Patent Description:
Powered surgical stapling devices include sensors to provide real time feedback to a clinician regarding a variety of parameters including pressure strain imposed on tissue and status of a firing stroke of the stapling device. Some powered surgical stapling devices use current sensors to detect electrical current drawn from a motor of the device, or load reading sensors along a drive assembly of the device, as an indicator of the forces required to compress tissue, to form staples, and/or to transect the tissue. Load reading sensors can be used to detect pre-set loads and cause the powered surgical stapling device to react thereto. For example, during clamping of thick tissue, the load will rise to a pre-determined limit where the device can slow clamping to maintain the clamping force as the tissue relaxes. This allows for clamping of thick tissue without damage to such tissue (e.g., serosa tears). Data collected from these sensors may also be used to control the speed of firing, which has been shown to improve staple formation by slowing the stapler speed and lowering the staple firing force. The data may also be used in other aspects of the stapling process such as detecting end stop and emergency stopping to prevent damage to the end effector.

In these stapling devices, a flex cable is sometimes provided to couple the sensors which are typically located in a distal portion of the device, e.g., a tool assembly, with a processor located in a proximal portion of the device, e.g., a handle assembly or robotic controller. In some stapling devices, the tool assembly is secured to an adapter assembly about a pivot member that facilitates articulation of the tool assembly in relation to the adapter assembly. When the tool assembly is articulated, the tool assembly pulls on the flex cable to extend the flex cable distally from within the adapter assembly. When the tool assembly is returned to a non-articulated position, the flex cable tends to herniate into a joint formed by the pivot member. This may cause damage to the flex cable.

A continuing need exists for a powered stapling device that includes a mechanism to minimize a likelihood that the flex cable will herniate.

The invention is defined in the appended independent claim. Additional embodiments are disclosed in the dependent claims.

This disclosure is directed to a surgical device that includes an adapter assembly, a tool assembly that is supported on a distal portion of the adapter assembly, sensors supported on the tool assembly, a flex cable that is coupled to the sensors and extends from the tool assembly through the adapter assembly, and a tensioner mechanism that is engaged with the flex cable within the adapter assembly to maintain tension in the flex cable. This disclosure is also directed to a tensioner assembly that is coupled to a flex cable and is configured to maintain tension in the flex cable. The tensioner mechanism is provided to maintain tension in the flex cable to prevent herniation of the flex cable during operation of the surgical device.

Aspects of this disclosure are directed to a surgical device including an adapter assembly, a tool assembly, a flex cable, and a tensioner mechanism. The adapter assembly defines a first longitudinal axis and has a proximal portion and a distal portion. The body of the adapter assembly defines a recess. The tool assembly defines a second longitudinal axis and is supported on the distal portion of the adapter assembly. The tool assembly supports a sensor and is pivotable between a non-articulated position in which the first and second longitudinal axes are aligned and articulated positions in which the first and second axes are misaligned. The flex cable has a distal portion and a proximal portion. The distal portion of the flex cable is fixedly coupled to the sensor and the proximal portion extends from the proximal portion of the adapter assembly. The tensioner mechanism is supported in the recess of the body of the adapter assembly and includes a sled and a biasing member. The sled is secured to the flex cable and is movable within the recess of the body of the adapter assembly from a first position towards a second position to provide tension in the flex cable. The biasing member is positioned to urge the sled towards the second position.

Further aspects of the disclosure are directed to a surgical stapling device that includes an adapter assembly, a tool assembly, a flex cable, and a tensioner mechanism. The adapter assembly defines a first longitudinal axis and has a proximal portion and a distal portion. The adapter assembly includes a body defining a recess. The tool assembly defines a second longitudinal axis and is supported on the distal portion of the adapter assembly. The tool assembly includes an anvil and a cartridge assembly. The cartridge assembly has a staple cartridge. The tool assembly supports a sensor and is pivotable between a non-articulated position in which the first and second longitudinal axes are aligned and articulated positions in which the first and second axes are misaligned. The flex cable has a distal portion, a central portion, and a proximal portion. The distal portion is fixedly coupled to the sensor and the proximal portion extends from the proximal portion of the adapter assembly. The tensioner mechanism is supported in the recess of the body of the adapter assembly and includes a sled and a biasing member. The sled is secured to the flex cable and is movable within the recess of the body of the adapter assembly from a first position towards a second position to provide tension in the flex cable. The biasing member is positioned to urge the sled towards the second position.

Other aspects of the disclosure are directed to a flex cable and tensioner assembly that includes a flex cable and a tensioner mechanism. The flex cable has a distal portion, a central portion, and a proximal portion. The distal portion extends from the central portion in a first direction and the proximal portion extends from the central portion in a second direction opposite to the first direction. The tensioner mechanism is supported on the flex cable and includes a sled and a biasing member. The sled is secured to the flex cable and the biasing member is engaged with the sled to urge the sled towards the second position.

In aspects of the disclosure, the sled includes a sled base and a sled cover.

In some aspects of the disclosure, the sled base is positioned on a first side of the flex cable and the sled cover is positioned on a second side of the flex cable.

In certain aspects of the disclosure, the sled cover is pivotably coupled to the sled base and fixedly coupled to the flex cable.

In aspects of the disclosure, the sled base includes a body and a post that extends distally from the body within the recess.

In some aspects of the disclosure, the biasing member is positioned about the post between the body of the sled base and a wall of the body of the adapter assembly to urge the sled towards the second position.

In certain aspects of the disclosure, the flex cable includes a central portion that is positioned adjacent the recess, and the sled is secured to the central portion of the flex cable.

In aspects of the disclosure, the distal portion of the flex cable is bifurcated and includes first and second leg portions.

In some aspects of the disclosure, the tool assembly includes an anvil and a cartridge assembly, and the anvil is coupled to the cartridge assembly such that the tool assembly is movable between open and clamped positions.

In certain aspects of the disclosure, the surgical device includes a handle assembly that is coupled to the proximal portion of the adapter assembly.

In aspects of the disclosure, the handle assembly includes a processor, and the proximal portion of the flex cable extends into the handle assembly and communicates with the processor.

Various aspects of a surgical device are described herein below with reference to the drawings, wherein:.

The disclosed surgical device with a flex cable and tensioner mechanism will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that aspects of the device disclosed are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. In addition, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.

In this description, the term "proximal" is used generally to refer to that portion of the device that is closer to a clinician, while the term "distal" is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term "clinician" is used generally to refer to medical personnel including doctors, nurses, and support personnel.

This disclosure is directed to a surgical device including an adapter assembly and a tool assembly that can articulate in relation to the adapter assembly. The stapling device includes sensors in a distal portion of the surgical device that are coupled to a processor in a proximal portion of the surgical device by a flex cable. The surgical device includes a flex cable tensioner mechanism to maintain tension in the flex cable and prevent herniation of the flex cable during articulation of the tool assembly.

<FIG> illustrates a surgical device shown generally as stapling device <NUM> that includes a handle assembly <NUM>, an elongate body or adapter <NUM> that defines a longitudinal axis "X", and a tool assembly <NUM>. As illustrated, the handle assembly <NUM> is powered and includes a stationary handgrip <NUM> and actuation buttons <NUM>. The actuation buttons <NUM> are operable to actuate various functions of the tool assembly <NUM> via the adapter assembly <NUM> including approximation, stapling, dissection, and/or articulation. In certain aspects of the disclosure, the handle assembly <NUM> supports batteries (not shown) that provide power to the handle assembly <NUM> to operate the stapling device <NUM>. In some aspects of the disclosure, the stapling device <NUM> includes a rotation knob <NUM> that is rotatably coupled to the handle assembly <NUM> and supports the adapter assembly <NUM> to facilitate rotation of the adapter assembly <NUM> and tool assembly <NUM> in relation to the handle assembly <NUM>. Although the stapling device <NUM> is illustrated as a powered stapling device, it is envisioned that the advantages of this disclosure are suitable for use with manually powered surgical stapling devices, robotically controlled stapling devices, and other surgical devices that require connection between sensors supported in a distal portion of a surgical device and a processor located in a proximal portion of the surgical device.

The tool assembly <NUM> of the stapling device <NUM> defines a longitudinal axis "Y" (<FIG>) and is coupled to the adapter assembly <NUM> by a pivot member <NUM> that defines a pivot axis "Z". The tool assembly <NUM> can pivot about the pivot axis "Z" between a non-articulated position in which the longitudinal axis "Y" (<FIG>) of the tool assembly <NUM> is coaxial with the longitudinal axis "X" of the adapter assembly <NUM> and articulated positions in which the longitudinal axis "Y" of the tool assembly <NUM> defines different angles with the longitudinal axis "X" of the adapter assembly <NUM>. In aspects of the disclosure, the tool assembly <NUM> includes a cartridge assembly <NUM> and an anvil <NUM>. The cartridge assembly <NUM> and the anvil <NUM> are coupled together such that the tool assembly <NUM> can pivot between open and clamped positions. The cartridge assembly <NUM> includes a channel member <NUM> (<FIG>) and a staple cartridge <NUM> that is received within the channel member <NUM>. In aspects of the disclosure, the staple cartridge <NUM> is releasably coupled to the channel member <NUM> to facilitate replacement of a spent staple cartridge <NUM> and reuse of the stapling device <NUM>. <CIT> (hereinafter "the '<NUM> publication") discloses a powered surgical stapling device and describes a handle assembly suitable for use with the stapling device <NUM> in further detail.

<FIG> illustrates the portion of the stapling device <NUM> (<FIG>) that is positioned distally of the handle assembly <NUM> including the rotation knob <NUM>, the adapter assembly <NUM>, and the tool assembly <NUM>. The stapling device <NUM> (<FIG>) includes sensors <NUM>, e.g., strain gauges (shown schematically in <FIG>), that are supported in the tool assembly <NUM> and a processor <NUM> (shown schematically in <FIG>) that is supported in the handle assembly <NUM>. The sensors <NUM> and the processor <NUM> are connected together by a flex cable <NUM> that extends from the handle assembly <NUM>, through the adapter assembly <NUM>, past the pivot axis "Z", and into the tool assembly <NUM>. The sensors <NUM> provide real time feedback to a clinician regarding a variety of parameters including pressure strain imposed on tissue and status of a firing stroke of the stapling device <NUM>. Data from the sensors <NUM> is communicated to the processor <NUM> in the handle assembly <NUM> via the flex cable <NUM>. The '<NUM> Publication describes a surgical device <NUM> including the construction and function of sensors, a flex cable, and a processor in further detail.

The adapter assembly <NUM> includes a body <NUM> that supports the flex cable <NUM> along its length between the handle assembly <NUM> (<FIG>) and the tool assembly <NUM>. The body <NUM> defines a recess <NUM> (<FIG>) that supports a tensioner mechanism <NUM> that is coupled to a central portion of the flex cable <NUM> and is described in detail below. The adapter assembly <NUM> includes an outer housing <NUM> (shown in phantom in <FIG>) that is received about the body <NUM> and confines the tensioner mechanism <NUM> within the recess <NUM> of the body <NUM>. In aspects of the disclosure, the outer housing <NUM> includes a cylindrical tube although other configurations are envisioned.

<FIG> illustrate the flex cable <NUM> and the tensioner mechanism <NUM>. The flex cable <NUM> (<FIG>) includes an elongate body which can be formed from a substrate that includes one or more dielectric layers, one or more conductive layers, and one or more resistive layers. Alternately, the flex cable <NUM> can be formed of a variety of different materials having a variety of different configurations that are capable of electrically coupling the sensors <NUM> (<FIG>) to the processor <NUM> (<FIG>). In aspects of the disclosure, the flex cable <NUM> has linear proximal portion 50a (<FIG>), a central portion 50b and a bifurcated distal portion 50c. The proximal portion 50a extends proximally from the central portion 50b of the flex cable <NUM>, through the adapter assembly <NUM>, and into the handle assembly <NUM>. The central portion 50b of the flex cable <NUM> is engaged with the tensioner mechanism <NUM> and is positioned adjacent the recess <NUM> of the body <NUM> of the adapter assembly <NUM>. The bifurcated distal portion 50c of the flex cable <NUM> includes leg portions <NUM> (<FIG>) that extend from the central portion 50b of the flex cable <NUM>, through the adapter assembly <NUM>, about the pivot member <NUM>, and into the tool assembly <NUM>. The distal ends of the leg portions <NUM> are fixedly secured within the tool assembly <NUM> and are coupled to the sensors <NUM> (<FIG>). Although the distal portion 50c of the flex cable <NUM> is shown to be bifurcated, it is envisioned that the distal portion 50c of the flex cable <NUM> can include a single leg like the proximal portion 50a of the flex cable <NUM>.

The tensioner mechanism <NUM> (<FIG>) includes a sled <NUM> (<FIG>) and a biasing member <NUM>. The sled <NUM> includes a sled base <NUM> and a sled cover <NUM>. The sled base <NUM> includes a body <NUM> and a post <NUM> that extends distally from the body <NUM>. The body <NUM> defines a through bore <NUM> (<FIG>). The sled cover <NUM> (<FIG>) includes a body <NUM> (<FIG>), and protrusions <NUM> and a post <NUM> that extend from the body <NUM> towards the sled base <NUM>. The post <NUM> includes a head 84a that has a diameter that is greater than the diameter of the remaining portion of the post <NUM>.

The central portion 50b of the flex cable <NUM> defines openings <NUM> (<FIG>). In aspects of the disclosure, the central portion 50b of the flex cable <NUM> defines three openings <NUM> including two distal openings and a proximal opening. The protrusions <NUM> of the sled cover <NUM> are received through the distal openings <NUM> of the flex cable <NUM> and the post <NUM> of the sled cover <NUM> is received through the proximal opening <NUM> of the flex cable <NUM>. The post <NUM> is also received within the through bore <NUM> of the body <NUM> of the sled base <NUM> to pivotably secure the sled base <NUM> to the sled cover <NUM> and to secure the sled base <NUM> and the sled cover <NUM> to opposite sides of the central portion 50b of the flex cable <NUM>. In aspects of the disclosure, the head 84a of the post <NUM> has a diameter that is larger than the diameter of the through bore <NUM> of the body <NUM> of the sled base <NUM> to retain the post <NUM> within the through bore <NUM>. In aspects of the disclosure, the head 84a can be formed of a resilient material to facilitate insertion of the post <NUM> through the through bore <NUM>. Although the sled cover <NUM>, the sled base <NUM>, and the flex cable <NUM> are shown to be secured together with the protrusions <NUM> and the post <NUM>, it is envisioned that the sled base <NUM> and sled cover <NUM> could be secured to the flex cable <NUM> using a variety of different types of fasteners including adhesives, screws, welding, or the like. It is also envisioned that the sled <NUM> could be formed of an integral sled member that is secured to only one side of the flex cable <NUM>.

<FIG> illustrate views of a central portion of the adapter assembly <NUM> with the tensioner mechanism <NUM> secured to the flex cable <NUM> and positioned within the recess <NUM> of the body <NUM> of the adapter assembly <NUM>. When the tensioner mechanism <NUM> is secured to the flex cable <NUM> and positioned within the recess <NUM> of the body <NUM>, the post <NUM> extends distally from the body <NUM> of the sled base <NUM> within the recess <NUM>. In aspects of the disclosure, the biasing member <NUM> includes a coil spring that is received about the post <NUM> and is compressed between the body <NUM> of the sled base <NUM> and a distal wall <NUM> of the body <NUM> of the adapter assembly <NUM>. In this position, the sled <NUM> is urged proximally within the recess <NUM> of the body <NUM> of the adapter assembly <NUM> to pull the distal portion 50c and central portion 50b of the flex cable <NUM> proximally within the recess <NUM>. As described above, the distal portion 50c of the flex cable <NUM> is fixedly secured within the tool assembly <NUM> (<FIG>). As such, the distal portion 50c is placed in tension by the tensioner mechanism <NUM>. When the sled <NUM> of the tensioner mechanism <NUM> is in its proximal-most position, the sled <NUM> is engaged with a proximal wall <NUM> (<FIG>) of the body <NUM> of the adapter assembly <NUM> that defines the recess <NUM>.

<FIG> illustrate the stapling device <NUM> when the tool assembly <NUM> is moved to an articulated position. When the tool assembly <NUM> is moved to an articulated position about pivot member <NUM> in the direction of arrow "A" in <FIG>, the distal portion 50c of the flex cable <NUM> that is positioned radially outward of the pivot axis "Z" (<FIG>) is pulled distally about the pivot member <NUM> in the direction indicated by arrow "B" in <FIG>. When the distal portion 50c of the flex cable <NUM> includes bifurcated portions <NUM>, the bifurcated portion <NUM> of the distal portion 50c of the flex cable <NUM> positioned inwardly of the pivot member <NUM> will be move proximally within the adapter assembly <NUM> in the direction of arrow "C" in <FIG> and the bifurcated portion <NUM> positioned outwardly of the pivot member <NUM> will move distally in the direction of arrow "B" in <FIG>. When the bifurcated portion <NUM> of the flex cable <NUM> moves distally, the central portion 50b of the flex cable <NUM> will move distally within the recess <NUM> of the body <NUM> of the adapter assembly <NUM>. This distal movement will cause the sled <NUM> to move distally within the recess <NUM> of the body <NUM> of the adapter assembly <NUM> in the direction of arrow "D" in <FIG> against the urging of the biasing member <NUM>. The biasing member <NUM> will continue to apply a force on the sled <NUM> of the tensioner mechanism <NUM> to apply a force on the flex cable <NUM> to maintain tension in the flex cable <NUM> when the tool assembly <NUM> is in an articulated position.

When the tool assembly <NUM> is returned to a non-articulated position (<FIG>) from an articulated position (<FIG>), the tensioner mechanism <NUM> maintains tension in the distal portion 50c and pulls the flex cable <NUM> proximally in the direction of arrow "E" in <FIG> to prevent herniation of the flex cable <NUM> in the area of the pivot member <NUM> (<FIG>). When the tool assembly <NUM> returns to the non-articulated position (<FIG>), the sled <NUM> returns to a retracted position in which the sled <NUM> is engaged with the wall <NUM> of the body <NUM> of the adapter assembly <NUM>.

Herniation of the flex cable <NUM> in the area of the pivot member <NUM> may cause the flex cable <NUM> to become compressed between the tool assembly <NUM> and the adapter assembly <NUM> and damaged. This damage may prevent the translation of data between the sensors <NUM> in the tool assembly <NUM> and the processor in the handle assembly <NUM> (or robotic controller) to prevent operation and/or proper operation of the surgical device.

As described above, when the flex cable <NUM> has a bifurcated distal portion including a bifurcated portion <NUM> positioned inwardly and outwardly of the pivot member <NUM>, the bifurcated portion <NUM> positioned inwardly of the pivot member <NUM> will move proximally while the bifurcated portion <NUM> positioned outwardly of the pivot member <NUM> will move distally. In order to compensate for the different directions of movement, the distal openings <NUM> in the central portion 50b of the flex cable <NUM> are slightly elongated such that the <NUM> protrusions <NUM> on the sled cover <NUM> can slide within the distal openings <NUM>. This allows the sled cover <NUM> to pivot in relation to the sled base <NUM> as the central portion 50b of the flex cable <NUM> is twisted in response to the movement of the bifurcated portions <NUM> of the distal portion of the flex cable <NUM> in different directions.

Claim 1:
A flex cable and tensioner assembly comprising:
a flex cable (<NUM>) having a distal portion (50c), a central portion (50b), and a proximal portion (50a), the distal portion extending from the central portion in a first direction and the proximal portion extending from the central portion in a second direction opposite to the first direction; and
a tensioner mechanism (<NUM>) supported on the flex cable, the tensioner mechanism including a sled (<NUM>) and a biasing member (<NUM>), the sled being secured to the flex cable and the biasing member is engaged with the sled to urge the sled towards the second position characterised in that the sled includes a sled base (<NUM>) and a sled cover (<NUM>), the sled base positioned on a first side of the flex cable and the sled cover positioned on a second side of the flex cable wherein the sled cover is pivotably coupled to the sled base and fixedly coupled to the flex cable.