Apparatus and method for applying surgical staples to attach an object to body tissue

Abstract: An apparatus 10 is disclosed for endoscopic application of surgical staples adapted to attach surgical mesh to body tissue in laparoscopic hernia surgery. The apparatus includes a frame 12, and a generally elongated endoscopic section 14 connected to the frame and extending distally therefrom. A staple storage cartridge 16 is removably supported on a pivotal support system at the distal end portion of the endoscopic section with each staple being configured and adapted to attach the mesh to the body tissue. An elongated pusher system 24 formed of several assembled components and extending from the frame to the endoscopic section is provided for individually advancing at least one staple at a time distally for positioning adjacent the surgical mesh and the body tissue. The pusher system also includes a trigger system 20 to actuate the pusher. The trigger system is provided with perceptible tactile sensing means to indicate when the legs of the staple 110 being advanced are exposed so as to be visible to the user for positioning and orientation purposes. Anvil means 116, 118 provides for individually closing each staple to encompass at least a portion of the surgical mesh and to penetrate the body tissue in a manner to attach the portion of the mesh to the body tissue. Projecting distally of the cartridge support system is a pair of legs which are dimensioned and configured to engage the staple during closure to prevent unwanted roll or deformation outside of the plane of the staple. The staple storage cartridge may be pivoted with respect to the longitudinal axis of the endoscopic section from 0° to about 32.5° and about 65°. Further, the cartridge may be rotated from a proximal location about its own axis independent of the endoscopic section while pivoted to any of the predetermined angles relative to the longitudinal axis of the endoscopic section.

Description: BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for applying surgical staples to attach objects to body tissue. More particularly, this invention relates to a staple applier particularly adapted for attaching surgical mesh to body tissue to reinforce a surgical repair of the body tissue, as in hernia repair. 2. Background of the Invention The present invention represents a further improvement on the apparatus disclosed in Applicant's earlier EP-A-0541987 document under Art 54 (3), EPC, to which the reader is referred for a description of the apparatus shown in Figures 1 to 41 of this specification. WO89-10094 discloses a device for stapling a hernia opening. A cartridge containing a staple is located at the distal end of the device. In use, it rotates through 90° from a disposition aligned with the longitudinal axis of the device to a disposition transverse to the axis, for firing the staple in a distal direction, on the longitudinal axis. In particular, this document discloses an apparatus for endoscopic application of a surgical fastener which comprises a frame, an elongated member connected to said frame and extending distally therefrom, said elongated member having a generally longitudinal axis and having a proximal end portion, an intermediate portion and a distal end portion which pivots about an axis transverse to the longitudinal axis. Up to the present there remains a need for an apparatus which is particularly adapted to endoscopically apply staples for attaching objects such as surgical mesh to body tissue in a manner to accurately position and orient the staples to positively secure the object to the body tissue without danger of separation thereof after the attachment is completed. The present invention relates to such an apparatus. SUMMARY OF THE INVENTION The apparatus of the present invention is defined in claim 1 hereinbelow. It is distinguished from the apparatus of Figures 1 to 41 and the disclosure of EP-A-0541987 most noticeably by the rotatability of its distal end portion about the longitudinal axis at least independent of the intermediate portion of the elongate member. In one embodiment, an apparatus is disclosed for endoscopic application of a surgical staple adapted to attach an object to body tissue, which comprises frame means, generally elongated endoscopic means connected to the frame means and extending distally therefrom, cartridge means for storing at least one surgical staple at the distal end portion, the staple being configured and adapted to attach an object to body tissue. Means is provided for individually advancing the at least one staple distally for positioning adjacent the body tissue, and anvil means is provided for closing the staple in a manner to encompass at least a portion of the object and to penetrate the body tissue to attach the portion of the object to the body tissue. In the preferred embodiment, the apparatus includes on the elongated endoscopic means, means for engageably receiving and supporting the cartridge in a manner to advance the staples individually for endoscopic application. A cartridge is also disclosed for containing a plurality of surgical staples for fastening body tissue which comprises housing means adapted to support the plurality of surgical staples, and means dimensioned, positioned and adapted to engage each staple as the staple is advanced from the housing means in a manner to prevent the staple from deforming out of the plane of the staple when the staple is deformed to attach the staple to body tissue. The apparatus according to the invention is also suitable for attaching surgical mesh to body tissue adjacent a tissue repair within a body cavity which comprises, a frame, and an elongated endoscopic section connected at the proximal end thereof to the frame and extending distally therefrom, the endoscopic section configured and adapted for insertion into an endoscopic cannula within the body cavity. The endoscopic section includes a disposable cartridge adapted to store a plurality of surgical staples in stacked relation, the cartridge being removably engageably supported by a pivotal support member, each staple being formed of a first length of wire having at least one leg portion at each end extending generally perpendicular to the first length of wire, the leg portions being continuous with the first length of wire and configured to facilitate insertion into surgical mesh and adjacent body tissue therebeneath when said staple is advanced toward the mesh. The staple is further configured to facilitate folding the legs inwardly toward the first length of wire when at least a portion of the first length of wire is advanced against anvil means, whereby the leg portions and the first length of wire grip the mesh and the body tissue therebetween to attach at least the gripped portion of the mesh to the body tissue. In this apparatus, means is provided for individually advancing the staples distally for positioning adjacent the mesh and the body tissue. Means is also included for providing perceptible tactile indicator when each staple is advanced to a predetermined position. Means is provided for closing each staple while the staple is advanced toward the mesh and the body tissue so as to penetrate the mesh and the body tissue while causing the leg members to fold inwardly toward the first wire of the staple to grip the mesh and the body tissue between the first wire and the leg members. A method for using the apparatus of the invention for endoscopically applying surgical staples to attach objects such as surgical mesh to body tissue comprises the steps of storing at least one surgical staple cartridge positioned at the distal end portion and adapted for advancing and closing the staple, positioning the object adjacent the body tissue for attachment to the body tissue, and advancing the surgical staple distally so as to penetrate the object and the body tissue and to close the staple at least sufficient to attach said portion of the object to the body tissue. The apparatus for endoscopic application, of a surgical fastener, comprises a frame, an elongated member connected to the frame and extending distally therefrom, and means cooperating with said elongated member for storing at least one surgical fastener. Pusher means is provided for advancing the at least one fastener distally for positioning adjacent the body tissue. Means is provided for closing the fastener, and means is provided to rotate the staple storing means about an axis extending generally longitudinally thereof. Preferably, the endoscopic apparatus comprises an elongated member having a distal end portion and a proximal end portion and defining a longitudinal axis, a working head at the distal end portion of the elongated member, means to control the operation of the working head from a proximal end portion, and means to rotate the working head about an axis extending therethrough independent of the elongated member. Preferably, the apparatus further comprises means to rotate the elongated member about the longitudinal axis from a proximal position. Also the means to rotate the elongated member from a proximal position about the longitudinal axis preferably comprises means to pivotally rotate the working head to at least two selected angles relative to the longitudinal axis of the elongated member. The first angle is about 32.5° and the second angle is about 65°. The working head preferably comprises cartridge support means pivotally attached to the elongated member, and cartridge means supported by the cartridge support means and adapted to contain surgical fasteners wherein the fasteners are surgical staples. The means to rotate the elongated member comprises control means positioned at a proximal end portion of the elongated member. The means for effecting rotation of the working head about its own axis comprises a staple advancing plate member nestled within the working head in a manner such that rotation of the plate member effects rotation of the working head, elongated means extending from the frame means to the staple advancing plate member and connected thereto, and control means connected to frame means and operable for effecting rotation of the working head about an axis extending therethrough. Generally, this embodiment facilitates application of staples at predetermined locations and at predetermined angles, with improved extreme precision, with ease of operation to the user. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention are described hereinbelow with reference to Figures 42 to 63 of the drawings wherein: Fig. 42 is a perspective view of an embodiment of the invention wherein articulation of the staple storage magazine section is possible between 0°, 32.5°and 65°, respectively; Fig. 43 is an exploded perspective view with parts separated, of the slidable collar and related mechanism for articulating the staple storage magazine section; Fig. 44 is a view taken along lines 44-44 of Fig. 42, illustrating in phantom lines the pivoting system for the staple storage magazine section and related attachment system; Fig. 45 is a partial cross-sectional view taken along lines 45-45 of Fig. 44, illustrating the system for pivoting the staple storage magazine section at the distal end portion of the endoscopic section; Fig. 46 is a cross-sectional view taken along lines 46-46 of Fig. 42, illustrating the slidable collar and related mechanism for articulating the staple storage magazine section, wherein the magazine section is at the 0° position with respect to the longitudinal axis of the endoscopic section; Fig. 47 is a cross-sectional view taken along lines 47-47 of Fig. 46, illustrating the first selective detent mechanism for articulating the staple storage magazine section between 0°, 32.5° and 65°, respectively; Fig. 48 is a partial cross-sectional view from the side, illustrating the relative component positions at the distal end portion of the endoscopic section with the staple storage magazine section articulated to 32.5° from the longitudinal axis of the endoscopic section; Fig. 49 is a cross-sectional view similar to Fig. 46 illustrating the slidable collar and related mechanism when the staple storage magazine section is in the 32.5° position relative to the longitudinal axis of the endoscopic section; Fig. 50 is a cross-sectional view taken along lines 50-50 of Fig. 49; Fig. 51 is a partial cross-sectional view similar to Fig. 48 illustrating the relative component positions when the staple storage magazine section is articulated to 65° from the longitudinal axis of the endoscopic section; Fig. 52 is a partial cross-sectional view similar to Fig. 49 illustrating the slidable collar and related mechanism when the staple storage magazine section is articulated to 65° as shown in Fig. 51; Fig. 53 is a cross-sectional view of a portion of the detent ball system of the slidable collar mechanism for retaining the staple storage magazine section in selected positions, illustrating the proximal-most ball and pin when the slidable collar is moved proximally a small -amount from the 0° magazine section position; Fig. 54 is a cross-sectional view similar to Fig. 53 illustrating the ball and detent positions when the staple storage magazine section is in the 32.5° position; Fig. 55 is a cross-sectional view similar to Fig. 54 illustrating the ball and detent position when the staple storage magazine section is in the 65° position; Fig. 56 is a cross-sectional view of the proximal portion of the endoscopic section and the distal portion of the handle section, with the handle outer structure removed for convenience of illustration, illustrating one system for rotating the staple storage cartridge about its own axis from the handle section; Fig. 56A is a cross-sectional view taken along lines 56A-56A of Fig. 56; Fig. 57 is a side view of the staple storage magazine section pivoted to the 32.5° position and illustrating schematically by arrows, the rotational capability of the staple storage magazine about its own central axis; Fig. 58 is a frontal view taken along lines 58-58 of Fig. 57 illustrating in phantom lines, several of the angular orientations of the staple storage magazine section which are possible about its own axis when the section is pivotably rotated to the 32.5° angular position shown in Fig. 57; Fig. 59 is a perspective view, with parts separated, of the proximal control system shown in Fig. 56, for rotating the staple storage magazine about the central axis thereof from the handle section mounted in conjunction with the ratchet and pawl system of the previous embodiments; Fig. 60 is a cross-sectional view of the assembled components shown in Fig. 59 illustrating an alternative system for rotating the staple storage magazine section about its own longitudinal axis, incorporating an alternative ratchet and pawl system arrangement; Fig. 60A is a cross-sectional view taken along lines 60A-60A of Fig. 60 illustrating the attachment for rotating the staple advancing member; Fig. 61 is a side view similar to Fig. 57, illustrating the staple storage magazine section in the 65° position with respect to the longitudinal axis of the endoscopic section; Fig. 62 is a view similar to Fig. 58 taken along lines 62-62 of Fig. 61, illustrating several of the angular orientations of the staple storage magazine section which are possible about its own axis when the section is pivoted to the 65° angular position shown in Fig. 61; and Fig. 63 is a perspective view similar to Fig. 59 illustrating the alternative embodiment of the proximal control system shown in Figs. 60 and 60A. For a description of what is shown in Figures 1 to 41, the reader is referred to EP-A-0541987. In the description of the embodiments which follows, reference is made to Figs. 42-63 in which, wherever possible, like components are identified by numerals similar to the numerals for like components of the previous embodiments except that they begin with the numeral "3". Accordingly, for example, whereas the entire apparatus for the previous embodiments were respectively identified by numerals "10" and "210", the present embodiment illustrated in Fig. 42 is identified by numeral "310". In addition, for convenience of illustration, certain components will be identified by three digit numerals beginning with the numeral "4" and where possible, by three digit numerals beginning with the numeral "5". Furthermore, the features described in connection with the present embodiment are contemplated to be complementary to the features and improvements described previously. Accordingly, those features described in connection with the previous embodiments which are incorporated herein need not be repeated. For example, one magazine for storing staples is preferably a removable and replaceable cartridge as shown in Fig. 33 of the previous embodiment and the description thereof is not repeated herein. However, it is also contemplated as another mode of storing and applying staples to incorporate a permanently attached magazine as shown for example in Figs. 1 and 15. That system need not be repeated herein since reference is made to the description hereinabove. Referring now to Fig. 42, there is illustrated a perspective view of an alternative embodiment of the apparatus constructed according to the invention. In general, the apparatus of the present embodiment is similar in most respects to the apparatus of the previous embodiments, but incorporates the following additional features: 1. Pivotal movement of the staple storage magazine section to 32.5° and 65° respectively via a double knurled collar similar to collar 60 shown in Figs. 8-14; 2. Dual detent mechanisms to positively establish the positions of the staple storage magazine section in either of the 0°, 32.5° or the 65° positions; and 3. Independent rotational capability with control from a proximal location, of the staple storage magazine section to rotate about its own central axis in all angular orientations. The combination of the above-listed features provides extremely precise positioning of the staples at numerous angular orientations to facilitate application thereof at the precise location and orientation which may be predetermined by the surgeon. These features, combined with the features described in connection with the previous embodiments, individually or in combination, provide an apparatus which represents a significant improvement over the highly effective embodiments described previously. Referring now to Fig. 42, there is illustrated a perspective view of apparatus 310 constructed according to the present embodiment. The apparatus 310 includes frame portion 312 and endoscopic section 314 having at the distal end portion a staple storage section 315 which includes staple cartridge support member 366 on which is supported staple storage cartridge 316. Generally, the frame portion 312 supports the actuating components as described hereinabove in connection with the previous embodiments. Preferably, the frame portion is configured as a handle as shown, grippable by hand. Generally, it may be stated that the staple cartridge support member 366 is pivotally mounted to the distal portion of the endoscopic section and such resultant pivotal movement will result in similar pivotal movement of the staple storage cartridge 316 since the cartridge is directly supported thereon. The pivotal movement of the staple storage cartridge support member and related mechanism is somewhat similar to the system described in connection with the previous embodiments with the additional features described hereinbelow. The mechanism for pivoting the staple storage cartridge between positions of 0°, 32.5° and 65° with respect to the central longitudinal axis of the endoscopic section is illustrated generally in Figs. 43-55. In particular, the operation is described to pivot the cartridge via dual knurled collar 322. The appropriate dimensions of the links, the rods and related components have been selected to effect pivotal movements of the staple storage magazine section to about 32.5° and about 65°. However, the relevant dimensions and mechanical advantages may be selected to provide other alternative angular orientations for the staple storage section. Collar 322 includes dual gripping knurled surfaces similar to the collar described in connection with the previous embodiments. The distal knurled surface 322a facilitates distal and proximal movement of the collar and the proximal knurled surface 322b facilitates rotational movement of the collar about the central axis of the endoscopic section. Referring in particular to Fig. 43, collar 322 is structured and dimensioned to contain a series of plates including an upper plate 402, a lower plate 404 and a central centering plate 406 having distally extending leg 408 and proximally extending leg 410. Lower plate 404 includes a cut-out 412 which is dimensioned and configured to receive intermediate centering plate 406 as shown in Fig. 46 with legs 408 and 410 respectively surrounded by coil springs 414 and 416. When the plates are assembled and positioned within opening 322c in collar 322 as shown in Fig. 46 centering springs 414 and 416 serve to maintain the centered position of intermediate centering plate 406 within the cut-out 412 of lower plate 404. Referring once again to Fig. 43 in conjunction with Fig. 47, lower plate 404 contains cylindrical apertures 418, 420, 422 in which are positioned locator balls 424, 426 and 428. Depending upon the position of the lower plate 404 with respect to the lower housing 314b, pin 430 is biased upwardly by spring 432 to position the ball within the respective conical aperture 434, 436, 438 to locate and fix the position of upper plate 402. Referring now once again to Fig. 43, pin 440 extends through aperture 442 in collar 322 and through aperture 444 in upper plate 402 as well as through aperture 446 in central plate 406 to key these components together for common distal and proximal movement. In Fig. 43, proximal link 444 is pivotal about pin 446 which extends through aperture 448 in link 444, aperture 467 in upper housing 464 and aperture 315 in lower housing. The link 444 contains slot 450 for slidable reception of pin 452. Pin 452 is slidable distally and proximally within slot 466 in upper housing 464 and also extends through aperture 404d in upper plate 404. Similarly, distal link 454 is pivotal about pin 456 which extends through aperture 458 and contains slot 460 for slidable reception of pin 462. Pin 462 is slidable proximally and distally in slot 468 in upper housing 464 and which also extends through aperture 404c in upper plate 404. Detent spring 463 contains three arcuate relief sections including distal arcuate detent relief 466, proximal detent relief 464 and intermediate U-shaped detent relief 468 for respective engaged resilient reception of proximal slidable pin 452 as shown in Figs. 43, 46, 47 and 49. Links 444 and 454 respectively receive the bent "L-shaped" end 470p and 472p of drive rods 470 and 472 respectively, each of which are respectively arranged at their distal ends 470d and 472d to engage wall portions 421, 423 of the cartridge support member 366 to effect pivotal movement of the cartridge section as rod 472 is moved proximally and rod 470 is moved distally to effect pivotal movement of cartridge section 315. The operation of the system to effect pivotal movement of the staple cartridge section will now be described. When collar 322 is in the distalmost position, the staple cartridge 316 is at 0° relative to the longitudinal axis of the endoscopic section, i.e. in line with the section 314 as shown in solid lines in Fig. 42. In this position, pin 452 is engageably nestled within distal spring detent 466 as shown in Fig. 46 while proximal link 444 and distal link 454 are positioned as shown. The engaged nestled position of rod 452 in spring detent 466 provides a first detent to retain cartridge push rods 470 and 472 from movement thereby securing the 0°angular position of the staple cartridge section. In addition as shown in Fig. 47, locator ball 428 is positioned within conically shaped indentation 434 in upper plate 402 to provide a second detent mechanism to restrain movement of push rods 470 and 472 by outer plate 402 against proximal and distal movements. Thus, the 0° position of cartridge 316 is established and fixed by a dual detent system. Referring now to Fig. 46 in conjunction with Figs. 43-49, the mechanical movements required to produce pivotal movement of the staple cartridge section 315 and cartridge 316 will now be described. When collar 322 is moved proximally by hand, outer plate 402 and central centering plate 406 also move proximally therewith through common connector pin 440. This movement causes coil spring 416 to engage walls 412a and 412b of lower plate 404 until the spring is sufficiently compressed and the proximal wall of proximal leg 410 moves the distance "A" shown in Fig. 46. At this point, leg 410 engages wall 404a of lower plate 404 such that continued proximal movement of the collar 322 causes corresponding movement of lower plate 404. Prior to such engagement limited movement of upper plate has taken place as shown by dimension "A" in Figs. 46 and 53 to begin camming ball 428 out of conical indentation 434 as shown in Fig. 53. The effect of such movement of ball 428 is to depress ball 428 and pin 430 against spring 432 causing upper plate 402, intermediate plate 406 and lower plate 404 to move proximally together until pin 430 engages central ball 436. This movement in turn results in proximal movement of pin 452 to the central detent 468 of spring 463 as shown in Fig. 49 such that the positions of the components are as shown in Fig. 49. In this Fig., the distal link 454 has moved counterclockwise and the proximal link 448 has moved clockwise (as viewed from above in Fig. 43). The rotational movement of proximal link 448 is due to the constraint on pin 452 to slide in slot 466 in upper housing 464 whereas pin 462 associated with proximal link 454 is constrained to move longitudinally within slot 468 i upper housing 464. Thus, the respective rotational movement of links 448 and 454 as described, in turn, result in proximal movement of the bent proximal end 472p of push rod 472 which is slidably positioned in the upper portion 461 of slot 460 in link 454 and the distal movement of bent proximal end 470p of push rod 470 which is slidably positioned in lower slot 445 of proximal link 444. The result of the pivotal rotation of the links 448 and 454 thus causes the distal ends 470d and 472d of push rods 470 and 472 to move proximally and distally, respectively, causing the cartridge 316 to pivot to the 32.5° position shown in Fig. 48. At the same time lower plate 404 has moved proximally to the position shown in Fig. 49 while central ball 426 is now positioned in engagement with conical indentation 436 via pin 430 and resilient spring 432 as shown in Fig. 54. During the movement of the components as described to effect pivotal movement of cartridge 316, push rod 470 is slidably nestled within elongated slot 415 in the upper and lower housings 464 and 314b and push rod 472 is slidably nestled within elongated slot 417 in the upper and lower housings 464 and 314b. The lower half portions of these slots 415, 417 are seen clearly in Fig. 43 in the lower housing 314b. The respective working end portions of push rods 470, 472 engage suitably configured wall portions 421, 423 of the cartridge support member 366 as shown in Figs. 48 and 51 to effect the desired cartridge movement. After the pivotal movement of cartridge 316 has been completed and the cartridge position established, collar 422 may be released and this action will relieve the pressure of coil spring 416 and permit the central centering plate 406 to assume the neutral central position within aperture 412 of lower plate 404 under the natural resilient action of spring 416. Referring now to the drawings and in particular to Figs. 51, 52, and 55, the movement of the components to effect pivotal movement of the staple cartridge from the 32.5° position to the 65° position shown in Fig. 1 will now be described. This movement is produced by continued manual proximal movement of collar 322 to effect corresponding continued proximal movement of centering plate 406 and lower plate 404 in the same manner as described to effect 32.5° of movem3nt of cartridge 316. Until collar spring 416 once again engages shoulders 412a and 412b in the same manner described previously, continued proximal movement of collar 322 causes collar spring 416 to become compressed as described above, until the proximal tip of leg 410 of centering plate 406 engages the proximal wall portion 404 of lower plate 404 thus keying continued proximal movement of collar 322 with lower plate 404 via intermediate centering plate 406. During the initial movement described, the camming action between central conical aperture 436 in upper plate 402 begins depressing central ball 426 against spring 432 to begin releasing the locking engagement therebetween as shown in Fig. 53, for example, such that at approximately the point when the central centering plate becomes keyed to the lower plate the ball 426 has been withdrawn from conical indentation 436 thus permitting movement of the plates 402, 406, and 404 thus keyed toward the position shown in Fig. 55. In Fig. 55, pin 432 is now positioned beneath distal ball 424 permitting the ball to be received into distal aperture 418 of upper plate 402 as shown. With this movement of the upper plate 402 and lower plate 404 in the proximal direction the pin 462 which is slidably received within the lower portion of slot 461 of link 454, and which extends through aperture 404c, causes continued clockwise rotation of distal link 454 about pivot pin 456 to the position shown in Fig. 46 causing continued proximal movement of upper push rod 472 within slot 417. Correspondingly, proximal link 44 is constrained to rotate further counterclockwise as shown in Fig. 52 causing continued distal movement of lower push rod 470 within slot 415. This movement results in further pivotal movement of the staple cartridge section to the 65° position shown in Fig. 51 in a manner similar to that described previously. In the position of the components shown in Figs. 51 and 52, the staple cartridge section is locked in the 65° position by the bias of spring 432 against pin 430 which locks ball 424 within distal conical aperture 418 in upper plate 404. Further locking action is obtained by the resilient force of proximal detent relief 464 of spring 463 against pin 452 slidably positioned in slot 445 of proximal link 44. When the position of the staple cartridge 316 has been achieved as shown in Fig. 51, release of collar 322 will permit central centering plate 406 to return to its central position within aperture 412 of lower plate 404, thereby relieving the stress on coil spring 416. Once the cartridge is pivoted to either of the 32.5° or 65° angular orientations reversal of the motion of cartridge 316 to return it toward the 0° position is simply obtained by reversal of the movements described hereinabove. In particular, collar 322 is manually returned toward its original distal position causing the movement of the components as previously described to be reversed. Ultimately when the collar is moved to the distalmost position, all internal components return to the relative positions shown in Figs. 46 and 47 and the cartridge returns to the 0° angular position. In addition, whereas movement of the central centering plate 406 to pivot staple cartridge 316 causes compression of proximal spring 416, such opposite movements will cause similar compression of distal spring 415 as part of the reverse motions to return the cartridge to the 0° position. Referring now to Figs. 48, 51, and 56-61, the system for rotating the cartridge 316 about an axis extending longitudinally thereof is illustrated. According to this feature, the cartridge 316 and the cartridge support member 366 are capable of rotation about their own central axis B-B as shown in Figs. 57 and 61. In these views, it is clear that the central axis B-B of cartridge 316 is oriented at an angle of bout 32.5°, and about 65°, respectively, with respect to the central axis A-A of the endoscopic section 314. Referring initially to Figs. 48 and 51, the cartridge section 315 is formed of cartridge support member 366 and cartridge 316 supported thereon by internal annular snap ringe 317 shown in dotted lines n those Figs. The snap ring 317 is a resilient spring which is positioned within an annular groove 366a formed in cartridge support member 366 and which is also received by annular groove 316a formed in cartridge 316. Thus, the entire cartridge 316 is capable of rotation about its own central axis B-B independent of the endoscopic section 314 and the longitudinal axis A-A of that section. In particular, rotation of the cartridge occurs at the annular interface 325 between cartridge support member 366 and cartridge 316 as well as about the circumferential interface 327 shown clearly in Figs. 48 and 51. The super elastic firing wire 478 extends through aperture 479 in the central boss 481 of cartridge support member 366. In all other respects, the actual cartridge which contains endoscopic staples is removable and replaceable as described in connection with the previous embodiment and in connection with Figs. 32-39. As seen particularly in Fig. 43, staple advancement plate 474 is attached by upwardly bent U-shaped portion 476 which contains apertures in the distal and proximal wall s thereof for reception of the elongated super elastic metal firing wire 478. The wall portions defining these apertures are swaged for permanent attachment to the super elastic firing wire 478 and this firing wire is in turn attached to staple advancement tube 480 by insertion into the central opening at the distal end and swaging the metal tubular portion inwardly for attachment to the super elastic firing wire. As described in connection with the previous embodiment, the super elastic firing wire is preferably TINEL (registrated trade mark) brand metal available from Raychem Corporation, Menlo Park, California. As noted hereinabove, another example of such super elastic firing wire is NITINOL (registrated trade mark) brand metal. The purpose of the super elastic firing wire 478 is identical to that of the previous embodiments, namely, i.e., to be resiliently deformed about the pivoted cartridge axis 482 as shown in Figs. 48 when it is articulated to about 32.5° and 51 when it is articulated to about 65°. When the cartridge is oriented at either of the angles mentioned previously and caused to return to its original straight condition no hysteresis is evident therein when the cartridge is returned to the 0° position. At the same time super elastic wire 478 is also effective in transmitting rotational forces from tube 480 to staple advancing plate 474 in order to rotate cartridge 316 about its own central axis B-B as shown in Figs. 48-51. The application of such rotational forces to staple advancing tube 480 will be described further hereinbelow. The rotation of the cartridge is effected by the fact that the staple advancing plate 474 is snugly nestled within the cartridge structure in a manner similar to the nestling of staple advancing plate 104 shown in Fig. 15 in cartridge 116 in the first previous embodiment and staple advancing plate 204 shown in Fig. 32 in cartridge 216 in the alternative embodiment. Essentially the staple advancing plate is nestled between the housing sections of the cartridge and permitted to slide proximally and distally. This nestling arrangement causes the entire cartridge to rotate about its own axis B-B when the staple advancing tube 480 is rotated to cause staple advancing plate 474 to rotate. The rotational forces are effectively transmitted about the pivot 482 of the cartridge support member 466 independent of the angle which the cartridge 416 may have assumed. The structure for transmitting the rotational forces to staple advancing tube 480 from a proximal location to effect rotation of the cartridge 316 will now be described. Referring to Figs. 56-59 manually operable star wheel 484 shown in Figs. 42 and 56 is mounted for rotation within handle 312 and includes a distal surface defining a plurality of ratchet teeth 486 extending annularly therearound for mating with identically shaped ratchet teeth 488 at the proximal surface of tube 490 which is biased in the proximal direction by coil spring 492. The star wheel 484 is connected to the proximal portion of staple advancing tube 480 which is configured to have a rectangular cross section as shown in Figs. 56a and 59. Accordingly, star wheel 484 has a similarly shaped opening 484a with corresponding flat support sides 484b and 484c such that rotation of the star wheel 484 will cause corresponding rotation of staple advancing tube 480. Thus, rotation of cartridge 316 about its own axis B-B as shown in Figs. 57 and 61 is effected by rotating star wheel 484 with sufficient force to overcome the restraining force of the ratchet teeth 486 and 488. This rotational motion of star wheel 484 in turn causes staple advancing tube to rotate ultimately causing cartridge 316 to rotate therewith as previously described. As shown in Figs. 56 and 59, the proximal end of staple advancing tube 480 contains attachment head 480a which is attached to the distal tab 326a of flanged thrust bar 326 which contains reception slot 326b. This arrangement permits staple advancing tube 480 to rotate independent of the thrust bar 326 while the thrust bar is normally restrained from rotation. Thus, the system for rotating the cartridge per se which is located at the distal end of the endoscopic section is thereby completed with the rotation forces being applied from a proximal location, i.e. at the handle 312. Referring once against to Fig. 56, the system for advancing staples by pivotally squeezing trigger 220 together with the advantageous ratcheting system describe din the previous embodiment is shown. This system is identical to the clutch mechanism as described previously and accordingly further details herein are unnecessary. However, further specific details of this system are illustrated more clearly in Fig. 59 which is a perspective view of the clutch mechanism with parts separated for convenience of illustration. Rotation of cartridge 316 about its own axis B-B is shown in Fig. 58 is thus possible. Referring to Fig. 60 there is illustrated a cross section of an alternative system for effecting rotation of the cartridge 316 from a proximal location, i.e. at the handle 312. In particular, star wheel 584 is shown which contains a proximally extending tubular section 586 integral therewith. The inner portion of the tubular section 586 houses ratchet plate 352 which forms part of the elements of the same clutch mechanism as described hereinabove. The inner portion of cylindrical member 586 is adapted to receive pawl 358 in the same manner as was described previously. Furthermore, the operation between trigger 518 and the staple advancing system is identical in all respects to the system described previously. This embodiment permits positioning of the cartridge rotating star wheel further proximally than the previous embodiment shown in Figs. 56-59. Referring to Figs. 60A and 63, the structure for effecting rotation of the staple advancing system via star wheel 584 is illustrated. In this embodiment, the star wheel 584 is positioned in a more proximal position than in the first embodiment to facilitate accessibility to the user. Star wheel 584 contains distal ratchet teeth 486 which mate with proximally positioned ratchet teeth 588 of tube 590 which is biased proximally by spring 592 similar to spring 492 in Fig. 59. Additionally, the clutch ratchet mechanism for the handle is positioned within the rotation mechanism. More specifically, in this embodiment, pawl 558 is pinned for rotation to the proximal section 559 attached to staple advancing tube 480. Pawl 558 is attached by pin 560 such that when pawl 558 is in engagement with ratchet plate 552, rotation of star wheel 584 will also cause rotation of proximal section 559 as well as staple advancing tube 480. As shown in Figs. 60A and 63, pin 560 extends from slot 586a in cylindrical member 586, through pawl 558 and spring 561 on pins 559b and 559c, into slot 480a in staple advancing member 480 and through aperture 559a in proximal staple advancing tube 559. Thus, when pawl 480 is in engagement with ratchet plate 552 within cylindrical member 586, rotation of the star wheel 584 will cause rotation of the staple advancing system. Proximal tubular member 559 which is engageably received within slot 534a of triangular member 534 will rotate within the slot as star wheel 584 is rotated. As described hereinabove, rotation of the staple advancing system will thereby cause corresponding rotation of the staple cartridge 316 which includes the exemplary angles illustrated in Figs. 58 and 62. Other suitable fastening techniques may be utilized. In the embodiments of Figs. 56-62, rotation to any angle up to 360° and beyond is possible independent of the pivotal angle of the staple cartridge by simply rotating the star wheel. The claims which follow identify embodiments of the invention additional to those described in detail above.

Claims: Apparatus (310) for endoscopic application of a surgical fastener, which comprises: a) a frame (312); b) an elongated member (314) connected to said frame and extending distally therefrom, said elongated member having a generally longitudinal axis and having a proximal end portion, an intermediate portion, and a distal end portion (315) which pivots about an axis transverse to the longitudinal axis, said distal end portion being rotatable about said longitudinal axis at least independent of said intermediate portion; c) means (316) co-operating with said elongated member for storing at least one surgical fastener; and d) a fastener pusher for advancing said at least one surgical fastener distally and at an angle to the longitudinal axis for positioning adjacent the body tissue. The apparatus according to claim 1 further comprising actuating means (322) spaced from said distal end portion of said elongated member for moving said distal end portion from a first position to a second position angularly oriented relative to said longitudinal axis. Apparatus according to claim 2 further comprising means (484, 584) spaced from said distal end portion for rotating said distal end portion. Apparatus according to claim 2 wherein said storing means comprises a cartridge (316) and said surgical fasteners are stored in stacked relation in said cartridge. Apparatus according to claim 3 or 4 wherein said means (316) for storing said surgical fasteners is removably positioned at the distal end portion of said endoscopic portion. Apparatus according to claim 4 wherein said endoscopic tubular portion defines said longitudinal axis and said surgical fasteners are stacked to form an angle with respect to said longitudinal axis. Apparatus according to claim 5 wherein said cartridge for storing surgical fasteners is supported by support means (366) pivotally attached at the distal end portion of said endoscopic tubular portion and said cartridge support means is selectively pivotal by the user such that said cartridge means is pivotal therewith. Apparatus according to claim 2 wherein said actuating means (322) is located at the proximal end portion of said elongated member. Apparatus according to claim 3 wherein each said surgical fastener is a surgical staple (210) and said fastener pusher (24) individually advances each said staple distally and comprises a plate member (104) positioned adjacent and proximal of the lowermost staple and is adapted to be movable distally whereby said plate member engages said lowermost staple and advances said staple in the distal direction. Apparatus according to claim 9 further comprising an anvil (116, 118) positioned distally of said storing means and configured and dimensioned and adapted to be engaged by each said staple when said staple is advanced distally by said plate member. Apparatus according to claim 3 wherein each said surgical fastener is a surgical staple (110) and further comprising means (233, 236) for providing a perceptible tactile indicator to the user when each said staple has been advanced to a predetermined staple position, said predetermined staple position is such that said leg portions of said staple extend outwardly of said cartridge and are thereby visible to the user. The endoscopic apparatus according to claim 2, wherein said actuating means comprises at least one slidable control member (322). The endoscopic apparatus according to claim 2 wherein said distal end portion is pivotable to at least two selected angles with respect to said longitudinal axis. The endoscopic apparatus according to claim 1 wherein said elongated member is comprised of a first generally elongated member extending from said frame to a position proximal of said axis of rotation of said distal end portion and has a resilient member (102) connected thereto and extending distally therefrom to a position within said distal end portion wherein said resilient member is connected to a staple advancing plate. The endoscopic apparatus according to claim 14 wherein said resilient member (102) is formed of a super elastic metal. The endoscopic apparatus according to claim 2 wherein said rotating means (484, 584) comprises a manually operable wheel rotatably mounted to said frame and extending through said generally elongated member. The endoscopic apparatus according to claim 12 wherein said slidable control member comprises collar means (322) slidably positioned at a proximal end portion of said elongated member and movable between proximal and distal positions to effect pivotal movement of said distal end portion to and from predetermined acute angles relative to said longitudinal axis. The endoscopic apparatus according to claim 17 wherein said collar means is mechanically connected to said pivotal distal end portion and adapted to retain said distal end portion at a zero angle when said collar means is positioned at its distalmost position. The endoscopic apparatus according to claim 18 wherein said collar means is movable to a second position proximal of said first position to effect pivotal movement of said distal end portion to an angle of about 32.5° relative to said longitudinal axis. The endoscopic apparatus according to claim 19 wherein said collar means is movable to a third position proximal of said second position to effect pivotal movement of said distal end portion to an angle of about 65° relative to said longitudinal axis. The endoscopic apparatus according to claim 20 wherein said mechanical connection between said collar means and said distal end portion comprises linkage means (470, 472) extending between said collar means and said distal end portion including: a) at least two plate members (402, 4, 6) at least one of which is mechanically connected to said collar means for movement therewith and at least a second of which is mechanically connectable to said collar means for movement therewith; and b) at least two link members (444, 454) connected to said plate members in a manner to pivotally rotate with respect to said elongated member between preselected positions when said plate members are moved proximally or distally, one of said link members being positioned proximally of the other. The endoscopic apparatus according to claim 21 wherein said plate members comprise at least an upper plate (402) member and a lower plate member (404) opposed to said upper plate member, said lower plate member having a preconfigured and predimensioned cut-out portion for reception of an intermediate centering plate member (406), said centering plate member being connected to a collar member for movement therewith proximally and distally within said cut-out portion such that when said centering plate member is moved a predetermined proximal or distal distance therewithin the centering plate member engages said lower plate member whereby continued movement thereof in said proximal or distal direction causes corresponding movement of said lower plate member. The endoscopic apparatus according to claim 22 wherein said upper plate member contains at least three indentations (418, 420, 422) adapted and positioned to receive a portion of one of at least three detent balls (424, 426, 428) when an elongated pin (430) is positioned therebeneath and caused to be resiliently biased thereagainst by a spring member (432) so as to fix the position of said lower plate member with respect to said upper plate member in dependence upon their relative positions and the preselected location of the spring (432) biased pin member (430) when said selected ball is biased into said indentation of said upper plate member. Apparatus as claimed in any one of the preceding claims, wherein the storing means is provided by: cartridge means for storing a plurality of surgical staples, said staples configured and adapted to attach an object to body tissue; the apparatus further comprising means spaced from said distal end portion to pivotally rotate said storing means about an axis generally transverse to the longitudinal axis of said elongated member and having associated therewith at least first detent means (452, 466) for retaining said storing means at a predetermined angle with respect to said longitudinal axis of said elongated endoscopic portion. The endoscopic apparatus according to claim 24 further comprising at least second detent means (428, 434, 402) for retaining said storing means at said predetermined angle with respect to said longitudinal axis of said elongated endoscopic portion. The apparatus according to claim 24 further comprising at least second detent means for retaining said storing means at a second predetermined angle with respect to said longitudinal axis of said elongated endoscopic portion. The endoscopic apparatus according to claim 25 or 26 wherein said first detent means comprises at least one movable member having at least one indentation (434) configured and dimensioned for reception of a generally spherical member (428) and at least one generally spherical member (428) positioned and resiliently biased toward and away from said indentation. The endoscopic apparatus according to claim 27 wherein said second detent means comprises resilient spring means for resilient reception of a detent pin in at least two predetermined locations corresponding to the angular position of said cartridge means with respect to said longitudinal axis of said endoscopic means. The endoscopic apparatus according to claim 24 further comprising staple advancing means comprising a staple advancing plate positioned within said cartridge and means dimensioned and configured to be nestled therewithin such that rotation of said plate causes corresponding rotation of said cartridge means.

Inventors: DEFONZO STEPHAN A, GREEN DAVID T, PENNATTO SAMSON, YOUNG WAYNE P, DEFONZO, STEPHAN A., GREEN, DAVID T., PENNATTO, SAMSON, YOUNG, WAYNE P.
Applicants: UNITED STATES SURGICAL CORP, UNITED STATES SURGICAL CORPORATION
Application year: 1993
Main classification: A61B17
IPC codes: A61B17