Adjunct therapy device having driver with cavity for hemostatic agent

[0001] In some settings, endoscopic surgical instruments may be preferred over traditional open surgical devices since a smaller incision may reduce the post-operative recovery time and complications. Consequently, some endoscopic surgical instruments may be suitable for placement of a distal end effector at a desired surgical site through a cannula of a trocar. These distal end effectors may engage tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, stapler, clip applier, access device, drug/gene therapy delivery device, and energy delivery device using ultrasound, RF, laser, etc.). Endoscopic surgical instruments may include a shaft between the end effector and a handle portion, which is manipulated by the clinician. Such a shaft may enable insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby facilitating positioning of the end effector within the patient. Positioning of an end effector may be further facilitated through inclusion of one or more articulation joints or features, enabling the end effector to be selectively articulated or otherwise deflected relative to the longitudinal axis of the shaft.

[0002] Examples of endoscopic surgical instruments include surgical staplers. Some such staplers are operable to clamp down on layers of tissue, cut through the clamped layers of tissue, and drive staples through the layers of tissue to substantially seal the severed layers of tissue together near the severed ends of the tissue layers. Merely exemplary surgical staplers are disclosed in U.S. Pat. No. 4,805,823, entitled “Pocket Configuration for Internal Organ Staplers,” issued Feb. 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 Nov. 14, 1995; U.S. Pat. No. 5,597,107, entitled “Surgical Stapler Instrument,” issued Jan. 28, 1997; U.S. Pat. No. 5,632,432, entitled “Surgical Instrument,” issued May 27, 1997; U.S. Pat. No. 5,673,840, entitled “Surgical Instrument,” issued Oct. 7, 1997; U.S. Pat. No. 5,704,534, entitled “Articulation Assembly for Surgical Instruments,” issued Jan. 6, 1998; U.S. Pat. No. 5,814,055, entitled “Surgical Clamping Mechanism,” issued Sep. 29, 1998; U.S. Pat. No. 6,978,921, entitled “Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism,” issued Dec. 27, 2005; U.S. Pat. No. 7,000,818, entitled “Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems,” issued Feb. 21, 2006; U.S. Pat. No. 7,143,923, entitled “Surgical Stapling Instrument having a Firing Lockout for an Unclosed Anvil,” issued Dec. 5, 2006; U.S. Pat. No. 7,303,108, entitled “Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack,” issued Dec. 4, 2007; U.S. Pat. No. 7,367,485, entitled “Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission,” issued May 6, 2008; U.S. Pat. No. 7,380,695, entitled “Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing,” issued Jun. 3, 2008; U.S. Pat. No. 7,380,696, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism,” issued Jun. 3, 2008; U.S. Pat. No. 7,404,508, entitled “Surgical Stapling and Cutting Device,” issued Jul. 29, 2008; U.S. Pat. No. 7,434,715, entitled “Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout,” issued Oct. 14, 2008; and U.S. Pat. No. 7,721,930, entitled “Disposable Cartridge with Adhesive for Use with a Stapling Device,” issued May 25, 2010. The disclosure of each of the above-cited U.S. Patents is incorporated by reference herein. While the surgical staplers referred to above are described as being used in endoscopic procedures, it should be understood that such surgical staplers may also be used in open procedures and/or other non-endoscopic procedures.

[0003] While various kinds of surgical stapling instruments and associated components have been made and used, it is believed that no one prior to the inventor(s) has made or used the invention described in the appended claims.

[0020] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

[0021] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0022] I. Exemplary Surgical Stapler

[0023] FIGS. 1-6 depict an exemplary surgical stapling and severing instrument (10) that is sized for insertion, in a nonarticulated state as depicted in FIG. 1A, through a trocar cannula passageway to a surgical site in a patient for performing a surgical procedure. Surgical and stapling and severing instrument (10) includes handle portion (20) connected to implement portion (22), the latter further comprising shaft (23) distally terminating in an articulating mechanism (11) and a distally attached end effector (12). Once articulation mechanism (11) and distally end effector (12) are inserted through the cannula passageway of a trocar, articulation mechanism (11) may be remotely articulated, as depicted in FIG. 1B, by articulation control (13). Thereby, end effector (12) may reach behind an organ or approach tissue from a desired angle or for other reasons. It should be understood that terms such as “proximal” and “distal” are used herein with reference to a clinician gripping handle portion (20) of instrument (10). Thus, end effector (12) is distal with respect to the more proximal handle portion (20). It will be further appreciated that for convenience and clarity, 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 and absolute.

[0024] End effector (12) of the present example includes a lower jaw (16) and a pivotable anvil (18). Handle portion (20) includes pistol grip (24) toward which closure trigger (26) is pivotally drawn by the clinician to cause clamping, or closing, of the anvil (18) toward lower jaw (16) of end effector (12). Such closing of anvil (18) is provided through an outmost closure sleeve (32), which longitudinally translates relative to handle portion (20) in response to pivoting of closure trigger (26) relative to pistol grip (24). A distal closure ring (33) of closure sleeve (32) is indirectly supported by frame (34) of implement portion (22). At articulation mechanism (11), a proximal closure tube (35) of closure sleeve (32) communicates with the distal portion (closure ring) (33). Frame (34) is flexibly attached to lower jaw (16) via articulation mechanism (11), enabling articulation in a single plane. Frame (34) also longitudinally slidingly supports a firing drive member (not shown) that extends through shaft (23) and communicates a firing motion from firing trigger (28) to firing bar (14). Firing trigger (28) is farther outboard of closure trigger (26) and is pivotally drawn by the clinician to cause the stapling and severing of clamped tissue in end effector (12), as will be described in greater detail below. Thereafter, release button (30) is depressed to release the tissue from end effector (12).

[0025] FIGS. 2-5 depict end effector (12) employing an E-beam firing bar (14) to perform a number of functions. As best seen in FIGS. 3A-3B, firing bar (14) includes a transversely oriented upper pin (38), a firing bar cap (44), a transversely oriented middle pin (46), and a distally presented cutting edge (48). Upper pin (38) is positioned and translatable within an anvil pocket (40) of anvil (18). Firing bar cap (44) slidably engages a lower surface of lower jaw (16) by having firing bar (14) extend through channel slot (45) (shown in FIG. 3B) that is formed through lower jaw (16). Middle pin (46) slidingly engages a top surface of lower jaw (16), cooperating with firing bar cap (44). Thereby, firing bar (14) affirmatively spaces end effector (12) during firing, overcoming pinching that may occur between anvil (18) and lower jaw (16) with a minimal amount of clamped tissue and overcoming staple malformation with an excessive amount of clamped tissue.

[0026] FIG. 2 shows firing bar (14) proximally positioned and anvil (18) pivoted to an open position, allowing an unspent staple cartridge (37) to be removably installed into a channel of lower jaw (16). As best seen in FIGS. 4-5, staple cartridge (37) of this example includes a cartridge body (70), which presents an upper deck (72) and is coupled with a lower cartridge tray (74). As best seen in FIG. 2, a vertical slot (49) is formed through part of staple cartridge (37). As also best seen in FIG. 2, three rows of staple apertures (51) are formed through upper deck (72) on one side of vertical slot (49), with another set of three rows of staple apertures (51) being formed through upper deck (72) on the other side of vertical slot (49). Referring back to FIGS. 3-5, a wedge sled (41) and a plurality of staple drivers (43) are captured between cartridge body (70) and tray (74), with wedge sled (41) being located proximal to staple drivers (43). Wedge sled (41) is movable longitudinally within staple cartridge (37); while staple drivers (43) are movable vertically within staple cartridge (37). Staples (47) are also positioned within cartridge body (70), above corresponding staple drivers (43). In particular, each staple (47) is driven vertically within cartridge body (70) by a staple driver (43) to drive staple (47) out through an associated staple aperture (51). As best seen in FIGS. 3A-3B and 5, wedge sled (41) presents inclined cam surfaces that urge staple drivers (43) upwardly as wedge sled (41) is driven distally through staple cartridge (37).

[0027] With end effector (12) closed as depicted in FIG. 3A, firing bar (14) is advanced in engagement with anvil (18) by having upper pin (38) enter a longitudinal anvil slot (42). A pusher block (80) is located at the distal end of firing bar (14), and is configured to engage wedge sled (41) such that wedge sled (41) is pushed distally by pusher block (80) as firing bar (14) is advanced distally through staple cartridge (37). During such firing, cutting edge (48) of firing bar (14) enters vertical slot (49) of staple cartridge (37), severing tissue clamped between staple cartridge (37) and anvil (18). As shown in FIGS. 3A-3B, middle pin (46) and pusher block (80) together actuate staple cartridge (37) by entering into a firing slot within staple cartridge (37), driving wedge sled (41) into upward camming contact with staple drivers (43) that in turn drive staples (47) out through staple apertures (51) and into forming contact with staple forming pockets (53) on the inner surface of anvil (18). FIG. 3B depicts firing bar (14) fully distally translated after completing severing and stapling tissue.

[0028] FIG. 6 shows end effector (12) having been actuated through a single stroke through tissue (90). As shown, cutting edge (48) has cut through tissue (90), while staple drivers (43) have driven three alternating rows of staples (47) through the tissue (90) on each side of the cut line produced by cutting edge (48). Staples (47) are all oriented substantially parallel to the cut line in this example, though it should be understood that staples (47) may be positioned at any suitable orientations. In the present example, end effector (12) is withdrawn from the trocar after the first stroke is complete, spent staple cartridge (37) is replaced with a new staple cartridge, and end effector (12) is then again inserted through the trocar to reach the stapling site for further cutting and stapling. This process may be repeated until the desired amount of cuts and staples (47) have been provided. Anvil (18) may need to be closed to facilitate insertion and withdrawal through the trocar; and anvil (18) may need to be opened to facilitate replacement of staple cartridge (37).

[0029] It should be understood that cutting edge (48) may sever tissue substantially contemporaneously with staples (47) being driven through tissue during each actuation stroke. In the present example, cutting edge (48) just slightly lags behind driving of staples (47), such that a staple (47) is driven through the tissue just before cutting edge (48) passes through the same region of tissue, though it should be understood that this order may be reversed or that cutting edge (48) may be directly synchronized with adjacent staples. While FIG. 6 shows end effector (12) being actuated in two layers (92, 94) of tissue (90), it should be understood that 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 understood that the formation and positioning of staples (47) adjacent to the cut line produced by cutting edge (48) may substantially seal the tissue at the cut line, thereby reducing or preventing bleeding and/or leaking of other bodily fluids at the cut line. Various suitable settings and procedures in which instrument (10) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0030] It should be understood that instrument (10) may be configured and operable in accordance with any of the teachings of U.S. Pat. No. 4,805,823; U.S. Pat. No. 5,415,334; U.S. Pat. No. 5,465,895; U.S. Pat. No. 5,597,107; U.S. Pat. No. 5,632,432; U.S. Pat. No. 5,673,840; U.S. Pat. No. 5,704,534; U.S. Pat. No. 5,814,055; U.S. Pat. No. 6,978,921; U.S. Pat. No. 7,000,818; U.S. Pat. No. 7,143,923; U.S. Pat. No. 7,303,108; U.S. Pat. No. 7,367,485; U.S. Pat. No. 7,380,695; U.S. Pat. No. 7,380,696; U.S. Pat. No. 7,404,508; U.S. Pat. No. 7,434,715; and/or U.S. Pat. No. 7,721,930. As noted above, the disclosures of each of those patents are incorporated by reference herein. Additional exemplary modifications that may be provided for instrument (10) will be described in greater detail below. Various suitable ways in which the below teachings may be incorporated into instrument (10) will be apparent to those of ordinary skill in the art. Similarly, various suitable ways in which the below teachings may be combined with various teachings of the patents cited herein will be apparent to those of ordinary skill in the art. It should also be understood that the below teachings are not limited to instrument (10) or devices taught in the patents cited herein. The below teachings may be readily applied to various other kinds of instruments, including instruments that would not be classified as surgical staplers. Various other suitable devices and settings in which the below teachings may be applied will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0031] II. Exemplary Alternative Staple Cartridge

[0032] FIG. 7 depicts an exemplary alternative staple cartridge (100). Cartridge (100) of the present example comprises a cartridge body (102) having an upper deck (110). Cartridge (100) may include a cartridge tray, such as cartridge tray (74), but this is merely optional. Upper deck (110) comprises a plurality of staple apertures (112), a plurality of fluid orifices (114), and a vertical slot (106). In the present example, the plurality of staple apertures (112) comprise a first set of three rows of staple apertures (112) that are formed through upper deck (110) on one side of vertical slot (106) and another set of three rows of staple apertures (112) being formed through upper deck (110) on the other side of vertical slot (106). As best seen in FIG. 8, a plurality of fluid orifices (114) also extend through upper deck (110) with one fluid orifice (114) corresponding to each staple aperture (112). Other suitable configurations for upper deck (110) and cartridge (100) will be apparent to one of ordinary skill in the art in view of the teachings herein. For instance, more than one fluid orifice (114) may be provided for each staple aperture (112), or a single fluid orifice (114) may correspond to a group of staple apertures (112). In addition, a plug, such as a bioresorbable plug, may be inserted into orifice (114) or a film may be placed atop orifice (114) to seal orifice (114) prior to use of staple cartridge (100). In the case of a plug, the plug may be forced out when fluid (122) is expelled, as will be described below.

[0033] Referring now to FIGS. 9-10B, a container (120) is coupled to each fluid orifice (114) and extends below upper deck (110). Container (120) of the present example comprises a vertically compressible container configured to contain a fluid (122) therein. Merely exemplary fluids (122) that may be used with container (120) include thrombin, lyophilized thrombin (such as that used in Surgiflo® of Ethicon, Inc. in Somerville, N.J.), mussel-based or derived adhesives, platelet poor plasma (PPP) platelet rich plasma (PRP), Chitosan, calcium alginate, fibrin, adhesives, image enhancing agents, necrosing agents, sclerosing agents, coagulants, therapeutic agents, medicaments, analeptic agents, anesthesia agents, antidiuretic agents, analgesic agents, antiseptic agents, antispasmodic agents, cardiac agents, depressant agents, diuretic agents, hemostatic agents, hormonal agents, sedative agents, stimulant agents, vascular agents, time release agents, drugs, absorbable materials, colorants, plasticizing agents, bulking agents, tamponade materials, thixotropic agents, antibacterial agents, buffers, catalysts, fillers, micro particles, thickeners, solvents, natural or synthetic rubbers, stabilizers, pH modifiers, bioactive agents, cross-linking agents, chain transfer agents, fibrous reinforcements, colorants, preservatives, formaldehyde reducing or scavenging agents, and/or any other fluid, including liquids, gels, pastes, etc., suitable to be introduced to tissue. Moreover, components that may be suspended in a liquid, gel, and/or paste may also be used within container (120). Other suitable compounds, materials, substances, etc., that may be used in container (120) will be apparent to one of ordinary skill in the art in view of the teachings herein. Fluid (122) of the present example may be injected into container (120) through orifice (114).

[0034] A wedge sled (41), shown in FIG. 10B, and a staple driver (130) are disposed within cartridge body (102), with wedge sled (41) being initially located proximal to staple driver (130). Wedge sled (41) is translatable longitudinally within staple cartridge (100); while staple driver (130) is translatable vertically within staple cartridge (100). Staple driver (130) of the present example comprises a driver body (132) and an integral container protrusion (134). Staples (140) are included within cartridge body (102) and are above a corresponding driver body (132) of staple drivers (130). Each staple (140) is vertically translatable within cartridge body (102) by an associated driver body (132) to drive staple (140) out through a corresponding staple aperture (112). Container protrusion (134) of the present example is configured be in substantial vertical alignment with container (120) such that when staple driver (130) is cammed upward by the longitudinal movement of wedge sled (41), container protrusion (134) contacts and compresses container (120), thereby expelling fluid (122) through orifice (114). As will be appreciated by one skilled in the art, if container (120) is initially in contact with container protrusion (134), fluid (122) may be expelled upon the initial vertical translation of container protrusion (134). In an alternative configuration, container (120) may be initially not in contact with container protrusion (134), and the vertical displacement between container (120) and container protrusion (134) may provide a timing delay between the initial vertical translation of staple driver (130) and the expulsion of fluid (122).

[0035] Referring specifically to FIG. 10A, staple (140) and container (120) having fluid (122) therein are shown in an undeployed state. In the present example, cartridge (100) has been inserted into lower jaw (16) and anvil (18) has been pivoted closed on to tissue (90). Staple (140) is positioned below staple aperture (112) and atop staple driver (130). Container (120) extends downwardly from orifice (114) and contains fluid (122), as described above. Staple driver (130), having staple body (132) and container protrusion (134) may rest atop the bottom of container body (102), or staple driver (130) may be propped up to aid wedge sled (41) in camming staple driver (130) vertically. In one configuration, staple driver (130) may comprise a bottom surface having a complementary wedge to wedge sled (41) such that a top surface of staple driver (130) may be parallel to upper deck (110) as staple driver (130) is vertically cammed by wedge sled (41).

[0036] When firing trigger (28), discussed above, is pulled, firing bar (14) and wedge sled (41) translate distally through staple cartridge (100), as shown in FIG. 10B. Specifically, as firing bar (14) advances, middle pin (46) engages wedge sled (41) to slidably translate wedge sled (41) distally. When wedge sled (41) encounters a staple driver (130), wedge sled (41) engages driver body (132) and begins to cam staple driver (130) vertically. As staple driver (130) cams vertically, container protrusion (134) contacts container (120) and begins to vertically compress container (120), thereby forcing fluid (122) out through orifice (114). As staple driver (130) continues to cam upwardly, staple (140) pierces through tissue (90), engages staple forming pocket (53), and deforms according to staple forming pocket (53). Container protrusion (134) may continue to vertically compress container (120) until staple driver (130) is at the peak of wedge sled (41). As can be appreciated by one skilled in the art, in the present configuration fluid (122) expels from orifices (114) as staples (140) staple tissue (90) and cutting edge (48) of firing bar (14) severs tissue (90). If a hemostatic fluid is used as fluid (122), the excretion of fluid (122) may reduce or limit blood loss when severing and stapling tissue. In addition, if a medicinal component is included in fluid (122), inflammation or other tissue conditions may be treated when severing and stapling tissue (90). While one merely exemplary configuration for staple driver (130) and container (120) has been described, other configurations for staple driver (130), container protrusion (134), and/or container (120) will be apparent to one of ordinary skill in the art in view of the teachings herein.

[0037] One such alternative configuration, shown in FIG. 11, has a container (220) that may be a solid container extending downwardly from orifice (114) and having a channel (226) extending vertically along a portion of container (220). In the present example, container (220) is shown as a cylindrical container, but it should be understood that other shapes, sizes, and configurations for container (220) may be used. Indeed, in an alternative configuration, container (220) may be a cavity formed within cartridge body (102) and/or upper deck (112). Additionally, one or more plugs, such as bioresorbable plugs, may be inserted into orifice (114) and/or a portion of container (220), or, alternatively, a film may be laid atop one or more orifices (114) on upper deck (110) of cartridge (100). Channel (226) of the present example may be filled with a pierceable sealant (228), such as RTV, silicone, or other semi-solid, flexible, or pierceable sealants. Sealant (228) substantially fluidly seals channel (226) such that container (220) may be filled with a fluid (222) without substantially leaking through channel (226). Fluid (222) of the present example may be injected into container (220) through orifice (114) or from the bottom of container (220) prior to inserting container protrusion (234), as described below.

[0038] As shown in the present example, staple driver (230) comprises a driver body (232) configured to vertically translate a staple, a piercing portion (236) extending from driver body (232), and a container protrusion (234) configured to vertically slide within container (220) to force fluid (222) out orifice (114). Container protrusion (234) may be configured in a substantially similar manner to a syringe plunger, such as including one or more seals (not shown) disposed about container protrusion (234) to prevent fluid (222) from leaking around container protrusion (234). Piercing portion (236) comprises a cutter portion (238) that is configured to pierce sealant (228) as staple driver (230) is cammed vertically. Thus, container protrusion (234) may vertically translate within container (220) to force out fluid (222) while piercing portion (236) couples container protrusion (234) to driver body (232) and cutter portion (238) pierces sealant (226). The pressure of fluid (222) when container protrusion (234) translates vertically may be sufficient to “pop out” the one or more bioresorbable plugs noted previously. Accordingly, fluid (222) may be delivered to tissue (90) and/or staple (140) via this additional configuration. While container protrusion (234) is shown as substantially planar with driver body (232), container protrusion (234) may alternatively be offset, above or below, driver body (232).

[0039] In another configuration shown in FIG. 12, staple driver (330) includes an elongate vertical U-shaped portion (336) coupling container protrusion (334) to driver body (332). The vertical dimensioning of U-shaped portion (336) may be such that container protrusion (334) may slidably translate within a solid container (320) to expel fluid (322) out orifice (114) without the bottom of U-shaped portion (336) contacting the lower edge of container (320). Alternatively, the bottom of U-shaped portion (336) may contact container (320) when staple driver (330) is at the apex, or U-shaped portion (336) may be configured to break-away at a predetermined position when expelling fluid (322) and driving a staple with staple driver (330). Still other suitable configurations for staple drivers and containers will be apparent to one of ordinary skill in the art in view of the teachings herein.

[0040] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The following-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0041] Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures.

[0042] Versions of described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may 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.

[0043] By way of example only, versions described herein may be sterilized before and/or after a procedure. 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 field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. 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. A 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.

[0044] Having shown and described various versions in the present disclosure, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, versions, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.