Surgical scissors

[0001] Various embodiments are directed to surgical scissors devices and methods of manufacturing and using the same.

[0002] Minimally invasive procedures are desirable because such procedures can reduce pain and provide relatively quick recovery times as compared to conventional open medical procedures. Many minimally invasive procedures are performed with an endoscope (including without limitation laparoscopes). Such procedures permit a physician to position, manipulate, and view medical instruments and accessories inside the patient through a small access opening in the patient's body. Laparoscopy is a term used to describe such an “endosurgical” approach using an endoscope (often a rigid laparoscope). In this type of procedure, accessory devices are often inserted into a patient through trocars placed through the body wall. Still less invasive treatments include those that are performed through insertion of an endoscope through a natural body orifice to a treatment region. Examples of this approach include, but are not limited to, cystoscopy, hysteroscopy, esophagogastroduodenoscopy, and colonoscopy.

[0003] Many of these procedures employ a flexible endoscope during the procedure. Flexible endoscopes often have a flexible, steerable articulating section near the distal end that can be controlled by the clinician by utilizing controls at the proximal end. Some flexible endoscopes are relatively small (1 mm to 3 mm in diameter), and may have no integral accessory channel (also called biopsy channels or working channels). Other flexible endoscopes, including gastroscopes and colonoscopes, have integral working channels having a diameter of about 2.0 to 3.7 mm for the purpose of introducing and removing medical devices and other accessory devices to perform diagnosis or therapy within the patient. Certain specialized endoscopes are available, such as large working channel endoscopes having a working channel of 5 mm in diameter, which can be used to pass relatively large accessories, or to provide capability to suction large blood clots. Other specialized endoscopes include those having two or more working channels.

[0026] Various embodiments are directed to surgical scissors devices. The surgical scissors devices may, for example, be deployed through the working channel of an endoscope. The surgical scissors devices described herein may have various features for enhancing performance. For example, various embodiments may have blade members that are held in compression relative to one another by a fastener. This may tend to hold the blade members together during use and prevent or minimize tissue slipping between the scissor blades. Also, in various embodiments, the blade members of the scissors device may be cam actuated. This may allow increased mechanical advantage, allowing the clinician to more easily open and close the blade members.

[0027] Various other embodiments described herein are directed to methods and devices for constructing surgical scissors. For example, according to some embodiments, a compressive force may be applied to the first and second blade members, tending to push them together. While the compressive force is applied, a fastener may be installed to hold the blade members together. Then the compressive force may be released. The fastener may serve to maintain the blade members in compression against one another. The compressive force may be applied by any suitable mechanism including, for example, a clamp having a first clamp member, a second clamp member and a clamp mechanism, as described herein. One or more of the clamp members may define a cavity shaped to receive one or both the blade members. This may secure the blade members while the compressive force is applied.

[0028] Various embodiments of the surgical scissors devices described herein may be used in endoscopic surgical environments. FIG. 1 illustrates one embodiment of an endoscope 14 (illustrated here as a gastroscope) inserted into the upper gastrointestinal tract of a patient. The endoscope 14 has a distal end 16 that may include various optical channels, illumination channels, and working channels. According to various embodiments, the endoscope 14 may be a flexible endoscope, and may be introduced via natural orifices.

[0029] In one embodiment, Natural Orifice Translumenal Endoscopic Surgery (NOTES)™ techniques may be employed to introduce the endoscope 14 and various instruments (e.g., the surgical scissors devices described herein) into the patient and carry out the various procedures described herein. A NOTES™ technique is a minimally invasive therapeutic procedure that may be employed to treat diseased tissue or perform other therapeutic operations through a natural opening of the patient without making incisions in the abdomen. A natural opening may be the mouth, anus, and/or vagina. Medical implantable instruments may be introduced into the patient to the target area via the natural opening. In a NOTES™ technique, a clinician inserts a flexible endoscope into one or more natural openings of the patient to view the target area, for example, using a camera. During endoscopic surgery, the clinician inserts surgical devices through one or more lumens or working channels of the endoscope 14 to perform various key surgical activities (KSA). These KSAs include forming an anastomosis between organs, performing dissections, repairing ulcers and other wounds. Although the devices and methods described herein may be used with NOTES™ techniques, it will be appreciated that they may also be used with other surgical techniques including, for example, other endoscopic techniques and laparoscopic techniques.

[0030] FIG. 2 illustrates one embodiment of a distal portion 16 of the endoscope 14, which may be used with the scissors devices described herein. The example endoscope 14 shown comprises a distal face 4, which defines the distal ends of illumination channels 8, an optical channel 6 and a working channel 10. The illumination channels 8 may comprise one or more optical fibers or other suitable waveguides for directing light from a proximally positioned light source (not shown) to the surgical site. The optical channel 6 may comprise one or more optical fibers or other suitable waveguides for receiving and transmitting an image of the surgical site proximally to a position where the image may be viewed by the clinician operating the endoscope 14. As described above, the working channel 10 may allow the clinician to introduce one or more surgical tools to the surgical site. Examples of such surgical tools include scissors, cautery knives, suturing devices and scissors devices. It will be appreciated that the endoscope 14 is but one example of an endoscope that may be used in accordance with various embodiments. Endoscopes having alternate configurations of optical channels 6, illumination channels 8 and/or working channels 10 may also be used.

[0031] FIG. 3 illustrates one embodiment of a scissors device 100, which may be used, for example, with an endoscope such as the endoscope 14. The scissors device 100 may comprise a handle assembly 102, a flexible shaft 104 and an end effector 106. The end effector 106 may comprise a first blade member 108 and a second blade member 110. The first blade member 108 and second blade member 110 may be connected to a clevis 112, which, in turn, may be coupled to the flexible shaft 104. FIG. 4 illustrates one embodiment of the end effector 106 of the scissors device 100. The blade members 108, 110 may have respective blade ends 150, 152 and cam ends 206, 208. The blade members may be configures such that the blade ends 150, 152 overlap one another in the open position. In some example embodiments, the overlap may be between about 0.127 mm (0.005 inches) and 0.152 mm (0.006 inches). The blade members 108, 110 may pivot about a pivot point 130 that may comprise a pin or other connector to fasten the blade members 108, 110 to one another, or to fasten the blade members 108, 110 between arms 111, 115 of the clevis 112, which may hold them together. The respective arms 111, 115 of the clevis may each define a pin hole that aligns with the pivot point 130 and may receive the fastener. A shuttle 122 may comprise one or more pin features 214 received into one or more cam slots 210, 212 of the respective blade members 108, 110, for example, as described herein below. The shuttle 122 may be coupled to a translating member 116, which may extend proximally through the flexible shaft 104 to the handle 102.

[0032] Referring back to FIG. 3, the translating member 116 may extend within the flexible shaft 104 from the end effector 106 to the handle 102. The translating member 116 may be made from any suitable material. For example, the translating member 116 may be, a metal wire (e.g., a multi-layered steel cable, such as a tri-layered steel cable), a plastic or metal shaft. According to various embodiments, the translating member may comprise a spiral cut or otherwise slotted hypotube (e.g., a cylindrical object with slots cut therein to provide or enhance flexibility). For example, in FIG. 4, the translating member 116 is illustrated as comprising a cut hypotube. At the handle 102, the flexible shaft 104 may be directly or indirectly coupled to an actuator 113. In use, a clinician may cause the actuator 113 to pivot along arrow 118 from a first position to a second position. When the actuator 113 moves from the first position to the second position, it may translate the translating member 116 distally or proximally. Distal or proximal motion of the translating member 116 may, in turn, cause the end effector 106 to transition from an open position to a closed position. Repeatedly transitioning the end effector 106 from the open position to the closed position may affect cutting of tissue or other materials.

[0033] FIG. 5 illustrates one embodiment of the handle 102 of the scissors device 100. The actuator 113 may pivot about pivot point 502 along arrow 118 as shown. The pivot point 502 may comprise a pin or other connector fastening the actuator to the handle body 508. The handle body 508 may define a grip 501 opposite the actuator 113 as shown. In one example, use, the clinician may place one or more fingers through the grip 501, allowing the clinician to manipulate the actuator 113 with a thumb. According to various embodiments, the actuator 113 may comprise a lock element 504 configured to be securely received into a lock cavity 506. The lock element 504 and cavity 506 may allow the clinician to secure the actuator 113, and thus the end effector 106, into a given position.

[0034] FIG. 6 illustrates one embodiment of the handle 102 with the handle body 508 not shown. The actuator 113 is shown with a pair of arms 510 defining slots 516. The arms 510 receive a pin 518 to slidably couple the actuator to a slider mechanism 512. FIG. 7 illustrates a cross section of one embodiment of the handle 102. FIG. 8 illustrates one embodiment of the slider mechanism 512. The translating member 116 is received at the distal portion of the handle body 508 and extends proximally to the slider mechanism 512. Within the slider mechanism 512, the translating member 116 may be received by a pair of spring holders 524, 526 and a collar 520. From the collar 528, the translating member 116 may extend proximally to the rotation knob 114. The translating member 116 may be securely fastened to the collar 520 such that the translating member 116 cannot translate distally and proximally with respect to the collar 520.

[0035] In use, the clinician may move the actuator 113 towards the grip 501 to force the translating member 116 proximally. The resulting rotation of the actuator 113 about the pivot point 502 may pull the slider mechanism 512 proximally within the cavity 522 defined by the handle body 508. This may also pull the collar 520 and translating member 116 proximally. Spring 528 may resist motion of the slider mechanism 512 and thus the translating member 116. To move the translating member 116 distally, the clinician may pivot the actuator 113 away from the grip 501 about the pivot point 502. This may force the slider mechanism 512 and thus the translating member 116 distally.

[0036] FIG. 9 illustrates an exploded view of the end effector 106 and flexible shaft 104 of one embodiment of the scissors device 100 having cam-actuated blade members. As shown, the blade members 108, 110 comprise the proximal cam ends 206, 208. Each of the cam ends 206, 208 defines a respective cam slot 210, 212. A shuttle 122 may comprise one or more pin features 214 that ride in the cam slots 210, 212. For example, the shuttle 122 may comprise a single pin feature 214 extending through both sides or separate pin features 214 on each side. According to various embodiments, the pin features 214 may also protrude from a slot 216 defined by the clevis 112.

[0037] FIG. 9A illustrates one embodiment of the shuttle 122. In use, the shuttle 122 may be coupled to the translating member 116. As shown, the shuttle 122 may have two arm members 902 defining holes 904 for receiving the pin feature or features 214. The cam ends 206, 208 of the blade members 108, 110 may be received between the arm members 902. A wedge feature 906 may be positioned at a proximal portion of the shuttle 122 and may serve to wedge the cam ends 206, 208 of the blade members 108, 110 apart from one another when the shuttle 122 is it its distal position. Referring back to FIG. 9, distal motion of the translating member 116 may cause corresponding distal motion of the shuttle 122, which may, in turn, force the pin features 214 to slide within the cam slots 210, 212, forcing the blade members 108, 110 into an open position. In some embodiment, the wedge feature 906 of the shuttle may provide an additional force tending to open the blade members 108, 110 by forcing the cam ends 206, 208 away from one another.

[0038] According to various embodiments, the end effector 106 may be rotatably coupled to the flexible shaft 104. For example, an outer coupler 126 may be fastened to the flexible shaft 104. An inner coupler 124 may be fastened within the outer coupler 126 such that the inner coupler 124 can rotate relative to the outer coupler 126 and the flexible shaft 104. The inner coupler 124 may also be coupled to the clevis 112 (and hence the end effector 106). Accordingly, the end effector 106 may be rotatable, with the inner coupler 124, about the outer coupler 126 and the flexible shaft 104. As described above, the translating member 116 may be coupled to the end effector 106, for example, via the shuttle 122. The clinician may bring about rotation of the end effector 106 by rotating the translating member 116. For example, referring to FIG. 5-7, the handle 102 may comprise a knob 114 or other control device allowing the clinician to rotate the translating member 116.

[0039] The flexible shaft 104 may be made from any suitable material and/or device. In various embodiments the flexible shaft 104 may be made from a material or device that is flexible and also able to withstand tension and compression forces to avoid significant losses in the opening and closing forces provided by the clinician via the actuator 113. For example, when the actuator 118 causes the translating member 116 to move distally, the flexible shaft 104 may be placed in compression. When the actuator 118 causes the translating member 116 to move proximally, the flexible shaft 104 may be placed in tension. Excessive compression or stretching of the flexible shaft 104 may attenuate the force ultimately provided to open or close the end effector 106.

[0040] In various embodiments, the flexible shaft may comprise a coil pipe 128, as illustrated in FIG. 9. The coil pipe 128 may be made from wire or a narrow ribbon of material formed into a cylindrical coil. The coiled nature of the coil pipe 128 may cause it to perform well in compression. In tension, however, the coil pipe 128 may tend to expand, thus attenuating the force applied to the end effector 106. The attenuation may be minimized by selecting a coil pipe 128 with a high pre-load. This may make the coil pipe 128 relatively stiff and more difficult to bend, but may also improve its performance in tension. FIG. 10 illustrates another embodiment of the scissors device 100 with a flexible shaft 104 comprising a cut hypotube 1002 in place of the coil pipe 128. The cut hypotube 1002 may be a cylindrical piece of material (e.g., surgical steel or other metal) with a plurality of cuts or cut-out features 1004. The cuts may allow the hypotube 1002 to bend. Because the hypotube 1002 may bend on the cuts, the spatial frequency of the cuts in any given portion of the hypotube 1002 may determine the flexibility of that portion. A higher spatial frequency of cuts may correspond to a higher flexibility. Because the hypotube 1002 is not configured to stretch under ordinary operating conditions, it may provide increased tensile performance compared to the coil pipe 128.

[0041] FIGS. 11-14 illustrate one embodiment of the end effector 106 transitioning from a closed position shown in FIG. 11 to an open position shown in FIG. 14. Referring to FIG. 11, the end effector 106 is shown in the closed position. The blade members 108, 110 are illustrated in a closed, overlapping position. The shuttle 122 is shown coupled to the translating member 116 and in a proximal position. For example, a clinician operating the actuator 113 may have caused the translating member 116 to translate through the flexible shaft 104 in a proximal direction. This may, in turn, have caused the shuttle 122 to assume the proximal position shown. When the shuttle 122 is in the proximal position the pins 214 may be positioned within the slots 210, 212 such that the blade members 108, 110 are in the closed position.

[0042] FIGS. 12 and 13 illustrate one embodiment of the end effector 106 transitioning from the closed position to the open position. As the translating member 116 and shuttle 122 are pushed distally, the pins 214 may also move distally within the cam slots 210, 212. Due to the curvature of the cam slots 210, 212, this may force the blade members 108, 110 into the open position. In FIG. 14, the end effector 106 is shown with the shuttle 122 in its fully distal position and the blade members 108, 110 in their fully open position. It will be appreciated that the profile (e.g., shape) of the cam slots 210, 212, may bring about a mechanical advantage, lessening the force necessary to open or close the end effectors 106. For example, configuring the cam slots 210, 212 with a shallow profile may reduce the mechanical advantage between the actuator 113 and the end effector 106. This may, in turn, minimize the movement of the actuator 113 that is necessary to open the end effector 106, but maximize the required force. Similarly, configuring the cam slots 210, 212 with a more curved profile may increase the mechanical advantage between the actuator 113 and the end effector 106. This may decrease the force that the clinician must apply to the actuator 113, but increase the necessary movement.

[0043] FIG. 15 illustrates another embodiment of the scissors device 100 with a link-actuated end effector 1500. The end effector 1500 may comprise a pair of blade members 1502, 1504. A shuttle 1508 may be coupled to the translating member 116, similar to the shuttle 122. Each blade member 1502, 1504 may be coupled to the shuttle 1508 via links 1510, 1512. When the shuttle 1508 is pushed distally, as shown in FIG. 15, the links 1510, 1512 may push the blade members 1502, 1504 into the open position. As the shuttle 1508 is pulled proximally (e.g., via the translating member 116) the blade members 1502, 1504 may be pulled into the closed position.

[0044] FIG. 16 is a diagram illustrating one embodiment of a process flow 1600 for assembling the blade members 108, 110 of the scissors device 100. Initially, the blade members 108, 110 and the clevis 112 may be aligned 1602 for assembly. For example, the blade members 108, 110 may be placed between the arms 111, 115 of the clevis 112. According to various embodiments, the blade members 108, 110 and clevis 112 may be aligned 1602 by placing them into a clamp assembly. FIG. 17 illustrates one embodiment of a clamp assembly 1700 in which the blade members 108, 110 and clevis 112 may be aligned. The clamp assembly 1700 may comprise a first clamp member 1702 and a second clamp member 1704. The clamp members 1702, 1704 may be coupled to any suitable kind of clamping mechanism. For example, in the embodiment shown in FIG. 17, the clamping mechanism comprises a threaded screw 1706 that may be coupled to the clamp members 1702, 1704 such that tightening of the threaded screw forces the clamp members 1702, 1704 towards one another. As shown, the clamp member 1704 defines a cavity 1708 shaped to receive the blade members 108, 110. The cavity 1708 may serve to align the blade members 108, 110. According to various embodiments, the clamp member 1702 may have a corresponding cavity (not shown) that may augment and/or replace the cavity 1708.

[0045] Referring back to the diagram 1600, a compressive force may be applied 1604 to the blade members 108, 110 and clevis 112. For example, referring to FIG. 17, the threaded screw 1706 may be rotated, forcing the clamp member 1702 towards the clamp member 1704 to apply the compressive force. FIG. 18 illustrates one embodiment of the clamp assembly 1700 with the blade members 108, 110 and clevis 112 under compressive force. Again referring to FIG. 16, a fastener may be applied 1606 to the blade members 108, 110 and clevis 112 while maintaining the compressive force. The fastener may be applied 1606, for example, to the pivot point 130 (see FIG. 4). The fastener may be any suitable fastener type. For example, the fastener may be a rivet or a screw. In various embodiments, the fastener may comprise a pin welded to the blade members 108, 110 and/or clevis 112 at the pivot point. For example, the pin (not shown) may be laser welded. One or both of the clamp members 1702, 1704 may be configured to allow access to the pivot point 130 for installing the fastener. For example, the clamp member 1702 defines an access opening 1710 over the point where the pivot point 130 of the blade members 108, 110 is located. In the embodiment shown in FIG. 17, the access opening 1710 takes the form of a notch in the clamp member 1702. The notch 1710 may have a beveled edge 1711 as shown to allow greater access through to the pivot point 130 during use. The compressive force may be released 1608. When the compressive force is released 1608, the fastener may serve to maintain the blade members 108, 110 in compression. Reciprocally, the blade members 108, 110 may maintain the fastener in tension.

[0046] Referring again to FIG. 18, the clamp assembly 1700 may comprise one or more guide pins 1712. The first clamp member 1702 may slide along the guide pins 1712 as the clamp assembly 1700 is opened and closed. An optional set screw 1707 may serve to stabilize the clamp members 1702, 1704. FIG. 19 illustrates one embodiment of the clamp member 1702. As illustrated, the clamp member 1702 may comprise a cavity 1714 for receiving a portion of one or both of the blade members 108, 110. Guide holes 1716 may receive the guide pins 1712. A threaded set screw hole 1720 may receive the set screw 1707. A threaded hole 1718 may receive the threaded screw 1706. A corresponding hole (not shown) may be defined by the clamp member 1704. Accordingly, rotation of the threaded screw 1706 may force the clamp member 1702 towards the clamp member 1704.

[0047] FIG. 20 illustrates another embodiment of the clamp assembly 1700 comprising an alternate clamp member 1702′. The clamp member 1702′ may be shorter than the clamp member 1702. This may allow the clamp member 1702′ to expose more of the cavity 1708 than the clamp assembly 1702. In turn, this may allow the clamp member 1702′ to have a smaller access opening or notch 2002. FIG. 21 illustrates one embodiment of the alternate clamp member 1702′. The clamp member 1702′ may comprise guide holes 1716, a set screw hole 1720 and a threaded hole 1718 similar to the clamp member 1702. As illustrated, however, the clamp member 1702′ may lack a cavity for receiving all or a portion of the blade members 108, 110. It will be appreciated that the clamp assembly 1700 may be manually or automatically operated. For example, assembly personal may actuate the clamp by manually turning the threaded screw 1706. Also, in some embodiment the screw 1706 may be actuated by an electric or other motor (not shown).

[0048] The clamp mechanism of the clamp assembly 1700 described above comprises a threaded screw 1706. It will be appreciated that any other suitable manual or automatic clamp mechanism may be used. For example, FIG. 22 illustrates one embodiment of the clamp assembly 1700 with a lever clamp mechanism. A lever frame 2204 may support a lever bar 2202, which may be pivot about the frame 2204 as shown by arrow 2212. The lever bar 2202 may be pivotably coupled to a link 2206 at pivot point 2208. The link 2206, in turn, may be pivotably coupled to the clamp member 1702 at pivot point 2210. To operate the clamp assembly 1700 as shown in FIG. 22, assembly personnel may rotate the lever bar 2202 towards the clamp member 1702 along arrow 2212. This may force the clamp member 1702 towards the clamp member 1704 as described above. The lever bar 2202 may be manually actuated, for example, directly by assembly personnel, or may be automatically actuated.

[0049] FIG. 23 illustrates another embodiment of the clamp assembly 1700 with a hydraulic or pneumatic clamp mechanism. As shown, cylinder frame 2304 may be pivotably coupled to a cylinder 2302, which may be a pneumatic or hydraulic cylinder. When the cylinder 2302 is activated, it may extend, providing the compressive force between the clamp members 1702, 1704. The cylinder 2302 may be activated, for example, by a hydraulic or pneumatic compressor (not shown) which may be manually and/or automatically actuated.

[0050] In various embodiments, surgical instruments utilizing various embodiments of the scissors device 100 may be employed in conjunction with a flexible endoscope, such as a GIF-100 model available from Olympus Corporation, for example. In at least one such embodiment, the endoscope, a laparoscope, or a thoracoscope, for example, may be introduced into the patient trans-anally through the colon, the abdomen via an incision or keyhole and a trocar, or trans-orally through the esophagus, or trans-vaginally through the cervix, for example. These devices may assist the clinician to guide and position the scissors device 100 near the tissue treatment region to treat diseased tissue on organs such as the liver, for example. In another embodiment, these devices may be positioned to treat diseased tissue near the gastrointestinal (GI) tract, esophagus, and/or lung, for example. In various embodiments, the endoscope may comprise a flexible shaft where the distal end of the flexible shaft may comprise a light source, a viewing port, and at least one working channel. In at least one such embodiment, the viewing port may transmit an image within its field of view to an optical device such as a charge coupled device (CCD) camera within the endoscope, for example, so that an operator may view the image on a display monitor (not shown).

[0051] It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician manipulating an end of an instrument extending from the clinician to a surgical site (e.g., through a trocar, through a natural orifice, through an open surgical site). The term “proximal” refers to the portion closest to the clinician, and the term “distal” refers to the portion located away from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be 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.

[0052] While several embodiments have been illustrated and described, and while several illustrative embodiments have been described in considerable detail, the described embodiments are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. Those of ordinary skill in the art will readily appreciate the different advantages provided by these various embodiments.

[0053] While several embodiments have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the embodiments. For example, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. The described embodiments are therefore intended to cover all such modifications, alterations and adaptations without departing from the scope of the appended claims.

[0054] The devices disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the device may be reconditioned for reuse after at least one use. Reconditioning may include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device may be disassembled, and any number of particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device may utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of this application.

[0055] Preferably, the embodiments described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that may penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

[0056] Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials do not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

[0057] The embodiments are not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the scope of the claims. Accordingly, it is expressly intended that all such equivalents, variations and changes that fall within the scope of the claims be embraced thereby.

[0058] In summary, numerous benefits have been described which result from employing the embodiments described herein. The foregoing description of the one or more embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments were chosen and described in order to illustrate principles and practical applications to thereby enable one of ordinary skill in the art to utilize the various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the claims submitted herewith define the overall scope.