SURGICAL FASTENER

[0001] The present application is a Continuation Application claiming the benefit of and priority to U.S. patent application Ser. No. 12/137,702, filed on Jun. 12, 2008, which claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/934,254, filed on Jun. 12, 2007, now expired, the entire contents of which are incorporated herein by reference.

[0002] 1. Technical Field

[0003] The present disclosure relates to surgical instruments and, more particularly, to biomechanical fasteners for use with mechanical surgical instruments, electro-mechanical surgical instruments and energy-based surgical instruments and systems.

[0004] 2. Background of Related Art

[0005] Surgical instruments used in open and minimally invasive surgery are limited in their ability to sense and/or control conditions and/or parameters and factors critical to effective operation. For example, conventional surgical instruments cannot measurably detect the amount or degree of formation of the fastener(s) deployed therefrom in order to ascertain whether said fastener(s) are under-formed, over-formed or properly formed.

[0006] Proper formation of the fasteners is an important factor in tissue stapling. For example, if the fasteners are under-formed, the tissue secured thereby may not be compressed sufficiently in order to heal efficiently and properly. If the fasteners are over-formed, the tissue secured thereby may be over compressed and result in inefficient healing of the same.

[0007] Additionally, the determination of proper fastener formation is dependent upon the particular characteristics of the tissue being fastened. For example, if relatively thinner tissue or relatively highly vascular tissue is being fastened, then it may be desirable for the fasteners to be formed by a relatively greater degree. Likewise, if relatively thicker tissue or relatively less vascular tissue is being fastened, then it may be desirable for the fasteners to be formed by a relatively lesser degree.

[0008] Accordingly, it would be advantageous to provide surgical instruments and/or systems that employ biomechanical fasteners and the like which provide an indication of proper fastener formation for particular surgical procedures and/or for particular tissues which are to be fastened.

[0009] According to an aspect of the present disclosure, a surgical instrument for operating on tissue is provided. The surgical instrument includes an indicating circuit which is preferably activated upon the proper formation of the surgical staples fired therefrom.

[0010] According to an aspect of the present disclosure, a surgical fastener is provided and includes a backspan defining an upper surface, a lower surface and a pair of side surfaces; at least a pair of legs on the backspan; and a contact pad. At least one of the pair of legs is configured to contact the contact pad to provide an indication of formation thereof.

[0011] In one embodiment, the contact pad extends from the lower surface to the upper surface of the backspan, preferably by extending along a side surface. In another embodiment, the contact pad extends through the backspan so as to be exposed at the upper surface and the lower surface of the backspan. The fastener may further include a pair of contact pads supported on the backspan wherein each contact pad may be operatively associated with a respective leg such that in use, the legs may contact a respective contact pad upon formation thereof.

[0012] The at least one leg and the respective contact pad may be fabricated from an electrically conductive material.

[0013] In one embodiment, at least a portion of the backspan is non-conductive. A layer of non-conductive material in one embodiment is interposed between the backspan and the contact pad(s).

[0014] It is contemplated that each contact pad may be electrically isolated from one another.

[0015] According to another aspect of the present disclosure, a biomechanical fastener is provided and includes a backspan defining an upper surface and a lower surface, the backspan defining at least one aperture therein that extends completely from the upper surface through the lower surface; and at least a pair of legs depending from the backspan, wherein a free end of each leg extends through the at least one aperture formed in the backspan upon a formation of the fastener.

[0016] In another aspect of the present disclosure, a surgical fastener is provided comprising first and second fastener legs extending from a backspan and the backspan has an electrical contact surface, wherein contact of at least one of the fastener legs with the electrical contact surface completes a circuit to provide an indication of staple formation. In one embodiment, completion of the circuit provides an indication of proper formation of the fastener. In another embodiment, completion of the circuit provides an indication of improper formation of the fastener.

[0017] According to yet another aspect of the present disclosure, an electrosurgical system is provided and includes a fastening device including a cartridge and an anvil, wherein the anvil is in juxtaposed relation relative to the cartridge, and the cartridge and the anvil have a spaced apart position and an approximated position. The cartridge has a plurality of fasteners therein and the anvil is configured to form the plurality of fasteners upon advancement of the fasteners from the cartridge. At least one of the fasteners includes a backspan, a pair of legs depending from the backspan, and at least one contact pad on the backspan, wherein at least one of the pair of legs is configured to contact the at least one contact pad upon a formation thereof. The electrosurgical system further includes an indicating circuit associated with the plurality of fasteners, the indicating circuit including an electrical conduit in electrical contact with a first contact pad of each fastener and an electrical conduit in electrical contact with a second contact pad of each fastener.

[0018] Upon formation of the fasteners, the legs are formed to either contact a respective contact pad or not contact a respective contact pad, wherein in one embodiment when the respective legs of each fastener properly contact the contact pad a circuit loop of the indicating circuit is established, and when the respective legs of each fastener do not properly contact the contact pads the circuit loop of the indicating circuit is not established.

[0019] The circuit loop may be established when the electrical conduit associated with the first contact pad and the electrical conduit associated with the second contact pad are electrically connected to one another when the legs of the fastener properly contact the respective first and second contact pads.

[0020] The indicating circuit may include an energy source and an indicator, wherein the indicator activates upon one of a proper formation of the fasteners and an improper formation of the fasteners. The indicator may activate upon a proper formation of a predetermined number of proper formations of the fasteners.

[0021] In one embodiment, at least a portion of the backspan of each fastener may be non-conductive.

[0022] Each contact pad of each fastener may be electrically isolated from the backspan.

[0023] In one embodiment, at least one contact pad of each fastener extends from the lower surface to the upper surface of the backspan along at least one side surface of the backspan. In another embodiment, at least one contact pad of each fastener may extend through the backspan so as to be exposed at the upper surface and the lower surface of the backspan.

[0040] Preferred embodiments of the presently disclosed surgical instruments and systems will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein and as is traditional, the term “distal” will refer to that portion which is further from the user while the term “proximal” will refer to that portion which is closer to the user.

[0041] A surgical instrument in accordance with an embodiment of the present disclosure is shown generally as 10 in FIG. 1. Surgical instrument 10 includes a body 12 defining a stationary handle 14, a pivotable trigger 16, an elongated body portion 18, and an end effector including a first member or cartridge assembly 20 and a second member or anvil assembly 22. A thumb button 24 is slidably positioned on each side of body 12. Thumb buttons 24 are movable to manually advance an alignment pin assembly (not shown). A release button 150 is positioned on the proximal end of body 12 and is depressible to allow cartridge assembly 20 to return from an approximated position disposed adjacent to anvil assembly 22 to an unapproximated position spaced from anvil assembly 22 (as shown).

[0042] As seen in FIG. 2, cartridge assembly 20 includes a cartridge 50 having an array of fastener receiving slots 52 formed therein, and a fastener pusher assembly 54 operatively associated with cartridge 50 and including a plurality of pusher members 58. Each pusher member 58 is configured to be slidably received within a respective fastener receiving slot 52. A respective pusher member 58 is positioned behind each fastener 56 in slots 52 such that, in operation, advancement of pusher member 58 effects ejection of fasteners 56 from slots 52. As used herein, fasteners are understood to include and are not limited to, surgical staples, surgical clips, two-part surgical fasteners, surgical tacks, and the like.

[0043] Reference may be made to U.S. Pat. No. 6,817,508, the entire contents of which is incorporated herein by reference, for a more detailed discussion of the structure and operation of surgical instrument 10.

[0044] While a surgical instrument for performing a transverse anastomosis surgical procedure has been shown and described, the present disclosure is not limited to such a surgical instrument. It is contemplated that other surgical instruments may employ the features and concepts of the present disclosure, including and not limited to, open gastro-intestinal surgical instruments, endoscopic gastro-intestinal surgical instruments, and/or end-to-end anastomosis surgical instruments.

[0045] As seen in FIG. 3A, a fastener or staple, in accordance with a first embodiment of the present disclosure, is designated as 56. Staple 56 includes a backspan or crown 60 and at least a pair of legs 62 depending from opposed ends of backspan 60. Legs 62 are spaced apart from one another and have an initial, un-formed condition. Preferably, in this un-formed condition, legs 62 are substantially parallel to one another and substantially orthogonal to backspan 60. Although two legs are shown as is typical, a fastener having a different number of legs or different fastener leg configuration is also contemplated.

[0046] Staple 56 includes at least one, preferably a pair of contact pads 64a, 64b spaced apart and supported on backspan 60. Each contact pad 64a, 64b wraps around a side surface of backspan 60. As best seen in the cross-section view of FIG. 3A(2) as taken along line 3A(2)-3A(2) of FIG. 3A, each contact pad 64a, 64b extends from an upper surface of backspan 60, around a side of backspan 60, to a lower surface of backspan 60 (see FIGS. 3A(1) and 3A(2)). Each contact pad 64a, 64b is fabricated from an electrically conductive, biologically compatible material, such as, for example, stainless steel, titanium or the like. Contact pads 64a, 64b, when position on a backspan composed on conductive material may be electrically isolated or insulated from backspan 60 by, for example, a suitable electrically insulative and biologically compatible material or layer 63 which as shown in phantom in FIG. 3A, surrounds the contact pads 64a, 64b.

[0047] In one embodiment, backspan 60 may have a substantially flattened profile. In this embodiment, it is envisioned that a plane defined by the flattened backspan is substantially orthogonal to a plane defined by the pair of legs 62.

[0048] In an embodiment, backspan 60 is fabricated from a non-conductive or insulative material and legs 62 and contact pads 64a, 64b are fabricated from an electrically conductive material and biologically compatible material, such as, for example, stainless steel, titanium or the like. Thus, contact pads 64a, 64b are electrically isolated from one another due to the non-conductive material of the backspan.

[0049] In the embodiment of FIG. 3B, staple 256 is identical to staple 56 except for the configuration of the contact pads 264a, 264b which have a substantially rectangular shape with substantially straight edges wrapping around a side surface of the backspan 260, rather than the substantially circular shape of the contact pads of FIG. 3A on the top surface of the backspan 60.

[0050] In the alternate embodiment of FIG. 3C, staple 356 has a backspan 360 with a through hole 361. The staple legs, when formed, will extend through the hole 361 to contact conductive pads on the staple pusher. Alternatively, a cap can be provided in the hole as shown in FIG. 3D to fill the hole. Cap 463 is seated within the hole of backspan 462 of staple 456. The cap 463 forms an electrical contact pad, or includes an electrical contact pad supported thereon, that is pushed up by the formed staple legs (of conductive material) to make electrical contact with the pusher contacts.

[0051] As seen in FIG. 4, each pusher member 58 includes a pair of spaced apart, longitudinally extending lumens 66a, 66b, and a connector 68a, 68b disposed within each respective lumen 66a, 66b. Each connector 68a, 68b includes a head portion 70a, 70b, and a rod portion 72a, 72b, respectively, extending from each respective head portion 70a, 70b. A conductive head 170a and 170b is fixedly positioned at the distal end of the respective lumens 66a and 66b, with a portion exposed at the end of the lumens. A conductive wire 172a, 172b connects the conductive heads 170a, 170b with the head portions 70a, 70b, respectively. When the pusher member 58 is in the retracted position (not shown), the conductive heads 170a and 170b are closer to head portions 70a, 70b and the wires 172a, 172b are flexed or coiled. When the pusher member 58 is advanced to fire the staples, heads 170a, 170b are likewise advanced, with the wires 172a, 172b straightening as shown in FIG. 4.

[0052] As an alternative to the flexible conductive wires, inner conductive telescoping rods could be provided. In such embodiment, head portions 70a, 70b would be connected to a respective inner rod slidably received within a lumen of rods 72a, 72b of connectors 68a, 68b. The head portions 70a, 70b would also be fixedly attached within the lumens 66a, 66b of the pusher 58. Thus, in the retracted position of the pusher member 58, the inner rods would be at least partially inside rods 72a, 72b, positions in a lumen therein. Upon advancement of the pusher member 58, the inner rods would advance outwardly from the lumen of the rods 72a, 72b as the head portions 70a, 70b are carried distally with the pusher member 58. Thus electrical connection is made via the respective head portion, inner rod, and outer rod.

[0053] Connectors 68a, 68b may be fabricated from electrically conductive materials, or contain electrically conductive materials, and are preferably electrically isolated or insulated from one another.

[0054] In operation, connectors 68a, 68b and rods 72a, 72b remain fixed within lumens 66a, 66b as staple pushers 58 are advanced to fire the staples. In an alternate embodiment, plungers 68a, 68b may be slidably supported in spaced apart lumens 66a, 66b formed in an electrically non-conductive or insulative pusher member 58.

[0055] In the embodiment of FIG. 9, fingers 92 are attached to the cartridge and remain stationary as pusher 90 is advanced to fire the staples.

[0056] As seen in FIGS. 5 and 6, an indicating circuit 100 is provided which is electrically connected to connectors 68a, 68b. Indicating circuit 100 may include an energy source 102 (e.g., a battery, etc.), and an indicator 104 (e.g., illumination element, light-emitting-diode, etc.) electrically connected to energy source 102. Additionally, the first connector 68a is electrically connected to energy source 102 and the second connector 68b is electrically connected to indicator 104.

[0057] In use, as seen in FIGS. 5 and 6, during a firing of surgical instrument 10, pusher members 58 are actuated to eject, push or otherwise expel staples 56 (FIG. 5) or staples 356 (FIG. 6) out of fastener receiving slots 52 (see FIG. 2) and against respective anvil pockets 23 of anvil assembly 22 to form legs 62 (or 362) of staple 56 (or 356). As legs 62 of staple 56 are formed as shown in FIG. 5, legs 62 are bent towards and against backspan 60 (or 360). When staple 56 is properly formed legs 62 (or 362) contact or electrically engage contacts 64a, 64b (or contacts 264a, 264b or pads 210, 220). Note the legs of staple 356 would contact the conductive pads of the pusher and the legs of staple 456 would contact the cap to move it into engagement with the pusher contact pads to complete the circuit. The contacts or pads as described above are electrically connected to respective heads 170a, 170b of pusher 58, which in turn are electrically connected to the head portions 70a, 70b via wires or rods as described above. The staples of the other embodiments described herein would be formed to complete the circuit in a similar manner.

[0058] When the staple of the foregoing embodiments is properly formed, a circuit loop of indicating circuit 100 is completed and triggers a first particular or unique response signal or indication signal (e.g., an audible signal, a color indication, a graphic or alphanumeric display, or any combination thereof). If a staple 56 is not properly formed (as shown in FIG. 10), the circuit loop of indicating circuit 100 is not completed and thus a response signal or indication signal is either not triggered or a second particular or unique response signal or indication signal (e.g., an audible signal, a color indication, a graphic or alphanumeric display, or any combination thereof). As seen in FIG. 10, one leg 62 is in contact with contact pad 64a, and another leg 62 has been bent such that the other leg 62 is not in contact with contact pad 64b. As the staple 56 is not properly formed, the circuit loop of indicating circuit 100 is not completed.

[0059] The signals generated by indicating circuit 100 may be displayed or broadcast from a visual display 30 and/or a speaker 32 provided on body 12 of surgical instrument 10. Alternatively, the signals generated by indicating circuit 100 may be displayed or broadcast from a separate unit 40, e.g., CPU, monitor, etc., (see FIG. 1) electrically connected to surgical instrument 10.

[0060] In operation, each of the foregoing staples (e.g., staple 56) is so monitored in order to determine if staples 56 have been properly formed and/or what percentage of the total number of staples have been properly formed in order to ascertain if an acceptable firing of surgical stapler 10 has occurred. If a percentage of the total number of staples 56 that are properly fired exceeds a predetermined level, then a determination can be made that the stapler firing is acceptable. The predetermined level may depend on the type of surgical procedure, the type of underlying tissue, the biology and medical/physical condition of the patient, the medical history of the patient and/or patient's family, the physical dimensions of the staples, and any other suitable parameters.

[0061] In the event that an acceptable firing of surgical instrument 10 has not occurred, the staple line may be reinforced by suturing or by redoing the procedure.

[0062] As can be appreciated from the above, in a preferred embodiment, completion of the circuit provides an indication of proper formation of the fastener. However, it is also contemplated in an alternate embodiment, the contact pads can be positioned such that contact of the legs with the contact pad (or structure) completes the circuit to indicate improper formation of the staples.

[0063] Turning now to FIGS. 7 and 8, a connector pad assembly, in accordance with another embodiment of the present disclosure, is generally designated as 200. Connector pad assembly 200 may be removably or fixedly supported on or connected to a backspan 60 of a conventional surgical staple 156. Connector pad assembly 200 may be secured to backspan 160 of surgical staple 156 by various methods including for example, a suitable adhesive, welding, or an interference, press or friction fit.

[0064] Connector pad assembly 200 includes an electrically non-conductive or insulative body portion 202 configured for support or connection to backspan 160 of surgical staple 156. Body portion 202 may be in the form of a U-shaped channel having a back wall 202a, and a pair of spaced apart side walls 202b, 202c extending from back wall 202a and defining a channel 202d therebetween. Channel 202d of body portion 202 is sized and dimensioned to receive backspan 160 of surgical staple 156 therein.

[0065] Connector pad assembly 200 further includes a pair of spaced apart electrical contact pads 210, 220 disposed on or suitably supported on an outer surface of body portion 202. Each contact pad 210, 220 extends from first side wall 202b of body portion 202, across back wall 202a of body portion 202, and to second side wall 202c of body portion 202. Each contact pad 210, 220 is fabricated from an electrically conductive, biologically compatible material, such as, for example, stainless steel, titanium or the like.

[0066] In use, a connector pad assembly 200 is attached to a backspan of a conventional surgical staple and the surgical staple, including the connector pad assembly 200 is loaded into staple receiving slots 52 of a cartridge 50 of a surgical stapling instrument 10, including an indicating circuit 200 as described above. The surgical stapling instrument 10 is then used in a surgical procedure, in a manner similar to the method described above. A surgical instrument 10 loaded with surgical staples 156, including connector pad assemblies 200, will function similar to a surgical instrument 10 loaded with surgical staples 56 as described above (as the staples come onto electrical contact with the pads) and thus will not be discussed in greater detail herein.

[0067] As various changes could be made in the above constructions without departing from the scope of the disclosure, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense. In the view above it will be seen that several objects of the disclosure are achieved and other advantageous results attained, as defined by the scope of the following claims.