Cable actuated end-effector for a surgical instrument

Various embodiments are directed to a surgical instrument comprising a handle, a shaft coupled to the handle and extending along a longitudinal axis, an end effector, and a cable. The end effector may comprise a first jaw member, a second jaw member and a reciprocating member. The cable may extend distally from the handle through the shaft to a first pulley of the first jaw member. From the first pulley, the cable may extend proximally to the reciprocating member, such that proximally directed motion of the cable exerts a distally directed force on the reciprocating member.

BACKGROUND

Various embodiments are directed to cable actuated end effectors for surgical instruments and surgical instruments having cable-actuated end effectors.

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 (such as end effectors for creating energy-induced tissue welds) are 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.

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. For example, end effectors for creating an energy-induced weld or seal. Certain specialized endoscopes or steerable overtubes are available, such as large working channel endoscopes having a working channel of 5 mm, or larger, 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.

A common task both in minimally invasive and open surgical environments is to grasp, cut and fasten tissue while leaving the cut ends hemostatic (e.g., not bleeding). For example, it is often desirable to cut and seal bodily lumens, such as individual blood vessels or tissue including various vasculature. When sealing a fluid-carrying bodily lumen, it is often necessary for the seal to have sufficient strength to prevent leakage of the fluid, which may exert considerable fluid pressure.

Instruments exist for simultaneously making a longitudinal incision in tissue and fastening the tissue on opposing sides of the incision. Such instruments commonly include an end effector having a pair of cooperating jaw members that, if the instrument is intended for minimally invasive applications, are capable of passing through a cannula passageway or endoscopic working channel. In use, the clinician is able to close the jaw members to clamp the tissue to be cut. A reciprocating cutting instrument (or knife) is drawn distally along the jaw members to transect the clamped tissue. Simultaneously, a fastening mechanism fastens the cut ends of the tissue on opposing sides of the incision. Known fastening mechanisms include staples, sutures or various instruments utilizing energy sources. For example, various energy sources such as radiofrequency (RF) sources, ultrasound sources and lasers have been developed to coagulate, seal or join together tissue volumes.

SUMMARY

Various embodiments are directed to a surgical instrument comprising a handle, a shaft, an end effector, a reciprocating member and a cable. The shaft may be coupled to the handle and may extend distally along a longitudinal axis. The end effector may be positioned at a distal portion of the shaft and may comprise first and second jaw members. The first jaw member may define a first longitudinal slot and may comprise a first pulley positioned at a distal portion of the first jaw member. The second jaw member may define a second longitudinal slot and may be pivotable towards the first jaw member. The reciprocating member may be translatable distally and proximally parallel to the longitudinal axis, and may comprise a transverse member positioned to pass through the first and second longitudinal slots as the reciprocating member translates distally and proximally, at least one flange positioned on a distal portion of the reciprocating member to exert a force tending to close the first and second jaw members when the transverse member passes through the first and second longitudinal slots, and a distal leading edge that defines a blade. The cable may extend distally from the handle through the shaft to the first pulley and proximally from the first pulley to the reciprocating member, such that proximally directed motion of the cable exerts a distally directed force on the reciprocating member.

Also, various embodiments may be directed to a surgical instrument comprising a handle, a shaft, an end effector, a reciprocating member and a handle. The shaft may be coupled to the handle and may extend distally along a longitudinal axis. The end effector may be positioned at a distal portion of the shaft, and may comprise a stationary first jaw member and a pivotable second jaw member. The first jaw member may define a first longitudinal slot and may comprise a first pulley positioned at a distal portion of the first jaw member; and a first electrode comprising a first electrically conductive portion and a positive temperature coefficient (PTC) portion. The second jaw member may define a second longitudinal slot, comprise a second electrode and be pivotable towards the first jaw member. The reciprocating member may be translatable distally and proximally parallel to the longitudinal axis, and may comprise a transverse member positioned to pass through the first and second longitudinal slots as the reciprocating member translates distally and proximally; at least one flange positioned on a distal portion of the reciprocating member to exert a force tending to close the first and second jaw members when the transverse member passes through the first and second longitudinal slots; and a distal leading edge that defines a blade. The cable may extend distally from the handle through the shaft to the first pulley and proximally from the first pulley to the reciprocating member, such that proximally directed motion of the cable exerts a distally directed force on the reciprocating member.

Additionally, various embodiments may be directed to a surgical instrument comprising a handle, a shaft, an end effector, a reciprocating member and a cable. The shaft may be coupled to the handle and may extend distally along a longitudinal axis. The end effector may be positioned at a distal portion of the shaft and may comprise first and second jaw members and a collar. The first jaw member may comprise a first pulley positioned at a distal portion of the first jaw member. The second jaw member may be pivotable towards the first jaw member. The reciprocating member may be translatable distally and proximally parallel to the longitudinal axis and may comprise a transverse member and a distal leading edge. The transverse member may be positioned to pass through the first and second longitudinal slots as the reciprocating member translates distally and proximally. The distal leading edge may define a blade. The collar may be translatable distally and proximally from a position proximal from a pivot point of the second jaw member to a position distal from the pivot point of the second jaw member. The cable may extend distally from the handle through the shaft to the first pulley and proximally from the first pulley to the collar, such that proximally directed motion of the cable exerts a distally directed force on the collar.

DESCRIPTION

Various embodiments are directed to cable actuated end effectors and surgical instruments comprising cable actuated end effectors. According to various embodiments, an end effector may comprise a pair of jaw members. One or both of the jaw members may be pivotable relative to one another such that the jaw members may transition from an open position to a closed position (or vice versa). A first cable may be routed from a handle of the surgical instrument through a shaft of the surgical instrumet to a pulley position within at least one of the jaw members. From the pulley, the cable may be routed proximally to a reciprocating member. A second cable may be routed from the reciprocating member to the handle via a shaft. To close the jaw members, a proximally directed force may be applied to the first cable. This may, in turn, cause the reciprocating member to be translated distally through slots in the jaw members. Flanges of the reciprocating member may ride above the slots tending to close the jaw members with a compressive force. To open the jaw members, a proximally directed force may be applied to the second cable, which may pull the reciprocating member proximally, allowing the jaw members to open.

FIG. 1illustrates one embodiment of a transection and sealing instrument100. The instrument100may be used with an endoscope, laparoscope, or any other suitable introduction device. According to various embodiments, the transection and sealing instrument100may comprise a handle assembly102, a shaft104and an end effector106. The shaft104may be rigid (e.g., for laparoscopic application and/or open surgical application) or flexible, as shown, (e.g., for endoscopic application). In various embodiments, the shaft104may comprise one or more articulation points. The end effector106may comprise a first jaw member108and a second jaw member110. The first jaw member108and second jaw member110may be connected to a clevis112, which, in turn, may be coupled to the shaft104. In various embodiments, as illustrated below, the jaw members108,110may be directly coupled to the shaft104and the clevis112may be omitted. As illustrated inFIG. 1, the end effector106is shown with the jaw members108,110in an open position. A reciprocating member340is illustrated between the jaw members108,110.

According to various embodiments, one or both of the jaw members108,110may include, or serve as electrodes in monopolar or bi-polar electrosurgical applications including, for example, cutting, coagulation and welding.FIG. 2illustrates one embodiment of the transection and sealing instrument100for use in electrosurgical applications. The jaw members108,110of the end effector106may comprise respective electrodes120,122. The electrodes120,122may be connected to an electrosurgical generator124via wires (not shown) extending from the end effector106through the shaft104and handle102. The generator124may generate any suitable type of signal for electrosurgical applications. For example, the generator124may make various alternating current (A/C) and/or direct current (D/C) signals at suitable voltages, currents, frequencies and wave patterns. According to various embodiments, the transection and sealing instrument100may be configured for monopolar operation. In this case, the end effector106may comprise a single electrode, rather than two. According to various embodiments, all or a portion of the end effector106may serve as the single electrode.

A translating member116may extend within the shaft104from the end effector106to the handle102. The translating member116may be made from any suitable material. For example, the translating member116may be, a metal wire (e.g., a tri-layered steel cable), a plastic or metal shaft, etc. In some embodiments, one or more additional translating members (not shown inFIG. 2) may be included to control the motion of the end effector106and/or the shaft104. In various embodiments, the instrument100may comprise multiple translating members116, for example, as described below. At the handle102, the shaft104may be directly or indirectly coupled to an actuator113(FIG. 1). In use, a clinician may cause the actuator113to pivot along arrow118from a first position to a second position. When the actuator moves from the first position to the second position, it may translate the translating member116distally or proximally. Distal or proximal motion of the translating member116may, in turn, cause the end effector106to transition from an open position to a closed position (or vice versa) and/or to perform various other surgical activities such as, for example, severing and/or joining or welding. According to various embodiments, the handle102may comprise multiple actuators113. When multiple actuators113are present, each actuator113may be used by a clinician to cause the end effector106to perform different surgical activities. In various embodiments a single actuator113may cause the end effector106to perform more than one activity. For example, a clinician may activate a single actuator113to force a reciprocating member340distally. This may, as described, both close the jaw members108,110and transect any tissue between the jaw members108,110.

FIGS. 3 and 4illustrate one embodiment of an end effector106of the instrument100adapted for transecting captured tissue and contemporaneous sealing of the captured tissue with RF energy delivery. The end effector106is carried at the distal end304of the shaft104that can be rigid, articulatable or deflectable in any suitable diameter. For example, the shaft104can have a diameter ranging from about 2 mm to 20 mm to cooperate with cannulae in endoscopic/laparoscopic surgeries or for use in open surgical procedures. The shaft104extends from a proximal handle, such as the handle102. The handle102can be any type of pistol-grip or other type of handle known in the art that carries actuator levers, triggers or sliders for moving the translating member116or members distally and proximally to actuate the jaws as will be disclosed below. The shaft104has a bore308extending therethrough for carrying actuator mechanisms (e.g., translating member116) for actuating the jaws and for carrying electrical leads309a-309bfor the electrosurgical components of the end effector106.

FIGS. 3 and 4show details of the end effector106, including the (upper) jaw element108and (lower) jaw element110that are adapted to close or approximate along an axis315. The jaw elements108,110may both be moveable or a single jaw may rotate to provide the open and closed positions. In the exemplary embodiment ofFIGS. 1 and 2, both the lower and upper jaws110,108are moveable relative to a rolling pivot location316defined further below.

An opening-closing mechanism of the end effector106operates on the basis of cam mechanisms that provide a positive engagement of camming surfaces both distal and proximal to a pivoting location (i) for moving the jaw assembly to the (second) closed position to engage tissue under very high compressive forces, and (ii) for moving the jaws toward the (first) open position to apply substantially high opening forces for “dissecting” tissue. This feature allows the surgeon to insert the tip of the closed jaws into a dissectable tissue plane—and thereafter open the jaws to apply such dissecting forces against the tissues.

According to various embodiments, the lower and upper jaws110,108may have a first end318, in the open position, that defines first (proximally-facing) arcuate outer surface portions indicated at320aand320bthat are engaged by a first surface portions322aand322bof a reciprocatable I-beam member340(FIG. 4) that is adapted to slide over the jaw elements108,110to thereby move the jaws toward closed position.FIGS. 5 and 6show views that illustrate the cam surfaces of reciprocating member340de-mated from jaws110and108. The first end portion318of the lower and upper jaws, in the open position, further defines second (distally-facing) arcuate surface portions indicated at330aand330bthat are engaged by second surface portions332aand332b(FIG. 5) of the reciprocatable member340for moving the jaw elements to the open position. The effective point of jaw rotation may lie between the first and second arcuate cam surfaces of the jaws. The distal (second) end region333of the paired jaws is rounded with a lip334that can serve as an electrode for surface coagulation as will be described below.

In this embodiment ofFIGS. 3,4and5, the reciprocating member340may be actuatable from the handle of the instrument by any suitable mechanism, such as actuator113, which may be coupled to a proximal end341of member340. The proximal end341and medial portion341′ of member340are dimensioned to reciprocate within bore308of the shaft104. The distal portion342of reciprocating member340carries first (lower) and second (upper) laterally-extending flanges or shoulder elements344A and344B that are coupled by an intermediate transverse element345. The transverse element345further is adapted to transect tissue captured between the jaws with a leading edge346(FIG. 5) that can be a blade or a cutting electrode. The transverse element345is adapted to slide within channels348aand348bin the paired first and second jaws110,108. As can be seen best inFIGS. 5 and 6, the laterally-extending shoulder elements344A and344B define the surfaces322a,322b,332a,332bthat slidably engage the arcuate cam surfaces of the jaws and that apply high compressive forces to the jaws in the closed position.

According to various embodiments, the first and second jaws108and110may define tissue-engaging surfaces or planes350aand350bthat contact and deliver energy to engaged tissues, in part, from RF electrodes120,122. The engagement plane350aof the lower jaw110may be adapted to deliver energy to tissue, and the tissue-contacting surface350B of upper jaw108may be electrosurgically active or passive as will be described below. Alternatively, the engagement surfaces350a,350bof the jaws can carry any suitable electrode arrangement known in the art.

The jaws108,110may have teeth or serrations356in any location for gripping tissue. The embodiment ofFIGS. 3 and 4depicts such serrations356at an inner portion of the jaws along channels348aand348bthus leaving engagement planes350aand350blaterally outward of the tissue-gripping elements. The serrations356may be of any suitable symmetric or asymmetric shape or combination of shapes including, for example, triangular, rounded, sinusoidal, etc. In the embodiments described below, the engagement planes350aand350band electrode(s)120,122generally are shown with a non-serrated surface for clarity of explanation, but such engagement planes and electrodes themselves can be any non-smooth gripping surface. The axial length of jaws108,110indicated at L can be any suitable length depending on the anatomic structure targeted for transection and sealing. In various embodiments, the length L may be between 10 mm and 50 mm. In some embodiments, the length L may be longer. For example, one embodiment of an end effector106for resecting and sealing organs such as a lung or liver may have a length L of about 200 mm. Also, for example, for some surgical tasks, the jaws having a shorter length L may be used, including, for example, jaws having a length L of about 5.0 mm.

FIG. 9illustrates an end view of one embodiment of the reciprocating member340with the jaws110and108in phantom view. The view shown inFIG. 9is a head-on view with the distally positioned blade surface346pointed out of the page.FIG. 10illustrates a cross-sectional view of the embodiment shown inFIG. 9along a cross-section taken at a position proximally located from the end view shown inFIG. 9. The transverse element345of the reciprocating member340may define a transverse dimension d between innermost surfaces358aand358bof the flanges344A,344B of the reciprocating member340and cooperating medial and distal outer surfaces360A and360B of the jaws. The selected transverse dimension d between the flanges or shoulders344A and344B thus further defines the engagement gap g between the engagement planes350aand350bof the jaws in the closed position. It has been found that very high compression of tissue combined with controlled RF energy delivery is optimal for welding the engaged tissue volume contemporaneous with transection of the tissue. According to various embodiments, the engagement gap g between the engagement planes350a,350bmay range from about 0.001″ to about 0.050″. For example, the gap g between the engagement planes ranges from about 0.001″ to about 0.010″. As can be seen inFIGS. 5 and 10, the medial portion341′ of the reciprocating member340may have an “I”-beam shape with inner surface portions363aand363bthat engage the cooperating medial outer surfaces of the jaws. Thus, in various embodiments, the entire length L of the jaws can be maintained in a fixed spaced-apart relationship to define a consistent engagement gap g. According to various embodiments, the engagement gap g may be selected to be large enough to prevent tissue engaged between the jaws108,110from being sheared and to prevent electrical shorts between the electrodes120,122.

FIGS. 7 and 8illustrate one embodiment of the actuation of the reciprocating member340from a first retracted position to a second extended position to move the jaws110and108from an open position to a closed position. Referring toFIG. 7, it can be seen that the translatable member340is being moved in the proximal direction so that the proximal-facing surfaces332aand332b(FIG. 5) of reciprocating member340about the outer surfaces330aand330bof the jaws thus forcing the jaws apart, for example to apply dissecting forces to tissues or to open jaws108and110to engage targeted tissues for hemostasis and transection.FIG. 8shows the reciprocating member340after having been fully extended in the distal direction so that the distal-facing surfaces322aand322bof reciprocating member340have ridden up and over the proximal arcuate surfaces320aand320bof the jaws (and medial outer surfaces360A and360B) thus forcing the jaws together thereby producing a compressive force between jaws108and110. According to various embodiments, the orientation of surfaces322a,322bof the reciprocating member340and/or the arcuate surfaces320a,320bmay be modified to modify the compression rate provided by the reciprocating member340. For example, the orientation of the322a,322bof the reciprocating member340and/or the arcuate surfaces320a,320bmay vary from one embodiment to another, or may vary within a single embodiment in order to cause variable compression rates within a single stroke of the reciprocating member340.

According to various embodiments, the jaws108,110may rollably contact one another along the interface370between inner surfaces372of the first end318of the jaws. As jaws108and110articulate, the pivot point is moving as the point of contact changes at the interface between surfaces370and372. Thus, the jaw assembly may not need to define a true single pivot point as is typical of hinge-type jaws known in the art. The pivotable action of the jaws along interface370may be described as a rolling pivot that optionally can allow for a degree of dynamic adjustment of the engagement gap g at the proximal end of the jaws.FIG. 11illustrates one embodiment of the jaw108de-mated from the end effector106. ReferencingFIG. 11, the jaws elements110,108can be retained relative to one another and the shaft104by means of protruding elements375that couples with arcuate slots376in an internal member377that is fixedly carried in bore308of shaft104. Alternatively, outwardly protruding elements can cooperate with slots in the wall of shaft104. Also, for example, the jaw assembly may (optionally) comprise springs for urging the jaws toward the open position, or closed position depending on the desired at-rest state of the device.

FIGS. 12-13illustrate one embodiment of an end effector1200having a single rotating jaw member. Like the end effector106described above, the end effector1200is carried at the distal end304of the shaft104that has a bore308extending therethrough. According to various embodiments, the first (lower) jaw1210may be a fixed extension portion of the shaft104. As can be seen inFIGS. 12 and 13, the second (upper) jaw1208is adapted to close or approximate along longitudinal axis1215.

The opening-closing mechanism of end effector1200may provide cam surfaces for positive engagement between reciprocating member340and the jaws (i) for moving the jaws to a closed position to engage tissue under high compressive forces, and (ii) for moving the jaws toward the (first) open position thereby providing high opening forces to dissect tissue with outer surfaces of the jaw tips. The reciprocating member340operates as described previously to reciprocate within bore308of the shaft104. As can be seen inFIG. 13, the distal end portion342of reciprocating member340carries distal first and second laterally-extending flange portions344A and344B with the blade-carrying transverse element345extending therebetween. The blade-carrying member slides within channels348aand348bin the jaws.

In the example embodiment ofFIGS. 12 and 13, the first and second jaw members1210and1208again define engagement surfaces or planes1250aand1250bthat deliver energy to engaged tissue. The engagement planes may carry one or more conductor/electrodes1255and, in various embodiments, may comprise a PTC matrix1285in at least one of the jaws' engagement surfaces1250aand1250b. In the embodiment ofFIGS. 12 and 13, the upper jaw1208has a proximate end region1258that, in the open position, defines a first (proximally-facing) arcuate cam surface indicated at1260that is engaged by a first surface portion1562of the reciprocating member340. The first (proximal) end region1258of the upper jaw, in the open position, further defines second (distally-facing) surface portions indicated at1270aand1270a′ that are engaged by second surface1272of reciprocating member340for moving the jaw assembly to an open position.

As can be seen best inFIG. 13, the cam surfaces1270aand1270a′ may be formed into pins or projecting elements1274and1274′ that may serve multiple purposes. Referring toFIG. 14, the pins1274and1274′ extend through the upper jaw body1276band are received within arcuate bores1277in body1276aof lower jaw1210. The lower portions1278(collectively) of the pins1274and1274′ thus can retain upper jaw1208and prevent it from moving axially or laterally relative to the jaw axis1215while still allowing the jaw's rotation for opening and closing. The pin mechanism further allows for greatly simplified assembly of the instrument.

The pins1274and1274′ may provide additional functionality by providing a degree of “vertical” freedom of movement within the first (proximal) end portion1258of the jaw. As can be seen inFIGS. 12 and 19, the distal laterally-extending flange portions344A and344B define a transverse dimension d (cf.FIG. 19) that in turn determines the dimension of the engagement gap g of the distal end of the jaws in the jaw-closed position (FIG. 14). The transverse dimension d equals the dimension between inner surfaces of flange portions344A and344B that slidably contact the outer surfaces of both jaws.

FIGS. 15-18illustrate another embodiment of an end effector1500that provides both electrosurgical functionality and improved grasping and dissecting functionality for endoscopic surgeries. InFIGS. 15-18, both the upper and lower jaws are shown in cut-away views to show internal cam surfaces of the upper jaw1510and the reciprocating member340. The jaw assembly1500may carry engagement surfaces for applying electrosurgical energy to tissue as in the previously described embodiments, as well as cutting means for transecting the engaged tissue volume. The jaw assembly1500relates to the ability of the jaw structure, in one mode of operation, to be used for general grasping and dissecting purposes wherein the distalmost tips1513of the jaws can close tightly on tissue with little movement of the actuator lever113in the handle of the instrument. At the same time, in another mode of operation, the jaw assembly1500can close to apply very high compressive forces on the tissue to enable welding. Thus, the jaw structure may provide (i) a first non-parallel jaw-closed position for grasping tissue with the distal jaws tips (FIG. 17), and (ii) a second parallel jaw-closed position for high compression of tissue for the application of electrosurgical energy (FIG. 18).

Referring toFIG. 15, the end effector1500again has a shaft104that is similar to the shaft104as used by the end effector1200with first (lower) jaw1510comprising a fixed extending portion1514of the shaft104. As can be seen inFIG. 15, the second (upper) jaw1508is adapted to close or approximate about longitudinal axis1515. The opening-closing mechanism of jaw assembly1500provides cam elements and cooperating jaw surfaces for positive engagement between the reciprocating member340as described previously (i) for moving the jaws to a closed position to engage tissue, and (ii) for moving the jaws toward the open position thereby providing high opening forces to dissect tissue with outer surfaces of the jaw tips313.

The reciprocating member340(FIG. 19) operates as described previously to reciprocate within bore308of the shaft104(FIG. 15). As can be seen inFIG. 15, the distal end342of the reciprocating member340again carries distal flange portions344A and344B with a blade-carrying transverse portion345therebetween. The transverse portion345slides within channels348aand348bin the paired jaws. In the example embodiment ofFIG. 15, the first and second jaws1510and1508again define engagement surfaces1550aand1550bthat can deliver electrosurgical energy to engaged tissue.

In the embodiment ofFIG. 15, the upper jaw1508has a proximal end1558that defines a first (proximally-facing) arcuate jaw surface1560that is engaged by a first cam surface element1562of reciprocating member340for opening the jaw. The proximal end1558of the upper jaw further defines second (distally-facing) jaw surface portions indicated at1570aand1570a′ that are engaged by second cam element1572of reciprocating member340for moving the jaw assembly to an open position.

The embodiment ofFIG. 15shows that the upper jaw1508has a floating primary pivot location indicated at P1that is provided by the projecting elements or rectangular pins1574(collectively) on either side of the channel portions348athat slidably extend into bores1577(collectively) in the lower jaw body (cf. Figure Z3). The lower portions of the pins1574thus allow upper jaw1508to rotate while at the same time the pin-and-bore mechanism allows the upper jaw to move upwardly away from the lower jaw.

For example, the degree of “vertical” freedom of movement of the upper jaw allows for the system to “tilt” the distal tip1513of upper jaw1508toward the axis1515to thereby allow the distal jaw tips1513to grasp tissue. This is termed a non-parallel closed position herein. The tilting of the jaw is accomplished by providing a plurality of cam surfaces in the upper jaw1508and the reciprocating member340.

As can be seen inFIGS. 15 and 19, the lower and upper laterally-extending flange portions344A and344B of the reciprocating member340define a transverse dimension d that determines the dimension of gap g between the engagement surface of the jaws in the fully jaw-closed position (FIG. 18). The transverse dimension d equals the dimension between inner surfaces of flange portions344A and344B that slidably contact the outer surfaces of both jaws.

FIG. 19illustrates one embodiment of the reciprocating member340configured with separate elevated step or cam surfaces1590in the lower flange portions344A that are adapted to slidably engage the ends1595of the rectangular pins1574on either side of upper jaw1508. The elevated cam surfaces1590of reciprocating member340thus create another transverse dimension d′ between inner surfaces of the flange portions344A and344B that move the jaws toward either the first jaw-closed position or the second jaw-closed position.

Now turning toFIGS. 15-18, the sequence of cut-away views illustrate how the multiple cam surfaces cause the jaws to move between a first “tilted” jaw-closed position to a second “high-compression” jaw-closed position. InFIG. 15, the jaws are in an open position. InFIG. 16, the reciprocating member340is moved distally and its cam surface element1562pushes on jaw surfaces1560to move the jaws toward a closed position wherein the jaws rotate about primary pivot location P1. InFIG. 16, it can be seen that the elevated cam surfaces1590in the lower flange344A have not yet engaged the ends1595of the rectangular pins1574.

Now turning toFIG. 17, the reciprocating member340is moved further distally wherein the elevated cam surfaces1590of lower flange344A have now engaged and elevated the ends1595of rectangular pins1574thereby tilting the upper jaw. The upper jaw1508is tilted slightly by forces in the direction of the arrows inFIG. 17as the upper flange1544B holds the upper jaw1508at a secondary pivoting location indicated at P2—at the same time that the step of the cam surface element1590lifts the pins1574and the proximal portion1558of the upper jaw1508upward.

Thus, the system functions by providing a slidable cam mechanism for lifting the proximal end of the jaw while maintaining the medial jaw portion in a fixed position to thereby tilt the distal jaw to the second jaw-closed position, with the pivot occurring generally about secondary pivot P2which is distal from the primary pivot location P1.

FIG. 18next shows the reciprocating member340moved further distally wherein the elevated cam surfaces1590of lower flange344A slides distally beyond the ends1595of rectangular pins1574thus causing the flanges344A and344B together with the trailing edge portions1575of the “I”-beam portion (FIG. 19) of the member340to apply very high compression forces over the entire length of the jaws as indicated by the arrows inFIG. 18. This position is termed a parallel jaw-closed position herein. Another advantage is that the jaw structure is in a “locked” position when the reciprocating member340is fully advanced.

FIGS. 20-22illustrates a cable-actuated embodiment of the end effector2000. The end effector2000may comprise jaw members2008,2009and shaft104as described above. The jaw members2008,2009may be pivotally coupled to one another in any suitable manner. For example, proximal portions of the jaw members2008,2009may rollably contact one another to cause the members2008,2009to open and close, as described above. In various embodiments, the jaw members2008,2009may be pivotally coupled at a clevis with a pin or other mechanical pivot device (not shown). A cable driven reciprocating member340′ may operate in a manner similar to member340described above. The member340′ may comprise a transverse element345′ and a pair of flanges344A′ and344B′. The member340′ may be driven by a pair of cables2002and2004. The cables2002,2004may be made from any suitable material including, for example, a tri-layered steel cable. The cable2004may be pulled proximally to pull the member340′ proximally and open the jaw members2008,2009, as shown inFIG. 20.

The cable2002may be pulled proximally to close the jaw members2008,2009. At a splitter,2014, the cable2002may be split into two cables2002aand2002b.2002amay be routed by one or more pulleys2010through an interior portion of the jaw member2008. An additional pulley2006, located at a distal portion of the jaw member2008, may re-route the cable2002aback through the jaw member2008to the member340′. The pulleys2010,2006may be any suitable devices configured to route the direction of the cable2002without exerting an excessive frictional force. For example, the pulleys2010,2006may comprise rotating wheel members or may, in various embodiments, comprise rotatable or stationary posts or pegs around which the cable2002is wrapped. The stationary posts or pegs could be a dual-purpose component and may, for example, serve as a support to the jaw members2008,2009. According to various embodiments, a low-friction coating material such as VECTRAN may be applied to the post and/or the cable2002.

Pulling the cable2002proximally (e.g., exerting a proximally directed force on the cable2002) may cause the respective cables2002a,2002bto pull the member340′ distally, closing the jaw members2008,2009, as described above with respect toFIGS. 7 and 8. For example, flanges344A′ and344B′ may contact surfaces330A and330B of the respective jaw members2009,2008, causing the jaw to transition into the closed position shown inFIG. 21. After the jaw members2008,2009are in the closed position, continued exertion of proximal force on the cable2002may cause the member340′ to traverse the jaw members2008,2009via respective channels348b,348a(FIGS. 4 and 11), as shown inFIGS. 20 and 22. As illustrated inFIGS. 20-22, the flanges344A′ and344B′ ride within the respective jaw members2008,2009instead of outside the jaw members2008,2009, as shown inFIGS. 3-4and7-8. It will be appreciated that either configuration may be used.

To open the jaw members2008,2009, the cable2004may be pulled proximally. This may, in turn, return the member340′ to the position shown inFIG. 20. The jaw members2008,2009may be spring-biased to the open position shown inFIG. 20. Alternatively, or in addition, the member340′ may act on the jaw members2008,2009to cause them to open, for example, as described above with respect toFIGS. 7 and 8.

FIGS. 23-25illustrate one embodiment of an end effector2300having a cable-operated moving jaw member2302and a stationary jaw member2304. According to various embodiments, the stationary jaw member2304may be fastened to the shaft104. The moving jaw member2302may be pivotally coupled to the stationary jaw member2304, allowing the jaw members2302,2304to transition from the open position shown inFIG. 23to the closed position shown inFIGS. 22 and 24. For example, the moving jaw member2302may be coupled to the stationary jaw member2304about a pivot pin2306. According to other various embodiments, the moving jaw member2302may be coupled in a manner similar to that of the jaw member1208of the end effector1200described above such that the jaw member1208defines a rolling pivot point.

In use, the end effector2000may be transitioned to the closed position by exerting a proximally directed force on the cable2002. The cable2002may be routed by pulleys2308,2310and2320to exert a distally directed force on the member2306. This may, initially, cause the moving jaw member2302to close against the stationary jaw member2304, as described above. After the jaw members2302,2304are in the closed position, the member340′ may traverse the jaw members2302,2304as illustrated inFIGS. 24-25. As described above, this may increase a compressive force on tissue that may be between the jaw members2302,2304. In addition, the leading edge346′ of the member340′ may transect the tissue, as described. To open the jaw members, a proximally directed force may be exerted on cable2002. This may cause the member340′ to translate proximally within the jaw members2302,2304, returning to the position shown inFIG. 23. The jaw members2302,2304may then be opened according to any suitable manner. For example, the jaw members2302,2304may be biased to the open position by a spring (not shown). Also, for example, the member340′, as it translates proximally, may exert a force on the moving jaw member2302tending to cause it to pivot open. This may occur in a manner similar to that described above with respect toFIGS. 3-4and7-8.

According to various embodiments, the cable-driven end effectors2000and2300shown inFIGS. 20-25may provide certain advantages. For example, as illustrated, the respective jaw members are both opened and closed by a proximally directed force. This may make it easier for the shaft104to be flexible and/or articulatable. For example,FIG. 26illustrates one embodiment of the end effector2300installed on a shaft104comprising an articulation pivot2602. The articulation pivot2602may be actuated in any suitable manner known in the art. As illustrated, the articulation pivot2602may comprise a pulley and/or routing post2604that may route one or both of the cables2002,2004through the pivot2602. Because the jaw members are both opened and closed by a proximally directed force, the cables2002,2004may be placed in tension, rather than compression. This may avoid mechanical problems associated with trying to direct a compressive force around a pivot.

FIGS. 25a-25billustrate one embodiment of an end effector2500with separately actuatable closure and cutting. The end effector2500may comprise a pair of rotatable jaw members2502,2504. It will be appreciated, however, that in various embodiments, only one of the jaws may be rotatable, for example, similar to the embodiments shown inFIGS. 23-25. Referring back toFIG. 25a, the end effector2500may comprise a slidable collar2516, which may translate distally to close the jaw members2502,2504and provide a compressive force tending to hold the jaw members2502,2504closed. The collar2516is shown in cross-section inFIGS. 25aand25b. According to various embodiments, the collar2516may be advanced distally from the position shown inFIG. 25ato transition the jaw members2502,2504to the closed position shown inFIG. 25bwith a cable2508. The cable2508may break into two branches2508a,2508bat junction2518. The respective branches2508a,2508bof the cable2508may be routed by pulleys2512a,2512band2514a,2514band may, ultimately, be coupled the collar2516. When the cable2508is translated proximally, for example, in response to the motion of an actuator113or other trigger mechanism, the collar2516may be pulled distally, as shown inFIG. 25b.

To open the end effector2500(e.g., to transition from the position shown inFIG. 25bto the position shown inFIG. 25a), a second cable2506may be pulled proximally. Again, the cable2506may be pulled proximally by the motion of an actuator113or other trigger mechanism. Similar to the cable2508, the cable2506may be split into branches2506aand2506bat junction2520. The branches2506a,2506bmay be coupled to a proximal portion of the collar2516. Proximal motion of the cable2506, for example, as the result of the motion of an actuator113, may pull the collar proximally from the position shown inFIG. 25bto the position shown inFIG. 25a. In the end effector2500, the reciprocating member340″ may extend proximally to the shaft104to an actuator, such as the actuator113. The reciprocating member may be actuatable separately from the collar2516. For example, the reciprocating member340″ and its cutting edge346′ may be extended distally to cut tissue either at the same time that the collar2516is advancing to close the jaw members2502,2504, or at a later time.

According to various embodiments, the end effectors106,1200,2000and2300may be used to cut and fasten tissue utilizing electrical energy. The examples described below are illustrated with the end effector106. It will be appreciated, however, that similar configurations and techniques may be used with the end effectors2000and2300described above. Referring to the end effector106shown inFIGS. 3-4and7-8, the electrodes120,122of the end effector106may be arranged in any suitable configuration. In use, for example, tissue (not shown) may be captured between the jaw members2008,110. RF current may flow across the captured tissue between the opposing polarity electrodes120,122. This may serve to join the tissue by coagulation, welding, etc. The RF current may be activated according to any suitable control method. For example, according to various embodiments, the electrodes120,122may be used to implement a “power adjustment” approach, a “current-path directing” approach or an approach referred to herein as a “weld” or “fusion” approach. These various approaches are illustrated herein with reference toFIGS. 27-30, which show the walls of an example blood vessel acted upon by various RF end effectors including those using the power adjustment and current-path directing approaches from above.

FIG. 27shows an example embodiment of a vessel having opposing wall portions2aand2b.FIG. 28is a graphic illustration of one embodiment of the opposing vessel walls portions2aand2bwith the tissue divided into a grid with arbitrary micron dimensions. For example, the grid may represent 5 microns on each side of the targeted tissue. In order to coagulate or weld tissue, collagen and other protein molecules within an engaged tissue volume may be denatured by breaking the inter- and intra-molecular hydrogen bonds. When heat or other energy is removed (e.g., thermal relaxation), the molecules are re-crosslinked to create a fused-together tissue mass. It is desirable that each micron-dimensioned volume of tissue be elevated to the temperature needed to denature the proteins therein in a substantially uniform manner.

Failing to heat tissue portions in a uniform manner can lead to ohmic heating, which can create portions of tissue that are not effectively joined and reduce the strength of the joint. Non-uniformly denatured tissue volume may still be “coagulated” and can prevent blood flow in small vasculature that contains little pressure. However, such non-uniformly denatured tissue may not create a seal with significant strength, for example in 2 mm to 10 mm arteries that contain high pressures. It is often difficult to achieve substantially uniform heating with a bipolar RF device in tissue, whether the tissue is thin or thick. For example, as RF energy density in tissue increases, the tissue surface tends to become desiccated and resistant to additional ohmic heating. Localized tissue desiccation and charring can sometimes occur almost instantly as tissue impedance rises, which then can result in a non-uniform seal in the tissue. Also, many RF jaws cause further undesirable effects by propagating RF density laterally from the engaged tissue thus causing unwanted collateral thermal damage.

To achieve substantially uniform coagulation, various embodiments described herein may utilize a “power adjustment” approach, a “current-path directing” approach and/or an approach referred to herein as a “weld” or “fusion” approach. According to the “power adjustment” approach, the RF generator124can rapidly adjust the level of total power delivered to the jaws' engagement surfaces in response to feedback circuitry, which may be present within the generator124and/or at the end effector106, and may be electrically coupled to the active electrodes. The feedback circuitry may measure tissue impedance or electrode temperature.FIG. 29illustrates one embodiment of the blood vessel ofFIG. 27acted upon by a device implementing a “power adjustment” approach to energy delivery. Opposing vessel walls2aand2bare shown compressed with cut-away phantom views of opposing polarity electrodes2902,2904on either side of the tissue. For example, the electrode2902may be positioned on one jaw member2008,110, while the electrode2904may be positioned on the opposite jaw member. One advantage of such an electrode arrangement is that 100% of each jaw engagement surface comprises an “active” conductor of electrical current—thus no tissue is engaged by an insulator which theoretically would cause a dead spot (no ohmic heating) proximate to the insulator.

FIG. 29also graphically depicts current paths p in the tissue at an arbitrary time interval that can be microseconds (μs) apart. Such current paths p would be random and constantly in flux—along transient most conductive pathways through the tissue between the opposing polarity electrodes. The thickness of the paths is intended to represent the constantly adjusting power levels. Typically, the duration of energy density along any current path p is on the order of microseconds and the thermal relaxation time of tissue is on the order of milliseconds. Instruments using the power adjustment approach may be useful for sealing relatively small vessels with relatively low fluid pressure. This is because, given the spatial distribution of the current paths and the dynamic adjustment of their power levels, it is unlikely that enough random current paths will revisit and maintain each discrete micron-scale tissue volume at the targeted temperature before thermal relaxation. Also, because the hydration of tissue is constantly reduced during ohmic heating—any region of more desiccated tissue will lose its ohmic heating, rendering it unable to be “welded” to adjacent tissue volumes.

In a second “current-path directing” approach, the end effector jaws carry an electrode arrangement in which opposing polarity electrodes are spaced apart by an insulator material, which may cause current to flow within an extended path through captured tissue rather than simply between surfaces of the first and second jaws. “Current-path directing” techniques are also used to improve the quality of energy-delivered seals.FIG. 30illustrates one embodiment of the blood vessel ofFIG. 27acted upon by a device implementing a current-path directing approach to energy delivery. InFIG. 30, vessel walls2aand2bare engaged between opposing jaws surfaces with cut-away phantom views of electrodes3002,3004,3006,3008, with opposing polarity (+) and (−) electrodes (3002,3004and3006,3008) on each side of the engaged tissue. For example, electrodes3002and3004may be positioned on one of the jaw members2008,110while electrodes3006and3008maybe positioned on the opposite electrode. An insulator3010is shown in cut-away view that electrically isolates the electrodes in the jaw. The tissue that directly contacts the insulator3010will only be ohmically heated when a current path p extends through the tissue between the spaced apart electrodes.FIG. 30graphically depicts current paths p at any arbitrary time interval, for example in the μs range. Again, such current paths p will be random and in constant flux along transient conductive pathways.

A third approach, according to various embodiments, may be referred to as a “weld” or “fusion” approach. The alternative terms of tissue “welding” and tissue “fusion” are used interchangeably herein to describe thermal treatments of a targeted tissue volume that result in a substantially uniform fused-together tissue mass, for example in welding blood vessels that exhibit substantial burst strength immediately post-treatment. Such welds may be used in various surgical applications including, for example, (i) permanently sealing blood vessels in vessel transection procedures; (ii) welding organ margins in resection procedures; (iii) welding other anatomic ducts or lumens where permanent closure is desired; and also (iv) for performing vessel anastomosis, vessel closure or other procedures that join together anatomic structures or portions thereof.

The welding or fusion of tissue as disclosed herein may be distinguished from “coagulation”, “hemostasis” and other similar descriptive terms that generally relate to the collapse and occlusion of blood flow within small blood vessels or vascularized tissue. For example, any surface application of thermal energy can cause coagulation or hemostasis—but does not fall into the category of “welding” as the term is used herein. Such surface coagulation does not create a weld that provides any substantial strength in the treated tissue.

A “weld,” for example, may result from the thermally-induced denaturation of collagen and other protein molecules in a targeted tissue volume to create a transient liquid or gel-like proteinaceous amalgam. A selected energy density may be provided in the targeted tissue to cause hydrothermal breakdown of intra- and intermolecular hydrogen crosslinks in collagen and other proteins. The denatured amalgam is maintained at a selected level of hydration—without desiccation—for a selected time interval, which may be very brief. The targeted tissue volume may be maintained under a selected very high level of mechanical compression to insure that the unwound strands of the denatured proteins are in close proximity to allow their intertwining and entanglement. Upon thermal relaxation, the intermixed amalgam results in protein entanglement as re-crosslinking or renaturation occurs to thereby cause a uniform fused-together mass.

To implement the welding described above, the electrodes120,122(or electrodes that are part of the other end effector embodiments described herein) may, one or both, comprise an electrically conductive portion and a portion comprising a positive temperature coefficient (PTC) material having a selected increased resistance that differs at selected increased temperatures thereof. The PTC material may be positioned between the electrically conductive portion and any tissue to be acted upon by the end effector106. One type of PTC material is a ceramic that can be engineered to exhibit a selected positively slope curve of temperature-resistance over a temperature range of about 37° C. to 100° C. Another type of PCT material may comprise a polymer having similar properties. The region at the higher end of such a temperature range brackets a targeted “thermal treatment range” at which tissue can be effectively welded. The selected resistance of the PTC matrix at the upper end of the temperature range may substantially terminate current flow therethrough.

In operation, it can be understood that the electrode120or122will apply active RF energy (ohmic heating within) to the engaged tissue until the point in time that the PTC matrix is heated to exceed the maximum of the thermal treatment range. Thereafter, RF current flow from the engagement surface will be lessened—depending on the relative surface areas of the first and second electrodes120,122. This instant and automatic reduction of RF energy application may prevent any substantial dehydration of tissue proximate to the engagement plane. By thus maintaining an optimal level of moisture around the engagement plane, the working end can more effectively apply energy to the tissue—and provide a weld thicker tissues with limited collateral thermal effects.

In various embodiments, surgical instruments utilizing various embodiments of the transection and sealing instrument100, with the various end effectors and actuating mechanisms described herein may be employed in conjunction with a flexible endoscope.FIG. 31illustrates one embodiment of an endoscope3114(illustrated here as a gastroscope) inserted into the upper gastrointestinal tract of a patient. The endoscope3114may be any suitable endoscope including, for example, the GIF-100 model available from Olympus Corporation. The endoscope3114has a distal end3116that may include various optical channels, illumination channels, and working channels. According to various embodiments, the endoscope3114may be a flexible endoscope.

FIG. 32illustrates one embodiment of a distal portion3116of the endoscope3114, which may be used with the transection and sealing instrument100described herein. The example endoscope3114shown comprises a distal face3104, which defines the distal ends of illumination channels3108, an optical channel3106and a working channel3110. The illumination channels3108may 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 channel3106may 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 endoscope3114. As described above, the working channel3110may 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 dissectors. It will be appreciated that the endoscope3114is but one example of an endoscope that may be used in accordance with various embodiments. Endoscopes having alternate configurations of optical channels3106, illumination channels3108and/or working channels3110may also be used. According to various embodiments, the endoscope3114may be, or may be used in conjunction with, steerable devices such as traditional flexible endoscopes or steerable overtubes as described in U.S. Patent Application Publication No. 2010/0010299, incorporated herein by reference. Combinations of flexible endoscopes and steerable overtubes may also be used in some embodiments.

In at least one such embodiment, the endoscope3114, 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 transection and sealing instrument100near the tissue treatment region to treat diseased tissue on organs such as the liver, for example.

In one embodiment, Natural Orifice Translumenal Endoscopic Surgery (NOTES)™ techniques may be employed to introduce the endoscope3114and various instruments 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 endoscope3114to 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.

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 or 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.

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.

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.

The entire disclosures of the following non-provisional United States patents are hereby incorporated by reference herein:U.S. Pat. No. 7,381,209, entitled ELECTROSURGICAL INSTRUMENT;U.S. Pat. No. 7,354,440, entitled ELECTROSURGICAL INSTRUMENT AND METHOD OF USE;U.S. Pat. No. 7,311,709, entitled ELECTROSURGICAL INSTRUMENT AND METHOD OF USE;U.S. Pat. No. 7,309,849, entitled POLYMER COMPOSITIONS EXHIBITING A PTC PROPERTY AND METHODS OF FABRICATION;U.S. Pat. No. 7,220,951, entitled SURGICAL SEALING SURFACES AND METHODS OF USE;U.S. Pat. No. 7,189,233, entitled ELECTROSURGICAL INSTRUMENT;U.S. Pat. No. 7,186,253, entitled ELECTROSURGICAL JAW STRUCTURE FOR CONTROLLED ENERGY DELIVERY;U.S. Pat. No. 7,169,146, entitled ELECTROSURGICAL PROBE AND METHOD OF USE;U.S. Pat. No. 7,125,409, entitled ELECTROSURGICAL WORKING END FOR CONTROLLED ENERGY DELIVERY;U.S. Pat. No. 7,112,201, entitled ELECTROSURGICAL INSTRUMENT AND METHOD OF USE;U.S. Patent Application Publication No. 2010/0010299, entitled ENDOSCOPIC TRANSLUMENAL ARTICULATABLE STEERABLE OVERTUBE; andU.S. Patent Application Publication No. 2006/0111735, entitled CLOSING ASSEMBLIES FOR CLAMPING DEVICE.

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.

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.

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.

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.