Patent Application
20180271535
The present disclosure relates generally to clip applier devices, and more particularly, to clip applier devices having replaceable tips configured to secure surgical clips.
Ligation of tissue (e.g., blood vessels, lymph nodes, nerves, fallopian tubes, and cardiac tissue) is a common practice for many surgical procedures. This can be performed by closing the vessel with a surgical clip or by suturing the vessel with the surgical thread. The use of surgical thread requires complex manipulations of a needle and surgical thread to form knots required to secure the vessel. Such complex manipulations are time consuming and difficult to perform, particularly endoscopic surgical procedures characterized by limited space and/or visibility. In contrast, surgical clips are relatively quick and easy to apply. Accordingly, the use of surgical clips in endoscopic and open surgical procedures has grown dramatically.
The present inventors recognize that there is a need to improve one or more features of the surgical clips, such as stability of the surgical clip in a clip applier. Currently available clip appliers often secure the clip with two points of contact between opposing jaws of the clip applier and leg members of the clip. This engagement is insufficient because the clip can often rotate to become laterally misaligned or even fall out of the clip applier during use. Furthermore, each of the points of contact often relies on a snap or interference fit between a boss member on the clip and a recess on the clip applier. The recess can often loosen after multiple uses, which would even further reduce the stability of the clip. The disclosed methods and devices are directed to mitigating or overcoming one or more of the problems set forth above and/or other problems in the prior art.
A first aspect of the present disclosure is directed to a method of securing a clip to a clip applier having first and second jaw members. The method may include engaging a first applier tip with the first jaw member, and engaging a second applier tip with the second jaw member. The method may further include receiving the clip between the first and second jaw members, and securing the clip with the first and second applier tips to the clip applier.
In some embodiments, the method may further include aligning the surgical clip by receiving a proximal portion of the surgical clip between a first protrusion of the first applier tip and a second protrusion of the second applier tip. In some embodiments, securing the surgical clip with the first applier tip may include receiving a first boss member on a first leg member of the surgical clip in a recess of the first applier tip, and securing the surgical clip with the second applier tip may include receiving a second boss member on a second leg member of the surgical clip in a recess of the second applier tip. In some embodiments, the method may further include inserting the first and second jaw members into at least one first compartment of a cartridge to engage the first applier tip and the second applier tip, and inserting the first and second jaw members into a second compartment of the cartridge to receive the surgical clip between the first and second jaw members. In some embodiments, the method may include inserting the first jaw member into a first sleeve portion of the first applier tip; and inserting the second jaw member into a second sleeve portion of the second applier tip. In some embodiments, engaging the first applier tip may include releasably securing an engaging member on the first applier tip to an engaging member on the first jaw member, and engaging the second applier tip may include releasably securing an engaging member on the second applier tip to an engaging member on the second jaw member. In some embodiments, engaging the first applier tip may include deflecting a first flexible arm of the first applier tip and receiving a projection on the first flexible arm in a recess of the first jaw member, and engaging the second applier tip may include deflecting a second flexible arm of the second applier tip and receiving a projection on the second flexible arm in a recess of the second jaw member. In some embodiments, the method may include approximating the first and second jaw members to compress the surgical clip, removing the first applier tip from the first jaw members, and removing the second applier tip from the second jaw member.
A second aspect of the present disclosure is directed to a clip applier device configured to be loaded with a surgical clip. The clip applier device may include a clip applier having first and second jaw members, a first applier tip releasably secured to the first jaw member, and a second applier tip releasably secured to the second jaw member. The first and second applier tips may be configured to secure the surgical clip between the first and second jaw members.
In some embodiments, the first applier tip may include a first protrusion extending from an inner surface, the second applier tip may include a second protrusion extending from an inner surface, the first and second protrusions may be configured to receive a proximal portion of the surgical clip therebetween to reduce lateral movement of the surgical clip. In some embodiments, the first and second protrusions may extend off-center of a longitudinal axis of the applier tip. In some embodiments, the first applier tip may include a first recess at a distal portion configured to receive a boss member on the first jaw member, and the second applier tip may include a second recess at a distal portion configured to receive a boss member on the second jaw member. In some embodiments, the first applier tip may include a first sleeve portion receiving the first jaw member, and the second applier tip may include a second sleeve portion receiving the second jaw member. In some embodiments, the first sleeve portion may include an engaging member releasably secured to an engaging member of the first jaw member, and the second sleeve portion may include an engaging member releasably secured to an engaging member of the second jaw member. The engaging member of the first sleeve portion may include a first flexible arm having a first projection, the engaging member of the first jaw member may include a first recess receiving the first projection, the engaging member of the second sleeve portion may include a second flexible arm having a second projection, and the engaging member of the second jaw member may include a second recess receiving the second projection. In some embodiments, the first sleeve portion may be on a proximal portion of the first applier tip and extend less than an entire length of the first applier tip, and the second sleeve portion may be on a proximal portion of the second applier tip and extend less than an entire length of the second applier tip.
A third aspect of the present disclosure is directed to an applier tip that may be secured to a jaw member of a clip applier and secure a surgical clip to the clip applier. The applier tip may include a sleeve portion configured to receive the jaw member of the clip applier. The applier tip may also include a protrusion extending from an inner surface and configured to engage a proximal portion of the clip.
In some embodiments, the protrusion may extend off-center of a longitudinal axis of the applier tip. In some embodiments the applier tip may include a recess at a distal portion configured to receive a boss member on the surgical clip. In some embodiments, the engaging member of the sleeve portion may include a flexible arm having a projection configured to engage a recess on the jaw member of the surgical clip applier.
A fourth aspect of the present disclosure is directed to a cartridge. The cartridge may include at least one tip compartment containing an applier tip and a clip compartment containing a surgical clip.
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 may refer to the specified portion of a device or its component which is opposite the proximal portion.
The present invention is generally directed to a clip applier having replaceable applier tips. The applier tips may be securing members configured to be loaded onto jaw members of the clip applier prior to loading a surgical clip onto the clip applier. The applier tips may be releasably secured to the jaw members by receiving the jaw members in a sleeve portion of the applier tips and interlocking an arm on the sleeve portion with a groove on the respective jaw member. After applying one or more of the surgical clips, the applier tips may be removed from the clip applier and disposed of. One or more applier tips may be housed in a common cartridge (but separate compartments) as one or more surgical clips for convenience in loading the clip applier device. The applier tips may be separate and unconnected, when not secured to the clip applier. Regularly replacing the applier tips may ensure sterility and reduce wear of interlocking parts of the applier tips.
The applier tips may provide at least three-points of contact with the surgical clip, which may ensure alignment of the surgical clip and prevent lateral movement (e.g., fishtailing) of the surgical clip during application. The applier tips may have one or more recesses on a distal portion configured to engage a boss member on a distal portion of the surgical clip. The distal portion of the applier tips may include first and second distal extensions from the sleeve portion. Each of the distal extensions may have a recess configured to receive opposing boss members of the surgical clip. The applier tips may also have a protrusion extending from an inner portion of the sleeve portion off-center of the longitudinal axis, such that a proximal end (e.g., a hinge member) of the surgical clip may be received in a space between protrusions of opposing applier tips. The opposing protrusions may prevent the proximal end of the surgical clip from fish-tailing during loading and/or application with the clip applier. The protrusion may be in the shape of a wall or fin and have opposing substantially flat side surfaces. The applier tips may be formed of an inexpensive, disposable plastic, and the clip applier may be formed of a more durable, re-usable metal.
The surgical clip 300 may comprise a first leg member 302 and a second leg member 304 pivotably joined with a hinge member 306. The first leg member 302 may have a generally concave inner surface, a generally convex outer surface, and a hook member 308 on a distal portion. The second leg member 304 may have a generally convex inner surface, a generally concave outer surface, and a tip member 310 on a distal portion. The surgical clip 300 may be configured to be applied to tissue (e.g., ligate a blood vessel) by applying compression to the first and second leg members 302, 304. The hook member 308 may engage and deflect around the tip member 310, while one or both of the first and second leg members 302, 304 straighten and lengthen. The tip member 310 may then be received in the hook member 308 to secure the surgical clip 300 in a latched configuration. Each of the first and second leg members 302, 304, may have one or more boss members 312 on a distal portion configured to engage the applier tips 200. An exemplary embodiment of the surgical clip 300 is further described in U.S. Pat. No. 4,834,096, the disclosure of which is expressly incorporated herein in its entirety. However, it is contemplated that the clip applier device 10 may be configured to apply any number of configurations of the surgical clip 300.
The clip applier 100 may include first and second jaw members 102 pivotably coupled at a hinge member 104. The clip applier 100 may be actuatable between open and closed configurations by any number of handle mechanisms (not shown). The clip applier 100 may also include a biasing mechanism (not shown) configured to bias the jaw members 102 into the open configuration. For example, the biased, open configuration may align the first and second jaw members 102 with apertures of one or more compartments of the cartridge 400 to facilitate loading of the applier tips 200 and/or the surgical clip 300. The jaw members 102 may be configured to not directly contact the surgical clip 300.
Each of the first and second jaw members 102 may be configured to releasably receive an applier tip 200 thereon. The first and second jaw members 102 may include a recess 106 positioned on an outer surface (as further illustrated in
The applier tips 200 (as further illustrated in
As further illustrated in
The protrusion 212 may be configured to align the surgical clip 300 by reducing lateral movement of a proximal portion (e.g., the hinge member 306). The protrusions 212 may extend inwardly front the sleeve portion 202 and off-center of a longitudinal axis of the applier tip 200. Protrusions 212 of opposing applier tips 200 may therefore form a space that receives the proximal portion of the surgical clip 300 and reduces relative movement in either lateral direction. The protrusions 212 may be in the form of a wall or a fin having substantially flat side surfaces that do not hinder closure of the surgical clip 300. The protrusions 212 may also allow the curved leg members to lengthen as the surgical clip 300 closes, and the hook member 308 deflects around the tip member 310. In that sense, the applier tips 200 may not have any portion positioned proximal of the surgical clip 300 that impedes proximal lengthening of the leg members 302, 304. The protrusions 212 may have a tip portion 220 adjacent and substantially parallel with the proximal portion (e.g. the hinge member 306) of the surgical clip 300 when the jaw members 102 are in an open configuration. However, in some embodiments, the tip portions 220 of opposing protrusions 212 may not overlap each other in the open configuration. The tip portion 220 may be formed at the junction of a concave distal portion 222 and a substantially flat angled proximal portion 224. The protrusions 212 may slide vertically along opposing sides of the surgical clip 300, as the jaw members 102 pivot and close the surgical clip 300.
Although
As illustrated in
As further illustrated in
The clip applier 500 may include first and second jaw members 502 pivotably coupled at a hinge member 504. The clip applier 500 may be actuatable between open and closed configurations by any number of handle mechanisms (not shown). The clip applier 500 may also include a biasing mechanism (not shown) configured to bias the jaw members 502 into the open configuration. For example, the biased open configuration may align the jaw members 502 with apertures of one or more of compartments of a cartridge to facilitate the loading of the applier tips 600 and/or the surgical clip 300. The jaw members 502 may be configured to not directly contact the surgical clip 300. Each of the jaw members 502 may be configured to receive an applier tip 600 thereon.
As illustrated in
The applier tips 600 may include a sleeve portion 602 configured to receive the shank portions 505 of the jaw members 502. The sleeve portion 602 may have a flexible arm 606 extending proximally from the sleeve portion 602. The flexible arm 606 may have a projection 608 on its free end. The flexible arm 606 may be pivotably secured to the sleeve portion 602 and configured to deflect outward as one of the shank portion 505 is inserted into the sleeve portion 602. As the shank portion 505 is advanced through the sleeve portion 602, the flexible arm 606 may pivot back toward a relaxed state, such that the projection 608 may be received in the recess 506 to releasably interlock the applier tip 600 to the jaw member 502. The engagement between the applier tips 600 and the jaw members 502 may be sufficient to secure the surgical clip 300 onto the clip applier 500. The applier tips 600 may also be removed and/or disposed of after application of one or more surgical clips 300. As further illustrated in
As further illustrated in
The protrusion 612 may be configured to align the surgical clip 300 by reducing lateral movement of a proximal portion (e.g., the hinge member 306). The protrusions 612 may extend inwardly from the sleeve portion 602 and off-center of a longitudinal axis of the applier tip 600. Protrusions 612 of opposing applier tips 600 may form a space that receives the proximal portion of the surgical clip 300 and reduces relative lateral movement in either lateral direction. The protrusions 612 may be in the form of a wall or a fin having substantially flat side surfaces that do not hinder closure of the surgical clip 300. The protrusions 612 may also allow the curved leg members to length as the surgical clip 300 closes, and the hook member 308 deflects around the tip member, in that sense, the applier tips 600 may not have any portion positioned proximally of the surgical clip 300 that impedes proximal lengthening of the leg members 302, 304. The protrusions 612 may have a tip portion 620 adjacent and substantially parallel with the proximal portion (e.g. the hinge member 306) of the surgical clip 300 when the jaw members 502 are in an open configuration. However, in some embodiments, the tip portions 620 of opposing protrusions 612 may not overlap each other in the open configuration. The tip portion 620 may be formed by a substantially flat angled distal portion 622 and a substantially flat angled proximal portion 624. Each of the flat angled distal and proximal portions 622, 624 may extend distally at an acute angle. The protrusions 612 may slide vertically along opposing sides of the surgical clip 300, as the jaw members 502 pivot and close the surgical clip 300,
Although the
To assemble the clip applier device 20, the applier tips 600 may be initially stored in a tip compartment of a cartridge (e.g., as illustrated in
The various embodiments of the applier tips and clip applier devices may therefore provide at least three-points of contact with the surgical clip. The applier tips may engage the distal portion of the surgical clip with the engagement of the recesses to the boss members, and the applier tips may laterally align the surgical clip by receiving the proximal portion of the surgical clip between the opposing protrusions. The opposing protrusions may reduce lateral movement of the proximal portion and prevent the surgical clip from fish-tailing.
The surgical clip 300 of the present disclosure may be made of any suitable size and may be applied to any number of tissues, such as blood vessels, lymph nodes, nerves, fallopian tubes, or cardiac tissue. The surgical clip 300 may be constructed from any suitable biocompatible material, such as certain metals and polymers. However, the present invention is particularly suitable for practice with polymeric clips. Thus, the surgical clip 300 preferably has a one-piece integral polymeric body formed from a suitable strong biocompatible engineering plastic such as the type commonly used for surgical implants. Exemplary materials include homopolymer or co-polymer polyacetal, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene, or other thermoplastic materials having similar properties that can be injection-molded, extruded or otherwise processed into like articles.
The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.
The present non-provisional patent application claims priority to U.S. Provisional Patent Application No. 62/474,505, filed on Mar. 21, 2017 and entitled “CLIP APPLIER WITH REPLACEABLE TIPS”, the entirety of the disclosure of which is incorporated herein.
| Number | Date | Country | |
|---|---|---|---|
| 62474505 | Mar 2017 | US |
