Active wedge for surgical stapler

An exemplary active wedge for use with surgical staples, comprising a wedge base having an upper surface; and at least one wedge grate movable relative to the wedge base between a first position and a second position, where in the first position of the wedge base substantially all of the wedge grate is located below the upper surface of the wedge base, and where in the second position at least part of the wedge grate is positioned above the upper surface of the wedge base.

FIELD OF THE INVENTION

The invention generally relates to a surgical tool and method, and more specifically to an endocutter.

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 known endocutters and linear staplers, wedges are moved longitudinally, where each wedge sequentially encounters a plurality of staple drivers during its travel. Those staple drivers convert the longitudinal motion of the wedges into vertical motion of the staples, driving the staples upward into an anvil. The wedges are simply solid pieces of metal or other material shaped in a way to facilitate contact between the wedges and the staple drivers.

The use of the same reference symbols in different figures indicates similar or identical items.

DETAILED DESCRIPTION

Three Staple Rows

Referring toFIG. 1, an endocutter2includes an end effector4attached to a shaft6, which in turn is attached to a handle8. The end effector4may be one or more separate components that are connected to the shaft6, or may be fabricated integrally with the distal end of the shaft6. Referring also toFIG. 2, the end effector4and the shaft6may be sized to pass through a standard trocar port10that may be placed through tissue12of a patient. Advantageously, the end effector4may be sized to pass through a trocar port10having an opening between 5-10 millimeters in diameter. Alternately, the endocutter2may be used in the course of conventional open surgery, where a trocar port is not used. Alternately, the endocutter2may 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.

The trocar port10may be a hollow generally-tubular structure inserted into an incision in tissue12of a patient to hold that incision open and to prevent damage to the tissue12defining the incision opening that may result from the motion of tools and other objects through the incision. The trocar port10may be made from plastic or any other suitable biocompatible material. The trocar port10may have a substantially circular cross section, a substantially oval cross section, or any other suitable cross section. The particular dimensions of a trocar port10depend on the particular procedure to be performed on the patient, and may be any suitable dimensions. The trocar port10may be coupled to a cutting tool (not shown) through its center that makes an opening in tissue12, after which the trocar port10is placed into tissue12. The cutting tool may be a spike or other cutting or puncturing device, which is removed from the trocar port10when the trocar port10is in position in the chest wall. The combination of a trocar port10and a cutting tool is standard in the art.

Referring toFIG. 1, the shaft6of the endocutter2extends proximally from the end effector4. The shaft6may be flexible or rigid. The shaft6may be articulated in at least one location, if desired. Optionally, the shaft6may 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 endocutter2.

The handle8may be attached to the proximal end of the shaft6, or any other suitable portion of the shaft6. The shaft6may be fabricated integrally with the handle8. Alternately, the shaft6and the handle8may be two separate items that are connected together in any suitable manner. The handle8may include any mechanism, mechanisms, structure or structures that are suitably configured to actuate the end effector4. The handle8may also include a source of stored energy for actuating the end effector4. The source of stored energy may be mechanical (such as a spring), electrical (such as a battery), pneumatic (such as a cylinder of pressurized gas) or any other suitable source of stored energy. The source of stored energy, its regulation, and its use in actuating the end effector4may be as described in the U.S. patent application Ser. No. 11/054,265, filed on Feb. 9, 2005, which is herein incorporated by reference in its entirety. The handle8may instead, or also, include a connector or connectors suitable for receiving stored energy from an external source, such as a hose connected to a hospital utility source of pressurized gas or of vacuum, or an electrical cord connectable to a power source.

Referring toFIGS. 3-5, a portion of a feeder belt16is positioned within the end effector4. The feeder belt16may be a long, narrow, thin strip of material from which one or more staples18extend. The feeder belt16may be fabricated from stainless steel, nickel-titanium alloy, or any other suitable metallic or non-metallic material. The feeder belt16is 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, the feeder belt16may be rigid or at least partially rigid, and may be advanced or retracted substantially linearly without redirection about a structure.

Two rows26of staples18may extend from the feeder belt16. With such a feeder belt16, one row26of staples18may be located along each side of the feeder belt16. At least two staples18in different rows26may be staggered relative to one another. That is, at a given longitudinal position along the feeder belt16at which a staple18in one row26is attached to the feeder belt16, the other row26does not have a staple18attached to the feeder belt16. This staggering of the staples18promotes hemostasis in tissue treated with the end effector4. Alternately, staples18in each row26may be aligned with one another, such that at a given longitudinal position along the feeder belt16at which a staple18in one row26is connected to the feeder belt16, each other row26has a staple18connected to the feeder belt16as well.

The staples18in each row26may be substantially evenly spaced apart from one another. That is, the distance between any two longitudinally-adjacent staples18in a row is substantially the same. Alternately, at least two longitudinally-adjacent staples18in each row26may be spaced apart a distance different from the distance between two other longitudinally-adjacent staples18. Such a configuration may be useful where the length of the staple line is not adjustable. The staple line to be created with the end effector4may be fixed at a particular number of staples18, and the staples18in each row may be grouped together in groups each having a length substantially the same as that fixed staple line. Each group of staples18in a row26may thus be separated from the adjacent group of staples18by a blank space on the feeder belt16, where that blank space may have any suitable length.

Each staple18may be shaped in any suitable manner; the staples18may be shaped substantially the same as one another, or may be shaped differently. As one example, each staple18is generally V-shaped, and has two legs20extending from the base of the V-shape. The base of the V-shape of the staple18may be curved, pointed or otherwise configured. One leg20of the staple18may be generally straight, and the other leg20of the staple18may be gently curved. However, the legs20may be shaped in a different manner. For example, both legs20may be curved. Further, each leg20may be shaped in the same manner. The staple18need not be symmetrical, but can be fabricated symmetrically if desired.

As another example, referring also toFIGS. 6-8, at least one staple18may be shaped as a continuous curve, as may be most clearly seen inFIG. 26. A distal end of the staple18may be connected to the feeder belt16, such as via a tab28protruding laterally from the feeder belt16, such as described above. However, as used in this document, the term “tab” encompasses any frangible connection between the staple18and the feeder belt16. Further, as used in this document, the terms “frangible” and “frangibly” have their ordinary meaning, which is “breakable.” The staple18may extend proximally and downward from the tab28. Then, the staple18may continue to curve downward, but also curve distally to form a bump136. This bump136may extend to the longitudinal position of the tab28, further distally than the longitudinal position of the tab28, or not as far longitudinally as the tab28. Then, the staple18may continue to curve downward, but also curve proximally. The staple18continues to curve proximally, then begins to curve upward at an inflection point138. The staple18then continues to curve upward and proximally until terminating at a free end22at its proximal end.

One leg20of the staple18has a free end22that may be characterized as a tissue penetrating tip22. The tissue penetrating tip22may be sharpened, if desired, to facilitate penetration of tissue. However, the legs20of the staple18may have a cross-section that is small enough that the tissue penetrating tip22need not be sharpened in order to easily penetrate tissue. The other leg20is attached at one end to the feeder belt16. Advantageously, that leg20is frangibly connected to the feeder belt16. Thus, one end of the staple18may be affixed to the feeder belt16and the other end of the staple18may be free. Alternately, the staple18may have three or more legs20, or may be shaped in any other suitable manner.

The feeder belt16and staples18may be fabricated in any suitable manner. As one example, a flat, thin sheet of material is laser cut into long strips, after which each strip is laser cut to form fingers therein that are then bent into the shape of the staples18. In this way, the staples18and the feeder belt16form an integral structure. However, the feeder belt16and staples18may be fabricated in any other suitable manner. As one example, the staples18and feeder belt are fabricated separately, and the staples18are then connected to the feeder belt16by welding, adhesive, or any other method that provides a frangible connection between the staples18and the feeder belt16.

A frangible connection between the feeder belt16and each corresponding staple18may be configured in any suitable manner. As one example, referring particularly toFIG. 5, each feeder belt16may include at least one tab28protruding laterally therefrom, or defined laterally in the center thereof. Alternately, at least one tab28may be oriented differently. Advantageously, the tabs28result from laser cutting and subsequent mechanical deformation of the staples18during manufacturing, such that the tabs28and staples18are integral with the corresponding feeder belt16. However, the tabs28and/or staples18may be fabricated and connected to the feeder belt16in any other suitable manner. At least one staple18may be attached to a corresponding tab28in any suitable manner. The attachment between a staple18and the corresponding tab28may be made in any suitable manner, and the connection between a staple18and the corresponding tab28may have any suitable orientation. As one example, at least one tab28is generally rectangular, and the corresponding staple18extends from the proximal edge of that rectangular tab28. The staple18may be separable from the tab28, at a location generally at the intersection between the staple18and the tab28. The connection between a staple18and the corresponding tab28is strong enough to hold the staple18securely in place relative to the feeder belt16prior to deployment, and weak enough to be broken or otherwise separated from the tab28during or after deployment. Optionally, a staple18and/or tab28may include a weakened area at or near their intersection, in order to facilitate separation between the staple18and the feeder belt16during or after deployment. The weakened area may have a reduced cross-sectional area, may be notched, or otherwise structurally weakened. Alternately, the weakened area may also, or instead, be physically treated or otherwise configured to be weaker than the surrounding material, while having substantially the same physical dimensions as that surrounding material.

As shown inFIGS. 3-5, the staples18are in an initial configuration prior to being deployed. In the initial configuration, the staples18do not substantially contact one another. Alternately, at least two of the staples18may contact one another in the initial configuration. The staples18each may lie substantially in a single plane. That is, the staple18may be shaped such that a single plane extends through and substantially bisects the staple18. Alternately, at least one staple18does not lie substantially in a single plane. At least one staple18may be positioned in a plane that is generally perpendicular to the feeder belt16. Alternately, at least one staple18may be positioned in a plane that is angled differently relative to the feeder belt16. One or more rows26of staples18are connected to the feeder belt16. Each row26of staples18is the group of staples18positioned at substantially the same lateral location relative to the longitudinal centerline of the feeder belt16, and each row26of staples18is oriented generally longitudinally. The feeder belt16may form a continuous loop, or may have a discrete beginning and end that are not attached to one another. Alternately, more or fewer rows26of staples18may be attached to the feeder belt16. Each row26may extend along part, or all, or the length of the feeder belt16. Different rows26may extend different lengths along the feeder belt16.

Staples18in two or more different rows26along a single feeder belt16may be arranged in any suitable manner relative to one another. As one example, staples18in two or more different rows26along a single feeder belt16may be staggered relative to one another. That is, at a given longitudinal position along a single feeder belt16at which a staple18in one row26is attached to the feeder belt16, at least one other row26does not have a staple18attached to that feeder belt16. This staggering of the staples18promotes hemostasis in tissue treated with the end effector4. Alternately, staples18in two or more of the rows26along a single feeder belt16may be aligned with one another, along at least part of the length of the rows26, such that at a given longitudinal position along the feeder belt16at which a staple18in one row26is attached to the feeder belt16, each other row26has a staple18attached to the feeder belt16as well. Alternately, staples18in two or more rows26along a single feeder belt16may be arranged differently along different longitudinal portions of that feeder belt16. Staples18may be arranged relative to one another in the same manner, or differently, on different feeder belts16of the endocutter2.

The staples18in each row26may be substantially evenly spaced apart from one another. That is, the distance between any two longitudinally-adjacent staples18in a row may be substantially the same. Alternately, at least two longitudinally-adjacent staples18in each row26may be spaced apart a distance different from the distance between two other longitudinally-adjacent staples18. Such a configuration may be useful where the length of the staple line is not adjustable. The staple line to be created with the end effector4may be fixed at a particular number of staples18, and consequently the staples18in each row may be grouped together in groups each having a length substantially the same as that fixed staple line. If so, each group of staples18in a row26may be separated from a adjacent group of staples18by a blank space on the feeder belt16, where that blank space may have any suitable length. Advantageously, no staples18extend from, or into an area bounded by, the blank space of the feeder belt16.

Referring also toFIG. 9, the end effector4may include a staple holder30and an anvil32. The anvil32may be movable about a pin34of other structure relative to the staple holder30to clamp and/or compress tissue therebetween in any suitable manner. The anvil32may include standard staple bending features defined therein to facilitate closure of the staples18. Alternately, staple bending features may be omitted from the anvil32. The anvil32may be pivotable relative to the staple holder30. In this way, the distal end of the anvil32may be spaced apart from and positioned above the staple holder30in a first, initial position prior to clamping tissue, while the proximal end of the anvil32may be connected to the staple holder30. Clamping of tissue by between the staple holder30and the anvil32may be performed in any suitable manner, and example of which is set forth in U.S. patent application Ser. No. 12/612,614, filed on Nov. 4, 2009, which is herein incorporated by reference in its entirety. Alternately, the anvil32may be connected to and/or movable relative to the staple holder in a different manner. Alternately, the staple holder30may be movable relative to the anvil32. Alternately, the staple holder30and the anvil32may be movable relative to one another. The distal end of the staple holder30and the distal end of the anvil32may be blunt, in order to prevent inadvertent engagement of tissue with the end effector4during insertion of the end effector4into the patient and motion of the end effector4to a treatment site. Advantageously, the staple holder30is fixed to a remainder of the end effector4and/or the shaft6, and is not detachable therefrom. As set forth in greater detail below, the staple holder30may be fired multiple times without being withdrawn from the patient, such that there is no need to withdraw the end effector4from the patient after each firing of staples18in order to replace a staple cartridge or other component. Nevertheless, if desired the staple holder30may be detachable from a remainder of the end effector4and/or the shaft6; the end effector4may be detachable from the shaft6; and/or the shaft6may be detachable from the handle8.

The staple holder30may include any suitable components. Referring also toFIG. 10, the staple holder30may include a feeder belt guide40. The feeder belt guide40may be configured in any suitable manner. The feeder belt guide40may be located in proximity to the distal end of the staple holder30. The feeder belt guide40may include one or more reversal wheels42that rotate about a reversal axle44. Optionally, one or more reversal wheels42may include teeth46that engage corresponding apertures51in a feeder belt16, as described in greater detail below. The reversal axle44may be held in place via fixation to a lateral part of the staple holder30, which is omitted fromFIG. 7for clarity. The bottom inner surface49of the staple holder30may include one or more generally-longitudinal channels48defined therein. A step50may be defined on the lateral side of one or more channels48, and may extend along some or all of the length of each channel50. Each step50may be located slightly above and generally parallel to the lower surface of the corresponding channel48. As another example of feeder belt guide40, a feeder belt guide may be used as described in commonly-assigned U.S. Pat. App. Publication No. 2009/0065552 of Knodel et. al., published on Mar. 12, 2009, (the “Endocutter Document”), which is herein incorporated by reference in its entirety.

As used in this document, the term “upper” and similar terms of orientation mean a direction that is both perpendicular to the longitudinal centerline of the staple holder30and oriented toward the anvil32. The term “lower” and similar terms of orientation refer to the direction opposite to the “upper” direction defined immediately above. The terms “distal” and “proximal” are used in the same manner as is standard to those of ordinary skill in the art, and refer to opposite directions along the longitudinal centerline of the staple holder30, as illustrated inFIG. 10. The distal direction is oriented toward the free end of the staple holder30, and the proximal direction is opposite to the distal direction.

Referring also toFIG. 11, the end effector4may include one or more feeder belts16. In this way, staples18can be deployed on either side of an incision or transection to be made in tissue. Alternately, the end effector4may include only one feeder belt16, or three or more feeder belts16. The feeder belts16may be independent of one another, or connected to one another in any suitable manner. A feeder belt16may be routed around each reversal wheel42. If provided, teeth46in one or more reversal wheels42may engage apertures50in a corresponding feeder belt or belts16. Each feeder belt16may be routed along a path that starts generally straight and in the distal direction, then is curved along the surface of the corresponding reversal wheel42, and then is generally straight and in the proximal direction. That is, the reversal wheel42changes the direction of motion of the corresponding feeder belt16from generally distal to generally proximal.

The feeder belts16need not each contain the same number of staples18. Referring toFIG. 12, a plurality of apertures62may be defined through the upper surface60of the staple holder30, where the apertures62allow for deployment of staples18through the upper surface60. The apertures62may be arranged into one or more longitudinally-oriented rows. As seen inFIG. 9, six longitudinally-oriented rows of apertures62may be provided. A knife slot64may be defined through the upper surface60of the staple holder30as well to allow for passage of a knife, as described in greater detail below. The rows of apertures62may be arranged symmetrically about the knife slot64as seen inFIG. 9, where three rows of apertures62are provided on each side of the knife slot64. However, the apertures62may be arranged asymmetrically or otherwise arranged about the knife slot64. Where three rows of apertures62are present on each side of the knife slot64, two feeder belts16may be utilized, as seen inFIG. 11. If so, staples18may extend at an angle from each of two lateral edges of one feeder belt16a, and staples18may extend at an angle from only one lateral edge of an adjacent feeder belt16b. As another example, two identical feeder belts16may be provided, each of which includes staples18that extend at an angle from each of two lateral edges of the feeder belt16, but staples18are only deployed from both lateral edges of one feeder belt16; staples18are only deployed from one edge of the other feeder belt16. An advantage of doing so is simplicity of manufacture, in that the manufacturer only need stock and track one type of feeder belt16, rather than two separate feeder belts16each having a different number of staples18.

Referring toFIGS. 13-14, a wedge base70forms part of an active wedge, as described in greater detail below. The wedge base70includes one or more bulkheads72. Referring also toFIG. 22, each bulkhead72is sized to fit underneath a corresponding feeder belt16. Each bulkhead72has a width generally similar to the width of the corresponding feeder belt16. In this way, each bulkhead72has a width that allows the bulkhead72to slide longitudinally along a corresponding feeder belt16between the staples18affixed to the feeder belt16. Referring back toFIGS. 13-14, as one example, the bulkheads72may be arranged into two groups of two, where each group is laterally spaced from the other a distance greater than the distance between the bulkheads72in a single group. Each bulkhead72may have an upper surface74. The upper surface74may contact, or be spaced apart vertically from, the corresponding feeder belt16. Each bulkhead72may have a lower surface76. The lower surface76may be generally parallel to the upper surface74. Alternately, the lower surface76may be shaped and/or oriented in a different manner. Each bulkhead72may have a front surface78, which may take any suitable shape. As one example, the front surface78may be angled upward in the proximal direction. Similarly, each bulkhead72may have a rear surface80, which may take any suitable shape. As one example, the rear surface80may be angled downward in the proximal direction.

A channel82may be defined in each lateral side of each bulkhead72. The channels82allow for motion of a wedge grate relative to the wedge base70, as described in greater detail below. The channel82may have any suitable shape. As one example, the distal end84of the channel82is also the lowest end of the channel82. The channel82may include a central segment86that is angled upward in the proximal direction from the distal end84. The distal end84may extend a short distance distal to the distal end of the central segment86, and that distal end84may extend generally longitudinally. In this way, the central segment86is angled relative to the distal end84. At the upper, proximal end of the central segment86, a detent88may be positioned. That is, the channel82defines a detent at its most proximal location. The detent88may extend a short distance proximal to the proximal end of the central segment86, generally longitudinally. Above the detent88, the upper end of the channel82may include an insertion aperture89.

The wedge base70may include a boss90. The boss90may be located at or near the proximal end of the wedge base70, generally along the longitudinal centerline thereof. Alternately, the boss90may be located at any suitable position on the wedge base70. The boss90may be positioned proximal to the bulkheads72, or may be positioned differently relative to the bulkheads72. Optionally, the wedge base70may include a knife mount92. The knife mount92to be located at or near the distal end of the wedge base70, generally along the longitudinal centerline thereof. Alternately the knife mount92may be located at any suitable position on the wedge base70. The knife mount92be positioned distal to the bulkheads72, or may be positioned differently relative to the bulkheads72. The wedge base70may include one or more return arms94. Each return arm94may be oriented generally longitudinally, and may be cantilevered proximally from a part of the lower surface76of the wedge base70. In this way, the proximal end of the return arm is movable vertically at its proximal end. At the proximal end of the return arm94, a tooth96extends downward. The proximal face of the tooth96may be a substantially vertical plane98, and the distal face of the tooth96may be a substantially planar surface99angled downward in the proximal direction.

Referring also toFIG. 15, an actuation band100is connected to the boss90. Advantageously, the actuation band100is fixed to the boss90in any suitable manner. Alternately the actuation band100may be removable from the boss90. The actuation band100may have any suitable shape, and may be fabricated from any suitable material, such as but not limited to stainless steel. As one example, the actuation band100may be generally rectangular in cross-section, where the lateral width of the actuation band100spans a lesser distance than the vertical height of the actuation band100. In this way, the actuation band100may have some lateral flexibility to allow it to pass through an articulation in the shaft6, while still providing vertical stiffness. The actuation band100is axially stiff enough for it to both push the wedge base70distally and pull the wedge base70proximally. The actuation band100may extend from the wedge base70through the entirety of the shaft6into the handle8.

Referring also toFIGS. 16-17, at least one wedge grate110is movably connected to the wedge base70. Each wedge grate110includes at least one wedge plate112. The wedge plates112may be substantially planar, and substantially parallel to one another within the same wedge grate110. A cross pin114may connect the distal ends of the different wedge plates112of the wedge grate110. The cross pin114may be generally cylindrical. The cross pin114may have any other suitable shape; for example, a rectangular or triangular solid. As described in greater detail below, at least one wedge plate112sequentially contacts staples18along a longitudinal row along a feeder belt16, first deforming a staple18and then breaking that staple18from the feeder belt16. Each wedge plate112may have any suitable shape. As one example, referring toFIG. 16, a wedge plate112may include an encounter surface116, a deformation surface118, and a separation surface120. The encounter surface116may be substantially vertical. Proximal to the encounter surface116, the deformation surface118may extend upward in the proximal direction, where the deformation surface118is substantially a straight line. The surfaces116,118may be immediately adjacent to one another, or maybe longitudinally separated any suitable distance. Proximal to the deformation surface118, the separation surface120may extend further upward in the proximal direction. The surfaces118,120may be immediately adjacent to one another, or maybe longitudinally separated any suitable distance. As another example, referring toFIG. 18, the encounter surface116may extend vertically a shorter length than the encounter surface116ofFIG. 16. The deformation surface118may be smoothly curved, and may be a convex surface. As another example, each wedge plate112may have any other suitable shape. The wedge plates112in a single wedge grate110may all have substantially the same shape. Alternately, at least one wedge plate112within a wedge grate110they be shaped differently than at least one other wedge plate112.

Each wedge plate112has at least one pin122extending therefrom. Each pin122is received in a corresponding channel82in the wedge base70. During assembly, the pins122may be inserted into the corresponding insertion apertures89of the channels82. Advantageously, each bulkhead72of the wedge base70includes channels82on both lateral sides thereof. Wedge plates112may be positioned lateral to each lateral side of each bulkhead72. The term “active wedge” is defined to mean the combination of the wedge base70with at least one wedge grate110movably connected thereto. Referring toFIG. 15, where two groups of two bulkheads72are utilized, two wedge grates110may be utilized, where each wedge grate110is associated with a corresponding group of two bulkheads72. One wedge plate112may be positioned laterally inward from the innermost lateral side of the innermost bulkhead72; another wedge plate112may be positioned between the bulkheads72in the same group, and the third wedge plate112may be positioned laterally outward from the outermost lateral side of the outermost bulkhead72.

Referring toFIG. 18, a knife124may be connected to the knife mount92of the wedge base70, or to any other suitable portion of the wedge base70. The knife124may have a sharp edge126that is substantially vertical and that is at the distal edge of the knife124. Alternately, the sharp edge126may be shaped and/or oriented differently. Optionally, an I-beam head128may be positioned at the top of the knife124, or at any other suitable location on the knife124. The I-beam head128may be received in a corresponding cavity within the anvil32, and may slide along that cavity to facilitate clamping.

A proximal wedge catch130may be fastened to the bottom inner surface49of the staple holder30. The proximal wedge catch130may be a wire or wire spring that slopes upward in the proximal direction to a peak132, then slopes downward to a proximal end that is lower than the peak132. The proximal wedge catch130may be generally U-shaped, or may define a closed perimeter. The distal end of the proximal wedge catch130may be held in a notch133in the bottom inner surface49of the staple holder30. Referring also toFIG. 24, distal to the proximal wedge catch130, in proximity to the distal end of the staple holder30, a distal wedge catch134may be fastened to the bottom inner surface49of the staple holder30. The distal wedge catch may be a wire or wire spring that slopes upward in the distal direction to a peak136, then slopes downward to a distal end138that is lower than the peak136. The distal wedge catch134may be generally U-shaped, or may define a closed perimeter. The proximal end of the distal wedge catch134may be held in a notch139in the bottom inner surface49of the staple holder30.

Operation

Referring toFIG. 2, at least one trocar port10may be inserted into an opening in tissue12of a patient14. Where a trocar port10includes a cutting tool (not shown) such as a spike, that cutting tool makes an opening in tissue12, after which the trocar port12is placed in tissue. The cutting tool may be removed from the trocar port10after the trocar port10is in position in tissue12. Alternately, an opening in tissue12may be made first with a separate tool, and the trocar port10is then placed in that opening. Multiple trocar ports10, having the same or different cross-sectional shapes and/or areas, may be placed in the patient14. The tissue12may be the chest wall of the patient14, thereby providing access to the thoracic cavity. However, the tissue12may be the abdominal wall or any other suitable tissue in the patient14. Alternately, the trocar port or ports10are not used, and access to the surgical site is gained in another manner, such as described above.

Referring also toFIGS. 1 and 9, the user of the endocutter2, a medical professional such as a surgeon, then receives the endocutter2. “Receiving” the endocutter2means that the user takes the endocutter2in hand, either directly from out of its package, or indirectly via a nurse, medical technician or other person. The end effector4of the endocutter2may be introduced into the patient14through one of the trocar ports10. Referring toFIG. 9, the end effector4may be inserted into the patient14in a closed configuration. At least part of the shaft6of the endocutter2may follow the end effector4into the patient14. Alternately, the trocar port or ports10are not used, and the endocutter2is used during a conventional open surgical procedure or is introduced into the patient14directly through an incision in tissue12. The end effector4is positioned by the user at a surgical site. As one example, referring also toFIG. 26, a surgical site is located on a blood vessel148which is to be transected. For clarity, this document describes the operation of the endocutter2for transection of a blood vessel148. However, the use of the endocutter2is not limited to blood vessel transection; the endocutter2may be used to perform any other suitable procedure at any other surgical site in the body. For example, the endocutter2may be used to transect a bile duct, to remove a diseased appendix, to transect gastrointestinal tissue, to remove a diseased lobe of a lung or liver, and/or to transect soft tissue or organs.

As set forth in the Endocutter Document, at least the distal end of the anvil32is initially spaced apart from the staple holder30, such that the end effector4is open. The end effector4is advanced over the blood vessel148to be transected, until the entire diameter of the blood vessel148is located between the anvil32and the staple holder30. Advantageously, the blood vessel148is substantially at a right angle to the anvil32and the staple holder30. However, the blood vessel148may be oriented at any other suitable angle relative to the anvil32and the staple holder30. The end effector4is then closed, by moving the anvil32closer to the staple holder30, such that the blood vessel148is compressed between the anvil32and the staple holder30. Such closure of the end effector4may be accomplished as set forth in the Endocutter Document. Closure of the end effector4may be performed by actuating one or more controls on the handle8of the endocutter2, and/or by releasing energy stored in the handle8. After the end effector4has been closed, the tissue to be treated is held securely by, and affirmatively controlled by, the end effector4.

Referring toFIGS. 18 and 20, the active wedge71is in an initial position, in a first configuration. The initial position of the active wedge71in the staple holder30is proximal to the apertures62therein, and proximal to the staples18to be deployed. In the first position, the knife124may extend through the knife slot64, such that part of the sharp edge126is located above the knife slot64and part of the sharp edge126is located below the knife slot64; advantageously the sharp edge126is located proximal to tissue148and does not contact tissue148in the first position. The “first configuration” refers to a position of each wedge grate110relative to the wedge base70. The first configuration also may be referred to as the “wedge down” configuration. In the first configuration, the entirety of the wedge grate110is positioned below the upper surface74of the wedge base70. Also in the first configuration, the cross pin114of each wedge grate110is positioned proximal to the peak132of the proximal wedge catch130. Further, the cross pin114of each wedge grate110may be positioned at the proximal end of a corresponding channel48defined in the bottom inner surface49of the staple holder30. Advantageously, referring also toFIG. 10, at least one cross pin114rests on at least one step50defined in a channel48. In this way, the cross pin114may be vertically spaced above the bottom inner surface49of the staple holder30. Alternately, at least one cross pin114may slide along the bottom of a corresponding channel48. Advantageously, when the active wedge71is in the first position and the first configuration, the cross pin114is held between the peak132of the proximal wedge catch130and a proximal wall140of the corresponding channel48, where the proximal wall140extends inward from the outermost portion of the laterally-outermost step50and thereby prevents proximal motion of the cross pin114beyond that proximal wall140. Referring also toFIGS. 13 and 17, in the first configuration, each pin122extending from a corresponding wedge plate112may be positioned at the distal end84of the corresponding channel82defined in a bulkhead72of the wedge base70. Further, referring also toFIG. 22, an upper channel surface142is spaced vertically from the bottom inner surface49of the staple holder30, and prevents the cross pin114from moving substantially upward. That is, aside from a small amount of play to allow the cross pin114to slide longitudinally, the cross pin114is vertically constrained between the upper channel surface142and the step50.

The user then actuates one or more controls on the handle8to actuate the end effector4. As a result, the actuation band100is moved distally, by any suitable mechanism or method. As one example, the proximal end of the actuation band100may extend near to or into the handle8, and a mechanism within the handle8urges the actuation band100distally. The mechanism may be actuated by a release of energy stored within the handle8. A mechanism for moving a actuation band100linearly is standard; any suitable mechanism or mechanisms may be utilized. Distal motion of the actuation band100in turn urges the active wedge71distally, due to the attachment between the actuation band100and the boss90.

As the active wedge71is urged distally, each cross pin114of a wedge grate110is urged distally as well. However, each peak132of the proximal wedge catch130resists the distal motion of the corresponding cross pin114, because each peak132is distal to and in the path of the cross pin114, which in turn is constrained to move substantially longitudinally and not vertically. Consequently, each cross pin114does not immediately ride up over the corresponding peak132, but rather is pushed longitudinally against the proximal wedge catch130, which acts against the distal force applied to the active wedge71. As a result, each cross pin114is held in place while the wedge base70advances distally. This relative motion between the cross pin114and the wedge base70urges each pin122extending from a corresponding wedge plate112out of the distal end of the corresponding channel82in the wedge base70, referring also toFIG. 13. Each pin122then slides up the central segment86of the channel82, until that pin122is caught by and stops in the detent88in the channel82. As a result of this motion of the pins122, the wedge plate112and thus the wedge grate110as a whole moves upward relative to the wedge base70to the second configuration.

Referring toFIGS. 21-22, the “second configuration” means that at least part of at least one wedge plate112is positioned above the upper surface74of the wedge base70. The second configuration may be referred to as the “wedge up” configuration as well. Advantageously, in the second configuration, at least part of the separation surface120of each wedge plate112is positioned above the upper surface74of the wedge base70. The wedge base70is still substantially positioned at the initial position, and each cross pin114is still located between the corresponding peak132of the proximal wedge catch130and the proximal wall140of the corresponding channel48. The actuation band100continues to apply a force in the distal direction to the active wedge71. Because the wedge grate110can no longer move relative to the wedge base70, that distal force applied to the active wedge71causes each crossbar114to push the proximal end of the proximal wedge catch130downward. This may be facilitated by a distally-sloped upward bend or angle in the proximal wedge catch130proximal to each peak. That is, the force applied to the proximal wedge catch130by the active wedge71grows large enough to push the proximal wedge catch130out of the path of motion of the wedge grate110.

At that time, the active wedge71is free to move distally, sliding longitudinally along the channels48defined in the bottom inner surface49of the staple holder30. Distal motion of the active wedge71causes deployment of the staples18. For clarity, motion of a single wedge plate112to deploy one or more staples18in a corresponding row26is described.

Referring also toFIGS. 3-5and6-8, the active wedge71is initially proximal to the staples18in the corresponding generally-linear row26, and the path of motion of each wedge plate112may be generally parallel to or collinear with the corresponding row26. Referring also toFIGS. 16-17, as the wedge plate112moves distally, the encounter surface116of the wedge plate112contacts the most-proximal staple18in the corresponding row. Contact between the encounter surface116and the staple18applies force to the staple18. Because the encounter surface116is substantially vertical, that force applied to the staple18is exerted in substantially a distal, longitudinal direction substantially normal to the encounter surface116. This force is applied to the leg20or portion of the smooth curve of the staple18that is located closer to the tab28than to the free end22. As a result, the distal force applied to the staple18results in a moment about the tab28or other frangible connection that connects the staple18to the feeder belt16. The moment acts on the staple18to rotate the staple18about the tab28, such that the free end22of the staple18moves upward, out of the corresponding aperture62in the upper surface60of the staple holder30and into the blood vessel148or other tissue clamped between the anvil32and the staple holder30. During motion of the active wedge71, the feeder belt16may be held substantially in place.

The active wedge71continues to slide distally, such that the encounter surface116of the wedge plate112exerts a force on the staple18that causes a moment about the tab28. As the staple18rotates about the tab28, and the wedge plate112continues to move distally, the lowest point of the staple18moves upward. When the lowest point of the staple18moves above the encounter surface116, the deformation surface118begins to contact the staple18. The deformation surface118is angled and/or curved upward in the proximal direction such that contact between that deformation surface118and the staple18continues to cause a moment about the tab28such that the staple18continues to rotate upward about the tab28. As the free end22of the staple18rotates upward, it penetrates completely through the blood vessel148and then contacts the lower surface of the anvil32. Optionally, a standard staple bending feature may be defined in the anvil32at the location where the free end22of the staple18contacts the anvil32. As the free end22of the staple18contacts the anvil32, the rotation of the staple18about the tab28results in motion of the free end2both upward and distally. However, contact between the free end22of the staple18and the anvil32prevents further upward motion of the free end22of the staple18. As a result, the free end22of the staple18moves distally along the lower surface of the anvil32and/or staple bending feature defined thereon. This motion may bend or deform the leg20of the staple18associated with the free end22, closing the staple18to form a D-shape or other suitable shape. The staple18may be fabricated from a plastically-deformable material such as stainless steel, such that deformation of the staple18may be plastic deformation. Alternately, at least part of at least one staple18may be elastically deformable or superelastically deformable.

As the active wedge71continues to move distally, the separation surface120of the wedge plate112slides distally toward the tab28. As seen inFIG. 22, the top of the separation surface120extends above the upper surface74of the wedge base70, and may extend above the upper surface of the feeder belt16. As the separation surface120contacts the tab28during the longitudinal travel of the active wedge71, it applies a force to the tab28. As a result of the rotation of the staple18at its point of connection to the feeder belt16, that connection may have experienced work hardening and become more brittle. As the separation surface120of the wedge plate112contacts and applies force to the tab28, the that force applied by the separation surface120breaks or shears the staple18from the feeder belt16at the tab28. Where the staple18and/or tab28include a weakened area at or near their intersection, the staple18may shear, break or otherwise separate from the feeder belt16at that weakened area. The separation surface120may be shaped to also actively push, urge or otherwise eject the staple18completely out of the staple holder30. Alternately, the staple18is passively ejected from the staple holder30, meaning that the staple18is not affirmatively urged out of the staple holder30; rather, it is simply released from the staple holder30and allowed to exit therefrom. At this point, the deformed and ejected staple18is in position in the blood vessel148. The frangibility of the staples18allows the staples18to be held securely and reliably by the feeder belt16, and thus by the staple holder30, while providing for reliable separation and deployment.

After the staple18has been separated from the feeder belt16, the active wedge71continues its motion in the distal direction. As it does so, it encounters another staple18, and deforms that staple18and separates that staple18from the feeder belt16in substantially the same manner as described above. The wedge grate110may be long enough that, as the wedge grate110has deformed one staple18a substantial amount but that staple18has not yet separated from the feeder belt16, the wedge grate110engages and begins to deform the next most distal staple18. Alternately, the wedge grate110is short enough that it completely deforms one staple18, which is then ejected, before the wedge grate110engages and begins to deform the next most proximal staple18. As the active wedge71moves distally, the knife124also slides distally along the knife slot64, such that the sharp edge126of the knife124cuts the tissue held between the anvil32and staple holder30. The knife124cuts tissue as the staples18are being deformed and ejected. Optionally, where the I-beam head128is fixed to the knife124, that I-beam head128slides along a corresponding channel in the anvil32, such that clamping is reinforced at or near the location of stapling as the active wedge72slides distally.

Referring toFIG. 23, the active wedge71may continue to move distally until the cross pin114of each wedge grate110encounters the distal wall144of the corresponding channel48. Contact between each cross pin114and the corresponding distal wall144prevents further distal motion of the cross pin114, and thus prevents further distal motion of the active wedge71. Because the pins122of the wedge plates112are already in the corresponding detents88in the channels82in the wedge base70, the wedge grate110cannot move further proximally relative to the wedge base70as a result of contact between the wedge grate110and the distal wall144. This position of the active wedge71may be referred to as the second, final position, and the wedge grate110is still in the second configuration.

The endocutter2may then be reset for another firing. To do so, the actuation band100is retracted proximally such as by actuating one or more controls on the handle8. As the band100moves proximally, it exerts a force in the proximal direction on the active wedge71and the wedge grate110. When each cross pin114reaches the distal wall144, the cross pin114may have already moved distally to the distal wedge catch134, referring also toFIG. 24. The distal wedge catch134may include a portion proximal to its peak136that slopes gently upward in the distal direction, so that each cross pin114can push down the distal wedge catch134and slide over the peak136as it moves distally; after the cross pin114has moved distally to the peak136, the peak136springs back upward. Thus, in the final position of the active wedge71, each cross pin114may be held between the distal wall144and a peak136of the distal wedge catch134. As the active wedge71is urged proximally, each cross pin114of a wedge grate110is urged proximally as well. However, each peak136of the distal wedge catch134resists the proximal motion of the corresponding cross pin114, because each peak136is proximal to and in the path of the cross pin114, which in turn is constrained to move substantially longitudinally and not vertically, as set forth above. Consequently, each cross pin114does not ride up over the corresponding peak136but rather is pulled longitudinally against the distal wedge catch134, which acts against the distal force applied to the active wedge71. As a result, each cross pin114is held in place while the wedge base70moves proximally. This relative motion between the cross pin114and the wedge base70urges each pin122extending from a corresponding wedge plate112distally out of the detent88in the corresponding channel in the wedge base70, referring also toFIG. 13. Each pin then slides down the central segment86of the corresponding channel82, until that pin122is caught by and stops in the distal end84of the corresponding channel82. As a result of this motion of the pins122, the wedge plates112and thus the wedge grate110as a whole moves downward relative to the wedge base70to the first configuration, as seen inFIG. 25. In the first, wedge-down configuration, each wedge grate110is below the upper surface74of the wedge base70, such that the wedge grate110does not contact or otherwise engage the feeder belt16during motion of the wedge base70proximally.

Optionally, where the wedge base70includes one or more return arms94, the return arms94may act to advance each feeder belt16. The tooth96may be biased against the lower portion of the feeder belt16. During advancement of the active wedge71, the tooth96sequentially engages apertures51in the corresponding feeder belt16, but due to the angled distal surface99of the tooth96, the tooth96slides out of each aperture51as the angled distal surface99slides against the distal edge of each aperture51, causing the cantilevered return arm94to flex upward. In this way, the return arms94do not cause motion of the feeder belts16during deployment of staples18. However, as the wedge base70moves distally, the tooth96of each return arm94slides into an aperture51in the feeder belt16if those teeth96are not already located in apertures51. As the wedge base70moves distally, the substantially vertical planar face98at the proximal end of each tooth96encounters the proximal end of the corresponding aperture51. Because the face98is substantially vertical, and not angled to allow the tooth96to slip out, the face98engages the aperture51, pushing the feeder belt16via the proximal edge of the corresponding aperture51. Each feeder belt16is routed around a reversal wheel42, along a path that starts generally straight and in the distal direction, then is curved downward along the surface of the corresponding reversal wheel42, and then is generally straight and in the proximal direction, such that the reversal wheel42changes the direction of motion of the corresponding feeder belt16from generally distal to generally proximal. The portion of the feeder belt16located under and proximal to the reversal wheel42may be retracted proximally, thereby pulling the portion of the feeder belt16located above and proximal to the reversal wheel42in the distal direction and advancing fresh staples18into the housing60. As the bottom portion of the feeder belt16is moved proximally by the return arm94, the upper portion of the feeder belt16moves distally; this reversal of motion is caused by the wrapping of the feeder belts16about substantially half a circumference of the reversal wheels42, as seen inFIGS. 10-11. Thus, as the wedge base70slides proximally back to its initial position, the return arms94cause the feeder belt16to advance a fresh set of unfired staples18into place within the staple holder30. The motion of the feeder belt16that advances fresh staples18into position for firing may be referred to as “advancing” the feeder belt16, regardless of the fact that part of the feeder belt16may be moved in a direction other than distally during that advancing.

As the active wedge71is urged proximally by proximal motion of the actuation band100, each cross pin114of a wedge grate110is urged distally as well. However, each peak136of the distal wedge catch134resists the proximal motion of the corresponding cross pin114, because each peak136is proximal to and in the path of the cross pin114, which in turn is constrained to move substantially longitudinally and not vertically. Consequently, each cross pin114does not immediately ride up over the corresponding peak134, but rather is pulled longitudinally against the distal wedge catch134, which acts against the proximal force applied to the active wedge71. As a result, each cross pin114is held in place while the wedge base70withdraws proximally. This relative motion between the cross pin114and the wedge base70urges each pin122extending from a corresponding wedge plate112out of the detent88at the proximal end of the corresponding channel82in the wedge base70, referring also toFIG. 13. Each pin122then slides down the central segment86of the channel82, until that pin122is caught by and stops at the distal end84of the channel82. As a result of this motion of the pins122, the wedge plate112and thus the wedge grate110as a whole moves downward relative to the wedge base70to the first, wedge-down configuration.

As set forth above, in the first, wedge-down configuration, each wedge plate112is positioned substantially below the upper surface74of the wedge base70. The wedge base70is still substantially positioned at the final position, and each cross pin114is still located between the corresponding peak136of the distal wedge catch134and the distal wall144of the corresponding channel48. The actuation band100continues to apply a force in the proximal direction to the active wedge71. Because the wedge grate110can no longer move relative to the wedge base70, that proximal force applied to the active wedge71causes each crossbar114to push the distal wedge catch134downward. This may be facilitated by a distally-sloped downward bend or angle in the distal wedge catch134distal to each peak. That is, the force applied to the distal wedge catch134by the active wedge71grows large enough to push the distal wedge catch134out of the path of motion of the wedge grate110.

The active wedge71is then moved proximally until each cross pin114of the active wedge71reaches the proximal wall140of each channel48in the bottom inner surface49of the staple holder30. Before it does so, each cross pin114may slide past the proximal wedge catch130. The proximal wedge catch130may include a portion distal to its peak136that slopes gently upward in the proximal direction, so that each cross pin114can push down the proximal wedge catch130and slide over the peak132as it moves proximally; after the cross pin114has moved proximal to the peak132, the peak132springs back upward.

Next, the end effector4may be actuated again at the option of the user, substantially as described above. In this way, the end effector4may be actuated multiple times without removing the end effector4through the trocar port10or other incision, structure or mechanism that allows access to the interior of the body of the patient. Keeping the end effector4within the body of the patient without withdrawing that end effector4through the trocar port10or other incision, structure or mechanism that allows access to the interior of the body of the patient may be referred to as maintaining the end effector within the body of the patient. The endocutter2may be actuated multiple times within the patient, without being removed from the patient, until the staples18in the endocutter2are exhausted. An indicator may be provided in the handle8or at another location in the endocutter2that shows how many unfired staples18remain in the endocutter2.

Actuation of the endocutter2above has been generally described in terms of deployment and ejection of a single row26of staples18for clarity, where that deployment and ejection may be performed in substantially the same manner along each row26of staples18. Operation of the endocutter2may be substantially as described above with regard to any number of rows26of staples18on a feeder belt16, or any number of feeder belts16.

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.