The present disclosure relates generally to clip appliers, and more particularly, to clip appliers with improved actuation mechanisms and/or stabilizing members configured to stabilize a surgical clip.
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 in 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 clip appliers, such as stability of the surgical clip in a clip applier and/or ease of actuation. 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. Furthermore, current clip appliers often do not provide sufficient closing force and/or reliable opening of the jaws. 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.
A first aspect of the present invention is directed to a clip applier configured to apply a surgical clip. The clip applier may include a first jaw member and a second jaw member. The first jaw member may include a first inner surface and a first stabilizing member extending from the first inner surface, and may be configured to engage a distal portion of a first leg member of the surgical clip. The second jaw member may include a second inner surface and a second stabilizing member extending from the second inner surface. The second jaw member may be configured to engage a distal portion of a second leg member of the surgical clip. The first stabilizing member and the second stabilizing member may be configured to be positioned on opposite lateral sides of a proximal portion of the surgical clip to reduce lateral movement of the surgical clip.
A second aspect of the present invention is directed to an assembly including a surgical clip having a first leg member and a second leg member, and a clip applier. The clip applier may include a first jaw member and a second jaw member. The first jaw member may include a first inner surface and a first stabilizing member extending from the first inner surface, and may be configured to engage a distal portion of the first leg member of the surgical clip. The second jaw member may include a second inner surface and a second stabilizing member extending from the second inner surface. The second jaw member may be configured to engage a distal portion of the second leg member of the surgical clip. The first stabilizing member and the second stabilizing member may be configured to be positioned on opposite lateral sides of a proximal portion of the surgical clip to reduce lateral movement of the surgical clip.
In some embodiments, an inner portion of the first stabilizing member is spaced apart from the second jaw member in an open configuration, and an inner portion of the second stabilizing member is spaced apart from the first jaw member in the open configuration. In some embodiments, the first jaw member has a first channel in the first inner surface, and the second jaw member has a second channel in the second inner surface, where the first channel does not receive the second stabilizing member in the open configuration, the first channel receives the second stabilizing member in a closed configuration, the second channel does not receive the first stabilizing member in the open configuration, and the second channel receives the first stabilizing member in the closed configuration. In some embodiments, the first channel has a widened proximal portion configured to receive the second stabilizing member, and the second channel has a widened proximal portion configured to receive the first stabilizing member. In some embodiments, the first stabilizing member includes a first wall extending longitudinally along the first inner surface, the second stabilizing member includes a second wall longitudinally extending along the second inner surface, and the first wall and the second wall are disposed on opposite lateral sides of a longitudinal axis of the clip applier. In some embodiments, each of the first stabilizing member and the second stabilizing member has at least one substantially flat lateral surface. In some embodiments, the first stabilizing member and the second stabilizing member extend substantially parallel in the open configuration and the closed configuration. In some embodiments, the first stabilizing member and the second stabilizing member laterally overlap in the closed configuration. In some embodiments, the first stabilizing member and the second stabilizing member do not laterally overlap in the open configuration.
In some embodiments, each of the first stabilizing member and the second stabilizing member has an inner portion defining an apex extending distally in the open configuration. In some embodiments, the first inner surface has at least one first recess on a distal portion configured to receive a first boss on the first leg member of the surgical clip, and the second inner surface has at least one second recess on a distal portion configured to receive a second boss on the second leg member of the surgical clip. In some embodiments, the first stabilizing member is integral to the first jaw member, and the second stabilizing member is integral to the second jaw member. In some embodiments, the first stabilizing member and the second stabilizing member are configured to not proximally contact a proximal end of the surgical clip in the open configuration.
A third aspect of the invention is directed to a clip applier configured to apply a surgical clip. The clip applier may include a first jaw member and a second jaw member, where the first jaw member is configured to pivot between an open configuration and a closed configuration. The clip applier may also include a leaf spring configured to bias the first jaw member into the open configuration, and a tubular member configured to advance over the first jaw member to cam the first jaw member into a closed configuration against the bias of the leaf spring.
In some embodiments, the clip applier has a second leaf spring configured to bias the second jaw member into an open configuration, where the second jaw member is configured to pivot between the open configuration and the closed configuration, and the tubular member is configured to advance over the second jaw member to cam the second jaw member into the closed configuration against the bias of the second leaf spring. In some embodiments, the leaf spring overlaps with a proximal portion of the first jaw member to bias the first jaw member into the open configuration, and the second leaf spring overlaps with a proximal portion of the second jaw member to bias the second jaw member into the open configuration. In some embodiments, the proximal portion of each of the first and second jaw members includes a proximal extension angled relative to a longitudinal axis of the clip applier. In some embodiments, the proximal extension extends from only one lateral side of the respective first and second jaw member. In some embodiments, the first jaw member and the second jaw member each has a proximal portion and a distal portion, the proximal portion having a width less than the distal portion and configured to be received in the tubular member. In some embodiments, the clip applier has a connector disposed in the tubular member, where the leaf spring and the second leaf spring are disposed on opposite lateral sides of the connector. In some embodiments, a proximal portion of the leaf spring and a proximal portion of the second leaf spring are fixed to the connector. In some embodiments, at least one of the first jaw member and the second jaw member is pivotably coupled to the connector. In some embodiments, the first jaw member is pivotably coupled to the connector at a first pivot pin, and the second jaw member is pivotably coupled to the connector at a second pivot pin. In some embodiments, the proximal portion of at least one of the first jaw member and the second jaw member straddles a distal portion of the connector. In some embodiments, the tubular member includes a distal portion and a proximal portion, the distal portion having a larger diameter than the proximal portion, where the distal portion is configured to cam the first jaw member and second jaw member into the closed configuration. In some embodiments, the connector has a pin, the tubular member has an elongated slot, where the pin travels through the elongated slot as the tubular member advances. In some embodiments, the pin of the connector is fixed to a shaft receiving the tubular member. In some embodiments, the clip applier includes a shaft, a handle assembly on a proximal end of the shaft, and an actuator extending through the shaft and actuated by the handle assembly, where the actuator is configured to advance through the shaft to advance the tubular member over the first jaw member and the second jaw member.
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” refers to the relative positioning of a clip applier or component generally closer to a user or medical personnel handling or manipulating the device as it is intended to be used, and the term “distal” refers to the relative positioning of the clip applier or component further from the user or medical personnel handling or manipulating the device as it is intended to be used. The term “vertical” refers to a relative direction of the clip applier parallel or along a plane extending evenly through both jaw members or similarly to the component. The term “longitudinal” refers to a relative direction along a long axis or length of the clip applier or component. The term “lateral” refers to a relative direction parallel to or along a plane extending perpendicularly between the first and second jaw members or similarly to the component.
As illustrated in
The stabilizing members 126, 136 may or may not laterally overlap each other in the open configuration (e.g.,
As illustrated in
The surgical clip 50 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 50 may be constructed from any suitable biocompatible material, such as metals and polymers. In some embodiments, the surgical clip 50 consists of 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. Exemplary embodiments and features of the surgical clip 50 are further disclosed in U.S. Pat. No. 4,834,096, the disclosure of which is incorporated herein by reference in its entirety.
As illustrated in
One of the proximal members 144 of each of the jaw members 110, 112 may further include a proximal extension 148 proximal of the pivot pin 146 and angled relative to the longitudinal axis of the clip applier 100. The proximal extensions 148 may be leg extensions extending from one proximal member 144 further proximally than the opposing proximal member 144 of the same jaw member 110, 112. The proximal extensions 148 of the first and second jaw members 110, 112 may laterally cross each other at the longitudinal axis of the clip applier 100. Only one of the proximal members 144 of each jaw member 110, 112 max have a proximal extension 148 to enable pivoting by the respective leaf spring 140 and preventing interference by the opposing jaw member 110, 112. The proximal extension 148 may extend from only one lateral side of the respective first and second jaw member 110, 112. Thus, the proximal extensions 148 of the jaw members 110, 112 may extend on opposing lateral sides of the connector 142. The proximal extensions 148 may include an upper surface 149 angled relative to the longitudinal axis. The leaf springs 140 may overlap with or symmetrically lay radially on top of the angled surface of each of the proximal extension 148 of the jaw members 110, 112 in both of the open configuration (
The tubular member 114 may be actuated by longitudinal movement of an actuator 150. The actuator 150 may be an actuating shaft extending through the lumen 108 of the shaft 104 and connected to the handle assembly 106. Squeezing or compressing of the second handle member 118 relative to the first handle member 116 may cause longitudinal advancement of the actuator 150 that causes longitudinal advancement of the tubular member 114 to cam the proximal members 144 of the jaw assembly 102 into the closed configuration against the bias of the leaf springs 140. Release of the second handle member 118 may release the distal force applied to the tubular member 114, such that the bias of the leaf springs 140 may open the jaw members 110, 112 to longitudinally retract the tubular member 114. The tubular member 114 may have a distal portion 152 and a proximal portion 154, where the distal portion 152 has a larger diameter than the proximal portion 154. The distal portion 152 may extend distally of the shaft 104 and may have a diameter that is substantially the same as the diameter of the shaft 104. Thus, the proximal end of the distal portion 152 may abut the distal portion of the shaft 104 when the jaw assembly 102 are in an open configuration (as illustrated in
The proximal portion 154 of the tubular member 114 may be slideably received in the lumen 108 of the shaft 104. The proximal portion 154 may be secured to the actuator 150 by receiving the actuator 150 in a lumen of the proximal portion 154 and/or mating one or more radial projections of the actuator 150 with one or more proximal slots in or on the proximal portion 154. The proximal portion 154 may receive the proximal end of the connector 142 in a distal opening and include an elongated slot 160 along its length that receives a pin 162 on the connector 142. Longitudinal movement of the tubular member 114 relative to the connector 142 may cause the pin 162 to slide longitudinally through the elongated slot 160. The pin 162 may be fixedly secured (e.g., welded) to the shaft 104 to stabilize the connector 142. For example, the pin 162 may extend through and be welded into an elongated slot 164 of the shaft 104 that overlaps with the elongated slot 160 of the tubular member 114. The overlap of the elongated slots 160, 164 may allow visibility of the relative longitudinal position and/or movement of the tubular member 114 during actuation of the jaw assembly 102.
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 application claims the benefit of priority of U.S. Provisional Application No. 62/906,585 (filed Sep. 26, 2019), and is a continuation-in-part of International (PCT-WIPO) patent application Ser. No. 19/053145 (filed Sep. 26, 2019), which claims the benefit of priority to 62/737,043 (filed Sep. 26, 2018), and is continuation-in-part of international (PCT-WIPO) patent application Ser. No. 19/042390 (filed Jul. 18, 2019), which claims the benefit of priority to Provisional Application No. 62/700,031 (filed Jul. 18, 2018), and is a continuation-in-part of U.S. patent application Ser. No. 15/927,763 (filed Mar. 21, 2018), which claims the benefit of priority to U.S. Provisional Application No. 62/474,544 (filed Mar. 21, 2017), and is a continuation-in-part of U.S. patent application Ser. No. 15/927,885 (filed Mar. 21, 2018), which claims the benefit of priority to U.S. Provisional Application No. 62/474,535 (filed Mar. 21, 2017), and is a continuation-in-part of U.S. patent application Ser. No. 15/927,774 (filed Mar. 21, 2018), which claims the benefit of priority to U.S. Provisional Application No. 62/474,538 (filed Mar. 21, 2017) and to U.S. Provisional Application No. 62/627,536 (filed Feb. 7, 2018), and is a continuation-in-part of U.S. patent application Ser. No. 15/927,660 (filed Mar. 21, 2018), which claims the benefit of priority to U.S. Provisional Application No. 62/474,505 (filed Mar. 21, 2017), and is a continuation-in-part of U.S. patent application Ser. No. 15/927,408 (filed Mar. 21, 2018), which claims the benefit of priority to U.S. Provisional Application No. 62/474,523 (filed Mar. 21, 2017), the disclosures of all the above-mentioned applications are incorporated herein by reference in their entireties.
Number | Date | Country | |
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62906585 | Sep 2019 | US | |
62474544 | Mar 2017 | US | |
62474535 | Mar 2017 | US | |
62474538 | Mar 2017 | US | |
62627536 | Feb 2018 | US | |
62474505 | Mar 2017 | US | |
62474523 | Mar 2017 | US | |
62700031 | Jul 2018 | US | |
62737043 | Sep 2018 | US |
Number | Date | Country | |
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Parent | 15927763 | Mar 2018 | US |
Child | 17033199 | US | |
Parent | 15927885 | Mar 2018 | US |
Child | 15927763 | US | |
Parent | 15927774 | Mar 2018 | US |
Child | 15927885 | US | |
Parent | 15927660 | Mar 2018 | US |
Child | 15927774 | US | |
Parent | 15927408 | Mar 2018 | US |
Child | 15927660 | US | |
Parent | PCT/US2019/042390 | Jul 2019 | US |
Child | 15927408 | US | |
Parent | PCT/US2019/053145 | Sep 2019 | US |
Child | PCT/US2019/042390 | US |