Patent Document

RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/795,014, entitled “Plastic Surgical Instruments,” filed Oct. 9, 2012, from which priority is claimed under 35 U.S.C. 119, and the disclosure of which is hereby incorporated herein by reference in its entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    The invention relates to improved surgical tools, methods and systems for treating patients using inexpensive, easily manufactured and/or disposable/recyclable plastic surgical instruments. 
       BACKGROUND OF THE INVENTION 
       [0003]    Currently, surgical instruments used for cutting, severing or “biting” tissue and bone are made entirely from stainless steel. While the manufacture of such instruments can involve significant expense, these metal instruments can be re-sterilized numerous times and re-used for multiple surgeries involving different patients, which justifies their significant expense. In addition, the cutting edges of metal instruments can dull with use, depending on the type and extent of their use during surgery as well as the care with which the OR and sterilization department personnel use when handling and storing the instruments. When such metal instruments become sufficiently dull, they may be re-sharpened or, in the vast majority of cases, the instruments are discarded. 
       SUMMARY OF THE INVENTION 
       [0004]    There is a need for disposable grasping, cutting, severing and/or biting instruments for surgical procedures that remain sharp during each surgery. Desirably, such instruments would be lighter than their equivalent stainless steel instruments currently being used, and the component materials and processing requirements (i.e., manufacturing) would be less expensive than traditional stainless steel instruments. Such instruments would also desirably be disposable and/or recyclable, although the ability to re-sterilize the instruments would be desirable, should the need arise. 
         [0005]    Various embodiments described herein include disposable, single use and/or re-sterilizable surgical instruments of various configurations molded or cast from a flowable material such as a plastic polymer or resin, with integral and/or replaceable metallic cutting and/or slicing features incorporated into the surgical instruments. In various alternative embodiments, features of the plastic instrument may be formed integrally with the metallic sub-components (i.e., overmolding, etc.), may be permanently bonded or otherwise irremovably secured to the metallic sub-components (i.e., locked or adhered), or the metallic subcomponents may be removable and/or replaceable for repair of the instrument and/or recycling of the component materials (i.e., plastic recycling and sharps disposal). Such surgical instruments may take the form of a wide variety of instruments, including designs similar to rongeurs, kerrison rongeurs, and/or kerrison punches. 
         [0006]    In various embodiments, plastic surgical instruments may include a plurality of features that support a combination of grasping, severing, and cutting. The plastic instrument may include modular heads that may be desirably removably attached, or the instrument may be designed with bores or channels that allow insertion of cutting rods, instruments, surfaces, etc. In various embodiments, one or more of the cutting tips or other metallic portions could be modular and/or replaceable. 
         [0007]    In an alternative embodiment, the plastic instrument may be designed with features that allow it to be used with applied energy systems such as electro-cautery and/or RF power sources for cutting, coagulating, desiccating, fulgurating or otherwise applying energy to tissue in a desired manner. It can be advantageous to design plastic instruments to accept and transmit electrical energies and/or currents. The plastic instrument may include one or more desired current pathways and could include replaceable and/or modular heads that may be connected to an electrosurgical generator to supply an electric current to the replaceable and/or modular heads. In other embodiments, the replaceable and/or modular heads may be changed or integrated with grasper features. Desirably, the plastic or non-metallic portions of the instrument will act as insulators for the surgeon during use. 
         [0008]    The provision of cutting instruments comprised primarily of plastic or other nonmetallic and easily-moldable materials desirably fulfills the need for disposable grasping, cutting and/or biting instruments that are sharp for each surgery. Such disposable medical products offer many advantages for the clinicians, staff, and/or patients, which may be expressed with increased safety, convenience, or availability. Disposable instruments can be essential for streamlining patient care because the instrument can be readily available at a moment&#39;s notice, can be stored in a sterile form (and thus alleviate patients&#39; and/or physicians&#39; concerns with tool sterility), and such tools could save the clinician or staff valuable time, effort and expense by not requiring an autoclave and/or sufficient sterilization time to sterilize their equipment. 
         [0009]    Disposable and/or recyclable instruments such as those described herein also offer medical device manufacturers various benefits over traditional stainless steel instruments. Such instruments may be produced at a fraction of the cost due to the way disposables are manufactured. Moreover, the plastic and metal components of such tools could be easily and conveniently recycled, and any small portions of the tools that cannot be recycled are easily compacted and/or crushed for disposal in landfills, burned in incinerators or disposed of using other traditional methods. 
         [0010]    There are a wide variety of advantages that can be realized by the incorporation of plastic materials into surgical cutting instruments. For example, the use of flexible polymers in the design and manufacture of surgical instruments has the potential to significantly broaden the “design space” available and/or provide increased “design freedom” for the instrument designer as compare to traditional all-metal instruments. Specifically, plastics and polymers are particularly well-suited to the construction of flexible features and/or “living hinges” that are ill-suited to metals. Moreover, plastics are impact and dent resistant, and resist fracture or “shattering” of the component material during tool failure. Plastics are also more flexible than metals, which, allows them to be manufactured in tight tolerances and assembled together in “snap-fit” arrangements. 
         [0011]    Other advantages in the use of plastics in surgical tools can include the fact that plastics and polymers are highly corrosion resistant, are impervious to many chemical compounds, and are typically electrically non-conductive. In addition, plastics are typically nonmagnetic, and can be safely utilized in the vicinity of strong magnetic fields, such as used in Magnetic Resonance Imaging equipment (MRI). 
         [0012]    Plastics are typically radiolucent and do not scatter x-rays or other high-energy particles. However, where radiopacity is an important consideration, plastics may have controlled levels of radiopacity premixed or introduced into the polymer mixture to enhance fluoroscopic visualization. 
         [0013]    As previously noted, plastic is lighter than metal, and plastics can be reinforced with core-throughs and kiss-offs for added strength. Plastics are versatile and can be used to create complex geometries, and many plastics are self-lubricating. 
         [0014]    One extremely important consideration is that plastic is significantly cheaper than metal, and plastic parts can be manufactured for a fraction of the cost of their metallic counterparts. In addition, color can be integrated into the plastic material, and graphics and/or surface features can be integrated (i.e., molded) into the part, which prevents the graphic from ever coming off. 
         [0015]    With the range of advantages that are experienced by clinicians, staff, patients and medical device manufacturers for the development of disposable cutting instruments, there exists a need to improve the cost, safety, convenience, and availability of plastic surgical instruments to satisfy these demands. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0016]      FIG. 1  depicts a perspective view of one embodiment of a surgical instrument constructed in accordance with various teachings described herein; 
           [0017]      FIG. 2  depicts an exploded perspective view of the surgical instrument of  FIG. 1 ; 
           [0018]      FIG. 3  depicts a partial perspective view of a tip of the surgical instrument of  FIG. 1 ; 
           [0019]      FIG. 4  depicts a partial perspective view of the tip of the surgical instrument of  FIG. 3 , from a different angle of view; 
           [0020]      FIG. 5  depicts a partial perspective view of various surgical instrument tip designs; 
           [0021]      FIG. 6  depicts a partial perspective view the surgical instrument of  FIG. 4 , with a portion of the tool depicted in shadow; 
           [0022]      FIG. 6A  depicts a perspective view of the upper slide cutting tip of  FIG. 6  and associated handle body cutting tip; 
           [0023]      FIGS. 6B through 6D  depict views of various additional embodiments of handle body cutting tips; 
           [0024]      FIG. 7  depicts a partial perspective view of the tip of the surgical instrument of  FIG. 1 , with a portion of the tool depicted in shadow; 
           [0025]      FIG. 8  depicts a partial transparent view of a middle portion of the surgical instrument of  FIG. 1 , showing various moving parts; 
           [0026]      FIGS. 9A through 9E  depict various views of one alternative embodiment of an upper slide cutting tip support structure; 
           [0027]      FIG. 9F  depicts a perspective view of an additional alternative embodiment of an upper slide cutting tip support structure; 
           [0028]      FIGS. 10A through 10C  depict various views of one alternative embodiment of a handle body cutting tip and associated structure; 
           [0029]      FIGS. 11A and 11B  depict views of an upper slide cutting tip and associated handle body cutting tip in open and closing configurations; 
           [0030]      FIG. 12A  depicts a perspective view of one embodiment of a handle body cutting tip having an elongated support structure; 
           [0031]      FIG. 12B  depicts the handle body cutting tip of  FIG. 12A  embedded in an injection-molded surgical instrument body; 
           [0032]      FIGS. 13A through 13E  depicts various exemplary tip configurations for either or both of the cutting tips of the various embodiments described herein; 
           [0033]      FIGS. 14A and 14B  depict an exemplary operation of the surgical instrument of  FIG. 1 ; 
           [0034]      FIGS. 15A and 15B  depict partial magnified views of the trigger body and upper slide  FIG. 14A ; 
           [0035]      FIG. 16A  depicts a side plan view of the trigger body of  FIG. 14A ; 
           [0036]      FIG. 17A  depicts a side plan view of one alternative embodiment of a trigger body with cam arrangement; 
           [0037]      FIG. 17B  depicts a side plan view of an upper slide body for use with the trigger body of  FIG. 17A ; 
           [0038]      FIG. 17C  depicts an assembled view of the trigger pivot head and slide body of  FIGS. 17A and 17B ; 
           [0039]      FIG. 17D  depicts a partial side plan view of an alternative embodiment of an upper slide body and handle body associated for use with the trigger body of  FIG. 6C ; and 
           [0040]      FIGS. 18A through 21B  depict views of various arrangements and designs for cutting tips. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0041]      FIGS. 1 and 2  depict a perspective and an exploded perspective view of one embodiment of a surgical instrument  10  that incorporates various features of the present invention. The surgical instrument  10  includes a trigger body  20  and handle body  40 . The trigger body  20  includes a trigger body spring  30  and a trigger pivot head  35 . The handle body  40  includes a handle body spring  50 , a central slot  55 , a first handle body pivot hole  90  and a second handle body pivot hole  95 . 
         [0042]    A pivot screw body  60  and associated pivot nut  70  are provided that extend through a trigger pivot hole  80  and a handle body pivot hole  90 , securing the trigger and handle together while allowing the trigger body  20  to rotate relative to the handle  40 . The handle  40  further including a handle slide body  100  with a handle body cutting tip  110  (otherwise referred to as a footplate or anvil) formed at a distal end thereof. An upper slide body  120  of the surgical instrument  10  includes an upper slide actuator slot  180  (see  FIG. 2 ) extending into the upper slide body  120 , with an upper slide cutting tip  130  formed at a distal end of the upper slide body  120 . 
         [0043]      FIG. 2  highlights the upper slide body  120  which further includes an upper slide tee feature  140  which slides into a corresponding handle body tee feature  150 . The upper slide body  120  also includes a distal tee pin  160  which slides into a corresponding handle body distal cutting tip slot  170 . 
         [0044]    To assemble one exemplary embodiment of the surgical instrument  10 , the trigger pivot head  35  can be slid through the central slot  55  of the handle body  40 , with the pivot screw body  60  and pivot nut  70  extending into the first and second handle body pivot holes  90 ,  95  and through the trigger pivot hole  80 . The upper slide body  120  is positioned adjacent the handle slide body  100 , with the trigger pivot head  35  extending into the upper slide actuator slot  180  and the upper slide tee feature  140  sliding into the handle body tee feature  150  and the distal tee pin  160  and enlarged tee head  162  (see  FIG. 6 ) sliding into the handle body distal cutting tip slot  170 . The distal male end  185  of the trigger body spring  20  can then be inserted into a female slot  190  formed in the handle body spring  50 . 
         [0045]    Once the surgical instrument  10  is assembled, closing and/or squeezing of the trigger body  20  towards the handle body  40  will desirably induce the upper slide body  120  to slide along the handle slide body  100 , with the upper slide cutting tip  130  approaching the handle body cutting tip  110 . With sufficient compression, the cutting tips  130  and  110  will desirably meet, slide and/or “scissor” past each other (depending upon their relative size, shape and positioning), and thereby cut, sever and/or otherwise “bite” tissue and/or bone there between. 
         [0046]    Once a desired cutting operation has been accomplished, releasing or lessening pressure on the trigger body  20  and handle body  40  will desirably permit the trigger body spring  20  and handle body spring  50  arrangement to flex and rotate the trigger body  20  relative to the handle body  40  away from the handle body  40 , pulling and sliding the upper slide body  120  relative to the handle slide body  100  and displacing the upper slide cutting tip  130  away from the handle body cutting tip  110  in a known manner. 
         [0047]      FIGS. 3 and 4  depict partial perspective views of a distal tip of the surgical instrument  10  from opposing angles, showing a handle body cutting tip  110 , the upper slide cutting tip  130  and a distal tee pin  160 . Desirably, as the handle (not shown) is actuated, the handle slide body  100  and upper slide body  120  will move relative to each other, bringing the handle body cutting tip  110  and upper slide cutting tip  130  towards each other and meeting in a known fashion to grasp, pinch, cut and/or sever a target material there between. 
         [0048]    In one alternative embodiment, the handle body cutting tip  110  could optionally include a bore, channel or through-hole feature  112  where a wire, a guide wire, a hypotube, laparoscopic surgical graspers with loops or any standard diameter instrument that is commercially available in the operating room may be positioned or placed. The guide wire or grasper may be inserted from the back of the handle slide body  100  (not shown) and the upper slide body  120  (not shown) and align with the through-hole  112  should the surgeon require more precise placement of the tip of the surgical instrument embodiment or where manipulation of a body organ, tissue or bone prior to cutting is desired and/or required. 
         [0049]    In various alternative embodiments, such as various exemplary embodiments shown in  FIG. 5 , the cutting tips  110  and  130  can comprise knife-edge (i.e., sharp) surfaces  140 , or one or both surfaces can be relatively blunt or flat  141 . Various other arrangements can include a tip surface having a projecting portion or “beak”  142  that can advantageously secure and/or pierce tissue intended to be cut. In other embodiments, one or more of the cutting tips can be serrated  143  or formed in a variety of shapes for differing surgical objectives. In one embodiment, it may be desirable to manufacture the cutting tips may  110  and  130  by metal injection molding. The tips may return to the manufacturer for further processing, such as sharpening the edges, shaping the edges, beveling the edges or add other features prior to assembling into the handle body cutting tip  110  and/or the upper slide cutting tip  130 . Alternatively, the metal tips may be overmolded into the handle body cutting tip  110  and/or the upper slide cutting tip  130 , and the manufacturer may decide to perform additional processing on the metal cutting tips prior to assembling the surgical instrument. In various alternative embodiments, one or more tips that are blunt, rounded, comprised of flexible materials and/or other arrangements can be provided, where desired 
         [0050]    In various embodiments, the cutting surfaces may meet and contact at their respective sharp or blunt edges, or the surfaces may be sized and positioned such that one surface will ride over or past the other surface, inducing a sliding or scissoring effect by the surfaces that can be employed to create a desired cutting or severing action. In various alternative embodiments, the cutting surfaces may meet and contact at their respective sharp or blunt edges to grasp tissue, or any other target material intended there between. Alternatively, the edge may be curved in such a way that as the tips come together and contact at the top and as more pressure is applied, the handle slide body  100  (see  FIG. 2  or  FIG. 4 ) may be designed to flex downward, to have the cutting edges roll or slide across each other causing a slicing and or scissor action. Where the handle slide body  100  is formed of a sufficiently flexible material, such as a polymer, this flexibility can facilitate the flexing downward motion and subsequent rolling and/or sliding of the cutting edges relative to each other. In a desired embodiment, this can result in a deflection of the handle body cutting tip (or deflection of the handle body which reorients the cutting tip) such that the cutting tip  110  and the cutting tip  130  are no longer parallel, and thus the contact point propagates along the cutting tips, thereby creating a slicing or scissoring action. 
         [0051]      FIG. 6  depicts a partial perspective view of the surgical instrument  10  and upper slide cutting tip  130 , with a portion  185  of the handle slide body  100  in shadow. This view depicts how the distal tee pin  160  can slide within a track, groove or slot  170  formed within the handle slide body  100 , which slidably secures the upper slide body  120  to the handle slide body  100  in a known fashion. 
         [0052]      FIG. 6A  depicts a perspective view of the upper slide cutting tip  130  of  FIG. 6  and associated handle body cutting tip  110  prior to assembly. 
         [0053]      FIG. 6B  depicts a vertical cross-sectional view of the handle body cutting tip  110 , L-shaped body  225  and handle body cutting tip support structure  200 . This view highlights the slot  170  formed within the L-shaped body  225 . The slot  170  includes a proximal opening  183  which is desirably sized to accommodate the enlarged head  162  of the distal tee pin  160  (see  FIG. 6A ). The slot  170  depicted in this embodiment may be designed to a specified length to allow for cutting, pinching, scissoring cut tips  110  and  130  to meet each opposing surface or to cross-over each opposing surface. However, other embodiments may vary the lengths and shapes the slot  170  for adjustability of the opposing cutting surfaces (i.e. they do not have to meet or cross-over) which could include the provision of opposing tip surfaces that, in a closed position, remain separated by a desired spacing. Such an arrangement could be particularly useful for use in handling and/or manipulating fragile tissue structure such as blood vessels, where excessive compression and/or crushing of the anatomy between the jaws of the instrument might be extremely undesirable. 
         [0054]      FIG. 6C  depicts a vertical cross-sectional view of one alternative embodiment of a handle body cutting tip  1106 , L-shaped body  225 B and handle body cutting tip support structure  200 B, showing the slot  170 B formed within the L-shaped body  225 B. The track  170 B includes a proximal opening  183 B which is desirably sized to accommodate the enlarged head  162  of the distal tee pin  160 . In this embodiment, the slot includes a ramped section that progressively drops in the handle slide body  100 B as it travels from the proximal opening  183 B towards the cutting tip  1106 , which desirably deflects the slide body cutting tip (not shown) in a desired manner towards the L-shaped body and, in various embodiments, causes the cutting tip to follow a non-linear, angled, curved, arctuate and/or otherwise complex path (depending upon the chosen ramp geometry) relative to the corresponding surface of the handle body cutting tip. In various embodiments, this may induce a downward slicing action which can significantly improve the ability of the tool to cut dense and/or fibrous tissues. The upper slide body  120 D (see  FIG. 17D ) may also be designed to have a spaced region  400  between the slide body  120 D and handle body  100 D which allows a portion of the upper slide body  120 D to flex as the slot pulls the cutting tip down. 
         [0055]      FIG. 6D  depicts a top plan view of one another alternative embodiment of a handle body cutting tip  110 C, L-shaped body  225 C and handle body cutting tip support structure  200 C, showing opposing slots  170 C with a central ridge  181 C that narrows in width as it extends from the proximal openings  183 C to the cutting tip  110 C. This embodiment may be particularly useful in conjunction with the upper slide cutting tip  130 A of  FIGS. 9A through 9E , in first and second tip portions  131 A and  132 A may flex relative to each other. In this embodiment, as the slide cutting tip travels towards the handle body cutting tip, the reduced width of the central ridge  181 C can permit the first and second tip portions to flex towards each other, which may allow the edges of the cutting tips to assume a desired orientation relative to the handle body cutting tip  110 C as well as potentially induce a “clipping” or scissoring action in addition to the slicing and/or compressing forces on the targeted anatomy. 
         [0056]      FIG. 7  depicts a partial perspective view of the surgical instrument  10  and upper slide cutting tip  130 , with portions  183  and  184  of the upper slide body  120  and the handle slide body  100  in shadow. In this view, various features of the internal design of the upper slide cutting tip support structure  190  and the handle body cutting tip support structure  200  can be seen. The upper slide cutting tip support structure  190  includes an elongated central support body  210  connected to the upper slide cutting tip  130 , with one or more openings or voids  220  formed in the support body  210 . The voids  220  desirably reduce the amount of material to manufacture the support structure  190 , increase the strength of the support structure, and also desirably facilitate securement of the support structure to the upper slide body  120 . In one exemplary embodiment, the upper slide body  120  can be formed by overmolding a plastic material over the elongated central support body  210 , with plastic material desirably extending through the various voids and interdigitating with the support body  210 , thereby creating a unitary upper slide body  120  and upper slide cutting tip  130 . 
         [0057]    It should be understood that the overmolding material could include a variety of biomedical and/or biocompatible materials, including materials that exhibit superior properties for their intended use such as high performance polyethylenes, low friction polymers, flexible materials or hybrids of biomaterial combinations. In various embodiments, it would be desirable to employ the use of flowable materials known in the surgical arts, including plastics and polymers, latex, rubber, silicone, various ceramics and/or other known materials. In various embodiments described herein, the components of the instrument can primarily comprise a non-metallic material, with various features of either or both of the sliding and/or stationary components including some metallic, ceramic and/or other materials. 
         [0058]    The handle slide body can be formed in a similar fashion, with the handle body cutting tip  110  including an L-shaped body  225  (see  FIG. 4 ) that can be formed integrally with a handle body cutting tip support structure  200 . The handle body cutting tip support structure  200  includes an elongated central support body  240  connected to the L-shaped body  225  of the handle body cutting tip, with one or more openings or voids  220  formed in the support body  240 . The voids  220  desirably reduce the amount of material to manufacture the support structure  200 , increase the strength of the support structure, and also desirably facilitate securement of the support structure to the handle body  100 . In one exemplary embodiment, the handle body  100  can be formed by overmolding a plastic material over the elongated central support body  240 , with plastic material desirably extending through the various voids and interdigitating with the support body  240 , thereby creating a unitary handle slide body  100  and handle body cutting tip  110 . 
         [0059]      FIG. 8  depicts a partial perspective view of the surgical instrument  10 , with various features of the handle body  40 , the upper slide body  120  and the trigger body  20  shown in phantom. In this view, the surgical instrument  10  has been assembled, with the trigger pivot head  35  slid through the central slot  55  of the handle body  40 , and the pivot screw body  60  and pivot nut (not shown) extending into and through the handle body pivot holes (not shown) and through the trigger pivot hole (not shown). The upper slide body  120  is positioned adjacent the handle slide body  100 , with the trigger pivot head  35  extending into the upper slide actuator slot  180  and the upper slide tee feature  140  sliding into the handle body tee feature  150 . 
         [0060]    Once assembled in this manner, closing and/or squeezing of the trigger body  20  towards the handle body  40  will desirably induce the upper slide body  120  to slide along the handle slide body  100 , with the upper slide cutting tip and handle body cutting tip (not shown) approaching and contacting or sliding past one another. As previously noted, with sufficient compression, the cutting tips will desirably meet and/or “scissor” past each other (depending upon their relative size, shape and positioning), and thereby cut, sever and/or otherwise “bite” tissue and/or bone between there between. 
         [0061]      FIGS. 9A through 9C  depict various views of one alternative embodiment of an upper slide cutting tip support structure  190 A. This support structure  190 A includes an elongated central support body  210 A connected to the upper slide cutting tip  130 A, with one or more openings or voids  220 A formed in the support body  210 A. The voids  220 A desirably reduce the amount of material to manufacture the support structure  190 A, increase the strength of the support structure, and also desirably facilitate securement of the support structure to the upper slide body  120 A. A central slot  135 A can be seen extending through the upper slide cutting tip  130 A and support body  210 A, which desirably reduces the amount of metal incorporated into the upper slide as well as facilitates additional interdigitation and flow of the overmolded plastic around the support structure  190 A. In addition, the cutting tip  130 A includes a pair of guiding tabs  137 A that slide into a pair of slots  226 A (see  FIG. 10A ) In one exemplary embodiment, the upper slide body  120 A can be formed by overmolding a plastic material over the elongated central support body  210 A, with plastic material desirably extending through the various voids and interdigitating with the support body  210 A, thereby creating a unitary upper slide body and upper slide cutting tip. 
         [0062]    In various alternative embodiments, reinforcing materials or “strips” could be included to stiffen and/or strengthen the various tool components described herein. For example, the handle body could include one or more longitudinally extending strips or fibers that bind with and extend through the flowable material, in a manner similar to reinforcement using cement re-bar or composite materials. Other embodiments could include reinforcing metallic strips or features, such as strips of metal over various portions of the handle (i.e., a strip of metal over the bottom heel of the handle and extending to and past the pivot location) which can be positioned outside the flowable material, positioned adjacent to the flowable material (i.e., on the surface) or that can be overmolded during the injection molding process. 
         [0063]      FIG. 9D  shows a partial side plan view of the cutting tip  130 A and support structure  190 A, with  FIG. 9E  depicting a cross-sectional view of the tip  130 A taken along plane  9 E- 9 E of  FIG. 9D . In the exemplary embodiment, the cutting tip  130 A includes the central slot  135 A and also includes a centrally-positioned dumbbell-shaped void  138 A. In one embodiment, the dumbbell shaped slot  138 A (see  FIG. 9E ) may be designed to accept and capture any “I” beam shaped part (not shown) that can be sized to keep or maintain the guiding tabs  137 A (see  FIG. 9C ) on the lower track, desirably prevent movement, and/or may allow the cutting tip  130 A to translate toward each other until it contacts the handle body cutting tip  110 A (see  FIG. 10A ) to achieve a scissors action. 
         [0064]      FIG. 9F  depicts another alternative embodiment of a cutting tip  130 B and support structure  190 B formed entirely of a metallic, ceramic or sufficiently hard plastic material, which does not include an internal slot and void arrangement of  FIGS. 9A through 9C . 
         [0065]      FIGS. 10A through 10C  depict various views of one alternative embodiment of a handle body cutting tip  110 A, including an L-shaped body  225 A that is formed integrally with a handle body cutting tip support structure  200 A. The L-Shaped body includes a pair of slots  226 A, with each slot including a tab opening  227 A and an elongated retention tab  228 A that desirably accommodates and retains the corresponding guiding tabs  137 A of the upper slide cutting tip  130 A. 
         [0066]      FIGS. 11A and 11B  are views depicting the closing motion of the upper slide cutting tip  130 A and handle body cutting tip  110 A in an open configuration ( FIG. 11A ) and in a closing configuration ( FIG. 11B ). Desirably, the guiding tabs  137 A are retained within the slots  226 A and guide the motion of the slide cutting tip  130 A as it moves towards the body cutting tip  110 A. This arrangement desirably ensures good alignment of the cutting edges even when cutting hard or dense tissue (i.e., bone) as well as softer or fibrous tissues. 
         [0067]      FIG. 12A  depicts a perspective view of an alternative embodiment of a handle body cutting tip  1108 , which includes an elongated support member  250 B extending from the handle body cutting tip support structure  200 B. Desirably, the elongated support member  250 B provides additional stiffening and support to the handle body slide, and is desirably encased within the flowable plastic material during the injection molding process that can be employed to create the handle body. To facilitate interdigitation of the flowable material, the elongated support member  250 B may include opening or voids  255 B along its length, which can desirably reduce the amount of material used to create the member  250 B, potentially stiffen the member  250 B and/or the handle slide body (in a manner similar to concrete rebar), and allow for “flow-through” of the flowable material during the manufacturing process. To stabilize the support member  250 B within the mold during plastic injection, one or more horizontal tabs  260 B can be provided (with corresponding vertical tabs included alternatively or in addition, if desired).  FIG. 12B  depicts one view of a handle body including the embodiment of  FIG. 12A  embedded at least partially therein. 
         [0068]    In one alternative embodiment, the elongated support member  250 B could alternatively comprise a highly flexible metal strip or “string” with enlarged portions (i.e., beads) positioned along its length (not shown). A mold gate for injecting a flowable plastic material to create the handle body could be positioned proximate the cutting tip, allowing the flowable material entering the mold to flow along the string of beads and straighten the string as the molten plastic is injected into the mold. In another alternative embodiment, the elongated support member could comprise a metal track or guide along which the slide member (not shown) can travel during cutting and retraction actions, with the track at least partially embedded in the polymer (with track portions at least partially exposed) as previously described. 
         [0069]      FIGS. 13A through 13E  depicts various exemplary tip configurations that can be provided for one or more of the cutting tip described herein.  FIG. 13A  depicts a punch tip  300 A which can be used to perforate tissue. Alternatively, the punch tip  300 A can pierce and secure tissue for a variety of reasons, including for holding and manipulating the patient&#39;s anatomy, securing tissue for other operations (i.e., cutting with the same or another surgical tool) and/or to create a pathway or opening through a variety of tissue structures. In addition, the punch tip  300 A significantly reduces the cross-sectional area of the tip, which commensurately increases the contact and penetrating pressure that can be generated on tissue by the tool. 
         [0070]      FIG. 13B  depicts a modified punch tip or “hawks bill” tip  300 B, which is designed to pierce and cut tissue along an accurate plane. By angling the cutting surface, the hawk&#39;s bill tip  300 B provides for a significant sliding or slicing cutting action near the tip, which significantly increases the ability of the tool to cut harder and fibrous tissue. 
         [0071]      FIG. 13C  depicts a dual-action cutting tip  300 C having a pair of cutting edges. In various embodiments, the dual edges of the cutting tip can interact with corresponding dual cutting edges on the handle body cutting tip (not shown), or alternatively a flat or recessed handle body cutting tip. In one alternative embodiment, the handle body cutting tip can include a single edge that fits between the dual edges of the dual-action cutting tip  300 C, which significantly increases the cutting ability of the various cutting tip edges by combining a scissoring action with the cutting action of the sharp edge(s). This design could also be useful for trapping, compressing, smashing and/or cutting anatomical features for a variety of surgical reasons. 
         [0072]      FIG. 13D  depicts a modified punch or corrugated tip  300 D having a piercing portion  305 D and serrated or wavered edges  310 D. This tip  300 D can be particularly advantageous in obtaining biopsies or for cutting fibrous tissue requiring significant edge strength as compared to a standard knife edge tip. 
         [0073]      FIG. 13E  depicts a hawk&#39;s bill-type tip  300 E that includes a piercing tip  302 E, scalloped or thinned-edge sections  304 E and thicker edge-sections  310 E. The scalloped sections desirably reduce the profile of the cutting blade (and potentially decrease the profile and “sharpness” of the blade section) while the thicker edge sections strengthen and add stiffness to the cutting edge. This arrangement may be particularly useful for cutting of extremely hard tissues like cortical bone or other structures. In addition, the piercing tip  302 E can be especially useful for cutting of tissues having difficult, hard to reach profiles or that may be especially “slippery” for the tool to grasp. 
         [0074]      FIGS. 14A and 14B  depict an exemplary operation of the surgical instrument  10 , with the trigger body  20  being compressed relative to the handle body  40 , which induces the trigger body  20  to rotate relative to the handle body  40  around the pivot screw body  60  and associated pivot nut  70 , which pushes the trigger pivot head  35  (which extends through the central slot  55  of the handle body  40 ) into contact with an anterior wall of the upper slide actuator slot  180  and forcing the upper slide body  120  forward relative to the handle body  40  (see  FIG. 14B ). Continued compression of the trigger body  20  will desirably bring the cutting tips into contact or close proximity with each other to cut, sever or otherwise contact the targeted tissues or bone in a desirable manner. 
         [0075]      FIGS. 15A and 15B  depict partial magnified views of the trigger body  20  and upper slide body  120  of  FIGS. 14A and 14B , respectively. In an exemplary embodiment, the trigger pivot head  35  may designed to closely match the dimensions of the upper slide actuator slot  180  to prevent loosening during actuation, ease of assembly, and removal. In other embodiments, the trigger pivot head may have features that assist with connection to the upper slide actuator slot  180 , such as a hook (see  FIG. 17B ), to prevent unintended disassembly.  FIG. 16A  depicts a side plan view of the trigger body  20  of  FIGS. 14A and 14B . 
         [0076]      FIG. 17A  depicts a side plan view of one alternative embodiment of a trigger body  20 A which includes a cam arrangement that desirably causes the upper slide to move non-linearly during compression of the trigger body.  FIG. 17B  depicts a side plan view of an upper slide body  120 A for use with the modified trigger body  20 A of  FIG. 17A . In this embodiment, the trigger body  20 A includes a modified trigger pivot head  35 A which interacts with a cam  181 A positioned within the upper actuator slot  180 A of the upper slide  120 A. Depending upon the rotational position of the trigger pivot head  35 A and the cam  181 A, movement of the trigger body  20 A can cause greater or lesser resulting movement of the upper slide body  120 A relative to the handle (not shown).  FIG. 17C  depicts a partial view of the trigger pivot head  35 A and upper slide body  120 A. 
         [0077]      FIGS. 18A through 21B  depict views of various cutting tip arrangements and designs suitable for incorporation into the various embodiments described herein. For example, the embodiment of  FIGS. 18A and 18B  include corresponding edged cutting surfaces where the edges of the upper slide cutting tip  300 A are overlapped by the cutting surfaces at the edges of the handle body distal cutting tip  310 A. This embodiment also includes a central slot  315 A which desirably allows flexing of the sections of the upper slide cutting tip  300 A when they come into contact with the handle body distal tip  310 A.  FIGS. 19A and 19B  depict an embodiment of cutting tips similar to that of  FIGS. 18A and 18B , but without a central slot. 
         [0078]      FIGS. 20A through 20B  depict one embodiment of a cutting tip section having a modified flat or “anvil” type cutting arrangement. In this embodiment, the edges of the upper slide cutting tip  300 B are overlapped by the cutting surfaces of the handle body distal cutting tip  310 B. A flattened tip section or anvil  315 B (or  315 C) is also provided on the handle body distal cutting tip  310 B (or  310 C), which desirably interacts with the upper slide cutting tip  300 B (or  300 C) when the upper slide cutting tip  300 B (or  300 C) is sufficiently advanced. In use, a sharp edge  312 B of the upper slide cutting tip  300 B will desirably approach a corresponding edge  313 B of the handle body distal cutting tip  310 B, with targeted anatomy desirably positioned there between. As the sharp edge  312 B is further advanced, the anatomy will desirably be wedged between the sharp edge  312 B and the angled cutting surface  314 B. Further advancement of the sharp edge  312 B will desirably advance the edge to the flattened section or anvil  315 B. This action desirably provides a composite cutting action to the anatomy, which can comprise combinations of nipping, cutting, punching and slicing of the anatomical structures between the cutting tips.  FIGS. 21A and 21B  depict an embodiment of cutting tips similar to that of  FIGS. 20A and 20B , but with a central slot  320 B. 
         [0079]    If desired, various embodiments herein could include sensors or other features integrated into the various tool portions and/or overmolded therein. In various alternative embodiments, one or more wires or power supplies could be embedded or overmolded by flowable material, connected or otherwise linked to the metallic portions of the device (i.e., the cutting tips) and monopolar and/or bipolar energy provided there through to enable cauterization or other energy application to anatomical tissues by one or more of the metallic subcomponents. Because the operator&#39;s hand would be protected from such energy by the nonconductive nature of the flowable material (assuming the incorporation of such insulating material), no additional shielding would be required, unlike currently-available cautery instruments. In one embodiment, it may be advantageous to incorporate a through-hole or a bore in the upper slide body  130  and/or the handle slide body  100 , where the bore may be lined and/or filled with a material that allows conduction of electricity to the cutting tips (not shown). The back of the surgical instrument may be designed to accommodate a fixed or removable coupling that can be attached to the electrocautery machine (not shown). An independent electrical conductor may extend from the electrocautery machine to be removably connected to the surgical instrument coupling to potentially transmit electrical energy through the through-hole or bore to the cutting tips to cut tissue. Alternatively, the through-hole or the bore may be lined with some insulation tube to separate the surgical instrument from the conduction of electrical energy to prevent the electrical conduction to pass along the surgical instrument, the surgeon or to the patient. The electrical insulation tubing may comprise of any of the suitable low dielectric materials, such as PTFE, TFE, polyimide, silicone, and/or polypropylene. 
         [0080]    In other alternative embodiments, the instrument may include other actuating mechanisms to achieve linear motion. For example, the instrument may incorporate various other mechanical lead screw systems, cylinders with pistons powered by compressed air, hydraulic cylinders with pistons to provide large forces and quick strokes for hard tissue, cartilage or bone. Other embodiments may include other types of rotary motion to achieve linear motion, such as cam or rack and pinion designs. Also, various lead screws, roller screws, and ball bearing sliders may also be desirable. 
         [0081]    In at least one exemplary embodiment, a surgical instrument kit can be provided that includes a surgical instrument having a plurality of upper slide tips, with the upper slide tips including multiple copies of a given cutting tip design. Alternatively, a surgical instrument kit could include a surgical instrument having a plurality of upper slide tips, with the upper slide tips including differently shaped and/or sized cutting tips. The various slide tips of such kits could be replaced when the cutting tip became damaged and/or dulled, or if a different cutting and/or manipulating action were desired by the physician. If desired, the handle and/or actuating lever/mechanism of such surgical instruments could be formed of a durable material such as metal, while the upper slide could comprise a hybrid of a plastic body integrally formed with metallic cutting tips, such as those described herein. 
       INCORPORATION BY REFERENCE 
       [0082]    The entire disclosure of any publications, patent documents, and other references referred to herein is incorporated herein by reference in its entirety for all purposes to the same extent as if each individual source were individually denoted as being incorporated by reference. 
       EQUIVALENTS 
       [0083]    The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Various modifications to the embodiments described will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of the present invention as defined by the appended claims. The true scope of the invention is thus indicated by the descriptions contained herein, as well as all changes that come within the meaning and ranges of equivalency thereof, and the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclose herein.

Technology Category: 1