Patent Description:
Surgical clips are often applied by clip appliers with a pair of opposing jaws. Currently available clip appliers often secure the clip with two points of contact, for example, the opposing jaws may engage bosses on distal ends of the surgical clip. However, the two points of contact do not provide sufficient stability to the surgical clip, which may cause the surgical clip to become misaligned relative to the clip applier during a surgical procedure, or even fall out. The disclosed methods and systems are directed to mitigating or overcoming one or more of the problems set forth above and/or other problems in the prior art.

The invention is as defined by the appended set of claims. The present invention is directed to a clip applier configured to apply a surgical clip to tissue. The clip applier includes a first jaw member, a second jaw member, and a stabilizing member, each configured to engage the surgical clip. The stabilizing member is configured to move longitudinally with respect to the clip applier from a first position at least partially between the first and second jaw members to a second position at least partially between the first and second jaw members. The stabilizing member has a shaft portion extending from a distal end portion, and first and second sidewalls on laterally opposite sides of the shaft portion, the first and second sidewalls extending vertically between the first and second jaw members and being configured to receive a proximal end of the surgical clip therebetween and be positioned on laterally opposite sides of the surgical clip to stabilize the surgical clip in a lateral direction.

The longitudinal movement of the stabilizing member is constrained to longitudinal movement between the first and second positions.

In order that the disclosure may be readily understood, aspects of this disclosure are illustrated by way of examples in the accompanying drawings.

The same or similar reference numbers are used in the drawings and the following detailed description to refer to the same or similar parts.

The invention will now be described with reference to the figures, in which like reference numerals refer to like parts throughout. In accordance with conventional practice, as used herein, and unless otherwise indicated herein, the term "proximal portion" refers to the specified portion of a device or its component which is generally closer to the medical personnel handling or manipulating the device as it is intended to be used, and the term "distal portion" shall refer to the specified portion of a device or its component which is opposite of the proximal portion.

The present invention is generally directed to a clip applier configured to increase stability of surgical clips during a medical procedure. The clip applier includes a stabilizing member disposed between first and second jaw members. The stabilizing member and the first and second jaw members may provide at least three points of contact with the surgical clip to prevent relative movement of the surgical clip during the medical procedure. The stabilizing member has vertical walls extending from a distal portion. The vertical walls are positioned on opposing sides of a proximal portion of the surgical clip to reduce lateral movement of the surgical clip. A distal portion of the stabilizing member with the vertical walls may have a width greater than a shaft extending from the distal portion. The increased width of the distal portion may increase stability of the surgical clip between the jaw members, and prevent retraction of the distal portion through the shaft of the clip applier. The stabilizing member may further have lateral protrusions extending between the vertical walls and being configured to reduce vertical movement.

The stabilizing member may be biased into a first, distal position at least partially between the first and second jaw members to facilitate front-loading of the clip applier. The stabilizing member may engage the surgical clip as it is loaded between the first and second jaw members. The stabilizing member may also retract as the surgical clip is fed between the first and second jaw members to a second, proximal position. The second, proximal position is at least partially positioned between the first and second jaw members. The stabilizing member is constrained between the first and second positions, for example, through a pin and channel configuration and/or the greater width of the distal portion. The pin may be a pivot pin of the first and second jaw members, and the channel may extend longitudinally through a shaft of the stabilizing member. The stabilizing member may move from the first position to the second position and from the second position to the first position, but the stabilizing member cannot move distally of the first position or proximally of the second position. The stabilizing member may therefore be configured to apply a sufficient distal stabilizing force when the surgical clip is received between the first and second jaw members of the clip applier during front-loading of the surgical clip from a cartridge. The clip applier may also be configured hold the surgical clip without any bosses. The clip applier may stabilize the surgical clip while being applied to tissue (e.g., to ligate a blood vessel) preventing the surgical clip from fish-tailing.

Aspects of the invention can alternatively be described in the following words: the stabilizing member includes first and second sidewalls configured to stabilize the surgical clip. In some embodiments, the clip applier may include a hinge pin configured to pivotably secure the first and second jaw members, where the stabilizing member may have a longitudinal channel configured to receive the hinge pin, and the hinge pin may be configured to constrain the longitudinal movement of the stabilizing member between the first and second positions. In some embodiments, the stabilizing member may include a tubular portion proximal of the elongate slot and a shaft portion distal of the tubular portion. A width of a distal portion of the stabilizing member may be greater than a width of the shaft portion. In some embodiments, the clip applier may include a spring positioned on a proximal end of the stabilizing member, where the spring is configured to bias the stabilizing member to the first position, and the first position is distal of the second position. In some embodiments, the clip applier may include a shaft secured to proximal ends of the first and second jaw members, the shaft having at least one elongated slot along its length, and the spring being visible through the at least one elongated slot of the shaft. In some embodiments, the clip applier may include a tubular member abutting a proximal end of the spring, where a distal portion of the spring abuts a tubular portion on a proximal portion of the stabilizing member. In some embodiments, the stabilizing member may include a plurality of protrusions on the distal portion, the plurality of protrusions being configured to stabilize the surgical clip in a vertical direction. In some embodiments, the first jaw member may be configured to engage a distal portion of a first leg member of the surgical clip, the second jaw member may be configured to engage a distal portion of a second leg member of the surgical clip, and the stabilizing member may be configured to engage a proximal portion of the surgical clip. In some embodiments, the first jaw member may be configured to engage a first substantially flat surface on the distal portion of the first leg member, and the second jaw member may be configured to engage a second substantially flat surface on the distal portion of the second leg member.

Furthermore, a method of loading a clip applier with a surgical clip is disclosed, the method not being part of the claimed invention. The method may include receiving a proximal portion of the surgical clip between first and second jaw members of the clip applier, and then engaging a stabilizing member with the proximal portion of the surgical clip with the stabilizing member in a first position at least partially between the first and second jaw members. The method may include retracting the stabilizing member to a second position at least partially between the first and second jaw members. The method may further include stabilizing the surgical clip between the stabilizing member and the first and second jaw members.

In some examples of this method not being part of the claimed invention, the longitudinal movement of the stabilizing member is constrained to longitudinal movement between the first position and the second position. In some examples of this method not being part of the claimed invention, stabilizing the surgical clip may include stabilizing the surgical clip in a lateral direction with first and second walls extending from a distal end of the stabilizing member. In some examples of this method not being part of the claimed invention, stabilizing the surgical clip may include stabilizing the surgical clip in a vertical direction with a plurality of protrusions on a distal surface of the stabilizing member. In some examples, the method not being part of the claimed invention may include picking the surgical clip up from a cartridge Aspects of the invention can alternatively be described also in the following words: the stabilizing member includes an elongated body having a proximal portion and a distal portion. The stabilizing member includes first and second sidewalls on the distal portion of the elongated body that are configured to stabilize a proximal portion of a surgical clip in a lateral direction. The stabilizing member further includes a shaft portion of the elongated body extending from the distal portion, where a width of the distal portion including the first and second walls may be greater than a width of the shaft portion.

In some embodiments, the stabilizing member may further include a longitudinal channel extending through the elongated body. In some embodiments, the shaft portion may have a substantially rectangular cross-section. In some embodiments, the stabilizing member may include a tubular portion of the elongated body forming the proximal portion. In some embodiments, the stabilizing member may include a plurality of protrusions on the distal portion that may be configured to stabilize the proximal portion of the surgical clip in a vertical direction.

<FIG> illustrate a clip applier <NUM> configured to apply a surgical clip <NUM> according to the present disclosure. The clip applier <NUM> may include a proximal portion 100A and a distal portion 100B. The clip applier <NUM> may further include a handle mechanism <NUM>, a shaft <NUM>, and includes a jaw structure <NUM>. The jaw structure <NUM> may be pivotally connected to the shaft <NUM> and actuated by the handle mechanism <NUM>.

The jaw structure <NUM> includes a first jaw member <NUM> and a second jaw member <NUM> which may be pivotally coupled at a hinge mechanism <NUM> having a pivot pin <NUM>. The jaw structure <NUM> may receive the surgical clip <NUM> between the first and second jaw members <NUM>, <NUM>, and the first and second jaw members <NUM>, <NUM> may stabilize the surgical clip <NUM> at points of contact on distal portions of first and second leg members <NUM>, <NUM>. The jaw members <NUM>, <NUM> may have engaging surfaces <NUM> at distal ends. The engaging surfaces <NUM> may be substantially flat and/or hook shaped and may be configured to releasably engage distal ends of leg members <NUM>, <NUM> of the surgical clip <NUM> without bosses. The jaw structure <NUM> may also be configured to compress the surgical clip <NUM> by applying opposing forces on the first and second leg members <NUM>, <NUM>. The jaw structure <NUM> may be actuated by an actuator <NUM> advanced and retracted by the handle mechanism <NUM>, as illustrated in <FIG>. The actuator <NUM> may have projections <NUM> on a distal end configured to be received within linear, angled slots <NUM> on proximal ends of each of the first and second jaw members <NUM>, <NUM>. The actuator <NUM> may open the jaw structure <NUM> when the projections <NUM> are in a proximal position within the slots <NUM>, and the actuator <NUM> may close the jaw structure <NUM> when the projections are in a distal position within the slots <NUM>. The actuator <NUM> may be biased into the proximal position to open the jaw members <NUM>, <NUM>.

The clip applier <NUM> further includes a stabilizing member <NUM> configured to be received between the first and second jaw members <NUM>, <NUM> and to provide additional stability to the surgical clip <NUM>. The stabilizing member <NUM> may be spring-loaded to apply a distal force on a proximal portion of the surgical clip <NUM>, applying a distal pressure to the surgical clip <NUM> against the first and second jaw members <NUM>, <NUM>. The stabilizing member <NUM> is configured to move longitudinally between a first, distal position at least partially between the first and second jaw members <NUM>, <NUM> and a second, proximal position at least partially between the first and second jaw members <NUM>, <NUM>. The stabilizing member <NUM> is constrained to longitudinal movement between the first and second positions to ensure that suitable pressure is applied by the stabilizing member <NUM> to the surgical clip <NUM>. The stabilizing member <NUM> may be positioned symmetrically between the first and second jaw members <NUM>, <NUM>. The positioning of the stabilizing member <NUM> may allow a user to pick up the surgical clip <NUM> from a cartridge <NUM> with the clip applier <NUM> in either of two opposite orientations. For example, the first jaw member <NUM> may engage with either of the first leg member <NUM> or the second leg member <NUM> of the surgical clip <NUM>, while the second jaw member <NUM> engages with the other of the first leg member <NUM> and the second leg member <NUM>. The clip applier <NUM> may also pick up the surgical clip <NUM> with bosses, rather the surgical clip <NUM> may be engaged between the stabilizing member <NUM> and the engaging surfaces <NUM>.

The stabilizing member <NUM> may be biased distally by a spring member <NUM> disposed between the stabilizing member <NUM> and a tubular member <NUM>. The spring member <NUM> may be compressed as the stabilizing member <NUM> is retracted when the surgical clip <NUM> is received within the first and second jaw members <NUM>, <NUM>. The spring member <NUM> may provide a distal force to the stabilizing member <NUM> to engage the surgical clip <NUM>. The spring member <NUM> may also be further compressed as the surgical clip <NUM> is compressed, allowing lengthening of the leg members <NUM>, <NUM> when latching in a closed configuration. As depicted in <FIG>, <FIG>, internal components (e.g., the spring member <NUM>) may be exposed and/or visible through elongated slots <NUM> extending through the shaft <NUM>. The elongated slots <NUM> may allow for inspection, cleaning, and/or flushing of the internal components without disassembly of the clip applier <NUM>. The actuator <NUM> may extend through the shaft <NUM>, the tubular member <NUM>, and the spring member <NUM> to engage the slots <NUM> of each of the first and second jaw members <NUM>, <NUM>.

As further depicted in <FIG>, the stabilizing member <NUM> may include an elongated body having a tubular portion <NUM> on and forming a proximal portion and a shaft portion <NUM> distal of the tubular portion <NUM>. The tubular portion <NUM> may be received in the shaft <NUM> and have a proximal end that abuts the spring member <NUM>. The tubular portion <NUM> may have a lumen configured to receive the actuator <NUM>. The shaft portion <NUM> may have a substantially rectangular cross-section having substantially flat side surfaces configured to be received through longitudinal slot <NUM> on inner surfaces of the first and second jaw members <NUM>, <NUM>. The shaft portion <NUM> may therefore extend into an opening between the first and second jaw members <NUM>, <NUM>. A distal face <NUM> distal of the shaft portion <NUM> may engage the proximal portion (e.g., a hinge portion <NUM>) of the surgical clip <NUM>. The distal face <NUM> may be on a distal end portion of the stabilizing member <NUM> and have a width greater than a width of the longitudinal slot <NUM>, preventing retraction of the distal face <NUM> past the second position and passage through the first and second jaw members <NUM>, <NUM>.

The shaft portion <NUM> may have a longitudinal channel <NUM> that receives the pivot pin <NUM>. The interaction between the pivot pin <NUM> and the longitudinal channel <NUM> may constrain the longitudinal movement of the stabilizing member <NUM> to longitudinal movement between the first and second positions. For example, the pivot pin <NUM> may contact a proximal surface of the longitudinal channel <NUM> when the stabilizing member <NUM> is in the first, distal position, and the pivot pin <NUM> may contact a distal surface of the longitudinal channel <NUM> when the stabilizing member <NUM> is in the second, proximal position. The pivot pin <NUM> may also prevent rotation of the stabilizing member <NUM>. The longitudinal channel <NUM> may be in communication with the lumen of the tubular portion <NUM>. The shaft portion <NUM> may have a neck region with a height less than a height of proximal and distal portions of the shaft portion <NUM>.

As further depicted in <FIG>, the distal face <NUM> may have a distal surface <NUM> with lateral protrusions <NUM> configured to engage with the proximal portion of the surgical clip <NUM>. The distal surface <NUM> may grip the surgical clip <NUM> and/or stabilize the surgical clip <NUM> in a vertical direction when positioned between the first and second jaw members <NUM>, <NUM>. The distal face <NUM> may include vertical walls <NUM> extending on opposing sides of the stabilizing member <NUM>. The vertical walls <NUM> may be configured to receive the proximal end of the surgical clip <NUM>, reducing lateral movement of the surgical clip <NUM>. The distal face <NUM> including the vertical walls <NUM> may have a width greater than the shaft portion <NUM> and the longitudinal slot <NUM> of the first and second jaw members <NUM>, <NUM>, preventing retraction of the distal face <NUM> through the first and second jaw members <NUM>, <NUM>. The vertical walls <NUM> may be substantially parallel, and the protrusions <NUM> may extend therebetween. The vertical walls <NUM> may each have a substantially flat distal surface and a tapered proximal surface joining the shaft portion <NUM>.

The vertical walls <NUM> may not extend the entire height of the distal surface <NUM>.

<FIG> illustrates the surgical clip <NUM> according to a first embodiment of the disclosure. The surgical clip <NUM> may include the first leg member <NUM> and the second leg member <NUM> joined at the hinge portion <NUM>. Each of the first and second leg members <NUM>, <NUM> may include an inner surface <NUM>, <NUM> and an outer surface <NUM>, <NUM>. Each of the inner surfaces <NUM>, <NUM> may include a convex portion <NUM>, <NUM> and a concave portion <NUM>, <NUM>, the concave portions <NUM>, <NUM> being configured to receive the convex portions <NUM>, <NUM> in a closed and/or latched configuration. The convex portions <NUM>, <NUM> may be configured to pinch tissue proximate the hinge portion <NUM> prior to full closure of the surgical clip <NUM>, to allow manipulation and/or retraction of the tissue. Each of the inner surfaces <NUM>, <NUM> may further include a plurality of teeth <NUM>, <NUM> configured to further secure the tissue between the first and second leg members <NUM>, <NUM>.

Each of the first and second leg members <NUM>, <NUM> may also include an engaging surface <NUM>, <NUM> configured to engage the first and second jaw members <NUM>, <NUM> of the clip applier <NUM>. As depicted in <FIG>, the engaging surfaces <NUM>, <NUM> may include substantially flat, distallyfacing surfaces, formed on the outer surfaces <NUM>, <NUM> of the first and second leg members <NUM>, <NUM>. The engaging surfaces <NUM>, <NUM> may be configured to engage the engaging surfaces <NUM> of the jaw members <NUM>, <NUM> when secured in the clip applier <NUM>. Therefore, the surgical clip <NUM> may be secured by the clip applier <NUM> without any circularly, round and/or laterally protruding bosses. The clip applier <NUM> does not require the bosses at the distal end of the surgical clip <NUM>, due to positive locking of the surgical clip <NUM> caused by the distal force applied by the stabilizing member <NUM>. Eliminating the bosses on the surgical clip <NUM> reduces the vertical and/or lateral profile of the surgical clip <NUM>, reducing the space needed and/or trauma caused by the surgical clip <NUM>.

The first leg member <NUM> may include a tip member <NUM>, and the second leg member <NUM> may include a hook member <NUM>. As the surgical clip <NUM> is closed, the hook member <NUM> may deflect around the tip member <NUM> to secure the surgical clip <NUM> in a latched configuration. The first and/or second leg members <NUM>, <NUM> may straighten and/or elongate during the latching process. The engaging surface <NUM> of the first leg member <NUM> may be positioned immediately proximal of the tip member <NUM>, and the engaging surface <NUM> of the second leg member <NUM> may be positioned immediately proximal of the hook member <NUM>. <FIG> illustrates a surgical clip <NUM> according to a second embodiment of the disclosure. The surgical clip <NUM> may include a first leg member <NUM> and a second leg member <NUM> joined at a hinge portion <NUM>. The first leg member <NUM> may have an inner surface <NUM> with a convex curvature, and the second leg member <NUM> may have an inner surface <NUM> with a concave curvature. The concave curvature of the second leg member <NUM> may be configured to receive the convex curvature of the first leg member <NUM> in a latched and/or closed configuration. Each of the inner surfaces <NUM>, <NUM> may further include a plurality of teeth <NUM>, <NUM> configured to further secure the tissue between the first and second leg members <NUM>, <NUM>.

Each of the first and second leg members <NUM>, <NUM> may also include an engaging surface <NUM>, <NUM> configured to engage the first and second jaw members <NUM>, <NUM> of the clip applier <NUM>. As depicted in <FIG>, the engaging surfaces <NUM>, <NUM> may include substantially flat, distallyfacing surfaces, formed on the outer surfaces <NUM>, <NUM> of the first and second leg members <NUM>, <NUM>. The engaging surfaces <NUM>, <NUM> may be configured to engage the engaging surfaces <NUM> of the jaw members <NUM>, <NUM> when secured in the clip applier <NUM>. Therefore, the surgical clip <NUM> may be secured by the clip applier <NUM> without any bosses, as further discussed above.

The first leg member <NUM> may include a tip member <NUM>, and the second leg member <NUM> may include a hook member <NUM>. As the surgical clip <NUM> is closed, the hook member <NUM> may deflect around the tip member <NUM> to secure the surgical clip <NUM> in a latched configuration. The first and/or second leg members <NUM>, <NUM> may straighten and/or elongate during the latching process. The engaging surface <NUM> of the first leg member <NUM> may be positioned immediately proximal of the tip member <NUM>, and the engaging surface <NUM> of the second leg member <NUM> may be positioned immediately proximal of the hook member <NUM>. <FIG> illustrate the clip applier <NUM> being loaded with the surgical clip <NUM> from a cartridge <NUM>. <FIG> illustrates a cutaway view of the clip applier <NUM> as it engages the surgical clip <NUM> positioned in the cartridge <NUM>, and <FIG> illustrates an isometric view of the clip applier <NUM> shortly after removing the surgical clip <NUM> from the cartridge <NUM>. As shown, the three point engagement between the clip applier <NUM> and the surgical clip <NUM> increases the security of the surgical clip <NUM>. Two points of contact occur on the surgical clip <NUM> at distal surfaces of the first and second leg members <NUM>, <NUM>, and a third point of contact is at a proximal portion of the surgical clip <NUM> (e.g., the hinge portion <NUM>). Compression of the spring member <NUM> may provide a distal force by the stabilizing member <NUM> as the surgical clip <NUM> is picked up, such that the surgical clip <NUM> remains positively engaged despite external forces. Only when the clip applier <NUM> fully closes and/or latches the surgical clip <NUM>, does the surgical clip <NUM> become free of the first and second jaw members <NUM>, <NUM>. The first and second jaw members <NUM>, <NUM> may then be opened and removed to leave the surgical clip <NUM> in place. Although <FIG>, and <FIG> illustrate the clip applier <NUM> loaded with the surgical clip <NUM>, it should be readily understood that the clip applier <NUM> may be used with the surgical clip <NUM>.

Claim 1:
A clip applier (<NUM>) configured to apply a surgical clip (<NUM>) to tissue, the clip applier comprising:
first and second jaw members (<NUM>, <NUM>) configured to engage the surgical clip; and
a stabilizing member (<NUM>) configured to engage the surgical clip, the stabilizing member being configured to move longitudinally with respect to the clip applier from a first position at least partially between the first and second jaw members to a second position at least partially between the first and second jaw members, the stabilizing member having a shaft portion (<NUM>) extending from a distal end portion,
and first and second sidewalls on laterally opposite sides of the shaft portion, the first and second sidewalls extending vertically between the first and second jaw members and being configured to receive a proximal end of the surgical clip therebetween and be positioned on laterally opposite sides of the surgical clip to stabilize the surgical clip in a lateral direction,
wherein longitudinal movement of the stabilizing member is constrained to longitudinal movement between the first and second positions.