1. Technical Field
The present disclosure relates to a surgical fastening apparatus and, more particularly, to a surgical fastening apparatus having a fastener and retainer system.
2. Background of the Related Art
Various types of surgical stapling instruments for performing a circular anastomosis are well known, wherein an operator actuates the apparatus at a location which is relatively remote from the location at which the circular anastomosis takes place. Anastomosis is the surgical joining of separate hollow organ sections. Typically, an anastomosis procedure involves surgery in which a diseased or defective section of hollow tissue is removed.
A conventional surgical stapling instrument for performing a circular anastomosis in a hemorrhoidal or other surgical procedure generally includes a shell assembly having an annular array of staples and staple slots and an anvil assembly having a circular array of staple forming pockets in a proximal surface thereof. An example of surgical stapling instruments for performing circular anastomosis is described in U.S. Pat. Nos. 7,168,604, 7,303,106 and pending U.S. application Ser. No. 12/550,443, filed Aug. 31, 2009, all of which are incorporated herein in their entirety by reference. Typically, the anvil assembly is longitudinally movable from an open position to a closed position which places the anvil assembly adjacent to the shell assembly to clamp the body tissue therebetween. After bringing the anvil and shell assemblies to a closed position to clamp tissue, an annular pusher including a plurality of pushers which are configured to eject a corresponding staple from the staple slot through the tissue and against a receiving pocket of the anvil to form staples is actuated by the operator in a relatively remote region to perform a circular anastomosis. After stapling the tissues together, the tissue is severed by the annular blade and extracted.
Surgical fastening instruments applying two part surgical fasteners are known. In these instruments, a plurality of retainers are supported in an anvil assembly and a plurality of fasteners are supported in a fastener holding assembly. The fasteners are advanced through tissue and into engagement with openings in respective retainers. These two part fasteners are typically composed of resorbable material. The firing force of the fasteners in some of these instruments could shift the retainers out of position which may result in misalignment. In addition, the retainers may slip against the anvil and/or may come off the anvil before firing which may also result in misalignment. Accordingly, it would be advantageous to provide a configuration which enhances mating of the fasteners and the retainers and it may be useful to provide such configuration in a circular anastomosis instrument.
Additionally, the thickness of the clamped tissue can vary in different regions. Therefore, it would be advantageous to provide a fastener-retainer configuration which can accommodate such varying tissue thickness.
In accordance with one aspect of the present disclosure, a surgical fastening apparatus is provided including a fastener receiving frame including a plurality of spaced apart openings formed therein and a fastener supporting member having a plurality of spaced apart surgical fasteners extending therefrom. The surgical fasteners are engagable with the plurality of openings to mate with the fastener receiving frame to fasten tissue therebetween, the fasteners engageable with the openings in a plurality of positions dependent on a tissue thickness between the fastener receiving frame and the fastener supporting member.
The fastener receiving frame is preferably detachably secured to a supporting structure of the surgical apparatus. Preferably, a pusher advances the fastener supporting member into engagement with the fastener receiving frame.
In a preferred embodiment, the pusher is an annular pusher and the fastener supporting member includes an annular supporting frame. Preferably, an annular blade advanceable by the annular pusher to sever tissue is provided.
In some embodiments, the fasteners each have a series of locking tabs spaced axially along the fasteners to mate with the respective opening in the fastener receiving frame at various positions to provide a variable depth of engagement. In some embodiments, the openings can have a series of locking surfaces to engage the respective fastener at various positions to provide a variable depth of engagement. In one embodiment, the locking tabs include a plurality of substantially semi-circular ribs. In one embodiment, the locking tabs include a plurality of projections angled to enable movement of the fastener in a first direction toward the opening in the fastener receiving frame and prevent movement of the fastener in a second opposite direction away from the opening. The fasteners can include a longitudinally extending slot formed therein.
The fastener can include a reservoir to receive a drug.
In some embodiments, the opening in the fastener receiving frame has a first depth and the respective fastener has a first length, wherein the first length is less than the first depth.
In another aspect, the present disclosure provides a surgical fastening apparatus comprising a fastener receiving frame including a plurality of spaced apart openings formed therein and a fastener supporting member containing a plurality of spaced apart surgical fasteners extending therefrom. The surgical fasteners are engagable with the plurality of openings to mate with the fastener receiving frame to fasten tissue therebetween. The fasteners and openings are configured to allow locking engagement of the fasteners in the openings at two or more depths of the fastener, the depth of the fastener preselected prior to advancement of the fasteners into the openings.
Preferably, the fastener receiving frame is detachably secured to a supporting structure of the surgical apparatus and a substantially annular pusher advances the fastener supporting member into engagement with the fastener receiving frame. In preferred embodiments, the fastener supporting member and fastener receiving frame are substantially annular. The fasteners can include a series of locking tabs spaced axially along a length of the fastener.
In one embodiment, the surgical fastening apparatus includes a sensor positioned at a distal portion to determine a tissue parameter to send a signal to determine the extent of advancement of the fastener supporting member. In another embodiment, the surgical fastening apparatus includes a sensor positioned at the distal portion to determine an apparatus parameter to send a signal to determine the extent of advancement of the fastener supporting member.
The fastener receiving frame, fastener supporting member and/or plurality of fasteners can be made of biodegradable polymer. The fastener receiving frame and/or fastener supporting member can be elastic to provide flexibility.
The above and other objects and features of the present disclosure will become apparent from the following description of embodiments given in conjunction with the accompanying drawings, in which:
Various embodiments of the presently disclosed end effector will now be described in detail with reference to the drawings, wherein like references numerals identify similar or identical elements. In the drawings and in the description which follows, the term “proximal” will refer to the end of the component that is closer to the operator during use, while the term “distal” will refer to the end of the component that is further from the operator, as is traditional and conventional in the art.
With reference to
The handle assembly 200 generally includes a stationary handle 240, a pivotable trigger 210 and a rotatable knob 220. When rotatable knob 220 is manually rotated, anvil assembly 20 will longitudinally translate in relation to shell assembly 10 between an open position and a closed position in a manner described below. Actuation of trigger 210 towards stationary handle 240 advances annular pusher 40 (
Referring now to
Anvil assembly 20 includes an anvil 22, fastener retaining frame 24, and a flange member 16. Flange member 16 is preferably composed of plastic material such as HDPE. As will be discussed in further detail below, fastener retaining frame 24 includes a plurality of perforations 26 and a plurality of retainers 28 (
Shell assembly 10 accommodates therein a fastener guide member 30 which includes a plurality of axially extending and circumferentially arranged fastener slots 34 (
With particular reference to
With reference still to
With reference still to
Turning to
Still referring to
In use, anvil assembly 20 is spaced from shell assembly 10 as shown in
The attachment of fastener retaining frame 24 to flange member 16, which is fixedly attached to anvil 22, reduces slippage of fastener retaining frame 24 against anvil 22 and retains its position with respect to anvil 22 during axial translations thereof. Once the clamping of the body tissues has taken place, the operator actuates trigger 210 which in turn distally drives the drive shaft connected to annular pusher 40. The plurality of pushers 42 on the distally translated annular pusher 40 ejects the corresponding set of surgical fasteners 32 from fastener slots 34 of fastener guide member 30. Each of the ejected set of surgical fasteners 32 pierce through the body tissue and are received into a corresponding retainer 28. Specifically, a portion of each of the prongs of fasteners 32 is received into a respective cavity 29a formed in posts 29 in retainer 28. This is shown in the fastener advancement steps of
Note that since fastener retaining frame 24 is securely attached to flange member 16 which is fixedly attached to anvil 22, slippage of fastener retaining frame 24 against anvil 22 due to the firing force produced by the actuation of trigger 210 which ejects the plurality of fasteners 32 from fastener slots 34 into the body tissues is reduced. Thus, the position of fastener retaining frame 24 is maintained with respect to anvil 22 during the firing of surgical fasteners 32. Moreover, the plurality of retainers 28 are either monolithically formed or individually formed and connected by suitable structures, e.g., links, thereby forming a single body. In either instance, the configuration of the plurality of retainers 28 as a single body, in conjunction with fastener retaining frame 24 being secured to flange member 16 which is fixedly attached to anvil 22, reduces the radial misalignment of surgical fasteners 32 with fastener retaining frame 24.
As noted above, fastener retaining frame 24 and fastener guide member 30 may be configured to provide a plurality of rings of surgical fasteners 32 on tissue, e.g., two rings of surgical fasteners wherein each ring is defined by sixteen fasteners, to meet the needs of the specific procedure being performed. Upon mating of the plurality of surgical fasteners 32 with fastener retaining frame 24, an annular blade 51 is actuated to distally translate through shell assembly 10. Note the annular blade can be translatable by actuation of the trigger 210 which advances the fasteners, or alternatively by a separate actuator actuated in a separate step. The annular blade 51 comes into contact with fastener retaining frame 24 and is pressed against the plurality of perforations 26 defined in the fastener retaining frame 24 severing or breaking perforations 26. This is illustrated in
A fastener supporting member or plate 90, preferably substantially annular in configuration, contains a plurality of spaced apart fasteners 92 extending therefrom. The fasteners 92 are illustratively substantially equidistantly spaced along the frame 90 to correspond to the spacing of the openings 82 in frame 80. It is contemplated that other spacings of the fasteners 92 and openings 82, including non-uniform spacings, are also contemplated.
The fastener assembly of
The projecting surfaces, e.g. tabs 94, can also have an angled surface 96 to enable movement of the fastener in a direction toward the frame 80 while the straight surface 97 prevents movement in a reverse direction (away from the fastener receiving frame 80).
In use, after the fastener receiving frame 80 and fastener supporting member 90 are approximated to clamp tissue therebetween by a knob such as rotatable knob 220 of
The fastener support frame 90 can be composed of an elastic material so that it can flex during application to tissue. In this manner, accommodation can be made for varying tissue thicknesses of the tissue clamped between frames 80 and 90. For example, if a first region of the clamped tissue is thicker than a second region, the frame 90 can flex so that fasteners 92 adjacent the second region can penetrate a greater depth than fasteners 92 adjacent the first region and a different locking tab 94 can locking engage the wall 84. Fastener receiving frame 80 can also be composed of an elastic material to provide bending/flexibility.
Although locking tabs are shown on the fasteners 92, it is also contemplated that the openings 82 can be configured with tabs, walls or other structure at various “levels” to provide the locking structure.
An annular cutting blade, similar to blade 51 of
In alternative embodiments, the depth of the fasteners can be preset prior to firing the fasteners. That is, the fastener pusher would be preset to the distance of travel to accommodate the desired degree of advancement of the fastener supporting member and fasteners into the openings 82 of the fastener receiving frame 80. Additionally, several pushers could be provided, e.g. arranged in quadrants or other regional separations, so that each of the pushers could be preset so that various pushers can be advanced to various depths. This can be achieved by placement of a sensor adjacent the end effector at the distal portion of the apparatus which can measure a tissue parameter, e.g. tissue thickness, and/or measure an end effector parameter at the distal portion of the apparatus, e.g. the gap between the fastener receiving frame 80 and fastener supporting frame 90 once approximated to clamp tissue therebetween. The sensor sends a signal to a controller which sends a signal to the pusher to control the extent of advancement of the pushers and thus the extent of advancement of fasteners 92 in response to the parameter determined by the sensor. For example, as shown in
The foregoing embodiments for the fastening receiving frame and fastening supporting frame can be used with the instrument of
The apparatus described herein can be used in various surgical procedures, including for example, hemorrhoid surgery.
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example, the annular blade may be fixedly secured to the anvil and configured to break the plurality of perforations on the fastener retaining frame upon firing of the plurality of fasteners. Such design eliminates the need for a longitudinal translation of the annular blade. Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, the above description, disclosure, and figures should not be construed as limiting, but merely as exemplary of various embodiments.
This application claims priority from provisional application Ser. No. 61/326,292, filed Apr. 21, 2010 and priority from provisional application Ser. No. 61/255,529, filed Oct. 28, 2009. The entire contents of each of these applications are incorporated herein by reference.
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