WO2001076489A1 - Appareil et procede de fixation chirurgicale - Google Patents

Appareil et procede de fixation chirurgicale Download PDF

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Publication number
WO2001076489A1
WO2001076489A1 PCT/US2000/009623 US0009623W WO0176489A1 WO 2001076489 A1 WO2001076489 A1 WO 2001076489A1 US 0009623 W US0009623 W US 0009623W WO 0176489 A1 WO0176489 A1 WO 0176489A1
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WO
WIPO (PCT)
Prior art keywords
fastener
slide
applicator
handle portion
anvil
Prior art date
Application number
PCT/US2000/009623
Other languages
English (en)
Inventor
Helmut L. Kayan
James E. Jervis
Original Assignee
General Surgical Innovations, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by General Surgical Innovations, Inc. filed Critical General Surgical Innovations, Inc.
Priority to AU2000242290A priority Critical patent/AU2000242290A1/en
Priority to PCT/US2000/009623 priority patent/WO2001076489A1/fr
Publication of WO2001076489A1 publication Critical patent/WO2001076489A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0684—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying above the tissue during stapling

Definitions

  • the present invention relates generally to surgical fastening tools for fixating tissue and/or surgical materials during minimally invasive surgery, and particularly to a surgical fastening tool having a space-efficient, simplified fastening mechanism that permits deployment of the tool through a minimal opening but which also maximizes the gripping area of the applied surgical fastener. More particularly, the invention relates to a reduced diameter (5mm) surgical fastening tool for use in hernia repair. The tool is deployed through a reduced diameter access port in the body to fasten a piece of surgical mesh to body tissue using a specially formed fastener having a maximized gripping area. The tool also has a simplified, jam-free fastening mechanism.
  • the present invention also relates to methods for repairing a patient's hernia through a minimized diameter access port while maximizing the gripping area of the surgical fastener as well as methods for applying surgical fasteners from a miniatured device with reduced risk of jamming.
  • 34- 53 describes a device for deployment through a 12 mm trocar guide tube wherein the device stacks a set of staples at roughly a forty-five degree angle to the axis of the device to provide greater visibility. See Green et al. Fig. 18.
  • Green et al. cannot be readily scaled down because of physical limitations caused by the generally transverse stacking of fasteners. See Green et al., Fig. 18.
  • the design of Green et al. cannot be effectively scaled down because the fastener discharged by the application tool must be of sufficient scale to securely span across the defect and/or strands of surgical mesh and efficaciously engage sufficient tissue area for adequate gripping strength.
  • Green et al. employs a fastener forming system which unduly reduces the finished span or width of the fastener relative to its initial width. See Green et al., Fig. 20-21, col. 22, 11. 38-48. Thus, reduction in Green et al.'s tool diameter would result in an unsatisfactory gripping area for the finished fastener.
  • miniaturization of the surgical fastening tool increases the likelihood of " jamming, a common problem for minimally invasive surgical fastener tools, because the critical tolerances for the device's moving parts would be reduced along with the size of the instrument. Accordingly, slight changes in deployment stress and temperature can effect the mobility of the moving tool parts.
  • the Origin Tacker though of 5 mm diameter, employs a rotational actuation mechanism to deploy a helical fastener. Rotation increases the complexity needed for the actuation mechanism, and creates greater need to ensure reliable translation of trigger action.
  • the fastening mechanism of the desired surgical fastening tool must not be complicated and should be limited to a few actuated parts to reduce the probability of jamming during minimally invasive surgery.
  • the device should be designed to avoid double firing and incomplete firing.
  • the device should also permit for the easy reloading of additional fasteners during extensive surgical procedures.
  • the prior art devices are inadequate to meet these objectives.
  • the present invention relates to surgical fasteners, fastening tools and methods for securing tissue and/or surgical materials during minimally invasive surgery.
  • the devices of the present invention are adapted to minimize the diameter of the surgical fastening tool while maximizing the area gripped by the fastener.
  • the devices of the present invention are adapted to discharge the fastener by way of a simplified fastemng mechanism with few actuated parts.
  • the surgical materials to be fastened may be surgical mesh, sutures, prostheses, linings or the like.
  • the tissue to be fastened may be tissue, foreign or endogenous to the patient.
  • the apparatus includes three major elements: a fastener applicator comprising a fastener magazine; a handle portion to which the applicator is attached; and a triggering mechanism.
  • the triggering mechanism may be housed in either the fastener applicator, the handle portion or in a combination of the two.
  • the fastener applicator has a cantilevered anvil with a cross section around which the fastener may be formed at a single focal point when the fastener is pressed by a slide.
  • the fastener may initially be M-shaped, upside-down U-shaped or other suitable shape.
  • the anvil has a cross section that is essentially triangular and a shaping slide with a cooperating notch that is angled to closely receive the triangular cross-section of the anvil.
  • Fig. 1 the single-point anvil permits the width of the slide which forms the fastener to be the same or less than the width of the stored fastener but without sacrificing the finished span (installed width) of the applied fastener and the area it encloses.
  • An anvil with a semi-circular or other round edged cross-section may also be used in combination with a round-notched slide.
  • the space-efficiency of the slide and anvil permits a reduction in the overall width of the fastener applicator relative to the width of the fastener.
  • Traditional staple type surgical fasteners have a slide which, when of reduced width, unacceptably reduce the span of the applied fastener to accommodate the "horns" of the slide. See Fig. 2.
  • the apparatus is of unitary, non-detachable design wherein a fastener applicator, handle portion and a triggering mechanism are provided in a single integral unit.
  • the fasteners may be stored in the handle portion of the apparatus or loaded from outside the device just prior to use.
  • the applicator functions as a fastener magazine and is readily removed from or locked onto the handle portion by virtue of a novel mechanism for quick attachment and detachment.
  • the applicator comprises a slide actuator which operates a slide in response to operation of the triggering mechanism to discharge fasteners.
  • the novel mechanism locks the slide actuator into a secure, locked position within the detached applicator magazine so that the slide actuator is properly located to engage the motion-translating parts of the triggering mechanism of the device when attached.
  • the novel mechanism then automatically frees the slide actuator upon attachment of the applicator to the handle thereby making the device ready for use.
  • the novel mechanism employs an "L-shaped" pin with a recessed region that rotates into and out of engagement with the slide actuator based on its interaction with pre-formed recesses in the handle of the device during attachment and detachment.
  • the applicator comprising a magazine of fasteners runs out of fasteners
  • the user may substitute a second applicator containing a fresh magazine.
  • This construction also permits the handle portion to be sterilized and re-used.
  • the fastener applicator may either be of unitary construction or made of several interconnecting pieces.
  • a tube of circular cross-section houses a magazine formed by the juxtaposition of two cooperating half shells, known collectively as the insert, each half-shell having essentially a semi-circular cross section.
  • the two-half shells are preferably inserted into the tube during manufacture.
  • the two half-shells and the slide form the magazine or storage channel which contains a set of vertically stacked fasteners.
  • the fastener applicator is separable from the handle portion so that the handle portion may be supplied with a new applicator containing a new set of fasteners once the first set of fasteners has been used.
  • a third aspect of the invention minimizes the possibility of jamming caused by an improperly timed interplay between independently moving parts and also reduces the probability of jamming due to the failure of the trigger to actuate a key part of a multi-part actuation mechanism.
  • the insert and slide form two channels: a fastener storage channel and a fastener- driving channel.
  • the fastener storage channel contains a plurality of vertically stacked fasteners, stacked tips to back, thereby reducing applicator width relative to tools which use transversely stacked fasteners.
  • the fasteners are continually urged toward the distal end of the applicator by a pusher that is biased by a pusher spring.
  • the fastener-driving channel further houses a slide that rides in the driving channel to engage the back of the first fastener positioned within the driving channel.
  • movement of the slide drives the fastener onto the anvil while the notch in the slide shapes the fastener over the anvil according to the first aspect of the invention.
  • the insert additionally comprises a system of leaf springs that assist in securely positioning and advancing the fasteners one at a time during the repeated fastener application process.
  • the action of the leaf springs is controlled by slide location.
  • the applicator contains one actuated part, the slide, that is moved by the active application of force generated by the triggering mechanism. The rest of the moving parts in the applicator are biased to move in a certain direction but are restrained or liberated based on the location of the slide.
  • the slide is fully advanced distally to drive the first fastener's tips into the target and to shape the fastener on the anvil.
  • a pair of biased ejector springs are liberated and kick the formed fastener off the end of the anvil, freeing the apparatus from the fastener.
  • a biased fastener positioning spring is released and pushes the second fastener from the distal most position in the storage channel into the driving channel.
  • a biased stop spring restrains the third fastener from advancing in the storage channel until the second fastener is being advanced in the driving channel.
  • the apparatus may employ a unique jam-free ratchet and pawl mechanism, housed in the handle portion, that assures complete travel of the slide in both directions during application of each fastener.
  • This embodiment of the apparatus comprises a plunger assembly that is linked to the slide by means of the slide actuator.
  • the plunger assembly reciprocates forward and backward within the body of the handle portion.
  • the body of the handle has a tapered slot, adjacent to the plunger assembly, which contains a pawl.
  • the side of the plunger assembly that is immediately adjacent to the tapered slot contains a series of grooves which collectively form a ratchet extending for a distance approximately equal to the travel of the plunger assembly.
  • the length of the pawl is longer than the pe ⁇ endicular distance from the bottom of the tapered slot to the bottom of the ratchet grooves, such that once the pawl is engaged in the ratchet grooves, the pawl is oblique and prevents reversal of the plunger's direction of travel.
  • a wire spring urges the pawl to assume a position transverse to the direction of travel.
  • the plunger assembly is moved back towards its original position, the pawl again engages the ratchet but with opposite orientation.
  • the pawl again prevents reverse travel of the plunger assembly until the stroke is pawl has cleared the length of the ratchet.
  • the spring then reorients the paration for the next stroke.
  • the invention prevents the slide, which is connected to the plunger assembly by the slide actuator, from reversing mid-stroke and safeguards against jamming, non-firing and misfiring.
  • the methods of the present invention relate to deploying a fastener with maximized gripping area using a space-efficient deployment mechanism having few actuated parts.
  • a hernia repair patient is incised and fitted with a port to access the site of the hernia. After access to the site of the hernia is achieved, the hernia is reduced and the surgical mesh is placed over the defect using minimally invasive techniques.
  • the surgical fastening tool apparatus is deployed through an access port and its tip pressed against the mesh and the tissue to be fastened. The tool is then triggered by means of the triggering mechanism.
  • the fastener is then formed by the action of the slide pressing the fastener onto the surface of the anvil. In this manner, the mesh is secured to the body tissue by the gripping strength of the fastener.
  • the method of the present invention generally includes the following steps: forming a fastener by placing it over a single focal point anvil; pressing the fastener against the single focal point anvil using a slide having a width that is approximately the same as or less than the width of the fastener; discharging the fastener into the tissue of the patient.
  • a fastener is applied by the following preferred steps: the fastener is moved from the storage channel where it has been vertically stacked to the driving channel by the biased fastener positioning spring as the slide is retracted; the slide is then advanced until the slide engages the fastener in the driving channel and drives the fastener over the anvil to form the fastener.
  • the biased stop spring is forced back into a recess in the insert thereby allowing the next fastener to move forward in the storage channel in response to the force of the biased pusher spring; the slide is then retracted, freeing the biased ejector springs to kick the formed fastener off the end of the anvil; finally the slide is further retracted until the fastener positioning spring is once again is free to move the distal-most fastener from the storage channel into the driving channel.
  • the present invention was developed, in part, out of recognition of the need for a reduced diameter fastening tool which could discharge, from a reduced diameter applicator, a fastener that firmly holds mesh and tissue together.
  • a reduced diameter fastening tool which could discharge, from a reduced diameter applicator, a fastener that firmly holds mesh and tissue together.
  • the present invention teaches that a U-form wire, fastener applied in the form of a diamond relative to the tissue surface has certain advantages including reduction in the size of fastener needed to achieve high gripping strength.
  • the installed span of the fastener and the area captured by the fastener are two useful parameters for evaluating the efficacy of a fastener. Figs.
  • the invention's preferred diamond shaped fastener described in Figs. 4b and Table 2 has a finished span of .707 x the initial width, W, and encloses a projected area double the size of the maximum traditional design (16).
  • the preferred diamond-shaped finished fastener shown in Fig. 4b maintains a span greater than all but the most extreme of possible finished shapes made by the conventional process (shapes which suffer from greatly diminished gripping area).
  • the fastener may be initially formed with . an upwardly concave back of an arbitrary angle and with legs which are initially parallel, approximating the capital letter "M".
  • Fig. 5a In the embodiment shown, the angle of the concave back is greater than ninety-degrees.
  • the central bend is reversed to allow the legs to finish more parallel to the tissue surface.
  • Fig. 5b According to this embodiment, the length of the finished span remains essentially the same as the finished span shown in Fig. 4a, 4b but the projected area gripped by the fastener is reduced.
  • the gripping area is reduced to a value that is still greater than or equal to the maximum area gripped by the conventionally processed U-shaped design described in Fig. 3b.
  • the conventional mechanism necessarily results in a fastener with a smaller finished span for a given tool diameter. See Fig. 2.
  • the finished diamond and triangular fasteners shown in Figs. 1, 4b and 5b do not need the slide to be wider than the finished span of the fastener.
  • the tool design need not sacrifice the length of the finished span to accommodate the fastener forming apparatus itself.
  • the disclosed invention requires less force to deploy the fastener because only one bend is formed during deployment rather than two bends as with the conventional design. This reduction in force is a significant advantage for a miniaturized device whose miniaturized parts are relatively weak and may fail under repeated stress.
  • the present invention was also developed in part to solve other problems associated with miniaturization of fastener devices, such as jamming, non-firing and misfiring.
  • the invention contemplates that the deployment mechanism of the device has few mechanically he critical tolerances for such actuated parts are reduced in the
  • the fastener would begin as an "M" such as in Fig. 5a but finish as an inverted triangle, the top end lying substantially flat against the fastened tissue or mesh with the legs bent to essentially form a triangle as shown in Fig. 5c.
  • finished span is maximized. This result can be accomplished by limiting travel of the slide so as to stop short of complete forward compression against the anvil.
  • the finished span may be further maximized, as shown in Figs. 20a and 20b and Figs. 21a and 21b.
  • One way of doing this involves deploying two anvils attached to the applicator tube rather than a single anvil.
  • Fig. 22 depicts a two-anvil system with slide forming the finished fastener of Fig. 20b.
  • Fig. 23 depicts the same two anvil system with slide forming the finished fastener of Fig 21b by virtue of a reduction in the forward travel of the slide.
  • the slide/anvil combination shown in Figs. 22 and 23 is effectively a mechanical inversion of that used to produce Fig. 3b and Fig.4b.
  • the fastening tool comprises an interchangeable fastener magazine.
  • the insert of the fastener applicator incorporates only one actuated component.
  • Another object of the present invention is to maximize the gripping area of the fastener while reducing the diameter of the applicator of the surgical fastening tool. Because of the nature of surgical repair, it is undesirable to have to refasten the surgical material after surgery is completed. Accordingly, the fasteners should form a strong link between the fastened materials and or tissue so that the materials stay in place during post-surgical patient activity. Secure fasteners have previously required larger diameter fastening tools which are incompatible with the new, reduced-diameter, minimally invasive surgery techniques. It is a further object of the invention to provide a surgical fastening tool that is economical and convenient for fastening hernia mesh and the like during minimally invasive surgery.
  • one object of the invention is to provide a fastening mechanism that is both compatible with minimally invasive surgery techniques using reduced port diameters (5mm is the newest standard in the field of minimally invasive surgery) and which provides fasteners that maximally grip the area of tissue and material.
  • Fig. 1 is a schematic front view of an embodiment of the preferred fastener, space- efficient shaping slide and anvil of the present invention.
  • Fig. 2 is a schematic front view of a traditional staple with its shape-forming slide about to form the staple on a rectangular anvil.
  • Fig. 3a is a schematic front view of a traditional U-shaped staple prior to application of a conventional shaping slide.
  • Fig. 3b is a schematic front view of a finished traditional U-shaped staple after application of a conventional shaping slide.
  • Fig. 4a is a schematic front view of an embodiment of the fastener of the present ation of the shaping slide.
  • Fig. 4b is a schematic front view of an embodiment of the fastener of the present invention after application of an embodiment of the shaping slide of the present invention.
  • Fig. 5a is a schematic front view of alternate embodiment of the fastener of the present invention prior to application of an embodiment of the shaping slide of the present invention.
  • Fig. 5b is a schematic front view of the alternate embodiment of the fastener of the present invention after application of an embodiment of the shaping slide of the present invention.
  • Fig. 5c is a schematic front view of an alternate embodiment of the fastener of the present invention, after application of an embodiment of the shaping slide of the present invention.
  • Fig. 6 is a longitudinal view of one embodiment of the surgical fastening tool that includes a handle portion, a trigger portion and an applicator.
  • Fig. 7 is a cross-section of the applicator of one embodiment of the surgical fastening tool with the slide fully extended distally.
  • Fig. 8 is the same cross-section of the applicator of the embodiment of the surgical fastening tool shown in Fig. 7 but with the slide in the fully retracted position.
  • Fig. 9 is a three-dimensional rendering of the first half-shell and fastener positioning SDrine of the atiDlicator shown in cross-sectional perspective in Figs. 7 and 8.
  • Fig. 10 is a three-dimensional rendering of the second half-shell of the applicator and stop spring shown in cross-sectional perspective in Figs. 7 and 8, with the first half shell poised above.
  • Fig. 11 is a front view of the slide, slide actuator and anvil rotated ninety-degrees from their depiction in Figs. 7 and 8.
  • Fig. 12a is a schematic front view of the preferred slide and fastener of the present invention prior to forming of the fastener.
  • Fig 12b is a schematic front view of the preferred slide and fastener of the present invention after the forming of the fastener.
  • Fig. 12c is a three-dimensional rendering of the preferred slide of the present invention.
  • Fig. 13 is a cross-sectional view of the handle portion and trigger portion of a preferred embodiment of the surgical fastening tool.
  • Fig. 14 is a three-dimensional cross-sectional perspective view of a preferred embodiment of the fastening tool wherein the applicator is readily detachable from the body portion.
  • Fig. 15a is a three-dimensional perspective view of the proximal end of the slide actuator and "L"-shaped pin with the pin in the unlocked position.
  • Fig. 15b is an exploded view of the handle portion revealing the cam surfaces and recessed regions which provide the mechanism for attaching the applicator to the handle portion as well as the slide actuator lock and release mechanism.
  • Fig. 16 is a cross-section of the preferred handle portion of the present invention wherein the handle portion contains a tapered slot that houses a pawl.
  • Fig. 17 is a three-dimensional rendering of the preferred plunger assembly of the present invention showing a pawl standing clear of the ratchet portion of the plunger assembly following completion of a stroke.
  • Fig. 18 is a time-sequenced frontal view of the plunger and pawl mechanism undergoing one complete cycle of application and retraction.
  • Fig. 19 is a three-dimensional perspective view of the pawl and wire spring.
  • Fig. 20a is a schematic front view of an embodiment of the fastener of the present invention prior to application of the shaping slide and double anvil of Fig. 22.
  • Fig. 20b is a schematic front view of an embodiment of the fastener of the present invention after the application of the shaping slide and double anvil of Fig.22.
  • Fig. 21a is a schematic front view of an embodiment of the fastener of the present invention prior to application of the shaping slide and double anvil as shown in Fig. 23.
  • Fig. 21b is a schematic front view of an alternate embodiment of the fastener of the present invention after the application of the shaping slide as shown in Fig. 23.
  • Fig. 22 shows an alternate slide/anvil combination which will maximize finished span as shown in Fig. 20b.
  • Fig. 23 shows an alternate slide/anvil combination which, with reduced travel of the slide relative to that shown in Fig. 22, will maximize finished span as shown in Fig. 21b.
  • Fig. 24 is a schematic top view of the storage channel of an alternate embodiment of the first half-shell of the fastener applicator.
  • Fig. 25 is a three-dimensional perspective view of the storage channel of an alternative embodiment of the first half-shell of the fastener applicator.
  • Fig. 26 is a three-dimensional perspective view of the storage channel of an alternative embodiment of the first half-shell of the fastener applicator.
  • Fig. 27 is a cut-away side view of the alternative embodiment of the fastener applicator with the slide in the retracted position.
  • Fig. 28 is a cut-away side view of the alternative embodiment of the fastener applicator with the slide fully extended.
  • Fig. 6 shows one embodiment of the surgical fastening tool.
  • the surgical fastening tool comprises a handle portion 10 an applicator 20 and a trigger portion 30.
  • Fig. 7 shows a cut-away cross-section of a preferred embodiment of the applicator portion of the device.
  • the applicator comprises a tubular housing 40 having an insert contained within.
  • the insert could be made as a single unit or even be manufactured out of a single piece that forms the tubular housing, the insert is preferably made from two cooperating half-shells which are inserted into the tubular housing.
  • the half-shells preferably have a beveled outer edge which permits crimping of the distal most end of the tubular housing to secure the insert.
  • the first half-shell 50 has a rounded side 52 which abuts the tubular housing 40 and a flat side 54 that has recessed region 70 whose surface forms one the walls of the fastener storage channel containing fasteners 80.
  • a pusher 82 Above the fasteners 80 sits a pusher 82, which rides in the fastener storage channel. The pusher 82 continuously exerts a downward pressure on the vertically stacked fasteners 80 by virtue of a biased pusher spring 84.
  • Recessed region 70 gradually rises to the diametrical plane of flat side 54 (diametrical relative to the tube circumference on flat side 54) by virtue of a slanted ramp 72.
  • a fastener positioning spring 60 attached to and flush with the recessed portion 70 of flat side 54 of the first half-shell 50 is biased to extend beyond both the recessed region 70 of the flat side 54 and the mn ⁇ :t n minpnt -nlnnp nf the flat side 54.
  • the spring 60 is capable of being completely contained within a slot 90 in the first half-shell.
  • the first half-shell 50 has a cut-away region 92 at the distal end of the applicator to permit ejection of the fastener.
  • FIG. 9 A perspective view of the first half-shell 50 is shown in Fig. 9.
  • the diametrical plane of flat side 54 appears uppermost in the drawing. This view shows that in a preferred embodiment the cut-away region 92 has two further recessed regions 94a and 94b.
  • a second half-shell 100 shown in Fig. 10, has a flat side 102 and a rounded side 104.
  • Flat side 102 has a recessed area 110 whose plane forms one of the walls of the driving channel in which slide 120 rides.
  • the distal end of second half-shell 100 comprises an anvil 130 with a triangular cross-section.
  • Anvil 130 is a cantilever that extends beyond the recessed area 110 across the driving channel and into cut-away region 92 on the first half-shell of the insert.
  • slot regions 140a and 140b shown in the cross-section of Fig. 10, which house ejector springs 150a and 150b (not shown).
  • Ejector springs 150a and 150b are, at their proximal end, attached to round side 104 and are flush with its outer circumference. However, the distal parts of the ejector springs 150a and 150b are biased such that, when unrestrained, the springs extend beyond the anvil 130 and enter the further recessed regions 94a and 94b of first half-shell 50. Alternatively, the cutaway region 92 may fully accommodate the ejector springs 150a and 150b without the need for recessed regions 94a and 94b. Spring 150b is shown in phantom line in Fig. 7.
  • the recessed region 110 of the second half-shell has a slotted top spring 170.
  • Stop spring 170 is secured nearby in a radial hole 171 in the second half-shell 100. Stop spring 170 is also biased such that, when unrestrained, it extends out beyond recessed area 110 through slotted region 200 in slide 120 and beyond joint diametrical planes of the inserts 50 and 100 to engage the fasteners.
  • Slide 120 shown in detail in Fig. 11, along with slide actuator 190 are the only actuated parts in the preferred embodiment of the applicator 20. According to the preferred embodiment, slide 120 alternately restrains and releases all the biased moving parts of the applicator 20. Slide 120 is connected to slide actuator 190 within tube 40 at a point beyond the proximal end of both half-shells, 50 and 100. Alternatively, for an apparatus which does not have a detachable applicator, slide 120 may extend all the way into the handle portion, thus reducing the number of actuated parts in the applicator to one
  • slide 120 has a slotted region 200, which alternately restrains and releases stop spring 170 by allowing it to protrude through the slide.
  • Slide 120 forms one wall of the storage channel created by the recessed region 70 in first half-shell 50.
  • the distal end of the slide 120 in the preferred embodiment, is forked and beveled to cooperate with triangular shaped anvil 130, as shown in Fig. 11, 12a, 12b and 12c.
  • This feature permits the slide width to be equal to or less than the fastener width.
  • the width of the slide 120, as well as that of the storage channel created by the surfaces of recessed region 70 and slide 120 extends almost the entire diameter of the joined half-shells, 50 and 100.
  • the preferred method of applying the fastener is demonstrated by Figs. 7 and 8.
  • Fig. 8 shows that when the slide 120 is fully retracted, the fastener positioning spring 60 urges the distal-most vertically-stacked fastener 80 from the storage channel to the driving channel located distal to slide 120.
  • the tines of the forked bottom of slide 120 exert a downward pressure on the first fastener 80.
  • the slide 120 advances, it lifts the stop spring 170 out of slotted region 200 of the slide 120 (not shown), out of the storage channel where it previously restrained the second of the stacked fasteners and into recessed region 160 of the second half- shell piece 100.
  • the second of the stacked fasteners is thereby released by stop spring 170 and advanced by the pusher 82 which is forward biased by pusher spring 84 (not shown in Fig. 8).
  • the second fastener thus advances to the distal-most position in the storage channel, a position previously occupied by the first fastener.
  • advancement of the slide as described above also blocks fastener egress from the storage channel along its length, thereby preventing the next fastener from prematurely entering the driving channel. Additional advancement of the slide 120 pushes ejector springs 150a and 150b back into slotted regions 140a and 140b (not shown). This permits the foremost fastener to rest on the anvil 130 until the fully advanced slide shapes the fastener on the anvil, as demonstrated in Figs. 7, 12a and 12b.
  • the slide 120 is subsequently retracted until the stop spring 170 passes through the slotted region 200 of the slide and hooks underneath a third fastener in the storage channel thereby preventing the third fastener's further advancement.
  • the biased fastener positioning spring 60 is freed, thereby pushing the second fastener into the driving channel space vacated by slide 120.
  • sequence of steps triggered by the slide's action may involve simultaneous execution, or may even be reversed, as long as the method achieves the objectives of not permitting two fasteners into the driving channel at the same time, not permitting empty firing and not permitting the device to jam.
  • the invention contemplates a mechanism for moving the distal-most fastener from the storage channel to the driving channel in a way that is not unduly dependent on the length of travel or size of the subsequent fastener in the storage channel.
  • the fastener 80 is moved out of the storage channel by virtue of a two-part ramp arising out of recessed region 70 of the storage channel, shown in Figs.
  • said ramp comprising an interior section 71a and an exterior section 71b.
  • the interior section of the ramp 71a transfers the back of the fastener 80 up into the driving channel. Because the interior section of the ramp 71a has a steeper angle than the exterior section of the ramp 71b, which is responsible for guiding the toes of the fastener into the driving channel, the back of the fastener 80 is brought into the driving channel while the toes remain in the interior section of the ramp within the storage channel.
  • Fig. 29 shows the "most preferred interior and exterior section angles of incline for the ramp, namely thirty percent incline for the interior section and nine percent incline for the exterior section.
  • the transfer mechanism only requires the back of the distal-most fastener to reach the driving channel, the subsequent fastener in the storage channel need not travel forward as great of distance or be as great of length to move the distal-most fastener fully into the driving channel.
  • the fastener applicator may store and use fasteners of shorter toe lengths.
  • the alternative embodiment also reduces the sensitivity of the transfer mechanism by reducing the reliance on precision in the forward positioning of the subsequent storage channel fastener.
  • the alternative embodiment eliminates the fastener positioning spring 60 (depicted in Fig. 7 and 8) thereby simplifying the 5 overall fastener mechanism and eliminating any concern for precise spacing and fastener length created by engagement of the fastener with the fastener positioning spring.
  • the invention contemplates that there are many ways to fashion these elements. However, to further the goals of minimal jamming and misfiring by the miniaturized tool, the invention teaches a preferred
  • the handle portion 10 consists of a pistol grip portion 12 and a barrel portion 14.
  • the trigger portion 30 of the preferred embodiment comprises a trigger 302 having a cam follower 304 which fits within the handle portion 10 and is pivotally attached at pivot 303 to the
  • the cam follower 304 engages a cam 308 which extends from a cooperating hinged lever 310 that resides within the pistol grip portion 12.
  • the hinged lever 310 is pivotally attached near the butt of the pistol grip portion 12 and extends through the handle portion 10 into the barrel portion 14.
  • the hinged lever 310 has at its upper end a fork 312 whose crotch is aligned with the axis of the tubular housing 40 of applicator 20
  • plunger/ratchet assembly 316 which has a distal and proximal end.
  • the proximal end of plunger/ratchet assembly 316 is grooved to accept the fork 312.
  • the distal end of plunger/ratchet assembly 316 connects to slide actuator 190 which in turn connects to slide 120 (not shown) within the applicator 20.
  • the trigger portion 30 is contained in a recess of handle portion 10 which may consist of two halves fitted together, such as 10a and 10b.
  • squeezing trigger 302 causes lever fork 312 to be thrust toward the distal end of the barrel portion 14 by the response of the cam 308 to action of the cam follower 304. Release of the trigger 302 causes fork 312 to retract to its original position by virtue of a fork biasing spring 314 and trigger biasing spring 306 which returns these same elements back to their resting positions. -
  • Fig. 14 shows a preferred embodiment in which an applicator 20 containing stacked fasteners 80 (not shown) that is readily detachable from body portion 10 by rotating the applicator 20 and axially moving it away from the handle portion 10. A new applicator is readily attached in the reverse manner.
  • the applicator 20 thus functions as a fastener magazine and is replaced every time a new supply of fasteners is required.
  • slide actuator 190 is notched at its proximal end to accept the drive pin 318 present on the distal end of the plunger/ratchet r, because the slide actuator 190 would otherwise freely move within applicator 20 when the applicator 20 is not attached to the handle portion 10, the slide actuator 190 is locked into place by virtue of an "L"-shaped pin 320 having a flat spot on its shank.
  • Fig. 15a illustrates a simplified close-up of this locking feature.
  • the leg of "L"-shaped pin 320 passes through hub 321 (not shown) and engages a notched region 330 of slide actuator 190.
  • the leg portion of "L"-shaped pin 320 is parallel to the bore of the tubular housing 40, as in Fig. 14, the shank engages notched region 330 of the slide actuator 190 and the slide actuator is locked.
  • the flat portion of the pin shank is free of notches 330 and as a result the actuator 190 is free to slide axially in response to actuation by the handle and trigger portions.
  • Fig. 15a illustrates a simplified close-up of this locking feature.
  • the pin 320 and the proximal end of the slide actuator 190 are preferably protected by a skirt 340 to prevent any inadvertent change in the position of the "L"- shaped pin 320 during handling of the actuator.
  • the skirt 340 also protects against damage to the proximal end of the slide actuator 190. According to this feature, the distal end of the barrel portion 14 of handle portion 10 of the fastener applicator tool is received within the skirt 340 and connected to the slide actuator 190 within the skirt.
  • the handle portion 10 is made of two body portions, 10a and 10b, which fit together, house the trigger 302, fork lever 312 and plunger/ratchet assembly 316.
  • the handle portion 10 comprises a socket at its distal end
  • applicator 20 may simply have a grip disposed about its circumference that allows the user to grip the applicator 20 during assembly with the handle portion 10.
  • the applicator 20 is inserted into the handle portion 10, comprised of two handle halves 10a and 10b, by sliding its proximal end into the socket of the handle portion 10, and rotating the applicator.
  • the act of inserting the proximal end of the applicator 20 into the distal end of the handle portion 10 and rotating it serves several purposes: first, it locks the applicator 20 onto the handle body 10; second, the rotation causes the "L"-shaped pin 320 to rotate in response to a cam surface 328 thereby freeing the slide actuator 190 from its locked position into a ready position; third, rotation causes the notch in the slide actuator 190 to engage the drive pin 318 on the plunger/ratchet assembly 316; and fourth, detent structure 327 engages the shank of the "L"- shaped pin, preventing inadvertent rotation in use.
  • Fig. 15b shows the detail of the mechanism for connecting the applicator to the handle.
  • the two handle halves 10a and 10b comprising relief grooves 323, 324, 325 and 326 and cam surfaces 328 and 329, engage the proximal end of the actuator hub 321 for the purpose of releasably holding the applicator to the assembled handle.
  • the handle halves are shown separated and opened out in juxtaposition to illustrate their features.
  • the embodiment shown here does not incorporate a skirt as in Fig. 14.
  • the relief grooves 323, 324, .325 and 326 form grooves of different depths such that the hub may only be assembled in one position because of the profile of the "L"-shaped pin 320.
  • clockwise rotation presses the arm of the "L"-shaped pin against cam surface 328 and turns the arm 90° to the axis of the hub 321. Rotation is continued until the shank of the "L"- shaped pin passes past the detent 327 at the end of the groove in the handle to lock the actuator in position. The actuator is thus locked in place ready for use, and cannot inadvertently back-rotate and uncouple.
  • the device After insertion, the device is ready for operation as if it were a tool of unitary construction. Reversing this rotation step frees the slide actuator 190 from drive pin 318, and on withdrawal, cam 329 rotates the leg of the "L"-shape pin back into engagement with the notched region of the slide actuator 190 on withdrawal, thereby locking the actuator, and disconnects the applicator 20 from the handle portion 10. If a skirt is incorporated into this attachment apparatus as in Fig. 14, it may be integral with or attached to the hub 321. If the apparatus is of unitary construction, the releasable attachment mechanism may be eliminated and the cooperating elements are non-detachably joined.
  • the preferred embodiment includes a ratchet and pawl system designed to guarantee complete, irreversible travel of the applicator mechanism during each stroke of the application cycle.
  • This aspect of the invention shown in Figs. 16 and 17, contemplates that the plunger/ratchet assembly 316 reciprocates backward and forward within the barrel portion 14 of the handle portion 10.
  • a tapered slot 400 is provided in the r. ⁇ r. ; ⁇ r. 1 f> ⁇ ri . a p aw l 402 is placed within that tapered slot.
  • the pawl spring 406 urges the pawl 402 into a pe ⁇ endicular position relative to the direction of plunger travel by means of a slot in the pawl.
  • the side of the plunger/ratchet assembly 316 that faces pawl 402 has a series of grooves forming a ratchet 408 which extends approximately as far as the extent of travel of the plunger/ratchet assembly 316 within the handle portion 10.
  • the length of pawl 402 is somewhat greater than the distance between the bottom of the tapered groove and the bottom of the ratchet grooves. The pawl 402 is thus trapped at an oblique angle between the slot 400 and the ratchet 408 during plunger travel.
  • Fig. 18 shows the complete fastener application cycle with reference to the plunger/ratchet assembly 316.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un appareil comprenant généralement un manche (10), un mécanisme (30) de déclenchement et un applicateur (20) d'attache. Dans un mode de réalisation de l'invention, l'attache est formée autour d'un seul point de focalisation sur une enclume (130). Dans un autre mode de réalisation, les attaches (80) sont empilées verticalement dans un applicateur (40) d'attache facilement détachable du manche (10) grâce à un système de blocage rotatif et pouvant être remplacé par une nouvel applicateur d'attache comprenant une nouvelle charge d'attaches (80) verticalement empilées. Dans un troisième mode de réalisation de l'invention, l'applicateur d'attache ne possède qu'une partie commandée dans son mécanisme d'application, et utilise des ressorts polarisés commandés par la position de la pièce commandée pour la partie restante du mécanisme. Dans un quatrième mode de réalisation, l'invention déploie un ensemble (408) piston/rochet et cliquet (400) dans le manche (10) de l'appareil garantissant que le mécanisme d'application de l'appareil ne s'inverse pas au milieu d'une course d'application déclenchée. Les divers modes de réalisation peuvent se combiner différemment dans un seul dispositif.
PCT/US2000/009623 2000-04-11 2000-04-11 Appareil et procede de fixation chirurgicale WO2001076489A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2000242290A AU2000242290A1 (en) 2000-04-11 2000-04-11 Apparatus and method for surgical fastening
PCT/US2000/009623 WO2001076489A1 (fr) 2000-04-11 2000-04-11 Appareil et procede de fixation chirurgicale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2000/009623 WO2001076489A1 (fr) 2000-04-11 2000-04-11 Appareil et procede de fixation chirurgicale

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Cited By (9)

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WO2011090832A1 (fr) * 2010-01-20 2011-07-28 Ethicon Endo-Surgery, Inc. Procédé pour charger des agrafes dans une agrafeuse chirurgicale extra-plate
WO2011090831A1 (fr) * 2010-01-20 2011-07-28 Ethicon Endo-Surgery, Inc. Appareil pour charger des agrafes dans une agrafeuse chirurgicale extra-plate
US8439244B2 (en) 2010-01-20 2013-05-14 Ethicon Endo-Surgery, Inc. Surgical stapler fastening device with movable anvil
US8453905B2 (en) 2009-01-26 2013-06-04 Ethicon Endo-Surgery, Inc. Surgical fastener for applying a large staple through a small delivery port
US8469252B2 (en) 2009-01-26 2013-06-25 Ethicon Endo-Surgery, Inc. Surgical stapler fastening device with adjustable anvil
US8801732B2 (en) 2009-01-26 2014-08-12 Ethicon Endo-Surgery, Inc. Surgical stapler to secure a tissue fold
US9713471B2 (en) 2009-01-26 2017-07-25 Ethicon Endo-Surgery, Inc. Surgical device with tandem fasteners
US9713468B2 (en) 2009-01-26 2017-07-25 Ethicon Endo-Surgery, Inc. Surgical stapler for applying a large staple through a small delivery port and a method of using the stapler to secure a tissue fold
US9980716B2 (en) 2012-03-21 2018-05-29 Ethicon Llc Methods and devices for creating tissue plications

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US5356064A (en) 1991-10-18 1994-10-18 United States Surgical Corporation Apparatus and method for applying surgical staples to attach an object to body tissue
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EP0168244A2 (fr) * 1984-07-10 1986-01-15 Syncare Inc. Dispositif d'agrafage chirurgical
EP0509513A1 (fr) * 1991-04-17 1992-10-21 United States Surgical Corporation Clip pour la fascia et instrument
US5356064A (en) 1991-10-18 1994-10-18 United States Surgical Corporation Apparatus and method for applying surgical staples to attach an object to body tissue
US5497933A (en) * 1991-10-18 1996-03-12 United States Surgical Corporation Apparatus and method for applying surgical staples to attach an object to body tissue
DE19751791A1 (de) * 1997-11-22 1999-05-27 Arnold Dipl Ing Dr Med Pier Chirurgisches Klammersetzinstrument

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9713471B2 (en) 2009-01-26 2017-07-25 Ethicon Endo-Surgery, Inc. Surgical device with tandem fasteners
US9713468B2 (en) 2009-01-26 2017-07-25 Ethicon Endo-Surgery, Inc. Surgical stapler for applying a large staple through a small delivery port and a method of using the stapler to secure a tissue fold
US11540825B2 (en) 2009-01-26 2023-01-03 Ethicon Endo-Surgery, Inc. Surgical device with tandem fasteners
US10779819B2 (en) 2009-01-26 2020-09-22 Ethicon Endo-Surgery, Inc. Surgical device with tandem fasteners
US8453905B2 (en) 2009-01-26 2013-06-04 Ethicon Endo-Surgery, Inc. Surgical fastener for applying a large staple through a small delivery port
US8469252B2 (en) 2009-01-26 2013-06-25 Ethicon Endo-Surgery, Inc. Surgical stapler fastening device with adjustable anvil
US8801732B2 (en) 2009-01-26 2014-08-12 Ethicon Endo-Surgery, Inc. Surgical stapler to secure a tissue fold
US8602286B2 (en) 2009-01-26 2013-12-10 Ethicon Endo-Surgery, Inc. Apparatus for feeding staples in a low profile surgical stapler
CN102724920B (zh) * 2010-01-20 2015-04-01 伊西康内外科公司 用于将缝钉送进薄型外科缝合器中的装置
WO2011090832A1 (fr) * 2010-01-20 2011-07-28 Ethicon Endo-Surgery, Inc. Procédé pour charger des agrafes dans une agrafeuse chirurgicale extra-plate
WO2011090831A1 (fr) * 2010-01-20 2011-07-28 Ethicon Endo-Surgery, Inc. Appareil pour charger des agrafes dans une agrafeuse chirurgicale extra-plate
US8439244B2 (en) 2010-01-20 2013-05-14 Ethicon Endo-Surgery, Inc. Surgical stapler fastening device with movable anvil
CN102724920A (zh) * 2010-01-20 2012-10-10 伊西康内外科公司 用于将缝钉送进薄型外科缝合器中的装置
US9980716B2 (en) 2012-03-21 2018-05-29 Ethicon Llc Methods and devices for creating tissue plications
US10595852B2 (en) 2012-03-21 2020-03-24 Ethicon Llc Methods and devices for creating tissue plications

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