Abstract:
One example of a surgical apparatus may include at least one resorbable feeder belt, and a plurality of staples fixed to that feeder belt. Another example of a surgical apparatus may include at least one feeder belt and at least one resorbable carrier detachably connected to a corresponding feeder belt, where the carrier includes a plurality of staples attached to it. An exemplary surgical method of treating tissue within the body of a patient may include providing a surgical instrument that includes an end effector moveable between an open configuration and a closed configuration, where the end effector includes an anvil and a staple holder pivotally connected to one another, where the anvil holds a knife; and at least one resorbable feeder belt and a plurality of staples fixed to the feeder belt, where the feeder belt extends into said staple holder; placing the end effector in proximity to tissue; deploying a plurality of staples into tissue; separating a distal segment of at least one feeder belt from a remainder of that feeder belt; and leaving that distal segment within the body of the patient.

Description:
FIELD OF THE INVENTION 
     The invention generally relates to surgical staples and stapling. 
     BACKGROUND 
     An endocutter is a surgical tool that staples and cuts tissue to transect that tissue while leaving the cut ends hemostatic. An endocutter is small enough in diameter for use in minimally invasive surgery, where access to a surgical site is obtained through a trocar, port, or small incision in the body. A linear cutter is a larger version of an endocutter, and is used to transect portions of the gastrointestinal tract. A typical endocutter receives at its distal end a disposable single-use cartridge with several rows of staples, and includes an anvil opposed to the cartridge. The surgeon inserts the endocutter through a trocar or other port or incision in the body, orients the end of the endocutter around the tissue to be transected, and compresses the anvil and cartridge together to clamp the tissue. Then, a row or rows of staples are deployed on either side of the transection line, and a blade is advanced along the transection line to divide the tissue. 
     During actuation of an endocutter, the cartridge fires all of the staples that it holds. In order to deploy more staples, the endocutter must be moved away from the surgical site and removed from the patient, after which the old cartridge is exchanged for a new cartridge. The endocutter is then reinserted into the patient. However, it can be difficult and/or time-consuming to located the surgical site after reinsertion. Further, the process of removing the endocutter from the patient after each use, replacing the cartridge, and then finding the surgical site again is tedious, inconvenient and time-consuming, particularly where a surgical procedure requires multiple uses of the endocutter. That inconvenience may discourage surgeons from using the endocutter for procedures in which use of an endocutter may benefit the patient. Similar inconveniences may accompany the use of surgical staplers other than endocutters. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of an endocutter. 
         FIG. 2  is a cross-section view of a trocar port positioned in a patient. 
         FIG. 3  is a cross-section view of trocar ports positioned in a patient. 
         FIG. 4  is a perspective view of an exemplary feeder belt with three rows of staples frangibly connected thereto. 
         FIG. 5  is a side view of the feeder belt of  FIG. 4 . 
         FIG. 6  is a top view of the feeder belt of  FIG. 4 . 
         FIG. 7  is a perspective view of another exemplary feeder belt with two rows of staples frangibly connected thereto. 
         FIG. 8  is a side view of the feeder belt of  FIG. 7 . 
         FIG. 9  is a top view of the feeder belt of  FIG. 7 . 
         FIG. 10  is a side view of an exemplary end effector of an endocutter that utilizes the feeder belt of  FIGS. 1-9 . 
         FIG. 11  is a side view of another exemplary feeder belt. 
         FIG. 12  is a side view of another exemplary feeder belt, to which at least one detachable carrier is connected. 
         FIG. 13  is a detail cross-section view of the staple holder. 
     
    
    
     The use of the same reference symbols in different figures indicates similar or identical items. 
     DETAILED DESCRIPTION 
     U.S. patent application Ser. No. 11/851,379, filed Sep. 6, 2007; U.S. patent application Ser. No. 11/956,988, filed Dec. 14, 2007; and U.S. patent application Ser. No. 12/263,171, filed Oct. 31, 2008 (the “Endocutter Applications”) are hereby incorporated by reference herein in their entirety. 
     The Endocutter Applications describe in detail examples of a true multi-fire endocutter. For example, referring to  FIG. 1 , an endocutter  2  includes an end effector  4  attached to a shaft  6 , which in turn is attached to a handle  8 . The end effector  4  may be one or more separate components that are connected to the shaft  6 , or may be fabricated integrally with the distal end of the shaft  6 . The shaft  6  of the endocutter  2  extends proximally from the end effector  4 . The shaft  6  may be flexible or rigid. The shaft  6  may be articulated in at least one location, if desired. Optionally, the shaft  6  may include a cutaway, trough or other feature (not shown) to allow a guidewire (if any) or other positioning aid that may be used in the surgical procedure to remain in place during actuation of the endocutter  2 . The end effector  4 , shaft  6  and handle  8  may be substantially as described in the Endocutter Applications, unless otherwise described in this document. 
     Referring also to  FIGS. 2-3 , the end effector  4  and the shaft  6  may be sized to pass through a standard trocar port  10  that may be placed through tissue  12  of a patient  14 . Advantageously, the end effector  4  may be sized to pass through a trocar port  10  having an opening between 5-10 millimeters in diameter. Alternately, the endocutter  2  may be used in the course of conventional open surgery, where a trocar port is not used. Alternately, the endocutter  2  may be used in the course of minimally-invasive surgery, where access to the surgical site in the patient is gained through a mechanism or structure other than a trocar port, such as the LAP DISC® hand access device of Ethicon Endo-Surgery, Inc., or where access to the surgical site in the patient is gained through an incision or opening in which no port or other mechanism or structure is placed. 
     Referring to  FIGS. 4-9 , a portion of an exemplary feeder belt  16  is positioned within the end effector  4 . The feeder belt  16  and associated hardware may be as set forth in the Endocutter Applications. The feeder belt  16  may be a long, narrow, thin strip of material from which one or more staples  18  extend. The feeder belt  16  may be fabricated from stainless steel, nickel-titanium alloy, or any other suitable metallic or non-metallic material. The feeder belt  16  is flexible enough, and strong enough, to be advanced linearly and then redirected around a nose or other structure in substantially the opposite direction, as described in greater detail below. Alternately, at least part of the feeder belt  16  may be rigid or at least partially rigid, such that the feeder belt  16  may be advanced or retracted substantially linearly without redirection about a structure, or may be otherwise manipulated. Each staple  18  may be shaped in any suitable manner; the staples  18  may be shaped substantially the same as one another, or may be shaped differently. As one example, each staple  18  is generally V-shaped, and has two legs  20  extending from the base of the V-shape. Referring particularly to  FIG. 5 , one leg  20  of the staple  18  may be generally straight, and the other leg  20  of the staple  18  may be gently curved. However, the legs  20  may be shaped in a different manner. Further, each leg  20  may be shaped in the same manner. The staple  18  need not be symmetrical, but can be fabricated symmetrically if desired. The base of the V-shape of the staple  18  may be curved, pointed or otherwise configured. One leg  20  of the staple  18  has a free end  22  that may be characterized as a tissue penetrating tip  22 . The tissue penetrating tip  22  may be sharpened, if desired, to facilitate penetration of tissue. However, the legs  20  of the staple  18  may have a cross-section that is small enough that the tissue penetrating tip  22  need not be sharpened in order to easily penetrate tissue. The other leg  20  is attached at one end to the feeder belt  16 . Advantageously, that leg  20  is frangibly connected to the feeder belt  16 . Thus, one end of the staple  18  may be attached to the feeder belt  16  and the other end of the staple  18  may be free. Alternately, the staple  18  may have three or more legs  20 , or may be shaped in any other suitable manner. The staples  18  may be connected to the feeder belt  16  in any suitable orientation. As one example, one or more of the staples  18  are oriented generally parallel to the longitudinal centerline of the feeder belt  16 . That is, one or more of the staples  18  each may lie in a plane that is generally parallel to the longitudinal centerline of the feeder belt  16 , as shown in  FIG. 6 . As another example, one or more of the staples  18  each may be oriented in a direction angled relative to the longitudinal centerline of the feeder belt  16 . As another example, the staples  18  each may be oriented in a direction angled relative to the transverse direction, which is the direction perpendicular to the longitudinal centerline of the feeder belt  16 . 
     The staples  18  may be arranged on a corresponding feeder belt  16  in any suitable manner, such as described in the Endocutter Applications. A connection between the feeder belt  16  and each corresponding staple  18  may be made in any suitable manner. That connection may be frangible or fixed. The Endocutter Applications describe a frangible connection between the feeder belt  16  and at least one staple  18 . At least one staple  18  may be fixedly connected to the feeder belt  16 , such that the staple  18  is retained on the feeder belt  16  after its deployment. Such a fixed connection may be accomplished in any suitable manner. As one example, a fixed connection between a staple  18  and the corresponding feeder belt  16  may be made in a similar manner as the frangible connection, where the weakened area at the junction between the staple  18  and the corresponding feeder belt  16  simply is omitted. As another example, a positively strengthened area may be provided at the junction between the staple  18  and the corresponding feeder belt  16 . That strengthened area may be a wider and/or thicker leg  20  of the staple  18 , at least in the vicinity of the junction between that leg  20  and the feeder belt  16 . Such a strengthened area may instead, or additionally, be a differently-shaped and/or sized junction between the feeder belt  16  and the corresponding leg  20  of the staple  18  and the feeder belt  16 , such that an increased cross-sectional area is present at the junction as compared to the cross-sectional area of such junction where a staple  18  is frangibly connected to the feeder belt  16 . As another example, the strengthened area may also, or instead, be physically treated or otherwise configured to be stronger than the surrounding material, while having substantially the same physical dimensions as that surrounding material. 
     Where at least one staple  18  is fixedly connected to the feeder belt  16 , the feeder belt  16  may be fabricated such that it remains in place in the body along with one or more staples  18 . If so, the feeder belt  16  and the staple or staples  18  fixedly connected thereto may be fabricated from any biocompatible material which does not degrade substantially in the body, such as stainless steel or a titanium alloy. 
     Where at least one staple  18  is fixedly connected to the feeder belt  16 , the feeder belt  16  may be fabricated such that it is resorbable. The staples  18  may also be configured to be resorbable, or may be fabricated to remain in place in the body after the feeder belt  16  has been resorbed. A resorbable feeder belt  16  may be fabricated from any suitable material that is resorbed by the body over time. Those suitable materials include, and are not limited to, polymers such as polydioxanone, polylactic acid and polyglycolic acid; polycarbonates such as poly(desaminotyrosyl-tyrosine-ethyl ester carbonate) (PDTE carbonate); polysaccharides such as starch/cellulose acetate blends, starch/polycaprolactone blends, and glucosaminoglycans; polyanhydrides such as aliphatic polyanhydrides or aromatic polyanhydrides; polyaminoacids such as poly-L-lysine; pseudo-polyaminoacids; and polyphosphazenes. 
     Where the feeder belt  16  and at least one staple  18  are made of different materials, the one or more staples  18  may be attached to the feeder belt  16  in any suitable manner. As one example, where the feeder belt  16  is resorbable and one or more staples  18  are not, the feeder belt  16  may be molded onto the one or more staples  18  that are non-resorbable. As another example, one or more staples  18  may be welded to the feeder belt  16 , or attached to the feeder belt  16  with adhesive. As another example, one or more staples  18  may be attached to the feeder belt  16  by localized melting of the feeder belt  16  at the junction between at least one staple  18  and the feeder belt  16 ; as the feeder belt  16  cools, the junction hardens to form an attachment to one or more staples  18 . Any other suitable structure, mechanism or method may be used to attach one or more staples  18  to a resorbable feeder belt  16 . In a similar manner, or in any other suitable manner, the feeder belt  16  may be attached to a top plate and/or bottom plate, and/or any other suitable structure or mechanism, of the endocutter  2  that is utilized to advance the feeder belt  16 . 
     Where the feeder belt  16  is resorbable, the feeder belt  16  itself and/or the end effector  4  of the endocutter  2  may be configured in any way to allow a portion of the feeder belt  16  to be deployed into the patient along with one or more staples  18  fixed thereto. Referring also to  FIG. 9 , at least one feeder belt  16  may include at least one perforation  24 . Each perforation  24  may include one or more holes  26  defined partially or completely through the feeder belt  16 . Where the perforation  24  includes two or more holes  26 , the holes  26  may lie substantially along a straight line. That straight line may be oriented generally perpendicular to the longitudinal centerline of the feeder belt  16 , or may form a different angle relative to the longitudinal centerline of the feeder belt  16 . Alternately, the holes  26  of a perforation  24  may lie substantially along a curved line. Alternately, a perforation  24  may include at least one hole  26  that is not aligned with the other holes  26  along either a straight line or a curved line. Each perforation  24  is strong enough to allow for advancement of the feeder belt  16  in which it is defined, but weak enough to allow the section of the feeder belt  16  distal to the perforation  24  to detach from the remainder of the feeder belt  16 . Optionally, the perforation  24  may be stronger in compression than in tension, to allow the feeder belt  16  to be pushed distally (during which the perforation  24  is in compression) and then separated from the remainder of the feeder belt  16  by the application of a tensile force. The end effector  4  may be configured to provide such a tensile force in any suitable manner. As another example, after the staples  18  are deployed into tissue such that they hold the distalmost section of the feeder belt  16  in place at a surgical site in the body, the feeder belt  16  may simply tear at the perforation  24  upon motion of the end effector  4  away from that surgical site. 
     As another example, referring also to  FIG. 10 , at least one knife  29  may extend from the anvil  32  of the end effector  4 , facing toward the staple holder  30 . As another example, at least one knife  29  may extend from the staple holder  30  toward the anvil  32 . As another example, two knives  29  may be provided, one extending from the staple holder  30  and one extending from the anvil  32 , where both are oriented and positioned relative to one another such that the knives  29  move together as the end effector  4  moves from an open configuration to a closed configuration. At least one knife  29  may be fixed directly to the anvil  32  or to the staple holder  30 , depending on the particular configuration of the end effector  4 . As another example, at least one knife  29  may extend from and be movable relative to the staple holder  30  and/or the anvil  32 . In this situation, as one example, the knife  29  may be fabricated from spring steel or similar material, which is held in a channel defined in the corresponding staple holder  30  or anvil  32 . The knife  29  may be actuated before, during or after closure of the end effector  4  to move along and/or out of the corresponding channel. 
     Referring also to  FIG. 11 , the nose or pulley disclosed in the Endocutter Applications optionally may be omitted where the feeder belt  16  is deployed in addition to the staples  18  attached to it. Concurrently, the lower section of the feeder belt  16  may be omitted, because the feeder belt  16  need not wrap around the nose or pulley where the distalmost section of the feeder belt  16  is separated from a remainder of the feeder belt  16  after each deployment of staples  18 . As a result, the feeder belt  16  may be advanced generally linearly without substantially bending, and the feeder belt  16  may be generally straight and lie substantially in a single plane. Consequently, the choice of materials from which the feeder belt  16  may be fabricated may expand, because the feeder belt  16  need not be flexible enough to wrap around a nose or pulley. 
     In another exemplary embodiment, referring also to  FIG. 12 , at least one resorbable carrier  40  may be detachably held on a feeder belt  16 , where the staples  18  are fixed to the carrier  40  rather than the feeder belt  16 . The feeder belt  16  may wrap around a nose, pulley or other structure at its distal end, such as described in the Endocutter Applications. Referring also to  FIG. 13 , the term “redirector”  17  is defined to include a nose, a pulley or any other structure or mechanism about which the distal end of the feeder belt  16  wraps or extends. In such an embodiment, the feeder belt  16  simply may urge the carrier or carriers  40  distally, and may not include staples  18  extending therefrom. Each carrier  40  may be held on an upper surface of the corresponding feeder belt  16  in order to facilitate deployment of the carrier  40  out of the staple holder  30 . That is, each carrier  40  may be located between the corresponding feeder belt  16  and the aperture, slot or other opening in the upper surface of the staple holder  30  through which the carrier  40  is to be deployed. Alternately, at least one carrier  40  may extend at least partially underneath the corresponding feeder belt  16 . Each carrier  40  may be held by the feeder belt  16  in any suitable manner. As one example, adhesive may connect a carrier  40  to the corresponding feeder belt  16 . As another example, at least one carrier  40  may be frangibly connected to the corresponding feeder belt  16 . As another example, at least one carrier  40  may be pressure fit or interference fit onto the corresponding feeder belt  16 . As another example, at least one carrier  40  may be snap fit onto a corresponding feeder belt  16  such as via a tab extending from the carried  40  into a slot on the feeder belt  16 , or vice versa. The carriers  40  may be independent from one another, and independently held by the corresponding feeder belt  16 . Alternately, at least two carriers  40  may be connected directly to one another, such that a connection between two adjacent carriers  40  is severed during deployment of the most-distal carrier  40 . Such connection and severing may be, for example, as set forth above with regard to the embodiment of  FIGS. 9-11 . As another example of a carrier  40 , the staples  18  may be resorbable as well as the carrier  40 . As another example, the carrier  40  may be non-resorbable, as well as the staples  18  attached thereto. 
     Operation 
     Operation of the endocutter  2  is substantially as described in the Endocutter Applications. For clarity and brevity, the differences between that operation described in the Endocutter Applications and the operation of the end effector  4  of this document are described here. The end effector  4  is placed in proximity to tissue to be treated, whether in a conventional or minimally-invasive surgical procedure. At such time, if the end effector  4  is in the closed configuration, it is then moved to the open configuration. The end effector  4  is then moved to the closed configuration such that the tissue to be treated is positioned between the staple holder  30  and the anvil  32 . The end effector  4  is then actuated, such as by depressing a firing trigger on the handle  8 , as described in the Endocutter Applications. 
     Where at least one knife  29  is fixed to the anvil  32 , as the end effector  4  moves from an open configuration to a closed configuration, at least one knife  29  may encounter and then cut through at least one feeder belt  16 . Advantageously, that knife  29  encounters and cuts through at least one feeder belt  16  at a perforation  24 . The staple holder  30  may include an aperture defined therein through which the knife  29  is received, in order to allow the knife  29  to make contact with at least one feeder belt  16 . That aperture may be independent from one or more apertures in the staple holder  30  through which the staples  18  are deployed, or may be a larger slot through which at least one staple  18  is deployed. Where at least one knife  29  is fixed to the staple holder  30  under a corresponding feeder belt  16 , the anvil  32  may be configured to press against the feeder belt  16  at a location above the knife  29 , such that the resulting pressure causes the knife  28  to cut through the feeder belt  16 . Where at least one knife  29  is fixed to the anvil  32  and/or staple holder  30 , that knife  29  cuts through one or more feeder belts  16  during closure of the end effector  4 . Thus, the most-distal section of at least one feeder belt  16  is separated from a proximal remainder of the feeder belt  16  during closure of the end effector  4 . That distalmost section of the feeder belt  16  may be held within the staple holder  30  in any suitable manner, such as by a clamping force exerted by the anvil  32  against the staple holder  30 , by clamps within the staple holder  30  such as described in the Endocutter Applications, by pressure or interference fit between the feeder belt  16  and the staple holder  30 , or by any other suitable structure or method. The staples  18  are then deployed such as described in the Endocutter Applications. After the staples  18  have been deployed, the staples  18  hold the separated portion of the feeder belt  16  in place relative to the tissue that was stapled. The feeder belt  16  is unclamped, and the separated portion of that feeder belt  16  is then free to exit the staple holder  30  as the staple holder  30  is moved away from tissue, such that the separated portion of the feeder belt  16  is passively ejected from the staple holder  30 . Alternately, the separated portion of the feeder belt  16  may be actively ejected from the staple holder  30  in any suitable manner. 
     Where at least one knife  29  is movable relative to the staple holder  30  and/or the anvil  32 , the end effector  4  can be moved to the closed configuration without simultaneously cutting at least one feeder belt  16 . Consequently, at least one knife  29  can be actuated after the end effector  4  has moved to the closed configuration. Advantageously, that knife  29  encounters and cuts through at least one feeder belt  16  at a perforation  24 . As one example, the staples  18  may be deployed such as described in the Endocutter Applications, and at least one knife  29  may then be actuated to contact and then cut through a corresponding feeder belt  16 , separating the most distal part of that feeder belt  16  from a remainder of that feeder belt  16 . As another example, at least one knife  29  may be actuated to contact and then cut through a corresponding feeder belt  16 , separating the most distal part of that feeder belt  16  from a remainder of that feeder belt  16 , and then the staples  18  connected to that separated portion of the feeder belt  16  may be deployed such as described in the Endocutter Applications. As described in the Endocutter Applications, regardless of the timing of the actuation of the knife  29  to cut through a corresponding feeder belt  16 , that feeder belt  16  may be clamped securely relative to the staple holder  30  during deployment of the staples  18 . After the staples  18  have been deployed, the staples  18  hold the separated portion of the feeder belt  16  in place relative to the tissue that was stapled. The feeder belt  16  is unclamped, and the separated portion of that feeder belt  16  is then free to exit the staple holder  30  as the staple holder  30  is moved away from tissue, such that the separated portion of the feeder belt  16  is passively ejected from the staple holder  30 . Alternately, the separated portion of the feeder belt  16  may be actively ejected from the staple holder  30  in any suitable manner. 
     As another example, the knife  29  may be omitted. If so, the feeder belt  16  may include at least one perforation  24 , where that perforation  24  is strong enough in compression to allow the feeder belt  16  to be advanced relative to the staple holder  30 , and weak enough to allow the distalmost portion of the feeder belt  16  to separate easily from a remainder of the feeder belt  16 . If so, the feeder belt  16  may be clamped into place relative to the staple holder  30 , along a length that extends proximal to the most-distal perforation  24 . The staples  18  are then deployed into tissue, and then the feeder belt  16  is unclamped. The staple holder  30  is then moved away from the tissue into which the staples  18  were deployed, such that a tensile force is applied to the portion of the feeder belt  16  distal to the most distal perforation  24 . That tension causes the distalmost section of the feeder belt  16  to tear away at the perforation  24 , leaving that distalmost section of the feeder belt  16  within the patient. 
     As another example, where at least one carrier  40  is detachably held on a feeder belt  16 , at least one carrier  40  may be independent from adjacent carriers. The term “independent” means that a carrier  40  is not directly connected to any adjacent carrier  40 . The feeder belt  16  optionally may be clamped in place, and then the staples  18  are deployed, such as described in the Endocutter Applications. After the staples  18  have been deployed into tissue, the staple holder  30  is moved away from the tissue. This motion exerts a force on the carrier  40 , detaching it from the corresponding feeder belt  16 . Alternately, the carrier  40  may be actively ejected from the corresponding feeder belt  16  in any suitable manner. Where the carrier  40  is connected to another carrier  40 , the knife  29  may be utilized as described above to sever the distalmost carrier  40  from the carrier  40  located proximal to it. The knife  29  may separate the distalmost carrier  40  during closure of the end effector  4 , or after the end effector  4  has been closed, as described above. 
     In each example above, the feeder belt  16  may be advanced after each deployment, without the need to remove the end effector  4  from the patient, such that true multi-fire capability is provided. 
     The resorbable material left in the patient degrades over time. Where the feeder belt  16  or carrier  40  left within the patient is resorbable, and the staples  18  are not, the staples  18  remain in place in the patient after the feeder belt  16  or carrier  40  have degraded. Where the staples  18  are resorbable as well, the staples  18  degrade along with the feeder belt  16  or carrier  40 . Complete resorbability may be desirable where the tissue to be treated is expected to heal quickly, and where the use of permanently-implanted staples  18  is not advantageous. Where neither the staples  18  nor the feeder belt  16  or carrier  40  are resorbable, then they remain in place in the patient at the treatment site. Permanent implantation may be desirable where the tissue to be treated is expected to heal slowly or not at all, and where the use of permanently-implanted staples  18  is advantageous. 
     While the invention has been described in detail, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention. It is to be understood that the invention is not limited to the details of construction, the arrangements of components, and/or the method set forth in the above description or illustrated in the drawings. Statements in the abstract of this document, and any summary statements in this document, are merely exemplary; they are not, and cannot be interpreted as, limiting the scope of the claims. Further, the figures are merely exemplary and not limiting. Topical headings and subheadings are for the convenience of the reader only. They should not and cannot be construed to have any substantive significance, meaning or interpretation, and should not and cannot be deemed to indicate that all of the information relating to any particular topic is to be found under or limited to any particular heading or subheading. Therefore, the invention is not to be restricted or limited except in accordance with the following claims and their legal equivalents.