Surgical stapler having cartridge pan retention features - Patents.com

Abstract

The surgical instrument end effector includes a first jaw, a second jaw, a staple cartridge, and a retaining cap. The second jaw includes an anvil having a plurality of staple-forming pockets. The first jaw and the second jaw are operable to clamp and staple tissue positioned between the first jaw and the second jaw. The staple cartridge is configured to be received within the first jaw. The staple cartridge includes a cartridge body, a lower tray, and a plurality of staples. The cartridge body and the lower tray are configured to couple to one another. The retaining cap is fastened to a proximal end of the cartridge body and configured to engage the lower tray. The retaining cap is further configured to secure the position of the lower tray relative to the cartridge body.

Description

[Background technology]

[0001] In some situations, endoscopic surgical instruments may be preferable over traditional open surgical devices because smaller incisions can reduce postoperative recovery time and complications. To this end, some endoscopic surgical instruments are suitable for positioning a distal end effector at a desired surgical site through a trocar cannula. These distal end effectors can engage tissue in a variety of ways to achieve diagnostic or therapeutic effects (e.g., endocutters, graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy delivery devices, and energy delivery devices using ultrasound, RF, lasers, etc.). Endoscopic surgical instruments may include a shaft manipulated by the clinician between the end effector and a handle portion. Such a shaft may facilitate insertion to a desired depth and rotation about the shaft's longitudinal axis, thereby facilitating positioning of the end effector within the patient's body. Positioning of the end effector may be further facilitated by including one or more articulation joints or features that allow the end effector to be selectively articulated or otherwise deflected relative to the shaft's longitudinal axis.

[0002] Examples of endoscopic surgical instruments include surgical staplers, some of which are operable to clamp tissue layers, cut the clamped tissue layers, and drive staples through the tissue layers to substantially seal the cut tissue layers together near the cut ends of the tissue layers. Exemplary surgical staplers include U.S. Pat. No. 4,805,823, entitled "Pocket Configuration for Internal Organ Staplers," issued February 21, 1989; U.S. Pat. No. 5,415,334, entitled "Surgical Stapler and Staple Cartridge," issued May 16, 1995; U.S. Pat. No. 5,465,895, entitled "Surgical Stapler Instrument," issued November 14, 1995; U.S. Pat. No. 5,597,107, entitled "Surgical Stapler Instrument," issued January 28, 1997; U.S. Pat. No. 5,632,432, entitled "Surgical Instrument," issued May 27, 1997; U.S. Pat. No. 5,632,432, entitled "Surgical Instrument," issued October 7, 1997; No. 5,673,840 entitled "Articulation Assembly for Surgical Instruments," issued January 6, 1998; U.S. Patent No. 5,704,534 entitled "Articulation Assembly for Surgical Instruments," issued September 29, 1998; U.S. Patent No. 5,814,055 entitled "Surgical Clamping Mechanism," issued December 27, 2005; U.S. Patent No. 6,978,921 entitled "Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism," issued February 21, 2006; U.S. Patent No. 7,000,100 entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems," issued February 21, 2006;No. 818, entitled "Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil," issued December 5, 2006; U.S. Patent No. 7,143,923, entitled "Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack," issued December 4, 2007; U.S. Patent No. 7,367,485, entitled "Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission," issued May 6, 2008; U.S. Patent No. 7,380,695, entitled "Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing," issued June 3, 2008; U.S. Patent No. 7,380,695, entitled "Articulating Surgical Stapling Instrument Incorporating a U.S. Patent No. 7,380,696 entitled "Two-Piece E-Beam Firing Mechanism," U.S. Patent No. 7,404,508 entitled "Surgical Stapling and Cutting Device," issued July 29, 2008; U.S. Patent No. 7,434,715 entitled "Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout," issued October 14, 2008; U.S. Patent No. 7,721,930 entitled "Disposable Cartridge with Adhesive for Use with a Stapling Device," issued May 25, 2010; U.S. Patent No. 8,408,410 entitled "Surgical Stapling Instrument with An Articulatable End Effector," issued April 2, 2013;No. 439, and U.S. Patent No. 8,453,914, entitled "Motor-Driven Surgical Cutting Instrument with Electric Actuator Directional Control Assembly," issued June 4, 2013. The disclosures of each of the above-cited U.S. patents, U.S. patent application publications, and U.S. patent applications are incorporated herein by reference.

[0003] While the surgical stapler described above has been described as being used in endoscopic procedures, it should be understood that such a surgical stapler can also be used in open procedures and / or other non-endoscopic procedures. By way of example only, in thoracic surgical procedures that do not use a trocar as a stapler conduit, a surgical stapler can be inserted between a patient's ribs through a thoracotomy to access one or more organs. In such procedures, a stapler may also be used to cut and close blood vessels leading to the lungs. For example, blood vessels leading to an organ can be cut and closed with the stapler before the organ is removed from the chest cavity. Of course, surgical staplers can be used in a variety of other settings and procedures.

[0004] While many different types of surgical stapling instruments and related components have been made and used, it is believed that no one prior to the present inventors has made or used the invention as set forth in the appended claims. [Brief explanation of the drawings]

[0005] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention. [Figure 1] FIG. 1 is a perspective view of an exemplary articulating surgical stapling instrument. [Figure 2] FIG. 2 is a side view of the device of FIG. 1. [Figure 3]FIG. 2 is a perspective view of the open end effector of the instrument of FIG. 1; [Figure 4A] 4 is a side cross-sectional view of the end effector of FIG. 3 taken along line 4-4 of FIG. 3 with the firing beam in a proximal position. [Figure 4B] 4 is a side cross-sectional view of the end effector of FIG. 3 taken along line 4-4 of FIG. 3 with the firing beam in a distal position. [Figure 5] 5 is a cross-sectional end view of the end effector of FIG. 3 taken along line 5-5 of FIG. 3. [Figure 6] FIG. 4 is an exploded perspective view of the end effector of FIG. 3. [Figure 7] 4 is a perspective view of the end effector of FIG. 3 after being placed in tissue and actuated once within the tissue. [Figure 8] FIG. 2 is a perspective view of an exemplary staple cartridge for use with the instrument of FIG. 1; [Figure 9] FIG. 9 is an enlarged perspective view of the proximal end of the staple cartridge of FIG. 8; [Figure 10] 10 is a rear cross-sectional view of the proximal end of the staple cartridge of FIG. 8, taken along line 10-10 of FIG. 8; [Figure 11] FIG. 2 is a perspective view of the proximal end of another exemplary staple cartridge for use with the instrument of FIG. 1 . [Figure 12A] 12 is a rear cross-sectional view of the staple cartridge of FIG. 11 taken along line 12-12 of FIG. 11 according to one embodiment of a method of assembly. [Figure 12B] 12 is another rear cross-sectional view of the staple cartridge of FIG. 11 taken along line 12-12 of FIG. 11 according to another embodiment of a method of assembly; [Figure 13A] 13 is yet another rear cross-sectional view of the staple cartridge of FIG. 11 taken along line 13-13 of FIG. 11 according to another embodiment of a method of assembly; [Figure 13B] 13 is yet another rear cross-sectional view of the staple cartridge of FIG. 11 taken along line 13-13 of FIG. 11 according to another embodiment of a method of assembly; [Figure 14]12 is an enlarged perspective view of the proximal end of the staple cartridge of FIG. 11 , the staple cartridge being used with an exemplary retainer; FIG. [Figure 15] 15 is a rear cross-sectional view of the staple cartridge of FIG. 11 with the retainer of FIG. 14 attached thereto, taken along line 15-15 of FIG. 14; [Figure 16] 15 is an exploded perspective view of the proximal end of the staple cartridge of FIG. 11 and the retainer of FIG. 14; FIG. [Figure 17] 12 is another enlarged perspective view of the proximal end of the staple cartridge of FIG. 11 , the staple cartridge being used with another exemplary retainer; FIG. [Figure 18] FIG. 12 is yet another enlarged perspective view of the proximal end of the staple cartridge of FIG. 11, the staple cartridge being used with yet another exemplary retainer; [Figure 19] FIG. 12 is yet another enlarged perspective view of the staple cartridge of FIG. 11 , the staple cartridge being used with yet another exemplary retainer; [Figure 20] FIG. 2 is a perspective view of the proximal end of another exemplary staple cartridge for use with the instrument of FIG. 1 . [Figure 21A] 21 is a rear cross-sectional view of the staple cartridge of FIG. 20 taken along line 21-21 of FIG. 20; [Figure 21B] 21 is another rear cross-sectional view of the staple cartridge of FIG. 20 taken along line 21-21 of FIG. 20 in accordance with one embodiment of a heat staking assembly method.

[0006] The drawings are not intended to be limiting in any manner, and it is contemplated that various embodiments of the invention may be embodied in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention. It will be understood, however, that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE INVENTION

[0007] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is by way of example only one of the best modes contemplated for carrying out the invention. As will be understood, the present invention is capable of other different and obvious aspects, all without departing from the present invention. Accordingly, the drawings and description should be regarded as illustrative in nature, and not as restrictive.

[0008] I. Exemplary Surgical Stapler 1-7 illustrate an exemplary surgical stapling and severing instrument 10, sized for insertion through a trocar cannula to a surgical site within a patient in a non-articulated state as depicted in FIG. 1 to perform a surgical procedure. By way of example only, such a trocar may be inserted into the patient's abdomen, between two of the patient's ribs, or elsewhere. In some situations, the instrument 10 is used without a trocar. For example, the instrument 10 may be inserted directly through a thoracotomy or other type of incision. The instrument 10 in this example includes a handle portion 20 connected to a shaft 22. The shaft 22 terminates distally in an articulation joint 11, which is further coupled to an end effector 12. It should be understood that terms such as "proximal" and "distal" are used herein with reference to a clinician holding the handle portion 20 of the instrument 10. Thus, the end effector 12 is distal relative to the more proximal handle portion 20. It will be further understood that for convenience and clarity of illustration, spatial terms such as "vertical" and "horizontal" are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting or absolute.

[0009] In some variations, shaft 22 is configured in accordance with at least some of the teachings of U.S. Patent No. 9,795,379, entitled "Surgical Instrument with Multi-Diameter Shaft," issued October 24, 2017, the disclosure of which is incorporated herein by reference. Other suitable configurations for shaft 22 will be apparent to those skilled in the art in view of the teachings herein.

[0010] Once the articulation joint 11 and end effector 12 are inserted through the cannula passage of the trocar, the articulation joint 11 may be remotely articulated by the articulation control 13, as depicted in phantom in FIG. 1 , to deflect the end effector 12 at a desired angle (α) from the longitudinal axis (LA) of the shaft 22. This allows the end effector 12 to reach behind an organ or approach tissue from a desired angle or for other reasons. In some variations, the articulation joint 11 may deflect the end effector 12 along a single plane. In some other variations, the articulation joint 11 may deflect the end effector 12 along two or more planes. The articulation joint 11 and articulation control 13 may be configured according to the teachings of any of the numerous references cited herein. Alternatively, articulation joint 11 and / or articulation control 13 may have any other suitable configuration. By way of example only, articulation control 13 may instead be configured as a knob that rotates about an axis perpendicular to the longitudinal axis LA of shaft 22.

[0011] In some variations, articulation joint 11 and / or articulation control 13 are constructed and operative in accordance with at least some of the teachings of U.S. Pat. No. 9,186,142, entitled "Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks," issued November 17, 2015, the disclosure of which is incorporated herein by reference. Articulation joint 11 may also be constructed and operative in accordance with at least some of the teachings of U.S. Pat. No. 9,795,379, entitled "Surgical Instrument with Multi-Diameter Shaft," issued October 24, 2017, the disclosure of which is incorporated herein by reference. Other suitable forms that articulation joint 11 and articulation control 13 may take will be apparent to those skilled in the art in view of the teachings herein.

[0012] The end effector 12 of this example includes a lower jaw 16 and an upper jaw in the form of a pivotable anvil 18. In some variations, the lower jaw 16 is constructed in accordance with at least some of the teachings of U.S. Patent No. 9,808,248, entitled "Installation Features for Surgical Instrument End Effector Cartridge," issued November 7, 2017, the disclosure of which is incorporated herein by reference. The anvil 18 may be constructed according to at least some of the teachings of U.S. Pat. No. 9,517,065, entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler," issued December 13, 2016, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 9,839,421, entitled "Jaw Closure Feature for End Effector of Surgical Instrument," issued December 12, 2017, the disclosure of which is incorporated herein by reference; and / or U.S. Pat. No. 10,092,292, entitled "Staple Forming Features for Surgical Stapling Instrument," issued October 9, 2018, the disclosure of which is incorporated herein by reference. Other suitable forms that the lower jaw 16 and the anvil 18 may take will be apparent to those skilled in the art in view of the teachings herein.

[0013] The handle portion 20 includes a pistol grip 24 and a closure trigger 26. The closure trigger 26 is pivotable toward the pistol grip 24 to clamp or close the anvil 18 toward the lower jaw 16 of the end effector 12. Such closure of the anvil 18 is effected via a closure tube 32 and a closure ring 33, both of which translate longitudinally relative to the handle portion 20 in response to pivoting of the closure trigger 26 relative to the pistol grip 24. The closure tube 32 extends along the length of the shaft 22, and the closure ring 33 is positioned distal to the articulation joint 11. The articulation joint 11 is operable to transmit / transmit longitudinal movement from the closure tube 32 to the closure ring 33.

[0014] The handle portion (20) also includes a firing trigger (28). An elongate member (not shown) extends longitudinally through the shaft (22) and transfers longitudinal firing motion from the handle portion (20) to the firing beam (14) in response to actuation of the firing trigger (28). As described in further detail below, this distal translation of the firing beam (14) effects stapling and severing of tissue clamped within the end effector (12). The triggers (26, 28) can then be released, releasing the tissue from the end effector (12).

[0015] FIGS. 3-6 illustrate an end effector (12) incorporating a firing beam (14) in the form of an E-beam to perform a number of functions. It should be understood that the E-beam configuration is merely an illustrative example. The firing beam (14) may take any other suitable form, including, but not limited to, a non-E-beam configuration. As best seen in FIGS. 4A-4B, the firing beam (14) includes a transversely oriented upper pin (38), a firing beam cap (44), a transversely oriented middle pin (46), and a distally presented cutting edge (48). The upper pin (38) is positioned within a longitudinal anvil slot (42) in the anvil (18) and is translatable within the longitudinal anvil slot (42). The firing beam cap (44) slidably engages the underside of the lower jaw (16) by having the firing beam (14) extend through a lower jaw slot (45) (shown in FIG. 4B) formed through the lower jaw (16). The middle pin (46) slidably engages the upper surface of the lower jaw (16) in cooperation with the firing beam cap (44), thereby allowing the firing beam (14) to reliably space the end effector (12) during firing.

[0016] Some non-E-beam configurations of the firing beam 14 may lack the upper pin 38, middle pin 46, and / or firing beam cap 44. Some such variations of the instrument 10 may simply rely on the closure ring 33 or some other feature to pivot the anvil 18 to the closed position and hold the anvil 18 in the closed position while the firing beam 14 advances to its distal position. By way of example only, the firing beam 14 and / or associated lockout feature may be constructed and operative in accordance with at least some of the teachings of U.S. Patent No. 9,717,497, entitled "Lockout Feature for Movable Cutting Member of Surgical Instrument," issued August 1, 2017, the disclosure of which is incorporated herein by reference. Other suitable forms that the firing beam 14 may take will be apparent to those skilled in the art in view of the teachings herein.

[0017] Figure 3 shows the firing beam (14) of this example positioned proximally and the anvil (18) pivoted to an open position to allow an unused staple cartridge (37) to be removably loaded into the channel of the lower jaw (16). As best seen in Figures 5-6, the staple cartridge (37) of this example includes a cartridge body (70) that presents an upper deck (72) and is coupled to a lower cartridge tray (74). As best seen in Figure 3, a vertical slot (49) is formed through a portion of the staple cartridge (37). As also best seen in Figure 3, three rows of staple openings (51) are formed through the upper deck (72) on one side of the vertical slot (49), and another set of three rows of staple openings (51) are formed through the upper deck (72) on the other side of the vertical slot (49). Of course, any other suitable number of rows of staples (e.g., two, four, or other numbers) may be provided. Referring again to Figures 4A-6, a wedge-shaped sled (41) and a plurality of staple drivers (43) are captured between the cartridge body (70) and the tray (74), with the wedge-shaped sled (41) positioned proximal to the staple drivers (43). The wedge-shaped sled (41) is longitudinally movable within the staple cartridge (37), while the staple drivers (43) are vertically movable within the staple cartridge (37). Staples (47) are also positioned within the cartridge body (70) above their corresponding staple drivers (43). Specifically, each staple (47) is driven vertically within the cartridge body (70) by the staple driver (43) to drive the staple (47) out of an associated staple opening (51). As best seen in Figures 4A-4B and 6, wedge-shaped sled (41) presents an inclined cam surface that urges staple driver (43) upward as wedge-shaped sled (41) is driven distally through staple cartridge (37).

[0018] In some variations, staple cartridge (37) is constructed and operative in accordance with at least some of the teachings of U.S. Pat. No. 9,517,065, entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler," issued December 13, 2016, the disclosure of which is incorporated herein by reference. Additionally, or alternatively, staple cartridge (37) may be constructed and operative in accordance with at least some of the teachings of U.S. Pat. No. 9,808,248, entitled "Installation Features for Surgical Instrument End Effector Cartridge," issued November 7, 2017, the disclosure of which is incorporated herein by reference. Other suitable forms that staple cartridge (37) may take will be apparent to those skilled in the art in view of the teachings herein.

[0019] As shown in Figures 4A-4B, when the end effector 12 is closed by distally advancing the closure tube 32 and closure ring 33, the firing beam 14 advances and the upper pin 38 enters the longitudinal anvil slot 42, thereby engaging the anvil 18. A pusher block 80 (shown in Figure 5) is located at the distal end of the firing beam 14 and is configured to engage the wedge-shaped sled 41 such that the wedge-shaped sled 41 is pushed distally by the pusher block 80 as the firing beam 14 advances distally through the staple cartridge 37 upon actuation of the firing trigger 28. During such firing, the cutting edge 48 of the firing beam 14 enters the vertical slot 49 of the staple cartridge 37, severing the tissue clamped between the staple cartridge 37 and the anvil 18. As shown in FIGS. 4A-4B, the middle pin 46 and pusher block 80 together actuate the staple cartridge 37 by entering the vertical slot 49 therein, driving the wedge-shaped sled 41 into upward camming contact with the staple driver 43, which forces the staples 47 out of the staple openings 51 and into forming contact with the staple-forming pockets 53 (shown in FIG. 3) on the inner surface of the anvil 18. FIG. 4B shows the firing beam 14 fully translated distally after the tissue has been severed and stapled. While the staple-forming pockets 53 have been intentionally omitted from the views of FIGS. 4A-4B, it should be understood that the staple-forming pockets 53 are shown in FIG. 3. It should also be understood that the anvil 18 has been intentionally omitted from the view of FIG. 5.

[0020] FIG. 7 shows the end effector 12 actuated with a single stroke through tissue 90. As shown, the cutting edge 48 (hidden in FIG. 7) cuts the tissue 90, while the staple driver 43 drives three alternating rows of staples 47 through the tissue 90 on each side of the cut line created by the cutting edge 48. In this example, all of the staples 47 are oriented substantially parallel to the cut line, although it should be understood that the staples 47 may be positioned in any suitable orientation. In this example, after the first stroke is completed, the end effector 12 is withdrawn from the trocar, the spent staple cartridge 37 is replaced with a new staple cartridge, and the end effector 12 is then reinserted through the trocar to reach the stapling site and perform additional cutting and stapling. This process can be repeated until the desired amount of cutting and staples 47 has been applied. The anvil (18) may need to be closed to facilitate insertion and removal through the trocar, and may need to be opened to facilitate replacement of the staple cartridge (37).

[0021] It should be appreciated that during each actuation stroke, the cutting edge 48 can cut the tissue substantially simultaneously as the staples 47 are driven through the tissue. In this example, the cutting edge 48 lags behind the driving of the staples 47 very slightly, so that the staples 47 are driven through the tissue just before the cutting edge 48 passes through the same area of ​​tissue, although it should be appreciated that this order may be reversed, or the cutting edge 48 may be directly synchronized with an adjacent staple. While Figure 7 shows the end effector 12 actuated within two layers 92, 94 of tissue 90, it should be appreciated that the end effector 12 may be actuated through a single layer of tissue 90 or more than two layers 92, 94 of tissue. It should also be appreciated that the formation and positioning of staples 47 adjacent the cut line formed by cutting edges 48 can substantially seal the tissue at the cut line, thereby reducing or preventing bleeding and / or leakage of other bodily fluids at the cut line. Furthermore, while Figure 7 shows end effector 12 being actuated on two substantially flat, apposed, planar layers of tissue 92, 94, it should be understood that end effector 12 can be actuated across tubular structures, such as blood vessels, sections of the digestive tract, and the like. Figure 7, therefore, should not be construed as indicating any limitations on the intended use of end effector 12. Various suitable situations and procedures in which instrument 10 can be used will become apparent to those skilled in the art in view of the teachings herein.

[0022] In one variation, the instrument 10 provides motorized control of the firing beam 14. Exemplary components that may be used to provide motorized control of the firing beam 14 are shown and described in U.S. Patent No. 9,622,746, issued April 18, 2017, entitled "Distal Tip Features for End Effector of Surgical Instrument," the disclosure of which is incorporated herein by reference. Additionally or alternatively, at least a portion of the motorized control may be configured according to at least a portion of the teachings of U.S. Patent No. 8,210,411, issued July 3, 2012, entitled "Motor-Driven Surgical Instrument," the disclosure of which is incorporated herein by reference. Additionally or alternatively, features operable to drive the firing beam 14 may be configured in accordance with at least some of the teachings of U.S. Pat. No. 8,453,914, the disclosure of which is incorporated herein by reference, and / or at least some of the teachings of U.S. Pat. No. 8,453,914, the disclosure of which is also incorporated herein by reference. Other suitable components, features, and configurations for providing motorization of the firing beam 14 will be apparent to those skilled in the art in view of the teachings herein. It should also be understood that in some other variations, manual drive of the firing beam 14 may be provided such that a motor may be omitted. By way of example only, the firing beam 14 may be operated in accordance with at least some of the teachings of any other patent / patent publication references cited herein.

[0023] The instrument 10 may also include a lockout switch and lockout indicator as shown and described in U.S. Patent No. 9,622,746, entitled "Distal Tip Features for End Effector of Surgical Instrument," issued April 18, 2017, the disclosure of which is incorporated herein by reference. Additionally, the lockout switch and / or lockout indication, and associated components / functionality, may be configured in accordance with at least some of the teachings of U.S. Patent No. 7,644,848, entitled "Electronic Lockouts and Surgical Instrument Including Same," issued January 12, 2010, the disclosure of which is incorporated herein by reference.

[0024] The instrument 10 also includes a manual return switch 116 configured to act as a "bailout" feature, allowing the operator to immediately initiate proximal retraction of the firing beam 14 during the firing stroke. That is, the manual return switch 116 can be manually activated if the firing beam 14 is only partially advanced distally. The manual return switch 116 may provide additional functionality in accordance with at least some of the teachings of U.S. Patent No. 9,622,746, entitled "Distal Tip Features for End Effector of Surgical Instrument," issued April 18, 2017, the disclosure of which is incorporated herein by reference.

[0025] In describing the operation of the instrument 10, use of the term "pivot" (and synonyms based on "pivot") should not be construed as necessarily requiring pivotal movement about a fixed axis. In some variations, the anvil 18 pivots about an axis defined by a pin (or similar feature) that slides along an elongated slot or channel as the anvil 18 moves toward the lower jaw 16. In such variations, the pivot axis translates along a path defined by the slot or channel, while the anvil 18 simultaneously pivots about its axis. Additionally or alternatively, the pivot axis may first slide along the slot / channel, and then the anvil 18 may pivot about the pivot axis after the pivot axis has slid a certain distance along the slot / channel. It should be understood that such sliding / translational pivotal movement is encompassed within terms such as "pivot," "pivoting," "pivoting," "pivotable," "pivoting," and the like. Of course, some variations may remain fixed and provide for pivotal movement of the anvil (18) about an axis that does not translate within a slot or channel or the like.

[0026] The device (10) is a medical device that is manufactured in accordance with U.S. Patent Nos. 4,805,823, 5,415,334, 5,465,895, 5,597,107, 5,632,432, 5,673,840, 5,704,534, 5,814,055, 6,978,921, 7,000,818, 7,143,923, 7,144,924, 7,144,925, 7,144,926, 7,144,927, 7,144,928, 7,144,929, 7,244,929, 7,244,929, 7,344,929, 7,465,895, 7,597,107, 7,632,432, 7,673,840, 7,704,534, 7,814,055, 7,978,921, 7,000,818, 7,143,923, 7,244,929, 7,344,929, 7,465,895, 7,597,107, 7,597,107, 7,632,432, 7,673,840, 7,704,534, 7,814,055, 7,244,929, 7,344,929, 7,465,929, 7,143,923, 7,244,929, 7,344,929, 7, It should be understood that the device 10 may be constructed and operable in accordance with any of the teachings of U.S. Patent Nos. 7,303,108, 7,367,485, 7,380,695, 7,380,696, 7,404,508, 7,434,715, 7,721,930, 8,408,439, and / or 8,453,914. As noted above, the disclosures of each of these patents and publications are incorporated herein by reference. Further exemplary modifications that may be provided to the device 10 are described in more detail below. Various suitable ways in which the following teachings may be incorporated into the device 10 will be apparent to those skilled in the art. Likewise, various suitable ways in which the following teachings may be combined with the various teachings of the patents / publications cited herein will be apparent to those skilled in the art. It should also be understood that the following teachings are not limited to the instrument 10 or devices taught in the patents cited herein. The following teachings are readily applicable to a variety of other types of instruments, including instruments not classified as surgical staplers. Various other suitable apparatus and situations to which the following teachings may be applied will become apparent to those skilled in the art in view of the teachings herein.

[0027] II. Staple Cartridges Having Proximal Fastening Features As described above, the instrument's end effector 12 is configured to receive a staple cartridge 37. The distal end of the firing beam 14 can then be received into the proximal end of the staple cartridge 37 to drive the wedge-shaped sled 41 and cutting edge 48 distally within the staple cartridge 37, simultaneously severing the tissue 90 and driving the staples 47 upward to seal the tissue 90. It should be understood, therefore, that alignment between the staple cartridge 37 and the firing beam 14 is desirable to facilitate proper driving of the staples 47 and severing of the tissue 90.

[0028] However, in some circumstances, certain portions of the staple cartridge (37) may become misaligned relative to one another during packaging, shipping, and / or handling of the staple cartridge (37). For example, in some circumstances, a portion of the cartridge body (70) may become misaligned relative to a corresponding portion of the lower cartridge tray (74). In such circumstances, challenges may arise in driving the firing beam (14) distally within the staple cartridge (37). Therefore, it should be understood that in some embodiments, variations of staple cartridges similar to the staple cartridge (37) may be desirable that incorporate features that promote secure fastening between the various components of the staple cartridge (37), thereby promoting consistent and reliable alignment between the components of the staple cartridge (37). While various suitable fastening features are described herein in particular configurations and in combination with particular devices, it should be understood that in other embodiments, such fastening features may be arranged in other configurations and with other devices.

[0029] 8-10 illustrate an exemplary alternative staple cartridge (200) configured for use with the above-described instrument (10) in place of staple cartridge (37). Unless otherwise noted herein, it should be understood that staple cartridge (200) is substantially similar to staple cartridge (37) described above. For example, like staple cartridge (37), staple cartridge (200) of this embodiment includes a cartridge body (220). As also described above, cartridge body (220) defines an upper deck (222) and is coupled to lower cartridge tray (260). Upper deck (222) at least partially defines a vertical slot (224) formed through a portion of staple cartridge (200). The upper deck (222) further defines three rows of staple openings (226) extending through the upper deck (222) on one side of the vertical slot (224), and another set of three rows of staple openings (226) formed through the upper deck (222) on the other side of the vertical slot (224). Of course, any other suitable number of rows of staples (e.g., two rows, four rows, etc.) may be provided.

[0030] It should be understood that, similar to staple cartridge 37, staple cartridge 200 of this embodiment is configured for use with wedge-shaped sled 41 and firing beam 14 to drive a plurality of staple drivers (not shown). The staple drivers can be captured between cartridge body 220 and tray 260, with wedge-shaped sled 41 positioned proximal to the staple drivers. Wedge-shaped sled 41 is longitudinally movable within staple cartridge 200, while the staple drivers are vertically movable within staple cartridge 200. Staples (not shown) are also positioned within cartridge body 220 above their corresponding staple drivers. Thus, each staple can be driven vertically within cartridge body 220 by its corresponding staple driver, driving the staple out through associated staple openings 226.

[0031] The staple cartridge (200) of this embodiment includes certain features configured to promote secure retention and alignment between the cartridge body (220) and the cartridge tray (260). As described in further detail below, such retention features are generally located near the proximal end of the staple cartridge (200). This proximal location may generally be desirable because movable components of the instrument (10), such as the firing beam (140), directly engage the proximal end of the staple cartridge (200). Therefore, proper alignment between the cartridge body (220) and the cartridge tray (260) is particularly desirable at the proximal end of the staple cartridge (200).

[0032] 9, each side of cartridge body (220) includes a distal, laterally extending projection (230) and a proximal, laterally extending projection (232). Projections (230, 232) are generally configured to be received within corresponding windows (270, 272) in cartridge tray (260), thereby providing a snap-fit ​​arrangement between cartridge body (220) and cartridge tray (260).

[0033] Each protrusion (230, 232) extends outward from a side of cartridge body (220) and defines a generally rectangular shape with rounded corners. The outward extension of each protrusion (230, 232) generally corresponds to the thickness of cartridge tray (260). As explained in more detail below, this particular outward extension may be desirable to promote generally flat or flush sides of staple cartridge (200) when cartridge body (220) and cartridge tray (260) are coupled to one another.

[0034] The cartridge tray 260 correspondingly defines a distal window 270 and a proximal window 272 on each side thereof. Each window 270, 272 is configured as a generally rectangular cutout in each side of the cartridge tray 260. As such, each window 270, 272 is configured to receive a corresponding protrusion 230, 232 on the cartridge body 220. While the specific shapes of the protrusions 230, 232 and windows 270, 272 are shown as generally rectangular in this embodiment, it should be understood that various alternative shapes may be used in other embodiments. For example, in some embodiments, the protrusions 230, 232 and windows 270, 272 may be oval or circular. In other embodiments, the protrusions 230, 232 and windows 270, 272 may be triangular, square, or any other suitable shape. It should be understood that, regardless of shape, an additional number of protrusions (230, 232) and window (270, 272) combinations may be used along the length of staple cartridge (200).

[0035] The cartridge body 220 further includes a side pocket 238, recess, or opening on each side of the cartridge body 220. The side pocket 238 is generally configured to receive a corresponding feature on the cartridge tray 260 to securely fasten the cartridge body 220 to the cartridge tray 260. In this embodiment, the side pocket 238 is configured as a rectangular opening in the side of the cartridge body 220. Of course, various other suitable shapes can be used, as described in more detail below. The side pocket 238 in this embodiment extends through the cartridge body 220 from the outer surface of the cartridge body 220 to the internal cavity. Thus, the side pocket 238 in this embodiment is a through-hole. It should be understood that in other embodiments, the side pocket 238 may alternatively extend through only a portion of the cartridge body 220, similar to a recess, groove, or blind hole.

[0036] The cartridge tray 260 further includes a distal tab 278 on each side corresponding to each side pocket 238 of the cartridge body 220. Each distal tab 278 is configured to be received within the side pocket 238 of the cartridge body 220 to securely fasten the cartridge body 220 to the cartridge tray 260. Each distal tab 278 defines an inverted L-shape. As such, each distal tab 278 includes an approximately 90° bend followed by an inward extension. The particular length of the inward extension of each distal tab 278 may be any suitable amount that facilitates coupling between the cartridge body 220 and the cartridge tray 260. For example, in some embodiments, the inward extension of each distal tab 278 corresponds to the approximate wall thickness of the cartridge body 220. The extension of each distal tab (278) can be configured to retain the cartridge body (220) in the lower cartridge tray (260), thus preventing lateral or upward movement of the cartridge body (220).

[0037] The cartridge body (220) further includes a retaining cap (240). The retaining cap (240) in this example is generally configured to be securely secured to a portion of the cartridge body (220) and capture at least a portion of the lower cartridge tray (260) within the cartridge body (220). As best seen in FIG. 9 , the cartridge body (220) defines a proximal recess (234) configured to receive the retaining cap (240). The particular depth of the proximal recess (234) is configured to provide a generally smooth transition between the surface of the upper deck (222) and the surface of the retaining cap (240). As described in more detail below, this transition can be determined, at least in part, by the thickness of the retaining cap (240).

[0038] The retaining cap 240 of this example is separated into a left portion 242 and a right portion 244 so that the retaining cap 240 can at least partially define the vertical slot 224 when fastened to the cartridge body 220. Each side portion 242, 244 is generally a mirror image of the other and is therefore symmetrical. However, it should be understood that in other examples, some asymmetry may exist.

[0039] The retaining cap 240 generally forms a square with a vertical slot 224 extending through its center. Thus, each side portion 242, 244 generally defines a rectangular shape. The thickness of each side portion 242, 244 is generally configured to support mating arrangements with various components of the cartridge body 220 and the lower cartridge tray 260. Various suitable thicknesses for each side portion 242, 244 are described in more detail below.

[0040] As described above, the retaining cap 240 is configured to be securely fastened within the proximal recess 234 of the cartridge body 220. In this embodiment, the retaining cap 240 is configured to be fastened by ultrasonic welding. It should be understood that in other embodiments, various alternative fastening means may be used, such as adhesive bonding, mechanical fastening, and / or the use of any other suitable components or techniques.

[0041] To facilitate robust ultrasonic welding between the retaining cap (240) and the cartridge body (220), the retaining cap (240) includes multiple energy directors (250). Each energy director (250) is configured to engage a corresponding feature of the cartridge body (220) and thereby focus the ultrasonic energy or vibrations provided by the sonotrode during welding to a predetermined area or point. In this embodiment, each side portion (242, 244) includes two energy directors (250). Each energy director (250) projects downward from the bottom surface of the respective side portion (242, 244) and mates with a corresponding energy well (236) defined in the proximal recess (234) of the cartridge body (220).

[0042] Each energy director (250) in this embodiment defines a generally rectangular cross-sectional shape extending downward from the bottom surface of each side portion (242, 244). Additionally, the end of each energy director (250) is chamfered or tapered to an edge or substantial edge. Thus, it should be understood that the edge of each energy director (250) forms a substantially triangular shape. In some embodiments, this edge configuration is generally desirable to promote concentration of ultrasonic energy at the tip of each energy director (250). For example, if there is an edge (or substantial edge), the edge will concentrate the highest stress during welding. Therefore, melting during welding occurs first at the edge, thereby providing greater control over the location of the melt and the ultimate amount of material melted during ultrasonic welding.

[0043] Each energy director (250) is oriented to generally promote uniform welding. As can be seen, each energy director (250) originates at an outer corner of the corresponding side portion (242, 244) and then extends inward toward the centerline of each side portion (242, 244). This orientation is configured to provide uniform weld coverage across the mating surfaces between the cartridge body (220) and the retention cap (240).

[0044] As described above, the proximal recess (234) includes a plurality of energy wells (236) corresponding to each energy director (250). In this embodiment, each energy well (236) forms an elongated depression in the upper surface of the cartridge body (220) defined by the proximal recess (234). Because each energy well (236) is configured to receive a corresponding energy director (250), each energy well (236) has an orientation corresponding to the corresponding energy director (250). Additionally, it should be understood that the depth of each energy well (236) is small relative to the downward extension of each energy director (250). This smaller depth allows at least a portion of each energy director (250) to melt during ultrasonic welding before the mating surfaces between the cartridge body (220) and the retention cap (240) contact each other.

[0045] Although various specific configurations of the energy directors 250 and energy wells 236 are described herein, various alternative configurations may be used in other embodiments. For example, in some embodiments, the energy directors 250 may be associated with the proximal recess 234, and the energy wells 236 may be associated with the retention cap 240. Additionally or alternatively, it should be understood that the energy directors 250 (and correspondingly, the energy wells 236) may take on various shapes, forms, and orientations. For example, while the present embodiment includes four energy directors 250, in other embodiments, any other suitable number of energy directors may be used (e.g., six, eight, or ten). Similarly, the length and orientation of each energy director 250 may vary. For example, in other embodiments, each energy director 250 may be oriented axially rather than at an angle. Additionally or alternatively, the combined energy directors 250 may be arranged in a linear array (e.g., row / column). Still other suitable alternative configurations of energy directors 250 and energy wells 236 will be apparent to those skilled in the art in view of the teachings herein.

[0046] While this embodiment shows energy director 250 and energy well 236 used in connection with the proximal end of cartridge body 220, it should be understood that in other embodiments, substantially similar features may be used in other portions of cartridge body 220. Additionally, in still other embodiments, substantially similar features to energy director 250 and energy well 236 may be used in other portions of instrument 10 described herein, or throughout other instruments. Suitable alternative instruments may include, by way of example only, other instruments having small mating parts where secure fastening is desirable for proper performance.

[0047] Each side portion (242, 244) further includes a tab receiving portion (252) extending through a portion of the side portion (242, 244). As described in more detail below, each tab receiving portion (252) is generally configured to receive and capture a portion of the lower cartridge tray (260) and securely fasten the lower cartridge tray (260) to the cartridge body (220). Each tab receiving portion (252) includes a horizontal channel (254) and a vertical channel (256) to form a generally L-shaped configuration within each side portion (242, 244). As best seen in FIG. 9 , the horizontal channel (254) extends inward from the exterior of each side portion (242, 244) toward its center. The horizontal channel (254) is also formed as a rectangular notch in the bottom surface of each side portion (242, 244). As will be described in more detail below, this configuration of the horizontal channel (254) is generally configured to accommodate a horizontal extension of the lower cartridge tray (260) between each side portion (242, 244) and the cartridge body (220).

[0048] The vertical channel 256 extends upward from the horizontal channel 254 through the entire thickness of each side portion 242, 244. Like the horizontal channel 254, the vertical channel 256 defines a generally rectangular shape. However, unlike the horizontal channel 254, the vertical channel 256 is generally configured to receive a vertical extension of the lower cartridge tray 260 to prevent lateral or side-to-side movement of the cartridge tray 260 relative to the cartridge body 220.

[0049] The lower cartridge tray 260 further includes a proximal tab 280 on each side thereof. Each proximal tab 280 is generally configured to be received within a tab receiving portion 252 of each side portion 242, 244. It should be understood, therefore, that each proximal tab 280 cooperates with a respective tab receiving portion 252 to capture the lower cartridge tray 260 between the cartridge body 220 and the retaining cap 240.

[0050] As best seen in FIG. 9 , the proximal tab 280 includes a horizontal extension 282 and a vertical extension 284. The horizontal extension 282 and the vertical extension 284 are rounded together to form a generally S-shaped pattern. As best seen in FIG. 10 , the horizontal extension 282 is configured to be received within the horizontal channel 254 of each tab receiving portion 252 when the retention cap 240 is fastened to the cartridge body 220. Meanwhile, the vertical extension 284 is configured to be received within the vertical channel 256 of each tab receiving portion 252. It should therefore be understood that the horizontal extension 282 fixes the vertical, or up-and-down, orientation of the lower cartridge tray 260 relative to the cartridge body 220. Meanwhile, the vertical extension 284 fixes the lateral, or left-to-right, orientation of the lower cartridge tray 260 relative to the cartridge body 220.

[0051] In some embodiments, it may be desirable to have a predetermined relationship between the thickness of the retaining cap 240, the length of the vertical extension 284 of the proximal tab 280, and the depth of the proximal recess 234. For example, in this embodiment, the thickness of the retaining cap 240 generally corresponds to the length of the vertical extension 284 to facilitate a flush or slightly recessed fit between the upper end of the vertical extension 284 and the upper surface of the retaining cap 240. Such a configuration may generally be desirable to prevent interference between the proximal tab 280 and the operation of the instrument 10. In other embodiments, this relationship may also be configured to correspond to the depth of the proximal recess 234 so that the upper deck 222, the upper end of the vertical extension 284, and the upper surface of the retaining cap 240 are all aligned along a plane. Of course, in other embodiments, the thickness of the retaining cap 240 may be slightly greater than the depth of the proximal recess 234, as shown in this embodiment.

[0052] III. Exemplary Staple Cartridge with Distorted Portions 11 illustrates an exemplary alternative staple cartridge (300) configured for use with the above-described instrument (10) in place of staple cartridge (37). Unless otherwise noted herein, it should be understood that staple cartridge (300) is substantially similar to the staple cartridges (37, 200) described above. For example, like staple cartridge (37), staple cartridge (300) of this example includes a cartridge body (320). As also described above, cartridge body (320) defines an upper deck (322) and is coupled to lower cartridge tray (360). Upper deck (322) at least partially defines a vertical slot (324) formed through a portion of staple cartridge (300). The upper deck (322) further defines three rows of staple openings (326) extending through the upper deck (322) on one side of the vertical slot (324), and another set of three rows of staple openings (326) formed through the upper deck (322) on the other side of the vertical slot (324). Of course, any other suitable number of rows of staples (e.g., two rows, four rows, etc.) may be provided.

[0053] It should be understood that, similar to staple cartridge 37, staple cartridge 300 of this embodiment is configured for use with wedge-shaped sled 41 and firing beam 14 to drive a plurality of staple drivers (not shown). The staple drivers can be captured between cartridge body 320 and tray 360, with wedge-shaped sled 41 positioned proximal to the staple drivers. Wedge-shaped sled 41 is longitudinally movable within staple cartridge 300, while the staple drivers are vertically movable within staple cartridge 300. Staples (not shown) are also positioned within cartridge body 320 above their corresponding staple drivers. Thus, each staple can be driven vertically within cartridge body 320 by its corresponding staple driver, driving the staple out through associated staple openings 326.

[0054] Similar to the staple cartridge 200 described above, the staple cartridge 300 of this embodiment includes certain features configured to promote secure retention and alignment between the cartridge body 320 and the cartridge tray 360. As also described above, such retention features are generally located near the proximal end of the staple cartridge 300. This proximal location may generally be desirable because movable components of the instrument 10, such as the firing beam 14, directly engage the proximal end of the staple cartridge 300. Therefore, proper alignment between the cartridge body 320 and the cartridge tray 360 is particularly desirable at the proximal end of the staple cartridge 300.

[0055] As best seen in Figure 11, cartridge body (320) is similar to cartridge body (220) in that each side of cartridge body (320) includes a distal, laterally extending projection (330) and a proximal, laterally extending projection (332). Projections (330, 332) are generally configured to be received within corresponding windows (370, 372) in cartridge tray (360), thereby providing a snap-fit ​​arrangement between cartridge body (320) and cartridge tray (360).

[0056] Similar to protrusions (230, 232) described above, each protrusion (330, 332) extends outward from a side of cartridge body (320) and defines a generally rectangular shape with rounded corners. The outward extension of each protrusion (330, 332) generally corresponds to the thickness of cartridge tray (360). As explained in more detail below, this particular outward extension may be desirable to promote generally flat or flush sides of staple cartridge (300) when cartridge body (320) and cartridge tray (360) are coupled to one another.

[0057] The cartridge tray 360 correspondingly defines a distal window 370 and a proximal window 372 on each side thereof. Each window 370, 372 is configured as a generally rectangular cutout in each side of the cartridge tray 360. As such, each window 370, 372 is configured to receive a corresponding protrusion 330, 332 on the cartridge body 320. While the specific shapes of the protrusions 330, 332 and windows 370, 372 are shown as generally rectangular in this embodiment, it should be understood that various alternative shapes may be used in other embodiments. For example, in some embodiments, the protrusions 330, 332 and windows 370, 372 may be oval or circular. In other embodiments, the protrusions 330, 332 and windows 370, 372 may be triangular, square, or any other suitable shape. It should be understood that, regardless of shape, an additional number of protrusions (330, 332) and window (370, 372) combinations may be used along the length of staple cartridge (300).

[0058] The cartridge body 320 further includes a side pocket 338, recess, or opening on each side of the cartridge body 320. The side pocket 338 is generally configured to receive a corresponding feature on the cartridge tray 360 to securely fasten the cartridge body 320 to the cartridge tray 360. In this embodiment, the side pocket 338 is configured as a rectangular opening in the side of the cartridge body 320. Of course, various other suitable shapes can be used, as described in more detail below. The side pocket 338 in this embodiment extends through the cartridge body 320 from the outer surface of the cartridge body 320 to the internal cavity. Thus, the side pocket 338 in this embodiment is a through-hole. It should be understood that in other embodiments, the side pocket 338 may alternatively extend through only a portion of the cartridge body 320, similar to a recess, groove, or blind hole.

[0059] The cartridge tray 360 further includes a distal tab 378 on each side corresponding to each side pocket 338 of the cartridge body 320. Each distal tab 378 is configured to be received within the side pocket 338 of the cartridge body 320 to securely fasten the cartridge body 320 to the cartridge tray 360. Each distal tab 378 defines an inverted L-shape. As such, each distal tab 378 includes an approximately 90° bend followed by an inward extension. The particular length of the inward extension of each distal tab 378 may be any suitable amount that facilitates coupling between the cartridge body 320 and the cartridge tray 360. For example, in some embodiments, the inward extension of each distal tab 378 corresponds to the approximate wall thickness of the cartridge body 320. The extension of each distal tab (378) can be configured to retain the cartridge body (320) in the lower cartridge tray (360), thus preventing lateral or upward movement of the cartridge body (320).

[0060] Unlike the staple cartridge (200) described above, the staple cartridge (300) of this embodiment omits certain features similar to those of the retaining cap (240) described above. Instead, the staple cartridge (300) of this embodiment includes certain fastening features combined with various operating methods for securely fastening the cartridge body (320) to the lower cartridge tray (360). As best seen in FIG. 11 , the cartridge body (320) includes a pair of proximal channels (340) located on either side of its proximal end. Each proximal channel (340) extends downward from the upper deck (322) into the surface of the cartridge body (320) and extends longitudinally along a portion of the length of the cartridge body (320). In addition, each proximal channel (340) is offset inwardly by a predetermined amount from its respective side of the cartridge body (320). As described in more detail below, each proximal channel (340) is configured to receive a corresponding retention feature of the lower cartridge tray (360).

[0061] The lower cartridge tray (360) includes a proximal tab (380) on each side thereof. Each proximal tab (380) corresponds to a respective proximal channel (340) of the cartridge body (320). Thus, at least a portion of each proximal tab (380) is configured to be received within a respective proximal channel (340). Each proximal tab (380) includes a double fold to define a 270° bend. This bend defines a structure resembling a three-sided box. In other words, each proximal tab (380) initially extends horizontally and inward from a side of the lower cartridge tray (360) at an angle of approximately 90° relative to the side of the lower cartridge tray (360). Then, each proximal tab (380) bends approximately 90° and extends downward.

[0062] As can be seen in FIG. 11 , each proximal tab 380 is received within a respective proximal channel 340 of the cartridge body 320 when the cartridge body 320 and the lower cartridge tray 360 are coupled together. As can be seen, a portion of each proximal tab 380 extends above the surface of the upper deck 322 from the side of the cartridge body 320 approximately the inward offset distance of the respective proximal channel 340. This horizontal extension of each proximal tab 380 is configured to retain the cartridge body 320 within the lower cartridge tray 360 along a vertical or up-down plane or axis. Each proximal tab 380 then bends downward and extends into its respective proximal channel 340. This vertical extension of each proximal tab 380 is configured to retain the cartridge body 320 within the lower cartridge tray 360 along a horizontal or left-right plane or axis. It should therefore be understood that the relationship between the proximal tab (380) and the proximal channel (340) is configured to maintain the position of the cartridge body (320) relative to the lower cartridge tray (360) along at least two axes.

[0063] In some embodiments, additional fastening means may be desirable to more firmly hold the cartridge body 320 in place relative to the lower cartridge tray 360. In some embodiments, after the cartridge body 320 and the lower cartridge tray 360 are coupled together, additional manipulation of the lower cartridge tray 360 can be performed to increase the robustness of the coupling. For example, as seen in FIG. 12A , each proximal tab 380 may be manipulated after coupling to deform each proximal tab 380. In this embodiment, this deformation involves applying a downward force to the top of each proximal tab 380 until the tab is deformed. In this embodiment, this force is applied by peening each proximal tab 380 at one or more locations along its top. By way of example only, this process of peening each proximal tab (380) may create a series of dimples, depressions, or divots in its surface to increase engagement between the proximal tab (380) and the cartridge body (320). In other embodiments, the force may be applied by other suitable means, such as a press or any other suitable means, as will be apparent to those skilled in the art in view of the teachings herein.

[0064] In other embodiments, the above-described forces may be applied in different ways to manipulate the proximal tab 380, as described above. While the different force applications described herein are described independently, it should be understood that in some embodiments, the different force applications may be applied together to further deform the lower cartridge tray 360. FIG. 12B illustrates another force application for deformation of the proximal tab 380. As can be seen, the force application illustrated in FIG. 12B is substantially similar to the force application illustrated in FIG. 12A, except that the force application in this embodiment is directed at an angle of approximately 45° relative to the horizontal extension of the proximal tab 380. As with the force applications described above, the force applied in this embodiment is generally applied using peening or another pressing means. However, in some embodiments, it may be desirable to apply a force at a 45° angle to deform either the horizontal extension of the proximal tab (380), the vertical extension of the proximal tab (380), the 90° bend of the proximal tab (380), or some combination thereof.

[0065] In other embodiments, it may be desirable to apply the above-described force to other portions of the lower cartridge tray 360 to deform those portions. For example, as seen in FIG. 13A , in some embodiments, the force may be applied to the side of the lower cartridge tray 360. In this embodiment, the force is similarly applied using peening or another pressing means. Such a force may be applied at multiple locations along the length of the lower cartridge tray 360 using a pointed peening tool 390. As shown in FIG. 13A , the force causes the lower cartridge tray 360 to deform to have one or more rounded or dome-shaped depressions similar to detent features. This deformation can provide additional fastening between the cartridge body 320 and the lower cartridge tray 360 by allowing the lower cartridge tray 360 to bite into the surface of the cartridge body 320.

[0066] In other embodiments, the applied force may be sufficient to penetrate the lower cartridge tray 360. Such penetration may be desirable to increase engagement between the lower cartridge tray 360 and the cartridge body 320. For example, as seen in FIG. 13B, the perforation tool 390 may be used with sufficient force so that its pointed end completely penetrates the side of the lower cartridge tray 360 (or any other portion of the lower cartridge tray 360). This penetration may cause a portion of the lower cartridge tray 360 to extend into the surface of the cartridge body 320, thereby increasing the coupling between the cartridge body 320 and the lower cartridge tray 360.

[0067] Although not shown, it should be understood that similar deformation principles may be applied in different ways in other embodiments to increase the interlock between the cartridge body 320 and the lower cartridge tray 360. For example, in some embodiments, a slot may be provided in a portion of the lower cartridge tray 360 to form a tab or engagement section that can later be deformed by peening and / or other pressing means. By way of example only, in one embodiment, a three-legged rectangular or radial slot may be pre-cut into a portion of the lower cartridge tray 360 having a larger cross-sectional area (e.g., a side surface) to form a tab or other feature. Such tabs may initially be flush with the rest of the lower cartridge tray 360. However, once the lower cartridge tray 360 is attached to the cartridge body 320, such tabs can then be deformed to increase the engagement between the lower cartridge tray 360 and the cartridge body 320. Such a configuration may be desirable in some embodiments to facilitate easier or more controlled deformation of the lower cartridge tray 360.

[0068] IV. Exemplary Retainers for Staple Cartridges In some embodiments, it may be desirable to provide additional interlocking mechanisms in addition to, or in place of, the interlocking features described above with respect to staple cartridge 37, 200, 300. For example, in some embodiments, it may be desirable to provide external features or assemblies for physically maintaining engagement between structures similar to the cartridge body 70, 220, 320 and lower cartridge tray 74, 260, 360 described above prior to use of staple cartridge 37, 200, 300 in instrument 10. Such physical engagement structures can then be removed or otherwise disabled upon use of staple cartridge 37, 200, 300 in instrument 10. Such physical engagement structures may be desirable either to simplify the structure of staple cartridges similar to staple cartridge 37, 200, 300 or to provide additional interlocking mechanisms. Examples of such engagement structures are described in more detail below.

[0069] 14 illustrates an exemplary retainer (400) that can be readily used with any one or more of the staple cartridges (37, 200, 300) described herein. While retainer (400) is illustrated herein as being used with the above-described staple cartridge (300), it should be understood that any other staple cartridge, including staple cartridges (37, 200), can be used with retainer (400).

[0070] As can be seen, the retainer 400 includes a manipulator 410 and a cartridge-receiving portion 420. Both the manipulator 410 and the cartridge-receiving portion 420 are generally integrally formed from a plastic material in this embodiment. However, it should be understood that in some embodiments, various portions of the retainer 400 may include metal. For example, in some embodiments, the cartridge-receiving portion 420 may include a metal insert. Such a metal insert may be desirable in some embodiments to prevent wear of the cartridge-receiving portion 420 by the staple cartridge 300. In embodiments in which only plastic is used for the retainer 400, certain features of the staple cartridge 300 may be modified (e.g., rounded corners and elimination of sharp edges) to also prevent wear of the receiving portion 420.

[0071] The manipulator (410) is generally configured as a tab-like grip for an operator to grasp for manipulation of the retainer (400). As described in more detail below, the retainer (400) is configured to be removable from the staple cartridge (300). As such, the manipulator (410) may be used for manual removal. Accordingly, it should be understood that the manipulator (410) may take various forms other than the rounded tab shown in FIG. 14. For example, in some embodiments, the manipulator (410) may be an elongated square tab. Additionally or alternatively, the manipulator (410) may include multiple gripping features, knurling, ribs, etc. Of course, various alternative configurations for the manipulator (410) will be apparent to those skilled in the art in view of the teachings herein.

[0072] The cartridge receiving portion (420) is generally configured to receive at least a portion of the proximal end of the staple cartridge (300). As such, it should be understood that the cartridge receiving portion (420) is generally hollow. Additionally, the cartridge receiving portion (420) defines a shape that closely corresponds to the shape of the proximal end of the staple cartridge (300) (e.g., an interference fit). In some variations, the cartridge receiving portion (420) includes an elastomeric material that promotes friction between the cartridge receiving portion (420) and the proximal end of the staple cartridge (300). Additionally, or alternatively, the cartridge receiving portion (420) may be slightly smaller than the proximal end of the staple cartridge (300) to provide an interference fit between the cartridge receiving portion (420) and the proximal end of the staple cartridge (300). Similarly, the interior of cartridge receiving portion 420 may include ridges, ribs, or other features that provide an interference fit between cartridge receiving portion 420 and the proximal end of staple cartridge 300. In either case, the relationship between cartridge receiving portion 420 and the proximal end of staple cartridge 300 is such that retainer 400 will not inadvertently fall out of the proximal end of staple cartridge 300 and, further, such that an operator can intentionally remove retainer 400 from staple cartridge 300 without undue difficulty.

[0073] As best seen in FIG. 15 , cartridge receiving portion (420) closely aligns with the proximal end of staple cartridge (300) to provide minimal clearance between cartridge receiving portion (420) and staple cartridge (300). This minimal clearance is generally desirable to retain cartridge body (320) within lower cartridge tray (360) until staple cartridge (300) is ready for use. Thus, cartridge receiving portion (420) is configured to provide physical containment of the proximal end of staple cartridge (300) until staple cartridge (300) is ready for use.

[0074] As can be seen in FIG. 16 , in use, the retainer (400) can be selectively attached to the proximal end of the staple cartridge (300) and then selectively removed. In this use, the retainer (400) can be attached after assembly of the staple cartridge (300). During attachment, the retainer (400) can function as a pass / fail gauge to verify full connection between the cartridge body (320) and the lower cartridge tray (360). The retainer (400) can then remain in place on the staple cartridge (300) during shipping and storage to maintain alignment between the cartridge body (320) and the lower cartridge tray (360). When an operator desires to use the staple cartridge (300), the retainer (400) can be removed prior to inserting the staple cartridge (300) into the instrument (10).

[0075] 17 illustrates an exemplary alternative retainer (500) that may be used in place of the retainer (400) described above. Unless otherwise noted herein, the retainer (500) of this example is substantially similar to the retainer (400) described above. For example, the retainer (500) is generally configured for use with the staple cartridges (37, 200, 300) described herein or any other suitable staple cartridge. Similarly, the retainer (500) is also configured to physically engage the proximal end of the staple cartridge (37, 200, 300) to maintain alignment between the cartridge body (70, 220, 320) and the lower cartridge tray (74, 260, 360). Additionally, while retainer (500) is described herein as being used with staple cartridge (300), it should be understood that in other embodiments, retainer (500) can readily be used with any other suitable staple cartridge, such as staple cartridges (37, 200) described herein.

[0076] Unlike the retainer (400) described above, the retainer (500) of this embodiment is generally configured to remain fixed to the staple cartridge (300). For example, as can be seen in FIG. 17, the retainer (500) includes a hoop portion (510) that extends around the proximal end of the staple cartridge (300). The hoop portion (510) of this embodiment is configured as a thin film polymer overwrap. The hoop portion (510) of this embodiment is further configured to have an interference fit with the proximal end of the staple cartridge (300). This interference fit is configured to provide sufficient hoop stress to maintain alignment between the cartridge body (320) and the cartridge tray (360).

[0077] In this embodiment, the hoop stress provided by hoop portion (510) is also sufficient to secure retainer (500) to staple cartridge (300). However, it should be understood that in other embodiments, an adhesive backing may be used to provide an adhesive bond between retainer (500) and staple cartridge (300). In such embodiments, the adhesive backing may be applied to the interior of hoop portion (510).

[0078] As described above, the hoop portion 510 comprises a polymeric material. In this embodiment, a bioimplantable / absorbable grade polymeric material is used. This bioimplantable / absorbable grade is generally desirable due to the attachment means used for the hoop portion 510. For example, as described above, the hoop portion 510 in this embodiment uses only hoop stress to secure the retainer 500 to the staple cartridge 300. Therefore, it is possible that part or all of the retainer 500 may become detached from the staple cartridge 300 during a procedure. Therefore, it may be desirable for the retainer 500 to be bioimplantable / absorbable so that it can remain within the patient's body if desired. In contrast, if the hoop portion 510 is secured to the staple cartridge 300 by an adhesive backing, the hoop portion 510 may comprise only a biocompatible material because the retainer 500 remains secured to the staple cartridge 300 during use.

[0079] The retainer 500 of this example further includes a plurality of perforations 520 in the surface of the hoop portion 510. As can be seen, the perforations 520 are generally aligned with the vertical slots 324 of the staple cartridge 300. This arrangement is configured to allow the cutting edge 48 of the instrument 10 to easily cut or otherwise remove the retainer 500 when the staple cartridge 300 is used with the instrument 10.

[0080] In use, the retainer (500) can be fastened to the proximal end of the staple cartridge (300) during assembly and after connection between the cartridge body (320) and the lower cartridge tray (360). The retainer (500) can then hold the cartridge body (320) and the lower cartridge tray (360) in alignment during shipping, storage, or any other time prior to use with the instrument (10). When an operator desires to use the staple cartridge (300), the operator can remove the retainer (500) from the staple cartridge (300) by cutting the retainer (500) at the perforations (520). Alternatively, the retainer (500) can remain in place on the staple cartridge (300) during use with the instrument (10). In this use, the retainer (500) can still be cut by the cutting edge (48) of the instrument (10), but after the retainer (500) is cut by the cutting edge (48), the cut portion of the retainer (500) remains attached to the staple cartridge (300).

[0081] 18 illustrates another exemplary alternative retainer (600) that may be used in place of the retainers (400, 500) described above. Unless otherwise noted herein, the retainer (600) of this example is substantially similar to the retainer (400) described above. For example, the retainer (600) is generally configured for use with the staple cartridges (37, 200, 300) described herein or any other suitable staple cartridge. Similarly, the retainer (600) is also configured to physically engage the proximal end of the staple cartridge (37, 200, 300) to maintain alignment between the cartridge body (70, 220, 320) and the lower cartridge tray (74, 260, 360). Additionally, while retainer (600) is described herein as being used with staple cartridge (300), it should be understood that in other embodiments, retainer (600) can readily be used with any other suitable staple cartridge, such as staple cartridges (37, 200) described herein.

[0082] Unlike retainer (400) described above, retainer (600) of this embodiment is a thin film laminate including a proximal wall (610) and four tabs (620) extending distally therefrom. Each tab (620) includes an adhesive backing such that each tab (620) is configured to adhere to a surface of staple cartridge (300). Optionally, proximal wall (610) also includes an adhesive backing for adhering to one or more proximal surfaces of staple cartridge (300).

[0083] As described above, the retainer (600) of this embodiment includes a thin film having an adhesive backing at one or more portions thereof. Due to the presence of the adhesive, the retainer (600) of this embodiment is configured to remain secured to the staple cartridge (300) even during use of the staple cartridge (300). Therefore, the retainer (300) may include only a biocompatible polymer. However, in some embodiments, a bioimplantable / absorbable polymer grade may be used, if desired, to allow a portion of the retainer (600) to remain within the patient after use of the staple cartridge (300).

[0084] In use, the retainer (600) may initially be planar, with the proximal wall (610) and the tabs (620) all aligned in a single plane. The retainer (600) may then be applied to the staple cartridge (300) by first abutting the proximal wall (610) against the proximal end of the staple cartridge (300). Each tab (620) may then be bent at approximately 90° relative to the proximal wall (610) and adhered to a corresponding surface on the staple cartridge (300), thereby attaching the retainer (600) to the staple cartridge (300). Once the retainer (600) is attached to the staple cartridge (300), the retainer (600) may remain in place during shipping, storage, or any other activity. When an operator desires to use staple cartridge (300), retainer (600) can be removed by pulling one or more tabs (620) away from the corresponding surface of staple cartridge (300). Alternatively, retainer (600) may remain in place during use of staple cartridge (300) with instrument (10). It should be understood that in such use, cutting edge (48) of instrument (10) can be used to cut retainer (600) without affecting the performance of instrument (10).

[0085] 19 illustrates another exemplary alternative retainer (700) that may be used in place of, or in addition to, the retainers (400, 500, 600) described above. Unless otherwise noted herein, the retainer (700) of this example is substantially similar to the retainer (400) described above. For example, the retainer (700) is generally configured for use with the staple cartridges (37, 200, 300) described herein or any other suitable staple cartridge. Similarly, the retainer (700) is also configured to physically engage the proximal end of the staple cartridge (37, 200, 300) to maintain alignment between the cartridge body (70, 220, 320) and the lower cartridge tray (74, 260, 360). Additionally, while retainer (700) is described herein as being used with staple cartridge (300), it should be understood that in other embodiments, retainer (700) can readily be used with any other suitable staple cartridge, such as staple cartridges (37, 200) described herein.

[0086] Unlike the retainer 400 described above, the retainer 700 of this embodiment is a piece of biocompatible tape that is applied to the bottom of the staple cartridge 300 (e.g., the side opposite the top deck 322). The application of the retainer 700 is configured to cover the entire bottom surface of the staple cartridge 300, thereby spanning the gap defined by the vertical slots 324. This configuration may be desirable to prevent the "legs" of the staple cartridge 300 defined by the vertical slots 324 from splaying laterally outward during shipping, storage, and / or handling (or to easily identify when such a condition occurs due to rupture of the retainer 700). Such splaying is generally undesirable because it can result in dislodgment of staples, staple drivers, or other components of the staple cartridge 300.

[0087] While retainer 700 in this embodiment is shown as covering the entire bottom surface of staple cartridge 300, it should be understood that in other embodiments, this coverage may vary. For example, in some instances, retainer 700 may be shortened to cover only a proximal portion of the bottom surface of staple cartridge 300. Still other coverage configurations will be apparent to those skilled in the art in view of the teachings herein.

[0088] In use, the retainer (700) is applied during assembly of the staple cartridge (300). In some use situations, application may occur either after or before coupling of the cartridge body (320) with the lower cartridge tray (360). In either case, once the retainer (700) is applied, the retainer (700) can remain in place during transportation, handling, and / or storage of the staple cartridge (300). When an operator desires to use the staple cartridge (300), the retainer (700) can be removed by pulling the retainer (700) from the staple cartridge (300). Alternatively, the retainer (700) may remain in place during use of the staple cartridge (300) with the instrument (10). During such use, the retainer (700) can be easily severed using the cutting edge (48) of the instrument (10).

[0089] V. Exemplary Cartridge with Heat Staking FIG. 20 illustrates an exemplary alternative staple cartridge (800) configured for use with the above-described instrument (10) in place of staple cartridge (37). Unless otherwise noted herein, it should be understood that staple cartridge (800) is substantially similar to the above-described staple cartridges (37, 200, 300). For example, like staple cartridge (37), staple cartridge (800) of this example includes a cartridge body (820). As also described above, cartridge body (820) defines an upper deck (822) and is coupled to lower cartridge tray (860). Upper deck (822) at least partially defines a vertical slot (824) formed through a portion of staple cartridge (800). The upper deck (822) further defines three rows of staple openings (826) extending through the upper deck (822) on one side of the vertical slot (824), and another set of three rows of staple openings (826) formed through the upper deck (822) on the other side of the vertical slot (824). Of course, any other suitable number of rows of staples (e.g., two rows, four rows, etc.) may be provided.

[0090] It should be understood that, similar to staple cartridge 37, staple cartridge 800 of this embodiment is configured for use with wedge-shaped sled 41 and firing beam 14 to drive a plurality of staple drivers (not shown). The staple drivers can be captured between cartridge body 820 and tray 860, with wedge-shaped sled 41 positioned proximal to the staple drivers. Wedge-shaped sled 41 is longitudinally movable within staple cartridge 800, while the staple drivers are vertically movable within staple cartridge 800. Staples (not shown) are also positioned within cartridge body 820 above their corresponding staple drivers. Thus, each staple can be driven vertically within cartridge body 820 by its corresponding staple driver, driving the staple out through an associated staple opening 826.

[0091] Similar to the staple cartridges (200, 300) described above, the staple cartridge (800) of this embodiment includes certain features configured to promote secure retention and alignment between the cartridge body (820) and the cartridge tray (860). As also described above, such retention features are generally located near the proximal end of the staple cartridge (800). This proximal location may generally be desirable because movable components of the instrument (10), such as the firing beam (14), directly engage the proximal end of the staple cartridge (800). Therefore, proper alignment between the cartridge body (820) and the cartridge tray (860) is particularly desirable at the proximal end of the staple cartridge (800).

[0092] Similar to the cartridge body 320 described above, the cartridge body 820 similarly includes side pockets 838, recesses, or openings on each side of the cartridge body 820. The side pockets 838 are generally configured to receive corresponding features on the cartridge tray 860 to securely fasten the cartridge body 820 to the cartridge tray 860. In this embodiment, the side pockets 838 are configured as rectangular openings in the sides of the cartridge body 820. Of course, various other suitable shapes can be used, as described in more detail below. The side pockets 838 in this embodiment extend through the cartridge body 820 from the outer surface of the cartridge body 820 to the interior cavity. Thus, the side pockets 838 in this embodiment are through-holes. It should be understood that, alternatively, in other embodiments, the side pockets 838 may extend through only a portion of the cartridge body 820, similar to recesses, grooves, or blind holes.

[0093] Similar to the cartridge tray 360 described above, the cartridge tray 860 similarly includes a distal tab 878 on each side corresponding to each side pocket 838 of the cartridge body 820. Each distal tab 878 is configured to be received within the side pocket 838 of the cartridge body 820 to securely fasten the cartridge body 820 to the cartridge tray 860. Each distal tab 878 defines an inverted L-shape. As such, each distal tab 878 includes an approximately 90° bend followed by an inward extension. The particular length of the inward extension of each distal tab 878 may be any suitable amount that facilitates coupling between the cartridge body 820 and the cartridge tray 860. For example, in some embodiments, the inward extension of each distal tab 878 corresponds to the approximate wall thickness of the cartridge body 820. The extension of each distal tab (878) can be configured to retain the cartridge body (820) in the lower cartridge tray (860), thus preventing lateral or upward movement of the cartridge body (820).

[0094] The cartridge body (820) also includes a pair of proximal channels (840) similar to the proximal channels (340) described above. Like the proximal channels (340), a proximal channel (840) is located on each side of its proximal end. Each proximal channel (840) extends downward from the upper deck (822) into the surface of the cartridge body (820) and extends longitudinally along a portion of the length of the cartridge body (820). Additionally, each proximal channel (840) is offset inward by a predetermined amount from its respective side of the cartridge body (820). As described in more detail below, each proximal channel (840) is configured to receive a corresponding retention feature of the lower cartridge tray (860).

[0095] The lower cartridge tray 860 also includes a proximal tab 880 on each side thereof, substantially similar to the proximal tab 380 described above. Like the proximal tabs 380, each proximal tab 880 in this embodiment corresponds to a respective proximal channel 840 in the cartridge body 820. Accordingly, at least a portion of each proximal tab 880 is configured to be received within a respective proximal channel 840. Each proximal tab 880 includes a double fold to define a 270° bend. This bend defines a structure resembling a three-sided box. In other words, each proximal tab 880 initially extends horizontally and inward from a side of the lower cartridge tray 860 at an angle of approximately 90° relative to the side of the lower cartridge tray 860. Then, each proximal tab 880 bends another approximately 90° and extends downward.

[0096] As best seen in Figure 20, cartridge body (820) is similar to cartridge body (320) in that each side of cartridge body (820) includes a distal, laterally extending projection (830) and a proximal, laterally extending projection (832). Projections (830, 832) are generally configured to be received within corresponding windows (870, 872) in cartridge tray (860).

[0097] Unlike the protrusions 330, 332 described above, the protrusions 830, 832 of this example are generally configured to provide a heat-staking type engagement with the cartridge tray 860. For example, each protrusion 830, 832 extends outward from a side of the cartridge body 820 and defines a generally rectangular shape with rounded corners. The outward extension of each protrusion 830, 832 is generally greater than the thickness of the cartridge tray 860. As described in more detail below, this particular outward extension may be desirable for excess material on each protrusion 830, 832 to later melt to cover at least a portion of the cartridge tray 860.

[0098] The cartridge tray 860 correspondingly defines a distal window 870 and a proximal window 872 on each side thereof. Unless otherwise noted herein, each window 870, 872 is substantially similar to each window 370, 372 described above with respect to the staple cartridge 300. For example, like each window 370, 372 described above, each window 870, 872 in this embodiment is configured as a generally rectangular cutout in each side of the cartridge tray 860. As such, each window 870, 872 is configured to receive a corresponding protrusion 830, 832 on the cartridge body 820.

[0099] Unlike the windows 370, 372 described above, one or more of the windows 870, 872 in this example may include a chamfered edge 876 to facilitate the heat staking configuration described above. For example, in this example, the proximal window 872 is shown as including a chamfered edge 876. The chamfered edge 876 is generally configured to reduce the thickness of the lower cartridge tray 860 in the area adjacent the proximal window 872 to facilitate flow of the material of the cartridge body 820 onto the lower cartridge tray 860. While in this example, only the proximal window 872 is shown as including a chamfered edge 876, it should be understood that in other examples, a structure similar to the chamfered edge 876 may be added to both windows 870, 872.

[0100] As best seen in FIGS. 21A and 21B, additional fastening in this embodiment may be provided by heat staking. Heat staking involves using heat to melt plastic parts so that they encase or cover a portion of an adjacent part. In this embodiment, this heat staking is achieved by applying heat to the protrusions (830, 832) of the cartridge body (320). As seen in FIG. 21A, the protrusions (830, 832) first extend outward through windows (870, 872) in the lower cartridge tray (860). Heat is then applied to the protrusions (830, 832). Heat can be applied in a variety of ways, such as with a hot metal surface (e.g., an iron). This heat melts or otherwise deforms at least a portion of the excess material of the protrusions (830, 832) provided by the additional lateral extensions. Upon melting or otherwise deforming, a portion of each protrusion (830, 832) may mushroom or distort into the configuration shown in FIG. 21B to cover at least a portion of the lower cartridge tray (860). While not shown, it should be understood that in some embodiments, the heat staking process may also include applying a flat tool or other manipulator to each protrusion (830, 832), thereby manipulating each protrusion (830, 832) into a desired shape. In this embodiment, one preferred desired shape is flat, such that each protrusion (830, 832) is substantially in-plane with the lower cartridge tray (860). However, in other embodiments, a variety of alternative shapes may be used.

[0101] VI. Exemplary Combinations The following examples illustrate various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of the claims that may be presented at any time in this application or any subsequent application related to this application. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that certain features referred to in the following examples may be omitted in some variations. Accordingly, none of the aspects or features referred to below should be deemed critical unless later expressly indicated as such by the inventors or their successors. If a claim presented in this application or any subsequent application related to this application includes additional features other than those referred to below, those additional features should not be deemed added for any reasons of patentability. [Example]

[0102] 1. A surgical instrument end effector comprising: (a) a first jaw; (b) a second jaw having an anvil with a plurality of staple-forming pockets, the first jaw and the second jaw being operable to clamp and staple tissue disposed between the first jaw and the second jaw; (c) a staple cartridge configured to be received within the first jaw, the staple cartridge including: (i) a cartridge body; (ii) a lower tray, the cartridge body and the lower tray being configured to interlock with each other; and (iii) a plurality of staples; and (d) a retaining cap fastened to a proximal end of the cartridge body and configured to engage the lower tray, the retaining cap being further configured to fix the position of the lower tray relative to the cartridge body. [Example]

[0103] A surgical instrument end effector as described in Example 1, wherein the cartridge body and the retaining cap each include one or more complementary ultrasonic welding features. [Example]

[0104] 2. A surgical instrument end effector as described in Example 1, wherein the complementary ultrasonic welding feature includes an energy director and an energy well, and the energy well is configured to receive the energy director. [Example]

[0105] A surgical instrument end effector as described in Example 3, wherein the retaining cap includes an energy director and the cartridge body includes an energy well. [Example]

[0106] A surgical instrument end effector as described in Example 3 or 4, wherein the energy director includes a chamfered portion, the chamfered portion forming an edge configured to engage with the energy well. [Example]

[0107] A surgical instrument end effector according to any one or more of Examples 3-5, wherein the energy director is oriented at an oblique angle relative to a longitudinal axis defined by the staple cartridge. [Example]

[0108] A surgical instrument end effector described in any one or more of Examples 2-5, wherein the complementary ultrasonic welding features include four pairs of complementary ultrasonic welding features. [Example]

[0109] The surgical instrument end effector of any one or more of Examples 1-7, wherein the lower tray includes tabs configured to engage with the retaining cap. [Example]

[0110] A surgical instrument end effector as described in Example 8, wherein the retaining cap includes a tab receiving portion configured to receive a tab of the lower tray and capture the tab between the retaining cap and the cartridge body. [Example]

[0111] A surgical instrument end effector described in any one or more of Examples 8 to 9, wherein the tab of the lower tray includes a first leg and a second leg, the first leg extending inward from the side of the lower tray, and the second leg extending upward relative to the first leg. [Example]

[0112] A surgical instrument end effector as described in Example 10, wherein the tab receiving portion has a first channel and a second channel, and the first channel is configured to receive a first leg of the tab so that the first leg is positioned between the top surface of the cartridge body and the retaining cap. [Example]

[0113] 12. The surgical instrument end effector of Example 11, wherein the second channel is configured to receive the second leg and allow the tab to extend through the retaining cap. [Example]

[0114] A surgical instrument end effector according to any one or more of Examples 1 to 12, wherein the cartridge body defines a recess configured to receive a retaining cap therein. [Example]

[0115] A surgical instrument end effector described in any of Examples 1 to 13, wherein the retaining cap has a first side portion and a second side portion, the first side portion and the second side portion being separated by a vertical slot extending through the staple cartridge. [Example]

[0116] A surgical instrument comprising: (a) a body; (b) a shaft extending distally from the body; and (c) a surgical instrument end effector as described in Example 1, the surgical instrument end effector being disposed at the distal end of the shaft. [Example]

[0117] A staple cartridge assembly for use with a surgical instrument end effector, comprising: (a) a staple cartridge configured to be received in a first jaw of the surgical instrument end effector, the staple cartridge including: (i) a cartridge body; (ii) a lower tray coupled to the cartridge body; and (iii) a plurality of staples; and (b) a retainer selectably connectable to one or both of the cartridge body or the lower tray at a proximal end of the staple cartridge, at least a portion of the retainer configured to extend around at least a portion of the staple cartridge to fix the position of the cartridge body relative to the lower tray. [Example]

[0118] A staple cartridge assembly as described in Example 16, wherein the retainer includes a grip and a cartridge receiving portion, the cartridge receiving portion configured to receive a proximal end of the staple cartridge. [Example]

[0119] A staple cartridge assembly as described in Example 17, wherein the grip is configured to be grasped by an operator to remove the retainer from the staple cartridge before the staple cartridge is received within the first jaw of the surgical instrument end effector. [Example]

[0120] 1. A method for securing a lower tray of a staple cartridge to a cartridge body, the method comprising: (a) inserting the cartridge body into the lower tray, the inserting step including inserting a first tab of the lower tray into a first channel of the cartridge body; (b) applying a force to a first portion of the lower tray or cartridge body to deform the first portion, thereby increasing engagement between the lower tray and the cartridge body; and (c) applying further force to the first portion until a predetermined amount of engagement between the lower tray and the cartridge body is achieved. [Example]

[0121] 20. The method of example 19, wherein the first portion corresponds to a portion of the first tab of the lower tray. [Example]

[0122] 21. The method of any one or more of Examples 19 or 20, wherein the first tab includes a first leg and a second leg, the first leg being oriented at approximately 90 degrees relative to the second leg, and the step of applying the force includes applying the force at an angle of approximately 90 degrees relative to the first leg. [Example]

[0123] 21. The method of any one or more of Examples 19 or 20, wherein the first tab includes a first leg and a second leg, the first leg being oriented at approximately 90 degrees relative to the second leg, and the step of applying the force includes applying the force at an angle of approximately 45 degrees relative to the first leg. [Example]

[0124] 23. The method of any one or more of examples 19-22, wherein applying the force comprises applying the force using a peening operation. [Example]

[0125] 23. The method of any one or more of Examples 19-22, wherein applying the force comprises applying the force using a pressing action. [Example]

[0126] 25. The method of any one or more of Examples 19-24, wherein the applying force comprises applying force to both the side of the lower tray and the first tab. [Example]

[0127] The method of any one or more of Examples 19-25, wherein the step of applying the force is performed using a tool having a sharp tip, and the step of applying the force includes a step of penetrating at least a portion of the lower tray and deforming at least a portion of the lower tray into the surface of the cartridge body. [Example]

[0128] 20. The method of example 19, wherein the cartridge body includes a first protrusion, the lower tray includes a first window configured to receive the first protrusion of the cartridge body, and the first portion corresponds to the first protrusion of the cartridge body. [Example]

[0129] 28. The method of example 27, wherein the first window comprises a chamfered edge. [Example]

[0130] The method of any one or more of Examples 19-27, wherein the applying a force comprises applying at least some heat to the cartridge body. [Example]

[0131] The method of any one or more of Examples 19-27, wherein applying a force comprises using a heat staking process. [Example]

[0132] 1. A staple cartridge assembly for use with a surgical instrument end effector, comprising: (a) a staple cartridge configured to be received within a first jaw of the surgical instrument end effector, the staple cartridge including: (i) a cartridge body; (ii) a lower tray, the cartridge body and the lower tray configured to couple to one another; and (iii) a plurality of staples; (b) a retaining cap fastened to a proximal end of the cartridge body and configured to engage the lower tray, the retaining cap further configured to fix a position of the lower tray relative to the cartridge body; and (c) a retainer selectably connectable to the proximal end of the staple cartridge, at least a portion of the retainer configured to extend around the staple cartridge to fix the position of the cartridge body relative to the lower tray. [Example]

[0133] A staple cartridge assembly for use with a surgical instrument end effector, comprising: (a) a staple cartridge configured to be received within a first jaw of the surgical instrument end effector, the staple cartridge including: (i) a cartridge body; (ii) a lower tray, the cartridge body and the lower tray configured to be coupled to one another; and (iii) a plurality of staples; and (b) a retaining cap fastened to a proximal end of the cartridge body and configured to engage the lower tray, the retaining cap further configured to fix the position of the lower tray relative to the cartridge body. [Example]

[0134] A method for use with the staple cartridge assembly described in Example 32, comprising the step of applying a force to the lower tray to deform a portion thereof and increase engagement with the cartridge body.

[0135] VI. Other It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Thus, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be within the scope of the claims.

[0136] It should be understood that all or part of any patent, publication, or other disclosure referred to herein as being incorporated by reference is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, opinions, or other disclosures set forth in this disclosure. As such, and to the extent necessary, the disclosures explicitly set forth herein shall supersede any conflicting statements incorporated herein by reference. Any material, or portions thereof, that is referred to herein as being incorporated by reference but that contradicts current definitions, opinions, or other disclosures set forth herein shall be incorporated only to the extent that no conflict arises between the incorporated material and the current disclosures.

[0137] Variations of the above-described devices can be applied not only to traditional medical procedures and surgeries performed by medical professionals, but also to robotic-assisted medical procedures and surgeries. By way of example only, the various teachings herein can be readily incorporated into robotic surgical systems such as the DAVINCI™ system by Intuitive Surgical, Inc. (Sunnyvale, California).

[0138] The device variations described above can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either or both cases, the variations can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, some device variations can be disassembled, and any number of particular portions or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, some device variations can be reassembled for subsequent use either at a reconditioning facility or by the user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0139] By way of example only, the variations described herein may be sterilized before and / or after treatment. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or a high-energy electron beam. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. The device may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.

[0140] While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be realized by those skilled in the art through appropriate modifications without departing from the scope of the present invention. While some such possible modifications have been described, other modifications will be apparent to those skilled in the art. For example, the above examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. are illustrative and not required. Accordingly, it will be understood that the scope of the present invention should be considered in terms of the following claims, and is not limited to the details of construction and operation shown and described in the specification and drawings.

[0141] [Embodiment] (1) A surgical instrument end effector, comprising: (a) a first jaw; (b) a second jaw including an anvil having a plurality of staple-forming pockets, the first jaw and the second jaw operable to clamp and staple tissue disposed between the first jaw and the second jaw; (c) a staple cartridge configured to be received within the first jaw, (i) a cartridge body; (ii) a lower tray, wherein the cartridge body and the lower tray are configured to couple to each other; (iii) a plurality of staples; a staple cartridge including: (d) a retaining cap fastened to a proximal end of the cartridge body and configured to engage the lower tray, the retaining cap further configured to secure the position of the lower tray relative to the cartridge body; A surgical instrument end effector comprising: (2) A surgical instrument end effector as described in embodiment 1, wherein the cartridge body and the retaining cap each include one or more complementary ultrasonic welding features. (3) A surgical instrument end effector as described in embodiment 1, wherein the complementary ultrasonic welding feature includes an energy director and an energy well, and the energy well is configured to receive the energy director. (4) A surgical instrument end effector according to embodiment 3, wherein the retaining cap includes the energy director and the cartridge body includes the energy well. (5) A surgical instrument end effector according to embodiment 3, wherein the energy director includes a chamfered portion, the chamfered portion forming an edge configured to engage with the energy well.

[0142] (6) A surgical instrument end effector according to embodiment 3, wherein the energy director is oriented at an oblique angle relative to a longitudinal axis defined by the staple cartridge. (7) A surgical instrument end effector according to embodiment 2, wherein the complementary ultrasonic welding features include four pairs of complementary ultrasonic welding features. (8) A surgical instrument end effector according to claim 1, wherein the lower tray includes a tab configured to engage with the retaining cap. (9) A surgical instrument end effector according to embodiment 8, wherein the retaining cap includes a tab receiving portion configured to receive the tab of the lower tray and capture the tab between the retaining cap and the cartridge body. (10) A surgical instrument end effector according to embodiment 8, wherein the tab of the lower tray includes a first leg and a second leg, the first leg extending inward from a side of the lower tray, and the second leg extending upward relative to the first leg.

[0143] (11) A surgical instrument end effector according to embodiment 10, wherein the tab receiving portion has a first channel and a second channel, and the first channel is configured to receive the first leg of the tab such that the first leg is positioned between the top surface of the cartridge body and the retaining cap. (12) The surgical instrument end effector of embodiment 11, wherein the second channel is configured to receive the second leg and allow the tab to extend through the retaining cap. (13) A surgical instrument end effector according to embodiment 1, wherein the cartridge body defines a recess configured to receive the retaining cap therein. (14) The surgical instrument end effector of claim 1, wherein the retaining cap has a first side portion and a second side portion, the first side portion and the second side portion being separated by a vertical slot extending through the staple cartridge. (15) A surgical instrument, (a) a main body; (b) a shaft extending distally from the body; (c) a surgical instrument end effector according to claim 1, the surgical instrument end effector being disposed at a distal end of the shaft; and A surgical instrument comprising:

[0144] (16) A staple cartridge assembly for use with a surgical instrument end effector, comprising: (a) a staple cartridge configured to be received in a first jaw of the surgical instrument end effector, (i) a cartridge body; (ii) a lower tray coupled to the cartridge body; (iii) a plurality of staples; a staple cartridge including: (b) a retainer selectably connectable to one or both of the cartridge body or the lower tray at a proximal end of the staple cartridge, at least a portion of the retainer configured to extend around at least a portion of the staple cartridge to fix the position of the cartridge body relative to the lower tray; A staple cartridge assembly comprising: (17) A staple cartridge assembly according to claim 16, wherein the retainer includes a grip and a cartridge receiving portion, the cartridge receiving portion configured to receive the proximal end of the staple cartridge. (18) A method for fixing a lower tray of a staple cartridge to a cartridge body, comprising: (a) inserting the cartridge body into the lower tray, the inserting step including inserting a first tab of the lower tray into a first channel of the cartridge body; (b) applying a force to the lower tray or a first portion of the cartridge body to deform the first portion, thereby increasing engagement between the lower tray and the cartridge body; (c) further applying the force to the first portion until a predetermined amount of engagement between the lower tray and the cartridge body is achieved; A method comprising: (19) The method of claim 18, wherein the first portion corresponds to a portion of the first tab of the lower tray. (20) The method of claim 18, wherein the step of applying a force includes using a heat staking process.

Claims

1. 1. A surgical instrument end effector, comprising: (a) a first jaw; (b) a second jaw including an anvil having a plurality of staple forming pockets, the first jaw and the second jaw operable to clamp and staple tissue disposed between the first jaw and the second jaw; (c) a staple cartridge configured to be received within the first jaw, (i) a cartridge body defining a plurality of staple openings; (ii) a lower tray, wherein the cartridge body and the lower tray are configured to couple to each other; (iii) a plurality of staples retained in said plurality of staple openings and capable of being fired from said plurality of staple openings; a staple cartridge including: (d) a retaining cap secured to a proximal end of the cartridge body and configured to engage the lower tray, the retaining cap further configured to secure the position of the lower tray relative to the cartridge body; Equipped with A surgical instrument end effector wherein the retaining cap is located proximal to the plurality of staple openings in the cartridge body, the retaining cap does not cover the plurality of staple openings, and the plurality of staples can be fired from the plurality of staple openings with the retaining cap secured to the proximal end of the cartridge body.

2. The surgical instrument end effector according to claim 1 , wherein the cartridge body and the retaining cap each include one or more complementary ultrasonic weld features.

3. The surgical instrument end effector according to claim 2 , wherein the complementary ultrasonic welding features include four pairs of complementary ultrasonic welding features.

4. The surgical instrument end effector of claim 1 , wherein the lower tray includes tabs configured to engage the retaining cap.

5. 5. The surgical instrument end effector according to claim 4, wherein the retaining cap includes a tab receiving portion configured to receive the tab of the lower tray and capture the tab between the retaining cap and the cartridge body.

6. 5. The surgical instrument end effector of claim 4, wherein the tabs of the lower tray include a first leg and a second leg, the first leg extending inward from a side of the lower tray and the second leg extending upward relative to the first leg.

7. The retaining cap includes a tab receiving portion; 7. The surgical instrument end effector according to claim 6, wherein the tab receiving portion has a first channel and a second channel, the first channel configured to receive the first leg of the tab such that the first leg is disposed between a top surface of the cartridge body and the retaining cap.

8. The surgical instrument end effector according to claim 7, wherein the second channel is configured to receive the second leg and allow the tab to extend through the retaining cap.

9. The surgical instrument end effector according to claim 1 , wherein the cartridge body defines a recess configured to receive the retaining cap therein.

10. 2. The surgical instrument end effector of claim 1, wherein the retaining cap has a first side portion and a second side portion, the first side portion and the second side portion being separated by a vertical slot extending through the staple cartridge.

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