Patent Description:
<CIT> forms prior art according to Art. <NUM>(<NUM>) EPC and relates to a surgical cutting and stapling instrument that has an articulable end effector and a staple cartridge. <CIT> relates to a surgical cutting and fastening instrument that comprises an end effector coupled to a robotic system. <CIT> relates to a surgical stapler that has a cartridge-adjustable clamp gap.

Minimally invasive surgical instruments are often preferred over traditional open surgical devices due to the reduced post-operative recovery time and minimal scarring associated with minimally invasive procedures. Laparoscopic surgery is one type of minimally invasive surgery (MIS) procedure in which one or more small incisions are formed in the abdomen and a trocar is inserted through the incision to form a pathway that provides access to the abdominal cavity. The trocar is used to introduce various instruments and tools into the abdominal cavity, as well as to provide insufflation to elevate the abdominal wall above the organs. Endoscopic surgery is another type of MIS procedure in which elongate flexible shafts are introduced into the body through a natural orifice.

Due to the benefits associated with minimally invasive surgeries, significant efforts have gone into developing a range of endoscopic and laparoscopic surgical instruments that are suitable for precise placement of a distal end effector at a desired surgical site. These distal end effectors engage the tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., grasper, cutter, stapler, clip applier, access device, drug/gene therapy delivery device, and energy device using ultrasound, radiofrequency, laser, etc.).

For example, staplers including end effectors for grasping tissue have been developed which secure tissue between two jaws. Staples contained in one of the jaws can be driven into the grasped tissue and deformed to hold the tissue by impinging on the other jaw. The staples can form a predetermined pattern (e.g., one or more lines of staples) based upon the configuration of the staples in the one of the jaws. The stapler can be a linear stapler, in which the predetermined pattern includes one or more longitudinal lines of staples. Though staplers can be effective to grasp and staple tissue, it can be difficult to grasp and/or staple the tissue based on a variety of factors, such as a size and/or shape of the staple, a thickness and/or toughness of the tissue, etc..

Some staplers can be refilled after firing staples. In some staplers, the staples can be contained in a cartridge which can be removable from the stapler's jaw to allow the stapler to be refilled with staples contained in another cartridge inserted into the jaw. However, this refilling of cartridges can be difficult since the cartridges can be relatively small and accordingly difficult to manipulate and/or properly secure within the jaw. Refilling a stapler with a new cartridge can thus be time consuming and/or can result in an improperly loaded cartridge that can misfire staples or otherwise function improperly during use on a patient.

Accordingly, there remains a need for improved devices for stapling tissue.

This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:.

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.

It will be appreciated that the terms "proximal" and "distal" are used herein with reference to a user, such as a clinician, gripping a handle of an instrument. Other spatial terms such as "front" and "back" similarly correspond respectively to distal and proximal. It will be further appreciated that for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these spatial terms are not intended to be limiting and absolute.

<FIG> illustrates one embodiment of a surgical device <NUM> that is configured to apply staples to tissue. The device <NUM> in this illustrated embodiment includes a linear stapler configured to apply linear rows of staples. Other embodiments of surgical devices that are configured to apply staples to tissue are described in <CIT>, <CIT>, <CIT>, and <CIT>.

Referring again to <FIG>, the device <NUM> includes a proximal handle portion <NUM> having an elongate shaft <NUM> extending distally therefrom. As also shown in <FIG> and <FIG>, the shaft <NUM> has an end effector <NUM> coupled to a distal end thereof. The end effector <NUM> is coupled to the shaft <NUM> at a pivot joint <NUM>. A proximal end of the end effector <NUM> is pivotally coupled to the joint <NUM> at a distal end of the shaft <NUM>. The end effector <NUM> in this illustrated embodiment includes a tissue grasper having a pair of opposed first and second jaws 1110a, 1110b configured to move between open and closed positions. The first jaw is also referred to herein as a "bottom jaw" and a "cartridge jaw," and the second jaw is also referred to herein as an "upper jaw" and an "anvil. " As discussed further below, the handle portion <NUM> is configured to be manipulated to effect the opening and closing of the opposed jaws 1110a, 1110b, e.g., movement of one or both the jaws 1110a, 1110b about the pivot joint <NUM>, and the handle portion <NUM> is configured to be manipulated to effect the firing of staples (not shown) from a one of the jaws 1110a, 1110b, e.g., a bottom or cartridge one of the jaws 1110a. In this embodiment, The staple firing is independent of the opening and closing of the jaws 1110a, 1110b.

The handle portion <NUM> can have a variety of sizes, shapes, and configurations. As illustrated, The handle portion <NUM> includes a main housing <NUM>, which houses a variety of elements therein and has some elements accessible outside thereof, such as a movable trigger <NUM> and a stationary handle <NUM>. The movable trigger <NUM> is configured to be manually manipulated to move the movable trigger <NUM> relative to the stationary handle <NUM> so as to, e.g., effect closing of the jaws 1110a, 1110b.

The shaft <NUM> can have a variety of sizes, shapes, and configurations. In an exemplary embodiment, the shaft <NUM> is rigid, e.g., made from a generally non-bendable material such as a metal (e.g., stainless steel, titanium, etc.) or a hard polymer. In other embodiments, the shaft <NUM> can be configured to bend, such as being made from a generally flexible material, by including one or more articulation regions, etc. The shaft <NUM> can have any longitudinal length, although in an exemplary embodiment it is long enough to allow the handle portion <NUM> to be manipulated outside a patient's body while the shaft <NUM> extends through an opening in the body with the end effector <NUM> disposed within a body cavity. In this way, the end effector <NUM> can be easily manipulated when the device <NUM> is in use during a surgical procedure. The shaft <NUM> can have any suitable diameter. For example, the shaft's diameter can be less than or equal to about <NUM>, e.g., less than or equal to about <NUM>, less than or equal to about <NUM>, etc., which allows for insertion of the shaft <NUM> through an minimally invasive access device, e.g., a trocar, a cannula, a multiport access device, etc., such as during a laparoscopic surgical procedure. The end effector <NUM> coupled to the shaft's distal end can have a diameter equal to or less than the shaft's diameter, at least when the jaws 1110a, 1110b are in the closed position, which facilitates insertion of the device's distal portion into a patient's body.

The end effector <NUM> can have a variety of sizes, shapes, and configurations. In an exemplary embodiment, the end effector <NUM> is rigid. As shown in <FIG> and <FIG>, the end effector <NUM> including the first and second jaws 1110a, 1110b is disposed at a distal end of the surgical device <NUM>. in this illustrated embodiment, when the jaws 1110a, 1110b move between the open and closed positions, the second jaw 1110b is configured to remain stationary relative to the shaft <NUM>, and the first jaw 1110a is configured to move relative to the shaft <NUM> and the second jaw 1110b by pivoting at the pivot joint <NUM>.

The end effector <NUM> is configured to releasably and replaceably seat a cartridge <NUM> therein, as shown in <FIG>. In this way, when the staples have been fired from the cartridge <NUM>, the cartridge <NUM> can be removed from the second jaw 1110b and, optionally, replaced with another cartridge having another plurality of staples disposed therein. <FIG> shows the end effector <NUM> without the cartridge <NUM> seated therein. The end effector <NUM> is configured to receive the cartridge <NUM> in the first jaw 1110a thereof, e.g., in a channel formed in the first jaw 1110a. The first jaw 1110a can be configured to seat cartridges of different sizes, thereby facilitating versatility of the device <NUM>.

The cartridge <NUM> can have a variety of sizes, shapes, and configurations, as will be appreciated by a person skilled in the art. As shown in <FIG>, <FIG>, the cartridge <NUM> includes a sled <NUM> and has a plurality of staples <NUM> disposed therein. The sled <NUM> is also illustrated in <FIG>. The cartridge <NUM> includes a plurality openings <NUM> formed in a tissue engaging surface <NUM> thereof, as shown in <FIG>, <FIG>. The staples <NUM> disposed in the cartridge <NUM> may be configured to be ejected from the cartridge <NUM> through the openings <NUM>, e.g., one staple <NUM> out of each opening <NUM> (as in this illustrated embodiment), two staples out of each opening <NUM>, etc. The openings <NUM> define staple-receiving recesses of the cartridge <NUM> in which the staples <NUM> are seated prior to being ejected from the cartridge <NUM>.

The staples <NUM> can have a variety of sizes, shapes, and configurations. In this illustrated embodiment, the staples <NUM> each have a D-shape and include a first leg that is substantially straight and a second leg that is curved. A person skilled in the art will appreciate that the first leg may not be precisely straight, e.g., due to manufacturing tolerances, but nevertheless be considered to be substantially straight. Each of the staples <NUM> is configured to be plastically deformable such that the staples <NUM> can each be configured to change shape, such as when the staple <NUM> is pressed against a tissue engaging surface (not shown) of the first jaw 1110a that faces the tissue engaging surface <NUM> of the second jaw 1110b, while remaining a single unit, e.g., without either of the first and second legs breaking. A gap of space exists between a terminal end of the first leg and a terminal end of the second leg. In other words, the "D" shape has a gap therein. The gap of space facilitates plastic deformation of the staple <NUM>.

The staples <NUM> are each frangibly attached to a carrier <NUM>, also referred to herein as a "carrier strip," disposed within the cartridge <NUM>. The staples <NUM> can be frangibly attached to the carrier <NUM> by, e.g., being stamped together with the carrier <NUM> such that the staples <NUM> and the carrier <NUM> forms a single piece. The staples <NUM> can each be configured to detach from the carrier <NUM> when fired from the cartridge <NUM>. In some embodiments, some or all of the staples <NUM> can be frangibly attached to another element, such as another element disposed within the cartridge <NUM>, an inner surface of the cartridge <NUM>, the tissue-engaging surface <NUM> of the cartridge <NUM>, etc. The carrier <NUM> can be fixedly attached to an upper surface of one or more rails <NUM> defined by the cartridge <NUM>. The carrier <NUM> is configured to remain stationary relative to the cartridge <NUM>.

As shown in <FIG>, <FIG>, the cartridge <NUM> has a longitudinal slot <NUM> formed therein. The longitudinal slot <NUM> extends along a substantially flat central portion 1118f of the tissue-engaging surface <NUM>. The slot <NUM> is configured to have a cutting element such as a knife (not shown) extend therethrough so as to cut tissue engaged by the tissue-engaging surface <NUM>, as discussed further below. The openings <NUM> can be formed in angled portions 1118a of the tissue-engaging surface <NUM> on both sides of the slot <NUM>, as shown in <FIG>, <FIG>. In some embodiments, the tissue-engaging surface <NUM> is substantially flat, e.g., not have angled portions, while in other embodiments, the tissue-engaging surface <NUM> can be angled, e.g., not have any substantially flat portions.

As shown in <FIG>, the cartridge <NUM> includes a gap-setting feature <NUM> configured to set of gap of space between the first and second jaws 1110a, 1110b when the jaws 1110a, 1110b are closed and the cartridge <NUM> is seated in the second jaw 1110b. In this way, the gap-setting feature <NUM> defines a minimum distance between the facing tissue-engaging surfaces of the first and second jaws 1110a, 1110b. The gap-setting feature <NUM> can have a variety of sizes, shapes, and configurations. in this illustrated embodiment, the gap-setting feature <NUM> includes an indentation inward toward a lateral center of the cartridge <NUM>, where a portion of a lateral edge of the cartridge <NUM> immediately proximal to the gap-setting feature <NUM> is located laterally inward relative to a portion of a lateral edge of the cartridge <NUM> located immediately distal to the gap-setting feature <NUM>.

The sled <NUM> of the cartridge <NUM> can have a variety of sizes, shapes, and configurations. The sled <NUM> is configured to translate longitudinally along the cartridge <NUM> to cause deployment of the staples <NUM> therefrom and to cause tissue engaged by the end effector <NUM> to be cut with the cutting element extending through the slot <NUM>. The staples <NUM> are arranged longitudinally in the cartridge <NUM>, as shown in <FIG>, and the sled <NUM> is configured to sequentially engage the longitudinally arranged staples <NUM> as the sled <NUM> translates longitudinally. As illustrated in <FIG>, the sled <NUM> includes a plurality of wedges <NUM> and includes a cutting element <NUM>, which in this illustrated embodiment includes a knife with a blade <NUM>. The sled <NUM> in this illustrated embodiment includes four wedges <NUM> but the sled <NUM> can include any other number of wedges <NUM> as appropriate for the arrangement of the staples <NUM> in the cartridge <NUM>. Each of the wedges <NUM> has a shape configured to cause the staples <NUM> contacted by that wedge <NUM> to move upward toward the second jaw 1110b through the openings <NUM> and deform against the second jaw 1110b. As shown in <FIG>, the cartridge <NUM> includes a plurality of longitudinal slots <NUM> formed therein, each of the slots <NUM> being configured to slidably receive one of the wedges <NUM> therein. The slots <NUM> facilitate consistent, straight movement of the wedges <NUM> through the cartridge <NUM> to help ensure proper engagement of the wedges <NUM> with the staples <NUM>.

Each of the wedges <NUM> is attached to a base <NUM> of the sled <NUM> and is in a fixed position relative thereto. The base <NUM> has a guide element <NUM> extending generally downward therefrom. The guide element <NUM> is configured to slide within a channel formed in the cartridge <NUM> that includes the sled <NUM>. The cutting element <NUM> can also be attached to the base <NUM>, but the cutting element <NUM> can instead be configured to move relative to the base <NUM>. The cutting element <NUM> can be substantially laterally centered in the base <NUM>, which facilitates substantially central positioning of the cutting element <NUM> relative to tissue engaged by the end effector <NUM>.

The cutting element <NUM> is movable relative to the remainder of the sled <NUM> between a first position, shown in <FIG>, and a second position, shown in <FIG> and <FIG>. The first position is an initial position of the cutting element <NUM>. In the first position, also referred to herein as a "stowed position," the blade <NUM> is generally obscured, e.g., oriented generally downward as shown in the embodiment of <FIG>, <FIG>, <FIG>, and <FIG>, which helps prevent the blade <NUM> from inadvertent cutting, such as accidentally cutting a user of the device <NUM> during seating of the cartridge <NUM> within the end effector <NUM> and/or premature cutting of tissue engaged by the end effector <NUM>. The base <NUM> has a cavity <NUM> formed therein, as shown in <FIG>, which is configured to seat the cutting element <NUM> at least partially therein when the cutting element <NUM> is in the first position. In the second position, also referred to herein as an "upright position," the blade <NUM> is generally unobscured and facing distally as shown in the embodiment of <FIG> and <FIG>, which allows the blade <NUM> to extend through the slot <NUM> and cut tissue engaged by the end effector <NUM>.

The sled <NUM> includes a pivot member <NUM> configured to facilitate movement of the cutting element <NUM> relative to the remainder of the sled <NUM>. The pivot member <NUM> can have a variety of sizes, shapes, and configurations. The pivot member <NUM> is attached to the cutting element <NUM> such that engagement of the pivot member <NUM> causes the cutting element <NUM> to pivot about a pivot point so as to move relative to the remainder of the sled. As in this illustrated embodiment the pivot member <NUM> includes two separate pins extending laterally from opposite sides of the cutting element <NUM>. In other embodiments, the pivot member <NUM> can include a single pin extending through the cutting element <NUM> to extend laterally from opposite sides therefrom, a single pin extending laterally from one side of the cutting element <NUM>, etc. At the pivot point, the sled <NUM> includes a pivot axle <NUM> extending laterally from the cutting element <NUM>, and includes an axle cavity <NUM> formed in the base <NUM> and configured to receive the pivot axle <NUM> therein.

The surgical devices described herein can be used in a variety of surgical procedures. In an exemplary embodiment, the procedure can be a minimally invasive procedure in which the surgical device is advanced into a body of a patient through a relatively small opening in the patient. In a minimally invasive surgical procedure, one or more introducer devices (not shown), e.g., a cannula, a trocar, etc., may be advanced through an opening in the patient to provide access to a surgical site. A person skilled in the art will appreciate that one or more viewing devices, e.g., a scoping device such as an endoscope, can be advanced into the body through the incision or through another opening, e.g., another incision or a natural orifice, to provide visualization of the surgical site from outside the body. As will be appreciated by a person skilled in the art, the surgical device can be advanced into the patient's body in a variety of ways, such as by being inserted transorally therein, inserted through an introducer device, inserted through a scoping device, inserted directly through an incision, etc. Although the following embodiment of use of a surgical device in a surgical procedure is described with respect to the device <NUM> of <FIG>, any of the surgical devices described herein can be similarly used.

The surgical devices described herein can have any one or more variations to facilitate effective use of the device. Examples of such variations are described further below.

In some embodiments, a surgical device such as the above-mentioned surgical device <NUM> configured to have an adjustable gap of space between a cartridge jaw and an anvil of the device's end effector when the end effector is in a closed position. In general, the end effector, e.g., the cartridge jaw, is configured to removably couple to a cartridge, as discussed herein. The cartridge is configured to define the gap of space between the cartridge jaw and the anvil when the end effector is in a closed position. In other words, the gap of space can be a function of the cartridge. The gap of space can be a minimum distance between facing tissue-engaging surfaces of the cartridge jaw and the anvil. The end effector is thus configured to selectively accommodate tissues of different thicknesses since the end effector's tissue gap can be different based upon the specific cartridge loaded therein. In an exemplary embodiment, the cartridge includes an anvil coupling member configured to define the gap of space so as to provide a minimum distance between the facing tissue-engaging surfaces of the cartridge jaw and the anvil when the end effector is in the closed position. The anvil coupling member can form a partial portion of an I-beam configured to translate longitudinally along the end effector, as discussed herein. The anvil coupling member forming a partial portion of the I-beam allows the I-beam to be appropriately sized for the tissue gap defined by the anvil coupling member such that the I-beam can properly translate along the cartridge, e.g., via a foot of the I-beam, and along the anvil, e.g., via a guide pin of the I-beam. The anvil coupling member forming a partial portion of the I-beam results in the I-beam being different in the surgical device as a function of the cartridge seated in the end effector. The I-beam is thus configured to be adjustable so as to correspond to the adjustable gap of space between the end effector's jaws.

A surgical device may be configured to have an adjustable gap of space between a cartridge jaw and an anvil of the device's end effector when the end effector is in a closed position in a variety of ways. In the embodiments described below, staples are used as examples of fasteners, but as will be appreciated by a person skilled in the art, other types of fasteners can be similarly configured and used.

In some embodiments, an anvil coupling member is in the form of a partial portion of an I-beam. As discussed herein, an I-beam is configured to translate longitudinally along an end effector to fire fasteners from a cartridge seated in the end effector. The I-beam is configured to contact the end effector's bottom jaw with a first portion thereof, e.g., with a foot thereof, and the end effector's anvil with a second portion, e.g., with a guide pin thereof. The anvil coupling member includes the second portion of the I-beam configured to contact the anvil such that the cartridge being loaded into the bottom jaw of the end effector defines a gap of space between the cartridge's tissue-engaging surface and the anvil's tissue-engaging surface.

<FIG> illustrate one embodiment of a cartridge <NUM> that includes an anvil coupling member <NUM> coupled thereto. The anvil coupling member <NUM> is configured to move relative to a housing <NUM> of the cartridge <NUM> that has fasteners (not shown) disposed therein, as discussed further below. In general, the cartridge <NUM> is configured to be removably coupled to an end effector <NUM> coupled to a distal end of an elongate shaft <NUM>, such as by being releasably and replaceably seated in a channel <NUM> formed in a bottom jaw <NUM> of the end effector <NUM>. The cartridge <NUM> can also be configured to be releasably and replaceably seated in a slot <NUM> formed in an anvil <NUM> of the end effector <NUM>, such as by coupling the anvil coupling member <NUM> thereto. The anvil coupling member <NUM> is configured to slidably move within the slot <NUM> as part of an I-beam <NUM>, shown in <FIG>.

The anvil coupling member <NUM> can have a variety of sizes, shapes, and configurations. in this illustrated embodiment, the anvil coupling member <NUM> includes a protrusion extending upwardly from the cartridge <NUM> so as to extend above a tissue-engaging surface 8000a of the cartridge <NUM>. This protrusion includes a guide pin <NUM> extending laterally from the protrusion and being configured to slidably move with the anvil's slot <NUM>.

In this illustrated embodiment, the anvil coupling member <NUM> includes a proximal portion of the I-beam <NUM>. The anvil coupling member <NUM> includes a first coupling element <NUM>' configured to removably couple to a second coupling element <NUM>' of the remainder of the I-beam <NUM>, e.g., a distal portion of the I-beam <NUM>. The distal portion of the I-beam <NUM> in this illustrated embodiment includes the foot <NUM> of the I-beam <NUM>, but in other embodiments, the anvil coupling member <NUM> includes the foot <NUM>. in this illustrated embodiment, the first coupling element <NUM>' includes at least one depression formed in a proximal side of the anvil coupling member <NUM>, and the second coupling element <NUM>' includes at least one protrusion formed in a distal side of the remainder of the I-beam <NUM>. In other embodiments, the first coupling element includes at least one protrusion, and the second coupling element includes at least one depression. When the cartridge <NUM> is fully seated in the cartridge jaw <NUM>, as shown in <FIG>, the first and second coupling elements are coupled together so as to allow the I-beam <NUM> including the anvil coupling member <NUM> and the remainder of the I-beam <NUM> to move as a single unit through the end effector <NUM>.

The anvil coupling member <NUM> is configured to define a distance <NUM> between the tissue-engaging surface 8004a of the cartridge <NUM> and a tissue-engaging surface 8002a of the anvil <NUM>. As shown in <FIG>, a height of the anvil coupling member <NUM>, defines a distance that the anvil coupling member <NUM> extends above the cartridge's tissue engaging surface 8004a and defines how far away the anvil <NUM> is from the bottom jaw <NUM> when the end effector <NUM> is in the closed position based on a location of the guide pin <NUM> on the anvil coupling member <NUM>. The anvil coupling member <NUM> is thus configured to help ensure that the guide pin <NUM> can slide within the slot <NUM> when the end effector <NUM> is in the closed position, thereby allowing for firing of the fasteners.

As shown in <FIG>, the cartridge <NUM> is configured to be advanced into the channel <NUM> of the bottom jaw <NUM> simultaneously with the guide pin <NUM> being advanced in a proximal direction into the slot <NUM> of the anvil <NUM>. The guide pin <NUM> is thus properly seated within the slot <NUM> when the cartridge <NUM> is fully seated in the bottom jaw <NUM>.

<FIG> illustrates an alternate embodiment of an anvil coupling member <NUM> that is configured and used similarly to the anvil coupling member <NUM> of <FIG>. The anvil coupling member <NUM> in this illustrated embodiment includes the foot <NUM> of the I-beam <NUM> of which the anvil coupling member <NUM> can form a proximal portion.

In this illustrated embodiment, the I-beam <NUM> is configured to be automatically released from the anvil <NUM> such that the I-beam <NUM> need not be retracted after advancing through the anvil <NUM> and a cartridge jaw <NUM> coupled thereto so as to fire fasteners <NUM> into tissue <NUM> clamped in a tissue gap <NUM> between the anvil <NUM> and the cartridge jaw <NUM>. The I-beam <NUM> is configured to advance in a distal direction <NUM> to fire the fasteners <NUM> in this illustrated embodiment. The anvil <NUM> includes an opening <NUM> adjacent a distal end thereof configured to release the anvil coupling member <NUM>, e.g., a guide pin <NUM> thereof, therefrom. The anvil coupling member <NUM>, and hence the I-beam <NUM>, is configured to be automatically released from the anvil <NUM> by the guide pin <NUM> passing out of the opening <NUM>, which is in communication with a slot in the anvil <NUM> through which the guide pin <NUM> translates. The release of the anvil coupling member <NUM>, and hence the I-beam <NUM>, from the anvil <NUM> allows the anvil <NUM> to open.

In some embodiments, a shim of a cartridge configured to be removably coupled to a bottom jaw of an end effector of a surgical device is configured to define a gap of space between the bottom jaw and an anvil coupled thereto. In general, the size of the shim can define the gap of space. The larger the shim, the smaller the gap of space.

<FIG> illustrate one embodiment of a cartridge <NUM> that includes a shim <NUM>. The cartridge <NUM> is configured to be removably coupled to a cartridge jaw <NUM> by being seated in a channel <NUM> formed therein. The shim <NUM> can have a variety of sizes, shapes, and configurations. in this illustrated embodiment, the shim <NUM> includes an upwardly extending protrusion that is formed on a bottom inner surface of the cartridge <NUM>. The shim <NUM> extends along a longitudinal length of the cartridge <NUM>.

The cartridge jaw <NUM> includes a receiving slot <NUM> formed therein that is configured to slidably receive the shim <NUM> therein. The cartridge <NUM> is configured to be seated within the channel <NUM> by sliding the cartridge <NUM> in a proximal direction <NUM> with the shim <NUM> sliding proximally within the slot <NUM>. The shim <NUM> can thereby define the height <NUM> of a gap of space <NUM>, shown in <FIG>, between the cartridge jaw <NUM> and an anvil <NUM> coupled thereto. The shim <NUM> extending along the cartridge's longitudinal length helps the shim <NUM> to define the height <NUM> consistently along the end effector's longitudinal length.

The height <NUM> of the shim <NUM> defines the tissue gap's height <NUM>. By way of comparison, <FIG> shows a cartridge <NUM> without a shim seated in the cartridge jaw <NUM> coupled to the anvil <NUM>. The height <NUM> of a tissue gap <NUM> is thus greater than the tissue gap's height <NUM> defined by the shim <NUM> of <FIG>.

<FIG> illustrates another embodiment of a cartridge <NUM> that includes a shim <NUM>. The shim <NUM> can be generally configured and used similarly to the shim <NUM> of <FIG>. The shim <NUM> in this illustrated embodiment has a height <NUM> that is greater than the height <NUM> of the shim <NUM> of <FIG>. Thus, the height <NUM> of the tissue gap <NUM> is less than the tissue gap's height <NUM> defined by the shim <NUM> of <FIG>.

In some embodiments, a cutting element of the sled is configured to define a gap of space between a bottom jaw and an anvil coupled thereto. As discussed herein, the sled can be part of a cartridge configured to be removably coupled to an end effector of a surgical device. The cartridge is thus configured to define the gap of space.

<FIG> illustrates one embodiment of a cutting element <NUM> configured to define a gap of space (not shown) between jaws of an end effector (not shown). The cutting element <NUM> can be part of a sled (not shown) of a cartridge (not shown) configured to be removably coupled to an end effector (not shown), as discussed herein. The cutting element <NUM> includes an I-beam mating feature <NUM> formed on a proximal side thereof, opposite to a blade <NUM> formed on a distal side thereof. The I-beam mating feature includes a ramped surface <NUM> that slopes upward in a distal direction <NUM> toward a pin stop depression <NUM> that extends in the distal direction <NUM>. The I-beam mating feature <NUM> is configured to removably couple to an I-beam <NUM>. The I-beam <NUM> includes a guide pin <NUM> configured to be movable relative to the remainder of the I-beam <NUM>. As in the illustrated embodiment, the I-beam <NUM> includes an I-beam pin slot <NUM> in which the pin <NUM> is configured to slide. The pin slot <NUM> extends in an upward/downward or vertical direction <NUM> that can be substantially perpendicular to the distal direction <NUM>. The pin <NUM> is thus configured to slide in the slot <NUM> in the upward/downward direction <NUM>.

The pin <NUM> is configured to engage the cutting element <NUM> when the cartridge including the cutting element <NUM> is removably coupled to the end effector that is attached to an elongate shaft (not shown) along which the I-beam <NUM> extends. The pin <NUM> is configured to engage a lower portion of the ramped surface <NUM> of the cutting element <NUM> and slide upward therealong until the pin <NUM> reaches the depression <NUM>, which causes the pin's sliding to stop. The depression <NUM> can seat the pin <NUM> therein. The upward/downward location of the pin <NUM> is thus defined by the cutting element <NUM>. The guide pin <NUM> seated in the depression <NUM> is configured to slide along an anvil of the end effector. In this way, a tissue gap between the anvil and a cartridge jaw of the end effector can be defined by the cutting element <NUM>.

<FIG> illustrates another embodiment of a cutting element <NUM>' that is configured and used similarly to the cutting element <NUM>. <FIG> also illustrates another embodiment of a cutting element <NUM>" that is configured and used similarly to the cutting element <NUM>. The ramped surfaces <NUM>, <NUM>', <NUM>" of the cutting elements <NUM>, <NUM>', <NUM>", respectively, can all start at the same location in a downward direction, thereby facilitating engagement of the pin <NUM> with the ramped surface of the cutting element loaded into the surgical device's end effector. The cutting element <NUM>' has a longer ramped surface <NUM>' than the cutting element <NUM> such that the depression <NUM>' of the cutting element <NUM>' is located at a higher location than the depression <NUM> of the cutting element <NUM>. The pin <NUM> seated in the depression <NUM>', as shown in FIG. <NUM>, is thus up higher than the pin <NUM> when seated in the lower depression <NUM>. The tissue gap can thus be greater when using the cutting element <NUM>' versus the cutting element <NUM>. The cutting element <NUM>" has a longer ramped surface <NUM>" than the cutting element <NUM> and the other cutting element <NUM>' such that the depression <NUM>" of the cutting element <NUM>" is located at a higher location than the depression <NUM> of the cutting element <NUM> and the depression <NUM>' of the cutting element <NUM>'. The pin <NUM> seated in the depression <NUM>" is thus up higher than the pin <NUM> when seated in either of the lower depressions <NUM>, <NUM>'. The tissue gap is thus greater when using the cutting element <NUM>" versus the cutting element <NUM> and versus the cutting element <NUM>'.

<FIG> illustrates another embodiment of a cutting element <NUM> that is configured and used similarly to the cutting elements <NUM>, <NUM>', <NUM>" and removably coupled to the I-beam <NUM>. <FIG> shows the I-beam <NUM> disengaged from the cutting element <NUM>. <FIG> shows the pin <NUM> of the I-beam <NUM> seated in a depression <NUM> of the cutting element's mating feature <NUM>.

In some embodiments of a surgical device in which the cutting element of the sled is configured to define a gap of space between a bottom jaw and an anvil coupled thereto, the surgical device includes a push rod configured to facilitate engagement of the I-beam's pin with the cutting element. The push rod helps to ensure that the pin is seated within a depression of the cutting element's mating feature, thereby helping to ensure that the anvil is at an intended position relative to the bottom jaw when the bottom jaw and the anvil are closed. The push rod helps to hold the pin within the depression, which helps to prevent the pin from shifting position relative to the cutting element. The tissue gap is thus less likely to change once the pin is seated in the depression.

<FIG>, <FIG> illustrate one embodiment of a push rod <NUM> configured to removably couple to the guide pin <NUM> to facilitate engagement of the pin <NUM> with the cutting element <NUM>'. Although the push rod <NUM> is shown with the I-beam <NUM> and the cutting element <NUM>' of <FIG>, the push rod <NUM> can be similar used with other I-beams and other cutting elements. The push rod <NUM> can have a variety of sizes, shapes, and configurations. in this illustrated embodiment, the push rod <NUM> includes an elongate bar having a forked distal end <NUM>. The fork's tines can define spaces therebetween, each of which is configured to removably seat the pin <NUM> therein. The forked distal end <NUM> in this illustrated embodiment includes four tines defining three spaces therebetween, but a push rod includes another plural number of tines to define at least one space.

In use, after the cartridge including the cutting element <NUM>' has been seated in the end effector so as to mate the pin <NUM> with the cutting element's mating feature, as shown in <FIG> and <FIG>, the push rod <NUM> can be advanced in a distal direction <NUM> until the forked distal end <NUM> engages the pin <NUM> so as to seat the pin <NUM> in one of the spaces. <FIG> shows the pin <NUM> seated in the depression <NUM>' and seated in a middle one of the push rod's spaces. Continued movement of the push rod <NUM> in the distal direction <NUM> causes the I-beam <NUM> and the sled including the cutting element <NUM>' to advance distally, thereby firing fasteners from the cartridge.

In some embodiments, the surface of the cartridge is configured to define a gap of space between the bottom jaw and an anvil coupled thereto. As discussed herein, the cartridge is configured to be removably coupled to an end effector that includes the bottom jaw and the anvil. The cartridge is thus configured to define the gap of space.

<FIG> illustrates one embodiment of a cartridge <NUM> configured to define a gap of space (not shown) between jaws of an end effector (not shown). In general, the cartridge <NUM> cooperates with an I-beam <NUM> removably engageable with the cartridge <NUM> to define the gap of space. The cartridge <NUM> includes a proximal sloped surface <NUM> that slopes upward in a distal direction. The sloped surface <NUM> is configured to engage a guide pin <NUM> of the I-beam <NUM> to facilitate positioning of the guide pin <NUM> relative to the cartridge <NUM> and, hence, to an anvil <NUM>, shown in <FIG>. The guide pin <NUM> of the I-beam <NUM> is configured to be movable relative to the remainder of the I-beam <NUM>.

As in the illustrated embodiment, the I-beam <NUM> includes an I-beam pin slot <NUM> in which the pin <NUM> is configured to move. The I-beam <NUM> includes a bias element <NUM> configured to bias the pin <NUM> toward a bottom surface of the slot <NUM>, as shown in <FIG> and in <FIG>. The bias element <NUM> includes a coil spring in this illustrated embodiment, but the bias element <NUM> may have other configurations. The pin slot <NUM> extends in an upward/downward or vertical direction <NUM> that can be substantially perpendicular to a proximal/distal direction <NUM> in which the I-beam <NUM> is configured to translate through the cartridge <NUM>. The pin slot <NUM> includes a plurality of notches formed therein on a proximal side thereof, as also shown in <FIG>. The pin slot <NUM> includes three notches in this illustrated embodiment, but the pin slot may include any other suitable number of notches. Each of the notches is configured to seat the pin <NUM> therein, depending on the sloped surface <NUM> of the cartridge <NUM>. The pin <NUM> is thus configured to move in the slot <NUM> in the upward/downward direction <NUM> and in the proximal/distal direction <NUM>.

The pin <NUM> is configured to engage the sloped surface <NUM> when the cartridge <NUM> is removably coupled to the end effector that is attached to an elongate shaft (not shown) along which the I-beam <NUM> extends. The pin <NUM> is configured to engage and slide upward and distally along the sloped surface <NUM> until the pin <NUM> reaches the top end of the sloped surface <NUM>, e.g., until the sloped surface <NUM> ends. The force of the sloped surface <NUM> on the pin <NUM> can exceed the force provided by the bias element <NUM>, thereby allowing the pin <NUM> to slide along the sloped surface <NUM> and move upward within the slot <NUM>. When the pin <NUM> reaches the top end of the sloped surface <NUM>, e.g., when the cartridge <NUM> has been fully seated in the end effector, the pin <NUM> can automatically move proximally so as to be seated in one of the notches. With the pin <NUM> seated in the one of the notches, the I-beam <NUM> can be advanced distally so as to fire fasteners (not shown) from the cartridge <NUM> with the tissue gap defined by the pin's vertical location within the slot <NUM>.

<FIG> illustrates another embodiment of a cartridge <NUM>' that is configured and used similarly to the cartridge <NUM>. <FIG> also illustrates another embodiment of a cartridge <NUM>" that is configured and used similarly to the cartridge <NUM>. In this illustrated embodiment, the cartridge <NUM> has a first size, e.g., a first longitudinal length and a first height, the cartridge <NUM>' has a second size, e.g., a second longitudinal length greater than the first longitudinal length and a second height greater than the first height, and the cartridge <NUM>" has a third size, e.g., a third longitudinal length greater than the second longitudinal length and a third height greater than the second height. The sloped surfaces <NUM>, <NUM>', <NUM>" of the cartridges <NUM>, <NUM>', <NUM>", respectively, all start at the same location in a downward direction, thereby facilitating engagement of the pin <NUM> with the sloped surface of the cartridge loaded into the surgical device's end effector. The cartridge <NUM>' has a longer and steeper ramped surface <NUM>' than the cartridge <NUM> such that the pin <NUM> moves into one of the notches at a higher location than with the cartridge <NUM>. The pin <NUM> seated in the middle one of the notches <NUM> in response to the cartridge <NUM>', as shown in <FIG>, can thus be up higher than the pin <NUM> when using the cartridge <NUM>. The tissue gap is thus greater when using the cartridge <NUM>' versus the cartridge <NUM>. The cartridge <NUM>" has a longer and steeper sloped surface <NUM>" than the cartridge <NUM> and the other cartridge <NUM>' such that the pin <NUM> moves into one of the notches at a higher location than with the cartridge <NUM> or with the cartridge <NUM>'. The pin <NUM> seated in the notch in response to the cartridge <NUM>" is thus up higher than the pin <NUM> when using either of the cartridge <NUM>, <NUM>'. The tissue gap is thus greater when using the cartridge <NUM>" versus the cartridge <NUM> and versus the cartridge <NUM>'.

A person skilled in the art will appreciate that the present invention has application in conventional minimally-invasive and open surgical instrumentation as well application in robotic-assisted surgery.

Claim 1:
A staple cartridge (<NUM>), comprising:
a cartridge housing (<NUM>), wherein the cartridge housing defines a plurality of openings (<NUM>) formed in a tissue engaging surface (<NUM>) thereof;
a plurality of staples (<NUM>) disposed within the cartridge housing, the plurality of staples being frangibly attached to a carrier (<NUM>), wherein the staples can be ejected from the staple cartridge through the plurality of openings; and
an anvil coupling member (<NUM>) slidably disposed within a track formed in the cartridge, the anvil coupling member including a proximal portion (<NUM>) having an engagement feature on a proximal-facing surface thereof for mating with a drive shaft, and the anvil coupling member including a distal portion, wherein the distal portion comprises a knife (<NUM>) on a distal-facing surface thereof, characterized in that the distal portion is pivotally coupled to the proximal portion.