Surgical Clip Application Device

Abstract

A surgical clip applying device for applying and crimping surgical clips to ligate blood vessels.

Description

[Technical field]

[0001]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 241,288, filed September 7, 2021, the disclosure of which is incorporated herein by reference for all purposes. [Background technology]

[0002] Clip applying devices or clip appliers may be used during microsurgery procedures. Microsurgery encompasses a variety of procedures using a microscope to operate on successively smaller blood vessels, nerves, etc. Traditional suturing techniques in microsurgery have transitioned to the use of surgical clips that are applied to the ends of severed blood vessels or to the junctions of blood vessels. For example, surgical clips hold or close tissue in a manner similar to traditional sutures. Clips used in microsurgery are very small and are usually called microclips. An exemplary microclip may have a size of around 2 mm in height and 2 mm in width.

[0003]

[0003] Microclips are generally applied in surgery by forceps that load and use a single clip at a time. Since several clips may be required for a surgical procedure, a single loading and use device is burdensome for medical professionals. Multiple reloading operations can lead to handling accidents (e.g., dropping clips to the floor, dropping instruments, dropping closed or partially closed clips into wounds), clips being loaded incorrectly, etc. Furthermore, the use of several forceps sets requires cleaning and otherwise maintaining a stock of several forceps.

[0004] SUMMARY OF THE DISCLOSURE The present invention is directed to a surgical microclip applier for use in microsurgery which offers significant advantages over prior art instruments of the type discussed above. Summary of the Invention

[0005]

[0005] The present disclosure provides a surgical clip applying device or clip applier for applying surgical clips to ligate blood vessels during surgery. The clip applier disclosed herein is capable of automatically loading clips that allow a user to ligate multiple blood vessels during surgery. When the user aligns a blood vessel within the jaws of the device and squeezes the device handles, a surgical clip is crimped to ligate the blood vessel aligned within the jaws. When the handles are released, another clip is automatically loaded and ready to ligate another blood vessel.

[0006] In one example, a surgical clip applying device includes an enclosure formed from a top housing, a bottom housing, and a window cover. The clip applying device also includes a pair of handles including a left handle and a right handle, a main rail supporting a jaw closer, and a pair of clip applying jaws fixedly attached to the bottom housing and retained within the main rail. The pair of clip applying jaws have arms terminating in a pair of jaw heads. The clip applying device further includes a clip loader assembly having a clip loading tip at a distal end and a dispenser disposed above the clip loader assembly. The dispenser includes a pair of clip forks and a retaining protrusion disposed between the pair of clip forks at a distal end of the dispenser. The clip loading tip is configured to push a surgical clip supported by the pair of clip forks onto the retaining protrusion. The clip applying device also includes a clip pusher assembly configured to advance a plurality of clips toward the pair of jaw heads, and a drive mechanism including a plurality of levers and at least one spring. The drive mechanism is configured to translate actuation of the pair of handles into linear motion of the jaw closer and clip loader assembly.

[0007]

[0007] The surgical clip applying device or clip applier disclosed herein is expected to provide convenience as compared to devices and systems that require manual loading of individual clips.

[0008] Another advantage of the present disclosure is to provide a surgical clip applying device (eg, a clip applier) having automatic surgical clip reloading.

[0009]

[0009] Additionally, another advantage of the present disclosure is providing a surgical clip applying device (e.g., a clip applier) having a transparent window, thereby allowing a user to easily see the remaining number of surgical clips contained within the device.

[0010] A further advantage of the present disclosure is providing a surgical clip applying device (eg, a clip applier) having multiple touch points, finger loops, and a gripping surface for ambidextrous surgical clip application.

[0011]

[0011] Additional features and advantages of the disclosed surgical clip applying devices (e.g., clip appliers), systems, and methods will be described in and become apparent from the following detailed description and drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those skilled in the art in view of the drawings and description. Also, any particular embodiment need not have all of the advantages recited herein. Furthermore, it should be noted that the language used herein has been selected primarily for readability and descriptive purposes, and is not intended to limit the scope of the inventive subject matter. [Brief description of the drawings]

[0012] [Figure 1A] 1 is a perspective view of an exemplary clip applying device according to the present disclosure; [Figure 1B] 1B is an exploded perspective view of the exemplary clip applying device of FIG. 1A. [Figure 1C] 1 is an exploded perspective view of an alternative embodiment of an exemplary clip applying device according to the present disclosure; [Figure 1D]1 illustrates an exemplary clip applying device in an open configuration according to the present disclosure. [Figure 1E] 1A-1D illustrate an exemplary clip applying device in a closed configuration according to the present disclosure. [Figure 1F] 13A-13C illustrate another alternative embodiment of an exemplary clip applying device according to the present disclosure. [Figure 1G] 13 is another view illustrating another alternative embodiment of the exemplary clip applying device according to the present disclosure. [Figure 1H] 13 is another view illustrating another alternative embodiment of the exemplary clip applying device according to the present disclosure. [Figure 1I] 13 is another view illustrating another alternative embodiment of the exemplary clip applying device according to the present disclosure. [Figure 1J] 13 is another view illustrating another alternative embodiment of the exemplary clip applying device according to the present disclosure. [Figure 1K] 13 is another view illustrating another alternative embodiment of the exemplary clip applying device according to the present disclosure. [Figure 2A] FIG. 13 shows a clip being advanced into the distal end of a clip applying device. [Figure 2B] FIG. 13 is another view showing a clip advancing to the distal end of the clip applying device. [Figure 2C] FIG. 13 is another view showing a clip advancing to the distal end of the clip applying device. [Figure 2D] FIG. 13 is another view showing a clip advancing to the distal end of the clip applying device. [Figure 2E] FIG. 13 is another view showing a clip advancing to the distal end of the clip applying device. [Figure 2F] FIG. 13 is another view showing a clip advancing to the distal end of the clip applying device. [Figure 3A] 1 illustrates an exemplary upper housing according to the present disclosure. [Figure 3B] FIG. 13 illustrates another view of an exemplary upper housing according to the present disclosure. [Figure 3C] FIG. 13 illustrates another view of an exemplary upper housing according to the present disclosure. [Figure 3D] 1 illustrates another exemplary upper housing according to the present disclosure. [Figure 3E] FIG. 13 is another view of another exemplary upper housing according to the present disclosure. [Figure 3F] FIG. 13 illustrates yet another exemplary upper housing according to the present disclosure. [Figure 3G] FIG. 13 is another view of yet another exemplary upper housing according to the present disclosure. [Figure 3H] FIG. 13 is another view of yet another exemplary upper housing according to the present disclosure. [Figure 4A] 1 illustrates an exemplary bottom housing according to the present disclosure. [Figure 4B] FIG. 13 illustrates another view of an exemplary bottom housing according to the present disclosure. [Figure 4C] FIG. 13 illustrates another view of an exemplary bottom housing according to the present disclosure. [Figure 4D] 1 illustrates another exemplary bottom housing according to the present disclosure. [Figure 4E] FIG. 13 illustrates another exemplary bottom housing according to the present disclosure. [Figure 4F] FIG. 13 illustrates another exemplary bottom housing according to the present disclosure. [Figure 4G] 1 illustrates yet another exemplary bottom housing according to the present disclosure. [Figure 4H] FIG. 13 is another view of yet another exemplary bottom housing according to the present disclosure. [Figure 4I] FIG. 13 is another view of yet another exemplary bottom housing according to the present disclosure. [Figure 5A] FIG. 1 illustrates an exemplary main rail according to the present disclosure. [Figure 5B] FIG. 2 illustrates another view of an exemplary main rail according to the present disclosure. [Figure 5C] FIG. 2 illustrates another view of an exemplary main rail according to the present disclosure. [Figure 5D] FIG. 2 illustrates another view of an exemplary main rail according to the present disclosure. [Figure 5E]FIG. 2 illustrates another view of an exemplary main rail according to the present disclosure. [Figure 5F] FIG. 2 illustrates another exemplary main rail according to the present disclosure. [Figure 5G] FIG. 2 illustrates another exemplary main rail according to the present disclosure. [Figure 6A] 1 illustrates an exemplary jaw closer according to the present disclosure; [Figure 6B] FIG. 13 is another view of an exemplary jaw closer according to the present disclosure. [Figure 6C] FIG. 13 is another view of an exemplary jaw closer according to the present disclosure. [Figure 6D] 13 illustrates another exemplary jaw closer according to the present disclosure; [Figure 6E] 13 is another view of another exemplary jaw closer according to the present disclosure; FIG. [Figure 7A] 1 illustrates an exemplary pair of clip applying jaws according to the present disclosure. [Figure 7B] 13 is another view of an exemplary pair of clip applying jaws according to the present disclosure. [Figure 7C] 13 is another view of an exemplary pair of clip applying jaws according to the present disclosure. [Figure 7D] 13 is another view of an exemplary pair of clip applying jaws according to the present disclosure. [Figure 7E] 13 illustrates another exemplary pair of clip applying jaws according to the present disclosure. [Figure 7F] 13 is another view of another exemplary pair of clip applying jaws according to the present disclosure. [Figure 8A] 1 illustrates an exemplary clip loader assembly according to the present disclosure. [Figure 8B] 1 illustrates an exemplary proximal clip loader according to the present disclosure. [Figure 8C] FIG. 13 illustrates another view of an exemplary proximal clip loader according to the present disclosure. [Figure 8D] FIG. 13 illustrates another view of an exemplary proximal clip loader according to the present disclosure. [Figure 8E] FIG. 13 illustrates another view of an exemplary proximal clip loader according to the present disclosure. [Figure 8F] 1 illustrates an exemplary distal clip loader according to the present disclosure. [Figure 8G] FIG. 13 is another view illustrating an exemplary distal clip loader according to the present disclosure. [Figure 8H] FIG. 13 is another view illustrating an exemplary distal clip loader according to the present disclosure. [Figure 8J] FIG. 13 is another view illustrating an exemplary distal clip loader according to the present disclosure. [Figure 8K] 13A-13C illustrate another exemplary distal clip loader assembly according to the present disclosure. [Figure 8L] 13 is another view illustrating another exemplary distal clip loader assembly according to the present disclosure. [Figure 8M] 13 is another view illustrating another exemplary distal clip loader assembly according to the present disclosure. [Figure 8N] 13 illustrates another exemplary proximal clip loader according to the present disclosure. [Figure 8P] 13 is another view illustrating another exemplary proximal clip loader according to the present disclosure. [Figure 8Q] 13 is another view illustrating another exemplary proximal clip loader according to the present disclosure. [Figure 9A] FIG. 1 illustrates an exemplary dispenser according to the present disclosure. [Figure 9B] FIG. 2 illustrates another exemplary dispenser according to the present disclosure. [Figure 9C] FIG. 2 illustrates another exemplary dispenser according to the present disclosure. [Figure 9D] FIG. 2 illustrates another exemplary dispenser according to the present disclosure. [Figure 9E] FIG. 2 illustrates another exemplary dispenser according to the present disclosure. [Figure 9F] FIG. 1 illustrates another exemplary dispenser according to the present disclosure. [Figure 9G] FIG. 13 illustrates another exemplary dispenser according to the present disclosure. [Figure 9H] FIG. 13 illustrates another exemplary dispenser according to the present disclosure. [Figure 9I] FIG. 13 illustrates another exemplary dispenser according to the present disclosure. [Figure 9J] FIG. 1 illustrates yet another exemplary dispenser according to the present disclosure. [Figure 9K] FIG. 13 is another diagram illustrating yet another exemplary dispenser according to the present disclosure. [Figure 9L] FIG. 13 is another diagram illustrating yet another exemplary dispenser according to the present disclosure. [Figure 9M] FIG. 13 is another diagram illustrating yet another exemplary dispenser according to the present disclosure. [Figure 9N] FIG. 13 is another diagram illustrating yet another exemplary dispenser according to the present disclosure. [Figure 10A] 1 illustrates an exemplary clip pusher bar according to the present disclosure. [Figure 10B] FIG. 13 illustrates another view of an exemplary clip pusher bar according to the present disclosure. [Figure 10C] 1 illustrates another exemplary clip pusher bar according to the present disclosure. [Figure 11A] 1 illustrates an exemplary ratchet pawl according to the present disclosure. [Figure 11B] FIG. 13 illustrates another view of an exemplary ratchet pawl according to the present disclosure. [Figure 11C] FIG. 13 illustrates another view of an exemplary ratchet pawl according to the present disclosure. [Figure 11D] FIG. 13 illustrates another view of an exemplary ratchet pawl according to the present disclosure. [Figure 11E] FIG. 13 illustrates another view of an exemplary ratchet pawl according to the present disclosure. [Figure 12A] FIG. 1 illustrates an exemplary trough according to the present disclosure. [Figure 12B] FIG. 13 illustrates another diagram of an exemplary trough according to the present disclosure. [Figure 12C] FIG. 13 illustrates another diagram of an exemplary trough according to the present disclosure. [Figure 12D] FIG. 13 illustrates another diagram of an exemplary trough according to the present disclosure. [Figure 12E] FIG. 13 illustrates another diagram of an exemplary trough according to the present disclosure. [Figure 13A] FIG. 1 illustrates an exemplary window covering of the present disclosure. [Figure 13B] FIG. 2 is another diagram illustrating an exemplary window covering of the present disclosure. [Figure 13C] FIG. 2 is another diagram illustrating an exemplary window covering of the present disclosure. [Figure 13D] FIG. 1 illustrates another exemplary window covering of the present disclosure. [Figure 13E] FIG. 2 is another diagram illustrating another exemplary window covering of the present disclosure. [Figure 13F] FIG. 2 is another diagram illustrating another exemplary window covering of the present disclosure. [Figure 14A] FIG. 2 illustrates an exemplary lever of the present disclosure. [Figure 14B] FIG. 13 illustrates another view of an exemplary lever of the present disclosure. [Figure 15A] FIG. 2 illustrates an exemplary lever of the present disclosure. [Figure 15B] FIG. 13 illustrates another view of an exemplary lever of the present disclosure. [Figure 15C] FIG. 13 illustrates another view of an exemplary lever of the present disclosure. [Figure 16A] 1 illustrates an exemplary lockout clip of the present disclosure. [Figure 16B] FIG. 13 illustrates another view of an exemplary lockout clip of the present disclosure. [Figure 16C] 1 illustrates another exemplary lockout clip of the present disclosure. [Figure 17A] 13A-13D illustrate a clip applier in various orientations while applying a clip according to an example of the present disclosure. [Figure 17B] 11A-11C are further diagrams illustrating a clip applier in various orientations while applying a clip according to an example of the present disclosure. [Figure 17C] 11A-11C are further diagrams illustrating a clip applier in various orientations while applying a clip according to an example of the present disclosure. [Figure 17D] 11A-11C are further diagrams illustrating a clip applier in various orientations while applying a clip according to an example of the present disclosure. [Figure 17E]11A-11C are further diagrams illustrating a clip applier in various orientations while applying a clip according to an example of the present disclosure. [Figure 17F] 11A-11C are further diagrams illustrating a clip applier in various orientations while applying a clip according to an example of the present disclosure. [Figure 17G] 11A-11C are further diagrams illustrating a clip applier in various orientations while applying a clip according to an example of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013]

[0051] The surgical clip applying devices (eg, clip appliers) for ligating blood vessels described herein provide improved application of surgical clips, automatic reloading of surgical clips, and a safety lockout feature.

[0014]

[0052] 1A and 1B show an exemplary embodiment of a clip applier 100. The clip applier 100 is configured to apply a clip to a surgical site. The clip applier 100 includes a top housing 102, a bottom housing 104, a left handle 106a, and a right handle 106b that together form an enclosure for the clip applier 100. Each of the left handle 106a and the right handle 106b, hereafter generally referred to as handle 106, is pivotally mounted relative to the remainder of the enclosure. The enclosure for the clip applier 100 may be secured to one another by fasteners or other attachment means. Each of the top housing 102, the bottom housing 104, the left handle 106a, and the right handle 106b may be manufactured from molded plastic. As shown in FIG. 1A, the clip applier 100 has a proximal end 101 and a distal end 103 (e.g., a clip application end). Specifically, distal end 103 corresponds to the portion of clip applier 100 where clips are crimped and applied.

[0015]

[0053] The handles 106 cooperate to impart a linear reciprocating motion to the clip application components housed within the enclosure. In one example, the handles 106 are biased to an open position. The handles 106 include a looped body with finger rings, similar to scissors, as shown in FIGS. 1A and 1B. In another example, the handles 106 may instead include a body without a loop, similar to a pair of pliers. In either case, the finger ring of the looped body or the corresponding gripping surface of the non-looped body may be made from or overmolded with a rubber-like material to improve grip and comfort.

[0016]

[0054] The window covering 108 and trough 110 seat on the upper housing 102. The enclosure of the clip applier 100 houses the main rail 120, the jaw closer 130, the clip applying jaw 140, and the clip loader assembly 150, which includes a proximal clip loader 154 and a distal clip loader 152. The clip loader assembly 150 cooperates with the handle 106 and various other internal components such that the distal clip loader 152 moves in a linear reciprocating motion to load a clip into the clip applying jaw 140.

[0017]

[0055] The enclosure of the clip applier 100 also houses a dispenser 160 and a clip pusher assembly 170. The clip pusher assembly 170 includes a clip pusher spring 172 and a clip pusher bar 174. In addition, the clip applier 100 includes a right lever assembly 180a and a left lever assembly 180b. The right lever assembly 180a includes a proximal lever 182a, a distal lever 184a, and a spring 186a. The left lever assembly 180b includes a proximal lever 182b, a distal lever 184b, and a spring 186b.

[0018]

[0056] As discussed in more detail below, right and left lever assemblies 180a, 180b, hereafter generally referred to as lever assemblies 180, move in conjunction with actuation of the handle 106 to control movement of the jaw closer 130 and the clip loader assembly 150. In the open position, the proximal and distal levers 182, 184 are approximately parallel to one another with the clip loader assembly 150 fully advanced (see FIG. 1D). As the handles are transitioned from the open position to the closed position, the proximal and distal levers 182, 184 create a diamond shape, pulling the clip loader assembly 150 back to the retracted position to grasp the next surgical clip. Additionally, as the handles are transitioned from the open position to the closed position, the distal lever 184 pushes the jaw closer 130 forward to close the jaw heads and crimp the surgical clip advanced to the end of the clip applying jaw 140. When the handle is again transitioned from the closed to the open position, the jaw closer 130 retracts to the fully retracted position.

[0019]

[0057] A jaw anchor 190, such as a pin or screw (e.g., a flat head cap screw), couples the clip application jaw 140 to the jaw closer 130 and the main rail 120. Additionally, the anchor 190 secures the clip application jaw 140 and the main rail 120 to the bottom housing 104. As discussed in more detail below, the anchor 190 limits the range of motion of the jaw closer 130. In another example, the jaw anchor 190 may instead be a post formed as part of the bottom housing 104. As shown in FIG. 1B, the jaw anchor 190 is received within a corresponding slot 195 in the lower housing 104.

[0020]

[0058] A handle anchor 191, such as a pin or screw (e.g., a button head cap screw), couples the top housing 102 to the bottom housing 104 near the proximal end of the clip applier 100. As shown in FIG. 1B, the handle anchor 191 is received in a corresponding slot 197 in the lower housing 104.

[0021]

[0059] Clip applier 100 also includes a ratchet pawl 192 that functions as an anti-backup mechanism that cooperates with other clip handling components housed within the enclosure for clip applier 100. As shown in FIG. 1B, ratchet pawl 192 cooperates with proximal clip loader 154 such that proximal clip loader 154 moves in a linear reciprocating motion. Ratchet pawl 192 includes a pawl pin that is disposed through corresponding openings in jaw closer 130 and main rail 120 before being received within corresponding slots 193 in lower housing 104.

[0022]

[0060] The clip applier 100 may also include various attachment mechanisms, such as a set of right and left pins 194a and 194b that fixedly attach one end of the levers to their corresponding handles. For example, the set of pins 194a fixedly attaches one end of each of the proximal and distal levers 182a and 184a to the left handle 106a. Similarly, the set of pins 194b fixedly attaches one end of each of the proximal and distal levers 182b and 184b to the right handle 106b. The clip applier 100 may also include a set of screws 196 that connect the top housing 102 to the bottom housing 104. The pins 194a, 194b (collectively hereinafter pins 193) and the screws 196 are exemplary attachment mechanisms shown in FIG. 1B. It should be understood that the clip applier 100 may include various other attachment means, including other types of fasteners, press-fit connections, adhesives, welding (e.g., electrowelding), and the like.

[0023]

[0061] FIG. 1C illustrates another exemplary embodiment of the clip applier 100. Many of the components illustrated in FIG. 1C may be the same as or have similar features as those illustrated in FIG. 1B. In the illustrated example, the alternative embodiment includes variations of the main rail 120, jaw closer 130, clip applying jaw 140, clip loader assembly 150 (e.g., distal clip loader 152 and proximal clip loader 154), dispenser 160, and the like. These variations are described in more detail and shown in some of the component figures below. The exploded view illustrated in FIG. 1C also illustrates a stack 105 of surgical clips (not depicted in FIG. 1B). Additionally, the alternative embodiment of the clip applier 100 illustrated in FIG. 1C also includes a lockout clip 185.

[0024]

[0062] FIG. 1D shows the clip applier 100 in an open position, and FIG. 1E shows the clip applier 100 in a closed position.

[0025]

[0063] 1F, 1G, 1H, 1I, 1J, and 1K show yet another exemplary embodiment of the clip applier 100. Some of the components of the exemplary embodiment of the clip applier 100 shown in FIGS. 1F-1K may be the same as or have similar features as the corresponding components shown in FIGS. 1B and / or 1C. The alternative embodiment of the clip applier 100 shown in FIGS. 1F-1K includes variations of the top housing 102, bottom housing 104, window cover 108, main rail 120, dispenser 160, and lockout clip 185. These variations are described and / or illustrated in more detail in other exemplary examples of the present disclosure.

[0026]

[0064] FIG 1F illustrates a perspective view of an exemplary clip applier 100. FIG 1G illustrates an exploded view of the exemplary clip applier 100 of FIG 1F. In the illustrated example of FIG 1G, the clip applier 100 includes a left handle assembly 10, a right handle assembly 12, a bottom enclosure assembly 14, a clip dispenser assembly 16, an upper housing 102, and a clip loader assembly 150. More generally, in some examples, one or more portions of the clip applier 100 are implemented as separate subassemblies (e.g., the left handle assembly 10, the right handle assembly 12, the bottom enclosure assembly 14, the clip dispenser assembly 150, etc.) that are then combined to assemble the clip applier 100.

[0027]

[0065] FIG. 1H shows an exploded view of the left handle assembly 10. As best shown in FIG. 1H, the left handle assembly 10 includes a left handle 106a, a proximal lever 182a, a distal lever 184a, a spring 186a, and a pin 194a. In some examples, the length of the distal lever 184a (e.g., a "short link") is shorter than the length of the proximal lever 182a (e.g., a "long link", a "proximal support long link", etc.). In some examples, the left handle assembly 10 can be assembled by sliding the levers 182a and 184a into the left handle 106a and then attaching the levers 182a, 184a to the left handle 106a by pushing the pin 194a into the respective holes in the left handle 106a and / or the levers 182a, 184a. The respective ends of the spring 186a can then be connected to the levers 182a and 184a.

[0028]

[0066] FIG. 1I shows an exploded view of the right handle assembly 12. As best shown in FIG. 1I, the right handle assembly 12 includes a right handle 106b, a proximal lever 182b, a distal lever 184b, a spring 186b, and a pin 194b. In some examples, the length of the distal lever 184b (e.g., a "short link") is shorter than the length of the proximal lever 182b (e.g., a "long link"). In some examples, the right handle assembly 12 can be assembled by sliding the levers 182b and 184b into the right handle 106b and then attaching the levers 182b, 184b to the right handle 106b by pushing the pin 194b into respective holes in the right handle 106b and / or the levers 182b, 184b. The spring 186b can then be connected to the levers 182b and 184b.

[0029]

[0067] FIG. 1J shows an exploded view of the bottom enclosure assembly 14. As best shown in FIG. 1J, the bottom enclosure assembly 14 includes an insert 18, a bottom housing 104 (including a slot 195), a main rail 120, a jaw closer 130, a clip application jaw 140, and a jaw anchor 190. The insert 18 may be a threaded insert or any other type of mechanical coupling device that is received in the slot 195 to facilitate coupling between the bottom housing 104 and the jaw anchor 190. The insert 18 may be formed from any suitable material, such as brass, other metals or metal oxides, plastic, or any other material. In some examples, the jaw anchor 190 is implemented as a screw or flat head screw. In some examples, the bottom enclosure assembly 14 is assembled by inserting (e.g., sliding) the clip application jaw 140 and the jaw closer 130 into the main rail 120. The main rail 120 can then be placed into the bottom housing 104 with the threaded insert 18 aligning with the respective holes in the jaw 140, jaw closer 130, and main rail 120. Thus, in the illustrated example of FIG. 1J, one or more components of the bottom enclosure assembly 14 (i.e., main rail 120, jaw closer 130, and jaw 140) can be attached to the bottom housing 104 (e.g., by coupling or torquing screws 190 into the insert 18 and slots 195). In alternative examples, different attachment mechanisms can be used.

[0030]

[0068] 1K illustrates an exploded view of clip dispenser assembly 16. As best shown in FIG. 1K, clip dispenser assembly 16 includes a stack of surgical clips 105 (exemplified by clip 50), a window covering 108, a dispenser 160, a clip pusher spring 172, a clip pusher bar 174, and a lockout clip 185. In some examples, the clip dispenser assembly 16 is assembled by connecting the clip pusher spring 172 to the clip pusher bar 174 (e.g., by sliding the spring 172 over the pusher bar 174), then connecting the clip pusher bar 174 to the dispenser 160 (e.g., by sliding the combination of the bar 174 and spring 172 into the dispenser 160), then loading the stack of surgical clips 105 and the lockout clip 185 into the dispenser 160, and then attaching the window covering 108 to the dispenser 160. Other attachment mechanisms and / or processes are possible.

[0031]

[0069] As noted above, in some examples, the clip applier 100 can be assembled by coupling together the left handle assembly 10, the right handle assembly 12, the bottom enclosure assembly 14, the clip dispenser assembly 16, the top housing 102, and the clip loader assembly 150. In one particular example, the clip applier 100 of FIGS. 1F-1K is assembled by placing the left handle assembly 10 into the bottom enclosure assembly 14 and securing the distal lever 184a onto the jaw closer 130. The clip loader assembly 150 is then attached by securing the rear hole of the clip loader assembly 150 onto the proximal lever 182a. The right handle assembly 12 is then placed into the assembly of the clip applier 100 by similarly securing the distal lever 184b onto the jaw closer 130. The clip dispenser assembly 16 is then placed into the assembly of the clip applier 100 by aligning the window cover 108 with the main rail 120. In this example, the main rail 120 may then be crimped to the window covering 108. The upper housing 102 may then be attached by pressing it onto the assembly of the clip applier 100. Other exemplary attachment mechanisms are possible.

[0032]

[0070] 2A, 2B, 2C, 2D, and 2E show the movement of various drive components at the distal end 103 of the clip applier 100 while the device delivers and crimps a surgical clip, in accordance with at least one exemplary embodiment herein. FIGURE 2F shows a stack of surgical clips, exemplified by clip 50, that may be provided in a cartridge at the distal end 103 of the clip applier 100, in accordance with at least one exemplary embodiment herein.

[0033]

[0071] 3A, 3B and 3C show top, side and bottom views of upper housing 102. FIG.

[0034]

[0072] 3D and 3E show another exemplary top housing 102 (e.g., top housing 102 of FIG. 1C). Top housing 102 may also include handle pegs 187a and 187b configured to pass through handle slots (e.g., handle slots 183a and 183b shown in FIG. 1C, hereinafter generally referred to as handle slots 183) and couple to corresponding receiving pegs (e.g., receiving pegs 189a and 189b shown in FIG. 4E, hereinafter generally referred to as receiving pegs 189). Handle pegs 187a and 187b, receiving pegs 189, and handle slots 183, hereinafter generally referred to as handle pegs 187, are configured and arranged such that left handle 106a and right handle 106b can pivot relative to an enclosure formed by handle 106, top housing 102, and bottom housing 104. In the example shown in Figures 3D and 3E, the upper housing 102 may incorporate a trough portion (eg, trough 110 of Figures 12A-12E) instead of having a separate trough component.

[0035]

[0073] 3F, 3G, and 3H show top, side, and bottom views of yet another exemplary upper housing 102 (e.g., the upper housing 102 of FIG. 1G). As best shown in FIGS. 3G and 3H, the exemplary upper housing 102 includes handle pegs 187a, 187b, an anchor peg 390, and a number of tabs, exemplified by tab 392. In this example, the upper housing 102 can be attached (e.g., pressed, crimped) to other components of the clip applier 100 by aligning the pegs 187a, 187b, 390, and / or tabs 392, etc., with corresponding receiving features in the bottom housing 104 and / or other components of the clip applier 100. For example, handle pegs 187a and 187b can be received by corresponding receiving pegs (e.g., receiving pegs 189a and 189b shown in FIG. 4I), anchor peg 390 can be received by corresponding receiving slots (e.g., slot 197 shown in FIG. 4I), and multiple tabs (exemplified by tab 392) can align with and / or be received in corresponding recesses (e.g., recess 492 shown in FIG. 4I, etc.).

[0036]

[0074] 4A, 4B, and 4C show top, side, and bottom views of bottom housing 104. As discussed in connection with FIG. 1B, bottom housing 104 includes slots 193, 195, and 197. Slot 193 is adapted to receive and retain a pawl pin of ratchet pawl 192 (e.g., pawl pin 1102 of FIG. 11A) after the ratchet pawl pin passes through corresponding openings in jaw closer 130 and main rail 120. Slot 195 is adapted to receive and retain jaw anchor 190 after jaw anchor 190 passes through corresponding openings in clip application jaw 140, jaw closer 130, and main rail 120. Slot 197 is adapted to receive and retain handle anchor 191.

[0037]

[0075] 4D, 4E, and 4F show another exemplary bottom housing 104 that may include many of the same or similar features as the bottom housing 104 shown in FIGS. 4A, 4B, and 4C. As described above, the bottom housing 104 may include receiving pegs 189a and 189b. The receiving pegs 189 may be sized and shaped to receive and mate with corresponding handle pegs 187 of the top housing 102. Specifically, the handle slots 183 may be positioned through the handle pegs 187 before the handle pegs 187 are positioned (e.g., press-fit) into the receiving pegs 189, thereby creating a pivot point for the handle 106. In one example, the handle pegs 187 and receiving pegs 189 may be snap-fit ​​gripper pins that form a rotation axis or pivot point for the handle 106. In another example, the handle pegs 187 and receiving pegs 189 may be dowel pins and bosses. A snap fit gripper pin may advantageously provide a rotation or pivot point with fewer components.

[0038]

[0076] 4G, 4H, and 41 show bottom, side, and top views of yet another exemplary bottom housing 104 (e.g., bottom housing 104 of FIG. 1J). In this illustrated example, bottom housing 104 includes receiving pegs 189a, 189b, slots 195, slots 197, a plurality of recesses exemplified by tabs 492, and a plurality of protruding edges exemplified by edges 494. In this example, bottom housing 104 can be attached (e.g., pressed, crimped, etc.) to other components of clip applier 100 by aligning pegs 189a, 189b, slots 197, recesses 492, etc. and / or edges 494, etc. with corresponding features in top housing 102 and / or other components of clip applier 100. For example, receiving pegs 189a and 189b can receive corresponding handle pegs (e.g., handle pegs 187a and 187b of FIG. 3H), slot 197 can receive corresponding anchor pegs (e.g., anchor peg 390 of FIG. 3H), and a number of recesses (exemplified by tab 492) can align with and / or receive corresponding tabs (e.g., tab 392 of FIG. 3H, etc.). Further, in this example, edges 494, etc. can be formed to align with and / or receive corresponding edges of upper housing 102 of FIG. 3H.

[0039]

[0077] 5A, 5B, 5C, 5D, and 5E show various views of an exemplary main rail 120. In this example, the main rail 120 includes an elongated base 510 and side walls 520a and 520b that form a channel 530 having a proximal end 501 and a distal end 503. FIG. 5D shows a cross-sectional view of the main rail 120 along line AA in FIG. 5B, showing the channel 530 formed from the base 510 and the side walls 520a, 520b. Near the distal end 503, the side walls 520a and 520b (hereinafter generally referred to as side walls 520) fold over to form flanges 522a and 522b. The flanges, hereinafter generally referred to as flanges 522, are configured to inhibit interaction between the clip applying jaw 140 and the jaw closer 130, thereby preventing disengagement of the clip applying jaw 140 and the jaw closer 130.

[0040]

[0078] Additionally, in this example, the main rail 120 includes an opening or through hole 540 that accommodates the jaw anchor 190. Additionally, in this example, the main rail 120 includes an opening or through hole 550 that accommodates the pawl pin of the ratchet pawl 192. In this example, the main rail 120 also includes a pawl slot 552 for accommodating a pawl flange (see pawl flange 1130 in FIG. 11E ) of the ratchet pawl 192. The pawl slot 552 is sized and shaped to allow the ratchet pawl 192 to pass through the main rail 120 (e.g., flanges 1130a and 1130b of the ratchet pawl 192 in FIG. 11A may pass through the slot 552) while the main rail 120 remains fixedly coupled to the bottom housing 104.

[0041]

[0079] The main rail 120 may be manufactured from plastic or metal. In one example, the main rail 120 is manufactured as a stamped piece of metal. As shown in the detailed view of the example in FIG. 5E, the pawl slot 552 is a curved, oval shaped slot or track that allows the ratchet pawl 192 to rotate within the slot 552.

[0042]

[0080] FIG. 5F illustrates another example of a main rail 120. Similar to the main rail 120 illustrated in FIGS. 5A-5E, the main rail 120 illustrated in FIG. 5F includes a base 510 and side walls 520a and 520b that form a channel 530. The main rail 120 also includes flanges 522a and 522b. The main rail 120 also includes through holes 542a and 542b that may be adapted to position, align, and / or secure the main rail 120. Unlike the main rail illustrated in FIGS. 5A-5E, the main rail 120 illustrated in FIG. 5F may be adapted for use without the ratchet pawl 192.

[0043]

[0081] In this example, the jaw closer 130 is placed within the main rail 120 after the main rail 120 is placed within the lower housing 102. Specifically, the channel 530 is configured to receive the jaw closer 130 located on the base 510 of the main rail 120. The jaw closer 130 is further described and shown in Figures 6A, 6B, and 6C.

[0044]

[0082] FIG. 5G illustrates yet another example of a main rail 120 (e.g., the main rail 120 of FIG. 1J). Similar to the main rail 120 of FIG. 5F, the main rail 120 of FIG. 5G also includes a base 510 and side walls 520a and 520b that form a channel 530, and includes holes 542a and 542b. Additionally, in the example illustrated in FIG. 5G, the main rail 120 also includes a plurality of elongated members, exemplified by elongated members 560a, 560b, 560c (hereinafter generally referred to as elongated members 560). In some examples, the elongated members 560 can be used to mechanically couple the main rail 120 to a window covering (e.g., the window covering 108 of FIG. 1K).

[0045]

[0083] As shown in FIGS. 6A, 6B, and 6C, the jaw closer 130 includes an elongated base 610 having two drive flanges 682 and 684 configured to couple to respective ends of levers 184b and 184a (see FIG. 1B), which will be described in more detail below. The jaw closer 130 has a proximal end 601 and a distal end 603. In addition, the jaw closer 130 includes a slot 640 that receives the jaw anchor 190. The slot 640 is an oval slot adapted to limit the range of motion of the jaw closer 130 by providing front and rear stops 642 and 644 for the jaw anchor 190. Specifically, the jaw closer 130 may move forward toward the distal end 103 of the clip applier 100 until the jaw anchor 190 abuts the rear stop 644. Similarly, the jaw closer 130 can be moved rearwardly toward the proximal end 101 of the clip applier 100 until the jaw anchor 190 abuts the front stop 642 of the slot 640 .

[0046]

[0084] The jaw closer 130 also includes a pawl track 652 for accommodating the locating post 1120 and flanges 1130a and 1130b (see FIG. 11A ) of the ratchet pawl 192. The pawl track 652 is sized and shaped to allow the ratchet pawl 192 to rotate and move freely within the pawl track 652 while the main rail 120 remains fixedly coupled to the bottom housing 104.

[0047]

[0085] The jaw closer 130 also includes an engagement notch 650 having cam members 652a and 652b that cooperate with ramps or protrusions (see FIGS. 7B and 7C) on the clip applying jaw 140. For example, the cam member, hereafter generally referred to as cam member 652, may form a notch 650 that is configured to close the clip applying jaw 140 when the jaw closer 130 is extended toward the distal end 103 (e.g., the clip applying end) of the clip applier 100. As shown in FIG. 6C, which is an enlarged detailed view of the distal end 603 of the jaw closer 130 showing the shape of the engagement notch 650, the engagement notch 650 has a triangular shape. It should be understood that the engagement notch 650 is sized and shaped to cooperate with a corresponding cam surface on the clip applying jaw 140, and thus other shapes, geometries or means for closing the clip applying jaw 140 may be implemented. Like the main rail 120, the jaw closer 130 may be manufactured from plastic or metal. In one example, the jaw closer is manufactured as a stamped piece of metal. In one example, the jaw closer 130 is made from stainless steel (e.g., semi-rigid 304SS).

[0048]

[0086] After the jaw closer 130 is placed within the main rail 120, the clip applying jaw 140 is placed over the jaw closer 130. Specifically, the clip applying jaw 140 is placed over the main rail 120 and secured in place via a jaw anchor 190, which passes through a corresponding slot or through-hole in the clip applying jaw 140 and then through a slot 640 in the jaw closer 130 and a through-hole 540 in the main rail. The jaw anchor 190 secures the clip applying jaw 140 in place by securing it to a corresponding slot 195 in the lower housing 104.

[0049]

[0087] Figures 6D and 6E show an alternative embodiment of the jaw closer 130. In the alternative embodiment (e.g., the jaw closer 130 of Figure 1C), the jaw closer 130 includes many of the same features of the jaw closer 130 shown in Figures 6A-6D. However, in the illustrated example, the jaw closer 130 is shown without the pawl track 652.

[0050]

[0088] Clip applying jaw 140 is further described and shown in Figures 7A, 7B, 7C, and 7D. In the illustrated example, clip applying jaw includes a body portion 710 at a proximal end and arms 720a, 720b (e.g., right arm 720a and left arm 720b) ​​extending from body portion 710 toward a distal end of clip applying jaw 140. Additionally, clip applying jaw 140 includes an opening or through hole 741 that receives jaw anchor 190. Arms 720a and 720b, hereafter generally referred to as arms 720, terminate in cooperating jaw heads 730a, 730b at distal end 703.

[0051]

[0089] Jaw heads 730a, 730b, hereafter generally referred to as jaw head 730, are oriented in a downwardly tilted position. At the end of arm 720 where jaw head 730 begins, jaw head 730 is initially positioned above the arm such that jaw head 730 is stepped above top surface 722 of arm 720 and tilted downward so that the end of jaw head 730 at distal end 703 is approximately in line with bottom surface 724 of arm 720 (see FIG. 7B).

[0052]

[0090] Each respective arm 720 includes a ramp or protrusion (e.g., ramps 740a and 740b) configured to cooperate with a cam member 652 or notch 650 of the jaw closer (see FIGS. 6B and 6C). When ramps 740a and 740b, generally referred to herein as ramps 740, cooperate with notches 650, the clip applying jaw 140 is transitioned to a closed position. In the closed position, the jaw heads 730 are moved toward one another to crimp or pinch a surgical clip. Specifically, as the jaw closer 130 is extended toward the distal end 103 (e.g., the clip applying end) of the clip applier 100, the ramps 740 ride along the cam member 652 of the jaw closer, thereby causing the arms 720 and jaw heads 730 to approach one another.

[0053]

[0091] In the illustrated example, Fig. 7C shows the clip applying jaw 140 in an open configuration with the arms 720 and jaw head 730 spaced apart. Conversely, Fig. 7A shows the clip applying jaw 140 in a closed configuration with the arms 720 and jaw head 730 in a parallel arrangement with a smaller clip gap. For example, the clip gap 760 in Fig. 7C (open position) is larger than the clip gap 760 in Fig. 7A (closed position).

[0054]

[0092] As shown in FIG. 7C, a ramp 740 that functions as a cam surface is located behind each jaw head 730 toward the distal end 703 of the clip applying jaw 140. The ramps 740 may have a triangular shape when pressed together and viewed from above to cooperate with the triangular notch 650 of the jaw closer 130. As the jaw closer 130 retracts, the arms 720 and their corresponding jaw heads 730 are released to return to the open position. In one example, the arms 720 and their corresponding jaw heads 730 are biased (e.g., spring biased) to the open position and only close by interaction with the jaw closer 130. For example, the jaws may have a natural spring bias to the open position and are forced closed when the jaw closer 130 is extended toward the distal end 703 of the clip applying jaw 140 to crimp a surgical clip during surgery.

[0055]

[0093] As shown in FIG. 7D , each jaw head 730 has a recessed channel 761 (e.g., recessed channel 761a on jaw head 730a and recessed channel 761b on jaw head 730b) that cooperate to form a clip track 770. For example, recessed channel 760 or groove is sized and shaped to allow the legs of a surgical clip to slide along channel 760. Clip track 770 formed between jaw heads 730 is configured to provide a track to guide the surgical clip as it advances to distal end 703 of clip applying jaw 140. For example, as discussed in more detail below, when clip applying jaw 140 opens, clip pusher assembly 150 (see FIGS. 2A, 2B, 2C and 8A ) moves toward distal end 703 of clip applying jaw 140, pushing a surgical clip into jaw head 730. More specifically, the clip pusher pushes and positions the surgical clip into a clip track 770 formed by cooperating recessed channels 761 in the jaw head 730. The surgical clip then travels along the clip track 770 until the surgical clip reaches the distal end 703, where the clip applying jaws are transitioned to a closed position to crimp the surgical clip.

[0056]

[0094] Each recessed channel 761 begins with an opening 762 and terminates at a stop surface 764 short of reaching the distal end of the clip applying jaw 140. The openings 762 may be larger than the height or diameter of the channels 761 to aid in aligning and positioning the respective surgical clip legs within the channels 761. The stop surfaces 764 may preferably prevent the surgical clip from progressing beyond the distal end 703 of the clip applying jaw 140 prior to application. For example, without the stop surfaces 764, the surgical clip may inadvertently fall out of the clip applier 100 before the clip applier 100 and clip applying jaw 140 transition to the closed position to crimp and apply the surgical clip to the surgical site.

[0057]

[0095] 7E and 7F show other examples of jaw head 730. Specifically, in alternative embodiments, jaw head 730 may also include recessed channels 761 (e.g., recessed channel 761a on jaw head 730a and recessed channel 761b on jaw head 730b) that cooperate to form clip track 770. For example, as shown in FIG. 7F, a portion of jaw head 730 may be removed, thereby forming a larger opening 762 at the beginning of channel 761. Opening 762 may be larger than the height or diameter of channel 761 to aid in aligning and positioning the respective surgical clip legs within channel 761. Additionally, material removed from jaw head 730 near region 765 may further aid in aligning and positioning the respective surgical clip legs within channel 761.

[0058]

[0096] Once the clip applying jaws 140 are positioned within the enclosure, the clip loader assembly 150 is positioned above the clip applying jaws. As mentioned above, the clip loader assembly 150 includes a proximal clip loader 154 and a distal clip loader 152. The clip loader assembly 150 cooperates with the handle 106 and various other internal components such that the distal clip loader 154 moves in a linear reciprocating motion to load clips into the clip applying jaws.

[0059]

[0097] 8A shows an example of a clip loader assembly 150 having a proximal end 801 and a distal end 803. The clip loader assembly 150 includes a proximal clip loader 154 and a distal clip loader 152. In one example, the proximal clip loader 154 and the distal clip loader 152 may be spot welded to each other at various locations or points within a weld region 802.

[0060]

[0098] 8B, 8C, 8D, and 8E show various views of an exemplary proximal clip loader 154. The proximal clip loader 154 may be manufactured from plastic or metal. In one example, the proximal clip loader 154 is manufactured as a stamped piece of metal. In one example, the proximal clip loader is made from stainless steel (e.g., 316SS). The proximal clip loader 154 includes an elongated base 810 having two retention flanges 820a and 820b adapted to engage corresponding structures on the upper housing 102 to further align (e.g., horizontally align) and secure the proximal clip loader 154 in place. Additionally, a portion of the elongated base 810 has an engagement portion 815 including a plurality of teeth 817. The engagement portion, more specifically the plurality of teeth 817, is configured to cooperate with the ratchet pawl 192. For example, the proximal clip loader has an engagement portion 815 having teeth 817 and two recessed notches 818a and 818b disposed on either side of the engagement portion 815. The teeth 815 and recessed notches 818a, 818b (hereinafter referred to generally as recessed notches 818) function as an anti-backup mechanism, which will be described in more detail below. The teeth 817 are shown in further detail in Figure 8E, which is a detailed view of Figure 8D.

[0061]

[0099] The proximal clip loader 154 also includes a drive opening 830 configured to receive a drive flange (e.g., drive flange 1510, see FIG. 15A) of the proximal lever 182a of the right lever assembly 180a. For example, the proximal clip loader 154 is positioned on the proximal lever 182a such that the drive flange 1510 (see FIG. 15A) of the proximal lever 182a extends upwardly through the drive opening 830. When the drive flange of the proximal lever 182a is positioned through the drive opening 830, a corresponding through hole (e.g., through hole 1404, see FIG. 14A) of the proximal lever 182b is positioned over the remaining portion of the drive flange 1510 that extends upwardly of the proximal clip loader 154. For example, the drive opening 830 is aligned with the corresponding through hole 1404 of the proximal lever 182b.

[0062]

[0100] 8F, 8G, 8H, and 8J show various views of an exemplary distal clip loader 152. The distal clip loader 152 may be manufactured from plastic or metal. In one example, the distal clip loader 152 is manufactured as a stamped piece of metal. In one example, the proximal clip loader is made from stainless steel (e.g., 316SS). The proximal clip loader 152 includes an elongated base 860 having two flanges 862a and 862b adapted to engage corresponding structures on the proximal clip loader 154 for alignment prior to spot welding. The distal clip loader 152 also includes a notched window 864 such that when the distal loader 152 is placed on the proximal clip loader 154, the window 864 provides access to the teeth 817 and the engagement portion 815 having two recessed notches 818 of the proximal clip loader 154. It should be appreciated that instead of stacking and spot welding the proximal clip loader 154 to the distal clip loader 152, the clip loader assembly 150 may be fabricated as a single piece.

[0063]

[0101] An end of the distal clip loader (e.g., the end corresponding to distal end 803 of clip loader assembly 150) includes a clip loading tip 870. Prior to reaching clip loading tip 870, elongated base 860 narrows at a clip loading portion 866 of elongated base 860. Clip loading portion 866 further curves upward at shoulder 871 until terminating at clip loading tip 870. Clip loading portion 866 narrows to reduce the width of elongated base 860, thereby allowing distal clip loader 152, and more specifically clip loading tip 870, to engage an individual surgical clip of the clip magazine. During application, distal clip loader 152 pushes a leading surgical clip from the clip magazine over retention projection 950 (see FIGS. 9C and 9D) of dispenser 160.

[0064]

[0102] In one example, as shown in FIG. 8J, the clip loading tip 870 curves upward to form a U-shaped channel having a base 872 and side walls 874a and 874b. The U-shaped channel is sized and shaped to fit around the retention protrusion 950 and between the forks 940a and 940b of the dispenser (see FIGS. 2A, 2B, 9C and 9D), allowing the clip loading tip 870 to engage the leading surgical clip without contacting the retention protrusion 950 or the forks 940a, 940b. For example, the side walls 874a and 874b contact respective points of the leading surgical clip 50 that overhang each side of the retention protrusion. Wedging the leading surgical clip 50 onto the retention protrusion is further shown in FIGS. 2A and 2B.

[0065]

[0103] 8K, 8L, and 8M show another exemplary clip loader assembly 150. In the illustrated example, clip loader assembly 150 includes a distal clip loader 152 and a proximal clip loader 154. The detailed view shown in FIG. 8M shows where the proximal clip loader 154 and the distal clip loader 152 may be spot welded to one another. For example, the proximal clip loader 154 may be spot welded to the distal clip loader 152 at various locations or points within the weld area (e.g., weld points 802a and 802b). The distal clip loader 152 shown in FIG. 8K has many of the same features as the clip loader 152 shown in FIG. 8F.

[0066]

[0104] 8N, 8P, and 8Q show another example of a proximal clip loader 154. Similar to the proximal clip loader 154 shown in FIG. 8B, the proximal clip loader 154 shown in FIG. 8N includes an elongated base 810 and a drive opening 830 configured to receive a drive flange (e.g., drive flange 1510, see FIG. 15A) of the proximal lever 182a of the right lever assembly 180a. For example, the proximal clip loader 154 is positioned on the proximal lever 182a such that the drive flange 1510 (see FIG. 15A) of the proximal lever 182a extends upwardly through the drive opening 830. When the drive flange of the proximal lever 182a is positioned through the drive opening 830, a corresponding through hole (e.g., through hole 1404, see FIG. 14A) of the proximal lever 182b is positioned over the remaining portion of the drive flange 1510 that extends upwardly of the proximal clip loader 154. For example, the drive aperture 830 is aligned with a corresponding through hole 1404 in the proximal lever 182b. The proximal clip loader 154 also includes an alignment slot 832 and a vertical spacing and alignment protrusion 834.

[0067]

[0105] 9A, 9B, 9C, 9D, and 9E show various views of an exemplary dispenser 160. The dispenser 160 may be manufactured from plastic or metal. In one example, the dispenser 160 is manufactured as a stamped piece of metal. In one example, the dispenser 160 is made from stainless steel (e.g., semi-rigid 304SS). The dispenser 160 includes an elongated base 910 having flanges 920a, 920b, 920c, and 920d that may function as fastening flanges or snaps. For example, the flanges 920a-920d may form a press fit or snap fit with corresponding structures on the bottom housing 104. Additionally, the dispenser 160 includes two openings or through holes 930a and 930b that may be adapted to aid in the initial placement and alignment of the dispenser 160. The dispenser 160 has a proximal end 901 and a distal end 903.

[0068]

[0106] At the distal end 903, the dispenser includes forks 940a and 940b that curve downwardly from the elongated base 910 at a shoulder 942. Additionally, the dispenser 160 includes a retaining projection 950 that curves upwardly from the elongated base 910 at the shoulder 942 (see FIGS. 9C and 9D). The forks 940a and 940b, hereafter generally referred to as forks 940, form both a support surface and a track for the legs of the surgical clip 50. Additionally, the forks 940 are sized and shaped similarly to cooperating recessed channels 760 of the jaw head 730 that form the clip track 770. For example, the forks 940 curve downwardly such that the ends of the forks open directly into the cooperating recessed channels 760 of the jaw head (see FIGS. 2A and 2B). Thus, the forks 940 curve to have the same slope (at their distal ends) as the cooperating recessed channels 760.

[0069]

[0107] As discussed above, the retaining projection 950 curves upwardly to retain the leading surgical clip 50 until the leading clip is pushed off of the retaining projection 950 by the clip loading tip 870. The retaining projection 950 is adapted to be sufficiently rigid to support and retain the leading surgical clip 50 while at the same time being sufficiently flexible to allow the clip loading tip 870 to momentarily bend the retaining projection 950 downwardly to allow the leading surgical clip 50 to advance over the retaining projection 950, along the fork 940 and through the clip track 770 formed by cooperating recessed channels 760 in the jaw head 730.

[0070]

[0108] As shown in FIG. 9E, the elongated base 910 may include two ridges 912a and 912b forming a channel 970. The channel 970 is adapted to receive a clip pusher assembly 170 including a clip pusher spring 172 and a clip pusher bar 174, which will be described in more detail below. Additionally, the elongated base 910 includes two V-shaped flanges 914a and 914b, with a first leg of each V-shaped flange 914 extending downward from a ridge 912 below the elongated base 910, and then a second leg of the V-shaped flange 914 extending upward to the height of the top of the ridge 912. The V-shaped flanges 914 may be adapted to align and attach. For example, the V-shaped flanges 914 may be press-fit into a corresponding mating structure in the housing. For example, the V-shaped flanges 914 may be first pressed inward and then snap back to hook into a corresponding mating structure in the housing.

[0071]

[0109] Figures 9F, 9G, 9H and 91 illustrate another exemplary dispenser 160. Similar to the dispenser 160 illustrated in Figure 9A, the dispenser 160 illustrated in Figure 9F includes an elongated base 910. Instead of flanges (e.g., flanges 920a, 920b, 920c and 920d illustrated in Figure 9A), the dispenser 160 may include various mounting members 925a-f, which may include square through-holes adapted to engage (e.g., snap-fit ​​or press-fit) with corresponding fastening features on the bottom housing 104.

[0072]

[0110] Dispenser 160 has a proximal end 901 and a distal end 903. Similar to the embodiment shown in Figure 9A, the example shown in Figure 9F includes forks 940a and 940b (at distal end 903) that curve downwardly from an elongated base 910. In addition, dispenser 160 includes a retention protrusion 950 that curves upwardly from elongated base 910 to retain a leading surgical clip 50 until the leading surgical clip is pushed off retention protrusion 950 by clip loading tip 870.

[0073]

[0111] As shown in Figures 9G and 9H, the dispenser 160 may include side walls 935a and 935b that fold over to form a spring retaining channel 937 near the proximal end 901 of the dispenser 160. The spring retaining channel 937 may preferably house the clip pusher spring 172 (see Figure 1B) and prevent the clip pusher spring 172 from buckling and popping out of the channel 937 or channel 970. For example, without the spring retaining channel 937, the clip pusher spring 172 may buckle and lose containment when the stack of clips 105 becomes nearly empty. Moving from the proximal end 901 toward the distal end 903 and after the spring retaining channel 937, attachment members (e.g., attachment members 925c and 925f) may be formed from the side walls of the dispenser 160 and may form the channel 970 (as shown in Figure 9I). The channel 970 is adapted to receive a clip pusher assembly 170, which includes a clip pusher spring 172 and a clip pusher bar 174, which are described in more detail below.

[0074]

[0112] Figures 9J, 9K, 9L, 9M, and 9N show yet another exemplary dispenser 160 (e.g., dispenser 160 of Figure 1K). Figure 9J shows a perspective view of an alternative embodiment of dispenser 160. Figures 9K, 9L, and 9M show cross-sectional views of dispenser 160 of Figure 9J. Figure 9N shows a partial side view of dispenser 160 of Figure 9J. The exemplary dispenser 160 shown in Figures 9J-9N includes a proximal end 901, a distal end 903, an elongated base 910, a spring retaining channel 937, forks 940a and 940b, a retaining protrusion 950, and a channel 970 similar to the proximal end 901, a distal end 903, an elongated base 910, a spring retaining channel 937, forks 940a and 940b, a retaining protrusion 950, and a channel 970, respectively, of the exemplary dispenser 160 of Figures 9F-9I. However, it should be noted that the shape and size of one or more of these components may vary. For example, the dimensions and / or shape of the channels 937 and / or 970 of the dispenser 160 of Figures 9J-9N may differ from the dimensions / shape of the channels 937 and / or 970 of the dispenser of Figures 9F-9I. As another example, as best seen in FIG. 9N, the retention protrusions 950 in this illustrative example have a different shape than the exemplary retention protrusions 950 shown in FIG. 9C.

[0075]

[0113] In the example shown in Figures 9J-9N, the dispenser 160 also includes a number of connectors (hereinafter referred to as connectors 926) exemplified by connectors 926a, 926b, 926c (e.g., attachment mechanisms, etc.) that can be used to mechanically couple (e.g., via a snap-fit ​​or press-fit engagement) the dispenser 160 to a corresponding socket of a window covering (e.g., sockets 1304a, 1304b, 1304c, etc. of the window covering 108 shown in Figures 13D-13F).

[0076]

[0114] As best shown in FIG. 9L, the shape (e.g., width) of the channel 970 is defined by the various walls (e.g., connectors 926b, 926c, base 910, etc.) of the dispenser 160. In this example, the channel 970 is adapted to receive the clip pusher spring 172 and the clip pusher bar 174 (see, e.g., FIGS. 1G and 1K). Similarly, as best shown in FIG. 9M, the shape (e.g., width, etc.) of the spring retaining channel 937 is defined by the various walls of the dispenser 160, including the folded side walls 936a and 936b. Similar to the exemplary dispenser 160 of FIGS. 9F-9I, the spring retaining channel 937 of FIGS. 9J-9N can prevent and / or reduce the possibility of the clip pusher spring 172 popping out of the channel 937 and / or 970.

[0077]

[0115] 10A and 10B show an example of a clip pusher bar 174. The clip pusher bar 174 and the clip pusher spring 172 (see FIG. 1B) may be coupled together to form the clip pusher assembly 170. For example, a proximal end 1001 of the clip pusher bar 174 may be attached to a distal end of the clip pusher spring 172. The clip pusher bar 174 includes an elongated shaft 1010 adapted to couple to the clip pusher spring 172. At the other end of the elongated shaft 1010, the clip pusher bar 174 includes a clip pusher head 1020 having a surgical clip contact notch 1030. Additionally, clip pusher bar 174 may include a lockout window 1040 adapted to be grasped by protrusion 950 to bring clip pusher head 1020 into jaws 730, thereby locking out jaws 730 after the last surgical clip 50 has been applied and dispensed. FIG. 10C illustrates another exemplary clip pusher bar 174 having many of the same features as the clip pusher bar shown in FIGS. 10A and 10B, but instead of including a lockout window 1040, clip pusher bar 174 of FIG. 10C is adapted for use with a lockout clip (e.g., lockout clip 185 as shown in FIGS. 1C, 1K, 16A-16B, and / or 16C).

[0078]

[0116] Clip pusher spring 172 provides a constant biasing force to clip pusher bar 174, thereby causing clip pusher head 1020, and more specifically clip contact notch 1030, to continuously apply pressure to the clip magazine. The constant pressure ensures that the next leading surgical clip advances to retention protrusion 950 of dispenser 160. For example, both clip pusher bar 174 and clip magazine move along channel 970 of dispenser 160 until the leading surgical clip 50 contacts retention protrusion 950. As discussed above, the leading surgical clip 50 is retained by retention protrusion 950 until the clip is released (e.g., pushed forward) by clip loading tip 870.

[0079]

[0117] In one example, a surgical clip magazine (not shown) may support a stack 105 of surgical clips 50 (e.g., a stack 105 of fifteen surgical clips 50). Clip pusher assembly 170 provides a biasing force to the stack of surgical clips in the magazine until the magazine is empty. Referring back to FIG. 2F, the stack of surgical clips is shown with a leading surgical clip 50 at the end of clip applying jaw 140.

[0080]

[0118] 11A-11E show an example of a ratchet pawl 192. The ratchet pawl 192 has a pawl pin 1102. As discussed above, the pawl pin 1102 is adapted to fit through an opening or through hole 550 in the main rail 120 and into a corresponding slot 193 in the bottom housing 104. The ratchet pawl 192 includes a pick 1110 and a locating post 1120 having flanges 1130a and 1130b. As shown in FIG. 11E, the flanges 1130a and 1130b form a curved, oval shaped flange, generally referred to as flange 1130, that corresponds to the shape of the pawl slot 552 in the main rail 120. The locating post 1120 seats into the curved, oval shaped pawl slot 552 in the main rail 120 allowing the ratchet pawl 197 to rotate. The positioning post 1120 may also be coupled to a torsion spring (not shown) that advances the ratchet pawl pick 1110 (depending on forward or reverse movement) past the respective notch 818a or 818b so that the ratchet pawl pick 1110 can engage the teeth 817 (see FIGS. 8B and 8E) of the engagement portion 815 of the clip loader assembly 150. For example, the pick 1110 may advance forward along the teeth 817 (towards notch 818a) when pushing a clip from the dispenser 160, and may advance rearward along the teeth 817 (towards notch 818b) when retracting the clip after it has been loaded into the jaws.

[0081]

[0119] The ratchet pawl 192 also includes protrusions 1140a and 1140b sized and shaped to extend beyond the pawl slot 552 such that the ratchet pawl 192 maintains a horizontal orientation without pivoting or tilting within the pawl slot 552. As noted above, the pawl slot 552 is sized and shaped to allow the flange 1130 of the ratchet pawl 192 to pass through and seat below the main rail 120, thereby allowing the ratchet pawl 192 to rotate while the main rail 120 remains fixedly coupled to the bottom housing 104.

[0082]

[0120] The main rail 120 may be manufactured from plastic or metal. In one example, the main rail 120 is manufactured as a stamped piece of metal. As shown in the detailed view of FIG. 5E, the pawl slot 552 is a curved oval shaped slot or track that allows the ratchet pawl 192 to rotate within the slot 552.

[0083]

[0121] 12A-12E show an exemplary embodiment of a trough 110 configured to cover clip pusher spring 172 within an enclosure of clip applier 100. Trough 110 may include tabs 1202a, 1202b, 1202c, and 1202d, hereinafter generally referred to as tabs 1202, configured to snap into corresponding mating features on upper housing 102.

[0084]

[0122] 13A, 13B, and 13C show an exemplary window covering 108. In this example, the window covering 108 and trough 110 are assembled onto the upper housing 102 after the remaining surgical clip drive components are installed within the clip applier 100 (e.g., the clip pusher assembly 170 is disposed within a track or channel formed by the clip dispenser 160). In this example, the window covering 108 provides a transparent window to allow viewing of the surgical clip magazine and the clip pusher assembly 170. In this example, the window covering 108 may be attached to the upper housing 102 via tabs 1302a, 1302b, 1302c, and 1302d, hereafter generally referred to as tabs 1302. The tabs 1302 are configured to snap into corresponding mating features on the upper housing 102.

[0085]

[0123] Window covering 108 has a proximal end 1301 and a distal end 1303. At the distal end 1303, window covering 108 is curved and slopes downward to further help hold, guide and direct surgical clip 50 into the jaw head of clip applying jaw 140 (see FIGS. 2B and 2C). The transparent window also allows a user to monitor and track the movement of surgical clip 50 as it progresses through clip applier 100 and to the end of clip applying jaw 140.

[0086]

[0124] 13D, 13E, and 13F show top, side, and cross-sectional views of another exemplary window covering 108 (e.g., the window covering 108 of FIG. 1K). In this example, the window covering 108 includes a plurality of sockets (interchangeably referred to herein as sockets 1304), exemplified by sockets 1304a, 1304b, and 1304c. Each of the sockets 1304 is configured to attach to and / or align with (e.g., snap-fit ​​or press-fit engagement, etc.) a corresponding connector or other type of attachment member in a dispenser (e.g., the dispenser 160 of FIG. 1K). Alternatively or additionally, in some examples, the exemplary window covering 108 is crimped or otherwise mechanically attached to a main rail (e.g., the main rail 120 of FIG. 1J).

[0087]

[0125] 14A and 14B show an exemplary embodiment of the proximal lever 182b, the distal lever 184a, and the distal lever 184b. As shown in FIG. 1B, the proximal lever 182b may be longer than the distal levers 184a and 184b. Each lever includes two openings or through holes 1402 and 1404 on each side of the lever. The levers may be made of metal. In one example, the levers are manufactured as stamped pieces of metal. In one example, the levers are made of stainless steel (e.g., 304SS). Additionally, each lever may include a spring retaining slot 1406 (and a spring retaining slot 1506 for the lever 182a shown in FIG. 15A) adapted to receive and retain an end of either the spring 186a or the spring 186b such that the levers of each lever assembly are spring biased toward each other. Specifically, when spring 186a is disposed within spring retention slots 1406 of proximal lever 182a and distal lever 184a, the ends of the levers are spring biased toward one another. Similarly, spring 186b couples levers 182b and 184b to one another.

[0088]

[0126] For each of proximal lever 182b, distal lever 184a, and distal lever 184b, through hole 1402 is adapted to secure one end of each lever to a respective handle via pin 194 (see FIG. 1B). In the case of proximal lever 182b, through hole 1404 corresponds to drive aperture 830 of proximal clip loader 154. As noted above, drive flange 1510 (see FIGS. 15A, 15B, and 15C) of proximal lever 182a passes through the bottom of drive aperture 830 through proximal clip loader 154 and also extends through through hole 1404 of proximal lever 182b to control linear motion of clip loader assembly 150 during handle actuation.

[0089]

[0127] The through hole 1404 in the distal lever 184b corresponds to the left drive flange 684 of the jaw closer 130. Similarly, the through hole 1404 in the distal lever 184a corresponds to the right drive flange 682 of the jaw closer 130. The distal levers 184a, 184b bias the drive flanges 682, 684 (and thus the jaw closer 130) forward during handle actuation, thereby causing the jaw closer 130 to move linearly toward the distal end of the clip applier 100.

[0090]

[0128] 15A, 15B, and 15C show an exemplary embodiment of the proximal lever 182a of the right lever assembly 180a. As shown in FIG. 1B, the proximal lever 182a may be longer than the distal levers 184a and 184b. The proximal lever 182a includes an opening or through hole 1502 on one side of the lever and a drive flange 1510 on the opposite end. The proximal lever 182a may be made of metal. In one example, the proximal lever 182a is manufactured as a stamped piece of metal. In one example, the proximal lever 182a is made of stainless steel (e.g., 304SS). Additionally, the proximal lever 182a may include a spring retaining slot 1506 adapted to receive and retain an end of the spring 186 such that the levers of each lever assembly are spring biased toward one another. For example, spring retention slot 1506 may provide the same functionality and have the same characteristics as spring retention slot 1406 described in FIG. 14A.

[0091]

[0129] The through hole 1502 is adapted to secure one end of the proximal lever 182a to its respective handle via pin 194 (see FIG. 1B). As noted above, the drive flange 1510 of the proximal lever 182a (see FIGS. 15A, 15B and 15C) passes through the bottom of the drive opening 830 through the proximal clip loader 154 and also extends through the through hole 1404 of the proximal lever 182b to control the linear motion of the clip loader assembly 150 during handle actuation.

[0092]

[0130] 16A and 16B show an exemplary lockout clip 185. The lockout clip 185 may include two legs 1610a and 1610b sized and shaped similarly to the legs of a surgical clip such that the lockout clip 185 may be advanced through the clip applier 100 and into a clip track 770 formed by the jaw head 730 of the clip applying jaw 140. However, the lockout clip 185 also includes a resilient section 1620 having sufficient stiffness and strength to prevent the clip applying jaw 140 from closing. For example, when the resilient section is disposed within the clip track 770, the strength and stiffness of the resilient section 1620 preferably prevents the clip applying jaw 140 from closing, thereby preventing a clinician from unintentionally closing the clip applying jaw 140 when no surgical clip is present. In some examples, lockout clip 185 (including resilient section 1620) is formed from titanium grade 5 material, and other clips (e.g., clip 50, or any other clips in stack 105 shown in FIG. 1K) are formed from titanium grade 1 material. In alternative examples, lockout clip 185, clip 50 (shown in FIG. 1K), and / or stack 105 (shown in FIG. 1K) are formed from one or more different materials.

[0093]

[0131] FIG 16C illustrates another exemplary lockout clip 185 (e.g., the lockout clip 185 of FIG. 1K). Similar to the exemplary lockout clip 185 of FIGS. 16A-16B, the exemplary lockout clip 185 of FIG. 16C includes two legs 1610a, 1610b and a resilient section 1620. For example, the shape of the legs 1610a, 1610b and / or the resilient section 1620 of the lockout clip 185 of FIG. 16C may differ from the corresponding shapes of the corresponding components of the lockout clip 185 of FIGS. 16A-16B.

[0094]

[0132] 17A, 17B, 17C, 17D, 17E, 17F and 17G show the jaws of clip applier 100 at various stages of loading a surgical clip 50, crimping a surgical clip 50 and applying a surgical clip 50 to ligate a blood vessel.

[0095]

[0133] For each component having multiple or alternative embodiments, it is understood that each or any of the embodiments may include the same or similar features as the embodiments described above or below. In particular, any of the components or features shown in Figure 1B that are shown or described in more detail in connection with other figures may be attributed to any of the components or features shown in Figure 1C, and vice versa.

[0096]

[0134] Further, it should be understood that some exemplary embodiments herein may include fewer or more components than other exemplary embodiments. For example, some exemplary embodiments of the clip applying device 100 herein may be implemented without one or more of the ratchet pawl 192, the trough 110, and / or any other components (e.g., pins, screws, etc.) used in other exemplary embodiments of the clip applying device 100.

[0097]

[0135] Aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein. In one example, a surgical clip applying device includes an enclosure formed from a top housing, a bottom housing, and a window cover. The clip applying device also includes a pair of handles including a left handle and a right handle, a main rail supporting a jaw closer, and a pair of clip applying jaws fixedly attached to the bottom housing and retained within the main rail. The pair of clip applying jaws have arms that terminate in a pair of jaw heads. Additionally, the clip applying device includes a clip loader assembly having a clip loading tip at a distal end and a dispenser disposed above the clip loader assembly. The dispenser includes a pair of clip forks and a retaining protrusion disposed between the pair of clip forks at a distal end of the dispenser. The clip loading tip is configured to press a surgical clip supported by the pair of clip forks onto the retaining protrusion. The clip applying device also includes a clip pusher assembly configured to advance the plurality of clips toward the pair of jaw heads and a drive mechanism including a plurality of levers and at least one spring, the drive mechanism being configured to translate actuation of the pair of handles into linear motion of the jaw closer and clip loader assembly.

[0098]

[0136] In another aspect of the present disclosure, the jaw closer includes a notch at a distal end with a cam member configured to engage and urge corresponding ramps on the arms of the clip applying jaw, thereby forcing the arms and jaw heads closer together as the jaw closer advances toward the jaw head.

[0099]

[0137] In another aspect of the present disclosure, the clip applying device includes a lockout clip.

[0100]

[0138] In another aspect of the present disclosure, the lockout clip is sized and configured to advance into the jaw head.

[0101]

[0139] In another aspect of the present disclosure, the lockout clip is configured to prevent the clip applying jaws from closing when disposed within the jaw head.

[0102]

[0140] To the extent any of these aspects are mutually exclusive, it is understood that such mutual exclusivity in no way limits the combination of such aspect with any other aspect, whether or not such aspect is explicitly recited. Any of these aspects may be claimed as, but are not limited to, a system, method, apparatus, device, medium, or the like.

[0103]

[0141] Many features and advantages of the present disclosure are apparent from the written description, and therefore, the appended claims are intended to cover all such features and advantages of the present disclosure. Moreover, since numerous modifications and changes will readily occur to those skilled in the art, the present disclosure is not limited to the exact same configuration and operation as shown and described. Therefore, the described embodiments should be construed as illustrative rather than restrictive, and the present disclosure should not be limited to the details given herein, but should be defined by the full scope of the following claims and their equivalents, regardless of whether present or future foreseeable or unforeseeable.

Claims

1. 1. A surgical clip applying device comprising: an enclosure formed from a top housing, a bottom housing, and a window cover; a pair of handles including a left handle and a right handle, respectively, mounted for pivotal movement within said bottom housing; a main rail fixedly mounted to the bottom housing within the enclosure, the main rail including an elongated base and upstanding side walls defining a U-shaped channel; a pair of clip applying jaws fixedly attached to the bottom housing and mounted through the main rail, the pair of clip applying jaws having arms terminating in a pair of spaced apart opposing jaw heads and including a pair of angled ramps disposed on the arms spaced inwardly from the jaw heads; a jaw closer having an elongated base including a pair of upstanding drive flanges disposed at a proximal end of the jaw closer, the elongated base including a V-shaped notch at a distal end of the jaw closer defining a cam member at the distal end, and an elongated slot defined in the base intermediate the distal and proximal ends of the jaw closer, the jaw closer being disposed between the clip applying jaw and the base of the rail and mounted for slidable movement within the channel toward and away from the jaw head, the cam members configured to engage and urge against corresponding ramped surfaces of the arms of the clip applying jaw, thereby urging the arms and jaw heads together as the jaw closer advances toward the jaw head; a drive mechanism including a plurality of levers and at least one spring connecting the handles to the upright drive flange of the jaw closer, the drive mechanism being configured to translate actuation of the pair of handles into linear movement of the jaw closer.

2. a clip loader assembly disposed within the enclosure above the clip applying jaw, the clip loader assembly including a clip loading tip at a distal end thereof and a drive opening at a proximal end thereof; a dispenser disposed above the clip loader assembly, the dispenser including a pair of clip forks and a retaining protrusion disposed between the pair of clip forks at the distal end of the dispenser, the clip loading tip configured to press a surgical clip supported by the pair of clip forks onto the retaining protrusion; a clip pusher assembly configured to advance a plurality of clips toward the pair of jaw heads; 10. The surgical clip applying device of claim 1, further comprising: a drive mechanism including a plurality of levers and at least one spring connecting the handles to the drive opening of the clip loader assembly, the drive mechanism being configured to translate actuation of the pair of handles into linear movement of the jaw closer and the clip loader assembly.

3. The surgical clip applying device of claim 2 , further comprising a lockout clip.

4. The surgical clip applying device of claim 3 , wherein the lockout clip is sized and shaped to advance within the jaw head.

5. The surgical clip applying device of claim 4 , wherein the lockout clip is configured to prevent the clip applying jaws from closing when disposed within the jaw head.

6. The surgical clip applying device of claim 2 , wherein the clip loader assembly and the drive mechanism provide for automatic reloading of the jaws with surgical clips when the handles are moved from a closed position to an open position.

7. The surgical clip applying device of claim 2 , wherein the window covering provides visibility to a clip number of surgical clips loaded in the dispenser.

Images