in housing 104 of handle assembly 102. Counter mechanism 190 includes a display 192, a processor 194, and an energy source 198 in the form of a battery or the like. Display 192 is a liquid crystal display that displays one or more operating parameters of clip applier 100 to the surgeon. The operating parameter displayed may be an amount or number of remaining clips, a number of clips that have been used, a position parameter, a surgical time of usage, or any other parameter of the procedure.
[0128] Counter mechanism 190 includes a tab 192a, made from PVC, disposed between battery or energy source 198 and a contact 194a of processor 194 or between the contacts 194a of processor 194 to prevent the battery or energy source 198 from becoming drained during storage. As seen in FIGS. 1A and 1B , tab 192a extends out of housing 104 of clip applier 100 in order to allow for easy removal of the tab therefrom. Once the tab 192a is removed, battery or energy source 198 comes into electrical contact with the contact 194a of processor 194 or between the contacts 194a of the processor 194.
[0129] Counter mechanism 190 is actuated by nub 140e formed in drive channel 140. In use, as seen in FIG. 36 , as drive channel 140 is driven forward, nub 140e thereof engages contact 194a causing contact 194a to complete a circuit and trigger processor 194 to perform a function (e.g., reduce the number appearing on display 192 by a give increment or value).
[0130] As seen in FIGS. 1A and 1C , clip applier 100 includes a shipping wedge 200 supported on housing 104 and interposed between handles 106. Shipping wedge 200 functions to maintain handles 106 spaced apart or un-squeezed during a shipment and/or storage of clip applier 100. Shipping wedge 200 is connected to tab 192a of counter mechanism 190, such that in order for an end user to use clip applier 100, the end user must remove shipping wedge 200 thereby also removing tab 192a to activate counter mechanism 190.
[0131] As seen in FIGS. 1A and 1C , shipping wedge 200 includes a body portion 202 in the form of a collar, defining a passage 204 configured and dimensioned for receipt of a portion of housing 104 therein. Shipping wedge 200 includes uprights 206 extending outwardly from opposed sides of body portion 202 and being configured to receive handles 106 therein. Shipping wedge 200 further includes tabs 208 extending inwardly from opposed sides of uprights 206. Tabs 208 of shipping wedge 200 are configured and dimensioned to engage with handles 106 when shipping wedge 200 is properly secured to clip applier 100.
[0132] With reference to FIGS. 22-53 , the operation of clip applier 100 is provided. Prior to any initial squeezing of handles 106 of clip applier 100, as seen in FIGS. 22-24 , the internal components of the clip applier 100 are in a so-called “home” position or “starting” position. More particularly, in the “home” position, the drive pin 124 is located at a proximal-most position, pawl 142 is located distal of rack 140d of drive channel 140, second finger 179c of pivot arm 179 is located at a distal-most position in the distal portion of window 140g of drive channel 140 such that wedge plate 180 is located at a distal-most position, and no clips “C” are positioned within jaws 120. Since drive pin 124 is at a proximal-most position, pusher bar 160, stabilizer 162, and drive channel 140 are also at a proximal-most position.
[0133] As seen in FIG. 24 , when drive channel 140 and pusher bar 160 are located at the proximal-most position, driving post 156c of pivoting drive arm 156 is located at a proximal-most position and second resilient finger 148b of indicator 148 is disposed proximal of edge 149 formed in lower housing half 104b. In embodiments, edge 149 may be formed in upper housing half 104a with slight modification to indicator 148. In the “home” position, angle “α” of proximal linkage member 154 may range from about 45° to about 60°, while angle “β” of pivoting drive arm 156 may range from about 20° to about 25°. Also, prior to an initial squeezing of handles 106 of clip applier 100, with wedge plate 180 located at a distal-most position, distal end 180a thereof is interposed between jaws 120.
[0134] As seen in FIGS. 22 , 24 and 24A, also in the “home” position coupling pin 158a of distal linkage member 158 is located on a first side of the longitudinal axis “X1.”
[0135] The following equations are used to calculate the mechanics of the motion multiplier system 155 in a “home” position. The “home” position directly relates to when pusher bar 160 is in the “home” position (i.e., proximal-most position), for example, when “α” is about 60°.
XP=(2)(L1)(cos α)−(L1) (1)
where distance “XP” is the distance traveled by sliding post 158c and length “L1” is the length of proximal and distal linkage members 154 and 156, as shown inFIG. 24A .
XD=(B)+(C)(cos α)−(L2)(cos β) (2)
where distance “XD” is the distance traveled by pivot post 156a of pivoting drive arm 156 along longitudinal axis “X2,” distance “B” is distance between pivot pin 156a of pivoting drive arm 156 and fixed rod 154a of proximal linkage member 154 taken along the longitudinal axis of “X1,” distance “C” is the distance between fixed rod 154a of proximal linkage member 154 and driving post 156c of pivoting drive aim 156, and length “L2” is the length of pivoting drive arm 156 taken from pivot post 156a to driving post 156c, as shown inFIG. 24A .
XP=(2)(L1)(cos α)−(L1) (1)
where distance “XP” is the distance traveled by sliding post 158c and length “L1” is the length of proximal and distal linkage members 154 and 156, as shown in
XD=(B)+(C)(cos α)−(L2)(cos β) (2)
where distance “XD” is the distance traveled by pivot post 156a of pivoting drive arm 156 along longitudinal axis “X2,” distance “B” is distance between pivot pin 156a of pivoting drive arm 156 and fixed rod 154a of proximal linkage member 154 taken along the longitudinal axis of “X1,” distance “C” is the distance between fixed rod 154a of proximal linkage member 154 and driving post 156c of pivoting drive aim 156, and length “L2” is the length of pivoting drive arm 156 taken from pivot post 156a to driving post 156c, as shown in
[0136] Also prior to the initial squeeze, there are no clips “C” present within jaws 120. A clip “C” is first loaded into jaws 120 during the initial squeezing of handles 106. As seen in FIGS. 25-33 , during an initial squeeze of handles 106 (i.e., a working stroke), distal ends 122a of link members 122 are moved distally relative to housing 104. As distal ends 122a of link members 122 are moved distally, drive pin 124 is moved distally thereby transmitting distal axial movement to drive channel 140.
[0137] Subsequently, as seen in FIGS. 25-31 , as drive channel 140 is moved distally, motion multiplier system 155 moves from the “home” position to an initial actuated position. More particularly, drive channel 140 advances in a distal direction, which, in turn, causes pivoting drive arm 156 to move in a distal direction. That is, pivoting drive arm 156 pivots and drives proximal linkage member 154 to rotate in a direction such that angle “β” increases, for example, but not limited from about 22° to about 45°. In this manner, when angle “β” is increased, proximal linkage member 154 is rotated about fixed rod 154a of proximal linkage member 154, which, in turn, causes driving post 158c of distal linkage member 158 to be driven distally along slot 162b of stabilizer 162 and proximal window 160d of pusher bar 160. As driving post 158c of distal linkage member 158 is driven distally, driving post 158c of distal linkage member 158 drives pusher bar 160 in a distal direction.
[0138] As seen in FIGS. 25 , 32 and 33, during the initial squeeze of handles 106, indicator 148 is moved distally along with the distal movement of drive channel 140. In use, indicator 148 functions to create an audible click and/or a tactile vibration, thereby indicating to the user that handles 106 of surgical clip applier 100 have gone through at least a portion of a stroke. In particular, as seen in FIGS. 32 and 33 , as handles 106 are actuated, first resilient arm 148a of audible/tactile indicator 148 rides over and/or along a ledge 149 formed in at least one of upper and lower housing halves 104a, 104b and is flexed thereby. As arm 148a of audible/tactile indicator 148 reaches the proximal end of ledge 149, resilient arm 148a snaps over the proximal end of ledge 149 and comes into contact with a surface 149a of ledge 149, thereby creating a first audible sound and a tactile vibration as resilient arm 148a comes into contact with surface 149a of ledge 149. The first indication of audible/tactile indicator 148 indicates to the user that a clip “C” has been appropriately loaded.
[0139] As seen in FIGS. 28 and 30 , also during the initial squeeze of handles 106, as pusher bar 160 is moved in a distal direction, pusher 160c thereof engages a backspan of a distal-most clip “C1” and begins to move or urge distal-most clip “C1” distally out of clip carrier 170 and into jaws 120. As distal-most clip “C1” is moved distally, tangs 171 of clip carrier 170 are deflected or cammed out of engagement with distal-most clip “C1” and return to their un-deflected or un-cammed state to capture a subsequent clip of the stack of clips “C”. During the initial squeeze of handles 106, pusher bar 160 is advanced an amount sufficient to place distal-most clip “C1” in channels 120a of jaws 120.
[0140] As seen in FIGS. 27 and 31 , also during the initial squeeze of handles 106, as drive channel 140 is moved in a distal direction, rack member 141 of ratchet mechanism 144 is moved distally causing teeth 141a thereof to move into engagement with and over or across a tooth of pawl 142. Once rack member 141 of ratchet mechanism 144 is moved into engagement with pawl 142, drive channel 140 can not return to a home or proximal-most position until rack member 141 has cleared pawl 142.
[0141] During the initial squeeze of handles 106, as seen in FIGS. 25-33 , drive channel 140 is moved distally until finger 179c of pivot arm 179 is engaged by the transverse portion of slot 140g of drive channel 140 (i.e., the dwell). Once the transverse portion of slot 140g is in abutment with finger 179c of pivot arm 179 (i.e., after the dwell has been exhausted), further distal movement of drive channel 140 causes finger 179c to move and rotate pivot arm 179. Rotation of pivot arm 179 causes movement of finger 179b thereof which, in turn, causes wedge plate 180 to be pulled in a proximal direction, thereby withdrawing distal end 180a thereof from between jaws 120 and allowing for jaws 120 to eventually be closed or approximated thus allowing for jaws 120 to eventually be closed or approximated.
[0142] Once the required rotation of pivot arm 179 is achieved, pivot arm 179 stops rotating as finger 179c of pivot arm 179 rides through the proximal portion of slot 140g of drive channel 140. Finger 179c of pivot arm 179 remains in the proximal portion of slot 140g of drive channel 140 until the stroke of drive channel 140 is completed.
[0143] As seen in FIGS. 25-31 , during a further squeeze of handles 106, pusher bar 160 is moved distally with drive channel 140, as described above, until pivoting drive arm 156 has reached a position, such that angle “β” is 45°. In this configuration, proximal and distal linkage members 154 and 158 are aligned along longitudinal axis “X1” such that angle “a” therebetween is about 0°.
[0144] The following equation is used to calculate the mechanics of the motion multiplier system 155 when in a “fully extended” position. The “fully extended” position directly relates to when pusher bar 160 is in a “fully extended” position (i.e., distal-most position), for example, when angle “α” is about 0°.
XE=(B)+(C)−(L2)(cos β0) (3)
where distance “XE” is the distance between the “home” position of pivot pin 156a of pivoting drive arm 156 and the “fully extended” position of pivot pin 156a of pivoting drive arm 156 taken along longitudinal axis “X2” of drive channel 140, distance “B” is the distance between pivot pin 156a of pivoting drive arm 156 and fixed rod 154a of proximal linkage member 154 taken along longitudinal axis “X1”, distance “C” is the distance between coupling pin 158c of distal linkage member 158 and driving post 156c of pivoting drive arm 156, length “L2” is the length of pivoting drive arm 156 taken from pivot post 156a to driving post 156c, and angle “β0” is the “fully extended” position angle of angle “β” when angle “α” is about 0°. In this case, angle “β0” of pivoting drive arm 156 is about 45°, as described above and shown inFIG. 27A .
XE=(B)+(C)−(L2)(cos β0) (3)
where distance “XE” is the distance between the “home” position of pivot pin 156a of pivoting drive arm 156 and the “fully extended” position of pivot pin 156a of pivoting drive arm 156 taken along longitudinal axis “X2” of drive channel 140, distance “B” is the distance between pivot pin 156a of pivoting drive arm 156 and fixed rod 154a of proximal linkage member 154 taken along longitudinal axis “X1”, distance “C” is the distance between coupling pin 158c of distal linkage member 158 and driving post 156c of pivoting drive arm 156, length “L2” is the length of pivoting drive arm 156 taken from pivot post 156a to driving post 156c, and angle “β0” is the “fully extended” position angle of angle “β” when angle “α” is about 0°. In this case, angle “β0” of pivoting drive arm 156 is about 45°, as described above and shown in
[0145] As seen in FIG. 31 , as drive channel 140 is further advanced distally, drive channel 140 pulls or flexes resilient finger 148a of indicator 148 over a proximal end of ledge 149. In this manner, a first indication (i.e., audible and/or tactile) is created indicating to a user that a surgical clip “C” has been appropriately loaded.
[0146] As seen in FIGS. 25 and 27 , also in the “fully extended” position, proximal and distal linkage member 154 and 158 are aligned and/or parallel with longitudinal axis “X1.”
[0147] Referring now to FIGS. 32-35 , during a further squeezing of handles 106, distal ends 122a of link members 122 are caused to be moved further distally relative to housing 104. As distal ends 122a of link members 122 are moved further distally, drive pin 124 is caused to be moved further distally thereby transmitting distal axial movement to drive channel 140.
[0148] As seen in FIGS. 32 , 33, and 35, as handles 106 are continuously squeezed, pivoting drive arm 156 continues to move in a distal direction such that angle “β”, between pivoting drive arm 156 and longitudinal axis “X2” of drive channel 140, continuously increases as drive channel 140 moves in the distal direction to about 90°. This movement also causes proximal linkage member 154 (i.e., positioned on the first side) to pivot or move over-center to the second side, with reference to longitudinal axis “X1”, such that angle between proximal linkage member 154 is pivotally oriented at an angle “−α” relative to longitudinal axis “X1” (as shown in FIG. 35 ). In this manner, as proximal linkage member 154 rotates about longitudinal axis “X1,” angle “−α” decreases from about 0° to about 60° causing distal linkage member 158 to move in a proximal direction. In this configuration, sliding post 158c of distal linkage member 158 slides in a proximal direction, which, in turn, slides pusher bar 160 and stabilizer 162 back to a retracted position or a “safe” position. In the “safe” position, other components of clip applier 100, such as drive bar 140, are still moving in a distal direction so that clip “C” may be formed between jaw members 120. However, in the “safe” position, pusher bar 160 is safely retracted to a proximal position such that pusher bar 160 does not interfere with clip applier 100 when jaw members 120 are approximated towards one another.
[0149] The following equation is used to calculate the mechanics of the motion multiplier system 155 when in a “safe” position. The “safe” position, as discussed above, directly relates to when pusher bar 160 is in a safe retracted position (i.e., proximal-most position), while other components of clip applier 100, for example, handles 106 are still in a working stroke.
(L2)−(C)(sin (−α))=A (4)
where length “L2” is the length of pivoting drive arm 156 taken from pivot post 156a to driving post 156c, distance “C” is the distance between coupling pin 158c of distal linkage member 158 and driving post 156c of pivoting drive arm 156 taken along the longitudinal axis “X1,” and distance “A” is the distance between fixed rod 154a of proximal linkage member 154 and pivot pin 156a of pivoting drive arm 156 taken along a reference axis orthogonal to the longitudinal axis “X1,” as shown inFIG. 42B .
(L2)−(C)(sin (−α))=A (4)
where length “L2” is the length of pivoting drive arm 156 taken from pivot post 156a to driving post 156c, distance “C” is the distance between coupling pin 158c of distal linkage member 158 and driving post 156c of pivoting drive arm 156 taken along the longitudinal axis “X1,” and distance “A” is the distance between fixed rod 154a of proximal linkage member 154 and pivot pin 156a of pivoting drive arm 156 taken along a reference axis orthogonal to the longitudinal axis “X1,” as shown in
[0150] With continued reference to FIG. 32-38 , during the further squeezing of handles 106, with tab 192a removed from counter mechanism 190, as drive channel 140 is advanced distally, nub 140e thereof engages contact 194a of processor 194 thereby completing a circuit and causing processor 194 to perform a function, as described above.
[0151] Referring now to FIGS. 39-44 , clip applier 100 is illustrated during a final squeezing of handles 106. In this condition, drive channel 140 is at a distal position, pusher bar 160 is at a distal position, wedge plate 180 is at a proximal position, biasing member 146 is stretched, and pawl 142 is located proximal of rack 140d.
[0152] Additionally, as seen in FIG. 43 , with distal end 180a of wedge plate 180 removed from between jaws 120, as drive channel 140 is moved further distally, a distal edge of drive channel 140 and/or drive channel strap 143 engages against camming surfaces 120b of jaws 120 thus causing jaws 120 to approximate toward one another and to form surgical clip “C1” interposed therebetween. Since drive channel strap 143 is fixed to drive channel 140 and moves therewith, drive channel strap 143 functions to cap drive channel 140 so as to maintain jaws 120 within drive channel 140 during the approximation of jaws 120 and to maintain wedge plate 180 within drive channel 140 during operation of clip applier 100.
[0153] As seen in FIG. 44 , surgical clip “C1” may be formed or crimped onto a vessel “V” or any other biological tissue.
[0154] Drive channel 140 is permitted to move distally relative to pusher bar 160 due to the translation of bosses 148b of indicator 148 through slot 160d of pusher bar 160.
[0155] Also, as drive channel 140 is fully advanced distally, as seen in FIG. 41 , rack member 141 of ratchet mechanism 144 is moved distally to a location beyond pawl 142 such that the teeth 141a of rack member 141 are moved distally of the tooth of pawl 142 thereby disengaging rack member 141 and pawl 142 from one another. In this manner, drive channel 140 is permitted or free to return to a home or proximal-most position.
[0156] As seen in FIG. 42 , as drive channel 140 is moved distally, resilient arm 148a of audible/tactile indicator 148 snaps over the distal end of ledge 149 and comes into contact with a surface 149a of ledge 149, thereby creating an audible sound and/or a tactile vibration. Such audible sound and/or tactile vibration coincide with the loading of surgical clip “C”.
[0157] Referring now to FIGS. 45-52 , during an opening or release of handles 106, distal ends 122a of link members 122 are caused to be moved proximally relative to housing 104. As distal ends 122a of link members 122 are moved proximally, drive pin 124 is caused to be moved proximally thereby transmitting proximal axial movement to drive channel 140 and, in turn, pusher bar 160. The proximal movement of drive channel 140 is facilitated by the constriction of biasing members 146. Alternatively, the release of handles 106 results in biasing member 146 withdrawing drive channel 140 in a proximal direction.
[0158] As drive channel 140 is moved proximally, the distal edge of drive channel 140 and/or drive channel strap 143 disengages from against camming surfaces 120b of jaws 120 thus freeing jaws 120 for separation from one another for reinsertion of distal end 180a of wedge plate 180 therebetween, and to receive another surgical clip “C” therebetween. In particular, as drive channel 140 is moved proximally, the transverse portion of slot 140g acts on finger 179c to cause pivot arm 179 to rotate and cause finger 179b of pivot arm 179 to urge wedge plate 180 distally. As wedge plate 180 is moved in a distal direction, as seen in FIGS. 51 and 52 , distal end 180a of wedge plate 180 is reinserted or reintroduced into jaws 120, thereby spreading jaws 120 apart.
[0159] As seen in FIGS. 48 and 49 , as wedge plate 180 is moved distally, proximal tab 176 of clip follower 174 engages in a window 180b of wedge plate 180 and is thus urged distally a given distance. As clip follower 174 is urged distally, stack of clips “C” is also urged distally. As seen in FIG. 50 , when wedge plate 180 reaches a distal-most position, clip channel 170 abuts, engages, urges or otherwise cams against proximal portion 175b of distal tab 175 until web 180f of wedge plate 180 rests substantially beneath distal portion 175a of distal tab 175. In so doing, proximal portion 175b of distal tab 175 is moved to extend into an incrementally more distal window 172 of clip channel 170.
[0160] As seen in FIGS. 50 and 51 , as clip follower 174 is urged forward, moving the stack of clips “C” forward, a distal-most clip “C1” moves distal of pusher 160c by camming beneath pusher 160c of pusher bar 160 until distal-most clip “C1” is caught by tangs 171 of clip applier 170.
[0161] Turning momentarily to FIG. 47 , as drive channel 140 is moved in a proximal direction, arm 148a of audible/tactile indicator 148 snaps back over ledge 149 and re-sets itself for the next firing stroke or squeeze of handles 106.
[0162] As drive channel 140 is moved further in a proximal direction, drive channel 140 effectuates proximal movement of pivoting drive arm 156, which, in turn, reverses the movement of the motion multiplier system.
[0163] As seen in FIGS. 45-51 , while handles 106 are released and driving channel 140 is moved in a proximal direction via biasing member 146 (as shown in FIG. 39 ), coupling pin 156a of pivoting drive arm 156 moves in a proximal direction such that angle “β,” between pivoting drive arm 156 and longitudinal axis “X2” of drive channel 140, continuously decreases as drive channel 140 also moves in the proximal direction. In this manner, driving post 158c of distal linkage member 158 starts to move in a distal direction, such that, pusher bar 160 and stabilizer 162 via sliding post 158c distally move back to the “fully extended” position. At substantially the same time, as driving post 158c of distal linkage member 158 starts to move in a distal direction, angle “−α” of proximal linkage member 154, positioned on the second side of longitudinal axis “X1,” increases from about −60° to about 0°. As drive channel 140 further moves in the proximal direction, proximal linkage member 154 pivots from the second side to the first side of longitudinal axis “X1,” such that, in the “fully extended” position, proximal and distal linkage members 154 and 158 are again pivotally located in alignment with each other, such that angle “α” is about 0°. In other words, proximal and distal linkage member 154 and 158 are between the first side and the second side of longitudinal axis “X1.”
[0164] In this configuration, as driving channel is 140 further continues to move in the proximal direction, pusher bar 160 is moved proximally with drive channel 140, as described above, until pivoting drive aim 156 has reached a position, such that angle “β,” between pivoting drive arm 156 and longitudinal axis “X2” of drive channel 140, is about 45°. In this manner, proximal linkage member 154 moves to the first side, such that angle “α” starts to increase from about 0° to about 60°.
[0165] Subsequently, as drive channel 140 is moved proximally, the reversing motion multiplier system 155 moves from the “fully extended” position to the “home” position. More particularly, drive channel 140 advances in a proximal direction, which, in turn, causes pivoting drive arm 156 to move in a proximal direction. That is, pivoting drive arm 156 pivots and drives proximal linkage member 154 in a direction such that angle “β,” between pivoting drive arm 156 and longitudinal axis “X2” of drive channel 140, decreases to about 22° to about 45°. In this manner, proximal linkage member causes distal linkage member to pivotally slide proximally along slot 162b of stabilizer 162 and proximal window 160d of pusher bar 160. In this configuration, distal linkage member 158 drives pusher bar 160 in a proximal direction.
[0166] When drive channel 140 and pusher bar 160 are located at the distal-most position, sliding post 156c of pivoting drive arm 156 is located at a distal-most position and second resilient finger 148b of indicator 148 is disposed proximal of edge 149. Also, as handles 106 of clip applier 100 are released, with wedge plate 180 located at a distal-most position, distal end 180a thereof is interposed between jaws 120. Additionally, as drive channel 140 is moved in a proximal direction, nub 140e thereof disengages contact 194a of processor 194.
[0167] Turning now to FIG. 52 , a distal end of clip applier 100 is illustrated following a complete stroke or squeezing of handles 106 and after a final clip has been expelled therefrom. Following firing of the last clip, as seen in FIG. 52 , proximal tab 176 of clip follower is disposed within a distal-most aperture or window of apertures 180b of wedge plate 180. In this manner, as wedge plate 180 is moved distally following a firing of a clip, in the manner described above, clip follower 174 is also moved distally. Accordingly; as clip follower 174 is moved distally, distal tab 175 thereof is moved distal of a distal-most window of windows 172 of clip carrier 170. In this manner, proximal portion 175b of distal tab 175 engages against an inner surface of a top wall of clip carrier 170 and is cammed or urged downwardly.
[0168] As proximal portion 175b of distal tab 175 is cammed or urged downwardly, distal portion 175a of distal tab 175 engages against an upper surface of tab 178a of lockout 178 and cams or urges tab 178a of lockout 178 downwardly, across a path of strap 143, supported on drive channel 140, and into distal window 180c of wedge plate 180. In this manner, if drive channel 140 is advanced distally, in the manner described above, strap 143 will abut against tab 178a of lockout 178 and prevent or block strap 143 and, in turn, drive channel 140 from moving distally. At this stage, pawl 142 is located in a dwell, distal of rack 140d, and handles 106 are arranged in a fully opened position and are thus not capable of being opened any further. In this configuration, clip applier is locked out and can no longer be used.
[0169] Depending on the size of the surgical clip, the size of components of clip applier 100 will have to be scaled accordingly. The majority of the components of the various sized clip appliers will be substantially identical to one another. Components size relating to the width of the clips, such as the jaws 120 and the wedge plate 180, or components size relating to the length of the clip, such as the pusher bar 160 and the pivot arm 179, are adjusted accordingly. In this manner, each clip applier, of varying size, will be assembled in substantially the same manner and the inner mechanism thereof will operate in substantially the same manner.
[0170] For example, clip applier 100 may be provided in a relatively small, medium and large scale, wherein each of the sizes of clip appliers stores and fires a relatively small, medium or large surgical clip. Based on the relative dimensions of the surgical clips, the corresponding clip appliers, and their corresponding components, must be scaled appropriately. However, in accordance with the present disclosure, each of the various sized clip appliers comprise the same component and may be assembled in the same sequence as one another. In this manner, a technician assembling the clip appliers will only have to learn the sequence and/or steps required for the assembly of one of the sizes of clip appliers and, in turn, be able to assemble the other sizes of clip appliers equally, without having to learn a new sequence or step of assembly.
[0171] Accordingly, the assembly method and/or steps for a relatively small, medium or large clip applier are substantially identical to one another.
[0172] Many other remaining components or parts are identical or have minor variations in feature size or scale. However, if desired, the shapes of the following parts may be modified in order to achieve the same result, namely, the length of proximal linkage member 154, the length of pivoting drive arm 156, and/or the length of distal linkage member 158.
[0173] It is contemplated that varying the starting angle of angle “α,” for example, at about 45° versus at about 60°, is more effective, such that the angle difference creates a smoother starting action for the working stroke of clip applier 100. However, when starting angle “α” is about 45°, more area is taken up within housing 104 of clip applier 100 due to longer proximal and distal linkage members 154 and 158 than when the starting angle “α” is about 60°. All parameters of the motion multiplier system 155 can and should be individually designed for any configuration need in the specific device in which the motion multiplier system is considered to be implemented within.
[0174] 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.
Claims
The invention claimed is:
1. A surgical clip applier for applying surgical clips to body tissue, the surgical clip applier comprising:
a housing;
at least one handle pivotably connected to the housing;
a channel assembly extending distally from the housing;
a clip carrier disposed within the channel assembly and defining a channel and a plurality of windows therein;
a plurality of clips slidably disposed within the channel of the clip carrier;
a drive channel reciprocally disposed within at least one of the housing and the channel assembly, the drive channel having a first end operatively connected to the at least one handle and a second end operatively connected to a distal end of the channel assembly;
a wedge plate reciprocally disposed within the channel assembly, the wedge plate being operatively connected to the at least one handle and including a plurality of apertures formed along a length thereof;
a pusher bar reciprocally positioned within the housing and the channel assembly, the pusher bar having a proximal end operatively connected to at least one handle and a distal end defining a pusher, wherein the distal end of the pusher bar is configured for engagement with a distal-most clip of the plurality of clips; and
a motion multiplier system having a plurality of linkage members configured to distally move the pusher bar by an incremental amount upon an initial actuation of the handles, and configured to proximally move the pusher bar and the wedge plate subsequent to the initial actuation of the handles; wherein the plurality of linkages of the motion multipliers system includes:
a proximal linkage member pivotally supported in the housing and operatively connected to the drive channel, wherein the proximal linkage member is configured to receive a fixed rod therethrough such that a pivotable connection between the proximal linkage member and the housing is established;
a pivoting drive arm interconnecting the drive channel and the proximal linkage member; and
a distal linkage member interconnecting the proximal linkage member the pusher bar;
wherein a distal translation of the drive channel causes the proximal linkage member to pivotally rotate via the pivoting drive arm, such that proximal linkage member causes a first end of the distal linkage member to pivotally rotate in a first direction and a second end to slidably move the pusher bar in a distal direction.
2. The clip applier according to claim 1, wherein a further distal translation of the drive channel cause the proximal linkage member to pivotally rotate via the pivoting drive arm, such that the proximal linkage member causes the first end of the distal linkage member to pivotally rotate in a second direction and the second end to slidably move the pusher bar in a proximal direction.
3. The clip applier according to claim 1,
wherein a distal translation of the drive channel causes a pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the pivotal rotation of the proximal linkage member causes a pivotal rotation of the distal linkage member, and wherein the pivotal rotation of the distal linkage member causes a distal translation of the pusher bar.
4. The clip applier according to claim 3, wherein a further distal translation of the drive channel causes a further pivotal rotation of the proximal linkage member via the pivoting drive arm, wherein the further pivotal rotation of the proximal linkage member causes a further pivotal rotation of the distal linkage member, and wherein the further pivotal rotation of the distal linkage member causes a proximal translation of the pusher bar.
5. The clip applier according to claim 3, wherein when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a first position, the proximal linkage member and the distal linkage member define a first angle, wherein proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby increasing the first angle to a second angle of about 180 degrees such that the proximal linkage member and the distal linkage member are linear to each other, such that the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in a second position.
6. The clip applier according to claim 5, wherein when the proximal linkage member, the distal linkage member, the pivoting drive arm, the drive channel and the pusher bar are in the second position, further proximal translation of the drive channel causes the proximal linkage member and the distal linkage member, via the pivoting drive arm, to pivotally rotate thereby decreasing the second angle of about 180 degrees to a third angle, such that the distal linkage member, the pivoting drive arm, and the drive channel are in a third position, while the pusher bar is in the first position.
7. The clip applier according to claim 3, wherein the rotation of the proximal linkage member via the pivoting drive arm causes the proximal linkage member and the distal linkage member to be linear to each other and along a longitudinal axis defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, such that the distal linkage member causes a distal translation of the pusher bar.
8. The clip applier according to claim 7, wherein further rotation of the proximal linkage member via the pivoting drive arm causes the proximal member and the distal linkage member to be angularly offset from each other, such that the distal linkage member causes a proximal translation of the pusher bar.
9. The clip applier according to claim 3, wherein a longitudinal axis, defined by a reference axis between the proximal end of the proximal linkage member and the distal end of the distal linkage member, and the proximal linkage member define a first acute angle on a first side of the longitudinal axis, and the pusher bar is in a proximal position, wherein distal translation of the drive channel causes the proximal linkage member and the distal linkage member to pivot such that the first acute angle on the first side of the longitudinal axis increases until the proximal linkage member and the distal linkage member are linear to each other and the pusher bar has been distally translated via the distal linkage member to a distal position.
10. The clip applier according to claim 9, wherein further distal translation of the drive channel causes the proximal linkage member and the distal linkage member to pivot from the side of the longitudinal axis to a second side of the longitudinal axis such that the proximal linkage member and the longitudinal axis define a second acute angle and the pusher bar has been proximally translated via the distal linkage member to a proximal position.
11. The clip applier according to claim 1, wherein the clip follower is configured to engage the wedge plate and move distally upon distal translation of the wedge plate, and is configured to engage the clip carrier and stop proximal movement thereof upon proximal translation of the wedge plate.
12. The clip applier according to claim 1, further comprising a jaw assembly including a pair of jaws extending from an end of the channel assembly, opposite the housing, the jaw assembly adapted to accommodate a clip of the plurality of clips therein and being operable to effect formation of the clip in response to movement of the handles.
13. The clip applier according to claim 12, wherein the pusher bar is movable towards the jaws as the handles are approximated in a first direction by an initial amount in order to move a distal-most clip between the jaws, and the pusher bar being configured and adapted to move towards the housing as the handles are approximated an additional amount in the first direction to move the pusher behind a distal-most clip in the plurality of clips.
14. The clip applier according to claim 13, wherein the drive channel is configured and dimensioned to at least partially surround the jaws and the wedge plate, wherein the drive channel includes a strap extending across a distal end thereof for maintaining the jaws and the wedge plate within the drive channel.
15. The clip applier according to claim 13, wherein the drive channel is moved towards the jaw assembly as the at least one handle is moved actuated in a first direction to move the second end of the drive channel against the jaws to close the jaws, the drive channel being moved away from the jaws as the at least one handle is moved a second amount to move the second end of the drive channel away from the jaws to allow the jaws to open.
16. The clip applier according to claim 15, further comprising a motion reversing mechanism operatively connected to the wedge plate and the drive channel, wherein rotation of the motion reversing mechanism, during distal movement of the drive channel, results in proximal movement of the wedge plate.
17. The clip applier according to claim 1, further comprising:
a clip follower slidably disposed within the channel of the clip carrier and disposed proximally of the plurality of clips, the clip follower being configured and adapted for selective engagement with the windows of the clip carrier and the apertures of the wedge plate, wherein the clip follower is configured and adapted to urge the plurality of clips, in a distal direction relative to the clip carrier, upon reciprocal movement of the wedge plate.
18. The clip applier according to claim 1, further comprising:
a motion reversing mechanism operatively connected to the drive channel and the wedge plate and selectively engageable with the pusher bar, wherein rotation of the motion reversing mechanism, during the distal translation of the drive channel, results in proximal movement of the wedge plate and the pusher bar.
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