Patent Description:
This disclosure is generally related to ligation clips and, more particularly, to a ligation clip loading device for intra-cavity loading of ligation clips to a ligation clip applicator device.

Polymeric ligation clips typically include first and second beams that are coupled together at one end by a pivotable connection, e.g., living hinge, such that the first and second beams can be moved in relation to each other between open and clamped positions. The ligation clips can be applied to tissue endoscopically through a small diameter incision or through a small diameter cannula positioned through the incision to minimize trauma to a patient during a surgical procedure.

Typically, when polymeric clips are applied to tissue through a cannula and/or stored within an endoscopic clip applier, the clips are supported in a compressed or partially compressed state to minimize an overall dimension of the clips and facilitate delivery of the clips through the cannula or incision. Storing polymeric clips in a compressed or partially compressed state may impact the condition of the clips which may impact the performance of the clips.

In minimally-invasive surgical procedures, operations are carried out within an internal body cavity through small entrance openings in the body. The entrance openings may be natural passageways of the body or may be surgically created, for example, by making a small incision into which a cannula is inserted.

Minimally-invasive surgical techniques may be used for placement of ligation clips within an internal body cavity, such as an intra-abdominal space, by a ligation clip application device (e.g., endoscopic clip applier). Ligation clips are loaded into an end effector of an endoscopic clip applier and the endoscopic clip applier clamps the ligation clip at a desired site.

<CIT> relates to multifunctional clip supplying catheters that are passed externally to the body over a flexible endoscope and slid there over into the body to a work site.

<CIT> discloses a clip holder for holding a plurality of clips.

<CIT> relates to a snap-on surgical clip cartridge configured to retain and dispense clips intracorporeally during a surgical operation.

In one aspect of the disclosure, an intra-cavity clip loading device includes a cannula including a cannula body defining an instrument lumen extending along a longitudinal axis of the cannula body. A clip stack is defined in the cannula body. The clip stack includes ligation clips axially arranged about the instrument lumen. Clip retention features are formed in the cannula body. Each clip retention feature holds a ligation clip.

In some aspects of the disclosure, each ligation clip includes a first arm and a second arm defining a central region between the first and second arms. The instrument lumen extends through the central region. The cannula includes an inner wall and an outer wall. The inner wall defines the instrument lumen. The first and second arms of each of the ligation clips are positioned between the inner wall and the outer wall of the cannula. The inner wall of the cannula separates the plurality of ligation clips from the instrument lumen to maintain a fluid integrity of the instrument lumen.

In some aspects of the disclosure, the cannula body includes slots formed in the cannula body. Each slot is associated with a clip retention feature. Each ligation clip is accessible by a clip applier through a respective slot.

In some aspects of the disclosure, the first arm of each ligation clip includes a first boss and the second arm of each ligation clip includes a second boss. The first boss and the second boss are each coupled to a clip retention feature.

In some aspects of the disclosure, the slots are covered by a sheath positioned about the cannula body. The slots may be located proximate a distal end portion of the cannula body.

In some aspects of the disclosure, the cannula includes a mate cap and an instrument seal formed in the mate cap to maintain a predetermined pressure in the instrument lumen.

In some aspects of the disclosure, a distal seal provides a barrier between an internal body cavity and the instrument lumen.

In one aspect of the disclosure, a method of robotic intra-abdominal clip loading includes robotically introducing the intra-cavity clip loading device into an intra-abdominal space. A robotic ligation clip application device is loaded into the intra-abdominal space. The end effector of the ligation clip application device is robotically inserted into a portion of the clip stack. The end effector of the ligation clip application device grasps the ligation clip of the plurality of ligation clips. The end effector of the ligation clip application device is withdrawn to remove the ligation clip from the clip stack defined in the distal end portion of the cannula body.

In some aspects of the disclosure, the end effector of the ligation clip application device is robotically inserted into a slot of the clip stack to grasp the ligation clip. The end effector may be robotically inserted into the slot at a location proximate the distal end portion of the cannula body. The first arm and the second arm of the end effector may be inserted into the portion of the clip stack to grasp the ligation clip. The first arm and the second arm of the ligation clip application device separates the ligation clip from the clip retention feature.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects and features of the disclosure and, together with the detailed description below, serve to further explain the disclosure, in which:.

As used herein, the term "distal" refers to the portion that is being described which is further from a user, while the term "proximal" refers to the portion that is being described which is closer to a user. Further, to the extent consistent, any of the aspects and features detailed herein may be used in conjunction with any or all of the other aspects and features detailed herein.

Exemplary axes or directions such as an X-axis direction, a Y-axis direction and a Z-axis direction may be illustrated in the accompanying drawings and/or described herein. As an example, the X-axis direction may perpendicular to the Y-axis direction, and the Z-axis direction may be orthogonal to the X-axis direction and the Y-axis direction.

"About" or "approximately" or "substantially" as used herein may be inclusive of the stated value and means within an acceptable range of variation for the particular value as determined by one of ordinary skill in the art, considering the measurement in question and the error associated with measurement of the particular quantity (e.g., the limitations of the measurement system). For example, "about" may mean within one or more standard variations, or within ± <NUM>%, <NUM>%, <NUM>%, <NUM>% of the stated value.

Descriptions of technical features or aspects of an exemplary embodiment of the disclosure should typically be considered as available and applicable to other similar features or aspects in another exemplary embodiment of the disclosure. Accordingly, technical features described herein according to one exemplary embodiment of the disclosure may be applicable to other exemplary embodiments of the disclosure, and thus duplicative descriptions may be omitted herein.

Exemplary embodiments of the disclosure will be described more fully below (e.g., with reference to the accompanying drawings). Like reference numerals may refer to like elements throughout the specification and drawings.

The intra-cavity clip loading devices described herein allow intra-cavity loading of ligation clips while still optionally providing an instrument lumen (e.g., for use by <NUM> instruments). Thus, a single endoscopic port can be employed for intra-cavity ligation clip storing and loading of a ligation clip application device and for providing access to a surgical instrument through the instrument lumen extending between the ligation clips.

<FIG>, <FIG> illustrate an embodiment of an intra-cavity clip loading device <NUM>. The intra-cavity clip loading device <NUM> includes cannula <NUM> including distal cannula portion <NUM> defining an instrument lumen <NUM> extending along a longitudinal axis "X-X" defined by the cannula <NUM>.

A clip stack <NUM> is defined in the cannula <NUM>. The clip stack <NUM> includes ligation clips <NUM> axially arranged about the instrument lumen <NUM>. The clip stack <NUM> includes a stack of ligation clips <NUM> spaced apart from each other such that each ligation clip <NUM> can be individually removed by a ligation clip application device <NUM> (see, e.g., <FIG>). The ligation clip application device <NUM> may be a robotically controlled device (see, e.g., <FIG>).

The ligation clips <NUM> each include a first arm <NUM> and a second arm <NUM> positioned at opposite sides of the instrument lumen <NUM>. The instrument lumen <NUM> allows passage of a surgical instrument through the instrument lumen <NUM> between the first arm <NUM> and the second arm <NUM> of each of the ligation clips <NUM>.

In some aspects of the disclosure, the instrument lumen <NUM> of cannula <NUM> may be omitted, and the intra-cavity clip loading device <NUM> may provide intra-cavity ligation clip loading without providing an access port for an additional surgical instrument. Thus, the clip stack <NUM> may be defined in the body of an obturator without the presence of the instrument lumen <NUM>.

In use, with specific reference to <FIG>, the intra-cavity clip loading device <NUM> may be inserted and secured to an endoscopic port <NUM> (e.g., by mate cap <NUM>) at a proximal end portion <NUM> of the cannula <NUM>. The cannula <NUM> extends through a body cavity wall <NUM> (e.g., an intra-abdominal wall). A distal end portion <NUM> of the intra-cavity clip loading device <NUM> is positioned in an intra-cavity space <NUM> (e.g., intra-abdominal) such that the ligation clips <NUM> can be removed by the ligation clip application device <NUM> without removing the intra-cavity clip loading device <NUM> from the intra-cavity space. The ligation clip application device <NUM> may extend through a separate endoscopic port <NUM>. The ligation clip application device <NUM> may include an end effector <NUM> (e.g., jaws) configured to grasp and apply ligation clips <NUM>. The end effector <NUM> is configured for insertion into slots <NUM> of the clip stack <NUM> to individually remove ligation clips <NUM> stored within the intra-cavity space <NUM>.

<FIG> illustrate an exemplary intra-cavity clip loading device <NUM>. The intra cavity clip loading device <NUM> includes a cannula <NUM> including a cannula body <NUM> defining an instrument lumen <NUM> extending along a longitudinal axis "X-X" defined by the cannula body <NUM>. A clip stack <NUM> is defined in the cannula body <NUM> (e.g., at a location proximate a distal end thereof). The clip stack <NUM> includes ligation clips <NUM> axially arranged about the instrument lumen <NUM>. Clip retention features <NUM> are formed in the cannula body <NUM>. Each clip retention feature <NUM> holds a ligation clip <NUM>.

The intra-cavity clip loading device <NUM> may include a mate cap <NUM> for securing the intra-cavity clip loading device <NUM> to an endoscopic port. The mate cap <NUM> may include an instrument seal <NUM> and/or a zero seal <NUM> for allowing access to a surgical instrument through the instrument lumen <NUM>. The instrument seal <NUM> or the zero seal <NUM> can maintain a fluid integrity of the instrument lumen <NUM>. A distal seal <NUM> may be formed at a distal end portion <NUM> of the cannula body <NUM>. The distal seal <NUM> may include a first flap <NUM> and a second flap <NUM> for allowing passage of a surgical instrument therethrough, while also maintaining a fluid integrity of the instrument lumen <NUM>. The distal seal <NUM> provides a barrier between an internal body cavity and the instrument lumen <NUM>. It is envisioned that instrument seal <NUM> and zero seal <NUM> may be incorporated directly into clip loading device <NUM>.

As an example, the cannula body <NUM> may have a diameter of from about <NUM> to about <NUM>, and the instrument lumen <NUM> may have a diameter of from about <NUM> to about <NUM>.

Each ligation clip <NUM> includes a first arm <NUM> and a second arm <NUM> defining a central region between the first and second arms <NUM> and <NUM>. The first and second arms <NUM> and <NUM> may reversibly pivot or flex with respect to each other through compression or flexure of a hinge <NUM>. The instrument lumen <NUM> extends through the central region between the first and second arms <NUM> and <NUM> of each ligation clip <NUM>.

With reference to <FIG>, the cannula <NUM> and cannula body <NUM> include an inner wall <NUM> and an outer wall <NUM>. The inner wall <NUM> defines the instrument lumen <NUM>. The first and second arms <NUM> and <NUM> of each of the ligation clips <NUM> are positioned between the inner wall <NUM> and the outer wall <NUM> of the cannula <NUM>. The inner wall <NUM> of the cannula <NUM> separates the plurality of ligation clips <NUM> from the instrument lumen <NUM> to maintain a fluid integrity of the instrument lumen <NUM>.

The cannula body <NUM> includes slots <NUM> formed in an outer surface thereof (e.g., outer wall <NUM>). Each slot <NUM> is associated with a clip retention feature <NUM>. Each ligation clip <NUM> is accessible by a clip applier (e.g., a ligation clip application device) through a respective slot <NUM>. The use of separate slots <NUM> each employing a separate clip retention feature <NUM> allows each ligation clip <NUM> to be individually securely removed by the clip applier.

The first arm <NUM> of each ligation clip <NUM> includes a first boss <NUM> and the second arm <NUM> of each ligation clip <NUM> includes a second boss <NUM>. The first boss <NUM> and the second boss <NUM> are each coupled to a clip retention feature <NUM>. Thus, the first and second bosses <NUM> and <NUM> may be employed for securing the ligation clips <NUM> to corresponding clip retention features <NUM> in corresponding slots <NUM>.

The slots <NUM> may be covered by a sheath <NUM> positioned about the cannula body <NUM>. As an example, the sheath <NUM> may include or may be formed of plastic. The sheath <NUM> may assist in guiding an end effector <NUM> of a ligation clip application device <NUM> into a desired slot <NUM>, and may assist in maintaining ligation clips <NUM> within slots <NUM>.

The slots <NUM> may each be located proximate a distal end portion <NUM> of the cannula body <NUM>. As an example, the clip stack <NUM> may include a stack of six ligation clips <NUM> and a six corresponding slots <NUM>.

The cannula <NUM> and cannula body <NUM>, or the cannula <NUM> and cannula body <NUM> may be configured for bladeless insertion by employing a distal tip having bladeless insertion geometry (see, e.g., <FIG>), in the manner of an obturator or the like.

<FIG> illustrates removal of a single ligation clip <NUM> through a single slot <NUM> by a ligation clip application device <NUM>. The ligation clip application device <NUM> may include an end effector <NUM> having a first arm <NUM> and a second arm <NUM>. The first arm <NUM> may grasp a first arm <NUM> of the ligation clip <NUM> and the second arm <NUM> may grasp a second arm <NUM> of the ligation clip <NUM>. The bosses <NUM> and/or <NUM> may be employed by the end effector <NUM> for grasping the ligation clip <NUM>. The hinge <NUM> of the ligation clip <NUM> allows flexing of the first and second arms <NUM> and <NUM> toward or away from each other to detach the ligation clip <NUM> from the clip retention feature <NUM>. Thus, the ligation clip <NUM> may be freed from the clip retention feature <NUM> and retracted out of slot <NUM> while being securely grasped by end effector <NUM> of ligation clip application device <NUM>.

<FIG> is a flowchart illustrating a method of robotic intra-abdominal clip loading. The method includes robotically introducing the intra-cavity clip loading device <NUM> having the clip stack <NUM> into an intra-abdominal space (step <NUM>; see, e.g., <FIG> - intra-cavity space <NUM>). The method includes introducing a robotic ligation clip application device <NUM> into the intra-abdominal space (step <NUM>). The end effector <NUM> of the ligation clip application device <NUM> is robotically inserted into a portion (e.g., a slot <NUM>) of the clip stack <NUM> (step <NUM>). The end effector <NUM> of the ligation clip application device <NUM> grasps the ligation clip <NUM> (step <NUM>). The end effector <NUM> of the ligation clip application device <NUM> is withdrawn to remove the ligation clip <NUM> from the clip stack <NUM> (step <NUM>; see, e.g., <FIG>).

The end effector <NUM> of the ligation clip application device <NUM> is robotically inserted into the slot <NUM> of the clip stack <NUM> to grasp the ligation clip <NUM>. The end effector <NUM> may be robotically inserted into the slot <NUM> (e.g., at a location proximate the distal end portion <NUM> of the cannula body <NUM>). The first arm <NUM> and the second arm <NUM> of the end effector <NUM> may be inserted into the portion (e.g., the slot <NUM>) of the clip stack <NUM> to grasp the ligation clip <NUM>. The first arm <NUM> and the second arm <NUM> of the ligation clip application device <NUM> separates the ligation clip <NUM> from the clip retention feature <NUM>.

The various embodiments disclosed herein may also be configured to work with robotic surgical systems and what is commonly referred to as "Telesurgery. " Such systems employ various robotic elements to assist the surgeon and allow remote operation (or partial remote operation) of surgical instrumentation. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the surgeon during the course of an operation or treatment. Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc..

The robotic surgical systems may be employed with one or more consoles that are next to the operating theater or located in a remote location. In this instance, one team of surgeons or nurses may prep the patient for surgery and configure the robotic surgical system with one or more of the instruments disclosed herein while another surgeon (or group of surgeons) remotely controls the instruments via the robotic surgical system. As can be appreciated, a highly skilled surgeon may perform multiple operations in multiple locations without leaving his/her remote console which can be both economically advantageous and a benefit to the patient or a series of patients.

The robotic arms of the surgical system are typically coupled to a pair of master handles by a controller. The handles can be moved by the surgeon to produce a corresponding movement of the working ends of any type of surgical instrument (e.g., end effectors, graspers, knifes, scissors, etc.) which may complement the use of one or more of the embodiments described herein. The movement of the master handles may be scaled so that the working ends have a corresponding movement that is different, smaller or larger, than the movement performed by the operating hands of the surgeon. The scale factor or gearing ratio may be adjustable so that the operator can control the resolution of the working ends of the surgical instrument(s).

The master handles may include various sensors to provide feedback to the surgeon relating to various tissue parameters or conditions, e.g., tissue resistance due to manipulation, cutting or otherwise treating, pressure by the instrument onto the tissue, tissue temperature, tissue impedance, etc. As can be appreciated, such sensors provide the surgeon with enhanced tactile feedback simulating actual operating conditions. The master handles may also include a variety of different actuators for delicate tissue manipulation or treatment further enhancing the surgeon's ability to mimic actual operating conditions.

<FIG> illustrates a medical work station shown generally as work station <NUM> and generally may include a plurality of robot arms <NUM>, <NUM>; a control device <NUM>; and an operating console <NUM> coupled with control device <NUM>. Operating console <NUM> may include a display device <NUM>, which may be set up in particular to display three-dimensional images; and manual input devices <NUM>, <NUM>, by means of which a person (not shown), for example a surgeon, may be able to telemanipulate robot arms <NUM>, <NUM> in a first operating mode.

Each of the robot arms <NUM>, <NUM> may include a plurality of members, which are connected through joints, and an attaching device <NUM>, <NUM>, to which may be attached, for example, a surgical tool "ST" supporting an end effector <NUM>, in accordance with any one of several embodiments disclosed herein, as will be described in greater detail below.

Robot arms <NUM>, <NUM> may be driven by electric drives (not shown) that are connected to control device <NUM>. Control device <NUM> (e.g., a computer) may be set up to activate the drives, in particular by means of a computer program, in such a way that robot arms <NUM>, <NUM>, their attaching devices <NUM>, <NUM> and thus the surgical tool (including end effector <NUM>) execute a desired movement according to a movement defined by means of manual input devices <NUM>, <NUM>. Control device <NUM> may also be set up in such a way that it regulates the movement of robot arms <NUM>, <NUM> and/or of the drives.

Medical work station <NUM> may be configured for use on a patient <NUM> lying on a patient table <NUM> to be treated in a minimally invasive manner by means of end effector <NUM>. Medical work station <NUM> may also include more than two robot arms <NUM>, <NUM>, the additional robot arms likewise being connected to control device <NUM> and being telemanipulatable by means of operating console <NUM>. A medical instrument or surgical tool (including an end effector <NUM>) may also be attached to the additional robot arm. Medical work station <NUM> may include a database <NUM>, in particular coupled to with control device <NUM>, in which are stored, for example, pre-operative data from patient/living being <NUM> and/or anatomical atlases.

Claim 1:
An intra-cavity clip loading device (<NUM>), comprising:
a cannula (<NUM>) including a cannula body (<NUM>) defining an instrument lumen (<NUM>) extending along a longitudinal axis (X-X) of the cannula body; and
a clip stack (<NUM>) defined in the cannula body, the clip stack including:
a plurality of ligation clips (<NUM>) axially arranged about the instrument lumen; and
a plurality of clip retention features (<NUM>) formed in the cannula body, each clip retention feature of the plurality of clip retention features holding a ligation clip (<NUM>) of the plurality of ligation clips, characterized in that:
the cannula body (<NUM>) includes a plurality of slots (<NUM>) formed therein, wherein each slot of the plurality of slots is associated with a clip retention feature (<NUM>) of the plurality of clip retention features, wherein each ligation clip (<NUM>) of the plurality of ligation clips is accessible by a clip applier through a respective slot (<NUM>) of the plurality of slots formed in the cannula body.